Latest Drugwonks' Blog
Important, fascinating, discouraging, and urgent new government-sponsored study (courtesy of Harvard) shows that life expectancy actually declined in a substantial number of US counties from 1983 to 1999, particularly for women. Most of the counties with declines are in the Deep South, along the Mississippi River, and in Appalachia, as well as in the southern Plains and Texas.
The study, published in the journal PLoS Medicine, concluded that the progress made in reducing deaths from cardiovascular disease, thanks to new drugs, procedures and prevention, began to level off in those years. Those gains, as they shrank, were outpaced by rising mortality from lung cancer, chronic obstructive pulmonary disease and diabetes. Smoking, which peaked for women later than for men, is thought to be a major contributor, along with obesity and hypertension.
Some, like former Senator John Edwards, are using the study to further fan the class warfare flames. And socio-economic conditions are certainly an important part of this issue but, as Sam B. Harper, an epidemiologist at McGill University who has studied the issue commented, “We know from hundreds of studies that income does have an impact on health, but it’s not a simple relationship."
Indeed. But politicians -- and especially frustrated ones like Senator Edwards, are always looking for simplistic, talking point-friendly answers to complicated problems.
According to one of the report's authors, Dr. Majid Ezzati, "... life expectancy disparities would have to be addressed through public health strategies directed at reducing the risk factors that cause chronic disease and injuries."
And that means a more deliberate effort at patient-based care -- focusing on earlier diagnosis (and better diagnostics) and more targeted health care (right treatment for the right patient at the right time). What it does not mean is a knee-jerk move towards "European" style healthcare and the ensuing cost-based rationing that inevitably comes with it.
For more detail on the study, click here: www.nytimes.com/2008/04/27/weekinreview/27sack.html
We mustn't allow the next generation of Americans to be the first in our nation's history to enjoy a shorter life than their parents. And to achieve that goal we must abandon the rhetoric of divisiveness and work together (government, academia, and industry) towards this common purpose.
The study, published in the journal PLoS Medicine, concluded that the progress made in reducing deaths from cardiovascular disease, thanks to new drugs, procedures and prevention, began to level off in those years. Those gains, as they shrank, were outpaced by rising mortality from lung cancer, chronic obstructive pulmonary disease and diabetes. Smoking, which peaked for women later than for men, is thought to be a major contributor, along with obesity and hypertension.
Some, like former Senator John Edwards, are using the study to further fan the class warfare flames. And socio-economic conditions are certainly an important part of this issue but, as Sam B. Harper, an epidemiologist at McGill University who has studied the issue commented, “We know from hundreds of studies that income does have an impact on health, but it’s not a simple relationship."
Indeed. But politicians -- and especially frustrated ones like Senator Edwards, are always looking for simplistic, talking point-friendly answers to complicated problems.
According to one of the report's authors, Dr. Majid Ezzati, "... life expectancy disparities would have to be addressed through public health strategies directed at reducing the risk factors that cause chronic disease and injuries."
And that means a more deliberate effort at patient-based care -- focusing on earlier diagnosis (and better diagnostics) and more targeted health care (right treatment for the right patient at the right time). What it does not mean is a knee-jerk move towards "European" style healthcare and the ensuing cost-based rationing that inevitably comes with it.
For more detail on the study, click here: www.nytimes.com/2008/04/27/weekinreview/27sack.html
We mustn't allow the next generation of Americans to be the first in our nation's history to enjoy a shorter life than their parents. And to achieve that goal we must abandon the rhetoric of divisiveness and work together (government, academia, and industry) towards this common purpose.
Steve Walker of the Abigail Alliance weighs in on the issue of timely commencement of promised Phase IV trials:
"I think in some cases you are probably right about the failure to conduct Phase IV studies being a "self-inflicted" wound, but there is perhaps a bigger problem in the design of a lot of the studies. Once a drug is approved and deemed safe and effective (in many cases proven in compelling fashion despite the absence of a perfect p-value), conducting randomized studies where patients are randomized into treatment arms that do not serve their best medical interests is fraught with all kinds of ethical and practical problems, and challenges for sponsors, physicians and doctors. Coupled with the undeniable fact that after approval the development and learning process about many drugs accelerates dramatically (a good thing that usually leaves the slow-moving FDA far behind) often causes the trials mandated by FDA to become obsolete before they start, and even more commonly before they are completed. When that occurs, the FDA's and other's mandates that the trials be conducted anyway degenerates into nothing but a form over substance pursuit of compliance for no other purpose than compliance. That should not be the purpose of the regulation of medical products because it is harmful to the public health, not to mention a waste of money and patients.
