Latest Drugwonks' Blog
Lead graph from a post by Trevor Butterworth on The Huffington Post:
Among the many febrile statements that followed the publication of a study in The New England Journal of Medicine (NEJM) contending that a diabetes pill carried an unacceptable risk of heart attack, one comment stood out, not so much for the scale of prognostication (deaths from Avandia may "dwarf 9/11," said study author Dr. Steven Nissen on ABC), or the degree of vitriol over the way drugs are regulated in the U.S., but because it managed the remarkable feat of sounding both stupifyingly naive and disingenuous at the same time. "We are a scholarly journal, not a news outlet," NEJM executive editor Gregory Curfman told BioCentury, a publication covering the drugs industry. 'What happens in the media is beyond our control."
The full post can be found at
http://www.huffingtonpost.com/trevor-butterworth/medical-journal-malpracti_b_52677.html
"Febrile." Great Scrabble word.
Among the many febrile statements that followed the publication of a study in The New England Journal of Medicine (NEJM) contending that a diabetes pill carried an unacceptable risk of heart attack, one comment stood out, not so much for the scale of prognostication (deaths from Avandia may "dwarf 9/11," said study author Dr. Steven Nissen on ABC), or the degree of vitriol over the way drugs are regulated in the U.S., but because it managed the remarkable feat of sounding both stupifyingly naive and disingenuous at the same time. "We are a scholarly journal, not a news outlet," NEJM executive editor Gregory Curfman told BioCentury, a publication covering the drugs industry. 'What happens in the media is beyond our control."
The full post can be found at
http://www.huffingtonpost.com/trevor-butterworth/medical-journal-malpracti_b_52677.html
"Febrile." Great Scrabble word.
No, not Thomas the Tank Engine.
The toxic train referred to herein is the one leaving the station on comparative effectiveness.
Or as Jill Wechsler of Pharmaceutical Executive writes, "The comparative-research bandwagon is gathering steam in Washington health-policy circles."
Except that a bandwagon doesn't "gather steam" -- it gathers hangers-on.
But choose your metaphor, it's a free country.
Gathering steam? Perhaps. Generating a lot of hot air? Definitely.
Two sample paragraphs to whet your interest:
"The danger is, of course, that effectiveness studies could be used to limit coverage and treatment options to low-cost products. And additional research requirements for sponsors could be costly. Prospective studies cost hundreds of millions of dollars and are vastly different from relatively low-cost retrospective data reviews, points out health economist Bryan Luce of United BioSource at a March seminar on comparative-effectiveness research sponsored by the Center for Medicine in the Public Interest."
"Variations in patient response to treatments and the desire to link provider payments to quality measures speak to the need for more valid comparative healthcare information."
Here's a link to the article:
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=429153
Comparative Effectiveness. The wrong train leaving the station in the wrong direction.
The toxic train referred to herein is the one leaving the station on comparative effectiveness.
Or as Jill Wechsler of Pharmaceutical Executive writes, "The comparative-research bandwagon is gathering steam in Washington health-policy circles."
Except that a bandwagon doesn't "gather steam" -- it gathers hangers-on.
But choose your metaphor, it's a free country.
Gathering steam? Perhaps. Generating a lot of hot air? Definitely.
Two sample paragraphs to whet your interest:
"The danger is, of course, that effectiveness studies could be used to limit coverage and treatment options to low-cost products. And additional research requirements for sponsors could be costly. Prospective studies cost hundreds of millions of dollars and are vastly different from relatively low-cost retrospective data reviews, points out health economist Bryan Luce of United BioSource at a March seminar on comparative-effectiveness research sponsored by the Center for Medicine in the Public Interest."
"Variations in patient response to treatments and the desire to link provider payments to quality measures speak to the need for more valid comparative healthcare information."
Here's a link to the article:
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=429153
Comparative Effectiveness. The wrong train leaving the station in the wrong direction.
Not much in "Sicko," Moore's film advocating "free" universal health care for America. Rather, he spends a few minutes claiming that drug companies -- because Billy Tauzin wound up becoming head of PhRMA -- got the government to spend $800 billion on a new drug entitlement. Yawn. (PS/ He doesn't mention that Part D works and that seniors love it.)
