Thoughts on Ghostwriting

There has been a lively and thoughtful discussion about ghostwriting in the comments section of my post on BlueSpark’s invitation to a doctor to write a review article on bupropion and depression. Here are some of the issues that have come up.

1. What’s in a name?

Michael Altus has been tenacious in his efforts to educate us in the still evolving vocabulary of this business.

“Ghostwriter”= A person who writes or otherwise assists in presenting the author's work without being acknowledged.

“Ghost author” = Identical to a ghostwriter.

“Guest author” = A person who is listed as an author without having made substantial contributions. This is what has also been called “identified author,” or “named author.”

Beyond this, there are acknowledged medical writers, usually listed at the end of an article, and typically described as providing “editorial assistance,” “assistance with data analysis,” etc…. These are not really ghostwriters, because they are visible. However, they are often spectral writers, or semi-ghost writers, because in some cases they have essentially done all the work, including the conception (in conjunction with the company’s marketing team), the outlining, the writing of the first draft, and the final editing. Anybody who does all that, or even part of that, should be listed as an official author. But it doesn’t look very legitimate to have a medical writer without an MD recorded as an author, and what the drug companies are looking for is legitimacy, whether genuine or fabricated.

2. So who should be listed as an “author”?

According to the web site of the International Committee of Medical Journal Editors (ICJME), in order to get your name up in lights as an author of a scientific paper, there are three specific criteria. To quote from their recommendations:

“Authorship credit should be based on 1) substantial contribution to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published.”

As you can see, there’s quite a bit of wiggle room here. For example, what should count as “substantial contribution to conception”? If an academic has a brief phone conversation or an email exchange with a pharma-funded medical writing firm in which the topic of the article is discussed, the firm might later argue that this counted as a “substantial contribution to conception.” In fact these criteria do not require that an author do any actual writing—as long as they do some “revising.” As an editor myself, I know that “revising” is an expandable term, and can include everything from reading a draft of an article and saying “that looks great, I have no changes for you,” all the way to performing major surgery on the very organization of a paper.

3. Isn’t ghostwriting acceptable in some circumstances?

This is really the crux of the controversy about ghostwriting. Many commenters have pointed out that making science understandable is difficult, specialized work. It is unrealistic to think that scientists have the time or expertise to do the wordsmithing needed.

I agree, which is why I draw a bright line between industry-funded medical writing and academia-funded medical writing. Both ghostwriting and acknowledged editorial assistance are perfectly acceptable when the assistance is not arranged by a company that has a stake in the topic of the article. Most academic departments hire research assistants and editors whose jobs are to help write the many articles that get churned out by the more productive members of the departments. There is no incentive for such editors to bias the articles in any way.

But when an editor is paid, either directly or indirectly, by a drug company to work on an article, readers should be concerned, because now there is a powerful incentive for the editor to manipulate the content of the article to promote the sponsor’s product. If the final published article is not promotional enough, the writer won’t get a future assignment from the funding company. It’s as simple as that.

4. What’s the solution?

I have two recommendations:

--Journals should not publish articles that are clearly written in order to promote the funder’s product. Generally speaking, this would exclude any articles involving medical writing companies, even when their involvement is acknowledged. After the many recent example of corrupted scientific literature by drug company/medical writing firm partnerships, we can no longer have any trust that such teamwork is anything other than marketing.

--Journals should continue to publish research funded by industry, as long as the researchers sign disclosure statements assuring editors that they had complete control and involvement in every aspect of the paper. This means essentially no contact with the drug company after having accepted the money. Obviously, such research can still be highly tainted by bias, but the degree of bias is likely to be less extreme. Furthermore, as the medical literature gate-keepers, editors will scrutinize such research with extra care in order to make sure they are not unwittingly publishing advertisements in guise of science.

Check Out Antidote: The Best Blog on Ghostwriting

Occasionally I admire the work of William Heisel, a journalist and blogger who writes the razor-sharp health blog Antidote, hosted by the University of Southern California and the Annenberg School for Communication. Lately, Heisel has been digging into UCSF's Drug Industry Document Archive (DIDA), specifically its huge collection of smoking gun documents about the medical writing company DesignWrite. There are reams of material here and there is nobody better than Heisel at making sense of it all, and revealing the bankrupt sense of morality that seemed to have permeated DesignWrite and everything it touched.

Currently, Heisel is blogging about Dr. David Archer, an ob/gyn and a key part of the Wyeth/DesignWrite team. Wyeth pharmaceuticals hired DesignWrite to ghostwrite dozens of articles to promote its various products, including birth control pills, antibiotics, and the hormone replacement pill Premarin. Heisel traces Dr. Archer's activities with DesignWrite with devastating tenacity, following the path of financial relationships through the drug company, bought-out "journals," medical writers, and so-called "authors." Each time, the punch line ends up being a glowing endorsement of a Wyeth product, authored by Dr. Archer, but written by...who knows?

