Wait - Medical Devices Have To Work Before The F.D.A. Approves Them?
Picky, picky. Do you really care that that stent the cardiologist is putting in your heart is safe and effective? Let's hope not, vis a vis this Gardiner Harris story for The New York Times on apparent misconduct at the F.D.A:
WASHINGTON -- Top federal health officials engaged in "serious misconduct" by ignoring concerns of scientists at the Food and Drug Administration and approving for sale unsafe or ineffective medical devices, the scientists have written in a letter to Congress....The letter says that the scientists have documentary evidence that senior agency managers "corrupted the scientific review of medical devices" by ordering experts to change their opinions and conclusions in violation of the law.
Dr. von Eschenbach asked William McConagha, the agency's assistant commissioner for integrity and accountability, to investigate the accusations, the letter states. Mr. McConagha characterized the documentary evidence supporting the accusations as "compelling" and sufficient to justify disciplinary actions, it says.
Mr. McConagha may have recommended the removal of certain agency managers, Mr. Dingell and Mr. Stupak said.
...The letter further says that Congress should consider reforming a process in which, the scientists say, the F.D.A. agrees to approve complex medical devices on the basis of little evidence of effectiveness.
Same NYT journo here, writing of more sleaze in medicine; this time, a "renowned child psychiatrist," Dr. Joseph Biederman, who apparently pushed Johnson & Johnson to fund a research center whose goal was "to move forward the commercial goals of J&J":
The documents also show that the company prepared a draft summary of a study that Dr. Biederman, of Harvard, was said to have written.Dr. Biederman's work helped to fuel a fortyfold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children.
Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions.
Johnson & Johnson makes a popular antipsychotic medicine called Risperdal, or risperidone. More than a quarter of its use is in children and adolescents.
Last week, a panel of federal drug experts said that medicines like Risperdal were being used too cavalierly in children and that regulators must do more to warn doctors of their substantial risks. Other popular antipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made by Eli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and Abilify, made by Bristol-Myers Squibb.
Thousands of parents have sued AstraZeneca, Eli Lilly and Johnson & Johnson, claiming that their children were injured after taking the medicines; they also claim that the companies minimized the risks of the drugs.
I just had an acquaintance return from a trip from Cambodia with some kind of gastrointestinal ailment. He's been very sick since July, but he couldn't get his doctor to okay a colonoscopy, which he obviously needed. Instead -- unbelievably -- the doctor removed his gall bladder. Based, apparently, on a guess. He was too upset or too bashful to talk much about this, but eventually got the colonoscopy he really needed, got diagnosed based on it, and is on medication for apparent parasites.
This guy is not some dumb naif, either, but people, even the most intelligent people, are often at the mercy of the medical profession. I'm not one of those advising people to forego western medicine for the advice of some gray-skinned hippie in the healthfood store (as if there's no profit motive in that industry!). But, a doctor's advice should always be approached with skepticism. A pity that most people aren't that equipped to have it or exercise it in any meaningful way.







Given that doctors kill more people every year than anything else, you'd think they would be a little less surprised when you question their judgment.
We've erected a wall of infallibility around doctors, and most people believe doctors unquestioningly. This was not always the case.
brian at November 26, 2008 6:55 AM
Amy Alkon
http://www.advicegoddess.com/archives/2008/11/26/wait_medical_de.html#comment-1607721">comment from brianMy own doctor at Kaiser, judged one of the best in some doctor ranking, decided to put me on serious medicine for GERD -- gastroinestinal reflux disease -- after getting an e-mail from me about my symptoms. I had only a single symptom of GERD (lots of tiny little ladylike burps all day), and I did not have GERD -- I knew that. She told me, heh heh...that I could help my supposed GERD by cutting down on my drinking (oh, you mean from maybe a glass of wine a week to maybe a half-glass?), or losing weight (I weight about what I did in high school), or by exercising (I exercise daily on a bike and I'm in really good shape).
Oh yeah, I figured out what was wrong with me -- after an endoscopy that ate my memory and put me out of commission, cognitively, for a week, while I was in a haze and couldn't get out of bed. (I think it was that they gave me -- skinny, delicately-constitutioned me, who gets drunk on a single glass of wine and gets carsick from her own driving -- a "standard" does of anesthesia.) I'm fine now, and I was the one who eventually figured out what was wrong with me: bizarrely, roquefort cheese makes me deathly ill.
