Latest Drugwonks' Blog
Here’s a headline right out of 2004:
“McCain Calls for Drug Reimportationâ€
According to an AP report, Senator John McCain said he wants to again allow the importation of prescription drugs from Canada as a way to bring health care costs under control.
The Arizona senator, speaking to reporters about a mile from the Canadian border and just across the river from New Hampshire, said too much of health care costs are based on high drug prices.
"If we are going to control health care cost, we need to control the rising costs of pharmaceuticals," McCain said.
Except that’s not true. Drug costs represent about 11.5% of the American health care spend. Hospital costs represent over 30%. What’s a better bargain: time spent in the hospital, or drugs that keep Americans healthy and productive?
That’s a good question to ask Senator McCain during the next debate.
The Senator also blamed drug costs for rising insurance premiums.
That’s also not true. Consider this, from 1998 to 2003; insurance companies increased their premiums by an average of $104.62 per person. During that same time period prescription-drug costs increased by $22.48.
Are the majority of Americans with private health insurance spending more for drugs? Yes — because their insurance companies are paying less. In 2000, people under 65 with private health insurance paid 37.2 percent of the cost of their prescription drugs costs out of their own pockets. (Not surprisingly, this leads many Americans to believe that their increased out-of-pocket expenses are because of higher drug costs.) The truth is that the growth in prescription-drug co-payments outpaced the growth rate of prescription drug prices four to one.
"These are drugs being reimported. They go to Canada and then they can come back in. It's a strawman to say that a country like Canada could not be responsible for safe drugs to be brought into our country. Many of them are manufactured in Canada, as you know," he said.
Yep – heard that one before. And very untrue. The drugs that are being sold to Americans by Canadian internet pharmacies come from the EU – and are not even legal for sale in Canada. The McCain scheme (it cannot really be called a “planâ€) would not provide Americans with the “same drugs Canadians get.†That’s just a fact. What we would get are drugs from all the nations of the EU – the UK as well as Latvia; France as well as Portugal -- with no real quality control or reliable chain of custody. And if you don’t believe this causes safety problems, just ask the folks over at the MHRA.
The hard fact, Senator McCain, is that there is no such thing as “Canada-only re-importation.†It’s just a snake-oil soundbite.
And, for a guy who positions himself as the no BS candidate, we expect better.
“McCain Calls for Drug Reimportationâ€
According to an AP report, Senator John McCain said he wants to again allow the importation of prescription drugs from Canada as a way to bring health care costs under control.
The Arizona senator, speaking to reporters about a mile from the Canadian border and just across the river from New Hampshire, said too much of health care costs are based on high drug prices.
"If we are going to control health care cost, we need to control the rising costs of pharmaceuticals," McCain said.
Except that’s not true. Drug costs represent about 11.5% of the American health care spend. Hospital costs represent over 30%. What’s a better bargain: time spent in the hospital, or drugs that keep Americans healthy and productive?
That’s a good question to ask Senator McCain during the next debate.
The Senator also blamed drug costs for rising insurance premiums.
That’s also not true. Consider this, from 1998 to 2003; insurance companies increased their premiums by an average of $104.62 per person. During that same time period prescription-drug costs increased by $22.48.
Are the majority of Americans with private health insurance spending more for drugs? Yes — because their insurance companies are paying less. In 2000, people under 65 with private health insurance paid 37.2 percent of the cost of their prescription drugs costs out of their own pockets. (Not surprisingly, this leads many Americans to believe that their increased out-of-pocket expenses are because of higher drug costs.) The truth is that the growth in prescription-drug co-payments outpaced the growth rate of prescription drug prices four to one.
"These are drugs being reimported. They go to Canada and then they can come back in. It's a strawman to say that a country like Canada could not be responsible for safe drugs to be brought into our country. Many of them are manufactured in Canada, as you know," he said.
