Wednesday, September 12, 2007
BLOGSCAN - Seeking to Punish Health Care Leaders
On PharmaLot, Ed Silverman reports on a bereaved mother, Marianne Skolek, whose daughter died after being prescribed OxyContin, who seeks to punish executives of Purdue Pharma, the drug's manufacturer. I just noted that even when the actions of health care organizations result in legal penalties, very rarely do the organizations' leaders suffer any consequences. The OxyContin case was an exception to this rule, since the company's executives were actually fined significant amounts (see our post here). Ms Skolek is going further, and is seeking to have at attorney who worked for Purdue disbarred, and to have the company's former medical director lose his medical license. Stay tuned on this one....
BLOGSCAN - Bringing the Pharmaceutical Industry into Disrepute
First, this post on PharmaGossip, and then this post on PharmaLot addressed how AstraZeneca was found to bring the "industry into disrepute," by engineering a special supplement to the UK based Pharmaceutical Journal which was really marketing of Crestor in disguise. Another reminder of the extent that dishonesty now permeates health care and academics.
BLOGSCAN - Another Look at the Perils of P4P
On the Covert Rationing Blog, DrRich (Dr Richard Fogoros) starts his dissection of the pay-for-performance (P4P) movement. The result is insightful. Particularly important is his critique of the "axiom of industry," that process standardization reduces costs and improves quality, when applied to health care.
$190 Million Settlement for Sanofi-Aventis
I had the feeling that once we got through the August doldrums, the floodgates of stories of health care organizations behaving badly would open up. It turns out I was right. This story was picked up by the wire services, e.g., from Reuters,
$190 million here, $190 million there, soon it adds up to real money.
Again, this is one of many, many stories of how the ever enlarging and more powerful organizations that dominate health care, in this case, a pharmaceutical company, but including biotechnology companies, medical device companies, health care providers, hospitals and health care systems, managed care companies and health insurers, health care information technology companies, etc, etc, etc, are willing to go right up to, and often over the legal line. The resulting fine may just be their cost of business, often just taken out of the stock-holders profits. Almost never does a high corporate executive pay any penalty in these cases. So there is little incentive for the leaders of these organizations to stop pushing the envelope. But the result is a health care system that collectively puts the self-interests of its organizations' leaders before the interst of patients or the advancement of science.
I have said that before, haven't I?
A U.S. subsidiary of drugmaker Sanofi-Aventis has paid about $190 million to federal and state governments to settle charges that it overcharged Medicare for an anti-nausea drug, the Justice Department said on Monday.
Aventis Pharmaceuticals, now known as Sanofi-Aventis U.S. Inc, agreed to make the payment to resolve allegations that the company artificially inflated the price the Medicare program paid for Anzemet, a drug used to prevent nausea and vomiting in patients undergoing radiation treatment, the department said.
The department said Aventis increased the cost of Medicare reimbursement for Anzemet by inflating the reported price for the drug, which are used to set reimbursement rates.
$190 million here, $190 million there, soon it adds up to real money.
Again, this is one of many, many stories of how the ever enlarging and more powerful organizations that dominate health care, in this case, a pharmaceutical company, but including biotechnology companies, medical device companies, health care providers, hospitals and health care systems, managed care companies and health insurers, health care information technology companies, etc, etc, etc, are willing to go right up to, and often over the legal line. The resulting fine may just be their cost of business, often just taken out of the stock-holders profits. Almost never does a high corporate executive pay any penalty in these cases. So there is little incentive for the leaders of these organizations to stop pushing the envelope. But the result is a health care system that collectively puts the self-interests of its organizations' leaders before the interst of patients or the advancement of science.
I have said that before, haven't I?
Dialysis Providers and the Restraint of Competition
This story almost made it under the radar. Our local Providence Journal provided this exclusive,
Although the report was local, it involved actions by two large commercial provider of dialysis services, Fresenius Medical Care Holdings, part of Fresenius Medical Care, a German firm claiming to be the world's largest provider of services to patients with chronic renal disease, and American Renal Associates, which claims to be one of the largest US dialysis providers. As such, it indicates the goals of the leaders of these organizations, and the means they will utilize to achieve these goals. Fresenius has received much more coverage lately for its efforts to stave off proposed reductions in payments for large doses of epoetin to treat anemia in dialysis patients, even given that such aggressive treatment has not shown to provide any clear benefit to patients.
This story is particularly interesting because it is, to my knowledge, one of the few reports of an anti-trust action against commercial health care service providers in the US, even though the provision of health care services is more and accomplished by corporations that grow ever larger and more powerful. This suggests that one way such organizations may grow large and powerful is by collaborating with others with whom they are ostensibly competing.
On the other hand, this is just one of many stories, found on Health Care Renewal, the other blogs that now act as health care watchdogs, and of course in the news media, of health care organizations bumping up against legal limits in their pursuit of money.
The problem is that these stories are scattered around blogs and the news media, and very rarely in medical and health care journals. I believe that were they better aggregated, physicians and the public alike would realize how much of health care is now driven by the self-interest of the leaders of large health care organizations, and how little is unfortunately driven by the needs of patients and the advancement of science.
Two area dialysis clinic operators — American Renal Associates and Fresenius Medical Care Holdings — have signed consent orders with the Federal Trade Commission settling charges that they unlawfully tried to restrain competition.
According to the FTC, the parties entered into an asset purchase agreement on Aug. 3, 2005, under which ARA proposed to purchase five Rhode Island dialysis clinics from Fresenius. The agreement also required Fresenius to close an additional three clinics — two in Rhode Island and one in Fall River. The parties terminated the asset purchase agreement on March 13, 2006, after FTC staff raised antitrust concerns.
The FTC’s complaint alleges two separate violations of antitrust laws. The commission charges that the agreement between ARA and Fresenius to close three Fresenius clinics was an agreement to eliminate competition in the affected areas of East Providence, North Providence and Fall River. The effect of this elimination of competition would have been an increase in ARA’s ability to raise prices in these areas and to reduce ARA’s incentives to improve service and quality.
Also, commission charged that ARA’s proposed acquisition of two Fresenius clinics in Warwick would substantially reduce competition for outpatient dialysis services in the Warwick/Cranston area.
According to the FTC, agreements to pay a competitor to exit a market, such as the one allegedly negotiated between ARA and Fresenius, are illegal.
Although the report was local, it involved actions by two large commercial provider of dialysis services, Fresenius Medical Care Holdings, part of Fresenius Medical Care, a German firm claiming to be the world's largest provider of services to patients with chronic renal disease, and American Renal Associates, which claims to be one of the largest US dialysis providers. As such, it indicates the goals of the leaders of these organizations, and the means they will utilize to achieve these goals. Fresenius has received much more coverage lately for its efforts to stave off proposed reductions in payments for large doses of epoetin to treat anemia in dialysis patients, even given that such aggressive treatment has not shown to provide any clear benefit to patients.
This story is particularly interesting because it is, to my knowledge, one of the few reports of an anti-trust action against commercial health care service providers in the US, even though the provision of health care services is more and accomplished by corporations that grow ever larger and more powerful. This suggests that one way such organizations may grow large and powerful is by collaborating with others with whom they are ostensibly competing.
On the other hand, this is just one of many stories, found on Health Care Renewal, the other blogs that now act as health care watchdogs, and of course in the news media, of health care organizations bumping up against legal limits in their pursuit of money.
The problem is that these stories are scattered around blogs and the news media, and very rarely in medical and health care journals. I believe that were they better aggregated, physicians and the public alike would realize how much of health care is now driven by the self-interest of the leaders of large health care organizations, and how little is unfortunately driven by the needs of patients and the advancement of science.
Another Storied US Teaching Hospital Facing Financial Collapse
Grady Memorial Hospital, part of the Grady Health System, in Atlanta, Georgia, is another renowned US teaching hospital facing financial disaster. The Atlanta Journal-Constitution has been covering the story. Late last month, this report blamed the hospital's troubles on the equally renowned Emory School of Medicine, part of Emory University,
Three days later, another AJC article suggested that Emory's claims about the hours its physicians worked were based on questionable data.
Finally, last week the AJC reported that while Grady may stay open, its financial trouble will likely lead to significant down-sizing.
Well, here we go again, another storied hospital on the brink of financial collapse, amidst finger-pointing by the leaders of the hospital and the academic medical organizations that are supposed to be supporting it. I cannot tell who is to blame. I also cannot tell how much the hospital's problems are due to the larger dysfunction in the US health care system.
But it would be nice if the leaders involved clearly focused on their health care and educational missions.
If Grady collapses, or even if it just continues to "limp on," the results would be bad for many patients in Atlanta who depend on its services, and many medical students and interns and residents who benefit from the educational experiences it provides.
A former member of the Grady hospital board has accused the Emory School of Medicine of cherry-picking Grady patients to benefit its own hospitals.
Bill Loughrey said Emory has systematically steered paying patients from Grady to Emory-owned hospitals, leaving Grady in fragile financial shape as it serves the poor and uninsured.
Loughrey said Tuesday that he detailed his concerns to state Sen. David Shafer (R-Duluth), who has started looking into the matter. The accusations were also discussed during a meeting of a state House committee on Grady's general financial malaise Tuesday.
Dr. Thomas Lawley, dean of Emory's medical school, denied that Emory has shorted Grady to benefit its own hospitals. He said Emory has worked hard to help Grady, accepting partial payments for its doctors and being patient regarding the $45 million Grady owes Emory.
Loughrey, who was recently replaced on the board after nine years, said Emory has underfunded and understaffed such areas cardiology and orthopedics, which compete with Emory-owned hospitals. This has cost Grady millions of dollars, Loughrey said.
In addition, he said Emory has been transferring paying Grady patients to Emory-owned hospitals, "leaving Grady with an unsustainable patient mix dominated by indigent and other nonpaying patients."
His concerns arise as Grady, a major health provider for the metro poor, is spiraling in debt and may, in a worst case scenario, close by year's end.
Emory officials said they do not understaff Grady, but Lawley said recruiting doctors to serve there is difficult.
Loughrey's letter cited an audit he said has been kept secret regarding the contract between Grady and Emory. Loughrey said the audit, performed about two years ago, revealed that Emory did a poor job of keeping records, which Loughrey said raises questions about whether the services Grady paid for were provided.
Lawley, the Emory dean, said the audit actually determined that Emory was in conformity with the Grady contract.
Three days later, another AJC article suggested that Emory's claims about the hours its physicians worked were based on questionable data.
The Emory School of Medicine has not implemented key recommendations from an audit two years ago that criticized the way its doctors record time worked at Grady hospital.
The record-keeping is crucial to the amount of money Emory bills Grady for the use of its doctors. The issue has reemerged at a time when Emory says the financially troubled Grady owes it $45 million.
