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one issue which is once again being overlooked amid the outcry against an unexpected possible side effect of a drug is the efficacy of the drug itself. The reason I am not stopping Avandia on every patient I have who is taking it is not just that the possible deleterious effect on the heart remains unproven, that the association, as Bob Goldberg has said, is not at the level of cause/effect. there is another problem - that the glitazones are great drugs, that we already saw Rezulin tarred and feathered and ultimately hung from a tree until dead. Is Avandia to be the new Rezulin, followed by Actos, arguably the most effective of the three.
By the way, how many lives did Rezulin save because it was an effective diabetes drug verses how many liver deaths were associated with its use? This is not a rhetorical question - it was removed after a handful of possible cases of severe liver damage.
Believe me, I am not championing drug side effects, nor am i against the idea of widening post market initiatives. It is clear that unexpected side effects need to be watched out for, and that drug safety is an ongoing concern that involves more than just the target organ.
But drug safety and cost/benefit analyses mean looking at more than just a weakly observed mathematically determined association. These shadows will be found in many more places the harder we look for them. And great drugs will be unfairly targeted and destroyed. The cost is too high. Two TZDs down. One left to go. By the way, did I forget to mention that these drugs are perhaps the best drugs we have for type 2 diabetes - i see that I began my post this way - so I've come full circle.
By the way, how many lives did Rezulin save because it was an effective diabetes drug verses how many liver deaths were associated with its use? This is not a rhetorical question - it was removed after a handful of possible cases of severe liver damage.
Believe me, I am not championing drug side effects, nor am i against the idea of widening post market initiatives. It is clear that unexpected side effects need to be watched out for, and that drug safety is an ongoing concern that involves more than just the target organ.
But drug safety and cost/benefit analyses mean looking at more than just a weakly observed mathematically determined association. These shadows will be found in many more places the harder we look for them. And great drugs will be unfairly targeted and destroyed. The cost is too high. Two TZDs down. One left to go. By the way, did I forget to mention that these drugs are perhaps the best drugs we have for type 2 diabetes - i see that I began my post this way - so I've come full circle.
I spent two days in Brazil late last week. Gave a speech in Sao Paulo and another in Rio.
Wonderful country. Smart people.
And especially smart when it comes to the issue of compulsory licensing of pharmaceuticals.
The people I met with (from a wide variety of professions) all agreed that the Brazilian government's move towards expropriating patents was nothing more than a media stunt that might save a few political lives -- but no real ones.
More importantly, the people I met with agreed that, in the long run, such unethical moves were unwise for the future of Brazilian health care -- because what their nation needs are partnerships in health care -- not meaningless confrontations. Allies not adversaries.
So, don't believe everything you hear from certain NGOs. All this running dog lackey health care imperialism blather is nothing more than anti-pharma agitprop.
I was there. I heard it.
(Hear that, Jamie?)
Wonderful country. Smart people.
And especially smart when it comes to the issue of compulsory licensing of pharmaceuticals.
The people I met with (from a wide variety of professions) all agreed that the Brazilian government's move towards expropriating patents was nothing more than a media stunt that might save a few political lives -- but no real ones.
More importantly, the people I met with agreed that, in the long run, such unethical moves were unwise for the future of Brazilian health care -- because what their nation needs are partnerships in health care -- not meaningless confrontations. Allies not adversaries.
So, don't believe everything you hear from certain NGOs. All this running dog lackey health care imperialism blather is nothing more than anti-pharma agitprop.
I was there. I heard it.
(Hear that, Jamie?)
US hearing set on FDA handling of Glaxo drug
By Reuters | May 21, 2007
WASHINGTON (Reuters) - A House committee will hold a hearing on June 6 on the Food and Drug Administration's oversight of the safety of GlaxoSmithKline Plc's diabetes drug, Avandia, the panel's chairman said in a statement Monday.
In a statement, Rep. Henry Waxman, a California Democrat who chairs the House Oversight and Government Reform Committee, said the hearing was called following publication of study that reported Avandia may be associated with an increase in heart attacks and deaths.