Yep – heard that one before. And very untrue. The drugs that are being sold to Americans by Canadian internet pharmacies come from the EU – and are not even legal for sale in Canada. The McCain scheme (it cannot really be called a “planâ€) would not provide Americans with the “same drugs Canadians get.†That’s just a fact. What we would get are drugs from all the nations of the EU – the UK as well as Latvia; France as well as Portugal -- with no real quality control or reliable chain of custody. And if you don’t believe this causes safety problems, just ask the folks over at the MHRA.
The hard fact, Senator McCain, is that there is no such thing as “Canada-only re-importation.†It’s just a snake-oil soundbite.
And, for a guy who positions himself as the no BS candidate, we expect better.
Mostly excellent choices -- with the best at the top -- Mark McClellan, "the hardest working man in American health care" as the foundation's chair.
Other members are:
Georges C. Benjamin, M.D., Executive Director, American Public Health Association
William Brody, President, The Johns Hopkins University
Helen Darling, President, National Business Group on Health
Cal Dooley, President and CEO, Grocery Manufacturers Association
Michael Doyle, Ph.D., Regents Professor and Director, Center for Food Safety, University of Georgia
Joseph M. Hogan, President and CEO, GE Healthcare
Kay Holcombe, Senior Health Policy Advisory, Genzyme Corporation
Sharon Levine, M.D., Associate Executive Medical Director, The Permanente Medical Group
Gary Neil, M.D., Group President, Johnson & Johnson Pharmaceutical Research & Development
Phillip A. Sharp, Ph.D., Institute Professor, Center for Cancer Research, Massachusetts Institute of Technology
Ellen V. Sigal, Ph.D., Chair and Founder, Friends of Cancer Research
Tadataka Yamada, M.D., President, Global Health Program, Bill & Melinda Gates Foundation
Diana Zuckerman, Ph.D., President, National Research Center for Women and Families
Other members are:
Georges C. Benjamin, M.D., Executive Director, American Public Health Association
William Brody, President, The Johns Hopkins University
Helen Darling, President, National Business Group on Health
Cal Dooley, President and CEO, Grocery Manufacturers Association
Michael Doyle, Ph.D., Regents Professor and Director, Center for Food Safety, University of Georgia
Joseph M. Hogan, President and CEO, GE Healthcare
Kay Holcombe, Senior Health Policy Advisory, Genzyme Corporation
Sharon Levine, M.D., Associate Executive Medical Director, The Permanente Medical Group
Gary Neil, M.D., Group President, Johnson & Johnson Pharmaceutical Research & Development
Phillip A. Sharp, Ph.D., Institute Professor, Center for Cancer Research, Massachusetts Institute of Technology
Ellen V. Sigal, Ph.D., Chair and Founder, Friends of Cancer Research
Tadataka Yamada, M.D., President, Global Health Program, Bill & Melinda Gates Foundation
Diana Zuckerman, Ph.D., President, National Research Center for Women and Families
Two views on the subject. One from me in today's New York Post which argues that Hillary should go first in explaining her view on whether illegal immigrants should receive free cancer care in the Empire State.. another from The New Republic claiming it we owe to the public health to do so. No, illegals owe it to themselves to stay healthy and we owe it to ourselves to make health care affordable on the open market. We don't owe it to them to provide free healthcare.
http://www.nypost.com/seven/11162007/postopinion/opedcolumnists/hill__illegals_health_care_351972.htm
http://www.tnr.com/politics/story.html?id=55c072cf-0d36-41e2-a4e3-388af9a360da&p=2
http://www.nypost.com/seven/11162007/postopinion/opedcolumnists/hill__illegals_health_care_351972.htm
http://www.tnr.com/politics/story.html?id=55c072cf-0d36-41e2-a4e3-388af9a360da&p=2
According to the Associated Press, "The Food and Drug Administration announced proposed rules Thursday to reduce potential conflicts of interest among outside experts who advise the government on approval of drugs and other regulated products. The experts would have to disclose any financial ties to the industry under review."
