Princess Health and An Australian Survey of Threats to Research Integrity. Princessiccia

Princess Health and An Australian Survey of Threats to Research Integrity. Princessiccia

manipulating clinical research suppression of medical research surveys

Gusty 07:48 Add Comment

Another important article on threats to the integrity of clinical research has appeared in the Medical Journal of Australia. (Henry DA et al. Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience. Med J Aust 2005; 182: 557-560.)
The authors sent a survey to 5000 Australian specialists, excluding general practitioners, but also surgeons and anesthesologists, and obtained a 39% response rate. 388 specialists (41% of respondents) had done pharmaceutical industry sponsored research. Of these,

• 100 (25.7% of those engaging in research) reported that the first draft of a research report was written by pharmaceutical company or contract research organization personnel
• 55 (14.2%) reported a delay in presentation or publication of key study findings
• 41 (10.6%) reported failure to publish key findings
• 22 (5.7%) reported editing of the report to make the drug appear better than was justified by the study results
• 18 (4.6%) reported concealment of relevant findings.

This study suggests that manipulation and suppression of research results in favor of commercial research sponsors' products is an international pheonomenon, and one that involves not only academic researchers but those in private practice.
An accompanying editorial (Gotzsche PC. Research integrity and pharmaceutical industry sponsorship. Med J Aust 2005; 182: 549-550) suggested that "testing drugs in patients" should be "a public enterprise." It asked, "who would buy a washing machine that is five or 10 times more expensive than other washing machines just because its manufacturer has compared it with other machines and claims that it is the best?"
Thanks to Sue Pelletier's Capsules blog for the tip.

Princess Health and An Australian Survey of Threats to Research Integrity.Princessiccia

Princess Health and An Australian Survey of Threats to Research Integrity.Princessiccia

manipulating clinical research suppression of medical research surveys

Gusty 07:48 Add Comment

Another important article on threats to the integrity of clinical research has appeared in the Medical Journal of Australia. (Henry DA et al. Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience. Med J Aust 2005; 182: 557-560.)
The authors sent a survey to 5000 Australian specialists, excluding general practitioners, but also surgeons and anesthesologists, and obtained a 39% response rate. 388 specialists (41% of respondents) had done pharmaceutical industry sponsored research. Of these,

• 100 (25.7% of those engaging in research) reported that the first draft of a research report was written by pharmaceutical company or contract research organization personnel
• 55 (14.2%) reported a delay in presentation or publication of key study findings
• 41 (10.6%) reported failure to publish key findings
• 22 (5.7%) reported editing of the report to make the drug appear better than was justified by the study results
• 18 (4.6%) reported concealment of relevant findings.

This study suggests that manipulation and suppression of research results in favor of commercial research sponsors' products is an international pheonomenon, and one that involves not only academic researchers but those in private practice.
An accompanying editorial (Gotzsche PC. Research integrity and pharmaceutical industry sponsorship. Med J Aust 2005; 182: 549-550) suggested that "testing drugs in patients" should be "a public enterprise." It asked, "who would buy a washing machine that is five or 10 times more expensive than other washing machines just because its manufacturer has compared it with other machines and claims that it is the best?"
Thanks to Sue Pelletier's Capsules blog for the tip.

Princess Health and Two Massachusetts Hospitals to Offer Discounts Off "List Prices" for Uninsured Patients. Princessiccia

Princess Health and Two Massachusetts Hospitals to Offer Discounts Off "List Prices" for Uninsured Patients. Princessiccia

health care prices Partners Healthcare UMass Memorial Health Care

Gusty 13:44 Add Comment

Two Massachusetts hospital systems will begin offering discounts off "list prices" for uninsured patients, according to the Boston Globe. The systems are Partners HealthCare and UMass Memorial Health Care. The article noted that most hospitals do not routinely give such patients discounts. These two hospitals' policies are "among the first formal, publicized policies in Massachusetts that guarantee discounts to a broad group of patients and don't depend on patients requesting a markdown," according to the Globe.
Not emphasized in this article was how high "list prices" are at most hospitals. For example, see previous posts here, here and here.
This actions by Partners and UMass are a great first step, but the article does underline who widespread the practice of charging uninsured patients full freight has become. Susan Sherry, of Community Catalyst, asserted that many hospitals are either not offering discounts or are keeping them secret (see the report by the Access Project here). She did applaud the actions by Partners and UMass, "this is kind of out there in terms of national leadership. They're doing much more than hospitals in other parts of the country."

Princess Health and Two Massachusetts Hospitals to Offer Discounts Off "List Prices" for Uninsured Patients.Princessiccia

Princess Health and Two Massachusetts Hospitals to Offer Discounts Off "List Prices" for Uninsured Patients.Princessiccia

health care prices Partners Healthcare UMass Memorial Health Care

Gusty 13:44 Add Comment

Two Massachusetts hospital systems will begin offering discounts off "list prices" for uninsured patients, according to the Boston Globe. The systems are Partners HealthCare and UMass Memorial Health Care. The article noted that most hospitals do not routinely give such patients discounts. These two hospitals' policies are "among the first formal, publicized policies in Massachusetts that guarantee discounts to a broad group of patients and don't depend on patients requesting a markdown," according to the Globe.
Not emphasized in this article was how high "list prices" are at most hospitals. For example, see previous posts here, here and here.
This actions by Partners and UMass are a great first step, but the article does underline who widespread the practice of charging uninsured patients full freight has become. Susan Sherry, of Community Catalyst, asserted that many hospitals are either not offering discounts or are keeping them secret (see the report by the Access Project here). She did applaud the actions by Partners and UMass, "this is kind of out there in terms of national leadership. They're doing much more than hospitals in other parts of the country."

