Latest Drugwonks' Blog
Here are two new publications (one from the new Journal of Life Sciences by yours truly and the other from Health Affairs by Scott Gottlieb, MD) that discuss the pharmaceutical risk/benefit equation.
Both articles ask and address the same question: Has "safety" become deliterious to the public health?
Here's a link to the Scott's Health Affairs paper:
Download file
And the link to my article in the Journal of Life Sciences:
http://www.tjols.com/commentary/may8_is_it_safe.jsp
Both articles ask and address the same question: Has "safety" become deliterious to the public health?
Here's a link to the Scott's Health Affairs paper:
Download file
And the link to my article in the Journal of Life Sciences:
http://www.tjols.com/commentary/may8_is_it_safe.jsp
Thomas Fleming, described my Matt Herper as a world reknown biostatistician who couldn't sleep the night of the FDA's Ad Comm vote on Provenge because he "knew" without randomized controlled trials the data on survival might be a fluke. Fleming wrote to Herper "Patients might drop out of the ongoing clinical trial in order to get the drug, not placebo. How, he asked, would that be good for prostate cancer patients?"
This is not a scientist writing, but a zealot trying to defend a religious position to himself by writing his Boswell. See Dendreon's Dilemma by Herper
http://www.forbes.com/home/sciencesandmedicine/2007/05/09/dendreon-provenge-fda-biz-sci_cx_mh_0509dendreon.html
This does not justify the FDA's deadly decision to delay Provenge but it speaks volumes about the slavish mindset regarding clinical trials -- both inside and outside the agency and how to determine safety and efficacy. A bigger push to change the paradigm to evaluate personalized treatments -- of which cancer immunotherapies are a subset -- is needed.
That said, Fleming's publish confession of anguish reminds me of Cotton Mather who sought to unburden his soul after unleashing the Salem Witch trials. Don't give us this "I was doing it for the cancer patients." This is you protecting the probabilistic priesthood by offering up sacrificial lambs.
Sleep well.
This is not a scientist writing, but a zealot trying to defend a religious position to himself by writing his Boswell. See Dendreon's Dilemma by Herper
http://www.forbes.com/home/sciencesandmedicine/2007/05/09/dendreon-provenge-fda-biz-sci_cx_mh_0509dendreon.html
This does not justify the FDA's deadly decision to delay Provenge but it speaks volumes about the slavish mindset regarding clinical trials -- both inside and outside the agency and how to determine safety and efficacy. A bigger push to change the paradigm to evaluate personalized treatments -- of which cancer immunotherapies are a subset -- is needed.
That said, Fleming's publish confession of anguish reminds me of Cotton Mather who sought to unburden his soul after unleashing the Salem Witch trials. Don't give us this "I was doing it for the cancer patients." This is you protecting the probabilistic priesthood by offering up sacrificial lambs.
Sleep well.
I had posted an entry from Martyn Postle, Director, Cambridge Healthcare & Biotech in the how the UK did compared to the European countries on providing cancer care. I received a request to take down the post because CHB didn't want others -- or maybe just us -- to share it. Rather, it wants people to crawl their way to the site on their own.
Have it your way.
Have it your way.
The Senate just passed the FDA Revitalization Act, S. 1082, Final vote was: 93/1 -- with the one "Nay" vote coming from Bernie Sanders, the junior senator from Ben & Jerry's.
Some notable amendment wrap-ups:
Grassley amendment: to require the Office of Surveillance and Epidemiology and the Office of New Drugs at FDA to make joint decisions with respect to an action related to post marketing safety issues, labeling changes, post-approval studies and restrictions or use of drugs with serious risks. In the case of disagreement between the two offices, the Commissioners office would have made the determination.
Failed by a vote of 46/47
Durbin amendment: to disallow members of FDA advisory committees with a conflict of interest to vote on consideration of approval of a drug where they have a financial interest, refines evaluation and criteria for term of appointment to an advisory committee, limits waivers for conflicts of interest per committee meeting.