The 2005 audit, commissioned by the Grady board of trustees and performed by the accounting firms of Cherry, Bekaert and Holland and Horne, examined the contractual relationship between Grady and Emory, which provides the hospital with many of its doctors.
The audit said Emory's method for tracking its doctor's time at Grady was "inadequate" to accurately monitor whether the work was actually being performed.
To avoid having doctors record every hour they spend at Grady, Emory doctors typically track their hours worked for a single week every 3 months. Emory uses that figure to calculate how much Grady should pay for all of the doctors' services.
The audit recommended that Emory have the doctors record their time at Grady more frequently.
Emory's dean of medicine, Dr. Thomas Lawley, said, "We believe in our record reporting, and we believe in its accuracy."
He stressed it conforms with the contract with Grady and abides by the law.
[state Sen. David] Shafer said he obtained the audit from Grady Thursday under Georgia open records laws.
Shafer, who has passed the letter on to Lt. Gov. Casey Cagle, said, "It's very troubling that Grady and Emory have ignored the audit." He added, "The audit should be implemented."
As for Emory's statement that the method complies with its contract with Grady, Shafer said, "That's like saying the Titanic had the legally required number of lifeboats. It misses the point."
Finally, last week the AJC reported that while Grady may stay open, its financial trouble will likely lead to significant down-sizing.
Despite talk of gloom and doom, Grady Memorial Hospital won't close at the end of the year or in the foreseeable future, even in a worst case scenario, said hospital chief executive Otis Story.
Even if the hospital can't get more funding, Grady will simply scale back operations to a manageable, affordable level, Story said.
Grady has lost money every year since 2000.
"You don't lock the doors — you resize and keep tweaking until it works," Story said. "It can continue to limp on."
Well, here we go again, another storied hospital on the brink of financial collapse, amidst finger-pointing by the leaders of the hospital and the academic medical organizations that are supposed to be supporting it. I cannot tell who is to blame. I also cannot tell how much the hospital's problems are due to the larger dysfunction in the US health care system.
But it would be nice if the leaders involved clearly focused on their health care and educational missions.
If Grady collapses, or even if it just continues to "limp on," the results would be bad for many patients in Atlanta who depend on its services, and many medical students and interns and residents who benefit from the educational experiences it provides.
Tuesday, September 11, 2007
Informatics "Director of Nothing" position offers continue unabated
This post reflects what I believe is a continuing problem regarding leveling of medical informatics roles within healthcare organizations for experienced medical informatics professionals. It also reflects what I believe is a more general bias against leadership roles for physicians.
One might think that after holding a "Director of Medical Informatics" position at a 1,000-bed major medical center a decade ago, a Group Director of informatics position in a major trans-national pharma with 50+ reports, and research/academic positions in informatics at an Ivy university as well as a non-Ivy but well-regarded university, companies such as the major medical insurers would come up with informatics job offers at a level higher than "Director." Further, one might believe they might think twice before sending such position offers to experienced informaticists.
Yet I find myself, as do my colleagues, presented with repeated offers at the manager or director level. The director positions most often have few to no reports, no budgetary authority, and an "internal consultant" perception by superiors. In other words, they are "Director of Nothing" positions without the executive presence to function effectively. Also, it does nothing to help us advance our careers to hold repeated "director"-level positions.
I believe this phenomenon has to do with a combination of a thorough misunderstanding of Medical Informatics, as well as a fear and bias against physicians holding leadership roles in healthcare.
I note that a few healthcare organizations are starting to "get it" and are offering roles at higher levels in the organization, but I believe this has to do with desperation more than anything else. Expensive clinical IT difficulties and medical errors requiring costly 'salvage' care (that Medicare and likely other payers are moving away from covering) are probably part of this slow change:
I had outlined "leveling" issues in applied informatics positions -- almost a decade ago -- in this essay entitled "Ten critical rules for applied informatics positions."
The following email thread, featuring a "senior talent consultant" in the "Talent Optimization" department (what adorable corporate-speak!) at a major Medical Insurance Company is self-explanatory. Names are anonymized to protect confidentiality.
Paradoxically, recruiters seem to come back for more as a result of such confrontational (but quite true) responses. Note how this occured early in the exchange below after my first rather direct response, see below on Sept. 2.
I have not yet recieved a reply to my latest message, but paradoxically do expect one, attempting once again to draw me in with some corporate HR mumbo-jumbo.
-- SS
One might think that after holding a "Director of Medical Informatics" position at a 1,000-bed major medical center a decade ago, a Group Director of informatics position in a major trans-national pharma with 50+ reports, and research/academic positions in informatics at an Ivy university as well as a non-Ivy but well-regarded university, companies such as the major medical insurers would come up with informatics job offers at a level higher than "Director." Further, one might believe they might think twice before sending such position offers to experienced informaticists.
Yet I find myself, as do my colleagues, presented with repeated offers at the manager or director level. The director positions most often have few to no reports, no budgetary authority, and an "internal consultant" perception by superiors. In other words, they are "Director of Nothing" positions without the executive presence to function effectively. Also, it does nothing to help us advance our careers to hold repeated "director"-level positions.
I believe this phenomenon has to do with a combination of a thorough misunderstanding of Medical Informatics, as well as a fear and bias against physicians holding leadership roles in healthcare.
I note that a few healthcare organizations are starting to "get it" and are offering roles at higher levels in the organization, but I believe this has to do with desperation more than anything else. Expensive clinical IT difficulties and medical errors requiring costly 'salvage' care (that Medicare and likely other payers are moving away from covering) are probably part of this slow change:
New York Times
August 21, 2007Medicare, the government insurance program for older Americans, has announced that it will soon stop paying hospitals for the extra costs of treating certain patients whose illnesses are compounded by preventable errors. The effort won’t save much money at first, and it will impose additional testing and documentation burdens on many hospitals, but it should promote better care. If the initial steps are expanded, it could yield greater savings as well.
Under current payment rules, Medicare typically pays hospitals more for treating a surgical patient whose illness is complicated by an infection than it would if there were no infection present. That is true even if the infection is caused by sloppy sanitary practices in the hospital itself. The perversity of a payment system that actually rewards incompetence rather than penalizing it seems self-evident. So Medicare is clearly wise to start changing the incentives.
I had outlined "leveling" issues in applied informatics positions -- almost a decade ago -- in this essay entitled "Ten critical rules for applied informatics positions."
The following email thread, featuring a "senior talent consultant" in the "Talent Optimization" department (what adorable corporate-speak!) at a major Medical Insurance Company is self-explanatory. Names are anonymized to protect confidentiality.
Paradoxically, recruiters seem to come back for more as a result of such confrontational (but quite true) responses. Note how this occured early in the exchange below after my first rather direct response, see below on Sept. 2.
From: MedInformaticsMD
To: Senior_Talent_Consultant@Major_Insurer.com
Sent: Tue, 11 Sep 2007 9:58 am
Subject: Re: Clinical Informatics Director
Dear Ms. Talent,On thinking about this, I see no "long term advantages" of an employee-at-will position in today's business environment. Perhaps you've leveled the position too low. I am interviewing for VP positions at other organizations.
The formally-trained medical informatics community is also aware of my concerns about leveling of medical informatics positions via my internationally-known health care IT failures web site entry on this topic.
Here is an essay you should pass along to those in your organization seeking medical informatics expertise. "Ten critical rules for applied informatics positions: What every Chief Medical Informatics Officer should know" (http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=tenrules). This was recently reprinted in Healthcare Informatics.
Best regards,
MedInformaticsMD
-----Original Message-----
From: Senior_Talent_Consultant@Major_Insurer.com
To: MedInformaticsMD
Sent: Mon, 3 Sep 2007 1:40 pm
Subject: RE: Clinical Informatics Director
I'd like to share the long-term advantages of the position. Are you available to speak on Wednesday of this week?
Ms. Talent
Major_Insurer Talent Optimization Department
1000 Dontpayem Highway
City, State 99999
Email: Senior_Talent_Consultant@Major_Insurer.com
Office:123-456-7890
Fax: 123-456-7891
http://careers.major_insurer.com/
-----Original Message-----
From: MedInformaticsMD
To: Senior_Talent_Consultant@Major_Insurer.com
Sent: Saturday, September 01, 2007 12:24 PM
Subject: Re: Clinical Informatics Director
Dear Ms. Talent,
Due to layoffs/reductions in force at my previous two corporate employers (Comdisco and Merck & Co., Inc.), I am not seeking industry positions except under an employment contract, as opposed to traditional employee at will arrangements. If this position offers such an arrangement, then I may be interested.
Best regards,
MedInformaticsMD
-----Original Message-----
From: Senior_Talent_Consultant@Major_Insurer.com
To: MedInformaticsMD
Sent: Fri, 31 Aug 2007 5:57 pm
Subject: Clinical Informatics Director
Hi MedInformaticsMDYour resume was forwarded to me regarding a Clinical Informatics Director position that we have. I would definitely like to speak with you as soon as possible. Please feel free to contact me at your earliest convenience.
Thanks
Ms. Talent, Senior Talent Consultant
Major_Insurer Talent Optimization Department
1000 Dontpayem Highway
City, State 99999
Email: Senior_Talent_Consultant@Major_Insurer.com
Office:123-456-7890
Fax: 123-456-7891
http://careers.major_insurer.com/
I have not yet recieved a reply to my latest message, but paradoxically do expect one, attempting once again to draw me in with some corporate HR mumbo-jumbo.
-- SS
Monday, September 10, 2007
Oceania in New Hampshire?
We recently discussed a proposed attempt to "reform" the governance of Dartmouth College, an elite US educational institution and home to a well-regarded medical school. As noted earlier, Dartmouth is unusual in that it allows almost half of its board of trustees to be elected by alumni. Furthermore, it allows candidates to be nominated by petition of the alumni. Many US colleges and universities' boards are entirely self-appointed. Those that allow elections usually restrict these to a few seats, and usually only permit candidates chosen by the board, university administration, or their agents. Thus, the top leadership of most US higher educational institutions is mostly self-appointed. Dartmouth was a partial exception to this pattern.
Now the Dartmouth board has decided to become more like its peers. The board just announced that it will expand its membership by eight. All the new members will be chosen by the current board. None will be elected. (See Dartmouth press release here.)
This is a setback for a nascent movement to make the governance of academic institutions more representative, accountable, and transparent.
What may be most notable about the current dispute at Dartmouth is how it has thrown some light onto the thinking of those who have been made uncomfortable by the college's modicum of democratic governance. At most colleges and universities, the leadership does not need to attempt to justify its power. When some Dartmouth leaders were forced to do so, the results were Orwellian.
