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It is obvious Nissen tailors his remarks to the audience....so here he is talking trash about Andy von Eschenbach and Scott Gottlieb to an NPR crowd a while back...
Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, was recently a member of a panel debating the topic of: "Government Science Panels: Fair and Balanced?" which was moderated by National Public Radio's Snigdha Prakash, and sponsored the Center for Science in the Public Interest on Aug. 2 2006.
Dr Nissen spoke about the conflict-of-interest problems "evident at the highest levels of the FDA," the article says.
"For years," Dr Nissen said in describing FDA leadership, "we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies."
"Then the administration appointed Andrew Von Eschenbach as interim commissioner, creating another conflict," he noted.
"In his role as director of the National Cancer Institute," Dr Nissen said, "Von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict."
But even worse, he said, "the administration appointed Scott Gottlieb as deputy commissioner."
"He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter
"Between them, Drs. Von Eschenbach and Gottlieb have whined incessantly about the need to speed drug development."
"So while the American people worry about the safety of drug the top FDA leadership tells us we need faster drug approval."
Funny, I thought people cared about both. And for such a smart guy who wants to be FDA commish, the inability to conceive of faster drug approval and safer medicines being one in the same reflects scientific stupidity or political cupidity, or both. And for someone whose own studies have demonstrated excess mortality in the wake of promoting the stocks of companies he conducts research for, I would not be talking about putting profits before safety if I were him.
Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, was recently a member of a panel debating the topic of: "Government Science Panels: Fair and Balanced?" which was moderated by National Public Radio's Snigdha Prakash, and sponsored the Center for Science in the Public Interest on Aug. 2 2006.
Dr Nissen spoke about the conflict-of-interest problems "evident at the highest levels of the FDA," the article says.
"For years," Dr Nissen said in describing FDA leadership, "we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies."
"Then the administration appointed Andrew Von Eschenbach as interim commissioner, creating another conflict," he noted.
"In his role as director of the National Cancer Institute," Dr Nissen said, "Von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict."
But even worse, he said, "the administration appointed Scott Gottlieb as deputy commissioner."
"He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter
"Between them, Drs. Von Eschenbach and Gottlieb have whined incessantly about the need to speed drug development."
"So while the American people worry about the safety of drug the top FDA leadership tells us we need faster drug approval."
Funny, I thought people cared about both. And for such a smart guy who wants to be FDA commish, the inability to conceive of faster drug approval and safer medicines being one in the same reflects scientific stupidity or political cupidity, or both. And for someone whose own studies have demonstrated excess mortality in the wake of promoting the stocks of companies he conducts research for, I would not be talking about putting profits before safety if I were him.
I have decided to pull together the best of the blog commentary on Nissen's Avandia study:
From the Angry Pharmacist
http://www.theangrypharmacist.com/archives/2007/05/avandia_oh_why.html
From Respectful Insolence..
http://scienceblogs.com/insolence/2007/05/well_well_well_what_have_we_here_about_t_1.php
Kevin MD (who cites Medpage who cites but does not attribute my comparison of the WHI to Avandia risk)
http://www.kevinmd.com/blog/2007/05/avandia-and-heart-attacks.html
Dr. Kevin links to Nissen -- one day after making his Avandia > 9-11 tragedy with this ask and answer with Newsweek:
"Is there a case for prescribing Avandia? Are there some patients for whom the benefits outweigh the risks?
Again, I don’t think I want to go there. It’s important for me as a physician-scientist to put the data out there in a very neutral fashion, and not cast judgment about what people ought to do. We’re going to let everybody read our paper and make up their own minds. Obviously the FDA read our paper because they just issued a safety alert."
What a creep.
http://www.msnbc.msn.com/id/18789572/site/newsweek/
From the Angry Pharmacist
http://www.theangrypharmacist.com/archives/2007/05/avandia_oh_why.html
From Respectful Insolence..
http://scienceblogs.com/insolence/2007/05/well_well_well_what_have_we_here_about_t_1.php
Kevin MD (who cites Medpage who cites but does not attribute my comparison of the WHI to Avandia risk)
http://www.kevinmd.com/blog/2007/05/avandia-and-heart-attacks.html
Dr. Kevin links to Nissen -- one day after making his Avandia > 9-11 tragedy with this ask and answer with Newsweek:
"Is there a case for prescribing Avandia? Are there some patients for whom the benefits outweigh the risks?
