Latest Drugwonks' Blog
My oped on how Arnold Relman is pleading with Canadians not to escape single payer purgatory.
http://washingtontimes.com/apps/pbcs.dll/article?AID=/20070821/EDITORIAL/108210009/1013/editorial&template=nextpage
http://washingtontimes.com/apps/pbcs.dll/article?AID=/20070821/EDITORIAL/108210009/1013/editorial&template=nextpage
This from the AFP
Cancer Survival Rate Up in Europe
"Cancer survival has improved across Europe, with eastern European nations beginning to close the gap with western neighbours, according to a study covering the decade up to 2002, released Tuesday.
The study, published in the British journal The Lancet, showed a clear link between high rates of survival and the amount spent on health, but pointed out that Britain lagged well behind other countries with similar national health budgets.
An accompanying editorial in the influential journal called for a "fundamental reassessment" of Britain's cancer policy in light of the fact that survival rates were comparable to eastern European countries that spent two-thirds less.
"So has the cancer plan worked? The short answer is seemingly no," it concluded, suggesting that the National Health Service should be "divorced from political control and short-term political gains."
http://news.yahoo.com/s/afp/20070821/ts_afp/healthcancereurope
Oh you mean the effort to place health care budgets under the wise and experienced direction of bureaucrats seeking to bring costs under control by limiting access to drugs in the political spotlight is killing patients? The most the NHS spends the less it gets for its dollars.
As in NICE which is hailed as the gold standard of comparative effectiveness and cost effectiveness evaluation by the folks at AHIP, Commonwealth Fund, HealthDespairs, Medpac and now at CMS.
Our government -- in the form of the FDA and now at CMS -- is at war against cancer patients. It is a direct result of the policies pursued by those whose politics are shaped by unchecked hatred against the companies that make medicines. They are supported by a fawning media, by nuts on the net, and financially by trial attorneys. They are killing patients and crippling their lives. Well done.
Cancer Survival Rate Up in Europe
"Cancer survival has improved across Europe, with eastern European nations beginning to close the gap with western neighbours, according to a study covering the decade up to 2002, released Tuesday.
The study, published in the British journal The Lancet, showed a clear link between high rates of survival and the amount spent on health, but pointed out that Britain lagged well behind other countries with similar national health budgets.
An accompanying editorial in the influential journal called for a "fundamental reassessment" of Britain's cancer policy in light of the fact that survival rates were comparable to eastern European countries that spent two-thirds less.
"So has the cancer plan worked? The short answer is seemingly no," it concluded, suggesting that the National Health Service should be "divorced from political control and short-term political gains."
http://news.yahoo.com/s/afp/20070821/ts_afp/healthcancereurope
Oh you mean the effort to place health care budgets under the wise and experienced direction of bureaucrats seeking to bring costs under control by limiting access to drugs in the political spotlight is killing patients? The most the NHS spends the less it gets for its dollars.
As in NICE which is hailed as the gold standard of comparative effectiveness and cost effectiveness evaluation by the folks at AHIP, Commonwealth Fund, HealthDespairs, Medpac and now at CMS.
Our government -- in the form of the FDA and now at CMS -- is at war against cancer patients. It is a direct result of the policies pursued by those whose politics are shaped by unchecked hatred against the companies that make medicines. They are supported by a fawning media, by nuts on the net, and financially by trial attorneys. They are killing patients and crippling their lives. Well done.
Sex is prime cause of China's HIV
By Jill McGivering
BBC News
Activists are pushing China to change the way it tackles HIV. China's state media says unsafe sex has, for the first time, become the main means of transmission of HIV/Aids, overtaking intravenous drug use.
http://news.bbc.co.uk/2hi/asia-pacific/6954859.stm
Attention must be paid.
By Jill McGivering
BBC News
Activists are pushing China to change the way it tackles HIV. China's state media says unsafe sex has, for the first time, become the main means of transmission of HIV/Aids, overtaking intravenous drug use.
http://news.bbc.co.uk/2hi/asia-pacific/6954859.stm
Attention must be paid.
