Latest Drugwonks' Blog
Did you see the house editorial in today’s New York Times, “Countering the Drug Salesmen�
Here’s the link:
http://www.nytimes.com/2008/03/20/opinion/20thu2.html?_r=1&ref=opinion&oref=slogin
The editorial supports planned legislation by Senators Herb Kohl, Democrat of Wisconsin, and Richard Durbin, Democrat of Illinois that would authorize federal grants to prepare “objective†educational materials designed to provide physicians with “unbiased†guidance on the safety and effectiveness of drugs. Such materials, along with a government-funded “counter-detailing†force are meant to offset the one-sided sales pitches America’s physicians get from pharmaceutical company representatives. The Times believes that, “The end result should be better care, quite often at lower cost.â€
The Times shares the hope of Senators Kohl and Durbin that this government-funded scheme “would pay for itself by lowering drug costs to federal programs.â€
Perhaps, but at what cost to patient care? And what about the fact that “unbiased†and “objective†are in the eyes of the beholder?
Clearly pharmaceutical companies detail because they believe it is in the interest of both the public health and their own commercial imperatives. Nothing wrong with that. Self-interest and public interest are not mutually exclusive.
But it’s only honest to point out that the government has significant self-interest too – Uncle Sam is the largest “payer†in the nation. So the more drugs these government-funded workers classify as "wasteful," the more money the government saves. Such a conflict is hardly" unbiased.â€
Ultimately, as the European model has shown time and again, budget analysts and Big Brother-funded anti-pharmaceutical “truth squads†will deliver the findings their “funders†wants to see -- that newer, pricier pills are no more effective than their older, cheaper counterparts. And the result will be the same as well -- Medicare, Medicaid, and the Department of Veterans Affairs will stop covering these more innovative medicines, forcing physicians to prescribe only the drugs that the government will pay for, not the ones that are best for patients.
That’s what “government†care really delivers.
Here’s the link:
http://www.nytimes.com/2008/03/20/opinion/20thu2.html?_r=1&ref=opinion&oref=slogin
The editorial supports planned legislation by Senators Herb Kohl, Democrat of Wisconsin, and Richard Durbin, Democrat of Illinois that would authorize federal grants to prepare “objective†educational materials designed to provide physicians with “unbiased†guidance on the safety and effectiveness of drugs. Such materials, along with a government-funded “counter-detailing†force are meant to offset the one-sided sales pitches America’s physicians get from pharmaceutical company representatives. The Times believes that, “The end result should be better care, quite often at lower cost.â€
The Times shares the hope of Senators Kohl and Durbin that this government-funded scheme “would pay for itself by lowering drug costs to federal programs.â€
Perhaps, but at what cost to patient care? And what about the fact that “unbiased†and “objective†are in the eyes of the beholder?
Clearly pharmaceutical companies detail because they believe it is in the interest of both the public health and their own commercial imperatives. Nothing wrong with that. Self-interest and public interest are not mutually exclusive.
But it’s only honest to point out that the government has significant self-interest too – Uncle Sam is the largest “payer†in the nation. So the more drugs these government-funded workers classify as "wasteful," the more money the government saves. Such a conflict is hardly" unbiased.â€
Ultimately, as the European model has shown time and again, budget analysts and Big Brother-funded anti-pharmaceutical “truth squads†will deliver the findings their “funders†wants to see -- that newer, pricier pills are no more effective than their older, cheaper counterparts. And the result will be the same as well -- Medicare, Medicaid, and the Department of Veterans Affairs will stop covering these more innovative medicines, forcing physicians to prescribe only the drugs that the government will pay for, not the ones that are best for patients.
That’s what “government†care really delivers.
Check out H.R. 5605, the “Physicians Payments Sunshine Act of 2008. The sponsor is Peter DeFazio (D-OR) and one of the co-sponsors is Pete Stark (D-CA). Here's a link to the proposed legislation:
Download file
(Another of the co-sponsors is Representative Dennis Kucinich – glad he’s getting back to work after the grueling primary season.)
