Latest Drugwonks' Blog
The attack on Avandia is really an attack on the FDa's authority wrapped up in a bogus concern about the risk of cardiovascular death associated with diabetes. Treatment of type 2 diabetes requires management of many diseases that contribute to heart attacks. That includes managing high cholesterol which of course Avandia is associated with. So it would seem logical to identify which patients on Avandia who had heart attacks were not on statins (something the FDA numbers crunchers did). Nissen and co simply gloss over this issue. But good diabetes management with respect to MI requires it. So why not make this an issue of improving CV outcomes instead of Avandia and the FDA?
See Gina Kolata's excellent article in the NYT from Aug 2007 to see how it can be done:
http://www.nytimes.com/2007/08/20/health/20diabetes.html?pagewanted=3&ei=5070&en=f729f5b46fa2a74d&ex=1190174400
See Gina Kolata's excellent article in the NYT from Aug 2007 to see how it can be done:
http://www.nytimes.com/2007/08/20/health/20diabetes.html?pagewanted=3&ei=5070&en=f729f5b46fa2a74d&ex=1190174400
The Washington Times editorializes on the stupid coverage decision CMS made on ESAs. Hillary has made her Best Practice Institute a cornerstone of her new "American Health Choices Plan" (has anyone been more manipulative in the use of the English language than Hillary) Yes, you will have choices, much like the choices you get from a elementary school cafeteria. The Best Practice Institute will tell which drugs at which dose at which time without regard to individual variation because that's what is required to cut $100 billion from health care spending. That and price controls on new drugs. You think a one size fits all dose for ESAs is a one shot deal (that ignores the impact of cost effectiveness or quality of life relative to transfusions). Think again. If CMS gets the power to impose a dose specific criteria on one drug, it can do it on ALL medicines.
That's Hillary's plan for Health Care Choices....
http://washingtontimes.com/article/20070916/EDITORIAL/109160019/1013/EDITORIAL
That's Hillary's plan for Health Care Choices....
http://washingtontimes.com/article/20070916/EDITORIAL/109160019/1013/EDITORIAL
In April of 2006 James Copping (Principal Administrator, European Commission Enterprise & Industry Directorate-General) had this to say about rethinking the EU Commission’s position on information-to-patients:
“From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.â€
Copping continued as to possible ways to achieve that goal:
“The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.â€
In April of 2007 the Director of the Enterprise and Industry Directorate General of the European Commission released its report for consultation on "current practice with regard to provision of information to patients on medicinal products." The report focuses on information publicly available on the internet from regulatory bodies or official sources in member states -- mostly of information on package leaflets, databases of approved drugs and regulatory reports, and other sources of information from regulatory bodies on approved drugs.
The report concludes, "Member States may not be in a position to fully address patients' needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals through Europe."
The idea of a public-private partnership stems from the recent second progress report of the European Commission's High Level Pharmaceutical Forum that proposes "to organise a platform to bring together relevant stakeholders to explore ways to exchange good practices and on ways to overcome barriers to accessing information." Although the Commission does not support direct to consumer advertising, they are clearly suggesting that reliable information could come jointly from both industry and regulatory bodies.
Indeed, efforts that include industry (and their proven ability to communicate health care information to patients – aka consumers – in partnership with governments (with their ability to use the bully pulpit on behalf of the public health) is a potent alliance and the right way to proceed.
But not everyone agrees.
Here’s what the British Medical Journal has to say in a recent editorial:
“We think that a partnership between drug companies and drug regulatory authorities in the area of information … would be confusing. Therefore, we propose two areas of real partnership with the drug industry that would reinforce public trust in the system.
The first would entail a real commitment to waive confidentiality and give full access to data on the effectiveness and safety of drugs. Giving full access to all clinical trial protocols (not just those that are registered for publication purposes) and to the periodic safety update reports available to regulatory agencies would enhance transparency.â€
Does the BMJ really think that practicing physicians have the time or inclination to plow through thousands of pages of clinical trial data? And, anyway, isn’t that besides the point?
If “more information†is good for physicians – why isn’t it equally good for patients?
Or does the BMJ believe that only medical professionals should have access to information?
The BMJ editorial concludes by saying that"
“The most sensible way to protect public health would be to identify sources of unbiased and systematically reviewed information and maintain the current European legislation on drug promotion, while reinforcing the role of the European Medicines Evaluation Agency.â€
Here’s a link to the complete BMJ editorial:
http://www.ifpma.org/PressReviewEmail/PressReviewDetail.aspx?nID=8133&SD=LoB8AhN%2fJP9w%3d%3d
Is more government control and a continued policy of information denied to patients the BMJ’s idea of progress?
“From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.â€
Copping continued as to possible ways to achieve that goal:
“The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.â€
In April of 2007 the Director of the Enterprise and Industry Directorate General of the European Commission released its report for consultation on "current practice with regard to provision of information to patients on medicinal products." The report focuses on information publicly available on the internet from regulatory bodies or official sources in member states -- mostly of information on package leaflets, databases of approved drugs and regulatory reports, and other sources of information from regulatory bodies on approved drugs.
The report concludes, "Member States may not be in a position to fully address patients' needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals through Europe."
