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Club For Growth
CNEhealth.org
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Doctors For Patient Care
Dr. Gov
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DTC Perspectives
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Furious Seasons
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01/29/2007 06:15 AM |
Jamie -- you still haven't explained why a country with no primary health care system, with a growth rate of 6 percent per quarter and a medical tourism industry has to rip off patents (and your interpetation of the Blackberry case is novel to say the least..but then you have way of leaving out the context of situations to assert that something was compulsory licensing -- more research for me--) For every case you cite there is another view or another ruling. And you -- as you often do -- mix up arguments.
My point about Gleevec was the availabiliy of competent oncologists. And in any event, once you start confiscating patents you kill innovation so there's no Gleevec like drugs...Your prize idea is nice if you want to reward an idea but you vastly underestimate the risk and unpredictabiity of drug development, the cost of PM surveillance, the investment of follow on research, the need for industry and VC support of pre-clinical work, investment in new genomic based tools....
A proliferation of AIDS drugs manufactured by Asian pharmaceutical companies and the lack of controls for quality or delivery could create drug-resistant strains of HIV, warns a Treat Asia report made available to the New York Times. Treat Asia is a network of clinics, hospitals and research institutions sponsored by the American Foundation for AIDS Research (AmfAR). Only three companies out of at least 27 Asian firms that are producing HIV drugs meet World Health Organization quality standards, though these drugs are increasingly available in Asia and abroad, said Treat Asia. The drugs made by the 24 other companies have either not been reviewed or have not met WHO standards.
In addition, there are too few qualified doctors trained to prescribe and monitor the use of the drugs, Treat Asia said. China has fewer than 200 doctors to treat its 840,000 people with HIV. In Thailand, 100 doctors are trained to treat AIDS - one for every 6,700 patients. Thailand has exported $3 million in HIV drugs, yet it has 84,000 HIV-positive citizens who are not receiving treatment.
When China offered free treatment to 5,000 HIV patients recently, 20-40 percent stopped taking the drugs due to a lack of counseling and combinations that caused side effects, said the group. Elsewhere, many patients are left with "little or no instruction on the safe and proper use of antiretroviral drugs," the report said.
"Our point is if there is proliferation of the generic drugs, as many are calling for, where is the
infrastructure to deliver them?" said Kevin Robert Frost, report co-author and a public health worker in Bangkok for Treat Asia.
Treat Asia - which called for the creation of a regional database to help determine which drugs are available where - will make the report available beginning Sunday on its Web site: www.treatasia.org.
I also provide the link to the US Pharmacopeia report on the poor quality of generic version of drugs in Thailand...produced at the request of the President's AIDS program, the one you and I support...
http://www.uspdqi.org/pubs/other/ANEReview.pdf
You are living in the 1980s... and you have cast your lot with the parasites as opposed to the producers of better health. Read More & Comment...
My point about Gleevec was the availabiliy of competent oncologists. And in any event, once you start confiscating patents you kill innovation so there's no Gleevec like drugs...Your prize idea is nice if you want to reward an idea but you vastly underestimate the risk and unpredictabiity of drug development, the cost of PM surveillance, the investment of follow on research, the need for industry and VC support of pre-clinical work, investment in new genomic based tools....
A proliferation of AIDS drugs manufactured by Asian pharmaceutical companies and the lack of controls for quality or delivery could create drug-resistant strains of HIV, warns a Treat Asia report made available to the New York Times. Treat Asia is a network of clinics, hospitals and research institutions sponsored by the American Foundation for AIDS Research (AmfAR). Only three companies out of at least 27 Asian firms that are producing HIV drugs meet World Health Organization quality standards, though these drugs are increasingly available in Asia and abroad, said Treat Asia. The drugs made by the 24 other companies have either not been reviewed or have not met WHO standards.
In addition, there are too few qualified doctors trained to prescribe and monitor the use of the drugs, Treat Asia said. China has fewer than 200 doctors to treat its 840,000 people with HIV. In Thailand, 100 doctors are trained to treat AIDS - one for every 6,700 patients. Thailand has exported $3 million in HIV drugs, yet it has 84,000 HIV-positive citizens who are not receiving treatment.
When China offered free treatment to 5,000 HIV patients recently, 20-40 percent stopped taking the drugs due to a lack of counseling and combinations that caused side effects, said the group. Elsewhere, many patients are left with "little or no instruction on the safe and proper use of antiretroviral drugs," the report said.
"Our point is if there is proliferation of the generic drugs, as many are calling for, where is the
infrastructure to deliver them?" said Kevin Robert Frost, report co-author and a public health worker in Bangkok for Treat Asia.
Treat Asia - which called for the creation of a regional database to help determine which drugs are available where - will make the report available beginning Sunday on its Web site: www.treatasia.org.
I also provide the link to the US Pharmacopeia report on the poor quality of generic version of drugs in Thailand...produced at the request of the President's AIDS program, the one you and I support...
http://www.uspdqi.org/pubs/other/ANEReview.pdf
You are living in the 1980s... and you have cast your lot with the parasites as opposed to the producers of better health. Read More & Comment...
01/28/2007 02:10 PM |
Robert, several points on this blog.
1. Countries can issue compulsory licenses for all sorts of reasons, not even limited to health, such as, for example, the recent US compulsory licenses for the Blackberry device, Microsoft DRM patents (held by Z4), Toyota, DirectTV and Johnson and Johnson.
2. Thailand has one of the best medical infrastructures in the world, which is one reason why it is becoming a common destination for European or US citizens, as a place for surgery. But this is besides the point. Since when do you need "infusion centers and trained technicians" to take Gleevec or Plavix?
3. Your claim that "The generic makers have developed unworkable and unsafe meds that have contributed to drug resistant HIV strains" is supported by what evidence? The WHO and the US FDA are both approving the quality of generic medicines for HIV. Is the Bush administration too "pro-generics" for you?
4. Your are free to have your own view of the Leavitt exchange. True, Leavitt did not issue a compulsory license to allow generic supplies. However, Leavitt has told Roche they must manufacture Tamiflu locally (a local working requirement on the patent), to protect US access and so the US can seize supplies in the case of an emergency. If Roche had refused this request? If they had refused, Leavitt was in the position to issue the compulsory license. The testimony has read by many as a unilateral demand by the US for local production, made at the very time the US Congress was asking for the compulsory license. As you noted, Leavett told the Congress, that if Roche did not expand production, "its important for Americans to know that the federal government will do everything necessary to protect people in this country." What exactly does that mean to you? Canceling Christmas cards for Roche? Read More & Comment...
1. Countries can issue compulsory licenses for all sorts of reasons, not even limited to health, such as, for example, the recent US compulsory licenses for the Blackberry device, Microsoft DRM patents (held by Z4), Toyota, DirectTV and Johnson and Johnson.
2. Thailand has one of the best medical infrastructures in the world, which is one reason why it is becoming a common destination for European or US citizens, as a place for surgery. But this is besides the point. Since when do you need "infusion centers and trained technicians" to take Gleevec or Plavix?
3. Your claim that "The generic makers have developed unworkable and unsafe meds that have contributed to drug resistant HIV strains" is supported by what evidence? The WHO and the US FDA are both approving the quality of generic medicines for HIV. Is the Bush administration too "pro-generics" for you?
4. Your are free to have your own view of the Leavitt exchange. True, Leavitt did not issue a compulsory license to allow generic supplies. However, Leavitt has told Roche they must manufacture Tamiflu locally (a local working requirement on the patent), to protect US access and so the US can seize supplies in the case of an emergency. If Roche had refused this request? If they had refused, Leavitt was in the position to issue the compulsory license. The testimony has read by many as a unilateral demand by the US for local production, made at the very time the US Congress was asking for the compulsory license. As you noted, Leavett told the Congress, that if Roche did not expand production, "its important for Americans to know that the federal government will do everything necessary to protect people in this country." What exactly does that mean to you? Canceling Christmas cards for Roche? Read More & Comment...
