GlaxoSmithKline, the UK-based pharmaceuticals group previously accused of concealing sensitive information on its medicines, has pledged to make public the findings and details of all clinical trials within 18 months of their completion.
In its latest corporate social responsibility report, the company says it will post on its clinical study register all research on new drugs.
Financial Times, 25/3/9
The Journal of the American Medical Association, one of the world’s most influential medical journals, says it is instituting a new policy for how it handles complaints about study authors who fail to disclose they have received payments from drug companies or others that pose a conflict: It will instruct anyone filing a complaint to remain silent about the allegation until the journal investigates the charge.
The unusual order drew criticism from editors at other journals and fuels a debate about the role of medical journals in policing financial conflicts of researchers. It comes after JAMA was criticized for taking five months to acknowledge that a study it published last year on the use of antidepressants in stroke patients was authored by a University of Iowa psychiatrist who failed to disclose he had a financial relationship with the maker of the drug studied.
JAMA editors, in a rare online editorial posted Friday, criticized the actions of a Tennessee researcher, Jonathan Leo, who first wrote about the disclosure problem in another medical journal.
Dr. Leo, a professor of neuro-anatomy at Lincoln Memorial University in Harrogate, Tenn., alerted JAMA to the disclosure problem last October. Earlier this month, he published a letter in BMJ, also known as the British Medical Journal, pointing out the study author’s relationship to the pharmaceutical company and also highlighting what he said were flaws in how the study results were reported. A week after BMJ published Dr. Leo’s letter, JAMA published a correction and a letter from the Iowa psychiatrist, Robert Robinson, acknowledging he had received payments from the drug company and failed to report them. JAMA said the publication of the correction and letter was in the works before the BMJ published Dr. Leo’s letter.
The JAMA editors said Dr. Leo was guilty of a “serious breach of confidentiality” by writing about the problems with the JAMA study while the medical journal was still investigating the matter. JAMA said that from now on, anyone complaining of an author failing to report a conflict of interest will “be specifically informed that he/she should not reveal this information to third parties or the media while an investigation is under way.”
JAMA said that contacting third parties “damages our ability to complete a fair and thorough investigation” and “potentially damages JAMA’s reputation by the insinuation that we would fail to do so.”
Dr. Leo said he uncovered in a Google search that Dr. Robinson, had served as a speaker for Forest Laboratories Inc. Forest Labs has said Dr. Robinson was a member of the company’s speaker’s bureau from 2004 to 2005. It wouldn’t say how much it paid him.
“I wrote about something in the public record,” Dr. Leo said. “It did not require an investigation—it only required a computer with Internet access.”
Jerome Kassirer, a Tufts University professor and former editor of the New England Journal of Medicine, said that Dr. Leo “did nothing wrong” and that the new JAMA policy of demanding silence while it investigates possible breaches of disclosure rules is inappropriate. “There is nothing that should distract a whistleblower from blowing the whistle when they think it is appropriate or necessary,” he said.
Fiona Godlee, the editor in chief of BMJ, said the new JAMA policy is “a dangerous position.” She said, “No one group or organization should have a monopoly on investigating a piece of work.” Dr. Godlee added that medical journals have an obligation to promote transparency, including publishing information critical of work in other journals, or run the risk of being viewed as a “cozy club.”
Medical journals have been under pressure to be more vigilant in ferreting out potential conflicts of interest among researchers submitting studies.
In 2006, JAMA instituted tougher disclosure requirements following a series of episodes in which researchers did not report major conflicts of interest. The JAMA policy requires authors to report any financial relationships over the past five years and any for the foreseeable future.
While requirements for reporting conflicts are often stringent, the penalties for failing to disclose information are often weak and informal. A handful of mostly minor journals have decided to be more punitive by banning authors who don’t report conflicts of interest from future publication, at least for a period of time. JAMA says it often contacts the superiors of authors who fail to disclose conflicts to get them to punish offenders, but does not ban authors.
After Dr. Leo wrote the letter to BMJ alleging flaws in the JAMA stroke study, JAMA editors contacted both Dr. Leo and the dean of his medical school, seeking a retraction.
In an interview with The Wall Street Journal, JAMA editor-in-chief Catherine DeAngelis called Dr. Leo “a nothing and a nobody.” In the editorial Friday, Dr. DeAngelis and co-author Phil Fontanarosa, JAMA’s executive deputy editor, said her comment about Dr. Leo “was erroneously reported” and that Dr. Leo “certainly is somebody doing something very important.”
