Dear FDA,

"FDA... Does that stand for Fuckin' Drug Administration?"

2011-04-28T09:56:00.000-07:00

Thank you, but I wouldn't like you to administer any more drugs to me. I'm fine, now... Thanks to a certain health supplement which you decried and banned the sale of.

". . .High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

. . .MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product."

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm220747.htm

Have I ever had nausea from taking MMS? Yes. Was it more severe than the nausea I experienced from "FDA-approved treatments." Actually, no. Most of the FDA-approved treatments I have tried--and they are more numerous than I will here state--make me extremely ill, including severe nausea, vomiting, stomach pain, burning of the skin, seizures, formication (that means feeling like there are bugs under your skin), akathisia (this is too unpleasant to describe), chronic endocrine problems requiring surgeries (which were then botched by "one of the best hospitals in the country"), and... the list goes on. And MMS generally makes me feel much better after I've stopped being nauseous. FDA-approved medications make me feel worse for several months or years after I stop taking them, while I am going through detox from addictive FDA-approved drugs, or have residual side effects that last for a very long time afterward. Sure, the drugs usually do what they claim to--to a degree--but it's generally not worth the HELL they put me through.

If the worst thing MMS causes is dehydration and nausea, GIMME A FEW MORE BOTTLES!

It has kept me out of the hospital on multiple occasions---thank God, because every time I go in there, they want to cut me up and put me on pills and IV antibiotics that make me see things and cause my skin to crawl and give me excruciating digestive problems. . . Well thank God for MMS, pro-biotics, and energy medicine, anyway. At least there's still HOPE in the world!!!

PLEASE WATCH THIS NICE MOOVIE WHICH I DID NOT MAKE

"I don't want people thinking I am a conspiracy theorist... because, in fact, there is no theory behind what I am telling you, it's all provable."

Dear FDA,

2010-02-26T04:09:00.001-08:00

"Adverse Reactions to Psychiatric Drugs

Use the following search tool to view a summary of adverse reactions experienced by patients taking psychiatric drugs, culled from Individual Safety Reports submitted to the FDA's Adverse Event Reporting System (MedWatch) between 2004 and 2008. (An extended report with a report by adverse reaction lookup feature can be found here.)

Atypical Antipsychotics		Reported By
Adverse Reaction	Cases	MD	CN	OT	PH	LW	NR
Suicidal Ideations	677	350	188	177	27	28	136
Attempted Suicides	759	607	79	160	40	25	110
Completed Suicides	774	540	68	263	87	10	93
Deaths Not From Suicide	5,649	3,113	835	1,560	536	788	1,614
Homicidal Ideations	63	36	15	28	1	4	15
Homicides	52	28	18	3	3	3	16
Hypomania/Mania	410	284	73	82	17	12	68
Heart Disease	1,652	1,138	253	361	163	143	256
Movement Disorders	4,910	2,546	940	1,370	407	114	566
Birth Defects	169	153	18	47	10	1	15
Premature Births	73	60	9	18	5	1	4
Prenatal/Neonatal Deaths	196	165	34	63	16	3	10

These are the Atypical Antipsychotic drugs that were reported to MedWatch as the Primary Suspect Drug (the drug suspected of causing or inducing the adverse reaction in the patient) in one or more Individual Safety Reports:

Abilify (aripiprazole), Aripiprazole (aripiprazole), Clozapine (clozapine), Clozaril (clozapine), FazaClo (clozapine), Geodon (ziprasidone), Invega (paliperidone), Leponex (clozapine), Olanzapine (olanzapine), Paliperidone (paliperidone), Quetiapine (quetiapine), Risperdal (risperidone), Risperidal (risperidone), Risperidona (risperidone), Risperidone (risperidone), Rispolept (risperidone), Seroquel (quetiapine), Seroquel XR (quetiapine), Zeldox (ziprasidone), Ziprasidone (ziprasidone), Zyprexa (olanzapine), Zyprexa Zydis (olanzapine)

Reported By is the occupation of the person who submitted the report: MD - Medical Doctor, CN - Consumer, OT - Other Healthcare Professional, PH - Pharmacist, LW - Lawyer, NR - Not Reported. The total Reported By will exceed the number of Cases (patients) if more than one report was submited for an Adverse Event; repeating Cases (same Case in multiple reports) are only counted once.

Deaths not from Suicide tallies the reported deaths of patients who did not commit suicide. This tally excludes any medication error deaths (accidental exposure, accidental overdose, incorrect dose administered, overdose, wrong drug administered, etc). This tally does not include Prenatal/Neonatal Deaths.

Heart Disease, when it occurred in a newborn, such as a Ventricular Septal Defect (a hole in the wall of the heart that separates the left and right lower chambers), is also tallied in the Birth Defects row.

Prenatal/Neonatal Deaths tallies the reported deaths of unborn or newborn babies where the adverse reaction to the drug was Abortion Spontaneous (miscarriage) or other drug-related abortions, Blighted Ovum (embryo never developed), Death Neonatal, Intra-Uterine Death, Stillbirth or Sudden Infant Death Syndrome."

Dear FDA,

2010-02-26T04:09:00.000-08:00

"Mercury exposure may increase susceptibility to diseases"

2010-02-06T07:29:00.000-08:00

"Mercury has often been implicated as the culprit for a variety of health issues, from being a possible source of developmental disorders like autism, due to the mercury preservative in vaccines, to being potentially toxic for tuna-ingesting sushi-lovers.

And though mercury poisoning often receives much of the publicity, it is a little known fact that mercury, in the form found in marine wildlife and in many workplaces, can cause severe autoimmune responses and even increase the body's susceptibility to infectious diseases.

"Research on mercury as an immunotoxic agent is relatively new, and these are the first studies to demonstrate effects on immune modulation in humans," said Ellen Silbergeld, the senior author of the study and a professor of Environmental Health Studies at Hopkins' Bloomberg School of Public Health.

When mice were exposed to inorganic mercury, the researchers found that it changed the pattern of cytokine release, which are compounds that function as signaling molecules in the immune system. Mercury exposure caused more pro-inflammatory cytokines and fewer anti-inflammatory cytokines to be released.

"There is evidence that mercury can increase risks of both autoimmune disease and certain infectious diseases," Silbergeld said. "These consequences may involve a set of fundamental mechanisms in which the proinflammatory response is not counterbalanced."

http://media.www.jhunewsletter.com/media/storage/paper932/news/2010/02/04/ScienceTech/Mercury.Exposure.May.Increase.Susceptibility.To.Diseases-3865948.shtml

WFMZ program

2010-01-17T12:20:00.000-08:00

"Monday January 18 live from 7:00-8:00 p.m. EST on the Philadelphia CNN-News affiliate WFMZ-TV and streaming online at WFMZ.com, The American Law Journal presents "Ask Your Doctor If 'x' is Right for You— Does Drug Advertising Help or Hurt the Consumer?" Philadelphia-based lawyers and a prominent pain physician address the legal, medical and social implications of direct to consumer drug advertising. Former New Jersey prosecutor Christopher Naughton, a legal commentator and 20-year legal broadcasting veteran, hosts the program."

http://www.prnewswire.com/news-releases/pharmaceutical-direct-to-consumer-advertising-on-the-american-law-journal-81915452.html

Well...

2010-01-09T13:39:00.000-08:00

Dear FDA,

I think I could tell you how I feel best in a song.

(You may have to go to youtube for optimal viewing)

"The Year in Medicine" now with commentary

2010-01-01T13:50:00.000-08:00

"The Obama effect and the Year in Medicine"

[ONE: ]

Lessons from a Pandemic:

. . . The H1N1 influenza pandemic turned out to be not as bad as some were expecting.

It's impossible to calculate the severity of the outbreak, because the vast majority of cases never come to the attention of public health officials. But using the best available evidence from the United States, researchers at Harvard's School of Public Health and the U.K.'s Medical Research Council, have come up with two estimates.

Under one set of data and assumptions, they concluded 1.44 per cent of people with H1N1 symptoms were hospitalized and 0.048 per cent died. Under another set, 0.16 per cent were hospitalized and 0.007 per cent died, according to their study published earlier this month in the online journal PLoS Medicine.

That works out to a potential range of 7,800 to 29,000 deaths in the United States from H1N1, compared to the annual flu, which kills 36,000 in that country.

. . . Does that mean public health officials over-reacted to the perceived threat? No, says Dr. Lipsitch. “It's a sign of good judgment in public health to prepare for something worse than actually happens, because you can't know until it happens how bad it's going to be. . .It's still bad. It's still putting people in hospital and it's killing more children than normal seasonal flu, So it's not harmless, but it's milder than other pandemics have been. . . "

http://www.theglobeandmail.com/life/new-year/the-obama-effect-and-the-year-in-medicine/article1415223/

Pandemic? Yep. There was totally reason to panic. Give me a break.

Now, just for kicks, let's see how many people are killed by prescription drugs annually.

"For the first time, law enforcement officials are saying that prescription drugs have passed illegal narcotics as the drug of choice among addicts. . . More than 7 million Americans are abusing prescription drugs - more than the number who are abusing cocaine, heroin, hallucinogens, Ecstasy, and inhalants combined, said Miller of North Wildwood, N.J. "Abuse is most prevalent among 18- to 25-year-olds," Miller said. "Prescription painkillers are now causing more drug overdose deaths than heroin and cocaine combined. They exceed the deaths from gunshot wounds."

http://readingeagle.com/article.aspx?id=181158

Hard to compare without cold numbers. Let's look at what's ACTUALLY killing enough people to be of public concern, according to statistics that float around on the web space:

"The Preventable Causes of Death in the United States: Comparative Risk Assessment of Dietary, Lifestyle, and Metabolic Risk Factors

. . .In 2005, tobacco smoking and high blood pressure were responsible for an estimated 467,000 and 395,000 deaths, accounting for about one in five or six deaths in US adults. Overweight–obesity (216,000) and physical inactivity (191,000) were each responsible for nearly 1 in 10 deaths. High dietary salt (102,000), low dietary omega-3 fatty acids (84,000), and high dietary trans fatty acids (82,000) were the dietary risks with the largest mortality effects. 90,000 deaths from other cardiovascular diseases, cancers, liver cirrhosis, pancreatitis, alcohol use disorders, road traffic and other injuries, and violence."

http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000058

In other words, physical inactivity kills five times as many people in the US as the regular flu, and about 20 times as many people as H1N1 "swine flu." Yet, the mass media would have you convinced that your health risks can be solved with vaccination. How come the news shows don't get excited about nutritional deficiencies and deaths caused by prescription drugs used as directed, which vastly outnumber flu deaths?

Speaking of which, let's verify some rough facts. The top five causes of death this year, from the New York Times 2009 Almanac:

629,191 people died from heart disease,
560000 from cancer,
137265 from stroke,
124614 from lower respiratory disease,
117748 from personal injuries/accidents

http://www.ritecode.com/aerobicgardening/topkill.html

And one more thing, directly from CDC.gov:

"From 1999 through 2006, the number of poisoning deaths nearly doubled from almost 20,000 to more than 37,000 In 2006, over 90% of poisoning deaths involved drugs.

Opioid analgesics were involved in almost 40% of all poisoning deaths in 2006, up from about 20% in 1999. The death records for about one-fifth of poisoning deaths each year indicated drug involvement, but did not specify the substance involved; an unknown proportion of these deaths involved opioid analgesics."

http://www.cdc.gov/nchs/data/databriefs/db22.htm

"The Obama effect and the year in Medicine"

[TWO]

Folic acid folly?

For more than a decade, food manufacturers in Canada and the United States have been required by law to add folic acid to bread, pasta, flour and other grain products. The fortification effort is meant to ensure that women receive adequate levels of folic acid in case they become pregnant. The B vitamin is critical in the early stages of fetal development. And, by all accounts, the mandatory program has been highly successful in reducing certain birth defects such as spina bifida, which has plunged by 50 per cent to about 110 cases a year in Canada.

However, other research has hinted that there might be a dark side to fortification – fuelling cancers in the general population. Two studies, published earlier this year, suggested folic acid supplements may boost the odds of getting prostate and colon cancers. Then, in November, yet another study showed an overall increase in cancer cases and deaths among Norwegians taking folic acid pills. Although these findings are worrisome, experts generally agree there's not enough evidence to justify pulling the plug on folic acid fortification."

[THREE]

Perplexing rise of celiac disease

Celiac disease was once considered to be a fairly rare disorder. But an increasing number of people are being stricken with the digestive ailment. And there is good reason to be concerned – it can lead to an early death. A study by researchers at the Mayo Clinic in Rochester, Minn., revealed the disease is 4.5 times more common today than it was about 50 years ago. “It now affects about one in 100 people,” said Joseph Murray, lead author of the study published in the journal Gastroenterology.

Celiac disease is an autoimmune disorder that damages the small intestine, interfering with the absorption of nutrients. It is triggered by gluten, a protein found in wheat, barley and rye. Dr. Murray says something must have changed in the environment to make the condition more common. He speculated that modern food production and processing could be to blame. But, he readily acknowledges, “it could be something entirely different. . .”

It could be, but let's face it. It's the food. I omitted part of the article about a "cure for MS" because it didn't seem very promising. Yes, you can put yourself through complex surgery in order to fix all the problems the body has developed, or you can simply change your lifestyle to accommodate the body's needs, i.e. stop eating industrial foods, which the human body never really learned how to deal with.

And check out the followg.

[FOUR]

Faux journals

Pharmaceutical companies will often use favourable studies and review articles published in peer-reviewed journals as part of their sale pitches to doctors. “See, look how well our drug works,” the drug reps will say as they hand physicians reprints of the seemingly objective reports. But what if there is a lack of published material? Or, more to the point, no articles with a positive spin?

Well, if you're especially audacious, it seems you just create a journal out of thin air. Pharmaceutical giant Merck paid an undisclosed sum to publishing firm Elsevier to produce several editions of what looked like peer-reviewed medical journals, The Scientist magazine revealed earlier this year. The pseudo-publications, part of a Merck marketing effort to raise the profile of the company's drugs among Australian physicians, came to light during court proceedings. One of the publications was titled The Australasian Journal of Bone and Joint Medicine and included glowing reviews of Merck's osteoporosis drug Fosamax and painkiller Vioxx, which has since been pulled from the market. This goes on a significant amount. The FDA sent me an email that stated I should rely on my doctor as my primary/sole supplier of medical information. Meanwhile, it's common knowledge that the information the doctors are receiving is incredibly skewed.

This goes on "a significant amount," yet the FDA is still telling consumers--as they told me specifically via email--that we should rely on our doctors as our primary/sole source of information about our medical care. So it is common knowledge that doctor's knowledge is molded insidiously by pharmaceutical interests, and the FDA is basically telling you that you should trust someone with your medical care who (unknowingly) is being fed false information about the dangers and advantages of the treatments you are receiving.

Yes, it is clear that the FDA is looking out for the consumer. That's why they spent their resources recalling "mislabeled juicy-juice" while approving medications for children that may lead half of recipients to have permanent movement disorders. We can't have juice in our children's hands, masquerading as a nutritional supplement or drug. We need to have real drugs in our kids hands. Drugs like the atypicals. Drugs that cause diabetes.

I was on low doses of the antipsychotics, and then of hormonal birth control, for under a year during my adult life, and now, months and months after stopping the drugs, and staying on a healthful diet, my body is essentially diabetic. I cannot eat sugar or starch. Eating any of either of those things is essentially debilitating.

Thanks, FDA. Thanks for protecting me from juicy juice. Because I can't drink it any more, now that the drugs have made my body incapable of processing its sugars.

I will not make further additions to this review of the year's medical happenings, as they are contained in the previous several posts.

"Old Friends Hypothesis"

2010-01-01T13:44:00.000-08:00

"As discussed in the previous article, David P. Strachan, in a 1989 paper that he published in the British Medical Journal, proposed an explanation for the lower incidence of allergy in younger siblings. He hypothesized that the exposure of the younger children to the germs that their older brothers and sisters had brought home had strengthened their immune systems, predisposing them to mount the type of immune response that eliminates foreign substances, rather than the type that causes allergies. Strachan’s proposal, which later became known as the Hygiene Hypothesis, is supported by the finding that allergies are less common among the children in farming families compared to those living in more urban areas. Further, children in families that keep household pets also have been observed to have fewer allergies. The rationalization for these observations is that the children in such families are exposed to animal germs early in life, building the ability to tolerate them. Thus, improvements in sanitation and hygiene increase susceptibility to allergies as germs from siblings, animals, and environment are eradicated, as well as the immune system’s tolerance to them.

An inverse relationship has also been observed between the incidence of allergies and autoimmune disorders and infection with parasitic worms. Indeed, in a 1976 letter to Lancet, John A. Turton reported obtaining relief from his severe hay fever by intentionally infecting himself with hookworm larvae. Research in pursuit of an explanation is continuing and clinical trials are being conducted to verify the therapeutic value of purposeful infection with parasitic worms. . .

Thus, a recent refinement of the Hygiene Hypothesis is the “Old Friends Hypothesis.” According to the latter, the presence of parasites and microbes that chronically infect us stimulates the regulatory cells which control and instruct the helper (Th1 and Th2) cells to not attack these “harmless” organisms even though they are foreign to our body. (The reader is referred to the earlier article on the Hygiene Hypothesis for a discussion of the action of helper and regulatory T cells.) These organisms are then able to grow and live inside us without eliciting an immune response. Examples of these organisms include the commensal (literally, eating together at the same table) microbes that reside in our guts (e.g., Lactobacilli), parasitic worms, and microorganisms that are found in soil, decaying matter, and untreated water (e.g., mycobacteria).

These parasitic organisms are “old friends” in that they have coexisted with us throughout our evolution. We have been in constant contact with them since way back when we were still swinging in trees and were eating freshly picked leaves and fruits and other unwashed and uncooked food. Interaction with these “old friends” through the ages undoubtedly helped shape our immune system in its present form. Living the real-life definition of “friends,” we depend on each other. Some of them help in our digestion, some produce substances that we need but which we do not produce ourselves, and some protect us from truly harmful microorganisms. They in turn need us for food and shelter. And now it seems that we need them also to regulate our immune system to prevent our getting allergies and autoimmune diseases."

http://www.philstar.com/Article.aspx?articleId=536903&publicationSubCategoryId=75

"FDA Approves Zyprexa Antipsychotic for Use in Teenagers"

2009-12-31T19:21:00.000-08:00

"Boston (DbTechNo) - The FDA (Food and Drug Administration) have just approved an antipsychotic drug made by Eli Lilly for use in Teenagers. Zyprexa is the name of the blockbuster drug which even before this approval was the best selling drug for the company. The drug has just been approved to treat teens diagnosed with schizophrenia and manic depression, despite the possible severe weight gain side effect. The drug has been approved in a lesser dose for teens than it is currently approved for in adults, and the label recommends that the drug be just part of a “total treatment program for teens with schizophrenia and bipolar I disorder.” Last year, sales of Zyprexa topped 4.7 billion dollars, a number that will skyrocket now that the drug has gained further approval."

http://www.dbtechno.com/health/2009/12/05/fda-approves-zyprexa-antipsychotic-for-use-in-teenagers/

New York Times Correction

2009-12-31T19:11:00.001-08:00

"FRONT PAGE

An article on Dec. 12 about a higher rate of antipsychotic drug prescriptions for children on Medicaid than for children whose parents have private insurance, using information from a Food and Drug Administration analyst, gave an incorrect estimate of the number of people in the United States under the age of 18 who use such drugs. An F.D.A. official who made the estimate of 300,000 at a public meeting on Dec. 8 subsequently said she intended for that the number to apply to one leading drug. There is no authoritative or official count of youths under 18 using antipsychotic drugs, but it is believed to be much higher than 300,000."

http://www.nytimes.com/2009/12/31/pageoneplus/corrections.html?_r=1

There is another way.

