Preventing The "Early OK" From The FDA

(And I also posted briefly over here, by the way.)

In an editorial today, the New York Times tells us that Bushco’s Food and Drug Administration doesn’t really care a whole hell of a lot about trying to determine whether or not the drugs or medical devices they regulate are safe or effective (surprised?)…

The makers of drugs or medical devices are required to obtain financial information from the scientists conducting clinical trials before the trials start, consult with the F.D.A. to resolve serious conflicts and submit all the financial information to the F.D.A. when they apply for marketing approval after the trials end. The agency is supposed to evaluate whether any conflicts that are uncovered undermine the reliability of the trial data, and if so, how tainted data should be handled.

The inspector general found that fewer than 1 percent of the doctors who helped oversee clinical trials reported any financial conflicts — such as consulting payments, honoraria, grants, patents or stock options — that might influence their studies. That number seems unbelievably low given credible estimates that one-fifth to one-third of all doctors have such conflicts.

Also…

The agency…strongly opposed a recommendation that it require companies to submit financial conflict information before a clinical trial is started, not after it is completed. The F.D.A. complained that that would increase its workload for no clear gain, especially since many drugs or devices that enter clinical trials never reach the market.

The Times said that they believe this is a lame excuse, and they’re right (and here is an example of a pesticide that received premature approval, Iodomethane, which apparently has less adverse side effects concerning ozone layer depletion, but which is known as a human carcinogen).

Something else to factor in, though, is the legal concept of “pre-emption,” which means that your product is immune (a device in particular, but the drug legalese is slightly different) from a lawsuit for alleged negligence if it received pre-market FDA approval first (as noted in this post about the ruling in the case of Riegel v. Medtronic, viewed as a victory for Bushco of course, with Scalia quoted as follows (according to the Times from a nested post link)…

A jury, looking only at the injured plaintiff, will tend to weigh only the dangers of a device and “is not concerned with its benefits,” Justice Scalia said, adding, “the patients who reaped those benefits are not represented in court.”

So, according to Scalia, if you or I are grievously harmed due to a drug or device wrongly approved by the FDA, it’s more important that the manufacturer is rewarded for the times that drug or device actually does what it’s supposed to, as opposed to punishing them for their negligence.

Soulless bastard…

(In the Riegel case, by the way, the Times reports that a patient was injured during an angioplasty when a balloon catheter burst while being inserted to dilate a coronary artery. The device won F.D.A. premarket approval in 1994, two years before the incident. The patient, Charles R. Riegel, died after the lawsuit was filed, and the case was carried on by his widow, Donna.)

There is actually some good news to report on this issue, though; this post tells us that the Supremes, in the case of Warner Lambert v. Kent, affirmed the lower court ruling (4-4, with Hangin’ Judge J.R. abstaining) which held that a drug manufacturer that failed to warn the public about the dangers of its product -- and may have concealed key information from the FDA regarding the risks of the drug -- cannot hide behind a Michigan state law that provides immunity to prescription drug manufacturers.

However, the Supremes (as noted here) recently heard oral arguments in the case of Wyeth v. Levine; here is a summary…

The Wyeth case originated with Diana Levine, a Vermont songwriter and musician who visited a clinic seeking treatment for headache-related nausea. She wound up developing tissue deterioration and gangrene in her arm, ultimately leading to its amputation. How? Clinic staff administered the antihistamine Phenergen, with a physician assistant inadvertently injecting the drug into one of Levine's arteries. The problem wasn't with the drug itself, but rather with its administration via IV push. Even though Phenergen-maker Wyeth and the FDA knew the IV push created a risk of inadvertent arterial injection and gangrene, the FDA approved labeling for Phenergen that warned against — but didn't prohibit — IV push administration.

And the post also tells us the following…

"The case of Wyeth v. Levine isn't about consumer protection, it's about whether we'll allow trial lawyers to get rich," said Peter Pitts, president of the Center for Medicine in the Public Interest, and a former FDA associate commissioner. "If the High Court rules against Wyeth, we can look forward to a flood of lawsuits that'll bring medical innovation to a halt and drive healthcare costs through the roof. Vital medicines will disappear from the marketplace because of the threat of litigation."

I objected to that so strenuously that I decided to find out more on Pitts, and this tells us that Pitts is more of a marketing guy than anything else, having plied his dark art for Reader’s Digest, the Lifetime cable TV network, the Moonie Times, Insight, and The Hudson Institute (of course, Pitts served as the FDA’s “chief messaging officer”).

And I thought this spoke volumes about Pitts, by the way (from Sourcewatch)…

In an interview with Pharmaceutical Executive, a drug industry trade magazine, Pitts lamented the withdrawal of Vioxx. "The more I think about Vioxx, the more I'm convinced that it should not have been pulled from the market"…

This tells us that Vioxx may have contributed to the deaths of upwards of 60,000 people (ditto what I said earlier about Scalia for this guy).

Finally, this Times story tells us that, though Tom Daschle will likely be confirmed as the next Health and Human Services Secretary under Obama, “a new FDA Commissioner has not been named.”

It looks like, whoever this person is, they will have to clean up yet another Bushco mess in the name of ensuring our safety (and just add this to "The 'O' List" too).