01/25/2007 09:48 PM |
In his blog in today's Huffington Post, Jamie Love implies it's ok to seize patents for all sorts of reasons. The fact is, there is only one reason, one measurable objective -- two actually -- that any nation can undertake to seize a patent before it expires and license to another manufacturer. First, it must demonstrate that their is an observable public health benefit that will be derived by that action as opposed to purely political gain. It's one thing to have a cheaper drug on a market. Another thing to have the infrastructure to deliver high-tech products. For instance, it would be nice to have Avastin available at discount prices in developing countries but you need infusion centers and trained technicians. Ditto Gleevec or Plavix.
Similarly, the whole HIV compulsory license thing has been a big fat joke on the developing world. The only people who have really benefit -- apart from those who are involved in the President's Global HIV plan and Gates activities -- are the profiteers in and out of the governments and the counterfeiters, those who mark up products fake or otherwise. The generic makers have developed unworkable and unsafe meds that have contributed to drug resistant HIV strains.
Now to top it all off, in his latest round of blogging...he misrepresents the truth. What a shock. He claims that Secretary Mike Leavitt testified he supported compulsory licensing. Here's the actual exchange between Congressman Tom Allen from Maine and Leavitt who just finished telling the House Commerce subcomm on Health that the prez wants to spend $7 billion to boost production of avian flu vaccine and anti-viral production
This video clip begins with Leavitt saying that Roche has promised not to let intellectual property be a barrier to generic production - Roche is willing to work with other companies that are able and prepared to produce the drug. He stresses that the drug is very difficult to produce, involving complicated steps, sometime dangerous - explosions are required in some of them. The Secretary concludes "It is not likely… that we will see any other manufacturers of Tamiflu certainly in a year and more likely two years. And that would be true in this country or any other country."
Allen responds that today the U.S. has insufficient manufacturing capacity for antiflu drugs, and Leavitt agrees. Allen tells Leavitt that on August 30, 2003 the WTO agreed on a set of rules under which countries with insufficient manufacturing capacity could import needed pharmaceuticals produced under compulsory license, but we opted out and persuaded other countries to opt out as well. The question from Allen: was this a wise decision? Leavitt answered that in times of a pandemic each country will only have access to what it can produce domestically, because each country will want to keep and use whatever it has inside its borders.
"Finally, Allen asks Leavitt if he would be prepared to issue a compulsory license if Roche failed to adequately expand production? Leavitt said that he did not think this would be needed, but he thinks its important for Americans to know that the federal government will do everything necessary to protect people in this country."
From this Jamie deduces that Leavitt is for compulsory licensing. What some people will do for America.... Read More & Comment...
Similarly, the whole HIV compulsory license thing has been a big fat joke on the developing world. The only people who have really benefit -- apart from those who are involved in the President's Global HIV plan and Gates activities -- are the profiteers in and out of the governments and the counterfeiters, those who mark up products fake or otherwise. The generic makers have developed unworkable and unsafe meds that have contributed to drug resistant HIV strains.
Now to top it all off, in his latest round of blogging...he misrepresents the truth. What a shock. He claims that Secretary Mike Leavitt testified he supported compulsory licensing. Here's the actual exchange between Congressman Tom Allen from Maine and Leavitt who just finished telling the House Commerce subcomm on Health that the prez wants to spend $7 billion to boost production of avian flu vaccine and anti-viral production
This video clip begins with Leavitt saying that Roche has promised not to let intellectual property be a barrier to generic production - Roche is willing to work with other companies that are able and prepared to produce the drug. He stresses that the drug is very difficult to produce, involving complicated steps, sometime dangerous - explosions are required in some of them. The Secretary concludes "It is not likely… that we will see any other manufacturers of Tamiflu certainly in a year and more likely two years. And that would be true in this country or any other country."
Allen responds that today the U.S. has insufficient manufacturing capacity for antiflu drugs, and Leavitt agrees. Allen tells Leavitt that on August 30, 2003 the WTO agreed on a set of rules under which countries with insufficient manufacturing capacity could import needed pharmaceuticals produced under compulsory license, but we opted out and persuaded other countries to opt out as well. The question from Allen: was this a wise decision? Leavitt answered that in times of a pandemic each country will only have access to what it can produce domestically, because each country will want to keep and use whatever it has inside its borders.
"Finally, Allen asks Leavitt if he would be prepared to issue a compulsory license if Roche failed to adequately expand production? Leavitt said that he did not think this would be needed, but he thinks its important for Americans to know that the federal government will do everything necessary to protect people in this country."
From this Jamie deduces that Leavitt is for compulsory licensing. What some people will do for America.... Read More & Comment...
01/25/2007 09:22 PM |
Telling 100 Democrat strategists to expect aggressive health care proposals from his wife (would we expect shy ones) ex-President Bill Clinton -- who has not stopped spinning and legacy seaching (among other things) since he left office -- proclaimed that the recent Democrat retreat from imposing the VA formulary on seniors was a....(ready for this) vindication of HIS administration's effort to impose price controls on prescription drugs (including the Biotechnology Price Inquisition which caused biotech stocks to tank 40 percent and venture capital investment to hit the lowest point in the industry's history).
Yeah and the slaughter in Rwanda that happened under his watch and the hasty retreat from Somalia (also a Clinton production) was a roadmap for how to win in Iraq and send the right messages to Islamic fanatics.
Why does Newt Gingrich keep calling him the smartest man in American politics? Is that supposed to be a good thing? Read More & Comment...
Yeah and the slaughter in Rwanda that happened under his watch and the hasty retreat from Somalia (also a Clinton production) was a roadmap for how to win in Iraq and send the right messages to Islamic fanatics.
Why does Newt Gingrich keep calling him the smartest man in American politics? Is that supposed to be a good thing? Read More & Comment...
01/25/2007 06:06 AM |
What? You haven't already read CBO's just released "The Budget and Economic Outlook: Fiscal Years 2008 to 2017!
Great prose? Certainly not. Great news? Absolutely (if you know where to look).
Consider this snippet which appears on pages 58-59 ...
"The current estimate for Part D spending is significantly lower than CBO's 2006 estimates, for two reasons. First, Medicare's payments for prescription drugs under Part D are largely based on competitive bids that drug plans submit to provide coverage. The bids submitted for calendar year 2007 are much lower than expected-about 15 percent below the 2006 bids, on average. As a result, CBO reduced its projection of the per capita costs of providing drug coverage. In addition, recent information from the Department of Health and Human Services' Centers for Medicare and Medicaid Services indicates that a larger-than-expected number of the Medicare beneficiaries who are not enrolled in Part D have some other form of drug coverage that is comparable to Part D. Because CBO expects that many of those beneficiaries will retain their existing coverage rather than enroll in Part D, it has lowered its estimate of the ultimate participation rate from 87 percent to 78 percent of Medicare beneficiaries."
"In its estimate for the Medicare Modernization Act, which established Part D benefits, CBO projected net spending for Part D at $32 billion for 2006 and $518 billion for 2007 to 2013. (CBO's overall estimate that the legislation would cost $395 billion from 2004 to 2013 included savings that would occur elsewhere in the budget that would be attributable to the creation of Part D and to the effects of other provisions unrelated to the drug benefit.) CBO's current estimate of net spending for Part D for 2007 to 2013 is $136 billion lower than the original forecast, a difference of about 26 percent."
Amazing as that news is, I do not predict a movie deal for the book. Read More & Comment...
Great prose? Certainly not. Great news? Absolutely (if you know where to look).
Consider this snippet which appears on pages 58-59 ...
