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BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
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DrugWonks Blog
10/12/2006 01:47 PM |
Yesterday I was privileged to participate in the latest in a series of Senator John Breaux’s “Ceasefire†debates. (Ceasefire events bring together a variety of speakers with opposing viewpoints in an effort to find common ground. Past speakers include former Speaker of the House Newt Gingrich, Senator Hillary Rodham Clinton, Former Secretaries of HHS Donna Shalala and Tommy Thompson, Press Secretaries Ari Fleischer and Mike McCurry, and former Senators Tom Daschle and Ron Nickles. The Ceasefire on Healthcare series is made possible by a grant from Pfizer Inc.)
I was paired with David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project at the Progressive Policy Institute.
We had, what’s the right word here, a robust conversation. The entire debate will shortly be posted (as a podcast) at http://www.ceasefireonhealthcare.org/podcast, but I wanted to share two things that seemed especially germane and interesting –
(1) We debated whether or not physician “pay-for-performance†is a good thing. (My position is that it all depends on what “performance†means.) Consider this – if we limit what medicines doctors can prescribe based on cost-centric rather than patient-centric models, how can we possibly measure “performance†outcomes?
(2) Senator Breaux asked if we thought health care would play a major role in the up coming Presidential election. David said, “yes.†I said “no.â€
If the current debate over health care is any indication, what we’re in store for is too many months of sounds bites, finger pointing, and pharma bashing.
And that is not a debate over health care. Read More & Comment...
I was paired with David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project at the Progressive Policy Institute.
We had, what’s the right word here, a robust conversation. The entire debate will shortly be posted (as a podcast) at http://www.ceasefireonhealthcare.org/podcast, but I wanted to share two things that seemed especially germane and interesting –
(1) We debated whether or not physician “pay-for-performance†is a good thing. (My position is that it all depends on what “performance†means.) Consider this – if we limit what medicines doctors can prescribe based on cost-centric rather than patient-centric models, how can we possibly measure “performance†outcomes?
(2) Senator Breaux asked if we thought health care would play a major role in the up coming Presidential election. David said, “yes.†I said “no.â€
If the current debate over health care is any indication, what we’re in store for is too many months of sounds bites, finger pointing, and pharma bashing.
And that is not a debate over health care. Read More & Comment...
10/12/2006 11:00 AM |
Maclean's, Mon 16 Oct 2006
Byline: DANYLO HAWALESHKA
In the pivotal courtroom scene from A Few Good Men, Tom Cruise shouts, "I want the truth!" at Jack Nicholson, whose truculent character is testifying. "You can't handle the truth!" Nicholson famously retorts. Today, in a real-life courtroom drama, CanWest MediaWorks Inc. has, in a manner, assumed Cruise's role, with a somewhat less altruistic goal in mind than simple verity.
In a civil lawsuit now before Ontario's Superior Court of Justice, CanWest contends Canadians are being denied important truths about prescription medications because of strict limits on drug advertising. Canada's largest media company claims the regulations thwart its constitutional right to freedom of expression.
CanWest's suit against the attorney general of Canada casts the country's Food and Drugs Act as the villain. The act forbids direct-to-consumer advertising (DTCA) that ties a prescription drug to a treatment, cure or disease. (It is illegal for CanWest to, for instance, run an ad to promote Viagra for impotence, but quite legal to separately publicize the brand, or the condition; there are no such restrictions on ads that target physicians exclusively in, say, trade journals.) In a sworn statement, Arturo Duran, a CanWest MediaWorks president, claims permitting DTCA in Canada would educate the public about drug risks and benefits. "There is no evidence to justify a ban on truthful advertising of prescription drugs," Duran says. Read More & Comment...
Byline: DANYLO HAWALESHKA
In the pivotal courtroom scene from A Few Good Men, Tom Cruise shouts, "I want the truth!" at Jack Nicholson, whose truculent character is testifying. "You can't handle the truth!" Nicholson famously retorts. Today, in a real-life courtroom drama, CanWest MediaWorks Inc. has, in a manner, assumed Cruise's role, with a somewhat less altruistic goal in mind than simple verity.
In a civil lawsuit now before Ontario's Superior Court of Justice, CanWest contends Canadians are being denied important truths about prescription medications because of strict limits on drug advertising. Canada's largest media company claims the regulations thwart its constitutional right to freedom of expression.
CanWest's suit against the attorney general of Canada casts the country's Food and Drugs Act as the villain. The act forbids direct-to-consumer advertising (DTCA) that ties a prescription drug to a treatment, cure or disease. (It is illegal for CanWest to, for instance, run an ad to promote Viagra for impotence, but quite legal to separately publicize the brand, or the condition; there are no such restrictions on ads that target physicians exclusively in, say, trade journals.) In a sworn statement, Arturo Duran, a CanWest MediaWorks president, claims permitting DTCA in Canada would educate the public about drug risks and benefits. "There is no evidence to justify a ban on truthful advertising of prescription drugs," Duran says. Read More & Comment...
10/12/2006 10:33 AM |
Open Letter from the Ontario Pharmacists' Association
TORONTO, Oct. 11
Hon. Tony Clement
Minister of Health, Government of Canada
Minister's Office, Health Canada
Brooke Claxton Building, Tunney's Pasture
Ottawa, Canada K1A 0K9
Dear Minister,
Ontario pharmacists are gravely concerned about the imminent threat to Canada's prescription drug supply, and the corresponding public health and safety threat to Canadians, arising from legislative changes and relaxed enforcement measures in the United States that re-open America's border to the importation of prescription drugs by U.S. patients.
As you know, Congressional leaders struck a deal on September 29 to allow Americans to carry back from Canada a 90-day personal supply of prescription drugs through "foot traffic" importation. The Department of Homeland Security compounded this change by ceasing confiscation by Customs and Border Protection agents of drugs ordered over the Internet and mailed to Americans, effective October 9.
We appreciate that these developments represent political deal-making by American lawmakers to take high U.S. prescription drug costs off the table as an issue to protect incumbents in the U.S. mid-term elections. However, the impact on Canada is clear: we are back to a free-for-all for cross-border drug importation.
We are deeply disturbed that in spite of the serious implications for Canada's drug supply and the health and safety of Canadians, there is no evidence of consultation with the Government of Canada, or of any effort to ask how our pharmacists and drug experts view American patients raiding Canada's medicine cabinet.
Our pharmacists do not want to become America's drug store. Our job is to provide medications and expertise to Canadian patients, not provide solutions or the shortcomings of the U.S. health care system and its problem with high drug costs.
U.S. demand is more than ten times the size of Canadian supply. We do not have the capacity to feed America's need for lower-cost drugs, and unimpeded depletion of our supply poses a serious threat to public health and safety in Canada.
We are further concerned that the legitimizing of Internet drug purchases by Americans encourages fraud by offshore criminals posing as Canadian pharmacists and selling counterfeit drugs. This is a health and safety threat to both American and Canadian patients who rely on the reputation of Canadian pharmacists and buy drugs from what they believe are Canadian Internet pharmacies, believing them to be safe and genuine.
In fact, U.S. customs statistics on mail-order seizures show at least 10 per cent of packages purportedly from Canadian Internet pharmacies contain counterfeit drugs.
We believe it is prudent and reasonable to also call attention at this time to the renewed emergence with these U.S. legislative and enforcement changes of a national security vulnerability in both the U.S. and Canada arising from the re-opening of the door to the potential for drug terrorism, with drugs sent by mail used as a vehicle of attack on innocent members of the public.
In this respect, an April 2005 report to Congress warned "the nation's medicine supply is vulnerable to exploitation by organized criminals, drug traffickers and terrorists. We should not contemplate opening our borders to threats to our medicine supply when in all other aspects we are searching for ways to tighten the security of our borders."
While the legislative changes enacted to date do not support bulk importation, we note that proponents of the changes in Congress have indicated their interest and intent to bring forward "full-blown" importation legislation in the future. We must warn unequivocally that bulk importation would quickly deplete the Canadian drug supply and cause a crisis in drug
availability for Canadians - in one credible U.S. analysis, within 38 days.
We also have a more fundamental concern that these developments further encourage the use of Internet pharmacies by patients who bypass their own community pharmacists. Patients who do so jeopardize their health and risk dangerous drug interactions by relinquishing expert consultation and crucial pharmacist-patient interaction.
We are disappointed that the Government of Canada has stood idly by while the U.S. has made changes that threaten the Canadian prescription drug supply, pose a danger to the health and safety of Canadians, raise national security vulnerabilities and undermine the important, long-standing relationship between pharmacists and patients.
We respectfully call on the Government of Canada to take immediate action to protect Canada's prescription drug supply by banning prescription drug sales to U.S. patients by all means, including "foot traffic", Internet and mail order.
We look forward to your reply at your earliest convenience.
Marc Kealey
Chief Executive Officer
Ontario Pharmacists' Association
For further information: or to set up an interview, please contact: Mary-Anne Cedrone, Manager of Communications, Ontario Pharmacists' Association, (416) 441-0788 ext.4266, Cell: (416) 278-5582 Read More & Comment...
