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:
Category Archives: Research with human subjects
Is drug research on humans who are addicted to drugs ethical?
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, New York, Minneapolis and San Antonio. The studies continue today and have an array of aims, from documenting the ways cocaine warps the brain to the intensity of pain from morphine withdrawal. …
John Walters, drug czar during both terms of George W. Bush’s administration, said he learned about the studies near the end of Bush’s term. “It’s not only questionable ethically, but probably — given the science — it may not be able to be defended at all,” Walters told The Examiner recently. …
“Most people see the things that people will do to themselves when they’re addicted — what they’ll do to themselves, to their families, to their loved ones,” Walters told The Examiner. “I think that when you bring someone in and say, ‘Well, they’re not seeking treatment yet and therefore it’s OK to use them as an experimental subject’ — that’s not the understanding that the current science gives us about this disease.” …
“The question is whether the results justify using these individuals as disposable subjects,” Walters said.
Walters seems to be saying that the use of people who are addicted to drug in research on those drugs cannot be ethical under any circumstances. (His claim that “it may not be able to be defended at all” at least strongly suggests that this is his position.) Is he right?
Your tax dollars at work: a look at clinical trials supported by NCCAM.
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 website to look at some of the clinical trials this federal agency has supported.
From the NCCAM website’s discussion of clinical trials being conducted on complementary and alternative medicine (CAM):
Conventional medicine, ‘alternative’ treatments, and the ethics of research with humans.
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:
A big pain for biomedicine: anesthesiologist commits massive research fraud.
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:
Animal rights activist takes drugs tested on animals.
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 drugs and medical interventions contributed to the author’s cancer.
Language barriers and human subjects research.
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 is no infrastructure like this in research at most major research universities. Consent forms are written in English. Even if I could provide verbal translation for this man, it would not be ethical for him to sign a document in a language he cannot read himself and understand. Thus, it all more or less becomes a moot point. Beyond that, while I am a fluent Spanish speaker, I am not a qualified medical interpreter. I have no idea how to say “indwelling arterial catheter.” Babelfish says it’s, “catéter arterial dejado en un órgano.” I know that can’t be right, but who am I to question Babelfish?. Even if I were completely confident saying, “We are studying the physiological effect of [Dr. Isis’s favorite stimulus] on vascular function” in Spanish, it’s not the best use of my time as a researcher (unless one of you folks want to write me in for 10% effort, and then I will make sure I learn to say it).
So, the question is, is there an ethical issue here at all … ? The National Institutes of Health mandate the inclusion of minorities in human research studies. In our area, members of the major minority groups often do not speak fluent English. However, the translation of study documents and the hiring of an interpreter to help with the consent is expensive and I have never known an investigator to include a translator in a budget when they could have a technician. Furthermore, if you are willing to translate a consent form into one language, what about all of the other languages that might be spoken in the area around where the study is being conducted, no matter how rare? Indeed, most people I know make the decision that the ability to understand and communicate in English at a 6th grade level is a criteria for participation.
Yet, if the ability to speak English is a criteria for participation, then we by default fail to include particular groups in research cohorts. We’re back to research cohorts being comprised of middle-aged white men.
(Bold emphasis added.)
It looks to me like there is an ethical issue here. Plus, I think I see a scientific issue. Together, the two kinds of issues make me think that tackling the issue of translation should be a priority for researchers (and for the agencies funding their work).
Seen elsewhere in the intertubes.
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.
Anesthesiology and addiction.
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:
Challenges of placebo-controlled trials.
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.