Latest Drugwonks' Blog
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…
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The issue at hand is FDA’s new draft guidance on a new category of complex diagnostic tests that are expected to play a growing role in tailoring medical treatments to specific patients.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Please note that this is a draft guidance — the agency is accepting comments.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.
Doctors in Botswana, already battling one of the highest levels of HIV per capita in the world, are being overwhelmed by a dramatic rise in cancer cases as a result of the epidemic….
The cost of treating Kaposi’s Sarcoma was an additional burden on the public service health budget.
“The cost per patient is 350 pula (58 US dollars) per course which is repeated four to six times. There is also the cost of radiotherapy which is between 5,000 and 7,000 pula. With other types of cancer, these amounts increase to 2,000 pula per course,” he said….”
Meanwhile at the Tenth International Obesity Conference experts noted that” the cost of treating health problems related to being overweight was immeasurable on a global scale, but was estimated at billions of dollars a year in countries such as Australia, Britain and the United States.
“We are not dealing with a scientific or medical problem, we’re dealing with an enormous economic problem that, it is already accepted, is going to overwhelm every medical system in the world,” said Prof. Philip James, the chairman of a global task force set up by medical organizations that deal with weight-related problems.
He said governments had been forced to confront rising obesity rates because of the expense of treating related health issues.”
Health care costs are rising, exploding like ballon…speading like a cancer…
The reason is not drug costs or greedy drug companies or useless medical technology.
The reason is disease. Disease — or our inability to prevent it or stop it early — is expensive. Things that killed us quickly and sooner have been replaced with illnesses that use a combination of genes and environment to trigger chronic and long term patterns of illness that cripple and kill. And there are some who believe that those who make profit out of finding ways to pre-empt these pathways are bigger evils than the diseases they fight.
So who is the bigger enemy of the human race?
David Cutler, Harvard University health care economist extraordinaire, was lead author of study look at the value of medical care. After estimating that half of gains in life expectancy are attributable to medical care (the rest due to lifestyle changes and fewer murders, accidents) Cutler and company found:
:…although medical spending has increased substantially during the past 40 years, the money spent has provided good value. However, temporal trends suggest that the value of health care spending is decreasing over time, particularly for older age groups. “
Cutler adds two important qualifications: “Studies suggest that there were substantial improvements in the quality of life during this period, especially among the elderly. Thus, our estimates are likely to have understated the value of medical spending. Finally, although we excluded gains in life expectancy that were due to nonmedical interventions, we did not exclude their associated costs, owing to the difficulty of disaggregating them from the overall costs of health care. This resulted in the overstatement of cost increases and thus the understatement of the value of medical advances. ” In otherwords, medical spending is probably more valuable than reflected in the study..
Of course the Leftists countered that other countries had similar increases in life expectancy with less money. But you can make international comparisons…too much variation within the US, let alone between countries. The true comparision, comarping gains due to medical intervention only demonstrate the superiority of our system…cancer, stroke and heart by pass mortality rates…no contest…Sorry Gooz…Get your facts straight for once..
And leave it to Sid Wolfe to come up with the meanest and most pointless comment:Ã¢The fact that someone is writing this paper shows how desperate the health care system is to justify these out-of-control increases in health spending,Ã¢ So in otherwords, every time Sid Vicious writes a paper it is an act of desperation? Here’s the difference: David Cutler is a well respected economist who has published in peer reviewed economic journals and has advised presidential candidates on health care reform ranging including Bill Bradley. And Sid Wolfe is just a hack.
The article on PDUFA in today’s WSJ is headlined “Drug Firms Use Financial Clout To Push Industry Agenda at FDA” conjures up an image of drug companies conspiring to ram useless and dangerous drugs through the FDA. I mean, what else do you with financial clout except water down regulations governing safety and efficacy?
Turns out (and Anna either doesn’t know or doesn’t think it’s important) both biotech and pharma companies would like to devote some user fee money to fund Critical Path programs that would allow the FDA to hire and train scientists who can use new molecular tools and new clinical trial methods leading to more targeted and personalized medicines. Then there is an effort to help the FDA establish collaborations with large health systems to collect clinical data in cooperation with companies after a drug is marketed. Finally, there is talk of devoting some money to promote industry, academic, and agency initiatives like the one created with MIT Center for Biomedical Innovation to develop software for detecting adverse drug effects and reactions of new drugs after they hit the U.S. market or the one with the Critical Path Institute to develop a biomarker to do the same thing before a drug goes into development.
Only a professional scowl like Sid Wolfe (see post above) would complain this is a waste of additional industry funding. Why is it that Mathews couldn’t report on these possibilities?
Remember the nearly gleeful article Stephanie Saul wrote about Apotex had outfoxed Bristol and Sanofi just a couple of weeks ago? And the fawning piece that described Apotex CEO Bernard Sherman as both a wily businessman, consumer crusader and man of charity? Well, now that Apotex has had the law shoved down its throat, Stephanie seems a bit dazed and uncharacteristically plays it straight for once … almost like the news jarred her back to the default settings of objective reporting…
September 1, 2006
Generic of Plavix Is Blocked
By STEPHANIE SAUL
A federal judge in Manhattan ordered a Canadian company yesterday to stop distributing its generic version of the blockbuster anticlotting drug Plavix, granting a reprieve to Bristol-Myers Squibb and Sanofi-Aventis, which co-market the brand-name drug.
The Plavix marketers had seen a drastic erosion of their United States sales since the Canadian company, Apotex, introduced its generic version on Aug. 8 in a challenge to the patent held by the big companies. Analysts say that the large supplies of the generic drug already on the market could continue to impinge on sales of Plavix for several months …
Judge Stein did say that the patent was likely to be enforceable, based on the evidence and testimony so far. He also observed that Bristol-Myers and Sanofi had suffered “irreparable harm” as a result of the patent infringement.
He nonetheless required Bristol-Myers and Sanofi to post a $400 million bond to compensate Apotex in the event the generic company won in a trial on the validity of the patent, now set to begin in his court next January …”
Apparently the judge did not buy, as did Stephanie, Bernie’s claim that he never intended his wheeling and dealing (getting BMS and Sanofi to pay for only half of generic sales if it lost its patent suit) to really mean anything, citing as evidence letters he sent to Chuck Grassley in which he wrote that he hated all the wheeling and dealing. The judge saw it for what it was: a shakedown that was part of an effort to void the patent without exploring the validity of the patent itself …
“In his 57-page ruling, Judge Stein wrote, ‘The public interest in lower-priced drugs is balanced by a significant public interest in encouraging the massive investment in research and development that is required before a new drug can be developed and brought to market.’”
Those of you who want to see Judge Stein’s entire ruling can go to this link:
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Thanks to all of you for helping make drugwonks.com such a success.
(Yes, you too Senator Grassley.)