TORONTO, Oct. 11
Hon. Tony Clement
Minister of Health, Government of Canada
Minister's Office, Health Canada
Brooke Claxton Building, Tunney's Pasture
Ottawa, Canada K1A 0K9
Dear Minister,
Ontario pharmacists are gravely concerned about the imminent threat to Canada's prescription drug supply, and the corresponding public health and safety threat to Canadians, arising from legislative changes and relaxed enforcement measures in the United States that re-open America's border to the importation of prescription drugs by U.S. patients.
As you know, Congressional leaders struck a deal on September 29 to allow Americans to carry back from Canada a 90-day personal supply of prescription drugs through "foot traffic" importation. The Department of Homeland Security compounded this change by ceasing confiscation by Customs and Border Protection agents of drugs ordered over the Internet and mailed to Americans, effective October 9.
We appreciate that these developments represent political deal-making by American lawmakers to take high U.S. prescription drug costs off the table as an issue to protect incumbents in the U.S. mid-term elections. However, the impact on Canada is clear: we are back to a free-for-all for cross-border drug importation.
We are deeply disturbed that in spite of the serious implications for Canada's drug supply and the health and safety of Canadians, there is no evidence of consultation with the Government of Canada, or of any effort to ask how our pharmacists and drug experts view American patients raiding Canada's medicine cabinet.
Our pharmacists do not want to become America's drug store. Our job is to provide medications and expertise to Canadian patients, not provide solutions or the shortcomings of the U.S. health care system and its problem with high drug costs.
U.S. demand is more than ten times the size of Canadian supply. We do not have the capacity to feed America's need for lower-cost drugs, and unimpeded depletion of our supply poses a serious threat to public health and safety in Canada.
We are further concerned that the legitimizing of Internet drug purchases by Americans encourages fraud by offshore criminals posing as Canadian pharmacists and selling counterfeit drugs. This is a health and safety threat to both American and Canadian patients who rely on the reputation of Canadian pharmacists and buy drugs from what they believe are Canadian Internet pharmacies, believing them to be safe and genuine.
In fact, U.S. customs statistics on mail-order seizures show at least 10 per cent of packages purportedly from Canadian Internet pharmacies contain counterfeit drugs.
We believe it is prudent and reasonable to also call attention at this time to the renewed emergence with these U.S. legislative and enforcement changes of a national security vulnerability in both the U.S. and Canada arising from the re-opening of the door to the potential for drug terrorism, with drugs sent by mail used as a vehicle of attack on innocent members of the public.
In this respect, an April 2005 report to Congress warned "the nation's medicine supply is vulnerable to exploitation by organized criminals, drug traffickers and terrorists. We should not contemplate opening our borders to threats to our medicine supply when in all other aspects we are searching for ways to tighten the security of our borders."
While the legislative changes enacted to date do not support bulk importation, we note that proponents of the changes in Congress have indicated their interest and intent to bring forward "full-blown" importation legislation in the future. We must warn unequivocally that bulk importation would quickly deplete the Canadian drug supply and cause a crisis in drug
availability for Canadians - in one credible U.S. analysis, within 38 days.
We also have a more fundamental concern that these developments further encourage the use of Internet pharmacies by patients who bypass their own community pharmacists. Patients who do so jeopardize their health and risk dangerous drug interactions by relinquishing expert consultation and crucial pharmacist-patient interaction.
We are disappointed that the Government of Canada has stood idly by while the U.S. has made changes that threaten the Canadian prescription drug supply, pose a danger to the health and safety of Canadians, raise national security vulnerabilities and undermine the important, long-standing relationship between pharmacists and patients.
We respectfully call on the Government of Canada to take immediate action to protect Canada's prescription drug supply by banning prescription drug sales to U.S. patients by all means, including "foot traffic", Internet and mail order.
We look forward to your reply at your earliest convenience.
Marc Kealey
Chief Executive Officer
Ontario Pharmacists' Association
For further information: or to set up an interview, please contact: Mary-Anne Cedrone, Manager of Communications, Ontario Pharmacists' Association, (416) 441-0788 ext.4266, Cell: (416) 278-5582 Read More & Comment...
10/11/2006 12:03 PM |
If you want a concise explanation as to why the drug safety issue is spiraling out of control and how the media's reporting on such issues contributes to a sense of danger in every drug, read this excellent post from The Scientist.....
A few years ago Princeton health economist Uwe Reinhardt, Dartmouth geriatrician Joann Lynn, and I filmed a documentary on the effect of advancing biomedical technology on affordable healthcare in the United States. Five hours of interviews were reduced to 10-minute bookends for a set of short, emotional stories that obliterated the complexities of the issues. As Reinhardt quipped in our cab, repeating the oft-cited quote, the plural of anecdote is not data. Except on television.
We've all had this experience: You bring work home and talk about concepts central to biomedical research such as evidence-based medicine, controlled trials, equipoise, peer-review, or impact factor. Friends' eyes roll up into their skulls in boredom. Yet the same topics come up in everyday conversation all the time, just framed in a different way: "I know a person who lost his house to the cost of drugs," and "you know a guy who is alive because of Lipitor." Heated arguments ensue about real problems in science, but driven by someone's single story.
Stories are not the enemy of good science and evidence-based medicine. Physicians make crucial but subtle changes in their practices based on individual experiences. Scientists all use intuition and inductive reasoning in the nascent period of an investigation. But anecdotes cannot substitute for either ethnography or controlled study. When Terri Schiavo became the world's test case for diagnosing persistent vegetative state (PVS), the emotional intonations about Ms. Schiavo waking up began to sound like Intelligent Design.
A paradox of biomedical research is that huge controlled trials, meta-analyses, and reviews of the literature are ubiquitous, but the number of "case reports" - and journals comprised entirely of incidental "findings" - is growing.
The media has no idea how to deal with case reports. The worst example of this in recent times was a case study of Zolpidem, the nonbenzodiazepine-branded 'Ambien' and approved by the US Food & Drug Administration for the treatment of insomnia. Physicians Ralf Clauss and Wally Nel have published, a few cases at a time, their very different use of the medication. The Guardian carried a breathless report of Clauss et al's August report in the journal NeuroRehabilitation of three cases involving patients who have been in PVS, they report, for more than three years. Claus and Nel grabbed the front page with the Guardian's report that they used Ambien to wake up these patients.
The 'investigators' had administered Zolpidem for between three and six years and saw each of the three 'treated' patients wake up each day as a result of the medication; one even "caught a baseball." When the medication wore off, the patients dropped back into PVS each evening.
Stunning science? It seemed so, too, back in 2000, when Claus and a different set of South African colleagues published in the South African Medical Journal on a single case with essentially the same outcome. In 2001 they made the same claim in a letter to the same journal. At no point did the investigators conduct an actual study of the phenomenon, with an IRB-approved research protocol or informed consent. Again and again they "wrote up" their "cases," describing their work as innovative medical management rather than research. Journal editors, asleep at the switch, have been derelict in publishing bad research disguised as cases - in this instance a case with the impact of finding a life-extending potion or the presence of extraterrestrial life.
Investigators who jumpstart their programs with case reports are often in search of research support, as was Claus - who as a result of the case report is now funded. In this respect they, and the journals who publish nothing but these case reports, are like the television producers I worked with: They aim at using the power of stories to make the claims and reap the rewards that come from research, but without doing the research. The victims are journalists, readers, and in the Claus case the patients and their families, who are exposed to uncontrolled experiments framed as good medicine. It is time for editors, journalists, the FDA, and the US Health & Human Services Office for Human Research Protections (OHRP) to clamp down on the "case study."
Glenn McGee is the director of the Alden March Bioethics Institute at Albany Medical College, where he holds the John A. Balint Endowed Chair in Medical Ethics.
gmcgee@the-scientist.com Read More & Comment...
A few years ago Princeton health economist Uwe Reinhardt, Dartmouth geriatrician Joann Lynn, and I filmed a documentary on the effect of advancing biomedical technology on affordable healthcare in the United States. Five hours of interviews were reduced to 10-minute bookends for a set of short, emotional stories that obliterated the complexities of the issues. As Reinhardt quipped in our cab, repeating the oft-cited quote, the plural of anecdote is not data. Except on television.
We've all had this experience: You bring work home and talk about concepts central to biomedical research such as evidence-based medicine, controlled trials, equipoise, peer-review, or impact factor. Friends' eyes roll up into their skulls in boredom. Yet the same topics come up in everyday conversation all the time, just framed in a different way: "I know a person who lost his house to the cost of drugs," and "you know a guy who is alive because of Lipitor." Heated arguments ensue about real problems in science, but driven by someone's single story.
