Latest Drugwonks' Blog
Our Golden Clipboard awards will be posted shortly but it's just coincidence that drugwonks is also undertaking an effort to carry on the tradition of rigorous scientific research that epitomizes meta-analysis both in terms of the intellectual firepower required to conduct it and the apolitical ways in which its conclusions are used to advance public understanding of the overall risk and benefits of treatments without regard to one's personal or political ambition.
To this end we intend to provide a prize for the best meta-analysis of the cardiovascular risks associated with participation in any clinical trials Steve Nissen has conducted. The only criteria for such research is that scholars must deliberately EXCLUDE any patients who did not have a heart attack or severe cardiovascular event as defined by them in their meta-analysis of Nissen-sponsored research. The events in the trial need not be independently adjudicated or be obtained from raw data. Just take the Ns from any trials you can find on Google, compare the cardiovascular risk of Nissen studies to any other set of studies at the same confidence level Dr. Nissen assigned to Avandia meta-analysis.
Oh -- and you can combine patients from as few as four studies.
Winners will have their studies posted well in advance of even on-line publication dates and handed directly to Henry Waxman if we can get to him.
To this end we intend to provide a prize for the best meta-analysis of the cardiovascular risks associated with participation in any clinical trials Steve Nissen has conducted. The only criteria for such research is that scholars must deliberately EXCLUDE any patients who did not have a heart attack or severe cardiovascular event as defined by them in their meta-analysis of Nissen-sponsored research. The events in the trial need not be independently adjudicated or be obtained from raw data. Just take the Ns from any trials you can find on Google, compare the cardiovascular risk of Nissen studies to any other set of studies at the same confidence level Dr. Nissen assigned to Avandia meta-analysis.
Oh -- and you can combine patients from as few as four studies.
Winners will have their studies posted well in advance of even on-line publication dates and handed directly to Henry Waxman if we can get to him.
Last week I gave a brief presentation to folks at the MHRA on the current state of affairs at the FDA. It was a Chatham House rules affair, so I don't want to reveal any confidences -- but the first question I was asked is worth sharing,
"How can the FDA earn back its reputation?"
(Nothing like a softball question from Our Regulatory Cousins.)
Without going into too much detail here, suffice it to say that what followed was a rather robust conversation about the best ways to stand up for what's right in light of the Kristelnacht tactics of many on our side of the pond.
There is indeed a "special friendship" between FDA and MHRA -- and we must all find ways to strengthen these important bonds of regulatory solidarity.
"How can the FDA earn back its reputation?"
(Nothing like a softball question from Our Regulatory Cousins.)
Without going into too much detail here, suffice it to say that what followed was a rather robust conversation about the best ways to stand up for what's right in light of the Kristelnacht tactics of many on our side of the pond.
There is indeed a "special friendship" between FDA and MHRA -- and we must all find ways to strengthen these important bonds of regulatory solidarity.
At last week's CMPI/FDA News conference on the Critical Path, Janet Woodcock discussed the urgency of 21st century bioinformatics by lamenting the fact that,
"Today the major tool of modern medicine seems to the clipboard."
This jives with the recent report of the FDA Science Panel that decries the state of IT at the FDA.
To that end, we are announcing a new award for those who stand in the way of medical progress -- "The Golden Clipboard."
2007's winner will be announced shortly.
"Today the major tool of modern medicine seems to the clipboard."
This jives with the recent report of the FDA Science Panel that decries the state of IT at the FDA.
To that end, we are announcing a new award for those who stand in the way of medical progress -- "The Golden Clipboard."
2007's winner will be announced shortly.
Here's an interesting and controversial thought that came from last week's CMPI/FDA News conference on the Critical Path --
What about mandatory gene mapping for all newborns?
After all, if you believe that mandatory vaccinations are appropriate (as we at Drugwonks certainly do), couldn't the same logic be applied to gene maps that could help physicians really understand the needs of their patients?