First consider some assertions by the current Chairman of the Board, Charles E. Haldeman Jr, in a letter to alumni here.
Then there was this,
Chairman Haldeman also revealed his intolerance for "divisiveness," that is, disagreement with him and the rest of the self-appointed Dartmouth leadership.
A final Orwellian theme emerged in a New York Times article about the run-up to Chairman Haldeman's assertion of power,
Thus, the controversy about the administration's packing of Dartmouth's board of trustees brought out the Orwellian set of contradictions that those in power used to justify their actions. Although I fear the immediate future of Dartmouth's governance does not include much representativeness, transparency, and accountability, I believe there is a pronounced silver lining in these events.
First, those with loyalty to Dartmouth will realize that the college is not a province of Oceania, and Chairman Haldeman does not have the backing of the Inner Party nor the power of Big Brother. Although there may be no dissent permitted at the moment on the Dartmouth Board of Trustees, the Dartmouth Association of Alumni, purporting to represent 68,000 alumni, condemned the illiberal new way Dartmouth is to be governed. If a good fraction of alumni are stirred to action, they could exert sufficient influence to ensure that Dartmouth will never come any closer to being an outpost of Oceania.
Second, this episode may make alumni worry whether whether the endlessly upbeat missives from their institutions conceal a leadership closer to Ingsoc than Mister Chips. When alumni (and students, faculty, and parents) start to question how much power academic leaders have, and what they are doing with that power, universities may be tempted to teach more about 1984, and emulate it less.
Finally, in case this seems too remote from the issues we usually address on Health Care Renewal... Every US medical school is part of a larger college or university. All US academic medical centers and teaching hospitals are tied to US medical schools. Thus all of US academic medicine, and thus a good chunk of US health care, is tied to American universities. Many of these universities have governance that may be as Orwellian as that of Dartmouth. (For some examples, see the web-site of FIRE, the Foundation for Individual Rights in Education.) Such governance cannot help but have a major deleterious impact on health care. If this impact seems obscure, it is because we have not been looking for it.
Now the Dartmouth board has decided to become more like its peers. The board just announced that it will expand its membership by eight. All the new members will be chosen by the current board. None will be elected. (See Dartmouth press release here.)
This is a setback for a nascent movement to make the governance of academic institutions more representative, accountable, and transparent.
What may be most notable about the current dispute at Dartmouth is how it has thrown some light onto the thinking of those who have been made uncomfortable by the college's modicum of democratic governance. At most colleges and universities, the leadership does not need to attempt to justify its power. When some Dartmouth leaders were forced to do so, the results were Orwellian.
First consider some assertions by the current Chairman of the Board, Charles E. Haldeman Jr, in a letter to alumni here.
- "The changes we are making preserve alumni democracy at Dartmouth by keeping eight alumni-nominated trustees. They expand the board with eight additional charter trustees...."
- "We are maintaining alumni trustee elections at their current level...."
Then there was this,
- "We are expanding the Board from 18 to 26 to ensure it has the broad range of backgrounds, skills, expertise, and fundraising capabilities needed to steward an institution of Dartmouth's scope and complexity."
- "We also are giving the Board more flexibility to select trustees who offer the specific talents and experiences that the College needs, which elections don't ensure."
- "A larger group of trustees representing even more diverse backgrounds will help us enhance board engagement with key areas of the college."
- 6 are executives of investment or financial services firms,
- 1 is an executive of an advertising agency, and
- 1 is an academic physician.
Of the four alumni trustees who were not nominated by petition:
- 1 is an executive in an investment of financial services firm,
- 2 are a former or current executives of e-commerce firms, and
- 1 is a lawyer.
(See board membership here.)
Since in the past the board has used its power to select new members with homogeneous backgrounds, skills, and expertise, Chairman Haldeman's assertion that allowing it to select even more members would produce the opposite result makes no sense.
So Haldeman made two bald assertions that seem contradicted by facts. Orwell would have understood. In 1984, the protagonist, Winston Smith, wrote that "freedom is the freedom to say that two plus two makes four." The power of Big Brother and the Inner Party was to make two plus two equal to five.Chairman Haldeman also revealed his intolerance for "divisiveness," that is, disagreement with him and the rest of the self-appointed Dartmouth leadership.
- "Dartmouth's trustee elections have become increasingly politicized, costly, and divisive."
- "But some of the recent rhetoric in this debate has become so harsh and divisive it is now doing harm to Dartmouth. "
- "Given the divisiveness of recent elections we did not believe that having more elections would be good for Dartmouth."
A final Orwellian theme emerged in a New York Times article about the run-up to Chairman Haldeman's assertion of power,
- "Now there is debate about whether all this democracy is such a good thing. Some in the administration, and some alumni, see the petition trustees as a throwback to the more conservative Dartmouth ethos of years ago, bent on undoing the liberalization of the campus ...."
Oceanic society rests ultimately on the belief that Big Brother is omnipotent and the Party is infallible. But since in reality Big Brother is not omnipotent and the Party is not infallible, there is need for an unwearying, moment-to-moment flexibility in the treatment of facts.
Thus, the controversy about the administration's packing of Dartmouth's board of trustees brought out the Orwellian set of contradictions that those in power used to justify their actions. Although I fear the immediate future of Dartmouth's governance does not include much representativeness, transparency, and accountability, I believe there is a pronounced silver lining in these events.
First, those with loyalty to Dartmouth will realize that the college is not a province of Oceania, and Chairman Haldeman does not have the backing of the Inner Party nor the power of Big Brother. Although there may be no dissent permitted at the moment on the Dartmouth Board of Trustees, the Dartmouth Association of Alumni, purporting to represent 68,000 alumni, condemned the illiberal new way Dartmouth is to be governed. If a good fraction of alumni are stirred to action, they could exert sufficient influence to ensure that Dartmouth will never come any closer to being an outpost of Oceania.
Second, this episode may make alumni worry whether whether the endlessly upbeat missives from their institutions conceal a leadership closer to Ingsoc than Mister Chips. When alumni (and students, faculty, and parents) start to question how much power academic leaders have, and what they are doing with that power, universities may be tempted to teach more about 1984, and emulate it less.
Finally, in case this seems too remote from the issues we usually address on Health Care Renewal... Every US medical school is part of a larger college or university. All US academic medical centers and teaching hospitals are tied to US medical schools. Thus all of US academic medicine, and thus a good chunk of US health care, is tied to American universities. Many of these universities have governance that may be as Orwellian as that of Dartmouth. (For some examples, see the web-site of FIRE, the Foundation for Individual Rights in Education.) Such governance cannot help but have a major deleterious impact on health care. If this impact seems obscure, it is because we have not been looking for it.
Friday, September 07, 2007
An Over the Top Denunciation of the "Comparative Effectiveness Crowd"
Many have raised concerns that physicians too often favor the latest, most expensive, most high-technology, and sometimes most invasive treatments, contributing to the high costs and often bad outcomes of health care. One solution would be better research comparing the various possible treatments for particular problems. We recently posted about the controversy over such comparative effectiveness research, particularly Dr Scott Gottlieb's reasonable concerns with the approach, but failure to acknowledge similar and worse problems affecting the alternatives to comparative effectiveness research.
In a new commentary in the Washington Times, Robert Goldberg, "vice president of the Center for Medicine in the Public Interest," went over the top in his denunciation of what he called "the comparative effectiveness crowd."
His first objections to comparative effectiveness came from a set of personal anecdotes. The first one was
The second one was
Obviously, neither anecdote provided any justification for Goldberg's assertion that comparative effectiveness research "can kill."
Beyond that, I was at first bewildered by these anecdotes, which seemed unrelated to any actual comparative effectiveness research. Goldberg did not cite and I am not otherwise aware of any comparative effectiveness research relevant to the treatment of the clinical problems he mentions, the use of atypical anti-psychotics for eating disorders, and genetic testing to identify susceptibility to adverse effects of statin drugs for increased cholesterol.
But I then realized that these anecdotes were about Goldberg's apparent grudge against Public Citizen's Worst Pills web-site and Consumers Union's Best Buy Drugs site.
Regardless of what one thinks about these two sites, however, equating them to some "comparative effectiveness crowd" makes little sense. There are lots of people, including yours truly, who believe that comparative effectiveness research has some merit, but have no affiliation with either of these organizations.
But it gets worse. Goldberg then criticized what the "comparative effectiveness people" had to say about hypertension. His first point was about the fixed-combination drug Bildil (isosorbide dinitrate plus hydralazine, made by Nitromed.)
There is one glaring problem with this argument. Bildil was not tested as a treatment for hypertension. The recent controversial research on Bildil assessed it as a treatment for congestive heart failure (CHF), not hypertension. [Taylor AL, Ziesche S, Yancey C et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Eng J Med 2004; 351: 2049-2057. Link here.] That study was indeed performed by people in the Association of Black Cardiologists, and it found that Bildil reduced the death rate for patients with congestive heart failure by 43% compared to placebo. But congestive heart failure and hypertension are not the same (although admittedly hypertension is one of several possible causes of CHF). The Taylor et al study has nothing to do with Bildil as a treatment for hypertension. (See our blog post here on the Bildil controversy.) For that reason, the first paragraph by Goldberg above makes no sense. Thus, the remainder of his disagreement with Professor Avorn on this issue also makes no sense.
Then Goldberg addressed the ALLHAT trial, which really was at least close to a comparative effectiveness study of some commonly used anti-hypertensive drugs. Goldberg described part of its methodology thus,
That would have been a bizarre way to run a study. But it was not how ALLHAT was conducted. Goldberg's description of the ALLHAT methodology also appears to be nonsense.
In fact, patients whose blood pressure was not controlled on the assigned drug were given additional drugs.
[From The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the Antihypertensive and Lipid-Lowering Treatment to prevent Heart Attack Trial (ALLHAT). JAMA 2000; 283: 1967-1975. Link here.]
Furthermore, the study drug could be discontinued for a variety of reasons, not just stroke or heart attack. These included refusal of the patient to take the drug, a "symptomatic adverse event," excess blood pressure, too low blood pressure, and "other." [From Figure 1 in Wright JT, Dunn JK, Cutler JA et al. Outcomes in hypertensive black and nonblack pateitns treated with chlortalidone, amlodipine, and lisinopril. JAMA 2005; 293: 1595-1608. Link here.]
Goldberg's description of the results of ALLHAT was,
That was wrong too. The main result of ALLHAT appeared to be that the two newer, more expensive drugs (amlodipine and lisinopril) did not reduce the rate of any of the bad outcomes of hypertension measured, death, coronary heart disease, congestive heart failure, stroke, or renal failure, compared to the older drug, the diuretic chlorthalidone, in either black or non-black patients.
