Latest Drugwonks' Blog
Two items of interest:
The first is the report of the U.S. Department of Justice’s Task Force on Intellectual Property. Must reading (and particularly so because they quote the CMPI report on the almost unobstructed growth of counterfeit prescription medicines).
The second is the latest report out of Europe on the same topic.
Both can be found at:
A follow up to the noxious fearmongering and the failure of the media to look at the implications of Congressman Markey, Waxman and the esteemed expert in clinical trial design Charles Grassley to scuttle non-inferiority studies and demand randomized clinical trials to determine safety and effectiveness for all medicines: There is no other way to say it than to state that such an approach would harm the sickest and most vulnerable among us and cripple efforts to accelerate treatments for Alzheimer’s, cancer and AIDS. Perhaps that it why even the NIH regards this politically motivated and doctrinaire approach to be unethical
Consider the following study:
“Enrolling children with asthma in the placebo arm of a clinical trial is common, harmful and ethically unjustified argue researchers from the University of Chicago and the National Institutes of Health (NIH) in the January 2004 issue of Pediatrics. After a systematic review of all clinical asthma trials involving children in the United States published between 1998 and 2001, the researchers found that children with asthma were more than twice as likely to be harmed — defined as forced to withdraw from the trial due to asthma exacerbation — if they did not receive standard asthma therapy compared to children who received standard treatment.”
Or here’s another way to look at it. If, as Markey (who has also pushed for a federal G force standard for rollercoasters) had his way, Ketek would be taken off the market. t’s “lethal” says he. Try telling that to the hundreds of thousands of children who would have died from community acquired pneumonia without it.
To my mind, the real killer in all this is not Ketek, but the politically motivated decisions of pols like Markey who ignore science and mislead the media for their own self serving agenda.
Thanks to the spreading outrage — unreported by the MSM — of the sanctioned anti-Jewish postings on the Moveon.org Actionforum (yes Osama, there was a moderator who saw and knew EVERYTHING) the blog itself has been shut down… Here is how the Moveon folks try to explain it away:
ActionForum Temporarily Offline
The MoveOn Great Goals ActionForum will be down until after the election. So much is happening with the MoveOn PAC Leave No Voter Behind campaign and other projects that our systems are at their limits. Suspending the Forum gives us a margin of safety and is a prudent thing to do. We will bring the forum back up after the election.
Well actually, Moveon changed course and is now imposing a 24 hour delay button its Forum monitors. So much for the margin of safety and prudence…
Wisely. Boldly. Timely.
Who Says What’s Best?
US News & Wold Report
By Bernadine Healy M.D.
Evidence-based medicine has the ring of scientific authority. But it’s not as self-evident as it sounds. EBM is a movement born in the 1990s as an alternative way of practicing medicine, in which “best” evidence, gleaned mostly from randomized clinical trials and cost-benefit studies, is the basis for what docs should or shouldn’t do. Touted as a way to improve patient care and restrain unnecessary treatment, EBM sees itself as a major shift away from traditional medicine that emphasizes the expertise of the medical profession. That includes knowledge of the underlying nature of disease, mechanisms of therapy, basic and clinical research, and physician experience. The autonomy and authority of the doctor, and the subsequent variability in care, are the problems that EBM wants to cure.
It’s no surprise that EBM draws strong support from governments that seek uniform standards to assess performance and cost effectiveness. According to Marc Rodwin, professor of law at Suffolk University Law School in Boston, EBM puts experts trained in social science, public health, epidemiology, and economic analysis on par with physicians and “breaks the lock hold” the profession has over how medicine is practiced and compensated. Depending on where you sit, that may be good or bad. But you still have to recognize that EBM carries its own ideological and political agenda separate from its clinical purpose.
Remember the mammogram wars over whether women should get them during their 40s? The protagonists were the EBM-ers who said no and the radiologists and oncologists who said yes. For the naysayers, randomized clinical trials were inadequate to show that the test saved lives, even though it did detect cancers sooner. Such a mammogram program would be costly, and unnecessary biopsies for false positive readings even costlier. But based on their interpretation of clinical evidence, cancer experts maintained that the test saved lives. What’s more, they factored in the nature of the disease: more aggressive in younger women and best cured if picked up early. But in 1997 the Department of Health and Human Services gave a thumbs down to recommending that women start having mammograms in their 40s. Women promptly exercised their political clout, which led to an HHS reversal. (In fact, the trend has been for more screening in this age group, not less.)