Rather than being treated as experts, AdComm members will now be treated as suspected felons. Not only will they have to fill out a form disclosing the potential conflicts -- but now they must also explain why they should still be able to advise the agency.
What's next? Fingerprinting?
Rather than being treated as experts, AdComm members will now be treated as suspected felons. Not only will they have to fill out a form disclosing the potential conflicts -- but now they must also explain why they should still be able to advise the agency.
What's next? Fingerprinting?
Jonathan Cohn, in an otherwise excellent and thoughtful piece in The New Republicv on how to shift health care systems to a value based reimbursement approach (from a single payer perspective) , resorts to the shibboleth that drug companies are not very innovative as if this is somehow their fault and by design. He relies on the totally useless work of Marcia Angell and Merrill Goozner, neither of whom know much about drug discovery and development and what they do write is selective and misleading.
First, if drug development and discovery were so easy it wouldn't be so expensive. Success rates have fallen not be design. Would any one want to invest $800 billion in a drug only to have it fail. But it happens all the the time. Incrementalism by the way is the norm of science and all things whereas the ability to use one medicine or insight to transform or extend life is rare indeed. Yet Cohn falls into the trap all amateurs fall into and believes that if drug or biotech companies tried a little harder they could nail it. That's arm chair quarterbacking at it's worst. If you think it's so easy to hit a Jaba Chamberlain splitter, why don't you try out for the Bosox and hit it not once every 1000 times but one out of three times. Hit .300 and you are in the Hall of Fame. My brother has worked for a drug company for 20 years and has 3 of the drugs he has worked on approved. That's a lot.
Now as to the heavy lifting. This notion that NIH discovers everything is just not true. The amount of collaboration is astounding and is what separates the US from other parts of the world. Angell and Goozner lie outright to avoid describing the partnerships that shape innovation in America and depict a Golden Age that never existed. Angell asserts that every breakthrough drug started without drug company involvement. She claims that Gleevec, the first cancer drug to target cancerous cells without side effects, was developed without any real input from Novartis, the company that makes the product. Angell says that Brian Druker, a cancer researcher at Oregon Health and Science University, said that Novartis showed little interest in the cancer compound until he discovered its tremendous properties. The real story--from the Journal of the National Cancer Institute--reflects the risky and collaborative nature of drug development, which requires massive capital and biopharmaceutical know-how to turn discoveries into effective treatments. An academic researcher and private company, working together, launched a revolution in the treatment of cancer. You wouldn't know it by reading Angell.
Goozner makes the same claim about drugs developed by Amgen. Everyone involved knows better.
Similarly both Goozner and Angell disdain the revolution in personalized medicine thereby ignoring genomic based science, something that Senator Obama has taken leadership on in the Senate along with Senator Richard Burr.
For instance, The Truth About the Drug Companies also claims there is no real evidence that any one drug is better than another or that most medicines really do much at all. And Angell goes as far as to say: "the idea that patients respond differently to me-too drugs is merely an untested and self-serving hypothesis." Rather, she says, "one or two drugs will do" for most medical conditions. And Goozner still can't figure out the difference between a surrogate end point like blood pressure and a genetic marker which both predicts and controls disease progression.
Cohn's article in the New Republic tries to argue that value based reimbursement can let people have the best of both worlds in a single payer system. I disagree. But he gets the point that health care is an investment and that innovation is valuable. I would recommend that he go beyond Goozner and Angell to understand the role the private sector plays in promoting innovation and just how difficult real invention is.
http://www.tnr.com/politics/story.html?id=53e206dd-c286-43b1-9c5b-079e81ab3474
First, if drug development and discovery were so easy it wouldn't be so expensive. Success rates have fallen not be design. Would any one want to invest $800 billion in a drug only to have it fail. But it happens all the the time. Incrementalism by the way is the norm of science and all things whereas the ability to use one medicine or insight to transform or extend life is rare indeed. Yet Cohn falls into the trap all amateurs fall into and believes that if drug or biotech companies tried a little harder they could nail it. That's arm chair quarterbacking at it's worst. If you think it's so easy to hit a Jaba Chamberlain splitter, why don't you try out for the Bosox and hit it not once every 1000 times but one out of three times. Hit .300 and you are in the Hall of Fame. My brother has worked for a drug company for 20 years and has 3 of the drugs he has worked on approved. That's a lot.
