Interview with a Ghostwriter

"Not sure there's anything new here" was the comment from my regular correspondent who kindly forwarded to me the link:
http://scholarlykitchen.sspnet.org/2010/10/29/interview-with-a-ghost-writer/

I agree that there's nothing earth-shattering for those of us who have been following the ghostwriting saga for the past few years, but on balance there were enough tidbits for me to feel this is worth sharing. The "ghost" who was interviewed made several important points:

• While all academic physicians accused of having their name placed on a ghostwritten manuscript routinely assert that they were actively engaged in the writing process, made extensive changes in multiple drafts, etc., etc., our "ghost" confirms that many of them do nothing at all and just take the money (and the credit).
• The universities are to blame, in part, when they impose publication requirements for faculty tenure and promotion, even when medical faculty have no time to write between their research and their patient care responsibilities, and even when some of them are simply lousy writers. (Indeed both are used by the "ghost" as clues for him to tell which academic physicians probably have their names on a lot of ghostwritten articles.)
• The "ghost" thinks that commonly quoted figures for the prevalence of ghostwriting in medical journals--in the 10 percent range-- are way low.
• The "ghost" makes the good point that if the science is marvelous, and the writing stinks, then the research paper will not get published in a top tier journal. Good science does not automatically make for good writing skills. If the official codes of ethics of the medical writers' societies were followed, and ghostwriters were honestly listed for their work on a manuscript, the system would work fine--the scientists could do their science and somebody who really knows how to write could make the stuff readable for the rest of us.
• His own ethical assessment of the present system? "Leaves a bad taste in my mouth..."

From Health Care Renewal: Commercial, and Dangerous, CME

Over on our friends the Health Care Renewal blog, Bernard Carroll posted this important message:
http://hcrenewal.blogspot.com/2010/10/thats-education.html

Dr. Carroll looks in detail at a single commercial CME offering in psychiatry, an apparently innocent (even if hardly earthshattering) chat between two prominent academic psychiatrists on mood disorders. He shows, first, how this program that is ostensibly about the physician-patient relationship manages to get in a number of "soft" messages promoting the drugs made by the two sponsoring firms. Second, and probably more important, he noted a slide that gives incorrect and indeed dangerous information about a set of little-used antidepressants (MAO inhibitors). This dangerous and incorrect content is contained in a program that features two academically highly-qualified psychiatrists and that is officially spopnsored by the Purdue College of Pharmacy. In short, the internal quality control within this medical "education" enterprise seems to be about the same as the quality control in GlaxoSmithKline's Puerto Rican manufacturing plant (latest post).

Drug Companies Are Tops in Fraud Payouts

Matthew Perrone of the Associated Press:
http://hosted.ap.org/dynamic/stories/U/US_DRUGMAKERS_SETTLEMENTS?SITE=CTDAN&SECTION=HOME&TEMPLATE=DEFAULT

--informs us that of the top 10 settlements paid to the US Dept. of Justice to settle claims of fraud in the past year, 8 were paid by drug firms. (Just to be sure that health care was fully represented, an insurer and a hospital chain filled out the list of 10.)

I have been trying to log in these settlement announcements as they arise, as regular readers of this blog know. Perrone's overall summary of the last year of activity drives home the point we pharmascolds have been stressing for some time--the number of such fraud charges and settlements strongly hints that whatever is going on here is not a matter of an occasional aberration or a few bad apples in the barrel. Rather it seems as if the business policies that lead to the fraudulent or near-fraudulent behavior are standard default practices among the pharmaceutical industry, and that the cost of paying out these sums to DOJ or whomever is simply toted up as part of the cost of doing business.

Incidentally, so far as I can tell, Perrone's "top 10" list was compiled before it was announced earlier today that GlaxoSmithKline is paying $750 million to settle criminal and civil charges related to massive contamination and product-quality problems in a large manufacturing plant in Puerto Rico (that the company reports was closed in 2009):
http://www.nytimes.com/2010/10/27/business/27drug.html?emc=eta1
This is a bit of change of pace as the usual fraud charge has been off-label marketing. It is also more worrisome, as we have tended to assume that while the big drug firms really want to push their pills so that more docs will prescribe them, at least they make good-quality pills. If pressures to turn big profits are now causing the firms increasingly not only to over-market, but also to skimp on quality and safety, then we are in a worse mess than we imagined.

From the American Society for Bioethics and Humanities: Panel on COI

I'm currently attending the annual meeting of the American Society for Bioethics and Humanities in San Diego, where earlier today was featured a panel presentation, "Conflicts of Interest: Institutional, Political, and Legal Responses." Here are some highlights.