EBM also questions the prostate-specific antigen test, or PSA, for prostate cancer. The evidence-based method concludes that the test brings more harm than benefit, as it leads to unneeded biopsies and surgeries on often slow-growing cancers. This is at odds with the American Cancer Society, which says that men should have annual PSAs starting at age 50, and African-Americans, who have a higher prostate cancer rate, at age 45. This does not help that young primary-care doctor who published a mournful essay in the Journal of the American Medical Association in 2004. He did not get a PSA on his 53-year-old patient, based on his dutiful practice of evidence-based medicine. When found to have advanced prostate cancer, the patient sued and won. The jury put its faith in the medical experts who testified that PSAs are the best way to pick up tumors when they are most treatable.
Sift and sliver. Were these tests not so well known, the selective rules of evidence-based medicine might have prevailed. Patients would have been none the wiser. This concern underlies a scathing commentary on the EBM movement in the International Journal of Evidence-Based Healthcare by Dave Holmes, a professor of nursing at the University of Ottawa. He and his colleagues argue that EBM is “outrageously exclusionary” and even “microfascism” in the way it sifts knowledge. Though harsh, he makes a point: By anointing only a small sliver of research as best evidence and discarding or devaluing physician judgment and more than 90 percent of the medical literature, patients are forced into a one-size-fits-all straitjacket. Ironically, this comes at a time when both human genomics and informed patients are demanding more tailored and personal prescriptions for care.
EBM has its merits, but let’s make it just what it claims to be: a system to gather and synthesize evidence and disseminate it widely in order to enhance medical decision making. Do so using the full range of relevant medical knowledge and science and the foremost thinking of its experts, without political or ideological bias. This “best” EBM should be integrated into medicine, not be at odds with it.
The Froward Five of FDA Reform — U.S. Reps. Edward Markey (D-MA), John Dingell (D-MI), Henry Waxman (D-CA), Bart Stupak (D-MI) of the House Energy and Commerce Committee, and Senate Finance Committee Chairman Charles Grassley (R-IA) — desperately looking for a way to reinvigorate their FDA jihad, have requested that the Government Accountability Office (GAO) investigate the agency’s “reliance” on non-inferiority studies.
(FYI: Mr. Markey’s website refers to the FDA as the “Federal Drug Administration.” Glad he’s on top of these issues.)
Markey remarked, “The Bush Administration’s FDA has been working hand in glove with the drug industry for six years, leaving Americans vulnerable to dangerous drugs and insufficient information about the side effects of those drugs.”
Yes Virginia, before President Bush took office all drugs were 100% safe and label information was clearly commuicated
Also, last time I looked, the GAO wasn’t staffed with clinical trial design experts — they’re at the FDA.
(FYI — Mr. Markey — that’s the Food & Drug Administration.)
Remember the National Institute for Health Care Management (NIHCM) study? Remember NIHCM, the “nonprofit, nonpartisan organization dedicated to improving the effectiveness, efficiency, and quality of America’s health care system that just happened to be brainchild of one CEO of one major HMO who wanted to launch an attack on drug costs to get the press off his back onto the Rx industry? But never mind that. The study, written by one Mick Hunt said that the increase in drug spending between 1995 and 2000 was largely due to spending on medications that the FDA did not categorize as providing significantly improved efficacy or safety even as it ignored the number of new medicines receiving priority review increased and ignored vaccines and biologics. It also ignored research by Lichtenberg (which it was forced to include in a second version of a report) demonstrating that the consumption of the medicines the study derided actually reduced treatment costs and increased life expectancy.
Part of the goal of the study was to demonstrate how out of control drug costs were and are in terms of explaining huge increases in HMO premiums (at least at the Blues) A recent study by Americ’s Health Insurance Plans finds that non-drug medical costs accounted for 70 percent of average health premium increase in 2005.
Increased spending on physician services was the largest single contributor to the 8.8 percent average health premium increase in 2005. Outpatient hospital services such as diagnostic testing accounted for 22 percent of the increase followed by inpatient hospital services which accounted for 18 percent. Prescription drugs? The subject of the NICHM study and a Peter Jennings report based on the report and a slew of mainstrem media attacks? 16 percent? Other medical services were at 6 percent.
