Latest Drugwonks' Blog
This from the Glaxo data submission. I can bet you won't see this reported anywhere else:
Using real world data from real world patients... this is clinical, not claims data...
"In the monotherapy cohorts, there were 12,440 users of rosiglitazone, 16,302 of
pioglitazone, 131,075 of metformin, and 48,376 of sulfonylureas. For the combined
endpoint of myocardial infarction plus coronary revascularizations, the hazard ratio forrosiglitazone versus pioglitazone was 0.97 (95%CI 0.78 – 1.20), indicating essentially no difference between these thiazolidinediones. Both agents had somewhat less favorable outcomes than metformin, and both had somewhat better outcomes than sulfonylureas. In the dual therapy cohorts, there were 37,906 users of rosiglitazone in conjunction with metformin or sulfonylureas and 27,415 users of pioglitazone in similar combinations. Outcome rates in the rosiglitazone users versus the pioglitazone users were similar in combination with both metformin (HR 0.97, 95%CI 0.81 – 1.17) and sulfonylureas (HR 1.12, 95%CI 0.89 – 1.41). No combination with rosiglitazone or pioglitazone was meaningfully different in terms of outcomerates from a metformin-sulfonylurea combination.
The incidence of a combined endpoint of myocardial infarction and coronary
revascularization in users of rosiglitazone appears to be nearly the same as in users of pioglitazone, metformin and sulfonylureas. There is strong evidence against the
proposition that rosiglitazone in particular is associated with as much as a 40 percent
increase in risk. As in previous analyses of observational data in the US, the results
from the monotherapy and the dual-therapy comparisons, though not individually
significant, are consistent in suggesting that the risk of CHD events in patients using
thiazolidinediones may lie between the risks associated with sulfonylureas (higher
incidence) and metformin (lower incidence)."
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4308b1-00-index.htm (Appendix D)
Using real world data from real world patients... this is clinical, not claims data...
"In the monotherapy cohorts, there were 12,440 users of rosiglitazone, 16,302 of
pioglitazone, 131,075 of metformin, and 48,376 of sulfonylureas. For the combined
endpoint of myocardial infarction plus coronary revascularizations, the hazard ratio forrosiglitazone versus pioglitazone was 0.97 (95%CI 0.78 – 1.20), indicating essentially no difference between these thiazolidinediones. Both agents had somewhat less favorable outcomes than metformin, and both had somewhat better outcomes than sulfonylureas. In the dual therapy cohorts, there were 37,906 users of rosiglitazone in conjunction with metformin or sulfonylureas and 27,415 users of pioglitazone in similar combinations. Outcome rates in the rosiglitazone users versus the pioglitazone users were similar in combination with both metformin (HR 0.97, 95%CI 0.81 – 1.17) and sulfonylureas (HR 1.12, 95%CI 0.89 – 1.41). No combination with rosiglitazone or pioglitazone was meaningfully different in terms of outcomerates from a metformin-sulfonylurea combination.
The incidence of a combined endpoint of myocardial infarction and coronary
revascularization in users of rosiglitazone appears to be nearly the same as in users of pioglitazone, metformin and sulfonylureas. There is strong evidence against the
proposition that rosiglitazone in particular is associated with as much as a 40 percent
increase in risk. As in previous analyses of observational data in the US, the results
from the monotherapy and the dual-therapy comparisons, though not individually
significant, are consistent in suggesting that the risk of CHD events in patients using
thiazolidinediones may lie between the risks associated with sulfonylureas (higher
incidence) and metformin (lower incidence)."
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4308b1-00-index.htm (Appendix D)
Here's Rita Rubin summing up the data on Avandia. Maybe she missed the risk of cancer associated with other diabetes drugs.
"A study in the August issue of the journal Diabetes Care concludes that the class of drugs to which Avandia and Actos belong may double heart failure risk. The authors analyzed clinical trials, observational studies and case reports. ?Everyone (who takes the drugs) is at risk,? says co-author Curt Furberg, a Wake Forest University medical epidemiologist who sits on the FDA?s Endocrinologic and Metabolic Drugs panel."
