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FDA Releases Medical Device Innovation Initiative

It’s about time.

According to the FDA website, “… The Center for Devices and Radiological Health (CDRH) is taking new steps to expand its current efforts to foster the development of safe and effective medical devices through a variety of initiatives and regulatory process improvements … This initiative includes the following efforts:

* Promoting scientific innovation in product development (Provide Regulatory Clarity Through Guidance Development, Invest in the Critical Path, Conduct Stakeholder Outreach and Improving Communications);

* Focusing device research on cutting edge science (Laboratory Research to Support Efforts to Improve the Device Development Process);

* Modernizing review of innovative devices (Implement a Quality Review Program, Provide Clarity Through Guidance Development, Leverage Information Technology Solutions, Expand Clinical and Scientific Expertise at FDA)”

A link to the full statement can be found at

Stephanie Saul has found the formula to make the front page of the NY Times: write article about the Rx industry that depict their products as unsafe or demonstrate an unholy link between clinical guidelines and industry support. Oh, and ignore the facts when you have to in order to keep the story line in shape. The most recent example of Stephanie’s shameless stylistics is today’s article entitled, “Unease on Industry’s Role in Hypertension Debate ” which starts out by noting that drug companies paid $700k ” to a medical society that used most of the money on a series of dinner lectures last year to brief doctors on the latest news about high blood pressure…. The same three companies â Merck, Novartis and Sankyo â also gave the money that the medical society used to formulate the main talking point of those briefings, an expanded concept of high blood pressure that many doctors say would increase the number of people taking drugs. …”

Let’s get one thing straight first. Most people with hypertension don’t take drugs and those that do fail to take them regularly or appropriately. So is it a bad thing to increase the numbe rof people taking drugs given the fact that high blood pressure is the leading cause of strokes and heart attack in the world and taking such drugs will cut strokes 35 to 40 percent and heart attacks 20 to 25 percent?

Now what Stephanie is talking about is something call pre-hypertension. No one seems to quibble about treating pre-cancer though fewer people die from cancer than heart disease but no matter. Or that from both a mechanistic and epidemiological level is pretty flat out certain that both elevation of blood pressure and lipid levels begin early in life, even in childhood in some people. Didn’t read that in Stephanie’s screed? What a suprise. High blood pressure was listed as a primary or contributing cause of death in about 277,000 American deaths in the year 2003. About 69 percent of people who have a first heart attack, 77 percent of those who have a first stroke, and 74 percent of patients with heart failure have blood pressure higher than 140/90 mmHg. Since blood pressure rises rapdily the idea is to prevent the exponential rise by getting to people who are on the cusp before it does as a way to stop hypertension before it starts. On the number of people on the cusp — prehypertenion — have been rising rapidly as well. So researchers wanted to see if you could slow the progression to hypertension by giving folks on the cusp blood pressure drugs. It did.

But all Stephanie could see was that Astra Zeneca paid for the study, not the potential public health beneifits of lowering blood pressure earlier than ever or the the fact that efforts to do so through diet and exercise alone have been a miserable failure. Obesity epidemic anyone?

Also, she left out some interesting facts. That the two “heroes” of her piece, Steve Nissen and Jean Sealey, have problems of their own. Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, as followers of this blog know, abused his position as a FDA media talking head and FDA advisory committee member along with another malcontent on Stephanie’s speed dial, Curt Furberg, MD to recommend a black box warning on drugs for ADHD in order to slow what he characterized as the âout of control growthâ use of the drugs.
Meanwhile Stephanie depicts Sealey leaving the professional association of hypertension specialists as a principled decision and a outgrowth over a battle about Rx influence. In fact, Sealey was on the verge of being forced to resign for reasons that are being investigated by the New York State Attorney General. Amazing how that never made it into the New York Times. It’s enough to give you pre-high blood pressure.

The Zipless Blog

  • 05.22.2006

Does Pharma suffer from Fear of Blogging? Of course. And with good reason. If you would like more information on this topic, may I recommend a new report by HCPro. It’s not out until June … but that’s, well, next week. It features interviews with various experts including the wonderfully bright Coleen Klasmeier and me.

The HCPro web address is

Friday’s Wall Street Journal editorial, “Medicare Bidding War,” left many people confused — me among them — as to how the Journal could be so wrong about something so important — the Part D benefit.

Not surprisingly, the man with the best answer is Mark McClellan. And, as per usual, he addressed the very questions posed by the Wall Streeet Journal even before they were asked. In this case at a May 2nd speech at the American Enterprise Institute.

