Latest Drugwonks' Blog
Can a guy who took a stretch limo to a $3000/day fat farm do a credible movie about health care in America? He can if he plays to people's deeply held stereotypes about scummy business practices and twists the truth in the process....
But Moore is claiming, again, that every fact in his movies are true. Sicko being no exception. So here's a reminder for those of you Sicko-phants about how much Moore has to lie to make his point.
http://www.slate.com/id/2102723/
But Moore is claiming, again, that every fact in his movies are true. Sicko being no exception. So here's a reminder for those of you Sicko-phants about how much Moore has to lie to make his point.
http://www.slate.com/id/2102723/
Members of Congress telling the FDA to relabel Oxy for only those with severe pain. No mention if having to endure lethal doses of stupidity from legislators and their staff qualifies. http://www.forbes.com
Oped this past Monday by CMPI board member Mark Thornton about the demise of the Office of Cancer Drugs at the FDA....When is the new commish going to inject some science and sanity into the agency?
http://online.wsj.com/article/SB117911315709601659.html
http://online.wsj.com/article/SB117911315709601659.html
Was the point to help the uninsured or simply stick it to the drug companies?
From http://www.fiercehealthcare.com
Arkansas Cancels Prescription Drug Discount Program Because of Lack of Interest
[May 16, 2007]
The Arkansas Department of Health and Human Services has decided to cancel Arkansas Rx, a state prescription drug discount program scheduled to begin enrolling uninsured state residents this year, according to department spokesperson Julie Munsell, the Arkansas Democrat-Gazette reports. Supporters of the program in 2005, when the program received funding approval, said that as many as 400,000 uninsured state residents would have qualified for the program.
However, only 2,800 uninsured Arkansas residents have expressed interest in the program, a number that would not have allowed the state to negotiate bulk discounts on prescription drugs, Munsell said. She attributed the lack of interest in the program, which the state promoted with a radio and newspaper advertising campaign, to the increased number of alternatives -- such as the Medicare prescription drug benefit, discounts on generic medications offered by Wal-Mart Stores pharmacies and discount programs sponsored by pharmaceutical companies. About 21 states have established or authorized prescription drug discount programs for low-income adults, according to Richard Cauchi, health program director for the National Conference of State Legislatures (Manthey, Arkansas Democrat-Gazette, 5/15).
From http://www.fiercehealthcare.com
Arkansas Cancels Prescription Drug Discount Program Because of Lack of Interest
[May 16, 2007]
The Arkansas Department of Health and Human Services has decided to cancel Arkansas Rx, a state prescription drug discount program scheduled to begin enrolling uninsured state residents this year, according to department spokesperson Julie Munsell, the Arkansas Democrat-Gazette reports. Supporters of the program in 2005, when the program received funding approval, said that as many as 400,000 uninsured state residents would have qualified for the program.
However, only 2,800 uninsured Arkansas residents have expressed interest in the program, a number that would not have allowed the state to negotiate bulk discounts on prescription drugs, Munsell said. She attributed the lack of interest in the program, which the state promoted with a radio and newspaper advertising campaign, to the increased number of alternatives -- such as the Medicare prescription drug benefit, discounts on generic medications offered by Wal-Mart Stores pharmacies and discount programs sponsored by pharmaceutical companies. About 21 states have established or authorized prescription drug discount programs for low-income adults, according to Richard Cauchi, health program director for the National Conference of State Legislatures (Manthey, Arkansas Democrat-Gazette, 5/15).
Effective for patients or effective for budgeteers?
When pols and pundits say that we need a system of comparative effectiveness measures "like the UK," it's important to understand what that means. Consider the following ...
An international study of patient access to cancer drugs has found that the UK is in the lowest category of 25 countries, which were measured on the uptake of 67 treatments. The study, by the Karolinska Institute and the Stockholm School of Economics, found that the overall performance was best in Austria, France, Switzerland and the USA.
The researchers noted that the biggest variations across the different national markets in the study were for bowel and lung cancer groups. In both cases, the UK ranked with Poland among the worst countries for patient access to drugs.
This is a system we want to adopt? When Representative Emerson, for example, points to saving "billions, maybe trillions, of dollars" what she means (whether or not she understands it) is that those savings come from denying care.
Yes -- even for cancer patients.
The Karolinska Institute and Stockholm School of Economics study was published in the Annals of Oncology.
When pols and pundits say that we need a system of comparative effectiveness measures "like the UK," it's important to understand what that means. Consider the following ...
An international study of patient access to cancer drugs has found that the UK is in the lowest category of 25 countries, which were measured on the uptake of 67 treatments. The study, by the Karolinska Institute and the Stockholm School of Economics, found that the overall performance was best in Austria, France, Switzerland and the USA.