"The current estimate for Part D spending is significantly lower than CBO's 2006 estimates, for two reasons. First, Medicare's payments for prescription drugs under Part D are largely based on competitive bids that drug plans submit to provide coverage. The bids submitted for calendar year 2007 are much lower than expected-about 15 percent below the 2006 bids, on average. As a result, CBO reduced its projection of the per capita costs of providing drug coverage. In addition, recent information from the Department of Health and Human Services' Centers for Medicare and Medicaid Services indicates that a larger-than-expected number of the Medicare beneficiaries who are not enrolled in Part D have some other form of drug coverage that is comparable to Part D. Because CBO expects that many of those beneficiaries will retain their existing coverage rather than enroll in Part D, it has lowered its estimate of the ultimate participation rate from 87 percent to 78 percent of Medicare beneficiaries."
"In its estimate for the Medicare Modernization Act, which established Part D benefits, CBO projected net spending for Part D at $32 billion for 2006 and $518 billion for 2007 to 2013. (CBO's overall estimate that the legislation would cost $395 billion from 2004 to 2013 included savings that would occur elsewhere in the budget that would be attributable to the creation of Part D and to the effects of other provisions unrelated to the drug benefit.) CBO's current estimate of net spending for Part D for 2007 to 2013 is $136 billion lower than the original forecast, a difference of about 26 percent."
Amazing as that news is, I do not predict a movie deal for the book. Read More & Comment...
01/24/2007 10:38 AM |
When is a drug risk not a drug risk? When you don't understand it. I refer, of course, to the so-called "Brief Summary" which, as some say, is like the Holy Roman Empire -- neither brief nor a summary.
A new paper (of which I am a co-author), in the January edition of Drug Information Journal, relates new research demonstrating that as the number of listed side effects increases, patient recall decreases.
The paper, "A New Model for Communicating Risk Information in Direct-to-Consumer Print Advertisements" can be found at http://www.cmpi.org
Not rocket science. Social science Read More & Comment...
A new paper (of which I am a co-author), in the January edition of Drug Information Journal, relates new research demonstrating that as the number of listed side effects increases, patient recall decreases.
The paper, "A New Model for Communicating Risk Information in Direct-to-Consumer Print Advertisements" can be found at http://www.cmpi.org
Not rocket science. Social science Read More & Comment...
01/24/2007 07:08 AM |
President Bush's State of the Union discussion of tax credits for health insurance should remind us all that the goal of health care shouldn't be, exclusively, to deal with acute medical problems -- but rather to provide patients with both the opportunity and the incentive to pursue care for chronic conditions (such as hypertension). Because, even with all of the advances in hospital care, it's still a much better deal -- both financially and personally -- to address a condition (such as hypertension) before it results in an acute, life-threatening event.
It's the same logic that propels Part D. Keep seniors healthy by providing low-cost access to the medicines they need and they (1) will be healthier, more productive citizens, and (2) will not need far more costly health care interventions (i.e., hospital procedures).
Eureka -- it works. Part D has propelled millions of seniors, for the first time, to seek out and receive appropriate treatment for their chronic conditions (such as hypertension).
And that's a success that demands greater attention. It's a success that goes a long way to improving the State of the Union. Read More & Comment...
It's the same logic that propels Part D. Keep seniors healthy by providing low-cost access to the medicines they need and they (1) will be healthier, more productive citizens, and (2) will not need far more costly health care interventions (i.e., hospital procedures).
Eureka -- it works. Part D has propelled millions of seniors, for the first time, to seek out and receive appropriate treatment for their chronic conditions (such as hypertension).
And that's a success that demands greater attention. It's a success that goes a long way to improving the State of the Union. Read More & Comment...
01/23/2007 05:49 PM |
I was both an attendee and speaker at the MedAdNews Drug Development Summit.
Two important takeaway points. Make that three. Ok four.
1. Companies are refilling their pipelines with new drugs that will hit new targets for unmet medical needs in areas like Alzheimer's, cancer, schizophrenia, Parkinson's, respiratory infections and stroke.
2. Companies are doing a better job of weeding out medicines that won't work or would "fail" because of toxicity issues earlier than ever. Drug development is becoming more predictive.
3. Many of the Critical Path recommendations are being adopted. Adaptive trial designs, bio-imaging, exploratory INDs are all being used.
4. Companies are interested in doing more collaborative work to identify biomarkers, both efficacy and safety. Creating the framework for doing so is difficult.
The takeaway: this is an industry furiously seeking to change. It probably should be more transparent and collaborative and find a better way to market its medicines but that will happen too.
The question is, why do some many people still believe that drug companies are sitting on cures for diseases so they can make money? I can't tell you how many otherwise intelligent people have actually asked me if this is true.... Another reason that biotech and drug companies need to tell the public what they do. Read More & Comment...
Two important takeaway points. Make that three. Ok four.
1. Companies are refilling their pipelines with new drugs that will hit new targets for unmet medical needs in areas like Alzheimer's, cancer, schizophrenia, Parkinson's, respiratory infections and stroke.
2. Companies are doing a better job of weeding out medicines that won't work or would "fail" because of toxicity issues earlier than ever. Drug development is becoming more predictive.
3. Many of the Critical Path recommendations are being adopted. Adaptive trial designs, bio-imaging, exploratory INDs are all being used.
4. Companies are interested in doing more collaborative work to identify biomarkers, both efficacy and safety. Creating the framework for doing so is difficult.
The takeaway: this is an industry furiously seeking to change. It probably should be more transparent and collaborative and find a better way to market its medicines but that will happen too.
The question is, why do some many people still believe that drug companies are sitting on cures for diseases so they can make money? I can't tell you how many otherwise intelligent people have actually asked me if this is true.... Another reason that biotech and drug companies need to tell the public what they do. Read More & Comment...
01/23/2007 05:07 PM |
The left has been complaining for years about how the tax system is unfair to the poor and working class. So when the president comes along with a plan level the playing field where it really counts -- a tax cut that makes health care affordable no matter where you are or whether you are working -- their reaction is predictable: spend money (either directly or in the form of tax credits) to shove people into Medicaid.
Here's Ron Pollack's predictable response to the tax cut:
“Instead of this ill-advised proposal, the President should expand health coverage for the 9 million children who are uninsured when Congress reauthorizes the State Children’s Health Insurance Program (SCHIP) later this year.â€
Right. The same 9 million kids who have not been enrolled since SCHIP started in 1997. Hey Ron, Families USA has been shoveled millions of bucks to do outreach and enrollment over the past decade.
Wonder why people didn't sign up despite your winning personality?
Because SCHIP equals Medicaid. Pollack and other child "advocates" call SCHIP a medical home for uninsured kids but that's like calling public housing as good as a private home. People want to buy into the real thing, something they can own, not some government assistance they have to apply for.
But the Left hates giving people control over health care dollars because that means they lose control over them. I once debated one of the advocates and asked them why they opposed just giving people money to buy health care. Did she think the same people they believe should have the choice about abortion were too stupid to choose which health plan to have the abortion in? She had no answer. Read More & Comment...
Here's Ron Pollack's predictable response to the tax cut:
“Instead of this ill-advised proposal, the President should expand health coverage for the 9 million children who are uninsured when Congress reauthorizes the State Children’s Health Insurance Program (SCHIP) later this year.â€
Right. The same 9 million kids who have not been enrolled since SCHIP started in 1997. Hey Ron, Families USA has been shoveled millions of bucks to do outreach and enrollment over the past decade.
Wonder why people didn't sign up despite your winning personality?
Because SCHIP equals Medicaid. Pollack and other child "advocates" call SCHIP a medical home for uninsured kids but that's like calling public housing as good as a private home. People want to buy into the real thing, something they can own, not some government assistance they have to apply for.
But the Left hates giving people control over health care dollars because that means they lose control over them. I once debated one of the advocates and asked them why they opposed just giving people money to buy health care. Did she think the same people they believe should have the choice about abortion were too stupid to choose which health plan to have the abortion in? She had no answer. Read More & Comment...
01/23/2007 04:57 PM |
We are not making this up.