At one point, Archer was the editor of a newsletter called "Menopausal Medicine," which is funded by Wyeth. As editor, he had accepted an article by Dr. James V. Fiorica (also a Wyeth-kept man) entitled "Mammographic breast density and hormone replacement therapy." Ghostwritten by DesignWrite, it was a carefully crafted argument that HRT does not interfere with images on mammography (as has been charged by others academics). In a move reminiscent of the Nemeroff/VNS/Neuropsychopharmacology fiasco, Archer was playing on both sides of the field, each side chock-full of conflicts of interest.

Says Heisel: "[Archer] was supposed to be, as the journal editor, the ultimate arbiter of the strength of the submissions to Menopausal Medicine. But, as documents in the Drug Industry Document Archive show, he also was working directly with DesignWrite on tailoring the article."

Subject: Invitation to Author a Review Article

Here is an email sent to one of my psychiatrist colleagues by BlueSpark, a medical communications company working under contract for the drug company sanofi-aventis. Read it, and decide whether you think this is a solicitation to become a ghost author.

Subject: Invitation to Author a Review Article
Date: Dec 2009

Dear Dr. XXXXXXX,

I hope this note finds you well. My name is Jonathan Wert, MD, and I am a medical director at BlueSpark Healthcare Communications, a medical communications company located in northern New Jersey. I was given your contact information by Dr. YYYYYYY , who spoke very highly of you.

I am writing to you on behalf of sanofi-aventis, which has authorized us to facilitate publication of an MDD/Bupropion-focused review article. We feel that your input on a multitude of topics including the following would be extremely valuable:

* Your views on MDD, including the variability in response to treatment.
* How MDD is currently being treated and how successful these treatments are at inducing remission and preventing relapse.
* What are the other benefits of available therapies?
* What are the unmet needs/drawbacks of these medications?
* What attributes novel antidepressants should have.

sanofi-aventis and BlueSpark would be pleased to have you serve as the author of this article, and we will work closely with you in its development. Initially we will help develop a draft outline. Once you have reviewed and approved this outline, we will proceed to development of a draft paper. We will then revise the manuscript according to your direction and assure that it is styled appropriately for submission to your proposed journal.

As I am sure you are very busy, our team would like to arrange a brief conference call to discuss the content to be included in the manuscript/outline. I look forward to hearing from you at your earliest convenience.

Best regards,
Jon

Jonathan M. Wert, MD, MAAP

Here’s the way I interpreted the letter.

Sanofi-aventis just introduced a “new” antidepressant called Aplenzin. Aplenzin is not really new at all, being simply a reformulated version of bupropion extended release. Its advantage is that it offers once a day dosing in all three of the usual doses prescribed (150 mg, 300 mg, and 450 mg), whereas generic bupropion ER offers once daily dosing for 150 mg and 300 mg only. The unusual patient who needs 450 mg dose has to combine 150 mg with 300 mg. So from a clinical standpoint, Aplenzin represents an “advance” in the most minutely incremental sense.

The disadvantage of Aplenzin is not so subtle. It is a health care budget-buster, costing 20 times more than generic bupropion ER. Where do I get this figure? Vermont’s Pharmaceutical Marketer Price Disclosure Law requires that drug companies disclose their drug’s wholesale price along with the prices of drugs in the same class. It turns out that the starting dose of Aplenzin costs $5.58, while the same dose of generic Bupropion ER costs only 28 cents. I’m sure Obama would be pleased to hear about this!

Obviously, selling Aplenzin is going to be an uphill battle, so along with the usual journal ads and drug rep visits, sanofi-aventis has added a publication plan to their marketing strategy. Here’s where Dr. Wert and BlueSpark come in. BlueSpark is looking for doctors to write, as they put it, an “MDD/Bupropion-focused review article.”

Although the letter is artfully crafted to make it appear that they are simply seeking the good doctor’s “input” on some issues, the flavor of input they are after is clear if you read between their lines. I’ve taken the liberty of deciphering the coded language used by BlueSpark, in order to further clarify the nature of their solicitation.

* “Your views on MDD, including the variability in response to treatment.”
[You should say that lots of patients don’t respond to SSRIs or to the usual doses of bupropion, in order to set up the conclusion that Aplenzin is useful.]

* “How MDD is currently being treated and how successful these treatments are at inducing remission and preventing relapse.”
[Here, your focus will be on how SSRIs are often not successful at achieving remission, so you better try Aplenzin.]

* “What are the other benefits of available therapies?”
[Similar to the point above, namely, say that available therapies suck, so hurray for Aplenzin].