2009-12-30T10:02:00.000-08:00

1

I'm tired of our tax dollars going to fund wars and big companies.

The FDA is always complaining about "not having enough resources" to monitor the products it approves. Meanwhile, it's approving and reviewing new drugs left and right, often dangerous drugs. Time is wasted catering to special interests to get dangerous drugs approved and marketed to blockbuster status, and time is wasted reviewing drugs that don't pass. This, to me, is ridiculous. If the drug company has done all the research, there is no reason they should be rejected by the FDA. In other words, they are simply wasting the FDA's "limited resources," already knowing that the product they seek to bring to market is not safe.

In the case of the antipsychotics, the FDA and the drug companies already know they are not safe. Meanwhile they approve them for wider use, catering to the big companies and pretending that they are not making so many people sick.

2

An update about my Mirena experience, as posted on various corners of the internet:

I've had a whole slew of bad side effects from Mirena and various antipsychotics... constant panic attacks, night sweats, hot flashes, head aches mood swings, endocrine tumor, digestive, metabolic problems, et al. Years/months after the drugs have been stopped, I've finally started to get a little better, and I'd like to share the things that have been working.

If you're sick and can't figure out what the hell to do, I'd definitely try some of this stuff. I posted this originally as a reply and decided to repost it because it's worth a look. For a detailed account of where I started out a few months ago, see my blog post here http://curezone.com/forums/fm.asp?i=1523842#i and www.dearfda.blogspot.com.

First of all, don't let the doctor send you off to a psychiatrist for some antidepressant or any bullshit like that. It will probably only make matters worse. Your problem isn't a chemical deficiency, so adding more chemicals won't help in most cases. Besides, exercise and diet have been scientifically proven to work more effectively than psychiatric medications. Not to mention cannabis--a medicinal herb that is still unfortunately still illegal in most states--has a much more pleasing side effect profile than any behavioral medication on the market, and can sometimes treat the symptoms just as well. No, I'm not advising you to break the law. But it is legal in handful of states.

The one pharma I found helped with the panic attacks and headaches is Tramadol. Tramadol is a pain medication that also acts (as a side effect) on the adrenal system, which my doctors didn't know when they prescribed it to me, and still don't recognize, despite that I have told them that it relieves my panic attacks better than anything else. Taking a couple tramadols each day allowed me to start thinking clearly again...

That, and giving up sugar and starch.

Diet plays a BIG role.

I was eating healthy from the start, but I came to realize that even some healthy foods--like whole grains and soy--seem to cause my symptoms to worsen. The diet I am on now consists of fruit, vegetables, nuts, and fish. I found that once I started avoiding starch (grain, corn, potato, beans, peanuts, et al) sugar, and dairy, my body stopped aching so much, leading me to believe it's some kind of autoimmune reaction... that or it's the result of months of adrenal stress messing up the digestive system. Or maybe for me, its that I've become diabetic as a result of a slew of mirena and other drugs. Perhaps eliminating the same foods can help you, or perhaps there are other allergens in your diet whose elimination could help.

If you haven't seen a nutritionist, you should perhaps try it. Some of your symptoms are most likely a result of nutritional/metabolic problems that were brought on/worsened by Mirena. Get a metabolic panel and find out what supplements may help. I was D deficient, on top of all the other stuff. A homeopath is definitely the way to go... As we've all seen here, conventional medicine doesn't have much to tell us! I was losing weight and getting sicker and sicker for months, then started taking vitamins/digestive enzymes (natural ones; the conventional ones just upset the stomach. I started with "Intramin" which is liquid trace minerals (and that made me perk up a bit) and seeing some homeopaths, and I can almost live again...

I recently started taking a couple of herbs "chaste tree berry" to lower prolactin (my bloodwork & symptoms showed raised levels), and "adrenal support liquid phyto-caps." Have not been on them long enough to discern the difference. I was advised on this by a GYN/homeopath, and I have a pituitary tumor and blood work results as indications... I don't know that I'd advise taking these so much as trying to find a homeopathic counselor with whom you can consult, and also, getting the hormone levels tested.

DETOX! I've been getting an ion-cleanse footbath weekly, which some people will say is "supported by weak science," but hey, so is the entire conventional medical field, and anyway, I've found it to really work. I've been doing that, coupled with reflexology (http://ladiehlcrr.abmp.com/), craniosacral therapy (http://en.wikipedia.org/wiki/Craniosacral_therapy), massage, and NES (http://www.nutrienergetics.com/infoceuticals.html). They all work vastly better than all the shitty advice the doctors gave me... though yes, some of these things do seem sort of "far out." If you find the right people, they can really really work.... At least it has been so for me.

I occasionally follow up about mirena on my blog, though lately have been primarily focusing on antipsychotics: DearFDA.blogspot.com ... there's a lot f info scattered about there about autoimmune disease, diet, hormones, medications, et al.

If you haven't gotten an MRI yet, do that if things don't improve. I discovered by way of one that I have a pituitary tumor that is causing some of the problems. Of course, I am delaying surgery in order to see which of the symptoms work themselves out over time through the avoidance diet, vitamins, detox, et al.

I also get this skin-crawling feeling. If you have that, too, soaking in a bath with a couple cups of Epsom salt dissolved in it works pretty well.

I've been doing some light stretching/yoga every day to help ease the muscles. It definitely helps, if you stick to it... Just 5-15 minutes of stretching or yoga at morning/bed sometimes goes a long way... at least does for me.

The hell won't last forever...

3

An update about my health: The pituitary tumor seems to have been caused/worsened by both antipsychotics and hormonal contraceptive (Mirena IUD). I think I had a pre-existing sugar intolerance that was exacerbated by the drugs, which only made my blood sugar more unstable and all my symptoms worse. Now I can't eat sugar at all, or I get very ill. I've also noticed that the debilitating psychotic symptoms I used to experience so often have subsided upon cutting sugar out of my diet. I have also had to eliminate starch, because of another severe autoimmune reaction to starchy foods. In other words, the mainsteam diet was making my illness 10 times worse, and the drugs were making it 50x worse. I have cut all grain (esp corn), starch, sugar, dairy, artificial/processed ingredients out of my diet, and stuck to fresh veggies, nuts, fish, steamed or fried up in a little bit of olive oil. Diet makes an ENORMOUS difference. Two years ago I was strapped to my bed in a hospital. Now I am sicker than I have ever been in my life--from the drugs they gave me at the hospital that time and others--yet more sound of mind, and surviving, due to my diet. If I were eating a "normal" diet, I would probably be back in the hospital. I would probably be bed ridden with arthritic autoimmune disorder.

But I'm not.

Why?

Because I found out what really works, and it's not the mainstream medicine. It's homeopathy. I have my boyfriend to thank, in large part, for helping me realize that. He has effectively suppressed his own debilitating autoimmune disorder (AS) by following the same elimination diet I am following.

We are effectively treating very serious illnesses without the help of dangerous psychotropic drugs. Every time I go to my primary doctor, she tells me I should "see a psychiatrist," not understanding that my anxiety is not a result of psychic disquiet, but rather a result of adrenal imbalance (and general annoyance at the medical establishment). I generally explain to the doctor--not always calmly--that seeing a psychiatrist is what got me into this mess to begin with. All the drugs he gave me made me incredibly sick. Now, the anxiety, heart pounding, headaches, incapacitation, is caused by the sickness that is caused by the drugs, yet my doctors still sometimes tell me that I should be on more drugs. Sorry, guys, but I don't have a chemical deficiency, and I don't need chemicals. I have come to realize that eliminating certain problem foods from my diet has worked MUCH BETTER than any psych med I've taking, in treating psychosis, depression, et al. And then, when going drug free not enough, when the pain gets too bad, tramadol and cannabis can be used. They are both low impact remedies that can treat anxiety, psychosis, depression, nausea, chest cough... and the list goes on.

Though I do admit, select chemicals can be a lifesaver. But let me be clear: these chemicals are tried and true, researched remedies that are not under patent, and pharmaceuticals should always be a last resort, as most of the research available about FDA approved drugs is not reliable. "Blockbuster" drugs never actually do what they're supposed to. Rather, perhaps they do, but they often leave the patient with diabetes or neuropathic pain some other very unpleasant side effect.

I was smoking an unbelievable amount of cannabis when my psychosis and endocrine illness were at their worst. I was also going to school and making dean's list, while holding down two internships. Some days, I woke up and could barely get out of bed, for the severe pain in my body, neck, head, the skin crawling, heart racing... not to mention all the mental disquiet, depression, mixed moods, et al. But once I took cannabis, I could calm down and push through my day. Many days I would not have made it to class but for the help of that one controversial medication. Like I said, I made dean's list, even with the pot smoking, and the excessive absences for illness. Two years ago, I was withdrawing from all my classes and quitting my part time job because I had begun experiencing terrifying psychosis, and then terrifying drug side effects. At the time, I thought there was no other way. But this year, I was smoking cannabis to manage my illness (which had worsened) instead of taking antipsychotics--and I've been making dean's list.

You can look at me as the poster child for what's wrong with western medicine--

Or simply look at me as living proof that There is another way.

Ask your doctor about reality?

2009-12-29T21:02:00.001-08:00

Maybe this blogger is a little bit schizophrenic, but has anyone else noticed a pattern here? Let me be explicit: The FDA is approving drugs that treat the sicknesses caused by other drugs and foods that they have already deemed "safe." Let's go right on up the food chain here:

Sugar, grain, dairy, and other common allergens (all of which are difficult to avoid at the grocery store) cause severe mental and metabolic illness (diet is the root of most medical pathology in our society, even the serious stuff like schizophrenia and autoimmune disease). Psychiatric drugs are prescribed to treat the "mental illness," but these drugs--particularly antipsychotics--worsen the metabolic/dietary problems that caused the illness to begin with, and cause "extrapyramidal symptoms" (i.e. movement disorders) and sexual dysfunction in about half of people who use them. Currently, atypical antipsychotics' use is being expanded and re-patented left and right. The FDA recently began approving some of the most popular antipsychotics for pediatric use, while ignoring the growing database of information about the dangerous side effects, especially severe weight gain. The FDA also recently announced the expanded use of statins to treat heart disease in healthy individuals (?) who are judged to have increased cardiovascular risk based on a test measuring CRP (C-reactive protein), an inflammation marker, which supposedly can indicate cardiovascular risk. The same week, news came out stating that antipsychotics have been shown to increase patient levels of CRP, and cause various metabolic problems such as hyperglycemia, diabetes, and obesity. Meanwhile, the FDA approves a new drug for "the treatment of obesity." The statins, touted to lower cholesterol levels and therefore lower risk of heart attack, have been linked to cancer, nerve damage, stroke, and memory loss, and have not been proven to extend patients' lives. And then, once you've reached old age, sick and listless and diabetic and memory lost, the antipsychotics roll back around to "treat" the dementia--even though they've been shown to cause sudden death in the elderly.

...and that's not even half of it. Yes, this is really how the American medical system works.

In other words, a problem that could have been solved through elimination of certain foods and addition of certain nutritional supplements is turned into a life long metabolic/neurological illness by the "treatment" handed out--ehem, sold--by the mainstream medical system.

My advice?

Proceed with caution!

...or die quickly.

New drug for treatment of obesity

2009-12-29T15:41:00.000-08:00

"VIVUS Submits Qnexa(R) New Drug Application to the FDA for the Treatment of Obesity

MOUNTAIN VIEW, Calif., Dec. 29 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity."

http://www.prnewswire.com/news-releases/vivus-submits-qnexar-new-drug-application-to-the-fda-for-the-treatment-of-obesity-80258207.html

"Cardiovascular Devices Often Approved by FDA Without High-Quality Studies"

2009-12-29T10:33:00.000-08:00

"Pre-market approval by the FDA of cardiovascular devices is often based on studies that lack adequate strength or may have been prone to bias, according to a new study. The researchers found that of nearly 80 high-risk devices, the majority received approval based on data from a single study. Cardiovascular devices are increasing in number and usage. "In 2008, at least 350,000 pacemakers, 140,000 implantable cardioverter-defibrillators, and 1,230,000 stents were implanted. Although there has been recent scrutiny of evidence used in the U.S. Food and Drug Administration (FDA) drug approval process, less attention has been paid to the approval process for medical devices," the authors write. They add that the study data on which FDA approval is based should be of high quality. . .

Sanket S. Dhruva, M.D., of the University of California, San Francisco, and colleagues analyzed the type and quality of study evidence used by the FDA for the premarket approval (PMA) of cardiovascular devices. These types of devices were included in the study because it was expected they would undergo the most stringent approval process, given their increasing usage and potential impact on illness and risk of death. The authors conducted a systematic review of 123 summaries of safety and effectiveness data (SSEDs) for 78 PMAs for high-risk cardiovascular devices that received PMA between January 2000 and December 2007, examining the methodological characteristics and primary end points. SSEDs are intended to present a reasoned, objective, and balanced critique of the scientific evidence which served as the basis of the decision to approve or deny the PMA. . . One hundred thirteen discrepancies (93 percent) were that more patients were enrolled than analyzed. They add that the discrepancies between the number of enrolled patients and the number analyzed for primary end points may introduce bias because patients with less favorable outcomes may be lost to follow-up and safety concerns may underlie this missing data. . .

"The emphasis at the FDA in the last 17 years since the Prescription Drug User Fee Act has been rapid approval of new drugs. This study suggests that the emphasis for the FDA in 2009 and beyond must be approvals based on research that meets rigorous scientific standards for evidence of benefit and lack of harm to patients. To uphold the FDA's mission of ensuring 'safe and effective' medical devices, it is essential that high-quality studies and data are available."

http://www.sciencedaily.com/releases/2009/12/091229164936.htm

SATIETY [pediatric antipsychotic] study

2009-12-29T10:32:00.000-08:00

"A study of the adverse effects of 4 second-generation antipsychotics in children and adolescents documented substantial weight gain during 11 weeks of treatment with each agent, with the increased abdominal fat that has been associated with development of metabolic syndrome in adults. Metabolic abnormalities emerged with 3 of the 4 agents, differing in type and severity with the agent and, in some cases, with the dose.

In this analysis from the Second-Generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth (SATIETY) study, 10% to 36% of 272 patients between 4 and 19 years of age (mean, 13.9 years) who had not previously received antipsychotic medication became overweight or obese. There was minimal weight change in a comparison group of patients who had refused the agent, or who discontinued it within 4 weeks.

Christoph Correll, MD, Zucker Hillside Hospital, Glen Oaks, NY, and colleagues conducted this observational cohort study as the largest to date of adverse experiences with second-generation antipsychotics in antipsychotic treatment–naive children. The researchers noted that there has been increasing use of these agents in younger patients for psychotic and bipolar disorders as well as nonpsychotic disorders, despite little available age-specific data on adverse reactions.

“Cardiometabolic adverse effects, such as age-inappropriate weight gain, obesity, hypertension, and lipid and glucose abnormalities are particularly problematic during development,” Correll and colleagues indicate, “because they predict adult obesity, the metabolic syndrome, cardiovascular morbidity, and malignancy.”

In an editorial accompanying the study in JAMA, Christopher Varley, MD, and Jon McClellan, MD, Seattle Children’s Hospital, added: “The development of clinically significant hyperlipidemias and insulin resistance after only 12 weeks of treatment portends severe long-term metabolic and cardiovascular sequelae. These results challenge the widespread use of atypical antipsychotic medications in youth. . .

. . .This study was published in October, as the FDA continued to consider recommendations from the June meeting of the Psychopharmacologic Drugs Advisory Committee to approve olanzapine, quetiapine, and ziprasidone (Geodon) for indications in children and adolescents, for which—as of this writing—only risperidone and aripiprazole are approved. Although the advisory panel voted to recommend approval of the drugs for treating young patients, a report in JAMA notes that the votes were split over issues of safety.3"

http://www.psychiatrictimes.com/display/article/10168/1504753?verify=0

Dear FDA, I guess I'm not the only one who's been trying to tell you this for months...

"Pressure rises to stop antibiotics in agriculture"

2009-12-28T21:10:00.000-08:00

"...more and more Americans -- many of them living far from barns and pastures -- are at risk from the widespread practice of feeding livestock antibiotics. These animals grow faster, but they can also develop drug-resistant infections that are passed on to people. The issue is now gaining attention because of interest from a new White House administration and a flurry of new research tying antibiotic use in animals to drug resistance in people.

Researchers say the overuse of antibiotics in humans and animals has led to a plague of drug-resistant infections that killed more than 65,000 people in the U.S. last year -- more than prostate and breast cancer combined. And in a nation that used about 35 million pounds of antibiotics last year, 70 percent of the drugs -- 28 million pounds -- went to pigs, chickens and cows. Worldwide, it's 50 percent.

"This is a living breathing problem, it's the big bad wolf and it's knocking at our door," said Dr. Vance Fowler, an infectious disease specialist at Duke University. "It's here. It's arrived."

The rise in the use of antibiotics is part of a growing problem of soaring drug resistance worldwide, The Associated Press found in a six-month look at the issue. As a result, killer diseases like malaria, tuberculosis and staph are resurging in new and more deadly forms.

In response, the pressure against the use of antibiotics in agriculture is rising. The World Health Organization concluded this year that surging antibiotic resistance is one of the leading threats to human health, and the White House last month said the problem is "urgent."

"If we're not careful with antibiotics and the programs to administer them, we're going to be in a post antibiotic era," said Dr. Thomas Frieden, who was tapped to lead the Centers for Disease Control and Prevention this year.

Also this year, the three federal agencies tasked with protecting public health -- the Food and Drug Administration, CDC and U.S. Department of Agriculture -- declared drug-resistant diseases stemming from antibiotic use in animals a "serious emerging concern." And FDA deputy commissioner Dr. Joshua Sharfstein told Congress this summer that farmers need to stop feeding antibiotics to healthy farm animals.

Farm groups and pharmaceutical companies argue that drugs keep animals healthy and meat costs low, and have defeated a series of proposed limits on their use . . .

. . . The FDA says without new laws its options are limited. The agency approved antibiotic use in animals in 1951, before concerns about drug resistance were recognized. The only way to withdraw that approval is through a drug-by-drug process that can take years of study, review and comment.

In 1977 the agency proposed a ban on penicillin and tetracycline in animal feed, but it was defeated after criticism from interest groups.

