From the NYT comes the news that Merck flacks were the real authors of "dozens of research studies" on Vioxx that were then shopped around to name-brand physicians. (WaPo reports as well, here.) Presumably, docs who agreed received some kind of compensation--even if it was just another publication, which is the currency of academic science--for adding their names to the papers and submitting them to journals for peer review and publication. You can read the source article from the Journal of the American Medical Association here.
What's the big deal? Well, for starters, there's the potential for conflict of interest when a drug manufacturer (or anyone else) writes up positive research results about a product in which they have a financial interest. Disclosing such interests is the usual "solution." In this case, there wasn't just non-disclosure; rather, there seem to have been purposeful steps to make it appear as though Merck wasn't involved. Moreover, from the standpoint of research ethics, it's not kosher for people to attach their names to papers they had no role in writing, or research they weren't involved in.
The news also raises the question of whether the research results reported are, in fact, valid and trustworthy. Journal articles are the primary way the medical community learns about advances in clinical care. If people or corporations are willfully putting bad information into the system, patients could suffer or be harmed as a result. The sketchy track record of Vioxx, combined with the news that at least some of the studies that encouraged its adoption in clinical practice might have been written by its manufacturer .... well, it doesn't look good for Merck.
Showing posts with label pharmaceutical. Show all posts
Showing posts with label pharmaceutical. Show all posts
Wednesday, April 16, 2008
Monday, February 25, 2008
Patient Responsibility for Medical Outcomes
Universal health care in the U.S. would be a step in the right direction toward solving some of our many problems in the area of costs and delivery. One of the numerous pressures on costs are malpractice and negligence lawsuits. Physicians pay astronomical liability premiums. A significant portion of hospitals' budgets is spent on in-house legal departments. All health care providers and facilities are at risk in our litigation-happy society.
The ideal doctor-patient relationship is a partnership. Ultimately, both parties need to agree to participate in the care rendered. Patients should hold up their end of the bargain and refrain from suing their doctors at the drop of a syringe. Tort reform regarding medical practice would provide significant relief. For example, an ombudsman-like system of board review could be implemented. If a physician's actions were deemed to have met the standards of care in her specialty, a potential lawsuit against her could not go forward. Such a system could address both malpractice and negligence.
Cost savings would be enormous and would impact bottom lines across a broad spectrum of agents and agencies. Federal, state, and local resources would be freed-up from costly courtroom expenditures on wasteful medical litigations.
In a groundbreaking example of high-level support for such proposals, the U.S. Supreme Court ruled on 2-20-08 that "makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the FDA approved the device before it was marketed".
A case involving similar preemption for FDA-approved drugs will be heard by the Court in its next term.
This is a welcome trend, both economically and socially. The concept of personal responsibility has been battered and broken-down in the U.S. for many decades. "It's not my fault", people claim. "Twinkie's made me do it." Yes, a doctor prescribed a drug. Yes, a medical device was used. Yes, that drug or device had a manufacturer. But the patient agreed to treatment. Medicine is an art. There are frequent unexpected outcomes. Of course, we want to uphold best practices. Given best practices, lawsuits in medicine are inappropriate and need to be reined-in.
Manufacturers of defective products will still be liable. However, quality control is not a 100% guarantee. One malfunctioning device in an otherwise successfully deployed lot should not be grounds for a multimillion dollar lawsuit. Risks need to be shared. Full disclosure and informed consent are the tools to make these lawsuits go away.
Likewise for drugs. It seems obvious that the bottom line for global pharmaceutical companies is stock price and shareholder value rather than patient welfare. It may be that ultimately, in many cases, reliance on pharmaceuticals is misguided. In Global Pharmaceuticals: Ethics, Markets, Practices, Adriana Petryna and Arthur Kleinman describe the American "fetishization of pharmaceuticals" and the "pharmaceuticalization of certain disorders".
