Latest Drugwonks' Blog
Health policy analysts, physicians, pharmaceutical company executives, business leaders and government officials recently met in Washington at the CMPI-Duke University Patient-Centric Leadership Forum to discuss developments in this exciting field.
Previously we have shared some of the comments made by noted cardiologist Dr. Michael Weber (“Weber Grillsâ€):
http://drugwonks.com/2008/02/weber_grills.html
and Dr. Ralph Snyderman, Chancellor Emeritus at Duke University and former Chancellor for Health Affairs at Duke University, President and CEO of Duke University Health System and James B. Duke Professor of Medicine (“The Greening of the American Health Care Systemâ€):
http://drugwonks.com/2008/03/the_greening_of_the_american_health_care_system.html
Today we are, as always, honored to share some of the comments offered by the hardest working man in American health care, Dr. Mark McClellan.
“We’ve got a healthcare delivery system that is organized the wrong way. It provides the wrong services with the wrong emphasis to get to personalized, predictive, preventative care. You can trace this back to the fact that reimbursement is wrong. We have payment incentives that encourage more intensity, especially after a health problem has developed and don’t have any real accountability for getting better results for patients’ health at the lowest overall cost. We have systems of choice in our healthcare system that don’t really give people a choice, where the policies, the coverage that you can get, is influenced by many factors beyond an individual’s preference.
There is a lot of potential for more targeted therapies, more prevention-oriented treatment strategies, more individualized predictive medicine. This is why I’m fundamentally optimistic about the future of our healthcare policies. As there is so much potential on the side of personalized, predictive patient-centric care, the discoveries are going to happen.
The question is simply how fast, and how quickly are we going to get to really irresistible pressure for the kinds of reforms that will close the gap between what we could do with the right reimbursement rules and the right ability for patients to choose their care?"
Yes, that is the question.
Full conference remarks will be available shortly. Watch this space for more details.
Previously we have shared some of the comments made by noted cardiologist Dr. Michael Weber (“Weber Grillsâ€):
http://drugwonks.com/2008/02/weber_grills.html
and Dr. Ralph Snyderman, Chancellor Emeritus at Duke University and former Chancellor for Health Affairs at Duke University, President and CEO of Duke University Health System and James B. Duke Professor of Medicine (“The Greening of the American Health Care Systemâ€):
http://drugwonks.com/2008/03/the_greening_of_the_american_health_care_system.html
Today we are, as always, honored to share some of the comments offered by the hardest working man in American health care, Dr. Mark McClellan.
“We’ve got a healthcare delivery system that is organized the wrong way. It provides the wrong services with the wrong emphasis to get to personalized, predictive, preventative care. You can trace this back to the fact that reimbursement is wrong. We have payment incentives that encourage more intensity, especially after a health problem has developed and don’t have any real accountability for getting better results for patients’ health at the lowest overall cost. We have systems of choice in our healthcare system that don’t really give people a choice, where the policies, the coverage that you can get, is influenced by many factors beyond an individual’s preference.
There is a lot of potential for more targeted therapies, more prevention-oriented treatment strategies, more individualized predictive medicine. This is why I’m fundamentally optimistic about the future of our healthcare policies. As there is so much potential on the side of personalized, predictive patient-centric care, the discoveries are going to happen.
The question is simply how fast, and how quickly are we going to get to really irresistible pressure for the kinds of reforms that will close the gap between what we could do with the right reimbursement rules and the right ability for patients to choose their care?"
Yes, that is the question.
Full conference remarks will be available shortly. Watch this space for more details.
Jerry Avorn ran a statistical analysis in the NEJM showing that there were more black box warnings and discontinuations after PDUFA than before.
If he is trying to show that PDUFA means unsafe drugs he is making a logical leap not supported by his numbers crunching. Increased black box warnings are a result of greater vigilance and post-market review. And lumping discontinuations with black boxes is a slick statistical trick to mask the fact that product removals as a percent of all new molecular entities has remained fairly stable at 2-3 percent for decades and after PDUFA. Ask the FDA.
Meanwhile Janet Woodcock underscores what is really at the heart of the current slowdown in drug approvals and greater scrutiny: we know more and understand more. And often companies dump too much data on the FDA that is not informed by what we know but by what companies thinks the agency wants.
