Princess Health and Media Reports on How Pharmaceutical Companies May Manipulate Information. Princessiccia

Princess Health and Media Reports on How Pharmaceutical Companies May Manipulate Information. Princessiccia

clinical trials direct to consumer advertising ghost writing pharmaceuticals

Gusty 14:15 Add Comment

Newspapers have become interested, again, in the issue of pharmaceutical companies manipulating information supplied to the public or health care professionals.

USA Today published several stories on the pharmaceutical industry. One was on various tactics the industry may used to mislead the public in television direct to consumer advertising, according to the US Food and Drug Administration (FDA). These included:

• Overstating the effectiveness of a drug. For example, a Novartis ad included graphics that implied, according to the FDA, Lamisil is completely effective in eradicating nail fungus. The FDA asserted, in contrast, that clinical trials only revealed a 38% cure rate.
• Advertising a drug for problems other than those for which its use was approved by the FDA. For example, Wyeth advertised Effexor as treatment of mild depressive symptoms, according to the FDA. The drug, however, was only approved by the FDA for major depressive disorder.
• Unsubstantiated claims. For example, Hoffman-La Roche advertised Xeloda, a cancer chemotherapy agent, using testimonials that the drug didn't make patients "too tired" or "too sick." However, the FDA noted "in stark contrast" the number of reports that Xeloda makes people feel sick and tired.

USA Today also ran a story on how pharmaceutical companies may ghost-write articles, and then try to get academics to pose as first authors. (Our last posting on ghost-writing is here, and a posting about how medical schools are willing to sign contracts with research sponsors that allow the sponsors to write up research results, is here.) It included an estimate by Dr. Martha Gerrity, Co-Editor of the Journal of General Internal Medicine, that two to four of the 70-80 manuscripts the journal receives each month may be ghost-written. Dr. Catherine DeAngelis, the Editor of the Journal of the American Medical Association said that before she became an editor, she got one phone call a month asking her to pose as the author of a ghost-written article. The article provides another bit of evidence that ghost-writing may be far more prevalent than most physicians and researchers realized. Yet, as Dr. DeAngelis said, ghost-writing is "manipulation by for-profits to alter what's in the (medical) literature so that they could sell their products."
Finally, the NY Times ran a story suggesting that pharmaceutical companies seem split about whether to submit information to online registries of controlled trials. These registries had been proposed as a way to prevent the companies from hiding unfavorable results of clinical trials.
Some companies, notably Eli Lilly, have apparently been quick to provide trial information to the registries. Dr. Alan Breier, the company's chief medical officer, said "fundamentally, what we're doing is in the interest of patients, and I think that this is the winning model, for academia, for industry, and the future."
On the other hand, some companies, e.g., Merck, Pfizer, and GlaxoSmithKline, have been stingy in the information they have provided to the NIH clinical trials registry, clinicaltrials.gov. Dr. Deborah Zarin, the director of the site, noted, for example, that Merck only said that one trial was a "one-year stury of an investigational drug in obese patients." Failing to provide crucial details, like the name of the drug, would make it impossible in the future to tell if Merck ever published a report of the trial's results.
The Times reported that "executives and press representatives at the companies said generally that disclosing too much information about early-state trials might reveal business or scientfic secrets." On the other hand, Dr. Breir of Lilly felt that it could supply information to the registry while still protecting its intellectual property.
In summary, physicians' efforts to make decisions for patients based on the best available research data are frustrated when companies hide or manipulate research results which put their products in a bad light. Manipulating or hiding research results betrays those patients who volunteered to participate in clinical trials intending to help advance science and improve patient care. Misleading advertising pushes patients to get treatments that are needlessly expensive, and sometimes needlessly hazardous. Too often, pharmaceutical companies seem to have forgotten their high-minded promises to help patients with better treatments in the pursuit of short-term profits.

Princess Health and Media Reports on How Pharmaceutical Companies May Manipulate Information.Princessiccia

Princess Health and Media Reports on How Pharmaceutical Companies May Manipulate Information.Princessiccia

clinical trials direct to consumer advertising ghost writing pharmaceuticals

Gusty 14:15 Add Comment

Newspapers have become interested, again, in the issue of pharmaceutical companies manipulating information supplied to the public or health care professionals.

USA Today published several stories on the pharmaceutical industry. One was on various tactics the industry may used to mislead the public in television direct to consumer advertising, according to the US Food and Drug Administration (FDA). These included:

• Overstating the effectiveness of a drug. For example, a Novartis ad included graphics that implied, according to the FDA, Lamisil is completely effective in eradicating nail fungus. The FDA asserted, in contrast, that clinical trials only revealed a 38% cure rate.
• Advertising a drug for problems other than those for which its use was approved by the FDA. For example, Wyeth advertised Effexor as treatment of mild depressive symptoms, according to the FDA. The drug, however, was only approved by the FDA for major depressive disorder.
• Unsubstantiated claims. For example, Hoffman-La Roche advertised Xeloda, a cancer chemotherapy agent, using testimonials that the drug didn't make patients "too tired" or "too sick." However, the FDA noted "in stark contrast" the number of reports that Xeloda makes people feel sick and tired.

USA Today also ran a story on how pharmaceutical companies may ghost-write articles, and then try to get academics to pose as first authors. (Our last posting on ghost-writing is here, and a posting about how medical schools are willing to sign contracts with research sponsors that allow the sponsors to write up research results, is here.) It included an estimate by Dr. Martha Gerrity, Co-Editor of the Journal of General Internal Medicine, that two to four of the 70-80 manuscripts the journal receives each month may be ghost-written. Dr. Catherine DeAngelis, the Editor of the Journal of the American Medical Association said that before she became an editor, she got one phone call a month asking her to pose as the author of a ghost-written article. The article provides another bit of evidence that ghost-writing may be far more prevalent than most physicians and researchers realized. Yet, as Dr. DeAngelis said, ghost-writing is "manipulation by for-profits to alter what's in the (medical) literature so that they could sell their products."
Finally, the NY Times ran a story suggesting that pharmaceutical companies seem split about whether to submit information to online registries of controlled trials. These registries had been proposed as a way to prevent the companies from hiding unfavorable results of clinical trials.
Some companies, notably Eli Lilly, have apparently been quick to provide trial information to the registries. Dr. Alan Breier, the company's chief medical officer, said "fundamentally, what we're doing is in the interest of patients, and I think that this is the winning model, for academia, for industry, and the future."
On the other hand, some companies, e.g., Merck, Pfizer, and GlaxoSmithKline, have been stingy in the information they have provided to the NIH clinical trials registry, clinicaltrials.gov. Dr. Deborah Zarin, the director of the site, noted, for example, that Merck only said that one trial was a "one-year stury of an investigational drug in obese patients." Failing to provide crucial details, like the name of the drug, would make it impossible in the future to tell if Merck ever published a report of the trial's results.
The Times reported that "executives and press representatives at the companies said generally that disclosing too much information about early-state trials might reveal business or scientfic secrets." On the other hand, Dr. Breir of Lilly felt that it could supply information to the registry while still protecting its intellectual property.
In summary, physicians' efforts to make decisions for patients based on the best available research data are frustrated when companies hide or manipulate research results which put their products in a bad light. Manipulating or hiding research results betrays those patients who volunteered to participate in clinical trials intending to help advance science and improve patient care. Misleading advertising pushes patients to get treatments that are needlessly expensive, and sometimes needlessly hazardous. Too often, pharmaceutical companies seem to have forgotten their high-minded promises to help patients with better treatments in the pursuit of short-term profits.

Princess Health and Editorial Argues Against Softening NIH Conflict of Interest Rules. Princessiccia

Princess Health and Editorial Argues Against Softening NIH Conflict of Interest Rules. Princessiccia

conflicts of interest NIH

Gusty 13:34 Add Comment

The question of whether the NIH should soften its now stringent conflict of interest rules re-surfaced in an editorial in the Hartford Courant. Some choice quotes:

"Prodded by newspaper exposes and congressional inquiries, the NIH instituted a series of reforms. Scientists were barred from accepting compensation from the biomedical industry. Also, the NIH's top 7,000 staffers were prohibited from owning stock in individual medical companies, while all other employees were directed to limit their holdings to $15,000."

"The stock restrictions have raised the ire of a group calling itself the Assembly of Scientists, whose members have threatened to leave the NIH if the reforms aren't scaled back. Health and Human Services Secretary Mike Leavitt, who oversees the NIH, said he's considering their request, calling it a would-be 'softening of the conflict-of-interest policy.'

"In truth, it's more like selling out. Fortunes can be made or lost in biomedical stocks, based on the development or demise of breakthrough drugs and treatments. If researchers were allowed to replenish their portfolios with drug industry stocks, the temptations and biases of recent years would return in force. Mr. Leavitt should stand pat. The NIH's conflict-of-interest policy doesn't need any loopholes blown through it. "

Princess Health and Editorial Argues Against Softening NIH Conflict of Interest Rules.Princessiccia

Princess Health and Editorial Argues Against Softening NIH Conflict of Interest Rules.Princessiccia

conflicts of interest NIH

Gusty 13:34 Add Comment

The question of whether the NIH should soften its now stringent conflict of interest rules re-surfaced in an editorial in the Hartford Courant. Some choice quotes:

"Prodded by newspaper exposes and congressional inquiries, the NIH instituted a series of reforms. Scientists were barred from accepting compensation from the biomedical industry. Also, the NIH's top 7,000 staffers were prohibited from owning stock in individual medical companies, while all other employees were directed to limit their holdings to $15,000."

