Latest Drugwonks' Blog
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.
Paris Hilton told the media that her friend Nicole Ritchie, who will be heading to jail to serve 4 days for a DUI (this after a history of drug abuse) "will be the best mom ever."
The Commonwealth Fund tells us that single payer health systems provide the best health care to the happiest patients anywhere, according to the NY Times.
Except the next day we find out that the courts in the UK say it is just fine for NICE to keep on depriving patients dying of cancer and Alzheimer's access to new medicines. Yes indeed, that's an marker of excellent care.
And as if we needed another example of just how many intellectual underachiever clutter the field of health care policy we get 101 irrelevant and incorrect explanations about why the infant mortality rate in the US is higher than anywhere else. The NY Times citing Michael Moore (!) despaired about how crappy America's health care system is because we do such a lousy job of keeping babies alive -- which in turn drags down our life expectancy.
In fact, if we counted live births like other nations and simply withdrew care from low birth weight babies like the UK, Canada, Netherlands and other places our life expectancy would exceed everyone else. I guess that would make the folks over the Commonwealth Fund and the NY Times really happy which is more important than anything else in the whole wide world.
Let me spell it out: Moore/NYTimes/Commonwealth makes a big deal about how America’s infant mortality rates are lower than El Salvador’s. That is a lie. First, many countries such as France, Switzerland, El Salvador and others do not count the deaths of very small babies as live births which brings the total number of deaths down. Meanwhile American advances in medical treatment now make it possible to save babies who would have surely died only a few decades ago. Until recently, very low birth-weight babies - less than 3 pounds - almost always died. Now, some of these babies survive. While such vulnerable babies may live with advanced medical assistance and technology, low birth-weight babies (weighing less than 5.5 pounds) recently had an infant mortality rate 20 times higher than heavier babies, according to the very same World Health Organization.
The United States devotes about twice as much money keeping each infant alive as most other countries. In some Western countries, doctors do not tell parents when they are withholding care to a vulnerable infant. Still others, countries that offer the “free†universal healthcare such as Britain and Canada set a birth weight and gestational age below which no intensive care is offered. So our infant mortality rate is really a measure of how much we care and the lengths we go to keep vulnerable infants alive just as our cancer expenditures at the end of life are as well.
That applies with greater force to Cuba where infants who are born at less than 28 weeks, weighing less than 1,000 grams or measuring less than 35 centimeters are not counted as live births if they die within seven days. The communist system stressed the need to keep infant mortality low. And in Cuba today hospitals and medical staff face penalties (prison) if they reported increases. As a result, they sometimes report the deaths of babies in their care as miscarriages or stillbirths.
The rest of the Commonwealth Measures -- taken from survey data -- are process measures and highly subjective. Pure junk. Wonder why it ignored stuff like access to new drugs, cancer survival rates, mortality after by-pass surgery, treatment for high blood pressure, etc. Because those are meaningful clinical endpoints which reveal lousy performance in Europe relative to the US of A. Ditto, the comparative rates of increase in glucose and cholesterol levels in UK, France and the US. We are going down, they are going up for the most part. Medicine is doing something about disease either prevention or intervention.
Which is why when either Paris Hilton or the Commonwealth Fund weigh in on a serious subject you can expect a serious answer. Neither are serious. They are 24/7 publicity machines designed to advance one thing: themselves.
The Commonwealth Fund tells us that single payer health systems provide the best health care to the happiest patients anywhere, according to the NY Times.
Except the next day we find out that the courts in the UK say it is just fine for NICE to keep on depriving patients dying of cancer and Alzheimer's access to new medicines. Yes indeed, that's an marker of excellent care.
And as if we needed another example of just how many intellectual underachiever clutter the field of health care policy we get 101 irrelevant and incorrect explanations about why the infant mortality rate in the US is higher than anywhere else. The NY Times citing Michael Moore (!) despaired about how crappy America's health care system is because we do such a lousy job of keeping babies alive -- which in turn drags down our life expectancy.
In fact, if we counted live births like other nations and simply withdrew care from low birth weight babies like the UK, Canada, Netherlands and other places our life expectancy would exceed everyone else. I guess that would make the folks over the Commonwealth Fund and the NY Times really happy which is more important than anything else in the whole wide world.
Let me spell it out: Moore/NYTimes/Commonwealth makes a big deal about how America’s infant mortality rates are lower than El Salvador’s. That is a lie. First, many countries such as France, Switzerland, El Salvador and others do not count the deaths of very small babies as live births which brings the total number of deaths down. Meanwhile American advances in medical treatment now make it possible to save babies who would have surely died only a few decades ago. Until recently, very low birth-weight babies - less than 3 pounds - almost always died. Now, some of these babies survive. While such vulnerable babies may live with advanced medical assistance and technology, low birth-weight babies (weighing less than 5.5 pounds) recently had an infant mortality rate 20 times higher than heavier babies, according to the very same World Health Organization.