Stories are not the enemy of good science and evidence-based medicine. Physicians make crucial but subtle changes in their practices based on individual experiences. Scientists all use intuition and inductive reasoning in the nascent period of an investigation. But anecdotes cannot substitute for either ethnography or controlled study. When Terri Schiavo became the world's test case for diagnosing persistent vegetative state (PVS), the emotional intonations about Ms. Schiavo waking up began to sound like Intelligent Design.
A paradox of biomedical research is that huge controlled trials, meta-analyses, and reviews of the literature are ubiquitous, but the number of "case reports" - and journals comprised entirely of incidental "findings" - is growing.
The media has no idea how to deal with case reports. The worst example of this in recent times was a case study of Zolpidem, the nonbenzodiazepine-branded 'Ambien' and approved by the US Food & Drug Administration for the treatment of insomnia. Physicians Ralf Clauss and Wally Nel have published, a few cases at a time, their very different use of the medication. The Guardian carried a breathless report of Clauss et al's August report in the journal NeuroRehabilitation of three cases involving patients who have been in PVS, they report, for more than three years. Claus and Nel grabbed the front page with the Guardian's report that they used Ambien to wake up these patients.
The 'investigators' had administered Zolpidem for between three and six years and saw each of the three 'treated' patients wake up each day as a result of the medication; one even "caught a baseball." When the medication wore off, the patients dropped back into PVS each evening.
Stunning science? It seemed so, too, back in 2000, when Claus and a different set of South African colleagues published in the South African Medical Journal on a single case with essentially the same outcome. In 2001 they made the same claim in a letter to the same journal. At no point did the investigators conduct an actual study of the phenomenon, with an IRB-approved research protocol or informed consent. Again and again they "wrote up" their "cases," describing their work as innovative medical management rather than research. Journal editors, asleep at the switch, have been derelict in publishing bad research disguised as cases - in this instance a case with the impact of finding a life-extending potion or the presence of extraterrestrial life.
Investigators who jumpstart their programs with case reports are often in search of research support, as was Claus - who as a result of the case report is now funded. In this respect they, and the journals who publish nothing but these case reports, are like the television producers I worked with: They aim at using the power of stories to make the claims and reap the rewards that come from research, but without doing the research. The victims are journalists, readers, and in the Claus case the patients and their families, who are exposed to uncontrolled experiments framed as good medicine. It is time for editors, journalists, the FDA, and the US Health & Human Services Office for Human Research Protections (OHRP) to clamp down on the "case study."
Glenn McGee is the director of the Alden March Bioethics Institute at Albany Medical College, where he holds the John A. Balint Endowed Chair in Medical Ethics.
gmcgee@the-scientist.com Read More & Comment...
10/11/2006 11:44 AM |
Now that the Yankees were eliminated from the ALCS in humiliating fashion I have found myself channel surfing to fill the time....I stumbled upon a C-SPAN broadcast of the debate between Congressman Harold Ford, Jr. and Bob Corker, the Dem and GOP candidates for Bill Frist's Tennessee Senate seat. I might have been hallucinating but I think I heard Ford say 2-3 times that if the government negotiated with drug companies (price controls) it could save Medicare $1 trillion. Since the Part D program will spend about $500 billion over ten years, I am waiting for Ford to explain his math. Or does he have a plan to force drug companies to kick in twice what the government spends on medicines? Or maybe this is over 100 years...
In any event, Ford's koolaid drinking on price controls contrasts with the bill he co-sponsored with Cal Dooley in 2003 which itself sounds and adds up remarkably like the Part D program now in operation. In case Ford forgot or you didn't know about it, here it is:
Zero-Premium, High-Cost Protection, Part B Drug Benefit
Universal ... Progressive ... Affordable
• Zero Premium: This benefit would be incorporated into the existing Medicare Part B
program. No separate premium and no increase in Part B premium.
• Universal Eligibility: All Part B enrollees.
• Universal Protection Against High Drug Costs: Medicare will pay 80 percent of the
cost of drugs after beneficiary has total drug costs of $4,000. The individual will pay
based on a flat three-tiered co-payment: $4/$16/$24*
• Benefit Counts All Drug Spending: Negotiated drug costs Β not just the
beneficiaries= out-of-pocket spending Î’ counts toward the $4,000 deductible.
• Low-Income Benefits: Beneficiaries up to 200 percent of poverty will be eligible to
receive enhanced benefits via Medicare drug discount cards, Medicare+Choice,
Medicaid, Medigap, and other new coverage options.
Medicaid – 135% of fpl tiered co-payment: $4/$16/$24*
135% - 150% of fpl tiered co-payment: $6/$24/$36**
150% - 200% of fpl tiered co-payment: $10/$40/$60***
(State option with a federal/state match at the SCHIP rate)
• Universal Benefit Via Medicare Approved Drug Card Plans: A wide variety of
Medicare approved drug card plans including PBMs, State Assistance Plans, retiree
coverage, Medigap, Medicare + Choice, Medicaid and others that offer all seniors access
to the market-based discounts widely available to people with private insurance. These
discounts would apply to all drug purchases.
• Universal Benefit Via Current Coverage: Encourage the continuation of current
drug coverage through Employer/Retiree plans, Medigap plans, Medicaid, State
pharmaceutical assistance plans, or Medicare+Choice plans; all based on
reimbursement agreements with Medicare.
• CBO Cost Estimate: Under $400 billion
"Market-based discounts" "PBMs" "Under 400 billion" Sounds like a program we already know.
I am still waiting to see how the D's will 'negotiate' down drug prices without closing down formularies and restricting choices like the VA does. Can anyone say Third Rail? Read More & Comment...
In any event, Ford's koolaid drinking on price controls contrasts with the bill he co-sponsored with Cal Dooley in 2003 which itself sounds and adds up remarkably like the Part D program now in operation. In case Ford forgot or you didn't know about it, here it is:
Zero-Premium, High-Cost Protection, Part B Drug Benefit
Universal ... Progressive ... Affordable
• Zero Premium: This benefit would be incorporated into the existing Medicare Part B
program. No separate premium and no increase in Part B premium.
• Universal Eligibility: All Part B enrollees.
• Universal Protection Against High Drug Costs: Medicare will pay 80 percent of the
cost of drugs after beneficiary has total drug costs of $4,000. The individual will pay
based on a flat three-tiered co-payment: $4/$16/$24*
• Benefit Counts All Drug Spending: Negotiated drug costs Β not just the
beneficiaries= out-of-pocket spending Î’ counts toward the $4,000 deductible.
• Low-Income Benefits: Beneficiaries up to 200 percent of poverty will be eligible to
receive enhanced benefits via Medicare drug discount cards, Medicare+Choice,
Medicaid, Medigap, and other new coverage options.
Medicaid – 135% of fpl tiered co-payment: $4/$16/$24*
135% - 150% of fpl tiered co-payment: $6/$24/$36**
150% - 200% of fpl tiered co-payment: $10/$40/$60***
(State option with a federal/state match at the SCHIP rate)
• Universal Benefit Via Medicare Approved Drug Card Plans: A wide variety of
Medicare approved drug card plans including PBMs, State Assistance Plans, retiree
coverage, Medigap, Medicare + Choice, Medicaid and others that offer all seniors access
to the market-based discounts widely available to people with private insurance. These
discounts would apply to all drug purchases.
• Universal Benefit Via Current Coverage: Encourage the continuation of current
drug coverage through Employer/Retiree plans, Medigap plans, Medicaid, State
pharmaceutical assistance plans, or Medicare+Choice plans; all based on
reimbursement agreements with Medicare.
• CBO Cost Estimate: Under $400 billion
"Market-based discounts" "PBMs" "Under 400 billion" Sounds like a program we already know.
I am still waiting to see how the D's will 'negotiate' down drug prices without closing down formularies and restricting choices like the VA does. Can anyone say Third Rail? Read More & Comment...
10/11/2006 11:05 AM |
It is hard not to miss the mass of pink products and pink ribbon promotions, this month being Breast Cancer Awareness Month. (Pink ribbons being the symbol of the quest to treat and cure breast cancer in case anyone has been sleeping the past decade.)
Several corporations are and have allocated a share of the sales of their products to specific breast cancer screening or research activities as part of this effort or as part of a particular company's effort to be socially responsible. No one seems to mind when company's past some sort of eco-friendly sign on their packaging but apparently the idea that capitalist concerns would link the marketing of their products to supporting better cancer care for women is driving a handful of angry, socialist women types crazy.
They argue that corporations are "getting rich" by promoting breast cancer awareness and research. The case rests on one or two isolated cases where the amount to be contributed to a particular organization was not made clear or by comparing marketing costs (for the product in general) to the actual contribution.
Now excuse me, but what is wrong about using a campaign to rid the world of disease or some problem a bad thing for a company to do? When the National Campaign to End Infantile Paralysis (polio) started the March of Dimes Campaign it used tie ins galore and even got then President Roosevelt to hawk products that we donating a share of its proceeds to the effort. And no one seems to give a rip when Ben and Jerry's donates a share of its profits to eliminating low self-esteem issues working in left wing NGOs or Paul Newman kicks in part of his pasta sauce proceeds to his camp for kids dyiing of cancer. And in both cases, people probably buy the products to support the cause. I bought a particular type of matzah for Passover because a share of the dough (unleavened) went to support the Jewish National Fund.
