Latest Drugwonks' Blog
There's money in it, maybe for the plaintiffs attorneys. But there is also the Holy Grail of overturing FDA pre-emption. Here is the logic driving the extremists in the tort community justifying yet another assault on the thin reed that Glaxo somehow deceived the FDA and the entire psychiatric community on the basis of one small (published study) but for the lack of intervention of trial attorney discovery power:
The reason that jury decisions may be superior to FDA decisions is that jurors often have superior information upon which to base their decision. Thanks to the discovery process, jurors often see reports, memos, and emails that pharmaceuticals specifically chose not to send to the FDA, such as internal concerns over drug safety and efficacy. Perhaps this wouldn’t be so if Congress chose to grant the FDA subpoena power.
www.tortdeform.com/archives/2008/06/critiquing_the_economic_argume.html
Makes sense to me. Jurors have infinite wisdom because they have infinite power to dredge up every piece of paper a tort lawyer regards as relevant to their case which in turn leads to a bigger, better supply of newer, safer medicines....
The reason that jury decisions may be superior to FDA decisions is that jurors often have superior information upon which to base their decision. Thanks to the discovery process, jurors often see reports, memos, and emails that pharmaceuticals specifically chose not to send to the FDA, such as internal concerns over drug safety and efficacy. Perhaps this wouldn’t be so if Congress chose to grant the FDA subpoena power.
www.tortdeform.com/archives/2008/06/critiquing_the_economic_argume.html
Makes sense to me. Jurors have infinite wisdom because they have infinite power to dredge up every piece of paper a tort lawyer regards as relevant to their case which in turn leads to a bigger, better supply of newer, safer medicines....
The pharmaceutical industry in
This is not a new idea – but it’s a good one. But it’s often derided as the pharmaceutical industry calling for a policy change for reasons of self-interest rather than public health.
But at last weeks BIO convention in San Diego a European Commission representative said that Brussels is seriously considering proposals that would ban repackaging – a move that, if taken would (according to Reuters), “deal a blow to the parallel trade and could also help drugmakers' profits, since companies' revenues are currently eroded by arbitrage dealings in their products across borders.”
Does this mean that the European Commission is in the “pocket of Big Pharma?”
Hardly.
(In fact, it’s humorous considering the way the industry is treated over there.)
What it does mean is that, enfin; the EC is taking seriously what we here at drugwonks.com have been saying for some time – that parallel trade is the weak link in the pharmaceutical chain of custody and a prime target for counterfeit infiltration.
It’s also important to note that what the Europeans call “parallel trade,” we refer to as “importation.” And that Canadian Internet pharmacies get their drugs from
“Safe” importation?
Perhaps in a parallel universe.
Sorry to healthcare renewal blog for getting their url wrong. That's not as bad as 1) failing to directly engage in serious debate and then 2) posting comments to say you engage in debate when you really don't.
I usually don't live in the past but since Dr. Poses is fairly well-intentioned and we actually see eye to eye more or less on the how comparative effectiveness should be conducted, constructed and used (I think?) I because he is real doctor I just want to point out the following regarding his criticisms about my article in The Washington Times on comparative effectiveness.
1. He beats up on me for conflating hypertension with congestive heart failure in discussing BiDil. I hereby announce that he wins this one. BiDil was first rejected as a treatment for hypertension but approved later for advanced heart failure because of clinical measures, not surrogate measures that everyone drools about these days. I then compounded the mistake by hauling up examples about how one uses the combination of drugs in BiDil (isosorbide dinitrate and hydralazine) are used to treat hypertension.
2, But then Poses goes to nitpick on my analysis of ALLHAT rather than engage me at the larger point I was trying to make: that the same people who were beating up on the use of BiDil which was designed to target excess mortality from CHF in blacks had no problem with ALLHAT which had a design that lead to excess stroke and mortality due to heart failure -- all in the name of well-designed comparative effectiveness and we urging even more ALLHAT like research to guide FDA and insurance reimbursement decisions.