There has been one ban: In 2000, for the first time, the FDA ordered the poultry medication Baytril off the market. Five years later, after a series of failed appeals, poultry farmers stopped using the drug.

In 2008 the FDA issued its second limit on an antibiotic used in cows, pigs and chickens, citing "the importance of cephalosporin drugs for treating disease in humans." But the Bush Administration -- in an FDA note in the federal register -- reversed that decision five days before it was going to take effect after receiving several hundred letters from drug companies and farm animal trade groups.

Laura Rogers, who directs the Pew Charitable Trusts Campaign on Human Health and Industrial Farming in Washington D.C., says the federal government, from Congress to the administration, has failed to protect the public.

"Because of poor regulations and oversight of drug use in industrial farm animals, consumers in the U.S. do not know what their food is treated with, or how often," she said. "Nor is there a system in place to test meat for dangerous antibiotic resistant bacteria."

. . . says a Missourian farmer: "I don't know why it took me that long to wake up to the fact that what we were doing, it was not the right thing to do and that there were alternatives," says Kremer, stooping to scratch a pig behind the ear. "We were just basically killing ourselves and society by doing this."

http://www.businessweek.com/ap/financialnews/D9CSGMM80.htm

How convoluted.

Schizophrenia & Diet

2009-12-28T11:18:00.000-08:00

"It is well known that diet affects a person's physical health and can lead to conditions such as diabetes and coronary heart disease. But can your diet affect your mental health as well? An article in the British Journal of Psychiatry suggests that it does. In order to asses international differences in the outcome of schizophrenia, the article reviewed evidence from the International Pilot Study of Schizophrenia (World Health Organization, 1979) and the Determinants of Outcome of Severe Mental Disorders study (Jablensky et al, 1992). Outcome was rated by the number of days spent in hospital and general social impairment. Dietary information correlating to the years of the studies was taken from the Food and Agricultural Organization database of apparent national food consumption. All of this data was then compared by statistical analysis.

The most consistent correlation found in this study, was that increased consumption of refined sugar results in an overall worse outcome for schizophrenia, as measured by both the number of days spent in the hospital and poor social functioning. This association was found in both databases used. Weaker correlations between increased intake and worsened outcome were found for alcohol, meat, and eggs. One study found that consumption of dairy products resulted in fewer days in the hospital but poorer overall outcome. A weak association was also found between consumption of pulses (pod-bearing plants like peas and beans) and improved outcome."

http://www.schizophrenia.com/sznews/archives/002546.html

Environmental factors play role in Lupus

2009-12-28T11:08:00.000-08:00

"MONDAY, Dec. 28 (HealthDay News) -- Cellular changes caused by environmental factors such as diet and chemical exposure may play a role in the autoimmune disease lupus, a new study suggests. . . "Our study suggests that the effect of the environment or differences in lifestyle may leave a molecular mark in key genes for immune function that contributes to the differential onset of [lupus] in twins," senior author Dr. Esteban Ballestar said in a news release."

http://health.msn.com/health-topics/articlepage.aspx?cp-documentid=100251762

Gardasil may cause seizures

2009-12-27T19:27:00.000-08:00

"On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. In the new label, information pertaining to syncope (fainting) is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. The addition of syncope to the Warnings and Precautions section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries. . . This minor change has taken the drug giants three whole years to put into place, although fainting was included in the small print in 2007. Merck have stated that these seizures are not epileptic in nature, however, even they have to admit that a faint followed by tonic-clonic movement and seizure like activity, which ever way they dress it up, is really saying in the broad sense, a child could have a 'Grand Mal Seizure' after having a Gardasil vaccination. Many girls have gone on to be diagnosed as epileptic after having Gardasil vaccines . . ."

http://www.americanchronicle.com/articles/view/105999

Re: Expanding antipsychotic use

2009-12-27T13:54:00.000-08:00

The drug information pamphlets are in no way complete, and you must know that as well as I do, as there have been studies done on long term antipsychotic users whose results have yet to see the light of day. According to the National Institute of Mental Health's CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness), which was published in 2005 to measure the efficacy of old antipsychotics to newer ones:

"In recent years clinical psychopharmacology research has been dominated by the pharmaceutical industry. While industry-sponsored research is critical to new product development, its emphasis is on meeting regulatory and marketing requirements and on obtaining expanded marketing claims for the drug. not on evaluating the effectiveness of the product at the general population level. As a result, industry-sponsored research does not address broad public health needs or the needs of individual practitioners seeking to make good clinical decisions for individual patients. Research within a broad public-health perspective is needed, addressing the needs of patients in general, in which exclusion criteria are minimal, outcomes are construed broadly, a wide range of treatment settings are included, and sample sizes are large enough to assure adequate power."

(from CATIE's information page for healthcare providers: http://www.catie.unc.edu/schizophrenia/about.html)

I am having immense difficulty tracking down information about instance of side effects in the study. The vague generalizations I have so far read about the study's results essentially said the new drugs are no more effective than the old one, and have similar side effect profiles, if not worse... so why is it that my doctor, and many others, seem to believe they work so much better? This study was published years ago. According to a bit of news I read today, the study linked Seroquel and other antipsychotics to quite serious metabolic side effects. I am baffled that there is has been so little information released about antipsychotics, and so untimely... Meanwhile, the FDA is only expanding the use of such dangerous drugs to groups such as the childhood population.

No, a generic response about "prescribing information" is not sufficient; I have read all the information I have found, and I know it is not all the information available. I would very much appreciate a response that answers my fundamental question, i.e.

Where is the consumer friendly information about the complete side effects of antipsychotics' long term use, as studied in the past decade, especially in the W-SOHO and CATIE?

I'm sure I am not the only citizen wondering such things. These drugs seem to be making more people sick all the time.

Thanks.

- -

**************************************

On Thu, Dec 24, 2009 at 1:21 PM, CDER DRUG INFO wrote:
Dear - -,

Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

The drug labeling, or package insert, that accompanies drug products, is the most complete single source of information on the drug. Labeling for most FDA approved drugs may often be found at the following websites:

DRUGS @ FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Daily Med: http://dailymed.nlm.nih.gov/dailymed/about.cfm

The labeling is also available from your local pharmacist and is also reprinted in the Physicians Desk Reference (PDR), which can be found in many libraries. In addition, it may be available on many manufacturers' websites.

We also have a website for these drugs,

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm

You can request additional information, including adverse event reports submitted to the FDA, under the Freedom of Information Act (FOIA).

http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm

Best Regards,

BD
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

Excerpt: Roger MacDougall's "My Fight Against Multiple Sclerosis"

2009-12-27T13:04:00.000-08:00

"This is the story of my fight against Multiple Sclerosis. What follows is based upon my own experiences and the conclusions I have drawn from them. It should be clearly understood that I am not a doctor and have no medical training. My theories are controversial, though a growing number of individual doctors have now reached similar conclusions.

As a layman expressing views not accepted by the medical profession in general, I obviously come in for much criticism from that quarter. My aims are very simple. I suffered down to a state of terminal disability and am now enjoying a healthier life than I can remember. I would be inhuman if I did not use that unusual experience to give what advice I can to those still suffering. Here are the facts:

I was diagnosed 30 years ago at the National Hospital for Nervous Diseases in Queen Square, London, in February 1953. At that time, my specialist was recognized as one of the world's leading neurologists and Queen Square as one of the most celebrated neurological centres.

Within a few years I was unable to use my legs, eyes, and fingers ... even my voice was affected, and I was quite unable to stand erect, even for a few seconds.

Many years later when I was living in Hollywood I was given a thorough neurological examination - encephalograph, radioactive brain scanning, and lumbar puncture. Evidence of scar tissue damage was found in the brain and a sample of my spinal fluid was sent for analysis to a New York Laboratory. It came back marked as a specimen for someone suffering from Multiple Sclerosis.

Today, my eyesight is restored, I can run up and down stairs and can lead a life as active as most men my age. In support of these statements I will refer later to a medical examination I was given in September 1975 by a leading neurologist. No miracle has been performed. I have not been cured. I am simply experiencing a remission - but A REMISSION WHICH I FIRMLY BELIEVE TO BE SELF- INDUCED.

While accepting that each person's body has a different metabolism, I think it is not unreasonable to assume that the benefit I obtained by following certain principles, may be applicable to others.

I would be totally dishonest, however, if I claimed that the regime I described in my previous booklet helped everyone who followed it. It appears to have helped me and many others. It is equally true to say that some people who have followed my recommendations have not in fact improved. I formerly thought they had not followed my recommendations to the letter for a sufficient length of time or had not perhaps had the same determination to succeed as I had.

But recent advances in the study of food allergies have disclosed a more likely explanation. The truth would seem to be that just as DIFFERENT PEOPLE HAVE DIFFERENT METABOLIC PROCESSES THEY HAVE DIFFERENT ALLERGIES AND ALSO DIFFERENT DEGREES OF REACTION TO VARIOUS ALLERGENS. THUS, THE DIET WHICH HELPED ME IS NOT NECESSARILY THE EXACT DIET CALLED FOR IN ALL OTHER CASES.

It is now possible to have one's allergies identified by a simple test. I had this done recently and the result provides further evidence in support of my contention. My most severe allergic reactions according to the test were to those foods I had removed from my diet all those years ago indicating that I had controlled my condition because I had removed gluten, milk fat and other animal fats and sugar from my diet.

So why did I take that action at a time when I knew nothing of allergies? The answer to that question, it seems to me, is of the utmost importance because it may really be the answer to another question - what did I believe was the cause of my multiple sclerosis?

It is important to understand what an allergen is. A food to which we are allergic (called an allergen) is a food which is not accepted by our autoimmune system. Instead of harmonising in our metabolic processes it attacks and even destroys the white blood cells whose function it is to stand guard against invasion by unwelcome intruders like viruses and germs. That is why it is so important to our health to remove them from the diet.

I was now considering my body as a biochemical process, or, more accurately, as a biochemical process going wrong. As I had not heard of allergy tests I had to find some other way of pinpointing the errors in my diet.

It seemed logical to stick to those foods which had been consumed by man since the very beginning. I BASED MY DIET ON THE FOOD CONSUMED BY THE HUNTER-GATHERER, BEFORE MANKIND SETTLED DOWN IN AGRICULTURAL COMMUNITIES, GREW CEREALS AND TENDED CATTLE.

It was this reasoning which led me to cut out gluten (a protein which surrounds the germ in grains), cow's milk and sugar. These are not foods from whose consumption we have evolved and I believe that fact is in some way connected with our rejection of them. Not enough is known yet but the close connection between diet and illness becomes more and more obvious. When I removed my three principle allergens, I stopped deteriorating and eventually began to make slow but nonetheless steady improvement.

The conclusion I draw from this is that foods which are alien to our species or to which we are allergic, and which attack the autoimmune system (our natural defenses) somehow contrive to prevent the manufacture of healthy replacement cell tissue and so become causative factors in the whole range of degenerative diseases up to and including aging."

http://web.archive.org/web/20041103093349/http://www.direct-ms.org/roger.html

Allergies cause everything from autoimmune illness to schizophrenia. Nutrition has been proven, in many cases, to work vastly better than pharmaceuticals. This is one example.

Cardiovascular mortality & inflammation linked to antipsychotics

2009-12-27T11:08:00.000-08:00

"Washington, DC: A new study of antipsychotics, including Seroquel, notes that the medications are reasonably effective and well-tolerated treatments for mood and psychotic disorders, but they do have a dark side—side effects that cause diabetes and hyperglycemia, among other adverse reactions.

The most recent issue of Biological Psychiatry addresses metabolic side effects and how they may contribute to the risk for diabetes, hypertension and other medical disorders associated with heart disease. Given the higher cardiovascular mortality among the severely mentally ill compared to the general population, it's a serious concern.

Researchers used data from the multi-center CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) study, funded by the National Institute of Mental Health. Researcher Jonathan Meyer and colleagues examined the impact of multiple antipsychotic therapies on changes in systemic inflammation.

According to the December 20 issue of Cardiovascular Device Liability Week, their findings provide evidence that antipsychotic medications like AstraZeneca's Seroquel increase the levels of inflammation markers.

"This analysis provides the most compelling evidence to date that differences in antipsychotic metabolic liability are also seen with markers of systemic inflammation," explained Dr. Meyer. "It also provides an impetus for monitoring cardiovascular risk markers in antipsychotic treated patients," he said.

The markers implicated include C-reactive protein, E-selectin and intercellular adhesion molecular-1 (ICAM-1). Increased levels of C-reactive protein in particular are associated with increased risk for the development or progression of heart disease and stroke."

http://www.lawyersandsettlements.com/articles/13337/seroquel-side-effects-diabetes-5.html

Dear FDA,
I hope you're not suggesting Seroquel patients go on statins. Also, this study came out in 2005, and I still haven't found a good report on the results, i.e. a report on the side effects of antipsychotics, which is what the study was about...

Letters: Expanding Use of Antipsychotics

2009-12-23T05:11:00.000-08:00

TO: CDER

It seems like there has been a lot of expanded use of atypical
antipsychotics lately. I find this quite disturbing... especially the
incidence of prescribing the drugs to children, and the rampant
over-prescription of antipsychotics to children on Medicaid. I noticed
that Lilly's Zyprexa is among the drugs whose use is being expanded. I
find it peculiar that, according to information I formerly received
via this email channel, the FDA did not review Lilly's
"Worldwide-Schizophrenia Outpatient Health Outcomes" study published
this year:

"The W-SOHO database comprises 17,384 patients from six regions; East
Asia (n = 1223), Central and Eastern Europe (n = 2175), Northern
Europe (n = 4291), Southern Europe (n = 5788), Latin America (n =
2566), North Africa and the Middle East (n = 1341). Overall, patients
were 38 ± 13 years old (mean ± SD), moderately ill (mean CGI-SCH
overall score of 4.4 ± 1.0) with a median duration of illness of 7
years (interquartile range 1–16 years); 43% were female, 10% were
receiving antipsychotic medication for the first time. Adverse events
were prevalent across all regions; on average, 50% (range 41–59%) of
patients taking antipsychotics exhibited extrapyramidal symptoms at
baseline, and 62% (34–67%) of patients reported sexual dysfunction in
the previous month. On average, only 19% (16–23%) of patients were in
paid employment and as many as 69% were living in dependent housing."

If I am interpreting that excerpt correctly, it seems that
antipsychotics aren't especially successful in treating schizophrenia,
and offer a wide array of unpleasant side effects. It seems peculiar
to me that the incidence of movement disorders and sexual dysfunction
among the population of "moderately ill" schizophrenics on these drugs
is greater than the incidence of employment and independent living.

I am once again requesting information about this study--and/or others
about the side effects of atypical antipsychotics--in a form that a
lay person can understand. I am especially interested in the incidence
of endocrine disorders, including hyperprolactinemia and pituitary
tumor, as reported by these studies, or the FDA's own side effect
report collecting system. Naturally, I believe that this information
should be available to not only myself but the general public,
especially considering the expanding market for antipsychotic drugs.

Please do not tell me that I should "talk to my doctor" about these
things or some nonsense. First of all, that is a contradiction of the
justification for direct to consumer advertising, secondly, the doctor
is receiving most of his information from a pharmaceutical marketer
just as myself and the rest of the public is, and third, I've already
asked my doctor about these things, and he doesn't seem to have any
more information than I do. There is more and more information coming
out about these drugs all the time, and a lot of it is in technical
language and not included on the drug labeling... which is, itself,
often confusing.

All I want is a little bit of information--information that should be
openly available to the public... I'm tired of jumping through hoops
for that.

Thanks.

"Pot Use doesn't exacerbate symptoms of schizophrenia, study says"

2009-12-23T03:05:00.000-08:00

". . . Britain's Advisory Council on the Misuse of Drugs (ACMD) concluded in 2006, "For individuals, the current evidence suggests, at worst, that using cannabis increases lifetime risk of developing schizophrenia by one percent."

A separate 2006 report by Britain’s Beckley Foundation speculated that cannabis may "precipitate schizophrenia in people who are already vulnerable" to the disease, but it also acknowledged that the "increased rates of cannabis use in the last thirty years have not been accompanied by a corresponding increase in the rate of psychosis in the population."

NORML Advisory Board Member Mitch Earleywine, author of the book Understanding Marijuana: A New Look at the Scientific Evidence (Oxford University Press), said: "Schizophrenia is a rare and heterogenous disorder that requires both biological and environmental contributors. I hope this latest work helps to counter the idea that there exists a distinct psychotic disorder related to cannabis as well as other equally simplistic, and often inaccurate, notions regarding the use of cannabis and mental illness."

A study co-authored by Earleywine and published in the journal Psychiatry Research in 2005 reported that cannabis use typically follows rather than precedes behavior suggestive of schizophrenia. "These findings do not support a causal link between cannabis use and schizotypal traits," the study concluded."

http://norml.org/index.cfm?Group_ID=7253

"Low Omega 3 linked to schizophrenia risk"

2009-12-23T02:57:00.000-08:00

"The researchers suggest low omega-3 may be linked to the information-processing problems found in people with afflictions of the nervous system including schizophrenia and bipolar, obsessive-compulsive, attention-deficit hyperactivity disorders.

The researchers looked at nervous system function in the offspring of four groups of pregnant mice that had been fed different diets with no or varying types and amounts of omega-3s. Only the mice raised on the two omega-3 fatty acids showed normal, adaptive sensorimotor nervous responses that did not result in the animals being perpetually startled and easily overwhelmed by sensory stimuli."

http://www.upi.com/Health_News/2009/12/18/Low-omega-3-linked-to-schizophrenia-risk/UPI-14731261118188/

WSJ Health Blog: "GE Sues a Doctor for Libel"

2009-12-23T02:49:00.000-08:00

". . .[Dr. Henrik Thomsen] described a cluster of cases at his hospital in Copenhagen where kidney patients who received Omniscan developed a rare disorder called nephrogenic systemic fibrosis. One of the patients died.

GE Healthcare told the Times that the presentation was defamatory because it accused the company of suppressing information and marketing the drug when it was aware of possible problems, according to the article. Thomsen told the Times: “I believe that the lawsuit is an attempt to silence me.”

European regulators recently said Omniscan and similar drugs, which enhance images in MRI scans, shouldn’t be given to patients with severe kidney problems; an FDA advisory committee recently recommended a similar policy in this country, Dow Jones Newswires reported earlier this month."

http://blogs.wsj.com/health/2009/12/21/ge-sues-a-doctor-for-libel/

NYT Opinion: "The 76 Million Food Victims"

2009-12-23T02:42:00.000-08:00

"According to the Centers for Disease Control and Prevention, 76 million cases of food-related illnesses are reported every year, with over 300,000 hospitalizations and 5,000 deaths. Under the registration system, food producers are supposed to tell the F.D.A. exactly how to get in touch with them when there is trouble. The system failed badly during last year’s salmonella outbreak that sickened 1,400 people and sent 286 to the hospital.

It took the F.D.A. two months to finally trace the source. Tomatoes were suspected at first, but then, as the sickness spread, investigators traced the original problem to spicy peppers from Mexico. These delays not only put more consumers at risk but also devastated the season for much of the tomato industry.