"The stock restrictions have raised the ire of a group calling itself the Assembly of Scientists, whose members have threatened to leave the NIH if the reforms aren't scaled back. Health and Human Services Secretary Mike Leavitt, who oversees the NIH, said he's considering their request, calling it a would-be 'softening of the conflict-of-interest policy.'

"In truth, it's more like selling out. Fortunes can be made or lost in biomedical stocks, based on the development or demise of breakthrough drugs and treatments. If researchers were allowed to replenish their portfolios with drug industry stocks, the temptations and biases of recent years would return in force. Mr. Leavitt should stand pat. The NIH's conflict-of-interest policy doesn't need any loopholes blown through it. "

Princess Health and Should US Not-For-Profit Hospitals Lose Their Privileged Status?. Princessiccia

Princess Health and Should US Not-For-Profit Hospitals Lose Their Privileged Status?. Princessiccia

hospitals non-profit organizations

Gusty 13:32 Add Comment

The Baltimore Sun reports that both the US House of Representatives Ways and Means Committee and the Senate Finance Committee are opening enquiries about whether US not-for-profit hospitals should keep their tax exemptions.
Rep. Bill Thomas (R-California) said, "We really can't tell the difference, all that much, between a for-profit and a not-for-profit. What is the taxpayer getting in return for the tens of billions of dollars per year in tax subsidy?" Sen. Charles Grassley (R-Iowa) said "It's also my job to make sure charities are earning their generous tax breaks. Tax-exempt status is a privilege."
Mark Everson, Commissioner of the Internal Revenue Service, testified "We at the IRS are now faced with a health care industry in which it is increasingly difficult to differentiate for-profit from nonprofit health care providers." The article further explained, "IRS reviews have turned up questions about excessive executive compensation, complex ventures with profitable companies, employment taxes and operations benefiting a private, not public good."
I am not surprised that politicians are beginning to question why supposedly "not-for-profit" hospitals should keep their privileged status. Since I first did the interviews that resulted in my European Journal of Internal Medicine article on health care dysfunction, I have heard about case after case about questionable leadership of large health care organizations, including many that involved not-for-profit hospitals. Just this month, for example, Health Care Renewal postings have included cases of :

• exaggerated and possibly misleading advertising (here and here);
• charging inflated "list prices," since managed care organizations think they are getting a bargain when they apply fixed discounts to whatever the hospitals want to charge, even if poor, uninsured patients are then charged full "list prices" (see here, here, and here); and
• miscellaneous fraud involving Medicaid billing (here), and construction kickbacks (here)

all involving not-for-profit hospitals.
Of course, ending all not-for-profit hospitals' tax exemption would be an exceedingly blunt way to address these problems. I have no doubt that there are many competently and honestly lead hospitals, whose leaders make real efforts to fulfill their missions, and to add real value to their communities. They do not deserve to lose their tax exemptions. However, they risk being thrown in the same bucket with their "bad apple" brethren. Up to now, hospital leaders as a group have not made readily apparent attempts to police their own ranks.
Thus, we need some better watchdog and/or regulatory mechanisms to address ill-informed, conflicted, and corrupt leadership of not-for-profit hospitals, (and of other health care organizations). Perhaps hospital leaders will develop develop a self-policing mechanism. Perhaps these mechanisms could be set up by physicians and other health care professionals, or as part of government regulatory agencies. However, not having these mechanisms means that continuing abuses will tempt politicians to employ indiscriminate, shot-gun approaches which will harm the good apples along with the bad.

Princess Health and Should US Not-For-Profit Hospitals Lose Their Privileged Status?.Princessiccia

Princess Health and Should US Not-For-Profit Hospitals Lose Their Privileged Status?.Princessiccia

hospitals non-profit organizations

Gusty 13:32 Add Comment

The Baltimore Sun reports that both the US House of Representatives Ways and Means Committee and the Senate Finance Committee are opening enquiries about whether US not-for-profit hospitals should keep their tax exemptions.
Rep. Bill Thomas (R-California) said, "We really can't tell the difference, all that much, between a for-profit and a not-for-profit. What is the taxpayer getting in return for the tens of billions of dollars per year in tax subsidy?" Sen. Charles Grassley (R-Iowa) said "It's also my job to make sure charities are earning their generous tax breaks. Tax-exempt status is a privilege."
Mark Everson, Commissioner of the Internal Revenue Service, testified "We at the IRS are now faced with a health care industry in which it is increasingly difficult to differentiate for-profit from nonprofit health care providers." The article further explained, "IRS reviews have turned up questions about excessive executive compensation, complex ventures with profitable companies, employment taxes and operations benefiting a private, not public good."
I am not surprised that politicians are beginning to question why supposedly "not-for-profit" hospitals should keep their privileged status. Since I first did the interviews that resulted in my European Journal of Internal Medicine article on health care dysfunction, I have heard about case after case about questionable leadership of large health care organizations, including many that involved not-for-profit hospitals. Just this month, for example, Health Care Renewal postings have included cases of :

• exaggerated and possibly misleading advertising (here and here);
• charging inflated "list prices," since managed care organizations think they are getting a bargain when they apply fixed discounts to whatever the hospitals want to charge, even if poor, uninsured patients are then charged full "list prices" (see here, here, and here); and
• miscellaneous fraud involving Medicaid billing (here), and construction kickbacks (here)

all involving not-for-profit hospitals.
Of course, ending all not-for-profit hospitals' tax exemption would be an exceedingly blunt way to address these problems. I have no doubt that there are many competently and honestly lead hospitals, whose leaders make real efforts to fulfill their missions, and to add real value to their communities. They do not deserve to lose their tax exemptions. However, they risk being thrown in the same bucket with their "bad apple" brethren. Up to now, hospital leaders as a group have not made readily apparent attempts to police their own ranks.
Thus, we need some better watchdog and/or regulatory mechanisms to address ill-informed, conflicted, and corrupt leadership of not-for-profit hospitals, (and of other health care organizations). Perhaps hospital leaders will develop develop a self-policing mechanism. Perhaps these mechanisms could be set up by physicians and other health care professionals, or as part of government regulatory agencies. However, not having these mechanisms means that continuing abuses will tempt politicians to employ indiscriminate, shot-gun approaches which will harm the good apples along with the bad.

Princess Health and A Troubling Study of the Contracts Between Medical Schools and Corporate Research Sponsors. Princessiccia

Princess Health and A Troubling Study of the Contracts Between Medical Schools and Corporate Research Sponsors. Princessiccia

conflicts of interest institutional conflicts of interest manipulating clinical research suppression of medical research

Gusty 12:45 Add Comment

The NEJM article about contracts for clinical trials between academic health centers (AHCs) and pharmaceutical companies mentioned in an earlier post deserves further attention. (The study is available here, and its citation is Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.)

First, let me summarze the study's design. The authors sent a survey to senior administrators in the offices of sponsored research in 122 medical schools. They received responses from 107, for 91% response rate, excluding four schools that did no clinical research. They asked the administrators questions about provisions they would usually allow in contracts between their medical schools and corporate sponsors. The proportions who would allow some particular research practices follow:

• The sponsor will own the data produced by the research - 80%
• The sponsor will store the data and release portions to the investigator - 35%
• The investigators (whether at your site or any other site) are not permitted to alter the study design after the agreement is executed - 68%
• The sponsor is permitted to alter the study design after the agreement is executed - 62%
• The sponsor may prohibit individual site investigators from publishing manuscripts independently of the sponsor or group - 15%
• The sponsor may include its own statistical analysis in manuscripts - 24%
• The sponsor will write up the results for publication and the investigators may review the manuscript and suggest revisions - 50%
• While the trial is going on, the investigators may not discuss research results (including presentations at scientific meetings) with people not involved in the trial - 66%
• After the trial is over, the investigators may not discuss research results (including presentations at scientific meetings) until the sponsor consents to dissemination - 21%
• The terms of the clinical-trial agreement are confidential - 62%
• After the trial is over, the industry sponsor may prohibit investigators from sharing raw research data with third parties - 41%

In summary, this study suggests that some medical schools will acquiesce to contracts that prevent their faculty from having meaningful control over research projects for which they are the ostensible investigators. Some medical schools will allow corporate research sponsors to manipulate the design, analysis, and interpretation of results to increase the likelihood of getting the results the sponsor wants. For example, 50% of medical schools would allow the corporate sponsor to write manuscripts reporting on study results, and only allow faculty to "suggest revisions." Thus, many medical schools acquiesce to contracts that could allow corporate sponsors to ghost-write articles. Furthermore, more than half of the medical schools acquiesce to contracts that are kept confidential, preventing easy discovery of manipulation of the conduct and dissemination of the research by the corporate sponsor.
(To see specific techniques that corporate sponsors may use to increase the likelihood that research produces the results they want, see our earlier post about the article entitled "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies" by Richard Smith.)
To underline the context, in my experience, to do clinical research, most medical school faculty are strongly pressured by their institutions to obtain external funding to support this work. Those who cannot obtain funding within a few years of unemployment often have to find something else to do other than research. However, although faculty are expected to find sources of funding, it is generally the medical schools or academic medical centers, not the researchers, who negotiate research agreements, and although such agreements may bind faculty members, the money paid under their auspices generally goes directly to the faculty member's employer. Thus, individual researchers are under considerable pressure to find grant and contract funding, and to keep their financial sponsors happy, but must work under whatever contract provisions their employers negotiate.
The New England Journal of Medicine article clearly suggests that some medical schools allow researchers to be bound by agreements that allow the study's sponsor to manipulate study design, analysis, and interpretation to make it more likely that the results will be to the sponsor's liking. Since clinical trials enroll real human beings as subjects with the promise that the data they contribute, and the risks they run, will lead to valid scientific results, allowing such manipulation appears to not only likely to produce biased results, but also to be allow unethical exploitation of human subjects, and thus is in conflict with the medical school's scientific and humanitarian mission.
This is yet another illustration of leaders of powerful health care organizations acting in conflict with physicians' and medical researchers' core values.
One can only hope that publicizing such practices will lead to more ethical research, and less exploitation of human subjects.
By the way, I do not in any sense mean to blame the research administrators who must try to negotiate these contracts. Note that 69% of the administrators "perceived that competition for research funds created pressure on administrators to compromise on the language of the contract." 24% described the pressure as "great." I do blame the higher leadership of the medical schools for fostering a climate in which money is more important than doing valid, ethical research. This raises several important questions:

• Why don't some medical school leaders enforce clearer ethical standards for clinical research sponsored by industry?
• Are they so worried about getting the money, and so worried that they will lose contracts if they insist on ethical standards?
• Are they so steeped in the exteme relativism of the post-modernist university that they don't believe in such standards?
• Are they so used to violating their own mission to support political causes, as is documented again and again on the FIRE web-site, that they aren't troubled by violating their mission for economic reasons?

