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Author Archive: Howard Brody

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08/23/2014

Not-So-Personalized Medicine

Jack E. James, who appears to hail from either Reykjavik University in Iceland or the National University of Ireland in Galway, or both, kindly sent me a copy of a paper published in June in the European Journal of Epidemiology:http://link.springer.com...

Full Article

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08/23/2014

Not-So-Personalized Medicine

Jack E. James, who appears to hail from either Reykjavik University in Iceland or the National University of Ireland in Galway, or both, kindly sent me a copy of a paper published in June in the European Journal of Epidemiology:http://link.springer.com...

Full Article

This entry was posted in Health Care and tagged . Posted by Howard Brody. Bookmark the permalink.

08/18/2014

Research on Pharmaceuticals: From Confidence to Commercialism

The main thrust of this commentary comes from Dr. Roy Poses and:
http://hcrenewal.blogspot.com/2014/08/desperate-vulnerable-research-subjects.html
--which in turn draws on two prior posts:
https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfe

https://medium.com/matter/why-are-dope-addicted-disgraced-doctors-running-our-drug-trials-aff6d20843bf

A little background: HOOKED described a major shift in pharmaceutical research. Initially, the vast majority of drug trials were conducted by universities. Over the past 30 years, companies found that universities were too slow in doing this research for maximum financial gains, and so gradually, contract research organizations replaced universities as the major players. Dr. Carl Elliott (first of two prior posts) has been one of the major writers about the fallout from these policies.

Dr. Elliott describes in some detail a group of subjects who can be found in typical contract research organizations, who talk openly about their ways of qualifying for research trials, and also of dodging the painful and burdensome procedures that typically form a part of some trials. It seems quite clear that the money, and not any goal of contributing to science, is the main and indeed the sole motivator. Dr. Elliott had previously described this "guinea pigging" in earlier published work.

The second prior post, by Peter Aldhous, describes some of the physicians who run the contract studies, and focuses on those who have been censured and who have various licensure problems. Aldhous admits that these misfits count as a minority of all the doctors running the contract research organizations, but adds, "My trawl netted dozens of doctors selected to work on clinical trials over the past five years who had previously been censured by state medical boards. Thousands of doctors are hired each year to test experimental drugs, making this a small minority. But most doctors have clean records, so companies should have few problems finding recruits without red flags against their name."

Aldhous concludes, "Some experts argue that the FDA’s entire rulebook for clinical trials, with its talk of things like 'institutional' review boards, reflects the academic past of clinical research—not today’s industrial juggernaut of for-profit clinical trials firms and for-hire review boards, which oversee a workforce of doctors drawn from regular medical practice. 'They are regulations for a world that doesn’t exist anymore,' says Elizabeth Woeckner, president of Citizens for Responsible Care and Research, which campaigns for the safety of medical research volunteers."

Dr. Poses then notes: "So given the push to do research rapidly at the lowest cost, the lack of supervision and regulation by the FDA, the hiring of physicians with problematic backgrounds, the willingness to take vulnerable patients desperately motivated by money, can we trust that the nice, clean, detailed descriptions of clinical trials implemented by contract research organizations presented in research articles and trial registries have anything to do with the reality of what went on? If not, what then should we make of the validity of the results of such trials?...This is yet another reason to ask whether we need to take research on human subjects meant to evaluate commercial products or services out of the hands of the companies that make those products and provide those services."

In other words, bait and switch. Get everyone used to research on human subjects while research institutions are running the shop and people who sign up as subjects have at least some motivation to behave in the interests of science. Then gradually change the system so that it's all about money and one can no longer trust the results. The money affects different players in different ways-- the companies and the CROs have their financial motives, the "guinea pigs" have theirs--but the one thing we can count on is that the money plays a role that's different from the ideal of scientific research. The end result is that things look legitimate up front, and all the people involved have strong motives to do what's less legitimate behind the scenes. We have no idea how that plays out in terms of scientific rigor.

And this is now how drugs are tested before we use them.

Full Article

This entry was posted in Health Care and tagged . Posted by Howard Brody. Bookmark the permalink.

08/18/2014

Research on Pharmaceuticals: From Confidence to Commercialism

The main thrust of this commentary comes from Dr. Roy Poses and:
http://hcrenewal.blogspot.com/2014/08/desperate-vulnerable-research-subjects.html
--which in turn draws on two prior posts:
https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfe

https://medium.com/matter/why-are-dope-addicted-disgraced-doctors-running-our-drug-trials-aff6d20843bf

A little background: HOOKED described a major shift in pharmaceutical research. Initially, the vast majority of drug trials were conducted by universities. Over the past 30 years, companies found that universities were too slow in doing this research for maximum financial gains, and so gradually, contract research organizations replaced universities as the major players. Dr. Carl Elliott (first of two prior posts) has been one of the major writers about the fallout from these policies.

