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PHYSICIANS/PHARMA: Is academic medicine beyond salvage? by The Industry Veteran

Several people are concerned about the integrity of our medical leaders, and the latest Cleveland Clinic spat has upset a few people, notably local MD Medpundit. I have a more jaded view. I liken it to when I heard that lawyers have to take an ethics test but are only not allowed to practice if they fail it, I assumed that any lawyer passing an ethics test lacked the aptitude required for the job! However, making a welcome return to THCB, even the usually cynical-beyond-belief contributor The Industry Veteran appears a little concerned. He writes:

I had previously viewed the tussle between renowned cardiologist Eric Topol and his boss at the Cleveland Clinic, Delos Cosgrove, as principally an academic spat whose significance did not extend beyond the personal fortunes and the organizational power positions of the two principals. The Times’s article, by contrast, suggests the Cleveland bash reveals that the integrity of academic/high research medicine is fundamentally compromised. Instead of remaining disinterested researchers who help to develop and evaluate new medicines and technologies, big time researchers and their institutions own equity positions in the companies whose products they evaluate. The very notion that medical researchers are gatekeepers for the public, motivated by professional ethics and the search for scientific truth, remains a fool’s myth. Who guards the guardians?I recently asked a friend who teaches marketing ethics at his university to tell me his views about the recent editorial in the New England Journal of Medicine. That was the one where the Journal’s editors belatedly said they were shocked, shocked by the fact that Merck’s shills neglected to include three instances of myocardial infarction among a sample of Vioxx users. The specific issue for which I sought clarity concerned the relative responsibility of the academic physicians who authored the study (or, more accurately, whose names appeared above the study, since Merck’s medical writers doubtlessly wrote the paper) versus that of Merck, who sponsored the research. My friend’s pontifications assigned the lion’s share of blame to the physicians. They must reasonably be expected to know that the first and final interests of any corporation’s operators lie in obtaining profit to satisfy shareholders. In this particular case, the academic physicians would have been psychotically detached from reality not to have known that Merck’s pursuit of Vioxx profits included a thoroughly unethical inclination to twist and hide data. “If they were willing to accept research money and sponsorship from known crooks such as Merck,” he wrote, “then they had a responsibility to act with the very highest possible standards of ethics, and my guess is that they fell far short of that.” The Times article flicks off the lid to reveal that these kinds of self-aggrandizing conflicts are the routine condition of high powered, medical research.

PHARMA: Looks like more good news for the Vioxx plaintiff bar!

So according to the NEJM there were serious errors in the original Vioxx study–that is errors of omission.

The New England Journal of Medicine publicly alleged Thursday at least two of the authors of a major Canadian-led study on the former blockbuster drug Vioxx withheld data on adverse events from the journal.

So as the NEJM now says the Merck team hid an additional three heart attacks from the data in the VIGOR study as the deaths occurred after a cut-off date. If they’d included them the risk of having an MI was 500% higher not 425% higher with Vioxx compared to an NSAID.

On the other hand why didn’t the researchers just move the cut-off dates for deaths in Vioxx patients in study back to before they started on the drug. That would have produced much better data!

PHARMA: Cox-2s–Really putting the boot in

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So the latest study about the Cox-2s shows not only that they give heart trouble, they’re used for people who shouldn’t need them, etc, etc, etc. No this study shows that they don’t even do what they’re supposed to do—they are no better than NSAIDS in preventing stomach bleeding

British scientists said on Friday they had found no evidence that prescription painkillers designed to protect against stomach bleeding were safer than older drugs.Julia Hippisley-Cox, of the University of Nottingham in England, said she had found no proof the painkillers, known as COX-2 inhibitors, were less likely to cause gastrointestinal bleeding than aspirin or other treatments called non-steroidal anti-inflammatory drugs (NSAIDS).

A benighted class of drugs, forsooth, as the 7,000 soon to be laid-off Merck employees must be thinking.