On the other hand, what explains the fact that some important medicines have received European approval even as they languish at the FDA? To be sure, Europe has often approved new drugs first and faster. However it is hard not to believe that having Grassley, Waxman, Stupak looking to turn new drug into a new scandal is slowing things down....
The Critical Path should lead to more science-based and population specific standards. But don't expect Avorn or any FDA commissioner wannabe to be satisfied...
http://www.ft.com/cms/s/0/7ae3646a-fad6-11dc-aa46-000077b07658.html?nclick_check=1
http://online.wsj.com/article/SB120648160360663519.html?mod=googlenews_wsj
If he is trying to show that PDUFA means unsafe drugs he is making a logical leap not supported by his numbers crunching. Increased black box warnings are a result of greater vigilance and post-market review. And lumping discontinuations with black boxes is a slick statistical trick to mask the fact that product removals as a percent of all new molecular entities has remained fairly stable at 2-3 percent for decades and after PDUFA. Ask the FDA.
Meanwhile Janet Woodcock underscores what is really at the heart of the current slowdown in drug approvals and greater scrutiny: we know more and understand more. And often companies dump too much data on the FDA that is not informed by what we know but by what companies thinks the agency wants.
On the other hand, what explains the fact that some important medicines have received European approval even as they languish at the FDA? To be sure, Europe has often approved new drugs first and faster. However it is hard not to believe that having Grassley, Waxman, Stupak looking to turn new drug into a new scandal is slowing things down....
The Critical Path should lead to more science-based and population specific standards. But don't expect Avorn or any FDA commissioner wannabe to be satisfied...
http://www.ft.com/cms/s/0/7ae3646a-fad6-11dc-aa46-000077b07658.html?nclick_check=1
http://online.wsj.com/article/SB120648160360663519.html?mod=googlenews_wsj
Senators Dick Durbin and Herb Kohl are proposing a federal grant program to allowing the hiring of physicians pharmacists and nurses who would to come up with "objective" promotional material (there's an oxymoron) about prescription drugs. These tax-payer paid reps would also go to doctor's offices to counter the promotion and use of higher-priced brand drugs that -- as the Senators claim -- are no more effective than generic versions.
If the goal is to increase generic prescribing shouldn't the generic industry be paying for these reps and the information? And if health care costs are the problem, why not send government paid reps to discourage use diagnostics, surgery and other services that are growing more rapidly than drug spending?
Oh wait, that's called rationing.
http://www.fiercehealthcare.com/story/senators-plan-bill-countering-pharma-detailing-tactics/2008-03-14
If the goal is to increase generic prescribing shouldn't the generic industry be paying for these reps and the information? And if health care costs are the problem, why not send government paid reps to discourage use diagnostics, surgery and other services that are growing more rapidly than drug spending?
Oh wait, that's called rationing.
http://www.fiercehealthcare.com/story/senators-plan-bill-countering-pharma-detailing-tactics/2008-03-14
Senator Claire McCaskill (D, MO) thinks that the FDA’s draft guidance on off-label communications is "a startling potential change in policy.â€
Um, no.
Someone should point out to the Senator that the “policy†that counts here is the First Amendment -- and there’s no question that it applies to commercial free speech. Judge Royce Lamberth (US District Court in DC) unambiguously ruled that restriction of off-label information, especially peer-reviewed journals, violates the First Amendment.
So much for the “startling change of policy.†(Was the Senator not briefed on this issue before she made her pronouncement? Sloppy staff work.)
Or, to quote Stephen Mahinka (veteran health care attorney and partner at Morgan Lewis), for the Senator (and her best pal Jerry Avorn) to imply a “startling change†is "intellectually dishonest or evidence that they are ignorant of the legal context.â€
Ouch.
Um, no.
Someone should point out to the Senator that the “policy†that counts here is the First Amendment -- and there’s no question that it applies to commercial free speech. Judge Royce Lamberth (US District Court in DC) unambiguously ruled that restriction of off-label information, especially peer-reviewed journals, violates the First Amendment.
So much for the “startling change of policy.†(Was the Senator not briefed on this issue before she made her pronouncement? Sloppy staff work.)
