Latest Drugwonks' Blog

Tysabri's Back

  • 06.06.2006

The FDA said it would make Tysabri available by early June and it has done so…The risk management plan is tough but was developed in concert with patients. No thanks to the traditional MS advocacy groups some of whom had even opposed returning Tsyabri to the market. The advisory committee and the FDA officials were moved by the efforts of patients who demanded the drug’s return and by how well informed they were about risks and benefits…

Health Affairs dedicates a bunch of articles about the Oregon effort to compare drug effectiveness. We all know just how reliable and up to date literature reviews of old classes of medicines are, particularly in an era where genomics will help select medicines for patients and targeted therapies and diagnostics will shape clinical care. But let is not be said that Health Affairs is nothing by on the cutting edge of 20th century medicine. In any event, as part of it’s effort to give the underachieving access to peer review publications, it allows one Alan Heaton, head of pharmacy at the the Minn blues to weight in as follows: Give us the hard evidence for open formularies,” he demands in his Perspective. Heaton cautions that using evidence-based principles to pick superior products within drug classes risks giving the manufacturers of anointed products unwarranted pricing leverage. âIronically, pharmaceutical companies spend hundreds of millions of dollars to market product differentiation,â he observes, but âthe reality is that 80-90 percent of the population can use one drug, leaving only a small group who cannot tolerate that particular drug and need one or two other choices in a given class.”

So much brilliance here it is hard to know where to start …

Last time I checked, evidence based principles were being used to exclude drugs and select just one to drive down prices…or maybe Heaton is just a lousy businessman — as for the claim that one drug fits all — it is so scientifically without merit — SSRIs, atypicals, anticonvulsants, lipid lowering drugs, beta blockers and combination therapies thereof — that it hard to know where to begin except to extend my sympathy to the million of people who as suscribers of Minn BCBS have to suffer under Heaton’s harebrained decisions.

The other day a senior FDA official asked what the agency should do to combat all the negative media coverage. My response, “Do something because nothing isn’t working.” In retrospect that was a bit harsh. FDA has been doing things, mostly from rule-making to infrastructure, that are making a difference — albeit not any that the MSM or many elected officials seem to notice.

Two examples of moving forward towards better risk communications are the long-awaited and hugely significant new physician labeling rule and the savvy personnel choice of Paul Seligman as CDER’s new Associate Center Director for Safety Policy and Communication in the Center for Drug Evaluation and Research. Two superb examples of forward motion.

Not sexy, but crucial.

Can more be done to aggressively battle a blood-thirsty media and bandwagon pols? Don’t get me started.

Actually — do get me started.

Lots of stories today about this being the 25th anniversary of the discovery of the AIDS virus and many stories noting how many people are alive today because of protease inhibitors which the last time I checked were developed not by NIH or the Cubans or global health collaborative funded by a global R&D tax but by drug companies. The death rate in the Western world has been slashed by these drugs and the gains to society in terms of increased productvity and deferred health care costs has been substantial. Much of the recent progress has come as a result of efforts to target and personalize therapy. There are now over 60 drugs and vaccines in development. Companies have by and large come around to offer their drugs for free or at cost in those parts of the world where AIDS has hit hardest. And yet the media and activist organiizations have largely ignored this contribution. Case in point was a recent article that started out by claiming that biotech company Gilead was a war profiteer in the battle against AIDS. The last time I checked the Gilead drug was being “sold” if that term can apply for about 27 bucks a bottle ini about 100 countries compared to $800 a bottle in the US. And Doctors without Morals and other HIV activitst groups have the gall to attack Gilead for denying access. And the MSM makes THIS the lead story? Gilead has done more for those dying of HIV with its one drug that than French based group of clinical nomads has done in its decade or so of withdrawing from war torn areas and getting media coverage from Paris for its sanctimony…

Per Dr. Bob’s thoughtful blog (see below), complicated is indeed good for patients. However, “complicated” is bad for two other important constituencies — the media and policy makers. For these folks (with important exceptions) “complicated” is bad because it’s not “simple.” (Sorry, I know that sounds solipsistic, but it’s important to make the point.)

That’s why we (and that’s a collective “we” fellow drugwonks) have to work even harder to make sure those who report and those who decide report and decide based on the facts — as hard as that may be and as naive as it may sound.

The alternative is unacceptable. That’s why it’s called the Critical Path.

The media is abuzz with the news that big drug companies are rolling out drugs that will compete with cancer drugs like Herceptin that target certain pathways or genetic mutations that cause cancer instead of killing the cancer cells themselves. Not exactly. By definition, a targeted medicine does not compete since it hones in on a specific approach or response. Case in point the BMS drug dasatinib which was developed after researchers noticed that a certain subset of patients on Gleevec developed resistance to the drug after a while. Other targeted cancer drugs have the same narrow application at first but then can expand to other uses as the same pathways are implicated in other disease mechanisms…And finally, genetic and protein analysis will determine who are high responders and who are not.

It is getting quite complicated. Better for patients. Which is what matters most. The challenge will be to translate all this into solutions that reduce death and suffering and extending the model to other diseases…

DateLine NBC ran a segment tonight on counterfeit drugs. While this story is nothing new to you drugwonks out there, it’s serving as an overdue wake-up call to tens of millions of Americans. This summer, in collaboration with the Stockholm Network and the Centre for the New Europe, the Center for Medicine in the Public Interest (the home of will publish a new book called “Coincidence or Crisis: Prescription Drug Counterfeiting.” It features articles by many leading policy experts, an introduction by Congressman Mark Souder, and is edited by your’s truly.