Congress is not yet ready to design a whole new system for tracing food contaminants. But the Senate bill would provide an important first step by setting up pilot programs to improve the agency’s ability to track toxins quickly to any source. It would provide new powers for the F.D.A., which has been understaffed and given too little authority to prevent food-borne illnesses, and it would finally give the agency the power to order a mandatory recall of a food product if there was a reasonable probability of causing “serious adverse health consequences or death.”

http://www.nytimes.com/2009/12/21/opinion/21mon2.html?_r=1

"Obama seeks drug imports outside of healthcare bill"

2009-12-23T02:15:00.000-08:00

"The pharmaceutical industry's powerful Washington lobbying group backs the healthcare reform legislation that is President Barack Obama's top legislative priority, but its important support for that effort could evaporate if drug imports are included.

White House adviser David Axelrod said the administration will pursue the issue, but not in the healthcare reform bill.

"Let me be clear. The president supports ... safe re-importation of drugs into this country," Axelrod told CNN's "State of the Union" program. "There's no reason why Americans should pay a premium for the pharmaceuticals that people in other countries pay less for."

The importation of drugs from other countries has been proposed for years as a way to lower prescription drug costs in the United States. The same prescription drugs sold in the United States often are sold at much lower prices in other countries, including Canada.

Both Obama and Republican rival John McCain supported drug imports during last year's presidential campaign. But the Obama administration recently issued a letter from the Food and Drug Administration citing safety concerns.

"The president is committed to moving forward once we resolve the issues that the FDA has. That's his responsibility, to protect the American people," Axelrod said.

The Senate on December 15 rejected two amendments to the healthcare bill to allow drug re-importation.

Allowing these cheaper drugs to be sold to Americans could cut revenues for the roughly $315 billion pharmaceutical industry, which strongly opposes the idea.

The Pharmaceutical Research and Manufacturers of America, a key White House ally in the healthcare reform push, has lobbied heavily against importation, and likely would not support a final healthcare bill if it was included.

In a letter sent to Republican Senator Sam Brownback on December 8, the FDA said it saw "significant safety concerns" with a drug re-importation amendment proposed in the Senate.

The FDA said overseeing the proposed drug imports would be "logistically challenging" and "resource intensive."

http://www.reuters.com/article/idUSTRE5BF0DW20091220

Dangerous precedent?

2009-12-19T09:24:00.000-08:00

"WASHINGTON -- An FDA advisory panel has overwhelmingly recommended that rosuvastatin (Crestor) be approved for patients with no history of heart disease as long as they have elevated levels of the inflammatory marker C-reactive protein. If the FDA follows the panel's recommendation, rosuvastatin would be the first statin approved for primary prevention of heart disease. . . The new indication would be for men 50 or older and women 60 or older who have fasting LDL of less than 130 mg/dL, a highly sensitive CRP of 2.0 mg/L or greater, triglycerides of less than 500 mg/dL, and no prior history of heart attack or stroke, or coronary heart disease risk. The committee's vote was immediately seized upon by cardiologists who characterized it using terms ranging from "great news" to "courageous."

"If the FDA accepts this recommendation, it will expand the number of Americans eligible for statin therapy by millions," said Steven E. Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic. James Stein, MD, of the University of Wisconsin School of Medicine and Public Health, called the vote "very significant," adding that, if approved, "it will also have the (possibly) unintended consequence of increasing highly sensitive CRP testing in the U.S." Cam Patterson, MD, of the University of North Carolina School of Medicine, agreed with Stein. "It's been difficult to find a compelling reason to order CRP levels on patients," Patterson said. "This is some guidance from the FDA about how to take high CRP levels into account, and that is good news." Patterson also predicted that clinicians will see this as a signal to use other statins for this population as well. . .

Noting that the panel's vote was a "somewhat courageous decision," Rubenfire said the "issue now is how the FDA, physicians, and insurers approach the results. That is, 'Are all statins the same?' The robustness of the results are unique to rosuvastatin."

And there were some risks associated with rosuvastatin, including 13 deaths due to gastrointestinal disorders in the rosuvastatin arm, and 18 patients reported a "confused state" while taking the drug. The most troubling adverse event, however, was an uptick in investigator-reported, new onset diabetes mellitus in the treatment arm, 2.8% versus 2.5%, for a hazard ratio of 1.27 (95% CI 1.05 to 1.53, P=0.015).

http://www.medpagetoday.com/Cardiology/Atherosclerosis/17569

THE REAL STORY ABOUT CRP:

"A C-reactive protein (CRP) test is a blood test that measures the amount of a protein called C-reactive protein in your blood. C-reactive protein measures general levels of inflammation in your body. High levels of CRP are caused by infections and many long-term diseases. But a CRP test cannot show where the inflammation is located or what is causing it. Other tests are needed to find the cause and location of the inflammation.

A C-reactive protein (CRP) test is done to:
-Check for infection after surgery. CRP levels normally rise within 2 to 6 hours of surgery and then go down by the third day after surgery. If CRP levels stay elevated 3 days after surgery, an infection may be present.
-Identify and keep track of infections and diseases that cause inflammation, such as:
Cancer of the lymph nodes (lymphoma).
Diseases of the immune system, such as lupus.
Painful swelling of the blood vessels in the head and neck (giant cell arteritis).
Painful swelling of the tissues that line the joints (rheumatoid arthritis).
Swelling and bleeding of the intestines (inflammatory bowel disease).
Infection of a bone (osteomyelitis).
-Check to see how well treatment is working, such as treatment for cancer or for an infection. CRP levels go up quickly and then become normal quickly if you are responding to treatment measures."

http://www.webmd.com/a-to-z-guides/c-reactive-protein-crp

An elevated CRP level can indicate infection, serious autoimmune illness, and myriad other health conditions that statins cannot treat and may only exacerbate. Using an inflammatory marker as a prescribing criterion for statins is insidious, especially considering the growing (and widely unrecognized) autoimmune epidemic in America. Doctors are being misled by the FDA to treat inflammation with statins rather than examine the real cause for concern. This marketing is merely a distraction to the reality, which is that our food and our drugs are making us sick, and this sickness is making us inflamed, and we're trying to treat ourselves in quite counterproductive ways.

Drug money

2009-12-19T09:12:00.001-08:00

"The industry has pumped upwards of $130 million into federal elections over the past decade and is now among the top 10 donors, according to the Center for Responsive Politics. At the same time, the White House needed the industry to spend its millions of dollars in advertising money on support of the health-care legislation, not against it.

The drug-money addiction could explain why the administration struck a sweetheart deal with the industry, which offered to give up $80 billion in revenue in exchange for an understanding that the government would not push for deeper concessions. The White House was determined not to go back on the deal -- even though the industry had demonstrated bad faith by raising prescription prices nearly 10 percent this year. So when Sen. Byron Dorgan (D-N.D.) brought his reimportation proposal to the floor, the administration pushed back with a letter from Food and Drug Administration chief Margaret Hamburg warning of "significant safety concerns. . . "

These arguments don't hold up well, considering that 40 percent of the active ingredients in American prescription drugs come from India and China, and that the latter slipped tainted heparin past the FDA. But fright was about the best argument opponents could use to defeat a popular proposal that would save the federal government $19 billion over 10 years, according to the Congressional Budget Office. Consumers would save many times that.

That's why the drug industry has been fighting for a decade against congressional efforts to allow reimportation. Obama co-sponsored one such proposal in the Senate. He also said during his presidential campaign that he wanted to "let Medicare negotiate for lower prices" for drugs. White House Chief of Staff Rahm Emanuel, when he was in Congress, also championed reimportation. Yet now, after their successful battle against it, the two are expected to fight off a similar legislative effort to allow Medicare to negotiate for lower drug prices.

Even before the vote came, it had become clear that President Obama's aides had the votes to kill the proposal Senator Obama once co-sponsored. This, said Sen. John McCain (R-Ariz.), "contributes to the enormous cynicism on the part of the American people about the way we do business here." To Dorgan, he pledged: "I will be by his side as we go back and back and back again on this issue until justice and fairness is done and we defeat the special interests of the pharmaceutical industry which have taken over the White House and will take over this vote.""

http://www.washingtonpost.com/wp-dyn/content/article/2009/12/15/AR2009121504196.html?hpid=topnews

FDA approves "excessive sedation events"

2009-12-19T09:04:00.000-08:00

"A long-acting depot formulation of the antipsychotic drug olanzapine (Zyprexa) has been approved by the FDA, which had rejected the same product early last year.

The new version, to be marketed as Zyprexa RelPrevv, is given by intramuscular injection every two to four weeks, depending on the dose, and is now approved for treatment of schizophrenia in adults. Olanzapine was previously approved in oral and injectable forms for daily use.

In March of 2008, the FDA had rejected an earlier application from the drug's manufacturer, Eli Lilly, citing concerns about an unusual side effect now called post-injection delirium/sedation syndrome (PDSS). (See FDA Rejects Olanzapine (Zyprexa) Depot for Schizophrenia)

Patients experiencing PDSS have walked into walls and fallen asleep in public places after receiving injections, usually within the first hour or two. Other reported symptoms included agitation, anxiety, and confusion.

In February 2008, the FDA's advisory committee on psychiatric drugs recommended approval of the drug, despite PDSS, which then was called "excessive sedation events."

http://www.medpagetoday.com/ProductAlert/Prescriptions/17539

"New research backs FDA ban on flavored cigarettes"

2009-12-19T08:55:00.000-08:00

"WASHINGTON DC, Dec. 14, 2009—New research showing that thrill-seeking teenagers are especially susceptible to fruit-flavored cigarettes is in line with the recent ban on the sale of flavored cigarettes by the U.S. Food and Drug Administration (FDA) in September 2009. According to the FDA, the ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by the FDA to reduce smoking, which is the leading preventable cause of death in America."

http://www.eurekalert.org/pub_releases/2009-12/bc-nrb121409.php

1. Obesity is the leading cause of preventable death.

2. The FDA doesn't need to research things it has already banned, it needs to research the things it has approved / is approving.

"Diamyd Medical gets OK from FDA to test diabetes vaccine on small children"

2009-12-19T08:44:00.000-08:00

"Swedish biotech company Diamyd Medical AB (STO: DIAM B) said today that the US Food and Drug Administration (FDA) has approved the experimental use of the diabetes vaccine Diamyd in children as young as three years of age. . .

The trial also includes extensive immunological studies to clarify the mechanism of action of the Diamyd product and to evaluate the correlation between the clinical and immunological outcomes of the treatment with the vaccine in new onset type 1 diabetes patients."

http://www.tradingmarkets.com/.site/news/Stock%20News/2723560/

It's ironic that the FDA is more worried about approving diabetes "vaccines" rather than trying to tackle the real cause of diabetes which is the industrialized diet. (90% of diabetes in this country is type 2, which is caused by diet and entirely preventable).

"Drugmakers fight plan to allow drug reimportation"

2009-12-19T08:13:00.000-08:00

"Drugmakers intensified their lobbying push Monday against a popular proposal to allow Americans to buy cheaper drugs from other countries, one of several heated disputes that have bogged down negotiations over a heath-care reform bill. . . The dispute traps Obama between his campaign rhetoric and the political realities of health-care reform, which depends in large part on tacit support from drugmakers and other industry groups. Under the earlier agreement with the White House, the pharmaceutical industry agreed to contribute $80 billion toward reform over 10 years in exchange for protection from further cuts. . .

Carper said in a statement that he shares the FDA's concerns that "Senator Dorgan's amendment could potentially allow unsafe, counterfeited drugs into the United States, contaminating our drug supply. This is a complicated issue that affects people's lives. We should make sure that the FDA says it's safe before we reimport drugs from other countries. . ."

The Congressional Budget Office estimated the proposal would save the government $19 billion over the next 10 years, and Dorgan estimated that consumers would save $80 billion more. He pointed to vast price differences in drugs made in the same factories; an equivalent amount of the heartburn medication Nexium, for example, costs $36 in Spain and $424 in the United States, he said.

"The pharmaceutical industry wouldn't be able to impose these price increases because then you would have competition," Dorgan said on the Senate floor last week. "Freedom equals competition in my judgment here on this issue."

http://www.prnewswire.com/news-releases/fda-grants-emergency-use-authorization-for-dxnas-genestattm-integrated-pcr-based-influenza-detection-system-for-h1n1-virus-79210682.html

The "debate" over "health care reform" has nothing to do with health. It's about business, like everything else. This chance at health care reform has passed. The bill has been raped to the point that it's only going to benefit industry if it passes.

It's peculiar how the FDA does not exercise the same oversight over, say, the patent drugs currently out on the market that are already known to be dangerous. And is there an excess of counterfeit drugs in Canada and Europe that I don't know about?

"FDA Grants Emergency Use Authorization for DxNA's GeneSTAT(TM) Integrated PCR-based Influenza Detection System for H1N1 Virus"

2009-12-19T08:07:00.000-08:00

"ST. GEORGE, Utah, Dec. 14 /PRNewswire/ -- DxNA announced today that the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its 2009 H1N1 influenza virus diagnostic test for use in DxNA's GeneSTAT(TM) detection platform. The new platform enables fast detection of the 2009 H1N1 influenza virus with a portable device weighing less than 10 pounds. In the United States, an Emergency Use Authorization (EUA) is a legal means for the FDA to authorize new medical devices or drugs during a declared public health emergency."

http://www.prnewswire.com/news-releases/fda-grants-emergency-use-authorization-for-dxnas-genestattm-integrated-pcr-based-influenza-detection-system-for-h1n1-virus-79210682.html

Seeing as they've already stated that H1N1 is no more dangerous than the normal flu, I suppose the FDA can declare an "emergency" every winter in order to quickly patent some drug that will "reduce the impact" of the flu. Dear FDA, This is 1984.

New York Times - Letters

2009-12-16T02:40:00.000-08:00

Re “Poor Children Likelier to Get Antipsychotics” (front page, Dec. 12):

I am the mother of a teenage boy who received a diagnosis of attention deficit disorder and oppositional defiant disorder eight years ago and was prescribed antipsychotic medication. Throughout the years, we have visited no fewer than five psychiatrists and countless other therapists.

I would often question why my son was prescribed medications (at one point three at a time) that failed to do as they promised. For example, the ones that were designed to help him sleep at night did the reverse, and the ones to keep him awake made him lethargic.

I decided that it was in my son’s best interest to take a break from the weekly therapy and daily medication. Surprisingly, he functioned much better: His sleeping patterns and appetite improved. He is now back on medication, but with new therapists and with the parents’ considerations in mind.

Families like ours are often duped into believing that there aren’t options other than medication, or should we refuse to comply, charges of neglect could be brought.

Suzanne Joblonski
Ridgewood, N.Y., Dec. 14, 2009

•

To the Editor:

In discussing the “off label” use of antipsychotic medications to treat children with attention deficit hyperactivity disorder and other disruptive behavior disorders, the article did not mention that there are well-established, effective, evidence-based treatment protocols for children with these diagnoses.

These programs use cognitive behavioral interventions with children, and, of at least equal importance, provide parent training and coordination between family, school and treatment provider. These treatment models are often used in conjunction with medication, but may reduce or in some cases obviate the need for medication.

Effective use of these protocols requires coordination and follow-up with teachers and parents, much of which is not currently reimbursable either by private insurance or Medicaid.

Arlene Klingman
New York, Dec. 14, 2009

The writer is director of the Child and Family Clinic-Plus Program of the Riverdale Mental Health Association.

•

To the Editor:

As a practicing child psychiatrist for the last 22 years, I am not surprised that poorer children on Medicaid are prescribed antipsychotic drugs at four times the rate of middle-class children. Sadly, it is symptomatic of the general trend in psychiatry over the last 15 years to “medicalize” complex behavioral problems and label them with an overly simplistic medical diagnosis, like bipolar disorder, implying that the right medication will solve the problem.

In a Medicaid population, the temptation for overwhelmed doctors and understaffed clinics to succumb to a potentially quick fix with a readily available treatment is often too compellingly expedient. If only the simple act of writing a prescription could cure the emotional distress of children subjected to the social ills of poverty.

Richard Levine
Berkeley, Calif., Dec. 12, 2009

•

To the Editor:

We are parents of a 10-year-old son who is on Medicaid as a result of long-term disability. He has been prescribed antipsychotics for more than five years. We have tried numerous times to taper off the medication and instead focus on counseling with various therapists.

After a few sessions with these therapists, we have been told either that his disorder is not their specialty or that his situation is too complex. We have always felt — and the study behind this article lends credence to our suspicions — that the motivation for not offering long-term counseling was tied to the reimbursement offered by his insurance.

We are fearful that the heavy reliance on medication is leaving our son ill equipped to live independently when he becomes an adult. He and every other child deserve to be provided the treatment that offers them the best chance to be functioning members of society, and a pill is not always the answer.

Duncan Cameron
Aimee Gunn
Eau Claire, Wis., Dec. 12, 2009

•

To the Editor:

One of the reasons for the disparate use of medication has to do with the large cohort of poor children and adolescents in residential treatment centers, foster care, group homes and juvenile justice facilities. These institutions often do not or cannot provide the kind of mental health services that ultimately would help children face issues like profound rage and deep sadness that fuel behaviors that are often frightening and violent, but not necessarily psychotic.

Because these institutions focus on controlling behavior instead of the more time-consuming process of helping children identify and understand their feelings, they are given drugs that, in the long run, do more harm than good. This is not only a disservice to children who already face tremendous hurdles, but will also ultimately increase the costs borne by Medicaid when it becomes necessary to address the physical and psychological damage done by the use of these drugs.

Debra Kuppersmith
Dobbs Ferry, N.Y., Dec. 12, 2009

The writer is a psychoanalyst.

•

To the Editor:

Federal funding allocated to help treat and study psychiatric disorders pales in comparison to that for other medical conditions. Research on cancer, heart disease and infectious diseases receives three to four times the annual funding of the National Institute of Mental Health. Within that small pool, childhood psychiatric disorders are allocated an even smaller portion of funds.

Because of the limited funds, few children with psychiatric disorders are treated by doctors with advanced training in this area. Rather, they are often managed by family practitioners and pediatricians.

Can the same be said of children with cancer or heart disease? Doesn’t a child with a serious psychiatric disorder deserve to be seen by a doctor with specialized training just as children with cancer are? Sadly, the answer from our current system of distributing medical funds is a resounding no.

Jonathan E. Posner
New York, Dec. 13, 2009

New York Times: "Poor Children Likelier to Get Antipsychotics"

2009-12-13T20:06:00.000-08:00

"New federally financed drug research reveals a stark disparity: children covered by Medicaid are given powerful antipsychotic medicines at a rate four times higher than children whose parents have private insurance. And the Medicaid children are more likely to receive the drugs for less severe conditions than their middle-class counterparts, the data shows. . .

On Tuesday, a pediatric advisory committee to the Food and Drug Administration met to discuss the health risks for all children who take antipsychotics. The panel will consider recommending new label warnings for [antipsychotic] drugs, which are now used by an estimated 300,000 people under age 18 in this country, counting both Medicaid patients and those with private insurance. . .