Again, I don’t think I want to go there. It’s important for me as a physician-scientist to put the data out there in a very neutral fashion, and not cast judgment about what people ought to do. We’re going to let everybody read our paper and make up their own minds. Obviously the FDA read our paper because they just issued a safety alert."
What a creep.
http://www.msnbc.msn.com/id/18789572/site/newsweek/
Yes, Steve Nissen has sleepless nights about drug safety, particularly about the misuse of surrogate endpoints to approve drugs (which is why he has developed IVUS to develop a surrogate endpoint for drug approval).
And he compares Avandia's risk of death to that of 9-11 (though even his own meta-analysis did not estimate increased number of deaths only risk of having a heart attack sooner and not death).
He tells Diedtra Henderson of the Boston Globe he doesn't want to be FDA commissioner but tells the NYT he won't rule it out.
He uses the "I give all my money to charity" line but there is nothing about the fact the charities are his own research organizations and the Steven E Nissen Healthy Heart fund that doled out gym memberships and travel money to people at the ACC.
He is described as an "informal advisor to Congress" on drug safety. How about someone who coordinated with Congress to preempt the FDA's own analysis of Avandia in order stoke support for alternative FDA reform proposals. Who was working with Congressman Waxman and the NEJM to release his paper, supposedly told a Glaxo rep he was going to "destroy Avandia" but had the chutzpah to claim to the media he offered Glaxo the chance to co-author a paper.
Nissen's behavior with respect to Avandia and the increasing criticism that has been leveled at his "study" (if all the short term data showed a 40 percent increased risk, why is there no hint of it in long term studies like RECORD) were all neglected in the NYT study.
I predict that when all is said and done Nissen will be revealed as the Michael Nifong of medical research.
http://www.nytimes.com/2007/07/22/business/22nissen.html
And he compares Avandia's risk of death to that of 9-11 (though even his own meta-analysis did not estimate increased number of deaths only risk of having a heart attack sooner and not death).
He tells Diedtra Henderson of the Boston Globe he doesn't want to be FDA commissioner but tells the NYT he won't rule it out.
He uses the "I give all my money to charity" line but there is nothing about the fact the charities are his own research organizations and the Steven E Nissen Healthy Heart fund that doled out gym memberships and travel money to people at the ACC.
He is described as an "informal advisor to Congress" on drug safety. How about someone who coordinated with Congress to preempt the FDA's own analysis of Avandia in order stoke support for alternative FDA reform proposals. Who was working with Congressman Waxman and the NEJM to release his paper, supposedly told a Glaxo rep he was going to "destroy Avandia" but had the chutzpah to claim to the media he offered Glaxo the chance to co-author a paper.
Nissen's behavior with respect to Avandia and the increasing criticism that has been leveled at his "study" (if all the short term data showed a 40 percent increased risk, why is there no hint of it in long term studies like RECORD) were all neglected in the NYT study.
I predict that when all is said and done Nissen will be revealed as the Michael Nifong of medical research.
http://www.nytimes.com/2007/07/22/business/22nissen.html
Last week I had the opportunity to speak to a roundtable of Turkish journalists on how the second largest nation in Europe can help to reinvent and reinvigorate its health care system.
We talked about why getting new drugs to market in a timely manner is in the best interest of the public health. We talked about how government-run health care systemts often make the mistake of focusing on cost-based rather than patient-centric care. We talked about the dangers of counterfeiting. We talked about the need to develop better "evidence" for the era of personalized medicine. We talked about the urgent need to design a health care system that stresses prevention and chronic care.
In short, it sounded very much like the health care debate in Europe and the United States.
Except there's one enormous difference -- Turkey, demographically speaking, is a young nation. And that's a terrific opportunity. Rather than focusing on the health care needs of a fast-aging population (as is the case in the US and the EU), Turkey has the chance to "start young and stay healthy" -- avoiding many of the "chronic" problems we now face (diabetes, hypertension, high cholesterol, obesity, etc.)
Turkey has the chance to avoid these health care anchors and show us all how to do it right.
We talked about why getting new drugs to market in a timely manner is in the best interest of the public health. We talked about how government-run health care systemts often make the mistake of focusing on cost-based rather than patient-centric care. We talked about the dangers of counterfeiting. We talked about the need to develop better "evidence" for the era of personalized medicine. We talked about the urgent need to design a health care system that stresses prevention and chronic care.
In short, it sounded very much like the health care debate in Europe and the United States.
