Latest Drugwonks' Blog

A PAP Gap?

  • 05.15.2006

The OIG stance is typically government: make a straightforward program that works well in the private sector a cumbersome and daunting process that discourages consumer participation and then makes any corporate deviation from the regulations or their interpetation by Asst. US attorneys or self-styled consumer groups grounds for criminal investigation or litigation.

Which goes to show you what life would be like if the government took direct control of the Medicare drug benefit….bad enough the nit-wits in OIG have screwed this one act of charity up…what would happen if every part of the pharmaceutical business was under government control?

Going for the Gold

  • 05.15.2006

Excellent article in today’s Financial Times about the impact the rapidly declining cost and increasing precision of clinical informatics is having on prescribing decisions and the Pharma model of simply marketing a drug based on FDA data. The article describes how health plans are developing better post market and predictive decision-making models on who gets what within the framework of disease managment. And it will soon be possible to integrate clinical data with some genomic data as well. Where is Pharma on all this? According to the FT article: “in a world where whoever controls the gold often rules, drugs companies no longer have a firm grasp on the most precious commodity: information.” See the article below..

I have been saying for years that Pharma has to get into the trenches and start looking at how their products actually work and where they work best to stay in the game and stay ahead of the price control crowd. What they spend on traditional marketing should be spent on developing sophisticated data mining and data analysis systems…it would deliver better value to both company and customers alike.

It’s PDUFA reauthorization time and the usual suspects are trotting out the usual evasive gabble.

PDUFA MYTH #1: Since drug companies provide about 40% of FDA funding via PDUFA, the agency is “beholden” to Big Pharma.

TRUTH: How can FDA be “in the pocket of the pharmaceutical industry” when the industry has nowhere else to go? Where’s the leverage? It’s FDA or nothing pal. The leverage is on the other side.

Proper retort to ignorant comment — “Industry pays FDA to approve drugs.”

Wrong! FDA gets paid to review drugs. (And they certainly don’t all get approved now, do they?)

More myth-busting to follow.

Send me your favorite PDUFA myths and I’ll post them. I can be reached at

Dumb and Dumber

  • 05.14.2006

Here’s a question: In the case where a life is on the line and you need a doctor who would you choose: someone who is world reknown, an expert in saving lives and treating the disease that threatens it but is under scrutiny by the mainstream media and the Left for consutling with drug companies or an untested doctor with no track record by who has done no consulting for biotech or drug firms? Only a dumb person — or a pure ideologue (an oxymoron) — would choose the latter.

Now apply this logic to banning people — regardless of their insight, clinical gifts or peer recognition — from advising the FDA because they consulted for the NIH or private companies. Merrill Goozner argues that there are plenty of oncologists for example that have not consulted for private firms that could serve the FDA. The question is: would excluding those that have consulted advance the public health. Applying the Goozner rule would exlude:
one of the world’s experts in prostrate cancer, one of the pioneers in using biomarkers to measure angiogenesis, a leader in the design of clinical trials for stomach cancer, one of the nation’s leading researchers dedicated to finding drugs that actually stop the progression of bladder cancer., and a Nobel Prize winner to boot…

This is dumber.

Peter and I have a better way that will increase the number of smart people helping the FDA as opposed to proposals that make them feel like criminals.


  • 05.12.2006

I am suffering from hypocrisy and stupidy overload….apart from the patently biased reporting on Pfizer’s clinical trials and cancer drug pricing in the WP and WSJ respectively we now have the double standard on the coverage of RU-486 safety. According to recent research, 1 in every 80,000 women who have a medical abortion die. 1 in every 1,000,000 women who have a surgical abortion die. I am not a math whiz but that means that RU-486 increases your risk of death 10 times. If Vioxx had done that, it would have been the subject of a Charles Grassley media orgy. And lost in the reporting is the fact that many of the deathrs attributed to RU-486 recently are linked to off-label use (vaginal vs. oral use). Or was this fact conveniently buried even as the press beats up on other forms of off-label use?