3. I won't use time or space now to respond to the Poses nitpick on ALLHAT: that I am wrong to claim that the ALLHAT study design except to say that when African American blood pressure levels are beyond acceptable levels and they are generally deprived of optimal care as part of the study protocol I will leave it to Poses to defend excess mortality among blacks and Jerry Avorn's peddling of the ALLHAT results as the gold standard for comparative effectiveness...which I frankly think Dr. Poses does not want to do. If he wants to go in depth on the ALLHAT mess I can refer him to other who were and are actually involved.
4. In short, I believe Dr. Poses to be much more fair minded and rigorous than many others, more driven by data and science than by ideology. I may be wrong on that point but my re-reading of his criticisms of me and his post suggests that.
hcrenewal.blogspot.com
I usually don't live in the past but since Dr. Poses is fairly well-intentioned and we actually see eye to eye more or less on the how comparative effectiveness should be conducted, constructed and used (I think?) I because he is real doctor I just want to point out the following regarding his criticisms about my article in The Washington Times on comparative effectiveness.
1. He beats up on me for conflating hypertension with congestive heart failure in discussing BiDil. I hereby announce that he wins this one. BiDil was first rejected as a treatment for hypertension but approved later for advanced heart failure because of clinical measures, not surrogate measures that everyone drools about these days. I then compounded the mistake by hauling up examples about how one uses the combination of drugs in BiDil (isosorbide dinitrate and hydralazine) are used to treat hypertension.
2, But then Poses goes to nitpick on my analysis of ALLHAT rather than engage me at the larger point I was trying to make: that the same people who were beating up on the use of BiDil which was designed to target excess mortality from CHF in blacks had no problem with ALLHAT which had a design that lead to excess stroke and mortality due to heart failure -- all in the name of well-designed comparative effectiveness and we urging even more ALLHAT like research to guide FDA and insurance reimbursement decisions.
3. I won't use time or space now to respond to the Poses nitpick on ALLHAT: that I am wrong to claim that the ALLHAT study design except to say that when African American blood pressure levels are beyond acceptable levels and they are generally deprived of optimal care as part of the study protocol I will leave it to Poses to defend excess mortality among blacks and Jerry Avorn's peddling of the ALLHAT results as the gold standard for comparative effectiveness...which I frankly think Dr. Poses does not want to do. If he wants to go in depth on the ALLHAT mess I can refer him to other who were and are actually involved.
4. In short, I believe Dr. Poses to be much more fair minded and rigorous than many others, more driven by data and science than by ideology. I may be wrong on that point but my re-reading of his criticisms of me and his post suggests that.
hcrenewal.blogspot.com
It always happens. As calmer heads prevail and political reality sets in, the radicals are tossed under the bus. The radicals, in turn, fulminate and issue press releases that border on hysteria.
Thus:
By Jim O'Sullivan,
Catherine Williams, and Michael Norton
STATE HOUSE NEWS SERVICE
SAN DIEGO, JUNE 18, 2008......A controversial Senate plan to forbid
gifts from pharmaceutical companies to health care workers appears
unlikely to survive intact, as Massachusetts state leaders have caught
an earful from industry executives while attending an international
biotechnology convention this week.
The plan's leading proponent, Senate President Therese Murray, said
researchers have told her the ban would prevent productive interactions
between doctors and researchers who are trying to treat the same
diseases.
"It's something that we didn't discuss when we did it, because we were
looking purely at gifts to doctors," Murray said in a telephone
interview with the News Service. "But the fact is that some of these
companies do bring researchers and doctors together to go over the
latest research."
"Through what we did, in their explaining, there are many things they
won't be able to do that are important to science," she said.
www.statehousenews.com
Whatever that means...
Meanwhile, the Prescription Project backed CEJA recommendations Report 1 of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine were soundly rejected Which led Daniel Carlat to become completely unhinged and attack Medscape and George Lundberg as a CME tool. Very mature. carlatpsychiatry.blogspot.com/
And on the heels of the resounding defeat the munchkins at the Association of American Medical Colleges had to issue a press release re-cycling the release of a study on CME which had to acknowledge there limited evidence of bias in CME or that sampling has any influence on prescribing practices. Then there is the underlying assumption that industry-based research is defacto corrupt, tainted and incorrect and information coming from centralized academic sources is pure. Yeah, right.
