Some complain that restrictions make it harder to find experts
Article Source: msnbc.com
from:msnbc.comLawmakers may relax FDA drug conflict rules
Seeded on Mon Aug 1, 2011 7:51 PM EDT (msnbc.com)
— Filed under: health
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Oh, good idea. Let's just strip away all regulations designed to prevent corporate abuses and declare a free-for-all on the American people. Everybody knows that industries will regulate themselves! (sarcasm)
No, let's not strip away all the regulations, but let's at least be able to put some reputable, ethical experts that have had some experience with some of these drugs on the committees. There are committee members serving right now that have very little interest or experience with some of the drugs they either approve or reject. The reputations of the experts are on the line, which should provide some assurance that they will be less likely to be corrupt, but they must have some knowledge about the drugs they are reviewing. An expert in gynecologic oncology is not always the best choice to serve on a committe reviewing lymphoma drugs and actually might still have conflicts of interest that are not obvious. At least let reputable experts in the specific field serve.
reputation vs profit...which one do you honestly believe will win in the end?
Talk about knee jerk reactions (or simply, jerk reactions). Update the policies to match the realities that the health care industry faces today...simple. Everyone has b!tched and moaned about the current FDA regs, yet whenever there is an initiative to change those regs, everyone is up in arms about "corporate this" and "greedy that,"...biased reactions fueled by the media that carry no weight with anyone who is knowledgeable on the subject. Drug approvals are at an all time low, not high. That means drugs are not going on the market "too quickly," they are not "untested." But that also means that potentially life-saving drugs (especially for orphan disease) have no chance of being approved in the near future...this new policy hopes to change that for the better.
People are suffering, other people have come up with solutions....yet the general public is more concerned with their political ideology and blind ignorance rather than researching the topic and proposing solutions. We are a nation of armchair PhD's, we think anyone with Google knows better than someone with 8-12 years of advanced degrees and 20 years experience. We take the "news" at face value and do no research for ourselves, never once stopping to think that the news is a business itself, only concerned with grabbing ratings and selling advertising. We sit behind our screens and complain about the policy makers and corporations who are innovating and trying to make the world better. It's sad, and speaks volumes as to why our country (from health care to economy) is spiraling quickly down the toilet.
that post could sum up almost every response I've ever read on here
well said
Ol Doc, I guess I'm not so cynical that I don't believe that there are experts in various type of cancers that would try to render an honest opinion about the efficacy of drugs in their field of expertise. I realize that there is never going to be a totally unbiased opinion just as there is no such thing as a truly altruistic act, but using experts who are only tangentially familiar with the treatment of a disease may be even less productive without eliminating bias.
This is going to be another BIG victory for Big Pharma. I wonder if the guy coming up with this idea is a former pharma executive.
It may be just me but everything with government seems to STINK of corruption.
If you want to know if this is a good idea or a bad idea, just look at the money trail of the lobbyists and campaign contributors who own Franken, Enzi, Gingrich, and, of course Woodcock, who gets all of her pimping money from the drug companies.
Oh great, the FDA already can't do an adequate job so let's make the process even more lax and prone to influence peddling and corruption. What we need to do is get rid of lawmakers like Al Franken and Mike Enzi and any other bastard who votes for this bill!
The FDA is a regulatory agency. They depend on physicians who practice medicine and carry outresearch for advice. You can't expect one agency to design research trials, carry them out, and then render an opinion on the drug being tested. NOt only would that be practically and financially impossible, but would be even MORE burdened with conflicts of interest than the current system
The current system where the drug company has its own private lab say its drugs are good and have no (reported) bad side effects.
Drug companies usually give grants to physicians to conduct large scale multi center trials to test out new drugs. HOw else are you going to conduct large scale human trials? Have every sick person travel to the drug co. headquaters?
Eric you are right one agency should not do all of that. However, the should regulate and improve the process which is why many of us in medicine have say the process is setup incorrectly. Drug companies should not be providing grants to physicains to conduct large scale multi-center trials. Drug companies should be giving money to the FDA to facilitate large scale multi-center trials. The FDA can then work with NIH, CDC, HHS, and others who work with physicians, foundations, and hospitals to give out grants to design and conduct the research trial. The results would of the trail would then to be analyzed by a panel of experts (similar to now). FDA would then grant final approval or disapproval. In this manner the conflict of interest for doctors would be minimize because they would be conducting the trail on the basis of an agency funded grant without knowing who the drug company was. Thus making experts more readily available to be able to sit on panels. This also gets the FDA out of attempting to design trials and completely focus on the business of facilitation, regulation, and approval.
