Research with human subjects

There is a story posted at ProPublica (and co-published with the Chicago Tribune) that examines a particular psychiatrist who was paid by a pharmaceutical company to travel around the U.S. to promote one of that company's antipsychotic drugs. Meanwhile, the psychiatrist was writing thousands of prescriptions for that same antipsychotic drug for his patients on Medicaid. You might think that there would be at least the appearance of a conflict of interest here. However, the psychiatrist in question seems certain that there is not: In an interview and in response to written questions, […

At Terra Sigillata, Abel notes that the Director of Duke University's Catholic Center is butting in to researchers' attempts to recruit participants for their research. As it happens, that research involves human sexuality and attitudes toward sex toys. Here's how Abel lays it out: Father Joe Vetter, director of Duke University's Catholic Center, is protesting trial participant accrual for a study being conducted on campus directed by Dr Dan Ariely, the James B Duke Professor of Behavioral Economics in the Fuqua School of Business (story and video). ... Ariely and his postdoctoral fellow, Dr…

A day later than promised, let's kick off our discussion of "Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site" (PDF). The case study concerns a clinical trial of whether tenofovir, an antiretroviral drug, could prevent HIV infection. Before it was halted in the face of concerns raised by activists and the media, the particular clinical trial discussed in this case was conducted in Cameroon. Indeed, one of the big questions the activists raised about the trial was whether it was ethical to site it in Cameroon. From the case study: Tenofovir was first…

Almost a month ago, I told you about a pair of new case studies released by The Global Campaign for Microbicides which examine why a pair of pre-exposure prophylaxis (PrEP) clinical trials looking at the effectiveness of antiretrovirals in preventing HIV infection were halted. In that post, I also proposed that we read and discuss these case studies as a sort of ethics book club. Next Monday, June 15, we'll be kicking off our discussion of the first case study, "Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site" (PDF). The case study is on the long side (54…

You may have heard that the Obama administration has proposed new rules for federal funding of embryonic stem cell (ESC) research. (The proposed rules are available in draft form through the end of the public comment period; the NIH expects to finalize the rules in July). While researchers are enthusiastic at the prospect under this administration of more funding for ESC research, not everyone is happy about the details of the proposed rules. Indeed, in a recent article in Cell Stem Cell [1], Patrick L. Taylor argues that there is something fundamentally misguided about the way the new…

Earlier this week, I found out about a pair of new case studies being released by The Global Campaign for Microbicides. These cases examine why a pair of pre-exposure prophylaxis (PrEP) clinical trials looking at the effectiveness of microbicides antiretrovirals in preventing HIV infection were halted. Here are some details: Between August 2004 and February 2005 the HIV prevention world was rocked by the suspension and cancellation of PrEP effectiveness trials in Cambodia and Cameroon. To the considerable surprise of researchers, advocates, and donors, the trials became embroiled in…

The Independent reports that drug giant Pfizer has agreed to pay a $75 million settlement nine years after Nigerian parents whose children died in a drug trial brought legal action against the company. It's the details of that drug trial that are of interest here: In 1996, the company needed a human trial for what it hoped would be a pharmaceutical "blockbuster", a broad spectrum antibiotic that could be taken in tablet form. The US-based company sent a team of its doctors into the Nigerian slum city of Kano in the midst of an appaling meningitis epidemic to perform what it calls a "…

DrugMonkey responds to the outgoing Drug Czar's deep concerns about research with illegal drugs conducted with subjects who are addicted to those drugs, those concerns reported in an article in the Washington Examiner. From that article: The federal government is giving crack and powder cocaine, morphine, and other hard-core drugs to taxpayer-funded researchers for testing on addicts, The Examiner has learned. For decades, the government has authorized, funded and lobbied for studies in which otherwise illegal drugs were given to addicts in cities such as Washington, Bethesda, Baltimore,…

In my last post, I started wading into the question of what kinds of ethical questions arise from clinical trials on "alternative" medical treatments, especially clinical trials supported by the National Center on Complementary and Alternative Medicine (NCCAM). The ethical questions include whether alternative treatments expose human subjects to direct harm, or to indirect harm (by precluding a more effective treatment), not to mention whether the money spent to research alternative modalities would be better spent on other lines of research. I think it's worthwhile to dip into the NCCAM…

A little while ago, PalMD put up a post at Whitecoat Underground about the current state of the National Center on Complementary and Alternative Medicine (NCCAM), especially at a moment in history when the federal government is spending loads of money (and thus maybe should be on the lookout for expenditures that might not be necessary) and when health care reform might actually happen. Pal wrote: The whole idea of setting up such an agency is a bit quixotic---after all, the National Institutes of Health already study health science. .... Many, many studies have been funded which fail basic…