Goldberg's final criticism of Avorn was,
This was, at best, a total non sequitur. Bildil, again, was not tested or advocated as a treatment for hypertension. It was a treatment for congestive heart failure. Furthermore, black patients given chlorthalidone had statistically significantly fewer strokes than those given lisinopril, but slightly (but not significantly) more strokes than those given amlodipine. Black patients and white patients given chlorthalidone had less CHF than black patients given either of the two other drugs. [From Wright JT et al.]
So Goldberg's attempt to link Avorn with the Tuskeegee experiment is, at best, further bizarre nonsense.
His final rant was really over the top, and was totally unsupported by any of his previous arguments.
We have noted before that Goldberg works for an organization, the Center for Medicine in the Public Interest, whose president is Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the CommuniqueLive.com site. This suggests at least an indirect conflict of interest, favoring the interests of the pharmaceutical industry, that should have been revealed in this op-ed article.
But my main complaint about Goldberg's article was not that it amounted to stealth health policy advocacy. It was non-stealthy health policy nonsense. The article was riddled with gross errors about how the results of particular clinical research studies, how they were done, and the context in which they should be interpreted. Most of its arguments amounted to nothing more than, to be charitable, a series of non sequiturs.
It sadly appears that comparative effectiveness research now arouses such passion in the supporters of the pharmaceutical industry as to render some incapable of coherent argument. Why respectable main stream media outlets would publish the resulting gibberish is hard to tell.
Hat tip to Kaiser Daily Health Policy Report.
ADDENDUM (27 September, 2007) - Robert Goldberg left a comment below, which in my humble opinion, does not do much to support his position. In case there is any doubt that he was the actual author, he posted the same thing on the DrugWonks blog. My full reply is here.
In a new commentary in the Washington Times, Robert Goldberg, "vice president of the Center for Medicine in the Public Interest," went over the top in his denunciation of what he called "the comparative effectiveness crowd."
The cost or comparative effectiveness crowd claims that, opposed to drug companies, it is guided purely by scientific and economic facts about which medicines are more effective for the money. And they only have our better health in mind — no matter what it costs.
Except that what guides these decisions smells more like bias or fear, not science. And both can kill.
His first objections to comparative effectiveness came from a set of personal anecdotes. The first one was
A couple of years ago my daughter was being treated for an eating disorder that required the use of Abilify, an atypical anti-psychotic. Public Citizen calls it a 'worst pill' that should not be on the market at all. Consumers Union calls a 30-year-old drug that causes cognitive impairment a 'Best Buy.'
The second one was
When my cholesterol nearly reached Barry Bonds levels, I went initially on a generic drug that was a Consumers Union best buy. My legs and arms cramped up in a week and my cholesterol levels were unchanged. I was gene tested and found that lovastatin, simvastin and Lipitor would cause muscle pain but that Crestor would not. The comparative effectiveness crowd hates gene testing because it identifies individual differences that screw up their ability to make sweeping judgments about what's best for everyone. Crestor is not a best buy and Public Citizen tells people not to use it.
Obviously, neither anecdote provided any justification for Goldberg's assertion that comparative effectiveness research "can kill."
Beyond that, I was at first bewildered by these anecdotes, which seemed unrelated to any actual comparative effectiveness research. Goldberg did not cite and I am not otherwise aware of any comparative effectiveness research relevant to the treatment of the clinical problems he mentions, the use of atypical anti-psychotics for eating disorders, and genetic testing to identify susceptibility to adverse effects of statin drugs for increased cholesterol.
But I then realized that these anecdotes were about Goldberg's apparent grudge against Public Citizen's Worst Pills web-site and Consumers Union's Best Buy Drugs site.
Regardless of what one thinks about these two sites, however, equating them to some "comparative effectiveness crowd" makes little sense. There are lots of people, including yours truly, who believe that comparative effectiveness research has some merit, but have no affiliation with either of these organizations.
But it gets worse. Goldberg then criticized what the "comparative effectiveness people" had to say about hypertension. His first point was about the fixed-combination drug Bildil (isosorbide dinitrate plus hydralazine, made by Nitromed.)
Black Americans have an 80 percent higher death rate associated with strokes due to hypertension than the general population. For years cardiologists have sought to find — in the absence of fully understanding the complex interaction of genetic, lifestyle and clinical factors — a treatment that could cut into the death rate. So the Association of Black Cardiologists cosponsored the research on a drug called Bidil. The FDA initially rejected the drug as a blood pressure treatment when it first tested on everyone. But sub-population and the sort of genetic analysis the comparative effectiveness people deride as "surrogate endpoints," suggested that it worked to reduce death in blacks. It retested the drug against placebo on blacks and demonstrated a 43 percent reduction in death.
Jerry Avorn, a Harvard Medical School professor, who is a high priest of comparative effectiveness research, when he isn't testifying on behalf of trial lawyers who sue drug companies for a living, derided the results. He called FDA regulation a "minimal standard that would be unacceptable anywhere else in research." He claimed since Bidil wasn't tested against other drugs the results were meaningless.
There is one glaring problem with this argument. Bildil was not tested as a treatment for hypertension. The recent controversial research on Bildil assessed it as a treatment for congestive heart failure (CHF), not hypertension. [Taylor AL, Ziesche S, Yancey C et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Eng J Med 2004; 351: 2049-2057. Link here.] That study was indeed performed by people in the Association of Black Cardiologists, and it found that Bildil reduced the death rate for patients with congestive heart failure by 43% compared to placebo. But congestive heart failure and hypertension are not the same (although admittedly hypertension is one of several possible causes of CHF). The Taylor et al study has nothing to do with Bildil as a treatment for hypertension. (See our blog post here on the Bildil controversy.) For that reason, the first paragraph by Goldberg above makes no sense. Thus, the remainder of his disagreement with Professor Avorn on this issue also makes no sense.
Then Goldberg addressed the ALLHAT trial, which really was at least close to a comparative effectiveness study of some commonly used anti-hypertensive drugs. Goldberg described part of its methodology thus,
That five-year, 42,000-patient trial studied the comparative effectiveness of older blood-pressure drugs (diuretics) against newer medicines in reducing heart attacks. Patients were allowed to switch to a combination of drugs only if they 'failed' on the older medicine first. 'Failed' is another word for having a stroke or heart attack.
That would have been a bizarre way to run a study. But it was not how ALLHAT was conducted. Goldberg's description of the ALLHAT methodology also appears to be nonsense.
In fact, patients whose blood pressure was not controlled on the assigned drug were given additional drugs.
The treatment goal ... was a DBP [diastolic blood pressure] of less than 90 mm Hg and an SBP [systolic blood pressure] of less than 140 mm Hg.
If participants did not meet the BP goal while taking the maximum tolerated dosage of the initial medication, an open-label Step 2 agent ... or an open-label Step 3 agent ... could be added.
[From The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the Antihypertensive and Lipid-Lowering Treatment to prevent Heart Attack Trial (ALLHAT). JAMA 2000; 283: 1967-1975. Link here.]
Furthermore, the study drug could be discontinued for a variety of reasons, not just stroke or heart attack. These included refusal of the patient to take the drug, a "symptomatic adverse event," excess blood pressure, too low blood pressure, and "other." [From Figure 1 in Wright JT, Dunn JK, Cutler JA et al. Outcomes in hypertensive black and nonblack pateitns treated with chlortalidone, amlodipine, and lisinopril. JAMA 2005; 293: 1595-1608. Link here.]
Goldberg's description of the results of ALLHAT was,
ALLHAT concluded that diuretics were more cost-effective in reducing death from all forms of heart failure, (not heart attacks) and were therefore cost-effective overall.
That was wrong too. The main result of ALLHAT appeared to be that the two newer, more expensive drugs (amlodipine and lisinopril) did not reduce the rate of any of the bad outcomes of hypertension measured, death, coronary heart disease, congestive heart failure, stroke, or renal failure, compared to the older drug, the diuretic chlorthalidone, in either black or non-black patients.
Goldberg's final criticism of Avorn was,
So, Avorn opposed approval of Bidil, which reduced deaths from stroke among blacks by 43 percent but is making money peddling the ALLHAT regimen to doctors even though it increases stroke related death among blacks by 40 percent. Can you say Tuskegee study?
This was, at best, a total non sequitur. Bildil, again, was not tested or advocated as a treatment for hypertension. It was a treatment for congestive heart failure. Furthermore, black patients given chlorthalidone had statistically significantly fewer strokes than those given lisinopril, but slightly (but not significantly) more strokes than those given amlodipine. Black patients and white patients given chlorthalidone had less CHF than black patients given either of the two other drugs. [From Wright JT et al.]
So Goldberg's attempt to link Avorn with the Tuskeegee experiment is, at best, further bizarre nonsense.
His final rant was really over the top, and was totally unsupported by any of his previous arguments.
Comparative effectiveness has nothing to do with patient wellbeing or better evidence. It's about hating drug companies and know-it-alls claiming they know better. Such studies are rigged against new drugs and designed to eliminate the individual differences that are at the heart of the next generation of personalized medicines. Drugs that Avorn, ALLHAT and Public Citizen claim are cost-effective could be hazardous to your health. Want to feel better or stay alive? Take a medicine advertised on TV instead.
We have noted before that Goldberg works for an organization, the Center for Medicine in the Public Interest, whose president is Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the CommuniqueLive.com site. This suggests at least an indirect conflict of interest, favoring the interests of the pharmaceutical industry, that should have been revealed in this op-ed article.
But my main complaint about Goldberg's article was not that it amounted to stealth health policy advocacy. It was non-stealthy health policy nonsense. The article was riddled with gross errors about how the results of particular clinical research studies, how they were done, and the context in which they should be interpreted. Most of its arguments amounted to nothing more than, to be charitable, a series of non sequiturs.
It sadly appears that comparative effectiveness research now arouses such passion in the supporters of the pharmaceutical industry as to render some incapable of coherent argument. Why respectable main stream media outlets would publish the resulting gibberish is hard to tell.
Hat tip to Kaiser Daily Health Policy Report.
ADDENDUM (27 September, 2007) - Robert Goldberg left a comment below, which in my humble opinion, does not do much to support his position. In case there is any doubt that he was the actual author, he posted the same thing on the DrugWonks blog. My full reply is here.
BLOGSCAN - Conflicts of Interest and the Study of Teen-Age Suicide Rates
A population-based study that showed an increase in suicide rates among teen-agers occurred the year after the US Food and Drug Administration (FDA) put a "black-box" warning on selective serotonin reuptake inhibitor (SSRI) antidepressants got a lot of press, with some reports making a causal connection between the warning and the rate increase. On the GoozNews blog, Merrill Goozner critiqued the study, noting that the absolute increase in the suicide rate was small, and certainly could have been due to events from 2003 and 2004 other than the FDA warning. He also noted that the authors of the study had some relevant conflicts of interest. The latter issue was discussed in more detail on the PharmaLot blog, where Ed Silverman criticized main-stream media coverage of this story for failing to note these conflicts.
