Latest Drugwonks' Blog
John Edwards wants to end long term patents on breakthrough drugs for Alzheimer's and cancer and replace them with cash prizes for inventors. So reducing the incentives for investing in life saving medicines will help improve health care how exactly?
I have a better idea...let's reduce the cash prizes currently available for tort lawyers like Edwards that now go to pay for 16 acre spreads like his and use it to buy health insurance for hundreds of people.
http://www.nytimes.com/aponline/us/AP-Edwards-Michigan.html?_r=1&oref=slogin
I have a better idea...let's reduce the cash prizes currently available for tort lawyers like Edwards that now go to pay for 16 acre spreads like his and use it to buy health insurance for hundreds of people.
http://www.nytimes.com/aponline/us/AP-Edwards-Michigan.html?_r=1&oref=slogin
We sent our roving reporter on the streets of New York City and asked following question:
"What do you think of a doctor who compares the adverse events of a diabetes drug to the events of 9-11?"
A non-scientific representative sample of these comments (on video) can be found at http://www.cmpi.org Just go to the section on podcasts and click on "Dr. Weber."
Yes, that Dr. Weber. Well-respected cardiologist, FDA maven, and Chairman of the Center for Medicine in the Public Interest. He comments (a bit more knowledgably) on the same question.
This podcast can also be found on YouTube and other social networking sites. We're trying to bring health care policy to the people.
"What do you think of a doctor who compares the adverse events of a diabetes drug to the events of 9-11?"
A non-scientific representative sample of these comments (on video) can be found at http://www.cmpi.org Just go to the section on podcasts and click on "Dr. Weber."
Yes, that Dr. Weber. Well-respected cardiologist, FDA maven, and Chairman of the Center for Medicine in the Public Interest. He comments (a bit more knowledgably) on the same question.
This podcast can also be found on YouTube and other social networking sites. We're trying to bring health care policy to the people.
From http://www.stat.org Trevor Butterworth, this time his trenchant comments from his blog on Huffington Post:
http://www.huffingtonpost.com/trevor-butterworth/the-avandia-nightmare-it_b_50596.html
http://www.huffingtonpost.com/trevor-butterworth/the-avandia-nightmare-it_b_50596.html
Yale University's David Katz, whose website http://www.davidkatzmd.com is a valuable tool for anyone interested in nutrition or learning ponders the rejection of Accomplia in a recent post on ABCnews.com. He thinks the panel -- devoid of physicians who actually treat people with obesity problems -- went too far in rejecting the drug. He asks a question the FDA did not pose to the AdComm:
"That's not trivial, but how great is two times your current risk of depression if you're not depressed? And how much does uncontrolled obesity increase the risk of depression, anxiety and sleep disturbances in comparison?"
Oh.
Read the entire post here: http://www.abcnews.go.com/Health/Diet/Story?id=3277937&page=2
"That's not trivial, but how great is two times your current risk of depression if you're not depressed? And how much does uncontrolled obesity increase the risk of depression, anxiety and sleep disturbances in comparison?"
Oh.
Read the entire post here: http://www.abcnews.go.com/Health/Diet/Story?id=3277937&page=2
After all the non-stop claptrap about there being too many new drugs comes a sobering fact: even as pharmaceutical companies poured a record $43 billion into research and development in 2006, U.S. Food and Drug Administration statistics show that the agency approved only 18 new drugs last year. That's down from 36 in 2004 and nearly as low as it's been at any time during the past decade.
According to Dr. Scott Gottlieb, the agency's former deputy commissioner for medical and scientific affairs, "Our concern is that the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end."
Which begs the question—wither the 21st century drug development tools that would make possible a swifter path from bench to bedside? More importantly, where's the outrage? Where are the scathing articles about the "critical path gap?" Where's the outcry from the halls of Congress about "who lost the critical path?"
Here's the rest of the story from The Journal of Life Sciences:
http://www.tjols.com/commentary/jun13_fda.jsp
Thoughts and comments most welcome.
According to Dr. Scott Gottlieb, the agency's former deputy commissioner for medical and scientific affairs, "Our concern is that the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end."
Which begs the question—wither the 21st century drug development tools that would make possible a swifter path from bench to bedside? More importantly, where's the outrage? Where are the scathing articles about the "critical path gap?" Where's the outcry from the halls of Congress about "who lost the critical path?"
Here's the rest of the story from The Journal of Life Sciences:
http://www.tjols.com/commentary/jun13_fda.jsp
Thoughts and comments most welcome.
Daniel Carlat has a near hysterical piece about that equates pharmaceutical and biotech funding of CME to money laundering. Which I guess makes all the academics, researchers and clinicians who particpate...criminals? Carlat needs to take a dose of the trazadone he defends in one of his newletters that are available for a hefty fee. Which leads me to another point: nothing is stopping self-righteous types like Carlat from going into business themselves to offer CME programs. Oh, and if I were Carlat, I would drop the characterization "Unbiased" from the description of his expensive newsletter. He is as biased as anyone. Anyone who calls his colleagues money launderers is biased.
I was incredibly wrong about the Adv Comm vote on Accomplia. The FDA's questions to the panel clearly indicated skittishness about approval and the committee simply went with the flow. Sanofi could have presented better -- more stratified-- data to identify who was more likley to have adverse events with Accomplia. Companies are simply going to have be more proactive in this regard.