But when some corporations decide to sponsor and promote their sponsorship of breast cancer activities, that is getting rich. The alternative I guess, if you read the bitter and disjointed screeds of the critics, is to have companies do nothing or, more precisely, contribute to their pet projects. In the case of breast cancer, it would be to fund massive studies and lawsuits about the role every food additive and greenhouse gas plays in triggering cancer instead of the effort to support treatments which just enrich drug companies anyway.
The way to deal with fringe elements in all these cases is to take the extreme thinking to its logical conclusion: when you do, you are confronted with a group of people who would rather women be denied better care in order to have their worldview adopted. (Of course they would have the government do it all with higher taxes..just like in Canada where the screening and awareness levels are lower than here). Given the choice between no corporate involvement and corporate involvement along with the funding for a variety of programs that promote early detection, treatment and research, the fringe groups attacking the pink ribbon programs would take a victory over "getting rich" any time. Read More & Comment...
Several corporations are and have allocated a share of the sales of their products to specific breast cancer screening or research activities as part of this effort or as part of a particular company's effort to be socially responsible. No one seems to mind when company's past some sort of eco-friendly sign on their packaging but apparently the idea that capitalist concerns would link the marketing of their products to supporting better cancer care for women is driving a handful of angry, socialist women types crazy.
They argue that corporations are "getting rich" by promoting breast cancer awareness and research. The case rests on one or two isolated cases where the amount to be contributed to a particular organization was not made clear or by comparing marketing costs (for the product in general) to the actual contribution.
Now excuse me, but what is wrong about using a campaign to rid the world of disease or some problem a bad thing for a company to do? When the National Campaign to End Infantile Paralysis (polio) started the March of Dimes Campaign it used tie ins galore and even got then President Roosevelt to hawk products that we donating a share of its proceeds to the effort. And no one seems to give a rip when Ben and Jerry's donates a share of its profits to eliminating low self-esteem issues working in left wing NGOs or Paul Newman kicks in part of his pasta sauce proceeds to his camp for kids dyiing of cancer. And in both cases, people probably buy the products to support the cause. I bought a particular type of matzah for Passover because a share of the dough (unleavened) went to support the Jewish National Fund.
But when some corporations decide to sponsor and promote their sponsorship of breast cancer activities, that is getting rich. The alternative I guess, if you read the bitter and disjointed screeds of the critics, is to have companies do nothing or, more precisely, contribute to their pet projects. In the case of breast cancer, it would be to fund massive studies and lawsuits about the role every food additive and greenhouse gas plays in triggering cancer instead of the effort to support treatments which just enrich drug companies anyway.
The way to deal with fringe elements in all these cases is to take the extreme thinking to its logical conclusion: when you do, you are confronted with a group of people who would rather women be denied better care in order to have their worldview adopted. (Of course they would have the government do it all with higher taxes..just like in Canada where the screening and awareness levels are lower than here). Given the choice between no corporate involvement and corporate involvement along with the funding for a variety of programs that promote early detection, treatment and research, the fringe groups attacking the pink ribbon programs would take a victory over "getting rich" any time. Read More & Comment...
10/11/2006 06:44 AM |
You’ve got a friend in Pennsylvania? Not if you’re a low-income patient who needs access to the best medical treatment for your condition.
First Health/Provider Synergies, the PBM used by the Quaker State to manage most of its Medicaid formulary decisions, has adopted a draconian new procedure that will make it almost impossible for Medicaid-eligible Pennsylvanians to get any new, cutting-edge medicines.
Astonishingly, FH/PS will give each pharmaceutical innovator one hour per year to make clinical presentations on all their products and one additional hour per year for "continuing education" on their products. This is not one hour per product; this is one hour per company!
This is a staggering demonstration of disinterest in clinical information, further demonstrating Medicaid’s broken process for choosing medicines -- more akin to a rug bazaar than proper science.
And it negatively impacts Pennsylvania’s neediest population. In a private plan, the consumer can make a choice to accept a higher co-pay for the medicines their doctor deem best for their condition. Medicaid recipients cannot. Typically, a prior authorization enforced by FH/PS makes it impossible for Medicaid recipients to get the medicine their doctors want them to have.
When cost-savings are put ahead of patient health, it’s not only bad process, it’s bad medicine. Read More & Comment...
First Health/Provider Synergies, the PBM used by the Quaker State to manage most of its Medicaid formulary decisions, has adopted a draconian new procedure that will make it almost impossible for Medicaid-eligible Pennsylvanians to get any new, cutting-edge medicines.
Astonishingly, FH/PS will give each pharmaceutical innovator one hour per year to make clinical presentations on all their products and one additional hour per year for "continuing education" on their products. This is not one hour per product; this is one hour per company!
This is a staggering demonstration of disinterest in clinical information, further demonstrating Medicaid’s broken process for choosing medicines -- more akin to a rug bazaar than proper science.
And it negatively impacts Pennsylvania’s neediest population. In a private plan, the consumer can make a choice to accept a higher co-pay for the medicines their doctor deem best for their condition. Medicaid recipients cannot. Typically, a prior authorization enforced by FH/PS makes it impossible for Medicaid recipients to get the medicine their doctors want them to have.
When cost-savings are put ahead of patient health, it’s not only bad process, it’s bad medicine. Read More & Comment...
10/10/2006 04:49 PM |
On the heels of Steve Usdin's great piece on the outdated approach FDA critics are takig to drug safety comes an excellent piece by the Newark Star-Ledger's Kitta MacPherson.
Pretty inteilligible quote by yours truly on the failure of second-guessers to call for more funding for Critical Path and to accelerate use of biomarkers and other approaches to identify safety signals before drugs are on the market and to "tag" people before they are prescribed. For Bruce Psarty to say -- "yes, pharmacogenomics is an exciting tool but not ready for prime time so let's spend billions on even larger clinical trials and reviewers and risk management programs" is to simply make it even more difficult to create better tools. And since the IOM report does claim that the most important recommendation it makes is to INTEGRATE safety and efficacy evaluation, why is everyone suggesting steps that separate them instead of supporting science-based techniques that achieve that goal.
Here's the link to the Star-Ledger article
http://www.nj.com/search/index.ssf?/base/news-9/1160455110190710.xml?starledger?ntop&coll=1&thispage=2#continue
And one more thing: Curt Furberg's article on drug safety in the Archives of Internal Medicine.... Here's Furberg explaining his reasoning for putting a "black box" or additional risk warning on drugs for ADHD:
"On the surface, it is hard to believe( so many children really have ADHD)," said Curt Furberg, professor of public health sciences at North Carolina's Wake Forest University Medical School, who voted for the black-box warning. "What is also interesting is this condition is not really recognized in other countries -- you wonder what we are treating. I am sure there are patients who need these drugs, but it is not 10 percent of all 10-year-old boys."
In otherwords, Furberg decided to scare people away from using "these drugs" because he thinks most kids don't need them.... That follows the bogus cancer scare and Psaty ginned up regarding calcium channel blockers... And we are supposed to follow his lead on how to reform the FDA. Read More & Comment...
Pretty inteilligible quote by yours truly on the failure of second-guessers to call for more funding for Critical Path and to accelerate use of biomarkers and other approaches to identify safety signals before drugs are on the market and to "tag" people before they are prescribed. For Bruce Psarty to say -- "yes, pharmacogenomics is an exciting tool but not ready for prime time so let's spend billions on even larger clinical trials and reviewers and risk management programs" is to simply make it even more difficult to create better tools. And since the IOM report does claim that the most important recommendation it makes is to INTEGRATE safety and efficacy evaluation, why is everyone suggesting steps that separate them instead of supporting science-based techniques that achieve that goal.
Here's the link to the Star-Ledger article
http://www.nj.com/search/index.ssf?/base/news-9/1160455110190710.xml?starledger?ntop&coll=1&thispage=2#continue
And one more thing: Curt Furberg's article on drug safety in the Archives of Internal Medicine.... Here's Furberg explaining his reasoning for putting a "black box" or additional risk warning on drugs for ADHD:
"On the surface, it is hard to believe( so many children really have ADHD)," said Curt Furberg, professor of public health sciences at North Carolina's Wake Forest University Medical School, who voted for the black-box warning. "What is also interesting is this condition is not really recognized in other countries -- you wonder what we are treating. I am sure there are patients who need these drugs, but it is not 10 percent of all 10-year-old boys."
In otherwords, Furberg decided to scare people away from using "these drugs" because he thinks most kids don't need them.... That follows the bogus cancer scare and Psaty ginned up regarding calcium channel blockers... And we are supposed to follow his lead on how to reform the FDA. Read More & Comment...
