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I met Joshua Lederberg four years ago when I was at the Manhattan Institute and was nominally the chair of the 21st Century FDA Reform Task Force. The idea for the task force was Dr. Lederberg’s and while he did not want to be chairman, he was it’s driving force. and it was conceived over lunch where I took notes as he spoke about using polymorphism and mechanistic pathways to improve not only the predictability of drug development and medicine but also the science governing reimbursement and legal proceedings shaping health care policy.

I had no clue what he was talking about. All I knew was that here was a Nobel Prize winner willing to spend time with me when he could be in his lab or lecturing. Over the next two years I met with Dr. Lederberg regularly, sometimes in his office, sometimes in his apartment where he made me lunch. Throughout he was too patient with me steep learning curve and too kind to say anything about the initial, rambling drafts of the Task Force report except “I admire your enthusiasm.”

Dr. Lederberg will be remembered for his endless contributions to molecular biology, to public understanding of medical progress and to the medical applications of the genome. Those who had the pleasure and honor of working with him will remember his kindness, his humility and his insistence on finding concrete answers to the difficult questions he often posed to Task Force members.

He once asked Peter (who was on the Task Force and my co-author): Is innovation possible? In posing that question, Dr. Lederberg (almost everyone called him Josh) simultaneously proposed the creation of a non-profit foundation that would fund the transfer of new knowledge of drug development to academics, entrepreneurs and others to accelerate biomedical innovation.

He passed away before that proposal was implemented. The last time I visited with him at his apartment I noticed a volume of Pirkei Avot, a chapter of the Mishnah, which is a compilation of ethical teachings of the rabbis of the Mishnaic period. One particular saying comes to mind: And "He [Rabbi Tarfon] used to say, it is not upon you to complete the task, but you are not free to idle from it. Joshua Lederberg, son of a rabbi, took that teaching to heart. It is now up to us to follow in his footsteps. Zichron l'bracha, his memory should be a blessing for us all.
Here is HillaryCare as far as I can figure it:

You will be forced to buy health insurance that buys coverage as defined by government and the premiums for that plan will be set by government. The only services and drugs covered by that plan will be those established by a government established Best Practice Institute.

And if you don't want this health care? Your wages are garnished. If you want to set up a health savings account to buy your own health care, in your own way? You can't. HSAs will be illegal under Hillarycare. So too under Obamacare.

I guess that's change.

Senior Moment

  • 02.05.2008
When talking with the media last week, Representative Henry Waxman had to be reminded what the Reagan-Udall provision was all about.

Must have been an, er, oversight.
Here's another great example of comparative effectiveness translated into clinical practice.....This from AP..

"A group of doctors from New Jersey is opposing a plan by Aetna Inc. to drop coverage of a type of anesthesia used during colonoscopies.

Gastroenterologists and other doctors say patients anxious about colorectal screening may balk unless they are assured that their insurance coverage includes the cost of anesthesiologists who administer propofol, an anesthesia the doctors say is effective and comfortable.

"The idea should be to encourage these procedures because of their lifesaving ramifications," said John Fanburg, counsel for the New Jersey State Society of Anesthesiologists and the New Jersey Gastroenterology and Endoscopy Society...

As of April 1, the Hartford-based insurer plans to continue to routinely cover moderate sedation, but limit coverage of so-called monitored anesthesia care by an anesthesiologist to patients who are at higher risk due to illness or other complications.

"Propofol works faster, but whether it results in improved patient satisfaction is difficult to prove," said Robert McDonough, head of Aetna's clinical policy unit.
"

Translation: We will let you know when there is enough data and what is the definition of improved patient satisfaction. Aetna is telling patients that for $200 they can suffer and worry through their surgery and exam. By the way, if it's difficult to prove, why is the burden of proof on the patient, not Aetna, especially since it's our money?

That my friends is a great metaphor for evidence-based medicine. It's your money and your tuchus but someone else is telling you how the procedure is going to be done because it might save money though in the words of McDonough, whether it does "is difficult to prove."

But for the comparative effectiveness crowd, who see patients as mere cost centers, there is no complaining. Just bend over and take it.

Anti-intellectual freedom. Anti-consumer choice. Is achieving a pharma free, single payer system really worth all this loss of freedom?
http://news.yahoo.com/s/ap/20080205/ap_on_he_me/aetna_colonoscopy_sedation
Why worry about obesity? Turns out it is a very good tool for saving money, along with smoking. So if I get this right, fast food and tobacco companies good because they save money. Drug companies evil because they extend life...
http://news.yahoo.com/s/ap/20080205/ap_on_he_me/obesity_cost
Anyone who has taken a look at the recent research review Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer should say a prayer that the EBM thought police do not get control over the practice of medicine in America under the banner of cost containment OR conflict of interest. The "guidelines", if you can call them that, are drivel, essentially conceding two points: First, that patient and tumor characateristics heavily influence treatment selections and do so over the course of disease. Second -- and by extension -- that clinical expertise matters. But of course many oncologist with the best expertise fail the holier than thou COI standard imposed by those who hide their agenda under the purity banner (the capitalism=corruption=corrupt medicine coalition). As the panels to decide what is best practice are picked, you can be sure that their will be tribunals, inquests, witchhunts and general suppression of the ability of any one who consults with pharma or biotech companies, anyone who has a research contract or runs a clinical trial for a drug company will be purged of participation. This is nothing short than an attack on intellectual freedom as harsh and as unrelenting as anything seen in the sciences or liberal arts in recent years. And this is not a matter of forcing college kids to do research on reasons why Bush should be impeached. This boils down to a bunch of autocrats trying to dictate to the rest of us a politically correct form of medicine....

