Pfizer: Sued in U.S. Courts over Nigerian Experiments

From MSNBC: Pfizer faces NY lawsuits over human medical tests

Nigerian families can sue Pfizer in U.S. courts with claims that the giant drug maker violated international law banning involuntary medical experimentation on humans when it tested an antibiotic to treat meningitis, an appeals court ruled Friday.

The 2nd U.S. Circuit Court of Appeals overturned rulings by a lower court judge who had tossed out the lawsuits in litigation that began in 2001.

The lawsuits sought unspecified damages on behalf of children and infants who were part of a 1996 study of the oral antibiotic Trovan. The testing occurred during a meningitis epidemic that killed more than 15,000 Africans.

(Here's an entry from the Business Ethics Blog back in 2006 that gives some of the back story: Pfizer's Unapproved Drug Tested on Nigerian Children)

The main reason this court decision is news is that the court is reaffirming that foreigners can sue U.S. companies when those companies seem to have violated international law. If that seems obvious, it's not: though I think there are good arguments, it's important to see that you do need good arguments for why a U.S. court should have jurisdiction over something that happened in another country, with its own government and its own courts.

From a research ethics point of view, it's worth nothing (and criticizing) the fact that — at least as reported by MSNBC — part of Pfizer's defence seems to be that the ends justified the means. Whether the fact that the trial in question went on under exigent circumstances, during an epidemic, matters to the validity of that defence is an interesting question.

Research into practice

The best research in the world is of little use if it isn't put into practice.
Sometimes the lag between research & practice is simply a matter of slow diffusion of knowledge. Other times, the story is more worrisome.

Case in point: this interesting story, from the Journal Sentinal: UW course for doctors pushed risky therapy

The conclusions were clear: Women who took hormone therapy drugs were at increased risk for breast cancer, heart disease, stroke and blood clots.

The findings were so strong that researchers stopped a clinical trial in 2002, five years early, because it would have been unethical to continue giving the drugs to women.

But that same year, the University of Wisconsin-Madison's School of Medicine and Public Health began a medical education program for doctors that promoted hormone therapy, touted its benefits and downplayed its risks.

Critics are pulling no punches:

"It is pure, undisguised marketing," said Anthony Scialli, an adjunct professor of obstetrics and gynecology at Georgetown University's School of Medicine.

Drug companies are "funneling money through universities for advertising and trying to disguise it as education...."

The University closed the course down one day after questions were posed to the University about the legitimacy of the program. At this point, the University is investigating the course to see if it met the standards of the medical school. I'm hopeful it did not.

The main problem here is obvious . A course for med students funded and run by a drug company, with views that do not reflect the medical community at large and in fact downplay important risks to potential patients, is worrisome at best.

Here are just some of the concerns that this case raises:

1. In terms of academic curriculum planning, it's clear that in the training of responsible, ethical and balanced health care professionals, we should encourage up-to-date curricula that encourage active and open debate about many kinds of issues alongside an awareness of the ever present involvement of outside influences into medical training and practice. Plenty of clinical issues should be critically critically examined, questioned and debated by medical students. Issues such as the most effective drug for depression or the optimal treatment of atrial fibrillation are both appropriately debatable topics with room for difference of opinion, based on the findings of clinical research. Some things, however, need to be clearly presented and aren't debatable. For example, it would be unethical to present a course on the treatment of atrial fibrillation without mentioning that Warfarin (used in patients with persistent atrial fibrillation) causes severe bleeding if mismanaged in patients. Furthermore, it would be problematic to present a course on hormone treatment without a discussion of the serious and significant risks to women alongside the potential benefits.

To have a course disguised as learning but really pushing the agenda of a pharmaceutical company, in exchange for revenue for the school, hardly seems worth it, in terms of potential harm to a significant number of future patients.

2. Clinical research is conducted with the goal of aiding future generations of patients by being applied to practice. That means, to put it simply, applying the good along with the bad, i.e. making sure that beneficial findings are accelerated into practice while at the same time, ensuring that negative findings, serious adverse events and newly identified risks become incorporated into standards of care and practice. Standards of care and practice should be the foundation upon which medical and allied health care curricula are based.

3. We talk a lot about the involvement of pharma in medical school training. It's one thing to have conferences bags with logos on it and lunches paid for by the local drug rep — I'm not saying that is right, but at least the involvement of the company and the overarching agenda are explicit. It's another thing, altogether, to implicitly embed what seems to be a misplaced and biased agenda of a pharmaceutical company into a medical school curriculum and disguise it as learning about standards of practice.