10/10/2006 06:42 AM |
The precise and prosaic Steve Usdin, Washington, DC editor of BioCentury, offers a prescient and penetrating perlustration on the impact and implications of the recent IOM report, the pending Enzi/Kennedy legislation, and their potential repercussions on the forthcoming battle over PDUFA reauthorization.
Must reading.
Here's a link to the article entitled, "Total Lifecycle Regulation" ...
Download file Read More & Comment...
Must reading.
Here's a link to the article entitled, "Total Lifecycle Regulation" ...
Download file Read More & Comment...
10/09/2006 04:20 PM |
NEJM is running with two editorials on the heels of the IOM report on FDA's drug safety performance. One editorial is written by IOM task force member Bruce Psaty who has a history of dredging up data designed to scare without regard to accuracy. As one observer put it: Another breast cancer-scare story came during NBCAM at the expense of a widely prescribed class of drugs used to treat high blood pressure, called "calcium channel blockers" or CCBs. Published in the journal Cancer, this study reported post-menopausal women using CCBs had a 150 percent increased risk of breast cancer.
But the study was small and, as stated in a National Institutes of Health press release, "the findings do not establish a causal link between calcium channel blocker use and breast cancer." Moreover, the study conflicts with results of SYST-EUR, a recent long-term clinical trial of CCBs that did not reveal any increased cancer incidence.
The Cancer study is just the latest in a series of CCB-scares manufactured by Dr. Curt Furberg of Bowman Gray Medical School and oft-time cohort Dr. Bruce Psaty of the University of Washington. Their first scare linked CCBs with increased heart attack risk. But the evidence was so shoddy that Dr. Psaty was forced to apologize to colleagues at the American Society of Hypertension for launching a scare based on a single study with serious limitations.
Psaty is the lead author of the editorial in the NEJM calling for more clinical trials after market and a ban on DTC.
In any event, as I have said before, the IOM missed an opportunity to build support for effort to support more funding for programs that could truly make medicines safer without burdening drug development with pointless studies that will only make the process more costly and limit access to new medicines without regard to more precise risk/benefit profiles. As the FDA's Critical Path report noted nearly 4 years ago:
"Safety issues should be detected as early as possible, ways to distinguish potential from actual safety problems should be available..." Neither the IOM and NEJM talk about the use of biomarkers and the development of observational databases that could be mined to develop predictive models, the creation of more targeted medicines, the use of genetic tests, investment in data consortium. No. Just bigger, government funded studies that take years to organize, conduct and sort out. And meanwhile, patients and doctors are supposed to labor under onerous risk management programs that dole out drugs under the scrunity of government appointed risk finders who limit the expanded use of medicines.
Is there anyone in the media who will challenge or examine this conventional wisdom? Read More & Comment...
But the study was small and, as stated in a National Institutes of Health press release, "the findings do not establish a causal link between calcium channel blocker use and breast cancer." Moreover, the study conflicts with results of SYST-EUR, a recent long-term clinical trial of CCBs that did not reveal any increased cancer incidence.
The Cancer study is just the latest in a series of CCB-scares manufactured by Dr. Curt Furberg of Bowman Gray Medical School and oft-time cohort Dr. Bruce Psaty of the University of Washington. Their first scare linked CCBs with increased heart attack risk. But the evidence was so shoddy that Dr. Psaty was forced to apologize to colleagues at the American Society of Hypertension for launching a scare based on a single study with serious limitations.
Psaty is the lead author of the editorial in the NEJM calling for more clinical trials after market and a ban on DTC.
In any event, as I have said before, the IOM missed an opportunity to build support for effort to support more funding for programs that could truly make medicines safer without burdening drug development with pointless studies that will only make the process more costly and limit access to new medicines without regard to more precise risk/benefit profiles. As the FDA's Critical Path report noted nearly 4 years ago:
"Safety issues should be detected as early as possible, ways to distinguish potential from actual safety problems should be available..." Neither the IOM and NEJM talk about the use of biomarkers and the development of observational databases that could be mined to develop predictive models, the creation of more targeted medicines, the use of genetic tests, investment in data consortium. No. Just bigger, government funded studies that take years to organize, conduct and sort out. And meanwhile, patients and doctors are supposed to labor under onerous risk management programs that dole out drugs under the scrunity of government appointed risk finders who limit the expanded use of medicines.
Is there anyone in the media who will challenge or examine this conventional wisdom? Read More & Comment...
10/09/2006 01:43 PM |
Our friend, colleague and thought leader in the health care field, Doug Badger is now in the private sector. We crossed the partisan divide (Doug is a Phillies fan and Peter and I are STILL Yankees fans despite the meltdown of the past week) to ask Doug to join us. We are glad he did. And so will those of you who follow this site and our work. Here's the release announcing his appointment as a senior fellow:
Doug Badger, a partner at the Nickles Group and former deputy assistant to President George W. Bush for legislative affairs is joining the Center for Medicine in the Public Interest as a Senior Fellow. Doug will conduct research and write on consumer-driven health care, Medicare reform and the impact of medical innovation on health care financing. He will also be a regular contributor to CMPI's popular blog, drugwonks.com.
CMPI co-founders Peter Pitts and Bob Goldberg said: "Having Doug Badger join an emerging think tank like CMPI is like having Derek Jeter sign with a new baseball franchise. He is one of the most creative and knowledgeable health care experts in America. We look forward to sharing Doug's energy, humor and optimism with the broader public."
Doug joined the Nickles Group in September 2006, after serving as a senior White House adviser. As deputy assistant to the President for legislative affairs, Doug helped formulate Administration policy and legislative strategy on a broad range of issues, including health care, energy, taxes, financial services, pensions and employee benefits, intellectual property, trade, and telecommunications.
Badger also served for two years as the President's lead health policy adviser, developing the Administration's proposal for adding prescription drug coverage to Medicare and representing the White House in negotiations with Congress that resulted in enactment of the Medicare Modernization Act. He also advised the President on other health-related matters, including Medicare and Medicaid reimbursement issues and the creation of health savings accounts.
Prior to joining the White House, Badger was a partner at Washington Counsel Ernst & Young, where his practice included health care, intellectual property, and employee benefits.
He also served for a decade as a U.S. Senate aide, including stints as chief of staff to Assistant Majority Leader Don Nickles and staff director of the Senate Republican Policy Committee. Badger also has held senior positions at the U.S. Department of Health and Human Services and the Social Security Administration. Read More & Comment...
Doug Badger, a partner at the Nickles Group and former deputy assistant to President George W. Bush for legislative affairs is joining the Center for Medicine in the Public Interest as a Senior Fellow. Doug will conduct research and write on consumer-driven health care, Medicare reform and the impact of medical innovation on health care financing. He will also be a regular contributor to CMPI's popular blog, drugwonks.com.
CMPI co-founders Peter Pitts and Bob Goldberg said: "Having Doug Badger join an emerging think tank like CMPI is like having Derek Jeter sign with a new baseball franchise. He is one of the most creative and knowledgeable health care experts in America. We look forward to sharing Doug's energy, humor and optimism with the broader public."
Doug joined the Nickles Group in September 2006, after serving as a senior White House adviser. As deputy assistant to the President for legislative affairs, Doug helped formulate Administration policy and legislative strategy on a broad range of issues, including health care, energy, taxes, financial services, pensions and employee benefits, intellectual property, trade, and telecommunications.
Badger also served for two years as the President's lead health policy adviser, developing the Administration's proposal for adding prescription drug coverage to Medicare and representing the White House in negotiations with Congress that resulted in enactment of the Medicare Modernization Act. He also advised the President on other health-related matters, including Medicare and Medicaid reimbursement issues and the creation of health savings accounts.
Prior to joining the White House, Badger was a partner at Washington Counsel Ernst & Young, where his practice included health care, intellectual property, and employee benefits.
He also served for a decade as a U.S. Senate aide, including stints as chief of staff to Assistant Majority Leader Don Nickles and staff director of the Senate Republican Policy Committee. Badger also has held senior positions at the U.S. Department of Health and Human Services and the Social Security Administration. Read More & Comment...
10/09/2006 08:23 AM |
Congressional Research Service reports that North Korea is producing counterfeit pharmaceuticals to finance its military-industrial complex.
Canada of course is a prime transhipment spot for counterfeiters in an indictment that was unsealed by a Joint Federal Task Force on drug counterfeiter that is going after a ring involving...North Korea of course.
Thank you Senator Vitter for standing tall on the issue of drug importation. Read More & Comment...
Canada of course is a prime transhipment spot for counterfeiters in an indictment that was unsealed by a Joint Federal Task Force on drug counterfeiter that is going after a ring involving...North Korea of course.
Thank you Senator Vitter for standing tall on the issue of drug importation. Read More & Comment...
10/09/2006 06:00 AM |
All is not quiet on the Western Front.
Since the EU’s High Level Pharmaceutical Forum (HLPF) recommended that Europe revisit new, more patient-friendly rules towards direct-to-consumer health care information (what our transatlantic cousins refer to as, “information-to-patients†or “ItPâ€) the merde has hit the fan.