AIDS group sues over Viagra ads
Andrew Bridges
The Associated Press
Tuesday, January 23, 2007
WASHINGTON -- An AIDS organization sued Pfizer Inc. on yesterday over ads the group says encourage use of Viagra as a party drug. The nonprofit group said such recreational use furthers the spread of HIV and other sexually transmitted diseases.
The suit, filed in Los Angeles by the AIDS Healthcare Foundation, calls Pfizer's ads for the impotence drug false and misleading. The suit echoes allegations made in an ad campaign announced by the group last month.
The nonprofit group alleges the marketing of Viagra has fostered an increase in the spread of STDs. Studies have found the drug is used -- illegally -- in conjunction with crystal methamphetamine to form a party drug "cocktail."
Drugwonks believes that the combo of crystal meth and Viagra is an off-label use that Pfizer has never promoted. There is no truth to the rumor that the company sought product placement in episodes of Six Feet Under, Entourage or Queer as Folk.... Read More & Comment...
AIDS group sues over Viagra ads
Andrew Bridges
The Associated Press
Tuesday, January 23, 2007
WASHINGTON -- An AIDS organization sued Pfizer Inc. on yesterday over ads the group says encourage use of Viagra as a party drug. The nonprofit group said such recreational use furthers the spread of HIV and other sexually transmitted diseases.
The suit, filed in Los Angeles by the AIDS Healthcare Foundation, calls Pfizer's ads for the impotence drug false and misleading. The suit echoes allegations made in an ad campaign announced by the group last month.
The nonprofit group alleges the marketing of Viagra has fostered an increase in the spread of STDs. Studies have found the drug is used -- illegally -- in conjunction with crystal methamphetamine to form a party drug "cocktail."
Drugwonks believes that the combo of crystal meth and Viagra is an off-label use that Pfizer has never promoted. There is no truth to the rumor that the company sought product placement in episodes of Six Feet Under, Entourage or Queer as Folk.... Read More & Comment...
01/23/2007 06:48 AM |
Ask the 10,000 people at Pfizer who are losing their jobs. Read More & Comment...
01/22/2007 10:49 PM |
After hearing from Representative Emerson, perhaps it's time to listen to the other famous American of the same name -- Ralph Waldo Emerson -- who said:
"No one cares how much you know until they know how much you care."
Words to remember as we fight for the future of America's health and health care system. Read More & Comment...
"No one cares how much you know until they know how much you care."
Words to remember as we fight for the future of America's health and health care system. Read More & Comment...
01/19/2007 05:42 PM |
Story Landis, director of the NIH's National Institute of Neurological Disorders and Stroke testified before a Senate committee today that need for federal funding for embyronic stem cell research was compelling:
"Science works best when scientists can pursue all avenues of research," Landis said. "If the cure for Parkinson's disease or juvenile diabetes lay behind one of four doors, wouldn't you want the option to open all four doors at once instead of one door?"
That's fine. Everyone's in favor of funding one form of stem cell research or another. But why then support a bill that would kill private sector funding of stem cell research or undermine private sector investment that complements or builds on federal funding. Namely the Wyden-Snowe bill requiring direct government negotiation -- meaning price controls, restricting/delaying access to new medicines -- under the following circumstances --
Under the Snowe-Wyden proposal, that ban would be lifted and the HHS Secretary would be required to negotiate if:
* A drug is a single source drug, which means there is only one brand name of the drug available;
* A drug was created with substantial taxpayer funding for its research and development;
* A private insurance plan requests help; and
* For any fallback plan for which the Secretary must provide.
A cure for Parkinson's would definitely pull a hat trick under this ingenious piece of legislation. Why not just hang out a sign that says: "Companies that successfully invest in stem cell research will be punished for doing so?" Read More & Comment...
"Science works best when scientists can pursue all avenues of research," Landis said. "If the cure for Parkinson's disease or juvenile diabetes lay behind one of four doors, wouldn't you want the option to open all four doors at once instead of one door?"
That's fine. Everyone's in favor of funding one form of stem cell research or another. But why then support a bill that would kill private sector funding of stem cell research or undermine private sector investment that complements or builds on federal funding. Namely the Wyden-Snowe bill requiring direct government negotiation -- meaning price controls, restricting/delaying access to new medicines -- under the following circumstances --
Under the Snowe-Wyden proposal, that ban would be lifted and the HHS Secretary would be required to negotiate if:
* A drug is a single source drug, which means there is only one brand name of the drug available;
* A drug was created with substantial taxpayer funding for its research and development;
* A private insurance plan requests help; and
* For any fallback plan for which the Secretary must provide.
A cure for Parkinson's would definitely pull a hat trick under this ingenious piece of legislation. Why not just hang out a sign that says: "Companies that successfully invest in stem cell research will be punished for doing so?" Read More & Comment...
01/19/2007 10:25 AM |
Here's a story right out of the movie "The Barbarian Invasions" and it can be summed up in two words, "Hello Plattsburgh."
For those who think that we should adopt the Canadian health care model this should serve as yet another cold shower of reality or, in the words of Stephen Colbert, a "Truth Mitzvah."
MDs forced abroad for scanner training
Limited access to cancer-detecting machines spurs Ontario university to look elsewhere
LISA PRIEST
Toronto Globe and Mail
January 19, 2007
The use of crucial cancer-detecting PET machines is so restricted in Ontario that one university must send its medical residents to the United States and elsewhere for training. The low number of cancer patients eligible for PET screening means University of Western Ontario residents cannot obtain the experience they require. St. Joseph's Health Care in London scans as few as four patients a week, sometimes none. The rest of the time it experiments on laboratory-bred dogs and pigs.
Of all the provinces that have Positron Emission Tomography scanners, Ontario has the most restrictive access. That's because it is running clinical trials to determine how best to use them on cancer patients.
"It breaks our hearts to have to send them [students] away," said Damien Maharaj, program director of nuclear medicine at Western's Schulich School of Medicine & Dentistry. “We simply have to meet their [Royal College of Physicians and Surgeons of Canada] guidelines. Failure to do so would be noted and the potential to go on probation exists."
The development follows an evaluation conducted by the Royal College of Physicians and Surgeons of Canada, a body that accredits postgraduate medical programs in addition to certifying specialists. The college told the university that the lack of resident training in PET scanning was a weakness that required a remedy.
The university was asked to put in writing its plan for ensuring that nuclear-medicine residents receive the necessary PET training elsewhere, Dr. Maharaj confirmed. He stressed the program remains fully accredited and that London produces some of the best nuclear-medicine specialists in Canada. Ultimately, though, Dr. Maharaj said: "PET is not a research tool, it's a clinical tool. We really should be offering it to people."
Cancer patients can access Ontario's nine PET scanners under five clinical trials or through a patient registry introduced a year ago. The registry is limited to suspected recurrent colorectal, thyroid or germ-cell cancer and patients with certain solitary pulmonary nodules. As of Oct. 31, 408 Ontario patients had obtained PET scans through the registry and 926 patients had scans as part of the clinical trials.
Compare that to Quebec, a province that provides the broadest access to PET scans; this year, it plans to do 21,000 scans. Patients can access PET scans in British Columbia, Alberta, Manitoba and New Brunswick. Nova Scotia also plans to purchase a scanner and expects to have it operating by the fall.
"It's terrible," said Christopher O'Brien, vice-president of the Canadian Association of Nuclear Medicine. "You have one of the major teaching programs that can't meet the Royal College standards because of a government moratorium on access to PET scanning."
Though Dr. Maharaj said the university will try to help defray the costs, ultimately it is a "financial hardship" for the residents who will have to pay rent in two cities, in addition to covering transportation and food costs for three months. Potential training spots include Duke University in North Carolina, Harvard in Boston and centres in Canada, possibly Winnipeg or Sherbrooke, he said.
