I received a few media calls yesterday asking me if I thought there would be an outcry from “the religious right” about Gardasil potentially “causing” sexual promiscuity in teenage girls. My response: I have heard nil (the same amount as the number of goals scored by Team USA yesterday in the World Cup). Seems to me that in the light of such a really important public health advance that the media would be reporting on, well, a really important public health advance. The only thing I have heard (and I’m hearing it a lot) is that this new vaccine should become mandatory. And, indeed, I agree that it should.

I have been stewing about this drive by reporting or smear for a couple of days….This from an article in the Boston Globe, a piece on Chuck Grassley entitled “Watching the Watchdog” which recounts the various safety molehills Grassley has made mountains out of. He is never asked, in reference to his grave concern about the FDA being too cozy with industry, why it is perfectly kosher for the chairman of the Finance committee to have an FDA employee in his office, on his staff doing his bidding for free free at taxpayer expense when the guy should be at his desk at Rockville or White Oak.

But that is not the only thing: Grassley implies that the drug industry tried to whack one his staffers because of his heroic work on drug safety. This is a serious charge and the way it is laid out makes it seem that drug safety was the reason she was attacked: “

Grassley also has reason to be concerned about his staff’s well-being. Last November, his chief investigator, Emilia DiSanto , was attacked outside of her suburban Virginia home. The assailant, dressed in black, clubbed her with what appeared to be a baseball bat. The FBI and Capitol Police are still investigating and no arrests have been made. Grassley suspects DiSanto was targeted because of her work on drug safety and other matters.

“Unless the guy was a psychopath, it doesn’t seem to me like it was random,” he said. “If they had knocked her out with the first hit, she’d be dead. She was able to just survive and fight back, and the guy got scared and ran off.”

“She’s OK,” he added, “but, obviously, we [will] live with this for a long, long, long time.”

For the record, over the last year the Senate Finance Committee has scrutinized healthcare fraud, organ-donation procedures used by hospitals, drug-safety matters and the use of nonprofit groups related to former lobbyist Jack Abramoff. That still doesn’t mean there is any connection but in the context of the article it seems that drug safety work was the trigger for the attempted hit when in fact there could have been any number of forces. Why was this subject even introduced? To make Grassley into some sort of crusader? To smear the drug industry by association. Shouldn’t such an allegation have some supporting evidence instead of just hanging out there like some spitball? Both Grassley and the Globe should keep their suspicions to themselves. Enough for now. I have to take a shower.

From the Kaiser Foundation’s daily dose of depressing news about how health care in America generally sucks, this time another piece about how horribly the Medicare drug benefit is mistreating seniors and — above all - the poor, poor pharmacists from the mind of Robert Pear: “The New York Times on Sunday examined the effects of the Medicare drug benefit on beneficiaries, pharmacists and doctors in McAllen, Texas, a town near the Mexican border in the Rio Grande Valley. According to the Times, beneficiaries in the town are “hav[ing] difficulty getting the drugs they need,” and pharmacists and doctors “are struggling to figure out which drugs are covered by which plans.” In addition, pharmacists are “swamped with questions and complaints from beneficiaries” and “have run into many practical problems as they try to navigate a complex program administered by dozens of prescription drug plans, each with its own policies and procedures,” the Times reports (Pear, New York Times, 6/11).

Yes Robert, and somehow 90 percent of all seniors have managed to navigate this “complex program” as easily as you have been able to navigate around their successes. Perhaps you could write an article about you go about avoiding writing about their stories for so damn long without including the words clueless or bias…

As the keynote speaker at our recent conference on the Critical Path (graciously sponsored by our think tank confreres at the Manhattan Institute) Dr. Andy von Eschenbach described 21st century medicine as having to be “personalized, predictive, and participatory.”

And the same can be said for the FDA.

The agency must become more personalized in the sense that it can no longer operate under a “one-size fits all” mentality to regulation — particularly (and for example) as relates to clinical trials.

