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Commenting on the current state of 21st century bioinformatics, Dr. Janet Woodcock quipped that, "Today the major tool of modern medicine seems to the clipboard."
And that gave us an idea – a new award for those who impede (unwittingly or otherwise) the advance of medical progress -- "The Golden Clipboard."
Herewith our 2007 honorees …
Honorable Mention: Representative Rosa DeLauro
An honorable mention goes to Representative Rosa DeLauro for her perplexing efforts to embog the work of the Reagan/Udall Critical Path Foundation. Ms. DeLauro has demonstrated a remarkable lack of understanding of the science of drug development and the purpose of the Critical Path in general. She has stated: “I believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials. The Foundation could play a significant role in recommending the use of biomarkers and other measures that may not be true measures of efficacy.†This is all the more surprising and concerning considering the fact that Ms. DeLauro chairs the appropriations subcommittee that funds the FDA.
We hope that Ms. DeLauro’s tenacity towards improving the FDA and passion for protecting the public health can be harnessed and redirected to better purposes in 2008.
The Bronze Clipboard: Representative Henry Waxman
A perennial Golden Clipboard contender, Representative Henry Waxman is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia. His oversight hearing – during which Mr. Waxman was both measured and civil in his handling of all witnesses – helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular. He also had a direct hand in undermining the FDA’s sound scientific policy towards “non-inferiority†trials for new antibiotics. The unintended (but not surprising) consequence is that several important antibiotics have been delayed or shelved. Congressman Waxman (we assume, again, unintentionally) helped to politicize the FDA by paving a separate and old score-settling path for those within the agency who disagree with scientific consensus.
In addition to his role as Congressional Oversighter-in-Chief, Mr. Waxman is one of the most knowledgeable members of Congress when it comes to how the FDA works and what it needs to succeed – and we look forward to his efforts to help the agency pursue its mission of both protecting and advancing the public health in 2008.
The Silver Clipboard: Dr. Steven Nissen
Dr. Nissen’s persistent undermining of the FDA came close to winning him Clipboard top honors for 2007. Among many memorable exploits, Dr. Nissen’s most Clipboard-worthy moment was on ABC’s 20/20 program, where he pronounced Avandia to be responsible for “more deaths than 9/11.†A few days later, when asked by Congressman Waxman if he would recommend that doctors take their patients off that drug, he responded, “No.†What’s the frequency, Steve?
Regularly positioning himself as “Dr. Transparency,†Dr. Nissen regularly neglected to come clean about his various consulting arrangements, conflicts and clinical trial activities. That, and his public flailing of drugwonks.com as “vile,†earns him this year’s Silver Clipboard and (at least hopefully) removes his name from any plausible consideration for FDA Commissioner anytime in the 21st century.
AND THE WINNER OF THE 2007 GOLDEN CLIPBOARD GOES TO
(Drum roll please …)
2007 Golden Clipboard Winner: Dr. David Graham
David Graham ostensibly works for the FDA -- but he seems to spend a lot of time in the Halls of Congress advising members and staff about which FDA medical reviewers should be hauled in for polite “conversations.†Setting aside Dr. Graham’s contribution to the Vioxx Populi literature -- which an FDA advisory committee considered to be a rather shoddy piece of research – he also helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides. Graham still maintains that the lipid-lowering drug Crestor should be off the market despite the fact that it has recently received new indications for treatment of fatal heart diseases. And his assertion that Avandia should be taken off the market because an observational study showed that another drug was safer and more effective was both shoddy science as well as remarkably insouciant since he relied on observational data that did not have safety as a primary endpoint – the same sort of science that, when it came to Vioxx, he rejected as insufficient.
Dr. Graham is a man on a mission. AKA “Dr. Precautionary Principle,†he wants the FDA to use meta-analysis to generate safety signals early and often, and stop the clinical testing, prescribing and marketing of medicines until all such signals are explored using large scale randomized clinical trials that use safety as a primary endpoint. In short, he wants fulfillment of his vision at the expense of human life and medical progress.