"I think in some cases you are probably right about the failure to conduct Phase IV studies being a "self-inflicted" wound, but there is perhaps a bigger problem in the design of a lot of the studies. Once a drug is approved and deemed safe and effective (in many cases proven in compelling fashion despite the absence of a perfect p-value), conducting randomized studies where patients are randomized into treatment arms that do not serve their best medical interests is fraught with all kinds of ethical and practical problems, and challenges for sponsors, physicians and doctors. Coupled with the undeniable fact that after approval the development and learning process about many drugs accelerates dramatically (a good thing that usually leaves the slow-moving FDA far behind) often causes the trials mandated by FDA to become obsolete before they start, and even more commonly before they are completed. When that occurs, the FDA's and other's mandates that the trials be conducted anyway degenerates into nothing but a form over substance pursuit of compliance for no other purpose than compliance. That should not be the purpose of the regulation of medical products because it is harmful to the public health, not to mention a waste of money and patients.
Even beginning a discussion of what to do about non-compliance with Phase IV trial requirements must be undertaken within the context of the broader discussion about how to modernize FDA's science (which despite all the talk, still isn't occurring at the review policy and practice level) and a recognition that a lot of the Phase IV trials required by FDA make little sense for progress, and even less sense for patients. Should we be forcing sponsors to complete Phase IV clinical trials that we know with a high degree of confidence, or even only strongly suspect, would be harmful to the patients enrolled in those trials? The ethical questions and scientific/medical deficiencies surrounding all of this pile up very quickly once one starts looking at the details of what the FDA is often asking the sponsors to do.
One of the most troubling aspects of the discussion about Phase IV trials is an almost complete dismissal of the effect these mandates have on patients, and the entirely appropriate and correct reaction those patients have, in consultation with their doctors, to avoid some Phase IV trials (usually the randomized ones). The patients and their physicians are actually medically correct to do that in most cases, and denying that fact virtually guarantees failure of the Phase IV system. Patients are simply not going to elect to expose themselves to harm, premature death or loss of control over their health and life in any great numbers when they don't have to, to get what they and their doctors think is the appropriate treatment for them. Combine that with the tight statistical restrictions on entry into randomized Phase IV trials, and you end up with an impossible situation for a lot of these trials.
If we want post-approval trials to work as an effective regulatory tool, and as a means for advancing the science of drug development, it has to be re-thought from the ground up.
Mandating unworkable, unethical ineffective "stupidity" is never the right solution, and all the talk about iron-fisted enforcement of Phase IV trails that fit that definition of "stupidity" is not going to fix the problems. The problem, as is almost always the case, is that FDA almost completely fails to recognize and accommodate reality in its approach to clinical trials, and in particular to Phase IV trials.
The solution of some at FDA has been to delay approval of good cancer drugs until the p-value they want arrives, thus solving the problem of trying to enroll unethical Phase IV trials by simply denying patients access to the drug they need by any other means so they have no choice but to enter the trials in Phase III. This leaves the large majority out of the progress because they don't qualify for the trial, or they don't fit into the trial (fully enrolled), or they can't reasonably get to the trial. This approach has turned the entire enterprise of the regulation of drugs for serious and life-threatening diseases on its head. The goal has to be delivery of progress to patients who have the disease as soon as reasonably possible, not delivery of pro forma p-values to regulators who don't have a disease at all.
If we want Phase IV trials to be enrolled and completed, they have to be useful, necessary, ethical and enrollable. If they become obsolete before they start or finish, the FDA has to be flexible enough to recognize it and adjust to reality, by dropping the requirement or allowing adaptation of the trial design to preserve its usefulness. If they are un-enrollable because they are unethical or unnecessary except as an exercise in regulation (and that is often the case), then they shouldn't have been requested in the first place.
