An ailing FDA needs a cure

San Francisco Chronicle ^ | 11/28/4 | Editorial

[SmithL]

IT'S HARD TO SEE how the country's drug safety agency will emerge unscathed from a string of failures -- nor should it. Devastating scandals, touching millions of lives, demand a tough appraisal of a fumbling agency that has lost its way.

The Food and Drug Administration badly needs a shakeup and fresh leadership. It also requires new rules that will bar a repeat of the sluggish and negligent conduct that produced so many mistakes.

Botched flu vaccines, late warnings on the dangers of anti-depression drugs for children, a pill recall by Vioxx maker Merck suggest the agency isn't doing its job. A safety expert within FDA ranks has suggested five other widely used drugs are too dangerous to be used.

Most tellingly, the FDA maverick, Dr. David Graham, told a Senate panel that the agency is "incapable'' of getting bad drugs off the market.

It's past time for reform. The question is which direction the agency will take to restore its lost credibility.

For two years the FDA has had an acting, not permanent, head. The White House has stayed oddly quiet as the FDA's problems multiplied. It needs to give full backing to a new agency head who will end the institutional drift.

More than anything, the agency needs a new definition of itself. In the 1960s, it was known for high standards and exhaustive testing. Thalidomide, a drug that caused birth deformities, was permitted in Europe, where it led to widespread deformities, but not here, where regulators rightly banned it.

Then came the AIDS epidemic in the 1990s when activists pushed for faster approvals of promising drugs.

[SmithL]

Then came the AIDS epidemic in the 1990s when activists pushed for faster approvals of promising drugs.

This has always been about the political clout of the AIDS Activism industry.

[Thebaddog]

How many dollars does the FDA eat up every year for this string of failures? If there were a real price to pay, as in death to the administrator that let pass a dangerous drug, would we still see the same problems?

[TASMANIANRED]

A few facts of life.

Nothing is 100% safe. Nothing can be made 100% safe.

An overdose of water can kill you and I'm not speaking of drowning.

Part of the problem is not that the FDA is improperly doing their job. Physicians are not prescribing medications properly.

Drugs are tested primarily in adults. It is unethical to test drugs randomly in children unless it is a condition that affects only children and then the benefits have to outweigh the risks.

Physicians routinely use drugs off label. I have seen children as young as 3 on prozac and it is a physician problem not an FDA problem.

The nature of testing is pretty much insane . In the early 90's there was a situation where a man had had a heart attach and collapsed at home. His arthritic wife called ems . She couldn't get down in the floor to do CPR so she did chest compressions with a toilet plunger.

Survival for a complete Cardiovascular collapse outside a hospital are not good, in fact they are almost 0, without immediate defibrilation.

This guy did great even though there was no mouth to mouth. The Er doc and the cardiologist thought about it and reasoned that the positive and negative pressure from the toilet plunger caused greatly improved cardiac filling and therefore greater circulation. Plus the pulling up on the plunger with the vacuum did ventilate the lungs.

These docs tried to create a device that could duplicate this for full arrests that rolled into ER. It could have had dramatic results in improving the outcome of patients in full arrest. The FDA shut them down completely.

No previous informed consent.

[SmithL]

All drugs are potentially dangerous and potentially helpful.

We don't need the government or the attack lawyers killing off drugs that may help some people, while posing a danger to others.

I want the truth about the risks and benefits. I want my doctor to not be beholden to any industry so he can help me decide which drugs are appropriate for me. If we have the facts, and I make an informed choice, then the consequences are on me.

[Thebaddog]

That would certainly be the perfect world. And then the FDA would be redundant in the British sense of the word. How did the FDA come into being, by the way?

[Carry_Okie]

How did the FDA come into being, by the way?

The FDA protects drug companies by limiting their liability for the product. The solution is proper market structure via insurance deregulation and tort reform without an FDA.

[TASMANIANRED]

I am in full agreement.

Before vioxx was pulled off the market,In the literature there were clear warnings about the increased risk of congestive heart failure, increased risk of bleeding and the possibility of clots.

It was available to every physician.

[labard1]

"If there were a real price to pay, as in death to the administrator that let pass a dangerous drug, would we still see the same problems?"

If those were the stakes, we'd never get ANY new drugs approved. It wouldn't be the "same problems", it would be different ones.

As someone whose life is dependent on the development and approval by the FDA of new drugs for a current life-threatening condition, I can tell you that my concern is more with getting drugs through the hurdles placed in the way by the FDA than with the possibility that drugs will be approved that help most users but which may have bad effects for some minority of users (even if I turn out to fit in that minority). People like me face the CERTAINTY of death if the FDA delays the process too much. To delay decision on approval of a potentially lifesaving drug is to make the decision to let people who could be helped by the drug die.

Mandatory disclosure (labeling) of known risks is far better than the current system of precluding the use of drugs that haven't undergone years of testing at a cost of millions of dollars. If there were no FDA, more Americans would live longer than under the current system.

Graham is a typical bureaucrat trying to make his position more powerful. I detest the authoritarians who try to make their fellow citizens stand in metaphoric lines and rows.

[labard1]

"The FDA protects drug companies by limiting their liability for the product."

I agree with your recommendations, but FDA approval doesn't carry any real protection against product liability. There have been massive class action lawsuits holding drug companies liable for drugs approved by the FDA.

[Thebaddog]

Good post.

[Carry_Okie]

There have been massive class action lawsuits holding drug companies liable for drugs approved by the FDA.

The heck they haven't. Those liabilities would have been even worse. Further, the vast expense of qualifying for FDA approval assures big drug companies a closed market.

[labard1]

"the vast expense of qualifying for FDA approval assures big drug companies a closed market."

The patent system itself provides a closed market, but has proven the best vehicle to expand human knowledge. But you're right, the FDA process makes getting approvals for new drugs so expensive that many good ideas simply fall by the wayside because they are too expensive to pursue, given the limited payoff. There are some special rules for so-called orphan drugs which help VERY small groups of people, but many more drugs are kept off the market by the process. It's amazing, but many ideas developed in the US are marketed in Europe and elsewhere long before they can be sold in the US because of the FDA.

[BlazingArizona]

It's time to totally defund and disband the FDA. If testing of new drugs were done by competing private testing organizations, corruption would be immediately punishable by loss of confidence in and bankruptcy of the testng company concerned. Without the FDA's coerceive power to keep drugs off the market at the behest of drug manufacturers, we would see a lot more innovation and faster release of new medications.

[labard1]

Bravo! It's probably politically impossible in the short run, but that's where we should want to go.