Can't wait to take this one on.
Thus:
By Jim O'Sullivan,
Catherine Williams, and Michael Norton
STATE HOUSE NEWS SERVICE
SAN DIEGO, JUNE 18, 2008......A controversial Senate plan to forbid
gifts from pharmaceutical companies to health care workers appears
unlikely to survive intact, as Massachusetts state leaders have caught
an earful from industry executives while attending an international
biotechnology convention this week.
The plan's leading proponent, Senate President Therese Murray, said
researchers have told her the ban would prevent productive interactions
between doctors and researchers who are trying to treat the same
diseases.
"It's something that we didn't discuss when we did it, because we were
looking purely at gifts to doctors," Murray said in a telephone
interview with the News Service. "But the fact is that some of these
companies do bring researchers and doctors together to go over the
latest research."
"Through what we did, in their explaining, there are many things they
won't be able to do that are important to science," she said.
www.statehousenews.com
Whatever that means...
Meanwhile, the Prescription Project backed CEJA recommendations Report 1 of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine were soundly rejected Which led Daniel Carlat to become completely unhinged and attack Medscape and George Lundberg as a CME tool. Very mature. carlatpsychiatry.blogspot.com/
And on the heels of the resounding defeat the munchkins at the Association of American Medical Colleges had to issue a press release re-cycling the release of a study on CME which had to acknowledge there limited evidence of bias in CME or that sampling has any influence on prescribing practices. Then there is the underlying assumption that industry-based research is defacto corrupt, tainted and incorrect and information coming from centralized academic sources is pure. Yeah, right.
Can't wait to take this one on.
The Prescription Project released a survey this week claiming that a majority to disclose of gifts and payments to physicians. Of course, what the poll didn’t ask (and maybe drugwonks will ask the question) if doctors should be jailed or sued for taking a pizza or if people really think doctors are brainwashed by pens and cups or that academics who are on retainer to trial attorneys who sue drug companies should do it…)
Which leads to my next point.
Hardly a chirp from the conflict of interest capos regarding the following:
The biases of the Prescription Project, namely being packed full with the usual suspects: those who are already behind the effort to extend government regulation of marketing, development, review and prescribing of medicines as well as congressional legislation to overturn FDA pre-emption. I guess a conflict only occurs when an academic researcher partners with pharmaceutical scientists….
Well since neither pharmalot, Carlat or Healthcarerenewal have the intellectual integrity to do so, here are the people associated with The Prescription Project and their “biases”:
Robert Restuccia, Executive Director
Restuccia is also executive director of Community Catalyst, Inc. a left wing advocacy group. Community Catalyst runs the Prescriptin Access Litigation Project which has “been involved in 26 class action lawsuits challenging drug industry tactics to illegally raise the price of prescription drugs.” PAL receives money from these settlements. One of the law firms that was representing PAL is the now discredited Milberg Weiss law firm that pled guilty in a multi-million dollar kickback case. And the conflict of interest capos like playing connect the dots?
David J. Rothman, Associate Director
President of the Institute on Medicine as a Profession which receives funding from George Soros and which has repeatedly called for bans on gifts and grants to physicians from industry. Rothman is also a mover and shaker behind the increasingly shrill attacks from Association of American Medical Colleges, writing editorials on behalf of articles written by AAMC staff in JAMA on the evils of industry-academia associations.
It turns out that the Greenwall Foundation – which supports Rothman – has a certain Troye Brennan on its board. That’s the same Troyen Brennan who co-authors work with Rothman and collaborates with him on projects.
Advisers of the Prescription Project include
Jerry Avorn Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital
Avorn has his own for profit academic detailing business that has a contract with the state of Pennsylvania. He stands to benefit from any ban or cutback by a reduction in industry sponsored CME.
Steven Nissen, M.D. Immediate Past President of the American College of Cardiology
Need I say more?
