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.