Latest Drugwonks' Blog

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.

AGENDA & REGISTRATION:

CENTER FOR MEDICAL PROGRESS

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

Registration

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

9:10-10:15AM
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

Panelists:
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
Break


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

Moderator: Steve Usdin, Senior Editor, BioCentury Publications

Panelists:
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 Fiercehealthcare.com: ” 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:http://content.nejm.org/cgi/content/full/354/22/2349?query=TOC

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:

http://content.nejm.org/cgi/content/full/354/22/2314?query=TOC

http://content.nejm.org/cgi/content/full/354/22/2312?query=TOC

We at drugwonks are relentless in the pursuit of more participants and wont rest until we exceed the traffic of insufferable and ego-bloated Huffington blog (amazing what how far one woman can go on her ex-husband’s money and a private jet) . But we do have a perspective…our hits are just beginning to exceed those average daily downloads of this gem: William Shatner’s rendition of Elton John’s “Rocket Man” at the 1978 Science Fiction something or other awards dinner

http://www.youtube.com/watch?v=MVbv6r_tKnE&search=Shatner%20Rocket%20Man

Cut, paste, download and enjoy and tell your friends…about drugwonks of course.

Democrat Congresswoman Rosa DeLauro is making a big stink that her amendment to have the FDA forcibly yank drugs off the market before companies are forced to conduct large randomized studies to establish a safety problem was lifted out of an appropriations bill. Rosa is hypocritical. Here’s Rosa — a cancer survivor — on the vaccine to prevent cervical cancer: âWomen across the country should be encouraged, as I am today, with mounting scientific evidence of the benefits of the HPV vaccine,â said DeLauro. âIt is clear that the science exists to fight a cancer that thousands of women fall victim to each year and there is now significant scientific and medical evidence proving the benefits of the HPV vaccine. With countless public health officials and medical providers agreeing on this medical breakthrough, I am hopeful the FDA will approve this vaccine for use.â

DeLauro, a member of that subcommittee and a cancer survivor, is also the ranking member of the House Appropriations Agriculture Subcommittee with oversight responsibilities of the FDA and its budget. In November, she and over 100 Members of Congress wrote the CDC Advisory Committee on Immunization Practices urging them to make a decision for use based on the advice of medical providers, researchers and public health officials.

As with all products, vaccines will yield safety problems in real world settings and may lead to serious illnesses and some deaths….Yet under Del Lauro’s proposal a vaccine that could wipe out 40percent of the viruses that cause cervical cancer could be yanked forcibly if companies don’t conduct safety studies that get at the source of the the problem….such studies could — because the statistical power and confidence level needed — be ten times the size of the study required to prove the product was effective. And with products As FDA official Scott Gottlieb noted in his blog (fdainsider.com),”The biggest reason why companies are unable to complete post-market studies after drugs are approved through the accelerated pathway, is that all of these drugs treat life-threatening disorders (they have to in order to qualify for accelerated approval) and dying patients are unwilling to roll the dice on a placebo controlled trial â taking a chance they may get little more than a sugar pill â when the drugs are readily available on the market.” Indeed, there are questions if it is ethical to deliberately deny a potentially effective treatment to a patient for study purposes. But Del Lauro would make it a crime not to run such trials.
In fact, there are dozens of studies being conducted independent of the FDA. For instance, Bristol Myers Squibb is working on a drug that is tailored to people whose cancer is Gleevec resistant. There are dozens of studies of genetic tests in development that if used before a drug is taken will help patients avoid well know toxicitieis.
But Del Lauro would suffocate medical progress in order to make a few headlines. She would fine the inventors of innovative medicines for life-threatening illnesses millions of dollars and would deny millions of patients accelerated access to medicines. Her amendment was a death sentence for people like her who live with cancer everyday. Is there anything people won’t do for political gain?

This will drive Drew Altman of the Kaiser Foundation nuts since he belives consumers are too stupid to decide what’s best for them when it comes to health care (has he been paying attention to the Medicare drug benefit?) it should be pointed out that in another step in helping consumers, providers, and payers make more informed healthcare decisions, CMS will be posting information on what Medicare pays for 30 elective inpatient hospital procedures and other common hospital admissions later today. The new information will be posted by CMS at www.cms.hhs.gov. The information takes a snapshot look down to the county level at the amounts paid by Medicare paid for a variety of treatments provided to seniors and people with disabilities in fiscal year 2005. These include procedures such as heart operations and implanting cardiac defibrillators, hip and knee replacements, kidney and urinary tract operations, gallbladder operations and back and neck operations, and common non-surgical admissions.

The information is scheduled to be posted around 2 pm today. A press release will announce the posting of this information.