In reality should not be that hard of a work flow since the government is practically a specialist at handing out grants. And NIH/FDA are practically involved with most foundations and hospitals anyway. But we have those tricky little things of lobbyist, money, and communication that get in the way.
there's a lot of knee jerk reaction here...slow down...
Its true that there are a few preeminent doctors in every field, and they are tapped by multiple organizations, both in industry and in academics, to lead comittees, offer advice, etc. What can you do if you are a regulatory agency looking for an opinion?
You could turn to smart, but less "famous" doctors--there are plenty of those, I agree with the Harvard paper
Or you could relax the rules as some have suggested. The diabetes example the article gives is perfect--I wonder if the Henry Ford physician even KNEW about the grant from the other company...if he's not involved in that project just let him on the FDA committee
I think its too easy to throw up your hands and declare "corporate america" again as some people are doing
The commissioner was telling the truth, they are looking for engineers (which includes software like all businesses are in the US, guess nobody wants to face the reality here and you can hear companies like Intel say the same thing. Laws can't fix that. So much of drug research is done via software any more too before a web lab is even opened and thus we get back to engineers again for drugs as well as devices. There's a great video that explains this reality that some don't seem to feel they can accept and still think laws can solve the problems at the FDA.
http://ducknetweb.blogspot.com/2011/07/fda-and-medical-devices-who-doesnt-get.html
Oh yes, Lets rush these drugs to market so we don't damage the job market.
Does the FDA even know what the hell their job is? It's not to make it easier for these companies to get bad drugs to market.
I actual heard a commercial disclamer for a drug. And cancer was one of the side effects. Cancer!
We don't need the jobs that these bad drugs create. I don't want to be a Lawyer or Mortician or a scientist who thinks a drug with six bad side effects and one marginally beneficial effect is a good drug.
What are they saying, all the experts are on big pharma's pay roll. Just because it is not convenient does not mean we should do away with rules that are in place to protect us from harm caused by greed. Have we learned nothing from the disasterous relaxing/abolishing of the rules in the financial industry. The FDA supposidly has their own unconnected experts or are they all doing work on the side for big pharma. If so make it a condition upon entering the publicly paid FDA (with all the benefits and pensions) that they can not work on the side for the companies they are supposed to regulate. Is it supposed to make me feel better that they will make it easier to sqeeuw the data disaster
@MmmMmmbear, it is funny you said that i have 5 advanced degree's and work in neurological research with 20 years work experience in europe as well as in the us. I have worked both consumer and pharmaceutical research. I now how easy it is for big pharm to get it their way. The research requirements on a phase3 and 4 study is developed by the company that developed the drug (protocol has to pass a so called independent review commitee most of whom have worked in this field for years and we all know eachother). In other words they let you know who and what they want in the studies done before we let it lose on the public, they can restrict the diseases an alzheimer study pt can have besides the target disease (so preferable the healthiest 65 year olds you know, how realistic is that) Your primary (treating dr) makes the decision if the any side effects seen are related to the drug (he gets paid per pt who completes the study) So yeah there is a lot to be concerned about if we give up even more control. The reason that so few are approved right now is because there have been so many recalls on drugs that turned out to be ineffective and/or a flat out danger to the public. The fda is concerned with getting even more egg on their face. My guess is that you or a loved one suffer from a disease for wich no effective drugs or only experimental drugs are available, i understand the feeling off inability to help or do something is devestating ( i have felt that way myself at times when i worked with patients with a tough disease) Letting them do whatever they want without oversight will kill more people then it saves, I can see were you are coming from but orphan disease would still not get a better deal if we made it easier to get approval. There simple is no money in developing a drug only a few people need, and it is all about the bottom line with these companies.
Unfortunately, money creates an environment of bias.
Scientists and researchers may truly believe that their decisions are not influenced by the 10's of thousands of dollars provided to them for consutation services and pitching drug company products, however they are wrong.
What we have now is bad, allowing drug companies to openly influence FDA regulators is a recipe for disaster.
Oh Boy! Create jobs, but who will work at them if you kill all the people who use the drugs passed by FDA panel? Oh, of course, it's all about the MONEY isn't it? God help us all....