Sunday, April 05, 2009

Ethics in the Academy -- and Its Media

April 5, 2009, 6:45 a.m.; April 6, 2009, 7:15 a.m. (now with appended "doctors' gag order" story)

The Story That Has Everything
(brought to you by FromDC2Iowa.blogspot.com*)

Friday I was blogging about Iowa's latest civil rights pride, Justice Cady's opinion for a unanimous Iowa Supreme Court upholding the right of gay and lesbian couples to marry. Nicholas Johnson, "Iowa's Civil Rights Leadership," April 3, 2009.

By Saturday an anonymous comment on that blog entry reminded me that the bloggers' responsibility is to do that which the local cheerleaders and boosters are sometimes reluctant to do -- support the local community by pointing out where it can improve rather than just where it has already excelled.

Here is that comment in its entirety:
Anonymous said...

Iowa may have a good record in some areas, however the newspapers and media fail miserably in others.

Why is an issue concerning full disclosure involving the U of Iowa covered in the Wall St Journal,
http://online.wsj.com/article/SB123776823117709555.html

NY Times
http://www.nytimes.com/2009/04/01/health/research/01journal.html?ref=health

Washington Post
http://www.washingtonpost.com/wp-dyn/content/article/2009/03
30/AR2009033002765.html

The Economist
http://www.economist.com/science/displaystory.cfm?story_id=13361480

Scientific American
http://www.sciam.com/blog/60-second-science/post.cfm?id=jama-editors-embroiled-in-brouhaha-2009-04-01

not even mentioned by local press? Scared of the U of Iowa? Not aware of the world?

Weird.
4/04/2009 06:41:00 PM
Needless to say, as is almost always the case, I have not a clue who "Anonymous" is in this case. But I did feel an obligation to follow up on his or her comment, especially since the author had been so kind as to provide me the links.

So why do I say the story has everything? Because it involves:
- Iowa City, the University of Iowa, its College of Medicine and Hospital

- ethical issues in the academy, especially with regard to research

- financial conflicts of interest

- the accuracy and adequacy of what passes for the "science" made available to the public, whether shaped by political ideology (as has been charged about the Bush Administration), corporate marketing and advertising, religious efforts to substitute creationism for evolution, distortions introduced by researchers or the media

- media ethics with regard to the influence of advertising on content, the reluctance/refusal to admit errors, and the human inclination to silence critics (and punish "whistle-blowers")

and

- if true, as the comment suggests, media ethics with regard to the pressures on local media to avoid stories that reflect adversely on major community institutions or advertisers
As is most often my practice, I won't mention the name of the Iowa City person at the center of the story. (a) My interest is in the issues set forth above, not personalities, (b) even if I had first-hand knowledge of the facts (which I don't), (c) those who need to know the name can easily find it elsewhere, and (d) none of the stories linked above provide him a full opportunity to tell his side of the story.

So to get the basic facts before us let me simply reproduce excerpts from one of the world's most prestigious publications, and the one published furthest from Iowa City, The Economist (with, of course, its British spelling):
In the past scientists sometimes managed to publish medical studies flogging the supposed benefits of some or other drug without disclosing that they had financial ties to the drug’s manufacturer. One of the leading voices arguing for full disclosure of such connections has been the Journal of the American Medical Association (JAMA). . . .

So it comes as something of a shock to see [this] journal now engulfed by a scandal concerning its handling of precisely such a matter. . . .

The trouble started when JAMA published a study last May that looked at how best to prevent depression in patients recovering from strokes. A team of researchers, led by [the researcher] of the University of Iowa, compared the usefulness of “problem-solving therapy” (ie, talking) and escitalopram (a popular antidepressant drug also known as Lexapro) against a placebo. Lexapro is made by Forest Laboratories, an American firm under investigation by the Department of Justice for marketing that drug “for unapproved paediatric use and for paying kickbacks to induce physicians to prescribe”.

The study prompted much favourable coverage of Lexapro, thanks in part to kind words from the its authors. In USA Today, a widely read newspaper, [the researcher] insisted that “every stroke patient who can tolerate an antidepressant should be given one”. But the study itself did not support such a clear conclusion. Rather, it found that although both forms of treatment were better than a placebo, there was no statistical difference between the results from the use of talk therapy and the popping of Lexapro.

Alas, as Jeffrey Lacasse of Arizona State University and Jonathan Leo of Lincoln Memorial University pointed out in a letter published in JAMA last October, [the researcher] failed to clarify that important point in his paper. In a response published alongside the critical letter from Drs Lacasse and Leo, [the researcher] and his colleagues acknowledged that Lexapro performed no better than talk therapy in their study, but insisted this omission was not intended to mislead.

To make matters worse, though, he had taken money from Forest Laboratories but did not disclose this fact. That surfaced only because Dr Leo did a bit of Googling after his letter was published, and found out that [the researcher] had served in the past as a paid speaker for the firm.