Except there's one enormous difference -- Turkey, demographically speaking, is a young nation. And that's a terrific opportunity. Rather than focusing on the health care needs of a fast-aging population (as is the case in the US and the EU), Turkey has the chance to "start young and stay healthy" -- avoiding many of the "chronic" problems we now face (diabetes, hypertension, high cholesterol, obesity, etc.)
Turkey has the chance to avoid these health care anchors and show us all how to do it right.
Take a look at who is board leader in conflict cash for the upcoming Avandia Adcomm.
Steve Nissen is pocketing nearly $1 million in study money from companies that are directly competing AGAINST Avandia. The rest of the folks have stock and speaking fees less than $10K per. In fact, St. Steven the Pure has racked up more conflict cash than the rest of the exemption seeking members combined..
And the media? Why, nary a word on the conflict back when or now even as Steve spins them feverishly in the lead up to Adcomm.
http://www.fda.gov/ohrms/dockets/ac/07/waivers/2007-4308w1-00-index.htm
Steve Nissen is pocketing nearly $1 million in study money from companies that are directly competing AGAINST Avandia. The rest of the folks have stock and speaking fees less than $10K per. In fact, St. Steven the Pure has racked up more conflict cash than the rest of the exemption seeking members combined..
And the media? Why, nary a word on the conflict back when or now even as Steve spins them feverishly in the lead up to Adcomm.
http://www.fda.gov/ohrms/dockets/ac/07/waivers/2007-4308w1-00-index.htm
CMPI held an event yesterday (as noted in my previous post) on Capitol Hill where it released a report entitled “The Effect of Chemotherapy
Innovation on Cancer Survival, 1991-2003: State Level Evidence from the SEERMedicare
Linked Database.†The report written by Dr. Frank R. Lichtenberg of Columbia University and the National Bureau of Economic Research in conjunction with the Center for Medicine in the Public Interest proves that using new cancer therapies is an effective way of lengthening the lives of cancer patients.
But it was more than your usual DC get out the report event. It was time to both celebrate what medical progress can provide and reassert the dying proposition that public policy should focus on what value medicines can add to people lives instead of what money can be squeezed from the lives of patients.
Michael Katz, VP of the International Myeloma Foundation http://www.myeloma.org/ spoke of not being a statistic because as a 17 year survivor of multiple myeloma, he should have been dead and not seen his three children grow and graduate college.
Congressman Mike Ferguson spoke of the joy he felt in hearing Michael's story and of the fact that his mom, who also had multiple myeloma, lived long enough to see her grandchildren. He spoke of the pride and joy he felt knowing that Celgene, the company that has developed a pill replacing blood transfusions for MM, is in his district.
Press events are usually canned activities but because of the people and passion that everyone brought, it was much more. I didn't know when we invited Mike that our event fell on the fourth anniversary of his mom's death. But it only reinforced our sense that CMPI's mission is, in Mike's words, to promote medical progress that saves and extends lives.
Thanks to everyone who made this possible.
Innovation on Cancer Survival, 1991-2003: State Level Evidence from the SEERMedicare
Linked Database.†The report written by Dr. Frank R. Lichtenberg of Columbia University and the National Bureau of Economic Research in conjunction with the Center for Medicine in the Public Interest proves that using new cancer therapies is an effective way of lengthening the lives of cancer patients.
But it was more than your usual DC get out the report event. It was time to both celebrate what medical progress can provide and reassert the dying proposition that public policy should focus on what value medicines can add to people lives instead of what money can be squeezed from the lives of patients.
Michael Katz, VP of the International Myeloma Foundation http://www.myeloma.org/ spoke of not being a statistic because as a 17 year survivor of multiple myeloma, he should have been dead and not seen his three children grow and graduate college.
Congressman Mike Ferguson spoke of the joy he felt in hearing Michael's story and of the fact that his mom, who also had multiple myeloma, lived long enough to see her grandchildren. He spoke of the pride and joy he felt knowing that Celgene, the company that has developed a pill replacing blood transfusions for MM, is in his district.
Press events are usually canned activities but because of the people and passion that everyone brought, it was much more. I didn't know when we invited Mike that our event fell on the fourth anniversary of his mom's death. But it only reinforced our sense that CMPI's mission is, in Mike's words, to promote medical progress that saves and extends lives.
Thanks to everyone who made this possible.
Berenson, not Rodriguez... With his latest piece describing how reimbursement factors create variations in oncology practice that appear delay access to new and in some individual cases, better, cancer drugs. (He calls them market forces, but why quibble.)