Doctor's Nutty Hoax

Well, most false submissions to medical journals fall into the category of academic fraud. This one probably deserves a gentler treatment.
Perhaps we should join the BMJ spokesman who said that this case "added to the gaiety of life."

According tho this story, from BBC News:
Peer reveals 'cello scrotum' hoax

A top doctor has admitted her part in hoodwinking a leading medical journal after inventing a medical condition called "cello scrotum".
Elaine Murphy - now Baroness Murphy - dreamt up the painful complaint in the 1970s, sending a report to the British Medical Journal.
She came clean when the hoax resurfaced in the 2008 Christmas edition.

Interesting to see that the BMJ is laughing this off — but at the same time contemplating a formal retraction. I guess a reputable scholarly journal with a sense of humour wants still to be thought of as a reputable scholarly journal.

Researcher lies to ethics review board about drug to treat kids

An Australian researcher lied to an institutional ethics review board, telling them that a "black box" warning on a drug under study, Strattera, had been removed by the Food and Drug Administration (FDA) following further exploration. Here is the story from The Weekend Australian: Researcher Made False Statements Regarding Strattera Trial in Kids

A "black box" warning is a warning that appears on prescription inserts warning users and prescribers of the most serious or life-threatening side effects. Some common examples include the warning of risk of severe bleeding causing death on Warfarin or warnings of the increased risk of suicidal ideation in children and adolescents taking antidepressants. It is the strongest warning that the FDA can issue. In this case, Strattera (being used in a trial with children), has been found to increase suicidal thoughts in children, especially after a change in dosage.

As the story notes, the researcher told the ethics review board that the black box warning for Strettera, a norepinephrine uptake inhibitor (used for the treatment of ADD and ADHD in the States along with off label treatment for unipolar and bipolar depression)had been removed when in fact, it had not been.

While clearly there is fault on the part of a researcher who makes a decision to lie about potentially life-threatening side effects of a trial drug, there are lessons here for ethics review boards:

1. While ethics review boards are not scientific review boards, it is imperative we ensure that a scientific review by an unbiased and discipline-relevant panel has been carried out and that all scientific or clinical concerns have been thoroughly addressed, prior to an ethics review.

2. Ethics review boards must have members with expertise in a variety of areas. Yes, it's vitally important to have an ethicist, a lawyer and community members on any ethics review board (and it's required). However it is equally important to ensure that, if you are reviewing drug trials, you have members with expertise in medicine and pharmacology. If not, consult an expert. Or two.

3. Do your homework. Reviewing research protocols takes time. Sometimes it means you have to look things up, ask questions, seek information. What you read on a research proposal is only part of the work you need to do as you review a research proposal. Granted, we do expect that researchers will provide, at the very least, an adequate amount of information in order for us to complete a through and meaningful review. But it is our responsibility, as members of a board with a mandate to protect human participants, to do our homework.

A Professional Association With a Spine

Ethics boards are responsible for, among other things, keeping an eye out for conflicts of interest, both their own and those of researchers. According to Tri-Council Policy Statement, for example:

Researchers and REB members shall disclose actual, perceived or potential conflicts of interest to the REB. REBs should develop mechanisms to address and resolve conflicts of interest.

Presumably, insisting that researchers divulge potential conflicts is easier if other organizations are likewise promoting such transparency. Here's one professional association that's helping:

From the Wall Street Journal: Spine Doctors are Adopting Strict Rules on Payments

A medical society representing U.S. spine surgeons has taken the rare step of requiring that researchers disclose not just the existence of financial ties to medical-device companies, but the dollar amounts as well.

The initiative is a response by the North American Spine Society to pressure from lawmakers, prosecutors and lawsuits by companies' former employees. Prominent surgeons doing research have been found to have significant financial relationships -- sometimes to the tune of millions of dollars -- with medical-device firms.

Does this new policy have teeth?

The society said its policy "is not a voluntary guideline, but a binding covenant which applies to all relationships engaged in by all participants in all" activities of the spine society. Failure to disclose would be a "sanctionable offense," the spine society said. Sanctions could include suspension, expulsion or public letters of censure.

Will it help?

As to whether mere disclosure is enough to deal with conflicts of interest, [the society's ethics-committee chairwoman] said it is at least a first step to ensure "that these things are addressed."