Hey, you gotta break some eggs to make an omelet.
Bouquets to MEP Jorgo Chatzimarkakis, one of the EU Parliament's three representatives on the HLPF, who finds the current information ban on medicines unacceptable. "I can understand a ban on advertisements but I can not agree on the ban on information, which leads us to a situation where patients are obliged to surf around the Internet to look for information on medicines. Citizens can not be deprived of information by their own governments on such crucial issues as one's health," he argues.
And brickbats to Health Action International (HAI) who claims, “there is no health information gap in Europe.†(www.haiweb.org). HAI (no relation to Hospital Acquired Infections – but you think they would have thought about that before adopting the acronym) disallows with a wave of their hand any useful participation by the pharmaceutical industry in providing patient information because of a “natural conflict of interest.†How very Rousseau. But concepts of natural liberty notwithstanding, HAI offers up al lot of the usual anti-industry accusations without even a scintilla of evidence. I guess since it’s “natural,†no proof is required. Weak argument.
And who does HAI consider excellent sources of patient information? Get this – IQWIG and NICE to name two. Really. I am not making this up.
HAI waves the usual banners of “evidence-based medicine,†“rational use of medicine,†and the “over-medicalisation of the European population.†And they are very clearly adherents to the Precautionary Principle of "doing nothing until you know everything" (not surprising since one of their major funders is the Rockefeller Foundation).
And listen to this, “For each option (of type of medicine) patients should be able to clearly identify benefits (degrees of clinical effectiveness on important outcomes, convenience, etc.) and harms (potential side effects, disturbances of personal and social life, etc.). Yes – and every taxpayer should have a deep and profound understanding of the tax code. How about this as a recommendation – let patients have access to information from every source and then let them speak with their physicians. That’s when good things happen.
“Degrees of clinical effectiveness?†Isn’t that the job of … physicians?
By the way, in case you’re wondering about where HAI gets its money -- out of a total budget of €1.022.169 (2002 figures are the latest available) €557.604 came from the Dutch Ministry of Foreign Affairs. Of that funding, €300.104 was spent on something called the “Drug Pricing Project.â€
Aha and indeed. Will better-informed consumers want broader access to more pharmaceutical options? Nuff said. And let's face it; EU governments don’t want to spend the money -- outcomes notwithstanding. No wonder HAI points to IQWIG and ilk as the best sources for consumer health care information.
What a blatant charade.
Information is Power. Read More & Comment...
Since the EU’s High Level Pharmaceutical Forum (HLPF) recommended that Europe revisit new, more patient-friendly rules towards direct-to-consumer health care information (what our transatlantic cousins refer to as, “information-to-patients†or “ItPâ€) the merde has hit the fan.
Hey, you gotta break some eggs to make an omelet.
Bouquets to MEP Jorgo Chatzimarkakis, one of the EU Parliament's three representatives on the HLPF, who finds the current information ban on medicines unacceptable. "I can understand a ban on advertisements but I can not agree on the ban on information, which leads us to a situation where patients are obliged to surf around the Internet to look for information on medicines. Citizens can not be deprived of information by their own governments on such crucial issues as one's health," he argues.
And brickbats to Health Action International (HAI) who claims, “there is no health information gap in Europe.†(www.haiweb.org). HAI (no relation to Hospital Acquired Infections – but you think they would have thought about that before adopting the acronym) disallows with a wave of their hand any useful participation by the pharmaceutical industry in providing patient information because of a “natural conflict of interest.†How very Rousseau. But concepts of natural liberty notwithstanding, HAI offers up al lot of the usual anti-industry accusations without even a scintilla of evidence. I guess since it’s “natural,†no proof is required. Weak argument.
And who does HAI consider excellent sources of patient information? Get this – IQWIG and NICE to name two. Really. I am not making this up.
HAI waves the usual banners of “evidence-based medicine,†“rational use of medicine,†and the “over-medicalisation of the European population.†And they are very clearly adherents to the Precautionary Principle of "doing nothing until you know everything" (not surprising since one of their major funders is the Rockefeller Foundation).
And listen to this, “For each option (of type of medicine) patients should be able to clearly identify benefits (degrees of clinical effectiveness on important outcomes, convenience, etc.) and harms (potential side effects, disturbances of personal and social life, etc.). Yes – and every taxpayer should have a deep and profound understanding of the tax code. How about this as a recommendation – let patients have access to information from every source and then let them speak with their physicians. That’s when good things happen.
“Degrees of clinical effectiveness?†Isn’t that the job of … physicians?
By the way, in case you’re wondering about where HAI gets its money -- out of a total budget of €1.022.169 (2002 figures are the latest available) €557.604 came from the Dutch Ministry of Foreign Affairs. Of that funding, €300.104 was spent on something called the “Drug Pricing Project.â€
Aha and indeed. Will better-informed consumers want broader access to more pharmaceutical options? Nuff said. And let's face it; EU governments don’t want to spend the money -- outcomes notwithstanding. No wonder HAI points to IQWIG and ilk as the best sources for consumer health care information.
What a blatant charade.
Information is Power. Read More & Comment...
10/06/2006 04:08 PM |
The FDA approved Zolinza for treating of advanced forms of cutaneous T-cell lymphoma (CTCL). Zolinza is the first in a new class of cancer drugs to win FDA approval. The drugs, called histone deacetylase inhibitors, are thought to silence some genes that, when left unchecked, allow cancerous cells to proliferate.
"We see CTCL as the tip of the iceberg," said Dr. Stanley Frankel, senior director of clinical research in oncology for Merck. (Which licensed the drug from a biotech firm) "It proves that this pathway can be attacked effectively and therefore make for an entirely new way of treating cancers."
While some early trial results seem promising, Zolinza's effect on the larger cancer question remains to be seen, said Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer. The pathway targeted by the drug is a relative newcomer in the cancer field, he added.
"There is a lot of excitement about targeted therapies. This is not the same type of mechanism as those other agents; nonetheless, any new approach to treating cancer — any novel approach that uses a new pathway, that can be taken by mouth, has limited side effects — merits more attention and hopefully will be successful over time," Lichtenfeld said.
Well that's what you think.
I can't wait for the next spate of articles from those reporters and pundits who I have named the Circle of Cancer Cynics. Their motto: if the drug doesn't increase survival by more than a month or so...who needs it? Founding member: Merrill Goozner who sees Avastin as a useless drug since it does not prolong median survival in cancer patients who have failed other treatments and are about to die. Platinum members include every reporter who has written or rewritten the "so much money and the portions are so small" story about cancer drugs into the ground. Gold members include the handful of doctors who get paid to say these sort of things in Europe and Canada to justify rationing
Using this new litmus test, Zolinza should be scrapped in favor of surgery, painful radiation and chemotherapy or just plain dying and stop wasting all the money that could be spent on universal health care for all. According to a report on the drug given at ASCO, the overall response rate for vorinostat was 29.5%. Time to progression was 148 days for all patients and greater than 203 days for responders.
Less than two lousy months of delayed tumor progression AND NO survival benefit?
Why if Goozner and co had their way, the government would set the research agenda consistent with other social goals -- like universal healthcare -- and have had the FDA reject the drug on the basis of some 5 year multi-center comparative effectiveness study developed, designed and administrered by the government. Every drug would have to pass through that hoop instead of going directly to doctors and patients.
Problem is, taking a look backward we see that survival rates have risen and mortality as a function of diagnosed cancer has declined because of the timely access to these 'useless' drugs. And their value to patients and their families -- in terms of more productive time together -- is in the hundreds of billions.
But if you are part of the Circle of Cancer Cynics, there is no accounting for value or quality of life over time or ever. Either a drug cures you or you should stick with what is now around.
I'd like to see them tell that to parents with kids dying of cancer. They don't have the guts. Read More & Comment...
"We see CTCL as the tip of the iceberg," said Dr. Stanley Frankel, senior director of clinical research in oncology for Merck. (Which licensed the drug from a biotech firm) "It proves that this pathway can be attacked effectively and therefore make for an entirely new way of treating cancers."
While some early trial results seem promising, Zolinza's effect on the larger cancer question remains to be seen, said Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer. The pathway targeted by the drug is a relative newcomer in the cancer field, he added.
"There is a lot of excitement about targeted therapies. This is not the same type of mechanism as those other agents; nonetheless, any new approach to treating cancer — any novel approach that uses a new pathway, that can be taken by mouth, has limited side effects — merits more attention and hopefully will be successful over time," Lichtenfeld said.
Well that's what you think.
I can't wait for the next spate of articles from those reporters and pundits who I have named the Circle of Cancer Cynics. Their motto: if the drug doesn't increase survival by more than a month or so...who needs it? Founding member: Merrill Goozner who sees Avastin as a useless drug since it does not prolong median survival in cancer patients who have failed other treatments and are about to die. Platinum members include every reporter who has written or rewritten the "so much money and the portions are so small" story about cancer drugs into the ground. Gold members include the handful of doctors who get paid to say these sort of things in Europe and Canada to justify rationing
Using this new litmus test, Zolinza should be scrapped in favor of surgery, painful radiation and chemotherapy or just plain dying and stop wasting all the money that could be spent on universal health care for all. According to a report on the drug given at ASCO, the overall response rate for vorinostat was 29.5%. Time to progression was 148 days for all patients and greater than 203 days for responders.