In fact, there is not much of anything new in the movie as a whole. If you are a Moore loyalist you will rave how great it is. But mainly Moore recycles tired old arguments for national health care, abeit with more charm, humor and poignancy than most leftists can ever muster even when high. And Moore's fact and anecdotes are mostly incorrect, outdated and easily rebutted -- something we will take pleasure in doing here.
Does this mean that health care shouldn't more affordable or available or that 9-11 workers shouldn't have been given comprehensive care immediately? Of course not. But there are tradeoffs too. Moore keeps referring to "free" universal health care. Health care is neither free nor universal in the UK, Canada or France. But on the whole our system provides better care for more conditions with less rationing and about the same out of pocket spending (yes, folks) than all others.
In fact, there is not much of anything new in the movie as a whole. If you are a Moore loyalist you will rave how great it is. But mainly Moore recycles tired old arguments for national health care, abeit with more charm, humor and poignancy than most leftists can ever muster even when high. And Moore's fact and anecdotes are mostly incorrect, outdated and easily rebutted -- something we will take pleasure in doing here.
Does this mean that health care shouldn't more affordable or available or that 9-11 workers shouldn't have been given comprehensive care immediately? Of course not. But there are tradeoffs too. Moore keeps referring to "free" universal health care. Health care is neither free nor universal in the UK, Canada or France. But on the whole our system provides better care for more conditions with less rationing and about the same out of pocket spending (yes, folks) than all others.
In the movie “Marathon Man,†Lawrence Olivier’s Mengele-inspired dentist threateningly asks, “Is it safe?†That same question, as Congress debates PDUFA reauthorization and FDA reform, has the real threat of crippling medical progress and the freedom physicians have in deciding which treatments are best for their patients. These are frightening thoughts — and attention must be paid lest we find ourselves, micron-by-micron, abdicating the hope of 21st century medicine to politically expedient measures that serve only to further the political aspirations of sound-bite hungry politicians and the voracious appetites of trial lawyers.
In today’s edition of the Wall Street Journal, Scott Gottlieb addresses the fact that …
“A decade ago, we were mostly focused on uncovering the remote risk that certain drugs could, in rare cases, cause immediate, unexpected and potentially life-threatening problems such as liver damage or disturbed heart rhythms. Surfacing these problems was made easier by the fact that the side effects occurred in close proximity to administration of the medicine, so it could be deduced when the drug was at fault.
Now we're focused on unearthing cases where prolonged use of some drugs may prompt small elevations in the risk of otherwise naturally occurring and even common events, like heart attacks. This was the issue that caused the withdrawal of the painkiller Vioxx and the premature flap around the diabetes drug Avandia.
Our heightened vigilance will surely improve the information people have to make informed choices. But finding and proving these kinds of rare and latent problems will often take many years and entail large and rigorous clinical testing. Even then, deciding if such remote kinds of risk outweigh benefits requires an often subjective calculus that is best left for patients and doctors to decide individually.â€
In short, rhetoric and politics, and now actual legislation in the form of REMS, are forcing the FDA ever more towards adopting the Precautionary Principle. That’s the one-dimensional dogma that dictates that nothing should be done until everything is understood. Prudent? No, puerile. And the unintended consequences are fatal. Fatal like in no new medicines.
A little harmless politicking? Hardly. Just ask the people who may soon longer have access to the medicines they need, or to those who will suffer needlessly in the wake of Tropical Storm Safety — since the inevitable result of the Precautionary Principle is a dearth of new medicines in the pipeline.
Is it time to recall Ivory Soap? Is it safe? After all, it’s only 99 44/100% pure.
We must not allow safety to be hijacked.
In today’s edition of the Wall Street Journal, Scott Gottlieb addresses the fact that …
“A decade ago, we were mostly focused on uncovering the remote risk that certain drugs could, in rare cases, cause immediate, unexpected and potentially life-threatening problems such as liver damage or disturbed heart rhythms. Surfacing these problems was made easier by the fact that the side effects occurred in close proximity to administration of the medicine, so it could be deduced when the drug was at fault.