Would the National Federation of Independent Businesses support legislation that would restrict the right of it's members to decide which distributors to sell or ship products to at what price or make it a federal crime to refuse to do business with a particular company because they were re-selling your products from China into America at below market price that hurt your bottom line? That's unconstitutional, right?
Well it has by destroyed one of the pillars of capitalism by supporting the Pharmaceutical Market Access and Drug Safety Act of 2007 which contains such provisions.
Shame on the NFIB for selling out. I hope it was worth it.
Well it has by destroyed one of the pillars of capitalism by supporting the Pharmaceutical Market Access and Drug Safety Act of 2007 which contains such provisions.
Shame on the NFIB for selling out. I hope it was worth it.
It's tough being the first. You are often called crazy. When the Human Genome Project was launched even David Baltimore derided it as a monumental waste of money. The researchers who claimed blood pressure was a marker for heart attacks were similarly attacked. So the chorus of "let's do the randomized studies" to validate what our genes tell us is so predictable in response to Larry Lesko's effort to push a gene testing label on a drug that I daresay the FDA has seen more safety data about than anyone who is criticizing Lesko has seen in their little lifetimes.
What I also find interesting in that the people criticizing Lesko are some of the very same people who have been writing articles in the past touting the value of genetic testing, albeit to promote THEIR research. That goes for Anne Wittkowsky of the University of Washington who has written optimistically about gene testing for warfarin in the past only to piss all over Lesko for the benefit of Anna Mathews piece. And of course insurers want all the data in the world to pay for new things but have no problem switching statins on folks without the slightest hint of evidence that doing so will improve patient care.
I know the plural of anecdotes is not evidence. But I have seen the impact of genetic testing in my family. I used both the Roche Amplichip and a battery of tests from Genomas to improve the dosing of certain drugs for my daughter and avoid the painful side effects of statin drugs. So has my mother who was on the cheapest generic statin that was causing the dizziness and muscle cramps she associated with fibromyalgia.
Lesko and Felix Frueh work largely alone to move the FDA -- and health care -- into the era of personalized medicine. It is symptomatic of the scientific community to exhibit pettiness, jealousy and hypocrisy when someone tries to move medicine into the clinic. But to my mind they should get a special award for their efforts. For now, a thank you from drugwonks will have to do.
http://online.wsj.com/article/SB118722561330199147.html
What I also find interesting in that the people criticizing Lesko are some of the very same people who have been writing articles in the past touting the value of genetic testing, albeit to promote THEIR research. That goes for Anne Wittkowsky of the University of Washington who has written optimistically about gene testing for warfarin in the past only to piss all over Lesko for the benefit of Anna Mathews piece. And of course insurers want all the data in the world to pay for new things but have no problem switching statins on folks without the slightest hint of evidence that doing so will improve patient care.
I know the plural of anecdotes is not evidence. But I have seen the impact of genetic testing in my family. I used both the Roche Amplichip and a battery of tests from Genomas to improve the dosing of certain drugs for my daughter and avoid the painful side effects of statin drugs. So has my mother who was on the cheapest generic statin that was causing the dizziness and muscle cramps she associated with fibromyalgia.
Lesko and Felix Frueh work largely alone to move the FDA -- and health care -- into the era of personalized medicine. It is symptomatic of the scientific community to exhibit pettiness, jealousy and hypocrisy when someone tries to move medicine into the clinic. But to my mind they should get a special award for their efforts. For now, a thank you from drugwonks will have to do.
http://online.wsj.com/article/SB118722561330199147.html
China Counterfeit Diabetes Tests Tracked by J&J
By Allan Dodds Frank and Lisa Rapaport
Aug. 16 (Bloomberg) -- A global manhunt launched by Johnson & Johnson has tracked to China counterfeit versions of an at-home diabetes test used by 10 million Americans to take sensitive measurements of blood-sugar levels.