Laura Landro has an article on how the web empowers patients. I am not so sure. Unless companies, academics, and other responsible third parties take great pains to roll out solid material, most of the space is taken up by misfits,manipulators and opportunistic feeders as Jay Byrne of V-influence describes them who engage in client shopping, fearmongering and peddling of alternative health solutions. The worst offenders: Consumers Union with their blog campaigns that scare people into noncompliance and hidden campaign to fatten the pocketbooks of trial attorneys, Joseph Mercola and his numerous snake oil solutions and well...the tort sharks themselves who hire firms to set up fake "consumer health site" that offer crappy health info but really collect data that they use to fill the FDA with questionable adverse drug events.
I linked to Jacob Goldstein's blog...one of the more reasonable sources
http://blogs.wsj.com/health/2007/06/13/in-a-switch-online-patient-groups-inform-researchers/
So if we shut down the right of drug companies to advertise then we will be left with all this responsible behavior AND Michael Moore.
I linked to Jacob Goldstein's blog...one of the more reasonable sources
http://blogs.wsj.com/health/2007/06/13/in-a-switch-online-patient-groups-inform-researchers/
So if we shut down the right of drug companies to advertise then we will be left with all this responsible behavior AND Michael Moore.
AEI's Joe Antos in The American on how quickly and conveniently CMS is using post market evidence on cancer drugs to suit it's needs and screw patients: "The CMS action is breathtaking for its speed and its incursion into the practice of medicine. As a long-time observer of CMS, and as a former official in the agency during the 1980s, I have never seen a proposal with this level of detail emerge from the thicket of clearances in such a short period of time. Perhaps CMS has found some new efficiency that permits it to release rules in record time?"
Want an idea of how patients will fare under this farce called a federally funded R and D center for comparative effectiveness, read Balancing the Budget on The Backs of Cancer Patients.
http://american.com/archive/2007/june-0607/balancing-the-budget-on-the-backs-of-cancer-patients
Want an idea of how patients will fare under this farce called a federally funded R and D center for comparative effectiveness, read Balancing the Budget on The Backs of Cancer Patients.
http://american.com/archive/2007/june-0607/balancing-the-budget-on-the-backs-of-cancer-patients
Note: This is Peter's blog...I am posting for him because his computer is experiencing technical difficulties that were not detected by meta analysis.
FDA reform, real reform, requires hard work, partnership, and candor -- not politics-as-usual.
As Matt Herper over at Forbes writes:
"One change that seems inevitable is the creation of more Steven Nissens--that is, more outside scientists looking over the FDA's shoulder. A Senate-passed bill from Senators Edward Kennedy (D--Mass.) and Michael Enzi (R--Wyo.) seeks to force manufacturers to make all study results public. Nissen was able to do his Avandia analysis because Glaxo, in order to get then New York attorney general Eliot Spitzer off its back, agreed three years ago to put drug-trial results up for public viewing. The bill would put all drug firms in this boat.
Think of this as the open-source FDA. Already outsiders have pinpointed valid safety issues, such as Vioxx. But open source can be an invitation to a lynching. AstraZeneca's blockbuster cholesterol pill Crestor was originally maligned over kidney worries but has since been cleared. Expect "a free-for-all" as academic researchers get more access to data from companies and from electronic health records, says FDA Deputy Commissioner Janet Woodcock. “You could imagine tort lawyers running those analyses," she says."
Matt’s article (“Lynch ‘Emâ€) can be found at www.forbes.com
Herper continues:
"Still, big pharma is backing the Kennedy-Enzi plan, which would also give the FDA more power to change drug labels and force companies to conduct studies. New Pfizer Chief Jeffrey Kindler praised the bill in a speech at the Economic Club of Washington, saying drug firms should absolutely support a bill that requires candor about clinical trials."
And candor is something this debate needs. And honesty and a focus on advancing the public health rather than settling private scores (both within the FDA and elsewhere).
Nobody said it was going to be easy.
FDA reform, real reform, requires hard work, partnership, and candor -- not politics-as-usual.
As Matt Herper over at Forbes writes:
"One change that seems inevitable is the creation of more Steven Nissens--that is, more outside scientists looking over the FDA's shoulder. A Senate-passed bill from Senators Edward Kennedy (D--Mass.) and Michael Enzi (R--Wyo.) seeks to force manufacturers to make all study results public. Nissen was able to do his Avandia analysis because Glaxo, in order to get then New York attorney general Eliot Spitzer off its back, agreed three years ago to put drug-trial results up for public viewing. The bill would put all drug firms in this boat.
Think of this as the open-source FDA. Already outsiders have pinpointed valid safety issues, such as Vioxx. But open source can be an invitation to a lynching. AstraZeneca's blockbuster cholesterol pill Crestor was originally maligned over kidney worries but has since been cleared. Expect "a free-for-all" as academic researchers get more access to data from companies and from electronic health records, says FDA Deputy Commissioner Janet Woodcock. “You could imagine tort lawyers running those analyses," she says."
Matt’s article (“Lynch ‘Emâ€) can be found at www.forbes.com
Herper continues:
"Still, big pharma is backing the Kennedy-Enzi plan, which would also give the FDA more power to change drug labels and force companies to conduct studies. New Pfizer Chief Jeffrey Kindler praised the bill in a speech at the Economic Club of Washington, saying drug firms should absolutely support a bill that requires candor about clinical trials."
And candor is something this debate needs. And honesty and a focus on advancing the public health rather than settling private scores (both within the FDA and elsewhere).
Nobody said it was going to be easy.
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.