Now we're focused on unearthing cases where prolonged use of some drugs may prompt small elevations in the risk of otherwise naturally occurring and even common events, like heart attacks. This was the issue that caused the withdrawal of the painkiller Vioxx and the premature flap around the diabetes drug Avandia.
Our heightened vigilance will surely improve the information people have to make informed choices. But finding and proving these kinds of rare and latent problems will often take many years and entail large and rigorous clinical testing. Even then, deciding if such remote kinds of risk outweigh benefits requires an often subjective calculus that is best left for patients and doctors to decide individually.â€
In short, rhetoric and politics, and now actual legislation in the form of REMS, are forcing the FDA ever more towards adopting the Precautionary Principle. That’s the one-dimensional dogma that dictates that nothing should be done until everything is understood. Prudent? No, puerile. And the unintended consequences are fatal. Fatal like in no new medicines.
A little harmless politicking? Hardly. Just ask the people who may soon longer have access to the medicines they need, or to those who will suffer needlessly in the wake of Tropical Storm Safety — since the inevitable result of the Precautionary Principle is a dearth of new medicines in the pipeline.
Is it time to recall Ivory Soap? Is it safe? After all, it’s only 99 44/100% pure.
We must not allow safety to be hijacked.
"There is no free lunch.†(A big “thank-you†to Grace-Marie Turner of the Galen Institute for the Latin translation.)
More to the point, there is no “cheap†lunch. In other words, there are rarely simple answers to complex questions.
For example -- John Edwards’ suggestion that the government take away patent rights for companies that develop breakthrough drugs and instead, reward them with “prizes†from the government.
Except that, er, it doesn’t work and has significant unintended consequences.
Details. Details.
The “prize†model has been used in the past – in the old Soviet Union. It didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isn’t much better. The federal government paid Robert Goddard (“the father of American rocketryâ€) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion.
Certainly not what Schumpeter had in mind when he wrote about “spectacular prizes … thrown to a small minority of winners.†Creative destruction indeed!
Does Candidate Edwards really want to replace a patent system that has allowed the average American lifespan to increase, over the past 50 years, by almost a full decade with a prize program that has a solid record of complete failure.
As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
As DiMasi and Grabowski presciently observed in 2004, “The main beneficiaries in the short-term would be private insurers and public sector purchaser of pharmaceuticals … Governments and insurers are focused myopically on managing health care costs. They are not likely to be strong advocates for funding new drug development that can increase individual quality of life and productivity."
Sound familiar? Correct. Europe. Sound familiar? Correct. Evidence-Based Medicine.
To be sure, there will be other unworkable, ill-considered, and precarious suggestions for ways to “fix†the U.S. health care system. But a prize system may be the worse of them all.
More to the point, there is no “cheap†lunch. In other words, there are rarely simple answers to complex questions.
For example -- John Edwards’ suggestion that the government take away patent rights for companies that develop breakthrough drugs and instead, reward them with “prizes†from the government.
Except that, er, it doesn’t work and has significant unintended consequences.
Details. Details.
The “prize†model has been used in the past – in the old Soviet Union. It didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isn’t much better. The federal government paid Robert Goddard (“the father of American rocketryâ€) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion.
Certainly not what Schumpeter had in mind when he wrote about “spectacular prizes … thrown to a small minority of winners.†Creative destruction indeed!
Does Candidate Edwards really want to replace a patent system that has allowed the average American lifespan to increase, over the past 50 years, by almost a full decade with a prize program that has a solid record of complete failure.
As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
As DiMasi and Grabowski presciently observed in 2004, “The main beneficiaries in the short-term would be private insurers and public sector purchaser of pharmaceuticals … Governments and insurers are focused myopically on managing health care costs. They are not likely to be strong advocates for funding new drug development that can increase individual quality of life and productivity."
Sound familiar? Correct. Europe. Sound familiar? Correct. Evidence-Based Medicine.
To be sure, there will be other unworkable, ill-considered, and precarious suggestions for ways to “fix†the U.S. health care system. But a prize system may be the worse of them all.
John Edwards wants to end long term patents on breakthrough drugs for Alzheimer's and cancer and replace them with cash prizes for inventors. So reducing the incentives for investing in life saving medicines will help improve health care how exactly?
