Latest Drugwonks' Blog
Dr. Marc Siegel, a senior fellow at the Center for Medicine in the Public Interest, is a practicing internist, an Associate Professor at the New York University School of Medicine and a fellow in the Master Scholars Society at New York University. Dr. Siegel is also a columnist for The Los Angeles Times and a frequent contributor to the Washington Post, USA Today, Slate, and many other publications. He is the author of False Alarm; the Truth About the Epidemic of Fear (top 20 books of 2005 - Discover Magazine) and Bird Flu: Everything You Need to Know About the Next Pandemic. Dr. Siegel appears regularly on CNN, the NBC Today Show, and the Fox News Channel. Dr. Siegel was a contributor to the U.S. Senate Finance committee investigation of the 2001 bioterror crisis.
In his essay, "The Virtual House Call," Dr. Siegel discusses many of the challenges facing the 21st century physician in the United States. Here is a free sample (yes, we here at drugwonks are still giving away free samples) of his discourse:
"I have a litmus test to check on my humanity. I call it the virtual house call. It isn’t an actual house call but it relies on similar notions of inconvenience in order to help a patient. Rarely do we have time these days to travel to a patient’s home. We must extend ourselves beyond our offices and our blackberries in caring for our patients in order to become truly empowered as physicians. This extension of self is the virtual house call.
Here is my litmus test: Every day I leave my office for a cup of coffee when I get restless. The coffee shop is one block south of where I practice. I ask myself what I would do if one of my patients, on his or her way to see me, suddenly collapsed right outside that same coffee shop I frequent and called my office from his cell phone while gasping for air.
Would I instruct my nurse to call 911, or would I run the same block I always walked?
Would I at least show as much commitment to my patient as I show to my caffeine habit?
I’ve never had to face this particular litmus test, but I certainly hope I would pass it. And each time I pick up the phone to check in on one of my patient, I’m conscious of a similar kind of litmus test. As I listen over the phone to the telling sounds of fast breathing or nervous coughing, I make determinations that my nurse or secretary could never make. I try to remain available, to not set strict limits. I’m convinced that continuity of care makes me a better doctor.
Dr. Siegel's entire composition can be found at both at the top of this page and at http://www.cmpi.org under the "Report" heading. The larger paper is titled, "The Hazards of Harassing Doctors."
In his essay, "The Virtual House Call," Dr. Siegel discusses many of the challenges facing the 21st century physician in the United States. Here is a free sample (yes, we here at drugwonks are still giving away free samples) of his discourse:
"I have a litmus test to check on my humanity. I call it the virtual house call. It isn’t an actual house call but it relies on similar notions of inconvenience in order to help a patient. Rarely do we have time these days to travel to a patient’s home. We must extend ourselves beyond our offices and our blackberries in caring for our patients in order to become truly empowered as physicians. This extension of self is the virtual house call.
Here is my litmus test: Every day I leave my office for a cup of coffee when I get restless. The coffee shop is one block south of where I practice. I ask myself what I would do if one of my patients, on his or her way to see me, suddenly collapsed right outside that same coffee shop I frequent and called my office from his cell phone while gasping for air.
Would I instruct my nurse to call 911, or would I run the same block I always walked?
Would I at least show as much commitment to my patient as I show to my caffeine habit?
I’ve never had to face this particular litmus test, but I certainly hope I would pass it. And each time I pick up the phone to check in on one of my patient, I’m conscious of a similar kind of litmus test. As I listen over the phone to the telling sounds of fast breathing or nervous coughing, I make determinations that my nurse or secretary could never make. I try to remain available, to not set strict limits. I’m convinced that continuity of care makes me a better doctor.
Dr. Siegel's entire composition can be found at both at the top of this page and at http://www.cmpi.org under the "Report" heading. The larger paper is titled, "The Hazards of Harassing Doctors."
The FDA is ramping up it's effort to monitor the safety of drugs through its Early Alert and REMS program. It could be that the constant release of information on safety will do two things:
First neutralize the fear mongering and it's impact of people like Steve Nissen (more on him later) by getting ahead of the curve early and often. Second, get people and doctors to think more generally about the risks and benefits of medicines as well as their proper use. Finally, maybe it will prod companies and insurers to offer genetic tests to increase safer and more tailored dosing and drug selection right off the bat...