Of course Rita ignores a study in Diabetes care showing no difference in all cause mortality or all the info on Avandia now available for the adcomm hearing. More important, she ignores an even greater threat from oral diabetes drugs.....cancer.
http://www.usatoday.com/news/health/2007-07-25-avandia-fda_N.htm?csp=34
Increased Cancer-Related Mortality for Patients With Type 2 Diabetes Who Use Sulfonylureas or Insulin
Samantha L. Bowker, MSC1,2, Sumit R. Majumdar, MD, MPH1,3, Paul Veugelers, PHD2 and Jeffrey A. Johnson, PHD1,2
OBJECTIVE—Numerous studies have identified an increased risk of cancer in type 2 diabetes. We explored the association between antidiabetic therapies and cancer-related mortality in patients with type 2 diabetes, postulating that agents that increase insulin levels might promote cancer.
RESEARCH DESIGN AND METHODS—This was a population-based cohort study using administrative databases from Saskatchewan Health. Cancer-related mortality was compared among inception cohorts of metformin users and sulfonylurea monotherapy users. Multivariate Cox regression was used to estimate the hazard ratio (HR) of cancer-related mortality, after adjusting for age, sex, insulin use, and chronic disease score. All statistical tests were two-sided.
RESULTS—We identified 10,309 new users of metformin or sulfonylureas with an average follow-up of 5.4 ± 1.9 years (means ± SD). The mean age for the cohort was 63.4 ± 13.3 years, and 55% were men. Cancer mortality over follow-up was 4.9% (162 of 3,340) for sulfonylurea monotherapy users, 3.5% (245 of 6,969) for metformin users, and 5.8% (84 of 1,443) for subjects who used insulin. After multivariate adjustment, the sulfonylurea cohort had greater cancer-related mortality compared with the metformin cohort (adjusted HR 1.3 [95% CI 1.1–1.6]; P = 0.012). Insulin use was associated with an adjusted HR of cancer-related mortality of 1.9 (95% CI 1.5–2.4; P < 0.0001).
CONCLUSIONS—Patients with type 2 diabetes exposed to sulfonylureas and exogenous insulin had a significantly increased risk of cancer-related mortality compared with patients exposed to metformin. It is uncertain whether this increased risk is related to a deleterious effect of sulfonylurea and insulin or a protective effect of metformin or due to some unmeasured effect related to both choice of therapy and cancer risk.
Gee, we don't know do we? But that's because we don't have USA Today/Nissen/Furberg peddling this panic. Maybe because these are generic drugs perhaps, no Big Pharma to attack?
http://care.diabetesjournals.org/cgi/content/abstract/29/2/254?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&searchid=1&FIRSTINDEX=0&minscore=5000&resourcetype=HWCIT
"A study in the August issue of the journal Diabetes Care concludes that the class of drugs to which Avandia and Actos belong may double heart failure risk. The authors analyzed clinical trials, observational studies and case reports. ?Everyone (who takes the drugs) is at risk,? says co-author Curt Furberg, a Wake Forest University medical epidemiologist who sits on the FDA?s Endocrinologic and Metabolic Drugs panel."
Of course Rita ignores a study in Diabetes care showing no difference in all cause mortality or all the info on Avandia now available for the adcomm hearing. More important, she ignores an even greater threat from oral diabetes drugs.....cancer.
http://www.usatoday.com/news/health/2007-07-25-avandia-fda_N.htm?csp=34
Increased Cancer-Related Mortality for Patients With Type 2 Diabetes Who Use Sulfonylureas or Insulin
Samantha L. Bowker, MSC1,2, Sumit R. Majumdar, MD, MPH1,3, Paul Veugelers, PHD2 and Jeffrey A. Johnson, PHD1,2
OBJECTIVE—Numerous studies have identified an increased risk of cancer in type 2 diabetes. We explored the association between antidiabetic therapies and cancer-related mortality in patients with type 2 diabetes, postulating that agents that increase insulin levels might promote cancer.
RESEARCH DESIGN AND METHODS—This was a population-based cohort study using administrative databases from Saskatchewan Health. Cancer-related mortality was compared among inception cohorts of metformin users and sulfonylurea monotherapy users. Multivariate Cox regression was used to estimate the hazard ratio (HR) of cancer-related mortality, after adjusting for age, sex, insulin use, and chronic disease score. All statistical tests were two-sided.