The agency must, similarly, become more predictive. Consider here the three “Bs” — Bayesian Statistics, Biomarkers, and Bioinformatics.

As for participatory, the 21st century FDA must both engage and lead. The agency’s recent rope-a-dope communications strategy has resulted in falling public confidence, increased media strutiny, more intense and self-serving political posturing, and an internal crisis of confidence. Unfair and unearned? You bet. But reality.

Andy spoke about “FDA Evolution.” He reminded the audience that a caterpillar is going to morph into a butterfly — and there’s nothing it can do to prevent that change. So too will the FDA change into something. But, unlike the caterpillar, the FDA can decide what it wants to become and choose how it wants to evolve. But evolve it must. According to Andy, the process must (must!) be a collaborative effort. FDA can neither work nor change in a vacuum.

And at the center of that evolution, said Dr. von Eschenbach, is the Critical Path initiative. This point was eloquently echoed by another conference speaker — Dr. Janet Woodcock.

To pursue Andy’s caterpillar/evolution theme, consider this — We are all crewmembers on board the FDA’s Voyage of the Beagle.

And we must all have a common mission — evolutionary change. It kind of puts “survival of the fittest” into a new context.

The FDA has announced that it “will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products — the so-called “pedigree” — throughout the distribution system.”

Most recently, in early 2004, FDA delayed the effective date of certain regulatory provisions regarding pedigrees to allow the industry time to adopt electronic technology for tracking drugs through the supply chain. Based on information from drug supply stakeholders, the FDA had expected this technology to be in widespread use in the drug supply chain by 2007, but it now appears that these expectations will not be met.

Accordingly, the hold, which will expire in December, will not be continued.

A paper pedigree? In the 21st century? Will this really be an effective deterrent in the battle to combat counterfeiters so sophisticated they can produce both packages and pills imperceptively different from the real McCoy? Do we really think the bad guys can’t produce their own paper pedigree documents?

This is a big problem — but it’s not the point. This is a signal from the FDA that industry cannot drag its feet when it come to developing and implementing more potent e-pedigree systems such as RFID.

According to the FDA’s announcement:

“A potential new measure to safeguard the drug supply is the use of electronic track and trace technology, such as radio-frequency identification (RFID), which creates an electronic pedigree (e-pedigree) for tracking the movement of the drug through the supply chain. The FDA had expected this technology to be in widespread use in the drug supply chain by 2007. In early 2004 FDA delayed the effective date of the regulatory provisions regarding pedigrees to allow the industry time to adopt this technology. However, it now appears that FDA’s expectations for adoption of the technology by 2007 will not be met. FDA therefore has determined it can no longer justify delaying implementation of the pedigree regulations.”

Any questions?

As Peter pointed out (try saying that ten times fast) the FDA leadership is poised to move the agency into the 21st century and with it the ability of medicine to be predictive and preventive. More to the point, it is imperative that, we are able to accelerate and reduce the cost of bringing new cures to market. There is no reason why the fight against Alzheimer’s Disease should not get the same Part E approach as cancer and HIV and no reason why the Critical path can’t be used to make it happen at the reviewer level. And there is no reason why the FDA cannot help pave the way for faster, smarter scale up of vaccine facilities for products against neglected global diseses.

IT will need help — a consortium with money will do. But the enemies of medical progress are all around. They put their political careers and hatred for drug companies first and foremost. They blame everything, include the tragic physicial attacks on their staffers, on drug companies and those that support them. As the Tysabri case showed, they created an environment where a highly effective medicine for a debilitating disease was treated as more toxic than aspirin.. This was the result not of scientific concern but of political pressure. People suffered and their condtions worsened because of the grandstanding and moralizing of some inthe media and the halls of Congress. And they will perpetuate that suffering if they get their way.

We won’t let that happen..

Today Dr. Bob and I officially released the “Prescription for Progress” taskforce report on the Critical Path. More on this shortly, but here’s a taste …

Our keynoter, Dr. Andrew von Eschenbach, noted that the FDA was at a “strategic inflection point” in its history. All you hi-tech wonks out there will no doubt be familiar with that phrase and it’s coiner — another Andy, Andy Groves of Intel.