Dr. Elliott describes in some detail a group of subjects who can be found in typical contract research organizations, who talk openly about their ways of qualifying for research trials, and also of dodging the painful and burdensome procedures that typically form a part of some trials. It seems quite clear that the money, and not any goal of contributing to science, is the main and indeed the sole motivator. Dr. Elliott had previously described this "guinea pigging" in earlier published work.

The second prior post, by Peter Aldhous, describes some of the physicians who run the contract studies, and focuses on those who have been censured and who have various licensure problems. Aldhous admits that these misfits count as a minority of all the doctors running the contract research organizations, but adds, "My trawl netted dozens of doctors selected to work on clinical trials over the past five years who had previously been censured by state medical boards. Thousands of doctors are hired each year to test experimental drugs, making this a small minority. But most doctors have clean records, so companies should have few problems finding recruits without red flags against their name."

Aldhous concludes, "Some experts argue that the FDA’s entire rulebook for clinical trials, with its talk of things like 'institutional' review boards, reflects the academic past of clinical research—not today’s industrial juggernaut of for-profit clinical trials firms and for-hire review boards, which oversee a workforce of doctors drawn from regular medical practice. 'They are regulations for a world that doesn’t exist anymore,' says Elizabeth Woeckner, president of Citizens for Responsible Care and Research, which campaigns for the safety of medical research volunteers."

Dr. Poses then notes: "So given the push to do research rapidly at the lowest cost, the lack of supervision and regulation by the FDA, the hiring of physicians with problematic backgrounds, the willingness to take vulnerable patients desperately motivated by money, can we trust that the nice, clean, detailed descriptions of clinical trials implemented by contract research organizations presented in research articles and trial registries have anything to do with the reality of what went on? If not, what then should we make of the validity of the results of such trials?...This is yet another reason to ask whether we need to take research on human subjects meant to evaluate commercial products or services out of the hands of the companies that make those products and provide those services."

In other words, bait and switch. Get everyone used to research on human subjects while research institutions are running the shop and people who sign up as subjects have at least some motivation to behave in the interests of science. Then gradually change the system so that it's all about money and one can no longer trust the results. The money affects different players in different ways-- the companies and the CROs have their financial motives, the "guinea pigs" have theirs--but the one thing we can count on is that the money plays a role that's different from the ideal of scientific research. The end result is that things look legitimate up front, and all the people involved have strong motives to do what's less legitimate behind the scenes. We have no idea how that plays out in terms of scientific rigor.

And this is now how drugs are tested before we use them.

Full Article

This entry was posted in Health Care and tagged . Posted by Howard Brody. Bookmark the permalink.

08/18/2014

Research on Pharmaceuticals: From Confidence to Commercialism

The main thrust of this commentary comes from Dr. Roy Poses and:
http://hcrenewal.blogspot.com/2014/08/desperate-vulnerable-research-subjects.html
--which in turn draws on two prior posts:
https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfe

https://medium.com/matter/why-are-dope-addicted-disgraced-doctors-running-our-drug-trials-aff6d20843bf

A little background: HOOKED described a major shift in pharmaceutical research. Initially, the vast majority of drug trials were conducted by universities. Over the past 30 years, companies found that universities were too slow in doing this research for maximum financial gains, and so gradually, contract research organizations replaced universities as the major players. Dr. Carl Elliott (first of two prior posts) has been one of the major writers about the fallout from these policies.

Dr. Elliott describes in some detail a group of subjects who can be found in typical contract research organizations, who talk openly about their ways of qualifying for research trials, and also of dodging the painful and burdensome procedures that typically form a part of some trials. It seems quite clear that the money, and not any goal of contributing to science, is the main and indeed the sole motivator. Dr. Elliott had previously described this "guinea pigging" in earlier published work.

The second prior post, by Peter Aldhous, describes some of the physicians who run the contract studies, and focuses on those who have been censured and who have various licensure problems. Aldhous admits that these misfits count as a minority of all the doctors running the contract research organizations, but adds, "My trawl netted dozens of doctors selected to work on clinical trials over the past five years who had previously been censured by state medical boards. Thousands of doctors are hired each year to test experimental drugs, making this a small minority. But most doctors have clean records, so companies should have few problems finding recruits without red flags against their name."