This should be a cautionary tale to those in the comparative effectiveness cult: a reimbursement code is as good as a death sentence to thousands of cancer patients if it creates practice variations that delay access to drugs that work for particular groups of patients.
For even more evidence of that, CMPI released study yesterday by Professor Frank Lichtenberg of Columbia University showing a direct association between access to new cancer drugs and increases in life expectancy and survival from cancer between the years 1991-2003. And for those who bleat that we need comparative effectiveness to turn each patient into a cost center consider that Dr. L found that each additional year of cancer free life cost $4300, a fraction of what other economists pegged the value of that achievement: $250k.
You can find the Lichtenberg study later at http://www.cmpi.org
The Berenson piece is here: http://www.nytimes.com/2007/07/14/health/14lymphoma.html?_r=1&oref=slogin
This should be a cautionary tale to those in the comparative effectiveness cult: a reimbursement code is as good as a death sentence to thousands of cancer patients if it creates practice variations that delay access to drugs that work for particular groups of patients.
For even more evidence of that, CMPI released study yesterday by Professor Frank Lichtenberg of Columbia University showing a direct association between access to new cancer drugs and increases in life expectancy and survival from cancer between the years 1991-2003. And for those who bleat that we need comparative effectiveness to turn each patient into a cost center consider that Dr. L found that each additional year of cancer free life cost $4300, a fraction of what other economists pegged the value of that achievement: $250k.
You can find the Lichtenberg study later at http://www.cmpi.org
The Berenson piece is here: http://www.nytimes.com/2007/07/14/health/14lymphoma.html?_r=1&oref=slogin
"Older, cheaper diabetes drugs are as safe and effective as newer ones, concludes an analysis that is good news for diabetics and may further hurt sales of Avandia, a blockbuster pill recently tied to heart problems.
The clear winner: metformin, sold as Glucophage and generically for about $100 a year. It works as well as other diabetes pills but does not cause weight gain or too-low blood sugar, the analysis found. It also lowers LDL or bad cholesterol."
http://news.yahoo.com/s/ap/20070716/ap_on_he_me/diabetes_drugs;_ylt=AjRpOmAY4PhCXhkEvojSg37VJRIF
I guess AP was just reading the press release and not the report or even the exec summary which carried these important tidbits:
The study only focused on monotherapy while the trend in diabetes care is towards combination therapy to maintain glycemic control, blood pressure, cholesterol. Hence, Avandia or Actos will be used in combination with Glucphage or insulin, not one or the other.
The study ignored many important clinical endpoints for which combination therapies are used, hyperinsulinaemia, for instance or fat build up.
The study acknowledges that combo therapy works better than monotherapy.
It also acknowledges that the supposed superiority of weight loss associated with metformin could be due to removing a prior drug used in head to head comparision trials so that the weight loss is an artifact of an experiment not the medicine. Oh.
So why did the authors not make these caveats in their statements to the media and so eager to push metformin as the....cheapest and best? Here is what the authors siad in their article in the Annals of Internal Medicine: Drugs like metformin "lower cost, longer use in practice and more intensive scrutiny in long-term trials" But the trend is towards combination therapy. Do I detect a bias, a falling into line with a ideological bent beyond what the data suggest? Is this ALLHAT and CATIE redux?
http://www.annals.org/cgi/content/full/0000605-200709180-00178v1
The clear winner: metformin, sold as Glucophage and generically for about $100 a year. It works as well as other diabetes pills but does not cause weight gain or too-low blood sugar, the analysis found. It also lowers LDL or bad cholesterol."
http://news.yahoo.com/s/ap/20070716/ap_on_he_me/diabetes_drugs;_ylt=AjRpOmAY4PhCXhkEvojSg37VJRIF
I guess AP was just reading the press release and not the report or even the exec summary which carried these important tidbits:
The study only focused on monotherapy while the trend in diabetes care is towards combination therapy to maintain glycemic control, blood pressure, cholesterol. Hence, Avandia or Actos will be used in combination with Glucphage or insulin, not one or the other.
The study ignored many important clinical endpoints for which combination therapies are used, hyperinsulinaemia, for instance or fat build up.
The study acknowledges that combo therapy works better than monotherapy.
It also acknowledges that the supposed superiority of weight loss associated with metformin could be due to removing a prior drug used in head to head comparision trials so that the weight loss is an artifact of an experiment not the medicine. Oh.
