Latest Drugwonks' Blog
The Congress is expected to begin debating SCHIP right after the Memorial Day recess, but final decisions are being made now about the legislative proposals that will be considered.
Here are some important things to think about and consider from the Health Policy Consensus Group (of which we are a proud participant) ...
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Have a look and feel free to share.
Here are some important things to think about and consider from the Health Policy Consensus Group (of which we are a proud participant) ...
Download file
Have a look and feel free to share.
Speaking of which...the online publication of Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes
Steven E. Nissen, M.D., and Kathy Wolski, M.P.H. signals a new low for both the NEJM and Nissen who's campaign to be FDA commissioner in a Democrat administration makes him look craven and small. http://www.nejm.org
The article proves no direct causal association. As the authors admit "these findings are based on limited access to trial results from publicly available sources, not on patient-level source data." Which means they cannot control for previous risks of heart disease or prior events.
Worse, the authors ignore the extensive literature demonstrating an association between diabetes and death from heart problems. Here's one article it failed to mention.
Diabetes mellitus: the major risk factor in unstable coronary artery disease even after consideration of the extent of coronary artery disease and benefits of revascularization.
Am Coll Cardiol. 2004 Feb 18;43(4):585-91.
Nissen has trawled for trouble before in the area of drugs for ADHD where he was rebuked by people who know better about the medicines benefit/risk profile. Here, he just did some data dredging of the worst sort and then even failed to cover his rear by citing literature about the link between diabetes and heart disease.
We know the NEJM is no longer a credible source of objective information on medicine. The question regarding Nissen is: Is he a real doctor or just playing one in the media?
Steven E. Nissen, M.D., and Kathy Wolski, M.P.H. signals a new low for both the NEJM and Nissen who's campaign to be FDA commissioner in a Democrat administration makes him look craven and small. http://www.nejm.org
The article proves no direct causal association. As the authors admit "these findings are based on limited access to trial results from publicly available sources, not on patient-level source data." Which means they cannot control for previous risks of heart disease or prior events.
Worse, the authors ignore the extensive literature demonstrating an association between diabetes and death from heart problems. Here's one article it failed to mention.
Diabetes mellitus: the major risk factor in unstable coronary artery disease even after consideration of the extent of coronary artery disease and benefits of revascularization.
Am Coll Cardiol. 2004 Feb 18;43(4):585-91.
Nissen has trawled for trouble before in the area of drugs for ADHD where he was rebuked by people who know better about the medicines benefit/risk profile. Here, he just did some data dredging of the worst sort and then even failed to cover his rear by citing literature about the link between diabetes and heart disease.
We know the NEJM is no longer a credible source of objective information on medicine. The question regarding Nissen is: Is he a real doctor or just playing one in the media?
CMPI Board member Fred Goodwin is on a unbalanced panel (in more ways than one) at the APA entitled Uneasy Partners: The Pharmaceutical Industry and the Psychiatric Profession..The point of the panel is to show that clinical studies used to develop clinical guidelines for shrinks have been corrupted by industry, are unscientific and can't be trusted.
The response to that should be twofold: Does that mean no drug is really safe or efficacious given the limits of clinical trials. Second, , why not do head to head studies of treatment approaches developed by "purists" and those "corrupted" by industry and see who does better? We actually have some examples.. ALLHAT and CATIE were run by purists, the UK's NICE system of comparative effectiveness is too.
For the most part, purists are lazy. They simply do meta-analyses of selective group of clinical trials that have exclusion critiera that will produce outcomes they support.
Meanwhile, are the purists, who take money from trial lawyers, left wing foundations funded by George Soros, agenda driven organizations and have their own biases really pure?
The response to that should be twofold: Does that mean no drug is really safe or efficacious given the limits of clinical trials. Second, , why not do head to head studies of treatment approaches developed by "purists" and those "corrupted" by industry and see who does better? We actually have some examples.. ALLHAT and CATIE were run by purists, the UK's NICE system of comparative effectiveness is too.
For the most part, purists are lazy. They simply do meta-analyses of selective group of clinical trials that have exclusion critiera that will produce outcomes they support.
Meanwhile, are the purists, who take money from trial lawyers, left wing foundations funded by George Soros, agenda driven organizations and have their own biases really pure?
Here's some comic relief ...
Representative Maurice "Slo Mo" Hinchey (D, NY) has introduced legislation that would direct pharmaceutical firms to deposit their PDUFA fees into a general fund of the U.S. Treasury rather than paying them directly to the FDA.
According to Mr. Hinchey, such a relationship would provide an "arms length relationship" between the agency and drug companies.
Hey, Mo -- would the actual applications also be sent from "anonymous?" (Because, er, the names on the NDAs might give the FDA a hint as to whose applications they were reviewing.)
Would meetings between pharmaceutical companies and the FDA take place with FDA employees wearing blindfolds? No, that wouldn't work. After all, how could they take notes or watch PowerPoint presentations? We should probably do away with those earplugs too.
Maybe in mark-up the bill's language could change to require drug company employees attending such meetings to wear dark glasses, wigs, and fake Groucho moustaches.
Slo Mo also wants to create a "Center for Postmarket Drug Safety and Effectiveness" -- which would be apart and independent from the initial drug approval process.
Hey Mo -- that's a good one -- separating safety from effectiveness.
Take my legislation -- please.
Representative Maurice "Slo Mo" Hinchey (D, NY) has introduced legislation that would direct pharmaceutical firms to deposit their PDUFA fees into a general fund of the U.S. Treasury rather than paying them directly to the FDA.
According to Mr. Hinchey, such a relationship would provide an "arms length relationship" between the agency and drug companies.
Hey, Mo -- would the actual applications also be sent from "anonymous?" (Because, er, the names on the NDAs might give the FDA a hint as to whose applications they were reviewing.)
Would meetings between pharmaceutical companies and the FDA take place with FDA employees wearing blindfolds? No, that wouldn't work. After all, how could they take notes or watch PowerPoint presentations? We should probably do away with those earplugs too.
Maybe in mark-up the bill's language could change to require drug company employees attending such meetings to wear dark glasses, wigs, and fake Groucho moustaches.
Slo Mo also wants to create a "Center for Postmarket Drug Safety and Effectiveness" -- which would be apart and independent from the initial drug approval process.
Hey Mo -- that's a good one -- separating safety from effectiveness.
Take my legislation -- please.
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
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.