The bill calls for the reporting of absolutely everything (and they thought of everything) over $25.00 considered “a transfer of value†to a physician.
(What’s the AWP for a large pizza and a liter of Diet Coke these days?)
The penalties are between $10,000 - $100,000 and multiple offenders can say adios to their corporate deductions for advertising related expenses.
According to Mr. Stark, “The Sunshine Act will help enable Medicare beneficiaries to determine if their doctors are acting in patients’ best interests. It may even convince doctors to quit taking what can only be described as industry kickbacks."
Kickbacks? That’s a pretty strong accusation. Mr. Stark should apologize to America’s physicians and to the pharmaceutical industry he slanders so easily. And as far as America’s Medicare beneficiaries, Mr. Stark might also want to mention that the Medicare Drug Benefit (Part D) doesn’t "pay" doctors.
Mr. DeFazio issued some equally thoughtful and measured comments:
"If the billions of dollars drug companies spend taking doctors on trips to the Caribbean and to expensive dinners at the country’s finest restaurants are above-board, then the pharmaceutical industry should support our legislation. This bill will keep the pharmaceutical industry honest."
Speaking of “honesty,†Mr. DeFazio should own up to the fact that the aforementioned boondoggle trips and are against the rules.
But this has nothing to do with honesty and everything to do with posturing – and hidden agendas. (One of the groups supporting this legislation is Consumers Union – yes, the same organization that receives millions of dollars from foundations supported by the generic drug industry.)
The concept that big bad Pharma is to blame for everything, and that a $25.15 pizza party is at the heart of the destruction of medical ethics, isn’t just simplistic and sophistic but deleterious to a serious conversation about the issue.
H. R. 5605 is just another example of superbity from our legislative Sultans of Sanctimony.
Download file
(Another of the co-sponsors is Representative Dennis Kucinich – glad he’s getting back to work after the grueling primary season.)
The bill calls for the reporting of absolutely everything (and they thought of everything) over $25.00 considered “a transfer of value†to a physician.
(What’s the AWP for a large pizza and a liter of Diet Coke these days?)
The penalties are between $10,000 - $100,000 and multiple offenders can say adios to their corporate deductions for advertising related expenses.
According to Mr. Stark, “The Sunshine Act will help enable Medicare beneficiaries to determine if their doctors are acting in patients’ best interests. It may even convince doctors to quit taking what can only be described as industry kickbacks."
Kickbacks? That’s a pretty strong accusation. Mr. Stark should apologize to America’s physicians and to the pharmaceutical industry he slanders so easily. And as far as America’s Medicare beneficiaries, Mr. Stark might also want to mention that the Medicare Drug Benefit (Part D) doesn’t "pay" doctors.
Mr. DeFazio issued some equally thoughtful and measured comments:
"If the billions of dollars drug companies spend taking doctors on trips to the Caribbean and to expensive dinners at the country’s finest restaurants are above-board, then the pharmaceutical industry should support our legislation. This bill will keep the pharmaceutical industry honest."
Speaking of “honesty,†Mr. DeFazio should own up to the fact that the aforementioned boondoggle trips and are against the rules.
But this has nothing to do with honesty and everything to do with posturing – and hidden agendas. (One of the groups supporting this legislation is Consumers Union – yes, the same organization that receives millions of dollars from foundations supported by the generic drug industry.)
The concept that big bad Pharma is to blame for everything, and that a $25.15 pizza party is at the heart of the destruction of medical ethics, isn’t just simplistic and sophistic but deleterious to a serious conversation about the issue.
H. R. 5605 is just another example of superbity from our legislative Sultans of Sanctimony.
The Center for Medicine in the Public Interest will shortly publish a series of essays on the consequences of physican disempowerment in both the US and the EU. The title of this collection is "The Hazards of Harassing Doctors," and features contributions by Dr. Alphonse Crespo (a Swiss physician) and Dr. Marc Siegel (an American).