Training in the United States poses a particular problem: malpractice insurance does not cover the residents so they can act only as observers and cannot interpret the scans. That is why J. C. Warrington, the chief nuclear-medicine resident at the University of Western Ontario, is hoping to relocate to another Canadian city. "We would prefer to not to have to go further than is absolutely required because of our expenses required with travel," said Dr. Warrington, a fourth-year nuclear-medicine resident, one of two who will have to relocate this July.
All other nuclear-medicine residents training at Western will also have to relocate for three months in their final year of training, until the hospital is able to provide more PET scans to patients, Dr. Maharaj said.
A PET scan can find a lung cancer that has spread, preventing a futile operation. Colorectal cancer patients may discover tumours on their liver can be safely removed. A scan can also help determine when chemotherapy is not working, prompting doctors to change a drug cocktail. It costs about $2,500.
Whatever the case, the results need to be carefully interpreted as non-cancerous conditions can resemble cancer; only a biopsy can confirm the presence of cancer.
Dr. Warrington said though relocating may pose an imposition, it is a far greater imposition for cancer patients to travel out of province or country to obtain PET scans. In 2005-2006, 82 Ontarians were sent out of country for PET scans at a cost of $653,255, while 42 others were denied, according to Health Ministry figures provided by John Letherby. However, the process of sending patients to the United States has been winding down since late August.
Figures obtained under a Freedom of Information and Protection of Privacy Act request reveals that Ontario has sent cancer patients to 20 different U.S. hospitals for PET scans for 18 different conditions, many of them cancers or suspected cases of cancer since April 1, 2002.
They include Duke University -- the very institution to which nuclear-medicine residents may be sent for training. As well, patients have been sent to Johns Hopkins in Baltimore; the Mayo Clinic in Rochester, Minn., and Scottsdale, Ariz.; Detroit Medical Centre; and Cleveland Clinic Foundation.
Of those sent to the United States, the patients had lymphoma and cancers of the breast, brain, esophagus, testes and lung. Read More & Comment...
For those who think that we should adopt the Canadian health care model this should serve as yet another cold shower of reality or, in the words of Stephen Colbert, a "Truth Mitzvah."
MDs forced abroad for scanner training
Limited access to cancer-detecting machines spurs Ontario university to look elsewhere
LISA PRIEST
Toronto Globe and Mail
January 19, 2007
The use of crucial cancer-detecting PET machines is so restricted in Ontario that one university must send its medical residents to the United States and elsewhere for training. The low number of cancer patients eligible for PET screening means University of Western Ontario residents cannot obtain the experience they require. St. Joseph's Health Care in London scans as few as four patients a week, sometimes none. The rest of the time it experiments on laboratory-bred dogs and pigs.
Of all the provinces that have Positron Emission Tomography scanners, Ontario has the most restrictive access. That's because it is running clinical trials to determine how best to use them on cancer patients.
"It breaks our hearts to have to send them [students] away," said Damien Maharaj, program director of nuclear medicine at Western's Schulich School of Medicine & Dentistry. “We simply have to meet their [Royal College of Physicians and Surgeons of Canada] guidelines. Failure to do so would be noted and the potential to go on probation exists."
The development follows an evaluation conducted by the Royal College of Physicians and Surgeons of Canada, a body that accredits postgraduate medical programs in addition to certifying specialists. The college told the university that the lack of resident training in PET scanning was a weakness that required a remedy.
The university was asked to put in writing its plan for ensuring that nuclear-medicine residents receive the necessary PET training elsewhere, Dr. Maharaj confirmed. He stressed the program remains fully accredited and that London produces some of the best nuclear-medicine specialists in Canada. Ultimately, though, Dr. Maharaj said: "PET is not a research tool, it's a clinical tool. We really should be offering it to people."
Cancer patients can access Ontario's nine PET scanners under five clinical trials or through a patient registry introduced a year ago. The registry is limited to suspected recurrent colorectal, thyroid or germ-cell cancer and patients with certain solitary pulmonary nodules. As of Oct. 31, 408 Ontario patients had obtained PET scans through the registry and 926 patients had scans as part of the clinical trials.
Compare that to Quebec, a province that provides the broadest access to PET scans; this year, it plans to do 21,000 scans. Patients can access PET scans in British Columbia, Alberta, Manitoba and New Brunswick. Nova Scotia also plans to purchase a scanner and expects to have it operating by the fall.
"It's terrible," said Christopher O'Brien, vice-president of the Canadian Association of Nuclear Medicine. "You have one of the major teaching programs that can't meet the Royal College standards because of a government moratorium on access to PET scanning."
Though Dr. Maharaj said the university will try to help defray the costs, ultimately it is a "financial hardship" for the residents who will have to pay rent in two cities, in addition to covering transportation and food costs for three months. Potential training spots include Duke University in North Carolina, Harvard in Boston and centres in Canada, possibly Winnipeg or Sherbrooke, he said.
Training in the United States poses a particular problem: malpractice insurance does not cover the residents so they can act only as observers and cannot interpret the scans. That is why J. C. Warrington, the chief nuclear-medicine resident at the University of Western Ontario, is hoping to relocate to another Canadian city. "We would prefer to not to have to go further than is absolutely required because of our expenses required with travel," said Dr. Warrington, a fourth-year nuclear-medicine resident, one of two who will have to relocate this July.
All other nuclear-medicine residents training at Western will also have to relocate for three months in their final year of training, until the hospital is able to provide more PET scans to patients, Dr. Maharaj said.
A PET scan can find a lung cancer that has spread, preventing a futile operation. Colorectal cancer patients may discover tumours on their liver can be safely removed. A scan can also help determine when chemotherapy is not working, prompting doctors to change a drug cocktail. It costs about $2,500.
Whatever the case, the results need to be carefully interpreted as non-cancerous conditions can resemble cancer; only a biopsy can confirm the presence of cancer.
Dr. Warrington said though relocating may pose an imposition, it is a far greater imposition for cancer patients to travel out of province or country to obtain PET scans. In 2005-2006, 82 Ontarians were sent out of country for PET scans at a cost of $653,255, while 42 others were denied, according to Health Ministry figures provided by John Letherby. However, the process of sending patients to the United States has been winding down since late August.
Figures obtained under a Freedom of Information and Protection of Privacy Act request reveals that Ontario has sent cancer patients to 20 different U.S. hospitals for PET scans for 18 different conditions, many of them cancers or suspected cases of cancer since April 1, 2002.
They include Duke University -- the very institution to which nuclear-medicine residents may be sent for training. As well, patients have been sent to Johns Hopkins in Baltimore; the Mayo Clinic in Rochester, Minn., and Scottsdale, Ariz.; Detroit Medical Centre; and Cleveland Clinic Foundation.
Of those sent to the United States, the patients had lymphoma and cancers of the breast, brain, esophagus, testes and lung. Read More & Comment...
01/19/2007 09:26 AM |
Now that the Democrats control the purse strings, left wing organizations will try to force their ideology on to science-based federal agencies. It will happen with the FDA and it has just happened with NIH where the crazies have decided that because researchers consult for industry they are a notch below or above being criminals. It's not enough that talented NIH scientists are leaving the agency in droves. Now anyone who lectures on subjects they know about can't participate in guideline development. That leaves people who, of course, are loyal to the left wing agenda of groups like the Center for the Science in the Public Interest.
As if THAT group is so pure and perfect. Center for the Science for in the Public Interest makes over 70 percent of its income from subscriptions to its monthly Nutrition Action Healthletter. The letter has passed out inaccurate information over the decades and the parent organization has claimed transfats were good and that salt was directly linked to 150,000 deaths a year. So an organization that makes money peddling health scares and false medical claims believes it is the moral authority when it comes to how the NIH should determine who should be on consensus guideline panels.
Well, not exactly. It reached out to Marcia Angell -- who believes that there is no evidence that people respond differently to the same drugs -- and Jerome Kassirer who perfected the marketing practice of selling drug ads in the same edition of the NEJM that favorable studies of the same drug would run and selling reprints to drug reps...The same Angell and Kassirer who , when they were running NEJM, never asked physicians who made money serving as experts in personal injury trials to disclose their conflicts.