Or, to quote Stephen Mahinka (veteran health care attorney and partner at Morgan Lewis), for the Senator (and her best pal Jerry Avorn) to imply a “startling change†is "intellectually dishonest or evidence that they are ignorant of the legal context.â€
Ouch.
In CMPI’s new paper, “The Hazards of Harassing Doctors:Regulation and Reaction in Trans-Atlantic Healthcare," Dr. Alphonse Crespo, a Swiss physician, points out that focusing on cost-savings rather than patient care has unintended – but highly predictable consequences:
“Obsession with cost-containment has brought about regulatory measures that significantly affect the independence of German doctors. The “Drugs Saving Package†voted by the German parliament, introduces penalties for prescription of “expensive†drugs and rewards physicians who restrict their prescriptions to low-cost copy generics. This ethically objectionable legal gimmickry - akin to bribing physicians not to treat to the best of their ability - was one of the sparks of the doctor protest movement. A recent survey suggests that 65% of German physicians condemn bureaucratic tampering with prescriptions. Public perceptions echo their concerns. Questioned on this issue, 60% of people at large reckon that they will no longer get the best possible treatment from their doctors. Judging by media coverage, most Germans sympathize with their doctors' plight but express scepticism as to their ability to influence government health care policy and budgeting.â€
Dr. Crespo’s complete essay and the complete paper can be found under the “Reports†heading at http://www.cmpi.org.
“Obsession with cost-containment has brought about regulatory measures that significantly affect the independence of German doctors. The “Drugs Saving Package†voted by the German parliament, introduces penalties for prescription of “expensive†drugs and rewards physicians who restrict their prescriptions to low-cost copy generics. This ethically objectionable legal gimmickry - akin to bribing physicians not to treat to the best of their ability - was one of the sparks of the doctor protest movement. A recent survey suggests that 65% of German physicians condemn bureaucratic tampering with prescriptions. Public perceptions echo their concerns. Questioned on this issue, 60% of people at large reckon that they will no longer get the best possible treatment from their doctors. Judging by media coverage, most Germans sympathize with their doctors' plight but express scepticism as to their ability to influence government health care policy and budgeting.â€
Dr. Crespo’s complete essay and the complete paper can be found under the “Reports†heading at http://www.cmpi.org.
How can the WSJ run a piece on using genetics to redirect failed medicines to smaller groups of patients that are high responders and then engage in an orgy of second guessing about Vytorin? The Vytorin case is a clear example of seeking ways to personalize medicine and stratifying statin therapy according to particular pathways...but the thirst for headlines trumps science-based reporting.
http://online.wsj.com/article/SB120632582431058683.html?mod=home_health_right
DItto FiercePharma's continuing fearmongering on SSRIs.... It cites an "expert" who claims "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent."
But the "expert" is none other than David Healy, whose flawed study about SSRI's and suicide triggered a series of events which lead to less SSRI use and more suicide. And Healy makes millions shilling for trial attorneys as an expert witness.
Some expert. Some reporting.
http://www.iht.com/articles/ap/2008/03/24/europe/EU-MED-Drug-Data-Laws.php
http://www.fiercepharma.com/story/could-full-data-disclosure-avert-scandal/2008-03-24?utm_medium=nl&utm_source=link
http://online.wsj.com/article/SB120632582431058683.html?mod=home_health_right
DItto FiercePharma's continuing fearmongering on SSRIs.... It cites an "expert" who claims "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent."
But the "expert" is none other than David Healy, whose flawed study about SSRI's and suicide triggered a series of events which lead to less SSRI use and more suicide. And Healy makes millions shilling for trial attorneys as an expert witness.
Some expert. Some reporting.
http://www.iht.com/articles/ap/2008/03/24/europe/EU-MED-Drug-Data-Laws.php
http://www.fiercepharma.com/story/could-full-data-disclosure-avert-scandal/2008-03-24?utm_medium=nl&utm_source=link
Interesting article in today’s Wall Street Journal on the use of genetic tools to resuscitate failed compounds.
Here how the story begins:
“As pharmaceutical makers find it increasingly difficult to bring new drugs to market, they are turning to genetic tools to seek uses for medicines that failed to make it out of the development pipeline.