Maybe it's time we start trying to address such questions.

Princess Health and A Troubling Study of the Contracts Between Medical Schools and Corporate Research Sponsors.Princessiccia

Princess Health and A Troubling Study of the Contracts Between Medical Schools and Corporate Research Sponsors.Princessiccia

conflicts of interest institutional conflicts of interest manipulating clinical research suppression of medical research

Gusty 12:45 Add Comment

The NEJM article about contracts for clinical trials between academic health centers (AHCs) and pharmaceutical companies mentioned in an earlier post deserves further attention. (The study is available here, and its citation is Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.)

First, let me summarze the study's design. The authors sent a survey to senior administrators in the offices of sponsored research in 122 medical schools. They received responses from 107, for 91% response rate, excluding four schools that did no clinical research. They asked the administrators questions about provisions they would usually allow in contracts between their medical schools and corporate sponsors. The proportions who would allow some particular research practices follow:

• The sponsor will own the data produced by the research - 80%
• The sponsor will store the data and release portions to the investigator - 35%
• The investigators (whether at your site or any other site) are not permitted to alter the study design after the agreement is executed - 68%
• The sponsor is permitted to alter the study design after the agreement is executed - 62%
• The sponsor may prohibit individual site investigators from publishing manuscripts independently of the sponsor or group - 15%
• The sponsor may include its own statistical analysis in manuscripts - 24%
• The sponsor will write up the results for publication and the investigators may review the manuscript and suggest revisions - 50%
• While the trial is going on, the investigators may not discuss research results (including presentations at scientific meetings) with people not involved in the trial - 66%
• After the trial is over, the investigators may not discuss research results (including presentations at scientific meetings) until the sponsor consents to dissemination - 21%
• The terms of the clinical-trial agreement are confidential - 62%
• After the trial is over, the industry sponsor may prohibit investigators from sharing raw research data with third parties - 41%

In summary, this study suggests that some medical schools will acquiesce to contracts that prevent their faculty from having meaningful control over research projects for which they are the ostensible investigators. Some medical schools will allow corporate research sponsors to manipulate the design, analysis, and interpretation of results to increase the likelihood of getting the results the sponsor wants. For example, 50% of medical schools would allow the corporate sponsor to write manuscripts reporting on study results, and only allow faculty to "suggest revisions." Thus, many medical schools acquiesce to contracts that could allow corporate sponsors to ghost-write articles. Furthermore, more than half of the medical schools acquiesce to contracts that are kept confidential, preventing easy discovery of manipulation of the conduct and dissemination of the research by the corporate sponsor.
(To see specific techniques that corporate sponsors may use to increase the likelihood that research produces the results they want, see our earlier post about the article entitled "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies" by Richard Smith.)
To underline the context, in my experience, to do clinical research, most medical school faculty are strongly pressured by their institutions to obtain external funding to support this work. Those who cannot obtain funding within a few years of unemployment often have to find something else to do other than research. However, although faculty are expected to find sources of funding, it is generally the medical schools or academic medical centers, not the researchers, who negotiate research agreements, and although such agreements may bind faculty members, the money paid under their auspices generally goes directly to the faculty member's employer. Thus, individual researchers are under considerable pressure to find grant and contract funding, and to keep their financial sponsors happy, but must work under whatever contract provisions their employers negotiate.
The New England Journal of Medicine article clearly suggests that some medical schools allow researchers to be bound by agreements that allow the study's sponsor to manipulate study design, analysis, and interpretation to make it more likely that the results will be to the sponsor's liking. Since clinical trials enroll real human beings as subjects with the promise that the data they contribute, and the risks they run, will lead to valid scientific results, allowing such manipulation appears to not only likely to produce biased results, but also to be allow unethical exploitation of human subjects, and thus is in conflict with the medical school's scientific and humanitarian mission.
This is yet another illustration of leaders of powerful health care organizations acting in conflict with physicians' and medical researchers' core values.
One can only hope that publicizing such practices will lead to more ethical research, and less exploitation of human subjects.
By the way, I do not in any sense mean to blame the research administrators who must try to negotiate these contracts. Note that 69% of the administrators "perceived that competition for research funds created pressure on administrators to compromise on the language of the contract." 24% described the pressure as "great." I do blame the higher leadership of the medical schools for fostering a climate in which money is more important than doing valid, ethical research. This raises several important questions:

• Why don't some medical school leaders enforce clearer ethical standards for clinical research sponsored by industry?
• Are they so worried about getting the money, and so worried that they will lose contracts if they insist on ethical standards?
• Are they so steeped in the exteme relativism of the post-modernist university that they don't believe in such standards?
• Are they so used to violating their own mission to support political causes, as is documented again and again on the FIRE web-site, that they aren't troubled by violating their mission for economic reasons?

Maybe it's time we start trying to address such questions.

Princess Health and Wall Street Journal: Medical Editor Turns Activist On Drug Trials. Princessiccia

Princess Health and Wall Street Journal: Medical Editor Turns Activist On Drug Trials. Princessiccia

Gusty 08:39 Add Comment

NEJM editor Drazen returns to the Light Side of the Force. The revelation about academic medical centers willingly accepting ghost-writing or marginalization of their faculty as principal authors is stunning.

JEFFREY DRAZEN, editor of the prestigious New England Journal of Medicine, has prescribed a strong dose of disclosure for the pharmaceutical industry he was once accused of embracing too closely.

This week, Dr. Drazen accused three big pharmaceutical companies of "making a mockery" of a government database designed to provide accessible information about drug trials. He also joined a dozen other medical-journal editors in again warning that they might refuse to publish studies that don't adhere to their disclosure demands. Dr. Drazen has also recently written, and his journal has published, pieces critical of companies suppressing negative information about drug trials.

And the journal today plans to publish a study suggesting that drug companies may be exerting more influence over the supposedly independent academic investigators that they hire to conduct drug trials than had previously been known. The study, a survey of 107 medical-school research centers, shows that half would allow sponsors of their research to draft manuscripts reporting the results while limiting the role of the investigator to suggesting revisions.

... Dr. Drazen's newfound activism is especially striking since he came under fire for his own financial ties to the pharmaceutical industry when he took his current job at the New England Journal five years ago.

"He's been converted," said Marcia Angell, senior lecturer at Harvard Medical School and Dr. Drazen's predecessor as editor-in- chief. "Through painful experience, Jeff is learning what these companies are about. He sees the ugly side that he hadn't seen before -- the bias that company-sponsored research contains, the suppression of results that they don't like, the spin of unfavorable results."

-- SS

Princess Health and Wall Street Journal: Medical Editor Turns Activist On Drug Trials.Princessiccia

Princess Health and Wall Street Journal: Medical Editor Turns Activist On Drug Trials.Princessiccia

Gusty 08:39 Add Comment

NEJM editor Drazen returns to the Light Side of the Force. The revelation about academic medical centers willingly accepting ghost-writing or marginalization of their faculty as principal authors is stunning.

JEFFREY DRAZEN, editor of the prestigious New England Journal of Medicine, has prescribed a strong dose of disclosure for the pharmaceutical industry he was once accused of embracing too closely.

This week, Dr. Drazen accused three big pharmaceutical companies of "making a mockery" of a government database designed to provide accessible information about drug trials. He also joined a dozen other medical-journal editors in again warning that they might refuse to publish studies that don't adhere to their disclosure demands. Dr. Drazen has also recently written, and his journal has published, pieces critical of companies suppressing negative information about drug trials.

And the journal today plans to publish a study suggesting that drug companies may be exerting more influence over the supposedly independent academic investigators that they hire to conduct drug trials than had previously been known. The study, a survey of 107 medical-school research centers, shows that half would allow sponsors of their research to draft manuscripts reporting the results while limiting the role of the investigator to suggesting revisions.

... Dr. Drazen's newfound activism is especially striking since he came under fire for his own financial ties to the pharmaceutical industry when he took his current job at the New England Journal five years ago.

"He's been converted," said Marcia Angell, senior lecturer at Harvard Medical School and Dr. Drazen's predecessor as editor-in- chief. "Through painful experience, Jeff is learning what these companies are about. He sees the ugly side that he hadn't seen before -- the bias that company-sponsored research contains, the suppression of results that they don't like, the spin of unfavorable results."