Now as to the heavy lifting. This notion that NIH discovers everything is just not true. The amount of collaboration is astounding and is what separates the US from other parts of the world. Angell and Goozner lie outright to avoid describing the partnerships that shape innovation in America and depict a Golden Age that never existed. Angell asserts that every breakthrough drug started without drug company involvement. She claims that Gleevec, the first cancer drug to target cancerous cells without side effects, was developed without any real input from Novartis, the company that makes the product. Angell says that Brian Druker, a cancer researcher at Oregon Health and Science University, said that Novartis showed little interest in the cancer compound until he discovered its tremendous properties. The real story--from the Journal of the National Cancer Institute--reflects the risky and collaborative nature of drug development, which requires massive capital and biopharmaceutical know-how to turn discoveries into effective treatments. An academic researcher and private company, working together, launched a revolution in the treatment of cancer. You wouldn't know it by reading Angell.
Goozner makes the same claim about drugs developed by Amgen. Everyone involved knows better.
Similarly both Goozner and Angell disdain the revolution in personalized medicine thereby ignoring genomic based science, something that Senator Obama has taken leadership on in the Senate along with Senator Richard Burr.
For instance, The Truth About the Drug Companies also claims there is no real evidence that any one drug is better than another or that most medicines really do much at all. And Angell goes as far as to say: "the idea that patients respond differently to me-too drugs is merely an untested and self-serving hypothesis." Rather, she says, "one or two drugs will do" for most medical conditions. And Goozner still can't figure out the difference between a surrogate end point like blood pressure and a genetic marker which both predicts and controls disease progression.
Cohn's article in the New Republic tries to argue that value based reimbursement can let people have the best of both worlds in a single payer system. I disagree. But he gets the point that health care is an investment and that innovation is valuable. I would recommend that he go beyond Goozner and Angell to understand the role the private sector plays in promoting innovation and just how difficult real invention is.
http://www.tnr.com/politics/story.html?id=53e206dd-c286-43b1-9c5b-079e81ab3474
The recent session of the WHO’s Intergovernmental Governmental Working Group (IGWG) ended without consensus. And that’s a good thing considering that many of the issues on the table would have resulted in a screeching halt to medical progress.
The IGWG discussions were completely void of innovators -- with pharmaceutical researchers relegated to the sidelines. In their place were activists who are unwilling (and seemingly unable) to engage in any discussion that does not begin and end with removing systems of intellectual property (IP) protection for medicines.
As with many of their ilk, these activists believe in freedom of speech – as long as what you say supports their position. Otherwise you’re a capitalist tool. Their grasp on the truth is, well, questionable.
Consider this statement from our comrades over at Médecins Sans Frontières:
“Patents are not a relevant factor in stimulating R&D and bringing new products to the market.â€
Really? What about HIV/AIDS, one of the WHO’s “neglected diseases,†where all of antiretrovirals currently in existence were developed under patent protection.
If their grasp on the truth is questionable, their chutzpah is unlimited.
Consider a recent editorial the latest publication of The Lancet where officials of the Thai military junta attack comments offered by patient organizations and other groups to the open forum of the IGWG.
“The issue that attracted the most responses was intellectual property (IP), which was cited in 43 of 68 submissions. Although we were not surprised to see that 11 of 12 organisations directly affiliated with the pharmaceutical industry supported strong IP protection, it was surprising that 14 patient advocacy groups took a similar position, which in several cases was the only point raised in their submissions; three professional associations also took similar positions … We declare that we have no conflict of interest."