Virginia A. Sharpe, PhD, Veterans Health Administration, Washington, DC, discussed the development of the recent VHA policy on financial relationships with the pharmaceutical industry:
http://www.ethics.va.gov/resources/ethicsresources.asp#84
The policy was issued in 2009 and the VHA recently did a survey to check on uptake. The policy discussed avoidance or management of COI, and is based on the fact that physicians and staff of the VHA have two separate sets of responsibilities--one as government employees with strict policies on accepting money from commercial interests, and the other as health providers within the VHA. The policy defines the "industry" as not only drug firms but also their various proxies such as medical education and communications companies, PR firms, etc. The follow-on survey showed that only 46% of providers were aware of the policy, though the rate was 67% among pharmacists and 72-82% among chiefs of activities. Of those who knew of the policy about a 2:1 ratio thought it helpful, but there were strong reactions at both ends of the spectrum. The VHA concluded that it needed to do much more work to educate and promulgate the substance of the policy (it appears many VHA staff feel "policied" to death).

James F. Childress, Ph.D., University of Virginia, reviewed the work of the panel of the Institute of Medicine that wrote the report, Conflict of Interest in Medical Research, Education, and Practice, April 2009 (see previous post at:
http://brodyhooked.blogspot.com/2009/05/iom-report-on-coi-yes-we-really-mean-it.html
...and report available for free on line at:
http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx).
He described the overriding goal as protecting the integrity of professional judgment and preserving public trust. Disclosure of COI is a generally necessary but very limited first step. The IOM panel recognized that there are benefits to interactions between medicine and Pharma, and so overly restrictive policies can have significant unintended consequences; but there are also significant risks. The basic procedural principles the IOM relied on for good policy formulation are proportionality, transparency, accountability, and fairness.

Charles Rosen, MD, UC-Irvine, spoke on behalf of the Association for Medical Ethics, an organization that I admit to not having previously been aware of:
http://www.ethicaldoctor.org/
Dr. Rosen formed the AME as an orthopedic surgeon tired of reading scandals about his colleagues pocketing millions of dollars from medical device companies, and he made common cause with Sens. Kohl and Grassley and helped them to pass the Physician Payment Sunshine Act that became law earlier in 2010 as part of the health reform law package. He noted how his individual lobbying efforts on behalf of the law were met with stiff, extremely well financed industry opposition at every step. His goals included "ending the myth of 'independent' validation" of industry claims for drugs and devices by revealing when the so-called "independent" expert was actually in the pay of the company, and "putting patient care 1st and industry profits 2nd."

David Armstrong, Bloomberg News, formerly of the Wall Street Journal, was one of the first reporters consistently to cover the COI "beat" starting around 2000. These stories, he explained, attracted huge media interest back then and continue to do so today because of the impact on medical practice that all readers can immediately grasp, the huge sums of money often involved, and the fact that Pharma is "big business." While as a reporter he depended on disclosures of COI by public institutions and contacts in the legal world as his sources, he also relied a good deal on whistleblowers in qui tam lawsuits, which have produced treasure troves of internal industry documents that otherwise would never have seen the light of day. More recently, medical journal editors, apparently embarrassed by revelations of how easily authors get away with nondisclosure, have started to crack down more severely. He gave the example of the Journal of Cardiovascular and Thoracic Surgery which recently announced a new policy of banning future publications from authors who fail to disclosure according to their policy:
http://jtcs.ctsnetjournals.org/misc/ifora.shtml#conflict_of_interest
(Such a ban will almost certainly make academic physicians sit up and take notice, given the rule of "publish or perish" that governs their lives.) Armstrong offered the prediction that the future big stories will come from conflicts of interest at the institutional level as universities and academic centers become more entrepreneurial in their search for scarce dollars.

From ProPublica: The Seamy Side of Pharma Speakers' Bureaus

In a previous post I provided the link to the new ProPublica database on drug company payments to physicians. ProPublica, in partnership with the Boston Globe, the Chicago Tribune, and others, has been mining the database for important information, some of which appears at:
http://www.propublica.org/article/dollars-to-doctors-physician-disciplinary-records

Some of their key findings:

• Many of the highest-paid docs in the company speakers' bureaus have records of numerous licensing violations and other practice and research misconduct
• Further evidence that being on a speakers' bureau has nothing to do with speaking--Cephalon records showed that that company dismissed great speakers who did not personally write enough scripts for their drug, and retained lousy speakers who were voluminous script writers, showing that the fees were more of a reward for high prescribing than anything else
• Bribery is turning out to be equal-opportunity--though most of the names listed are physicians, a few pharmacists, nurse practitioners, and dietitians are making it onto the list
• Many physicians who work for institutions that have officially banned participation in speakers' bureaus nevertheless remain active, showing that these rules are seldom enforced

Major New Study Published in PLoS Medicine

I have been waiting for some time to post this information and am delighted finally to be able to do it--see the article just published on line in PLoS Medicine:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000352#top

This article by Spurling et al. represents the brain trust of Healthy Skepticism in Australia, with input from Canada's Joel Lexchin--in short, the people around the world who have most closely tracked the evidence for drug industry influence over medical practice.