RESULTS—We identified 10,309 new users of metformin or sulfonylureas with an average follow-up of 5.4 ± 1.9 years (means ± SD). The mean age for the cohort was 63.4 ± 13.3 years, and 55% were men. Cancer mortality over follow-up was 4.9% (162 of 3,340) for sulfonylurea monotherapy users, 3.5% (245 of 6,969) for metformin users, and 5.8% (84 of 1,443) for subjects who used insulin. After multivariate adjustment, the sulfonylurea cohort had greater cancer-related mortality compared with the metformin cohort (adjusted HR 1.3 [95% CI 1.1–1.6]; P = 0.012). Insulin use was associated with an adjusted HR of cancer-related mortality of 1.9 (95% CI 1.5–2.4; P < 0.0001).
CONCLUSIONS—Patients with type 2 diabetes exposed to sulfonylureas and exogenous insulin had a significantly increased risk of cancer-related mortality compared with patients exposed to metformin. It is uncertain whether this increased risk is related to a deleterious effect of sulfonylurea and insulin or a protective effect of metformin or due to some unmeasured effect related to both choice of therapy and cancer risk.
Gee, we don't know do we? But that's because we don't have USA Today/Nissen/Furberg peddling this panic. Maybe because these are generic drugs perhaps, no Big Pharma to attack?
http://care.diabetesjournals.org/cgi/content/abstract/29/2/254?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&searchid=1&FIRSTINDEX=0&minscore=5000&resourcetype=HWCIT
Can anyone provide any examples of where comparative effectiveness was used to pay a higher price for a new product or treatment in any government run health system. And where are the follow up studies or studies that compare effectiveness of care conducted according to comparative effectiveness recommendations vs patient-centered care.
Where are the protections that permit doctors to practice medicine as they see fit? Where is the evidence that comparative effectiveness research has not led to government taking over the practice of medicine?
Where are the protections that permit doctors to practice medicine as they see fit? Where is the evidence that comparative effectiveness research has not led to government taking over the practice of medicine?
"Mr. Dingell (for himself, MR. RANGEL, MR. STARK, and MR. PALLONE) introduced the following bill; ..."
Thus begins SCHIP legislation so dangerously flawed that it's hard to know where to start.
But since we have to start the debate somewhere, let's start with Sections 904-906.
Sec. 904. Comparative effectiveness research. Establishes within the Agency of Healthcare Research and Quality a Center for Comparative Effectiveness Research to conduct research on the outcomes, effectiveness, and appropriateness of health care services.Also establishes an independent Comparative Effectiveness Research Commission to set priorities and ensure credibility for the Center’s work. It also establishes a Comparative Effectiveness Research Trust Fund, initially funded through the Medicare trust fund, to support the work of the Center and the Commission.
Translation: DERP on a national level courtesy of the AHRQ Angels. Evidence-based medicine without any good evidence. General population studies inappropriately used something they were not designed for --comparative effectiveness
Sec. 905. Implementation of health information technology (IT) under Medicare. Requires CMS to develop a plan to implement a health information technology system for Medicare.
Translation: A system akin to many in the EU (i.e., NICE) where reimbursement decisions are made on a cost-based, rather than a patient-centric matrix.
Sec. 906. Development, Reporting, and use of health care measures. Requires the Secretary to designate a single national entity to coordinate development of health care measures
Translation: The next step towards price controls and choice controls -- not to mention a further slide towards the enshrinement of practice variation over patient variation.
No matter how you cut it, evidence-based medicine based on bad evidence is bad medicine. This language disintermediatesphysicians, hurts patients and helps nobody other than payors (both public and private).
How about this -- let's keep our eye on the prize and reauthorize SCHIP for the population it has always been intended to serve, our nation's neediest children.
Thus begins SCHIP legislation so dangerously flawed that it's hard to know where to start.
But since we have to start the debate somewhere, let's start with Sections 904-906.
Sec. 904. Comparative effectiveness research. Establishes within the Agency of Healthcare Research and Quality a Center for Comparative Effectiveness Research to conduct research on the outcomes, effectiveness, and appropriateness of health care services.Also establishes an independent Comparative Effectiveness Research Commission to set priorities and ensure credibility for the Center’s work. It also establishes a Comparative Effectiveness Research Trust Fund, initially funded through the Medicare trust fund, to support the work of the Center and the Commission.