This last comment is made after they state that, "We strongly suggest that contributors to public hearings must disclose any conflicts of interest, as required of authors submitting papers to peer-reviewed journals."
The authors did not declare that the Thai Ministry of Health owns the Government Pharmaceutical Organization (GPO) -- and that the GPO stands to significantly benefit financially from a proposed IGWG agenda strongly supports compulsory licensing.
Well, what’s good for the goose is good for the gander. Transparency should cut both ways – even in Geneva.
The IGWG discussions were completely void of innovators -- with pharmaceutical researchers relegated to the sidelines. In their place were activists who are unwilling (and seemingly unable) to engage in any discussion that does not begin and end with removing systems of intellectual property (IP) protection for medicines.
As with many of their ilk, these activists believe in freedom of speech – as long as what you say supports their position. Otherwise you’re a capitalist tool. Their grasp on the truth is, well, questionable.
Consider this statement from our comrades over at Médecins Sans Frontières:
“Patents are not a relevant factor in stimulating R&D and bringing new products to the market.â€
Really? What about HIV/AIDS, one of the WHO’s “neglected diseases,†where all of antiretrovirals currently in existence were developed under patent protection.
If their grasp on the truth is questionable, their chutzpah is unlimited.
Consider a recent editorial the latest publication of The Lancet where officials of the Thai military junta attack comments offered by patient organizations and other groups to the open forum of the IGWG.
“The issue that attracted the most responses was intellectual property (IP), which was cited in 43 of 68 submissions. Although we were not surprised to see that 11 of 12 organisations directly affiliated with the pharmaceutical industry supported strong IP protection, it was surprising that 14 patient advocacy groups took a similar position, which in several cases was the only point raised in their submissions; three professional associations also took similar positions … We declare that we have no conflict of interest."
This last comment is made after they state that, "We strongly suggest that contributors to public hearings must disclose any conflicts of interest, as required of authors submitting papers to peer-reviewed journals."
The authors did not declare that the Thai Ministry of Health owns the Government Pharmaceutical Organization (GPO) -- and that the GPO stands to significantly benefit financially from a proposed IGWG agenda strongly supports compulsory licensing.
Well, what’s good for the goose is good for the gander. Transparency should cut both ways – even in Geneva.
Ed Silverman, the brains behind pharmalot ( www.pharmalot.com) has written a great piece on the trend towards patient reported outcomes in clinical trials. Must reading on this subject for anyone interested in personalized medicine and understanding how and why FDA yanked the QOL indications from Amgen's anemia drugs.
http://www.the-scientist.com/article/home/53617/
Now it seems that accessing this data can often be a problem for the researchers who want to use this research to find out what works. An editorial in JAMA by Norman Frost of the Univ of Wisc. Medical School writes that application of HIPAA rules has shut down research or scared off otherwise important studies in the name of privacy:
"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation."
http://www.sciencedaily.com/releases/2007/11/071113165648.htm
http://www.the-scientist.com/article/home/53617/
Now it seems that accessing this data can often be a problem for the researchers who want to use this research to find out what works. An editorial in JAMA by Norman Frost of the Univ of Wisc. Medical School writes that application of HIPAA rules has shut down research or scared off otherwise important studies in the name of privacy:
"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation."
http://www.sciencedaily.com/releases/2007/11/071113165648.htm
Here's USA Today crawling through the mud -- past Janet Woodcock who officially speaks for the FDA -- to talk to David Graham about Avandia:
"This is a warning that's not a warning," said Graham, speaking for himself. "The other thing that's missing is a statement that … there are other alternatives available that work as well as Avandia and don't have this cloud hanging over them."
So Graham wants the FDA to engage in comparative effectiveness which is clearly not it's statutory authority and for which there is no evidence anyways that could be slapped on a label. USA Today runs with this statement instead of the scientific one made by Dr. Woodcock based on the evidence.