Cathy DeAngelis, M.D. Editor-in-Chief of the Journal of the American Medical Association
Is it ethical for the editor of a major medical journal to be part of an advocacy organization, particulary one that is associated with litigation for pay purposes?
Sharon Levine, M.D. Associate Executive Director of Kaiser Permanente
Levine is in charge of Kaiser Permanente North. PP fails to disclose that Levine believes that it is just fine to use formularies and co-pays to limit utilization of drugs even though evidence has clearly shown a decline in utilization is associated with discontinuities in treatment.
Stephen Schondelmeyer, Pharm.D., Ph.D. Department Chair of Pharmaceutical Care and Health Systems, University of Minnesota College of Pharmacy
Schondelmeyer has long been a recipient of funding from generic drug companies and the generic drug trade group. He is also a consultant to PAL and trial attorneys. Though chair of a college of pharmacy, he has been lead author of only one article published in a peer-reviewed professional publication in the past 20 years: "Pharmacists' compensation and work patterns, 1990-91."
Which leads to my next point.
Hardly a chirp from the conflict of interest capos regarding the following:
The biases of the Prescription Project, namely being packed full with the usual suspects: those who are already behind the effort to extend government regulation of marketing, development, review and prescribing of medicines as well as congressional legislation to overturn FDA pre-emption. I guess a conflict only occurs when an academic researcher partners with pharmaceutical scientists….
Well since neither pharmalot, Carlat or Healthcarerenewal have the intellectual integrity to do so, here are the people associated with The Prescription Project and their “biases”:
Robert Restuccia, Executive Director
Restuccia is also executive director of Community Catalyst, Inc. a left wing advocacy group. Community Catalyst runs the Prescriptin Access Litigation Project which has “been involved in 26 class action lawsuits challenging drug industry tactics to illegally raise the price of prescription drugs.” PAL receives money from these settlements. One of the law firms that was representing PAL is the now discredited Milberg Weiss law firm that pled guilty in a multi-million dollar kickback case. And the conflict of interest capos like playing connect the dots?
David J. Rothman, Associate Director
President of the Institute on Medicine as a Profession which receives funding from George Soros and which has repeatedly called for bans on gifts and grants to physicians from industry. Rothman is also a mover and shaker behind the increasingly shrill attacks from Association of American Medical Colleges, writing editorials on behalf of articles written by AAMC staff in JAMA on the evils of industry-academia associations.
It turns out that the Greenwall Foundation – which supports Rothman – has a certain Troye Brennan on its board. That’s the same Troyen Brennan who co-authors work with Rothman and collaborates with him on projects.
Advisers of the Prescription Project include
Jerry Avorn Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital
Avorn has his own for profit academic detailing business that has a contract with the state of Pennsylvania. He stands to benefit from any ban or cutback by a reduction in industry sponsored CME.
Steven Nissen, M.D. Immediate Past President of the American College of Cardiology
Need I say more?
Cathy DeAngelis, M.D. Editor-in-Chief of the Journal of the American Medical Association
Is it ethical for the editor of a major medical journal to be part of an advocacy organization, particulary one that is associated with litigation for pay purposes?
Sharon Levine, M.D. Associate Executive Director of Kaiser Permanente
Levine is in charge of Kaiser Permanente North. PP fails to disclose that Levine believes that it is just fine to use formularies and co-pays to limit utilization of drugs even though evidence has clearly shown a decline in utilization is associated with discontinuities in treatment.
Stephen Schondelmeyer, Pharm.D., Ph.D. Department Chair of Pharmaceutical Care and Health Systems, University of Minnesota College of Pharmacy
Schondelmeyer has long been a recipient of funding from generic drug companies and the generic drug trade group. He is also a consultant to PAL and trial attorneys. Though chair of a college of pharmacy, he has been lead author of only one article published in a peer-reviewed professional publication in the past 20 years: "Pharmacists' compensation and work patterns, 1990-91."
Senator Sherrod Brown (D, OH) thinks that pharmaceutical companies are taking advantage of lower safety standards in countries like China and India to lower costs and has also asked Pfizer for details of its outsourcing to countries without the same drug safety standards as the US.