Aldhous concludes, "Some experts argue that the FDA’s entire rulebook for clinical trials, with its talk of things like 'institutional' review boards, reflects the academic past of clinical research—not today’s industrial juggernaut of for-profit clinical trials firms and for-hire review boards, which oversee a workforce of doctors drawn from regular medical practice. 'They are regulations for a world that doesn’t exist anymore,' says Elizabeth Woeckner, president of Citizens for Responsible Care and Research, which campaigns for the safety of medical research volunteers."

Dr. Poses then notes: "So given the push to do research rapidly at the lowest cost, the lack of supervision and regulation by the FDA, the hiring of physicians with problematic backgrounds, the willingness to take vulnerable patients desperately motivated by money, can we trust that the nice, clean, detailed descriptions of clinical trials implemented by contract research organizations presented in research articles and trial registries have anything to do with the reality of what went on? If not, what then should we make of the validity of the results of such trials?...This is yet another reason to ask whether we need to take research on human subjects meant to evaluate commercial products or services out of the hands of the companies that make those products and provide those services."

In other words, bait and switch. Get everyone used to research on human subjects while research institutions are running the shop and people who sign up as subjects have at least some motivation to behave in the interests of science. Then gradually change the system so that it's all about money and one can no longer trust the results. The money affects different players in different ways-- the companies and the CROs have their financial motives, the "guinea pigs" have theirs--but the one thing we can count on is that the money plays a role that's different from the ideal of scientific research. The end result is that things look legitimate up front, and all the people involved have strong motives to do what's less legitimate behind the scenes. We have no idea how that plays out in terms of scientific rigor.

And this is now how drugs are tested before we use them.

Full Article

This entry was posted in Health Care and tagged . Posted by Howard Brody. Bookmark the permalink.

08/11/2014

From Christopher Gregory: What’s Wrong with Profits in Medicine?

Now I'm turning the blog over to Dr. Christopher M. Gregory, a fellow Texan who runs the DocOnomics blog (http://www.doconomics.com/blog/). He sent an e-mail recently which so nicely, and briefly, captured a large issue that has perplexed me that I couldn't help but ask him to reprint, and he kindly consented:

This Modern Healthcare article Another Year of Pay Hikes for Nonprofit Hospital CEOs galls me. Almost as much as this articlethat reported the director of interventional cardiology at NY Mt Sinai was paid almost $5 million a year for being the rainmaker there, where far more stents are done than the national average.    



As I consider the proliferation of waste in the form of freestanding ERs, urgent care clinics, and shiny new hospitals popping up, and more doctors being bought off into economically forced subservience, I see nothing but the extreme excesses in our system. And for that there is a small group of these so-called “not-for-profit” CEOs getting pay packages that would choke a horse. Boards and compensation consultants continue to cite market forces—the need to keep up with peers to hold onto skilled healthcare leaders—as the main reason for the increases. The market forces they refer to are the market forces of excess, waste and profits that continue to make life increasingly intolerable for the group of physicians – primary care physicians – that would make this system much better if we let sanity retake the high ground. These high-talent CEOs are especially valued for the business smarts needed to make sure we are continuing to pay such disproportionate amounts for the unnecessary, costly care in this country .


To be precise, these pay packages are needed to keep these high-power hospital businessmen in the business of maintaining the well-oiled machine that is swallowing up nearly 20% of our GDP. And yet, millions of Americans can’t afford to get the care they need.  


Total cash compensation grew an average of 24.2% from 2011 to 2012 for the 147 chief executives included in Modern Healthcare's analysis of the most recent public information available for not-for-profit compensation. Of those 147 CEOs, 21, or 14.3%, saw their total cash compensation rise by more than 50%.


I talked with Dr Bob Kramerthis morning. He said that it will be an uphill battle getting ologists to passionately endorse a cutback in the sorts of conspicuous consumption that nets them many multiples of what PCPs are paid, and continues to siphon off the ranks of potential primary care doctors in training. We are going to reap a medical, economic whirlwind for all of this foolishness as we continue to lose the numbers of physicians who would serve us best on the front lines. If only we could overcome the entrenched stupidity of organizations like the AMA and the RUC, that keeps PCPs from making the economic and care-centric progress that would make our healthcare system run so much better.


What can be done – what group of physicians around the country – will stand up and make a definitive statement that the intensifying black hole of the overheated healthcare “business system”, with its goal for more money and more influence, is taking us in a terribly wrong direction? As my Canadian healthcare friend once pointed out, there is a healthcare noose around our national neck, and the “system” is the hangman. 