The United States devotes about twice as much money keeping each infant alive as most other countries. In some Western countries, doctors do not tell parents when they are withholding care to a vulnerable infant. Still others, countries that offer the “free†universal healthcare such as Britain and Canada set a birth weight and gestational age below which no intensive care is offered. So our infant mortality rate is really a measure of how much we care and the lengths we go to keep vulnerable infants alive just as our cancer expenditures at the end of life are as well.
That applies with greater force to Cuba where infants who are born at less than 28 weeks, weighing less than 1,000 grams or measuring less than 35 centimeters are not counted as live births if they die within seven days. The communist system stressed the need to keep infant mortality low. And in Cuba today hospitals and medical staff face penalties (prison) if they reported increases. As a result, they sometimes report the deaths of babies in their care as miscarriages or stillbirths.
The rest of the Commonwealth Measures -- taken from survey data -- are process measures and highly subjective. Pure junk. Wonder why it ignored stuff like access to new drugs, cancer survival rates, mortality after by-pass surgery, treatment for high blood pressure, etc. Because those are meaningful clinical endpoints which reveal lousy performance in Europe relative to the US of A. Ditto, the comparative rates of increase in glucose and cholesterol levels in UK, France and the US. We are going down, they are going up for the most part. Medicine is doing something about disease either prevention or intervention.
Which is why when either Paris Hilton or the Commonwealth Fund weigh in on a serious subject you can expect a serious answer. Neither are serious. They are 24/7 publicity machines designed to advance one thing: themselves.
On Sunday the New York Times ran a 1292 word jihad against the American healthcare system. The thesis of the editorial is that “Many Americans are under the delusion that we have the best health care system in the world†because, in the words of the Gray Lady, we lag "well behind other advanced nations in delivering timely and effective care.â€
For its facts and figures, the Times largely relies on “the highly regarded Commonwealth Fund†that has “pioneered†comparative studies with other advanced nations.
Let’s pause for a moment and shed a little light on the Commonwealth Fund and their most recent (heavily touted) comparative study of national healthcare systems.
The “highly regarded†Commonwealth Fund is also the same “highly Liberal†Commonwealth Fund that has been consistently lobbying for a U.S. single-payor healthcare system. It’s also important to note that the “pioneering†comparative study the Times refers to failed to sample in rural areas internationally where health and access disparities show up. And even then, Americans did as well or better than less diverse and urbanized countries in getting prompt care.
Why didn’t the Times mention this? At over 1290 words it certainly wasn’t because of space constraints. It’s worth repeating the old maxim that “research is like a bikini – what it shows you is interesting, but what it conceals is essential.â€
There are so many variables when it comes to healthcare. The Times mentions only the ones that fits its thesis. For our national newspaper of record (and on a Sunday, no less) it’s amazingly simplistic. According to the editorial, our system is bad and single payor systems are good. Almost like a print version of SiCKO penned by Paul Krugman on an off-day.
One point of discussion, conspicuous by its absence, is that Americans are the ones paying for global medical innovation. Indeed, what would survival rates for any number of diseases look like if a nation could only use medicines they helped pay to develop? This "disparity" is unfair to the American consumer and not sustainable. The rest of the world must accept its fair share of the burden for healthcarer R&D. Zero discussion of this by Andy Rosenthal and his associates.
Another issue absent from the Times editorial is the general state of healthcare record keeping from country to country. Perhaps the most polite way to address this issue is to say that it is uneven. And to allow the findings of the Commonwealth Foundation to drive the debate, while ignoring other, more detailed European-based research findings (such as those by Populus and the pan-European Stockholm Network) which point to significant dissatisfaction among EU citizens of single-payor nations on a wide swath of healthcare delivery issues is, well, curious.
But, most importantly, it’s crucial that we not allow slanted studies by folks at the Commonwealth Foundation or ill-considered propaganda like SiCKO to sucker us into believing that there is some universal “best†model for the delivery of healthcare – when what we really need to be debating is how to construct a healthcare system that provides the right care for the right patient at the right time. “Comparing†various national healthcare systems through poor research is as dangerous and fruitless as “comparing†the relative effectiveness of medicines using large scale population studies that weren’t designed for that purpose.
Unless, of course, you only want to use research that tells you what you want to hear.
For its facts and figures, the Times largely relies on “the highly regarded Commonwealth Fund†that has “pioneered†comparative studies with other advanced nations.
Let’s pause for a moment and shed a little light on the Commonwealth Fund and their most recent (heavily touted) comparative study of national healthcare systems.