I have a better idea...let's reduce the cash prizes currently available for tort lawyers like Edwards that now go to pay for 16 acre spreads like his and use it to buy health insurance for hundreds of people.
http://www.nytimes.com/aponline/us/AP-Edwards-Michigan.html?_r=1&oref=slogin
I have a better idea...let's reduce the cash prizes currently available for tort lawyers like Edwards that now go to pay for 16 acre spreads like his and use it to buy health insurance for hundreds of people.
http://www.nytimes.com/aponline/us/AP-Edwards-Michigan.html?_r=1&oref=slogin
We sent our roving reporter on the streets of New York City and asked following question:
"What do you think of a doctor who compares the adverse events of a diabetes drug to the events of 9-11?"
A non-scientific representative sample of these comments (on video) can be found at http://www.cmpi.org Just go to the section on podcasts and click on "Dr. Weber."
Yes, that Dr. Weber. Well-respected cardiologist, FDA maven, and Chairman of the Center for Medicine in the Public Interest. He comments (a bit more knowledgably) on the same question.
This podcast can also be found on YouTube and other social networking sites. We're trying to bring health care policy to the people.
"What do you think of a doctor who compares the adverse events of a diabetes drug to the events of 9-11?"
A non-scientific representative sample of these comments (on video) can be found at http://www.cmpi.org Just go to the section on podcasts and click on "Dr. Weber."
Yes, that Dr. Weber. Well-respected cardiologist, FDA maven, and Chairman of the Center for Medicine in the Public Interest. He comments (a bit more knowledgably) on the same question.
This podcast can also be found on YouTube and other social networking sites. We're trying to bring health care policy to the people.
From http://www.stat.org Trevor Butterworth, this time his trenchant comments from his blog on Huffington Post:
http://www.huffingtonpost.com/trevor-butterworth/the-avandia-nightmare-it_b_50596.html
http://www.huffingtonpost.com/trevor-butterworth/the-avandia-nightmare-it_b_50596.html
Yale University's David Katz, whose website http://www.davidkatzmd.com is a valuable tool for anyone interested in nutrition or learning ponders the rejection of Accomplia in a recent post on ABCnews.com. He thinks the panel -- devoid of physicians who actually treat people with obesity problems -- went too far in rejecting the drug. He asks a question the FDA did not pose to the AdComm:
"That's not trivial, but how great is two times your current risk of depression if you're not depressed? And how much does uncontrolled obesity increase the risk of depression, anxiety and sleep disturbances in comparison?"
Oh.
Read the entire post here: http://www.abcnews.go.com/Health/Diet/Story?id=3277937&page=2
"That's not trivial, but how great is two times your current risk of depression if you're not depressed? And how much does uncontrolled obesity increase the risk of depression, anxiety and sleep disturbances in comparison?"
Oh.
Read the entire post here: http://www.abcnews.go.com/Health/Diet/Story?id=3277937&page=2
After all the non-stop claptrap about there being too many new drugs comes a sobering fact: even as pharmaceutical companies poured a record $43 billion into research and development in 2006, U.S. Food and Drug Administration statistics show that the agency approved only 18 new drugs last year. That's down from 36 in 2004 and nearly as low as it's been at any time during the past decade.
According to Dr. Scott Gottlieb, the agency's former deputy commissioner for medical and scientific affairs, "Our concern is that the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end."
Which begs the question—wither the 21st century drug development tools that would make possible a swifter path from bench to bedside? More importantly, where's the outrage? Where are the scathing articles about the "critical path gap?" Where's the outcry from the halls of Congress about "who lost the critical path?"
Here's the rest of the story from The Journal of Life Sciences:
http://www.tjols.com/commentary/jun13_fda.jsp
Thoughts and comments most welcome.
According to Dr. Scott Gottlieb, the agency's former deputy commissioner for medical and scientific affairs, "Our concern is that the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end."
Which begs the question—wither the 21st century drug development tools that would make possible a swifter path from bench to bedside? More importantly, where's the outrage? Where are the scathing articles about the "critical path gap?" Where's the outcry from the halls of Congress about "who lost the critical path?"
Here's the rest of the story from The Journal of Life Sciences:
http://www.tjols.com/commentary/jun13_fda.jsp
Thoughts and comments most welcome.
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.