Because there can be long waits to see the psychiatrists accepting Medicaid, it is often a pediatrician or family doctor who prescribes an antipsychotic to a Medicaid patient — whether because the parent wants it or the doctor believes there are few other options.

Some experts even say Medicaid may provide better care for children than many covered by private insurance because the drugs — which can cost $400 a month — are provided free to patients, and families do not have to worry about the co-payments and other insurance restrictions.

“Maybe Medicaid kids are getting better treatment,” said Dr. Gabrielle Carlson, a child psychiatrist and professor at the Stony Brook School of Medicine. “If it helps keep them in school, maybe it’s not so bad.”

In any case, as Congress works on health care legislation that could expand the nation’s Medicaid rolls by 15 million people — a 43 percent increase — the scope of the antipsychotics problem, and the expense, could grow in coming years.

Even though the drugs are typically cheaper than long-term therapy, [the drugs] are the single biggest drug expenditure for Medicaid, costing the program $7.9 billion in 2006, the most recent year for which the data is available.. .

The data indicated that more than 4 percent of patients ages 6 to 17 in Medicaid fee-for-service programs received antipsychotic drugs, compared with less than 1 percent of privately insured children and adolescents. More recent data through 2007 indicates that the disparity has remained, said Stephen Crystal, a Rutgers professor who led the study. Experts generally agree that some characteristics of the Medicaid population may contribute to psychological problems or psychiatric disorders. They include the stresses of poverty, single-parent homes, poorer schools, lack of access to preventive care and the fact that the Medicaid rolls include many adults who are themselves mentally ill.

As a result, studies have found that children in low-income families may have a higher rate of mental health problems — perhaps two to one — compared with children in better-off families. But that still does not explain the four-to-one disparity in prescribing antipsychotics. . .

“They say it’s impossible to stop now,” Evelyn Torres, 48, of the Bronx, said of her son’s use of antipsychotics since he received a diagnosis of bipolar disorder at age 3. Seven years later, the boy is now also afflicted with weight and heart problems. But Ms. Torres credits Medicaid for making the boy’s mental and physical conditions manageable. “They’re helping with everything,” she said."

http://www.nytimes.com/2009/12/12/health/12medicaid.html?_r=1

So, essentially, the government pays out money to pharma companies for medications that only make people sicker. Good job, America. Awesome.

"FDA Drug Safety Monitoring No Better 3 Years Following Vioxx Recall"

2009-12-10T23:34:00.000-08:00

"A new report by the Government Accountability Office (GAO) indicates that the FDA has made little progress in its oversight of post-market drug safety, despite federal recommendations made in 2006. The agency’s drug safety monitoring came under closer scrutiny in the wake of the 2004 recall of the pain medication, Vioxx.

The GAO report found that the FDA has failed to implement changes to better monitor the side effects of drugs after they have been put on the market. While the agency has begun to take steps in the direction of restructuring to address some concerns, the agency has no timeframe for meeting objectives. The GAO report also suggests there may be too much influence being given to scientists who approve new drugs for the market. . .

The FDA says that currently the OND [Office of New Drugs] has the more experienced staff, lending it to be the go-to office for drug safety decisions. The FDA has said that it intends to give more power to the OSE [Office of Surveillance and Epidemiology] once its staff has equivalent experience as those in OND. However, the GAO report says there is no indication of when that would actually happen or how. Currently, the new drugs office has 900 employees, compared to only 200 allocated to OSE."

http://www.aboutlawsuits.com/fda-drug-safety-monitoring-criticized-report-7267/

"Safety Concerns over Antipsychotic Medication Treatment"

2009-12-09T23:10:00.001-08:00

"There seems to be concern with a number of antipsychotic medications being associated with weight gain, and for some, hyperglycemia and hyperlipidemia.

In the most recent issue of Biological Psychiatry, researchers discuss a variety of metabolic side effects and how it may contribute to the risk for diabetes, hypertension, and other medical disorders associated with heart disease. This is of a very large concern because there is a high level of cardiovascular mortality among the mentally ill compared to the general population.

Researchers are fully aware that differences exist between antipsychotics in their effect on clinical measures associated with cardiovascular risk, specifically weight, lipids and glucose. Systemic inflammation has recently appeared as an important marker of cardiovascular risk, but the effects of antipsychotics on inflammatory markers in the blood have not been studied until now.

Using data from the multi-center CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) study, Jonathan Meyer and colleagues examined the impact of multiple antipsychotic therapies on changes in systemic inflammation. Their study has been funded by the National Institute of Mental Health,

In their recent findings, they discovered that antipsychotic medications, particularly olanzapine (Zyprexa®, Eli Lilly and Co.) and quetiapine (Seroquel®, AstraZeneca), increase the levels of inflammation markers. The markers implicated increased levels of C-reactive protein in particular are associated with increased risk for the development or progression of many illnesses including heart disease, and stroke."

http://www.emaxhealth.com/1357/94/34709/safety-concerns-over-antipsychotic-medication-treatment.html

"Reefer Madness and more"

2009-12-09T23:07:00.001-08:00

Watch these hippies:

http://www.salem-news.com/articles/december092009/medmjvid_pl_bk.php

Dear FDA,

2009-12-09T22:49:00.001-08:00

Concerning antipsychotics:

Is it not imprudent to prescribe these medications based on a subjective judgment of "sickness," when the chemicals themselves increase the patients' risk of very real medical illness and mortality?

I think it is extremely imprudent.

"Additives in the H1N1 vaccine?"

2009-12-09T22:43:00.000-08:00

" there’s been much talk about adding "adjuvants" to the vaccine to stretch out the available stock. Adjuvants are additives that amp up the body’s immune response to the vaccine, meaning you need less of the active ingredient, or antigen, to trigger immunity. The less antigen used per vaccine, the farther the vaccine supply can be stretched.

But in the US, adjuvants haven’t been approved for use in the H1N1 vaccine, much to the chagrin of public health advocates and drug companies. In fact, a group of drug companies just approached Congress asking for help pressuring federal agencies to push through the adjuvant "seal of approval." Even the World Health Organization wants adjuvants approved in the US — and most other countries have already gone to adjuvanted vaccines. "WHO encourages the use of adjuvanted vaccine because it will help to stretch the global supply," says Marie-Paule Kieny, director of the Initiative for Vaccine Research at the World Health Organization. "There doesn’t seem to be — in terms of safety — a difference."

The reason for the American holdout, according to the CDC, is that Americans fear adjuvants and would be reluctant to get a vaccine containing them. As Dr. Anne Schuchat, a spokesperson for the U.S. Centers for Disease Control and Prevention said, "If we really do want pregnant women to trust this vaccine or even parents, we have to think about what is acceptable to them." Her colleague, Jeff Levi of Trust for America’s Health, added, "We have so much vaccine hesitancy in this country."

The tone of these comments implies that the paranoid public is just that — paranoid. The word from the public health and pharmaceutical community seems to be that the adjuvanted vaccine is as harmless as a Nutcracker matinee, plus even more effective than regular vaccines. "Adjuvanted vaccines produce higher immune response than unadjuvanted vaccines particularly in the elderly and young children," says Dr. Vas Narasimhan, president of Novartis Vaccines USA, with an underlying assumption that’s automatically a good thing. But those fearing adjuvants don’t believe that such a "high immune response" necessarily is benign.

The adjuvant found most effective with the H1N1 vaccine is squalene, an oil-and-water mix. Animal tests with squalene have found that it can make the immune system overreact, causing autoimmune conditions such as rheumatoid arthritis, multiple sclerosis, and lupus. One study on guinea pigsinjected with squalene resulted in the deaths of all but one animal. (Well, that’s certainly encouraging!) A 2004 study at the University of Florida found that squalene-exposed mice developed autoimmune conditions.

But experts dismiss the animal tests, insisting that it’s perfectly safe for humans. Martin Friede of the Initiative for Vaccine Research at WHO, for instance, points to two studies involving over 30,000 people. "In both of these very large studies no adverse affects were detected," he said. "It’s a bit of a surprise to see how the public opinion is so opposed to adjuvants because the scientific evidence is that the adjuvants are very safe."

This might be reassuring, except that the scientific evidence Dr. Friede refers to comes from studies that were conducted by — guess who? Novartis Vaccines! Independent studies looking at the human response to squalene, however, have not been so favorable. In fact, reliable research links the additive to the outbreak of Gulf War Syndrome among soldiers who received the squalene-containing anthrax vaccine in preparation for service in Desert Storm. Anthony Principi, the former Secretary of Veterans Affairs, notes that soldiers who received the vaccine had a 200 percent increased risk of developing Lou Gehrig’s disease, as well as a host of autoimmune conditions. Since these conditions take years after exposure to develop, we won’t know the real effect of adjuvanted H1N1 vaccines for a long, long time."

http://www.healthiertalk.com/additives-h1n1-vaccine-1210

"FDA readies new data systems for drug safety"

2009-12-09T22:37:00.000-08:00

"The Food and Drug Administration will use two new data systems for tracking prescription drug safety in 2010 and is developing a third drug safety tracking system, known as Sentinel, according to a new report today from the Government Accountability Office.

The new systems are MedWatchPlus, which is designed to improve the collection and processing of reports filed with the FDA on adverse effects from drugs, and the FDA Adverse Event Reporting System (FAERS), which will receive the reports and stores them in a single location, the report states."

http://fcw.com/articles/2009/12/09/fda-setting-up-new-data-systems-for-drug-safety.aspx

"Genocide for Freedom"

2009-12-09T22:35:00.001-08:00

(It was America's slogan from the start, it just hasn't caught on yet.)

Poem by Kelley Cosgrove:

Greetings citizens of earth,

I am the American super-messiah, here to show you

how democracy really works.

Good evening consumer,

I am the American super-dollar, here to show you

where to buy the best shoes.

Hi there,

I am the American super-coupon, here to show you

what you can get for just

$5.99.

Hey you,

I am the American super-sex, here to show you

hot wet genitals.

Dear Sir or Madam,

I am the American super-sin, here to show you

the true meaning of guilt.

Hello ladies and gentlemen,

I am the American super-media, here to show you

the way to talk, here to show you

the way to offend and the way to please, here to show you

the way to "live," here to show you

what you can get for just three easy payments of

$19.99:

Happiness.

Goodnight star children,

I am the great American delusion, here to show you

where to move, and how to be, here to show you

where to spend your money and how to eat, here to show you

how to get well and what to do when you get sick, here to show you

so many throbbing genitals, so many throbbing heads, so many

throbbing advertisements, dripping wet with lusty facade;

Goodnight star children,

It's a shame you never listened

to your big brother,

America.

Goodnight star children,

And thank God there were always a few

who never listened to their big brother,

America.

Sleep tight star children,

Burn your money and use the ashes to fertilize your hemp gardens,

and thank your lucky stars there are more each day

ignoring the cry of the misbehaving big brother,

heeding the call of the divine mother,

Earth.

"Zypreza, Seroquel Side Effects in Children Need Further Review: FDA Staff"

2009-12-07T13:23:00.000-08:00

"According to documents released Friday, FDA staff members say that the agency needs to conduct more of an in-depth investigation into the metabolic side effects for children using Seroquel, Zyprexa and other newer atypical antipsychotics, which could lead to weight gain, diabetes and other serious health problems.

"Reviewers from the FDA’s pharmacovigilance division warned the agency that there needs to be more study into Eli Lilly’s Zyprexa and AstraZeneca’s Seroquel side effects on children. However, on the same day, AstraZeneca announced that the FDA approved the use of Seroquel in children ages 13 to 17.

"The Division of Pharmacovigilance (DPV) report was originally written in October, however it was only released last week. The division was asked to do a safety review of a number of antipsychotics and how they affect teenagers in November 2008 by an FDA advisory committee. FDA staff looked at a number of drugs, including Seroquel and Zyprexa, as well as Johnson & Johnson’s Risperdal, Pfizer’s Geodon and Bristol-Meyers Squibb’s Abilify."

http://www.aboutlawsuits.com/zypreza-seroquel-side-effects-in-children-need-review-7226/

The myth of the BPA free diet

2009-12-03T04:05:00.000-08:00

"Materials from the American Chemistry Council quote the FDA as saying in February, “With regard to BPA generally, based on all available evidence, the consensus of regulatory agencies in the United States, Canada, Europe and Japan is that the current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and young children.”

What the American Chemistry Council’s materials don’t mention is that the FDA’s science advisory board rejected that declaration, as it was based on two industry-funded studies, ignoring the hundreds of studies showing adverse effects from BPA. A 2004 review of 115 published studies on BPA showed that 90 percent of government studies found adverse effects at low doses, while no industry-funded study did. . .

Vom Saal has prenatally exposed mice to BPA and watched as they got older and developed prostate cancer and obstruction to their ability to pee normally. The mice’s exposure to BPA was about 10 times lower per body weight than what the average adult takes in on a regular basis.

“So we actually can cause one of the most common ailments of aging in men, we can cause that with bisphenol A,” says vom Saal. . .

The FDA is chronically understaffed and underfunded, as reported regularly during salmonella or e. coli outbreaks. Conflicts of interests between the FDA and various industries have also been established. Dr. David Graham, the “Vioxx Whistleblower” within the FDA’s Office of Drug Safety, told Manette Loudon in a 2005 interview, “As currently configured, the FDA is not able to adequately protect the American public. It’s more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent.”

Meanwhile, U.S. chemical regulators use an innocent-until-proven- guilty methodology. Certainty of harm must be established before measures are taken to protect public health.

“It is a perverse situation, where if you’re a corporation and you know something bad about a chemical, you’re supposed to tell the government,” says vom Saal. “But if you don’t test it, you can declare it safe. The Europeans just passed the REACH law that reverses that. Now, are we going to be looking like a third-world country in terms of chemical regulation with the Europeans requiring chemical testing but in America, we don’t?”

Vom Saal finds the notion of a “safe level” of BPA laughable.

“There is no safe level,” he says. “Anything in your body is going to disrupt your endocrine system. How can it be a safe level when estrogen is controlling things in your body and any BPA that gets in there disrupts the normal estrogen your body is producing? If you look at it like, I just want my body to work the way God intended it to and not the way the plastics industry says it should work, any amount will disrupt the normal functioning of your system."

http://www.newsreview.com/reno/content?oid=1332356

PS "Water pipes tend to be made from PVC tubing, and BPA is often used in PVC. It’s also in newsprint, pizza boxes, CDs, DVDs, the air. Like he said, we don’t yet know exactly where BPA is, but we know that people who’ve attempted diets like mine still have it in their bodies. Studies have found that at least 93 percent of the population has BPA in their urine."

"New safety concern related to antipsychotic treatment"

2009-12-01T07:16:00.000-08:00

"Philadelphia, PA, 1 December 2009 - Overall, antipsychotic medications are reasonably effective, and fairly well tolerated treatments for mood and psychotic disorders. However, treatment with a number of antipsychotic medications is associated with weight gain, and for some, hyperglycemia and hyperlipidemia. In the current issue of Biological Psychiatry, published by Elsevier, researchers discuss this cluster of metabolic side effects and how it may contribute to the risk for diabetes, hypertension, and other medical disorders associated with heart disease. This is of particular concern because there is a higher cardiovascular mortality among the severely mentally ill compared to the general population."

http://www.eurekalert.org/pub_releases/2009-12/e-nsc120109.php

Art break:

2009-12-01T04:19:00.000-08:00

Antipsychotics and pituitary tumor

2009-11-30T15:54:00.001-08:00

Dear FDA,

Have you been ignoring your own data for years? HELLO. I saw a neurosurgeon today for treatment of my pituitary tumor, which grew over a year of antipsychotic use, and he didn't even know about this. Maybe you should consider investigating that.

http://www.medscape.com/viewarticle/533771

"While a connection between [antipsychotic] drugs and tumors has been suspected for more than 20 years, this is the first systematic study to document an association between specific antipsychotic medications and adverse reports of pituitary tumors in humans, according to the authors."

Um... Really? Thanks.

Love,

- -

Antipsychotic drugs linked to pituitary tumors

2009-11-30T15:47:00.000-08:00

June 3, 2006 – Treatment with potent D2-receptor antagonists such as risperidone (Risperdal, Janssen-Ortho) may be associated with pituitary tumors, researchers say. In the June 2006 issue of Pharmacotherapy, the team notes that while they haven't uncovered a causal relationship between the drugs and tumors, clinicians and patients should be aware of this important adverse effect.

"Atypical antipsychotics are lifesaving medications for a lot of people. By no means are we advocating that people stop using them — especially risperidone," senior author Murali Doraiswamy, MD, a psychiatrist at Duke University, Durham, North Carolina, told reporters. "But we do need to learn more about possible differences in their long-term side effects, and I believe this should be a high priority for investigation."

Dr. Doraiswamy said that if additional studies confirm the current findings, stronger warning labels should be considered for these drugs.

His group studied 6 atypical antipsychotics and 1 typical. They used data from the US Food and Drug Administration's (FDA's) adverse event reporting system database. With algorithm software, they searched for disproportionate reporting patterns of pituitary tumors.

Risperidone was linked to 54 (70%) of 77 cases of pituitary tumors reported in the FDA's database and was followed by haloperidol and ziprasidone. Risperidone is the most widely prescribed of the atypical antipsychotics and is generally used to treat schizophrenia and related psychotic disorders.

Numbers of Reported Adverse Events /b>

Antipsychotic Drug	Pituitary Tumor	Hyperprolactinemia	Galactorrhea	Amenorrhea	Gynecomastia
Risperidone	54	702	530	445	118
Olanzapine	11	37	17	21	23
Haloperidol	9	32	49	24	28
Ziprasidone	6	12	13	2	4
Clozapine	4	15	16	17	7
Quetiapine	1	13	12	3	5
Aripiprazole	0	5	5	2	4
Total ^*	77	796	630	503	186

*The total is not the sum of the column because a single report may mention more than one event or more than one antipsychotic drug.

D2-receptor antagonists inhibit dopamine production. A key function of dopamine is to suppress the release of prolactin, a hormone from the pituitary gland. Increased cellular production of prolactin can cause enlargement of the pituitary gland and disrupt production of other hormones. It can also lead to the development of pituitary tumors.

"The actual numbers of people known to have developed pituitary tumors as a possible side effect due to any of these medications remains unclear, because many adverse drug reactions are not reported to the FDA," Dr. Doraiswamy adds in a news release. "We also don't have exact numbers of how many people currently take these drugs. Another caveat is that pituitary tumors can occur incidentally among the population in general."

The researchers are also concerned about children developing pituitary tumors after the chronic use of antipsychotics. "In this population, we worry that symptoms may not be evaluated quickly enough, which, if due to a tumor, could lead to complications such as visual problems or localized bleeding near the pituitary gland," Dr. Doraiswamy said. "Although such serious side effects are quite rare, prescribing physicians, patients, and their family members should watch for them because they can be controlled."

Dr. Doraiswamy pointed out that because antipsychotic medications vary in their potency, some medications appear to increase prolactin levels more intensely than others.