The problem they set out to address is one I explained some time back:
http://brodyhooked.blogspot.com/2010/02/what-would-it-take-to-prove-harm-from.html

The ideal evidence that we pharmascolds seek--that accepting gifts and information from the drug industry leads to worse prescribing by docs--will never be available because the necessary randomized, controlled trial that would establish causation will never be done. Pharmapologists have seized upon this situation to assert the opposite state of affairs, that there's simply no evidence at all of harm arising from industry marketing, therefore we pharmascolds base our position solely on ideology and not on evidence. As I have also noted, we pharmascolds make things worse by repeatedly, in knee-jerk fashion, citing the systematic review by Wazana in JAMA, 2000. This review is now nearly worthless for two reasons. First, it's woefully out of date; second, if you read it carefully, it "proves" almost nothing--perhaps that more contact with drug reps makes docs who serve on formulary committees more likely to recommended company drugs.

In short, what we have needed for a long time is an up-to-date, very careful review of the existing literature that addresses the actual evidence base for the argument against drug company influence. Finally we have that review.

Spurling et al. surveyed the literature and carefully pared down their sample to 58 published studies. Almost all of these were observational studies. They were able to do a meta-analysis of one set of studies, but mostly had to do a narrative review because of the heterogeneity of the research methods. In short they were quite careful not to claim more than they could back up.

I will copy their abstract as to their main findings:

"Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. "

Their conclusion:

"With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies."

My own way of stating the results: There are a lot of reasonably well-done studies of the subject, given the inherent limitation that only observational studies and not randomized trials are usually feasible. These studies show that when an influence can be detected, drug industry marketing exerts a negative influence on the quality of physicians' prescribing (including unnecessarily higher costs as a negative feature). It is vanishingly rare to find a study that shows an improvement in quality. There is a body of evidence, and it overwhelmingly tilts in the direction of supporting recommendations that physicians try to minimize influence from and contact with the industry.

Wazana A (2000) Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 283: 373–380.

ProPublica Launches Database On Docs Taking $$

The website ProPublica, "Journalism in the Public Interest," has several articles about physicians accepting gifts (aka bribes) from drug companies, and also announces its searchable database, "Dollars for Docs":
http://projects.propublica.org/docdollars/

As seven firms have now begun to post payments to physicians on their websites, ProPublica says that they've combined the data on their site. Apparently the Chicago Tribune has already based an investigative reporting piece on this database:
http://www.chicagotribune.com/health/docdollars/ct-met-doctors-drug-dollars-20101018,0,2745754.story

Just to check it out , I put in the names of two of my colleagues in this area, neither of whom make any bones about accepting lots of funds from Pharma. One did not show up at all and the other was listed as having received two payments for less than $10,000 total. So it would appear that the data are far from complete.

More Embarrassment for the AAFP--or Not

First background item: debate/scandal over the American Academy of Family Physician's sweetheart financial deal with Coca-Cola to fund "educational" materials for patients:
http://brodyhooked.blogspot.com/2010/07/more-on-aafp-coca-cola-controversy.html

Second background item: recent Federal settlement with Allergan over off-label marketing of Botox:
http://brodyhooked.blogspot.com/2010/09/catching-up-pharma-settlements-in.html

Now comes Alan Blum, family physician, former editor of American Family Physician, and Professor and Director at the University of Alabama Center for the Study of Tobacco and Society, to inform me that the AAFP, virtually the same week that the Federal Allergan-Botox settlement was announced, sent out a mass mailing to its physician members called "Upper Limb Spasticity: Information for You and Your Patients." Now the first thing to notice about this, as Dr. Blum did, without any intention to minimize the suffering of any person with this condition, is that upper limb spasticity is not exactly near the top of anyone's list of common problems in primary care practice. (Nurse: "Doctor, can we work in Mrs. Jones this afternoon? She has a sore throat." Doctor: "Thank heavens! The last 20 patients I saw all had upper limb spasticity, and I was really getting bored silly.")