Dr Leo informed JAMA of this non-disclosure, and was assured that the matter would be investigated. On his account of events, he then endured five months of silence before—assuming that JAMA was not going to act—he and Dr Lacasse published their revelations in a letter to the British Medical Journal (BMJ) on March 5th. That set off a fiery response from JAMA. According to Drs Leo and Lacasse, Dr. [Catherine] DeAngelis [JAMA’s editor] rang up Dr Leo and his boss to express her displeasure in strong terms. They claim JAMA threatened to cut off access to its prestigious pages as punishment, but she denies that charge.

[The researcher] now acknowledges that he served as a paid member of Forest Laboratories’ speaker bureau “in 2004 and perhaps 2005”. His failure to disclose this violated JAMA’s policy, which insists on disclosure of such relationships going back five years. [The researcher] apologised in a letter published in JAMA on March 11th, blaming this omission as well as several other incidents on “errors of memory”. . . .

However, JAMA’s new editorial policy, announced nine days later, demands that similar whistle-blowers say nothing to the media or other journals during the weeks or months it decides to take to investigate. Both the editor of the BMJ and a former editor of the New England Journal of Medicine have criticised this heavy-handed approach. What could possibly justify a policy that requires whistle-blowers to remain silent at an accused journal’s pleasure?

The JAMA editorial explains that the new policy arises from a desire to “ensure a fair process of investigation and above all, to protect the integrity of science and the reputation of JAMA.” The first two goals are laudable, but the rule of silence seems designed with the third, rather more self-serving, goal in mind. If JAMA is not careful how it implements its new policy, that may yet work against the first two goals.
Medical journals and ethics; Pity the Messenger: A Leading Journal Unveils a Controversial Policy on Financial Disclosures," Science and Technology, The Economist (print edition), March 26, 2009.

So what do we have here?

- A University of Iowa researcher publishes a paper extolling the efficacy of a pharmaceutical company's profitable drug in which he fails to reveal the research results that showed it did no more good than talking to the patients, and also fails to reveal that he has been taking money from the company -- and subsequently blames both omissions on "errors of memory." (And note that the "speaking fees" are only what a casual search of Google revealed; so far as I know no one has asked, or answered, what other payments over time may have been made to the researcher by the company.)

- Putting aside the ethical issues that creates, the consequences for the public are that, at best, patients (relying on what they are told by their doctors, who are in turn relying on what they've read in the academic literature) have been, at best, wasting their money while increasing America's exorbitant costs of health care, and at worst possibly harming their health (or at a minimum failing to get what might be for them a more effective treatment).

- A respected academic journal (JAMA, the Journal of the American Medical Association) is seemingly failing to apply its own standards, possibly with regard to peer review, but at least with regard to financial conflicts of interest -- engendering criticism from its peers, the New England Journal of Medicine and the British Medical Journal.

- This is the second story within the past month involving a rather severe "code of silence" within the medical profession regarding criticism of doctors. (The earlier one was that there is a growing movement of doctors who are requiring their patients to sign "gag statements." "Patients who sign [the standardized waiver agreement] agree not to post online comments about the doctor, 'his expertise and/or treatment.'" For the story see the very bottom of this blog entry.) What chutzpah! JAMA actually thinks it has the right to silence whistle-blowers while it's investigating their charges -- however long JAMA may choose to take for that investigation, presumably up to and including forever? I guess the procedure in the future should be that anyone wanting to call an error to JAMA's attention should first publish elsewhere and then let JAMA know about it in order to avoid the heavy sanctions of its censors -- following which JAMA would probably forbid that practice as well.

- I cannot really confirm or deny the assertion in the comment on Friday's blog entry that local media have failed to carry this story. I haven't seen it, but I may have missed it -- or it may even be in this morning's papers, or perhaps it was reported by them weeks ago. But I guess I would have to agree with "Anonymous" that, at a minimum, for local papers to fail to accord such a national, and global, story involving Iowa City any mention whatsoever really would be, at best, rather odd.

[Since writing this last paragraph, a comment from "Anonymous" on this blog entry has directed me to the "UI in the News" March 2009 archives, where the following stories are in fact noted. Whether that makes it better or worse that the Des Moines Register, Gazette, and Iowa City Press-Citizen failed to pick up the story from that source as well as the national and global media -- if in fact that's the case -- I'll leave to your judgment. It at least clarifies that the University was not trying to hide the story from the media and public. Here are the official reports of those stories from the University of Iowa's publication:
Conflict-of-interest case leads to new guidelines (Bloomberg, March 23)
The Journal of the American Medical Association is instructing people who unearth possible financial conflicts of interest in studies it has published not to go public with their complaint before editors have completed an investigation. Jonathan Leo, an associate professor of neuro-anatomy at Lincoln Memorial University, uncovered a researcher's financial conflict of interest. The lead author, [the researcher] at the University of Iowa, had previously served on the speaker's bureau of Forest Laboratories. He didn't disclose the relationship in the publication of the study.
http://www.bloomberg.com/apps/news?pid=20601110&sid=a9E8PPudI5b4