The “highly regarded†Commonwealth Fund is also the same “highly Liberal†Commonwealth Fund that has been consistently lobbying for a U.S. single-payor healthcare system. It’s also important to note that the “pioneering†comparative study the Times refers to failed to sample in rural areas internationally where health and access disparities show up. And even then, Americans did as well or better than less diverse and urbanized countries in getting prompt care.
Why didn’t the Times mention this? At over 1290 words it certainly wasn’t because of space constraints. It’s worth repeating the old maxim that “research is like a bikini – what it shows you is interesting, but what it conceals is essential.â€
There are so many variables when it comes to healthcare. The Times mentions only the ones that fits its thesis. For our national newspaper of record (and on a Sunday, no less) it’s amazingly simplistic. According to the editorial, our system is bad and single payor systems are good. Almost like a print version of SiCKO penned by Paul Krugman on an off-day.
One point of discussion, conspicuous by its absence, is that Americans are the ones paying for global medical innovation. Indeed, what would survival rates for any number of diseases look like if a nation could only use medicines they helped pay to develop? This "disparity" is unfair to the American consumer and not sustainable. The rest of the world must accept its fair share of the burden for healthcarer R&D. Zero discussion of this by Andy Rosenthal and his associates.
Another issue absent from the Times editorial is the general state of healthcare record keeping from country to country. Perhaps the most polite way to address this issue is to say that it is uneven. And to allow the findings of the Commonwealth Foundation to drive the debate, while ignoring other, more detailed European-based research findings (such as those by Populus and the pan-European Stockholm Network) which point to significant dissatisfaction among EU citizens of single-payor nations on a wide swath of healthcare delivery issues is, well, curious.
But, most importantly, it’s crucial that we not allow slanted studies by folks at the Commonwealth Foundation or ill-considered propaganda like SiCKO to sucker us into believing that there is some universal “best†model for the delivery of healthcare – when what we really need to be debating is how to construct a healthcare system that provides the right care for the right patient at the right time. “Comparing†various national healthcare systems through poor research is as dangerous and fruitless as “comparing†the relative effectiveness of medicines using large scale population studies that weren’t designed for that purpose.
Unless, of course, you only want to use research that tells you what you want to hear.
Case in point...our favorite target, Steve Nissen. He is quite transparent --sort of -- about receiving all sorts of money from drug companies. But such transparency does not reveal his true biases. To wit we now see in print what many were telling drugwonks and the media, that his meta-analyses was a cherrypicking expedition designed to generate headlines but not establish a meaningful hypothesis ...
From the the online, early release of the Annals of Internal Medicine:
Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death
George A. Diamond, MD; Leon Bax, MSc; and Sanjay Kaul, MD
"A recent, widely publicized meta-analysis of 42 clinical trials concluded that rosiglitazone was associated with an approximately 43% increased risk for myocardial infarction and an approximately 64% increased risk for cardiovascular death. The sensitivity of these conclusions to several methodological choices was not assessed. The meta-analysis was not based on a comprehensive search for all studies that might yield evidence about rosiglitazone’s cardiovascular effects. Studies were combined on the basis of a lack of statistical heterogeneity, despite substantial variability in study design and outcome assessment. The meta-analytic approach that was used required the exclusion of studies with zero events in the treatment and control groups. Alternative meta-analytic approaches that use continuity corrections show lower odds ratios that are not statistically significant. We conclude that the risk for myocardial infarction and death from cardiovascular disease for diabetic patients taking rosiglitazone is uncertain: Neither increased nor decreased risk is established."
http://www.annals.org/cgi/content/full/0000605-200710160-00182v1
Anyone care to do an analysis of how many times we called out Nissen in our blog as opposed to how many times his meta-analysis was challenged in the literature but NOT reported in the media? We are being chastised by small minds who are picking fights with us to generate page views. But that's another matter.
Now with respect to this idiotic proposal to require doctors to register every mug and pen with some Gift Registry (maybe the federal government can subcontract the work to Bed Bath and Beyond) let's just restate the obvious...there are many sources of money and many sources of bias. So let's require every doctor, every pharmacist, every epidemiologist, every researcher to list every gift, every speaking engagement, every grant, every affiliation, every incentive, every cash bonus, ever expert witness retainer, every consulting agreement with any foundation, non-profit organization, any voluntary or political affiliation that may be a source of or give an appearance of conflict.
So for example, providing consulting services to members of Congress of one political party should be listed. The sames goes if you are providing consulting services or expert witness services to the plaintiff group suing Eli Lilly regarding the weight gain from Zyprexa. That's you Dr. Furberg. If you are on a board or participate in programs that receive money from the trial bar like Jerry Avorn, you should disclose that. And if you receive money from George Soros and sit on the board of the the liberal Commonwealth Fund and work with the Prescription Project which gets it money from suing drug companies if you serve on an IOM panel looking at drug safety like David Blumenthal, you should disclose that too. Oh, and if you are a blowhard like Sid Wolfe you should have no problem at all detailing just how much cash you get from the trial bar, disclosing if you or the state PIRGs receive any money at all for consulting or working with or for other organizations in advancing legislation at the state level to impose this disclosure restrictions on doctors but not yourself ...