Amy Alkon
at November 26, 2008 7:14 AM
"This was not always the case." I think you have it backwards. People question doctors a lot more now than they did in the past. While before our time look up stories for when doctors used to sell cigarettes. Particularly for the treatment of Asthma, bronchitis and sore throat.
vlad at November 26, 2008 7:40 AM
BTW have you tried Roquefort cheese again to make sure you are in fact correct? The cheese could be coincidental.
vlad at November 26, 2008 7:42 AM
Amy Alkon
http://www.advicegoddess.com/archives/2008/11/26/wait_medical_de.html#comment-1607738">comment from vladYes, I have "tried" it. Four times. It was the repetition and getting deathly ill each time that told me what it was. Each time it was in or on a different food and the tiniest amount of it makes me seriously sick.
Amy Alkon
at November 26, 2008 8:20 AM
Something that's a big deal right now is that FDA approval is giving corporations that make drugs/medical devices protection - even if their product was bad. It prevents consumers (VICTIMS) from being able to sue companies even if something really bad happens that could have been prevented with better labeling and more thorough, explicit information going to the doctors who give this stuff out.
The main goal was to bar superfluous lawsuits but it in effect gives too much power out of the hands of the people who are subjected to these medicines.
Check out the film "Access Denied?" over on www_afj_dot_org. A woman lost her arm when a drug was injected incorrectly into her arm causing gangrene. The whole thing is effed.
Gretchen at November 26, 2008 9:30 AM
Maybe it's just me, but I thought that the most disturbing thing by far in these articles was the fact that so many thousands of children are on drugs that should be reserved for mass-murdering lunatics in padded cells. "Popular" extra-strength antipsychotic medicines?!? I suspect that 100 years ago, any case of "pediatric bipolar disorder" would have been diagnosed & treated by parents with a quick trip to the woodshed. Nowadays the same paranoid parents (see yesterday's post) who don't let their kids climb trees or play softball rush them off to be medicated after every tantrum.
Who's more at fault - the quacks who are willing to prescribe these pills to children, or the pathetic parents who create the demand in the first place?
Martin at November 26, 2008 9:34 AM
Science and medicine have made some remarkable, miraculous advances. The polio vaccine. But one, or even many successes, can't be used to project that every doctor is a Jonas Salk.
Sadly, in so many cases, if you point out the systemic incentives to reward corruption (lying about data to get the grant, the promotion, the new lab, the patent, ...) and show that the testing is flawed, you're accused of being an anti-science luddite.
jerry at November 26, 2008 10:29 AM
Amy Alkon
http://www.advicegoddess.com/archives/2008/11/26/wait_medical_de.html#comment-1607774">comment from MartinI'm with you, Martin. I think it's horrifying, and especially since there's a good chance use of these drugs is based on the profit motive.
Amy Alkon
at November 26, 2008 10:30 AM
Martin - it could be the doctors convincing the parents that they need to drug the kid.
I had a doctor for a short while (change of insurance and my doctor wasn't covered) who would reach for the prescription pad before he even finished diagnosis.
Needless to say, I ran away as fast as I could when the opportunity presented itself.
brian at November 26, 2008 10:33 AM
Amy Alkon
http://www.advicegoddess.com/archives/2008/11/26/wait_medical_de.html#comment-1607779">comment from brianI've mentioned this before: When I was in my mid-twenties I had a shrink in New York who saw me for about half an hour before he whipped out his prescription pad and told me he was writing a prescription for...Lithium!
Hello?
What was ailing me? I was kind of down because I was having a string of bad luck with guys and also because wasn't making enough money to live comfortably in the city. The guy thing soon changed, and the money thing did, too, after an ad agency hired me to write and produce their Christmas film. Clearly, I had a very serious psychiatric disorder requiring heavy-duty drugs!
Amy Alkon
at November 26, 2008 10:48 AM
My rule, as a parent, before popping meds in my kids is 2-fold:
1. Has this been around a long time and does it effect a cure? Penicillen and things of that nature get a pass here
2. If my child incapable of living a normal life without this? People are sad sometimes. And pissed off sometimes. And irrational lots. I agree that autism is on the rise. I also think it's way overdiagnosed in people who would, a generation back, just been a little less than social. Ditto with ADHD/ADD. Some people have higher energy than others. Doesn't always require a pill.
Having been pregnant 3 times now, it's insane the # of category C drugs (no testing/unknown safety to fetus) are given to pregnant women. Apparently that's their new way of testing it. For instance, they give Ambien out like candy in the hospital and drs offices now, pregnant or no. Safe? Who knows? Like above, it needs to be lifesaving (and not fatal to the baby) for me, or around for generations already.
Poorly educated medical consumers are a problem. We expect car salesmen to be after our money. We need to expect it of the drug companies as well.
momof3 at November 28, 2008 7:41 PM
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