Thursday, September 06, 2007
BLOGSCAN - Pfizer's Zombie Computers
On BrandweekNRX, Dr Peter Rost posted the latest flash about Pfizer Inc: apparently the company has not responded to warnings that many of its in-house computers have become zombies, or bots, and now spew out spam, including spam mentioning Pfizer's famous product, Viagra.
Wednesday, September 05, 2007
Why "Resident Duty Hour Reform" Did Not Improve Patient Mortality
Soon after a heart-felt post on the Over My Med Body Blog described how it feels to be a sleep-deprived sub-intern, two major studies in JAMA brought media attention to the question of interns' and residents' work hours.(1-2)
These two studies were interpreted by their authors as meaning that reductions in work hours did not clearly do harm.
As MedInformaticsMD noted in a an earlier post, however, a major limitation of the two studies was that they only assessed mortality. While mortality is obviously an extremely important outcome of hospitalization, it is not the only one. Fatigue is likely to cause many errors that lead to bad outcomes short of mortality. Yet the current studies were not designed to determine if the reduction in work hours could have improved patient outcomes other than survival.
Another issue is the nature of the 2003 work hour limitations:
Consider the lot of house-staff under these new rules. It is still perfectly legal for house-staff to:
These two studies were interpreted by their authors as meaning that reductions in work hours did not clearly do harm.
As MedInformaticsMD noted in a an earlier post, however, a major limitation of the two studies was that they only assessed mortality. While mortality is obviously an extremely important outcome of hospitalization, it is not the only one. Fatigue is likely to cause many errors that lead to bad outcomes short of mortality. Yet the current studies were not designed to determine if the reduction in work hours could have improved patient outcomes other than survival.
Another issue is the nature of the 2003 work hour limitations:
No more than 80 hours per week, with 1 day in 7 free of all duties, averaged over 4 weeks; no more than 24 continuous hours with an additional 6 hours for education and transfer of care; in-house call no more frequently than every third night, and at least 10 hours of rest between duty periods.
Consider the lot of house-staff under these new rules. It is still perfectly legal for house-staff to:
- Work continuously for 30 hours (24 "work" hours plus 6 hours for "education and transfer of care")
- Work continuously for 30 hours, get 10 hours off, and then work for another 30 hours (see above, plus provision of "at least 10 hours of rest between duty periods)
- Work 24 days during a four-week, 28 day period
My still vivid memories of internship and residency were of being pretty fuzzy after working more than 16 hours, and of being a walking zombie after working for more than 24 hours.
And, as noted in the discussion section of the two articles, there is some evidence that limiting shifts to 16 hours might be better justified than allowing 24 or 30 hour shifts.
Yet the reformed rules still allow 24 hours of continuous, intense work, and then another 6 hours of "education" and for hand-off. Then imagine, after such a 30-hour experience, having all of 10 hours to sleep, eat, catch up on life, before it starts all over again....
So another obvious explanation for the failure of these two studies to find much effect of house-staff work hour reforms were that these reforms were woefully insufficient to prevent major sleep-deprivation and fatigue.
Another question is whether the reforms shifted work to those better able to perform it, or merely re-arrange the deck chairs? So who did the work that would have previously been done by house staff working more hours than are now allowed?
My guess is that most teaching hospitals did not rush out to hire more people to take on this responsibility. After all, the house-staff work hour reforms amounted to an "unfunded mandate." Nobody gave the hospitals more money after the reforms went into effect to hire people to do this work. (If I am wrong about this, someone please correct me.)
One possibility is that the same house-staff did the same amount of work, just in fewer hours, i.e., that the reforms resulted in greater intensity of work for house-staff on clinical rotations, and most likely less opportunity to sleep even a few hours when on-call. Another possibility is that the work was given to house-staff who previously were on lighter or elective rotations.
If the reforms did not lessen the overall workload of house-staff, it is doubtful that house-staff as a group are any less fatigued on average after the reforms.
Another possibility is that the work was given to already over-worked and increasingly scarce nurses, and to the faculty in charge of teaching the house-staff, thus reducing the time available to supervise house-staff and teach. These changes could have adverse effects on quality of care that might offset any small improvements made by slightly reducing house-staff fatigue and sleeplessness.
Because of extreme sleep deprivation and fatigue, my internship year was the worst year of my life so far. One reason I went into academic medicine was the hope that I could help reform the system to make it more humane for house-staff, and hence provide them better education, and patients better quality of care.
The gradual introduction of "night-float" systems into many internal and family medicine residencies did substantially reduce sleep deprivation and fatigue, although the work load shifts they caused lessened the possibility that house-staff would have any rotations that were not intense.
However, I am afraid there are still far to many "opportunities" for house-staff to be over-worked and sleep deprived.
In a two-trillion dollar plus US health care system, there ought to be some money to pay for the work that would allow house-staff to get sufficient sleep. But unless the money is forced to follow the mandate, to quote Over My Med Body,
interns on little sleep who’ve admitted patients all night, who are writing orders at 2 or 3 in the morning is, in the best of worlds, sub-optimal, and in the worst of worlds, dangerous.
ADDENDUM (6 September, 2007) - See also comments on the Medical Humanities Blog.
References
1. Volpp KG, Rosen AK, Rosenbaum PR, Romano PS, Even-Shosan O et al. Mortality among hospitalized Medicare beneficiaires in the first 2 years following ACGME resident duty hour reform. JAMA 2007; 298: 975-983. (link here)
2. Volpp KG, Rosen AK, Rosenbaum PR, Romano PS, Even-Shosan O et al. Mortality among patients in VA hospitals in the first 2 years following ACGME resident duty hour reform. JAMA 2007; 298: 984.992. (link here)
Why Might Switching Statins Be Bad for You?
At the risk of being thought redundant, I am going to take on a topic already covered today in the health care blogsphere, mainly because I think there is even more that can be added to the discussion.
There has been some media attention to this poster describing an observational study sponsored by Pfizer Inc., and authored mainly by Pfizer employees, presented at the European Society of Cardiology Congress 2007 [Phillips B, Roberts C, Rudolph AE, Morant S, Aziz F, O'Regan CP. Switching statins: the impact on patient outcomes. Br J Cardiol, in press.] AP coverage is here, and Pfizer's press release is here.
The poster described an observational study that used data from a primary-care data-base. The study compared a cohort of patients who were switched from atorvastatin (Lipitor) to simvastatin to a cohort who remained on atorvastatin. Patients who were switched were more likely to die or sustain major cardiovascular events, even controlling for certain patient characteristics.
The study's media coverage reiterated the authors' conclusion that it is bad to switch patients from Lipitor, a more expensive, brand-name statin, to generic simvastatin. For instance, a Reuters article stated, "switching was associated with a 30 percent increase in the relative risk of major cardiovascular events, including heart attacks, strokes and death."
But the study's observational design allowed for other interpretations.
Dr Peter Rost, writing on the BrandweekNRX blog, fumed, "Lies, damned lies, observational trials. And the morons who write about them." Rost noted that people may switch from one statin to another because the first drug failed to lower their cholesterol. Such people may be resistant to statin treatment, and hence more likely to have a bad outcome for that reason, not because of the switch itself.
A Wall Street Journal Health blog post interviewed Dr Mark Fendrick, who also suggested that people may resent switching drugs for economic reasons, and hence be less likely to comply with their new prescriptions.
I can think of two more plausible reasons that people who switch may have worse results than those who don't, regardless of the particular drugs involved. First, people switched because of side-effects of the first drug may be more prone to have side-effects on the second drug, and thus fail to take it, or a sufficient dose. Second, people switched because they were non-compliant with the first drug may not be complaint with the second drug too.
Thus, there are many reasons that the data from this study could simply indicate that people switched from one drug to another are more likely to have bad outcomes than people who stay on the first drug they are given.
To really test the hypothesis that switching from Lipitor to simvastatin produces worse results than staying on Lipitor would require a randomized, controlled trial.
But isn't it odd that the investigators didn't compare the results of people who switched from Lipitor to simvastatin to people who switched from say, simvastatin to Lipitor, or from Lipitor to a third drug? One wonders whether their failure to consider alternative explanations of their data had something to do with the economic interests of their employer?
It's also too bad that the media coverage of this study did not initially consider that there may be interpretations of its results other than those provided by its commercially sponsored study investigators.
There has been some media attention to this poster describing an observational study sponsored by Pfizer Inc., and authored mainly by Pfizer employees, presented at the European Society of Cardiology Congress 2007 [Phillips B, Roberts C, Rudolph AE, Morant S, Aziz F, O'Regan CP. Switching statins: the impact on patient outcomes. Br J Cardiol, in press.] AP coverage is here, and Pfizer's press release is here.
The poster described an observational study that used data from a primary-care data-base. The study compared a cohort of patients who were switched from atorvastatin (Lipitor) to simvastatin to a cohort who remained on atorvastatin. Patients who were switched were more likely to die or sustain major cardiovascular events, even controlling for certain patient characteristics.
The study's media coverage reiterated the authors' conclusion that it is bad to switch patients from Lipitor, a more expensive, brand-name statin, to generic simvastatin. For instance, a Reuters article stated, "switching was associated with a 30 percent increase in the relative risk of major cardiovascular events, including heart attacks, strokes and death."
But the study's observational design allowed for other interpretations.
Dr Peter Rost, writing on the BrandweekNRX blog, fumed, "Lies, damned lies, observational trials. And the morons who write about them." Rost noted that people may switch from one statin to another because the first drug failed to lower their cholesterol. Such people may be resistant to statin treatment, and hence more likely to have a bad outcome for that reason, not because of the switch itself.
A Wall Street Journal Health blog post interviewed Dr Mark Fendrick, who also suggested that people may resent switching drugs for economic reasons, and hence be less likely to comply with their new prescriptions.
I can think of two more plausible reasons that people who switch may have worse results than those who don't, regardless of the particular drugs involved. First, people switched because of side-effects of the first drug may be more prone to have side-effects on the second drug, and thus fail to take it, or a sufficient dose. Second, people switched because they were non-compliant with the first drug may not be complaint with the second drug too.
Thus, there are many reasons that the data from this study could simply indicate that people switched from one drug to another are more likely to have bad outcomes than people who stay on the first drug they are given.
To really test the hypothesis that switching from Lipitor to simvastatin produces worse results than staying on Lipitor would require a randomized, controlled trial.
But isn't it odd that the investigators didn't compare the results of people who switched from Lipitor to simvastatin to people who switched from say, simvastatin to Lipitor, or from Lipitor to a third drug? One wonders whether their failure to consider alternative explanations of their data had something to do with the economic interests of their employer?
