Is the FDA failing?

[BradleyRN]

With a booming pharmaceutical industry, the casualties from newly approved drugs have been in the news quite frequently. Drugs such as Rezulin, Celebrex, Vioxx, Fen Phen, Prempro, Bextra, and Avanida have all either been recalled, or required strict "black box warnings" regarding the potential serious risks of taking them. Sadly, after their release to the public, many people suffered liver and heart damage or strokes at the hands of some of these obviously under-scrutinized medications. At the same time, the pharmaceutical industry fought in court to defend them and keep them on the market, if only for a few extra months. How does the public not notice this profit-driven, underhanded lack of conscience on the part of pharmaceutical industry, who in the face of human beings suffering or even dying when taking their products, fight for years if necessary to keep them in use?

Now the pharmaceutical industry is fighting for legislation that prevents people from suing them, under the logic that the FDA had approved and deemed safe the drugs that may have caused the harm. If that legislation passes, then it will be long overdue for the FDA's unsound methods for drug approval to be revamped. At the same time, some drugs are able to go through a shortened approval process by the FDA. Rezulin was one of those, and it killed hundreds and caused permanent liver damage to thousands while it's manufacturer fought it's ban for 27 months before it was finally recalled. (drug recalls) The pharmaceutical lobby also recently halted legislation that would have put a stop to drug companies with name brand drugs paying generic manufacturers to delay the release of their generic equivalent. CBS reports that this practice will cost the public billions. How can that be legal in the first place?

It would seem that this pattern would eventually lead to a distrust in the safety of new drugs as well as the FDA's ability to provide an accurate assessment of their safety.

Do you believe the FDA is failing to effectively screen new drugs for their safety before release?

[Tash4nvyblues, RN]

The FDA will continue to fail, if this legislation goes through that the pharmaceutical companies cannot be sued, and it will go through, because the pharmaceutical lobby has far too much power. The FDA will still pass unsafe drugs because the pharmacy companies will make sure they are passed. The public will continue not to notice because they place total trust in their doctors, who I have no doubt are collecting a tidy little profit from the drug companies to promote the unsafe drugs in the first place.

[FERN-tastic]

I hadn't heard about the immunity from lawsuits legislation. That is terrifying. Already the FDA seems to be little more than a puppet of the pharmaceutical company. Much like the USDA is run by the same people it is supposed to police...very ineffective. It is very sad that the demand for outrageous profits has made public safety not only an afterthought, but an inconvenience.

[puggy232]

No wonder the FDA receives roughly 85% of it's founding from pham co why bite the hand that feeds you?

[BradleyRN]

No wonder the FDA receives roughly 85% of it's founding from pham co why bite the hand that feeds you?

Indeed! I just watched a documentary recently that 50% of the FDA's funding comes from pharmaceutical companies! I wonder where the other half comes from? Food companies? How can an organization regulate an industry that pays it's salary? What ever happened to conflict of interest in this country? And where are the rest of you to comment on this issue? Are you afraid of the FDA?

[azhiker96, BSN, RN]

No, I would not say the FDA is failing any more than I would say our Police and Fire departments are failing. The problems with Vioxx and several other drugs were discovered in Phase IV trails which is ongoing reporting to the FDA after a drug has passed phases 0, 1, 2, and 3 and been released to the public. The FDA is truly between a rock and a hard place where interest groups scream that new meds for their particular malady are hung up in years of testing and the general public is outraged if a drug that has been released turns out to have unforseen negative side effects.

I didn't see the documentary that is mentioned but I do know companies are required to pay for FDA required testing and those costs are very significant. Perhaps that is where the idea that the pharm companies are providing funding for a particular branch of our government. Maybe we should tell those rascals to keep their money and let the taxpayers pay for the trials so we can avoid a conflict of interest.

I do think there's room for improvement in the way the FDA oversees foods and nutritional supplements. It's an embarassment that salmonella made it's way into our peanut butter. It's also ridiculous that people are allowed to make all kinds of unsubstantiated claims about herbs and such without doing double blind studies to test those claims.

[BradleyRN]

"Only a drug can cure, prevent or treat a disease". That is FDA policiy. Or as it states here...http://vm.cfsan.fda.gov "The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."