This is much more complex and much more wrapped up with the self-imposed scientific stagnation and negative ethical creep that permeates the FDA and the clinical research community than most people realize.
Just doing more of the wrong thing in the wrong way because most people don't understand it is hardly a solution.
I suspect you understand most if not all of what I explain above, but it didn't come through in your post."
Thanks Steve -- for both the thoughtful comments and for giving me the benefit of the doubt.
Thanks Steve -- for both the thoughtful comments and for giving me the benefit of the doubt.
From our friends at www.Fastercures.org...It looks as though Europe is tearing down another anti-capitalist wall: the one between academia and industry that slowed translation of biotechnology into products. How? By using the same approach that President Reagan took by expanding the Bayh-Dole through executive order with Federal Technology Transfer Act. That put government agencies on notice to share all patentable technologies with the private sector to promote investment al presto.
This will make the pharmaceutical purists and conflict of interest capos sick am I sure. There is now nowhere in the world where their views have been turned into policy or law...except North Korea or Cuba. Here's the post from Fastercures Smartbrief...
EC wants more research headed to product development
The European Commission is asking for more interaction between universities and pharmaceutical companies to ensure that research knowledge is more quickly translated into products and services. The EC adopted a recommendation on how member states can revise their policies to allow public research organizations to leverage intellectual property more effectively. In-PharmaTechnologist.com
This will make the pharmaceutical purists and conflict of interest capos sick am I sure. There is now nowhere in the world where their views have been turned into policy or law...except North Korea or Cuba. Here's the post from Fastercures Smartbrief...
EC wants more research headed to product development
The European Commission is asking for more interaction between universities and pharmaceutical companies to ensure that research knowledge is more quickly translated into products and services. The EC adopted a recommendation on how member states can revise their policies to allow public research organizations to leverage intellectual property more effectively. In-PharmaTechnologist.com
Alastair Wood's excellent editorial in the NEJM, rising above the hysterics with wit and intellect:
content.nejm.org/cgi/content/full/358/17/1774
content.nejm.org/cgi/content/full/358/17/1774
According to Bloomberg (the news service not the mayor):
“Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators. The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA.”
Here's a link to the complete story:
www.bloomberg.com/apps/news
Yes, I know, it’s not that simple – but that being said, it’s true. And that has to change. While this issue does play into the hands of the usual suspect safety jihadists (note quote in article by Peter Lurie) – promised studies should be commenced promptly.
Yes, there are many relevant and extenuating circumstances (note quote from PhRMA), but, as far as industry is concerned, this is a self-inflicted wound that spin cannot fix.
“Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators. The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA.”
Here's a link to the complete story:
www.bloomberg.com/apps/news
Yes, I know, it’s not that simple – but that being said, it’s true. And that has to change. While this issue does play into the hands of the usual suspect safety jihadists (note quote in article by Peter Lurie) – promised studies should be commenced promptly.
Yes, there are many relevant and extenuating circumstances (note quote from PhRMA), but, as far as industry is concerned, this is a self-inflicted wound that spin cannot fix.
Maybe it has something to do with the strength of the Euro -- or maybe it has something to do with a patient's right to know. And just maybe things are beginning to change.
Have a look at this new article (from the Journal of Life Sciences) on how the EU is pondering changing what's allowable vis-a-vis what they call "Information to Patients" and we in the US call "Direct to Consumer Communications:
www.tjols.com/article-640.html
Bottom line -- knowledge is power.
Have a look at this new article (from the Journal of Life Sciences) on how the EU is pondering changing what's allowable vis-a-vis what they call "Information to Patients" and we in the US call "Direct to Consumer Communications:
www.tjols.com/article-640.html
Bottom line -- knowledge is power.
Finally we are going to settle the issue of genetic testing and personal privacy. And it's about time.
According to Andy Pollack's story in today's New York Times:
"Proponents say the new law, more than a dozen years in the making, would help usher in an age of genetic medicine, in which DNA tests might help predict if a person is at risk of a disease, allowing action to be taken to prevent it.