The dean of the medical school where Dr. Leo teaches said Dr. Catherine threatened in a telephone conversation earlier this month that she would “ruin the reputation of our medical school” if he did not force Dr. Leo to retract the BMJ letter and stop talking to the media. In an interview Friday, Dean Ray Stowers said Dr. DeAngelis “flat out” threatened him and attempted to bully him during the conversation.
The telephone call was followed by an email exchange. In a March 11 email, Dr. DeAngelis wrote to Dr. Stowers: “As I’ve already expressed to you, I don’t want to make trouble for your school, but I cannot allow Jonathan Leo to continue to seek media coverage without my responding. I trust you have already or soon will speak with him and alert me to what I should expect.”
Dr. Stowers responded the next day by saying he couldn’t find any fault in Dr. Leo’s actions and pressed JAMA editors for more specifics on what they believed was wrong with Dr. Leo’s writing or actions. “I think this can be worked out without your continued threats to our institution which are not appreciated and I believe to be below the dignity of both you and JAMA,” he wrote. Dr. Stowers says he has not heard from JAMA since sending that email. Dr. Godlee said BMJ would not retract Dr. Leo’s letter because “there are no factual inaccuracies.”
Dr. DeAngelis, through a spokeswoman, denied threatening the dean.
Dr. Leo said he received an angry call from Dr. Fontanarosa after his BMJ letter was published. “He said, ‘Who do you think you are,’ ” Dr. Leo said. “He then said, ‘You are banned from JAMA for life. You will be sorry. Your school will be sorry. Your students will be sorry.”
Dr. Fontanarosa said Dr. Leo’s retelling of the conversation is “inaccurate.”
In the editorial, the JAMA editors gave their version of that telephone conversation. “Leo was also informed that, if his actions represented his apparent lack of confidence in and regard for JAMA, he certainly should not plan to submit future manuscripts or letters for publication,” the editors wrote.
In the editorial, the JAMA editors said they were “strong and emphatic” in tone when discussing Dr. Leo’s letter with him and the dean of his medical school. The editorial said this tone was struck because of the importance of protecting JAMA’s reputation. “We regret if anyone involved in these communications interpreted our intentions in any other way,” the editorial said.
Wall Street Journal 22/3/9
The American Medical Association seems to have taken a report recommending the end of industry funding of Continuing Medical Education (CME) off its website. The recommendations, brought before the AMA’s Reference Committee on Amendments to Constitution and Bylaws by the Council on Ethical and Judicial Affairs (CEJA) last year, were unambiguous:
“Individual physicians and institutions of medicine, such as medical schools, teaching hospitals, and professional organizations (including state and medical specialty societies) must not accept industry funding to support professional education activities. Exception should be made for technical training when new diagnostic or therapeutic devices and techniques are introduced. Once expertise in the use of previously new devices has developed within the professional community, continuing industry involvement in educating practitioners is no longer warranted.
They have been replaced by this two-page update – “Industry Support for Professional Education in Medicine-Update” — that urges CEJA “to more fully address potentially different implications for different stakeholders in medical education and to seek further input from stakeholders.” As reported earlier (see Carlat’s post), the Council has been assigned to work with Council on Medical Education to develop “complementary, companion reports,” and word is that industry funding will be OKed this time around.
Meanwhile, the AMA continues to defend the impartiality of industry-funded CME through an industry-backed task force it has housed for two decades. This Task Force on CME Provider/Industry Collaboration, whose annual conference was supported by Educational Measures, Medscape, Pfizer Inc., Pri-Med, Wyeth and a host of MECC exhibitors, is made up of “50 senior professionals from CME providers, grantor companies, and other industry organizations.” The task force has launched a campaign called “Get the Facts,” which seems aimed to reverse a growing sense in the profession that the independence of physician education is compromised by its overwhelming financial reliance on the pharmaceutical industry:
“The media, state and federal law and policy makers as well as regulators and other ‘collective/consensus opinions’ frequently use and disseminate information that can lead to incorrect assumptions and false perceptions about CME. This has led to increased regulatory scrutiny and critical public opinion regarding CME practices. Get involved! Help Get the Facts straight!”
Jonathan Leo, Ph.D.