It's also too bad that the media coverage of this study did not initially consider that there may be interpretations of its results other than those provided by its commercially sponsored study investigators.
Metric myopia: does reducing exploitation of medical trainees have 'little effect' on patients?
In "On Sleep Deprivation and Medical Education" Roy Poses wrote that:
Now here come studies that may be used to justify a continuation of such abuses:
Here is my response, in the form of an Op Ed that is unlikely to be published:
If my op ed is published, even in abbreviated form, it will be a miracle.
I note that one study did show this:
I will probably be challenged for providing anecdotal evidence in my Op Ed. However, there is a principle from an unlikely source that should be considered when ignoring anecdotal evidence that many people can identify with:
I note that the studies' author is an Assistant Professor of Medicine and an Assistant Professor of Health Care Systems at the Wharton School. Perhaps he can undertake a study of the non-fatal consequences of the work hours of medical trainees that in other cognition-critical professions would probably be considered criminal.
Finally, the blog by "Panda Bear MD" is an excellent site for reading about the challenges of medical training in more depth.
-- SS
It's a sad testimony to our training system that the experience described [overwork, sleep deprivation, psychological abuse, etc.] is little different from the one I went through just about 30 years ago.
Now here come studies that may be used to justify a continuation of such abuses:
Limited effect in reduced hours for MDs in training (link to article)
By Kathy Matheson
Associated Press
Cutting the grueling work hours of doctors-in-training had little effect on reducing patient deaths, according to two large studies.
Death rates dropped in one group of patients in veterans' hospitals but not in three others, researchers reported.
The results come from the most comprehensive national look at work-hour restrictions, which were implemented four years ago to reduce medical errors by tired physicians.
"We were a little surprised," said Kevin Volpp, the studies' lead author and a physician at the Philadelphia Veterans Affairs Medical Center. "We thought that mortality outcomes would improve more consistently."
The studies are in today's Journal of the American Medical Association.
The new work-hour rules limit doctors-in-training to 80-hour weeks. Critics feared they would hurt continuity of care for patients and create a shift-work mentality among doctors. Others supported the limits, saying they might lead to fewer deaths from mistakes.
Before the rules, medical residents often worked 100-hour weeks, with some shifts lasting 36 hours straight. The new limits are still roughly double what other full-time jobs require, but advocates say long hours for doctors-in-training are seen as a traditional trial-by-fire approach that give them needed, intensive experience.The two studies included 318,000 VA patients and more than 8.5 million Medicare patients at hospitals nationwide. The researchers looked at deaths that occurred within 30 days of hospital admission in the years before and after the rules went into effect in 2003. They compared death rates among hospitals with a large number of residents and hospitals with few residents.
Here is my response, in the form of an Op Ed that is unlikely to be published:
To: inquirer.letters@phillynews.com
Date: 09/05/2007 10:55AM
cc: volpp70@mail.med.upenn.edu
Subject: Re: Limited effect in reduced hours for MDs in training
Sept. 5, 2007
Re: Limited effect in reduced hours for MDs in trainingDear Inquirer,
While I am relieved to see studies showing that “cutting the grueling work hours of doctors-in-training” did not increase patient deaths, I suggest that these studies reflect the old adage about “lies, damn lies, and statistics.”
An endpoint of “patient mortality” seems disingenuous. These studies will undoubtedly be used by reactive forces who wish to profit from the cheap labor provided by medical trainees. The medical “scut work” performed by these trainees, and the cost of labor required to replace it, would be considerable to any hospital.
In fact, non-fatal errors, not mortality rates alone, need a much more careful examination. Patient morbidity and related factors such as severity of illness, length of stay, and number of procedures and treatments required (especially in helping a patient recover from a medical error) need evaluation. Unpleasant but non-fatal adverse events are likely far more common than premature patient death due to errors of omission and commission by exhausted medical trainees on sleepless multi-day shifts.Let me provide some personal examples.
I have personally seen overtired surgical residents make such errors as falling asleep at the operating table due to exhaustion while holding a large clamp retractor on the aorta, during a procedure to bypass blockages in the major arteries of the leg. This resulted in an aortic tear, massive bleeding, blood transfusions, and an extra-long hospital stay for monitoring. The patient survived.
In another case, I witnessed an exhausted surgical resident insert a long hollow spear too deep. The spear was used to make a canal under the skin for an artificial blood vessel, but was inserted under an anatomic landmark instead of above it, thereby piercing the patient’s abdomen and damaging their intestines. This required major exploratory abdominal surgery and prolonged the patient’s stay a month. The patient also survived.
In medicine, I observed overtired residents making subtle errors such as ordering an intravenous bag of saline mixed with insulin for an out-of-control diabetic patient. With no glucose (sugar) in the infusion, the patient was found comatose several hours later with a blood sugar of about 8 (yes, eight). A rapid infusion of a large amount of high-sugar liquid brought the patient back to consciousness. There were no apparent consequences, but this patient could have suffered major injury.
I’ve observed exhausted interns administer too much narcotic to a jaundiced elderly patient with liver disease, causing them to become unconscious and their blood pressure to fall precipitously, requiring rapid infusion of a narcotic blocker to avoid death. Again, the patient survived.Need I go on? I am only one observer to the mayhem caused by exhaustion and exploitation of medical trainees. Many others have similar stories they have been disincented to share via the culture of medicine.
There is also the question of physician morale, which affects trainee interaction with patients – probably for the remainder of their career. Being broke, exhausted and abused by comfortable attending physicians does not make for the best long-term empathy and bedside manner. In my own medical internship at MCP [The Medical College of Pennsylvania in Philadelphia, now closed -- ed.], I was often times so tired that I could barely function. As an honors student, this certainly had nothing to do with ability.
Further, I experienced a level of abuse not uncommon in medical training programs. As an example, I was required by an attending to perform a pelvic exam and pap smear on any woman admitted for any reason at night to the medical service who had not had one in the prior year, “or else.” Performing pelvic exams at 3 AM on unfortunate patients with normal minds but severe physical deformities, admitted from Inglis House [a Philadelphia-area facility for people of normal mentation but with severe physical disability- ed.] for urinary tract infection or other non-gynecologic problems, was not my idea of humanistic medicine.
In another splendid example of the non-fatal but very real detrimental effects of cost-cutting, during my internship at MCP I rotated through the Philadelphia VA Hospital, the home of the studies’ lead author, for several months. An intern (one year out of medical school), a medical student, and two or three nurses covered perhaps fifty sick veterans. Many times in the middle of the night, veterans needed an IV replaced.
This task was the job of the intern. As it happened, the Philadelphia VA had only one length of intravenous catheter and it was quite rigid. Interns would often have to stick patients multiple times and waste many of these IV starters before a reliable IV could be placed in a fragile vein of an elderly vet. Being exhausted did not help the odds at all of this often tricky process. (I was so infuriated I put in an employee suggestion for change. Many months after I left the organization I was actually awarded a prize of $200 from the VA for my suggestion to get a larger variety of IV starters in different lengths.) [doing so saved them money -- ed.]
In conclusion, medical errors and the non-fatal “salvage” efforts they necessitate are a somewhat “taboo” subject. Reducing trainee abuses, especially exploitative work hours, are one effort at improving a patient’s chances of the shortest possible hospital stay and minimal discomfort. However, there are major financial incentives to continue the abuse and severe lack of a service mentality. Perhaps recent announcements by payers that “salvage care” due to medical errors will not be reimbursed will help even the financial balance sheet.
Significant work needs to be done to measure nonfatal morbidity-related issues resulting from cavalier practices in medical training. Mortality alone is a vastly inadequate statistic that can lead to further justification for abuses by reactionary forces in healthcare and those with financial conflict of interest.
One obstacle to performing such studies in any detail is the backwardness of Clinical Information Technology in healthcare organizations. We can judge the quality of our high tech manufacturing by internal QA records, but often cannot easily judge the quality of care delivered in acute settings at a fine level of “granularity.” Many of the causes for this Information Technology problem, another “taboo” subject related to inappropriate leadership structures for electronic medical records projects, are outlined in my web site “Sociotechnologic issues in clinical computing: Common examples of healthcare IT failure” at this link.
If my op ed is published, even in abbreviated form, it will be a miracle.
I note that one study did show this:
It seems that less-tired residents may actually save lives, especially when compared to non-teaching hospitals where physicians can be scarce as hen's teeth, especially at night. One can only wonder what changes there were in morbidity-related issues.One study examined VA patients treated for a heart attack, stroke, gastrointestinal bleeding, or congestive heart failure. It found that two years after the [trainee work hour restriction] rules were implemented, mortality improved by 11 to 14 percent in major teaching hospitals, compared with hospitals with few residents.
I will probably be challenged for providing anecdotal evidence in my Op Ed. However, there is a principle from an unlikely source that should be considered when ignoring anecdotal evidence that many people can identify with:
Ignoring all Anecdotal Evidence
Example: I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives.
I note that the studies' author is an Assistant Professor of Medicine and an Assistant Professor of Health Care Systems at the Wharton School. Perhaps he can undertake a study of the non-fatal consequences of the work hours of medical trainees that in other cognition-critical professions would probably be considered criminal.
Finally, the blog by "Panda Bear MD" is an excellent site for reading about the challenges of medical training in more depth.
-- SS
Tuesday, September 04, 2007
BLOGSCAN - To Get CME Credit, Read a "Ridiculous Text"
On the Carlat Psychiatry Blog, this post detailed the disdain for which a noted psychiatrist expressed for a ghost-written, medical education and communication company organized, pharmaceutical company sponsored CME publication which ostensibly was derived from a panel discussion in which that psychiatrist participated. His most pithy comments I will not print in this family-oriented blog ;-) Yet physicians can still get CME credit in part for reading what he called a “ridiculous text… parts of it were inaccurate, simplistic, and [contained] over-generalizations.”
BLOGSCAN - A Less Honorable Career Choice than Stone-Masonry
One of my favorite lines from the original Star Trek was by "Bones," the physician, when asked to patch up an alien, silicon-based creature, "I'm a doctor, not a stone-mason." Of course, there is nothing dishonorable about being a stone-mason. But on the Hooked: Ethics, Medicine, and Pharma blog, Howard Brody notes an outraged article by a physician about medicine's current relationship with the pharmaceutical industry. After noting multiple anecdotes of physicians' grubbing goodies from drug reps, he concluded, "we are physicians, not ...." The final word, of course, was a less honorable career option than stone-masonry.
Monday, September 03, 2007
A Bit of Representativeness, Accountability and Transparency in Academic Governance Threatened
In the opinion section of the Wall Street Journal (and available free here from OpinionJournal) was an interesting article about the governance of US higher education, with some lessons for academic health care.
