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Assuming that Kenzi is passed without amendments that make medicines less safe -- meaning importation or follow-on biologics -- the current bill will give FDA tons of money for new tools to monitor drug risks post market.
That should put the pressure on the agency and its overlords in Congress to allow medicines with targeted risk benefit profiles on the market right? (We know who is running the show absent real leadership at the FDA.) After all if we put REMS in place because all risks are unknown during and after a clinical trial, the same can and is true about benefits, nes pa? And who is to say whether the collective benefits are less important than the collective risks? Shouldn't patients in a subpopulation make that decision or do FDAers, the media, Hill staffers, etc in their infinite wisdom know in advance for everyone who will benefit and who will be harmed with such precision that they should be entrusted with making decisions for everyone else. Or are these REMS tools just for show?
That should put the pressure on the agency and its overlords in Congress to allow medicines with targeted risk benefit profiles on the market right? (We know who is running the show absent real leadership at the FDA.) After all if we put REMS in place because all risks are unknown during and after a clinical trial, the same can and is true about benefits, nes pa? And who is to say whether the collective benefits are less important than the collective risks? Shouldn't patients in a subpopulation make that decision or do FDAers, the media, Hill staffers, etc in their infinite wisdom know in advance for everyone who will benefit and who will be harmed with such precision that they should be entrusted with making decisions for everyone else. Or are these REMS tools just for show?
Many opinions out there on Kenzi.
Here's mine: Don't be dogmatic.
Change is not an all-or-nothing proposition. Small movement in the right direction is the beginning of momentum. (And small victories are better than explosive defeats.)
And remember the words of Plutarch, "Time is the wisest of all counselors."
Here's mine: Don't be dogmatic.
Change is not an all-or-nothing proposition. Small movement in the right direction is the beginning of momentum. (And small victories are better than explosive defeats.)
And remember the words of Plutarch, "Time is the wisest of all counselors."
When developing "evidence-based" guidelines, the World Health Organization routinely forgets one key ingredient: evidence. That is the verdict from a study published in The Lancet.
"This is a pretty seismic event," Lancet editor Dr. Richard Horton, who was not involved in the research for the article. "It undermines the very purpose of WHO."
Seismic, indeed. (But is it seismic enough to make the pages of Consumer Reports?)
WHO's Director of Research Policy Dr. Tikki Pang said that some of his WHO colleagues were shocked by The Lancet's study, but he acknowledged the criticism had merit, and explained that time pressures and a lack of both information and money sometimes compromised WHO work.
Gevalt!
"We know our credibility is at stake," Pang said, "and we are now going to get our act together."
Who's in charge over there? The Great Ballantine?
Here's the rest of the story:
http://www.miamiherald.com/852/story/99331.html
Evidence? We don't need no stinking evidence -- as long as our results provide back-up for evermore restrictive national formularies.
"This is a pretty seismic event," Lancet editor Dr. Richard Horton, who was not involved in the research for the article. "It undermines the very purpose of WHO."
Seismic, indeed. (But is it seismic enough to make the pages of Consumer Reports?)
WHO's Director of Research Policy Dr. Tikki Pang said that some of his WHO colleagues were shocked by The Lancet's study, but he acknowledged the criticism had merit, and explained that time pressures and a lack of both information and money sometimes compromised WHO work.
Gevalt!
"We know our credibility is at stake," Pang said, "and we are now going to get our act together."
Who's in charge over there? The Great Ballantine?
Here's the rest of the story:
http://www.miamiherald.com/852/story/99331.html
Evidence? We don't need no stinking evidence -- as long as our results provide back-up for evermore restrictive national formularies.
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
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.