New JAMA policy involved UI case (Wall Street Journal, March 22)
The Journal of the American Medical Association 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 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 [researcher] who failed to disclose he had a financial relationship with the maker of the drug.
http://online.wsj.com/article/SB123776823117709555.html.]
_______________

* Why do I put this blog ID at the top of the entry, when you know full well what blog you're reading? Because there are a number of Internet sites that, for whatever reason, simply take the blog entries of others and reproduce them as their own without crediting the source. I don't mind the flattering attention, but would appreciate acknowledgment as the source -- even if I have to embed it myself. -- Nicholas Johnson

# # #

Lindsey Tanner, "Docs seek gag orders to stop patients' reviews,"
Associated Press [as reproduced by Townhall.com], March 4, 2009.

The anonymous comment on the Web site RateMDs.com was unsparing: "Very unhelpful, arrogant," it said of a doctor. "Did not listen and cut me off, seemed much too happy to have power (and abuse it!) over suffering people." Such reviews are becoming more common as consumer ratings services like Zagat's and Angie's List expand beyond restaurants and plumbers to medical care, and some doctors are fighting back.

They're asking patients to agree to what amounts to a gag order that bars them from posting negative comments online.

"Consumers and patients are hungry for good information" about doctors, but Internet reviews provide just the opposite, contends Dr. Jeffrey Segal, a North Carolina neurosurgeon who has made a business of helping doctors monitor and prevent online criticism. . . .

His company, Medical Justice, is based in Greensboro, N.C. For a fee, it provides doctors with a standardized waiver agreement. Patients who sign agree not to post online comments about the doctor, "his expertise and/or treatment."

"Published comments on Web pages, blogs and/or mass correspondence, however well intended, could severely damage physician's practice," according to suggested wording the company provides.

Segal's company advises doctors to have all patients sign the agreements. If a new patient refuses, the doctor might suggest finding another doctor. Segal said he knows of no cases where longtime patients have been turned away for not signing the waivers.

Doctors are notified when a negative rating appears on a Web site, and, if the author's name is known, physicians can use the signed waivers to get the sites to remove offending opinion.

RateMd's postings are anonymous, and the site's operators say they do not know their users' identities. The operators also won't remove negative comments.

Angie's List's operators know the identities of users and warn them when they register that the site will share names with doctors if asked.

Since Segal's company began offering its service two years ago, nearly 2,000 doctors have signed up. In several instances, he said, doctors have used signed waivers to get sites to remove negative comments.

John Swapceinski, co-founder of RateMDs.com, said that in recent months, six doctors have asked him to remove negative online comments based on patients' signed waivers. He has refused.

"They're basically forcing the patients to choose between health care and their First Amendment rights, and I really find that repulsive," Swapceinski said.

He said he's planning to post a "Wall of Shame" listing names of doctors who use patient waivers.

Segal, of Medical Justice, said the waivers are aimed more at giving doctors ammunition against Web sites than against patients. Still, the company's suggested wording warns that breaching the agreement could result in legal action against patients.

Attorney Jim Speta, a Northwestern University Internet law specialist, questioned whether such lawsuits would have much success.

"Courts might say the balance of power between doctors and patients is very uneven" and that patients should be able to give feedback on their doctors' performance, Speta said.

Angie Hicks, founder of Angie's List, said her company surveyed more than 1,000 of its consumer members last month, and most said they had never been presented with a waiver; 3 percent said they would sign one.

About 6,000 doctors reviewed on the Angie's List site also were asked to comment. Only 74 responded, and about a fifth of them said they would consider using them.

Lenore Janecek, who formed a Chicago-based patient-advocacy group after being wrongly diagnosed with cancer, said she opposes the waivers.

"Everyone has the right to speak up," she said.

While she's never posted comments about her doctors, she said the sites are one of the few resources patients have to evaluate physicians.

The American Medical Association has taken no position on patient waivers, but President Dr. Nancy Nielsen has said previously that online doctor ratings sites "have many shortcomings." . . .

# # #

3 comments:

Anonymous said...

UI News Digest cited two news articles related to this matter in its March 24, 2009 issue, available online in the UI News Digest archives.

John Neff said...

There is an old joke the the Press Citizen once reported a hanging as "Local man dies in fall from platform while participating in a public ceremony."

Anonymous said...

Interesting that a Google search shows the author didn't just experience a 'lapse of memory' once. There appears to be something consistent about not naming drug companies in articles. How can the public evaluate research if authors do not disclose their financial influences?

http://neuro.psychiatryonline.org/cgi/reprint/19/4/399

http://neuro.psychiatryonline.org/cgi/reprint/16/4/426