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Thanks to the Bioethics Blog for the story.

The ethics of parents as researchers, and of researchers as parents.

The New York Times recently did a story on researchers' use of their own children as subjects.

The article discusses the case of Dr. Pawan Sinha, a neuroscience researcher at MIT who, shortly after his baby Darius was born, put a camera on Darius' head to record what the baby looked at, while awake.

Here's the story: Test Subjects Who Call the Scientist Mom or Dad

"Some research methods are clearly benign; others, while not obviously dangerous, might not have fully understood effects. Ethicists said they would consider participation in some projects acceptable, even valuable, but raised questions about the effect on the child, on the relationship with the parent, and on the objectivity of the researcher or the data.

“The role of the parent is to protect the child,” said Robert M. Nelson, director of the Center for Research Integrity at Children’s Hospital of Philadelphia. “Once that parent becomes an investigator, it sets up an immediate potential conflict of interest. And it potentially takes the parent-child relationship and distorts it in ways that are unpredictable.”

Using your own children in your research is not a new concept. Those who study language acquisition and child development have been using their own children as subjects for many years. Because of clear practical constraints, it seems for some kinds of longitudinal observational studies, such as the acquisition of language, it is the best or only method available (which doesn't necessarily make it right for other kinds of research).

Lots of discussions of this phenomenon focus on the perceived "conflict of interest" of the parent-researcher. But I think that there is more to it than simply "conflict of interest" although this is clearly an issue — for the parent as primary caregiver and the parent as researcher.

Here are several points worth considering:

1. The relationship between researcher and participant has obvious boundaries and usually, fairly explicit expectations. Part of ethically sound research involves trying to make the researcher-participant relationship and roles as predictable and objective as possible (and clearly distinguished from other roles and relationships), thereby mitigating certain kinds of risks, to some degree. The parent-child relationship involves emotions and dependency. It also not only predates the research but will also continue well after the research is completed. These attributes put predictability, objectivity and clear differntiation from other kinds of roles into question.

2. An unexpected "a-ha" moment, in most research projects, involves observing phenomenon that are unusual or were not predicted. Finding an unusual or unpredictable finding about your own child in any of a number of kinds of research (while asking questions, say, about sexuality or depression or doing an MRI of the brain) might certainly raise emotionally-challenging or otherwise difficult issues for parents, especially if it was a finding with negative connotations or sequelae.

3. The integrity of the research is, at the very least, in jeopardy. Those who look at research with a critical eye do pay attention to 'already-standing relationships' that researchers have with participants when evaluating the veracity, validity or reliability of research findings. In many kinds of qualitative research, the measures of quality are understandably different. However, even in these kinds of research, in which already-standing relationships are more common and acceptable, care must be taken to preserve the quality of the data as well as the integrity of both the researcher-participant relationship, and of the already-standing relationship. In the case of the latter, the focus must be on preserving the integrity of already-standing roles and relationships for the sake of the participant, not the researcher. When all the decisions about participation in research are made by a parent-researcher for a child, the integrity of the parent-child relationship is already altered for the child, who now clearly serves two roles.

4. Voluntariness is an issue for all children involved in research conducted by their parents, but — perhaps counterintuitively — it is especially problematic for children who are at an age at which they are capable of providing assent or consent. When REBs look at any kind of research involving children and youth, they want to see that the researcher has taken care to avoid coercion or undue influence to participate and that the voluntary nature of participation is protected. They also want to be sure to communicate to kids that the choice, for example, not to participate will not result in anyone being angry or disappointed. Not as easy to do when "dad" is the researcher, I'd suspect. For infants, that's not an issue; for older kids, it is.

5. As a parent, the choice of involving your child in research is generally up to you. Society expects that, as a parent, you have your child's best interest at heart. If the research is actually your own research, however, which you need to complete to further your career, to get an academic promotion or to put yourself in a better position to acquire research grants, I think it's reasonable to say that your child's best interests might not be the only thing you have in mind.

Apotex Sues Olivieri (Again)

Just a quick note, for those of you who haven't heard: the Olivieri affair is reigniting.

That's right: Canada's most famous research-ethics scandal isn't over, apparently. Pharmaceutical company Apotex is suing Dr. Nancy Olivieri. Again.

See the report/editorial in the CAUT Bulletin, here: Apotex Inc.: A Corporation Above the Courts?