If you believe (as we at Drugwonks certainly do) that being able to prescribe the right medicine to the right patient in the right dose at the right time is a goal worth pursuring then, perhaps, mandatory gene mapping for all newborns is something worth considering.
What about mandatory gene mapping for all newborns?
After all, if you believe that mandatory vaccinations are appropriate (as we at Drugwonks certainly do), couldn't the same logic be applied to gene maps that could help physicians really understand the needs of their patients?
If you believe (as we at Drugwonks certainly do) that being able to prescribe the right medicine to the right patient in the right dose at the right time is a goal worth pursuring then, perhaps, mandatory gene mapping for all newborns is something worth considering.
Wither the future of 21st century pharmaceuticals?
Consider what Mark McClellen said Thursday at the CMPI/FDA News conference on the Critical Path,
"The future is not going to be like the past."
(A comment that is much more profound the more you think about it.)
Reagan/Udall Foundation Chairman McClellan also shared this comment,
"Data isn't knowledge."
Now isn't that an apt and memorable motto for the Reagan/Udall Foundation.
Consider what Mark McClellen said Thursday at the CMPI/FDA News conference on the Critical Path,
"The future is not going to be like the past."
(A comment that is much more profound the more you think about it.)
Reagan/Udall Foundation Chairman McClellan also shared this comment,
"Data isn't knowledge."
Now isn't that an apt and memorable motto for the Reagan/Udall Foundation.
Now that FDA reform (referred to by many these days as "FDA Cubed") has passed -- many in Congress feel that the job is done.
Hardly.
I'm not specifically referring to the myriad difficuties of operating under a CR, but rather the overly long and circuitous route FDA hires must take before they take their seats and get to work. It just takes too long.
This isn't a problem for Congress, but rather for the White House and OMB. With hundreds of current vacancies at CDER, this is a problem that needs immediate attention. The hiring process must be addressed and truncated.
For those who support an FDA that addresses safety in a more timely way -- the best way to get it done is to have an agency that is properly staffed. And expediting hires of already budgeted slots seems a logical place to start.
Will this really help the agency do a better job? Here's what Bob Temple had to say on the matter at last week's CMPI/FDA News conference -- "Hell yeah."
We second the emotion.
Hardly.
I'm not specifically referring to the myriad difficuties of operating under a CR, but rather the overly long and circuitous route FDA hires must take before they take their seats and get to work. It just takes too long.
This isn't a problem for Congress, but rather for the White House and OMB. With hundreds of current vacancies at CDER, this is a problem that needs immediate attention. The hiring process must be addressed and truncated.
For those who support an FDA that addresses safety in a more timely way -- the best way to get it done is to have an agency that is properly staffed. And expediting hires of already budgeted slots seems a logical place to start.
Will this really help the agency do a better job? Here's what Bob Temple had to say on the matter at last week's CMPI/FDA News conference -- "Hell yeah."
We second the emotion.
"I think the industry is doomed if we don't change." So says Sid Taurel of Eli Lilly.
What's the answer to it's thinning near term pipeline, according to the WSJ?
Biotechnology. As if drug companies have not invested in biotech since it's inception. But biotech has been no more successful in bringing products to market than drug companies, just less profitable in the process. Which is why biotech has escaped government regulation until recently. Government only punishes success. Which is why it is so eager to create a generic biologics industry before a biotech industry really exists.
There are no easy or short term answers. Drug discovery and development is hard and risky. Of course, that's something the hard Left refuses to accept.
http://online.wsj.com/article/SB119689933952615133.html?mod=home_health_right
What's the answer to it's thinning near term pipeline, according to the WSJ?
Biotechnology. As if drug companies have not invested in biotech since it's inception. But biotech has been no more successful in bringing products to market than drug companies, just less profitable in the process. Which is why biotech has escaped government regulation until recently. Government only punishes success. Which is why it is so eager to create a generic biologics industry before a biotech industry really exists.