Potentially dangerous copies of the OneTouch Test Strip sold by J&J's LifeScan unit surfaced in American and Canadian pharmacies last year, according to federal court documents unsealed in June. New Brunswick, New Jersey-based J&J, the world's largest consumer-health products maker, learned of the counterfeit tests after 15 patients complained of faulty results last September.
Tipped off by J&J, the U.S. Food and Drug Administration issued a nationwide consumer alert in October without disclosing the link to China. While no injuries were reported, inaccurate test readings may lead a diabetic to inject the wrong amount of insulin, causing harm or death, the agency said. Fake medicines are a $32 billion global business, says the World Health Organization, and the FDA says it ran 54 counterfeit investigations in 2006, almost double the year before.
"Growth in counterfeit medicines and devices is probably the biggest health threat besides infectious disease,'' says Peter Pitts, director of the Center for Medicine in the Public Interest in New York and formerly an FDA official investigating knockoff drugs.
The court filings disclose, for the first time, that China is the source of about one million phony test strips that have turned up in at least 35 states and in Canada, Greece, India, Pakistan, the Philippines, Saudi Arabia, and Turkey.
`China, Through Canada'
``The source was from China, through Canada, to the United States,'' says Steven Gutman, director of the Office of In Vitro Diagnostic Devices and Evaluation at the FDA in Rockville, Maryland. ``As far as we can tell, the counterfeiter has been put out of business in the U.S.''
KEY PHRASE: “As far as we can tell …â€
TRANSLATION: Nobody has been caught and they are still very likely in business.
Here’s a link to the rest of the story:
http://www.bloomberg.com/apps/news?pid=20601103&sid=a5XA7.yplw9k&refer=news
Kudos to J&J for aggressively investigating and openly communicating -- and being loud and proud about the quality of the real product.
By Allan Dodds Frank and Lisa Rapaport
Aug. 16 (Bloomberg) -- A global manhunt launched by Johnson & Johnson has tracked to China counterfeit versions of an at-home diabetes test used by 10 million Americans to take sensitive measurements of blood-sugar levels.
Potentially dangerous copies of the OneTouch Test Strip sold by J&J's LifeScan unit surfaced in American and Canadian pharmacies last year, according to federal court documents unsealed in June. New Brunswick, New Jersey-based J&J, the world's largest consumer-health products maker, learned of the counterfeit tests after 15 patients complained of faulty results last September.
Tipped off by J&J, the U.S. Food and Drug Administration issued a nationwide consumer alert in October without disclosing the link to China. While no injuries were reported, inaccurate test readings may lead a diabetic to inject the wrong amount of insulin, causing harm or death, the agency said. Fake medicines are a $32 billion global business, says the World Health Organization, and the FDA says it ran 54 counterfeit investigations in 2006, almost double the year before.
"Growth in counterfeit medicines and devices is probably the biggest health threat besides infectious disease,'' says Peter Pitts, director of the Center for Medicine in the Public Interest in New York and formerly an FDA official investigating knockoff drugs.
The court filings disclose, for the first time, that China is the source of about one million phony test strips that have turned up in at least 35 states and in Canada, Greece, India, Pakistan, the Philippines, Saudi Arabia, and Turkey.
`China, Through Canada'
``The source was from China, through Canada, to the United States,'' says Steven Gutman, director of the Office of In Vitro Diagnostic Devices and Evaluation at the FDA in Rockville, Maryland. ``As far as we can tell, the counterfeiter has been put out of business in the U.S.''
KEY PHRASE: “As far as we can tell …â€
TRANSLATION: Nobody has been caught and they are still very likely in business.
Here’s a link to the rest of the story:
http://www.bloomberg.com/apps/news?pid=20601103&sid=a5XA7.yplw9k&refer=news
Kudos to J&J for aggressively investigating and openly communicating -- and being loud and proud about the quality of the real product.