It should also be noted that this is the same Sherrod Brown who supports drug importation.
In a letter to Janet Woodcock, the Senator referred to her testimony to the Senate Committee on Health, Education, Labor & Pensions (HELP) where she had said that drug companies outsource because of "different governmental regulations in different parts of the world", "lower, less stringent standards in some parts of the world", and lower labor costs in developing countries.
The senator has asked Dr Woodcock for details of the volume of outsourced drug ingredients, the added costs of regulating outsourced ingredients, and the 'bearer' of those costs. He has also asked for measures to hold companies accountable for outsourcing.
Perhaps Senator Brown is contemplating user fees for foreign inspections?
In a separate letter to Pfizer, the Senator asked about the drugmaker's annual savings through outsourcing and a list of instances where Pfizer has outsourced manufacturing due to lack of technical expertise.
That former list should be pretty short. Hopefully Pfizer will also discuss the technical expertise it provides.
What can Brown do for you?
It should also be noted that this is the same Sherrod Brown who supports drug importation.
In a letter to Janet Woodcock, the Senator referred to her testimony to the Senate Committee on Health, Education, Labor & Pensions (HELP) where she had said that drug companies outsource because of "different governmental regulations in different parts of the world", "lower, less stringent standards in some parts of the world", and lower labor costs in developing countries.
The senator has asked Dr Woodcock for details of the volume of outsourced drug ingredients, the added costs of regulating outsourced ingredients, and the 'bearer' of those costs. He has also asked for measures to hold companies accountable for outsourcing.
Perhaps Senator Brown is contemplating user fees for foreign inspections?
In a separate letter to Pfizer, the Senator asked about the drugmaker's annual savings through outsourcing and a list of instances where Pfizer has outsourced manufacturing due to lack of technical expertise.
That former list should be pretty short. Hopefully Pfizer will also discuss the technical expertise it provides.
What can Brown do for you?
Good piece by Jerry Norris (Hudson Institute) in today's FT:
A way to rank access to medicines
by Jeremiah Norris,
The Financial Times
USA, 6/20/2008 - Sir, Wim Leereveld (reports, June 16) has started an interesting and potentially important metric to judge how pharmaceutical companies are making drugs available and affordable to the poor. His Access to Medicines index says that GSK leads the pack in this regard. It isn’t obvious from his methodology whether he has been able to separate monetary value of products from their clinical value, or to ascertain how product donations spurned significant financial leverage from other actors.
For instance, Merck is ranked number 3. It has been contributing Ivermectin to combat river blindness for the past 20 years. The product itself is fairly inexpensive and is administered once yearly. Yet, it produces a clinical value to millions of people by preventing blindness. Once the corporate contribution was made, the World Bank syndicated it among a wide array of donors, investing at least $250m in the process. Another indirect benefit is that, according to a Bank evaluation, when farmers returned to their previously abandoned river villages, 17m hectares of land were reclaimed, enough to feed 25m people. The index states that companies score “least strongly for researching neglected diseases”. GSK has been a leader in this arena, building a $235m research and development facility in Spain to develop products identified by the World Health Organisation as “essential medicines” for the poor. Novartis has built a tropical disease research institute in Singapore, targeting only malaria, TB and chagas disease. It recently built a vaccine institute in Italy to work on neglected diseases. Pfizer constructed an Infectious Disease Institute in Uganda. It has now trained 40 per cent of the country’s physicians in Aids treatment and care. At present, 24 countries have sent staff to this institute for similar training. In these research facilities, the operating costs have by now far exceeded the capital costs.
However difficult, Mr Leereveld would want to strengthen his methodology in the future. This would allow a more comprehensive comparison between companies. They could then better position themselves and, measure for measure, determine where they really stand in the rankings on corporate social responsibility.
