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We can’t all have our own personal FDA. Not you. Not me. Not Senator Charles “I’m not a doctor but I play one on C-SPAN” Grassley, not Consumer Reports.

Consider Consumer Reports. Based on its “own” analysis of FDA data, it reached a significantly different conclusion than all of the scientists and food experts at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Despite the fact that both the FDA and the EPA said that pregnant women should eat more fish — including tuna fish — Consumer Reports says the opposite. All the best science supports the FDA. All the lawyers support Consumer Reports. And who do you think gets the media coverage?

And as Senator Grassley moseys over to the Department of Health and Human Services today for another session of media-savvy grandstanding, we would all do well to remember the words of Dr. Mark Goldberger, director of FDA’s office of antimicrobial products:

“It’s more complex than it seems at first glance.”

Indeed.

This just in off the AP wire …

An experimental vaccine is showing promise against Alzheimer’s disease, reducing brain deposits that are blamed for the disorder.

The deposits have been cut by between 15.5 percent and 38.5 percent in mice, with no major side effects, researchers said Monday in the online edition of Proceedings of the National Academy of Sciences.

Tests of the DNA-based vaccine are under way in monkeys, and if those are successful, testing in people could begin, perhaps within three years, said lead researcher Yoh Matsumoto of the Tokyo Metropolitan Institute for Neuroscience in Japan.

If all goes well, this type of treatment might be available for people in six or seven years, he said.

Scientists estimate that as many as 4.5 million Americans suffer from Alzheimer’s, the most common form of dementia. The illness, named after Dr. Alois Alzheimer, a German doctor who studied it in 1906, involves the parts of the brain that control thought, memory and language.

Its cause remains unknown, and while there is no cure some drugs can slow progress of the illness in people in the early and middle stages.

Other efforts to develop an Alzheimer’s therapy also are under way.

Two years ago, trials of a potential vaccine that seemed to help slow the memory decline caused by the disease were halted after several participants developed brain swelling.

Matsumoto said that problem did not occur in the tests of his vaccine.

The brains of people suffering from Alzheimer’s disease are cluttered with a plaque made up of a small protein called amyloid beta, or Ab.

In the mouse tests, the Ab deposits were reduced overall, and in certain parts of the brain the reduction was as much as 50 percent, the researchers said.

Dr. Sid Gilman, a professor of neurology at the University of Michigan who has done research in vaccines for Alzheimer’s, said the new research showed the vaccine was efficient and safe in the mice.

He cautioned, however, that it’s very difficult to compare the level of efficiency from one trial to another, “so how effective this may be compared to other approaches is debatable.”

The reasons for the brain swelling in the earlier tests have been determined, Gilman said, and new forms of that therapy are now being tested.

A variety of clinical trials are under way looking at other potential treatments for Alzheimer’s including a hormone that might prevent brain cell death, several drugs, antioxidants, cholesterol-lowering medications and antibodies.

The Japanese research was funded by the ministry of education of Japan and the Novartis Institute of Biomedical Research.

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.

Paper or Plastic?

  • 06.11.2006

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..

Intel from Andy

  • 06.08.2006

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.

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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