The thoughtful introduction is penned by Dr. Fred Goodwin, CMPI board member and Research Professor of Psychiatry at The George Washington University and Director of the University’s Center on Neuroscience, Medical Progress, and Society. Dr. Goodwin is the former Director of the National Institute of Mental Health
Here is a taste of Dr. Goodwin's take on the situation.
William Osler, generally regarded as the father of modern medicine wrote "If you listen carefully to the patient they will tell you the diagnosis." Arriving at a diagnosis and appropriate treatment plan has always represented collaboration between individual patients and their personal physician.
But today physicians are increasingly seeing the decisions that they and their individual patient reach about a specific treatment plan second guessed by distant “third parties†(working for government or insurance bureaucracies) who, of course do not –indeed cannot- know the physician or the unique individual circumstances of a particular patient. Lacking any knowledge of the patient or the doctor, these bureaucrats must fall back on general “guidelines†as the basis for approval or rejection of a particular treatment. Having served on guideline development bodies I can tell you that, at best, they represent the kind of “lowest common denominator†conclusions necessary to get the many different opinions represented on a committee to coalesce into a consensus. At worst guidelines represent a deliberate effort to drive down the cost of treatment by emphasizing “one size fits all†treatment approaches. While the physician-patient relationship theoretically remains the fulcrum of good medical practice and medical progress, in reality it is rapidly being replaced – on both sides of the Atlantic – by guidelines.
This movement towards guideline-driven medicine to which access to healthcare and physician reimbursement is increasingly linked, is based on the assumption that variations in medical practice are not only wasteful, but also potentially dangerous. Eliminating variations in clinical practice, we are told, will increase quality and save billions that could be poured into covering more uninsured or increasing coverage. The key to standardizing treatments – and outcomes – therefore are guidelines based on a combination of retrospective analysis of randomized clinical trials and the results of large prospective studies that compare the cost and effectiveness of established treatments or drugs in certain disease areas.
I bring a special perspective to this subject because of my professional background. On the one hand I have been a practicing physician for nearly 40 years and during almost all of those 40 years I was medical researcher and policy maker at the National Institute of Mental Health (NIMH). Incidentally my long experience in a part time private practice came about as a consequence of government salaries at the time not being competitive with academia so that a private practice was allowed in order to retain talent.
I was director of NIMH during the health care reform efforts of the first Clinton administration and, as such, I participated in some high level meetings of groups that were part of the effort. It is now well known that the perspective of practicing physicians was not included in this health care reform effort and my involvement was as the government’s principal mental health official, not as a clinician. Indeed I doubt that any of the other participants in the meetings I attended even knew that outside of my government job I was a physician in the private practice of a medical specialty.
I present this history so that the reader can understand what I am about to say. The meetings I attended had a surreal “Alice in Wonderland†quality. Here were all of these intelligent, well educated, well intended professionals discussing meta-analyses of controlled clinical trials, outcomes research, etc, etc, and yet it seemed that that none of them really understood what clinical practice was all about – it’s about enormous individual differences even among patients with the same diagnosis, it’s about cross-over trials where the physician uses each individual patient as their own control, trying treatment B when treatment A isn’t working, etc, etc Today’s advocates for coercive guideline driven medicine (as opposed to guidelines which are advisory to the doctor and the patient) seem to be cut from the same cloth as the people I encountered on those committees in the early 90s, except that now the lure of saving money and increasing the profits of managed care companies provides a new level of passion and intensity to these efforts.
In Europe, doctors are limited by reimbursement patterns and practice guidelines designed to control costs. This trend is growing in the United States. Yet there is no evidence that limiting access based on reviews of clinical literature or large scales trials either improves outcomes or saves money. On the contrary, the outcomes evidence suggests that seeking to elimination variations in practice and prescribing is actually more costly and contributes to morbidity.
The practice guidelines themselves are not the problem, it is how they are applied and for what purpose. Voluntary guidelines provide the intelligent physician with a benchmark from which to mark a patient’s progress or the impact of prevention. I have been involved in the development of practice guidelines for the treatment of mental illness for nearly three decades. It is a given that by the time there are developed, the guidelines themselves are outdated as new clinical insights and biomedical discoveries inform and shape both diagnosis and prescribing. The rigid imposition of guidelines regarding what to prescribe and how to treat insure that doctors cannot tailor treatments to the patient or deliver the best care.
