Fda

[Aki]

Anyone know about the Food and Drug Administration, and how they are corrupted. The drugs they recommend actually cause side-effects; yet these drugs are recommended because those drug companies pay the FDA to approve their products. This is just ridiculous. A group of people are making all huge sum of money, while the population are and are going to be suffering from side effects for years to come.

[Queso]

And I can't believe people still take the products (which should be taken off the market) even after they know they are harmful.

[Buffy]

Corrupted isn't quite the right word. First of all, most of the people who work at the FDA are lifers, who actually are there because they want to help people. The problem of course is that policy is set by the folks at the top who churn with the changes in the adminstration. At the moment, the word coming down from the top is to "let all these wonder drugs have a chance, there's *too much* testing required which is preventing useful drugs from coming to market."

 

I actually find much more fault with the drug companies--and worse, the incentives for investing which increasingly emphasize short-term profits--that mean that the companies are motivated to put all their R&D into drugs for live-or-die products that also have long regime requirements (you gotta take em for a long time). This of course includes AIDS drugs, but we are in big danger of a horrible Flu pandemic (check out Google news today), and no drug companies want to get into it because the costs are high and the margins are low.

 

Policy-wise, there are some great arguments for government funding things like this, but our profit-driven Republicans always disdain this course of action as "leading down the slippery slope to socialized medicine."

 

Bottom line: if you ever meet someone from the FDA, ask em if they've been appointed. If they say "no", say "I think its really great that people give up the extra money they could make elsewhere to make us all safer," and if they say "yes," kick them in the shin and say "what are you idiots *thinking*!"

 

Geez, this thread really belongs over in the Social Sciences forum....

 

Cheers,

Buffy

[Buffy]

And I can't believe people still take the products (which should be taken off the market) even after they know they are harmful.

This is so hard. I have a friend who was prescribed Vioxx just a month before the latest uproar. She stopped immediately, but it was not an easy decision. The stuff actually worked to relieve some *very* painful symptoms which all came back upon stopping. She stopped of course because of the not necessarily likely possibilty that she'd end up dead from a heart attack.

 

This doesn't excuse the unbelievably immoral behavior on the part of the drug companies, but there *are* trade-offs that aren't very clear cut...

 

Cheers,

Buffy

[Aki]

The sad part is that almost all doctors in the US are part of this. So they would prescribe and recommend the drugs. If doctors cannot be trusted, then who are you supposed to trust?

[Buffy]

Doctors are a "part" of it. But they rarely benefit directly. They DO get "free samples" (Tom Lehrer fans will recall "The Old Dope Peddler"), but kick-backs are grounds for losing ones license to practice, and patients tend to avoid doctors who prescribe drugs that aren't covered by their insurance companies and HMOs. The insurance/HMO folks are a *huge* counterweight to the drug companies, much worse that what the conservatives have accused the FDA of doing: I'm one of those many people with hereditary high cholesterol, and the only one of the many drugs out there that doesn't have serious side-effects for me is one that my insurer refuses to pay a dime for.

 

I actually feel pretty sorry for doctors these days, these folks are getting squeezed by everyone. The only way to make money these days is to be a specialist, and that's why its so hard to find a GP these days cuz its low income: they're the ones who write most of the prescriptions.

 

Cheers,

Buffy

[Fishteacher73]

One problem is that EVERY time you take a new medicine (For you, the medication could be decades old) it is an experiment. Add in this fact that you could be taking other medication that could interact as well means you really do not know how you will respond to any meds. You can have a good idea and the FDA assigns safty based on the most common results, not the abberant reaction to the med.

 

This is assuming that the system is working properly. No one aspect of the system is corrupt, but the subtle errors and abuses of the grey areas in each step have rendered the system inept and floundering. Drug regulation is a daunting task, and the whole system, from drug companies, doctors, insurance industry, to the media all have areas that need repair to end up with a functional system.

[pgrmdave]

I've always gotten the impression that drug regulation cannot be perfect, but we try to balance making sure drugs are safe with making sure that people who could benefit from the drug are able to obtain it quickly enough to make a difference. The problems tend to come when the drug companies put profit over people. While I tend to support a capitalist market, and think that competition tends to breed innovation, I think that drug companies should be national, or even universal. Once they were no longer concerned with profit, drugs that may not have been developed simply because they weren't profitable would be created.

[Fishteacher73]

A similar idea was brougfht up on another thread, but no one wanted to discuss it, maybe we can get it rolling now, but here the original post:

 

It seems that most industrialized countries are doing research that only will concern them. What is the role of medical science in terms of the whole world? Does it have a duty to look at the globe as a whole, or does it just concentrate on the needs of those in its society?