* “What are the unmet needs/drawbacks of these medications?”
[The main drawback: nobody is prescribing Aplenzin yet]

* “What attributes novel antidepressants should have.”
[Best attribute: be a once a day version of bupropion like Aplenzin].

Playing fair, I emailed Dr. Wert, telling him that this looked to me like a solicitation for a ghost author, which is contrary to the policies of the International Committee of Medical Journal Editors, and asking him if he wanted to comment.

I got a response from Michael Weems, BlueSpark’s COO, who disagreed with my assessment, saying that I had “misunderstood” his invitation: To quote from his response: “Any development of a draft manuscript would take place only after the author has developed a formal outline that would include tables, figures, and references. Following this, the author would review the draft manuscript and have total control of the content (ie., change, add, remove, or edit as he or she sees fit to meet the manuscript objectives). Our role would be to facilitate the development of the article by helping the author publish the article in a timely fashion. Additionally, our support is always acknowledged and can also lead to co-authorship if it meets the guidelines defined by the ICJME.”

As I read Mr. Weems’ letter, my built-in BS detector went as wild as a Geiger counter in Iran. Because let’s face it. No psychiatrist is going to wake up in the morning and say, “I think today is the day I’ll work on a review article on bupropion and depression and how awful it is that the tiny number of patients who require the maximum dose have to take two pills in the morning instead of one. Yes—this will be a significant contribution to the medical literature.”

This would never happen, because there’s nothing new or interesting in this topic. We know that bupropion works well for depression, and we’ve known it even since it was approved by the FDA in 1985.

No, the only reason a psychiatrist would get motivated to write such an article is if a cold-call email solicitation from BlueSpark gets past the spam filter. I’m guessing that BlueSpark hopes that eventually they will find an uncreative, mid-level academic who is treading water professionally, and who will jump at the chance to pocket a little extra money while simultaneously padding the resume with a publication that will require essentially no work to produce. (Dr. Wert’s line at the end of his solicitation, “As I am sure you are very busy…” seems a nudge-nudge wink-wink assurance that the company will take care of everything.)

Whether or not this meets the formal definition of ghost-writing, it is clearly a manipulation of the medical literature, a kind of plastic surgery of science. The articles may look impressive, and they may look real, but in fact they will be phony.

The most telling part of BlueSpark’s response to me came at the end of the COO's letter:

“Based on your misunderstanding of our invitation, we are requesting that you do not post this letter on your blog. If you have any additional questions or would like to discuss this topic further, please e-mail me or call me directly at the number below.”

Does this mean that if I had understood the invitation, they would have been happy to see it posted? I doubt that. Or was this simply BlueSpark’s effort to bully me into keeping this embarrassing letter out of the public eye? If so, I guess it didn't work.

Abe Lincoln put it well: “You can fool some of the people all of the time, and all of the people some of the time, but you cannot fool all of the people all the time.” For all of our sake, let’s hope this holds as true in the 21st century as it did in the 19^th.

Canadian Medical Association Gets Dumb (and $780,000)

The Canadian Medical Association is getting plenty of flak about their $780,000 CME deal with Pfizer, and anyone with half a brain can see why. Pfizer is not in the business of altruism. When they spend lots of money, they do so in order to make their shareholders happy.

For example, when the company cut a $12.3 million CME deal with a collaborative including the University of Wisconsin and the California Academy of Family Physicians, they did so in order to encourage doctors to talk to their patients about smoking cessation. Presumably, this increased sales of Pfizer's anti-smoking drug Chantix. While this CME program, called CS2 Day (Cease Smoking Today), does not have the blatant infomercial feel of most commercial CME, it treats Chantix with kid gloves. As covered in the Milwaukee Journal Sentinel, an online course for doctors fails to mention a small piece of the Chantix puzzle--the fact that its side effect profile includes serious psychiatric symptoms. Heck, they didn't mention any of their product's side effects in the presentation. You call that accredited CME?

So now the officials at the Canadian Medical Association are chugging the same kool-aid as UW's director of CME, George Mejicano, who had defended the Pfizer-funded courses with a pile of nonsense: "He said such courses are rarely comprehensive and are designed to meet selected learning objectives.” Now listen to his Canadian colleague:

“There's no connection between the funder and the people who are actually providing the content,” Dr. Sam Shortt, CMA's director of knowledge transfer, said. “We're confident that these two elements meet and exceed any expectations from any observer.”

In my experience with colleagues from Quebec and Ontario at American Psychiatric Association meetings, Canadians are generally far from naive--so why did Dr. Shortt and the CMA turn off their neurons? Hmmm. Let me count the reasons--all 780,000 (U.S.) of them.