Where oh where would some people be if they didn't have the trial bar and the NEJM to give them a platform.
http://content.nejm.org/cgi/content/full/357/7/633?query=TOC
http://content.nejm.org/cgi/content/full/357/7/633?query=TOC
And while we're on the topic, check out the new paper "Importation and Innovation," by Columbia University's Dr. Frank Lichtenberg. You can find the paper at this link ...
http://www.nber.org/papers/w12539
For those of you (yes, you Senator Dorgan and Senator Snowe and you Representative Emerson and Representative Emanuel) who think that drug importation is a good idea -- think again.
Think about the unintended consequences of a world without pharmaceutical innovation.
http://www.nber.org/papers/w12539
For those of you (yes, you Senator Dorgan and Senator Snowe and you Representative Emerson and Representative Emanuel) who think that drug importation is a good idea -- think again.
Think about the unintended consequences of a world without pharmaceutical innovation.
The National Federation of Independent Business (NFIB) has announced its support for the Pharmaceutical Market Access and Drug Safety Act (S. 242 / H.R. 380) to permit drug importation.
According to the NFIB, "Importation offers a means of reducing one of the most rapidly rising healthcare costs facing consumers today - spending on prescription drugs.â€
Well, actually, the biggest costs to small business – and large business for that matter – are an aging workforce, an antiquated focus on acute care, and insurance premiums. For every dollar spent on health care in the U.S., only 11.5 cents is for prescription drugs. And medicines, properly prescribed, reduce healthcare costs by keeping people healthy, productive – and out of the hospital.
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. What about the other $82.14? That’s a good question. And America deserves an answer.
The NFIB is thinking short term and being sold a false bill of goods. Here’s how …
"Today's NFIB endorsement reflects a clear consensus among America's small businesses that we must no longer pay the world's highest prices for prescription drugs," Senator Olympia Snowe (R-ME) said. The press release continues, stating that NFIB members “recognize overwhelmingly … that competition will help reduce drug costs and make health care more affordable for all Americans.â€
Well, that’s a good point. But it depends what you mean by competition. When the rest of the developed world shackles costs via price controls placing almost the entire burden of pharmaceutical R&D costs on the backs of the American healthcare consumer. This is what members of Congress and the NFIB should be up in arms about.
And as far as “dramatically lowering†costs is concerned, the Congressional Budget Office Study has reported that such a program would reduce the drug spend in the US by less than one percent -- and that doesn't include the monies needed to set up an entirely new, international system for drug regulation.
Of course no such press release would be complete without a list of the usual suspects who support this bozo proposition, including the AARP, AFL-CIO, Consumer’s Union, and Families USA.
And here’s the biggest falsehood, “"The Pharmaceutical Market Access and Drug Safety Act secures a framework for the safe and legal importation of prescription drugs.â€
Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few? Because that’s what S. 242 / H.R. 380 would allow since, for example, it would allow importation of drugs from the United Kingdom – which also means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere.
America’s small business owners deserve better, smarter Washington, DC representation.
According to the NFIB, "Importation offers a means of reducing one of the most rapidly rising healthcare costs facing consumers today - spending on prescription drugs.â€
Well, actually, the biggest costs to small business – and large business for that matter – are an aging workforce, an antiquated focus on acute care, and insurance premiums. For every dollar spent on health care in the U.S., only 11.5 cents is for prescription drugs. And medicines, properly prescribed, reduce healthcare costs by keeping people healthy, productive – and out of the hospital.
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. What about the other $82.14? That’s a good question. And America deserves an answer.
The NFIB is thinking short term and being sold a false bill of goods. Here’s how …
"Today's NFIB endorsement reflects a clear consensus among America's small businesses that we must no longer pay the world's highest prices for prescription drugs," Senator Olympia Snowe (R-ME) said. The press release continues, stating that NFIB members “recognize overwhelmingly … that competition will help reduce drug costs and make health care more affordable for all Americans.â€
Well, that’s a good point. But it depends what you mean by competition. When the rest of the developed world shackles costs via price controls placing almost the entire burden of pharmaceutical R&D costs on the backs of the American healthcare consumer. This is what members of Congress and the NFIB should be up in arms about.
And as far as “dramatically lowering†costs is concerned, the Congressional Budget Office Study has reported that such a program would reduce the drug spend in the US by less than one percent -- and that doesn't include the monies needed to set up an entirely new, international system for drug regulation.
