Latest Drugwonks' Blog
As we await the new version of the Kennedy/Enzi (nee, Enzi/Kennedy) bill and the debate over its half-brother PDUFA IV, it’s important to reflect on what “victory†looks like.
Consider REMS. On the face of it, certainly bad, but is it a go-to-the-mat issue? Many say “no.†Drugwonks says “yes.†Yes, because unopposed it allows the train to begin its journey in the wrong direction – and that means permitting momentum that will, in short order, lead to more dangerous policy ideas that will become even more difficult to derail. When it comes to bad ideas, there’s no time like the present to stop them in their tracks.
Consider advisory committee conflict of interest issues. A live-or-die proposition? Many say, “yawn.†Drugwonks says “yikes.†If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is, a significant disservice.
Kennedy/Enzi (or the inimitable Dan Troy refers to it, “Kenziâ€) is chockablock with unintended consequences that would significantly set back real FDA reform. Accepting Kenzi as a “least/worst†alternative (especially when the other option is the Dodd/Grassley abomination) represents not savvy political calculation but paralytic cowardice.
Who will step forward with the confidence and the credentials to lead the charge towards a more robust legislative endpoint?
Calling Dr. von Eschenbach ...
Consider REMS. On the face of it, certainly bad, but is it a go-to-the-mat issue? Many say “no.†Drugwonks says “yes.†Yes, because unopposed it allows the train to begin its journey in the wrong direction – and that means permitting momentum that will, in short order, lead to more dangerous policy ideas that will become even more difficult to derail. When it comes to bad ideas, there’s no time like the present to stop them in their tracks.
Consider advisory committee conflict of interest issues. A live-or-die proposition? Many say, “yawn.†Drugwonks says “yikes.†If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is, a significant disservice.
Kennedy/Enzi (or the inimitable Dan Troy refers to it, “Kenziâ€) is chockablock with unintended consequences that would significantly set back real FDA reform. Accepting Kenzi as a “least/worst†alternative (especially when the other option is the Dodd/Grassley abomination) represents not savvy political calculation but paralytic cowardice.
Who will step forward with the confidence and the credentials to lead the charge towards a more robust legislative endpoint?
Calling Dr. von Eschenbach ...
I get a kick out of politicians and policymakers who worship at the altar of evidence based medicine without knowing what the hell they are even talking about or even knowing the quality of the evidence. As if by default the information produced by a bunch of government paid contractors who punch up all the 'reliable' studies -- randomized clinical trials -- will come up with an objective answer that can be used to guide every doctor and every payment decision.
Under the Medicare Modernization Act, the Agency for Health Care Quality and Research was required to conduct comparative effectiveness studies of major classes of drugs. They have contracted out to places like RAND and the University of Oregon's Drug Evaluation Deathstar which was created by former Governor Kitzhaber who also came up with the idea of rationing care to Medicaid patients.
Anyways, here are the conclusions of the AHQR's panel comparing second generation antidepressants in treating major depression. I defy anyone to distill any message except: start out with what's cheapest and then switch if there are side effects:
"In general, the various second-generation antidepressants have similar rates of effectiveness. In controlled studies, about 38 percent of patients saw no improvement and 54 percent had only partial improvement.
According to the National Institute of Mental Health's Sequenced Treatment Alternative to Relieve Depression (STAR-D) trial, a substantial number (between about 25 percent and 33 percent) of patients will improve with the addition or substitution of a different drug."
Carol Clancy, who is smart and well intentioned, gave this piece of advice based on these findings:
"As with all medications, second-generation antidepressants should be used after careful consideration of benefits and risks. It's up to clinicians and patients to work closely together so the best possible results are achieved."
And we did the study because....? As Rosanna Danna used to say, "If it's not one thing, it's another."
The AHRQ called for future research to establish reliably the general efficacy of second-generation antidepressants for treating dysthymia and subsyndromal depression. Multiple-arm, head-to-head trials with placebo groups should be used.
Effectiveness studies with a high rate of applicability to primary care populations are generally lacking for most of the drugs. "Effectiveness trials with less stringent eligibility criteria, health outcomes, long study durations and a primary care population would be valuable to determine whether existing differences of second-generation antidepressants are clinically meaningful in 'real world' settings," the AHRQ said. Further research is needed on efficacy in population subgroups, such as the very elderly and patients with common comorbidities.
Recognising that approximately 40% of patients do not respond to initial treatment, the AHRQ said studies should explore whether combinations of antidepressants at initiation of therapy lead to better response rates than single agents.
Large, well-conducted observational studies are also needed to reliably assess the comparative risk of rare but serious adverse events, particularly for very elderly patients.