By Reuters | May 21, 2007
WASHINGTON (Reuters) - A House committee will hold a hearing on June 6 on the Food and Drug Administration's oversight of the safety of GlaxoSmithKline Plc's diabetes drug, Avandia, the panel's chairman said in a statement Monday.
In a statement, Rep. Henry Waxman, a California Democrat who chairs the House Oversight and Government Reform Committee, said the hearing was called following publication of study that reported Avandia may be associated with an increase in heart attacks and deaths.
It is becoming clear that the Nissen article in the NEJM is part of larger effort on the part of a tort lawyer sponsored group of academics who oppose PDUFA. The editorial in support of the Nissen article was written by Curt Furberg and Bruce Psaty who, as this blog has noted in the past, have participated in the efforts of the The Project on Scientific Knowledge and Public Policy (SKAPP), based at the George Washington University to undo current PDUFA legislation. Major support for SKAPP is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation.
It's time for the FDA to stand up to the bullying if it wants to retain authority...
It's time for the FDA to stand up to the bullying if it wants to retain authority...
The Congress is expected to begin debating SCHIP right after the Memorial Day recess, but final decisions are being made now about the legislative proposals that will be considered.
Here are some important things to think about and consider from the Health Policy Consensus Group (of which we are a proud participant) ...
Download file
Have a look and feel free to share.
Here are some important things to think about and consider from the Health Policy Consensus Group (of which we are a proud participant) ...
Download file
Have a look and feel free to share.
Speaking of which...the online publication of Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes
Steven E. Nissen, M.D., and Kathy Wolski, M.P.H. signals a new low for both the NEJM and Nissen who's campaign to be FDA commissioner in a Democrat administration makes him look craven and small. http://www.nejm.org
The article proves no direct causal association. As the authors admit "these findings are based on limited access to trial results from publicly available sources, not on patient-level source data." Which means they cannot control for previous risks of heart disease or prior events.
Worse, the authors ignore the extensive literature demonstrating an association between diabetes and death from heart problems. Here's one article it failed to mention.
Diabetes mellitus: the major risk factor in unstable coronary artery disease even after consideration of the extent of coronary artery disease and benefits of revascularization.
Am Coll Cardiol. 2004 Feb 18;43(4):585-91.
Nissen has trawled for trouble before in the area of drugs for ADHD where he was rebuked by people who know better about the medicines benefit/risk profile. Here, he just did some data dredging of the worst sort and then even failed to cover his rear by citing literature about the link between diabetes and heart disease.
We know the NEJM is no longer a credible source of objective information on medicine. The question regarding Nissen is: Is he a real doctor or just playing one in the media?
Steven E. Nissen, M.D., and Kathy Wolski, M.P.H. signals a new low for both the NEJM and Nissen who's campaign to be FDA commissioner in a Democrat administration makes him look craven and small. http://www.nejm.org
The article proves no direct causal association. As the authors admit "these findings are based on limited access to trial results from publicly available sources, not on patient-level source data." Which means they cannot control for previous risks of heart disease or prior events.
Worse, the authors ignore the extensive literature demonstrating an association between diabetes and death from heart problems. Here's one article it failed to mention.
Diabetes mellitus: the major risk factor in unstable coronary artery disease even after consideration of the extent of coronary artery disease and benefits of revascularization.
Am Coll Cardiol. 2004 Feb 18;43(4):585-91.
Nissen has trawled for trouble before in the area of drugs for ADHD where he was rebuked by people who know better about the medicines benefit/risk profile. Here, he just did some data dredging of the worst sort and then even failed to cover his rear by citing literature about the link between diabetes and heart disease.
We know the NEJM is no longer a credible source of objective information on medicine. The question regarding Nissen is: Is he a real doctor or just playing one in the media?
CMPI Board member Fred Goodwin is on a unbalanced panel (in more ways than one) at the APA entitled Uneasy Partners: The Pharmaceutical Industry and the Psychiatric Profession..The point of the panel is to show that clinical studies used to develop clinical guidelines for shrinks have been corrupted by industry, are unscientific and can't be trusted.
