Hi all,

I’m Owen Schaefer, one of the authors of the article being discussed here. Rose was kind enough to e-mail us about your discussions here, and I thought I’d respond to a few of the points people have brought up.

First of all, it’s great to see so many of you have thoughtful and insightful comments into this interesting issue. I’m a philosopher by training, and so I love a good discussion and can’t help but feel the article did its job when others feel encouraged by it to engage critically in our work and consider the larger issue of clinical trial participation.

Quick disclaimer: my comments below solely reflect my own opinion and not those of the NIH, which employs me, or the AMA, which runs JAMA, where the article was published. The article similarly solely reflects the authors’ opinions, not those of the NIH or JAMA. It’s analogous to an op-ed piece in the newspaper, as opposed to an editorial.


So, I should clarify the way I take the delay in generic drug availability to work vis-à-vis public goods. When a study is published proving the effectiveness of a patented drug, that knowledge becomes a public good essentially immediately, or at least after a few weeks. That’s because the good of knowledge is public not through the general population knowing about it – even if the journals were free, most people probably wouldn’t have the time, energy or expertise to become familiar with all the new advances – but rather through new or improved options becoming available via one’s physician, nurse-practitioner, etc.

The price of drugs, then, has bearing not directly on the good being public, but on how useful it is. Knowledge concerning very expensive treatments count as public goods, too – but ones that are less important, since fewer people will have access to the treatment. There are, indeed, many who would support shortening patent lengths for pharmaceuticals as a way to make such drugs more useful to society – after all, thanks in part to those patent laws, pharma is more absurdly profitable than almost any other major US industry – including oil, financial services and computing.

Even so, those who cannot currently afford cutting-edge patented products should think on this: without participants in the past who contributed to research, we would have fewer and know much less about generic medications available right now. You may have to wait until the patent expires in 2012 for generic Azilect, but what about currently-generic drugs like Sinemet (generic: Levodopa) or Parlodel (generic: Bromocriptine)? Nearly all of them underwent clinical trials with patient volunteers at some point. It might be true that by participating in a trial, you won’t be able to take advantage of that trial’s resultant medication due to cost and time, but you can take advantage of drugs that will soon become generic, thanks to previous individuals’ willingness to participate in trials. There’s an obligation, I think, to do one’s fair share in getting reliable, useful knowledge on such drugs.

There may be a subset of the population for whom the following is true: overall, recent and projected developments in medical knowledge will be of only minimal benefit, such that it would not be worth the trouble of participating in a trial to support those benefits. And for those people, there wouldn’t be an obligation to participate. However, it isn’t likely many such people would be found in the U.S., even with our large swathe of uninsured individuals. Consider the swine flu: everyone, including the uninsured, will benefit from a safe and effective vaccine through direct prevention as well as herd immunity. And many drugs given in the ER, where the uninsured often go for treatment, are the result of previous clinical trials – if the ER docs didn’t know about effectiveness of various options, treatment even for the uninsured suffers. Our system may be very inefficient at getting care to people, but people of all walks of life still benefit greatly from many medical advances.

To reiterate an important point raised by Rose, people may interpret our article as supporting compulsion to participate research, but that is not so. There are often cases when one might have a moral obligation to do something, but it would also be wrong to compel a person to do that. Free speech cases are like this – it might be wrong to, for instance, make a speech in favor of a political position when in fact you don’t believe in that position at all – but we usually think it would also be wrong to disallow that speech to be made. The right to privacy over one’s body offers similar protections - while it may be obligatory to participate in trials, it would in standard cases be wrong to compel people to participate.

Finally, I’d like to say a few words on a separate issue some brought up – the therapeutic misconception. Many people enter trials in the hopes of getting access to an effective, cutting-edge treatment. However, it is important to remember this: for a clinical trial to be ethical, it must be unknown in the profession whether or not the new treatment is more effective than standard treatment. If people knew beforehand one treatment was better, then we shouldn’t be wasting time, money and patients’ health in clinical trials. Indeed, in a trial, one is subjected to additional tests and procedures that impose risks and burdens one wouldn’t encounter in usual treatment. Hence, ethicists often talk about the “therapeutic misconception” – the idea that a clinical trial is done for the benefit of the subjects, when in fact it is to benefit future patients. In some cases, it may be in one’s best interest to participate – perhaps when the side-effects of the trial are small, ancillary care one wouldn’t otherwise get is provided, or there is a grim prognosis and the patient has ‘nothing to lose’ on a long shot – but participants should keep in mind the sharp distinction between the goals of research (to gather information for future use) and treatment (to care for the patient in front of you).

Again, thanks for your comments on this article – I’ll be thinking of them when preparing for a panel discussion on this topic at the American Society for Bioethics and Humanities conference in the fall.


G. Owen Schaefer
Fellow
NIH Clinical Center Department of Bioethics
10 Center Drive
Bldg. 10 room 1C118
Bethesda, MD 20892