Hey, why don't we just enroll the entire world in a multiple arm, real world randomized clinical triall alongside a global well-conducted observational study to detect serious adverse events so we can stratify for every subpopulation. By the time we get done collecting and analyzing data - 20 years from now -- there will be a whole new class of targeted therapies based on disease mechanisms which will render the one size fits all approach to medicine will become increasingly outdated.
Of course, we need research on what works. But AHRQ approach and the outlandish proposal to enroll the entire world in eternal clinical trials for specific indications ignores the fact there are better ways to answers the thousands of clinical questions.
We are coming up with one size fits all answers at a time when we are producing personalized medicines. We need medical information that fits the era and its insights.
Under the Medicare Modernization Act, the Agency for Health Care Quality and Research was required to conduct comparative effectiveness studies of major classes of drugs. They have contracted out to places like RAND and the University of Oregon's Drug Evaluation Deathstar which was created by former Governor Kitzhaber who also came up with the idea of rationing care to Medicaid patients.
Anyways, here are the conclusions of the AHQR's panel comparing second generation antidepressants in treating major depression. I defy anyone to distill any message except: start out with what's cheapest and then switch if there are side effects:
"In general, the various second-generation antidepressants have similar rates of effectiveness. In controlled studies, about 38 percent of patients saw no improvement and 54 percent had only partial improvement.
According to the National Institute of Mental Health's Sequenced Treatment Alternative to Relieve Depression (STAR-D) trial, a substantial number (between about 25 percent and 33 percent) of patients will improve with the addition or substitution of a different drug."
Carol Clancy, who is smart and well intentioned, gave this piece of advice based on these findings:
"As with all medications, second-generation antidepressants should be used after careful consideration of benefits and risks. It's up to clinicians and patients to work closely together so the best possible results are achieved."
And we did the study because....? As Rosanna Danna used to say, "If it's not one thing, it's another."
The AHRQ called for future research to establish reliably the general efficacy of second-generation antidepressants for treating dysthymia and subsyndromal depression. Multiple-arm, head-to-head trials with placebo groups should be used.
Effectiveness studies with a high rate of applicability to primary care populations are generally lacking for most of the drugs. "Effectiveness trials with less stringent eligibility criteria, health outcomes, long study durations and a primary care population would be valuable to determine whether existing differences of second-generation antidepressants are clinically meaningful in 'real world' settings," the AHRQ said. Further research is needed on efficacy in population subgroups, such as the very elderly and patients with common comorbidities.
Recognising that approximately 40% of patients do not respond to initial treatment, the AHRQ said studies should explore whether combinations of antidepressants at initiation of therapy lead to better response rates than single agents.
Large, well-conducted observational studies are also needed to reliably assess the comparative risk of rare but serious adverse events, particularly for very elderly patients.
Hey, why don't we just enroll the entire world in a multiple arm, real world randomized clinical triall alongside a global well-conducted observational study to detect serious adverse events so we can stratify for every subpopulation. By the time we get done collecting and analyzing data - 20 years from now -- there will be a whole new class of targeted therapies based on disease mechanisms which will render the one size fits all approach to medicine will become increasingly outdated.
Of course, we need research on what works. But AHRQ approach and the outlandish proposal to enroll the entire world in eternal clinical trials for specific indications ignores the fact there are better ways to answers the thousands of clinical questions.
We are coming up with one size fits all answers at a time when we are producing personalized medicines. We need medical information that fits the era and its insights.
Follow-on biologics is a matter of when not if. But if it's introduction and explanation is left to the political hacks representing the managed care plans and the generic drug industry, Ben Affleck will have a hit movie many times over before a follow on biotech product is approved.
That's because in their greed and haste to appease the new Democrat overlords, the political spinmeisters are introducing assumptions about the ease with which one can produce therapeutic analogues and break patents that just don't exist in nature. A look at the good science a company like Momenta Pharmaceuticals is undertaking to improve characterization of complex proteins and their analogues underscores that follow on products are years in the making and will not be the function of just handing over data.
But because the spinmeisters and staff approach the biologicals sciences -- deliberately at times -- with the neuronal sophistication of single cell oceanic life forms -- it looks like producing follow on biologics (and milking money to pay for social programs) should be as easy as tapping a keg at a Moveon.org fundraiser.
As usual, Steve Usdin's Biocentury steers us into reality with his trenchant analysis and factual reporting. Can anyone say gold standard for reporting on pharmaceutical and biotech policy issues?
Download file
That's because in their greed and haste to appease the new Democrat overlords, the political spinmeisters are introducing assumptions about the ease with which one can produce therapeutic analogues and break patents that just don't exist in nature. A look at the good science a company like Momenta Pharmaceuticals is undertaking to improve characterization of complex proteins and their analogues underscores that follow on products are years in the making and will not be the function of just handing over data.