Over the past several years, I have written about the potential impact of conflicts-of-Interest in medicine (COI). I have also watched how the mainstream media reports the results of medical research with great interest. As a neuroanatomist, I was particularly interested in a recent study published in the Journal of the American Medical Association (JAMA), which reported that the prescription of escitalopram lowered the rate of depression in patients who had recently suffered a stroke. I co-authored a letter to JAMA with Dr. Jeffrey Lacasse of Arizona State University, in which we pointed out the problem of selective reporting within the study: Problem-solving psychotherapy was statistically equivalent to escitalopram, but this was never mentioned. In the mass media, the principal investigator recommended that all stroke victims should be prescribed antidepressants without mentioning that problem-solving therapy was statistically equivalent.
In the process of reading this body of research, my co-author and I noticed a problem with the COI disclosures in this positive trial of escitalopram published in JAMA. The principal investigator on the project, Dr. Robert Robinson, had not declared that he had previously received funding from Forest Laboratories, the makers of escitalopram. The financial relationship with Forest Laboratories was well-documented and easily discoverable via a Google search, as evidenced by Dr. Robinson’s previous self-disclosures in varied sources such as here, here, here, here, and here.
I urge my students to carefully consider COI when they read an article as such conflicts can be important in how one interprets research. I do not consider myself a whistleblower, but I do think that the full story behind clinical trials should be transparent so that patients and doctors can make informed decisions. This instance of unreported COI in a gold-standard study published in JAMA seemed like a perfect case study of problematic COI issues. First, I informed JAMA of what we had found. We then co-authored a commentary describing this saga and the potential implications, linking together the unreported COI, selective reporting in JAMA, and in the mass media. We submitted it to the British Medical Journal (BMJ), who agreed to publish it as a Rapid Response on their website.
Months later, before publishing the BMJ letter, I called JAMA editorial staff twice to talk about the upcoming piece, and I also sent an email. Given the topic of the letter, I wanted to give JAMA an opportunity to correct any factual errors. No one from JAMA responded to my phone calls or email. The letter underwent legal review at BMJ and was approved for publication. We then published what we thought of as a fairly unremarkable letter primarily of interest to researchers who study COI.
The immediate, aggressive response from JAMA has been well documented. Threatening phone calls, personal attacks, and emails were accompanied by demands that we retract the entire BMJ letter.
Our letter was published without any negative commentary regarding JAMA itself, and included the following statement: ≥We are fully aware that JAMA is concerned about conflicts of interest and has taken a leading role in promoting policies to benefit the medical community. We are pleased to report that we learned at the end of business on Thursday (3/5/09) that the JAMA Editorial Staff has looked into this matter and will be discussing it in the forthcoming March 11 issue.≤ Our letter did not attack JAMA and, if anything, presents the facts of the matter flatly.
JAMA continued to ask that the entire piece be retracted. We were stunned by the continued, heated reaction from JAMA, and were concerned that we might have inadvertently made an error of fact in our letter. I made the following offer repeatedly: Please tell me what we have written that is factually incorrect, and if we have made a mistake or misinterpretation, we will retract the entire piece and issue a public apology. No factual errors were ever pointed out. I remain confused as to why JAMA felt they could demand that we retract an accurate letter.
Phone calls were followed by a scathing JAMA editorial which pinpoints my actions as the cause of the problem- with no mention of the culpability of the researchers who failed to disclose their COI, or the fact that the undisclosed COI was unearthed by a 5-minute Google search.
JAMA now insists that it was inappropriate to disclose the COI while they were conducting an investigation. This is curious, for several reasons. First, their investigation was complete by the time our letter was published. Second, the undisclosed COI information contained in the article is publicly available on the Internet (again, here, here, here, here, and here). JAMA has never clarified how the re-publication of publicly available information after the fact could interfere with a completed investigation. This investigation, which took five months, resulted in a short correction published in JAMA, along with a letter from the authors apologizing for their lapse of memory resulting in undisclosed COI. JAMA has claimed that the result of their investigation was more comprehensive than our BMJ piece. I only ask that readers actually compare the material published in JAMA with that published in BMJ. The material published in JAMA does not include any analysis of the context or potential implications. I believe our BMJ letter presents a more complete (and troubling) story.
Importantly, I am under the impression that JAMA objected not to the timing of the publication of the letter, but to us publishing the letter at all. In their most recent editorial, JAMA seems to assert that they have some right to control the publication of publicly available information outside their own medical journal. I do not believe they have any such right. It would seem to be an infringement of academic freedom to threaten academics who analyze publicly stored information. This information was available to anyone with access to the Internet. The view that JAMA should control such information is anachronistic at best. At worse, it is a reflection of a scientifically and ethically inappropriate effort to suppress the free exchange of information, which is at the heart of productive scientific discourse.
