PLoS Medicine article advocates using legal system to stem ghostwriting
An essay published by PLoS Medicine makes the case that the “guest” authors of ghostwritten articles – typically academic researchers who provide little or no input – in medical journals should be held legally liable for damages or deaths caused by the drug or device that is the subject of articles they sign their names to.
The article points out that ghostwriting “openly infringes academic standards and … contributes to fraud” but that journal editors have been ineffective at putting a stop to it.
We argue that when an injured patient’s physician directly or indirectly relied upon a journal article containing false/manipulated safety and efficacy data, then pursuant to the legal authority outlined above, the authors of that article, including guest authors, are legally liable for patient injuries and could be named as defendants.
Xavier Bosch, Bijan Esfandiari and Leemon McHenry, authors of the PLoS Medicine piece, even endorse the theory that the Racketeer Influenced and Corrupt Organizations Act (RICO) could be used, something that was mentioned in an article last year. Other recourses the authors recommend include the False Claims Act and the Anti-Kickback Statute.
Medtronic attracts attention from Baucus, Grassley
Readers of Covering Health are likely familiar with medical device manufacturer Medtronic and John Fauber’s coverage of conflicts of interest surrounding the company’s Infuse product.
It seems that U.S. Senators Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa) also are aware of the coverage.
The two, leaders of the Senate Finance Committee, have demanded “an extensive trail of documents, including financial records and communications between the company and doctors who have received millions in royalties and other payments.” [See the letter.]
Over the past year, Fauber, of the Milwaukee Journal Sentinel (see update), has reported that the company made payments to surgeons “involved in the clinical testing of Infuse or who wrote positive medical journal articles that failed to link the product to serious complications.” Those complications include unwanted bone growth outside the fusion site and sterility in men.
Infuse is a biological agent used in spinal fusion surgery that stimulates bone growth.
A professor of orthopedics at Dartmouth Medical School is pleased the Finance Committee is investigating, saying it is doing public health work because his profession and the FDA failed to prevent this circumstance.
It appears there is more news to come about Infuse:
Next week, independent researchers are expected to publish more papers revealing additional serious complications with Infuse that were not reported in numerous articles published over the last decade and co-authored by doctors with financial ties to Medtronic. The independent researchers said their research also was prompted in part by Journal Sentinel reports.
Update
This post should have mentioned that the Medtronic coverage is a joint project between the Milwaukee Journal-Sentinel and MedPage Today.
Peck reports another questionable PR pitch
Filed under: Conflicts of interest, Health journalism
In the wake of the discussion over whether public relations folks should offer money to journalists to serve on focus groups for pharmaceutical companies, MedPage Today Executive Editor Peggy Peck writes about a story pitch she recently received via email.
In this case, the PR person offers to set up an interview, record it and then send it to Peck. Sounds like a pretty helpful offer, right? Well, as Peck says, “I would say beware the wolf in sheep’s clothing.”
The email then goes on to suggest questions she might ask in the interview. And, to top it off, the PR person’s signature says the interview will be “provided” by a pharmaceutical company.
See Peck’s post for excerpts from the email and her reaction.
Related
- PR professional offers cash for attending Allergan-hosted event
- PR rep says journalists’ stipend to attend Allergan event was misconstrued
- Skin-crawling example of attempts to buy health care news coverage
PR rep says journalists’ stipend to attend Allergan event was misconstrued
Filed under: Conflicts of interest, Health journalism
An invitation to journalists to participate in an Allergan-hosted “Facial Aesthetics Advisory Panel” that included an offer of a $250 stipend was misconstrued, according to the public relations representative who sent it.
Sarah Smedley, of Chandler Chicco Companies, said the panel was intended to be “in the nature of a focus group.”
The agency, which sent the invitation to 10 freelancers, wanted the journalists to tell them what types of questions their readers have. Smedley characterized the questions they would put to journalists as broad and not product-specific. Allergan manufactures Botox, Juvederm and Latisse.
They chose freelancers because they have a broad view and write for multiple outlets, according to Smedley. “There was no intention to get stories or coverage; we wanted to listen.”
Two journalists have accepted the invitation but one of them has declined the stipend, she said. “We expected a few to come to participate as experts in the media.”