But because the spinmeisters and staff approach the biologicals sciences -- deliberately at times -- with the neuronal sophistication of single cell oceanic life forms -- it looks like producing follow on biologics (and milking money to pay for social programs) should be as easy as tapping a keg at a Moveon.org fundraiser.
As usual, Steve Usdin's Biocentury steers us into reality with his trenchant analysis and factual reporting. Can anyone say gold standard for reporting on pharmaceutical and biotech policy issues?
Download file
In his opening statement today on hearings about political interference with the work of government scientists (climate change) Henry Waxman said: I don't want politically correct science. I want the best science possible.
Here's Henry Waxman waxing on and off about non-inferiority trials less then four months ago:
“Permitting drug companies to take shortcuts in their clinical trials poses real risks to Americans,†said Rep. Waxman. “An antibiotic that is no better than a placebo can’t fight off an infection. Worse, it can subject you to serious, even life-threatening side effects without any compensating benefit. Americans deserve to have confidence that an FDA-approved drug will be both safe and effective.â€
It's hard to know even where to begin. Non-inferiority trials are not short cuts. And asserting that an antibiotic that is no better than a placebo equals non-inferiority trials is scientifically wrong....
In any event, the fact that a member of Congress (along with Markey and Grassley) asking the GAO to investigate the FDA's use of trial designs is not politically correct science? How is this meddling any different than an OMB review of the methodology of climate change study methodology? It's worse.
Here's one effect of the Waxman peer review process...
Supposedly, FDA reviewers have sent signals that a drug intended to keep people alive whose transplanted organs are being rejected and have six hours to live on average should undergo placebo controlled trials to determine safety.
The best science possible? I would argue that Waxman's micromanagement -- if this FDA anecdote is even has a glint of truth to it -- borders on compromising the canons of science and the integrity of the entire drug evaluation process.
Here's Henry Waxman waxing on and off about non-inferiority trials less then four months ago:
“Permitting drug companies to take shortcuts in their clinical trials poses real risks to Americans,†said Rep. Waxman. “An antibiotic that is no better than a placebo can’t fight off an infection. Worse, it can subject you to serious, even life-threatening side effects without any compensating benefit. Americans deserve to have confidence that an FDA-approved drug will be both safe and effective.â€
It's hard to know even where to begin. Non-inferiority trials are not short cuts. And asserting that an antibiotic that is no better than a placebo equals non-inferiority trials is scientifically wrong....
In any event, the fact that a member of Congress (along with Markey and Grassley) asking the GAO to investigate the FDA's use of trial designs is not politically correct science? How is this meddling any different than an OMB review of the methodology of climate change study methodology? It's worse.
Here's one effect of the Waxman peer review process...
Supposedly, FDA reviewers have sent signals that a drug intended to keep people alive whose transplanted organs are being rejected and have six hours to live on average should undergo placebo controlled trials to determine safety.
The best science possible? I would argue that Waxman's micromanagement -- if this FDA anecdote is even has a glint of truth to it -- borders on compromising the canons of science and the integrity of the entire drug evaluation process.
It's called Pharmalot (no relation to Spamalot) but the guy producing it does live about five minutes away from me. He's Ed Silverman, who has covered the drug and biotech industry for the Star-Ledger of New Jersey for over a decade. Ed's reporting has been hard hitting and informative (full disclosure, we have bought each other a cup of Dunkin Donuts cover twice in the past eight years).
Ed will be a panelist at our Media and Medical Science conference by the way and I urge you to check out his new blog which is at http://pharmalot.com/ . We will be linking to it and encourage everyone to become a regular reader.
Best of luck, Ed!
Ed will be a panelist at our Media and Medical Science conference by the way and I urge you to check out his new blog which is at http://pharmalot.com/ . We will be linking to it and encourage everyone to become a regular reader.
Best of luck, Ed!
Advertising is really a fancy word for calling attention to yourself, which is what the "authors" of a study -- more of a review of TV commercials -- in that prestigious medical journal the Annals of Family Medicine really is.
The article is entitled "Creating Demand for Prescription Drugs: A Content Analysis of Television Direct to Consumer Advertising." Translation: we Tivo'd a lot episodes of 24, CSI Miami and American Idol as a pretext to make fun of those silly drug ads and get some media attention.
Here's what Dominick Frosch the lead (I am trying not to laugh when I write this ) author of this "study" concluded from his "content analysis":
All of the ads … contained elements that we considered problematic. I think consumers should be more skeptical of the pharmaceutical ads than some surveys find they are."