The idea of a public-private partnership stems from the recent second progress report of the European Commission's High Level Pharmaceutical Forum that proposes "to organise a platform to bring together relevant stakeholders to explore ways to exchange good practices and on ways to overcome barriers to accessing information." Although the Commission does not support direct to consumer advertising, they are clearly suggesting that reliable information could come jointly from both industry and regulatory bodies.
Indeed, efforts that include industry (and their proven ability to communicate health care information to patients – aka consumers – in partnership with governments (with their ability to use the bully pulpit on behalf of the public health) is a potent alliance and the right way to proceed.
But not everyone agrees.
Here’s what the British Medical Journal has to say in a recent editorial:
“We think that a partnership between drug companies and drug regulatory authorities in the area of information … would be confusing. Therefore, we propose two areas of real partnership with the drug industry that would reinforce public trust in the system.
The first would entail a real commitment to waive confidentiality and give full access to data on the effectiveness and safety of drugs. Giving full access to all clinical trial protocols (not just those that are registered for publication purposes) and to the periodic safety update reports available to regulatory agencies would enhance transparency.â€
Does the BMJ really think that practicing physicians have the time or inclination to plow through thousands of pages of clinical trial data? And, anyway, isn’t that besides the point?
If “more information†is good for physicians – why isn’t it equally good for patients?
Or does the BMJ believe that only medical professionals should have access to information?
The BMJ editorial concludes by saying that"
“The most sensible way to protect public health would be to identify sources of unbiased and systematically reviewed information and maintain the current European legislation on drug promotion, while reinforcing the role of the European Medicines Evaluation Agency.â€
Here’s a link to the complete BMJ editorial:
http://www.ifpma.org/PressReviewEmail/PressReviewDetail.aspx?nID=8133&SD=LoB8AhN%2fJP9w%3d%3d
Is more government control and a continued policy of information denied to patients the BMJ’s idea of progress?
What? No "drugs from Canada" as the great panacea? How times change. Attention members of Congress who are still beating the dead horse of foreign drug importation ...
Healthy San Francisco is a new program that offers free or subsidized health care to all 82,000 San Francisco adults without insurance. It is financed mostly by the city which, according to the New York Times, “is gambling that it can provide universal and sensibly managed care to the uninsured for about the amount being spent on their treatment now, often in emergency rooms.â€
The Times reports that “Healthy San Francisco provides uninsured San Franciscans with access to 14 city health clinics and 8 affiliated community clinics, with an emphasis on prevention and managing chronic disease. It is, however, not the same as insurance because it does not cover residents once they leave the city.â€
Until November, enrollment will be limited to those living below the federal poverty line ($10,210 for a single person; $20,650 for a family of four). Then it will open to any resident who has been uninsured for at least 90 days, regardless of income or immigration status.
The coverage is not portable and city officials believe that people with private insurance will have little incentive to drop their policies to take advantage of the city’s cut-rate services.
Patients are asked to contribute nominal amounts through membership fees and co-payments that vary by income. Those from families with incomes below the federal poverty line pay nothing. Those who earn more pay quarterly fees that range from $60 to $675, which is the rate for those with incomes above 500 percent of the poverty level ($51,050 for a single; $103,250 for a family of four). That is where the subsidy ends. The co-payments range from $10 to $20 for a clinic visit and from $200 to $350 for an inpatient stay.
A final financing mechanism has placed the program in legal jeopardy. To make sure the new safety net does not encourage businesses to drop their private insurance, the city in January will begin requiring employers with more than 20 workers to contribute a set amount to health care. The Healthy San Francisco program is one of several possible destinations for that money, with others being private insurance or health savings accounts.
The full New York Times story can be found here:
http://www.nytimes.com/2007/09/14/us/14health.html?_r=1&hporef=slogin
Little cable cars riding half-way to the stars not included.
Healthy San Francisco is a new program that offers free or subsidized health care to all 82,000 San Francisco adults without insurance. It is financed mostly by the city which, according to the New York Times, “is gambling that it can provide universal and sensibly managed care to the uninsured for about the amount being spent on their treatment now, often in emergency rooms.â€
The Times reports that “Healthy San Francisco provides uninsured San Franciscans with access to 14 city health clinics and 8 affiliated community clinics, with an emphasis on prevention and managing chronic disease. It is, however, not the same as insurance because it does not cover residents once they leave the city.â€
Until November, enrollment will be limited to those living below the federal poverty line ($10,210 for a single person; $20,650 for a family of four). Then it will open to any resident who has been uninsured for at least 90 days, regardless of income or immigration status.
The coverage is not portable and city officials believe that people with private insurance will have little incentive to drop their policies to take advantage of the city’s cut-rate services.
Patients are asked to contribute nominal amounts through membership fees and co-payments that vary by income. Those from families with incomes below the federal poverty line pay nothing. Those who earn more pay quarterly fees that range from $60 to $675, which is the rate for those with incomes above 500 percent of the poverty level ($51,050 for a single; $103,250 for a family of four). That is where the subsidy ends. The co-payments range from $10 to $20 for a clinic visit and from $200 to $350 for an inpatient stay.
A final financing mechanism has placed the program in legal jeopardy. To make sure the new safety net does not encourage businesses to drop their private insurance, the city in January will begin requiring employers with more than 20 workers to contribute a set amount to health care. The Healthy San Francisco program is one of several possible destinations for that money, with others being private insurance or health savings accounts.
The full New York Times story can be found here:
http://www.nytimes.com/2007/09/14/us/14health.html?_r=1&hporef=slogin
Little cable cars riding half-way to the stars not included.