The story is about Dartmouth College, an Ivy League school, and home of a small, but distinguished medical school. Dartmouth has an unusual way of picking the members of its board of trustees.
Recently, this has lead to an interesting change in the membership of the board.
Since Mr Rogers' election, three more candidates have been elected to the board after nomination by alumni petition.
All petition candidates were known as dissidents or reformers. As Rogers put it, they are "independent people willing to challenge the status quo."
Thus, the composition of Dartmouth's board of trustees is very different from that of most major American universities. Most university boards pick their new members themselves. Some do allow for alumni membership of a few members, but the candidates for such positions are generally hand-picked by the board or an administration committee, and rarely advertise their policy positions. Thus, the key governing bodies of most US institutions of higher education, and hence the key governing bodies to which most US medical schools (other than the Dartmouth Medical School) report are self-elected.
The atypical members of the Dartmouth board have tried to reform how the institution runs. For example, Mr Rodgers' "first priority was to improve its 'very poor record of freedom of speech.' Soon enough, the college president, James Wright, overturned a speech code. The Foundation for Individual Rights in Education, a watchdog group, elevated Dartmouth's rating from 'red' to its highest, 'green,' one of only seven schools in the country with that status. 'We made progress, and I was feeling pretty good,' Mr. Rodgers says."
This was notable because, as we have discussed on Health Care Renewal, academic institutions, and academic medicine in particular, have not always had stellar records of defending their students' and faculties' right to say or write controversial things, especially those that offend vested interests. In particular, academic medical institutions have:
And,
Rogers noted the likely consequences of the "reform" that would prevent the popular election of any more reform candidates,
By the way, what does Rogers expect will happen after the publication of the WSJ article?
It is upsetting that the representativeness, accountability, and transparency that partially characterizes Darthmouth's governance model is under threat.
The troubles at Dartmouth, however, should also underline how little representativeness, accountability, and transparency characterize the government of any US university or medical school. As noted earlier, most university boards of trustees elect themselves. The reasons particular people are chosen for board service, and their positions on policy issues relevant to their institutions are generally unknown. The boards' deliberations are generally secret.
If any university faculty members, alumni/ae, or students in the audience can tell me their universities operate differently, I would love to hear about it. (And if those universities include medical schools, I would be happy to publicize their better governance models.)
Meanwhile, it is reasonable to hypothesize that the mismanagement and mission-hostile management that too often is found at US (and other countries') academic medical institutions is due in part to institutional governance that is unrepresentative, unaccountable, and opaque.
And instead of seeing movement toward representativeness, accountability, and transparency, at one of the few schools that has a somewhat better governance model, we see moves by the administration in the wrong direction.
The story is about Dartmouth College, an Ivy League school, and home of a small, but distinguished medical school. Dartmouth has an unusual way of picking the members of its board of trustees.
It is one of a few schools in the U.S. that allow alumni to elect leaders directly. Eight of the 18 members of Dartmouth's governing Board of Trustees are chosen by the popular vote of some 66,500 graduates. (The other seats are reserved mostly for major donors, along with ex officio positions for the governor of New Hampshire and the college president.) This arrangement has been in place since 1891.
Recently, this has lead to an interesting change in the membership of the board.
Until recently, though, Dartmouth's elections have been indifferent affairs, with the alumni choosing from a largely homogeneous slate handpicked by a committee closely aligned with the administration. In 2004, things got--interesting. Mr. [Thurman J] Rodgers [Founder and CEO of Cypress Semiconductor Corp] bypassed the official nomination channels and was named to the ballot by collecting alumni signatures; he needed 500 and ended up acquiring more than 15 times that. He was dissatisfied with the college's direction and resolved to either 'do something or stop griping about it.' He was elected by 54% of the voters.
Since Mr Rogers' election, three more candidates have been elected to the board after nomination by alumni petition.
Mr. Rodgers's candidacy was followed by two further elections, in which petition candidates--Peter Robinson, a fellow at the Hoover Institution, and Todd Zywicki, a professor of law at George Mason University--were also elected.
Earlier this year another petition trustee, Stephen Smith of the University of Virginia Law School, was elected with 55% of the voters.
All petition candidates were known as dissidents or reformers. As Rogers put it, they are "independent people willing to challenge the status quo."
Thus, the composition of Dartmouth's board of trustees is very different from that of most major American universities. Most university boards pick their new members themselves. Some do allow for alumni membership of a few members, but the candidates for such positions are generally hand-picked by the board or an administration committee, and rarely advertise their policy positions. Thus, the key governing bodies of most US institutions of higher education, and hence the key governing bodies to which most US medical schools (other than the Dartmouth Medical School) report are self-elected.
The atypical members of the Dartmouth board have tried to reform how the institution runs. For example, Mr Rodgers' "first priority was to improve its 'very poor record of freedom of speech.' Soon enough, the college president, James Wright, overturned a speech code. The Foundation for Individual Rights in Education, a watchdog group, elevated Dartmouth's rating from 'red' to its highest, 'green,' one of only seven schools in the country with that status. 'We made progress, and I was feeling pretty good,' Mr. Rodgers says."
This was notable because, as we have discussed on Health Care Renewal, academic institutions, and academic medicine in particular, have not always had stellar records of defending their students' and faculties' right to say or write controversial things, especially those that offend vested interests. In particular, academic medical institutions have:
- Gone along with attempts to suppress medical research that offended vested interests. (See posts here and here.)
- Allowed research contracts with commercial sponsors that allowed those sponsors to control the dissemination of research results (See post here.)
But the popularly elected alumni board members soon ran into opposition.
Perhaps sensing that a critical mass was building, Dartmouth's establishment then tried to skew the petition trustee process. The details are complex and tedious, but last autumn they cooked up a new alumni constitution that would have 'reformed' the way trustees were elected. In practice, it would have stacked the odds, like those in a casino, in favor of the house.After the election of the fourth alumni reform trustee, things got worse,
The measure needed two-thirds of alumni approval to pass, and in an election with the highest turnout in Dartmouth's history, it was voted down by 51%. 'It lost big time,' Mr. Rodgers says.
A former trustee, and a current chair of Dartmouth's $1.3 billion capital campaign, publicly charged that the petition process had initiated a 'downward death spiral' in which a 'radical minority cabal' was attempting to hijack the Board of Trustees. That was among the more charitable commentaries.
And,
One of the main criticisms leveled at the petition trustee process is that it is polarizing, divisive and somehow detrimental to the college. Mr. Rodgers replies, 'If 'divisive' means there are issues and we debate the issues and move forward according to a consensus, then divisive equals democracy, and democracy is good. The alternative, which I fear is what the administration and [Board of Trustees Chairman] Ed Haldeman are after right now, is a politburo--one-party rule.'
And so, after losing four consecutive democratic contests, the Dartmouth administration has evidently decided to do away with democracy altogether. 'Now I'm working on the existence question,' Mr. Rodgers notes mordantly.
Though he cannot say for sure--'I'll be kept in the dark until a couple of days before the meeting on what they're planning on doing'--a five-member subcommittee, which conducts its business in secret and includes the chair and the president, has embarked on a 'governance review' that will consolidate power. 'It looks like they're just going to abandon, or make ineffectual, the ability of alumni to elect half the trustees at Dartmouth,' Mr. Rodgers says.
He believes that the model is the Harvard Corporation, where a small group 'makes all the decisions. They elect themselves in secret. They elect themselves in secret for a life term. How's that for democracy?'
Rogers noted the likely consequences of the "reform" that would prevent the popular election of any more reform candidates,
The alternative remedy, he continues, is poor corporate governance, for one. 'This is committees working in secret, which is a very bad way to run any organization.' Besides transparency, it may also present conflicts of interest, in which the college president would dominate those who ultimately evaluate his performance.
By the way, what does Rogers expect will happen after the publication of the WSJ article?
Mr. Rodgers expects to be 'severely criticized, unfairly and personally,' for talking to The Journal. He may even be removed from his post entirely.
It is upsetting that the representativeness, accountability, and transparency that partially characterizes Darthmouth's governance model is under threat.
The troubles at Dartmouth, however, should also underline how little representativeness, accountability, and transparency characterize the government of any US university or medical school. As noted earlier, most university boards of trustees elect themselves. The reasons particular people are chosen for board service, and their positions on policy issues relevant to their institutions are generally unknown. The boards' deliberations are generally secret.
If any university faculty members, alumni/ae, or students in the audience can tell me their universities operate differently, I would love to hear about it. (And if those universities include medical schools, I would be happy to publicize their better governance models.)
Meanwhile, it is reasonable to hypothesize that the mismanagement and mission-hostile management that too often is found at US (and other countries') academic medical institutions is due in part to institutional governance that is unrepresentative, unaccountable, and opaque.
And instead of seeing movement toward representativeness, accountability, and transparency, at one of the few schools that has a somewhat better governance model, we see moves by the administration in the wrong direction.
Friday, August 31, 2007
Conflicted View on the Pitfalls of Government-Sponsored Comparative Effectiveness Research
Many have raised concerns that physicians too often favor the latest, most expensive, most high-technology, and sometimes most invasive treatments, contributing to the high costs and often bad outcomes of health care. One solution would be better research comparing the various possible treatments for particular problems. Yet some worry that this approach, too, has its problems.
The Wall Street Journal just printed a commentary warning about the dangers of government-sponsored studies comparing treatment effectiveness, written by Dr Scott Gottlieb, described as "a physician and resident fellow at the American Enterprise Institute, ... a former senior official at the Food and Drug Administration and the Centers for Medicare and Medicaid Services."
Dr Gottlieb raised some good points about pitfalls to be expected when comparing alternative treatments. These include:
The Wall Street Journal just printed a commentary warning about the dangers of government-sponsored studies comparing treatment effectiveness, written by Dr Scott Gottlieb, described as "a physician and resident fellow at the American Enterprise Institute, ... a former senior official at the Food and Drug Administration and the Centers for Medicare and Medicaid Services."
Dr Gottlieb raised some good points about pitfalls to be expected when comparing alternative treatments. These include:
- The need to do very large (and hence expensive) studies to have sufficient statistical power to determine if the treatments really are different, "detecting small clinical differences between two active drugs, such as whether one pill lowers blood pressure more than another, requires very large studies...."
- The tendency of investigators not to share results, making them harder to verify.
- The danger that results that fit preconceived notions will be too readily accepted.
- The danger that government-funded studies might be influenced by the government's need to control medical costs, and thus favor cheaper treatments. "Medicare is no ordinary payer: It dictates decisions made in the private market. So as the government begins tying its own payment decisions to the results of its own studies, there's a great temptation to selectively interpret data and arbitrarily release results. Clearly, this obvious conflict of interest demands even more outside scrutiny and transparency than has been the usual fare when it comes to government research."