No wonder patients are confused and afraid.
http://www.usatoday.com/news/health/2007-11-14-diabetes-heart_N.htm?loc=interstitialskip
"This is a warning that's not a warning," said Graham, speaking for himself. "The other thing that's missing is a statement that … there are other alternatives available that work as well as Avandia and don't have this cloud hanging over them."
So Graham wants the FDA to engage in comparative effectiveness which is clearly not it's statutory authority and for which there is no evidence anyways that could be slapped on a label. USA Today runs with this statement instead of the scientific one made by Dr. Woodcock based on the evidence.
No wonder patients are confused and afraid.
http://www.usatoday.com/news/health/2007-11-14-diabetes-heart_N.htm?loc=interstitialskip
Forget the black box for now..here's FDA's Janet Woodcock speaking clearly and confidently on what the agency decided and what the new labeling means:
"We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's Dr. Janet Woodcock told reporters in a phone briefing.
The studies have been inconclusive and those that appear to show a risk all compare Avandia to a placebo, she said."
Thus the FDA is closer to the European Medicine Agency than Canada. I am keeping a count to see how many news accounts or blogs note that the EMEA kept Avandia on the market without relabeling. Big zero so far.
http://www.reuters.com/article/governmentFilingsNews/idUSN1421392120071114
"We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's Dr. Janet Woodcock told reporters in a phone briefing.
The studies have been inconclusive and those that appear to show a risk all compare Avandia to a placebo, she said."
Thus the FDA is closer to the European Medicine Agency than Canada. I am keeping a count to see how many news accounts or blogs note that the EMEA kept Avandia on the market without relabeling. Big zero so far.
http://www.reuters.com/article/governmentFilingsNews/idUSN1421392120071114
John Edwards must know something -- like his campaign is dying. Why else would he decide to jump on the bandwagon of Bernie Sanders (the Senator from Ben & Jerry's) and come out in support of the year's worst idea in health care reform -- prizes rather than patents.
Here's what Senator Edwards had to say to a group of medical professionals at Dartmouth-Hitchcock Medical Center on the subject of prizes for pharmaceutical innovation:
"It would also create a different dynamic for drug companies and particularly for breakthrough drugs in big areas like Alzheimer’s, cancer, etc. We’d offer a cash prize for the research and development of these drugs, but they don’t get a patent. So we eliminate the monopoly…The idea is you’ve got to give the financial incentive for the companies to do it but on the flip side you get the products to the market quicker, available quickly and at a much lower cost.â€
Okay -- once more with feeling -- this is just not true. As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
For more reasons this is a crackpot idea see our October 22nd blog entry ("Et tu, Bernie") here:
http://drugwonks.com/2007/10/et_tu_bernie.html
Note to Senator Edwards: You should look into how much money is currently being spent by the biopharmaceutical industry on Alzheimer's research and development. (We assume you have already done so on the issue of breast cancer.)
Here's what Senator Edwards had to say to a group of medical professionals at Dartmouth-Hitchcock Medical Center on the subject of prizes for pharmaceutical innovation:
"It would also create a different dynamic for drug companies and particularly for breakthrough drugs in big areas like Alzheimer’s, cancer, etc. We’d offer a cash prize for the research and development of these drugs, but they don’t get a patent. So we eliminate the monopoly…The idea is you’ve got to give the financial incentive for the companies to do it but on the flip side you get the products to the market quicker, available quickly and at a much lower cost.â€
Okay -- once more with feeling -- this is just not true. As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
For more reasons this is a crackpot idea see our October 22nd blog entry ("Et tu, Bernie") here:
http://drugwonks.com/2007/10/et_tu_bernie.html
Note to Senator Edwards: You should look into how much money is currently being spent by the biopharmaceutical industry on Alzheimer's research and development. (We assume you have already done so on the issue of breast cancer.)
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.