From today's WSJ ...
Sick Sob Stories
By JOHN STOSSEL
September 13, 2007
In Michael Moore's movie "Sicko," a widow named Julie Pierce tells a tearful story: Her husband died of kidney cancer after their health-insurance company denied payment for a bone-marrow transplant that might have saved his life. Ms. Pierce's rage is palpable as she repeats the word her insurers used in response to her husband's request. "They denied it," she sneers. "Said it was 'experimental.'"
Viewers of the documentary are meant to understand that "experimental" is health-insurance code for "expensive," and that Ms. Pierce's husband was left to die for the sake of profit. According to Mr. Moore's movie, "Any payment for a claim is referred to as a medical loss," and when a claim is denied, "it's a savings to the company."
But Mr. Moore is so busy following the money that he doesn't take the time to follow the science. Treating cancer patients with bone-marrow transplants has a dubious history.
Twenty years ago, many oncologists believed that bone-marrow transplants, along with high doses of chemotherapy, might offer a cure for breast cancer. Insurance companies refused to pay, calling the treatment experimental and unproven. Breast-cancer sufferers went to court: In one case, a jury awarded $77 million to the family of a woman who was denied payment for the treatment. Wives and mothers told heart-rending stories in newspapers and on TV. Politicians quickly moved to guarantee the treatment to all breast-cancer patients. Ten state legislatures mandated that every insurance policy cover bone-marrow transplantation for breast-cancer patients. Amid the media circus and political self-congratulation, the question of whether bone-marrow transplants are medically effective faded into the background.
The sad truth is that the treatment isn't effective. When researchers released the results of their clinical trials to the American Society of Clinical Oncology in 1999, they showed that the treatment offered no benefit. Worse, it often killed women faster than their cancer, and caused them unnecessary pain. At a time when their health was at its greatest risk, more than 30,000 women were exposed to an invasive, harmful and ultimately useless treatment that the National Institutes of Health no longer recommends. But only one state legislature has repealed its law requiring insurance companies to pay for the treatment. Some doctors believe bone-marrow transplants might help kidney cancer patients, and the NIH is conducting clinical trials to find out. Until the treatment has been shown to do more good than harm, insurers are reluctant to pay for it.
Mr. Moore claims that because private insurance companies are driven by profit, they will always deny care to deserving patients. For this reason, he argues, profit-making health-insurance companies should be abolished, our health- care dollars turned over to the government, and the U.S. should institute a health-care system like the ones in Canada, Britain or France. But does Mr. Moore think, even for a second, that any of the government systems he touts in his movie would have provided a bone-marrow transplant to Ms. Pierce's husband? Fat chance.
When government is in charge of health care, the result is not that everyone gets access to experimental treatments, but that people get less of the care that is absolutely necessary. At any given time, just under a million Canadians are on waiting lists to receive care, and one in eight British patients must wait more than a year for hospital treatment. Canadian Karen Jepp, who gave birth to quadruplets last month, had to fly to Montana for the delivery: neonatal units in her own country had no room.
Rationing in Britain is so severe that one hospital recently tried saving money by not changing bed-sheets between patients. Instead of washing sheets, the staff was encouraged to just turn them over, British papers report. The wait for an appointment with a dentist is so long that people are using pliers to pull out their own rotting teeth.
Patients in countries with government-run health care can't get timely access to many basic medical treatments, never mind experimental treatments. That's why, if you suffer from cancer, you're better off in the U.S., which is home to the newest treatments and where patients have access to the best diagnostic equipment. People diagnosed with cancer in America have a better chance of living a full life than people in countries with socialized systems. Among women diagnosed with breast cancer, only one-quarter die in the U.S., compared to one-third in France and nearly half in the United Kingdom.
Mr. Moore thinks that profit is the enemy and government is the answer. The opposite is true. Profit is what has created the amazing scientific innovations that the U.S. offers to the world. If government takes over, innovation slows, health care is rationed, and spending is controlled by politicians more influenced by the sob story of the moment than by medical science.
Sick Sob Stories
By JOHN STOSSEL
September 13, 2007
In Michael Moore's movie "Sicko," a widow named Julie Pierce tells a tearful story: Her husband died of kidney cancer after their health-insurance company denied payment for a bone-marrow transplant that might have saved his life. Ms. Pierce's rage is palpable as she repeats the word her insurers used in response to her husband's request. "They denied it," she sneers. "Said it was 'experimental.'"
Viewers of the documentary are meant to understand that "experimental" is health-insurance code for "expensive," and that Ms. Pierce's husband was left to die for the sake of profit. According to Mr. Moore's movie, "Any payment for a claim is referred to as a medical loss," and when a claim is denied, "it's a savings to the company."
But Mr. Moore is so busy following the money that he doesn't take the time to follow the science. Treating cancer patients with bone-marrow transplants has a dubious history.
Twenty years ago, many oncologists believed that bone-marrow transplants, along with high doses of chemotherapy, might offer a cure for breast cancer. Insurance companies refused to pay, calling the treatment experimental and unproven. Breast-cancer sufferers went to court: In one case, a jury awarded $77 million to the family of a woman who was denied payment for the treatment. Wives and mothers told heart-rending stories in newspapers and on TV. Politicians quickly moved to guarantee the treatment to all breast-cancer patients. Ten state legislatures mandated that every insurance policy cover bone-marrow transplantation for breast-cancer patients. Amid the media circus and political self-congratulation, the question of whether bone-marrow transplants are medically effective faded into the background.