Brian Vastag's Concise Review of How Drug Companies Use CME for Marketing

What follows is an article written about commercial CME by the science journalist Brian Vastag, who writes for a number of publications, including the Washington Post, U.S. News and World Report, and JAMA. You can read the article on his blog at http://brianvastag.net/2009/10/cme/, but I have also reproduced in its entirety below, because I feel it is such an important piece of journalism. Congrats to Brian Vastag for telling it like it is.

A scientific journal recently commissioned this story from me, but after I reported and wrote it, the journal killed it. I think it’s an important story that serves the public good, so I’m posting it here to get it on the record. BV

Drug makers routinely exploited continuing education seminars as opportunities to market pills to doctors, company documents reveal.

Continuing medical education (CME) has exploded into a $2.3 billion business in the United States, with nearly half of the funds pouring in from drug and medical device manufacturers. Physicians must complete a certain number of CME courses each year to retain their medical licenses.

Today, the large pharmaceutical companies say their CME dollars support only independent education, with no input from the companies. But as recently as 2004, the documents show, marketing personnel played key roles in developing the seminars, treating CME as one element of their comprehensive sales plans.

“It is very clear…that continuing medical education has been used as marketing, and I think it continues to be,” said Allan Coukell, director of the Pew Prescription Project, which seeks to reduce or eliminate conflicts of interest in medicine.

For instance, GlaxoSmithKline’s “2003 Tactical Plan” – a marketing document – for their antidepressant Paxil lists $92 million in expenses, including $4.3 million for CME, $30 million for consumer advertising and $17.4 million for free samples. The plan includes “desired” CME topics, such as “anxiety symptoms/disorders in women” and “treating depression & anxiety in hispanic population.” The plan also proposes a “CME Tour” reaching 6,000 doctors, and provides detailed topics to be covered. The company prepared similar strategies for 1999 through 2004, according to the documents, which were uncovered by Senator Charles Grassley (R, Iowa), in his ongoing investigation of the drug industry.

A spokeswoman for GlaxoSmithKline, Mary Anne Rhyne, declined to answer questions regarding the documents.

Forest Laboratories, Inc., deployed similar strategies to push Lexapro, a Paxil competitor. One goal of the 2004 Lexapro plan: “More sponsorships of CME, increased level of speaker programs…and peer selling.” The plan includes $9 million for national and regional “CME symposia,” to be run by a for-profit company, CME Inc. Also included: $600,000 to pay for six “special reports,” to be labeled as CME: “A reporter from…CNS News, Psych Times, and the Journal of Clinical Psychiatry will be sent to cover key Lexapro data” at medical meetings, the document reads.

A third drugmaking enterprise, a partnership between Merck and Schering-Plough, dumped $64.5 million into CME courses on “cardiovascular risk management and/or cholesterol control and/or Vytorin” from 2004 through early 2008, a time when the companies were heavily promoting Vytorin, their soon-to-be-troubled anti-cholesterol pill. The funds were distributed in 1,930 individual payments to universities, professional societies and for-profit CME companies.

Companies improperly promoting products via CME may run afoul of the law, said Lewis Morris, the counsel to the inspector general of the Department of Health and Human Services. During a July hearing of the Senate Special Committee on Aging, chaired by Herbert Kohl (D, Wis.), Morris said, “A number of significant cases have involved allegations that funding for ‘educational support’ was a pretext for the payment of kickbacks” to physician-speakers who promoted off-label, or unapproved uses, of certain drugs. For instance, in 2004, Pfizer and Warner-Lambert paid the U.S. government $430 million to settle claims that the companies “corrupted the physician education process by fraudulently sponsoring ‘independent medical education’ events” on unapproved uses of Neurontin, an anti-epilepsy drug, Morris testified.

The 2003 Paxil marketing documents show that GlaxoSmithKline planned to market the drug for an unapproved indication – pre-menstrual dysphoric disorder, or PMDD – 10 months before the FDA approved that specific use of the drug. The November 2, 2002 plan lists “anxiety symptoms in PMDD” as a “desired topic” of the CME seminars the company funded. But the FDA did not approve Paxil for PMDD until September 2, 2003. As Morris noted in his testimony, promoting an unapproved use of a drug is illegal under the Food, Drug, and Cosmetics Act.

Pfizer learned that lesson in a huge way last month when the Department of Justice announced the company had agreed to pay $2.3 billion – the largest criminal fine of any kind in U.S. history, according to the department – for illegally marketing several drugs, including its anti-inflammatory Bextra.

Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education, which certifies CME providers, said his group tightened its rules in 2004. The rules now prohibit drug and device makers from directing educational content or even suggesting topics for courses. “We felt it necessary to define the bright line of what independence is,” he said.