The Canadian Association of University Teachers (CAUT) believes a new legal tactic adopted by Canadian pharmaceutical corporation Apotex Inc. against Canadian university teacher Dr. Nancy Olivieri is a blatant misuse of the Canadian legal system.

In a late December appeal to the Court of Appeal for Ontario, Apotex has requested to be relieved from complying with a settlement it entered into with Dr. Olivieri in 2004 to resolve defamation litigation.

Apotex has brought its new appeal even though the Court of Appeal ordered Apotex to comply with the settlement agreement 18 months ago....

That's all for now. We'll surely return to this topic soon.

Researchers, the Press, and Interpreting the Implications of Research

The relationship between researchers and the press is a complicated one. On one hand, researchers rely on the press to generate excitement about their research — the kind of excitement that sometimes leads to funding, and that probably makes it easier to recruit subjects into new studies. On the other hand, once the interview is over, it's hard to control how one's research is (mis)represented in the press.

In this regard, check out this commentary by renowned autism researcher, Simon Baron Cohen, in The Guardian:

"Our research was not about prenatal screening for autism"

Your front-page article on 12 January was given the headline "New research brings autism screening closer to reality" and the strapline "Call for ethics debate as tests in the womb could allow termination of pregnancies". It showed a photo of a foetus, which was given the caption, "The discovery of a high level of testosterone in prenatal tests is an indicator of autism." And inside the paper a double-page spread was devoted to the details of the study, and given the headline "Disorder linked to high levels of testosterone in the womb".

All four of these statements are inaccurate. The new research was not about autism screening; the new research has not discovered that a high level of testosterone in prenatal tests is an indicator of autism; autism spectrum disorder has not been linked to high levels of testosterone in the womb; and tests (of autism) in the womb do not allow termination of pregnancies.

(Here's the original Guardian article to which Prof. Baron Cohen refers here: New research brings autism screening closer to reality.)

It's a wonderful response from Prof. Baron Cohen; it's fair-minded, succinct, and clear.

Two ethical points need to be made, here:

1) As we've suggested before, health researchers have an ethical responsibility to correct media reports that misrepresent their research in ways that seriously misleads the public. This article is a good example of a health researcher living up to that responsibility.

2) It's not so clear that, in general, the line of defense offered by Prof. Baron Cohen is a workable one. Baron Cohen writes, "The new research was not about autism screening." Fair enough. But it's not clear that that fact supports Baron Cohen's denial of the Guardian's claim that Baron Cohen's research "brings autism screening closer to reality." Any study that looks at the causes — particularly, causes detectable in or associated with traits detectable in foetuses — is at least contributing, however indirectly, to the possibility of eventual prenatal testing. Whether that's a very good thing or a very bad thing, of course, is another topic.

Cardiologist sued for speaking out about research findings

Here's a story about a UK cardiologist being sued by a medical device manufacturer, over comments he made about why a clinical trial he ran didn't end positively.

Cardiologist is sued for comments on potential migraine device

A leading British interventional cardiologist who was a joint principal investigator in a clinical trial of a device made in the United States is being sued for libel and slander in the English courts by the manufacturer. The case concerns comments attributed to him about the trial that were posted on a US based news website for heart specialists.

NMT Medical, which is based in Boston, Massachusetts, makes the STARFlex septal repair implant. The company has launched the legal action against Peter Wilmshurst, a consultant cardiologist at the Royal Shrewsbury Hospital. Dr Wilmshurst and a headache specialist from King’s College London, Andrew Dowson, led the Migraine Intervention with STARFlex Technology (MIST) trial in the United Kingdom to study the effect of the device on migraine (Circulation 2008;117:1397-404).

The company is suing over an interview published in October 2007 by Heartwire, an online cardiology news service.

In this interview, Dr. Wilmshurst provided reasons for why he believed the trial results were negative. The premise of the trial was that closure of an (abnormal) right to left circulatory shunt in the septum of the atrium, the top chamber of the heart (a defect also called a patent foramen ovale), would reduce migraine headaches. Previous observational studies had demonstrated that, coincidentally, patients who had their right to left shunt closed also experienced a reduction in migraine headaches. In the MIST trial, Drs Wilmshurst and Dowson used the STARFlex septal repair device to close patent foramen ovales in patients and observed them for decreased migraine frequency.