-- SS

Princess Health and "Another Guy Who Ethically Ran Amok": Bellevue Hospital Executive Fired. Princessiccia

Princess Health and "Another Guy Who Ethically Ran Amok": Bellevue Hospital Executive Fired. Princessiccia

Bellevue Hospital Center conflicts of interest hospitals Mismanagement

Gusty 12:18 Add Comment

The New York Times reports yet another hospital chief executive leaving in disgrace. Carlos F. Perez, executive director of Bellevue Hospital Center, was fired after he was accused of taking a loan from a company that did business with city hospitals. The acting director the New York City Health and Hospitals Corporation, of which Bellevue is a part, declared, "We have no tolerance for unethical conduct in our city's public hospitals. This breach of the public trust is a disservice to our patients and the thousands of H.H.C employees."
Perez is the second chief executive of a New York City public hospital to depart under a cloud in the last week. We recently posted about how Joseph Orlando, the executive director of Jacobi Hospital, was fired because his hospital failed to notify hundreds of women about suspicious Pap test results.
A City Councilwoman declared, "I am shocked about the development at Bellevue and the fact that in less then [sic] a week we have lost two of our hospital leaders. It really raises questions to me about management of H.H.C. You had one guy who was not managing his staff, and now you have another guy who ethically ran amok."
Earlier this month, we posted about the firing of Joseph Pisani, the Chief Administative Officer of Westchester (NY) County Medical Center, after it was reported he had been involved in fraudulant practices at Staten Island (NY) University Hospital.
It hasn't been a good month for hospital leadership in New York.
However, this is not just a regional problem. This cluster of cases should remind us how widespread the problem of unethical leadership of large health organizations is. If we want things to get better, physicians must get involved in systematically uncovering incompetent, unethical, and corrupt leadership, while fostering representative, transparent, ethical and responsible health care governance.

Princess Health and "Another Guy Who Ethically Ran Amok": Bellevue Hospital Executive Fired.Princessiccia

Princess Health and "Another Guy Who Ethically Ran Amok": Bellevue Hospital Executive Fired.Princessiccia

Bellevue Hospital Center conflicts of interest hospitals Mismanagement

Gusty 12:18 Add Comment

The New York Times reports yet another hospital chief executive leaving in disgrace. Carlos F. Perez, executive director of Bellevue Hospital Center, was fired after he was accused of taking a loan from a company that did business with city hospitals. The acting director the New York City Health and Hospitals Corporation, of which Bellevue is a part, declared, "We have no tolerance for unethical conduct in our city's public hospitals. This breach of the public trust is a disservice to our patients and the thousands of H.H.C employees."
Perez is the second chief executive of a New York City public hospital to depart under a cloud in the last week. We recently posted about how Joseph Orlando, the executive director of Jacobi Hospital, was fired because his hospital failed to notify hundreds of women about suspicious Pap test results.
A City Councilwoman declared, "I am shocked about the development at Bellevue and the fact that in less then [sic] a week we have lost two of our hospital leaders. It really raises questions to me about management of H.H.C. You had one guy who was not managing his staff, and now you have another guy who ethically ran amok."
Earlier this month, we posted about the firing of Joseph Pisani, the Chief Administative Officer of Westchester (NY) County Medical Center, after it was reported he had been involved in fraudulant practices at Staten Island (NY) University Hospital.
It hasn't been a good month for hospital leadership in New York.
However, this is not just a regional problem. This cluster of cases should remind us how widespread the problem of unethical leadership of large health organizations is. If we want things to get better, physicians must get involved in systematically uncovering incompetent, unethical, and corrupt leadership, while fostering representative, transparent, ethical and responsible health care governance.

Princess Health and Lawyers Sue Hospital Based on What it Advertised. Princessiccia

Princess Health and Lawyers Sue Hospital Based on What it Advertised. Princessiccia

Gusty 11:56 Add Comment

Lawyers have noticed how hospitals are making exaggerated claims about their services, as reported by the Boston Globe.
The story involves the unfortunate case of a patient who died after bariatric surgery (i.e., after a procedure meant to reduce stomach size, and so induce weight loss). In Massachusetts, the law limits the damages collectable from civil suits against not-for-profit organizations, including hospitals, to $20,000. However, in this case, the plaintiff's lawyers are contending that "these stomach banding procedures are profit centers, that the hospitals advertise, they make promises, they do all things businesses do." Based on this argument, they initially asked Beth Israel Deaconess Hospital for a settlement of $8.5 million, and then filed a law-suit naming the hospital, as well as three members of the hospital's anesthesia staff.
The article also noted that other states are abolishing restrictions on the damages that can be collected from hospitals, based on reasoning that "the legal system should not treat hospitals differently than other corporations, especially as hospitals merge into large organizations that increasingly market their products and compete for patients."
Health Care Renewal has posted examples of hospitals (and other health care not-for-profits) acting more like for-profit businesses, and of some hospitals exhibiting unethical business practices. In particular, we have posted about questionable hospital advertising claims here and here. The second link is to a study of advertising done by prominent academic medical centers. The authors concluded, "Many of the ads seem to place the interests of the medical center before the interests of the patients."
The law may be a somewhat blunt tool to change these practices, but if we in health care cannot come up with a more nuanced approach, it is a tool likely to be increasingly employed.

Princess Health and Lawyers Sue Hospital Based on What it Advertised.Princessiccia

Princess Health and Lawyers Sue Hospital Based on What it Advertised.Princessiccia

Gusty 11:56 Add Comment

Lawyers have noticed how hospitals are making exaggerated claims about their services, as reported by the Boston Globe.
The story involves the unfortunate case of a patient who died after bariatric surgery (i.e., after a procedure meant to reduce stomach size, and so induce weight loss). In Massachusetts, the law limits the damages collectable from civil suits against not-for-profit organizations, including hospitals, to $20,000. However, in this case, the plaintiff's lawyers are contending that "these stomach banding procedures are profit centers, that the hospitals advertise, they make promises, they do all things businesses do." Based on this argument, they initially asked Beth Israel Deaconess Hospital for a settlement of $8.5 million, and then filed a law-suit naming the hospital, as well as three members of the hospital's anesthesia staff.
The article also noted that other states are abolishing restrictions on the damages that can be collected from hospitals, based on reasoning that "the legal system should not treat hospitals differently than other corporations, especially as hospitals merge into large organizations that increasingly market their products and compete for patients."
Health Care Renewal has posted examples of hospitals (and other health care not-for-profits) acting more like for-profit businesses, and of some hospitals exhibiting unethical business practices. In particular, we have posted about questionable hospital advertising claims here and here. The second link is to a study of advertising done by prominent academic medical centers. The authors concluded, "Many of the ads seem to place the interests of the medical center before the interests of the patients."
The law may be a somewhat blunt tool to change these practices, but if we in health care cannot come up with a more nuanced approach, it is a tool likely to be increasingly employed.

Princess Health and Fewer Physicians Interested in Generalist Careers. Princessiccia

Princess Health and Fewer Physicians Interested in Generalist Careers. Princessiccia

physicians primary care

Gusty 14:28 Add Comment

There is more information available about the decreasing number of physicians interested in being generalists.
A detailed survey based study of internal medicine residents' career choices just appeared in Academic Medicine, and was discussed in the American Medical News. [The article citation is: Garibaldi RA, Popkave C, Bylsma W. Career plans for trainees in internal medicine residency programs. Acad Med 2005; 80: 507-512.]
The article shows that the proportion of residents who go into general internal medicine has fallen from 54% in 1998 to 27% in 2003 (34% if hospitalists are added to general internists.) Reasons for going into sub-specialties admitted by survey respondents included higher income, and narrow practice area.
The American Medical News did not try to white-wash these results. It quoted a third year resident, chair of the AMA Resident's and Fellow's Section, who is going into gastroenterology because, "I'll be paid what my education is worth," and contrasted that situation with the lot of the general internist who makes "$110,000 a year.... That's a salary someone with less education and training can earn in other fields, without the debt of medical school, years spent training and commitment to a lifetime of being on call."
Steve Fihn, past President of the Society of General Internal Medicine, said "It's a pretty daunting task trying to reverse this trend when the economic forces are so strong."
On the other hand, the ASP Observer featured an article about the results of this year's internship match, i.e., how many medical students chose internal medicine training. The article was mainly positive, since the numbers choosing internal medicine have gone up slightly. "That's good news," since the numbers were dropping from 1998 to 2003.
However, the report also included the observation that internal medicine training program directors report that the proportion of residents going into general internal medicine has dropped from about 50% to about 20-25%, similar figures to those in the article by Garibaldi et al. But Steven E. Weinberger, ACP Vice President for Medical Knowledge and Education, suggested that the solution for dropping interest in general internal medicine would be the ACP's efforts to "fix Medicare reimbursement, for instance, and to help craft new chronic care models.... Creative models of high quality, team-based care offer a real opportunity to address the lifestyle issues." What sort of "chronic care models" he envisions, and how they will help generalists practice medicine, was not very obvious.
So the big question is whether our health care leaders and policy makers will make an effective attempt to reverse the decline of the generalist physician before the species becomes extinct.
At least some show understanding of the severity of stresses on generalists. Dr. Fihn, for example, is frank about the economic incentives.
However, as demonstrated by the issues discussed on this blog, not only are generalists at the bottom of the economic pecking order, they seem particularly impacted by the huge rise in health care bureaucracy, and particularly vulnerable to challenges to physicians' professional values instigated by large organizations lead by leaders with conflicting interests. They will need more than new "chronic care models" to survive these threats.