The sad truth is that the treatment isn't effective. When researchers released the results of their clinical trials to the American Society of Clinical Oncology in 1999, they showed that the treatment offered no benefit. Worse, it often killed women faster than their cancer, and caused them unnecessary pain. At a time when their health was at its greatest risk, more than 30,000 women were exposed to an invasive, harmful and ultimately useless treatment that the National Institutes of Health no longer recommends. But only one state legislature has repealed its law requiring insurance companies to pay for the treatment. Some doctors believe bone-marrow transplants might help kidney cancer patients, and the NIH is conducting clinical trials to find out. Until the treatment has been shown to do more good than harm, insurers are reluctant to pay for it.
Mr. Moore claims that because private insurance companies are driven by profit, they will always deny care to deserving patients. For this reason, he argues, profit-making health-insurance companies should be abolished, our health- care dollars turned over to the government, and the U.S. should institute a health-care system like the ones in Canada, Britain or France. But does Mr. Moore think, even for a second, that any of the government systems he touts in his movie would have provided a bone-marrow transplant to Ms. Pierce's husband? Fat chance.
When government is in charge of health care, the result is not that everyone gets access to experimental treatments, but that people get less of the care that is absolutely necessary. At any given time, just under a million Canadians are on waiting lists to receive care, and one in eight British patients must wait more than a year for hospital treatment. Canadian Karen Jepp, who gave birth to quadruplets last month, had to fly to Montana for the delivery: neonatal units in her own country had no room.
Rationing in Britain is so severe that one hospital recently tried saving money by not changing bed-sheets between patients. Instead of washing sheets, the staff was encouraged to just turn them over, British papers report. The wait for an appointment with a dentist is so long that people are using pliers to pull out their own rotting teeth.
Patients in countries with government-run health care can't get timely access to many basic medical treatments, never mind experimental treatments. That's why, if you suffer from cancer, you're better off in the U.S., which is home to the newest treatments and where patients have access to the best diagnostic equipment. People diagnosed with cancer in America have a better chance of living a full life than people in countries with socialized systems. Among women diagnosed with breast cancer, only one-quarter die in the U.S., compared to one-third in France and nearly half in the United Kingdom.
Mr. Moore thinks that profit is the enemy and government is the answer. The opposite is true. Profit is what has created the amazing scientific innovations that the U.S. offers to the world. If government takes over, innovation slows, health care is rationed, and spending is controlled by politicians more influenced by the sob story of the moment than by medical science.
FDA Adcomm decides no label changes for ESA use with respect to kidney patients on dialysis and can't decide on an optimal dose...What, no micromanagement of medicine? How refreshing.
Meanwhile as Scott Gottlieb points out, CMS is likely not to make any coverage decision because...it already has. Bundled payments for ESAs based on one size fits all hemocrit levels are due in 2010 for the Medicare renal program. We have been here before. Price per dose limits in the 90s led to increase in death among kidney patients.
http://www.boston.com/business/globe/articles/2007/09/12/panel_says_anemia_drug_doses_ok_as_is/
Meanwhile as Scott Gottlieb points out, CMS is likely not to make any coverage decision because...it already has. Bundled payments for ESAs based on one size fits all hemocrit levels are due in 2010 for the Medicare renal program. We have been here before. Price per dose limits in the 90s led to increase in death among kidney patients.
http://www.boston.com/business/globe/articles/2007/09/12/panel_says_anemia_drug_doses_ok_as_is/
It's not a new double play combo, it's the tired old triangle of terror trying to undo the measured approach the FDA took on Avandia. Flawed, cherry picked data that was held backed after the Adcomm (one can see the eyes rolling if GSK presented similar data to support Avandia's safety...oh wait, it did, it's called RECORD and it's a lot better than a meta-analysis of clinical trials that did not have safety as an endpoint).
If you want your peer review to be your cronies at the NY Times and not scientists, that's what you do.
http://www.nytimes.com/2007/09/12/health/12drug.html?_r=2&adxnnl=1&oref=slogin&adxnnlx=1189600152-vjb/dQOVeGSyHepZfiwa8w&oref=slogin
If you want your peer review to be your cronies at the NY Times and not scientists, that's what you do.
http://www.nytimes.com/2007/09/12/health/12drug.html?_r=2&adxnnl=1&oref=slogin&adxnnlx=1189600152-vjb/dQOVeGSyHepZfiwa8w&oref=slogin
From today's edition of the Wall Street Journal ...
Risk-Based System Urged for Import Safety
By JANE ZHANG
September 11, 2007
WASHINGTON -- A White House panel studying ways to improve import safety said the U.S. should shift to a preventive system focused on risky products, conceding that the U.S. can never inspect enough foreign goods to protect consumers from every potentially harmful item.
Under such a system, the government would collect data from private and public sources, identify safety hazards along the entire "life cycle" of the imported products and manage the risk earlier in the import process. A database for such use is already being developed and officials say its implementation could be pushed to 2009 from 2011.
"It's a change from an intervention-focused strategy to a risk-based approach focused on prevention with verification," said Health and Human Services Secretary Mike Leavitt, who heads the panel of senior officials from 12 federal agencies. "Instead of a point-in-time assessment at the border, we're recommending a focus on the full import life cycle, building safety into the products that we purchase every step of the way."
