Latest Drugwonks' Blog

Crew Cut

  • 02.07.2008
Page One story in today's New York Times on the continuing saga on Dr. Robert Jarvik and whether or not he can scull.

According to the story, "A newsletter published by the Lake Washington Rowing Club in Seattle describes how one of its rowers was a stunt double in the ad for Dr. Jarvik. The sculler, a professional photographer and rowing enthusiast named Dennis Williams, was picked partly for his size and partly because, like Dr. Jarvik, he has a receding hairline, according to the newsletter, which said a crew filmed the commercial for three days at Lake Crescent, near Port Angeles, Wash.

In the ad, Mr. Williams was shown as a solitary sculler navigating an unspoiled lake. Through deft editing, he appeared to be Dr. Jarvik. But, in fact, the frames that actually included Dr. Jarvik were shot in a rowing apparatus on a platform, according to the newsletter."

Yes, friends, it's "CrewGate."

Here's a link to the complete story:

http://www.nytimes.com/2008/02/07/business/media/07jarvik.html?_r=1&hp&oref=slogin

And here's what Dr. Jarvik had to say for himself, "I accepted the role of spokesman for Lipitor because I am dedicated to the battle against heart disease, which killed my father at age 62 and motivated me to become a medical doctor,” it said. “I believe the process of educating the public is beneficial to many patients, and I am pleased to be part of an effort to reach them.”

Yes, he's a real medical hero -- but he can't scull.

As to why the ad chose to make it look at though he could may be of interest to some -- but is it relevant? Obviously DDMAC didn't seem to think so.

And as far as "All the news that's fit to print," the article didn't point out that DTC advertising drives patients to ask their doctors about important health questions -- like high cholesterol, one of our nation's most under-diagnosed chronic diseases.

Also absent from the article is FDA research that disproves the myth that physicians prescribe a medicine just because a patient saw an ad on television. They don't. And of patients who visited their doctors because of an ad they saw and who asked about that prescription drug by brand name, 88 percent actually had the condition treated by the drug.

According to that same study, in 6 percent of DTC-generated office visits, a previously undiagnosed condition was discovered. Why is this so important? Because earlier detection combined with appropriate treatment means that more people will live longer, healthier, more productive lives without having to confront riskier, more costly medical interventions later on.

Coincidentally, the one word that links both hyperlipidaemia and sculling is ... stroke!

Immune To Reason

  • 02.06.2008
Think the latest study showing no connection between vaccines and autism will drive a stake through the heart through a sometimes vicious and violent movement that sought to replace science with emotional assertions?

Think again:

First this (and note the skeptical tone of the lamebrain reporter:

"A University of Kentucky chemist still thinks that a mercury-containing preservative in children's vaccines is behind rising rates of autism in youngsters, despite a recent California report that seems to dismiss the theory.

The California Department of Public Health reported that rates of autism have continued to rise in California, even though the mercury-based preservative thimerosal ostensibly was removed from most child vaccines by about 2001. Some scientists and medical groups are citing the report as disproving the theory that mercury in vaccines causes autism."

But UK's Boyd Haley, a mercury researcher and leading proponent of the mercury-autism connection, maintains that the California study proves nothing because it is based on a "false premise" that children in California haven't been getting any mercury from vaccines over the past several years.

...."They say that mercury was totally out of vaccines in 2001 ... and that's absolutely false," Haley declared.

Haley contends that some child vaccines still contained mercury preservative well after 2001, and that many children might have continued to receive the vaccines because California didn't actually enact a law banning them until 2006. If children were still getting mercury in vaccines after 2001, that could explain why autism rates didn't fall, Haley contends."

Never mentioned in the article is how reclassification of many behavioral diseases have been reclassified as autism, boosting rates.. The article gives "the other side" but barely. And it finishes with this precautionary note from pediatrician Erich Maul:

"Maul says research someday might conclude that mercury in vaccines can cause autism. But he says that evidence hasn't been found yet and that, for now, immunizations are essential to protect young children from serious infectious diseases.

I will continue to respect those parents who don't want it," he said. "But as someone who has a fourth child on the way, I guarantee you that she will be immunized. I've immunized all my kids, and I continue to recommend it."

For those looking for another source of speculation, scapegoating and sensationalism, David Mandell, an epidemiologist at the University of Pennsylvania medical school offer fields of gold. According to a recent article, Mandell "recently surveyed the adult patients in Norristown State Hospital in Eastern Pennsylvania, nearly all of whom are labeled schizophrenic, and found that about 20 percent of them meet the behavioral criteria for being autistic.

While he believes misdiagnosis in the past explains a part of the increase in autism numbers, Dr. Mandell also believes the growth has been too great to be accounted for just by continuing genetic abnormalities.

"The increase is probably too fast to be genetics," he said, "so there probably is something that is environmental, but there is nothing to suggest it's the vaccines."


Off we go.
http://www.kentucky.com/211/story/307394.html
http://www.post-gazette.com/pg/08037/854963-114.stm
Terrific editorial in today's edition of the Wall Street Journal. And the title says it all, "The Real FDA Scandal."

It puts the FDA Science Board report into the appropriate context -- that despite all of the Congressional bloviating about the FDA "not doing its job," there's plenty of blame to go around -- much of it belonging to those same elected representatives who are the first to throw stones. And you know the proverb.

Here's a link to the complete WSJ editorial:

http://online.wsj.com/article/SB120225742208745785.html?mod=opinion_main_review_and_outlooks

"Scienceboarding" shouldn't be used to torture the FDA and score political points, rather the Science Board report should be recognized and utilized for what it really is -- a clarion call for appropriate budgeting, smart reform, and strong support for the Critical Path program and the Reagan/Udall Foundation.
Senator McCain's chief policy advisor, Douglas Holtz-Eakin, points out that, "The first responsibility of the next president will be to keep this country safe from an enemy that so despises us they would unleash any terror to cause us harm."

Amen.

So it remains a mystery why Senator McCain continues to support drug importation from other nations. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation (which according to the CBO would result in a national health care savings of less than one percent) would only facilitate such actions.

It's time for Senator McCain - truly the candidate with the best national defense bona fides, to rethink his position on drug importation.
Josh consulted extensively with biotech and drug firms. So apparently he would be barred by the likes of Daniel Carlat, Relman, Cassirer, Angell, Health Care Renewal bloggers and the Macy Foundation from any participation on FDA Adcomms or CME.

What is the difference between boycotting academics because of their affiliation with industry and boycotting academics because of their affiliation with Israel?

Is this isn't a looming crisis of academic and intellectual freedom, it will be.
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
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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