Princess Health and Fewer Physicians Interested in Generalist Careers.Princessiccia

Princess Health and Fewer Physicians Interested in Generalist Careers.Princessiccia

physicians primary care

Gusty 14:28 Add Comment

There is more information available about the decreasing number of physicians interested in being generalists.
A detailed survey based study of internal medicine residents' career choices just appeared in Academic Medicine, and was discussed in the American Medical News. [The article citation is: Garibaldi RA, Popkave C, Bylsma W. Career plans for trainees in internal medicine residency programs. Acad Med 2005; 80: 507-512.]
The article shows that the proportion of residents who go into general internal medicine has fallen from 54% in 1998 to 27% in 2003 (34% if hospitalists are added to general internists.) Reasons for going into sub-specialties admitted by survey respondents included higher income, and narrow practice area.
The American Medical News did not try to white-wash these results. It quoted a third year resident, chair of the AMA Resident's and Fellow's Section, who is going into gastroenterology because, "I'll be paid what my education is worth," and contrasted that situation with the lot of the general internist who makes "$110,000 a year.... That's a salary someone with less education and training can earn in other fields, without the debt of medical school, years spent training and commitment to a lifetime of being on call."
Steve Fihn, past President of the Society of General Internal Medicine, said "It's a pretty daunting task trying to reverse this trend when the economic forces are so strong."
On the other hand, the ASP Observer featured an article about the results of this year's internship match, i.e., how many medical students chose internal medicine training. The article was mainly positive, since the numbers choosing internal medicine have gone up slightly. "That's good news," since the numbers were dropping from 1998 to 2003.
However, the report also included the observation that internal medicine training program directors report that the proportion of residents going into general internal medicine has dropped from about 50% to about 20-25%, similar figures to those in the article by Garibaldi et al. But Steven E. Weinberger, ACP Vice President for Medical Knowledge and Education, suggested that the solution for dropping interest in general internal medicine would be the ACP's efforts to "fix Medicare reimbursement, for instance, and to help craft new chronic care models.... Creative models of high quality, team-based care offer a real opportunity to address the lifestyle issues." What sort of "chronic care models" he envisions, and how they will help generalists practice medicine, was not very obvious.
So the big question is whether our health care leaders and policy makers will make an effective attempt to reverse the decline of the generalist physician before the species becomes extinct.
At least some show understanding of the severity of stresses on generalists. Dr. Fihn, for example, is frank about the economic incentives.
However, as demonstrated by the issues discussed on this blog, not only are generalists at the bottom of the economic pecking order, they seem particularly impacted by the huge rise in health care bureaucracy, and particularly vulnerable to challenges to physicians' professional values instigated by large organizations lead by leaders with conflicting interests. They will need more than new "chronic care models" to survive these threats.

Princess Health and Guideant's Short Circuit. Princessiccia

Princess Health and Guideant's Short Circuit. Princessiccia

Guidant ICD manufacturing problems

Gusty 14:03 Add Comment

The New York Times reports yet another story of flawed implantable cardiac defibrillators (ICDs). This time, Guidant Corporation revealed that its ICDs manufactured from 2000 to 2002, can short circuit, fail, and thus become unable to prevent cardiac arrhythmias. Guidant corrected the design flaw that allowed these failures to occur in ICDs manufactured after mid-2002.
However, it only got around to notifying physicians and the public about the problem recently, after the company was informed that the Times was working on an article about the problem. The company's argument was that short-circuits are rare: only 25 cases of short-circuts are known. Furthermore, replacing the ICD requires an invasive procedure, and hence is not risk-free.
However, doctors and patients ought be able to decide about whether to take this risk, based on full disclosure of the relevant data.
This is the third problem with ICDs that has appeared in this blog. The others involved problems in devices manufactured by Access Cardiosystems, and by Medtronic.
The NY Times article notes that ICDs cost about $25,000 a piece, and that Guidant sold about $1.9 billion worth last year. Given the low cost of very sophisticated modern electronics, this unit price seems very high. IT should at least buy unimpeachable reliability. Why managed care has not been able to bargain down the prices of such devices remains an open question. But meanwhile they surely account for some of the seemingly inexorable rise of health care costs.
But regardless of what $25,000 ought to buy, there seems to be no good excuse to hide data about this device's flaws from the public and from doctors.

Princess Health and Guideant's Short Circuit.Princessiccia

Princess Health and Guideant's Short Circuit.Princessiccia

Guidant ICD manufacturing problems

Gusty 14:03 Add Comment

The New York Times reports yet another story of flawed implantable cardiac defibrillators (ICDs). This time, Guidant Corporation revealed that its ICDs manufactured from 2000 to 2002, can short circuit, fail, and thus become unable to prevent cardiac arrhythmias. Guidant corrected the design flaw that allowed these failures to occur in ICDs manufactured after mid-2002.
However, it only got around to notifying physicians and the public about the problem recently, after the company was informed that the Times was working on an article about the problem. The company's argument was that short-circuits are rare: only 25 cases of short-circuts are known. Furthermore, replacing the ICD requires an invasive procedure, and hence is not risk-free.
However, doctors and patients ought be able to decide about whether to take this risk, based on full disclosure of the relevant data.
This is the third problem with ICDs that has appeared in this blog. The others involved problems in devices manufactured by Access Cardiosystems, and by Medtronic.
The NY Times article notes that ICDs cost about $25,000 a piece, and that Guidant sold about $1.9 billion worth last year. Given the low cost of very sophisticated modern electronics, this unit price seems very high. IT should at least buy unimpeachable reliability. Why managed care has not been able to bargain down the prices of such devices remains an open question. But meanwhile they surely account for some of the seemingly inexorable rise of health care costs.
But regardless of what $25,000 ought to buy, there seems to be no good excuse to hide data about this device's flaws from the public and from doctors.

Princess Health and No More Free Viagra for Sex Offenders. Princessiccia

Princess Health and No More Free Viagra for Sex Offenders. Princessiccia

Gusty 13:52 Add Comment

There are so many stories popping up now that I am having a hard time keeping up, but here goes...
Unintended flaws of bureaucratic decision-making department, government agency division:
This is not, repeat not a bad joke.
Per the Associated Press, available in many newspapers, e.g., the Washington Post.
The US government Centers for Medicare and Medicaid Services has begun notifying states that they do not hve to pay for Viagra and other drugs for "erectile dsyfunction" for convicted sex offenders. A New York State audit had shown that 198 convicted sex offenders in that state had received Viagra paid for Medicaid.

Princess Health and No More Free Viagra for Sex Offenders.Princessiccia

Princess Health and No More Free Viagra for Sex Offenders.Princessiccia

Gusty 13:52 Add Comment

There are so many stories popping up now that I am having a hard time keeping up, but here goes...
Unintended flaws of bureaucratic decision-making department, government agency division:
This is not, repeat not a bad joke.
Per the Associated Press, available in many newspapers, e.g., the Washington Post.
The US government Centers for Medicare and Medicaid Services has begun notifying states that they do not hve to pay for Viagra and other drugs for "erectile dsyfunction" for convicted sex offenders. A New York State audit had shown that 198 convicted sex offenders in that state had received Viagra paid for Medicaid.

Princess Health and From Nevada, More on Hospitals' List Prices. Princessiccia

Princess Health and From Nevada, More on Hospitals' List Prices. Princessiccia

health care prices hospitals

Gusty 12:21 Add Comment

The Las Vegas Review-Journal reported on the high cost of hospitalization in Nevada, where it asserted hospital charges are currently the highest in the US. For example, it compared charges for heart valve replacement at the Cleveland Clinic ($88,273) and the Mayo Clinic in Phoenix ($79,601), with charges at some Las Vegas hospitals: Valley Hospital Medical Center ($233,259), St. Rose Dominican-Siena ($199,179), Sunrise Hospital ($196,908), Desert Springs Hospital ($186,622), and University Medical Center ($156,953).
Bill Welch, head of the Nevada Hospital Association, blamed the high prices on "a high number of uninsured patients, a nursing shortage that drives up salaries, a mental health crisis that sees many people with emotional problems going to expensive emergency rooms for treatment, and a large percentage of patients who go to expensive emergency rooms for primary care."
However, these problems are common across the country.
University of Southern California Professor Glenn Melnick raised the issue of exaggerated list prices. "Raising list charges, which often bear little relationship to the actual cost of services... is a way hospitals also increase the amount they get from insurers, which often use the charges as a starting point in negotiating discounted contracts for their policy holders."
Once again we are hearing about how managed care organizations and insurers, who are often touted as tough agents for lowering health care costs, seem to think they are getting a great deal if they negotiate a fixed discount off wildly exaggerated list prices.
Nevada may be particularly at risk for high list prices because it is a state which attracts tourists. Melnick suggested that hospitals can make "millions" by charging sick or injured tourists full list prices.
Although Nevada hospitals appear not to be unduly profitable, Melnick also suggested that hospitals that are part of inter-state corporations may reduce their apparent profits by paying high prices for services provided by their corporate parent. "For example, if the corporate parent owns all the hospitals in a chain, it will often charge its hospitals high rent. It will do the same thing with the supplies that it buys for the entire chain.""The same goes for legal fees."
In summary, this article corroborates the previous post about California. Hospitals may charge very high list prices, because managed care organizations and insurance companies think they are getting bargains if they negotiate fixed percentage discounts off these prices, and because hospitals can get a away with charging tourists these full prices. Unfortunately, the uninsured are often charged the same high list prices, even if they are the least able to pay. The great variability in prices charged for the same service suggest that some hospitals are making unreasonable amounts of money for particular services even after the managed care organizations' or insurance companies' fixed percentage discount. Furthermore, hospitals can reduce the apparent profitability these prices generate by paying exaggerated rates to their parent health care system for services it provides them.
It's not a system that is likely to be give patients the best care for the most reasonable prices.
Let's see if anyone in managed care or government, who persistently seem to direct their cost-cutting efforts at primary care, will notice where much of their money really seems to be going.