The researchers noted that the biggest variations across the different national markets in the study were for bowel and lung cancer groups. In both cases, the UK ranked with Poland among the worst countries for patient access to drugs.
This is a system we want to adopt? When Representative Emerson, for example, points to saving "billions, maybe trillions, of dollars" what she means (whether or not she understands it) is that those savings come from denying care.
Yes -- even for cancer patients.
The Karolinska Institute and Stockholm School of Economics study was published in the Annals of Oncology.
As if we needed another example of the folly and bias of large studies, the following excerpt from http://www.scientificamerican.com says it all:
Gordon H. Guyatt, a professor of epidemiology and biostatistics at McMaster University in Hamilton, Ontario, who coined the term "evidence-based medicine," collaborated with 16 of his colleagues in an exhaustive survey of existing studies on the outcomes of various medical procedures in both the U.S. and Canada. Their work appears in the inaugural issue of the new Canadian journal Open Medicine, and comes at a time when many in Canada are debating whether or not to move that country's single-payer system toward for-profit delivery of care. The ultimate conclusion of the study is that the Canadian medical system is as good as the U.S. version, at least when measured by a single metric—the rate at which patients in either system died.
Here's what the authors left out to get to their conclusion:
"We included published and unpublished prospective or retrospective observational studies comparing health outcomes (mortality or morbidity) in Canada and the United States for patients of any age with the same diagnosis."
Unpublished? So we have no way of knowing if the study design or results are any good. Ok, next.
"We excluded randomized trials, studies that identified the patients on the basis of the occurrence of one of the adverse health outcomes of interest, and national disease-specific mortality studies that failed to define the population at risk (that is, those with the disease of interest)."
Translation: We excluded anyone who was sick.
"For instance, we excluded studies of national rates of death from cancers because lower mortality may be due either to a lower incidence of cancer or to better care for those with the disease."
That's right folks, better care is not considered a factor in determining which health system is better. Can you say George Orwell?
In otherwords, if you are healthy and "use" the Canadian health system you die at a slower rate than in the US. Wow.
This, from the person who coined the term evidence based medicine.
For those fans of EBM here's the link. Steffie Woolhanler, Canadian health system symp is a co-conspirator on this piece of propaganda.
http://www.openmedicine.ca/article/view/8/1
Gordon H. Guyatt, a professor of epidemiology and biostatistics at McMaster University in Hamilton, Ontario, who coined the term "evidence-based medicine," collaborated with 16 of his colleagues in an exhaustive survey of existing studies on the outcomes of various medical procedures in both the U.S. and Canada. Their work appears in the inaugural issue of the new Canadian journal Open Medicine, and comes at a time when many in Canada are debating whether or not to move that country's single-payer system toward for-profit delivery of care. The ultimate conclusion of the study is that the Canadian medical system is as good as the U.S. version, at least when measured by a single metric—the rate at which patients in either system died.
Here's what the authors left out to get to their conclusion:
"We included published and unpublished prospective or retrospective observational studies comparing health outcomes (mortality or morbidity) in Canada and the United States for patients of any age with the same diagnosis."
Unpublished? So we have no way of knowing if the study design or results are any good. Ok, next.
"We excluded randomized trials, studies that identified the patients on the basis of the occurrence of one of the adverse health outcomes of interest, and national disease-specific mortality studies that failed to define the population at risk (that is, those with the disease of interest)."
Translation: We excluded anyone who was sick.
"For instance, we excluded studies of national rates of death from cancers because lower mortality may be due either to a lower incidence of cancer or to better care for those with the disease."
That's right folks, better care is not considered a factor in determining which health system is better. Can you say George Orwell?
In otherwords, if you are healthy and "use" the Canadian health system you die at a slower rate than in the US. Wow.
This, from the person who coined the term evidence based medicine.
For those fans of EBM here's the link. Steffie Woolhanler, Canadian health system symp is a co-conspirator on this piece of propaganda.
http://www.openmedicine.ca/article/view/8/1
Representatives Tom Allen (D-ME) and Jo Ann Emerson (R-MO) held a press conference this morning to announce the introduction of their Enhanced Health Care Value for All Act of 2007.
Representatives of interest groups supporting the legislation and congressional staff out-numbered reporters.
Allen and Emerson mentioned the $3 billion over five years that would be turned over to the Agency for Healthcare Research and Quality (AHRQ) to conduct comparative effectiveness studies.
They did not mention that only one third of this funding would be allocated from the federal budget; two-thirds of the money would come from taxes on health insurance policies.
Oops.
Emerson said the program is needed to combat pharmaceutical company marketing to physicians. She accused physicians of being on the take and encouraged patients to “challenge prescription decisions†made by their physicians.