While a connection between these drugs and tumors has been suspected for more than 20 years, this is the first systematic study to document an association between specific antipsychotic medications and adverse reports of pituitary tumors in humans, according to the authors.

Pharmacotherapy. 2006;26(6):748-758

http://www.medscape.com/viewarticle/533771

"In the end, the finding of a risperidone/pituitary tumor signal is not all that surprising, Seligman told Psychiatric News. “Given that you have here a drug that is well known to cause elevated prolactin levels, and there is pretty solid evidence of induction of pituitary adenomas in rodent models,” the finding appears to confirm the validity of the new data-mining technique. In this case, the method successfully identified an increased frequency of reporting of an adverse event that would, in theory, not only be plausible, but also predictable."

http://pn.psychiatryonline.org/content/40/15/35.1.full

http://www.webmd.com/schizophrenia/news/20060531/schizophrenia-drugs-tumor-risk

"Indeed, reported side-effects to the FDA database included 796 reports of increased blood levels of the hormone prolactin (hyperprolactinemia); 503 reports of the cessation of menses in women (amenorrhea); 630 reports of production of breast milk in adults and children of both sexes (galactorrhea); and male breast development. Ninety of the reports of hyperprolactinemia and 96 of the reports of galactorrhea occurred in children and adolescents. According to Doraiswamy, these symptoms can be indicative of a pituitary disturbance but not necessarily of a pituitary tumor.

All reported side-effects were most strongly associated with risperidone, which also accounted for 82 percent of all reported occurrences of side-effects in children and adolescents, Doraiswamy said.

The researchers are concerned that development of pituitary tumors following chronic use of potent antipsychotics may pose a problem in mentally ill patients, particularly children.

"In this population, we worry that symptoms may not be evaluated quickly enough, which, if due to a tumor, could lead to complications such as visual problems or localized bleeding near the pituitary gland," Doraiswamy said. "Although such serious side-effects are quite rare, prescribing physicians, patients and their family members should watch for them because they can be controlled."

http://www.naturalnews.com/019628_tumors_drugs_drugss.html

http://pituitary.mgh.harvard.edu/NCBV10I1.htm

Okay, so, basically, we had an inkling of this decades ago, and we're still screwing people over. Did I mention that I saw a neurosurgeon today, touted as "really good," who hadn't the faintest clue about this? HELLO.

You know, it's funny, NOBODY mentioned to me how the antipsychotics affect hormones, and I spent a year on and off several of them.

Dear FDA, thanks for doing your f-ing job.

"Diabetes rates will skyrocket without major diet and lifestyle changes "

2009-11-30T12:46:00.000-08:00

"A new study published in the journal Diabetes Care this week concludes that the rate of diabetes will double in the next 25 years and the costs of dealing with this epidemic will triple over the same period.

Currently over 23.7 million Americans are living with diabetes and according to the Centers for Disease Control, diabetes is the sixth leading cause of death, killing over 63,000 people in 2002 and contributing to another 213,000 deaths.

According to the new study by researchers at the University of Chicago, over 44 million Americans will have diabetes in the year 2034 and the annual healthcare costs associated with the disease will balloon from the current $113 billion to $336 billion.

The lead author of the study, Elbert Huang, M.D., assistant professor of medicine at the University of Chicago, cautioned that diabetes will overburden the healthcare system unless there is a change in our diet and exercise habits or new, more effective and less expensive ways to prevent and treat diabetes are developed."

http://www.examiner.com/x-6753-Philadelphia-Nutrition-Examiner~y2009m11d29-Diabetes-rates-will-skyrocket-without-major-diet-and-lifestyle-changes

Modified Atkins Diet cures young boy’s epileptic seizures from Doose Syndrome "

2009-11-30T12:42:00.000-08:00

"After Austin began suffering from constant drop seizures and several grand mal seizures by mid-2007, his mother, Brooke, began scouring the Internet for alternatives to seizure medicines that weren’t working.
A neurologist at a children’s hospital in Denver, Colo., told Austin’s parents, Brooke and Jeff, the alternative would be to increase medications, which would likely leave Austin retarded. The diet would only be a last resort.
In her search, she came across a doctor at John Hopkins Medical Institute in Baltimore, Md., who specializes in using a ketogenic diet to control children’s epilepsy. . . Within weeks of starting the modified Aktins Diet, Austin’s seizures almost stopped completely. He suffered one setback but, as of his birthday, has remained seizure free for 700 days. On Dec. 22, he will be seizure free for two full years."

http://www.imperialrepublican.com/index.php?option=com_content&view=article&id=1432:modified-atkins-diet-cures-young-boys-epileptic-seizures-from-doose-syndrome&catid=36:news&Itemid=76

"Western diet turns on fat genes"

2009-11-30T12:38:00.000-08:00

"According to a new research report recently appearing online in The FASEB Journal (http://www.fasebj.org), a diet that is high in fat and in sugar actually switches on genes that ultimately cause our bodies to store too much fat. This means these foods hit you with a double-whammy as the already difficult task of converting high-fat and high-sugar foods to energy is made even harder because these foods also turn our bodies into "supersized fat-storing" machines.

In the research report, scientists show that foods high in fat and sugar stimulate a known opioid receptor, called the kappa opioid receptor, which plays a role in fat metabolism. When this receptor is stimulated, it causes our bodies to hold on to far more fat than our bodies would do otherwise."

http://www.eurekalert.org/pub_releases/2009-11/foas-hhf113009.php

Diet and autoimmune disease

2009-11-30T12:18:00.000-08:00

"The body DIGESTS food and transforms nutrients into BLOOD, structure and function. There are only two kinds of foods, nutrients: BUILDING and CLEANSING. The correct balance produces the correct amount of blood, structure and function where the body, brain, nervous sytem can thrive (HEALTH) Any amounts, greater or less, in the extreme, tend to cause DISEASE, via TOO MUCH or TOO LITTLE blood, structure and function.

All disease is defined by its symptoms. Biological functions (digestion, respiration, elimination, etc.) produce symptoms, positive (healthy) and negative (unhealthy). Biological structures (spleen, stomach, pancreas, lungs, intestines, etc.) produce biological functions. Food, nutrients, blood produces, builds and cleanses all structures.

All disease progresses in stages. Stage 1 is poor diet. Poor diet tends to cause indigestion (Stage 2). Indigestion tends to cause poor elimination (Stage 3) and blood deficiency (Stage 4) and poor circulation (stage 5), and in the extreme, months, years later, autoimmune illnesses (Stage 6). Autoimmune illnesses are chronic in nature. All chronic (long-lasting diseases) take time (months, years) to develop and consequently, months, years to cure."

http://www.articlesnatch.com/Article/Diets-That-Cause-And-Cure-Autoimmune-Illnesses/761635

Mysterious neurologic illness found in slaughterhouse workers in Austin and two other states

2009-11-30T12:06:00.000-08:00

"Researchers at Mayo Clinic and the Minnesota Department of Health had to conduct comprehensive tests to develop a clear picture of a mysterious neurologic illness found in slaughterhouse workers in Austin and two other states. . .

"The neurological disorder described is autoimmune in origin and is related to occupational exposure to multiple aerosolized (pig) brain tissue antigens," they write.

"This is a paper that describes how a certain group of people got sick when they were exposed to a certain process that removes brain from the pig while it's in the process of being slaughtered, and that process uses compressed air, and that compressed air led to brain material kind of being spread in a broad way into the air and into the environment," DeVries said. "It appears that people who were in close proximity to the brain tissue got sick in a very unique way where they became weak and didn't have very much strength in their legs and, in a limited way, in their arms ... that illness was very unique."

Mayo researcher and co-author Dr. Daniel Lachance said he believes the illness is caused by various components in pig-brain tissue that workers were exposed to through breathing or contact with the eyes, nasal system or mouth. "

http://www.postbulletin.com/newsmanager/templates/localnews_story.asp?z=28&a=427414

Bacteria linked to autoimmune disease

2009-11-26T07:09:00.000-08:00

"ScienceDaily (Nov. 24, 2009) — Current research suggests that a common oral bacterium may exacerbate autoimmune disease. Multiple sclerosis (MS), a disease where the immune system attacks the brain and spinal cord, affects nearly 1 in 700 people in the United States. Patients with multiple sclerosis have a variety of neurological symptoms, including muscle weakness, difficulty in moving, and difficulty in speech."

http://www.sciencedaily.com/releases/2009/11/091123171418.htm
http://www.upi.com/Health_News/2009/11/25/Bacteria-linked-to-autoimmune-disease/UPI-92211259161132/

Re: Abilify approved for autism

2009-11-25T14:40:00.000-08:00

from CDER DRUG INFO
date Wed, Nov 25, 2009 at 12:29 PM
subject RE: Abilify approved for autism:

Dear - -,

Thank you for your message to the Division of Drug Information in the
Center for Drug Evaluation and Research (CDER). The FDA evaluates both
the efficacy and safety of drug products before they are approved for
use in the United States. To market a drug in the U.S, a manufacturer
must demonstrate the drug is safe and effective for its intended use.
Antipsychotic drugs in the atypical class have been proven to be safe
and effective for their intended use(s). As such, they have been deemed
to have their appropriate place in therapy for treatment(s).

The FDA published a public friendly article "The FDA's Drug Review
Process: Ensuring Drugs Are Safe and Effective" which provides more
insight on the careful process FDA goes through to evaluate the efficacy
and safety of a drug prior to approval:
(http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm).

A primary care physician will determine what care is appropriate for you
or that of a family member in accordance with specific medical needs. It
will be up to your health care provider to decide if the potential
benefits outweigh the potential risks (or vice versa) prior to the start
of treatment with antipsychotic atypicals. The FDA also has an article
"Think It Through: Managing the Benefits and Risks of Medicines" which
contains tips from the FDA and some of its public health partners to
help weigh the risks and benefits when you make decisions about the
medicines you use
(http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143558.htm).

For more information, please visit
http://www.fda.gov/ForConsumers/Publications/ucm119456.htm for our
publications,
http://www.fda.gov/AboutFDA/CentersOffices/CDER/FAQsaboutCDER/default.ht
m for Frequently Asked Questions about the Center for Drug Evaluation
and Research (CDER) or use the Search Engine
http://www.fda.gov/default.htm for locating specific information on our
thousands of Web pages.

Best regards,
Division of Drug Information KW
Center for Drug Evaluation and Research
Food and Drug Administration

This communication is consistent with 21CFR10.85(k) and constitutes an
informal communication that represents our best judgment at this time
but does not constitute and advisory opinion, does not necessarily
represent the formal position of the FDA, and does not bind or otherwise
obligate or commit the agency to the views expressed.

"Pfizer faces $103 million in Prempro damages"

2009-11-25T00:36:00.000-08:00

"The verdicts show that "when jurors hear how Wyeth put huge profits over the safety of patients, they will react with a strong message of outrage," Esther Berezofsky, one of Barton's lawyers, said in a statement.

Tom Kline, cocounsel for plaintiffs in about 40 other Prempro cases, said the punitive awards "showed that juries clearly believed that Wyeth hid the risks of breast cancer from doctors and patients, making the defense of these claims harder down the road."

There have been larger verdicts in pharmaceutical cases involving individual plaintiffs - a Texas jury awarded one plaintiff $253 million, later reduced to $26 million by an appeals court, in litigation against Merck & Co. Inc. over the arthritis drug Vioxx. But yesterday's jury award in Philadelphia nonetheless was significant, another Center City plaintiffs' lawyer said."

http://www.philly.com/inquirer/front_page/20091124_Pfizer_faces__103_million_in_Prempro_damages.html

"The Autoimmune Epidemic: Bodies Gone Haywire in a World Out of Balance"

2009-11-24T23:32:00.000-08:00

"Type 1 diabetes researchers insist that today's rapid rise in this disease cannot be explained by either better diagnostics or by more people suddenly becoming genetically susceptible to type 1 diabetes; rather, a change in environmental factors is the "more plausible explanation." At the Mayo Clinic researchers are beginning to ask if rising rates of lupus are the result of an increased exposure to environmental triggers of some unknown origin. Because autoimmune disease is spreading in almost every industrialized nation, scientists the world over have dubbed it "the Western disease."

". . . The average patient with autoimmune disease sees six doctors before attaining a correct diagnosis. Recent surveys conducted by the American Autoimmune Related Diseases Association reveal that 45 percent of patients with autoimmune diseases have been labeled hypochondriacs in the earliest stages of their illnesses. Some of this, no doubt, has to do with the fact that 75 percent to 80 percent of autoimmune disease sufferers are women, who are more easily dismissed by the medical establishment when hard-to-diagnose symptoms arise. In half of all cases, women with autoimmune disease are told there is nothing wrong with them for an average of five years before receiving diagnosis and treatment. Patients -- most especially women -- are often left feeling both confused and marginalized, or worse, labeled as psychosomatic malingerers."

Yes, yes, and yes. I went to the doctor, and the doctor told me to see a psychiatrist, because she thought I was batshit. Not batshit. Autoimmune illness + medication side effect + pituitary tumor. Need better doctor. Need better medical system. Need better oversight. Better environmental protection. Less haste. Change should not be too rapid to catch up with itself.

". . .Eighty thousand chemicals have been approved for use in our environment. Every year 1700 new chemicals are approved -- that's an average of five a day. Have scientists studied the effects on our bodies of all these chemicals? No. However, those chemicals that have been researched -- in occupational studies and in studies of lab animals -- have been shown to play a role in triggering autoimmune reactions. For example, mice exposed to pesticides -- at levels four-fold lower than the level set as acceptable for humans by the EPA -- are more susceptible to getting lupus than control mice. Mice that absorb low doses of trichloroethylene (TCE) -- a chemical used in industrial degreasers, dry-cleaning, household paint thinners, glues and adhesives -- at levels deemed safe by the EPA, and equal to what a factory worker today might encounter, quickly develop autoimmune hepatitis. And low doses of perfluorooctanoic acid, a breakdown chemical of Teflon that can be found in 96 percent of humans tested for it, impair the development of a proper immune system in rats.

". . . Each person, with his or her unique genetic composition, is exposed to a myriad combination and level of autogens depending on what they encounter in their day-to-day lives through the air they breathe and what they come into contact with through their skin. This toxic stew consists not only of chemicals and heavy metals, but additives in our highly processed diet and viruses and bacterial agents to which we're exposed -- all of which combine to impact our immune system. Chronic stress, which releases cortisol into our body, also plays a role in triggering these diseases as do women's reproductive hormones -- which is why women are three times more likely than men to come down with an autoimmune disease. As long as your barrel is less than full, however, your immune system is still able to deal with what it confronts every day. But once the immune system becomes overburdened it can begin to send misread signals, causing the immune system to make costly mistakes and attack the body itself. Unfortunately in modern life we've created a perfect storm of factors -- a plethora of chemicals, heavy metals, processed food additives, viral hits and stressors -- for today's autoimmune epidemic to take hold. So much of what we encounter in twenty-first century life is causing our barrel to fill to the brim -- and spill over. At that point, disease strikes.

". . . Still, we say we can't "prove" that chemicals are impairing the human immune system. Meanwhile, European environmental policy uses the precautionary principle -- an approach to public health that underscores preventing harm to human health before it happens. In June 2007, the European Union implemented legislation known as REACH (the Registration, Evaluation, Authorization and Restriction of Chemical Substances), which requires companies to develop safety data on 30,000 chemicals over the next decade, and places responsibility on the chemical industry to demonstrate the safety of their products. America lags far behind, without any precautionary guidelines regarding chemical use.

"Obviously, political and economic considerations come into play here. There are over 1200 "superfund" sites around the U.S. -areas where deadly toxins are known to be seeping into the environment -- and these have yet to be cleaned up. At about 10 percent of these sites, people are freely entering the area and being exposed directly to the hazardous waste. Unfortunately, the Environmental Protection Agency does not release information about how much it plans to spend to remediate these sites, when the area will be cleaned up or how long it will take."

http://www.alternet.org/healthwellness/80129/

Hypothesis:
The hormonal birth control I was taking four months ago triggered a (possibly already brewing) autoimmune reaction, which I daily suffer with now. (Judgment based on significant research and documentation of my symptoms). Why couldn't my doctor suggest something so simple? I recently began getting reflexology, ion cleanse [detox] foot baths, craniosacral therapy, NES, and massage. I found that my condition--after months of doctors dicking around with me--actually began to improve. And I think this is why. The chemicals in the environment make the body do crazy things. Good medicine should be subtractive, not additive. Instead of saying "Add this drug" we should say "remove this toxin from your system."

Research should not be in drug development. It's a moot point. There are no chemicals that will cure our ills as well as the removal of the chemicals from our bodily systems. Medical research should be largely environmental. Where are our heads! The remedies we research should examine the removal of the root causes of pathologies, rather than treat with drugs to only add more pathologies.

I am currently researching autoimmune illness, pharmaceuticals, and corn syrup... Ah, and hormones. Hopefully more on that later.

"Ancient dietary wisdom for tomorrow's children"

2009-11-24T14:55:00.000-08:00

I found this to be an interesting read:

". . .The therapeutic value of foods rich in the X Factor was recognized during the years before the second World War. Price found that the action of "high vitamin" Spring and Fall butter was nothing short of magical, especially when small doses of cod liver oil were also part of the diet. He used the combination of high vitamin butter and cod liver oil with great success to treat osteoporosis, tooth decay, arthritis, rickets and failure to thrive in children.

Other researchers used such foods very successfully for the treatment of respiratory diseases such as TB, asthma, allergies and emphysema. One of these was Francis Pottenger whose sanitorium in Monrovia, California served liberal amounts of liver, butter, cream and eggs to convalescing patients. He also gave supplements of adrenal cortex to treat exhaustion.

Dr. Price consistently found that healthy "primitives", whose diets contained adequate nutrients from animal protein and fat, had a cheerful, positive attitude to life. He noted that most prison and asylum inmates have facial deformities indicative of pre-natal nutritional deficiencies.

Like Price, Pottenger was also a researcher. He decided to perform adrenalectomy on cats and then fed them the adrenal cortex extract he prepared for his patients in order to test its effectiveness. Unfortunately most of the cats died during the operation. He conceived of an experiment in which one group of cats received only raw milk and raw meat, while other groups received part of the diet as pasteurized milk or cooked meat. He found that only those cats whose diet was totally raw survived the adrenalectomy and as his research progressed, he noticed that only the all-raw group continued in good health generation after generation--they had excellent bone structure, freedom from parasites and vermin, easy pregnancies and gentle dispositions. All of the groups whose diet was partially cooked developed "facial deformities" of the exact same kind that Price observed in human groups on the "displacing foods of modern commerce"--narrowed faces, crowded jaws, frail bones and weakened ligaments. They were plagued with parasites, developed all manner of diseases and had difficult pregnancies. Female cats became aggressive while the males became docile. After just three generations, young animals died before reaching adulthood and reproduction ceased.