Princess Health and From Nevada, More on Hospitals' List Prices.Princessiccia

Princess Health and From Nevada, More on Hospitals' List Prices.Princessiccia

health care prices hospitals

Gusty 12:21 Add Comment

The Las Vegas Review-Journal reported on the high cost of hospitalization in Nevada, where it asserted hospital charges are currently the highest in the US. For example, it compared charges for heart valve replacement at the Cleveland Clinic ($88,273) and the Mayo Clinic in Phoenix ($79,601), with charges at some Las Vegas hospitals: Valley Hospital Medical Center ($233,259), St. Rose Dominican-Siena ($199,179), Sunrise Hospital ($196,908), Desert Springs Hospital ($186,622), and University Medical Center ($156,953).
Bill Welch, head of the Nevada Hospital Association, blamed the high prices on "a high number of uninsured patients, a nursing shortage that drives up salaries, a mental health crisis that sees many people with emotional problems going to expensive emergency rooms for treatment, and a large percentage of patients who go to expensive emergency rooms for primary care."
However, these problems are common across the country.
University of Southern California Professor Glenn Melnick raised the issue of exaggerated list prices. "Raising list charges, which often bear little relationship to the actual cost of services... is a way hospitals also increase the amount they get from insurers, which often use the charges as a starting point in negotiating discounted contracts for their policy holders."
Once again we are hearing about how managed care organizations and insurers, who are often touted as tough agents for lowering health care costs, seem to think they are getting a great deal if they negotiate a fixed discount off wildly exaggerated list prices.
Nevada may be particularly at risk for high list prices because it is a state which attracts tourists. Melnick suggested that hospitals can make "millions" by charging sick or injured tourists full list prices.
Although Nevada hospitals appear not to be unduly profitable, Melnick also suggested that hospitals that are part of inter-state corporations may reduce their apparent profits by paying high prices for services provided by their corporate parent. "For example, if the corporate parent owns all the hospitals in a chain, it will often charge its hospitals high rent. It will do the same thing with the supplies that it buys for the entire chain.""The same goes for legal fees."
In summary, this article corroborates the previous post about California. Hospitals may charge very high list prices, because managed care organizations and insurance companies think they are getting bargains if they negotiate fixed percentage discounts off these prices, and because hospitals can get a away with charging tourists these full prices. Unfortunately, the uninsured are often charged the same high list prices, even if they are the least able to pay. The great variability in prices charged for the same service suggest that some hospitals are making unreasonable amounts of money for particular services even after the managed care organizations' or insurance companies' fixed percentage discount. Furthermore, hospitals can reduce the apparent profitability these prices generate by paying exaggerated rates to their parent health care system for services it provides them.
It's not a system that is likely to be give patients the best care for the most reasonable prices.
Let's see if anyone in managed care or government, who persistently seem to direct their cost-cutting efforts at primary care, will notice where much of their money really seems to be going.

Princess Health and Conflicts of Interest and Jackson Memorial Hospital's Pharmacy Contract. Princessiccia

Princess Health and Conflicts of Interest and Jackson Memorial Hospital's Pharmacy Contract. Princessiccia

Cardinal Health conflicts of interest Jackson memorial hospital University of Miami

Gusty 11:25 Add Comment

The latest in the hit-parade of hospital management shenanigans, highlighting issues of conflict of interest, is this story in the Miami Herald.
The newspaper's investigation has uncovered a story of dubious management at Jackson Memorial Hospital, a major University of Miami teaching hospital.
In summary, after hospital President Ira Clark had announced his retirement in 2002, in 2003, the hospital's Fiscal Affairs Committee, chaired by Andres Murai Jr, hired Alson L. Cook as Vice President of Logistics, at a salary of $160,000. Cook advocated giving Cardinal Health a five-year, no-bid contract to manage Jackson Memorial's pharmacy, and to control its drug purchasing, worth $85 million a year.
Murai, it turns out, also is President and CEO of Berna Products Corp, a subsidiary of Acambis plc, which sells a typhoid vaccine to Cardinal Health.
The contract between Jackson Memorial and Cardinal in retrospect also had a significant built-in conflict of interest. "One branch of Cardinal was telling Jackson how much to pay for drugs - purchased from another branch of Cardinal," according to the Herald.
Cardinal's staff at Jackson Memorial included project manager Kevin Reece and pharmacy director Marc Calhoun.
In early 2004, G. William Tomecko Jr., the hospital's Associate Pharmacy Director, noticed billing errors in Cardinal's records. He wrote Calhoun, "This will cause serious consternation at the CFO level. We were supposed to reduce costs by $4 million." Tomecko said Calhoun resisted his enquiries, and "took all the documents from me and requested that I not continue to determine the concerns." Calhoun has since left Cardinal.
Tomecko also found invoices from Reece from a strip club, liquor stores, and fishing boat campgrounds. Reece has since been charged with fraud.
Cook, who had gone fishing with Reece, and approved his bills, resigned and moved out of state.
An outside audit showed that the contract with Cardinal, which was supposed to save $4 million a year, actually cost the hospital $15.5 million. The audit identified $3.1 million in incorrect billing, and $5.9 million in patient under-billing.
A million here, a million there, and after a while these add up to serious costs for the health care system....

Princess Health and Conflicts of Interest and Jackson Memorial Hospital's Pharmacy Contract.Princessiccia

Princess Health and Conflicts of Interest and Jackson Memorial Hospital's Pharmacy Contract.Princessiccia

Cardinal Health conflicts of interest Jackson memorial hospital University of Miami

Gusty 11:25 Add Comment

The latest in the hit-parade of hospital management shenanigans, highlighting issues of conflict of interest, is this story in the Miami Herald.
The newspaper's investigation has uncovered a story of dubious management at Jackson Memorial Hospital, a major University of Miami teaching hospital.
In summary, after hospital President Ira Clark had announced his retirement in 2002, in 2003, the hospital's Fiscal Affairs Committee, chaired by Andres Murai Jr, hired Alson L. Cook as Vice President of Logistics, at a salary of $160,000. Cook advocated giving Cardinal Health a five-year, no-bid contract to manage Jackson Memorial's pharmacy, and to control its drug purchasing, worth $85 million a year.
Murai, it turns out, also is President and CEO of Berna Products Corp, a subsidiary of Acambis plc, which sells a typhoid vaccine to Cardinal Health.
The contract between Jackson Memorial and Cardinal in retrospect also had a significant built-in conflict of interest. "One branch of Cardinal was telling Jackson how much to pay for drugs - purchased from another branch of Cardinal," according to the Herald.
Cardinal's staff at Jackson Memorial included project manager Kevin Reece and pharmacy director Marc Calhoun.
In early 2004, G. William Tomecko Jr., the hospital's Associate Pharmacy Director, noticed billing errors in Cardinal's records. He wrote Calhoun, "This will cause serious consternation at the CFO level. We were supposed to reduce costs by $4 million." Tomecko said Calhoun resisted his enquiries, and "took all the documents from me and requested that I not continue to determine the concerns." Calhoun has since left Cardinal.
Tomecko also found invoices from Reece from a strip club, liquor stores, and fishing boat campgrounds. Reece has since been charged with fraud.
Cook, who had gone fishing with Reece, and approved his bills, resigned and moved out of state.
An outside audit showed that the contract with Cardinal, which was supposed to save $4 million a year, actually cost the hospital $15.5 million. The audit identified $3.1 million in incorrect billing, and $5.9 million in patient under-billing.
A million here, a million there, and after a while these add up to serious costs for the health care system....

Princess Health and Support for the "Endangered Primary Care MD". Princessiccia

Princess Health and Support for the "Endangered Primary Care MD". Princessiccia

physicians primary care

Gusty 11:07 Add Comment

An op-ed piece in the Boston Globe by Ellen Lutch Bender, the Director of Health Care Strategies for the law firm Brown Rudnick, entitled "The Endangered Primary Care MD," speaks to the adverse consequences of the dominance of health care by ever larger organizations.
Lutch Bender extolled the virtues of primary care doctors whose ideal is "providing care within a patient-physician relationship based on understanding, honesty, and trust." Furthermore, she suggested that the decline in primary care relates to "consolidation [which] has created a concentration of giant market participants whose dominance has decreased competition." As a result, primary care doctors "spend so much time on paperwork that their ability to care for patients is strained. They work at a frenetic pace from dawn to duskc, seing more patients, faster, to meet productivity benchmarks. They operate in a resource-constrained environment that has skyrocketed the cost of managing their practice and racheted down their incomes." Sound familiar?
She concluded that "this trend has serious ramifications, not only to cost and quality of care but also in the potential loss of the heart and soul of the medical profession."
It seems like more and more people are noticing the issues that Health Care Renewal has been bringing up.
...if only they had some solutions to these problems. Unfortunately, Lutch Bender's suggested approach was pretty opaque, "there is enormous opportunity for physicians to think differently and seek innovative alliances with other providers in a way that will spur competition for those courageous and committed enough to protect the relationship between physicians and their patients." Hopefully, she will come up with something more concrete in the future.

Princess Health and Support for the "Endangered Primary Care MD".Princessiccia

Princess Health and Support for the "Endangered Primary Care MD".Princessiccia

physicians primary care

Gusty 11:07 Add Comment

An op-ed piece in the Boston Globe by Ellen Lutch Bender, the Director of Health Care Strategies for the law firm Brown Rudnick, entitled "The Endangered Primary Care MD," speaks to the adverse consequences of the dominance of health care by ever larger organizations.
Lutch Bender extolled the virtues of primary care doctors whose ideal is "providing care within a patient-physician relationship based on understanding, honesty, and trust." Furthermore, she suggested that the decline in primary care relates to "consolidation [which] has created a concentration of giant market participants whose dominance has decreased competition." As a result, primary care doctors "spend so much time on paperwork that their ability to care for patients is strained. They work at a frenetic pace from dawn to duskc, seing more patients, faster, to meet productivity benchmarks. They operate in a resource-constrained environment that has skyrocketed the cost of managing their practice and racheted down their incomes." Sound familiar?
She concluded that "this trend has serious ramifications, not only to cost and quality of care but also in the potential loss of the heart and soul of the medical profession."
It seems like more and more people are noticing the issues that Health Care Renewal has been bringing up.
...if only they had some solutions to these problems. Unfortunately, Lutch Bender's suggested approach was pretty opaque, "there is enormous opportunity for physicians to think differently and seek innovative alliances with other providers in a way that will spur competition for those courageous and committed enough to protect the relationship between physicians and their patients." Hopefully, she will come up with something more concrete in the future.