For his persistence, zeal, and determination to damage not only the FDA but the public health, for his effectiveness in fear mongering and willingness to subordinate medical progress to his ascetic view of safety, we award Dr. David Graham the 2007 Golden Clipboard Award.
And that gave us an idea – a new award for those who impede (unwittingly or otherwise) the advance of medical progress -- "The Golden Clipboard."
Herewith our 2007 honorees …
Honorable Mention: Representative Rosa DeLauro
An honorable mention goes to Representative Rosa DeLauro for her perplexing efforts to embog the work of the Reagan/Udall Critical Path Foundation. Ms. DeLauro has demonstrated a remarkable lack of understanding of the science of drug development and the purpose of the Critical Path in general. She has stated: “I believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials. The Foundation could play a significant role in recommending the use of biomarkers and other measures that may not be true measures of efficacy.†This is all the more surprising and concerning considering the fact that Ms. DeLauro chairs the appropriations subcommittee that funds the FDA.
We hope that Ms. DeLauro’s tenacity towards improving the FDA and passion for protecting the public health can be harnessed and redirected to better purposes in 2008.
The Bronze Clipboard: Representative Henry Waxman
A perennial Golden Clipboard contender, Representative Henry Waxman is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia. His oversight hearing – during which Mr. Waxman was both measured and civil in his handling of all witnesses – helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular. He also had a direct hand in undermining the FDA’s sound scientific policy towards “non-inferiority†trials for new antibiotics. The unintended (but not surprising) consequence is that several important antibiotics have been delayed or shelved. Congressman Waxman (we assume, again, unintentionally) helped to politicize the FDA by paving a separate and old score-settling path for those within the agency who disagree with scientific consensus.
In addition to his role as Congressional Oversighter-in-Chief, Mr. Waxman is one of the most knowledgeable members of Congress when it comes to how the FDA works and what it needs to succeed – and we look forward to his efforts to help the agency pursue its mission of both protecting and advancing the public health in 2008.
The Silver Clipboard: Dr. Steven Nissen
Dr. Nissen’s persistent undermining of the FDA came close to winning him Clipboard top honors for 2007. Among many memorable exploits, Dr. Nissen’s most Clipboard-worthy moment was on ABC’s 20/20 program, where he pronounced Avandia to be responsible for “more deaths than 9/11.†A few days later, when asked by Congressman Waxman if he would recommend that doctors take their patients off that drug, he responded, “No.†What’s the frequency, Steve?
Regularly positioning himself as “Dr. Transparency,†Dr. Nissen regularly neglected to come clean about his various consulting arrangements, conflicts and clinical trial activities. That, and his public flailing of drugwonks.com as “vile,†earns him this year’s Silver Clipboard and (at least hopefully) removes his name from any plausible consideration for FDA Commissioner anytime in the 21st century.
AND THE WINNER OF THE 2007 GOLDEN CLIPBOARD GOES TO
(Drum roll please …)
2007 Golden Clipboard Winner: Dr. David Graham
David Graham ostensibly works for the FDA -- but he seems to spend a lot of time in the Halls of Congress advising members and staff about which FDA medical reviewers should be hauled in for polite “conversations.†Setting aside Dr. Graham’s contribution to the Vioxx Populi literature -- which an FDA advisory committee considered to be a rather shoddy piece of research – he also helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides. Graham still maintains that the lipid-lowering drug Crestor should be off the market despite the fact that it has recently received new indications for treatment of fatal heart diseases. And his assertion that Avandia should be taken off the market because an observational study showed that another drug was safer and more effective was both shoddy science as well as remarkably insouciant since he relied on observational data that did not have safety as a primary endpoint – the same sort of science that, when it came to Vioxx, he rejected as insufficient.
Dr. Graham is a man on a mission. AKA “Dr. Precautionary Principle,†he wants the FDA to use meta-analysis to generate safety signals early and often, and stop the clinical testing, prescribing and marketing of medicines until all such signals are explored using large scale randomized clinical trials that use safety as a primary endpoint. In short, he wants fulfillment of his vision at the expense of human life and medical progress.
For his persistence, zeal, and determination to damage not only the FDA but the public health, for his effectiveness in fear mongering and willingness to subordinate medical progress to his ascetic view of safety, we award Dr. David Graham the 2007 Golden Clipboard Award.