The results of Pottenger's cat experiments are often misinterpreted. They do not mean that humans should eat only raw foods--humans are not cats. Part of the diet was cooked in all the healthy groups Price studied. (Milk products, however, were almost always consumed raw.) Pottenger's findings must be seen in the context of the Price research and can be interpreted as follows: When the human diet produces "facial deformities"--the progressive narrowing of the face and crowding of the teeth--extinction will occur if that diet is followed for several generations. The implications for western civilization--obsessed as it is with refined, highly sweetened convenience foods and low-fat items--is profound.

http://www.westonaprice.org/traditional_diets/ancient_dietary_wisdom.html

"Advertising to Consumers May Raise Drug Prices"

2009-11-24T13:47:00.000-08:00

"Direct-to-consumer drug ads may contribute to higher Medicaid costs, according to a new study that examined sales of the widely used antiplatelet drug clopidogrel (Plavix). The analysis of data from 1999 to 2005 for 27 state Medicaid programs found that direct-to-consumer advertising for clopidogrel did not increase people's use of the drug but appeared to be associated with increased drug costs and Medicaid pharmacy expenditures. . . "Consequently, payers and policy makers should ... be concerned about [direct-to-consumer advertising] increasing total drug costs for publicly funded reimbursement programs such as Medicaid and Medicare," the researchers concluded. "Future longitudinal studies should examine other drugs and settings because many other countries are currently considering whether to permit" such ads."

http://health.usnews.com/articles/health/healthday/2009/11/24/advertising-to-consumers-may-raise-drug-prices.html

Not to mention the ridiculous prospect that people can make sound decisions about their health based on information specifically designed to lure them into drug use.

"FDA Promotes Openness and Transparency to Public"

2009-11-24T13:17:00.000-08:00

This is straight from the FDA website. Yet, CDER didn't seem to be too keen on transparency via email.

"President Obama has pledged to strengthen our democracy by creating an unprecedented level of openness in government. The Administration believes that information maintained by the federal government is a national asset. Promoting transparency strengthens our democracy and promotes accountability and effectiveness in government. The Administration has pledged to take appropriate action, consistent with law and policy, to disclose information rapidly in forms that the public can readily find and use."

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm163900.htm

Okay, so the FDA wants info available "in forms that the public can readily find and use," but according to CDER, "The premise of prescription drugs is that they require a 'learned intermediary,' such as a licensed physician, to give guidance to the patient on the safe and proper use of the medicines, and of any risks and precautions regarding the particular drug in question." Goes on to say: "f there are adverse drug reaction reports submitted through the MedWatch program . . . for any product marketed in the U.S., they are covered under the U.S. Freedom of Information Act (FOIA). To obtain the reports, you may submit a request by following the instructions at http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm. You may also contact the FOI office directly at 301-827-6567."

So, FDA, what's the verdict? Medwatch collects all kinds of side effect reports via internet, but in order to see any of that information, I have to follow these instructions:

"All FOIA requests must be in writing and should include the following information:
A. Requestor's name, address, and telephone number.
B. A description of the records being sought. The records should be identified as specifically as possible. A request for specific records that are releasable to the public can be processed much more quickly than a request for "all information" on a particular subject. Also fees for a more specific and limited request will generally be less.
C. Separate requests should be submitted for each firm or product involved.
D. A statement concerning willingness to pay fees, including any limitations."

http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm

"If you wish to visit an FDA Public Reading Room in person, they are located at:
Division of Freedom of Information, 5600 Fishers Lane, HFI-35, Room 6-30, Rockville, MD 20857
Division of Dockets Management, 5630 Fishers Lane, Room 1061, Mail Stop HFA-305, Rockville, MD 20852.
Hours of operation for both sites are 9 a.m. to 4 p.m., Monday through Friday.
For a general overview of the Freedom of Information Act see the U.S. Department of Justice's FOIA homepage."

http://www.fda.gov/RegulatoryInformation/FOI/default.htm

... Field trip!

More links:
http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm113237.htm
http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/default.htm

Dear FDA, you waste so much of my time with your convoluted manner of writing.

So much for "transparency." The FDA is clear as mud.

"Hallucinogenic Salvia May Also Have Medical Use, Causing Controversy"

2009-11-24T12:44:00.000-08:00

"Salvia divinorum, a cousin of the common garden flower, is a strong hallucinogenic substance. Some say it should be made illegal, while others argue it may have medical uses and should remain legal so research can be done. . . The DEA recently listed salvia as a drug of concern. In 2007, the DEA, in conjunction with the Department of Health and Human Services, began evaluating the substance for possible placement on the federal controlled substance schedule. Researchers are afraid that could stunt pharmacological studies, said Naomi Long, the Washington office director of the Drug Policy Alliance Network, which promotes drug policies grounded in science, health and human rights."

http://www.infozine.com/news/stories/op/storiesView/sid/38774/

DEA Controlled Substances Act:

". . . the Attorney General shall consider the following factors with respect to each drug or other substance proposed to be controlled or removed from the schedules:

(1) Its actual or relative potential for abuse.

(2) Scientific evidence of its pharmacological effect, if known.

(3) The state of current scientific knowledge regarding the drug or other substance.

(4) Its history and current pattern of abuse.

(5) The scope, duration, and significance of abuse.

(6) What, if any, risk there is to the public health.

(7) Its psychic or physiological dependence liability.

(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

http://www.justice.gov/dea/pubs/csa/811.htm#b

"Researchers Urge FDA To Create Database To Monitor Rx Drug Safety"

2009-11-24T12:32:00.000-08:00

"Federal regulators should create a public database to improve the system for monitoring prescription drug safety, according to anArchives of Internal Medicine study published Monday, the New York Times reports. . . Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said new legislation would be necessary to establish such a drug monitoring database (Singer, New York Times, 11/24)."

http://www.ihealthbeat.org/articles/2009/11/24/researchers-urge-fda-to-create-database-to-monitor-rx-drug-safety.aspx
Hey wait a minute...

From: CDER

"We at the FDA are interested in learning of adverse experiences that patients encounter and to do so have implemented the MedWatch program. It is a voluntary system of reporting to FDA any adverse effects and/or product problems. We now have a new way to report directly to MedWatch via the Internet."

Uh... it really doesn't seem that hard to expand/improve a system that they basically already have in effect.

NYT: "What could be done to prevent another Vioxx? This pain medication for arthritis became a blockbuster after its introduction in 1999, only to be taken off the market in 2004 when a study linked the drug to an increased risk of heart attack and strokes. A new study published Monday in Archives of Internal Medicine offers an ambitious proposal to determine a drug’s risks sooner than they might otherwise become evident. The authors propose a system to examine widely prescribed drugs through safety analyses that would pool data as they emerge from various clinical trials of a medication and aggregate the information for a fuller picture of a drug’s harms and benefits. As policy makers in Washington push for various forms of evidence gathering to determine the safety and effectiveness of medical treatments, the study proposes a broad model for monitoring drug safety that would consist of detailed publicly available data that independent researchers could freely analyze. Such a database could be continually updated and aggregated with new information, as the results of new studies were published, to calculate a near real-time balance sheet of a drug’s risks and benefits."

http://www.nytimes.com/2009/11/24/health/24vioxx.html?_r=1&scp=1&sq=public%20database%20is%20urged%20to%20monitor%20durg%20safety&st=cse

...Or is the real issue that the FDA and various drug companies already know that they are currently marketing plenty of other "Vioxx"s and trying to avoid admitting it?

Re: Re: W-SOHO

2009-11-24T12:21:00.000-08:00

TO: CDER

I'm not sure I understand why a 3 year study of 17000 patients on antipsychotics worldwide was not reviewed by the FDA. It seems rather significant.

My doctor, as I mentioned before, doesn't seem to know much about the side effects of the medications. What doctor has time to review every medication he prescribes? Especially these new ones; there are new side effects being discovered all the time by patients who don't realize they're guinea pigs. It makes no sense that the information is not available to the consumer who seeks it out. I imagine that reading and sifting through all that technical language is somewhat taxing for my doctor, too. And, really, is it even completely technical language? It seems like some of it is just filler to make it harder to understand.

If you truly believe that "the selection of specific drug products or treatment regimens for particular patients are decisions to be made between the patient and a physician who is familiar with the individuals' current health status," then why hasn't more information about the side effects of drugs been aggressively distributed to doctors? It's incredibly hypocritical. Why is it that drugs can be marketed directly to the public, while the full safety information is not accessible to the public?

If I had trusted my doctor 100% and failed to do my own research, I would still be on psychotropics and incapable of holding a job and going to school due to the side effects.

If I understand correctly, it is the FDA's view that consumers should only get medical information from their doctors (and of course advertisements), while the doctors get information from marketing reps, and the FDA, which, for some reason, has a habit of failing to distribute comprehensive and intelligible information to both patients and doctors.

It is not my view that I should leave my medical care in the hands of marketing reps.

I hope your mother gets a prescription for Risperdal. Have you heard what it does to the elderly?

Love,
-

The one reason I should get a Twitter:

2009-11-24T12:07:00.001-08:00

http://twitter.com/fda_drug_info

Re: W-SOHO

2009-11-24T12:03:00.000-08:00

FROM: 2009/11/24 CDER DRUG INFO :

Dear -:

Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

Most of the FDA approved drug labeling is written in technical language for healthcare professionals. The labeling is the most comprehensive, up-to-date source of drug information. The FDA has the responsibility to ensure that the benefits of drug products outweigh their risks when used as directed in the labeling. However, the selection of specific drug products or treatment regimens for particular patients are decisions to be made between the patient and a physician who is familiar with the individuals' current health status, past medical history and product labeling, weighing the benefits over the risks. The premise of prescription drugs is that they require a "learned intermediary," such as a licensed physician, to give guidance to the patient on the safe and proper use of the medicines, and of any risks and precautions regarding the particular drug in question.

For drug information written in consumer friendly language, we suggest that you visit the MedlinePlus website: http://www.nlm.nih.gov/medlineplus/

If there are adverse drug reaction reports submitted through the MedWatch program (http://www.fda.gov/Safety/MedWatch/default.htm) for any product marketed in the U.S., they are covered under the U.S. Freedom of Information Act (FOIA). To obtain the reports, you may submit a request by following the instructions at http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm. If you have questions on how to submit your request, the FOI contact information site is at http://www.fda.gov/RegulatoryInformation/FOI/WhotoContactAboutFOIA/default.htm. You may also contact the FOI office directly at 301-827-6567.

The FDA has not published an analysis on the study W-SOHO. Please note that the FDA is unable to evaluate every study that may be published.

We at the FDA are interested in learning of adverse experiences that patients encounter and to do so have implemented the MedWatch program. It is a voluntary system of reporting to FDA any adverse effects and/or product problems. We now have a new way to report directly to MedWatch via the Internet. If you would like to report side effects of an antipsychotic medication, please visit the following link for the MedWatch Online Voluntary Reporting Form: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

Voluntary reports are essential for ensuring the continued safety of FDA-regulated products. Reports submitted to MedWatch are added to a postmarketing safety database and reviewed by the FDA's postmarketing safety staff. One or two well-documented case reports may provide an early signal of unexpected safety issues and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day. We carefully evaluate and analyze all reports that were available to us and make recommendations for possible actions if the science based risk evaluation warrants the actions. If the report contributed to the action, the labeling change and/or public advisory will reflect the action.

Thank you again for contacting the FDA.

Best regards,
Drug Information SH
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter: http://twitter.com/fda_drug_info

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

Re: Re: W-SOHO

2009-11-24T09:37:00.001-08:00

To: CDER

Thanks. But the information you linked me to no less convoluted than what I've already seen.

Here is a press release about the study I cited, for your information: http://www.sciencedaily.com/releases/2009/11/091116094501.htm

Comments?

By the way, according to the labeling information for Risperdal: "In clinical trials in 1885 children and adolescents treated with RISPERDAL®, 2 (0.1%) patients were reported to have tardive dyskinesia, which resolved on discontinuation of RISPERDAL® treatment " And for Abilify: "The only commonly observed adverse reaction associated with the use of aripiprazole in patients with schizophrenia (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) was akathisia (aripiprazole 8%; placebo 4%)." And for Seroquel: "In these studies, the most commonly observed adverse reactions associated with the use of SEROQUEL (incidence of 5% or greater) and observed at a rate on SEROQUEL at least twice that of placebo were somnolence (18%), dizziness (11%), dry mouth (9%), constipation (8%), SGPT increased (5%), weight gain (5%), and dyspepsia (5%). " And Geodon: Commonly observed adverse reactions (incidence ≥5% and at least twice the incidence for placebo) were: Schizophrenia: Somnolence, respiratory tract infection (6.1) Manic and Mixed Episodes Associated with Bipolar Disorder: Somnolence, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting (6.1) Intramuscular administration (≥5% and at least twice the lowest intramuscular ziprasidone group): Headache, nausea, somnolence (6.1)

Those are some of the top antipsychotics and that doesn't seem consistent with the information from the study.

Maybe I'm biased because I took half a milligram dose of Risperdal for a few weeks last year, which resulted in a grand mal seizure and the beginning of many months of hell for me. Thanks for the warnings about the possible link between pituitary tumors and antipsychotics... Let me rephrase that: I came across the information on the internet, published in 2006, and I wondered, while the antipsychotics are so aggressively marketed, why some regulatory agency did not inform my doctor of this and other dangerous side effects that could be linked to antipsychotic medications. I want up to date accurate information about the incidence of side effects. Specifically, I am interested in what was found in the recent study, cited above, about the implications of long term use of antipsychotics, rather than just a summary about how "schizophrenics all over the world are similar," which is primarily what the study has revealed to me so far. It seems kind of beside the point. I'd also like to know where I can find information about the side effect reports collected by the FDA from the public. My interest was piqued about such by the following article: http://www.webmd.com/schizophrenia/news/20060531/schizophrenia-drugs-tumor-risk (Naturally, because I have a rather sizable tumor after a year of light atypical antipsychotic use.)

Considering that the use of the atypicals is being constantly expanded--I noticed that Abilify was recently approved for use in autistic children--isn't it worth the FDA looking a little more deeply into the effects of the drugs, which are sometimes very serious? They weren't approved based on long term studies, yet are prescribed for long term use. Well, here's your long term study. I think. W-SOHO. Correct me if I'm wrong, but I think some deeper analysis is called for. Unfortunately, I don't have the medical background to decode medical studies with much ease. If only there were a regulatory agency whose job it was to decode the nearly unintelligible medical information and make it available to the public...

I suppose I may be naive to assume that complete, accurate, up to date information about heavy drugs is not much to ask.

Love,

- -. Patient. Concerned human being.

Re: W-SOHO

2009-11-24T07:56:00.000-08:00

On Tue, Nov 24, 2009 at 8:00 AM, CDER DRUG INFO wrote:

Dear -:

Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

You may find information on antipsychotic drugs in the product labeling, or package insert. The product labeling is the most complete single source of information on the drug. Labeling for most FDA approved drugs may often be found on the following websites:

DRUGS @ FDA:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Daily Med: http://dailymed.nlm.nih.gov/dailymed/about.cfm

Information on side effects, including the incidence rate, may be found in the ADVERSE REACTIONS section of the labeling. Information on studies may be found in the CLINICAL STUDIES section of the labeling.

You may also access the labeling and Medication Guides for atypical antipsychotic drugs at the following website:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm

You may find consumer friendly drug information on the MedlinePlus website, a service of the National Library of Medicine (NLM) at the National Institute of Health (NIH): http://www.nlm.nih.gov/medlineplus/. This service provides information about specific diseases and drugs, clinical trials, symptoms, diagnoses, prevention, treatment, special populations, etc.

I am not familiar with the study that you cite in your email. Please note that the FDA does not evaluate every study or statement that may be published in the news media.

Best regards,
Drug Information SH
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug
Information on Twitter: http://twitter.com/fda_drug_info

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

W-SOHO

2009-11-23T23:59:00.001-08:00

To: CDER

". . .on average, 50% (range 41–59%) of patients taking antipsychotics exhibited extrapyramidal symptoms at baseline, and 62% (34–67%) of patients reported sexual dysfunction in the previous month. On average, only 19% (16–23%) of patients were in paid employment and as many as 69% were living in dependent housing.""

Am I misinterpreting this or is that significant? When I began taking atypical antipsychotics, I definitely didn't realize that the incidence of "extrapyramidal symptoms" was about half. Dependent housing? Thanks but no thanks. That's not what I saw in the commercials. Where are the green fields and sunshine? I tried to find more information about the implications this study has on the use of atypicals, but I had a hard time finding much of anything. Is there information about this study available in a form the public can understand?

Worldwide-Schizophrenia Outpatient Health Outcomes (W-SOHO)

2009-11-23T22:25:00.000-08:00

"Conclusion: A review of the 2005 literature on this topic re-emphasizes the point that new-generation antipsychotics are an inhomogeneous group of drugs with different efficacy/safety/tolerability profiles. Next to differences based on group statistics, clinical experience has also taught us that there are large inter-individual variations regarding the clinical effects of these medications. Given this inhomogeneity, the concept of 'atypicality' that has implied common mechanisms and effects, therefore, as suggested previously[40,41] should really be abandoned. Clearly, the field desperately needs more information regarding the prediction of drug response in individual patients."

Uhh...

Let's take a step back for a second:

"Results: The W-SOHO database comprises 17,384 patients from six regions; East Asia (n = 1223), Central and Eastern Europe (n = 2175), Northern Europe (n = 4291), Southern Europe (n = 5788), Latin America (n = 2566), North Africa and the Middle East (n = 1341). Overall, patients were 38 ± 13 years old (mean ± SD), moderately ill (mean CGI-SCH overall score of 4.4 ± 1.0) with a median duration of illness of 7 years (interquartile range 1–16 years); 43% were female, 10% were receiving antipsychotic medication for the first time. Adverse events were prevalent across all regions; on average, 50% (range 41–59%) of patients taking antipsychotics exhibited extrapyramidal symptoms at baseline, and 62% (34–67%) of patients reported sexual dysfunction in the previous month. On average, only 19% (16–23%) of patients were in paid employment and as many as 69% were living in dependent housing."

http://www.medscape.com/viewarticle/711890

In other words:

A study was done about the health outcomes of over 17000 schizophrenics throughout the world, all of whom were taking antipsychotic medication. Half of them experienced movement disorders ("extrapyramidal symptoms"). More than half of them reported sexual dysfunction. Less than one fifth of them were well enough to be employed, and over 2/3 were living in dependent housing.

So... what is it these drugs are supposed to be doing? Is it far fetched to speculate that there is probably a larger population of employed alcoholics than of employed antipsychotic users? (I honestly tried to find a statistic about the employment rate of alcoholics and I could not. Venture to say 2/3 of alcoholics are not living in dependent housing?)

Okay, a couple more tidbits about this:

"26% of the study participants were taking more than one antipsychotic and about 74% were taking other prescribed drugs at the same time. 10% were taking antipsychotics for the first time."