Finally, the emphasis on cost-containment undermines continuity of care. The recognition that someone with mental illness is twice as likely to suffer from heart disease, diabetes or hypertension reveals the interaction of disease pathways which themselves have been show to be highly individualized. The evidence-based medicine movement fails to incorporate such insights. Rather, by emphasizing studies that evaluate the treatment of one aspect of a particular disease in a vacuum, the EBM movement is contributing to fragmentation of care.
Clinical decision-making is becoming increasingly centralized and the domains of economists or physicians who crunch numbers but never practice medicine.
Watch this space for more excerpts from this new and timely publication.
The thoughtful introduction is penned by Dr. Fred Goodwin, CMPI board member and Research Professor of Psychiatry at The George Washington University and Director of the University’s Center on Neuroscience, Medical Progress, and Society. Dr. Goodwin is the former Director of the National Institute of Mental Health
Here is a taste of Dr. Goodwin's take on the situation.
William Osler, generally regarded as the father of modern medicine wrote "If you listen carefully to the patient they will tell you the diagnosis." Arriving at a diagnosis and appropriate treatment plan has always represented collaboration between individual patients and their personal physician.
But today physicians are increasingly seeing the decisions that they and their individual patient reach about a specific treatment plan second guessed by distant “third parties†(working for government or insurance bureaucracies) who, of course do not –indeed cannot- know the physician or the unique individual circumstances of a particular patient. Lacking any knowledge of the patient or the doctor, these bureaucrats must fall back on general “guidelines†as the basis for approval or rejection of a particular treatment. Having served on guideline development bodies I can tell you that, at best, they represent the kind of “lowest common denominator†conclusions necessary to get the many different opinions represented on a committee to coalesce into a consensus. At worst guidelines represent a deliberate effort to drive down the cost of treatment by emphasizing “one size fits all†treatment approaches. While the physician-patient relationship theoretically remains the fulcrum of good medical practice and medical progress, in reality it is rapidly being replaced – on both sides of the Atlantic – by guidelines.
This movement towards guideline-driven medicine to which access to healthcare and physician reimbursement is increasingly linked, is based on the assumption that variations in medical practice are not only wasteful, but also potentially dangerous. Eliminating variations in clinical practice, we are told, will increase quality and save billions that could be poured into covering more uninsured or increasing coverage. The key to standardizing treatments – and outcomes – therefore are guidelines based on a combination of retrospective analysis of randomized clinical trials and the results of large prospective studies that compare the cost and effectiveness of established treatments or drugs in certain disease areas.
I bring a special perspective to this subject because of my professional background. On the one hand I have been a practicing physician for nearly 40 years and during almost all of those 40 years I was medical researcher and policy maker at the National Institute of Mental Health (NIMH). Incidentally my long experience in a part time private practice came about as a consequence of government salaries at the time not being competitive with academia so that a private practice was allowed in order to retain talent.
I was director of NIMH during the health care reform efforts of the first Clinton administration and, as such, I participated in some high level meetings of groups that were part of the effort. It is now well known that the perspective of practicing physicians was not included in this health care reform effort and my involvement was as the government’s principal mental health official, not as a clinician. Indeed I doubt that any of the other participants in the meetings I attended even knew that outside of my government job I was a physician in the private practice of a medical specialty.
I present this history so that the reader can understand what I am about to say. The meetings I attended had a surreal “Alice in Wonderland†quality. Here were all of these intelligent, well educated, well intended professionals discussing meta-analyses of controlled clinical trials, outcomes research, etc, etc, and yet it seemed that that none of them really understood what clinical practice was all about – it’s about enormous individual differences even among patients with the same diagnosis, it’s about cross-over trials where the physician uses each individual patient as their own control, trying treatment B when treatment A isn’t working, etc, etc Today’s advocates for coercive guideline driven medicine (as opposed to guidelines which are advisory to the doctor and the patient) seem to be cut from the same cloth as the people I encountered on those committees in the early 90s, except that now the lure of saving money and increasing the profits of managed care companies provides a new level of passion and intensity to these efforts.