There are no easy or short term answers. Drug discovery and development is hard and risky. Of course, that's something the hard Left refuses to accept.
http://online.wsj.com/article/SB119689933952615133.html?mod=home_health_right
Somehow the idea that the FDA will get a handle on this by forcing track and trace technology on distributors anytime soon is a joke. When will the importation kool-aid drinkers wake up?
Security concerns raised as China fills U.S. medicine chest
By Tim Johnson, McClatchy Newspapers
BEIJING — The medicine cabinet in the average U.S. home is filling with drugs made in China , and some experts say that could be a prescription for trouble.
China's booming pharmaceutical industry has doubled exports to the United States in the past five years, undercutting competitors and making American consumers reliant on the safety of Chinese factories and captive to any disruptions in Sino-U.S. commerce.
It might seem like merely a trade issue. But industry experts in Europe and the United States say national-security concerns are edging into the debate.
Consider this scenario:
If a major anthrax attack were to occur in the United States — larger than the one in 2001, when five people died— pharmaceutical companies that make the two antibiotics most suitable for treatment, Cipro and doxycycline, would have no choice but to rely on China or India for key ingredients once American stockpiles were exhausted. Those ingredients no longer are made in the West.
A Portuguese company that ramped up doxycycline production in 2001 at Washington's request said China now controlled the flow of its crucial drug component.
http://news.yahoo.com/s/mcclatchy/20071206/wl_mcclatchy/2774948
Security concerns raised as China fills U.S. medicine chest
By Tim Johnson, McClatchy Newspapers
BEIJING — The medicine cabinet in the average U.S. home is filling with drugs made in China , and some experts say that could be a prescription for trouble.
China's booming pharmaceutical industry has doubled exports to the United States in the past five years, undercutting competitors and making American consumers reliant on the safety of Chinese factories and captive to any disruptions in Sino-U.S. commerce.
It might seem like merely a trade issue. But industry experts in Europe and the United States say national-security concerns are edging into the debate.
Consider this scenario:
If a major anthrax attack were to occur in the United States — larger than the one in 2001, when five people died— pharmaceutical companies that make the two antibiotics most suitable for treatment, Cipro and doxycycline, would have no choice but to rely on China or India for key ingredients once American stockpiles were exhausted. Those ingredients no longer are made in the West.
A Portuguese company that ramped up doxycycline production in 2001 at Washington's request said China now controlled the flow of its crucial drug component.
http://news.yahoo.com/s/mcclatchy/20071206/wl_mcclatchy/2774948
Rosa DeLauro continues her mission against any one affiliated with companies who in turn want to work with the Reagan Udall foundation. This time it's president of the Bill and Melinda Gates Foundation Global Health Program, Dr. Tadataka (Tachi) Yamada who leads the foundation’s efforts to help develop and deliver low-cost, life-saving health tools for the developing world. He oversees our global health grant portfolio and Global Health Advocacy.
Before joining the foundation, Yamada served as Chairman of Research and Development and was a member of the Board of Directors at GlaxoSmithKline. Prior to that, he was chairman of the Department of Internal Medicine at the University of Michigan Medical School and Physician-in-Chief at the University of Michigan Medical Center. Yamada is a past president of the American Gastroenterological Association and the Association of American Physicians, a master of the American College of Physicians, and a member of the Institute of Medicine of the National Academy of Science in the United States and the Academy of Medical Sciences in the United Kingdom.
DeLauro wants Yamada's appointment investigated because when he was with GSK nearly ten years ago -- which is yesterday in politics, Yamada complained to John Buse, a University of North Carolina doctor (and now head of the American Diabetes Association) after he said at a 1999 medical conference that Avandia could cause heart attacks. Buse told Yamada to knock it off after Yamada made a phone call to Buse's boss, who Yamada calls "an old friend, so I felt comfortable calling him to probe informally about his opinion of Dr. Buse."
