Pharma’s Cutting Edge

On June 8th, the U.S. House narrowly passed an amendment to its FDA appropriations bill for the 2006 Fiscal year that would bar FDA from granting financial conflict-of-interest waivers to its Advisory Committtee members. The debate on the amendment was brief, but of enough interest to read, with Rep. Berry (D-Ark), the only registered pharmacist in the House, accusing the pharmaceutical industry of conspiring to rob the U.S. public at every opportunity. Those opposing the amendment did a poor job explaining why the amendment is a bad idea and why FDA has relied on such waivers frequently when appointing its committee members.

What they should have stated is that the waivers permit FDA to use the most qualified experts, those who know the drug or device under discussion the best. This is because the most knowledgable experts are those who participate in clinical trials with related drugs and devices before they reach the market. FDA typically does not allow experts who were actually paid by the sponsor whose drug/device is up for discussion to vote on an issue. Rather, FDA either makes them non-voting members or does not allow them to participate at all. The experts who vote are typically not paid by the relevant sponsor, except in cases where an entire drug class is being discussed and multiple sponsors are involved.

If waivers are not allowed (we’ll have to await Senate Appropriations Committee debate to see where the issue might be headed), FDA will be hard-pressed to staff its Advisory Committees with the most qualified experts. They will be forced to allow only those who are not paid by the sponsor or the sponsor’s competitors to participate, which leaves…basic scientists, epidemiologists, clinical practitioners, public advocates, and other academics, who mean well and certainly have something to contribute but who are not the only Advisors FDA must hear from at these forums in order to receive the expert guidance it requires.

Read this NY Times article about Peter Rost, the Pfizer VP who decided to speak his mind on drug reimportation to every media outlet in the world. He’s being given the silent treatment at work, probably so he’ll pack up in frustration. But he says he won’t, because where else can he get a $600,000 a year pay package? Gee, that’s a shame for him. Really people…if your employer takes a strong position on a policy issue of great importance to it, and you lambast your employer’s position at every opportunity in very public forums, what would you expect to happen? You would expect to be fired. Why would you even want to work for an entity that stood against something you believe in so strongly? Peter Rost is not a whistleblower attempting to right an injustice being perpetrated by Pfizer, he is merely a disloyal employee mouthing off about a hot-topic corporate and public policy issue , so that he can make a name for himself. If I were Pfizer’s head of HR, I’d fire the guy if for no other reason than so he can serve as an example to others who think they can become media celebrities on the company’s dime. What a putz.

Investors who enjoy spending an entire day listening to one company’s propaganda will want to check out the archived webcast of J&J’s pharma R&D day, their first such presentation in four years (Investor Relations - Webcasts/Presentations). Full disclosure: I was previously employed by J&J.

Leading the presentations were no less than five senior managers who hold the title of “Chairman” or “Vice Chairman” and four who hold the “President” title. Frankly, if you remember nothing more about J&J’s Pharma R&D day than this simple fact, you will have learned something about J&J Pharma’s history (a stitched together collection of companies), its culture (top-heavy, bureaucratic), and its approach to R&D–from their tolerance for risk (low), to their ability to make key decisions quickly (not so good).

The highlight of the meeting? Details surrounding the planned launch of dapoxetine, the first drug targeted at treating the debilitating disease of premature ejaculation. J&J hopes to get an indication to treat premature ejaculation with this short-acting SSRI based on studies of men with the severe form of the “disease”–those who failed to last more than two minutes after penetration in at least 75% of their encounters in the prior two weeks. Apparently, some guys find a reason to complain when they’re getting laid enough in two weeks to be able to record a percentage of times they came in less than two minutes.

No doubt this drug will get lots of airtime and attention in magazine columns in the coming (no pun intended) months. What’s the next big indication for J&J’s newest drug? Well, no confirmations yet, but rumor has it they’re considering the following “premature-activity/compulsion disorders:” Inability to eat just one potato chip; Skipping to the end of a novel before full character development; Taking a swing on the first pitch; Biting into the center of a Tootsie Pop with the candy coating intact; Reading magazines from back to front; Sipping red wine before it’s had a chance to breathe; and Experiencing love at first sight.

I found a copy of the Markey report on FDA’s accelerated approval program on the Huffington Post blog site. I made an independent check of some of the data, focusing on Markey’s allegations regarding the lack of public disclosure of accelerated approval study commitments by public companies. The three companies I looked into (Skyepharma, Mylan, and King) checked out–they hadn’t publicly disclosed accelerated approval study commitments in SEC filings as Markey alleged.

In addition to hammering public companies for non-disclosure of postmarketing study commitments, Rep. Markey cites data to support his conclusions that the accelerated approval system is in need of an overhaul. In particular: Half of the 91 study commitments (from 28 companies, representing 42 products) are not completed, and, of those not completed, half have not started an average of nearly two years after accelerated approval. Markey views this as non-enforcement by FDA of its rules. FDA doesn’t inform patients or their physicians about accelerated approval postmarketing study commitments. FDA provided different data to Markey and the public (via its website), suggesting improper monitoring and/or reporting of study commitments.

Assuming the evidence is correct, and not simply the result of sloppy record-keeping by the FDA, it’s hard to argue that Markey has no reason for concern. Even in those cases in which a postmarketing commitment has become irrelevant (for example, due to changing therapeutic strategies or supersession by non-required studies), FDA has an obligation to let the public know what it originally asked of the drug sponsor, and why their opinion might have changed. The information FDA provides should be consistent, regardless of who is asking for it. And companies have an obligation to shareholders, prescribers, and patients to make it known when drugs have been approved under an accelerated schedule. Such information should not be alarmist, but it should be readily available.

Finally, Markey’s call for financial penalties for non-compliance is overkill. FDA already has the authority to pull drugs off the market when their sponsors don’t comply with accelerated approval requirements. They just need to use the threat of this authority every so often to remind sponsors of their obligations.