While we dither about funding for the Reagan/Udall Center, the European Commission and the pharmaceutical industry have unveiled a €2 billion partnership to reverse the EU's declining international role in medical research. According to a report in the Financial Times, teams of commercial and not-for-profit researchers will be able to seek support for work on a range of medical projects, on condition that their findings are publicly shared in an effort to stimulate faster and safer drug development.
The Innovative Medicines Initiative (IMI), jointly supported by the Commission and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA), will shortly release details of its first 18 priorities, which will be funded by €123 million in awards to be given out by the spring of 2009.
This is a chance for us to really get back on the right foot," said Arthur Higgins, president of EFPIA and head of Bayer Healthcare of Germany. It was important for patients and the wealth and prosperity of
The first wave of projects includes the development of measurable biomarkers in the body to gauge the side-effects of new medicines on the kidneys and liver, as well as research into the basic mechanisms of pain, severe asthma, psychiatric disorders and neurodegenerative diseases.
The Commission has given €1 billion in funding for the seven-year program, which will be matched by support from pharmaceutical companies through loans of staff, laboratory equipment and libraries of compounds.
It’s time that we take the issue of 21st century medicine just as seriously.
Funding for Reagan/Udall now!
What does the European Commission know that Rosa DeLauro does not?
According to the Financial Times ...
The European Commission is poised to agree a groundbreaking €2bn ($2.9bn, £1.5bn) partnership with the pharmaceutical industry this week designed to win back Europe's place as a centre for global medical innovation.
The Innovative Medicines Initiative, financed equally by the industry and the Commission, will support research by academic and industry groups over seven years designed to speed up the predictable testing of the safety and efficacy of medicines. The move, part of the EU's "Lisbon agenda" to regain competitiveness, aims to boost collaboration between commercial companies, universities and regulators to more rapidly develop "pre-competitive" tests and accelerate the launch of innovative drugs.
According to the Financial Times ...
The European Commission is poised to agree a groundbreaking €2bn ($2.9bn, £1.5bn) partnership with the pharmaceutical industry this week designed to win back Europe's place as a centre for global medical innovation.
The Innovative Medicines Initiative, financed equally by the industry and the Commission, will support research by academic and industry groups over seven years designed to speed up the predictable testing of the safety and efficacy of medicines. The move, part of the EU's "Lisbon agenda" to regain competitiveness, aims to boost collaboration between commercial companies, universities and regulators to more rapidly develop "pre-competitive" tests and accelerate the launch of innovative drugs.
The Baltimore Sun reports that, “A long-running clash over the marketing of meat and milk from cloned animals is coming to a head in Washington as the government prepares to make a ruling that would allow the products to be sold to consumers for the first time.
Critics in Congress, including Sen. Barbara A. Mikulski of Maryland, are attempting to delay the action expected from the Food and Drug Administration, which could decide as early as this week to permit sales. These opponents are rushing to gain approval by Congress this week of a provision that would encourage the FDA to delay action until further studies are completed.â€
Here’s the complete story:
http://www.baltimoresun.com/news/health/bal-te.clone19dec19,0,6919236.story
According to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words –GRAS.
Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder†clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.
You want fries with that?
In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.
By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.
Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.
It's a contentious topic – but the fact is that the agency has been studying this issue in great detail for a very long period of time. In fact, many of the world's leading experts on this issue work at the FDA's Center for Veterinary Medicine. During my tenure at the FDA (which ended in 2004), this issue was already being deeply investigated and intensely debated. So, when people accuse the agency' of reaching a decision without either due regulatory process or focus on science, I say, where's the beef?
Critics in Congress, including Sen. Barbara A. Mikulski of Maryland, are attempting to delay the action expected from the Food and Drug Administration, which could decide as early as this week to permit sales. These opponents are rushing to gain approval by Congress this week of a provision that would encourage the FDA to delay action until further studies are completed.â€
Here’s the complete story:
http://www.baltimoresun.com/news/health/bal-te.clone19dec19,0,6919236.story
According to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words –GRAS.
Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder†clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.
You want fries with that?
In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.
By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.
Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.
It's a contentious topic – but the fact is that the agency has been studying this issue in great detail for a very long period of time. In fact, many of the world's leading experts on this issue work at the FDA's Center for Veterinary Medicine. During my tenure at the FDA (which ended in 2004), this issue was already being deeply investigated and intensely debated. So, when people accuse the agency' of reaching a decision without either due regulatory process or focus on science, I say, where's the beef?
Appropriations agriculture subcommittee chairwoman Rosa DeLauro has no problem cutting funding to promote the Critical Path initiative. Perhaps it was to make room for about $24.5 million worth of earmarks for her district. That includes about " $400,000 for Connecticut oyster fisheries. DeLauro, who is a member of the Commerce, Justice and Science Subcommittee, received $4.9 million in earmarks in one bill (Agriculture) alone, the "" including $500,000 for the Henry C. Lee Institute of Forensic Science Cold Case Center at the University of New Haven. " That's the same amount and the same bill from which she cut out money for FDA's Critical Path foundation.
Now that's leadership.
View Article
Now that's leadership.
View Article
The omnibus spending package moving through Congress would block FDA from transferring any money to the Reagan-Udall Foundation, the research institution created by the FDA Amendments Act.
The FDAAA. which implemented a slew of new policies while reauthorizing industry user fees, stipulates that FDA provide between $500,000 and $1.25 million per year to the Reagan-Udall Foundation. But the omnibus appropriations bill specifically blocks FDA from transferring any money to the foundation.
The prime mover behind this is Representative Rosa DeLauro (D-CT) (who chairs the appropriations subcommittee that funds FDA). Ms. DeLauro believes the Reagan-Udall Foundation “has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials.â€
That is just absurd. When a senior member of Congress can blatantly accuse the FDA and the pharmaceutical industry of wanting to lower standards for drug development and review, it illustrates just how low a point we have reached. It’s just the absolute nadir. A new low in politics trumping public health.
A 21st century Scopes Monkey Trial.
He that troubleth his own house shall inherit the wind:
and the fool shall be servant to the wise of heart.
Proverbs 11:29
The FDAAA. which implemented a slew of new policies while reauthorizing industry user fees, stipulates that FDA provide between $500,000 and $1.25 million per year to the Reagan-Udall Foundation. But the omnibus appropriations bill specifically blocks FDA from transferring any money to the foundation.
The prime mover behind this is Representative Rosa DeLauro (D-CT) (who chairs the appropriations subcommittee that funds FDA). Ms. DeLauro believes the Reagan-Udall Foundation “has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials.â€
That is just absurd. When a senior member of Congress can blatantly accuse the FDA and the pharmaceutical industry of wanting to lower standards for drug development and review, it illustrates just how low a point we have reached. It’s just the absolute nadir. A new low in politics trumping public health.
A 21st century Scopes Monkey Trial.
He that troubleth his own house shall inherit the wind:
and the fool shall be servant to the wise of heart.
Proverbs 11:29
My oped on VA health care in the Washington Times
http://washingtontimes.com/article/20071218/EDITORIAL/800572185/1013/editorial
http://washingtontimes.com/article/20071218/EDITORIAL/800572185/1013/editorial
What's worse than a bad idea? How about a bad idea without any details.
SAN FRANCISCO (AP) -- Mayor Gavin Newsom wants large grocery stores to help fight obesity by paying fees on sodas and other beverages they sell in San Francisco.
Newsom has asked his staff to prepare a law that would charge retail chains for stocking Coke, Pepsi and other drinks sweetened with high fructose corn syrup.
Mayoral spokesman Nathan Ballard says the size of the fee and how it would be assessed still have to be worked out.
He says there's a direct link between sweet beverages and obesity, which puts added pressure on San Francisco's health care system.
If the bill is approved by the Board of Supervisors, money generated from the fee would go toward a city program that emphasizes exercise, diet and other preventative health measures.
A direct link to obesity? The only direct link is the one between calories in and calories out. That being the case, perhaps the Mayor should also consider a "sit on your tuchus tax" on the sale of flat screen televisions.