The negative results, according to Dr. Wilmshurst, might have been due to either failure of the STARFlex device to properly seal open shunts or improper screening of patients enrolled in the trial. Both of these claims are very serious, and as Dr. Wilmshurst notes, in the best interests of the public to know.

I'm not a lawyer, but it's hard to imagine a lawsuit will succeed if what Wilmshurst said was true, and, as noted, in the public interest. Most worrisome, though, is the potential chilling effect on researchers speaking out. This case, while similar to the Olivieri case has some clear differences. Dr. Wilmshurst was not stopping a trial or preventing a trial from continuing. Nor was he speaking out before having all the results in hand. Basically, he was being honest about why he thought the trial didn't work — and either of the options he outlined as possibilities are arguably in the interest of the public to know about.
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The entire text of the BMJ article is reproduced by HealthWatch, here: Cardiologist is sued....

Harvard to Review Research Ethics Policies

Quite a few universities have come under fire over the last few months for the ties between key researchers and drug companies. One step in the right direction for institutions under fire is to review existing policies. Harvard Medical School has announced that it's going to be reviewing its research ethics policies — in particular, its conflict of interest policy.

See the story from Bloomberg, here:
Harvard Medical School to Review Drug Research Ethics

Harvard Medical School, which lists more than 10,000 faculty members, said a committee will review its policy on conflicts of interest on drug research.

The 19-person panel is charged with studying the school’s principles, provisions and procedures regarding interactions between faculty and the pharmaceutical industry, the school said in a statement today. The last policy review took place in 2004, the school in Boston said. The institution, part of Harvard University, boasts 15 Nobel Prize winners among its current and former faculty.

Institutions have come under fire as scientific researchers have been found to have financial interests that may bias their work....

Yesterday, Nancy asked who the most influential people in research ethics are. Given the status that Harvard Med School has in the world, and the fact that it employs over 10,000 faculty members, I'd say that whoever is chairing the committee reviewing Harvard's research ethics policies might just be a candidate.
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See also:
Conflict of Interest Policies at Canadian Universities: Clarity and Content, by Bryn Williams-Jones and Chris MacDonald, Journal of Academic Ethics 6:1, 2008.

Who are the most influential people in research ethics?

So my friend and co-author of this blog, Chris MacDonald, was recently honoured as one of the 100 Most Influential Persons in Business Ethics by Ethisphere Magazine, a list that also included such prominent persons as Obama Barack and Liu Qi. The criteria for the list were extensive. Ethisphere identified nine spheres in which people involved in business and business ethics could have influenced the field or the world at large, including being whistleblowers, making contributions to corporate culture and demonstrating thought leadership. Chris made the list for the Business Ethics Blog that he has been writing since 2005, and which is now the most widely read blog on business ethics.

So this led to an interesting question to ponder: Who are the 10, or 100, most influential people in research ethics?

First, it would be challenging to decide upon criteria. To begin, although many of us might consider influence to mean "having a positive effect", influence can be, just as easily, a neutral concept. Certainly in the world of research ethics, historical figures such as Laud Humphreys, Stanley Milgram and Philip Zimbardo can be said to have been influential. While they are usually cited, alongside the people who facilitated studies such as the Tuskegee Syphilis Experiment, as examples of how not to conduct research, their influence is obvious and has been fundamental to the advancement of the field.

Second, it would be equally challenging to think about what we consider influence to be, in this particular context? Would the Chairs of ethics review boards at large, influential research-intensive universities automatically be included on such a list by virtue of their influence setting the standard for what is accepted as ethically sound research? Or would we include scholars and academics who study and write about research ethics? What about particularly ethical researchers? Would they be considered to be influential in the field?

I'm presenting this as an interesting thought experiment. Research ethics, in my experience, has been, at times, the most neglected of all of the fields in health care ethics. Research ethics has also been seen, by some, as a highly regulatory and restrictive field, more concerned with oversight and control of research than with thoughtful debate and discussion over important issues that arise. To try to decide on what it means to be influential in the field of research ethics, is, I sense, a somewhat challenging task.

Brain death and organ procurement: New insights from the President's Council

This issue is much more of a bioethics issue than a research ethics issue, but I think it bears some discussion here.