Translation: DERP on a national level courtesy of the AHRQ Angels. Evidence-based medicine without any good evidence. General population studies inappropriately used something they were not designed for --comparative effectiveness
Sec. 905. Implementation of health information technology (IT) under Medicare. Requires CMS to develop a plan to implement a health information technology system for Medicare.
Translation: A system akin to many in the EU (i.e., NICE) where reimbursement decisions are made on a cost-based, rather than a patient-centric matrix.
Sec. 906. Development, Reporting, and use of health care measures. Requires the Secretary to designate a single national entity to coordinate development of health care measures
Translation: The next step towards price controls and choice controls -- not to mention a further slide towards the enshrinement of practice variation over patient variation.
No matter how you cut it, evidence-based medicine based on bad evidence is bad medicine. This language disintermediatesphysicians, hurts patients and helps nobody other than payors (both public and private).
How about this -- let's keep our eye on the prize and reauthorize SCHIP for the population it has always been intended to serve, our nation's neediest children.
Please have a look at this brief essay in the July edtion of Nature Biotechnology.
The topic is FDA advisory committies and conflicts of interest -- a topic that regular readers of Drugwonks are most familiar with.
Here's a link:
http://cmpi.org/archives/2007/07/settling_for_second_best.php
You'll find some tough questions about the infamous $50,000 limit. For example, does that also include dollars earned by adcomm members who have served as expert witnesses in court trials against pharmaceutical firms?
Or what about fees that are earned but later contributed to a charity?
Anyone come to mind?
The topic is FDA advisory committies and conflicts of interest -- a topic that regular readers of Drugwonks are most familiar with.
Here's a link:
http://cmpi.org/archives/2007/07/settling_for_second_best.php
You'll find some tough questions about the infamous $50,000 limit. For example, does that also include dollars earned by adcomm members who have served as expert witnesses in court trials against pharmaceutical firms?
Or what about fees that are earned but later contributed to a charity?
Anyone come to mind?
The BMJ is running a poll asking readers to vote whether medical schools and other academic institutions should boycott Israeli institutions.
BMJ is thus complicit in advancing anti-Semitism. If JAMA called for a boycott of Iranian or Palestinian or Cuban academics and medical researchers it would be pilloried in the MSM. Here at home, the BMJ pro-boycott poll (and you don't run such a poll unless you are promoting it) gets no mention. Double standard. You bet.
Here is a link to an article in the Jerusalem Post about the bastards at BMJ.
http://www.jpost.com/servlet/Satellite?apage=2&cid=1184766044837&pagename=JPost%2FJPArticle%2FShowFull
And here is a link to the ADL's anti-boycott campaign. The petition states "These highly politicized and blatantly biased attacks violate the basic tenets of journalistic and academic objectivity and disregard key facts of the complex Arab-Israeli conflict. Singling out Israel for boycott while ignoring the brutal human rights abuses occurring everyday in countries like Sudan, Zimbabwe and Iran isn't activism -- it's anti-Semitism."
We encourage drugwonk followers to click and take a stand against the BMJ and other outlets that offer safe haven to hatemongers.
http://www.adl.org/boycott/
BMJ is thus complicit in advancing anti-Semitism. If JAMA called for a boycott of Iranian or Palestinian or Cuban academics and medical researchers it would be pilloried in the MSM. Here at home, the BMJ pro-boycott poll (and you don't run such a poll unless you are promoting it) gets no mention. Double standard. You bet.
Here is a link to an article in the Jerusalem Post about the bastards at BMJ.
http://www.jpost.com/servlet/Satellite?apage=2&cid=1184766044837&pagename=JPost%2FJPArticle%2FShowFull
And here is a link to the ADL's anti-boycott campaign. The petition states "These highly politicized and blatantly biased attacks violate the basic tenets of journalistic and academic objectivity and disregard key facts of the complex Arab-Israeli conflict. Singling out Israel for boycott while ignoring the brutal human rights abuses occurring everyday in countries like Sudan, Zimbabwe and Iran isn't activism -- it's anti-Semitism."
