So Marcia Angell’s talk at the commonwealth Club was all that I expected. She is witty and charming and she really laid into big Pharma. Big pharma to her has no redeeming qualities. Everything they do is wrong and all they do is run biased clinical trials, and pay off the doctors (majority) and the politicians (minorly). A review of her book in the NEJM(BTW you can go to BugmeNot to break into these password protected sites, shh!!) from a Canadian Medical Association doc echoes her points, even though rational people (i.e. me) think that she was a little over the top.

I hope that there is a middle ground. Drugs save huge amounts of other health care costs and they do keep people alive who would otherwise be dead. If you read on in the review you get to this passage.

Angell’s concluding chapter, the least convincing one in an otherwise fascinating and penetrating book, contains the solutions, all of them predictable (and probably unattainable): control me-too drugs, re-empower the FDA, oversee Big Pharma’s clinical research, curb patent length and abuse, keep Big Pharma out of medical education, make company financial statements transparent (so we can tell what the costs of research really are, as distinct from marketing), and impose price controls or guidelines. Granted, the problems are so prevalent and the corporate tentacles so entwined with our way of being that it is hard to see what else to recommend.

But perhaps Angell is right. We must change the way we manage research and the development and distribution of new drugs. Not only are health and health care at risk, but so are the research enterprise and the reputations of universities and governments. The integrity of scientific research is too important to be left to the invisible hand of the marketplace.

The problem is that this logically leads to the idea that the only solution is heavy government regulation or even the total nationalization of the pharma business. Realistically, that’s not going to happen. So if you go to that extreme, all you can expect from pharma is a circling of the wagons and an attempt to keep paying off their servants in Congress and the Administration.

There needs to be a middle way, and I gave some ideas earlier this week about what that looks like. I don’t think Angell’s approach will get us there, even if 90% of what she says is true.

It’s all true and HHS Secretary Thompson has appealed to the general public not to take a Botox shot away from someone with a film role or major awards cermony coming up.

So it’s become apparent to THCB readers and anyone else following the reimportation issue that Pharma is, as the Christian Science Monitor puts it, the new corporate villain. And it isn’t playing its hand very well. The one person in big pharma who has gone off the reservation is the Pfizer exec Peter Rost. Here’s his very positive review of Marcia Angell’s book on Amazon. (BTW before they start I can dispel the rumors–Peter Rost is not The Industry Veteran!). But Pfizer’s lawyers have already visited Rost in a way that really didn’t show much subtlety.

To be fair, those attacking the pharma industry are also being a little over-aggressive. Marcia Angell was on a NPR radio show last week in which she attacked the pharma business over the creation of me-too drugs. (The drug discussion is about 5 minutes into the show here). Rost makes a cameo appearance and a flack from PhRMA also defends their touch position. The show is well worth a listen, but it’s worth trying to distinguish among the “me-toos” that Angell is attacking.

There are “me-toos” that are second to market for whatever reason, but usually because of the research process (e.g. Crestor developed later in the race after Lipitor). It may or may not be OK to have another statin on the market, but that type of competition in development is the American way. Furthermore, as the Vioxx mess shows, not all “me-toos” have identical clinical effects (or at least Pfizer is hoping like hell that that’s true!)

The thing that Angell should be going after is the set of other “me-tooisms”, such as

• creating an extended release version to extend the patents (see here for the AFL-CIOs version of the Glucophage XR story)
• delaying the introductions of generics by paying off generic companies (Lilly and Aventis were both known for paying generic companies to not market generic competitors to Prozac and Cardizem)
• And it wasn’t too long ago that the NY Times was reporting on some really naughty stuff on the marketing side from Schering in the late 1990s.

While much of this bad behavior is in the past, it doesn’t exactly help that DCI, a lobbying group for pharmaceutical companies (and by the way the publisher of the supposedly academically neutral Tech Central Station) was reported by The Hill a few days back to be “offering healthcare consultants almost $4,000 each to find senior citizens who are willing to speak out in favor of the Medicare drug discount card and write letters to Congress thanking members for saving them money on pharmaceuticals.” So I think it’s helpful to try to distinguish between the bad behavior and the market failure. My problem with Angell is that she sees no good in the industry at all, and that leads to the industry just circling the wagons and saying “screw you” to other approaches.

However, there are some vague signs that calmer heads may be able to prevail, even if they aren’t close to doing so yet. Most of this really bad behavior on the pharma industry’s part is in the past. Meanwhile, an interesting but very small survey being conducted on the Pharma-Marketing List-Serv suggests that a big section of that pharma audience realizes that reimportation is a) inevitable and b) not likely to be that harmful. Last week the NEJM had an article that more or less agreed with the CBOs analysis that reimportation won’t have that big an impact on prices. The author, Richard Frank a Harvard health economist, argues that:

The Congressional Budget Office has also suggested that direct negotiations would have a “negligible effect on federal spending.” But direct government negotiation may realize savings on brand-name drugs that have little competition — cases in which prescription-drug plans would be unable to negotiate lower prices by taking advantage of competition among similar products for positions on drug formularies. Paying VA prices for the drugs used by Medicare beneficiaries would benefit the federal budget. Of course, lower prices would also affect the revenues of pharmaceutical companies. For drugs that are unique, prescription-drug plans will have little ability to negotiate prices. Thus, higher prices would most likely be paid for the most innovative products. Yet it would not be politically acceptable simply to let the industry name its price. Thus, at a minimum, some direct price negotiation by the government is likely to occur regardless of which candidate is elected.

He goes on to suggest that as a consequence of re-importation prices will lower here and increase sharply in Europe, but that we’ll get to a place where we can have a rational discussion about how to fund the research for innovative products.

So is it too much to see if we calmer heads can start that conversation, as after the election it’ll have to happen anyway? Well tonight I’m going to see Angell talk live, so I can report back as to whether there is any middle ground. I actually have a spare ticket, so if any locals are looking for a hot date, let me know quick. (You think I jest? I actually took a date to see my colleague Paul Saffo once. It was pretty much our last date!)

More on this later but this is a stunner. Merck hits 8-yr. low on worldwide withdrawal of Vioxx, its Cox-2 inhibitor. No word on its direct competitor Celebrex (from Pfizer) as yet, but there have been criticisms in the recent past that it’s ineffective in reducing stomach complaints compared to ibuprofen and NSAIDS as was originally claimed.