Genomas for instance is developing a genetic test to predict and compare an individual's risk of getting muscle pain among atorvastatin, simvastatin and rosuvastatin. I have used the protoype for my statin selection. http://www.genomas.net
I was pretty critical about the Early Alert program at first, regarding it as not being science based. But maybe (is it possible?) I was wrong. I think that flooding the safety zone with information is useful. It would be great as part of the Alerts to note that incidence of safety problems as a percentage of total scrips to put things into perspective. Along those lines, we encourage everyone who cares about the safety and impact of their meds to sign up for Iguard.org, a patient community that shares information about the benefits and side effects of their drugs. You can enroll at www.iguard.org
First neutralize the fear mongering and it's impact of people like Steve Nissen (more on him later) by getting ahead of the curve early and often. Second, get people and doctors to think more generally about the risks and benefits of medicines as well as their proper use. Finally, maybe it will prod companies and insurers to offer genetic tests to increase safer and more tailored dosing and drug selection right off the bat...
Genomas for instance is developing a genetic test to predict and compare an individual's risk of getting muscle pain among atorvastatin, simvastatin and rosuvastatin. I have used the protoype for my statin selection. http://www.genomas.net
I was pretty critical about the Early Alert program at first, regarding it as not being science based. But maybe (is it possible?) I was wrong. I think that flooding the safety zone with information is useful. It would be great as part of the Alerts to note that incidence of safety problems as a percentage of total scrips to put things into perspective. Along those lines, we encourage everyone who cares about the safety and impact of their meds to sign up for Iguard.org, a patient community that shares information about the benefits and side effects of their drugs. You can enroll at www.iguard.org
No, really.
Health Affairs has announced that the NewsHour's Susan Dentzer will become the journal’s new editor-in-chief on May 1, 2008.
“It’s a great honor to be taking the reins at Health Affairs after John Iglehart and Jamie Robinson have done so much to make it the preeminent health policy journal of our time,†Dentzer said. “I’m delighted to become part of Project HOPE, and I look forward to working with the journal’s talented staff to continue to bring the best thinking and writing to bear on the top domestic and global health issues confronting us all.
Dentzer also serves on the Kaiser Commission on the Future of Medicaid and the Uninsured, and she is a member of the national advisory committee for the Robert Wood Johnson Foundation’s Investigator Awards in Health Policy Research. From 1993 to 2004, Dentzer was a member of the board of trustees for her alma mater, Dartmouth College, and she chaired the board from 2001 through 2004. As a Nieman Fellow at Harvard University in 1986 and 1987, Dentzer studied political economy, health economics, and business at the John F. Kennedy School of Government, Harvard Business School, and the Harvard School of Public Health.
Good luck Susan.
Health Affairs has announced that the NewsHour's Susan Dentzer will become the journal’s new editor-in-chief on May 1, 2008.
“It’s a great honor to be taking the reins at Health Affairs after John Iglehart and Jamie Robinson have done so much to make it the preeminent health policy journal of our time,†Dentzer said. “I’m delighted to become part of Project HOPE, and I look forward to working with the journal’s talented staff to continue to bring the best thinking and writing to bear on the top domestic and global health issues confronting us all.
Dentzer also serves on the Kaiser Commission on the Future of Medicaid and the Uninsured, and she is a member of the national advisory committee for the Robert Wood Johnson Foundation’s Investigator Awards in Health Policy Research. From 1993 to 2004, Dentzer was a member of the board of trustees for her alma mater, Dartmouth College, and she chaired the board from 2001 through 2004. As a Nieman Fellow at Harvard University in 1986 and 1987, Dentzer studied political economy, health economics, and business at the John F. Kennedy School of Government, Harvard Business School, and the Harvard School of Public Health.
Good luck Susan.
Why even bother having an FDA reporter when writing an FDA “expose†story is as easy as, well, Mad Libs.
New Report by (proper noun) Accuses FDA of (adjective) Oversight
Today (adjective) Citizens for (adjective) Health, a not-for-profit organization, released a (adjective) meta-analysis that (adverb) concludes the FDA, “is in the (noun) of (adjective) Pharma.â€
“Our research of (number) concerned (plural noun) points (adverb) to an agency that has once again (verb past tense) the American public. It’s a (adjective) indication that the FDA places (noun) over (noun) and cannot be trusted to (verb) or (verb) – and certainly not (verb) in the public interest,†said the author’s report Dr. Sidney (type of animal).