"The key reasons for changing medication were the same across all the regions surveyed, with two-thirds of the investigators citing lack of effectiveness, followed by intolerance, patient request and incomplete adherence to the medication."

http://www.alphagalileo.org/ViewItem.aspx?ItemId=62861&CultureCode=en

"Compared with other regions, the Northern European subgroup had a high prevalence of TD [tardive dyskinesia - lasting movement disorder], yet this was not matched by a high prevalence of the use of typical antipsychotics, as expected."

http://www.medscape.com/viewarticle/711890_4

In other words, the newer antipsychotics do not necessarily have a more pleasing side effect profile than the older ("typical") psychotics, in terms of movement disorders.

Every atypical I took caused extrapyramidal symptoms. And I took almost every atypical.

I'll be honest, I don't have the energy to interpret the whole of this study right now. It's all filled with fluff and bullshit, or I'm too much of a cynic and not enough of a doctor...

Though, I'll be honest, I'd rather my doctor be a cynic--in fact, I require it.

(And one more - - http://www.sciencedaily.com/releases/2009/11/091116094501.htm )

"Take Your Medicine" Kids Brochures Embarrass British Health Service

2009-11-23T19:40:00.000-08:00

"Your medicine is called Olanzapine. Pronounced 'o-lan-za-peen,'" says the lime green kids' brochure for the antipsychotic Zyprexa, published by Britain's National Health Service (NHS). "Many children, teenagers and young people need to take medicines prescribed by doctors to help them stay well and healthy," says the text amid cartoons of happy children skating, roller blading and playing soccer."

http://www.foodconsumer.org/newsite/Non-food/Miscellaneous/take_your_medicine_kids_brochures_221120091114.html

I got a kick out of this...

A kick in the face...

NIH News

2009-11-23T19:25:00.000-08:00

I find it quite peculiar that this article appeared immediately after the FDA approved a popular (and aggressively marketed) antipsychotic for "irritability linked to autism."

(I received it in my email, as I have a subscription to the National Institutes of Health email updates.)

"In the study, the RUPP group tested the benefits of medication alone compared to medication plus a parent training program that actively involves parents in managing their children's severely disruptive and noncompliant behavior. Parents were taught to modify their children’s behavior and learned to enhance their children’s daily living skills.

"The 24-week, three-site trial included 124 children ages 4 to 13 with pervasive developmental disorders (PDD) such as autism, Asperger’s or related disorders accompanied by tantrums, aggression and self-injury. The children were randomized to a combination of risperidone and parent training, or to risperidone only. Parents in combination therapy received an average of 11 sessions of training over the course of the study.

"Although both groups improved over the six-month trial, the group receiving combination therapy showed greater reduction in behavioral problems like irritability, tantrums and impulsiveness compared to the group receiving medication only. The combination therapy group also ended the trial taking an average dose of 1.98 milligrams (mg) per day of risperidone, compared to 2.26 mg/day in the medication-only group — a 14-percent lower dose. However, children in both groups gained weight, indicating "a need to learn more about the metabolic consequences of medications like risperidone," said the authors."

http://www.nih.gov/news/health/nov2009/nimh-20.htm and

http://www.sciencedaily.com/releases/2009/11/091121093234.htm

My complaint is this: Medication has become an assumption. Antipsychotic medication, nonetheless. Also, I noticed that this is based on a 24 week trial. I know that Abilify was approved for pediatric use recently based on an 8 week trial. They were approved after being tested for a couples months. So... naturally it's assumed that they're safe to put your kid on for years... Newsflash: the kids on this stuff are going to hate their parents and doctors when they get privy to what's up.

A note on corn fed beef

2009-11-23T16:27:00.000-08:00

From an interview on NPR's Fresh Air, with Michael Pollan:

". . . this phrase corn-fed beef has been around so long that we just take it for granted that this is some kind of old-fashioned virtue. But it's neither that old or that virtuous, as it turns out. These animals, in nature or, you know, when grazing, encounter very, very little grain. I mean, grain is essentially the seed of grasses. So when the bluestem that they're eating and the Western wheat grass they're eating flowers and puts on seed, they get a little bit of grain, but very, very little. And now suddenly they're given this incredibly rich diet. As one of the feedlot managers put it to me, it's like feeding them Snickers bars all day long. It's a very rich food, although they don't appear to like it quite as much as Snickers bars. But it wreaks havoc on a digestive system that has evolved to do something quite miraculous, which is digest grass.

"You know, that, for me, is the underlying insanity of this system. We have this animal, a ruminant--there's a class of animals; it includes cows, but also sheep and deer and several others--that has this unique ability to digest grass. We can't do it. If you consume grass you will not be able to digest it. So they can take this sort of substandard land that can only grow grass because it's too dry or too hilly or the soil is too thin, and because they have this digestive organ, this rumen, which is essentially a 45-gallon fermentation tank in which a resident population of bacteria goes to work on the grass and turns it into protein, they can make good use of this incredibly common solar-generated food source. So we've taken the solar system--you know, 'cause the grass is fed on sunlight and water. It's this miracle of photosynthesis, which is, when you think about it, the only free lunch in nature. And so they take this free lunch and can make very high-quality food out of it. But rather than use that system, we move to another kind of system, which is feeding them corn.

"Now corn, you might argue, well, that's a solar system to because, you know, the corn grows, is a kind of grass, and it grows out in the sun. But, in fact, to get the kind of harvest of corn we get and the surpluses, you have to apply vast quantities of fertilizer, which is a fossil fuel. It's ammonium nitrate. And we began doing this after World War II. It made corn grow incredibly well. We get 130 bushels of corn off an acre where a hundred years ago we got 20. And all of that fertilizer is made from oil. And, in fact, it takes 1.2 gallons of oil to grow a bushel of corn. So I realized I was looking at a different kind of system. We had gone from a solar system to a fossil fuel system. And this strikes me as a kind of crazy thing."

http://www.math.uic.edu/~takata/some_articles/FreshAir_Michael_Pollon_on_beef_industry,_hormones,_antibiotics.html

Nice shot at logic but no cigar.

2009-11-23T09:43:00.000-08:00

http://newledger.com/2009/11/pharmaceutical-companies-will-suffer-under-health-care-reform/

". . . needless to say, the disincentives that will come about as a result of this and other taxes/attacks on the pharmaceutical industry will hamper the manufacture of other drugs as well. R&D costs for pharmaceutical companies are onerous, to say the least, so these companies don’t have much margin for profit to begin with. When that margin gets reduced still further, fewer drugs come down the pipeline, sick patients get sicker, and many of them end up dying."

More like:

The financial incentives that have come about as a result of the current state of America's healthcare system have hampered the production of unbiased research, as pharmaceutical companies are encouraged to send drugs down the pipeline without sufficient testing simply in order to make a profit. This goes so far as ignoring research that exists about the dangers of the drugs being sold. That is, these companies, which would "suffer" under the new plan, are currently putting the health of their customers at risk on a daily basis simply to make a buck.

Hasn't anyone noticed that "big government" is the only thing powerful enough to compete with the disingenuous interests of big business? Yes, I want big government. I want big government that watches out for little people. Not little government that watches out for big corporations. Give me a break.

"The American Medical Association Calls for Ending the Schedule I Lie"

2009-11-22T11:59:00.000-08:00

". . .the AMA has adopted a report drafted by its Council on Science and Public Health (CSAPH) entitled, "Use of Cannabis for Medicinal Purposes," which states, "Results of short term controlled trials indicate that smoked cannabis reduces neuropathic pain, improves appetite and caloric intake especially in patients with reduced muscle mass, and may relieve spasticity and pain in patients with multiple sclerosis."

http://blog.norml.org/2009/11/10/ama-calls-for-ending-the-schedule-i-lie/

http://www.latimes.com/news/opinion/la-ed-ama21-2009nov21,0,406900.story?track=rss

A Patient Testimony

2009-11-22T11:01:00.000-08:00

To: PA House Reps

I had a series of very profound experiences that molded my views on this issue. I would kindly like to share them with my Pennsylvania legislators. Please read! Thank you!

I began suffering from depression when I was very young. It got so bad I sought help around age 15, and ended up on psychiatric medications by age 17. Around the same time, I started developing horrible anxiety, regularly becoming so nervous I was unable to eat.

I was a good kid. I attended Catholic school on scholarship, got good grades, and didn't stay out late or do any drugs. I did not so much as drink a sip of alcohol or take a puff of a cigarette. I had a healthy diet and exercised regularly. By age 19, I was having episodes of psychosis accompanying the depression, and the anxiety was getting worse. I began hallucinating and having delusions; I became out of touch with reality. I ended up checking myself into an inpatient facility in March of 2008, after several years of on-and-off emotional stress and turmoil.

They prescribed a low dose of Risperdal and discharged me. Weeks later, I had a grand mal seizure in my sleep. I stopped the Risperdal. Over the next year, my doctor subsequently prescribed me Zyprexa, Abilify, and Depakote. All had horrendous results, and had to be stopped. Finally, I tried Geodon. I took the lowest prescribable dose for under a week, but by the time that week was over, I was having constant headaches and general pain all over, along with twitches and a sort of feeling out of touch. This was March 2009. The headaches subsided a little bit after I stopped the Geodon, but they got worse and worse over the following months.

I began finding that a large number of depressant pharmaceuticals--even OTC drugs like Benadryl--cause my body to start aching and twitching. I have tried numerous antianxiety medications, antidepressants, antipsychotics, and mood stabilizers, and all left me in more dire straits.

In July of 2009 I decided to try hormonal birth control, as I had heard of other women having good results with it; that is, having the artificial hormone even out the mood swings a bit. Not so for me. I began having worse mood swings than I had ever had in my life. My head was pounding almost constantly. At times, I could barely stand, even sit. There was horrible insomnia. The feeling of my heart pounding out of my chest. I awoke with that every morning--and still do. All of my doctors told me the birth control could not be causing these things. Upon doing my own research, I found that they were wrong. I became so ill and desperate I walked to the ER from my house in downtown Philadelphia to be treated. The birth control was stopped. I was using it for under four weeks. That was four months ago, and the side effects of birth control coupled with those left from the antipsychotics have only gotten worse. A pituitary tumor was discovered on an MRI. The antipsychotics have been linked to pituitary tumors, which none of my doctors seemed to have any knowledge of as they prescribed me pill after pill after pill.

Because of leftover side effects from low doses of pharmaceuticals I took several months ago, I wake up with my heart pounding out of chest every morning. I wake up feeling as though I am an animal running from a predator, so pumped with adrenal energy, and so utterly terrified. Depressant pharmaceuticals, antipsychotics, antidepressants, et al, seem to only make me sicker. They make me twitch, and itch, and freak out. I don't have very many options in the way of medication. I don't have very many at all.

I know that if I use cannabis when I wake up, I can begin my day constructively rather than spending hours in a crazed state of panic. I know that I would not have been able to attain the 3.9 GPA I did last term (I am a full time college student) if I had not been medicating my terrible pain and panic with a medicinal herb, cannabis, which happens to be illegal in these United States.

Cannabis lifts my mood when I am depressed, and suffering from inertia. It calms down the manic and psychotic states for which my doctor was prescribing me antipsychotics. It allows me to sleep at night. (I have had horrible insomnia since my early teen years.) It stimulates my appetite when I cannot put on weight due to my illness. It treats the nausea brought on by eating. It eases the pain of headaches and body aches caused by the toxic pharmaceutical overload, and allows me to function--to do my errands and chores, to go to class, to work. It allows me to live a normal life, when all of the other medications out there seem to just make me sicker.

I am begging you to recognize that cannabis is no demon weed. It never was. You have been victims of misinformation for too long, and it is time you take a stand--that all of us, citizens and legislators do--and advocate for the patients who so desperately need help.

I want to be a functioning citizen, a functioning part of my city, my state, and my country, and cannabis is the medication that can help me function. And I think it can help a lot of other people too, with a potential for harm that is much less substantial than the harm caused to me by perfectly legal, and heavily marketed pharmaceutical remedies.

When discussing the matter with my mother, she argued that cannabis could be dangerous to some people, that people need to be protected from it. I told her, "Look at what the medications I was on did to me, but I'm not trying to take them away from the people who can be helped by them. So why am I not allowed to have the one--a natural herb--that helps me?"

I reiterate: Take the high ground. Break the cycle of misinformation and out of date law. Cannabis is here, and the potential for good in monitored medicinal use of cannabis cannot be ignored.

Thank you for your consideration.

Sincerely,
- -

"O Lord, help me not to despise or oppose what I do not understand."
-William Penn

FDA Warns Companies against Marketing Illegal Flavored Cigarettes

2009-11-22T10:40:00.000-08:00

"The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites."

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189436.htm

Give me a break. No one has better things to spend their time on?

(No, I don't either.)

"FDA OKs Abilify for autism-linked irritability"

2009-11-22T10:38:00.001-08:00

"The U.S. Food and Drug Administration has approved top-selling Abilify as a treatment for autism-related irritability in children from the ages of 6 to 17, drug maker Bristol-Myers Squibb Co. said Friday." [AP 20 NOV 2009]

http://finance.yahoo.com/news/FDA-OKs-Abilify-for-apf-167573670.html?x=0&.v=1

To whom it may concern:

2009-11-22T10:20:00.001-08:00

To whom it may concern,

Don't you think it would be prudent to examine the effects of antipsychotics on children in the long term before approving these incredibly powerful psychotropic drugs for children who have no power to grasp the gravity of the possible side effects? I'm sure there are plenty of kids who have already taken atypicals and ended up with permanent movement disorders, death, et al. Or did someone conveniently forget to collect that data? I am a concerned consumer (with a pituitary tumor exacerbated from antipsychotic use), suggesting that maybe a little more research should be done. The doctors I have met don't seem to understand how harmful these medications can be, or that they shouldn't be prescribed for long term use. I'm going to assume that there are some pharma reps responsible for this insidious misinformation.

Sincerely,

- - concerned citizen

PS. Enjoy this harmless 2 dimensional entertainment:

Re: RE: FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users

2009-10-23T10:49:00.000-07:00

Dear Kelley Cosgrove,

Thank you for your message to the Division of Drug Information at the Center for Drug Evaluation and Research (CDER), one of the five centers within the Food and Drug Administration (FDA).

The FDA is interested in learning of any adverse experiences or product problems that patients encounter and to do so has implemented the MedWatch program. This program is a voluntary system of reporting to FDA adverse effects and product problems and we view this reporting system as a source for signaling trends in these areas. As such, we encourage you to submit a MedWatch report .You can complete the form and submit online ( remember to print a copy for yourself before submitting) or you can download the forms, complete them manually and mail them to the address on the form. Forms can be accessed from our website: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

The FDA evaluates both the efficacy and safety of drug products before they are approved for use in the United States. First, the manufacturer of a drug must demonstrate the drug is safe in animals, and then they must demonstrate its’ safety in humans. Once the drug has shown to be safe, the manufacturer must then demonstrate the drug to be effective in treating the intended condition. In order to determine if a drug is safe and effective, the FDA uses the results of scientific clinical trials conducted by the drug’s manufacturer and other institutions. While the drug is in clinical studies common side effects that occur are determined with use of the drug. If a drug product gains FDA approval, the product labeling must include information about side effects, their frequency of occurrence, and any precautions that may be necessary to prevent them. The information in the product labeling serves to help health professionals determine whether or not to use a particular product, and how best to use it safely.

Once a drug product is proven to be safe and effective, and is “on the market” the FDA continues to monitor it through post-marketing surveillance studies (studies done after the drug is FDA-approved). The drug sponsor, or manufacturer, is required to report information about adverse events with their drug to the FDA. Sometimes, additional side effects and safety issues that were not found in clinical studies may occur after a drug has been on the market. In clinical studies prior to approval, a selected population with a specific condition is used to determine if the drug is safe and effective. However, after approval, drugs are prescribed to patients who may have multiple health conditions and are frequently on additional medications. As a result, additional side effects and safety issues may surface once a drug is on the market.

It is important to note that the FDA’s role is to determine whether the benefits of a drug outweigh its possible risks for the United States population as a whole. Only you and your doctor can decide if the potential benefits of a drug outweigh its potential risks for you. Consequently, many products that are FDA-approved have associated risks, but remain on the market because of their potential to bring benefit to many patients.
Best regards,
Drug Information BLS
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

RE: FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users

2009-10-16T10:47:00.000-07:00

I recently read the article on your website entitled, "FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users." It's absolutely ludicrous that Mirena is being approved for further use, while the FDA is still refusing to recognize some of the more serious side effects like anxiety, mood changes, and blood sugar problems. Not to mention debilitating hormonal symptoms, pounding heart and palpitations, crying spells, and hot flashes. I'm twenty-one years old; I should not be having hot flashes. Yet, when I was using Mirena, I awoke every night with hot flashes, and every morning with debilitating panic attacks, and spent every day feeling as though my heart was pounding out of my chest. I'm sure research will reveal to you evidence that my case is not an isolated one. I had Mirena for 3 weeks and had to have it removed in the emergency room, after calling my doctor who told me that my symptoms "could not be caused by the IUD," because, I presume, she was looking at the FDA's drug information, which did not list my symptoms, which were very obviously caused by the Mirena IUD. It's been three months since removal, and my hormones still have not normalized. I pity the fool who heeds the misinformed doctor. Thank God I didn't, I would have only suffered longer.

I'd like to thank the US Food and Drug Administration, which seems to be more concerned about Bayer's needs than mine. I mean, I guess it's nice you want to help them sell their product and all, but how about putting a little bit of consideration on giving the consumer accurate and complete information about the product before she uses it, seeing as it is marketed as a medical device.

I should not have to depend on internet forums to find a complete list of my prescription's side effects, when a little research done by the right people could give me (and the rest of the American consuming public) all the information I need.

As a side note, I also recently discovered that research has shown that Risperdal and other antipsychotics are linked to pituitary tumors, information I would have been interested in a year and a half ago, when Risperdal caused me to have a seizure and my doctor failed to notice the pituitary tumor on my first MRI--an oversight that was not corrected until post-Mirena medical examinations revealed a tumor that had grown since previous scans, after a year of constant psychiatric drug therapy. The article about the connection, which I discovered online, was published in 2006. My doctors didn't seem to know anything about it.

The incomplete informational materials available about the products you monitor are downright dangerous. But I'm going to venture to guess that you already knew that.

Godspeed, and Have a wonderful day.

Sincerely,
- -

FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users

2009-10-16T10:43:00.000-07:00

"The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.

Mirena was approved as a contraceptive by the FDA in 2000. It is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The device should be inserted by a trained health care professional.

“Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening,” said Kathleen Uhl, M.D., director of the FDA’s Office of Women’s Health. “Bleeding can be so heavy that women must miss work, school, or social activities.”

“In the primary clinical trial, women using Mirena showed a statistically significant reduction in menstrual blood loss,” said Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research.

Participants in the clinical trial had excessive menstrual blood loss prior to treatment and did not have any medical conditions that are known to cause heavy menstrual bleeding, except for small uterine fibroids in some cases.

Mirena is recommended for women who have had a child. Clinical studies to support both the contraception and heavy menstrual bleeding indications have excluded women who have never been pregnant."

That's funny, because I've seen it pushed pretty hard on women who have not had children. In fact, when I used Mirena, I was not aware that it had not been tested on my demographic.