Still, momentum is growing for an outright ban on industry-funded CME and a return to a system where physicians pay their own way, like lawyers and other professionals. The Institute of Medicine and the Association of American Medical Colleges support such a ban, and over the past two years, Stanford University, Memorial Sloan Kettering Cancer Center and the American Psychiatric Association have weaned themselves from the industry CME teat. Still, such funding comprises a critical slice of the budget pie for many professional groups. For example, the American Academy of Family Physicians, which claims 64,000 members, receives 8% of its operating budget from industry CME funds. President Ted Epperly said that AAFP follows ACCME guidelines and assiduously maintains a “firewall” between CME funding and content. “We believe this relationship can be managed,” he said. “It must be transparent and above board. You cannot have anybody telling you what the content ought to be, who the speaker ought to be.”


Where does Industry CME Money Go?

In 2008, drug and device companies spent $1.04 billion on continuing medical education in the U.S.

Where it went:

Hospitals: $39.5 m

Professional Societies: $202.5 m

Universities: $225.7m

For-Profit CME Companies: $463.4m

Other: $104 m

Source: Accreditation Council for Continuing Medical Education

Tom Sullivan, of ACRE Fame, Is Swimming in Drug Company Cash

Wherever there is a vocal battalion of defenders of drug industry funded medical education, you are certain to find Tom Sullivan leading the charge. Sullivan writes the most prolific pro-industry CME website, Policy and Medicine. He is a founding member of ACRE, and managed all the logistics for ACRE's first embarrassing meeting, held at Brigham and Women's Hospital. He collaborates closely with John Kamp, director of the pro-commercial CME front group, Coalition for Healthcare Communication.

Simply put, Tom Sullivan loves pharma funding of medical education, and he simply can't get enough of it. Why? If you ask Sullivan, he'll wax idealistic, as he did in one of his recent posts:

"Industry CME funding improves quality, because it helps support the development of an accreditation system for compliance and professional accredited providers that thrive by demonstrating quality and developing innovative education that improves professional practice."

It would be nice to believe that his passion stems from such an altruistic vision of industry/physician collaboration. But it's not true.

Sullivan's incentive, like most of his colleagues, is money. He is the president of Rockpointe, a medical education communication company. And while I always figured he made a good chunk of cash from drug companies, I had no idea just how much, until now. The Drug Industry Document Archive (DIDA) at UCSF just released a number of documents obtained from congressional sources, one of which is this list of drug company payments to Sullivan's company.

Here’s how much industry "educational grant" money Rockpointe has made over the last three and a half years:

2006: $4,209,685

2007: $8,701,080

2008: $7,298,064

2009 (first half only): $3,237,027

Sullivan is awash in cash from all the major drug companies. In 2008, he made over $400,000 each from AstraZeneca, Bristol-Myers Squibb, Daiichi Sanyo, Eli Lilly, Medimmune, Merck, and Novartis.

He specializes in crafting web programs and meeting symposia that are infomercials for specific drugs. For example, Novartis paid Sullivan $98,998.00 to create a two hour breakfast lecture which took place at the annual meeting of the American Society for Hypertension on May 17, 2008. The Symposium was entitled “Blocking the Renin Angiotensin System: Which Way is Best?”

Here's which way is best: the Novartis way. Novartis markets Diovan, an angiotensin receptor blocker. Furthermore, the FDA recently approved Novartis’ Valturna, a single pill combination of Diovan and Tekturna/Rasilez, another direct renin inhibitor. This symposium was chaired by Matthew Weir, M.D., who, yes, is a consultant for Novartis and who has frequently boosted Novartis products (see here, for example.)

By the way, the president of the American Society for Hypertension is none other than Henry Black, M.D., who, along with his pal Tom Sullivan, is on the steering committee of ACRE, and is also a consultant for Novartis.

My, there are a lot of dots to connect when it comes to Tom Sullivan, Rockpointe, ACRE, and the many physicians who have decided that helping drug companies market their products is the ethical way.

New York Times Covers Industry Funding of CME

It is unusual for the New York Times, or any other national news organization for that matter, to focus industry-funded CME. With examples of corrupted business practice everywhere, this particular little slice of corruption is easily glossed over. But Duff Wilson, in today's NYT business section, does a good job of covering the issue, and the big paper's attention has apparently done what nobody else has been able to accomplish--convincing the ACCME to finally publish its Rogue's Gallery of MECCs found guilty of commercial bias.

The article is centered on a little gem put out by CME Outfitters called "Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough." Funded by AstraZeneca, it is an elaborate commercial urging psychiatrists to use more atypical antipsychotics as adjunctive treatment of major depression.

Bernard Carroll, a psychiatrist and blogger for Health Care Renewal, complained about the program (see his post here) and while it took ACCME nine months, they eventually agreed that the program was biased in that it "lacked sufficient information about possible adverse effects of treatment with atypical antipsychotic drugs; and failed to emphasize sufficiently the efficacy of alternative treatments."