PHARMA: Pfizer fires Rost

Pfizer fired its troublesome VP Peter Rost, the one who’s been criticizing them for opposing drug re-importation.  It looks like they suckered him — he tried to start a whistleblower suit for the way that Pharmacia had been marketing a drug. “Pharmacia offered doctors illegal inducements to use genotropin, its growth hormone, as an anti-aging drug for adults”. He obviously thought that Pfizer (which bought Pharmacia in the middle of all this) was covering it up, but they’ve convinced the DOJ that they had brought it to the FDA’s attention before Rost did. So now that the government has pulled out of supporting his suit, Pfizer can call him a wrecker. So they’ve booted him.

Which leaves one issue behind. Given that his position involved being paid $600,000 a year to basically do nothing, how do I apply for the job?


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PHARMA: Cheerleaders and sex-symbols

Talk about slightly unfortunate timing.  Just one day after the New York Times has an article about how pharma companies go about recruiting cheerleaders as detail babes reps, Bayer announces that it’s hiring the ex-Ms Mick Jagger, and very leggy supermodel, Jerry Hall as a "Global Ambassador for its Erectile Dysfunction Campaign".  In case you’re a little innocent about cheerleaders’ place in American culture, guess what a Google search for "Cheerleaders turns up. (Don’t hit the "I’m feeling lucky" button if you’re at work!).

Jerry is of course well known for recounting that "my mother told me that men want a cook in the kitchen, a maid in the house and a whore in the bedroom. I told her that I’d take care of the bedroom part and hire the other two".

Somehow one gets the impression that the grown-ups have left Beavis and Butthead in charge down in the marketing department, which wouldn’t matter if it wasn’t for that teeny bit of criticism that pharma companies have been facing over their DTC and physician-based marketing activities.

PHARMA: Pain Therapeutics causes yet more headaches

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Those of you hanging out here for a while know that I’m a long term holder of Pain Therapeutics stock. The pitch is that it has three drugs in phase III trials, one for pain, one for IBS and one a non-alterable version of Oxycontin. the stock went public at 14, it usually trades between 6 and 9, and I bought a boatload at between 2 & 4 in the dark days of late 2002/early 2003.

Now I’ve been hanging on for the last of two phase III trials of its star drug Oxytrex, which is supposed to be a non-addictive version of Oxycodone (the active ingredient in Oxycontin which is a multi-billion $$ drug). The first Phase III trial looked good, but was a little inconclusive, and the stock that was hovering in the 5-6 range didn’t move much. Still given the company’s market cap is only in the low hundred millions and any one of these drugs alone if successful is worth several billions, it’s always looked a good bet to me.

Then last week Pain Therapeutics cut a great deal in which it essentially passed off a share of the profits and all of the costs for its third line drug Remoxy (yes the CEO’s name is "Remi"–no ego huh!), which is a non-alterable version of Oxycontin (and therefore can’t be abused as Oxycontin or "Hillbilly Heroin" is frequently), to King Pharma for up to $400m, including $150m in cash.  The stock went up about $2.50 and I was looking forward to a conclusive phase III for Oxytrex leading to an FDA approval.

So today the Phase III results are out and they are maddening.  The drug appears to work, but too many people dropped out of the trial, and so the results are not statistically significant. My guess is that the FDA will make them go around again.  The stock is now back down to more or less where it was before the King deal (so I suppose it could have been a good deal worse). But still no clear end in sight.

I’ve been hanging on for about 3 years.  And of course in the meantime I didn’t buy any Google stock because it didn’t have much upside….

Any suggestions from my readers as to what I should do now?

PHARMA/POLICY/POLITICS: Medicare Part D–A mess that will need fixing when the grown-ups get back into power

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Last week the most convoluted program in the history of Medicare began. I’ve heard comments from friends, neighbors and people in the press saying that they can’t make heads or tails of the new drug benefit. The Washington Post piled in on Saturday with yet more about how confused seniors are.

Whether you like it or loathe it, there are some interesting parts of the Medicare Modernization Act, including the HSA provision and the disease management provisions. But the main event–drug coverage–is neither rational nor ideologically consistent. It’s a dog’s breakfast put together to ensure that the PBMs and some private health plans have something extra to sell, and so that the pharmaceutical companies don’t have to deal directly with the government on pricing.