The President’s Council on Bioethics has recently released a new White Paper addressing the issue of determination of death for purposes of organ transplantation, entitled Controversies in the Determination of Death: A White Paper by the President's Council on Bioethics

This paper does two things. First it attempts to revisit the debate over the older, more traditional definition of death, i.e., cardiopulmonary death, versus the newer, more widely accepted but less well defined definition of death, i.e.,“whole brain death”or neurological death. In doing so, the Council reiterates the validity of whole brain death as the accepted standard for death and therefore, in this context, the standard definition of death for purposes of organ procurement. Second, it tries to provide new philosophical arguments or rationales for the continuing emphasis (the original President’s Report in 1981 first highlighted this concept and debate) on the validity of neurological death as the accepted standard for determination of death. It essentially does this by redefining the notion of what whole brain death means, from thinking about it in terms of cessation of the brain's control over our physiological processes to cessation of our meaningful engagement with the world.

While the paper is relatively firm in its discussion of whole brain death, there are clearly still ongoing debates over the definition of brain death. Here are just a couple that both relate to the fact that many feel the definition of whole brain death is still, at best, unclear:

1. Are patients in persistent vegetative states in a state of whole brain death? Traditionally, no. But there is enough disagreement on what constitutes whole brain death that some Council members feel that changing organ procurement practices based on the idea of whole brain death is not wise.

2. Does whole brain death equal death of the human being? Most of us would say “yes” but even still, some would disagree. Again, with disagreement over whether or not the irreversible end of all brain activities, including those that sustain basic life functions constitutes death and therefore an appropriate time for the possibility of organ procurement, is problematic.

The purpose of the paper is to try to clarify brain death in order to make organ donation and timing to donation clearer and less controversial. Some have claimed that this paper has “saved organ donation” by changing the way that we think about neurological or "whole brain death", from the cessation of control over physiological functions to a complete lack of engagement with the world.

In terms of research ethics, while many organ procurements are carried out with the goal of saving another person’s life through transplantation, it remains that organs are harvested for purposes of research. Transplantation is an evolving science. The White Paper may have implications for procurement of organs for research purposes. It may also have implications for consent and substitute decision-making (in both clinical and research contexts), with the new thinking about what whole brain death means. It is important that research ethics board members are, at the very least, aware of the iterations in the debates over these important issues in the world of bioethics and medicine and take some time to reflect on how these evolving notions have an impact upon the world of medical research that we review and oversee.

Controversial Research; Terrible Nomenclature

No, no, no!

Genetic research and preimplantation genetic testing are controversial enough, and subject to enough hyperbole, without this kind of bad scientific journalism — or bad scientific headline-writing? — making things worse.

From CNN Health:
'Cancer-free' baby born in London

The first child in Britain known to have been screened as an embryo to ensure she did not carry a cancer gene was born Friday, a spokesman for University College London told CNN.

Her embryo was screened in a lab days after conception to check for the BRCA-1 gene, linked to breast and ovarian cancer.

People with the gene are known to have a 50-80 percent chance of developing breast or ovarian cancer in their lifetimes.

British newspapers have dubbed the girl the "cancer-free" baby.

Probably everyone reading this blog will know already what the problem is, here. Calling this kid "cancer-free" is incredibly misleading, and grossly overstates the benefits of this controversial procedure. This kid is absolutely, positively, not "cancer free," at least if that term is meant to imply "free from ever getting cancer." This kid is, admittedly, free from one genetically-linked sub-type of one kind of cancer. That, in itself, is a good thing. But it's very different from being cancer-free. Cancer is roughly the #2 cause of death, and eliminating one type from this kid's future doesn't change the fact that cancer is still the second-most likely thing to kill this kid, over her lifetime.

This is a case of bad scientific journalism, but I think health researchers have an ethical responsibility to correct journalists in cases like this.

Canadian research ethics coming soon to a city near you!

I'm posting this entry as an FYI to my Canadian readers. As you know, the second draft of the Tri-Council Policy Statement was released in December 2008. Starting this month, The Interagency Advisory Panel on Research Ethics (PRE) is conducting The TCPS Regional Consultation Tour 2009 in order to engage the public, researchers and ethics review board members on the draft. The consultation period will end on March 31, 2009. The first session is scheduled for January 16th at the Université de Montréal.

The consultation tour involves scheduled sessions taking place in most major Canadian cities at academic institutions. At these 2 hour sessions, the draft will be presented and summarized and feedback along with discussion will be encouraged. Attendance is open to anyone, including researchers, ethics review board members, other interested academics and the public but note that registration is required.