Christopher M. Gregory

DocOnomics


1705 River Birch Drive


Flower Mound, TX75028


Full Article

This entry was posted in Health Care and tagged . Posted by Howard Brody. Bookmark the permalink.

08/11/2014

From Christopher Gregory: What’s Wrong with Profits in Medicine?

Now I'm turning the blog over to Dr. Christopher M. Gregory, a fellow Texan who runs the DocOnomics blog (http://www.doconomics.com/blog/). He sent an e-mail recently which so nicely, and briefly, captured a large issue that has perplexed me that I couldn't help but ask him to reprint, and he kindly consented:

This Modern Healthcare article Another Year of Pay Hikes for Nonprofit Hospital CEOs galls me. Almost as much as this articlethat reported the director of interventional cardiology at NY Mt Sinai was paid almost $5 million a year for being the rainmaker there, where far more stents are done than the national average.    



As I consider the proliferation of waste in the form of freestanding ERs, urgent care clinics, and shiny new hospitals popping up, and more doctors being bought off into economically forced subservience, I see nothing but the extreme excesses in our system. And for that there is a small group of these so-called “not-for-profit” CEOs getting pay packages that would choke a horse. Boards and compensation consultants continue to cite market forces—the need to keep up with peers to hold onto skilled healthcare leaders—as the main reason for the increases. The market forces they refer to are the market forces of excess, waste and profits that continue to make life increasingly intolerable for the group of physicians – primary care physicians – that would make this system much better if we let sanity retake the high ground. These high-talent CEOs are especially valued for the business smarts needed to make sure we are continuing to pay such disproportionate amounts for the unnecessary, costly care in this country .


To be precise, these pay packages are needed to keep these high-power hospital businessmen in the business of maintaining the well-oiled machine that is swallowing up nearly 20% of our GDP. And yet, millions of Americans can’t afford to get the care they need.  


Total cash compensation grew an average of 24.2% from 2011 to 2012 for the 147 chief executives included in Modern Healthcare's analysis of the most recent public information available for not-for-profit compensation. Of those 147 CEOs, 21, or 14.3%, saw their total cash compensation rise by more than 50%.


I talked with Dr Bob Kramerthis morning. He said that it will be an uphill battle getting ologists to passionately endorse a cutback in the sorts of conspicuous consumption that nets them many multiples of what PCPs are paid, and continues to siphon off the ranks of potential primary care doctors in training. We are going to reap a medical, economic whirlwind for all of this foolishness as we continue to lose the numbers of physicians who would serve us best on the front lines. If only we could overcome the entrenched stupidity of organizations like the AMA and the RUC, that keeps PCPs from making the economic and care-centric progress that would make our healthcare system run so much better.


What can be done – what group of physicians around the country – will stand up and make a definitive statement that the intensifying black hole of the overheated healthcare “business system”, with its goal for more money and more influence, is taking us in a terribly wrong direction? As my Canadian healthcare friend once pointed out, there is a healthcare noose around our national neck, and the “system” is the hangman. 


Christopher M. Gregory

DocOnomics


1705 River Birch Drive


Flower Mound, TX75028


Full Article

This entry was posted in Health Care and tagged . Posted by Howard Brody. Bookmark the permalink.

08/11/2014

From Health Care Renewal: The Free Market and Drugs

Let's see what's going on over at the Health Care Renewal blog, courtesy Dr. Roy Poses. Dr. Poses has been noting that there are some pharmaceutical developments that could easily help us out in the case of Ebola virus, which seems right now to be expa...

Full Article

This entry was posted in Health Care and tagged . Posted by Howard Brody. Bookmark the permalink.

08/11/2014

From Health Care Renewal: The Free Market and Drugs

Let's see what's going on over at the Health Care Renewal blog, courtesy Dr. Roy Poses. Dr. Poses has been noting that there are some pharmaceutical developments that could easily help us out in the case of Ebola virus, which seems right now to be expa...

Full Article

This entry was posted in Health Care and tagged . Posted by Howard Brody. Bookmark the permalink.

07/29/2014

More on Guinea Pigging–The Quality of Pharmaceutical Research

Two longish articles by our old friend Dr. Carl Elliott and by Peter Aldhous:https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfehttps://medium.com/matter/why-are-dope-addicted-disgraced-doctors-running-our-drug-trial...

Full Article

This entry was posted in Health Care and tagged . Posted by Howard Brody. Bookmark the permalink.