Now seniors are going to have to deal with a donut hole, out-of-pocket costs, in-network and out-of-network pharmacies, and deciding whether their employer-sponsored coverage is going to stay around. No wonder they’re confused.

And despite all this, the cost to taxpayers is going to be double what Congress was told it would be. Drug coverage for everyone (especially seniors) is needed. But the only prediction I can make is that a more fiscally and socially responsible government–should we get one–will be forced to re-sort this mess in the very near future.

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FDA examining Oseltamivir risks by John Pluenneke

If you read FierceHealthcare, you had advance warning of this one on  Monday. The Wall Street Journal reported yesterday afternoon that the  Food and Drug Administration is probing as many as 12 deaths it  believes may be linked to oseltamivir (i.e. Tamiflu) in Japan.  According to the paper, all of the victims were children.

Quoting from the source:

The FDA said there were 32 reports of "neuropsychiatric" adverse events, 31 of which happened in Japan, and included abnormal behavior, hallucinations, convulsions and encephalitis. The agency said it received a report of two patients, ages 12 and 13, jumping out of their windows after receiving two doses of Tamiflu.

The antiviral, which is jointly distributed by Roche and Gilead Life Sciences, is considered the best available treatment for the H5N1 virus, although not everybody agrees it will work. Given the recent hype about the drug, this is a development worth watching closely. Apparently the FDA has known about these allegations for some time – as in for many months. Expect a lot of talk in the media about this story and its implications once it sinks in.

Also expect the story to take center stage in the fight in Washington over the liability protections vaccine makers and drug companies say they want …Update: On Friday, an FDA advisory panel said it could find no evidence linking Tamiflu with the deaths in Japan.  Meanwhile, in response to public pressure, Japan’s independent Pharmaceuticals and Medical Devices agency  said it will begin publishing detailed data on all reports of adverse events it recieves related to prescription drugs and medical devices starting in January 2006.

PHARMA/POLICY/INTERNATIONAL: Not all the wingnuts are in the US

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Australia had some great news yesterday as the national team qualified for the soccer world cup, even though it’s only the 4th most popular team sport with the word "football" in the title in the country. But there was also some more bad news. The way that the national broadcaster ABC presented it as Australia’s rural doctors disappointed by Abbott’s abortion pill decision.

Abbott is not the drug company, it’s Tony Abbott the health minister. Because I randomly know his sister and parents, I can tell you that what’s not in the article is that Abbott is a devout Catholic who nearly became a priest. Meanwhile he’s been kicked around in the Australian press for kow-towing to the pharmacist lobby on pricing, and also for not forcing promised cuts in generic prices. He was also at the center of some more complex wrangling over drugs in the free trade pact that many on the left in Australia are very suspicious about, but where I felt they walked a tight-rope fairly well in getting the free-trade deal done.

But the reason given for the ban on RU-486 is that rural doctors wouldn’t be able to treat women using it. Well as evidenced from the statements by rural doctors managed just fine to treat women who spontaneously abort, that’s pure bunk.  Which leads us to the conclusion that yet again religion and ideology have trumped science at the highest levels of national decisions about drugs.

PHARMA/POLICY: GAO confirms the corruption of science forced on the FDA

Just in case there was any doubt that the White House’s filthy fingerprints were all over the Plan B non-decision, the Congressional GAO is out with a  report that call the FDA’s Plan B decision process ‘unusual’. And of course points out that senior FDA leadership (i.e. Crawford and his cronies) forced this over the heads of the FDA staffers responsible for such decisions, and even made the decision before the evidence was in.

The GAO probe found that high-level FDA officials were more involved than is usually the case in decisions to approve drugs for over-the-counter use. Also, investigators found conflicting accounts as to whether the decision to reject the application for OTC use was made before the agency’s reviews were finished, the report said. Also, three FDA directors who normally would have been responsible for approving the decision to reject the application did not do so because they disagreed with it, the report found.

This is only one small battle in the war to keep the creationists and fundamentalists loons outside of science. A battle that we’ve lost.

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