Some of the tests already exist, like one for breast cancer risk, and new ones are being introduced almost every month. But backers of the legislation say many people are afraid of taking such tests because they fear the results would be used to deny them employment or health insurance.
“This bill removes a significant obstacle to the advancement of personalized medicine,” said Edward Abrahams, the executive director of the Personalized Medicine Coalition. His group is an organization of drug and diagnostic companies, academic institutions and patient groups that advocate using genetic information to choose the most appropriate treatment for each patient."
Here's the rest of the story:
www.nytimes.com/2008/04/23/business/23gene.html
All sounds good, right? Hopefully.
We'll wait and see, when the payer is the government , if Uncle Sam retains the same "keep your hands outta my genes" philosophy.
But, in the meantime, well done.
According to Andy Pollack's story in today's New York Times:
"Proponents say the new law, more than a dozen years in the making, would help usher in an age of genetic medicine, in which DNA tests might help predict if a person is at risk of a disease, allowing action to be taken to prevent it.
Some of the tests already exist, like one for breast cancer risk, and new ones are being introduced almost every month. But backers of the legislation say many people are afraid of taking such tests because they fear the results would be used to deny them employment or health insurance.
“This bill removes a significant obstacle to the advancement of personalized medicine,” said Edward Abrahams, the executive director of the Personalized Medicine Coalition. His group is an organization of drug and diagnostic companies, academic institutions and patient groups that advocate using genetic information to choose the most appropriate treatment for each patient."
Here's the rest of the story:
www.nytimes.com/2008/04/23/business/23gene.html
All sounds good, right? Hopefully.
We'll wait and see, when the payer is the government , if Uncle Sam retains the same "keep your hands outta my genes" philosophy.
But, in the meantime, well done.
Yet another show trial held by another congressional committee on the FDA...There have been four or five over the last two months on heparin alone. Andy von Eschenbach, who is gaining momentum, along with the FDA, in shifting the agency towards a science and systems based approach to regulation -- using real time technology to promote full time compliance -- has to sit and take the following from the likes of Bart Stupak (D-Michigan):
"Last year, this nation's regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people," said Rep. Bart Stupak, D-Mich. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us."
That's rich coming from a guy who helped push up the suicide rates by scaring parents away from antidepressants. and who is pushing for drug importation at a time when Al Qaeda and Hezbollah are involved in drug counterfeiting....Andy must have to shower after sitting through such a show trial...
www.fraudaid.com/scamspeak/conprods.htm
Meanwhile the Steve Nissen fear factory spews out another piece of tabloid medicine: EKG monitoring of all kids getting stimulants for ADHD.. Now there's a way to achieve Nissen (who has never studied ADHD) goal of making a physician's hand quiver before writing a scrip for the drug....But will it improve prescribing? Ron Winslow of the WSJ nails it:
"Since 1999, fewer than 30 sudden deaths among children have been linked to the drugs, which are currently taken by more than 2.5 million youngsters in the U.S. Issues of cost, available expertise in reading children's ECGs and concern about false-positive tests are prompting some experts to question the rationale for urging an ECG in particular.
"This is a $250 million recommendation," says Mike Ackerman, a pediatric cardiologist at the Mayo Clinic in Rochester, Minn., who estimates the total cost of an ECG at about $100. "We're really trying to find a needle in a haystack, and we have no data yet to know that the screening program they're recommending would capture" those few at-risk individuals. Dr. Ackerman was a member of another American Heart Association panel that last year stopped short of recommending routine ECG screening for heart abnormalities in young competitive athletes."
Read the Wall Street Journal article
FInally a pattern appears to emerging that has escaped even the great John Wennberg: the life expectancy of poor people is declining even as that of others is increasing. Women in particular are dying earlier than men in rural areas. Can we say Medicaid and SCHIP anyone? And I should note that Frank Lichtenberg spotted a decline in life expectancy among the elderly in the VA, the same VA that Shannon Brownlee -- Wennberg's Boswell -- is pushing as the example of what we all should be forced into in the Dartmouth comparative effectiveness utopia. Eeech...