Here’s a link to his prescient remarks:,filter.all/event-detail.asp

Two years ago CMS stood for “Can McClellan Succeed?”

One year ago it meant “Can McClellan Survive?”

Today it means the future of American health care.

I attended a small lunch yesterday with Dr. McClellan and he made it very clear that now is not the time to take a victory lap. There’s much more yet to be done.

Typical McClellan. That’s why he is the Hardest Working Man in Health Care.

But he did share a few key facts and memorable anecdotes.

Key Fact #1:

The average premium cost is lower than the initial Federal estimate by 30%.

Can you say ” C - O - M - P - E - T - I - T - I - O - N “ ?

Mark also told of the time and shoe leather he and other members of the CMS team spent on the health care hustings. Two stories bear repeating.

The first, according to Dr. McC, happened on a number of occasions. He tells of seniors coming up to him in tears —because they can finally afford the medicines they need.

And Mark, as those of you who know him will attest, is not prone to hyperbole.

The second tells of a woman at a senior center who, after hearing him speak, said that even though she wasn’t currently taking any prescription drugs she was going to sign up because …

“You never know what’s going to happen when you get older.”

To which Mark asked, “How old are you now?”

Her reply, “102.”

With age comes wisdom.

Live free or ...

  • 05.19.2006

When it comes to New Hampshire, “Live free or die” is a great state motto — but it’s terrible health care policy.

Latest case-in-point, HB 1346, a bill just passed by the New Hampshire legislature, that would make it illegal for pharmaceutical companies to have any access at all to physician prescribing data. This is a simplistic solution to a complex problem.

While I agree that physician-prescribing data shouldn’t be available for marketing purposes minus individual physician consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.

When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor” letters to physicians who have prescribed the drug. This is accomplished quickly and precisely because industry has access to physician-specific prescribing data. And when safety issues arise, that same data helps define the scope of the problem (i.e., how many patients are taking the drug and for how long). Also, FDA-mandated risk management plans, developed for physicians who prescribe higher-risk therapies are targeted through the use of this same prescribing data. It’s also an important tool in clinical trial recruitment, allowing focused efforts towards doctors treating targeted patient populations.

According to a spokeswoman, Governor Lynch will be looking at HB 1346’s “impact on health care costs and personal privacy.” That’s fine. But the Governor should also consider its implications on public safety.

Our friend and fellow health care scribbler Sally Satel, MD makes a great case for why we should provide economic incentives for everything health care related including organ transplants in her recent NY Times op-ed“Death’s Waiting List”: Sally writes:“March was National Kidney Month. I did my part: I got a new one. My good fortune, alas, does not befall nearly enough people, and the federal government deserves much of the blame. Today 70,000 Americans are waiting for kidneys, according to the United Network for Organ Sharing, which maintains the national waiting list. Last year, roughly 16,000 people received one (about 40 percent are from living donors, the others from cadavers). More are waiting for livers, hearts and lungs, which mostly come from deceased donors, bringing the total to about 92,000. In big cities, where the ratio of acceptable organs to needy patients is worst, the wait is five to eight years and is expected to double by 2010. Someone on the organ list dies every 90 minutes. Tick. Tick. Tick.Until my donor came forward, I was desperate. I had been on the list only for a year and was about to start dialysis. I had joined a Web site,, and found a man willing to give me one of his kidneys, but he fell through. I wished for a Sears organ catalog so I could find a well-matched kidney and send in my check. I wondered about going overseas to become a ”transplant tourist,” but getting a black market organ seemed too risky. Paradoxically, our nation’s organ policy is governed by a tenet that closes off a large supply of potential organs—the notion that organs from any donor, deceased or living, must be given freely. The 1984 National Organ Transplantation Act makes it illegal for anyone to sell or acquire an organ for ”valuable consideration.” In polls, only 30 percent to 40 percent of Americans say they have designated themselves as donors on their driver’s licenses or on state-run donor registries. As for the remainder, the decision to donate will fall to their families who are as likely as not to deny the hospital’s request. In any event, only a small number of bodies of the recently deceased, perhaps 13,000 a year, possess organs healthy enough for transplanting. The verdict is in: relying solely on altruism is not enough. Charities rely on volunteers to help carry out their good works but they also need paid staff. If we really want to increase the supply of organs, we need to try incentives—financial and otherwise.”The rest of Sally’s excellent article can be found here:,filter.economic/pub_detail.aspAnd we are glad that she is doing great!