Meanwhile, the AP had this misleading headline : Paxil May Increase Suicide in Teens, FDA and GlaxoSmithKline Warn

Actually, the FDA said that nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the letter.

The FDA reported that there were 11 suicide attempts — none resulting in death — among the patients given Paxil in the trials. Just one of the dummy pill patients attempted suicide.

Given that small number, the results “should be interpreted with caution,” the FDA said. Eight of the 11 attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.”

Left unsaid of course is that people suffering from major depession are likely to exihbit suicidal behavior and that all medications are associated with an elevation of suicidadility and that use of antidepressants is associated with a decrease in the incidence of suicide among teens.

Meanwhile, USA today ran a story discussing whether Oprah is a modern day Billy Graham.

All of this reminds me of what Thomas Jefferson said: “The man who reads nothing at all is better educated than the man who reads nothing, but newspapers. “

The insanity of not permitting conflict-of-interest (COI) waivers for certain highly qualified members of FDA advisory committees is not only, well, insane, but also quite contrary to the best interests of the public health.

During my tenure at the FDA I was the senior official in charge of advisory committees and the final decision-maker on who got a COI waiver and who did not. Many did not — but those who did received their waivers because FDA professional career staff made a strong case that these people weren’t just important to the advisory committee — but critical.

Are we really going to pass legislation that bans the best and the brightest from serving the public health because their preeminent expertise has also been viewed as valuable by the pharmaceutical industry?

It looks like we just might. God help us.

Researchers have developed a screening tool for discovering unexpected effects that drugs may have on living cells. It could provide a better way of identifying both potential side effects of and applications for new drugs — and take the serendipity out of the drug discovery process. Published in the current issue of the journal Nature Chemical Biology, the new tool combines modern chemical screening techniques with computer analysis. Using it, pharmaceutical companies could get an early snapshot of the potential uses and possible side effects of particular drugs. Most drugs work by interacting with target proteins to influence their effect on biochemical pathways within cells. But because these pathways and their interactions are complex, a drug can often have side effects — beneficial or toxic. To ferret out these effects, drugs nowadays are usually screened one target protein at a time, says Graeme Milligan, a molecular pharmacologist at the Institute of Biomedical and Life Sciences, University of Glasgow. Although it works, this approach can be costly for the pharmaceutical industry. “Potentially toxic and off-target effects are generally not discovered until a later stage,” he says, after a lot of time, money, and effort have been spent.

Here’s a link to the entire article:

Godfather Ron Pollack is angry: 37 million seniors have signed up for Medicare Part D, including 10 million of the 14 million seniors without coverage. Best of all 90 percent of low income seniors are enrolled which makes Godfather Ron’s claim that most seniors have better coverage then Part D offers look stupid and silly. On another front, groups of Americans will be able to form their own health insurance associations, using Costco and others to compete with traditional insurers. The Godfather opposes this nationally though he supported such association health plans in Massachusetts.

When good things happen to good people and people in need, count on Families USA and its capo to scowl and pout. For Families USA and Ron Pollack, worse is always better and better is always bad (at least for their agenda).

Something to think hard about …

WASHINGTON — The Food and Drug Administration could compel drug makers to conduct additional clinical trials after it approves their products under an amendment passed by a US House committee.

To speed drug approvals, the FDA frequently defers some clinical trials until after a product is introduced on the market. But companies have failed to complete two-thirds of the post-marketing studies they pledged to conduct for drugs now sold to millions of Americans. Currently, the FDA does not have the authority to force drug makers to finish the trials.

Under the amendment, which was attached to a must-pass appropriations bill, the agency could begin proceedings to stop the sale of specific drugs if promised clinical trials for those products are not done.

Some attack the FDA with malice and ignorance. That’s not helpful. Others attack people at the FDA. And that’s just plain wrong.

Bob and I share our feelings today on NRO. Here’s the link. The title of our remarks is “Miller’s Crossing.”


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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