Why didn’t the media write stories about this fact? Why didn’t Ms. MickHunt include that in her dissembling and slanderous piece of propaganda? As Mark Twain noted, a lie can travel halfway round the world before the truth even gets its boots on….
Recently I wrote about a research paper in nature describing a procedure that supposedly produced stem cells without harming an embryo. Turns out that the paper had a lot of hot air and spin to it. It was written and published to appeal to those yearning to tip the balance in favor of embryonic stem cell research. But it claimed more than the procedure actually produced. In essence, the authors used science and shading of language to dupe us… Shame on them and on us for not reading more carefully…
http://www.nature.com/news/2006/060904/full/443012a.html
What’s the trade-off between quality and speed? Can’t we have both? While this is a regular debate in the world of pharmaceutical development — it’s not so familiar in the realm of diagnostics. Until now — and it’s about time.
The issue at hand is FDA’s new draft guidance on a new category of complex diagnostic tests that are expected to play a growing role in tailoring medical treatments to specific patients.
Here’s a link to the FDA announcement:
I also suggest, as recommended reading, an article in today’s edition of the New York Times by the always thoughtful Andrew Pollack. (Sorry — I am not able to provide a hot link, but the title is “F.D.A. Seeks to Regulate New Types of Diagnostic Tests.”)
Please note that this is a draft guidance — the agency is accepting comments. Now is the time to help the FDA design a final guidance that will allow for both speedier approval and higher quality.
It can be done. It must be done.
Arguably the most hardworking and innovative health care administrator in US history announced that he is leaving his position as administrator of the Center for Medicare and Medicaid Services. Mark McClellan has done more to change thinking and the culture of healthcare away from command and control, government run systems to a consumer driven approach that dovetails with the technological trend towards personalized medicine. Mark oversaw and helped engineer both transformations first as FDA commissioner through the Critical Path initiative and then as administrator of CMS with the implementation of MMA which apart from giving seniors drug coverage for the first time via Medicare has also caused millions of seniors to take charge of their health care dollars.
Mark’s tenure was not without controversy. He took on those who wanted to import unsafe drugs as a political stunt and threatened to demoralize and scare seniors into not signing up for the new benefit. But as Ronald Reagan said: “A leader, once convinced a particular course of action is the right one, must have the determination to stick with it and be undaunted when the going gets rough.”
That was the essence of McClellan as a health care policy leader.
On August 15 I had an op-ed in the Baltimore Sun on the growing dangers of counterfeit drugs (“Pharmaceutical Fakery is Health Care Terrorism”). I pointed out that one of the weakest links in the chain is the European practice of parallel trade.
I believed it then. I believe it now. Here’s a link to my original article:
But I clearly ruffled some feathers Over There. Richard Freudenberg, the Secretary General of the British Association of European Pharmaceutical Distributors, dashed off a very defensive letter that appeared in The Sun on August 25.
(Here’s a link to the letter: http://www.baltimoresun.com/news/opinion/letters/bal-ed.le.25aaug25,0,2130712.story?coll=bal-oped-headlines.)
Among other things, he rants that my “allegations are, at best, unfounded, at worst blatently false.”
But not only does he think I am completely wrong, he proposes that he is completely right. He continues, “In fact, to date, there has not been a single case of counterfeit drugs in Europe which have entered the legitimate supply chain via parallel trade.”
To rebut Mr. Freudenberg, I asked Graham Satchwell, one of the world’s undisputed experts on counterfeit prescription medicines, to address the issue. Here is what Mr. Satchwell had to say — unexpurgated — and he pulls no punches.
RESPONSE BY GRAHAM SATCHWELL TO RICHARD FREUDENBERG:
Over two years ago I published a book on counterfeit medicines and organized crime. Since that time the matter has gained greater attention and one could reasonably believe that the Pharmaceutical Industry, the middle-men and the American public were becoming more aware — as indeed they must if they are to be adequately protected. It was heartening for instance to see the British regulatory authority, the FDA and World Health Organisation and others beef up there anti-counterfeiting efforts.
As part of the global campaign to raise awareness Mr. Peter Pitts wrote an article published in the Baltimore Sun on August 15 (“Pharmaceutical Fakery is Health Care Terrorism”).
So much to the good.
How disappointing then that the leader of the British Association of European Pharmaceutical Distributors has apparently had his head up his harness for the last two years.