We encourage drugwonk followers to click and take a stand against the BMJ and other outlets that offer safe haven to hatemongers.
http://www.adl.org/boycott/
Drugwonks congratulates Genomas CEO Gualberto Ruano, a champion of personalized medicine, for the receipt of a NIH grant support his pathbreaking research on the development of a gene test for drug induced metabolic disorder and atypicals.
http://www.courant.com/business/hc-bizadd2-0723,0,133185.story?track=rss
Also http://www.genomas.net
http://www.courant.com/business/hc-bizadd2-0723,0,133185.story?track=rss
Also http://www.genomas.net
We have mentioned the increased risk of ALS and greater violence attributed to statins that lower LDL.
http://online.wsj.com/article/SB118314239102053337.html?mod=googlenews_wsj
http://archinte.ama-assn.org/cgi/content/abstract/164/2/153
It wasn't too long that someone would run an statistical correlation "showing" that statins are association with cancer. Not a specific cancer mind you. Just cancer.
http://www.cbsnews.com/stories/2007/07/24/health/webmd/main3092265.shtml
Would someone please create a federal program to give epidemiologists something constructive to do? Better yet, how about medical journals imposing a ban on running articles that do nothing to generate mechanistically informed hypotheses but everything to run articles that the average reporter can understand once it has been pre-digested by a PR firm by said medical journal?
PR for medical journal ok but PR for new medicines, not ok?
http://online.wsj.com/article/SB118314239102053337.html?mod=googlenews_wsj
http://archinte.ama-assn.org/cgi/content/abstract/164/2/153
It wasn't too long that someone would run an statistical correlation "showing" that statins are association with cancer. Not a specific cancer mind you. Just cancer.
http://www.cbsnews.com/stories/2007/07/24/health/webmd/main3092265.shtml
Would someone please create a federal program to give epidemiologists something constructive to do? Better yet, how about medical journals imposing a ban on running articles that do nothing to generate mechanistically informed hypotheses but everything to run articles that the average reporter can understand once it has been pre-digested by a PR firm by said medical journal?
PR for medical journal ok but PR for new medicines, not ok?
World reknown health care expert Reinhardt complains to the WSJ that he cannot get his extremely large and supple brain around the question about why we stupid Americans don't like socialized medicine:
"Why do I never hear any Republican political candidate, or the editorial page of the Journal for that matter, openly advocate the abolition and privatization of the VA health system? Why are even the staunchest American conservatives, and the veterans themselves, so protective of the VA health system, if socialized medicine is so bad?"
One explanation may be that the VA health system is generally viewed among health-policy experts as the cutting edge in the smart use of electronic information technology and of quality control in health care. The Journal itself featured an article on this point on its front page some time ago. In a peer-reviewed research paper published in the Annals of Internal Medicine (December 21, 2004), researchers of the RAND Corp. reported that the quality of care received by VA patients scored significantly higher overall than did comparable metrics for patients in the rest of the U.S. health system."
Again with the 2004 study (which by the way did not compare metrics with rest of the country, only a couple of other HMOs)
Perhaps Reinhardt hasn't read about the excellent care the VA is delivery to vets with mental illness and PTSD:
"The VA has seen its backlog of disability claims swell to 600,000 as soldiers return from ongoing wars, a logjam blamed for financial dislocation, despair and even suicides of vets. The suit says the claims system is "riddled with inconsistent and irrational procedures" that violate the due process rights of injured vets seeking care and compensation. For example, the VA employs the same officials both to challenge and judge claims.
"According to the suit, the biggest casualties of this bureaucratic morass are the unprecedented number of troops returning with PTSD, a mental disorder especially prevalent in soldiers stationed in Iraq and Afghanistan, where they're faced with multiple tours of duty, invisible battle lines and the "moral ambiguity of killing combatants dressed as civilians." The military says more than a third of the 1.6 million men and women who have served in Iraq or Afghanistan report mental health issues ranging from PTSD to brain injuries, yet only 27 of the nation's 1,400 VA hospitals have programs dedicated to treating PTSD. Worse yet, the complex process of applying for disability payments is especially daunting for these patients, who often experience memory lapses and disorientation."
http://news.yahoo.com/s/time/20070725/us_time/behindtheveteranslegalbattle
"Why do I never hear any Republican political candidate, or the editorial page of the Journal for that matter, openly advocate the abolition and privatization of the VA health system? Why are even the staunchest American conservatives, and the veterans themselves, so protective of the VA health system, if socialized medicine is so bad?"