WHO. No Clue.

  • 05.18.2006

Tomorrow WHO will call for a new policy in clinical trial transparency that is transparently absurd, absurdly transparent, and deleterious to the public health.

In its effort to develop worldwide standards of trial registration, WHO formally launched its International Clinical Trials Registry Platform (ICTRP) in April 2005. Tomorrow WHO plans to go public with its proposed final policy on which trials should be registered, and when. The policy will recommend registration of every “interventional study” (i.e. every trial for every intervention, whether marketed or not; whether randomized or not; and whether early phase or late phase).

Give me a break.

WHO wrongly claims that its policy is justified by the need to meet “ethical obligations to study participants.” Those obligations are already met in full, by disclosures to regulators, to independent review boards and ethics committees overseeing each trial, to every clinical investigator participating in each trial, and most importantly to every patient.

Ironically, while not remedying an ethical issue, WHO’s proposal may create one. In its call for registration of exploratory studies, particularly Phase I studies, WHO would fill the registry with vast amounts of data of no medical value. Every user would be compelled to sift this mountain of chaff to find the kernels of useful information; and might mistake the chaff for wheat. Phase I and other exploratory studies serve a narrow purpose and outside that context their results are inherently unreliable. Registering these trials or disclosing their results would at best confuse patients and encourage false hopes. At worst, where non-experimental drugs are being tested for new indications, physicians might inappropriately rely on disclosed trial information to make prescription decisions before confirmatory safety or efficacy trials have even been started.

From an ethical standpoint it is not at all clear what public health purpose is being served by this disclosure, nor which individuals it will benefit.

And then there are the myriad questions surrounding IP issues.

WHO’s policy of registering all interventional studies will make it harder or impossible for research based companies to secure important IP around selection inventions, manufacturing and formulation claims, and important new uses. Without this protection, sponsors may either abandon such research or else increase their precautionary patent filings at a time of high project attrition. This will drive up the cost of development, reduce the number of projects, and delay the progress of products to the marketplace.

The IOM has a better idea. In a recent workshop report they endorsed a more practical and beneficial guiding principle “Avoid reducing the incentive to do clinical research, whether public or privately funded.”

The net effect of the proposed WHO policy is that patients will wait longer for fewer and more expensive medicines, in exchange for a trial registry policy that benefits nobody.

That’s a Geneva Convention we can do without.

A recent stufy by the Tufts Center for the Study of Drug Development (home of Red Sox fan Joe DiMasi who is also the lead author of the study) found that “genomic technologies have helped to significantly increase the number of drug candidates that enter clinical trials.” According to the Center, “During 2003-05, the rate at which the 10 top selling U.S. drug companies initiated clinical trials for new drug candidates rose by 52 percent, following a 21 percent decline from 1993-97 to 1998-02.”

In an interview with GenomeWeb News sister publication BioCommerce Week, Tufts Center director Ken Kaitin noted though the study did not seek to learn why R&D productivity increased or to address technological tools that might have helped enable it.” Kenneth Kaitin said discussions he has with officials from big pharma indicate that genomic technologies and methodologies have played “an increasingly important role” in driving the improvement. These tools and methods include mass spectrometry, genome sequencing, gene-expression, high-content screening, and SNP-genotyping.

“I don’t think there is any question [genomic tools are] playing an increasingly important role in candidate selection for products that enter clinical testing,” Kaitin told . “Every company that I speak to now is saying that a significant improvement in their ability to select compounds for clinical development is access to these tools.”

Now the question is: can we apply the same science being used to improve drug discovery — characterized by the emergence of more validated drugs hitting more precise targets — to the process of drug development. The opportunity is enormous. Which is why supporting the Critical Path Initaitve is so critical.

Penalty Box

  • 05.18.2006

The MSM is so predictable. Rather than reporting on the success of Part D enrollment the stories are now all about “the penalty.” As Bob Goldberg has mentioned (see below) this draconian measure averages out to between about $2-$5 a month. But this fact, not surprisingly, hasn’t been reported. The issue that the media, lawmakers, and pundits have missed is that when you don’t have a deadline people who are eligible and entitled to Federal programs don’t sign up. A spot-on example is CHIP. As mayors and governors nationwide have bemoaned — if all of the CHIP-eligible families in the US were actually using the program, the numbers of children without health care coverage would plummet. But, there’s no deadline so there’s no urgency.

And that’s the ultimate penalty.


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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