AHCJ member Lisa Collier Cool shared the invitation with AHCJ, saying she considers this “an all-time low in drug company promotion to the media.”
Karl Stark, AHCJ’s vice president, said the organization’s board of directors was alarmed by the offer.
“We report all the time on the potential conflicts of interest that money creates between drug companies and doctors,” said Stark, a Philadelphia Inquirer editor. “How would this be any different?”
AHCJ’s Statement of Principles includes the advice to:
- Deny favored treatment to advertisers and special interests and resist their pressure to influence news coverage.
- Refuse gifts, favors, and special treatment. Refuse meals from drug companies and device manufacturers and refuse to accept unsolicited product samples sent in the mail.
- Weigh the potential benefits involved in accepting fees, honoraria, free travel, paid expenses from organizers of conferences or events against the desire to preserve our credibility with the audience and the need to avoid even the appearance of a conflict of interest.
“We really regret that Lisa [Collier Cool] misconstrued this,” Smedley said. “The allegation that it was a bribe took my breath away.”
Smedley, who said she has worked in health care public relations for about 15 years, said she was “disappointed that Lisa wouldn’t have called, reached out somehow … for more information.”
She said the invitation has been “misconstrued terribly wrong and out of proportion.”
When asked if she is aware of journalists’ codes of ethics, she replied, “We’re highly aware and we respect journalists and their code of ethics.” She said she also observes the PRSA’s code of ethics.
She does not believe their invitation was unethical and her agency will “conduct focus groups and adhere to codes of ethics, as we’ve always done.” This is the first focus group of this kind for Allergan.
A spokeswoman for Allergan told Forbes’ Matthew Herper that the stipend was “for their participation in a three-hour meeting as a means to compensate them for their time, nothing more.”
PR professional offers cash for attending Allergan-hosted event
Filed under: Conflicts of interest, Health journalism, Member news, Studies
Journalist Lisa Collier Cool was “truly appalled” to receive an email that offered her a $250 stipend if she would attend a “Facial Aesthetics Advisory Panel” hosted by Allergen – makers of Botox, Juvederm and Latisse.
The PR pro, of Chandler Chicco Companies, a health care public relations firm, wrote:
The goal of this Panel is to engage in a discussion about current facial aesthetics trends and innovations, perceived gaps in data, and any questions, concerns or misperceptions your readers may have about products and treatments. Allergan will provide an overview of the evolution of the facial aesthetics marketplace and then will open the panel for discussion.
As a seasoned reporter in this space, we would greatly value your feedback, and we’d like to offer you a stipend of $250 for your attendance and insights.
Cool, who brought the email to AHCJ’s attention, said she considers this “an all-time low in drug company promotion to the media” and that this is the first time she’s received such an offer in more than 25 years of health reporting.
AHCJ’s Vice President, Karl Stark, said AHCJ’s board of directors was alarmed by the offer.
“We report all the time on the potential conflicts of interest that money creates between drug companies and doctors,” said Stark, a Philadelphia Inquirer editor. “How would this be any different?”
Cool agreed, saying she is “shocked that along with questionable payments to doctors, the pharmaceutical industry – or at least Allergan – is now stooping to offering fees to reporters, presumably in the hope of securing favorable press coverage for its products. I view this as a thinly disguised attempt at bribery and hope that this practice won’t become widespread.”
Certainly accepting such money would violate common ethical guidelines for journalists. For example, AHCJ’s Statement of Principles includes the advice to:
- Deny favored treatment to advertisers and special interests and resist their pressure to influence news coverage.
- Refuse gifts, favors, and special treatment. Refuse meals from drug companies and device manufacturers and refuse to accept unsolicited product samples sent in the mail.
The Society of Professional Journalists’ code of ethics advises journalists to:
- Remain free of associations and activities that may compromise integrity or damage credibility.
- Refuse gifts, favors, fees, free travel and special treatment, and shun secondary employment, political involvement, public office and service in community organizations if they compromise journalistic integrity.
“Assisting medical companies with their public relations efforts is not the role of journalists,” Stark said.