“I find this new report both (adjective) and (adjective) – but (adverb) not (adjective),†commented Representative Henry (proper name).†“And I intend to hold televised (plural noun) on the matter.â€
“This is just another (adjective) example of the FDA’s lack of (adjective) (noun), added Dr. Steven (name of automobile company). If I were the FDA Commissioner this (adjective) circumstance would never have occurred.â€
In an embargoed editorial, the New (place name) Journal of Medicine opined that the (adjective) problem “is caused by the Prescription (noun) User-Fee Act and made even (adjective) by the agency’s continued (verb) of direct to (noun) advertising.†The editorial also points to the need for (adjective) importation of prescription (plural noun) from (name of country).
Supporting this notion, the AAR(letter) added that (adverb) high (plural noun) for drugs are a result of the (type of shrub) Administration's (adjective) program known as Part (letter) and supports (adjective) government (verb).
The FDA had (adjective) comment.
New Report by (proper noun) Accuses FDA of (adjective) Oversight
Today (adjective) Citizens for (adjective) Health, a not-for-profit organization, released a (adjective) meta-analysis that (adverb) concludes the FDA, “is in the (noun) of (adjective) Pharma.â€
“Our research of (number) concerned (plural noun) points (adverb) to an agency that has once again (verb past tense) the American public. It’s a (adjective) indication that the FDA places (noun) over (noun) and cannot be trusted to (verb) or (verb) – and certainly not (verb) in the public interest,†said the author’s report Dr. Sidney (type of animal).
“I find this new report both (adjective) and (adjective) – but (adverb) not (adjective),†commented Representative Henry (proper name).†“And I intend to hold televised (plural noun) on the matter.â€
“This is just another (adjective) example of the FDA’s lack of (adjective) (noun), added Dr. Steven (name of automobile company). If I were the FDA Commissioner this (adjective) circumstance would never have occurred.â€
In an embargoed editorial, the New (place name) Journal of Medicine opined that the (adjective) problem “is caused by the Prescription (noun) User-Fee Act and made even (adjective) by the agency’s continued (verb) of direct to (noun) advertising.†The editorial also points to the need for (adjective) importation of prescription (plural noun) from (name of country).
Supporting this notion, the AAR(letter) added that (adverb) high (plural noun) for drugs are a result of the (type of shrub) Administration's (adjective) program known as Part (letter) and supports (adjective) government (verb).
The FDA had (adjective) comment.
If I were a Carpenter or a Zucker or an Avorn, -- the three amigos who penned “Drug-Review Deadlines and Safety Problems†(NEJM, 2008; 358: 1354-61) – I’d be greasing up the old spin machine.
Consider the following from BioCentury Extra:
FDA refutes PDUFA safety study
FDA officials on Thursday criticized a study published in The New England Journal of Medicine that reports a statistically significant association between drug approvals near PDUFA deadlines and post-market safety problems.
The paper, by Daniel Carpenter of Harvard University and colleagues, concluded that drugs approved in the two months prior to their PDUFA deadlines were more likely to be withdrawn for safety reasons, to carry a subsequent black box warning, and to have one or more dosage forms discontinued by the manufacturer compared to drugs approved earlier or later. "Taken together, these findings suggest potential adverse effects of the deadlines governing FDA drug review," the paper said.
Clark Nardinelli, director of the economics staff in FDA's Office of Planning, told BioCentury that the agency has identified "at least two fundamental problems with the authors' data. We don't think their conclusions hold up." The paper misclassified a number of reviews as standard that actually had shorter deadlines because they were priority reviews, according to Nardinelli. When the reviews are classified correctly, the association between approvals near PDUFA deadlines and increased safety problems disappears, he said. The paper also understated the number of black box warnings, Nardinelli said. FDA plans to submit its data and conclusions to the NEJM and publish them on its Web site, spokesperson Christopher DiFrancesco said.
And all this time we thought it was the pharmaceutical industry playing fast and loose with data sets.
Well, as they say in Harvard Yard, "veritas."
We look forward to the FDA’s review … and hopefully to an apology from the authors and a retraction from NEJM.