Princess Health and Comments by Jacobi Hospital's Former Executive Director: "I Feel Really Good". Princessiccia

Princess Health and Comments by Jacobi Hospital's Former Executive Director: "I Feel Really Good". Princessiccia

Jacobi Hospital Mismanagement

Gusty 13:48 Add Comment

The Executive Director of Jacobi Hospital, who was fired because the hospital failed to notify hundreds of women about concerning Pap test results, had these comments for New York Post reporters:

• "I feel good. Everything is wonderful. I feel really good."

When asked if he wished to apologize to the women who were not informed of their abnormal test results, he referred the question to the New York Health and Hospitals Corporation, and slammed the door.
Another example of a hospital leader showing real concern about quality of care, and the concerns of his institution's patients - not.

Princess Health and Comments by Jacobi Hospital's Former Executive Director: "I Feel Really Good".Princessiccia

Princess Health and Comments by Jacobi Hospital's Former Executive Director: "I Feel Really Good".Princessiccia

Jacobi Hospital Mismanagement

Gusty 13:48 Add Comment

The Executive Director of Jacobi Hospital, who was fired because the hospital failed to notify hundreds of women about concerning Pap test results, had these comments for New York Post reporters:

• "I feel good. Everything is wonderful. I feel really good."

When asked if he wished to apologize to the women who were not informed of their abnormal test results, he referred the question to the New York Health and Hospitals Corporation, and slammed the door.
Another example of a hospital leader showing real concern about quality of care, and the concerns of his institution's patients - not.

Princess Health and Secret Hospital "List Prices" Revealed in San Jose. Princessiccia

Princess Health and Secret Hospital "List Prices" Revealed in San Jose. Princessiccia

health care prices hospitals

Gusty 13:12 Add Comment

A real health care market would require we have informed consumers who can make rational decisions. We have shown how some hospitals seem to be using marketing to undermine their patients' rational decision making. Meanwhile, patients are often completely in the dark about how much hospitals charge for their services.
A new California law has forced hospitals to disclose previously secret "list prices" for health care services. The San Jose Mercury News reports how hospitals in the San Jose area have wildly varying list prices for the same services:

• Comprehensive metabolic panel (blood test), $149 to $520
• One-day medical surgical stay, $1909 to $3900
• Screening mammogram, $95 to $405

At least one hospital spokesperson was frank about the lack of relationship between "list prices" and actual costs. Jan Emerson, a spokesperson for the California Hospital Association, stated "There's zero connection between costs, charges, and reimbursements. In many cases, to get $5 more from the health plans you have to raise your charges $50 or more."
The hospitals may be using inflated prices as a tool to extract more reimbursement from managed care organizations and insurance companies. These "list prices," however, are not without consequences for patients.
While insurance companies or managed care organizations usually pay just a fraction of these "list prices," the uninsured, who are often poor, may be charged the full prices, and may or may not easily obtain discounts. The article included the anecdote of an uninsured waiter who was charged a total of $43,000 by a not-for-profit hospital and his surgeon for an appendectomy. The hospital later offered him a discounted charge of $21,000, but this was still too much for him to afford. We have posted other examples of hospitals charging the uninsured their full, often stratospheric "rack rates." (Also see this post.)
The article noted that Medicare and managed care organizations often make their reimbursements functions of the "list prices," providing an inducement for hospitals to raise these prices as high as they can.
This last point is important. One would think that managed care organizations, which have been promoted primarily because of their ability to control costs, might have some idea what reasonable reimbursement might be for common health care services, regardless of how high hospitals set their "list prices." However, they seem to think they are getting a good deal if they can achieve a certain percentage discount from whatever the hospital charges, no matter how high it is. (Recall an earlier example of UnitedHealth being willing to reimburse a Tenet hospital $1275 after the hospital charged $2713 for a one-hour physical therapy evaluation session. Presumably this kind of astute bargaining is why the CEO of United Health Group got over $124 million in total compensation in 2004.)
In summary, although a true market for health care requires that consumers have complete pricing information, hospitals have traditionally kept the prices of their services secret. Furthermore, their list prices often seem wildly inflated, because managed care organizations think they are getting a good deal if they can reduce the list prices by what appears to them to be a large proportion. These organizations, who advertise themselves as rational agents of cost-control, seem clueless about how hospitals have manipulated their simplistic schemes to discount their charges.
This is another argument for physicians assuming the role of watchdogs on behalf of their patients, guarding them against the incompetence and self-interest of powerful health care organizations.

Princess Health and Secret Hospital "List Prices" Revealed in San Jose.Princessiccia

Princess Health and Secret Hospital "List Prices" Revealed in San Jose.Princessiccia

health care prices hospitals

Gusty 13:12 Add Comment

A real health care market would require we have informed consumers who can make rational decisions. We have shown how some hospitals seem to be using marketing to undermine their patients' rational decision making. Meanwhile, patients are often completely in the dark about how much hospitals charge for their services.
A new California law has forced hospitals to disclose previously secret "list prices" for health care services. The San Jose Mercury News reports how hospitals in the San Jose area have wildly varying list prices for the same services:

• Comprehensive metabolic panel (blood test), $149 to $520
• One-day medical surgical stay, $1909 to $3900
• Screening mammogram, $95 to $405

At least one hospital spokesperson was frank about the lack of relationship between "list prices" and actual costs. Jan Emerson, a spokesperson for the California Hospital Association, stated "There's zero connection between costs, charges, and reimbursements. In many cases, to get $5 more from the health plans you have to raise your charges $50 or more."
The hospitals may be using inflated prices as a tool to extract more reimbursement from managed care organizations and insurance companies. These "list prices," however, are not without consequences for patients.
While insurance companies or managed care organizations usually pay just a fraction of these "list prices," the uninsured, who are often poor, may be charged the full prices, and may or may not easily obtain discounts. The article included the anecdote of an uninsured waiter who was charged a total of $43,000 by a not-for-profit hospital and his surgeon for an appendectomy. The hospital later offered him a discounted charge of $21,000, but this was still too much for him to afford. We have posted other examples of hospitals charging the uninsured their full, often stratospheric "rack rates." (Also see this post.)
The article noted that Medicare and managed care organizations often make their reimbursements functions of the "list prices," providing an inducement for hospitals to raise these prices as high as they can.
This last point is important. One would think that managed care organizations, which have been promoted primarily because of their ability to control costs, might have some idea what reasonable reimbursement might be for common health care services, regardless of how high hospitals set their "list prices." However, they seem to think they are getting a good deal if they can achieve a certain percentage discount from whatever the hospital charges, no matter how high it is. (Recall an earlier example of UnitedHealth being willing to reimburse a Tenet hospital $1275 after the hospital charged $2713 for a one-hour physical therapy evaluation session. Presumably this kind of astute bargaining is why the CEO of United Health Group got over $124 million in total compensation in 2004.)
In summary, although a true market for health care requires that consumers have complete pricing information, hospitals have traditionally kept the prices of their services secret. Furthermore, their list prices often seem wildly inflated, because managed care organizations think they are getting a good deal if they can reduce the list prices by what appears to them to be a large proportion. These organizations, who advertise themselves as rational agents of cost-control, seem clueless about how hospitals have manipulated their simplistic schemes to discount their charges.
This is another argument for physicians assuming the role of watchdogs on behalf of their patients, guarding them against the incompetence and self-interest of powerful health care organizations.

Princess Health and Detroit Hospitals' Advertising War. Princessiccia

Princess Health and Detroit Hospitals' Advertising War. Princessiccia

deception hospitals marketing

Gusty 12:51 Add Comment

Although pharmaceutical companies have been rightly criticized for pushing marketing rather than science, they are not the only health care organizations that may do so.
The Detroit News reports on an advertising war being waged by area hospitals. What's notable is how some hospitals, as the paper put it, "say hawking hospital services is no different than selling cola or a car." (The quote is of the article, but was not attributed to a particular person by the reporter.)
In particular, Beaumont Hospital has pursued an advertising campaign to get patients to pick a Beaumont doctor. Its web-site has a pop-up that flashes, "Are you at risk for a heart attack? Do you have a Beaumont doctor?"
Beaumont Director of Marketing and Public Affairs Michael Killian defended the campaign, first noting that patients still need to check out their doctors themselves, "Patients ought to ask every question they can, probe into everything that worries them." But he justified the "foreboding" advertising by saying that connecting with patients emotionally is necessary to get them to seek needed care, "People don't make decisions based on fact. They make decisions based on feeling. If you don't connect with somebody emotionally, you don't connect."
Emotional appeals are unlikely to create better informed patients. Cynically advocating decision making based on emotions may bring in more money, but is unlikely to inspire better decision making.
As I stated in my comment below, physicians need to become watchdogs with loud barks and sharp teeth who will protect patients against all kinds of exploitation by all kinds of powerful health care organizations.