Princess Health and Waxman Summarizes the Marketing of Vioxx. Princessiccia

Princess Health and Waxman Summarizes the Marketing of Vioxx. Princessiccia

deception marketing Merck Vioxx

Gusty 13:27 Add Comment

The current issue of the New England Journal of Medicine also continues the journal's new skeptical approach to the business practices of the pharmaceutical industry with a second perspectives article, by Congressman Harvey Waxman, that reviews the results of his committee's investigation of the marketing of Vioxx. (Waxman JA. The lesson of Vioxx - drug safety and sales. N Engl J Med 2005; 352: 2576-2578.) (The most recent of the many Health Care Renewal posts on Vioxx is here.)
Waxman summarized techniques Merck used to try to minimize the cardiovascular adverse effects of Vioxx in its marketing efforts to physicians. Techniques included:

• Avoiding discussion of a specific study, the VIGOR study, which showed that Vioxx increased cardiovascular events
• Distributing outdated data from weaker studies that had not shown cardiovascular adverse effects, on a "Cardiovascular Card"
• Identifying speakers for "educational events" who would be "favorable" to Merck products
• Using "subliminal selling techniques" beyond intellectual persuasion.

Most strikingly, Waxman noted "Merck's marketing practices may be less aggressive and more ethical than those of many of its competitors."
My comment is that this suggests that the pharmaceutical industry ought to inject big doses of ethics and transparency into its marketing. But a quick scan of Health Care Renewal would also suggest that many large health care organizations, not just pharmaceutical manufacturers, could use similar injections of ethics and transparency into their business practices.

Princess Health and Waxman Summarizes the Marketing of Vioxx.Princessiccia

Princess Health and Waxman Summarizes the Marketing of Vioxx.Princessiccia

deception marketing Merck Vioxx

Gusty 13:27 Add Comment

The current issue of the New England Journal of Medicine also continues the journal's new skeptical approach to the business practices of the pharmaceutical industry with a second perspectives article, by Congressman Harvey Waxman, that reviews the results of his committee's investigation of the marketing of Vioxx. (Waxman JA. The lesson of Vioxx - drug safety and sales. N Engl J Med 2005; 352: 2576-2578.) (The most recent of the many Health Care Renewal posts on Vioxx is here.)
Waxman summarized techniques Merck used to try to minimize the cardiovascular adverse effects of Vioxx in its marketing efforts to physicians. Techniques included:

• Avoiding discussion of a specific study, the VIGOR study, which showed that Vioxx increased cardiovascular events
• Distributing outdated data from weaker studies that had not shown cardiovascular adverse effects, on a "Cardiovascular Card"
• Identifying speakers for "educational events" who would be "favorable" to Merck products
• Using "subliminal selling techniques" beyond intellectual persuasion.

Most strikingly, Waxman noted "Merck's marketing practices may be less aggressive and more ethical than those of many of its competitors."
My comment is that this suggests that the pharmaceutical industry ought to inject big doses of ethics and transparency into its marketing. But a quick scan of Health Care Renewal would also suggest that many large health care organizations, not just pharmaceutical manufacturers, could use similar injections of ethics and transparency into their business practices.

Princess Health and "Crying All the Way to the Bank" Revisited: Pfizer's Trials of Torcetapib-Atorvastatin. Princessiccia

Princess Health and "Crying All the Way to the Bank" Revisited: Pfizer's Trials of Torcetapib-Atorvastatin. Princessiccia

manipulating clinical research Pfizer

Gusty 13:05 Add Comment

The current issue of the New England Journal of Medicine continues the journal's recent skeptical approach to the business practices of pharmaceutical companies. A perspectives article (Avorn J. Torcetrapib and atorvastatin - should marketing drive the research agenda? N Engl J Med 2005; 352: 2573-2576) reviews Pfizer's trials of a new drug that may boost HDL ("good") cholesterol, torcetrapib, but only in fixed combination with Pfizer's block-buster "statin," Lipitor (atorvastatin).
Since the US Food and Drug Administration (FDA) has approved this approach, should the trials be succesful, Pfizer would be allowed to market the new torcetrapib-atorvastatin combination as a brand-name drug beyond 2010, when its patent on Lipitor runs out. The FDA approval also would allow Pfizer to avoid the risk of anti-trust litigation, which otherwise might have been engendered by it offering a drug only when "bundled" with another of its products.
The trials would not result in any information about how torcetrapib performs alone, or in combination with a statin other than atorvastatin. Physicians would not have the options of prescribing torcetrapib alone, in combination with generic atorvastatin, or in combination with another statin. Thus this approach would limit scientific data available to physicians and researchers, and would limit therapeutic options for patients.
We previously posted about this issue here, based on a March New York Times article.
Avorn commented,

• "the current trial design may not optimally meet the scientific needs of prescribers, the clinical needs of patients, the economic needs of payers, or the regulatory needs of policymakers. But they superbly meet the business needs of the sponsore - to create new knowledge in a way that will protect the market share of the largest drug company's most important product."

Therefore, he concluded, "the torcetrapib story suggests that we have become too dependent on manufacturers as the predominant source of our scientific knowledge about the effects of medication." He thus advocates having the National Institutes of Health (NIH) start supporting "public-interest" drug trials "fairly comparing competing therapies (especially costly new ones) with clinically realistic alternatives."
Maybe now that the NIH has strict conflict-of-interest rules, and top NIH officials are no longer allowed to get lucrative consulting contracts with pharmaceutical companies, (see post here), this idea will get more welcome reception there.