One explanation may be that the VA health system is generally viewed among health-policy experts as the cutting edge in the smart use of electronic information technology and of quality control in health care. The Journal itself featured an article on this point on its front page some time ago. In a peer-reviewed research paper published in the Annals of Internal Medicine (December 21, 2004), researchers of the RAND Corp. reported that the quality of care received by VA patients scored significantly higher overall than did comparable metrics for patients in the rest of the U.S. health system."
Again with the 2004 study (which by the way did not compare metrics with rest of the country, only a couple of other HMOs)
Perhaps Reinhardt hasn't read about the excellent care the VA is delivery to vets with mental illness and PTSD:
"The VA has seen its backlog of disability claims swell to 600,000 as soldiers return from ongoing wars, a logjam blamed for financial dislocation, despair and even suicides of vets. The suit says the claims system is "riddled with inconsistent and irrational procedures" that violate the due process rights of injured vets seeking care and compensation. For example, the VA employs the same officials both to challenge and judge claims.
"According to the suit, the biggest casualties of this bureaucratic morass are the unprecedented number of troops returning with PTSD, a mental disorder especially prevalent in soldiers stationed in Iraq and Afghanistan, where they're faced with multiple tours of duty, invisible battle lines and the "moral ambiguity of killing combatants dressed as civilians." The military says more than a third of the 1.6 million men and women who have served in Iraq or Afghanistan report mental health issues ranging from PTSD to brain injuries, yet only 27 of the nation's 1,400 VA hospitals have programs dedicated to treating PTSD. Worse yet, the complex process of applying for disability payments is especially daunting for these patients, who often experience memory lapses and disorientation."
http://news.yahoo.com/s/time/20070725/us_time/behindtheveteranslegalbattle
A letter from the current issue of The Economist penned by our friend and colleague Jacob Arfwedson:
Drug tests
SIR – Your leader on the reform of pharmaceutical regulations in America maintains that safety concerns must be addressed, but why assume that the government will do a better job than independent players (“From bench to bedsideâ€, June 30th)? In the United States private agencies ensure quality assessment (including off-label use and risks missed by the government) in a speedier way than the Food and Drug Administration.
As Peter Pitts, a former associate commissioner at the FDA, has shown, there is no direct link between additional clinical trials and safer medicines. The length of the FDA approval process has doubled since the 1960s as have the financial costs since the late 1980s. Moreover, the number of clinical trials doubled between 1977 and 1995 and the number of patients tripled. Yet in the past 40 years the share of medicines withdrawn from the market has remained constant.
Jacob Arfwedson
Centre for the New Europe
Brussels
The rest of the story is that the science of clinical trials needs updating. If we want to truly move into the era of personalized medicine, we need adaptive clinical trials that can look more precisely at sub-populations.
"Traditional" clinical trials that demonstrate a 40% efficacy rate without even attempting to isolate which 40% is expensive in financial terms and only marginally helpful in helping physicians best treat their patients. It also plays into the hands of the Evangelists of Evidence-based Medicine and the Votaries of Me-Tooism. We must think about clinical trials in new ways. It's a crucial aspect of the Critical Path.
Drug tests
SIR – Your leader on the reform of pharmaceutical regulations in America maintains that safety concerns must be addressed, but why assume that the government will do a better job than independent players (“From bench to bedsideâ€, June 30th)? In the United States private agencies ensure quality assessment (including off-label use and risks missed by the government) in a speedier way than the Food and Drug Administration.
As Peter Pitts, a former associate commissioner at the FDA, has shown, there is no direct link between additional clinical trials and safer medicines. The length of the FDA approval process has doubled since the 1960s as have the financial costs since the late 1980s. Moreover, the number of clinical trials doubled between 1977 and 1995 and the number of patients tripled. Yet in the past 40 years the share of medicines withdrawn from the market has remained constant.
Jacob Arfwedson
Centre for the New Europe
Brussels
The rest of the story is that the science of clinical trials needs updating. If we want to truly move into the era of personalized medicine, we need adaptive clinical trials that can look more precisely at sub-populations.
"Traditional" clinical trials that demonstrate a 40% efficacy rate without even attempting to isolate which 40% is expensive in financial terms and only marginally helpful in helping physicians best treat their patients. It also plays into the hands of the Evangelists of Evidence-based Medicine and the Votaries of Me-Tooism. We must think about clinical trials in new ways. It's a crucial aspect of the Critical Path.
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.
