By PAUL THACKER
In 2005, Trudo Lemmens and a colleague wrote "Ethics for Sale," an article in Slate that ripped the bandage off the sordid underbelly of human clinical trials in the United States.
"If you missed the movie The Constant Gardener and need your fix of moral outrage, you don't have to go to Africa to find it," they wrote.
The article caught the attention of editors over at the journal PLoS Medicine, who invited Lemmens and his co-author, bioethicist Carl Elliott, to publish a written debate against Ezekiel "Zeke" Emanuel, a government bioethicist who is the brother of Rahm Emanuel and was a close advisor to President Obama on healthcare issues.
The topic? Research ethics.
"We crushed him, because we were right and he was wrong," says Dr. Elliott, a professor at the University of Minnesota. "You can always depend on Zeke to give the industry perspective."
Not a physician, Lemmens is a professor of law at the University of Toronto. After law school, he did a master’s degree and then a doctorate in law at McGill University, where he examined genetic discrimination. In his spare time, he delved into the ethics of clinical trial research.
Mr. Lemmens then published papers on ethics in human research, conflicts of interest in medicine, and on restoring scientific credibility to commercial research. In "Leopards in the Temple," he argued that pharmaceutical research regulations have failed to protect patients' interests, and that our broken system must be replaced by an independent drug testing agency.
Last month, he brought together a host of experts for the first international meeting on corporate-funded ghostwriting in medicine. POGO caught up with Mr. Lemmens recently to ask him a few questions about ghostwriting—find his edited responses below.
POGO: Why did you decide to hold a conference on ghostwriting and how does ghostwriting affect average citizens?
Trudo Lemmens: I've worked for some time on various overlapping regulatory tools—from soft research ethics and conflicts of interest guidelines, to hard regulations such as Food and Drug Acts—and how they fail to deal with the over-consumption of pharmaceuticals and their adverse effects. It’s one of the major health challenges we face in health care in the industrialized world.
What I have found particularly striking is that health care providers and consumers have a false sense of security when it comes to the science. We generally think that the scientific literature is reliable and based on good research. Yet, there is a growing body of evidence that the scientific literature is part of a complex marketing scheme by corporations. A significant portion of the literature has been used to increase markets for pharmaceutical products and medical devices, often based on biased and seriously misrepresented data.
Ghostwritten academic articles have helped shape what physicians and consumers think about pharmaceutical treatment and which products are safe and effective. They also increase the prescriptions for patented products instead of cheaper generics. So ghostwriting contributes to over-consumption, inappropriate prescriptions, and increased costs for the health care system.
Particularly troubling, and less noticed, is that ghostwriting impacts the legal system which is supposed to help compensate those who are harmed. During litigation involving pharmaceuticals and medical devices, peer-reviewed scientific publications are taken very seriously by the courts. And when the company has ghostwritten studies that say the product is safe and reliable, it helps to protect companies against legal claims.
I've also been troubled, as an academic, by the fact that ghostwriting practices violate well-established academic standards. Academic authors who sign their name to ghostwritten publications pad their CVs and gain scientific credibility through publishing in journals. But if our students do this, and we find out, we sanction them. They could, in fact, be expelled for violating authorship rules.
When I taught as a guest professor at a university outside of Canada, the Dean of the law school reported two students to the local bar association after they had been caught plagiarizing a paper. Yet, we know that several academics have been involved in ghostwriting without being sanctioned or investigated, either by their institutions, or by their professional bodies.
From an academic integrity perspective, this seems unacceptable. The practice of ghostwriting undermines the credibility of our system.
POGO: What was your biggest takeaway from the conference?
TL: The conference confirmed what I had seen: there is a highly motivated community of dedicated people who share the same concerns and are thinking creatively about how to address them. I was also struck by the intelligent feedback from people who have worked as medical writers: how they worked, what they found challenging, how they dealt with their own concerns and dilemmas. Their testimony also confirmed that there are different levels of ghostwriting.
Finally, the awareness about the problem seems higher in the U.S. medical community than in Canada. The work of Senator [Charles] Grassley [R-IA] and the exposure in leading newspapers and other media outlets must have helped.
POGO: How does the practice of medical ghostwriting—and public reaction to it—differ in the United States and Canada or other countries?
TL: We have a different health care system, a different drug pricing system, and a smaller population. This does affect the practice of medicine and the interaction between the various actors. Also, there is less money at stake. So the magnitude of the problems may be somewhat smaller.
But at the same time, I think that Canadians live up to their stereotype as “nice people.” But I mean this in a negative way: they put too much trust in the system and tend to think that this type of problem only exists south of the border.
Yet, we know that there are very serious problems with pharmaceutical overconsumption here and that people are harmed by drug products; and we know that Canadian academics have put their name on ghost written publications.
Another problematic difference is that the Canadian media seem more cautious—in part because of different libel and slander rules—and less aggressive in pursuing these controversies.
POGO: What rules, regulations, or laws can policymakers put into place to curtail ghostwriting?
TL: Ghostwriting is the result of a regulatory system that relies too much on industry to create safety and effectiveness data. Ideally, we would want to see a complete transformation of the system, whereby industry is no longer in control of the research and the reporting of research in which it has a direct and huge financial interest (see my article “Leopards in the Temple”).
But in the absence of a complete system transformation, we can use tools to fight the practice: transparency rules, sunshine acts, professional disciplinary procedures, academic disciplinary procedures, food and drug regulations related to off-label prescription, and various other rules.
I personally think that in cases of misrepresentation of findings that result in serious harm, prosecutors should consider pursuing prosecution for criminal negligence. With my colleague Simon Stern, we're also exploring options to pursue class-action lawsuits against those involved in ghost-writing and holding academic authors who put their name on ghostwritten publications themselves liable for their misrepresentations in legal proceedings.
POGO: What responsibility do hospitals and research institutions have when it comes to ghostwriting? What effect have their actions had on ghostwriting thus far overall?
TL: Institutional responses have been very weak, notwithstanding a growing body of evidence that ghostwriting is common on campuses. Institutions should investigate and use existing rules about authorship to sanction where appropriate.
The difficulty is that it may not always be very clear who is involved in ghostwriting, and at what level. Sometimes ghostwriters may have helped write up the manuscript, but academics may still have contributed sufficiently to be considered an author. In other cases, they many not have done enough. But it can be hard to establish exactly who did what.
Paul Thacker is a POGO Investigator.