Or to quote Oliver Goldsmith: "You can preach a better sermon with your life than with your lips."
All this puts a chill on freedom of expression and impugns the reputation of decent and dedicated researchers.
NIH Cancels Meeting on Herpes --- Treatment Review Panel Faces Criticism Over Ties To Pharmaceutical Firms - 19 January 2007 The Wall Street Journal - By David Armstrong
The National Institutes of Health abruptly canceled a meeting scheduled for next month to draft guidelines for treating pregnant women and babies with herpes, after concerns were raised about conflicts of interest among a panel of experts tapped to review the issue.
The action came after a group of physicians, medical researchers and consumer and health groups urged the NIH in a letter yesterday to bar experts who are paid by drug makers from helping to draft government guidelines for how doctors treat diseases. Their action was touched off by the NIH's recent naming of five experts to present evidence at a conference next month aimed at drafting guidelines for treating pregnant women with herpes and babies born with the condition.
The five experts, including one who is responsible for coordinating the writing of the guidelines, are doctors employed at academic medical centers. Four of the five experts, including the writing coordinator, have financial ties to makers of herpes drugs, resulting in a panel that "is completely unbalanced," the letter says. The five were the only experts listed as presenters on an NIH draft agenda for the meeting.
In an email, an NIH spokeswoman said the agency "has canceled the meeting out of concern that misperceptions about this meeting could not be resolved prior to the scheduled meeting date." She said no decision has been made on whether the meeting, originally slated for Feb. 20, will be rescheduled.
The action comes amid concern that clinical guidelines that form the basis for how physicians and hospitals treat patients are being unduly influenced by the drug industry. In several recent cases, including one involving kidney treatment with the drug erythropoetin, guidelines composed by experts paid by drug companies have promoted treatment regimens that some other experts contended brought harm to patients while promoting wider use of a drug.
The letter was signed by 44 individuals and 16 organizations. Among the individuals were Richard Horton, editor of the British medical journal Lancet; Marcia Angell and Jerome Kassirer, both former editors of the New England Journal of Medicine; and doctors from medical schools including Harvard and Johns Hopkins. The organizations included the Center for Science and the Public Interest, the National Women's Health Network and the publisher of Consumer Reports.
The group wrote that the NIH agency "must be an honest broker in the development of medical evidence that will inform clinical practice" and that the NIH must ensure that all members of guideline-writing committees are "free from conflicts of interest."
As reported, several doctors who are paid consultants or speakers for GlaxoSmithKline PLC, maker of the best-selling herpes drug Valtrex, have traveled the country to promote testing and treatment of pregnant women with herpes as a way of preventing babies from picking up the infection. Newborn herpes, though rare, can be fatal. That treatment strategy, however, is controversial. Critics say that there isn't any evidence that treating pregnant women with herpes drugs will reduce cases of newborns born with the infection and that exposing as many as a million women a year to herpes medication could result in dangerous side effects for mother and baby.
The letter writers said the scheduled meeting on herpes added to a "sad record" at the NIH of drafting treatment guidelines using panels composed largely of experts receiving money from drug companies. They said that 2004 guidelines for treating cholesterol were drafted by a committee of nine physicians, eight of whom had financial relationships with makers of statins, which are widely given for high cholesterol.
According to a draft agenda of the Feb. 20 meeting, University of Washington obstetrician Zane Brown was to have presented information on testing pregnant women for herpes. Dr. Brown is a frequent speaker for Glaxo on herpes issues. In an interview with The Wall Street Journal for a prior story on the subject, Dr. Brown estimated he gives two to three lectures a week advocating universal testing of pregnant women, earning $1,000 to $2,500 a talk. The doctor who was slated to lead the session on writing the guidelines, Richard Whitley, is a pediatrician at the University of Alabama at Birmingham medical school who is a member of the Glaxo speakers bureau.
Also on the panel was Anna Wald, a University of Washington epidemiologist, who said yesterday she has been a consultant to Novartis AG, which makes a herpes drug, and has done research funded by Glaxo. Dr. Brown didn't respond to an email, and attempts to reach Dr. Whitley through a representative were unsuccessful.
The fourth member identified in the letter as having a conflict was Massachusetts General Hospital obstetrician Laura Riley, who is the secretary and treasurer of the American Herpes Foundation, a nonprofit largely funded by herpes drug makers. Dr. Riley says she has received a few $1,000 stipends for attending meetings of the herpes foundation, but doesn't receive a salary or other pay for her work at the organization. Read More & Comment...
As if THAT group is so pure and perfect. Center for the Science for in the Public Interest makes over 70 percent of its income from subscriptions to its monthly Nutrition Action Healthletter. The letter has passed out inaccurate information over the decades and the parent organization has claimed transfats were good and that salt was directly linked to 150,000 deaths a year. So an organization that makes money peddling health scares and false medical claims believes it is the moral authority when it comes to how the NIH should determine who should be on consensus guideline panels.
Well, not exactly. It reached out to Marcia Angell -- who believes that there is no evidence that people respond differently to the same drugs -- and Jerome Kassirer who perfected the marketing practice of selling drug ads in the same edition of the NEJM that favorable studies of the same drug would run and selling reprints to drug reps...The same Angell and Kassirer who , when they were running NEJM, never asked physicians who made money serving as experts in personal injury trials to disclose their conflicts.
Or to quote Oliver Goldsmith: "You can preach a better sermon with your life than with your lips."
All this puts a chill on freedom of expression and impugns the reputation of decent and dedicated researchers.
NIH Cancels Meeting on Herpes --- Treatment Review Panel Faces Criticism Over Ties To Pharmaceutical Firms - 19 January 2007 The Wall Street Journal - By David Armstrong
The National Institutes of Health abruptly canceled a meeting scheduled for next month to draft guidelines for treating pregnant women and babies with herpes, after concerns were raised about conflicts of interest among a panel of experts tapped to review the issue.
The action came after a group of physicians, medical researchers and consumer and health groups urged the NIH in a letter yesterday to bar experts who are paid by drug makers from helping to draft government guidelines for how doctors treat diseases. Their action was touched off by the NIH's recent naming of five experts to present evidence at a conference next month aimed at drafting guidelines for treating pregnant women with herpes and babies born with the condition.
The five experts, including one who is responsible for coordinating the writing of the guidelines, are doctors employed at academic medical centers. Four of the five experts, including the writing coordinator, have financial ties to makers of herpes drugs, resulting in a panel that "is completely unbalanced," the letter says. The five were the only experts listed as presenters on an NIH draft agenda for the meeting.
In an email, an NIH spokeswoman said the agency "has canceled the meeting out of concern that misperceptions about this meeting could not be resolved prior to the scheduled meeting date." She said no decision has been made on whether the meeting, originally slated for Feb. 20, will be rescheduled.
The action comes amid concern that clinical guidelines that form the basis for how physicians and hospitals treat patients are being unduly influenced by the drug industry. In several recent cases, including one involving kidney treatment with the drug erythropoetin, guidelines composed by experts paid by drug companies have promoted treatment regimens that some other experts contended brought harm to patients while promoting wider use of a drug.
The letter was signed by 44 individuals and 16 organizations. Among the individuals were Richard Horton, editor of the British medical journal Lancet; Marcia Angell and Jerome Kassirer, both former editors of the New England Journal of Medicine; and doctors from medical schools including Harvard and Johns Hopkins. The organizations included the Center for Science and the Public Interest, the National Women's Health Network and the publisher of Consumer Reports.
The group wrote that the NIH agency "must be an honest broker in the development of medical evidence that will inform clinical practice" and that the NIH must ensure that all members of guideline-writing committees are "free from conflicts of interest."