The idea to tax soda is well, flat.
SAN FRANCISCO (AP) -- Mayor Gavin Newsom wants large grocery stores to help fight obesity by paying fees on sodas and other beverages they sell in San Francisco.
Newsom has asked his staff to prepare a law that would charge retail chains for stocking Coke, Pepsi and other drinks sweetened with high fructose corn syrup.
Mayoral spokesman Nathan Ballard says the size of the fee and how it would be assessed still have to be worked out.
He says there's a direct link between sweet beverages and obesity, which puts added pressure on San Francisco's health care system.
If the bill is approved by the Board of Supervisors, money generated from the fee would go toward a city program that emphasizes exercise, diet and other preventative health measures.
A direct link to obesity? The only direct link is the one between calories in and calories out. That being the case, perhaps the Mayor should also consider a "sit on your tuchus tax" on the sale of flat screen televisions.
The idea to tax soda is well, flat.
Remember Ira Magaziner? He was one of the original architect's of HillaryCare. Today he serves as Chairman of the Clinton Foundation's HIV/AIDS Initiative -- known by the acronym CHAI. Well, what can one say other than, "To Life!"
Actually, there is something else that can be said -- like why is CHAI supporting the theft of intellectual property of pharmaceutical companies? Here's what Mr. Magaziner had to say at the recent meeting of the International Generic Pharmaceutical Alliance meeting in Miami:
"We publicly supported the Thai government and the Brazilian government when they issued compulsory licenses for AIDS drugs because we know that they are legal under TRIPS ..."
Well, actually, that's just his opinion -- others disagree quite vocally as to whether or not Thailand and Brazil acted "legally." Drugwonks certainly does not think they did.
But Ira is certainly entitled to his opinion. What makes this more interesting and important than it otherwise might be is whether this is a window into how a Hillary Clinton presidency might view intellectual property.
It would be a good question to ask Senator Clinton during the next debate.
Actually, there is something else that can be said -- like why is CHAI supporting the theft of intellectual property of pharmaceutical companies? Here's what Mr. Magaziner had to say at the recent meeting of the International Generic Pharmaceutical Alliance meeting in Miami:
"We publicly supported the Thai government and the Brazilian government when they issued compulsory licenses for AIDS drugs because we know that they are legal under TRIPS ..."
Well, actually, that's just his opinion -- others disagree quite vocally as to whether or not Thailand and Brazil acted "legally." Drugwonks certainly does not think they did.
But Ira is certainly entitled to his opinion. What makes this more interesting and important than it otherwise might be is whether this is a window into how a Hillary Clinton presidency might view intellectual property.
It would be a good question to ask Senator Clinton during the next debate.
How Free Trade Zones, where products are repackaged and redistributed and deregulated conditions, promote and encourage counterfeit drugs. All those libertarians who equate free trade with drug importation were right all along...
http://www.blueridgenow.com/article/20071217/ZNYT02/712170342/1171/AP/ZNYT02/Free_Trade_Zones_Ease_Passage_of_Counterfeit_Drugs
And as an added bonus...an article from the Financial Times dealing with how lackluster the Brits inspection of reimported drugs are, which in turn gives drug counterfeiter, crime organizations and terrorists a gaping hole from which to ship their fakes to...you guessed it, the USA. Meanwhile Congress continues to push for drug importation. And you wonder why we were not able to connect the dots before 9-11??
http://www.ft.com/cms/s/0/ad28168c-9951-11dc-bb45-0000779fd2ac.html
http://www.blueridgenow.com/article/20071217/ZNYT02/712170342/1171/AP/ZNYT02/Free_Trade_Zones_Ease_Passage_of_Counterfeit_Drugs
And as an added bonus...an article from the Financial Times dealing with how lackluster the Brits inspection of reimported drugs are, which in turn gives drug counterfeiter, crime organizations and terrorists a gaping hole from which to ship their fakes to...you guessed it, the USA. Meanwhile Congress continues to push for drug importation. And you wonder why we were not able to connect the dots before 9-11??
http://www.ft.com/cms/s/0/ad28168c-9951-11dc-bb45-0000779fd2ac.html
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.
