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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.
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.