Funny, last we encountered Representative Emerson, she was trying to limit the information that patients could get on their medicines.
Emerson claimed that the legislation is solely aimed at providing enhanced evidence, but also said it would save Medicare “billions and billions, maybe trillions of dollars.â€
That's a boatload of "maybe."
David Helms, president of AcademyHealth said that the U.S. lags other countries in evidence-based medicine, and that it could learn a lot from countries like Australia and the U.K.
He didn’t say what the U.S. could learn from countries that routinely deny their citizens access to breakthrough life-saving and life-extending therapies.
That's why this piece of legislation should more appropriately be called "The Denial of Care Act."
Representatives of interest groups supporting the legislation and congressional staff out-numbered reporters.
Allen and Emerson mentioned the $3 billion over five years that would be turned over to the Agency for Healthcare Research and Quality (AHRQ) to conduct comparative effectiveness studies.
They did not mention that only one third of this funding would be allocated from the federal budget; two-thirds of the money would come from taxes on health insurance policies.
Oops.
Emerson said the program is needed to combat pharmaceutical company marketing to physicians. She accused physicians of being on the take and encouraged patients to “challenge prescription decisions†made by their physicians.
Funny, last we encountered Representative Emerson, she was trying to limit the information that patients could get on their medicines.
Emerson claimed that the legislation is solely aimed at providing enhanced evidence, but also said it would save Medicare “billions and billions, maybe trillions of dollars.â€
That's a boatload of "maybe."
David Helms, president of AcademyHealth said that the U.S. lags other countries in evidence-based medicine, and that it could learn a lot from countries like Australia and the U.K.
He didn’t say what the U.S. could learn from countries that routinely deny their citizens access to breakthrough life-saving and life-extending therapies.
That's why this piece of legislation should more appropriately be called "The Denial of Care Act."
A lot of coverage about the risks of using EPO -- the anti-anemia drug produced by Amgen and J and J mainly in the news. Much of the coverage is the typical "the drug companies pushed over and off-label use so people died" which is probably 5 percent accurate in that you can always find the cowboys and bad apples in any endeavor.
For the most part the use of EPO in treating patients with chronic kidney failure and patients at risk for anemia has been safe, sane and subject to study via observational and randomized clinical trials. Indeed, reading accounts of the cautions placed on the use of EPO you would think the companies were bribing docs to pump as much of the stuff into people as they could. Quite the contrary. Medical literature abounds with studies about what is the right dose to increase survival while not risk the lives of very sick patients. This research in turn is then evaluated, transparently and independently, into guidelines that are continuously adjusted. In some cases, physicians believed that super-corrective hemo-levels were preferable or tried, with very sick and anemic patients, to give them additional strength even through they were not receiving chemotherapy. It may be not be a perfect approach but patient concerns are and were front and center in most cases.
The most recent clinical trials are a culmination of this ongoing effort. That it might lead to a decline in sales should not be a consideration. Finding the right dose for the right patient should be.
For the most part the use of EPO in treating patients with chronic kidney failure and patients at risk for anemia has been safe, sane and subject to study via observational and randomized clinical trials. Indeed, reading accounts of the cautions placed on the use of EPO you would think the companies were bribing docs to pump as much of the stuff into people as they could. Quite the contrary. Medical literature abounds with studies about what is the right dose to increase survival while not risk the lives of very sick patients. This research in turn is then evaluated, transparently and independently, into guidelines that are continuously adjusted. In some cases, physicians believed that super-corrective hemo-levels were preferable or tried, with very sick and anemic patients, to give them additional strength even through they were not receiving chemotherapy. It may be not be a perfect approach but patient concerns are and were front and center in most cases.
The most recent clinical trials are a culmination of this ongoing effort. That it might lead to a decline in sales should not be a consideration. Finding the right dose for the right patient should be.
Absent in the debate over FDA reform is reform of DSHEA.
Yesterday, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.
Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.
A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.
"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs," Nutraceutical said in its appeal, arguing that the FDA never met the "burden of proof" necessary to force the supplements off the market. The company
This ruling is good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
The answer -- DSHEA. And it's time for a change.
Yesterday, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.
Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.
A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.
"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs," Nutraceutical said in its appeal, arguing that the FDA never met the "burden of proof" necessary to force the supplements off the market. The company
This ruling is good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
The answer -- DSHEA. And it's time for a change.
My op-ed in today's Washington Times on how Bill Clinton legitimitized Brazil and Thailand self serving attack on pharma IP. The NGO's who give this exercise moral cover should be doubly ashamed...
http://washingtontimes.com/op-ed/20070514-093346-6396r.htm
http://washingtontimes.com/op-ed/20070514-093346-6396r.htm
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.