The response to that should be twofold: Does that mean no drug is really safe or efficacious given the limits of clinical trials. Second, , why not do head to head studies of treatment approaches developed by "purists" and those "corrupted" by industry and see who does better? We actually have some examples.. ALLHAT and CATIE were run by purists, the UK's NICE system of comparative effectiveness is too.
For the most part, purists are lazy. They simply do meta-analyses of selective group of clinical trials that have exclusion critiera that will produce outcomes they support.
Meanwhile, are the purists, who take money from trial lawyers, left wing foundations funded by George Soros, agenda driven organizations and have their own biases really pure?
The response to that should be twofold: Does that mean no drug is really safe or efficacious given the limits of clinical trials. Second, , why not do head to head studies of treatment approaches developed by "purists" and those "corrupted" by industry and see who does better? We actually have some examples.. ALLHAT and CATIE were run by purists, the UK's NICE system of comparative effectiveness is too.
For the most part, purists are lazy. They simply do meta-analyses of selective group of clinical trials that have exclusion critiera that will produce outcomes they support.
Meanwhile, are the purists, who take money from trial lawyers, left wing foundations funded by George Soros, agenda driven organizations and have their own biases really pure?
Here's some comic relief ...
Representative Maurice "Slo Mo" Hinchey (D, NY) has introduced legislation that would direct pharmaceutical firms to deposit their PDUFA fees into a general fund of the U.S. Treasury rather than paying them directly to the FDA.
According to Mr. Hinchey, such a relationship would provide an "arms length relationship" between the agency and drug companies.
Hey, Mo -- would the actual applications also be sent from "anonymous?" (Because, er, the names on the NDAs might give the FDA a hint as to whose applications they were reviewing.)
Would meetings between pharmaceutical companies and the FDA take place with FDA employees wearing blindfolds? No, that wouldn't work. After all, how could they take notes or watch PowerPoint presentations? We should probably do away with those earplugs too.
Maybe in mark-up the bill's language could change to require drug company employees attending such meetings to wear dark glasses, wigs, and fake Groucho moustaches.
Slo Mo also wants to create a "Center for Postmarket Drug Safety and Effectiveness" -- which would be apart and independent from the initial drug approval process.
Hey Mo -- that's a good one -- separating safety from effectiveness.
Take my legislation -- please.
Representative Maurice "Slo Mo" Hinchey (D, NY) has introduced legislation that would direct pharmaceutical firms to deposit their PDUFA fees into a general fund of the U.S. Treasury rather than paying them directly to the FDA.
According to Mr. Hinchey, such a relationship would provide an "arms length relationship" between the agency and drug companies.
Hey, Mo -- would the actual applications also be sent from "anonymous?" (Because, er, the names on the NDAs might give the FDA a hint as to whose applications they were reviewing.)
Would meetings between pharmaceutical companies and the FDA take place with FDA employees wearing blindfolds? No, that wouldn't work. After all, how could they take notes or watch PowerPoint presentations? We should probably do away with those earplugs too.
Maybe in mark-up the bill's language could change to require drug company employees attending such meetings to wear dark glasses, wigs, and fake Groucho moustaches.
Slo Mo also wants to create a "Center for Postmarket Drug Safety and Effectiveness" -- which would be apart and independent from the initial drug approval process.
Hey Mo -- that's a good one -- separating safety from effectiveness.
Take my legislation -- please.
Can a guy who took a stretch limo to a $3000/day fat farm do a credible movie about health care in America? He can if he plays to people's deeply held stereotypes about scummy business practices and twists the truth in the process....
But Moore is claiming, again, that every fact in his movies are true. Sicko being no exception. So here's a reminder for those of you Sicko-phants about how much Moore has to lie to make his point.
http://www.slate.com/id/2102723/
But Moore is claiming, again, that every fact in his movies are true. Sicko being no exception. So here's a reminder for those of you Sicko-phants about how much Moore has to lie to make his point.
http://www.slate.com/id/2102723/
Members of Congress telling the FDA to relabel Oxy for only those with severe pain. No mention if having to endure lethal doses of stupidity from legislators and their staff qualifies. http://www.forbes.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.