AHCJ has contacted the representative who sent the email for details on this arrangement, including whether other reporters have taken her up on the offer, if any reporters have raised questions about it and whether this is an approach she or her company has used in the past. We will update this post if we get a response. [Update: PR rep says journalists’ stipend to attend Allergan event was misconstrued]
Meanwhile, Forbes’ Matthew Herper contacted Allergan and posted its response.
Reporter examines ethics of interviewing patients
After joining a panel on media, ethics and trauma at the Anxiety Disorders Association of America’s annual conference, New Orleans Times Picayune reporter John Pope found himself questioning the sourcing practices he’d developed and followed during almost 20 years on the health beat.
As he writes for the Dart Center for Journalism & Trauma, he had no idea of the legion of ethical dilemmas each time he, like countless other health journalists around the country, simply called a specialist in a relevant field and asked for help finding patients who would be willing to talk.
At the panel, Pope suddenly found himself confronted with the questions his innocent requests were raising on the other end of the line. I’ve reproduced his list below, as it’s pretty thought-provoking material.
- Would a therapist be exerting undue influence by asking a patient to speak to a reporter?
- Would the patient feel obligated to comply as a condition of treatment?
- If the therapist were present during the interview, would that inhibit the patient?
- If the therapist weren’t present, would the patient exaggerate to help the reporter get a terrific story?
- Would talking to a reporter reopen psychic wounds if no professional were on hand to guide the conversation?
They are questions that defy easy answers. Many physicians assembled even said that they viewed allowing a patient to speak to a reporter as “unethical in all circumstances.” Nevertheless, a few folks provided suggestions such as posting solicitations for sources in waiting rooms, thus allowing reporters to bypass the doctor-patient relationship, or perhaps asking physicians to maintain source lists of willing and qualified patients.
Neither seems practical or satisfactory on deadline, and in the end their may really be no solution other than Pope’s own, that physicians and reporters form long-term relationships and build the sort of trust necessary in delicate situations.
Federal agency issues guide to covering suicides
Asserting that safe media reporting is one of the best ways to prevent suicide, the federal Substance Abuse and Mental Health Services Administration recently released recommendations for reporting on suicide.
The press release says the guidance was “developed by a group of suicide prevention experts, researchers and journalists and are based on more than 50 research studies.” It’s worth noting, however, that while the website lists a number of organizations that collaborated to develop the recommendations, none of those listed are journalism organizations.
Among its suggestions:
- Avoid sensational headlines and prominent placement
- Don’t use photos of grieving friends or family, memorials or funerals
- Don’t describe a suicide as inexplicable
- Don’t disclose the contents of suicide notes
- Avoid misinformation and offer hope
For some perspective from journalists about reporting on suicide, we recommend “Reporting Suicide and Finding a Balance,” by Meg Spratt of the Dart Center for Journalism & Trauma. The Dart Center has a collection of resources on the topic.
The “Minimize Harm” section of the Society of Professional Journalists’ Code of Ethics doesn’t specifically address suicide but does point out the need to show compassion and sensitivity, as well as realizing gathering and reporting the news can cause harm or discomfort.
The Radio Television Digital News Association has guidelines for reporting on suicide, from the American Association of Suicidology. The guidelines include minimizing reporting specific details and avoiding reporting simplistic reasons for suicide. It cautions against making suicide appear glamorous to someone who might be considering suicide and reporting on it in a straightforward manner.
Following the 9/11 terrorist attacks, Phil Nesbitt wrote an article for the American Press Institute about the ethical debates surrounding the publication of people jumping from the World Trade Center as well as an incident in Pennsylvania in which a state official committed suicide at a press conference.
Nesbitt reports that editors decide whether or not to publish photos on a case-by-case basis, often depending on the circumstances:
A picture of someone leaping from a high-rise fire would not necessarily merit publication. But someone jumping or falling from the World Trade Center tower as a direct result of the greatest terrorist attack on our soil, for most editors, would.
(Thanks to Charles Bingham and Gary Schwitzer for suggesting resources.)
