Latest Drugwonks' Blog
My ears weren’t burning but …
It seems that, while I was chairing a conference on the FDA’s Critical Path program (along with notables such as McClellan, Woodcock, and Temple), “Regulator-without-Portfolio†Steve Nissen was calling me names (“obscure flackâ€) and this blog (www.drugwonks.com) “vile.â€
And no one even called the hall monitor.
Well “vile†is in the eyes of the beholder – but better that then servile to the whims of the Patron Saint of Meta-Analysis. (The good news, however, is that (1) Dr. Nissen is reading drugwonks.com and (2) since his nasty comments our traffic has spiked. So, thanks Steve.)
Windhover’s Roger Longman offers this perspective on Steverino’s puerile bellyaching:
“In perhaps the most entertaining of talks, Regulator-without-Portfolio and Cleveland Clinic’s cardiovascular boss Steve Nissen blasted the FDA leadership for soulless toadying to industry. He started at the top with Andrew von Eschenbach – damned as a close Bush friend (admittedly, from our point of view, hardly a recommendation) and a “urologist†(an apparent reference to some religio-medical schema that blesses the cardiovascular as kosher and condemns the urological as treif) …
... There is also this odd fact: the Mafia which, the accusation goes, ran/runs FDA for the benefit of Republicans and Big Pharma, approved a mere trickle of new products while wrapping lots of existing ones with new warnings and restrictions. Were these Mammonites merely incompetent at serving their Master?â€
Roger’s complete musings can be found here …
http://therpmreport.com/Free/firsttake.aspx
For more on Dr. Nissen’s “issues†see here:
http://drugwonks.com/2007/06/nissens_plaque_problem.html
Cardiologists who live in glass houses shouldn’t throw epitaphs.
It seems that, while I was chairing a conference on the FDA’s Critical Path program (along with notables such as McClellan, Woodcock, and Temple), “Regulator-without-Portfolio†Steve Nissen was calling me names (“obscure flackâ€) and this blog (www.drugwonks.com) “vile.â€
And no one even called the hall monitor.
Well “vile†is in the eyes of the beholder – but better that then servile to the whims of the Patron Saint of Meta-Analysis. (The good news, however, is that (1) Dr. Nissen is reading drugwonks.com and (2) since his nasty comments our traffic has spiked. So, thanks Steve.)
Windhover’s Roger Longman offers this perspective on Steverino’s puerile bellyaching:
“In perhaps the most entertaining of talks, Regulator-without-Portfolio and Cleveland Clinic’s cardiovascular boss Steve Nissen blasted the FDA leadership for soulless toadying to industry. He started at the top with Andrew von Eschenbach – damned as a close Bush friend (admittedly, from our point of view, hardly a recommendation) and a “urologist†(an apparent reference to some religio-medical schema that blesses the cardiovascular as kosher and condemns the urological as treif) …
... There is also this odd fact: the Mafia which, the accusation goes, ran/runs FDA for the benefit of Republicans and Big Pharma, approved a mere trickle of new products while wrapping lots of existing ones with new warnings and restrictions. Were these Mammonites merely incompetent at serving their Master?â€
Roger’s complete musings can be found here …
http://therpmreport.com/Free/firsttake.aspx
For more on Dr. Nissen’s “issues†see here:
http://drugwonks.com/2007/06/nissens_plaque_problem.html
Cardiologists who live in glass houses shouldn’t throw epitaphs.
Senator Charles Schumer (D-NY) has introduced legislation to modernize Medicare reimbursement policies for certain laboratory tests such as molecular diagnostics. The Advanced Medical Technology Association said that the legislation would help ensure continued innovation and patient access to important diagnostic tools.
The legislation also has been introduced in the U.S. House of Representatives as the Medicare Advanced Laboratory Diagnostics Act (H.R. 1321), where it is sponsored by Rep. Bobby Rush (D-IL), Rep. Michael Ferguson (R-NJ), Rep. Mike Thompson (D-CA), and Rep. Phil English (R-PA).
Though these tests make up less than 2 percent of hospital costs, their findings influence as much as 70 percent of healthcare decision-making, the group said. It said the current Medicare reimbursement system provides few incentives to develop new tests which are critical to the future of healthcare.
The groups said the bill provides for significant reforms to outdated Medicare reimbursement policies that threaten to stifle innovation and the widespread diffusion of technologies. This includes establishing a demonstration project to test a new Medicare payment system for certain molecular diagnostics, allowing for a process to adjust items still on the Clinical Lab Fee Schedule through an appeals process to correct historic errors that set inadequate reimbursement for diagnostic tests, and improving processes for obtaining adequate reimbursement for new diagnostic lab tests.
The legislation also has been introduced in the U.S. House of Representatives as the Medicare Advanced Laboratory Diagnostics Act (H.R. 1321), where it is sponsored by Rep. Bobby Rush (D-IL), Rep. Michael Ferguson (R-NJ), Rep. Mike Thompson (D-CA), and Rep. Phil English (R-PA).
Though these tests make up less than 2 percent of hospital costs, their findings influence as much as 70 percent of healthcare decision-making, the group said. It said the current Medicare reimbursement system provides few incentives to develop new tests which are critical to the future of healthcare.
The groups said the bill provides for significant reforms to outdated Medicare reimbursement policies that threaten to stifle innovation and the widespread diffusion of technologies. This includes establishing a demonstration project to test a new Medicare payment system for certain molecular diagnostics, allowing for a process to adjust items still on the Clinical Lab Fee Schedule through an appeals process to correct historic errors that set inadequate reimbursement for diagnostic tests, and improving processes for obtaining adequate reimbursement for new diagnostic lab tests.
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
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.