Bio Logic

  • 06.01.2006

RE: Follow-on Biologics

Beware putting cart before horse.

And don’t call them generics.

“Indeed, wretched the man whose fame makes his misfortunes famous.”
— Lucius Accius

Bloomberg reports that, according to a sealed transcript of videotaped testimony taken for Vioxx litigation, Dr. David Graham accused FDA officials of working “hand in glove” with Merck to tarnish him.

Are you thinking “visions of grandeur?” Keep reading …

“I experienced threats, intimidation and actually what, in my view, appears to have been a very organized and orchestrated campaign to smear and discredit me,’” said Graham.

Here’s the threat — an important new job.

Graham said former FDA Commissioner Lester Crawford had offered him a promotion nine days before his Senate testimony. Graham said he declined and was surprised by the timing.

“The commissioner is offering me this really high-level job with a lot of responsibility, and then one week later, he’s calling me all sorts of names in an FDA public statement that’s issued on the eve of my Senate testimony,’” Graham said.

Really? I don’t recall any name-calling by Dr. Crawford. And why didn’t Graham accept this “really high level job with a lot of responsibility?”

Why not work to make things better?

Odd? Mysterious? Nope. Just sad.

David, your 15 minutes are up.

Many Canadian Internet pharmacies are quite open about the fact that they’re getting their southern-bound drug supply from the UK. No problem there, right? Na-ah.

The Royal Pharmaceutical Society of Great Britain (RBSGB) and the Medicines and Healthcare products Regulatory Agency (MHRA) have collaborated on new guidance for pharmacists which explains the causes and consequences of counterfeiting and provides pharmacists with practical advice on detecting and reporting suspected counterfeit medicines.

The guidance has been jointly developed by the Royal Pharmaceutical Society of Great Britain and the Medicines and Healthcare products Regulatory Agency following a meeting of the Society’s Practice Committee where the dangers of counterfeit medicines were debated.

Guidance for pharmacists explains the background to counterfeit medicine production and highlights how organised criminal gangs have become involved in the production of illegal medicines and are supplying them through the internet, often to unwitting patients. The guidance offers pharmacists invaluable practical advice on the correct steps to take when they encounter suspected counterfeit medicines. These steps include reporting the situation to the MHRA and ensuring immediate patient safety.

David Pruce, director of Practice and Quality at the RPSGB said, “Counterfeit medicines can be extremely dangerous. They may contain little or no active medicine, a totally different medicine or a toxic chemical. The RPSGB has teamed up with the MHRA to provide invaluable guidance for pharmacists, particularly on how to report instances of counterfeit medicine supply to the MHRA.”

The article by National Enquirer…I mean Philadelphia Inquirer writer Thomas Ginsberg “Donations tie drug firms and nonprofits; Many patient groups reveal few, if any, details on relationships with pharmaceutical donors.” is written like a big expose when in fact it is much ado about old news…. The organizations he writes about have been open about their funding for decades so what’s the big deal? As long as there is transparency — and there is — caveat emptor. Ginsberg tries to draw a nefarious connection between the funding and giving companies a pass on safety…which doesn’t exist. On the contrary, Ginsberg simply swallows whole cloth the assertions of some that ADHD are unsafe and misstates the risk of suicide (it’s suicidal thoughts or behavior)…and wonders why groups that push for access and destigmatization of mental illness wouldn’t spread panic about rare or even non-existent problems. As for transparency….Ginsberg fails to note that the David Oaks of Mindfreedom believes that mental illness has no biological basis and his organization has no problem linkking its website to Scientology funded operations…. I guess taking money from drug companies is worse than forming a coalition of the willing with Scientologists..bad not to disclose one but ok to gloss over the other, right Tommy boy?

It's Tool Time

  • 05.30.2006

In today’s edition of The Wall Street Journal, Scott Hensley reports on the issue of post-market safety studies (and the supposed tardiness thereof) …

… Some in Congress and a recent report by the Government Accountability Office have faulted the FDA for not being demanding or vigilant enough on post-market studies. One solution proposed by some critics would be to give the FDA the authority to order companies to perform such studies, something the agency can’t do routinely under current law.

But even when the FDA does ask for more data or requires additional studies of drugs approved on an express path, companies often don’t follow through, FDA data show. The agency can yank a drug from the market if manufacturers don’t follow through, but that almost never happens.

FDA Deputy Commissioner Scott Gottlieb defended the current approach and reiterated his view that the agency doesn’t need or want unilateral authority to impose such studies on companies. “I think we have the tools we need, but we need to make sure we’re using them effectively,” he said.

Here’s a link to the full article …

http://online.wsj.com/article/SB114894002957165658.html

CMPI

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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