In his response to the cautionary article by Peter Pitts, Richard Freudenburg commented, “Peter Pitts incorrectly links the worrisome issue of counterfeit medicines with the perfectly safe and legal practice of parallel distribution of medicines in Europe.”
Mr. F is of course wrong to glue the words perfectly safe to legal in the way he does, for they are certainly not inseparable. After all, prostitution, pot-holing, drunkenness, bungee jumping, and suicide are amongst the many types of behavior that are often legal but dangerous they also certainly are — similarly parallel trade in medicine — legal but not always safe.
Mr. F goes on to contend that, “parallel distributors source and sell products exclusively from EU countries and therefore do not facilitate the entry of products from non-EU countries such as Russia.” If only Mr. Fraudenberg could guarantee that that were always the case. However, if were to do so he would he would be naive, stupid or dishonest.
It seems to be a matter of overwhelming logic that in any given population you will have those who comply with the rules and who usually behave ethically and those who will break the rules because of perceived self interest or negligence. Were it not so then our planet would surely witness a race, tribe or occupation where crime and punishment were unknown.
Nevertheless, unprepared to leave his criticism there, Mr. F continues, and it seemed to me by this stage of reading Mr. F’s critique that he was developing a style, for he again links to distinct notions as if one, “Associating counterfeiting with Europe’s parallel distributors, who have operated successfully and safely for decades, is unjustified and irresponsible.”
“Successfully and safely?” The former means that they have made a lot of money, the latter is provably untrue for there have indeed been occasions on which counterfeit medicines have been found in the distribution chain and in the hands, or from the hands of those holding parallel traders licenses.
Perhaps Mr. F is unaware? Perhaps he shouldn’t be. Perhaps he should do a little research. Perhaps he would do a greater public service to the American public if he were to highlight the extreme weaknesses in the systems within Europe for the movement of pharmaceutical products and the dangers — real and potential — which that threat poses. But hang on, who does he represent? Well he is paid to represent the interests of those very European traders who benefit from parallel trade — strange coincidence you might think.
Mr. F’s slip is really showing when he offers the following, ‘In fact, to date there has not been a single case of counterfeit drugs in Europe which have entered the legitimate supply chain via parallel trade.” How very wrong you are Mr. F, please do some research.
Of course it might be that in Mr. F is only talking about the performance of his membership, which comprises, across Europe, only about 70 companies. Let me remind Mr.F. lest it slipped his memory, there are literally thousands of parallel traders licenses in existence in Europe.
The erstwhile Mr. F assures us “member companies across the EU, adherence to strict Good Distribution Practice guidelines is mandatory.” Yes Mr. F, like speeding restrictions on our roads, politicians declaring all their expenses properly, and little boys washing behind their ears.
Mr. F assures us all, “The idea that the EU’s latest enlargement round has compromised the safety of the European pharmaceutical supply chain also belies reality.” At this stage one might wonder about whose reality we are discussing here, Mr.F’s or the rest of the civilized world? For anyone with any doubt about the increased risk of all sorts of criminality which faces Western Europe from the newest members of the Union, please (a) do a Google search on such criteria as fraud+Eastern Europe, or (b) read what the EU officials or WHO or Interpol have said on the subject, or (c) read the rather detailed report of Dr. Jonathan Harper, or (d) simply ask any reasonably informed law officer.
There can be little doubt that few parallel traders would want to deal in counterfeit medicines, but as Mr. F knows, or should, it is the very act of removing original packaging with anti-counterfeiting features and repackaging those goods in translated items before shuffling them from country to country and dealer to dealer that affords the opportunity for the unscrupulous few to do real harm.
Two years ago I took the opportunity to publicly debate some of these issues, yet Mr. F. seems unaware of the evidence that so clearly undermines his position, surely he cannot have forgotten? If he has, then let me invite Mr. F to publicly debate these issues with me at any venue of his choice. This is a real and specific opportunity for Mr. F to set the record straight and once again here some hard facts.
Want to do it Mr.F?
There was a time when there were many voices in Europe and the USA echoing the sentiments of the bold Mr. F. Most have been embarrassed into silence, it is time for Mr. F to stop insulting the intelligence of consumers.
If any US reader wants to know more about the real situation in Europe then visit my website (PocoSolutions.com) go to articles and see the full text of A Sick Business and other articles.
Thank you, Graham. Well said.
Ringside seats for this debate between Mr. F and Mr. S (when scheduled) will be available at www.drugwonks.com.
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.