In Europe, doctors are limited by reimbursement patterns and practice guidelines designed to control costs. This trend is growing in the United States. Yet there is no evidence that limiting access based on reviews of clinical literature or large scales trials either improves outcomes or saves money. On the contrary, the outcomes evidence suggests that seeking to elimination variations in practice and prescribing is actually more costly and contributes to morbidity.
The practice guidelines themselves are not the problem, it is how they are applied and for what purpose. Voluntary guidelines provide the intelligent physician with a benchmark from which to mark a patient’s progress or the impact of prevention. I have been involved in the development of practice guidelines for the treatment of mental illness for nearly three decades. It is a given that by the time there are developed, the guidelines themselves are outdated as new clinical insights and biomedical discoveries inform and shape both diagnosis and prescribing. The rigid imposition of guidelines regarding what to prescribe and how to treat insure that doctors cannot tailor treatments to the patient or deliver the best care.
Finally, the emphasis on cost-containment undermines continuity of care. The recognition that someone with mental illness is twice as likely to suffer from heart disease, diabetes or hypertension reveals the interaction of disease pathways which themselves have been show to be highly individualized. The evidence-based medicine movement fails to incorporate such insights. Rather, by emphasizing studies that evaluate the treatment of one aspect of a particular disease in a vacuum, the EBM movement is contributing to fragmentation of care.
Clinical decision-making is becoming increasingly centralized and the domains of economists or physicians who crunch numbers but never practice medicine.
Watch this space for more excerpts from this new and timely publication.
According to the RPM Report:
“FDA Commissioner Andrew von Eschenbach expressed rare public irritability last week at the American Enterprise Institute.
What brought an edge to the voice of the usually unflappable, on-message commissioner? He bristled at the suggestion that the re-appointment of Janet Woodcock to head of the Center for Drug Evaluation & Research represents an attempt to rebuild the old ways of running the agency’s drug regulatory operations."
“I do not see her going back to CDER as business as usual,†von Eschenbach shot back in response to a question from a reporter during a Q&A session. She “is going back as a very, very strong change agent, and we have mapped and discussed many of those changes that she is embarking upon.â€
Here’s the complete story:
http://therpmreport.com/Free/41678225-dbfe-4f3a-972e-c223f74843d8.aspx?utm_source=RPMel
Some more aggressive retorts from the Commissioner:
Just because she has a long tenure in FDA management and is can be termed an “insiderâ€, the commissioner said, “does not in any way, shape or form mean that she is not a change agent.â€
Woodcock offers “understanding of the historical perspective as well as the external realities that are now impacting upon the agency,†the commissioner says (see here). She is “absolutely, the most extraordinarily gifted and talented person to lead†change at CDER.
Give 'em hell Andy -- it's about time.
“FDA Commissioner Andrew von Eschenbach expressed rare public irritability last week at the American Enterprise Institute.
What brought an edge to the voice of the usually unflappable, on-message commissioner? He bristled at the suggestion that the re-appointment of Janet Woodcock to head of the Center for Drug Evaluation & Research represents an attempt to rebuild the old ways of running the agency’s drug regulatory operations."
“I do not see her going back to CDER as business as usual,†von Eschenbach shot back in response to a question from a reporter during a Q&A session. She “is going back as a very, very strong change agent, and we have mapped and discussed many of those changes that she is embarking upon.â€
Here’s the complete story:
http://therpmreport.com/Free/41678225-dbfe-4f3a-972e-c223f74843d8.aspx?utm_source=RPMel
Some more aggressive retorts from the Commissioner:
Just because she has a long tenure in FDA management and is can be termed an “insiderâ€, the commissioner said, “does not in any way, shape or form mean that she is not a change agent.â€
Woodcock offers “understanding of the historical perspective as well as the external realities that are now impacting upon the agency,†the commissioner says (see here). She is “absolutely, the most extraordinarily gifted and talented person to lead†change at CDER.