If you would like additional information on how to order this important new book, please e-mail me at

Not coincidentally, on June 7th I will be testifying in front of the US-China Economic & Security Review Commission on the topic of prescription drug counterfeiting in China. My testimony will begin at 3:30 in room 385, Russell Senate Office Building. Transcripts of the entire hearing will be available at

Rumor de Jour

  • 06.03.2006

Recess appointment for an important public health official.

I had the privilege to chair an FDA reform task force for the Manhattan Institute, an undertaking Mark McClellan suggested after I invited him to speak at an MI event when I was an MI senior fellow in 2003. I met with two senior FDA officals — Peter Pitts and Scott Gottlieb — that same year about how the report might help to advance the FDA’s fledgling Critical Path initiative. Peter was — like the rest of the FDAers involved in the project — visionary, supportive and courageous in combatting the negativism surrounding the effort. The Task Force we put together was (and is) dedicated, caring and thoughtful, working for free and giving graciously of their time, effort and insights. The result is a biomedical call to arms to apply the insights of drug discovery to the process of drug develpment to make medicine more predictive, preventive and personalized. The agenda surrounding the rollout of the report is below. We hope you can all attend.



Prescription for Progress: The Critical Path for
Drug Development
by Robert Goldberg, PhD and Peter Pitts

M Street Hotel
1143 New Hampshire Avenue, N.W.
Washington, D.C.
Thursday, June 8, 2006

Keynote Speaker:

Andrew C. von Eschenbach, M.D.
Acting Commissioner, U.S. Food and Drug Administration

8:30-9:00 AM


9:00-9:10 AM
Introduction and Overview

Robert Goldberg, Ph.D., Chairman, 21st Century FDA Task Force, Vice President & Co-Founder, Center for Medicine in the Public Interest, Peter Pitts, Director, Center for Medicine in the Public Interest

Panel 1: Roundtable on Prescription for Progress: The Critical Path to Drug Development

Moderator: Michael Weber, M.D., Professor of Medicine, SUNY Downstate College of Medicine

Jeffrey Cossman, M.D., Chief Scientific Officer, The Critical Path Institute
Gualberto Ruano, M.D., Ph.D., President, Genomas, and Director of Cardiovascular Research, Hartford Hospital
Robert McBurney, Ph.D., Senior Vice President, Research and Development, and Chief Scientific Officer, BG Medicine, Inc,
Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA

10:15-10:30 AM

10:30-11:35 AM
Panel II: The Critical Path Today and Tomorrow: Challenges and Opportunities

Moderator: Steve Usdin, Senior Editor, BioCentury Publications

Janet Woodcock, M.D., Deputy Commissioner for Operations, FDA
Meryl Comer, Patient Advocate for Alzheimer龝 Research
Peter Hotez, Ph.D, M.D., Professor and Chair, Department of Microbiology, Immunology and Tropical Medicine, George Washington University Medical Center

11:35-12:15 PM
Keynote Address

Keynote: Andrew von Eschenbach, M.D., Acting Commissioner, FDA

This from ” A new study by researchers at Kaiser Permanente finds that spending caps on prescription drugs don’t save insurers money and may end up harming the health of patients—especially those who are chronically ill. The research, which appears in the New England Journal of Medicine, followed about 200,000 Kaiser Permanente patients in Northern California who had Medicare+Choice (now referred to as Medicare Advantage). The study found that those with limits were more likely to end up hospitalized and often chose not to pay for their medicines themselves. Researchers like Steve Soumerai at Harvard have essentially been saying the same thing for more than a decade now, but with Medicare in the business of paying for drugs, this type of research may have more impact on benefit design.”

So has our colleague and board member Susan Horn of the Inst. for CLinical Outcomes Research who showed way back in 1996 that formulary restrictions were associated with keeping people sicker and driving up health care costs.

On the one hand we have the WSJ editorial page claiming that there are no cost offsets to a drug benefit and on the other we have the leftists claiming that restrictive drug formularies as a tool for extracting price concessions won’t hurt patients. Yet here is another study showing that caps of any kind compromise health and drive up total spending…. And yet opponents of the drug benefit on either side keep serving up the same stupid argument in an increasingly hysterical form. How did Santayana define fanaticism: It consists of redoubling your effort when you have forgotten your aim. Exactly.

The NEJM article link can be found here:

And speaking of hysterical…get a load of Congresswoman Louise Slaughter’s off-base attack on Part D in the same medical journal. Compare it with the essay by Mark McClellan and Peter Bach. It’s not even worth trying to refute all the lies and inaccuracies except to say that any drug benefit that is cutting costs by massive use of generic drugs is not generating brand drug companes $139 billion in gross profits. That number, a fake factoid drawn up by the urban planner who pretends he is an economist — Alan Sager — was immediately discredited by the people who really know their stuff — the Wall Street analysts who would have issue heavy buy recommendations if gross profits would have increase 50 percent in one year….Yet the MSM and then John Kerry and now Slaughter continue to invoke this number… As it turns out of course, what drug companies that are making money are doing so with new products, many of which are not covered by Part D plans….because they are cancer products.

The two dueling articles can be found here:


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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