The risk-based concept isn't new. Major elements of the recommendation mirror a 2002 Food and Drug Administration proposal aimed at improving import safety, but was shelved because of, among other reasons, a lack of funding. Earlier this year, FDA officials dusted off the plan after a spate of food scares put them under fire on Capitol Hill.
The panel's recommendation, if adopted, would apply to all agencies that regulate imports, such as the Consumer Product Safety Commission. Mr. Leavitt declined to say how much the system would cost, or what specific actions are needed. The panel is scheduled to release action plans in November.
The Bush administration has been grappling with import-safety issues in the wake of a string of recalls and problem products, including toys, tires, seafood and tainted pet-food ingredients, almost all from China. (See related article.)
The turn of events pleased some food-safety experts. "It's a good thing they've gone back to the FDA's early thinking," said William Hubbard, a former FDA associate commissioner. "The question is whether sufficient funding can make it happen."
But Benjamin England, a co-author of the 2002 FDA plan who now runs a consulting firm, FDAImports.com, said Mr. Leavitt's recommendation falls short of addressing solutions to the current import mess.
"In an effort to elevate from an intra-agency risk-based program to an inter-agency risk-based program, a lot was lost in translation," he said. For example, the report didn't define risk, didn't place more responsibility onto foreign manufacturers and the proposed data system is intended more for collecting trade data than assessing risks with products.
U.S. officials are also holding private discussions with Chinese regulators, both in the U.S. and in China, to enhance the safety of products such as food and drugs.
In Beijing, China's top quality-inspection official challenged U.S. regulators to play a more active role in screening Chinese exports for tainted goods, proposing that the FDA ban products from companies that haven't passed muster with Beijing in order to weed out the most flagrant violators. An FDA spokesman said the agency looked forward to working with the Chinese, but declined to elaborate.
Yesterday, U.S. and Chinese regulators agreed on a plan to eliminate lead in toys from Chinese companies and to enhance scrutiny of the toy-making process, people familiar with the talks said. Details will be announced today at the Second Biennial Sino-U.S. Consumer Product Safety Summit here.
Risk-Based System Urged for Import Safety
By JANE ZHANG
September 11, 2007
WASHINGTON -- A White House panel studying ways to improve import safety said the U.S. should shift to a preventive system focused on risky products, conceding that the U.S. can never inspect enough foreign goods to protect consumers from every potentially harmful item.
Under such a system, the government would collect data from private and public sources, identify safety hazards along the entire "life cycle" of the imported products and manage the risk earlier in the import process. A database for such use is already being developed and officials say its implementation could be pushed to 2009 from 2011.
"It's a change from an intervention-focused strategy to a risk-based approach focused on prevention with verification," said Health and Human Services Secretary Mike Leavitt, who heads the panel of senior officials from 12 federal agencies. "Instead of a point-in-time assessment at the border, we're recommending a focus on the full import life cycle, building safety into the products that we purchase every step of the way."
The risk-based concept isn't new. Major elements of the recommendation mirror a 2002 Food and Drug Administration proposal aimed at improving import safety, but was shelved because of, among other reasons, a lack of funding. Earlier this year, FDA officials dusted off the plan after a spate of food scares put them under fire on Capitol Hill.
The panel's recommendation, if adopted, would apply to all agencies that regulate imports, such as the Consumer Product Safety Commission. Mr. Leavitt declined to say how much the system would cost, or what specific actions are needed. The panel is scheduled to release action plans in November.
The Bush administration has been grappling with import-safety issues in the wake of a string of recalls and problem products, including toys, tires, seafood and tainted pet-food ingredients, almost all from China. (See related article.)
The turn of events pleased some food-safety experts. "It's a good thing they've gone back to the FDA's early thinking," said William Hubbard, a former FDA associate commissioner. "The question is whether sufficient funding can make it happen."
But Benjamin England, a co-author of the 2002 FDA plan who now runs a consulting firm, FDAImports.com, said Mr. Leavitt's recommendation falls short of addressing solutions to the current import mess.
"In an effort to elevate from an intra-agency risk-based program to an inter-agency risk-based program, a lot was lost in translation," he said. For example, the report didn't define risk, didn't place more responsibility onto foreign manufacturers and the proposed data system is intended more for collecting trade data than assessing risks with products.
U.S. officials are also holding private discussions with Chinese regulators, both in the U.S. and in China, to enhance the safety of products such as food and drugs.
In Beijing, China's top quality-inspection official challenged U.S. regulators to play a more active role in screening Chinese exports for tainted goods, proposing that the FDA ban products from companies that haven't passed muster with Beijing in order to weed out the most flagrant violators. An FDA spokesman said the agency looked forward to working with the Chinese, but declined to elaborate.
Yesterday, U.S. and Chinese regulators agreed on a plan to eliminate lead in toys from Chinese companies and to enhance scrutiny of the toy-making process, people familiar with the talks said. Details will be announced today at the Second Biennial Sino-U.S. Consumer Product Safety Summit here.