On 2-15-08 the FDA proposed new guidelines that "would allow drug and device makers to provide doctors with copies of medical journal articles" that discuss off-label product uses. The rules also say "drug companies do not have to promise to adequately test the unapproved use discussed in the article".
These proposed guidelines represent a radical sea change in policy. On the surface, they seem to pander to the desires of big pharma. This seems very problematic. On the other hand, FDA approval is not a guarantee of development of significant side-effects, as with the COX-2 inhibitors such as Vioxx.
The reality is that most drugs are not magic bullets. The playing field has shifted. Patients need to be protected, and that protection is best offered by regulation and information. But our regulatory system seems badly broken, and off-label usage may provide great benefit. Or it may not.
Medical risks need to be shared. Patients are not merely consumers. They are obligated to do their best to make informed choices. On the other hand, physicians need to clean-up their questionable relationships with drug manufacturers and drug representatives.
We want a health care system based on best practices, not based on most money.
The ideal doctor-patient relationship is a partnership. Ultimately, both parties need to agree to participate in the care rendered. Patients should hold up their end of the bargain and refrain from suing their doctors at the drop of a syringe. Tort reform regarding medical practice would provide significant relief. For example, an ombudsman-like system of board review could be implemented. If a physician's actions were deemed to have met the standards of care in her specialty, a potential lawsuit against her could not go forward. Such a system could address both malpractice and negligence.
Cost savings would be enormous and would impact bottom lines across a broad spectrum of agents and agencies. Federal, state, and local resources would be freed-up from costly courtroom expenditures on wasteful medical litigations.
In a groundbreaking example of high-level support for such proposals, the U.S. Supreme Court ruled on 2-20-08 that "makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the FDA approved the device before it was marketed".
A case involving similar preemption for FDA-approved drugs will be heard by the Court in its next term.
This is a welcome trend, both economically and socially. The concept of personal responsibility has been battered and broken-down in the U.S. for many decades. "It's not my fault", people claim. "Twinkie's made me do it." Yes, a doctor prescribed a drug. Yes, a medical device was used. Yes, that drug or device had a manufacturer. But the patient agreed to treatment. Medicine is an art. There are frequent unexpected outcomes. Of course, we want to uphold best practices. Given best practices, lawsuits in medicine are inappropriate and need to be reined-in.
Manufacturers of defective products will still be liable. However, quality control is not a 100% guarantee. One malfunctioning device in an otherwise successfully deployed lot should not be grounds for a multimillion dollar lawsuit. Risks need to be shared. Full disclosure and informed consent are the tools to make these lawsuits go away.
Likewise for drugs. It seems obvious that the bottom line for global pharmaceutical companies is stock price and shareholder value rather than patient welfare. It may be that ultimately, in many cases, reliance on pharmaceuticals is misguided. In Global Pharmaceuticals: Ethics, Markets, Practices, Adriana Petryna and Arthur Kleinman describe the American "fetishization of pharmaceuticals" and the "pharmaceuticalization of certain disorders".
On 2-15-08 the FDA proposed new guidelines that "would allow drug and device makers to provide doctors with copies of medical journal articles" that discuss off-label product uses. The rules also say "drug companies do not have to promise to adequately test the unapproved use discussed in the article".
These proposed guidelines represent a radical sea change in policy. On the surface, they seem to pander to the desires of big pharma. This seems very problematic. On the other hand, FDA approval is not a guarantee of development of significant side-effects, as with the COX-2 inhibitors such as Vioxx.
The reality is that most drugs are not magic bullets. The playing field has shifted. Patients need to be protected, and that protection is best offered by regulation and information. But our regulatory system seems badly broken, and off-label usage may provide great benefit. Or it may not.
Medical risks need to be shared. Patients are not merely consumers. They are obligated to do their best to make informed choices. On the other hand, physicians need to clean-up their questionable relationships with drug manufacturers and drug representatives.
We want a health care system based on best practices, not based on most money.
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