Latest Drugwonks' Blog
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.
Welcome to the Age of YouTube.
We will be doing regular podcasts, where we will ask experts as well as average folks what they think about some of the most pressing health care issues we face as a nation.
Oh yes, and some that aren't so pressing -- like whether or not Michael Moore should be trusted to direct American health care.
To view our initial effort, click on the link below and follow it to the "Podcast" box:
http://www.cmpi.org
Enjoy. (We did.)
We will be doing regular podcasts, where we will ask experts as well as average folks what they think about some of the most pressing health care issues we face as a nation.
Oh yes, and some that aren't so pressing -- like whether or not Michael Moore should be trusted to direct American health care.
To view our initial effort, click on the link below and follow it to the "Podcast" box:
http://www.cmpi.org
Enjoy. (We did.)
Before you read any media reports, read Derek's balanced analysis of both the FDA and Sanofi's documents on the risks and benefits on Accomplia. As usual, he tees up the issue with insight and objectivity:
The incidence of suicidality – specifically suicidal ideation – was higher for 20 mg
rimonabant compared to placebo. Similarly, the incidence of psychiatric adverse events,
neurological adverse events and seizures were consistently higher for 20 mg rimonabant compared to placebo. . ."
They're also concerned about other neurological side effects, and seizures as well. The seizure data don't look nearly as worrisome, except in the obese diabetic patients, for whom everything seems to be amplified. And all of this happens at the 20-mg dose, not at the 5 (which doesn't do much for weight, either, as noted above). And for those who are wondering, yes, on my first pass through the data, I find these statistics much more convincing than I did the ones on the Avandia (rosiglitazone) association with cardiac events.
I had my worries about rimonabant a long time ago, but not for any specific reason. It's just that I used to work on central nervous system drugs, and you have to be ready for anything. Any new CNS mechanism, I figured, might well set off some things that no one was expecting, given how little we understand about that area."
Another important element that I think favors approval: Sanofi-Aventis is proposing labeling and prescribing limits to take into account the increased risk of a variety of pyschological side effects ranging from anxiety to suicidal thoughts (primarily among schizophrenics and others with a history of mental illness). Importantly, people in Accomplia trials had to go off antidepressants while on the drug so the label and risk management plan will limit use of the drug to people who are either on antidepressants or who are depressed. In Europe, compliance with such limits is around 95 percent.
Watch the fearmongers rise up and scream that no one should be allowed to have access to a drug that demonstrates the ability to reduce weight and glucose levels safely in a specific population. If Accomplia is NOT approved with the RISKMAP in place, with a pledge for post market studies and surveillance, no DTC ads for at least half a year, then what good is PDUFA?
Accomplia is a litmus test for the backbone of the agency and the political strength of the fearmongers.
The incidence of suicidality – specifically suicidal ideation – was higher for 20 mg
rimonabant compared to placebo. Similarly, the incidence of psychiatric adverse events,
neurological adverse events and seizures were consistently higher for 20 mg rimonabant compared to placebo. . ."
They're also concerned about other neurological side effects, and seizures as well. The seizure data don't look nearly as worrisome, except in the obese diabetic patients, for whom everything seems to be amplified. And all of this happens at the 20-mg dose, not at the 5 (which doesn't do much for weight, either, as noted above). And for those who are wondering, yes, on my first pass through the data, I find these statistics much more convincing than I did the ones on the Avandia (rosiglitazone) association with cardiac events.
I had my worries about rimonabant a long time ago, but not for any specific reason. It's just that I used to work on central nervous system drugs, and you have to be ready for anything. Any new CNS mechanism, I figured, might well set off some things that no one was expecting, given how little we understand about that area."
Another important element that I think favors approval: Sanofi-Aventis is proposing labeling and prescribing limits to take into account the increased risk of a variety of pyschological side effects ranging from anxiety to suicidal thoughts (primarily among schizophrenics and others with a history of mental illness). Importantly, people in Accomplia trials had to go off antidepressants while on the drug so the label and risk management plan will limit use of the drug to people who are either on antidepressants or who are depressed. In Europe, compliance with such limits is around 95 percent.
Watch the fearmongers rise up and scream that no one should be allowed to have access to a drug that demonstrates the ability to reduce weight and glucose levels safely in a specific population. If Accomplia is NOT approved with the RISKMAP in place, with a pledge for post market studies and surveillance, no DTC ads for at least half a year, then what good is PDUFA?
Accomplia is a litmus test for the backbone of the agency and the political strength of the fearmongers.
Previously we have discussed the half-baked and benighted ideas of Representative Maurice Hinchey -- author (along with Representative Bart Stupak) of a bill that would prohibit the agency from collecting fees from the companies it regulates. Instead, the money would be deposited into the general fund of the U.S. Treasury (see blog entry "Slo Mo," posted on 5/21/07).
Well, he's at it again. Here's what he had to say yesterday ...
"The FDA has essentially become the government affairs office of the pharmaceutical industry," Hinchey said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate."
This is anticipation of today's sitting of the House Energy and Commerce Subcommittee on Health.
A "Mo" untrue, unjust, and unfair statement is hardly imaginable.
The FDA is staffed with public health professionals on personal public health missions. They care, deeply, about safety and efficacy and about doing the right thing.
Mr. Hinchey, it seems, cares about headlines and hysteria.
An apology is in order.
Well, he's at it again. Here's what he had to say yesterday ...
"The FDA has essentially become the government affairs office of the pharmaceutical industry," Hinchey said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate."
This is anticipation of today's sitting of the House Energy and Commerce Subcommittee on Health.
A "Mo" untrue, unjust, and unfair statement is hardly imaginable.
The FDA is staffed with public health professionals on personal public health missions. They care, deeply, about safety and efficacy and about doing the right thing.
Mr. Hinchey, it seems, cares about headlines and hysteria.
An apology is in order.
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.