Yeah, right.
Consider the following from BioCentury Extra:
FDA refutes PDUFA safety study
FDA officials on Thursday criticized a study published in The New England Journal of Medicine that reports a statistically significant association between drug approvals near PDUFA deadlines and post-market safety problems.
The paper, by Daniel Carpenter of Harvard University and colleagues, concluded that drugs approved in the two months prior to their PDUFA deadlines were more likely to be withdrawn for safety reasons, to carry a subsequent black box warning, and to have one or more dosage forms discontinued by the manufacturer compared to drugs approved earlier or later. "Taken together, these findings suggest potential adverse effects of the deadlines governing FDA drug review," the paper said.
Clark Nardinelli, director of the economics staff in FDA's Office of Planning, told BioCentury that the agency has identified "at least two fundamental problems with the authors' data. We don't think their conclusions hold up." The paper misclassified a number of reviews as standard that actually had shorter deadlines because they were priority reviews, according to Nardinelli. When the reviews are classified correctly, the association between approvals near PDUFA deadlines and increased safety problems disappears, he said. The paper also understated the number of black box warnings, Nardinelli said. FDA plans to submit its data and conclusions to the NEJM and publish them on its Web site, spokesperson Christopher DiFrancesco said.
And all this time we thought it was the pharmaceutical industry playing fast and loose with data sets.
Well, as they say in Harvard Yard, "veritas."
We look forward to the FDA’s review … and hopefully to an apology from the authors and a retraction from NEJM.
Yeah, right.
FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs
and Biologics
New FDAAA requirements being implemented
The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.
Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.
Certain drugs present a dilemma: They can provide an important benefit to patients, but they can be especially dangerous if not used properly. For example, certain drugs may be safe and effective for patients, but if taken while pregnant can harm the fetus or cause miscarriage. Rather than deny FDA approval of such drugs, the agency has granted approval and required that the manufacturer develop a safety plan, or REMS, to help ensure that health care professionals prescribe the drug correctly and that patients use it safely. While FDA has previously approved some drugs and biologics with these safety plans, the new law makes explicit FDA’s authority to require them and contains specific enforcement authority when violations or noncompliance with the plan's requirements occur.
“These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use,†said Jane Axelrad, associate director for policy, Center for Drug Evaluation and Research, FDA. “The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS.â€
In addition to issuing this Federal Register notice about drugs approved before March 25, 2008, the FDA also is implementing the new authority for drugs that will be approved after March 25, 2008, as well as for already marketed drugs for which new risks are identified after March 25.
The FDA also advised the public to notify the agency if they believe other drugs should be considered to have REMS under the new statutory provisions.
The Federal Register notice, which includes a list of the 25 drugs and biologic products that will be required to submit REMS, is available at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf
One of the named products is Mifepristone -- the infamous "abortion pill." So now we'll see if "safety" and "choice" can live side-by-side.
and Biologics
New FDAAA requirements being implemented
The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.
Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.
Certain drugs present a dilemma: They can provide an important benefit to patients, but they can be especially dangerous if not used properly. For example, certain drugs may be safe and effective for patients, but if taken while pregnant can harm the fetus or cause miscarriage. Rather than deny FDA approval of such drugs, the agency has granted approval and required that the manufacturer develop a safety plan, or REMS, to help ensure that health care professionals prescribe the drug correctly and that patients use it safely. While FDA has previously approved some drugs and biologics with these safety plans, the new law makes explicit FDA’s authority to require them and contains specific enforcement authority when violations or noncompliance with the plan's requirements occur.
“These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use,†said Jane Axelrad, associate director for policy, Center for Drug Evaluation and Research, FDA. “The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS.â€
In addition to issuing this Federal Register notice about drugs approved before March 25, 2008, the FDA also is implementing the new authority for drugs that will be approved after March 25, 2008, as well as for already marketed drugs for which new risks are identified after March 25.
The FDA also advised the public to notify the agency if they believe other drugs should be considered to have REMS under the new statutory provisions.
The Federal Register notice, which includes a list of the 25 drugs and biologic products that will be required to submit REMS, is available at:
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf
One of the named products is Mifepristone -- the infamous "abortion pill." So now we'll see if "safety" and "choice" can live side-by-side.
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.
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.