Princess Health and Detroit Hospitals' Advertising War.Princessiccia

Princess Health and Detroit Hospitals' Advertising War.Princessiccia

deception hospitals marketing

Gusty 12:51 Add Comment

Although pharmaceutical companies have been rightly criticized for pushing marketing rather than science, they are not the only health care organizations that may do so.
The Detroit News reports on an advertising war being waged by area hospitals. What's notable is how some hospitals, as the paper put it, "say hawking hospital services is no different than selling cola or a car." (The quote is of the article, but was not attributed to a particular person by the reporter.)
In particular, Beaumont Hospital has pursued an advertising campaign to get patients to pick a Beaumont doctor. Its web-site has a pop-up that flashes, "Are you at risk for a heart attack? Do you have a Beaumont doctor?"
Beaumont Director of Marketing and Public Affairs Michael Killian defended the campaign, first noting that patients still need to check out their doctors themselves, "Patients ought to ask every question they can, probe into everything that worries them." But he justified the "foreboding" advertising by saying that connecting with patients emotionally is necessary to get them to seek needed care, "People don't make decisions based on fact. They make decisions based on feeling. If you don't connect with somebody emotionally, you don't connect."
Emotional appeals are unlikely to create better informed patients. Cynically advocating decision making based on emotions may bring in more money, but is unlikely to inspire better decision making.
As I stated in my comment below, physicians need to become watchdogs with loud barks and sharp teeth who will protect patients against all kinds of exploitation by all kinds of powerful health care organizations.

Princess Health and Questionable Deliberations on the Vagus Nerve Stimulator to Treat Severe Depression. Princessiccia

Princess Health and Questionable Deliberations on the Vagus Nerve Stimulator to Treat Severe Depression. Princessiccia

Cyberonics FDA

Gusty 15:01 Add Comment

The NY Times reports on the curious deliberations by a US Food and Drug Administration (FDA) expert advisory panel on the approval of an implanted vagus nerve stimulator as a treatment for severe depression. The committee was informed about the results of a randomized controlled trial which, as far as I can tell after several PubMed searches, has not yet been published.
The Times reports the trial showed that 17/111 patients who had the stimulator implanted and turned on had improvements in "standard measures of disease severity," while 11/110 who had it implanted, but not turned on also improved. This small increase in the likelihood of improvement was not statistically significant, i.e., could have been due to chance alone, rather than be an effect of the device. Furthermore, the absolute benefit increase implied by these data is at most 4.3%. That is, were 100 people to get the device, this data implies only 4 of them might improve because of it, while the rest would either not improve, or would have improved even without it.
Nonetheless, after hearing some emotional testimonials by patients who claimed that the device helped them, the advisory committee voted to make the device "approvable." The panel's chair, Dr. Kyra Becker, said "the feeling was that anything that gives these people hope is potentially worthwhile." However, one dissenter, Dr. Richard Malone, was bewildered by the panel's decision, "I walked out of there thinking I was nuts. It was stunning, but then I find much of life stunning."
The FDA does not have as rigorous standards to approve devices as those to approve drugs. However, when a device costs $15,000, is invasive, cannot be easily removed, and at best seems as if it may help only a small minority of patients, as is the case for the vagus nerve stimulator, the wisdom of these relatively lax standards comes into question.
Another question is why a scientific advisory committee, staffed ostensibly by medical experts, seemed more attentive to testimonials than to the results of a randomized controlled trial. Perhaps we will get some answers from an investigation by the Senate Finance Committee, which apparently is ongoing.

Princess Health and Questionable Deliberations on the Vagus Nerve Stimulator to Treat Severe Depression.Princessiccia

Princess Health and Questionable Deliberations on the Vagus Nerve Stimulator to Treat Severe Depression.Princessiccia

Cyberonics FDA

Gusty 15:01 Add Comment

The NY Times reports on the curious deliberations by a US Food and Drug Administration (FDA) expert advisory panel on the approval of an implanted vagus nerve stimulator as a treatment for severe depression. The committee was informed about the results of a randomized controlled trial which, as far as I can tell after several PubMed searches, has not yet been published.
The Times reports the trial showed that 17/111 patients who had the stimulator implanted and turned on had improvements in "standard measures of disease severity," while 11/110 who had it implanted, but not turned on also improved. This small increase in the likelihood of improvement was not statistically significant, i.e., could have been due to chance alone, rather than be an effect of the device. Furthermore, the absolute benefit increase implied by these data is at most 4.3%. That is, were 100 people to get the device, this data implies only 4 of them might improve because of it, while the rest would either not improve, or would have improved even without it.
Nonetheless, after hearing some emotional testimonials by patients who claimed that the device helped them, the advisory committee voted to make the device "approvable." The panel's chair, Dr. Kyra Becker, said "the feeling was that anything that gives these people hope is potentially worthwhile." However, one dissenter, Dr. Richard Malone, was bewildered by the panel's decision, "I walked out of there thinking I was nuts. It was stunning, but then I find much of life stunning."
The FDA does not have as rigorous standards to approve devices as those to approve drugs. However, when a device costs $15,000, is invasive, cannot be easily removed, and at best seems as if it may help only a small minority of patients, as is the case for the vagus nerve stimulator, the wisdom of these relatively lax standards comes into question.
Another question is why a scientific advisory committee, staffed ostensibly by medical experts, seemed more attentive to testimonials than to the results of a randomized controlled trial. Perhaps we will get some answers from an investigation by the Senate Finance Committee, which apparently is ongoing.

Princess Health and Jacobi Hospital's Executive Director Fired. Princessiccia

Princess Health and Jacobi Hospital's Executive Director Fired. Princessiccia

Jacobi Hospital Mismanagement

Gusty 14:55 Add Comment

Another quick follow-up on the story about Jacobi Hospital's failure to notify patients about abnormal pap smear results.
The NY Times reports that in an unusually fast response, the hospital's executive director and deputy director of nursing services have been fired. The hospital's chief operating officer (COO) and medical director have received disciplinary warnings.
Coincidentally, the NY Daily News noted that the hospital's executive director was previously employed at Staten Island University Hospital, which has just settled its second big case of Medicaid fraud.

Princess Health and Jacobi Hospital's Executive Director Fired.Princessiccia

Princess Health and Jacobi Hospital's Executive Director Fired.Princessiccia

Jacobi Hospital Mismanagement

Gusty 14:55 Add Comment

Another quick follow-up on the story about Jacobi Hospital's failure to notify patients about abnormal pap smear results.
The NY Times reports that in an unusually fast response, the hospital's executive director and deputy director of nursing services have been fired. The hospital's chief operating officer (COO) and medical director have received disciplinary warnings.
Coincidentally, the NY Daily News noted that the hospital's executive director was previously employed at Staten Island University Hospital, which has just settled its second big case of Medicaid fraud.

Princess Health and Is the adversary model the answer?. Princessiccia

Princess Health and Is the adversary model the answer?. Princessiccia

Gusty 13:13 Add Comment

In his post of Wed 18 May, Roy Poses commented on the PLoS article by former BMJ editor Richard Smith opining that medical journals have been co-opted into Big Pharma's marketing system. Coincidentally, the BMJ reports that the CEO of Merck has resigned, in a move widely seen as a response to the increasingly damaging disclosures about Merck's marketing of Vioxx (though Merck of course denies any connection).

Merck's campaign for marketing Vioxx was clearly a campaign of deliberate deception, with intensive training of detail reps in specific techniques for misleading physicians about the benefits and concealing the risks of the drug. Should we be surprised? No, not really. Consider what is at stake for any drug company marketing a new agent. Hundreds of millions of dollars have gone into its development. Even though the company itself probably hasn't paid for much if any of the actual basic science or discovery, the development of someone else's discovery to marketability costs a bloody fortune. There's no predicting whether it'll be a big seller, a market mediocrity, or a fiasco that proves dangerous but only after all the costs are incurred.

When big money is at stake, people will lie. It's human nature. Are they "bad people"? No, they're people. As the Milgrom experiment and others showed, and WWII gruesomely illustrated, the majority of people can convince themselves that literally anything - no matter how abhorent - is OK. We vastly underestimate in our usual thinking how readily people will believe what's in their interest to believe. Not just a few "bad apples", but the majority of normal people. Further, those few who are squeamish about fibbin' a bit in marketing the product are selected out at low rungs on the corporate ladder in Big Pharma. The upshot is that we just plain have to assume that Big Pharma will lie. Not because they're evil, but because they're humans in a system where extremely strong incentives exist to do so.

So what do we do? Well, we could propose that drug development be placed in the hands of neutral foundations or some similar arrangment that divorces self-interest from the product. Personally, I doubt that will work well though. The nice thing about self-interest is that it really motivates people. Only self-interest will reliably make the majority of people really work hard. Folks just naturally coast a bit if they don't have skin in the game. (You don't need to point to the economic failure of communism to illustrate that point; just check out any organization that has no competitors. Go down to the Secretary of State's office to get your driver's license paperwork, for example.)

So it's time we formally and clearly recognized that doctors and their patients vs. Big Pharma is an adversary relationship. Like prosecutors and defense attorneys, we need each other and society needs us both, but like any good defense attorney we're nuts to trust anything the prosecutor says. (The metaphor is apt, sadly, as the shocking number of falsely convicted men freed from death row or life imprisonment over the last decade demonstrates.) If we want to do the best for our patients, we need to behave adversarially toward Big Pharma. Don't socialize; assume an ulterior motive; if given a paper "proving benefit" look for how it might have been fudged or find out how many negative papers are being kept out of view; never believe industry-funded clinical trials; assume risks are being downplayed and benefits overplayed.

An adversary relationship will put a real crimp in the incomes of quite a few physicians who are used to taking drug money. It'll also raise some serious financing issues for CME, but it's time those came out on the table anyway. Patients deserve much more aggressive protection of their interests than our profession's cozy relationship with Big Pharma has provided. Time to un-cozy.