Of course, these also are pitfalls of studies comparing active treatment to placebo, and of studies funded by not-for-profit organizations or commercial firms.
In fact, Dr Gottlieb's essay seemed to do its best to raise suspicions about government-funded comparative effectiveness research while neglecting that the alternatives may be worse.
The evidence-based medicine paradigm, to which I obviously subscribe, suggests that physicians should make decisions about treatment based on a critical review of the best available evidence from clinical research, informed by their knowledge of biology and the medical context, and taking into account patients' preferences and values.
Where can physicians get the best available evidence from clinical research now, in the absence of many government-funded studies of comparative effectiveness? In most cases, the best they can do is to look at results of studies sponsored by the manufacturers of the drugs and devices they evaluated, often compared to placebo.
Dr Gottlieb used a few examples of government-sponsored comparative studies to illustrate their potential problems. But most of these problems have affected commercially sponsored studies even more severely.
Dr Gottlieb asserted that early results of the Women's Health Initiative "were rushed to print with a cleverly orchestrated PR blitz." Yet pharmaceutical, biotechnology, and device companies make huge marketing efforts to rapidly publicize results of the trials they sponsor that are favorable to their products. (This is so glaringly obvious that it needs no web-link.)
Dr Gottlieb accused the researchers who ran the Women's Health Initiative of refusing "to share bottom-line results, even with outside academics or the companies that manufactured the drugs." Well, at least the researchers had their own data. There have been noteworthy cases of researchers running commercially sponsored studies who were unable to access the data they collected, which were kept secret by the commercial sponsor. See, in particular, the case of Dr Aubrey Blumsohn, who was unable to analyze the data he collected in a trial of Actonel because the company's sponsor, Proctor & Gamble, refused to let him have it. (See this link on Dr Blumsohn's blog for numerous posts, and our most recent posts here and here.) And we have posted about a New England Journal of Medicine study(1) which showed that US medical schools are often quite willing to let commercial research sponsors maintain control of the data collected by academic researchers.
Dr Gottlieb worried that studies funded by the government might be biased to favor less expensive drugs. Yet there is copious evidence that commercially sponsored studies favor their sponsors' projects.(2-3)
Dr Gottlieb worried that government-funded comparative effectiveness studies might be too small to generate precise enough results. Yet there is considerable evidence that the design and implementation of commercially-funded are often manipulated to increase the likelihood that the studies' results will favor the sponsors' products. (4-6)
Finally, and most ironically, Dr Gottlieb worried that Medicare sponsorship of studies would constitute a conflict of interest. We have posted before about previous commentaries by Dr Gottlieb in which he failed to reveal his past ties to industry, including his past consulting work for a large public relations firm that has many pharmaceutical companies as clients, and a firm that recruits physicians to advise about particular health care related investments. Dr Gottlieb also failed to reveal his apparent current role as a "counsel" to a major pharmaceutical company.
Most recently, Dr Gottlieb was just appointed to the board of directors for a biotechnology firm, Molecular Insight Pharmaceuticals. Thus he now has responsibility to the share-holders of this firm to maximize its profits, profits which presumably would be at risk if a government-sponsored comparative effectiveness study were to find that one of its products were not as good as expected.
I would be more inclined to credit the comments of people who have financial ties to health care corporations if they revealed these ties when making public comments. It amounts to stealth health policy advocacy for someone with multiple ties to the pharmaceutical and biotechnology industries to write in the guise of a think-tank intellectual.
ADDENDUM (4 September, 2007) - See also Aubrey Blumsohn's comments on the Scientific Misconduct Blog here.
References
1. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21. (available here)
2. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003; 289: 454-465.
3. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. Brit Med J 2003; 326: 1167-1170.
4. Bero LA, Rennie D. Influences on the quality of published drug studies. Int J Technol Assess 1996; 12:209-237.
5. Brophy JM. Selling safety - lessons from muraglitazar. JAMA 2005; 294:2633-5.
6. Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PloS Medicine 2005; 2: 364-366.
Thursday, August 30, 2007
On Sleep Deprivation and Medical Education
On the Over My Med Body Blog, see this eloquent rant about what it is like to begin a sub-internship. A sub-internship is an experience for (usually fourth year) medical students during which they function like interns, and hence functions as an introduction to the world of post-graduate medical training. Sub-interns, and later interns and residents are up at all hours of the night, taking care of often severly ill patients, with little experience and less sleep. Yes, they do have various forms of back-up, from sub-specialty fellows to seasoned faculty. But nothing can make up for the cloud of cotton wool that fills one's head after being up all night.
It's a sad testimony to our training system that the experience described is little different from the one I went through just about 30 years ago.
But now the intrepid blogger of Over My Med Body may be getting an inkling why doctors who have had years of training like this can get so upset when their dedication, knowledge, or work habits are questioned by some "suit" with a six-, seven-, or eight-figure income, a "suit" who is comfortably in bed every night of the week, and who never has to handle an emergency, much less a patient throwing up blood, hallucinating, and febrile at three in the morning.
But perhaps some of the money going to pay for those "suits'" fancy salaries could be used to pay for more hands on care givers in teaching hospitals, alleviating the need for those sub-interns, interns, and residents to work so many hours straight.
It's a sad testimony to our training system that the experience described is little different from the one I went through just about 30 years ago.
But now the intrepid blogger of Over My Med Body may be getting an inkling why doctors who have had years of training like this can get so upset when their dedication, knowledge, or work habits are questioned by some "suit" with a six-, seven-, or eight-figure income, a "suit" who is comfortably in bed every night of the week, and who never has to handle an emergency, much less a patient throwing up blood, hallucinating, and febrile at three in the morning.
But perhaps some of the money going to pay for those "suits'" fancy salaries could be used to pay for more hands on care givers in teaching hospitals, alleviating the need for those sub-interns, interns, and residents to work so many hours straight.
BLOGSCAN - Make a Drug An "Orpha," Raise the Price 20x
On the Health Business Blog, David Williams posts about how Questor Pharmaceuticals got an "orphan drug" status for its formulation of ACTH (adrenocorticotrophic hormone) to treat a form of seizures that occur in early childhood. After doing so, the company will increase the price of the drug, which has been on the market a long time, 20x, that is, 2000%. Somehow methinks that this was not what the orphan drug law was meant to do.
Tuesday, August 28, 2007
Nissen and Califf on the Avandia Case, and the Evils of Suppressing Data from Clinical Research
We have posted quite a bit about the controversy sparked by a meta-analysis of the cardiovascular adverse effects of rosiglitazone (Avandia, by GlaxoSmithKline) by Nissen and Wolski. (For example, see this post.)
Medscape just published a conversation between Dr Robert Califf and Dr Steven Nissen. (Nissen, who wrote the controversial meta-analysis, is at the Cleveland Clinic, while Califf is at Duke.) Much of the discussion addressed technical and methodologic aspects of the Avandia controversy. But I was struck by what the two had to say about suppression of clinical research.
Starting with Dr Nissen, edited for clarity:
Response by Dr Califf:
Back to Dr Nissen:
And from Dr Califf:
So let's summarize the main points:
Medscape just published a conversation between Dr Robert Califf and Dr Steven Nissen. (Nissen, who wrote the controversial meta-analysis, is at the Cleveland Clinic, while Califf is at Duke.) Much of the discussion addressed technical and methodologic aspects of the Avandia controversy. But I was struck by what the two had to say about suppression of clinical research.
Starting with Dr Nissen, edited for clarity:
I believe that if you ask human subjects to participate in an experiment that the results of that experiment belong to the public. That it is not acceptable to do such an experiment and then to deep-six the results. And I want that to be a matter of law. I think if it's not a matter of law, we will continue to see negative publication bias where the studies that get published are the ones that show favorable effects of drugs. Things have gotten out of balance, Rob. We hear about the efficacy of drugs through media, on television, through advertising, detail people, CME, but we need to see all of the data in order for us to make good clinical judgments.
Response by Dr Califf:
I've asked the question: 'Will everyone in the room who's in favor of secret human experimentation please raise your hands?' And so far I haven't really had anyone -- well, maybe one exception, but I don't want to reveal who that was -- say they're in favor of that.
The definition of research ... is something that's done to create generalizable knowledge. And generalizable knowledge to me can't be present if the result is kept from the public if it's negative.
Back to Dr Nissen:
Well, ... [companies] argue that the data is proprietary. And they have gotten a lot of traction in the Congress. The companies have said through their lobbyists and so on that when they spend the money to run a clinical trial that they own those results and they should be free, in a free enterprise system, to do whatever they want with those results. And if they don't like them and they want to put them somewhere other than in the public domain, that should be their right.
And from Dr Califf:
while there are lobbyists arguing that, there are many good people in companies who feel quite differently and would like to have permission, as you say, with regard to their corporate boards, who are always looking after optimal profitability, they'd like to have that happen.
The fiduciary responsibility of the corporate board is to not do things that damage the profitability of the company, and that leads, I think, to a very distorted perspective on the ethics that are involved.
Although in the past the argument has been made about trade secrets and so on and so forth, but when you get into the human experiment arena, if we level the playing field so all companies are working under the same rules, then the best products will win out because the public will have better information and people will make better decisions about what to do.
So let's summarize the main points:
- People participating in clinical experimental research are told that their participation will benefit science and patient care.
- This benefit could only occur if the results of the research are made public, even if they go against the commercial (or idological) interests of the people who paid to have the research done.
- For the financial supporters of research to keep data they do not like secret violates the trust of the research subjects.
- However, if hiding data has no negative consequences, commercial sponsors will continue to hide data unfavorable to their interests.
- Government regulation would be one way to impose negative consequences for hiding data.
- Preventing the suppression of data from clinical research ultimately will favor the products that are actually best for patients, which would be good for patients, and, incidentally, good for companies that make the better products.
Sounds good to me. But will any politician have the courage to advocate the punishment of companies that hide data they don't like?
Another solution would be to ban research on humans done or supported by those who have financial interests in the products or services tested by such research. That would require some massive redirection of the flow of money that supports human research.
I am wondering when some clever attorney will figure out how to sue a company on behalf of a research subject in a trial whose results were suppressed by its commercial sponsor. That particular sledge hammer might prompt some re-thinking of the issue.
BLOGSCAN - Maggie Mahar's Health Beat Blog
Maggie Mahar, author of Money-Driven Medicine, one of the best of the current crop of books about the dysfunctional US health system, now has a blog. It's called Health Beat, and went live August 7, although most posts on it were from yesterday. Maggie had previously guest-blogged on The Health Care Blog. We welcome her feisty voice in the health care blogsphere.
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