We are sharnig, ahead of an embargo, an editorial and a release on two separate articles being issued by JAMA on Sept 11. One co-authored written by Curt Furberg and his colleagues at Wake Forest is entitled " Long-term Risk of Cardiovascular Events with Rosiglitazone" (Avandia) and another by Steve Nissen and colleauges on Pioglitazone and Risk of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus A Meta-analysis of Randomized Trials (Actos) The one by Nissen claims that Actos reduces risk of heart problems but has no impact on overall death from heart disease. This claim is made from a dataset that is observational, does not control for serverity of heart problems and does not have MI or heart safety as a primary endpoint. The one by Furberg -- a meta-analysis of only 4 clinical trials (a meta-analysis that must set some sort of record for being the smallest ever accepted for publication) claims that Avandia long term has a high risk of MI among long term users yet has no long term impact on total incidence of death from heart problems. That's sort of like saying that driving a certain kind of car leads to more car crashes by no increase in accidents or deaths.
We feel that the increased need for transparency, particularly in the wake of disturbing revelations that the release of safety studies directly to the media or to Congress have lead in the case of SSRIs, diabetes drugs and even pain killers to an over reaction of the public with adverse public health consequences justifies ignores this embargo. Indeed, the embargo is being used to subvert and undermine the ongoing post market review process of the FDA with respect to TZDs.
Both articles ignore and fail to cite the FDA data claiming no increased risk of heart problems apart from heart failure from Avandia and the problems of using observational data that did not have MI as a primary endpoint. Both articles fail to include more recent meta-analysis and re-analysis showing a lower risk of heart problems from Avandia from the Archives of Internal Medicine. (Diamond GA, Bax L, Kaul S. Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death. Ann Intern Med. 2007 Aug 6; [Epub ahead of print] ) Who's doing the peer review at JAMA these days?
And of course the articles are followed by an editioral calling for Avandia to be yanked from the market. That's a far cry from even a recommendation for a black box for MI which even Nissen et al conjecture might be associated with high cholesterol and treated with statins in this article.
The authors could have very well presented these findings at the Adcomm. Knowing the timing of the publication process as we do, it is clear that JAMA, NIssen and Furberg had the information in this article in advance of the FDA Adcomm hearing. Indeed, their reference to the proceedings, their willful refusal to acknowledge alternative findings from the hearings or from other peer-reviewed journals suggest that the publication of these articles are yet another attempt, much like the release of the original NEJM article to usurp the FDA's authority, engage in fearmongering and undo a careful consensus on drug safety evaluation.
Honoring an embargo that undermines the authority of duly constituted regulatory agency is not honorable. The first time it led to chaos and a near public health crisis. We release these articles now with our comments in the hope that we can contain whatever damage Nissen, Furberg and JAMA intended with the anticipated publicity. These articles should have been part of the public record and public debate. They were deliberately withheld to allow them to engage in drug safety vigilantism. That is an abuse of power that honoring the embargo only perpetuates at the expense of the FDA's authority.
Glycemic Control Medication Pioglitazone Appears to Have Overall Favorable Effect Regarding Risk of Cardiovascular Events
CHICAGO – A meta-analysis of previous research suggests that use of pioglitazone, a glycemic control medication for patients with type 2 diabetes, significantly reduces the risk of heart attack, stroke and death, but increases the risk for serious heart failure, according to an article in the September 12 issue of JAMA.
A. Michael Lincoff, M.D., and colleagues at the Cleveland Clinic, conducted a meta-analysis of research to evaluate the effect of pioglitazone on the incidence of ischemic cardiovascular complications for patients with type 2 diabetes. Previous evidence had been insufficient to evaluate this effect. This analysis included 19 randomized trials and 16,390 patients. Duration of pioglitazone use ranged from 4 months to 3.5 years.
The researchers found that heart attack, stroke or death occurred in 375 (4.4 percent) of 8,554 patients receiving pioglitazone and 450 (5.7 percent) of 7,836 patients treated with control therapy, an 18 percent relative reduction. These outcomes were all reduced by a similar magnitude with pioglitazone treatment. Serious heart failure was reported in 200 (2.3 percent) of pioglitazone-treated patients and 139 (1.8 percent) of control patients.
“These findings suggest that the net clinical cardiovascular benefit with pioglitazone therapy is favorable, with an important reduction in irreversible ischemic events that is not attenuated by the risk of more frequent heart failure complications,†the authors write.
(JAMA. 2007;298(10):1180-1188.)
Long-Term Use of Glycemic Control Medication Rosiglitazone Associated With Increased Risk of Heart Attack and Heart Failure
Patients with type 2 diabetes or impaired glucose tolerance who take the medication rosiglitazone appear to be at increased risk for a heart attack or heart failure, according to a meta-analysis article in this issue of JAMA.
Sonal Singh, M.D., of the Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues reviewed research to examine the risk of heart attack, heart failure and cardiovascular death with long-term rosiglitazone use. There have been recent reports of serious adverse events with rosiglitazone use, but information available to clinicians on the magnitude and public health impact of these events has been limited.
The researchers compiled data from four randomized trials that included 14,291 patients (n = 6,421 receiving rosiglitazone; n = 7,870 receiving control therapy). Follow-up for these studies was 1-4 years.
The pooled data from the trials indicated that rosiglitazone, compared with controls, significantly increased the risk of heart attack by 42 percent (94 of 6,421 patients who received rosiglitazone vs. 83 of 7,870 patients who received control therapy) and doubled the risk of heart failure (102 of 6,421 patients vs. 62 of 7,870 patients). Use of rosiglitazone was not associated with a significant increase in risk of cardiovascular death.
