Not only have less than two in five US medical schools implemented recommended policies governing institutional conflicts of interest, but those recommendations - from the US Department of Health and Human Services - don't address conflicts on the Institutional Review Boards that offer ethical approval for research involving human subjects. And the IRBs are often not informed of conflicts of interest by the researchers seeking approvals of their protocols. That's the take-home message of a blog post by Merrill Goozner, who cites results from a survey released in the new issue of the Journal of the American Medical Association.
Does disclosure of conflicts of interest to members of an IRB -- whether they exist within the institution, the management of the institution, or within the IRB itself -- ensure that the trial under review adheres to the highest ethical standards? Isn't it possible that those conflicts will influence the review? And doesn't the mere presence on the IRB of someone with a stake in the outcome of that trial create the appearance that the conflict of interest may have influenced a decision?...
There is a solution, of course. Forget about "guidance." Congress could step in and pass a law that prohibits investigators or university officials with conflicts of interest from sitting on IRBs and requires NIH to collect conflict-of-interest disclosure data from grant recipients and post it on its grants database (it's known as the CRISP database). To enforce the law, NIH could cut off all federal grants to that institution if those policies aren't adopted by a date specified in the legislation.
New Zealand and the U.S. are the only countries in the developed world that allow drug companies to peddle their prescription wares directly to the public. According to the Government Accountability Office, Big Pharma spent $4.2 billion on direct-to-consumer advertising in the U.S. during 2005 - and that already staggering sum is expanding at about 20% per year, which would put it at $7.25 billion in 2008. Lawmakers in several states have attempted to regulate or restrict the practice, mostly unsuccessfully.
Pharma is also eyeing other markets, and has mounted a major lobbying campaign to allow direct-to-consumer ads in Europe and Canada. Last week, the European Commission, which drafts legislation for the European Parliament, announced a public consultation [PDF] about a proposal to allow drug companies to put "non-promotional information" about prescription drugs on radio and television.
By opening the debate on drug company information provision, the EC is kowtowing to pharma industry's demands to advertise directly to consumers. This is the first step towards US-style drug advertising and concepts such as 'Pharma TV'. Prescription drugs are not washing powders and should not be sold as such. The EC must protect the right of European consumers to independent, impartial information about healthcare.
Want a more scholarly assessment? A 2007 study in the Annals of Family Medicine concluded:
Despite claims that ads serve an educational purpose, they provide limited information about the causes of a disease or who may be at risk; they show characters that have lost control over their social, emotional, or physical lives without the medication; and they minimize the value of health promotion through lifestyle changes. The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting population health.
The Marketing Overdose campaign has produced several short videos - some serious, some spoofs. The drug ads - clearly a tempting target - are also satirized by the U.S. Consumers Union, in the clip embedded here.
Yesterday at the annual biotechnology industry convention, the CEO of the company hoping to develop the first products from human embryonic stem cell research said that he expects the first clinical trials to begin around June of this year. We've highlighted Geron's Thomas Okarma 's habit of promising these clinical trials "next year" in every year since 2004. What's surprising about his advancing the date to just a few months from now is that the timing is completely out of his hands. Geron has submitted the application to the US Food and Drug Administration to test human embryonic stem cells in 40 patients with spinal cord injuries. The ball is now in court of the federal government.
Does Okarma really believe that the feds will so quickly turn around the first application for human testing of an entirely new method of medicine, a technique that has a track record of producing cancer in lab animals? I consider myself lucky if my 1040EZ gets processed in a few months. An analyst in the CNN story is quoted as saying, "This is the first time that a human embryonic stem cell application is being submitted to the FDA, so there's a good chance that some questions will arise." That's putting it mildly.
Investors appear to be skeptical as well. Geron's stock value is up only 2% for the day. That will do little to compensate for the dramatic fall it's taken over the last year, in which it lost nearly half its value.
From a recent Yahoo News story on embryos created with DNA from 3 different people:
"We are not trying to alter genes, we're just trying to swap a small proportion of the bad ones for some good ones," said Patrick Chinnery, a professor of neurogenetics at Newcastle University involved in the research.