Healthy Policy

Crawford and The Law -- a match made in heaven

Looks like financial holdings aren't Lester Crawford's only problem.

The former FDA commissioner failed to appear in court yesterday.  He was ordered to appear for a federally-ordered deposition in a lawsuit to press the confirmation of Plan B as an over the counter medication.  Worse, Crawford's lawyer told the press he might invoke his fifth amendment rights to avoid tesitfying. 

That's essentially an admission of guilt, although one that will probably provoke dozens of rounds of inquiry to elucidate whose ass he's covering.  Two top adivsors on the application, FDA Deputy Operations Commissioner Janet Woodcock and Steven Galson, director of FDA's Center for Drug Evaluation and Research testified that Crawford excluded them from the process of deciding on Barr's application.  That admission is extremely troubling as it illuminates the extent to which proper regulations for drug approval have broken down.

And think of the unplanned pregnancies that proceeded while these officials sat on their thumbs and refuse to show up for court.  It's sick.

Lester in trouble...

The FDA's crumbling reputation continues as former head Lester Crawford (of the refusal to issue a decision on Plan B fame) is being investigated for financial improprieties.

Apparently Crawford held stock in several biotech companies while acting as head commissioner.  The explanation, namely that his decisions weren't influenced simply because he disclosed investments, isn't cutting it for federal investigators. 

I guess the ethics rules regarding NIH researchers and financial investments don't hold for the head of the FDA.  Common sense rules again over at the administration...

Mixed Messages

A new report commissioned by Charles Grassley (R-IA) and administered by the GAO has found that the FDA's ability to deal with safety problems is, well, problematic. 

Grassley, unlike the other Republicans overseeing the FDA, believes "[the] problems are systemic and cultural, not isolated or easily fixed."  He's also proposed a drug safety bill to kick the FDA into gear. 

More on the report itself later on.

Ethics and the FDA

Kaiser is reporting that certain interest groups are calling on the FDA to take different variables into consideration besides safety and efficacy when approving drugs:

The Baltimore Sun on Monday examined how some critics are saying that FDA or another government entity should "look beyond the safety of the foods and drugs it regulates and consider decidedly unscientific factors, including the ethics and health care costs of approving certain products." Such a move would "represent a radical departure for the FDA, which prides itself on making data-driven decisions free from political and industry influence," according to the Sun. The Sun reports that issues raising ethical and social behavioral issues include considerations of the emergency contraceptive Plan B for over-the-counter sales and the possibility of products that are derived from cloned animals being sold.

Somehow I doubt that those behind these propositions are actually concerned about cost. No, I'm quite sure that they're only concerned about "ethical" questions, like whether Plan B should be available over the counter (or, for that matter, available period).

But why should cost be considered in terms of actually approving treatment for production? Cancer and AIDS therapies are prohibitively expensive -- often tens of thousands of dollars a year -- but that doesn't mean they shouldn't be produced at all. It's up to insurance providers (be they private or publicly paid for) to decide what will be covered. Those decisions should depend on the efficacy of therapies. Cancer treatments save lives, and for most of us that multi-thousand dollar cost is worth life. Inevitably we pay for insurance and pay taxes because we know if we were in a situation requiring expensive care that we'd need (and want) help.

Any effort to alter the FDA's role as a certifier of safety, efficacy, and objectivity is a slippery slope. Approval centered on ideology or cost concerns should be left up to payers and representatives. The agency will become useless if it opens itself to these concerns -- it has enough trouble making decisions as is.

Enough

The Government Accountability Office (GAO) released its report of the procedure involved in denying Barr Laboratory’s application to make Plan B available over the counter. Those following the debacle already know about the fishy reasons for rejection, but the GAO's report is a pretty stunning indictment (if you're new to the debate, I am nepotistically recommending my column over at Campus Progress as background).

According to the GAO several things were unusual about this approval process (from the report, but I've put them in bullet form for your easy reading pleasure):

• The directors of the offices that reviewed the application, who would normally have been responsible for signing the Plan B action letter, disagreed with the decision and did not sign the not-approvable letter for Plan B. The Director of the Office of New Drugs also disagreed and did not sign the letter.

• FDA’s high-level management was more involved in the review of Plan B than in those of other OTC switch applications.

• There are conflicting accounts of whether the decision to not approve the application was made before the reviews were completed

• The rationale for the Acting Director’s decision was novel and did not follow FDA’s traditional practices.

Okay, those are pretty serious irregularities.

The directors of the office that reviewed the application didn't sign the letter? Along with the director of the Office of New Drugs? That brings up some deeply troubling questions about the FDA. If the heads of department who are supposed to sign the letter do not, who makes the final call? The acting director, who is appointed by the current administration (Bush admin, in this case). It's clear the FDA should require all parties' signatures to prevent this kind of blatant politicking.

And there's even more politicking to be had:

The Plan B decision was not typical of the other 67 proposed prescription-to- OTC switch decisions made by FDA from 1994 through 2004. The Plan B OTC switch application was the only one during this period that was not approved after the advisory committees recommended approval. The Plan B action letter was the only one signed by someone other than the officials who would normally sign the letter. Further, there are no age-related marketing restrictions for any prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them. FDA identified no issues that would require age-related restrictions in the review of the original prescription Plan B new drug application.

Italics mine

As for the age question, numerous studies have shown that young girls, even if they're physically given Plan B to take home, show no increase in risky sexual behavior.

The science is against opponents of Plan B on every turn. Not only did the advisory panel conclude that Plan B is not an abortifacient (as anti-choice zealots claim), not only do numerous studies show no increase in risky behavior (despite the unusual request of having to prove this at all), but it's been used for years around the world and considered perfectly safe.

Clearly the FDA isn't concerned about science, but instead rejected an application due purely to politics. Because of their initial rejection, Barr had to revise its application to exclude girls under 16. What infuriates me so much about this is, of anyone, girls under 16 would be most profoundly affected by unplanned pregnancy. And the least able to get their own doctor appointment (you can't get a driver's license before 16, for God's sake) to get the prescription.

So what sorry excuse are opponents of Plan B using now that the report is public? The New York Times reported one response:

"We question the integrity of the investigative process that results in such partial conclusions by the G.A.O.," Ms. Zawisza said.

I hate to break it to you, lady, but GAO stands for "Government Accountability Office". The whole point is they're supposed to investigate, impartially, what goes on in the government. Calling them partial is quite a red herring.

Lester Crawford already resigned over this -- I'm not sure many more people can be held accountable. And that's what's really sad -- there's nothing to be done but write blog posts and write your senators, and I don't expect much change to come out of that. I usually try to be more optimistic about individual power to change and what not, but it's clear in this case that it doesn't much matter.