The discovery of new links between genes and diseases can help not only to design new treatments, but to salvage drugs that are shelved when they come up short in clinical trials.â€
And here’s the rest of the story:
http://online.wsj.com/article/SB120631682077958247.html?mod=dist_smartbrief
The better understanding of genetic tools (via a robust collaboration of industry, academia, and government) will both expedite failure (which lowers the cost of R&D) and provide a broader spectrum for success (which rewards it).
Sound familiar? Correct – the Critical Path.
Here how the story begins:
“As pharmaceutical makers find it increasingly difficult to bring new drugs to market, they are turning to genetic tools to seek uses for medicines that failed to make it out of the development pipeline.
The discovery of new links between genes and diseases can help not only to design new treatments, but to salvage drugs that are shelved when they come up short in clinical trials.â€
And here’s the rest of the story:
http://online.wsj.com/article/SB120631682077958247.html?mod=dist_smartbrief
The better understanding of genetic tools (via a robust collaboration of industry, academia, and government) will both expedite failure (which lowers the cost of R&D) and provide a broader spectrum for success (which rewards it).
Sound familiar? Correct – the Critical Path.
Our regulatory cousins to the north have begun the process of creating a biosimilar regulatory framework.
Health Canada recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics†once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway.
Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.
A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product.
Health Canada recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics†once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway.
Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.
A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product.
Two interesting reader comments on the issue of government-sponsored counter-detailing as discussed in yesterday's blog entry "Close(d) Encounters."
Names have been withheld to protect the intelligent:
Dear DrugWonks:
What I think is interesting is whether this will become part of P4P proposals. If the government funds these counter-detailers, what happens if a physician refuses to see them? Are they reported to CMS? Are there repercussions for those physicians? Will they get more reimbursement if they see the government counter-detailers? If generic prescribing habits are part of P4P, as some propose, will this be part of it as well. Interesting to think about.
Dear DrugWonks:
I’d want to make sure the gov't detailers have to go by the same rules as the Rx companies -- FDA approved claims, FDA approved materials, no off label etc. Isn’t more info good?
PS, good luck getting a gov't employee to get in to see a doctor without pens and pizza if they don’t have cutting edge science to share
And if pharma detailers drive up the cost of Rx, won’t their detailers do the same?
Names have been withheld to protect the intelligent:
Dear DrugWonks:
What I think is interesting is whether this will become part of P4P proposals. If the government funds these counter-detailers, what happens if a physician refuses to see them? Are they reported to CMS? Are there repercussions for those physicians? Will they get more reimbursement if they see the government counter-detailers? If generic prescribing habits are part of P4P, as some propose, will this be part of it as well. Interesting to think about.
Dear DrugWonks:
I’d want to make sure the gov't detailers have to go by the same rules as the Rx companies -- FDA approved claims, FDA approved materials, no off label etc. Isn’t more info good?
PS, good luck getting a gov't employee to get in to see a doctor without pens and pizza if they don’t have cutting edge science to share
And if pharma detailers drive up the cost of Rx, won’t their detailers do the same?
For those in Soros/Essential Action camp who fervently believe the way to develop drugs for global health is to have the government coordinate and run trials with IP seized from private companies, the latest HIV vaccine failures underscore the ideologically riven fecklessness of their position.
The notion that prizes to investigators plus a pittance to those who develop and manufacture medicines under a government-run clinical trial operation will yield breakthroughs is naive: the risky part, the hard part, the part requiring hundreds of billions of dollars a year, is development. That is why commercialization is critical to medical progress, as are profits.
The Soros/Essential Action model is based on hatred of capitalism not science. And in the end, it will doom the dying around the world to continued suffering. The groups will have their press clippings and accolades from the Left and those in need of breakthroughs will have nothing. Such is the perverted definition of "progress" advanced by George Soros and Essential Action
The notion that prizes to investigators plus a pittance to those who develop and manufacture medicines under a government-run clinical trial operation will yield breakthroughs is naive: the risky part, the hard part, the part requiring hundreds of billions of dollars a year, is development. That is why commercialization is critical to medical progress, as are profits.
The Soros/Essential Action model is based on hatred of capitalism not science. And in the end, it will doom the dying around the world to continued suffering. The groups will have their press clippings and accolades from the Left and those in need of breakthroughs will have nothing. Such is the perverted definition of "progress" advanced by George Soros and Essential Action
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.