Click on the link above to see the tour session dates and register for a session in your area. The draft second edition is available on line for you to review prior to attending but PRE will mail out a hard copy to you, if you send a request (indicating your preference for an english or french copy) to DraftE@pre.ethics.gc.ca

Throughout the process of compiling the second draft, PRE has been committed to seeking advice from stakeholders and responses from experts across Canada. The resultant second draft is the result of a great deal of work and a significant amount of feedback from Canadians engaged in active research and research ethics. It's a strong document and it does reflect some of the calls for change that came from the researchers and research ethics community regarding the first edition. This tour represents a final opportunity to have your voice heard or provide input into the second edition so do try to attend one of the sessions!

No more free lunches

This story has to do with money, medicine and influence — all topics that are relevant to medical ethics and yes, often, research ethics. The PhRMA (The Pharmaceutical Research and Manufacturers of America) Code on Interactions with Healthcare Professionals has been updated. The revisions will come into effect on January 19, 2009. As of December, approximately 40 drug companies have signed on to the voluntary Code, which indicates their intention to comply with it, revisions and all.

Here is the story in the New York Times: No Mug? Drug Makers Cut Out Goodies for Doctors

The revisions of the Code include a prohibition on the distribution of items such as pens, coffee mugs, t-shirts or mouse pads with logos or other promotional images on them. It also discontinues the practice of having drug reps take physicians and health care professionals out to meals in restaurants for educational presentations, a common practice up until now. It does allow for "modest" meals to be provided in-hospital accompanying an educational presentation. Interestingly, the Code gets very specific, even stating that the (very common!) "dine-and-dash" — in which a busy resident or nurse might pop in to grab a plate of food without staying for any of the presentation — is inappropriate and should not be permitted.

Two things to note. First, this is a voluntary Code. Signing onto it, however — as a number of large drug companies like Eli Lilly, Pfizer, Merck and Bayer have all done — does imply a commitment to comply with the principles and recommendations of the Code. It also means, for the kinds of large companies that I've listed here, that they face a serious decrease in revenue as a result of having their products prescribed less. While many physicians deny that they are influenced by the products names on their bandage scissors, pens, calculators and sticky notes (potentially everything one might pick up or use in a given day in the medical office), it must work. After all, drug companies have been spending up to 22 billion US dollars annually on distributing logo products and taking health care professionals out to lunch, on a paid vacation or for a round of golf. If they couldn't demonstrate that this kind of an expenditure really worked to influence prescribing habits, chances are that they would have stopped this expense long ago.

Second, this is an American Code. While drugs prescribed in the US account for a significant portions of revenue for most companies, there are other markets that may even be better than the States in which companies may now turn to with more aggressive marketing tactics (Besides, they need somewhere to distribute all those leftover pens, now prohibited in the US). Markets in which there may be even more freedom for a prescriber — without worries about HMOs and to some degree, the ability of many patients to be able to afford the drugs that are prescribed — will now appear much more attractive to drug companies. Like Canada, for example. While many Canadian medical schools are teaching strategies on how to practice ethically, including efforts to avoid coercion in prescribing practices, it remains that once medical residents are out in practice, their ethical standards will be put to the test by aggressive drug reps.

Does this story have a research ethics angle? Well, seeing as most large multi-centre drug trials are funded by drug companies, ethics review boards are responsible for ensuring that researchers are not overly influenced by large influential funders that prefer to see particular kinds of results. While this doesn't involve checking researchers' offices for mouse pads and coffee mugs with logos on them, it requires looking at contracts and the kinds of safeguards in place to protect participants and researchers while ensuring integrity in the research processes and outcomes. Furthermore, the Code still allows for physician "consultants" who are paid by the drug companies to play a variety of roles, from advising to providing legitimacy in the dissemination of trial results. There is certainly potential for conflict of interest if these physician "consultants" engage in related research. As the main mandate of ethics review boards is to protect participants, this involves protecting the integrity of results and the reporting of results, which means examining the kinds of relationships that physician researchers have with drug companies that provide funding support.

Here are two other interesting and related sites to read more on how prescribing practices are affected by gifts and products. The first one is a blog written by a Texan medical resident, called Drug Rep Toys, with clever commentaries on the kinds of promotional products he has received from drug reps. No Free Lunch is an organization aimed at physician and medical students to educate them on how to maintain promotion-free practices, institutions and medical schools.