As reported, several doctors who are paid consultants or speakers for GlaxoSmithKline PLC, maker of the best-selling herpes drug Valtrex, have traveled the country to promote testing and treatment of pregnant women with herpes as a way of preventing babies from picking up the infection. Newborn herpes, though rare, can be fatal. That treatment strategy, however, is controversial. Critics say that there isn't any evidence that treating pregnant women with herpes drugs will reduce cases of newborns born with the infection and that exposing as many as a million women a year to herpes medication could result in dangerous side effects for mother and baby.
The letter writers said the scheduled meeting on herpes added to a "sad record" at the NIH of drafting treatment guidelines using panels composed largely of experts receiving money from drug companies. They said that 2004 guidelines for treating cholesterol were drafted by a committee of nine physicians, eight of whom had financial relationships with makers of statins, which are widely given for high cholesterol.
According to a draft agenda of the Feb. 20 meeting, University of Washington obstetrician Zane Brown was to have presented information on testing pregnant women for herpes. Dr. Brown is a frequent speaker for Glaxo on herpes issues. In an interview with The Wall Street Journal for a prior story on the subject, Dr. Brown estimated he gives two to three lectures a week advocating universal testing of pregnant women, earning $1,000 to $2,500 a talk. The doctor who was slated to lead the session on writing the guidelines, Richard Whitley, is a pediatrician at the University of Alabama at Birmingham medical school who is a member of the Glaxo speakers bureau.
Also on the panel was Anna Wald, a University of Washington epidemiologist, who said yesterday she has been a consultant to Novartis AG, which makes a herpes drug, and has done research funded by Glaxo. Dr. Brown didn't respond to an email, and attempts to reach Dr. Whitley through a representative were unsuccessful.
The fourth member identified in the letter as having a conflict was Massachusetts General Hospital obstetrician Laura Riley, who is the secretary and treasurer of the American Herpes Foundation, a nonprofit largely funded by herpes drug makers. Dr. Riley says she has received a few $1,000 stipends for attending meetings of the herpes foundation, but doesn't receive a salary or other pay for her work at the organization. Read More & Comment...
01/18/2007 05:20 PM |
Lest anyone thinks that the brilliant suggestion that the government use its bulk purchasing power to drive down drug prices using the VA system is something new or will work like a charm...step into drugwonks Wayback machine and journey back to the year 2000, the last time the Yankees were World Champions and Al Gore did not tip the scales at 300 pounds......
This from US Medicine Information Central...
" While it may take two to tango, the SAMBA issue hanging over the Department of Veterans Affairs and pharmaceutical manufacturers is drawing a full dance card.
SAMBA in this case stands for the Special Agents Mutual Benefit Association, a participant in the Federal Employees Health Benefits Program (FEHBP). It covers about 16,000 employees and retirees of the Federal Bureau of Investigation and other federal law enforcement agencies and their dependents.
Under a two-year pilot project now in effect, SAMBA will have access to the Federal Supply Schedule (FSS) and its discounted drug prices as a means of holding down the size of premium increases. Office of Personnel Management (OPM) officials, who approved the pilot after SAMBA requested access to the FSS, say the "experiment" will provide valuable experience in establishing a schedule similar to the FSS for the entire FEHBP.
FSS discounted pricing generally is available only to the "big four" federal agencies that provide health care directly�VA, the Defense Department, the Public Health Service and the Coast Guard. Drug manufacturers are concerned that the SAMBA pilot could lead to a drop in revenues by making discounted pricing available to the entire FEHBP, which covers about 9 million "beneficiary lives"�and perhaps even extending it to other big-ticket programs such as medicare and medicaid."
A no-brainer right? In more ways than one...
Seems as though the VA had a problem or two with the project...
"Veterans advocates caution that the pilot ultimately could cut into the funds available to care for veterans by prompting manufacturers to raise the discounted prices they give to VA to make up for the funds lost because of the pilot or the creation of a new FEHBP pricing schedule. The issue is a complex one involving subparts of federal regulations and bureaucratic purchasing arrangements between drug firms, pharmacy benefit managers and the VA. A meeting held for manufacturers last month at OPM drew a full house but few questions, especially after an attorney from the Pharmaceutical Research and Manufacturers of America (PhRMA) cautioned that individual company reactions to the pilot program could not be discussed without violating antitrust regulations."
And companies simply walked away...
Washington Matters - November 2000
from Drug Benefit Trends
Big Drug Makers Scuttle New Drug Coverage
The federal government has backed off from a test of a new way to pay for the medications used by its employees. The reason for scuttling the pilot project is that both Pfizer and Merck refused to go along. The idea was that the 16,000 active and retired federal law enforcement employees who receive health care coverage through the health plan of the Special Agents Mutual Benefits Association (SAMBA) would be able to buy medications by mail and have them supplied through the Federal Supply Schedule (FSS). The FSS lists the price the government will pay for 17,000 drugs -- generally, about half the wholesale price of the product or around what the drug makers charge to their best private sector customers. The federal Office of Personnel Management (OPM) decided it could not go forward with the plan with the 2 major suppliers, who refused to fill orders from SAMBA enrollees at FSS prices."
Imagine what would happen if Medicare tried to extend VA prices to 50 million seniors.
Walk away? More like a stampede. Read More & Comment...
This from US Medicine Information Central...
" While it may take two to tango, the SAMBA issue hanging over the Department of Veterans Affairs and pharmaceutical manufacturers is drawing a full dance card.
SAMBA in this case stands for the Special Agents Mutual Benefit Association, a participant in the Federal Employees Health Benefits Program (FEHBP). It covers about 16,000 employees and retirees of the Federal Bureau of Investigation and other federal law enforcement agencies and their dependents.
Under a two-year pilot project now in effect, SAMBA will have access to the Federal Supply Schedule (FSS) and its discounted drug prices as a means of holding down the size of premium increases. Office of Personnel Management (OPM) officials, who approved the pilot after SAMBA requested access to the FSS, say the "experiment" will provide valuable experience in establishing a schedule similar to the FSS for the entire FEHBP.
FSS discounted pricing generally is available only to the "big four" federal agencies that provide health care directly�VA, the Defense Department, the Public Health Service and the Coast Guard. Drug manufacturers are concerned that the SAMBA pilot could lead to a drop in revenues by making discounted pricing available to the entire FEHBP, which covers about 9 million "beneficiary lives"�and perhaps even extending it to other big-ticket programs such as medicare and medicaid."
A no-brainer right? In more ways than one...
Seems as though the VA had a problem or two with the project...
"Veterans advocates caution that the pilot ultimately could cut into the funds available to care for veterans by prompting manufacturers to raise the discounted prices they give to VA to make up for the funds lost because of the pilot or the creation of a new FEHBP pricing schedule. The issue is a complex one involving subparts of federal regulations and bureaucratic purchasing arrangements between drug firms, pharmacy benefit managers and the VA. A meeting held for manufacturers last month at OPM drew a full house but few questions, especially after an attorney from the Pharmaceutical Research and Manufacturers of America (PhRMA) cautioned that individual company reactions to the pilot program could not be discussed without violating antitrust regulations."
And companies simply walked away...
Washington Matters - November 2000
from Drug Benefit Trends
Big Drug Makers Scuttle New Drug Coverage
The federal government has backed off from a test of a new way to pay for the medications used by its employees. The reason for scuttling the pilot project is that both Pfizer and Merck refused to go along. The idea was that the 16,000 active and retired federal law enforcement employees who receive health care coverage through the health plan of the Special Agents Mutual Benefits Association (SAMBA) would be able to buy medications by mail and have them supplied through the Federal Supply Schedule (FSS). The FSS lists the price the government will pay for 17,000 drugs -- generally, about half the wholesale price of the product or around what the drug makers charge to their best private sector customers. The federal Office of Personnel Management (OPM) decided it could not go forward with the plan with the 2 major suppliers, who refused to fill orders from SAMBA enrollees at FSS prices."