Give 'em hell Andy -- it's about time.
Here's Alan Greenspan on the economic models used by the Fed and the banking community that "justified" the deep exposure of some financial institutions in subprime mortgage instruments:
"The models used by the finance industry to determine risk and measure economic strength are too simple to fully account for human responses. We cannot hope to anticipate the specifics of future crises with any degree of confidence."
http://money.cnn.com/2008/03/17/news/economy/greenspan/index.htm?postversion=2008031707
Translation: the rational models of utility and discounting activities are outdated because they fail to capture rapid and wide variations in response to risk and uncertainty.
Similarly, comparative effectiveness research, complete with QALYs and the assumption that standardizing care will lead to lower costs and optimal health are essentially ersatz consumer welfare models based again on the "rational actor" view of economics. There is more variability in healthcare because valuations and value do not correspond to particular price but rather to individual perceptions of risk and uncertainty that are part and parcel of the effort to treat and prevent disease. The simple models developed to predict and shape human responses in the healthcare system will anticipate changes or outcomes with any accuracy. Nor have they.
We have come a long way from when the RAND experiment was conducted.
"The models used by the finance industry to determine risk and measure economic strength are too simple to fully account for human responses. We cannot hope to anticipate the specifics of future crises with any degree of confidence."
http://money.cnn.com/2008/03/17/news/economy/greenspan/index.htm?postversion=2008031707
Translation: the rational models of utility and discounting activities are outdated because they fail to capture rapid and wide variations in response to risk and uncertainty.
Similarly, comparative effectiveness research, complete with QALYs and the assumption that standardizing care will lead to lower costs and optimal health are essentially ersatz consumer welfare models based again on the "rational actor" view of economics. There is more variability in healthcare because valuations and value do not correspond to particular price but rather to individual perceptions of risk and uncertainty that are part and parcel of the effort to treat and prevent disease. The simple models developed to predict and shape human responses in the healthcare system will anticipate changes or outcomes with any accuracy. Nor have they.
We have come a long way from when the RAND experiment was conducted.
A post on the wsj.com healthblog by Heather Won Tesoriero claims
"Late last night, a pair of congressmen introduced a bill aimed at creating a pathway for approval of generic biotech drugs.
Finally, you say. But, wait, there’s a catch, and it’s a big one. The legislation would also give brand-name biotech drugs an extra 14 1/2 years of patent protection. (Read a summary of the bill, or the complete text.) That almost defeats the purpose of establishing a route to market for generic biotech drugs, advocates for them say. "
Well I read the summary and the text and it sounds like someone is buying the generic trade group's spin on the patent protection. No one is getting 15 years of additional patent protection. Rather, it gives companies going forward 12 years of data exclusivity and 2.5 years of patent life that of course begins well before a biologic enters clinical trials. The wailing is part of a larger strategy by the generic trade group to argue for the right to challenge biologic patents early and get market exclusivity as generic firms receive if they do make a successful challenge. Wailing as in: "Waah! Innovators get solid patent protection so I can't start copying their products from day one...waah!!
I am sure the anti-capitalists who attack pharma and BIO will go wild...
http://blogs.wsj.com/health/2008/03/14/want-generic-biotech-you-might-wait-14-more-years/?mod=googlenews_wsj
"Late last night, a pair of congressmen introduced a bill aimed at creating a pathway for approval of generic biotech drugs.
Finally, you say. But, wait, there’s a catch, and it’s a big one. The legislation would also give brand-name biotech drugs an extra 14 1/2 years of patent protection. (Read a summary of the bill, or the complete text.) That almost defeats the purpose of establishing a route to market for generic biotech drugs, advocates for them say. "
Well I read the summary and the text and it sounds like someone is buying the generic trade group's spin on the patent protection. No one is getting 15 years of additional patent protection. Rather, it gives companies going forward 12 years of data exclusivity and 2.5 years of patent life that of course begins well before a biologic enters clinical trials. The wailing is part of a larger strategy by the generic trade group to argue for the right to challenge biologic patents early and get market exclusivity as generic firms receive if they do make a successful challenge. Wailing as in: "Waah! Innovators get solid patent protection so I can't start copying their products from day one...waah!!