Apparently CME Outfitters has taken the program off its website, but never fear, I've managed to get ahold of the slides and have published the pdf on Scribd here.

The interesting thing is that while this course certainly is commercially biased in favor of atypicals, it is hardly the most blatant example of commercial bias I've seen. In fact, if you go right now over to the new activities area of CME Outfitters (called "neuroscience CME"), you'll find a entire series of "CME snacks" on the "Complex Presentations of Sleep Wake Dysfunction," each of which is a mini-commercial for Provigil and Nuvigil brought to you by Cephalon, which markets a vastly lucrative alertness drug empire.

My point being that if the Atypical Antipsychotic program is bad enough to be pulled for commercial, my conservative estimate is that at least half, probably more, of all industry funded psychiatry CME will also need the retraction treatment. The problem is, who on earth has the time to police these things? Certainly not ACCME. Dr. Carroll and I try to keep on top of the worst of the worst, but we have other things to do in order to make a living. The best and simplest solution would be to end industry funding of medical education altogether.

Indianapolis Star Reports on CVS Caremark-Eli Lilly Marketing Scam

For most of us, blogging is a labor of love, and our payment is the possibility of having a positive impact in the world. So it was gratifying to see that the Indianapolis Star published this story prompted by my prior post about how Eli Lilly is paying CVS Caremark to sell doctors on Cymbalta for fibromyalgia.

Reporter John Russell did an excellent investigation, finding that the practice is more widespread than I realized. For example, he interviewed Dr. Matthew Mintz, an internist in Washington, D.C., who said he too had received a deceptive pharmacy drug ad, this one funded by Merck and encouraging Dr. Mintz to switch one of his diabetes patients from a different company's drug to Merck's Januvia.

The Star's Russell also revealed that Lilly had used the pharmacy-whore technique to sell Zyprexa in 2002, when it apparently paid another drug benefit manager, AdvancePCS, to send out 120,000 letters promoting Zyprexa to doctors nationwide. AdvancePCS hawked its services for $5/letter, meaning that they stood to make $600,000 from the scam. In documents forced public in the context of a trial, AdvancePCS officials wrote that this direct-mail campaign was "designed to influence key prescribers" as part of a "tactical plan for Zyprexa."

Lilly declined to say whether it took AdvancePCS up on the offer. Translated from PR speak, this means, "Yes, we did pay them the $600,000 but it was such an obviously slimy marketing technique that we will not admit it."

An Eli Lilly spokeswoman told the reporter that the latest CVS Caremark letter was simply meant to "share medically accurate and relevant information with health-care professionals," and denied that it was deceptive at all. I guess we'll have to wait for another trial to find out that this, like the earlier Zyprexa letters, was designed as a "tactical plan," this time for Cymbalta.

At any rate, the debacle may have a silver lining for us all, since Lilly told the Star that they are "re-evaluating the entire practice" of using pharmacies to market their drugs to doctors.

That's great. Lilly is quite proud of its good corporate citizenship. Last year, John Lechleiter, Lilly's CEO, crooned in this press release that "With each of our industry firsts, from launching our clinical trials registry to the public reporting of educational grants, Lilly is striving to be a leader in improving transparency across our industry. As Lilly continues to look for more ways to be open and transparent about our business, we've learned that letting people see for themselves what we're doing is the best way to build trust."

Dr. Lechleiter failed to mention that Lilly's decision to become a leader in transparency was done with a gun to its head--it was part of a corporate integrity agreement that was bundled with $1.4 billion fine for illegal off-label marketing of Zyprexa.

Details, details.

CME Outfitters: Guilty of Pro-Seroquel Bias, According to ACCME

In ACCME's testimony before the Senate Special Committee on Aging on July 29 of this year, Dr. Murray Kopelow, the chief executive of ACCME, defended the integrity of the embattled organization in part by pointing out that they have beefed up their enforcement of anti-commercial bias policies.

He said that he has begun to give extra "scrutiny" to organizations that "receive a large amount of commercial support," and said that 10% of all ACCME providers are now on probation. But how well does ACCME actually regulate the bad apples of CME--generally speaking, those for profit MECCs who are completely dependent on commercial support for their very existence and who consistently bend the Standards of Commercial Support in order to maintain the flow of money?

In a fascinating post by Bernard Carroll on Health Care Renewal, we get a close-up view of ACCME's new commitment to enforcement, which while showing some signs of life is severely lacking in bite.

Dr. Carroll had filed a formal complaint on December 23, 2008 about a web-based round-table discussion of the use of antipsychotics in depression, which was chaired by Charles Nemeroff (the disgraced psychiatrist who resigned under pressure as chair of psychiatry at Emory after the New York Times reported that he lied to the University about payments from GlaxoSmithKline, promising officials that he would limit his earnings to the required $10,000/year from promotional talks, then going on to earn $170,000 that year alone.)