Imagine what would happen if Medicare tried to extend VA prices to 50 million seniors.
Walk away? More like a stampede. Read More & Comment...
01/18/2007 06:09 AM |
The always astute (and sometimes ascerbic) Steve Usdin of BioCentury has written an important and stimulating article on the road to PDUFA reauthorization.
Must reading.
Here's the link:
Download file
And many thanks to BioCentury for their permission to post this article in its entirety. Read More & Comment...
Must reading.
Here's the link:
Download file
And many thanks to BioCentury for their permission to post this article in its entirety. Read More & Comment...
01/17/2007 01:14 PM |
I've been getting a bunch of calls in the wake of the announcement that Alex Azar will resign as Deputy Secretary of HHS. People want to know what will it mean for this, what will it mean for that. But here's what's important: Alex brought the power of both compassion and intellect to HHS. His departure doesn't mean we'll see any particular shift for any given industry or issue, but it does mean that HHS will lose a certain dimension of thought leadership and sophistication.
Good Luck Alex. Read More & Comment...
Good Luck Alex. Read More & Comment...
01/17/2007 11:03 AM |
Here's the story according to AP
"Cancer deaths in the United States have dropped for a second straight year, confirming that a corner has been turned in the war on cancer.
After a decline of 369 deaths from 2002 to 2003, the decrease from 2003 to 2004 was 3,014 — or more than eight times greater, according to a review of U.S. death certificates by the American Cancer Society.
The drop from 2002 to 2003 was the first annual decrease in total cancer deaths since 1930. But the decline was slight, and experts were hesitant to say whether it was a cause for celebration or just a statistical fluke.
The trend seems to be real, Cancer Society officials said.
"It's not only continuing. The decrease in the second year is much larger," said Ahmedin Jemal, a researcher at the organization.
Cancer deaths dropped to 553,888 in 2004, down from 556,902 in 2003 and 557,271 in 2002, the Cancer Society found.
Experts are attributing the success to declines in smoking and to earlier detection and more effective treatment of tumors. Those have caused a fall in the death rates for breast, prostate and colorectal cancer — three of the most common cancers."
In the wake of this good news, the Dems are seeking to price control unique drugs -- breakthrough medicines in otherwords.
Which means medicines like those that helped reduce dying due to cancer.
Which means medicines from biotech firms that create these miracles.
The Clintons tried proposing a breakthrough drug pricing trigger in 1994 that would hammer and yammer about the price of first in class meds and whether they were all so cost effective or not. It caused biotech stocks to tank and venture capital to vanish.
I hope the D's listen to the Ron Pollacks of the world again and go ahead and do just that. As the Penn and Schoen poll shows, when people find out that price controls also mean an end to miracle cures, they hate price controls. But the D's are driven by their Beltway advisers and power brokers more than they are what people and patients truly want. Read More & Comment...
"Cancer deaths in the United States have dropped for a second straight year, confirming that a corner has been turned in the war on cancer.
After a decline of 369 deaths from 2002 to 2003, the decrease from 2003 to 2004 was 3,014 — or more than eight times greater, according to a review of U.S. death certificates by the American Cancer Society.
The drop from 2002 to 2003 was the first annual decrease in total cancer deaths since 1930. But the decline was slight, and experts were hesitant to say whether it was a cause for celebration or just a statistical fluke.
The trend seems to be real, Cancer Society officials said.
"It's not only continuing. The decrease in the second year is much larger," said Ahmedin Jemal, a researcher at the organization.
Cancer deaths dropped to 553,888 in 2004, down from 556,902 in 2003 and 557,271 in 2002, the Cancer Society found.
Experts are attributing the success to declines in smoking and to earlier detection and more effective treatment of tumors. Those have caused a fall in the death rates for breast, prostate and colorectal cancer — three of the most common cancers."
In the wake of this good news, the Dems are seeking to price control unique drugs -- breakthrough medicines in otherwords.
Which means medicines like those that helped reduce dying due to cancer.
Which means medicines from biotech firms that create these miracles.
The Clintons tried proposing a breakthrough drug pricing trigger in 1994 that would hammer and yammer about the price of first in class meds and whether they were all so cost effective or not. It caused biotech stocks to tank and venture capital to vanish.
I hope the D's listen to the Ron Pollacks of the world again and go ahead and do just that. As the Penn and Schoen poll shows, when people find out that price controls also mean an end to miracle cures, they hate price controls. But the D's are driven by their Beltway advisers and power brokers more than they are what people and patients truly want. Read More & Comment...
01/17/2007 09:26 AM |
A federal court judge has imposed a temporary injunction against the FDA over the agency's drug pedigree requirements, on the basis that the regulations leave sections of the supply chain unguarded and threaten the survival of smaller drug distributors.
Here’s a link to the complete story:
The Prescription Drug Marketing Act (PDMA), originally put into force in 1988, outlines the requirement for a drug pedigree – a statement of origin that identifies each prior sale, purchase or trade of a drug right back to the manufacturer. However, Authorized Distributors (ADs) are exempt from having to provide pedigrees for the drugs they provide, thus leaving sections of the supply chain unmonitored and pedigrees hard to establish further down the line. Authorized distributors are somewhat hazily defined as those who have ongoing relationships with manufacturers, identifiable by evidence of repeated transactions with the manufacturer. Over 90 per cent of the drug wholesale industry in the US is controlled by a handful of companies who are authorized distributors. This group is commonly referred to as the Big Five, made up of McKesson, Bergen Brunswig, AmeriSource, Cardinal Health and Bindley Western.
The exemption means that ADs tend not to maintain or pass on pedigrees for the products they obtain from manufacturers. This becomes problematic when those further down the supply chain, ‘unauthorized’ distributors for example, are required to provide pedigrees right back to the manufacturer. It also means that over 90 per cent of the prescription drugs in the US are essentially uncovered by the PDMA’s security measures.
This issue is further exacerbated by the fact that ADs are not required to provide a pedigree even if they themselves obtained the products from a secondary wholesaler. The FDA themselves noted that some drugs may go through several transaction cycles involving multiple primary and secondary wholesalers before arriving at their retail destination. According to the National Wholesale Druggists’ Association, the Big Five purchase 2-4 per cent of their products from sources other than manufacturers, and one of the group reported that $350 million of their total inventory came from non-manufacturer vendors. Read More & Comment...
Here’s a link to the complete story:
The Prescription Drug Marketing Act (PDMA), originally put into force in 1988, outlines the requirement for a drug pedigree – a statement of origin that identifies each prior sale, purchase or trade of a drug right back to the manufacturer. However, Authorized Distributors (ADs) are exempt from having to provide pedigrees for the drugs they provide, thus leaving sections of the supply chain unmonitored and pedigrees hard to establish further down the line. Authorized distributors are somewhat hazily defined as those who have ongoing relationships with manufacturers, identifiable by evidence of repeated transactions with the manufacturer. Over 90 per cent of the drug wholesale industry in the US is controlled by a handful of companies who are authorized distributors. This group is commonly referred to as the Big Five, made up of McKesson, Bergen Brunswig, AmeriSource, Cardinal Health and Bindley Western.
The exemption means that ADs tend not to maintain or pass on pedigrees for the products they obtain from manufacturers. This becomes problematic when those further down the supply chain, ‘unauthorized’ distributors for example, are required to provide pedigrees right back to the manufacturer. It also means that over 90 per cent of the prescription drugs in the US are essentially uncovered by the PDMA’s security measures.
This issue is further exacerbated by the fact that ADs are not required to provide a pedigree even if they themselves obtained the products from a secondary wholesaler. The FDA themselves noted that some drugs may go through several transaction cycles involving multiple primary and secondary wholesalers before arriving at their retail destination. According to the National Wholesale Druggists’ Association, the Big Five purchase 2-4 per cent of their products from sources other than manufacturers, and one of the group reported that $350 million of their total inventory came from non-manufacturer vendors. Read More & Comment...
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