Here's the article by the ever wonderful Maggie Fox of Reuters with a link to the study which is pretty methodologically sound:
www.reuters.com/article/scienceNews/idUSN2146521720080422
"Last year, this nation's regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people," said Rep. Bart Stupak, D-Mich. "If we don't make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us."
That's rich coming from a guy who helped push up the suicide rates by scaring parents away from antidepressants. and who is pushing for drug importation at a time when Al Qaeda and Hezbollah are involved in drug counterfeiting....Andy must have to shower after sitting through such a show trial...
www.fraudaid.com/scamspeak/conprods.htm
Meanwhile the Steve Nissen fear factory spews out another piece of tabloid medicine: EKG monitoring of all kids getting stimulants for ADHD.. Now there's a way to achieve Nissen (who has never studied ADHD) goal of making a physician's hand quiver before writing a scrip for the drug....But will it improve prescribing? Ron Winslow of the WSJ nails it:
"Since 1999, fewer than 30 sudden deaths among children have been linked to the drugs, which are currently taken by more than 2.5 million youngsters in the U.S. Issues of cost, available expertise in reading children's ECGs and concern about false-positive tests are prompting some experts to question the rationale for urging an ECG in particular.
"This is a $250 million recommendation," says Mike Ackerman, a pediatric cardiologist at the Mayo Clinic in Rochester, Minn., who estimates the total cost of an ECG at about $100. "We're really trying to find a needle in a haystack, and we have no data yet to know that the screening program they're recommending would capture" those few at-risk individuals. Dr. Ackerman was a member of another American Heart Association panel that last year stopped short of recommending routine ECG screening for heart abnormalities in young competitive athletes."
Read the Wall Street Journal article
FInally a pattern appears to emerging that has escaped even the great John Wennberg: the life expectancy of poor people is declining even as that of others is increasing. Women in particular are dying earlier than men in rural areas. Can we say Medicaid and SCHIP anyone? And I should note that Frank Lichtenberg spotted a decline in life expectancy among the elderly in the VA, the same VA that Shannon Brownlee -- Wennberg's Boswell -- is pushing as the example of what we all should be forced into in the Dartmouth comparative effectiveness utopia. Eeech...
Here's the article by the ever wonderful Maggie Fox of Reuters with a link to the study which is pretty methodologically sound:
www.reuters.com/article/scienceNews/idUSN2146521720080422
My latest article on the vaccine-autism mythology....
www.nypost.com/seven/04202008/postopinion/postopbooks/foul_shots_107320.htm
www.nypost.com/seven/04202008/postopinion/postopbooks/foul_shots_107320.htm
Important article in today's Wall Street Journal on OMB's Peter Orszag.
Here's how it begins ...
As the presidential candidates and Congress rev up the debate over the future of health care, Peter Orszag is already playing one of the toughest positions: referee.
Mr. Orszag, a 39-year-old economist, is the director of the Congressional Budget Office, the influential agency charged with toting up congressional bills' impact on the federal budget. Such scoring can sink bills that can't offset their costs with savings -- a serious risk for proposals that aim to expand federal health programs to cover more citizens.
Mr. Orszag increasingly is focusing on health issues, taking an unusually high profile for his nonpartisan office. He has become a prominent speaker at health conferences and co-wrote two pieces in the New England Journal of Medicine. He has launched a blog, cboblog.cbo.gov/, boosted the number of staffers who work on health to 47 from 31 and is seeking to add more. The agency has 235 employees.
"This actually is our fiscal future, and policymakers do not have as much analysis and options as they would need to make sound long-term decisions," says Mr. Orszag.
Here’s a link to the complete article:
http://online.wsj.com/article/SB120874132955630171.html?mod=hps_us_inside_today
The CBO's health-care work "will be very instructive to members when we attempt to take steps to right the ship," says Sen. Kent Conrad, the North Dakota Democrat who chairs the Senate Budget Committee.
Indeed – but let’s also add to the equation short-term versus long-term issues. And as obvious as that sounds, long-term often gets glossed over – particularly during a national election cycle – when "tough problems" (like safety and cost and rationing of care) don’t necessarily support more populist sound-bites like “importation” and “universal coverage.”
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.
