invincible summers

in the middle of winter I at last discovered that there was in me an invincible summer. (albert camus)

FDA: the good, the bad and the ugly September 23, 2006

Filed under: antipsychotics,big pharma,mental illness — clementine @ 7:57 pm
Tags: , , ,

let me start off by saying (and if you’re a regular reader you know this…) it disturbs me to see the ads for antidepressants, antipsychotics, etc on television. they are misleading…gravely misleading. the fda approves a drug and the pharmaceutical companies spend millions advertising their drug. the ad that always comes to mind is the zoloft commercial with the little cartoon egg.

zoloft is fda approved to treat depression, social anxiety disorder, posttraumatic stress disorder (ptsd), panic disorder, obsessive-compulsive disorder (ocd), and premenstrual dysphoric disorder (pmdd) in adults over age 18. it is also approved for ocd in children and adolescents age 6-17 years. that’s a wide range of disorders.

so, you’ve got this little egg and he is a sad egg. he pops a few zoloft and suddenly he’s HAPPY. and then, at the end of the commercial…you hear…

“the most common zoloft side effects are dry mouth, insomnia, sexual side effects, diarrhea, nausea, and sleepiness.”

say you’ve been diagnosed with depression. the symptoms of depression are: persistent sad, anxious, or “empty” mood, feelings of hopelessness, pessimism, feelings of guilt, worthlessness, helplessness, loss of interest or pleasure in hobbies and activities that were once enjoyed, including sex. decreased energy, fatigue, being “slowed down”, difficulty concentrating, remembering, making decisions, insomnia, early-morning awakening, or oversleeping. appetite and/or weight loss or overeating and weight gain. thoughts of death or suicide; suicide attempts. restlessness, irritability, persistent physical symptoms that do not respond to treatment, such as headaches, digestive disorders, and chronic pain.

in my experience ( and i have over 20 years of living with depression) sleepiness, loss of interest, pleasure and feelings of hopelessness have been the top 3. and doctors prescribe meds with a side effect of sleepiness. the majority of the meds i’ve taken have that side effect. suddenly i’m sleeping more. like 14-16 hours a day. now, how in the hell is this possible??? how can the fda approve a drug for treatment of depression to which sleepiness is a side effect? how does one “get out there and live!” “snap out of it!” when all they want to do is sleep! and it’s not even that they want to sleep- they are knocked out and have no choice but to sleep, thanks to the meds.

i’ve said here many times, we need meds that work. we need research. and today, to my surprise, there are over 262 articles online on this very subject. the new york times. usa today. abc. it’s everywhere. with headlines like: sweeping changes sought at FDA.

finally! the institute of medicine, a nonprofit organization created by congress to advise the federal government on health issues, issued a report which suggests the fda suffers from a lack of regulatory authority, organizational problems and a chronic lack of funds and staff. the report calls for increased funding and staffing at the fda, and more public access to drug studies and safety data. the report is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the government’s oversight. several senators have already proposed significant changes. the report by the committee on the assessment of the united states drug safety system, was led by sheila p. burke, deputy secretary and chief operating officer of the smithsonian institution.

some of the recommendations in the 200-plus-page report are:

1) newly approved drugs should display a black triangle on their labels for two years to warn consumers that their safety is more uncertain than that of older drugs.

2) drug advertisements should be restricted during this initial period. (absolutely!)

3) the fda should be given the authority to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies. (and they do often fail to complete studies.)

4) the fda should thoroughly review the safety of drugs at least once every five years. (important)

5) the fda commissioner should be appointed to a six-year term.

6) drug makers should be required to post publicly the results of nearly all human drug trials. (this is my favorite and should have been a requirement all along…)

the response from caroline loew (senior vice president of the pharmaceutical research and manufacturers of america) is interesting and disgusting. “it would be a mistake to accept the notion that the fda drug safety system is seriously flawed, after all, fewer than 3 percent of approved prescription drugs have been withdrawn from the american market for safety reasons over the last 20 years,” loew said.

sure, caroline, you get paid very well to say that, i’m sure. so many drugs have not been withdrawn because we haven’t had this study. the fda and the drug makers have not been held responsible, nor have they been called out…until now. kudos, however, to dr. andrew c. von eschenbach, the acting commissioner of the fda, for admitting “while considerable work has been done over the past two years to improve our approach to drug safety, work still needs to be done.”

the good news is the fda asked the institute of medicine to review its drug safety system shortly after the vioxx withdrawal in 2004, and the agency agreed to pay $3 million for the study. the bad news: the pharmaceutical industry is likely to fight at least some of the proposals.

of course this report is not directed solely at any particular medication but we all know antidepressants and antipsychotics make the pharmaceutical industry billions and billions. there are black-box warnings on the labels of most psychiatric drugs available today. yes, we need research and we need meds that work. we need people to stand up and say—the fda, the doctors and the pharmaceutical companies must be held responsible.

click here to read some of today’s headlines.


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