So why did the authors not make these caveats in their statements to the media and so eager to push metformin as the....cheapest and best? Here is what the authors siad in their article in the Annals of Internal Medicine: Drugs like metformin "lower cost, longer use in practice and more intensive scrutiny in long-term trials" But the trend is towards combination therapy. Do I detect a bias, a falling into line with a ideological bent beyond what the data suggest? Is this ALLHAT and CATIE redux?
http://www.annals.org/cgi/content/full/0000605-200709180-00178v1
To see what happens when too many people toady up to for too long and what being imperious does to one's brain cells and personality, read Arnold Relman's screed against Richard Epstein's book "Overdose: How Excessive Government Regulation Stifles Pharmaceuetical Innovation."
To be fair, Epstein lays into Relman in his book, so Arnie is entitled to hit back. But the review is long, boring and short on detail. He never rebuts Epstein's claim. Rather he just screams that Big Pharma buys and sells the FDA and every other major political institution. Well if that's the case, why do so many of their drugs fail to make past FDA reviewers? If the marketing is so successful why not crank out one me too after another and just ram them down the throats of stupid docs and consumers? Why invest in innovation at all? Then the problem of government regulation disappears.
Relman is so obsessed with his droning that he does not realize he has no point. That is the biomarker of a zealot or some other condition.
http://www.tnr.com/doc.mhtml?i=20070723&s=relman072307
To be fair, Epstein lays into Relman in his book, so Arnie is entitled to hit back. But the review is long, boring and short on detail. He never rebuts Epstein's claim. Rather he just screams that Big Pharma buys and sells the FDA and every other major political institution. Well if that's the case, why do so many of their drugs fail to make past FDA reviewers? If the marketing is so successful why not crank out one me too after another and just ram them down the throats of stupid docs and consumers? Why invest in innovation at all? Then the problem of government regulation disappears.
Relman is so obsessed with his droning that he does not realize he has no point. That is the biomarker of a zealot or some other condition.
http://www.tnr.com/doc.mhtml?i=20070723&s=relman072307
Avandia raises good cholesterol and (however it raises bad )while controlling diabetes..how about that? To quote the study... "Pioglitazone and rosiglitazone cause a small but significant increase in high-density lipoprotein, often called "good cholesterol" because it promotes the breakdown and removal of cholesterol from the body." This has been Nissen's holy grail...it must kill him to see it reported in a drug he tried to destroy while others he has worked on have tanked...
And the study which looks at all forms a drugs to control Type 2 diabetes, many of which are used in tandem, is a kick in a teeth to Nissen's sloppy and skewed handling of the data and Furberg's hysterical handling of the results thereof. Now that they two have been added to Adcomm, let's see if they behave responsibly before, during and after the meeting instead of trying to inflame passion. My guess is, on the heels of the AHQR study and a recent microvascular study by Eric Topol and colleagues showing a protective effect impact from Avandia in certain patients with metabolic disorders undergoing revascularization, the black box warning will be mild and some primary care docs might even begin to prescribe again, though not to patients at risk for CHF.
Now let's see how the media covers this study and its rebuke to Nissen.
http://www.ahcpr.gov/news/press/pr2007/effdiabpr.htm
Seel also "Peroxisome proliferator-activated receptor gamma agonists for the Prevention of Adverse events following percutaneous coronary Revascularization--results of the PPAR study."
Am Heart J. 2007 Jul;154(1):137-43.
And the study which looks at all forms a drugs to control Type 2 diabetes, many of which are used in tandem, is a kick in a teeth to Nissen's sloppy and skewed handling of the data and Furberg's hysterical handling of the results thereof. Now that they two have been added to Adcomm, let's see if they behave responsibly before, during and after the meeting instead of trying to inflame passion. My guess is, on the heels of the AHQR study and a recent microvascular study by Eric Topol and colleagues showing a protective effect impact from Avandia in certain patients with metabolic disorders undergoing revascularization, the black box warning will be mild and some primary care docs might even begin to prescribe again, though not to patients at risk for CHF.
Now let's see how the media covers this study and its rebuke to Nissen.
http://www.ahcpr.gov/news/press/pr2007/effdiabpr.htm
Seel also "Peroxisome proliferator-activated receptor gamma agonists for the Prevention of Adverse events following percutaneous coronary Revascularization--results of the PPAR study."
Am Heart J. 2007 Jul;154(1):137-43.
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.