Failed by a vote of 47/47
Needless to say, the additional amendment victories of free speech (DTC) and safety (importation) make Kenzi an exciting and important step forwards towards 21st century public health.
Some notable amendment wrap-ups:
Grassley amendment: to require the Office of Surveillance and Epidemiology and the Office of New Drugs at FDA to make joint decisions with respect to an action related to post marketing safety issues, labeling changes, post-approval studies and restrictions or use of drugs with serious risks. In the case of disagreement between the two offices, the Commissioners office would have made the determination.
Failed by a vote of 46/47
Durbin amendment: to disallow members of FDA advisory committees with a conflict of interest to vote on consideration of approval of a drug where they have a financial interest, refines evaluation and criteria for term of appointment to an advisory committee, limits waivers for conflicts of interest per committee meeting.
Failed by a vote of 47/47
Needless to say, the additional amendment victories of free speech (DTC) and safety (importation) make Kenzi an exciting and important step forwards towards 21st century public health.
Michael Moore's "Sicko" will roll out on June 29th.
Indeed, "roll out" is the right phrase. Can anyone take a film about health care from a clinically obese person seriously?
Well, obviously not.
Test-market screenings, according to inside sources, aren't going too well and the film's U.S. distributors (the Weinstein Company) may very well limit the marketing resources put behind the big man's latest pseudo-documentary.
Yawn.
Indeed, "roll out" is the right phrase. Can anyone take a film about health care from a clinically obese person seriously?
Well, obviously not.
Test-market screenings, according to inside sources, aren't going too well and the film's U.S. distributors (the Weinstein Company) may very well limit the marketing resources put behind the big man's latest pseudo-documentary.
Yawn.
Bill Clinton stood alongside Thailand's dictator to announce his support of patent theft in Thailand and Brazil.
So cancer patients should wait until Thomas Fleming and ODAC AdComm member Hussain thinks there are large enough trials to determine statistically significant benefit of survival to get medicines... It is the obsession with endpoints and large trials that is killing people with cancer as much as the disease itself. The only way to get answers is to either try these drugs in the real world or match these medicines to the most appropriate people with greater accuracy. We cannot do both using the methods Fleming and Hussain and old cancer order want to uphold. They claim they are protecting patients but patients are willing to take these medicines and participate in follow on studies that are scientifically sound.
How ODAC rules on the IDM immunotherapy will say much. It is time for Andy von Eschenbach to show some leadership on this and other issues of patient access, to show that there is a public health payoff to the Critical Path....
To see the level to which Fleming and Hussain have stooped you can go to www.cancerletter.com
How ODAC rules on the IDM immunotherapy will say much. It is time for Andy von Eschenbach to show some leadership on this and other issues of patient access, to show that there is a public health payoff to the Critical Path....
To see the level to which Fleming and Hussain have stooped you can go to www.cancerletter.com
New CMPI Report Presents First Estimates of the Potential Economic Impact That New Treatments for Alzheimer's Disease Could Have on the U.S. Economy
Who: ACT-AD and Alliance for Aging Research; The Center for Medicine in the Public Interest
What: New Report Launch: Press Conference and Lunch:
- New medication can stave off onset of Alzheimer’s, extending lives, saving money
- Report discusses ways to give more power to older consumers in an aging society
Where: National Press Club
529 14th Street NW – Washington, DC
Lisagor Room
When: Monday, May 14, 2007, 12:00 pm press conference and lunch
RSVP: Nicholas Terzulli, (212) 588-9148 / nterzulli@capitalhq.com
Speakers:
-- Meryl Comer, Alzheimer’sAssociation National Capital Area Chapter Board Member, and Emmy-award-winning reporter, producer, moderator; also the principal caregiverfor herhusband who has advanced Alzheimer’s.
-- Robert Goldberg, Ph.D.,Vice President and Director of Programs for the Center for Medicine in thePublic Interest.