Ya think Dominick? You mean the fact that jokes about Viagra ads and the warnings about how drugs to certain urinary incontinence in man cause your breasts to swell isn't content analysis enough.
Here's what I consider problematic: Dominick's previous 'scholarship' on the subject of risk communication and what to tell patients who might have a serious disease. Dominick has devoted himself to exploring whether videos or the internet or discussion groups or talking to your doctor are more effective in getting people to stop smoking, get a prostate exam, lose weight, etc. Seems as though there is no clear answer and Dominick never compares advertising of any sort to these other approaches. So how does he know if, as he told Rita Rubin's USA Today: "they leave a lot to be desired in terms of providing useful educational information to consumers."
Maybe they do. But at least the guys in the gym remember the stupid Viagra ads and know what's Viagra's for. And if you want to promote prostate screening would you do it with Dominick Forsch with a video on PBS or Paris Hilton during halftime at the Superbowl.
That's the difference between PSA's (pun intended) and advertising.
The article is entitled "Creating Demand for Prescription Drugs: A Content Analysis of Television Direct to Consumer Advertising." Translation: we Tivo'd a lot episodes of 24, CSI Miami and American Idol as a pretext to make fun of those silly drug ads and get some media attention.
Here's what Dominick Frosch the lead (I am trying not to laugh when I write this ) author of this "study" concluded from his "content analysis":
All of the ads … contained elements that we considered problematic. I think consumers should be more skeptical of the pharmaceutical ads than some surveys find they are."
Ya think Dominick? You mean the fact that jokes about Viagra ads and the warnings about how drugs to certain urinary incontinence in man cause your breasts to swell isn't content analysis enough.
Here's what I consider problematic: Dominick's previous 'scholarship' on the subject of risk communication and what to tell patients who might have a serious disease. Dominick has devoted himself to exploring whether videos or the internet or discussion groups or talking to your doctor are more effective in getting people to stop smoking, get a prostate exam, lose weight, etc. Seems as though there is no clear answer and Dominick never compares advertising of any sort to these other approaches. So how does he know if, as he told Rita Rubin's USA Today: "they leave a lot to be desired in terms of providing useful educational information to consumers."
Maybe they do. But at least the guys in the gym remember the stupid Viagra ads and know what's Viagra's for. And if you want to promote prostate screening would you do it with Dominick Forsch with a video on PBS or Paris Hilton during halftime at the Superbowl.
That's the difference between PSA's (pun intended) and advertising.
Our good friend John Kamp, Executive Director of the Coalition for Healthcare Communication, begs to differ with the recent report in the Annals of Family Medicine on the future of DTC communications. And he takes particular umbrage at a sidebar editorial by Dr. David Kessler.
As do we here at Drugwonks. Kamp's right and his statement deserves to be shared.
We are proud to do so.
Coalition Responds to DTC Study, Editorial In Annals of Family Medicine, January/February 2007
The January/February 2007 edition of the Annals of Family Medicine contains a report on a DTC research study and an accompanying editorial co-authored by former FDA Commissioner David Kessler. Although the FDA needs to ground its DTC policy on the science of consumer behavior, the study and the editorial would lead policy makers in the wrong direction.
Either editorialists Kessler and Levy didn’t read the study carefully or chose to ignore its limits. Nothing in the research supports their opinions and conclusions that more stringent DTC rules are needed. Further, the research authors largely ignore the significant body of studies on the effects of advertising on consumer beliefs and behaviors, including the FDA's own studies, that demonstrate that exposure to advertising leads to more and better doctor-patient conversations.
The full text of the statement can be found by clicking on this link:
Download file
Remember -- it's the First Amendment for a reason.
As do we here at Drugwonks. Kamp's right and his statement deserves to be shared.
We are proud to do so.
Coalition Responds to DTC Study, Editorial In Annals of Family Medicine, January/February 2007
The January/February 2007 edition of the Annals of Family Medicine contains a report on a DTC research study and an accompanying editorial co-authored by former FDA Commissioner David Kessler. Although the FDA needs to ground its DTC policy on the science of consumer behavior, the study and the editorial would lead policy makers in the wrong direction.
Either editorialists Kessler and Levy didn’t read the study carefully or chose to ignore its limits. Nothing in the research supports their opinions and conclusions that more stringent DTC rules are needed. Further, the research authors largely ignore the significant body of studies on the effects of advertising on consumer beliefs and behaviors, including the FDA's own studies, that demonstrate that exposure to advertising leads to more and better doctor-patient conversations.
The full text of the statement can be found by clicking on this link:
Download file
Remember -- it's the First Amendment for a reason.
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.
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.
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?
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?
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....
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....
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