I am sure the anti-capitalists who attack pharma and BIO will go wild...
http://blogs.wsj.com/health/2008/03/14/want-generic-biotech-you-might-wait-14-more-years/?mod=googlenews_wsj
Those who think a comparative effectiveness institute will generate super savings by imposing standardization on clinical practice should read Benjamin Brewer's latest blog in the WSJ entitled "Uncertainty is My Co-Pilot"
http://online.wsj.com/article/SB120527311006228441.html?mod=djempersonal
http://online.wsj.com/article/SB120527311006228441.html?mod=djempersonal
Two articles in the NY Times -- one about the discussion of off-label uses for Zyprexa and another accusing drug companies of launching meds at a higher dose than necessary -- are devoid of scientific context.
The failure to report on off-label uses without describing the process of arriving at them and the fact that most are the product of trying to solve a clinical problem is a consistent and glaring gap in reporting. And burying the science only empowers trial attorneys and federal prosecutors who are constantly prodded by Senator Grassley to use the threat of prosecution to shake down drug companies for settlement fees.
With respect to the allegation that Avastin, Herceptin, Cerazyme, etc., are overdosed on purpose is completely without merit. Dosing is -- by the nature of clinical trials -- one size fits all. Achieving an appropriate dose in the real world goes on all the time and hitting the right dose -- as the warfarin genetic labeling effort suggests -- is a matter of genetic variation and other factors that cannot be integrated into drug development. And consider this: in some instances changing the timing and dosing of certain drugs can be regarded as off-label use and therefore subject to prosecution and tort lawyer litigation.
When Avastin was being developed it's initial "failure" in early trials was -- according to Judah Folkman who pioneered angiogenesis drugs -- linked directly to the fact that the FDA wanted every patient to get the same dose even though he believed varying dosing to a number of criteria -- would have led to better and more precise outcomes.
Many drugs don't work in most people at the marketed dose. The failure of HMOs not to provide coverage of the most expensive and innovative medicines should have nothing to do with dosing. The right dose for the right patient at the right time for the best outcome is the goal of any doctor. The Critical Path leading to personalized medicine or tailored treatments reflects the commitment of companies and the FDA to move away from the one-size fits all approach.
The media continues to ignore the underlying science shaping medicine and it leads to the arrogant notion that prosecutors and policy analysts can strip doctors of their discretion about how to prescribe and use medicines to advance the health of their patients.
http://www.nytimes.com/2008/03/16/business/16gaucher.html?pagewanted=1&_r=1&ref=todayspaper
http://www.nytimes.com/2008/03/15/business/15drug.html?scp=1&sq=berenson&st=nyt
The failure to report on off-label uses without describing the process of arriving at them and the fact that most are the product of trying to solve a clinical problem is a consistent and glaring gap in reporting. And burying the science only empowers trial attorneys and federal prosecutors who are constantly prodded by Senator Grassley to use the threat of prosecution to shake down drug companies for settlement fees.
With respect to the allegation that Avastin, Herceptin, Cerazyme, etc., are overdosed on purpose is completely without merit. Dosing is -- by the nature of clinical trials -- one size fits all. Achieving an appropriate dose in the real world goes on all the time and hitting the right dose -- as the warfarin genetic labeling effort suggests -- is a matter of genetic variation and other factors that cannot be integrated into drug development. And consider this: in some instances changing the timing and dosing of certain drugs can be regarded as off-label use and therefore subject to prosecution and tort lawyer litigation.
When Avastin was being developed it's initial "failure" in early trials was -- according to Judah Folkman who pioneered angiogenesis drugs -- linked directly to the fact that the FDA wanted every patient to get the same dose even though he believed varying dosing to a number of criteria -- would have led to better and more precise outcomes.