“Our findings have potential regulatory and clinical implications. These data suggest a reversal of the benefit-to-harm balance for rosiglitazone present at the time of approval. Thus, currently there appear to be much safer treatment alternatives. Regulatory agencies ought to reevaluate whether rosiglitazone should be allowed to remain on the market. Health plans and physicians should not wait for regulatory actions. They should avoid using rosiglitazone in patients with diabetes who are at risk of cardiovascular events, especially since safer treatment alternatives are available,†the authors conclude.
(JAMA. 2007;298(10):1189-1195.)
Editorial: Cardiovascular Risk and the Thiazolidinediones – Déjà Vu All Over Again?
In an accompanying editorial, Daniel H. Solomon, M.D., M.P.H., and Wolfgang C. Winkelmayer, M.D., Sc.D., of Brigham and Women’s Hospital, Harvard Medical School, Boston, comment on the findings in this week’s JAMA regarding glycemic control medications and drug safety.
“The previous episode with the selective COX-2 inhibitors and the current one with the thiazolidinediones are instructive for designing a better drug safety system. First, early safety concerns must prompt strong and clear regulatory action. … Second, postmarketing adverse events not frequently observed in premarketing studies should be expected when there is incomplete understanding of the mechanism of action of a drug.â€
“Third, after several drugs are available for a given indication, new drug approval should be based on improvement in clinical outcomes, not surrogate measures. … Fourth, the decisions for initial approval of a drug and subsequent continued marketing should by symmetric. … Finally, and perhaps most difficult, safety and efficacy must be explicitly balanced when drugs are being considered for approval or for continued marketing.â€
(JAMA. 2007;298(10):1216-1218.
We feel that the increased need for transparency, particularly in the wake of disturbing revelations that the release of safety studies directly to the media or to Congress have lead in the case of SSRIs, diabetes drugs and even pain killers to an over reaction of the public with adverse public health consequences justifies ignores this embargo. Indeed, the embargo is being used to subvert and undermine the ongoing post market review process of the FDA with respect to TZDs.
Both articles ignore and fail to cite the FDA data claiming no increased risk of heart problems apart from heart failure from Avandia and the problems of using observational data that did not have MI as a primary endpoint. Both articles fail to include more recent meta-analysis and re-analysis showing a lower risk of heart problems from Avandia from the Archives of Internal Medicine. (Diamond GA, Bax L, Kaul S. Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death. Ann Intern Med. 2007 Aug 6; [Epub ahead of print] ) Who's doing the peer review at JAMA these days?
And of course the articles are followed by an editioral calling for Avandia to be yanked from the market. That's a far cry from even a recommendation for a black box for MI which even Nissen et al conjecture might be associated with high cholesterol and treated with statins in this article.
The authors could have very well presented these findings at the Adcomm. Knowing the timing of the publication process as we do, it is clear that JAMA, NIssen and Furberg had the information in this article in advance of the FDA Adcomm hearing. Indeed, their reference to the proceedings, their willful refusal to acknowledge alternative findings from the hearings or from other peer-reviewed journals suggest that the publication of these articles are yet another attempt, much like the release of the original NEJM article to usurp the FDA's authority, engage in fearmongering and undo a careful consensus on drug safety evaluation.
Honoring an embargo that undermines the authority of duly constituted regulatory agency is not honorable. The first time it led to chaos and a near public health crisis. We release these articles now with our comments in the hope that we can contain whatever damage Nissen, Furberg and JAMA intended with the anticipated publicity. These articles should have been part of the public record and public debate. They were deliberately withheld to allow them to engage in drug safety vigilantism. That is an abuse of power that honoring the embargo only perpetuates at the expense of the FDA's authority.
Glycemic Control Medication Pioglitazone Appears to Have Overall Favorable Effect Regarding Risk of Cardiovascular Events
CHICAGO – A meta-analysis of previous research suggests that use of pioglitazone, a glycemic control medication for patients with type 2 diabetes, significantly reduces the risk of heart attack, stroke and death, but increases the risk for serious heart failure, according to an article in the September 12 issue of JAMA.
A. Michael Lincoff, M.D., and colleagues at the Cleveland Clinic, conducted a meta-analysis of research to evaluate the effect of pioglitazone on the incidence of ischemic cardiovascular complications for patients with type 2 diabetes. Previous evidence had been insufficient to evaluate this effect. This analysis included 19 randomized trials and 16,390 patients. Duration of pioglitazone use ranged from 4 months to 3.5 years.
The researchers found that heart attack, stroke or death occurred in 375 (4.4 percent) of 8,554 patients receiving pioglitazone and 450 (5.7 percent) of 7,836 patients treated with control therapy, an 18 percent relative reduction. These outcomes were all reduced by a similar magnitude with pioglitazone treatment. Serious heart failure was reported in 200 (2.3 percent) of pioglitazone-treated patients and 139 (1.8 percent) of control patients.
“These findings suggest that the net clinical cardiovascular benefit with pioglitazone therapy is favorable, with an important reduction in irreversible ischemic events that is not attenuated by the risk of more frequent heart failure complications,†the authors write.
(JAMA. 2007;298(10):1180-1188.)