Jeremiah Norris,
Director,
Center for Science in Public Policy,
Hudson Institute,
Washington, DC 20005, US
A way to rank access to medicines
by Jeremiah Norris,
The Financial Times
USA, 6/20/2008 - Sir, Wim Leereveld (reports, June 16) has started an interesting and potentially important metric to judge how pharmaceutical companies are making drugs available and affordable to the poor. His Access to Medicines index says that GSK leads the pack in this regard. It isn’t obvious from his methodology whether he has been able to separate monetary value of products from their clinical value, or to ascertain how product donations spurned significant financial leverage from other actors.
For instance, Merck is ranked number 3. It has been contributing Ivermectin to combat river blindness for the past 20 years. The product itself is fairly inexpensive and is administered once yearly. Yet, it produces a clinical value to millions of people by preventing blindness. Once the corporate contribution was made, the World Bank syndicated it among a wide array of donors, investing at least $250m in the process. Another indirect benefit is that, according to a Bank evaluation, when farmers returned to their previously abandoned river villages, 17m hectares of land were reclaimed, enough to feed 25m people. The index states that companies score “least strongly for researching neglected diseases”. GSK has been a leader in this arena, building a $235m research and development facility in Spain to develop products identified by the World Health Organisation as “essential medicines” for the poor. Novartis has built a tropical disease research institute in Singapore, targeting only malaria, TB and chagas disease. It recently built a vaccine institute in Italy to work on neglected diseases. Pfizer constructed an Infectious Disease Institute in Uganda. It has now trained 40 per cent of the country’s physicians in Aids treatment and care. At present, 24 countries have sent staff to this institute for similar training. In these research facilities, the operating costs have by now far exceeded the capital costs.
However difficult, Mr Leereveld would want to strengthen his methodology in the future. This would allow a more comprehensive comparison between companies. They could then better position themselves and, measure for measure, determine where they really stand in the rankings on corporate social responsibility.
Jeremiah Norris,
Director,
Center for Science in Public Policy,
Hudson Institute,
Washington, DC 20005, US
We visited with Senator Jim DeMint (R, SC) and asked him about the future of American healthcare. What he told us is worth sharing:
www.vimeo.com/1187943
And his closing line (an ad lib!) is an instant classic.
www.vimeo.com/1187943
And his closing line (an ad lib!) is an instant classic.
- At present, “trial and error medicine” is the standard of care. Not good for providers, patients, nor payers. That’s true.
- What we today call “personalized medicine” will be referred to in the near future as “medicine.” That’s hopeful.
- Diagnostics will deliver personalized care via drug selection, dosing, efficacy, disease status, recurrence risk, and predisposition. That’s exciting.
- Diagnostics lead the league in the price/value proposition – and that’s what will initially drive uptake. That’s reality.
- To that point, there was also discussion of a diagnostics acceptance continuum beginning with “fear” and then moving to “value” and finally “acceptance.”
- And the constituencies moving along that path include pharmaceutical companies, physicians, patients, payers – and regulators.
- Specifically, to more expeditiously sashay down the Critical Path, the diagnostics industry needs industry-wide guidelines for clinical research.
According to PharmaTimes, CanWest Mediaworks, Canada’s largest newspaper publisher and owner of more than 30 television stations, is suing the federal government for not permitting direct-to-consumer advertising of prescription drugs because, it says, this breaches its freedom of expression under Canada’s Charter of Rights and Freedoms.
CanWest is arguing in the Ontario Superior Court that this prohibition, which is part of the Canadian Food and Drugs Act, places it at a competitive disadvantage to US newspaper and magazines which are sold on Canadian newsstands, because it prevents it from selling advertising space to pharmaceutical manufacturers. The company also points out that Canada does allow OTC medicines to be advertised directly to consumers, even though these products also carry risks.
The case will be heard this month.
CanWest is arguing in the Ontario Superior Court that this prohibition, which is part of the Canadian Food and Drugs Act, places it at a competitive disadvantage to US newspaper and magazines which are sold on Canadian newsstands, because it prevents it from selling advertising space to pharmaceutical manufacturers. The company also points out that Canada does allow OTC medicines to be advertised directly to consumers, even though these products also carry risks.
The case will be heard this month.
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.