Journalist makes case against sanitizing disaster coverage
At a time when the ethics of anecdotal and emotion-heavy disaster coverage have come into question, as they tend to do in the wake of events such as the earthquakes in Japan and New Zealand and the upheavals in the Middle East, it’s worth looking back on commentary from Donna Rosene Leff, Ph.D., titled “In Defense of Appealing to Emotions in Media Coverage of Catastrophe,” published last year in Virtual Mentor, the American Medical Association’s online journal about ethics.
Leff builds her case around a few key examples, most notably the collective decision not to air or publish images of men and women jumping from the twin towers on Sept. 11, 2001 – a decision she questions with some help from Tom Junod. It centers on the idea that journalists ought not withhold their most intense images and stories, because they can “put viewers in touch with what” victims experienced.
Sanitized stories about groups of victims or general circumstances may inform to a degree, but they also allow us to avoid experiencing the true devastation occurring on the ground. Emotional appeals—and disturbing images of disaster victims are the very epitome of emotional appeal—illuminate the reality of the situation in ways that mere facts cannot.
After all, Leff concludes, “journalists’ moral responsibility isn’t to elicit a particular reaction or outcome; their responsibility is to bring home the truth.” Though that conclusion leads to a few questions, the most salient being one she alludes to earlier in the piece. In modern disasters, from the Indian Ocean tsunami to the Haiti earthquake, news coverage hasn’t just brought home the truth, it also has home billions upon billions of dollars in donations. Disaster journalism seems to be a major driver of relief dollars, dollars that are often given in response to the most emotional coverage.
For AHCJ’s guidance regarding disaster coverage and aid to victims, see our relevant statement.
Journalists must heed ethics in disaster coverage
A little more than a week after the historic earthquake, tsunami and nuclear emergency in Japan, journalists are beginning to reflect on our profession’s performance. How good a job of getting the news and informing the public have we been doing?
The run on iodine tablets up and down the U.S. west coast is a discouraging example of the limited ability of the many balanced news reports about radiation risk – and iodine risk, including serious allergic reactions – to quell panic-buying. It’s Cipro and anthrax all over again.
Sailor provides food and water to Japanese citizens during relief efforts. Photo: Official U.S. Navy Imagery via Flickr
Recently, AHCJ posted a statement about some of the ethical issues that face journalists reporting from disaster zones. The statement focuses on the public service value of reporting from disaster zones and the imperative that the spotlight must remain on the people and events reporters observe, not the reporters themselves.
“In summary,” the statement concludes, “do not exploit vulnerability for gain or glory.”
Each disaster is different. The people of Japan are not interchangeable with the people of Haiti. Nevertheless, journalists inevitably encounter people who need help. The need may be for a bottle of water or for urgent medical care. Aid should be given freely, without creating a sense of obligation. When one hand offers a thirsty person a bottle of water, while the other hand holds a microphone, is consent to be interviewed truly unencumbered? Or does such an exchange inevitably plant the thought in a person’s mind that the interview is payment for the water?
There are legions of aid workers moving into the northeast coastal region of Japan. Reporters seeking to tell stories of the people providing care and those receiving it should have no trouble finding examples. Stories that feature the acts of a reporter have an inherent “look at me!” aspect that offers no additional value to readers and audiences.
Every day and every story is unique, so it is impossible to say without exception how a journalist should act in each and every circumstance; yet when we intrude on a scene of personal suffering, we should always remember why we are there.
Review: Doctors experimented on healthy people
Filed under: Government, Hot Health Headline, Member news
The Associated Press’ Mike Stobbe found more than 40 instances of doctors making patients sick for the sake of experimentation throughout U.S. history. Last fall’s government apology for doctors infecting Guatemala prisoners with syphilis 65 years ago sparked the review.
Stobbe, a member of AHCJ and a past board member, found healthy people were infected with malaria, Asian flu, gonorrhea, hepatitis and even a deadly stomach bug for the sake of broadening knowledge. Doctors violated the fundamental medical principle to “first do no harm.” Stobbe points out:
Attitudes about medical research were different then. Infectious diseases killed many more people years ago, and doctors worked urgently to invent and test cures. Many prominent researchers felt it was legitimate to experiment on people who did not have full rights in society - people like prisoners, mental patients, poor blacks. It was an attitude in some ways similar to that of Nazi doctors experimenting on Jews.
Disturbingly, some of these stories were never covered in the media.
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