‘Drug Disasters Are Built Into The System’
13 CommentsBy Ed Silverman // August 8th, 2008 // 11:19 am
Americans are likely to be exposed to unacceptable side effects of FDA-approved drugs because of flaws in the way new drugs are tested and marketed, according to research presented earlier this week at the annual meeting of the American Sociological Association.
“Drug disasters are literally built into the current system of drug testing and approvals in the United States,” says Donald Light, a sociologist and a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, who gave the talk. “Recent changes in the system have only increased the proportion of new drugs with serious risks.”
Systematic reviews indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects serious enough for the FDA to issue Black Box warnings, adverse reaction warnings, or even withdrawal of the drug. Based on this system, Light maintains new drugs are twice as likely to harm patients as provide benefits superior to existing drugs.
Light’s also contended drugmakers design trials to minimize evidence of toxic side effects. To do so, they sample from a healthier population atypical of patients who will actually take the drug, excluding people who are older, poorer or who have multiple health problems. Trials are run long enough to pick up main effects but not to detect some long term side effects. Approvals are based on these data; so drugs with harmful effects sometimes get through.
In his view, the current systems that boasts a drug is safe and effective could be replaced with ‘apparently safe based on incomplete information and more effective than a placebo.”
“Speed-up reviews for safety have more than tripled the number of ‘black box warnings’ of side effects or withdrawals after drugs are on the market,” Light said during the talk. “Despite recent reforms to strengthen the FDA’s role in protecting the public from harmful drugs, the harm-benefit ratio is worsening due to these reviews and relaxed rules that allow companies to promote drugs for unapproved uses.”
Dianne
“new [FDA approved] drugs are twice as likely to harm patients as provide benefits superior to existing drugs”
This is a great argument to dump FDA preemption, right now.
atlex
The author would make a more compelling case if he bothered to provide the data he based his hypothesis on, as well as the definitions he used to classify drugs as new vs. old; therapeutically equivalent or not; etc. He doesn’t seem to take into account the political dynamic that is leading to more black boxes now than in previous years. It doesn’t necessarily mean that newer drugs are more dangerous, it could just as easily mean that older drugs just don’t receive the same level of scrutiny. Finally, he clearly demonstrates a bias (notice, I didn’t write conflict of interest), otherwise he would have made an attempt to balance his presentation with one or more of these confounding factors.
Bob Freeman
Atlex, anytime anyone goes that “over the top” it diminishes whatever point he/she was trying to make. I’ve certainly done it, but I’m a curmudgeon.
John Q
atlex, clearly Professor Light sees the harm first hand. One of the harm,denial balances you could use is from a famous smoking cessation drug that is being promoted so strongly in his front door. I do believe the professor knows what he is talking about.
One does tend to have a bias attitude when they have seen the outlandish research lies firsthand. Lol about the political dynamics.
atlex
John Q,
Professor Light is not a physician, so seeing it firsthand is not quite accurate. Has he studied this…I presume so. Notice, I haven’t specifically argued against his statements, I’ve just questioned them since there is little actual evidence presented. If I and others actually saw the evidence we may or may not be able to dispute it.
Atlex
Dianne
Atlex – You raise some good points. However, I found Dr. Light’s comments to be very compelling as they relate to arguments regarding FDA preemption.
I’m from Michigan, a state where, thanks to Pharma, Engler, and a willing legislature, the “model” for FDA preemption was born. Rx victims here are denied legal redress in claims against drugs companies whose drugs are FDA approved
This Fall, the outcome of Levine will determine if this will be the fate for the rest of the country.
Silly me, but I want the old system back; the one that included the 14th Amendment which guaranteed American citizens “due process of law.”
I will write Dr Light and ask if he will provide me with his data. I have a feeling he has nothing to hide.
John Q
Atlex, it was a double entendre and clearly, that was all in vain.
Dr J Foulds is not a physician either, but he has generated quite the furry with his “expert” advice. He is currently on the same staff as Dr Light. That is why I referred to Dr Light as seeing the patients being feed pharma garbage out of his front door.(Well, I might not have said it in those exact words.)
It is refreshing to see an academic who is willing to argue the facts. The future of medicine and the health of patients must be taken away from big pharma corporation.
James R
There is also an issue with drugs that have been approved, and are being proposed for other medical issues. Let’s take Chantix, for example; this medicine was developed for smoking cessation, but has already been proposed for use for alcohol addiction. I’ve read that some doctors believe that Chantix can even help people stop chewing their finger nails, and other socially unacceptable behavior.
This medicine should be subject to more trials and research; if not for it’s current problem of severe side effects, but also for other problems that other uses might present.
So far it seems that this drug helps take away the pleasure of smoking, but also seems to take the pleasure away from other things; like life, family, and friends.
There is nothing wrong with more trials and testing; the alternative will more drug disaters.
Meg
I agree with James R that any new use dreamed up for a drug by Pharma (nail biting, for example) should have clinical trials to prevent more drug disasters.
But the article highlights the problems of initial clinical trials. Companies routinely hide lethal side effects and , gee whiz, the FDA doesn’t seem to notice, either. I believe in the Dr. Syd Wolfe (Public Citizen) theory: Wait seven years after a drug comes out, or a new use is dreamed up, before taking a drug. This way, you might dodge the bullet.
Sam
Atlex says, “Professor Light is not a physician, so seeing it firsthand is not quite accurate.
As a practiicing clinical pharmacist, I have warned physicians about
potential drug interaction problems, but they usually pay no
attention. In some cases the patients have ended up in the hospital -
so much for being a physician.
atlex
Sam, no argument with your statement.
John Q, as for your mention of Foulds. He is an expert in smoking cessation and I believe that is what he has commented on.
John Q
Atlex, hence my original statement!
Doug
Not that this posting directly relates to Professor Donald Light’s assertion that “Drug Disasters are built into the system”, but I would refer those interested parties committed to reducing human errors in drug dispensing to the following web site:
drugindexsafetysystems.com
If this resonates with you and the care of patients within your oversight, I would ask that you pass this URL along. It seems to me, that this could go a long way to reducing medication error fatalities throughout the U.S.