Latest Drugwonks' Blog
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?
I was in the middle of asking a panel of Euro reimbursement experts including Sir Michael Rawlins who helped create NICE about whether the $50K per QALY was too low and even authoritative (since Sir Michael noted that the $50K per QALY had no empirical basis) when he announced he could not stay to listen to speech and walked out...
I guess what I had to say was not worth $50K per QALY
I guess what I had to say was not worth $50K per QALY
The comparative effectiveness hurdle is firmly in place throughout Europe and it is all focusing on new drugs. And it is all one size fits all evaluations of whether or not there is improvement in actual benefit for drugs and benefit can be a matter of debate and deviation...and that is only the first part of the CE analysis. Then you have to demonstrate whether or not it is cost-effective
I find it interesting that health plans here that fought national health care have no problem importing the operating system of government medicine. The average time for a coverage decision is a year. Would health plans wait a year to get their premiums?
I find it interesting that health plans here that fought national health care have no problem importing the operating system of government medicine. The average time for a coverage decision is a year. Would health plans wait a year to get their premiums?
The quote is John Milton, but the practice is pure government health care.
Is this any way to treat a veteran... or anyone else for that matter ... like seniors on Part D?
Veterans filing disability claims with the Veterans Affairs Department wait for an average of almost six months for a response -- about six times longer than is typical in the private sector.
Pending disability claims with the VA take an average of 177 days to process, according to VA records. For some, the wait time is almost a year.
And for veterans appealing a decision on a claim, the average wait time is 657 days.
According to America's Health Insurance Plans (AHIP), for people filing disability claims with insurance companies, about 75 percent to 80 percent of claims are handled within 30 days. Federal law requires disability claims with private insurers to be settled within 45 days (although extensions of 30 days or longer are possible).
Here's the full story:
http://www.washingtontimes.com/national/20070508-122145-5910r.htm
Only in America does VA mean "stop."
Is this any way to treat a veteran... or anyone else for that matter ... like seniors on Part D?
Veterans filing disability claims with the Veterans Affairs Department wait for an average of almost six months for a response -- about six times longer than is typical in the private sector.
Pending disability claims with the VA take an average of 177 days to process, according to VA records. For some, the wait time is almost a year.
And for veterans appealing a decision on a claim, the average wait time is 657 days.
According to America's Health Insurance Plans (AHIP), for people filing disability claims with insurance companies, about 75 percent to 80 percent of claims are handled within 30 days. Federal law requires disability claims with private insurers to be settled within 45 days (although extensions of 30 days or longer are possible).
Here's the full story:
http://www.washingtontimes.com/national/20070508-122145-5910r.htm
Only in America does VA mean "stop."
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.