For a taste of force-fed medicine to come:

http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr&ProcessID=9&DocID=79
The President's new budget for the FDA allocates $68 million more for drugs and biologics in FY 2009. Backing out user fees which that's a real increase of $10 million. So core functions are finally getting user fee money and some real inflation adjusted increase. But it's not enough. That just allows the FDA to begin to dig into the science deficit years of political neglect have piled on the agency. There is still no additional money for Critical Path or other efforts that actually focus on improving the scientific integrity of the agency.

For starters we could take all the Ag Approp earmarks flowing into the the district of Rosa DelLauro who chairs that subcommittee and who has as her informal science advisers the anti-medical progress Center for Science in the Public Interest and Union of Conceited Scientists. DeLauro hogged $25.4 million in earmarks for herself last session while cutting funding for the Reagan Udall foundation that is established to help the FDA find ways to speed up the translation of basic research into personalized tools for testing cures for cancer and other illnesses that apparently can't be earmarked. DeLauro's earmarks are twice the increase the President has allocated for FDA core operations.

No that earmarks alone would be enough. I think we are coming to a time when the user fee program has outlived it's usefulness in its current structure. This last go round showed that user fee money is better used for Critical Path activities and that the user fee process dwells on the cause de jour to a more orderly and integrated oversight and funding of FDA operations. Maybe that's a starting point for everyone agreeing on a better, less political way to address the FDA's -- and the public's -- long term public health needs.
And speaking of surveys …

Another "survey" came out today -- the President’s budget proposal. No line for Critical Path – and, considering inflation, a decrease in federal appropriations for human drugs.

Here’s what Commissioner von Eschenbach had to say, ““This budget enables us to continue development of the staff and programs necessary to safeguard the food we eat and improve the safety and development of drugs, vaccines, devices, and other medical products.”

I don’t think so -- and Happy Talk isn't helping.
A new national survey shows that Americans overwhelmingly support the FDA’s Critical Path Initiative. The survey was comprised of a nationally representative sample of 1,049 adults and conducted by Opinion Research Corporation. It was commissioned by the Center for Medicine in the Public Interest and iGuard Inc.

When asked about Critical Path, nine in 10 Americans expressed support. The Critical Path Initiative was launched by the FDA in 2004 to streamline drug development.

The survey also examined attitudes regarding key features of Critical Path. When asked about the FDA's efforts to expand the use of biomarkers to identify which drugs are best for individual patients, 78 percent of those surveyed were supportive.

The survey also found that 77 percent of the public supports partnerships between private companies, the FDA, and academics to create new approaches to drug evaluation and development.

And nearly 80 percent want their member of Congress to support Critical Path.

Survey respondents also expressed support for a voluntary, confidential, online portal where patients could share information about their reactions to different drugs. 87 percent said such a program would boost their confidence in drug safety, and 50 percent said they would take part.

Day in and day out, congressional lawmakers bash the FDA. That may score political points, but the public’s support for this program should send a strong message to Congress: Don’t cut funding from the Critical Path Initiative.

For the full report, click below

http://www.cmpi.org

And then under "Reports" click on "Critical Path National Research Report."

Stone of Arc

  • 02.02.2008
Yes, Virginia, while some media will exploit public health myths for their own venal purposes, others can play an important role in advancing the public health.

By now you are certainly familiar with the controversy surrounding the ABC program “Eli Stone” – where the title character (an attorney who has spiritual visions) goes to court to prove that childhood vaccinations cause autism.

Well, rather than piling on to the already crowded anti-pharma bandwagon, here is what the New York Times said in an editorial:

“Nevermind that such authoritative bodies as the Institute of Medicine of the National Academy of Sciences, the Centers for Disease Control and Prevention and the World Health Organization have found no evidence of a causal link. Nevermind that the incidence of autism continued to rise even after mercury preservatives were phased out of almost all childhood vaccines. As far as Eli Stone is concerned, you can’t just rely on science. Sometimes you have to go on faith.

The American Academy of Pediatrics tried unsuccessfully to get the episode canceled, fearing that it could deter parents from getting their children vaccinated, exposing them to far greater dangers from disease. Let’s hope that any parents who watched don’t make that mistake. And let’s hope that in future episodes, Eli Stone and ABC show better judgment in picking causes.”

Here is a link to the editorial in its entirety:

http://www.nytimes.com/2008/02/02/opinion/02sat4.html?_r=1&ref=opinion&oref=slogin

And James Oliphant (Baltimore Sun) points out that good television shouldn’t be driven by bad science:

"In a statement yesterday, the association’s president, Sherman “Tiger” Joyce, said the show has the potential to scare millions of parents away from having their children properly vaccinated against dangerous diseases.”

Joyce cited a report from the Center for Medicine in the Public Interest’s, which offers case studies of real-life personal injury lawyers endangering public health by disseminating unfounded information that convinces some people to avoid drugs or other medical treatments that could improve their health or even save their lives. Now, Hollywood’s latest make-believe lawyer is getting in on the act, too."

Here’s a link to the complete Oliphant piece:

http://weblogs.baltimoresun.com/news/politics/blog/2008/01/a_trial_lawyer_as_a_ood_guy.html

ABC needs a lesson on public responsibility -- and Eli Stone needs to lose his Joan of Arc complex.
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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