The headlines bring news of another scientist (this time a physician-scientist) caught committing fraud, rather than science. This story is of interest in part because of the scale of the deception -- not a paper or two, but perhaps dozens -- and in part because the scientist's area of research, the treatment of pain, strikes a nerve with many non-scientists whose medical treatment may have been (mis-)informed by the fraudulent results. From Anesthesiology News: Scott S. Reuben, MD, of Baystate Medical Center in Springfield, Mass., a pioneer in the area of multimodal analgesia, is said to…

I'm not a regular reader of the Huffington Post, but I received a pointer to an article there that strikes me as worthy of comment. The article, Why I Take Animal-Tested Drugs, was written by Simon Chaitowitz, the former Communications director for the animal rights group Physicians Committee for Responsible Medicine. From the title, you might expect a defense of animal-tested drugs, or at least a coherent explanation for why the author is taking them. However, what the article actually offers is condemnation of the use of animals in biomedical research, and even a claim that animal-tested…

Over at On Becoming a Domestic and Laboratory Goddess, Dr. Isis looks at challenges of opening up participation in human subjects research to potential subjects who are not fluent English speakers: When one enters the university hospital here at MRU, there are a number of skilled and qualified translators that are available to help patients that can't dialogue in English to communicate with health care staff. They are able to sufficiently translate documents to allow a patient to provide some reasonable level of consent (my M.D. blog buddies can debate the quality of said consent). There…

While the ScienceBlogs upgrade was underway, a shiny new Bloggingheads diavlog was posted, featuring yours truly and PalMD. Mostly we talked about medical ethics, with some time spent on ethical issues around research with human subjects.

There's an interesting story on The New Republic website at the moment, "Going Under" by Jason Zengerle, that relates the sad story of a young anesthesiologist's descent into addiction. What I find interesting about it is the larger questions it raises about why this particular anesthesiologist's story is not so unusual. Indeed, the article offers an: Observation: Anesthesiologists seem to suffer from addiction in greater numbers than physicians in other specialties. And, it lays out Three hypotheses as to why this might be so: H1: Anesthesiologists have greater access to the addictive…

Back in November, at the Philosophy of Science Association meeting in Pittsburgh, I heard a really interesting talk by Jeremy Howick of the Centre for Evidence-Based Medicine at Oxford University about the challenges of double-blind trials in medical research. I'm not going to reconstruct his talk here (since it's his research, not mine), but I wanted to give him the credit for bringing some tantalizing details to my attention before I share them with you here. First, he noted that "blinding" might not be as apt a description of what actually happens in medical trials as "masking". A double…

Back in July, Science ran an interesting news article about an on again, off again clinical trial of chelation therapy in the treatment of autistic children. I found the story fascinating because it highlights some of the challenges in setting up ethical research with human subjects -- not to mention some of the challenges inherent in trying to help humans to make good decisions grounded in the best available scientific knowledge. From the Science article: Believing that mercury in vaccines triggers autism, thousands of parents, often at the advice of their physicians, have given their…

In the July 18, 2008 issue of Science, I noticed a news item, "Old Samples Trip Up Tokyo Team": A University of Tokyo team has retracted a published research paper because it apparently failed to obtain informed consent from tissue donors or approval from an institutional review board (IRB). Other papers by the same group are under investigation by the university. Observers believe problems stem in part from guidelines that don't sufficiently explain how to handle samples collected before Japan established informed consent procedures. The samples in question were "legacy samples", samples…

One of the key requirements that researchers conducting studies with human subjects must meet is that they obtain the informed consent of the participating subjects (or of a parent or guardian, if the subject is not able to give informed consent himself or herself). However, there are particular instances where giving the subjects complete information about the study at the outset may change the outcome of the study -- namely, it may make it practically impossible to measure what the research is trying to measure. If these studies are not to be ruled out completely, doing them necessitates…

A colleague of mine (who has time to read actual printed-on-paper newspapers in the morning) pointed me toward an essay by Andrew Vickers in the New York Times (22 January 2008) wondering why cancer researchers are so unwilling to share their data. Here's Vickers' point of entry to the issue: [A]s a statistician who designs and analyzes cancer studies, I regularly ask other researchers to provide additional information or raw data. Sometimes I want to use the data to test out a new idea or method of statistical analysis. And knowing exactly what happened in past studies can help me design…