Great minds think alike — like revolutionairies.

The British government has posted a “help wanted” ad for the post of director of the National Health Service in the Times of London.

I am not making this up. Check it out at http://jobs.timesonline.co.uk.

Hello Alistair Wood!

The fact that the government is willing to consider non-British candidates is (IMHO) an important sign that they’re (at least potentially) ready to look at new ways to approach the myriad of critical issues facing health care in the 21st century UK. (That’s a polite way of saying that maybe, just maybe, the Brits are beginning to admit that their system is in DEFCON 4 — not that we should brag too loudly.)

If you choose to apply, please feel free to use drugwonks.com as a reference.

I nominate Scott Gottlieb. Look British. Think Yiddish.

An incredibly clueless article on drug spending today in the AP typical of MSM coverage of Rx issues..all about prices and costs and nothing about value:

Spending on specialty drugs soar
By THERESA AGOVINO, AP Business Writer
Wed Jun 7, 12:48 AM ET

Spending on high cost specialty drugs soared 17.5 percent last year and is expected to more than double by 2009, according to a report released Wednesday.

She goes on to write:”The explosive growth is spending on specialty drugs is especially problematic because there is no pathway for generic competitors to enter the market.”

Why is this problematic? These medicines often replace halfway measures for which there are no effective treatment and are most always more cost effective than the endless surgery, hospitalization, lab tests, nursing support, home care that is required. That includes care for people with breast cancer, cystic fibrosis, Gaucher’s disease, HIV, and RA where the cost-effectiveness is well demonstrated. You did not care to cite any of this literature or experts.

Woud she be willing to hold the line on drug costs and suffer in order to make drug spending less “problematic.” Perhaps the addition of the new cervial cancer vaccine should be restricted because it to will add to “explosive growth” in drug spending.

Are reporters just that biased against drug companies or just too lazy to do more than merely regurgitate press releases or both?

The scaremongers at the NY Times are at it again with a biased piece about the use of medicines for manic depression in children:

June 6, 2006
Use of Antipsychotics by the Young Rose Fivefold
By BENEDICT CAREY
The use of potent antipsychotic drugs to treat children and adolescents for problems like aggression and mood swings increased more than fivefold from 1993 to 2002, researchers reported yesterday.

The researchers, who analyzed data from a national survey of doctors’ office visits, found that antipsychotic medications were prescribed to 1,438 per 100,000 children and adolescents in 2002, up from 275 per 100,000 in the two-year period from 1993 to 1995.

The findings augment earlier studies that have documented a sharp rise over the last decade in the prescription of psychiatric drugs for children, including antipsychotics, stimulants like Ritalin and antidepressants, whose sales have slipped only recently. But the new study is the most comprehensive to examine the increase in prescriptions for antipsychotics…

I am the father of a child who is bi-polar so my immediate response is thank goodness more parents are getting the right medication for their kids sooner then me and my ex-wife did. The years with which we and my daughter struggled with behavioral issues, depression, destructive outbursts, and other problems which I do not care to go into at this time were a direct result of misdiagnosis, mis-medication and failure to arrive at the proper combination of drugs. There is a reason the medication rates have increased: better diagnosis, earlier treatment, all of which have led to better outcomes. There is some mismanagement to be sure but with at least 1 million children with bipolar illness there is much more undertreatment. The failure of the NY Times article and Benedict Carey to even discuss the benefits of these medications and to suggest that an increase is questionable and without scientific support is reprehensible and irresponsible. This is so typical of the media who in lieu of a real story or controversy seeks to stir one up.

For real information instead of the garbage the NY Times passes off as medical reporting you can go to the website of The Juvenile Bipolar Research Foundation at
http://www.bpchildresearch.org/

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 drugwonks.com) 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 ppitts@cmpi.org.

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 www.uscc.gov

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.

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