Nemeroff's program was produced by CME Outfitters and was funded by Astra Zeneca, maker of Seroquel, an antipsychotic which was recently approved for add-on treatment of depression. After its investigation, according to Dr. Carroll, the ACCME determined that the program did, indeed, violate its standards. In particular, the course was commercially biased in favor of the sponsor's treatment because it downplayed negative side effects of Seroquel while giving short shrift to alternative, safer depression treatments.

So far, so good. The monitoring system appears to be working. Or is it?

Dr. Carroll asks a series of questions that will prod ACCME to think about the logical next step.

--If this accredited CME program was corrupted by commercial bias, shouldn't the ACCME force CME Outfitters to contact all the physicians who participated in the course in order to explain to them that they were given biased medical information?

--Shouldn't the CME credit obtained through this program be revoked?

--Shouldn't CME Outfitters be required to ascertain whether patients were harmed as a result of their biased education (for example, how many patients were put on Seroquel for depression and later developed obesity, diabetes, or heart disease as a result?).

--Will ACCME publically list its sanctions against CME Outfitters and other MECCs who have aired commercially biased CME? Or are we going to have to depend on the occasional blogger to reveal these egregious cases?

These are all crucial questions, and Dr. Carroll is awaiting a reply. Aren't we all?

Eli Lilly Hires CVS Caremark to Push Cymbalta

Eli Lilly has discovered a new advertising strategy: your pharmacy.

Check out this package of material I just received from CVS Caremark, a prescription benefit plan associated with CVS pharmacy. Pure and simply, it is an advertisement for Cymbalta, Eli Lilly's antidepressant which was recently approved for the treatment of fibromyalgia.

But it doesn't look like an ad. It looks like a letter from a pharmacy that is deeply concerned that my fibromyalgia patients receive the best treatment. Here's how the letter starts:

Dear Doctor:

CVS Caremark administers the prescription benefit plan for one or more of your patients. We are committed to providing health care professionals with information about drug therapy. As part of this commitment, we are providing you with this issue of RXViewpoints®, which focuses on the management of fibromyalgia with Cymbalta® (duloxetine HCI). Cymbalta is a therapeutic option on the CVS Caremark preferred drug lists. Patients may have a lower copayment for medications on these drug lists. Some prescription benefit plans may limit quantities or require prior authorization.

The letter came in a 9 X 12 inch envelope proclaiming "Confidential--May Include Protected Health Information." Along with the letter is a newsletter called "Rx Viewpoints" that appears to be written by Eli Lilly staff extolling the benefits of Cymbalta for fibromyalgia.

How touching that CVS Caremark is, in their words, so "committed to providing health care professionals with information about drug therapy." At the end of the letter, in small print, the source of all this benevolence becomes a tad clearer:

How much is Eli Lilly paying CVS Caremark to perpetrate this deception? Which executive at CVS became so overcome with greed that he or she approached Eli Lilly about this joint venture? Has CVS Caremark informed its patients that it is selling their pharmacy information to a drug company?

Whatever amount of money CVS is making on this scam, it had better be a bundle, because the pharmacy is going to have to spend at least that much dealing with the PR fiasco certain to be triggered by this foolish business decision.

I've called doctors who speak for drug companies "drug whores," a term that offends some readers. CVS Caremark has added another flinch-worthy phrase to the lexicon of medicine: "Pharmacy whores."

The Boston Globe: Let's Ban Hired Guns

Yesterday, the Boston Globe published an excellent editorial entitled: “Keep doctors independent; ban fees from drug makers.” Responding to revelations that Eli Lilly paid out $22 million in fees for promotional talks to doctors over the first 3 months of 2009, the Globe believes that “legislators should go beyond requiring disclosure of the relationships, and ban the practice.”

The piece soundly concludes that:

"Patients trust doctors as stewards of their health. They revere them as scientists who can exercise sound, independent judgment. Allowing doctors to promote drugs for pharmaceutical companies takes advantage of that trust and reverence. It also compromises doctors’ most important work: treating people who are ill."

I agree that doctors should cease speaking for drug companies, though I’m not convinced that legislation is the best way to accomplish this. Since the practice is unethical, it should be regulated in the same way that other matters of medical ethics are regulated—via medical societies and state medical licensing boards.

At any rate, I perused some of the dozens of comments to the Globe's editorial, and here are three common categories, along with my rebuttals.

1. Doctors are not wealthy and greedy. They train hard, only make around $150,000 per year, have lots of overhead, etc. Doctors are so poor that they need and deserve to supplement their income by speaking for drug companies.