Less than two lousy months of delayed tumor progression AND NO survival benefit?
Why if Goozner and co had their way, the government would set the research agenda consistent with other social goals -- like universal healthcare -- and have had the FDA reject the drug on the basis of some 5 year multi-center comparative effectiveness study developed, designed and administrered by the government. Every drug would have to pass through that hoop instead of going directly to doctors and patients.
Problem is, taking a look backward we see that survival rates have risen and mortality as a function of diagnosed cancer has declined because of the timely access to these 'useless' drugs. And their value to patients and their families -- in terms of more productive time together -- is in the hundreds of billions.
But if you are part of the Circle of Cancer Cynics, there is no accounting for value or quality of life over time or ever. Either a drug cures you or you should stick with what is now around.
I'd like to see them tell that to parents with kids dying of cancer. They don't have the guts. Read More & Comment...
10/06/2006 03:56 PM |
Here's Decode Genetics, a pioneer in the field of personalized medicine, foundering on the rocks of manufacturing...Seems as though if the drug doesn't dissolve at a certain rate, it won't work. The good news is that Decode was able -- before bringing the drug into later trials -- to pinpoint the problem because of the link between genetics and metabolism. It's an excellent example of why more money and time -- not less -- should be spent on the Critical Path to address drug safety issues.
deCode halts trial of heart attack drug
NEW YORK (AFX) - Biotech drug developer deCode Genetics Inc. said Friday it suspended a late-stage clinical trial for a heart attack prevention drug because of a manufacturing issue with tablets supplied for the study.
The company stopped the trial when it found tablets of the drug veliflapon appeared to be dissolving too slowly, which it said would interfere with gauging the drug's effectiveness.
Reykjavik, Iceland-based deCode said it had presented the problem to the U.S. Food and Drug Administration and is exploring alternative manufacturing processes for the drug.
The company may be best known for licensing the genetic information of Iceland's population.
Using the population data, Veliflapon is one of two compounds the company has linked to two genes that encode proteins that could raise the risk of a heart attack. The other compound is in early stage clinical trials. Read More & Comment...
deCode halts trial of heart attack drug
NEW YORK (AFX) - Biotech drug developer deCode Genetics Inc. said Friday it suspended a late-stage clinical trial for a heart attack prevention drug because of a manufacturing issue with tablets supplied for the study.
The company stopped the trial when it found tablets of the drug veliflapon appeared to be dissolving too slowly, which it said would interfere with gauging the drug's effectiveness.
Reykjavik, Iceland-based deCode said it had presented the problem to the U.S. Food and Drug Administration and is exploring alternative manufacturing processes for the drug.
The company may be best known for licensing the genetic information of Iceland's population.
Using the population data, Veliflapon is one of two compounds the company has linked to two genes that encode proteins that could raise the risk of a heart attack. The other compound is in early stage clinical trials. Read More & Comment...
10/06/2006 02:27 PM |
Imagine if we decided that there was a “crisis†in American transportation – that transportation was “too expensive.†Would we opt to slash spending for new road and bridge construction?
Now imagine there is a crisis in American health care.
Tyler Cowen (professor of economics at George Mason University), in a very thought-provoking article in the New York Times, makes some important points vis-Ã -vis investment in pharmaceutical development and a reality check on outcomes both in the US and abroad.
A few enticing cantlets:
“The American government could use its size, or use the law, to bargain down health care prices, as many European governments have done. In the short run, this would save money but in the longer run it would cost lives.â€
“Medical innovations improve health and life expectancy in all wealthy countries, not just in the United States. That is one reason American citizens do not live longer.â€
“The National Institutes of Health’s current annual research budget is $28 billion, All European Union governments, in contrast, spent $3.7 billion in 2000, and since that time, Europe has not narrowed the research and development gap.â€
“In the last 10 years, for instance, 12 Nobel Prizes in medicine have gone to American-born scientists working in the United States, 3 have gone to foreign-born scientists working in the United States, and just 7 have gone to researchers outside the country.â€
“Even when the initial research is done overseas, the American system leads in converting new ideas into workable commercial technologies.â€
“The gains from medical innovations are high. For instance, increases in life expectancy resulting from better treatment of cardiovascular disease from 1970 to 1990 have been conservatively estimated as bringing benefits worth more than $500 billion a year. And that is just for the United States.â€
Here is a link to the original article:
http://www.nytimes.com/2006/10/05/business/05scene.html?_r=1&oref=slogin Read More & Comment...
Now imagine there is a crisis in American health care.
Tyler Cowen (professor of economics at George Mason University), in a very thought-provoking article in the New York Times, makes some important points vis-Ã -vis investment in pharmaceutical development and a reality check on outcomes both in the US and abroad.
A few enticing cantlets:
“The American government could use its size, or use the law, to bargain down health care prices, as many European governments have done. In the short run, this would save money but in the longer run it would cost lives.â€
“Medical innovations improve health and life expectancy in all wealthy countries, not just in the United States. That is one reason American citizens do not live longer.â€
“The National Institutes of Health’s current annual research budget is $28 billion, All European Union governments, in contrast, spent $3.7 billion in 2000, and since that time, Europe has not narrowed the research and development gap.â€
“In the last 10 years, for instance, 12 Nobel Prizes in medicine have gone to American-born scientists working in the United States, 3 have gone to foreign-born scientists working in the United States, and just 7 have gone to researchers outside the country.â€
“Even when the initial research is done overseas, the American system leads in converting new ideas into workable commercial technologies.â€
“The gains from medical innovations are high. For instance, increases in life expectancy resulting from better treatment of cardiovascular disease from 1970 to 1990 have been conservatively estimated as bringing benefits worth more than $500 billion a year. And that is just for the United States.â€
Here is a link to the original article:
http://www.nytimes.com/2006/10/05/business/05scene.html?_r=1&oref=slogin Read More & Comment...
10/05/2006 02:40 PM |
Is it just me being cynical or is it my post--Yankee loss crankiness but isn't the NIH award of $500 million over 5 years to 12 universities to help them work together in order to come up with validated therapeutic targets and conduct outcomes studies based on mechanistic research generating more headlines than the news merits.
It's not just because the amount pales in signficance to what drug and biotech companies spend doing exactly what the NIH grant is, in part, supposed to do: pooling data, enrolling people in studies more quickly. (Where is the demand to have academics post their clinical trial data on a website for the world to see?)
Nor is it because the money seems to be going to fund exactly what the academic medical centers are already doing, except they will hold more conferences where people can squabble over control over data. For instance, according to the Sacramento Bee
"UC Davis plans to use the funds to expand clinical trials for people with cancer, infectious diseases, vascular diseases and neurological conditions including Alzheimer's disease and spinal cord damage, said Dr. Claire Pomeroy, vice chancellor and medical school dean.
Beyond clinical trials, it will also look for ways to ensure that the newest advances in treatment are spread throughout the community, so that underserved populations also can benefit"
Sounds great, but a business plan or opportunistic driven research agenda it ain't.
Perhaps it is because the phrase "translational medicine" has become the cool buzz word of those seeking additional NIH funding and twist it to mean anything and everything.
That fact is, we have a translational medicine problem in academia and it consists of NIH researchers and academics knowing next to nothing about drug development or the quality of data it takes or the medicine chemistry required to actually get a drug ready for human trials. Academia and NIH are awash in novel targets -- as are drug companie -- but in academia everyone thinks their compound is going to be grand slam when in fact they strike out more often than not.
And for VC and biotech firms, the reluctance to fund academic research is not just the prima donna behavior on the part of potential partners, it is the fact that most compounds or potential products are not far enough along the development continuum to know if they will work or not...The real translational work in an era of targeted medicine will take place in a new drug development paradigm where academia and companies work more closely -- in cooperation with the FDA -- to revamp the drug approval path consistent with what is known about medicine from the mounds of prior clinical experience and biomarker validation.
The fact is, the real barriers to translational medicine are the product of failing to apply cutting edge science to today's drug development regulations. So for David Kessler -- the former FDA commish who is now dean of the UC medical school to say that there are"not enough people who are pursuing research that connects the dots between what is done in our basic science labs and what can directly benefit patients." is galling. It was he who made it harder to bring medicines by opposing the introduction of science based changes to FDA processes permitting accelerated approval. There are plenty of people...but not enough dots. That's a political problem perpetuated by people like Kessler, Grassley, Waxman, etc. Read More & Comment...
It's not just because the amount pales in signficance to what drug and biotech companies spend doing exactly what the NIH grant is, in part, supposed to do: pooling data, enrolling people in studies more quickly. (Where is the demand to have academics post their clinical trial data on a website for the world to see?)