Long-Term Use of Glycemic Control Medication Rosiglitazone Associated With Increased Risk of Heart Attack and Heart Failure
Patients with type 2 diabetes or impaired glucose tolerance who take the medication rosiglitazone appear to be at increased risk for a heart attack or heart failure, according to a meta-analysis article in this issue of JAMA.
Sonal Singh, M.D., of the Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues reviewed research to examine the risk of heart attack, heart failure and cardiovascular death with long-term rosiglitazone use. There have been recent reports of serious adverse events with rosiglitazone use, but information available to clinicians on the magnitude and public health impact of these events has been limited.
The researchers compiled data from four randomized trials that included 14,291 patients (n = 6,421 receiving rosiglitazone; n = 7,870 receiving control therapy). Follow-up for these studies was 1-4 years.
The pooled data from the trials indicated that rosiglitazone, compared with controls, significantly increased the risk of heart attack by 42 percent (94 of 6,421 patients who received rosiglitazone vs. 83 of 7,870 patients who received control therapy) and doubled the risk of heart failure (102 of 6,421 patients vs. 62 of 7,870 patients). Use of rosiglitazone was not associated with a significant increase in risk of cardiovascular death.
“Our findings have potential regulatory and clinical implications. These data suggest a reversal of the benefit-to-harm balance for rosiglitazone present at the time of approval. Thus, currently there appear to be much safer treatment alternatives. Regulatory agencies ought to reevaluate whether rosiglitazone should be allowed to remain on the market. Health plans and physicians should not wait for regulatory actions. They should avoid using rosiglitazone in patients with diabetes who are at risk of cardiovascular events, especially since safer treatment alternatives are available,†the authors conclude.
(JAMA. 2007;298(10):1189-1195.)
Editorial: Cardiovascular Risk and the Thiazolidinediones – Déjà Vu All Over Again?
In an accompanying editorial, Daniel H. Solomon, M.D., M.P.H., and Wolfgang C. Winkelmayer, M.D., Sc.D., of Brigham and Women’s Hospital, Harvard Medical School, Boston, comment on the findings in this week’s JAMA regarding glycemic control medications and drug safety.
“The previous episode with the selective COX-2 inhibitors and the current one with the thiazolidinediones are instructive for designing a better drug safety system. First, early safety concerns must prompt strong and clear regulatory action. … Second, postmarketing adverse events not frequently observed in premarketing studies should be expected when there is incomplete understanding of the mechanism of action of a drug.â€
“Third, after several drugs are available for a given indication, new drug approval should be based on improvement in clinical outcomes, not surrogate measures. … Fourth, the decisions for initial approval of a drug and subsequent continued marketing should by symmetric. … Finally, and perhaps most difficult, safety and efficacy must be explicitly balanced when drugs are being considered for approval or for continued marketing.â€
(JAMA. 2007;298(10):1216-1218.
Comparative effectiveness? Well since you mentioned it ...
CBO’s Estimate of the Budgetary Impact of Section 904
(Sec. 904. Comparative effectiveness research. Establishes within the Agency of Healthcare Research and Quality a Center for Comparative Effectiveness Research to conduct research on the outcomes, effectiveness, and appropriateness of health care services.Also establishes an independent Comparative Effectiveness Research Commission to set priorities and ensure credibility for the Center’s work. It also establishes a Comparative Effectiveness Research Trust Fund, initially funded through the Medicare trust fund, to support the work of the Center and the Commission.)
* CBO estimates that Section 904 of the CHAMP act (H.R. 3162) would increase Federal spending (Medicare, Medicaid, and FEHBP) by $600 million between 2008 to 2012, and $2.4 billion from 2008-2017.
* While the agency estimates that the bill could reduce public and private health spending by up to $6 billion, direct Federal spending would only be reduced by $100 million over the 2008-2012 period and $1.3 billion between 2008 and 2017. (Those amounts would constitute a very small fraction of overall federal outlays for those programs.)
* Thus, enacting section 904 would increase federal direct spending by $0.5 billion over five years and $1.1 billion over 10 years.
* CBO assumes that the provision would result in better information about which health care services and procedures are ineffective and some changes in coverage rules that can be implemented under current law.
Well that's certainly reassuring.
CBO’s Estimate of the Budgetary Impact of Section 904
(Sec. 904. Comparative effectiveness research. Establishes within the Agency of Healthcare Research and Quality a Center for Comparative Effectiveness Research to conduct research on the outcomes, effectiveness, and appropriateness of health care services.Also establishes an independent Comparative Effectiveness Research Commission to set priorities and ensure credibility for the Center’s work. It also establishes a Comparative Effectiveness Research Trust Fund, initially funded through the Medicare trust fund, to support the work of the Center and the Commission.)
* CBO estimates that Section 904 of the CHAMP act (H.R. 3162) would increase Federal spending (Medicare, Medicaid, and FEHBP) by $600 million between 2008 to 2012, and $2.4 billion from 2008-2017.
* While the agency estimates that the bill could reduce public and private health spending by up to $6 billion, direct Federal spending would only be reduced by $100 million over the 2008-2012 period and $1.3 billion between 2008 and 2017. (Those amounts would constitute a very small fraction of overall federal outlays for those programs.)
* Thus, enacting section 904 would increase federal direct spending by $0.5 billion over five years and $1.1 billion over 10 years.
* CBO assumes that the provision would result in better information about which health care services and procedures are ineffective and some changes in coverage rules that can be implemented under current law.
Well that's certainly reassuring.
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.