Well that policy is skewed toward pharmaceutical companies. And the reason is, is that there is no profit in natural remedies. But if you look at Dr. Dean Ornish's diet, that successfully reverses heart disease, how could anyone support such a biased policy? Anyone who believes that only a drug can prevent, treat or cure a disease i hope is in on the profit, and not just blinded by government policy, because nutrition can certainly do all of those.

[azhiker96, BSN, RN]

"Only a drug can cure, prevent or treat a disease". That is FDA policiy. Or as it states here...http://vm.cfsan.fda.gov "The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."

Well that policy is skewed toward pharmaceutical companies. And the reason is, is that there is no profit in natural remedies. But if you look at Dr. Dean Ornish's diet, that successfully reverses heart disease, how could anyone support such a biased policy? Anyone who believes that only a drug can prevent, treat or cure a disease i hope is in on the profit, and not just blinded by government policy, because nutrition can certainly do all of those.

That's actually not policy, it's a definition of what items (drugs) must undergo rigorous testing to prove they are both safe and effective. Regarding food additives, and also from your source;

"By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products."

Now the industry that markets and sells nutritional supplements does so because they want to make a profit. If they had to test and prove their claims that would cut deeply into their profits and they're greedy. Besides, the people they market to don't require proof. In fact, the consumers don't even need to see it on the outside of the bottle which is how they skirt the intent of the FDA. If people can find websites and word of mouth that these things can cure cancer (noni juice) or whatever they are happy to shell out their bucks to grasp at straws. After all, who needs double blind studies when you heard it in a forwarded email!

I do like that Ornish Diet, thanks. I had not heard of that before but it's not at odds with modern medicine. In a nutshell, it's a low-fat high-fiber diet with exercise. Sounds pretty familiar to me and certainly something the US government has been trying to promote with it's food pyramid and exercise guidelines. I think I'll have to go check it out at Borders.

[hypocaffeinemia, BSN, RN]

"Only a drug can cure, prevent or treat a disease". That is FDA policiy. Or as it states here...http://vm.cfsan.fda.gov "The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."

Well that policy is skewed toward pharmaceutical companies. And the reason is, is that there is no profit in natural remedies. But if you look at Dr. Dean Ornish's diet, that successfully reverses heart disease, how could anyone support such a biased policy? Anyone who believes that only a drug can prevent, treat or cure a disease i hope is in on the profit, and not just blinded by government policy, because nutrition can certainly do all of those.

The billion dollar supplement and natural product industry disagrees with you.

Also, that's the naturalistic fallacy at its worst.

--

Another point: The FDA doesn't regulate or approve diets. They are not able to say whether or not a diet works to cure disease-- that's not their job. They just regulate specific products and ensure anything claiming an effect has been tested.

You're totally on the wrong path if you think that anyone, let alone the FDA, is arguing that only medication alone can cure, treat, or prevent disease. The scientific research that backs mainstream medicine and nursing totally supports the use of diet and exercise.

The FDA merely says that if you claim your product cures, treats, or prevents diseases, you better damn well pony up the research on it.

[BradleyRN]

If people can find websites and word of mouth that these things can cure cancer (noni juice) or whatever they are happy to shell out their bucks to grasp at straws. After all, who needs double blind studies when you heard it in a forwarded email!

Indeed! A whole plant diet is all i can recommend. Noni juice or Mangostein or any of those other "cures" should not be confused with true homeopathic treatments.

I do like that Ornish Diet, thanks. I had not heard of that before but it's not at odds with modern medicine. In a nutshell, it's a low-fat high-fiber diet with exercise. Sounds pretty familiar to me and certainly something the US government has been trying to promote with it's food pyramid and exercise guidelines. I think I'll have to go check it out at Borders.

Indeed it is not at odds with modern medicine, but there is a reason why you have never heard of it, when in fact it should have been the first thing we ever heard. Of course diet and exercise are not a new concept, but the idea that being a strict vegetarian with daily exercise will reverse heart disease is not nearly as widespread an idea as stents and bypasses.

[hypocaffeinemia, BSN, RN]

Noni juice or Mangostein or any of those other "cures" should not be confused with true homeopathic treatments.

There's no such thing as "true homeopathic treatments".

Homeopathy is pseudoscience-- water does not have "memory" and diluting substances down to 1 part per billion or less while expecting therapeutic effect is the epitome of ludicrousness.

Maybe you mean holistic instead of homeopathic?

[BradleyRN]

Maybe you mean holistic instead of homeopathic?

Holistic indeed.