Nor is it because the money seems to be going to fund exactly what the academic medical centers are already doing, except they will hold more conferences where people can squabble over control over data. For instance, according to the Sacramento Bee
"UC Davis plans to use the funds to expand clinical trials for people with cancer, infectious diseases, vascular diseases and neurological conditions including Alzheimer's disease and spinal cord damage, said Dr. Claire Pomeroy, vice chancellor and medical school dean.
Beyond clinical trials, it will also look for ways to ensure that the newest advances in treatment are spread throughout the community, so that underserved populations also can benefit"
Sounds great, but a business plan or opportunistic driven research agenda it ain't.
Perhaps it is because the phrase "translational medicine" has become the cool buzz word of those seeking additional NIH funding and twist it to mean anything and everything.
That fact is, we have a translational medicine problem in academia and it consists of NIH researchers and academics knowing next to nothing about drug development or the quality of data it takes or the medicine chemistry required to actually get a drug ready for human trials. Academia and NIH are awash in novel targets -- as are drug companie -- but in academia everyone thinks their compound is going to be grand slam when in fact they strike out more often than not.
And for VC and biotech firms, the reluctance to fund academic research is not just the prima donna behavior on the part of potential partners, it is the fact that most compounds or potential products are not far enough along the development continuum to know if they will work or not...The real translational work in an era of targeted medicine will take place in a new drug development paradigm where academia and companies work more closely -- in cooperation with the FDA -- to revamp the drug approval path consistent with what is known about medicine from the mounds of prior clinical experience and biomarker validation.
The fact is, the real barriers to translational medicine are the product of failing to apply cutting edge science to today's drug development regulations. So for David Kessler -- the former FDA commish who is now dean of the UC medical school to say that there are"not enough people who are pursuing research that connects the dots between what is done in our basic science labs and what can directly benefit patients." is galling. It was he who made it harder to bring medicines by opposing the introduction of science based changes to FDA processes permitting accelerated approval. There are plenty of people...but not enough dots. That's a political problem perpetuated by people like Kessler, Grassley, Waxman, etc. Read More & Comment...
10/05/2006 07:26 AM |
Did you know that Federal Reserve Chairman Ben Bernanke can talk to the animals? Specifically the 800-pound gorilla in the room – our aging baby boom generation.
Yesterday he addressed the issue that unless Social Security and Medicare are revamped, the massive burden from retiring baby boomers will place major strains on the nation's budget and the economy, said Wednesday.
"Reform of our unsustainable entitlement programs" should be a priority, he said in remarks to the Economics Club of Washington. "The imperative to undertake reform earlier rather than later is great," Bernanke added.
Bernanke suggested that, as the population ages, the nation will have to choose among higher taxes, less non-entitlement spending by the government, a reduction in spending on entitlement programs, a sharply higher budget deficit or some combination thereof.
Government spending on Social Security and Medicare alone will increase from about 7% of the total size of the U.S. economy to almost 13 percent by 2030 and to more than 15% by 2050, he said. Bernanke declared: "The fiscal consequences of these trends are large and unavoidable."
There are two additional crucial options we must aggressively pursue to address these generational and budgetary inevitabilities, (1) shift our public health paradigm from acute to chronic care and, (2) create more robust public health information campaigns focused on disease states that can be avoided/delayed through changes in lifestyle (for example diabetes, obesity, and cardio-vascular disease).
How? Many ways, including more robust personalized medicine, development of ever more targeted therapies, science-based prophylactic interventions (i.e., statins), and smart, well-funded, and prolonged public information campaigns funded by government and private industry -- both together and separately.
We must design and implement a 21st century baby boomer health care manifesto.
Can we do this? We must. Read More & Comment...
Yesterday he addressed the issue that unless Social Security and Medicare are revamped, the massive burden from retiring baby boomers will place major strains on the nation's budget and the economy, said Wednesday.
"Reform of our unsustainable entitlement programs" should be a priority, he said in remarks to the Economics Club of Washington. "The imperative to undertake reform earlier rather than later is great," Bernanke added.
Bernanke suggested that, as the population ages, the nation will have to choose among higher taxes, less non-entitlement spending by the government, a reduction in spending on entitlement programs, a sharply higher budget deficit or some combination thereof.
Government spending on Social Security and Medicare alone will increase from about 7% of the total size of the U.S. economy to almost 13 percent by 2030 and to more than 15% by 2050, he said. Bernanke declared: "The fiscal consequences of these trends are large and unavoidable."
There are two additional crucial options we must aggressively pursue to address these generational and budgetary inevitabilities, (1) shift our public health paradigm from acute to chronic care and, (2) create more robust public health information campaigns focused on disease states that can be avoided/delayed through changes in lifestyle (for example diabetes, obesity, and cardio-vascular disease).
How? Many ways, including more robust personalized medicine, development of ever more targeted therapies, science-based prophylactic interventions (i.e., statins), and smart, well-funded, and prolonged public information campaigns funded by government and private industry -- both together and separately.
We must design and implement a 21st century baby boomer health care manifesto.
Can we do this? We must. Read More & Comment...
10/04/2006 08:31 AM |
Our pal Anna Mathews at the WSJ reports today that “When Andrew von Eschenbach, the acting head of the Food and Drug Administration, paid a courtesy visit to Sen. David Vitter last spring, the Louisiana Republican zeroed in on a key issue: What is the agency doing about little turtles?â€
(Turtles often carry salmonella in their digestive tracts. Infected turtles can convey the bacteria to their eggs. The FDA also restricts the sale of turtle eggs in the U.S. Though bacteria-carrying turtles may not show symptoms of illness, they can spread salmonella to their handlers. Ingesting it -- typically, after failing to wash hands after playing with a turtle -- can lead to vomiting, fever and cramps, even death in vulnerable patients. After the 1975 restriction, turtle-related infections appeared to nearly vanish.)
Maybe Senator Vitter should introduce legislation promoting the sales of turtles to Canada. After all, one good turn deserves another. Read More & Comment...
(Turtles often carry salmonella in their digestive tracts. Infected turtles can convey the bacteria to their eggs. The FDA also restricts the sale of turtle eggs in the U.S. Though bacteria-carrying turtles may not show symptoms of illness, they can spread salmonella to their handlers. Ingesting it -- typically, after failing to wash hands after playing with a turtle -- can lead to vomiting, fever and cramps, even death in vulnerable patients. After the 1975 restriction, turtle-related infections appeared to nearly vanish.)
Maybe Senator Vitter should introduce legislation promoting the sales of turtles to Canada. After all, one good turn deserves another. Read More & Comment...
10/04/2006 06:32 AM |
The Wall Street Journal reports that “Under pressure from Congress, U.S. Customs and Border Protection officials scrapped their 11-month-old policy of seizing prescription drugs imported through the mail from Canada.â€
When politics trumps public health (not to mention outright security issues) we are heading down a slippery slope. Attention must be paid.
And shame on Senator Bill Nelson (D, FL) – a member (can you believe this!) of the Senate Committee on Homeland Security and Government Affairs – who was “investigating†the new Customs policy.
"This is a huge victory," Mr. Nelson said. "For nearly a year, the White House has been punishing seniors for filling their prescriptions at lower Canadian prices. Now it looks like the government is getting out of the business of harassing these consumers."
It’s a victory all right. A victory for profiteers masquerading as pharmacists. A victory for terrorists and smugglers who now have a brightly lit path for their nefarious schemes. And a victory for prescription drug counterfeiters who now need only a Canadian address to infiltrate the medicine chests of America.
Dan McLaughlin, a spokesman for Mr. Nelson, said the senator believes the seizures were politically motivated to bolster enrollments in Medicare Part D.
Note to Mr. McLaughlin -- didn’t the AARP say that American seniors get better deals on their medicines via Medicare Part D? (Answer – yes, they did.) Read More & Comment...
When politics trumps public health (not to mention outright security issues) we are heading down a slippery slope. Attention must be paid.
And shame on Senator Bill Nelson (D, FL) – a member (can you believe this!) of the Senate Committee on Homeland Security and Government Affairs – who was “investigating†the new Customs policy.
"This is a huge victory," Mr. Nelson said. "For nearly a year, the White House has been punishing seniors for filling their prescriptions at lower Canadian prices. Now it looks like the government is getting out of the business of harassing these consumers."
It’s a victory all right. A victory for profiteers masquerading as pharmacists. A victory for terrorists and smugglers who now have a brightly lit path for their nefarious schemes. And a victory for prescription drug counterfeiters who now need only a Canadian address to infiltrate the medicine chests of America.
Dan McLaughlin, a spokesman for Mr. Nelson, said the senator believes the seizures were politically motivated to bolster enrollments in Medicare Part D.
Note to Mr. McLaughlin -- didn’t the AARP say that American seniors get better deals on their medicines via Medicare Part D? (Answer – yes, they did.) Read More & Comment...
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