Of course no such press release would be complete without a list of the usual suspects who support this bozo proposition, including the AARP, AFL-CIO, Consumer’s Union, and Families USA.
And here’s the biggest falsehood, “"The Pharmaceutical Market Access and Drug Safety Act secures a framework for the safe and legal importation of prescription drugs.â€
Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few? Because that’s what S. 242 / H.R. 380 would allow since, for example, it would allow importation of drugs from the United Kingdom – which also means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere.
America’s small business owners deserve better, smarter Washington, DC representation.
The recent court decision by the full D.C. Circuit Court of Appeals (reversing an earlier decision by its own three-judge panel) ruled 8-2 against the Abigail Alliance for Better Access to Developmental Drugs' effort to enshrine as a constitutional right a patient's access to unapproved investigational (non-FDA-unapproved) medicines.
Now, before going any further, it's important to point out that there's been a lot of very heated rhetoric on both sides of the issue. And this shouldn't come as a surprise since this is, in the most literal sense, a matter of life and death.
But over-heated rhetoric generally means that each side demonizes the other and neither is listening.
Nobody believes expanded access to drugs under clinical investigation is a bad idea. That's precisely why, when I was at the FDA, we stopped calling such programs "compassionate use." That outdated phrase makes it sound like the FDA and/or any given pharmaceutical company is doing the patient a favor by "being compassionate." Now don't get me wrong, being compassionate is an admirable trait -- but allowing desperately ill patients into clinical trial programs shouldn't be an act of good will, it should be an act of civil society.
But there has to be oversight. There has to be a responsible body that sets rules. Libertarianism, when it comes to pharmaceutical safety, isn't in the best interests of the public health. Does that mean the status quo works? No.
The FDA has proposed changes to address this issue. Do they go far enough? No. Does that mean "expanded access" should morph into "total access" to experimental drugs? No.
In short, there is no black-and-white/right-wrong answer to this question. But that's not what many folks on both sides of the argument are saying.
The FDA needs to reconsider how it can broaden and facilitate expanded access to experimental drugs beyond the current state of affairs (and the state of pending rules). And the Abigail Alliance and their supporters need to keep up the pressure (legal and otherwise) -- but remember they must also work within the system.
Both sides want the same thing -- expedited expanded access programs. But name calling and bridge burning doesn't bring anyone closer together or experimental drugs to dying patients any faster.
Now, before going any further, it's important to point out that there's been a lot of very heated rhetoric on both sides of the issue. And this shouldn't come as a surprise since this is, in the most literal sense, a matter of life and death.
But over-heated rhetoric generally means that each side demonizes the other and neither is listening.
Nobody believes expanded access to drugs under clinical investigation is a bad idea. That's precisely why, when I was at the FDA, we stopped calling such programs "compassionate use." That outdated phrase makes it sound like the FDA and/or any given pharmaceutical company is doing the patient a favor by "being compassionate." Now don't get me wrong, being compassionate is an admirable trait -- but allowing desperately ill patients into clinical trial programs shouldn't be an act of good will, it should be an act of civil society.
But there has to be oversight. There has to be a responsible body that sets rules. Libertarianism, when it comes to pharmaceutical safety, isn't in the best interests of the public health. Does that mean the status quo works? No.
The FDA has proposed changes to address this issue. Do they go far enough? No. Does that mean "expanded access" should morph into "total access" to experimental drugs? No.
In short, there is no black-and-white/right-wrong answer to this question. But that's not what many folks on both sides of the argument are saying.
The FDA needs to reconsider how it can broaden and facilitate expanded access to experimental drugs beyond the current state of affairs (and the state of pending rules). And the Abigail Alliance and their supporters need to keep up the pressure (legal and otherwise) -- but remember they must also work within the system.
Both sides want the same thing -- expedited expanded access programs. But name calling and bridge burning doesn't bring anyone closer together or experimental drugs to dying patients any faster.
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.