These mailings go out on a fairly regular basis and if you look at the fine print at the bottom of the cover letter you see that it's sponsored by a drug company--in this case Allergan, the maker of Botox. And when you read the supposed "educational" material, it's a thinly disguised infomercial for the drug. So when I get these mailings they usually head immediately to the circular file. Dr. Blum, fortunately, paid more attention, and noted the unfortunate coincidence between the timing of the mailing and the announcement of Allergan's legal difficulties.

You might imagine that the AAFP would be embarrassed by the timing. But the Coca-Cola debacle has demonstrated to many of us that sadly, "our" supposed "professional" organization is beyond embarrassment.

CORRECTION ADDED 10/14/10: I misread a part of Dr. Blum's e-mail. While he was editor of two other medical journals, he was never editor of American Family Physician. The reason is interesting. He was offered the editorship by the AAFP, which publishes the journal. But at the time, AAFP had some sort of deal with two tobacco companies, and the contract offered to Dr. Blum contained a clause that would prohibit him from speaking out publicly about the health effects of tobacco. So he turned down the job.

More from Carl Elliott, on Crybaby Companies

In case you haven't had your daily serving of Carl Elliott, here is a recent piece on the Bioethics Forum blog from the Hastings Center:
http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4931&blogid=140#ixzz12IGpz6PB

Target for Elliott's ire is Wyeth, whose practices were in turn the target of a recent article by Adriane Fugh-Berman in PLoS Medicine (addressed in the post, http://brodyhooked.blogspot.com/2010/09/new-review-of-ghostwriting-for-selling.html). Wyeth sent a nasty letter to the journal taking righteous umbrage at Dr. Fugh-Berman's failure to disclose fully her own conflicts of interest. She stated that she had been paid as an expert witness in anti-Wyeth litigation. The letter's accusation: that she failed to say that she was still being paid as an expert witness.

Elliott adds up Wyeth's known misdeeds--first off, working as hard as it did to conceal the risks and harms related to its diet pill combo, Fen-Phen; and more recently, the ghostwriting of papers promoting hormone therapy--and compares them to Fugh-Berman's track record--using the wrong verb tense--and finds that the scales of justice tip over pretty heavily against Wyeth.

I myself might not have been quite as quick with the verbal barbs as my esteemed colleague Carl. Those of us who throw stones in the conflict-of-interest arena need to be prepared to receive similar missiles hurled back at us, and must do our level best to be squeaky-clean, both to maintain needed credibility and also to serve as good examples of ethical behavior. (Anyone old-fashioned enough to remember what that was all about?) Dr. Fugh-Berman quite appropriately admitted the use of incorrect verb tense and corrected the record in response to Wyeth's letter:
http://www.plosmedicine.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F9615f3f1-520f-43cd-a825-8afcab3c26d4&root=info%3Adoi%2F10.1371%2Fannotation%2F9615f3f1-520f-43cd-a825-8afcab3c26d4

Just Trying to Keep Up: Novartis Settlement

OK, here we go again:

Drug Company: Novartis
Drug: Trileptal, Diovan, Sandostatin, Exforge, Tekturna, Zelnorm
Amount of settlement: $422.5M
The settlement equals what percentage of one year's sales of the drugs?: 5%
Did the company admit wrongdoing? Pled guilty to one misdemeanor charge; otherwise denied wrongdoing
Link to detailed news coverage: http://www.nytimes.com/2010/10/01/health/policy/01novartis.html

The illegal, off-label marketing of which Novartis was accused occurred between 2000 and 2004 and consisted of (according to Duff Wilson in the New York Times) "paying illegal kickbacks to health care professionals through speaker programns, advisory boards, entertainment, travel and meals." Without more details we don't know just how the gifts/bribes were distributed or how many of them came after the PhRMA ethics code of 2002-3 and may have been in violation of that code.

Is there anyone left out there who does not believe that this sort of stuff is the standard business model of the pharmaceutical industry, rather than occasional bad behavior among a few bad apples?

UN Guidance on Pharmaceutical Companies

Thanks yet again to our colleague Roy Poses over at Health Care Renewal blog for this recent post:
http://hcrenewal.blogspot.com/2010/09/that-wheel-was-already-invented-un.html

The subject of the post is a 2008 UN Guidance document on management of pharmaceutical companies:
http://www.essex.ac.uk/human_rights_centre/research/rth/docs/GA2008.pdf

--which in turn was the subject of a recent paper:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000330

The basic gist of all this is that the UN considers access to necessary medicines a human rights issue, and that in turn places burdens on pharmaceutical companies to conduct business in a manner that's compatible with these basic human rights. Dr. Poses makes two very appropriate points: first, many of us (including me) had no idea that this UN document even existed; second, if drug companies managed their affairs in ways compatible with the UN guidelines, this blog could fold up shop, as almost all the abuses we rail about would disappear.