Many drugs don't work in most people at the marketed dose. The failure of HMOs not to provide coverage of the most expensive and innovative medicines should have nothing to do with dosing. The right dose for the right patient at the right time for the best outcome is the goal of any doctor. The Critical Path leading to personalized medicine or tailored treatments reflects the commitment of companies and the FDA to move away from the one-size fits all approach.
The media continues to ignore the underlying science shaping medicine and it leads to the arrogant notion that prosecutors and policy analysts can strip doctors of their discretion about how to prescribe and use medicines to advance the health of their patients.
http://www.nytimes.com/2008/03/16/business/16gaucher.html?pagewanted=1&_r=1&ref=todayspaper
http://www.nytimes.com/2008/03/15/business/15drug.html?scp=1&sq=berenson&st=nyt
Last August I commented on the Lou Dobbs program that it was unlikely that Congress would take FDA reform seriously “until there were dead bodies.â€
Unfortunately, I was right.
On Friday, in the shadows of tainted Heparin, the Senate passed a budget resolution to give the F.D.A. an additional $375 million, a 20 percent increase over this year.
Some representative quotes on this issue from an article by Gardiner Harris in today’s edition of the New York Times:
“Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the F.D.A.,†Senator Edward M. Kennedy, Democrat of Massachusetts.
“F.D.A. needs a serious infusion of resources and strong leadership dedicated to reforming the agency,†said Representative Henry A. Waxman, Democrat of California.
And, of course, everyone’s favorite FDA expert, Representative Rosa DeLauro, Democrat of Connecticut, “I don’t want to throw money at an agency that doesn’t have the infrastructure to carry out its mission.â€
Some top agency officials are simply “incompetent,†she added, and real change can occur only with a new administration.
Really, a new administration? Note to Representative DeLauro – the head of every center at the FDA is a career government employee. At the FDA, an agency of roughly 10,000, there are fewer than 10 “political†appointees. Does Ms. DeLauro, the chair of the House appropriations subcommittee with authority over the agency, believe that Dr. Janet Woodcock is “incompetent?†What about CBER’s Dr. Jesse Goodman – widely considered one of the finest scientists in government?
And then, of course, there’s the usual ranting from our favorite Sheep in Wolfe’s Clothing.
Here’s a link to the complete article:
http://www.nytimes.com/2008/03/17/health/policy/17fda.html?scp=2&sq=gardiner+harris&st=nyt
Alas, the title of the article says it all –“Tainted Drugs Put Focus on the F.D.A.â€
And it isn’t even a done deal.
Unfortunately, I was right.
On Friday, in the shadows of tainted Heparin, the Senate passed a budget resolution to give the F.D.A. an additional $375 million, a 20 percent increase over this year.
Some representative quotes on this issue from an article by Gardiner Harris in today’s edition of the New York Times:
“Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the F.D.A.,†Senator Edward M. Kennedy, Democrat of Massachusetts.
“F.D.A. needs a serious infusion of resources and strong leadership dedicated to reforming the agency,†said Representative Henry A. Waxman, Democrat of California.
And, of course, everyone’s favorite FDA expert, Representative Rosa DeLauro, Democrat of Connecticut, “I don’t want to throw money at an agency that doesn’t have the infrastructure to carry out its mission.â€
Some top agency officials are simply “incompetent,†she added, and real change can occur only with a new administration.
Really, a new administration? Note to Representative DeLauro – the head of every center at the FDA is a career government employee. At the FDA, an agency of roughly 10,000, there are fewer than 10 “political†appointees. Does Ms. DeLauro, the chair of the House appropriations subcommittee with authority over the agency, believe that Dr. Janet Woodcock is “incompetent?†What about CBER’s Dr. Jesse Goodman – widely considered one of the finest scientists in government?
And then, of course, there’s the usual ranting from our favorite Sheep in Wolfe’s Clothing.
Here’s a link to the complete article:
http://www.nytimes.com/2008/03/17/health/policy/17fda.html?scp=2&sq=gardiner+harris&st=nyt
Alas, the title of the article says it all –“Tainted Drugs Put Focus on the F.D.A.â€
And it isn’t even a done deal.
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.