From the the online, early release of the Annals of Internal Medicine:
Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death
George A. Diamond, MD; Leon Bax, MSc; and Sanjay Kaul, MD
"A recent, widely publicized meta-analysis of 42 clinical trials concluded that rosiglitazone was associated with an approximately 43% increased risk for myocardial infarction and an approximately 64% increased risk for cardiovascular death. The sensitivity of these conclusions to several methodological choices was not assessed. The meta-analysis was not based on a comprehensive search for all studies that might yield evidence about rosiglitazone’s cardiovascular effects. Studies were combined on the basis of a lack of statistical heterogeneity, despite substantial variability in study design and outcome assessment. The meta-analytic approach that was used required the exclusion of studies with zero events in the treatment and control groups. Alternative meta-analytic approaches that use continuity corrections show lower odds ratios that are not statistically significant. We conclude that the risk for myocardial infarction and death from cardiovascular disease for diabetic patients taking rosiglitazone is uncertain: Neither increased nor decreased risk is established."
http://www.annals.org/cgi/content/full/0000605-200710160-00182v1
Anyone care to do an analysis of how many times we called out Nissen in our blog as opposed to how many times his meta-analysis was challenged in the literature but NOT reported in the media? We are being chastised by small minds who are picking fights with us to generate page views. But that's another matter.
Now with respect to this idiotic proposal to require doctors to register every mug and pen with some Gift Registry (maybe the federal government can subcontract the work to Bed Bath and Beyond) let's just restate the obvious...there are many sources of money and many sources of bias. So let's require every doctor, every pharmacist, every epidemiologist, every researcher to list every gift, every speaking engagement, every grant, every affiliation, every incentive, every cash bonus, ever expert witness retainer, every consulting agreement with any foundation, non-profit organization, any voluntary or political affiliation that may be a source of or give an appearance of conflict.
So for example, providing consulting services to members of Congress of one political party should be listed. The sames goes if you are providing consulting services or expert witness services to the plaintiff group suing Eli Lilly regarding the weight gain from Zyprexa. That's you Dr. Furberg. If you are on a board or participate in programs that receive money from the trial bar like Jerry Avorn, you should disclose that. And if you receive money from George Soros and sit on the board of the the liberal Commonwealth Fund and work with the Prescription Project which gets it money from suing drug companies if you serve on an IOM panel looking at drug safety like David Blumenthal, you should disclose that too. Oh, and if you are a blowhard like Sid Wolfe you should have no problem at all detailing just how much cash you get from the trial bar, disclosing if you or the state PIRGs receive any money at all for consulting or working with or for other organizations in advancing legislation at the state level to impose this disclosure restrictions on doctors but not yourself ...
Senator Grassley is proposing legislation that would have pharmaceutical companies disclose payments made to physicians for just about eveything. The Senator wants "transparency."
And transparency is a good thing.
Should Big Pharma be disclosing payments or should the burden of transparency be on the physician? Good debate. But here's a bigger question -- if transparency is a good thing when it comes to Big Pharma's payments to doctors, how about transparency for everyone else paying docs in order to influence their prescribing habits?
Specifically, where is the transparency when it comes to the payments insurance companies provide to physicians for switching their patients from brand name to generic medicines?
It's not in the Grassley bill.
Or what about transparency regarding how some state governments are leveraging a physician's prescribing habits via state regulations?
Also not in the Grassley bill.
It seems the Grassley is always greener when it comes to slamming Big Pharma -- but that everyone else with an open wallet (or a tight wallet in the case of state governments) gets a free pass.
If transparency is good for the goose then it's good for the gander.
And transparency is a good thing.
Should Big Pharma be disclosing payments or should the burden of transparency be on the physician? Good debate. But here's a bigger question -- if transparency is a good thing when it comes to Big Pharma's payments to doctors, how about transparency for everyone else paying docs in order to influence their prescribing habits?
Specifically, where is the transparency when it comes to the payments insurance companies provide to physicians for switching their patients from brand name to generic medicines?
It's not in the Grassley bill.
Or what about transparency regarding how some state governments are leveraging a physician's prescribing habits via state regulations?
Also not in the Grassley bill.
It seems the Grassley is always greener when it comes to slamming Big Pharma -- but that everyone else with an open wallet (or a tight wallet in the case of state governments) gets a free pass.
If transparency is good for the goose then it's good for the gander.
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.
