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.
The latest moves are considerations by the government to alter the long-debated bill to revise oversight of assisted reproduction and research with embryos. Under the its current version, tissue donors must consent for their cells to be used in cloning-based stem cell research, and children must be "competent" in order to give consent. This makes sense, even beyond the typical goals of informed consent: The cloning process raises novel questions, and many potential research subjects will be opposed to the creation of embryonic clones of themselves. Furthermore, if a stem cell line were to be successfully derived through this technique, the subject's genetic material could be propagated and spread throughout the world, raising concerns of genetic privacy.
(Using an unfortunately common tactic, the advocates for this change cite the medical necessity of cloning-based stem cell research in a way that distorts the fact that no stem cell lines have yet been derived in this manner. This language is not only unchallenged by the media, but is parroted.)
Regardless, there is a clear trend on both sides of the Atlantic in bioethics rhetoric, recommendations, and policy. The potential benefits of research are increasingly seen as more important than the need to obtain informed consent.
Of course, these are examples of a common tension within bioethics. But there are strong reasons, many of which are historical, that the first sentence of the Nuremberg Code is, "The voluntary consent of the human subject is absolutely essential."