Before joining the foundation, Yamada served as Chairman of Research and Development and was a member of the Board of Directors at GlaxoSmithKline. Prior to that, he was chairman of the Department of Internal Medicine at the University of Michigan Medical School and Physician-in-Chief at the University of Michigan Medical Center. Yamada is a past president of the American Gastroenterological Association and the Association of American Physicians, a master of the American College of Physicians, and a member of the Institute of Medicine of the National Academy of Science in the United States and the Academy of Medical Sciences in the United Kingdom.
DeLauro wants Yamada's appointment investigated because when he was with GSK nearly ten years ago -- which is yesterday in politics, Yamada complained to John Buse, a University of North Carolina doctor (and now head of the American Diabetes Association) after he said at a 1999 medical conference that Avandia could cause heart attacks. Buse told Yamada to knock it off after Yamada made a phone call to Buse's boss, who Yamada calls "an old friend, so I felt comfortable calling him to probe informally about his opinion of Dr. Buse."
Steve Usdin has an excellent piece in this week's Biocentury on how Roche addressed concerns that there was a connection between Tamiflu, influenza and psychiatric problems in children...sort of an SSRI redux. It begins:
"Roche navigated through an important inflection point in the drug safety tempest last week, charting a course that other sponsors might use to overcome concerns that arise when drugs are a s s o c i a t e d with very rare, serious adverse effects.
The company deployed observational data to persuade FDA’s Pediatric Advisory
Committee to recommend that the agency tone down c a u t i o n s about Tamiflu
oseltamivir, an antiviral drug that has been associated with troubling neuropsychiatric events. The Tamiflu story provided an opportunity to test the hypothesis that even in an era when FDA and its advisory committees are loathe to take risks, good data can reverse the slide into the precautionary abyss. It also concretely demonstrated how
difficult it can be to determine causality when apparent drug safety issues emerge."
The data showed that the link between psychiatric problems was linked with the flu and not the drug by following groups that had the flu alone as well as careful tracking of each of the handful of cases among the millions of Tamiflu users world wide."
As Usdin reports:
"During the discussion, committee chair Rappley argued ROG should not be punished
for responding to the advisory committee’s request for additional information
on Tamiflu’s safety. And several committee members said they were pleased by ROG’s response. “This is a case where the system worked. We asked for more information a couple of years ago and a year ago. I feel quite a bit more informed and reassured,†Newman said. “I am reassured by most of what I saw today. I think the system
worked,†Daum said."
Chalk one up for commonsense and science.
"Roche navigated through an important inflection point in the drug safety tempest last week, charting a course that other sponsors might use to overcome concerns that arise when drugs are a s s o c i a t e d with very rare, serious adverse effects.
The company deployed observational data to persuade FDA’s Pediatric Advisory
Committee to recommend that the agency tone down c a u t i o n s about Tamiflu
oseltamivir, an antiviral drug that has been associated with troubling neuropsychiatric events. The Tamiflu story provided an opportunity to test the hypothesis that even in an era when FDA and its advisory committees are loathe to take risks, good data can reverse the slide into the precautionary abyss. It also concretely demonstrated how
difficult it can be to determine causality when apparent drug safety issues emerge."
The data showed that the link between psychiatric problems was linked with the flu and not the drug by following groups that had the flu alone as well as careful tracking of each of the handful of cases among the millions of Tamiflu users world wide."
As Usdin reports:
"During the discussion, committee chair Rappley argued ROG should not be punished
for responding to the advisory committee’s request for additional information
on Tamiflu’s safety. And several committee members said they were pleased by ROG’s response. “This is a case where the system worked. We asked for more information a couple of years ago and a year ago. I feel quite a bit more informed and reassured,†Newman said. “I am reassured by most of what I saw today. I think the system
worked,†Daum said."
Chalk one up for commonsense and science.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
