Medicine Looks to Online Disclosure to Address Financial Conflicts of Interest
In the January 22, 2009 online issue of the New England Journal of Medicine, Dr. Robert Steinbrook discusses how physicians and medical institutions can profitably use the internet to disclose information concerning relationships with the drug and device industry. That the medical community is doing so is welcome news, for several reasons. It will serve as a public relations boost at a time when the limited disclosure of such relationships has embittered patients and the public. But it will also allow the public to delve into the relationships, and the knowledge, as Dr. Steinbrook puts it, can “be used as a starting point for asking questions.” This is a move in the right direction. Has the drug and device industry taken a cue from President Obama’s call for greater transparency (in the federal government, anyway)?
It gets better. Not only are the medical institutions disclosing this information, but the manufacturers themselves have pledged to do so. Dr. Steinbrook notes that “Eli Lilly and Merck have said that they will soon begin disclosing on their web sites some payments to physicians…” I’m liking this news.
Use of Electronic Medical Records Hits Snag at VA Facilities
The good news is that VA health centers around the country have begun implementing the use of electronic medical records for their patients. The bad news is that since a software upgrade in August of 2008, various glitches in the computerized records have put VA patients at risk. And the worse news, according to today’s AP News, is that the VA kept it all a secret, failing to even alert the very patients it had put at risk.
According to the AP, the errors occurred at 1/3 of the VA’s 153 medical centers. The glitches resulted in incorrect displays of patients’ health records, which led to the giving of incorrect doses of medications, and delays in treatment. Vital signs, lab results, and listings of current medications were displayed under names other than the actual patient’s, and stop orders for medications were not properly displayed, which resulted in some patients continuing to receive medication no longer needed.
President-elect Obama continues to push for full-scale implementation of electronic medical records. It is probably unrealistic to expect that making such a vast change in American healthcare will happen without problems. But it does not help the process when federal agencies like the VA apparently value public relations over the health and peace of mind of the veterans for whom they are charged with caring.
FDA’s Lax Methodology, Part 2
In my December 10 posting, I discussed how physicians are troubled by the FDA’s lax methodology in conducting clinical trial of drugs and medical devices. In today’s Torts Prof Blog, Bill Childs points out that today’s NY Times features an article by Gardiner Harris entitled, “F.D.A. Is Lax On Oversight During Trials, Inquiry Finds.”
The focus of today’s news is the FDA’s historic failure to address the financial conflicts of doctors conducting clinical trials of drugs and medical devices. Apparently, there are growing concerns that money accepted by doctors from drug and device makers “may hurt patients and skew studies,” according to Mr. Gardiner.
You may remember that in my January 9 posting, I noted that the New England Journal of Medicine had instituted a new policy to disclose financial conflicts of its physician-authors, news to which I was alerted by Gardiner Harris’s article in that day’s NY Times.
I am hopeful that our President-Elect’s appointment of a new Surgeon General will help get the FDA back on track. It would be nice to see that organization receive some press that did not reveal the existence of sloppy and potentially dangerous procedures.
In the meanwhile, it is outrageous that federal preemption remains available to protect drug and device companies whose products have been cleared by the FDA from lawsuits by victims of negligence in state courts. When the FDA’s own clinical trials are suspect, the products that have passed clinical trials are suspect. So it should not come as a shock that they might injure or kill an end user. It is simply not fair to prevent a medical consumer who relied on the FDA’s “stamp of approval” from seeking redress in state court. Stay tuned.