The implications of the JAMA’s reaction to our letter are significant. For instance, the pharmaceutical industry is often criticized for their impact on evidence-based medicine. In the past, I have criticized direct-to-consumer advertising of psychiatric medications, which is not helpful to Big Pharma. However, I have never been telephoned or threatened by representatives from Big Pharma. In contrast to my experience with JAMA, any exchanges have been civil and appropriate.
The claim that JAMA can control the flow of information in the public record should be considered by bioethicists and other academics who study the process of medical research and publication. In my opinion, this claim has shifted this issue markedly. What began as a short (and potentially obscure) letter about undisclosed COI has now led to questions about the limits of institutional authority in the medical publishing industry, the extent of academic freedom, and even the role of the First Amendment.
Competing Interests: None.
Acknowledgement: Jeffrey R. Lacasse, Ph.D., provided editorial assistance in the preparation of this letter.
Come along to hear the .. .
‘Confessions of a Drug Rep’
We will be hearing from Shahram Ahari who is a former pharmaceutical sales representative from Eli Lilly’s Neuroscience Division where he successfully sold the blockbuster drugs olanzapine (Zyprexa) and fluoxetine (Prozac) until he left the industry to pursue public health and social justice issues.
In the past 3 years, Mr. Ahari has given over 90 medical lectures nationally and internationally on topics such as global access to essential medicines, drug marketing’s impact on public health, and the drug rep - physician relationship. He has been a speaker for the AMA (American Medical Association), AMSA, IFMSA (International Federation of Medical Students) among other organizations. Mr. Ahari advises private and government institutions on policy issues related to the drug industry. He has testified before the US Senate, the House of Representatives and has served as an expert in matters of drug marketing, public health and policy. He has appeared on numerous media programs including CNBC Business Nation, ABC Worldnews, CBS Evening News, The NY Times, The LA Times, The Washington Post, Rolling Stone Magazine, National Public Radio and American Public Radio for his work on public health and drug marketing.
Mr. Ahari earned a B.A. in Biochemistry, Molecular Biology and Asian Studies from Rutgers College and has a Masters in Public Health with specialties in Infectious Disease and International Health from UC Berkeley.
Monday 23rd March @ 7pm
Seminar Room 119, SAF Building
Imperial College London, South Ken, SW7 2AZ (map attached)
Like most social-networking sites, Inspire.com is a place where users talk about the most intimate details of their lives. They want advice on coping with stage III cancer or to offer encouragement to a mother deciding about life support for her premature baby. But Inspire’s nearly 100,000 users aren’t just sharing with each other (and the 62 nonprofits who partner with the site), they’re also receiving targeted information from pharmaceutical companies who use the site as a recruiting tool for drug studies.
www.newsweek.com/id/187882 10/3/9
Hundreds of patients in Canada’s Newfoundland and Labrador province with breast cancer were given inaccurate results of oestrogen and progesterone receptor hormone testing in a wholesale failure of accountability and oversight at all levels of the healthcare system, an inquiry found this week.
In the report Justice Margaret Cameron made 60 recommendations to ensure that what went wrong will not happen again, including more training for physicians, mandatory continuing education for laboratory technologists, and better record keeping.
The health authority at the centre of the scandal has announced that it has hired a new chief executive officer, Vickie Kaminski, a veteran administrator accustomed to the glare of publicity.
BMJ 13/3/9 http://www.bmj.com/cgi/content/full/338/mar09_2/b952
Aid agencies have condemned the Dutch government’s seizure of a shipment of antiretroviral drugs destined for sub-Saharan Africa, which they say flouts world trade rules and will put patients’ lives at risk.
Oxfam International, Health Action International, and the World Health Organization say that the 50 kg consignment of abacavir should be released immediately, before the health of hundreds of Nigerian patients with AIDS or infected with HIV is affected.
Dutch customs seized the drugs on their way from India in November at Schiphol airport, Amsterdam, on suspicion that they might be counterfeit or have breached local intellectual property rights.
BMJ 13/3/9 http://www.bmj.com/cgi/content/full/338/mar11_1/b1002
Drugs company Roche has agreed to merge with Genentech, and is to buy the remaining shares of the US firm for $46.8bn (£33.7bn). Roche already owned 55% of Genentech. The deal ends a long struggle between the two companies and is the latest merger in the pharmaceutical sector.
The combined group will generate about $17bn in annual revenues and be the seventh-largest US drugs company. Much of Genentech’s revenue comes from cancer-related drugs. Roche expects the merger to generate annual pre-tax cost savings of about $750m to $850m.
BBC News, 12/3/9
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