-- Daniel Perry, Chair of theACT-AD Coalition and Executive Director of the non-profit organization Alliance for Aging Research.
-- Peter Pitts, President of Center for Medicine in the Public Interest and former FDA Associate Commissioner for External Relations
-- John Vernon, Ph.D., Assistant Professor in the Finance Department at the University of Connecticut School of Business.
About the Report
One in 10 people over 65 – or 5.6 million Americans – will have Alzheimer’s Disease by 2010. Without interventional therapy, the number of cases is expected to rise to 13.5 million by 2050. Currently available treatments for Alzheimer’s disease provide only temporary symptomatic relief and only for some patients, while therapies under FDA review may significantly delay or reverse the course of the disease. This report presents the first scientific estimates of the potential economic impact that new treatments for Alzheimer's disease could have on the U.S. economy. The study was sponsored by ACT-AD, a coalition of 49 national organizations seeking to accelerate development of potential cures and treatments for Alzheimer’s disease. The report will also be posted and made available through the National Bureau of Economic Research.
Who: ACT-AD and Alliance for Aging Research; The Center for Medicine in the Public Interest
What: New Report Launch: Press Conference and Lunch:
- New medication can stave off onset of Alzheimer’s, extending lives, saving money
- Report discusses ways to give more power to older consumers in an aging society
Where: National Press Club
529 14th Street NW – Washington, DC
Lisagor Room
When: Monday, May 14, 2007, 12:00 pm press conference and lunch
RSVP: Nicholas Terzulli, (212) 588-9148 / nterzulli@capitalhq.com
Speakers:
-- Meryl Comer, Alzheimer’sAssociation National Capital Area Chapter Board Member, and Emmy-award-winning reporter, producer, moderator; also the principal caregiverfor herhusband who has advanced Alzheimer’s.
-- Robert Goldberg, Ph.D.,Vice President and Director of Programs for the Center for Medicine in thePublic Interest.
-- Daniel Perry, Chair of theACT-AD Coalition and Executive Director of the non-profit organization Alliance for Aging Research.
-- Peter Pitts, President of Center for Medicine in the Public Interest and former FDA Associate Commissioner for External Relations
-- John Vernon, Ph.D., Assistant Professor in the Finance Department at the University of Connecticut School of Business.
About the Report
One in 10 people over 65 – or 5.6 million Americans – will have Alzheimer’s Disease by 2010. Without interventional therapy, the number of cases is expected to rise to 13.5 million by 2050. Currently available treatments for Alzheimer’s disease provide only temporary symptomatic relief and only for some patients, while therapies under FDA review may significantly delay or reverse the course of the disease. This report presents the first scientific estimates of the potential economic impact that new treatments for Alzheimer's disease could have on the U.S. economy. The study was sponsored by ACT-AD, a coalition of 49 national organizations seeking to accelerate development of potential cures and treatments for Alzheimer’s disease. The report will also be posted and made available through the National Bureau of Economic Research.
That's "Reflexive Legislative Syndrome."
One possible patient is Senator Herb Kohl who is preparing a bill that would heavily restrict DTC advertising. Here's our read on the situation from The Wisconsin State Journal, the Cheesehead newspaper of record:
http://www.madison.com/wsj/home/column/other/index.php?ntid=132520&ntpid=5
If Senator Kohl is concerned about saving bucks -- he should look to the NBA.
One possible patient is Senator Herb Kohl who is preparing a bill that would heavily restrict DTC advertising. Here's our read on the situation from The Wisconsin State Journal, the Cheesehead newspaper of record:
http://www.madison.com/wsj/home/column/other/index.php?ntid=132520&ntpid=5
If Senator Kohl is concerned about saving bucks -- he should look to the NBA.
Another panel about what evidence should be used to make payment decisions and how studies should be structured...Medicine gets more complex and individualized and payors want simpler answers that are increasingly outdated. And we want to spend $5 billion a year on this?
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.