 

A good example is Chagas disease. A reasonably common disease in Latin America. It is estimated that 25% of the population is at risk (Arpox. 120 million people). Of those that contract the disease 25-30% die from it. That is a possible mortatlity of 30 million people. Yet in the US, the disease almost unheard of. There are a few cases each year in the boarder states, but very little is said about these. Currently there is no know cure, the only medications only are helpful in reducing the symptoms durring early onset. Should the US medical industry be responsible enough to investigate this disease even though there is no money in it for them?

[Aki]

Wasn't there a while ago a doctor who stood out and critized the FDA, and how other doctors should get out of it?

[Biochemist]

I hate to be the only contrarian here (OK, I don't- I sort of like it) but the US pharmaceutical industry is the envy of the world.

 

The capitalist system that spurs investors to put cash into extremely high risk endeavors is the strongest motivator to drive innovation. In the US market, this not only applies to pharmaceuticals, but also biopharmaceuticals, medical devices and (in some cases) innovative medical procedures.

 

It costs about $750 million to get a new drug to market. No one would make that kind of investment unless they got some sort of proprietary protection to get the money back, and that is why we grant patents to drug manufacturers. We do the same thing (copyrights) with authors and musicians as well.

 

It is true that medications are dangerous. No drug has one effect. But the majority of the dramatic improvements in morbidity and mortality over the last 50 years are directly related to advances in pharmaceuticals. Even advances in surgery are only possible because of advances in anesthesia. During the civil war, physicians would give patient a shot of whiskey and then saw off a leg. Literally.

 

If we nationalized the production of pharmaceuticals, the quality and quantity of innovation in the indutry would plummet. We can complain all day long about the profit motive of pharmaceutical companies or the conflicts of interest within the FDA, but those companies have added millions of life years in the US alone.

 

Hmmm. Did I sound emphatic enough? Time for another cup of coffee.

[McGyver]

Great thread discussion! Here are a few of my insights and details from in-depth experiences with the CDRH (Center for Devices and Radiological Health) division of the FDA. The CDRH regulates medical devices. Bear in mind that the FDA just began regulating products in 1976, and most existing products were just grandfathered in, the implications of such is a whole other discussion. I received a CNS Delta shunt implant to treat hydrocephalus following a 1992 auto accident. I was familiar with FDA regulations from prior medical work. But when it appeared that my "poor" post surgical outcome could be due to critical reports on this Delta shunt (Medtronic/PS Medical), it was safer for the U.S. neurosurgery field to just abandon me as a patient. I was then forced to explore and confirm this via a 1996 FDA Petiton, to which the manufacturer failed to report for years. I actually had to invent a new CNS Shunt Testing system, the DiaCeph Test, in order to get corrective surgery. After the FDA concurred with my Petition, they cut me off and refused to allow me to speak at the very 1999 STAMP Conference I helped create. Our U.S. health system is the most advanced and lucrative in the world, and with that comes responsibility. The most critical oversight mechanism is the "reporting" requirement, that is, when manufacturers become aware of problems with a drug or medical device through ANY means, that they are required to report this to the FDA within (I believe) 30 days. If they fail to do so, they can face stiff fines and JAIL. In the case of the CNS Delta shunt, the FDA kept their findings out of public record so that Medtronic could escape criminal prosecution, and could successfully acquire Sofomar Danek in the Oct. 1998. What may have been good for Wall Street handicapped an industry, when without accountability, Medtronic/PS Medical was able to take over as the market leader in the CNS shunt products industry. The reporting requirement works on the HONOR system, and SHOULD encourage more open dialogue between FDA and mfrs. But it hasn't. Instead, we've gotten extreme positions on either side of science. Issues are expected to arise in the approval process, but mfr's should refrain from using lobbyist to exert influence and interefere with FDA protocols, as this compromises science and integrity. Rather, they should use open communication, leading science, and reasonable compromise. Making things worse, some FDA scientists have left FDA posts and taken positions with the very companies who's products they were approving. Simply the appearance of impropriety is enough to raise suspicion with so much at stake, and so much behind public view. No drug or medical device will ever be 100% free from issues or defects under every condition. It is up to industry to continually re-evaluate and improve QA practices, and take us into the 21st Century. With more open lines of communication of issues of oversight, and product science and use, we just might find a healthy workable middleground. You can read much more on my efforts and experiences with CNS shunts, AI, and FDA modernization at http://www.diaceph.com/hydrocephalus.htm.

[Biochemist]

Great thread discussion! Here are a few of my insights and details from in-depth experiences with the CDRH (Center for Devices and Radiological Health) division of the FDA. The CDRH regulates medical devices....

Welcome to the forum, McG- I don't know much about the approval process for devices. How is it different than the approval process for drugs?

[McGyver]

Welcome to the forum, McG- I don't know much about the approval process for devices. How is it different than the approval process for drugs?

The approval processes for drugs is nearly identical to devices, except that a greater percentage of drugs must file under PMA rules, and will not be subject to the more expedient 6mo to 1 yr for 510ks. In 510ks' mfr's can piggyback on the expensive and 7 year process undertaken by first time technology and drug submissions.