Here’s a news flash, people. Most doctors are not poor; in fact, they are rich. In 2008, the average physician income ranged from a “low” of $159,000 (family practitioners) to a high of $527,000 (neurosurgeons). This places their income in the top 5-10% of all American wage earners, according the health economist Uwe Reinhardt.

Doctors don’t speak for drug companies because they need the money to feed and clothe their starving families. They do it because it’s fun and interesting, provides narcissistic satisfaction, a social outlet, and gives them extra money for the finer things in life. The point of the editorial is that doctors should make their money by practicing medicine rather than by promoting drugs.

2. But how will doctors get their medical education if drug companies can’t pay experts to give lectures?

There are hundreds of medical journals covering every conceivable specialty—here’s one list of them. Likewise, here is a directory of the hundreds of medical conferences throughout the US held in every state, varying widely in cost. Most medical education lectures are held in hospitals and academic medical centers as part of grand rounds, most of which are freely available to doctors in the community. The funding varies, sometimes coming from medical staff fees, sometimes from drug company money donated to a pool of funds that can be used at the hospital’s discretion—a far cry from doctors signing contracts to speak for drug companies.

3. You think doctors are greedy? What about congressmen and senators—look at all the money they get from drug companies and insurance companies. That’s where you should focus.

First, all contributions to elected officials are transparent and are available from a number of websites, such as http://www.opensecrets.org/. Second, politicians have, by definition, innumerable different consituents and interests, and it is appropriate that they receive campaign donations from these varied constituents. Not so for doctors. We don’t have different “constituents.” We have a single constituent: our patients. Our single professional responsibility is to treat them. On the other hand, we have no responsibility to drug companies to help them sell their drugs, and therefore we have no responsibility to accept money from them for that purpose. Research is different, because medical research is directly related to patient care, and so accepting drug company money for clinical research is far more defensible.

Kudos to the Boston Globe for taking such a strong and principled position on this issue.

The Ethics of Speakers Bureaus under the Spotlight

Eli Lilly's publication of a registry revealing all payments to doctors has opened up an overdue conversation. Is it ethical for a doctor to become a member of a drug company speaker's bureau? Or is it inherently deceptive for a doctor to pose as being an independent source of information while at the same time being under contract to speak for specific drugs?

In today's Boston Globe, Liz Kowalczyk does some investigative reporting based on information gleaned from the Lilly Registry. She found that two physicians at Boston Medical Center (BMC), neurologist Brian McGeeney, and endocrinologist Elliot Sternthal, were each paid thousands of dollars by Lilly during the first three months of 2009 to give education talks to other physicians. But according to Kowalczyk, for the past two years BMC has officially barred doctors from giving industry-sponsored talks unless the “lecture’s content, including slides and written materials, are determined by the clinician.’’

In fact, drug companies never allow doctors to determine their own content for promotional talks. As I described in a prior post, for example, Schering Plough's contract (view it here) for its asenapine speaker's bureau was explict in this regard: "You will used only the Schering approved materials for all presentations performed under this Agreement." While I have not seen Eli Lilly's speakers' contracts, on their website they describe their "healthcare professional education" in the following way: "The information presented in these programs is provided by Lilly alone, is closely regulated, and must conform to U.S. Food and Drug Administration (FDA) requirements."

I think this is pretty clear. The content is produced by Lilly, and not by the doctor giving the talk.

Given all this, it sounds very much like Drs. McGeeney and Sternthal did, indeed, break their employer's rules regarding allowable industry activities. Unfortunately, rather than admitting this, they defended themselves in e-mails to Kowalczyk in the most unconvincing terms:

Sternthal said he determines “the structure of the presentation by my choice of disease state and clinical trial slides, order of presentation and emphasis of teaching points. This is in compliance with BU/BMC policy.’’

Whaaaat? We know what disease state Dr. Sternthal chooses for his talks--it is diabetes, for which Lilly markets a plethora of products, including Byetta. We also know what "clinical trial slides" he chooses--those slides showing research conducted by Lilly to show that its diabetes products are effective. The fact that he chooses the order of his Lilly-boosting slides hardly constitutes compliance with BMC's policy that the "lecture’s content, including slides and written materials, are determined by the clinician.’’ Sternthal might argue that he follows the letter of the rules because he, in fact, determines which among a menu of Lilly slides he uses in his presentation. But this is a hollow argument, because he didn't write the menu.

Here's an analogy. If my son comes home and says that for lunch he ate a cheeseburger and french fries, I might express my dispeasure and ask him to make healthier choices in the future. "But there was nothing else on the menu," he might respond. "Where did you go for lunch?" "McDonalds!" If you choose to go to McDonald's for lunch, your "choice" of food is severely limited. Similarly, if Dr. Sternthal chooses to go to Lilly for his medical information, every slide on the menu will be Lilly-friendly, meaning that his defense that he "chooses" what to teach is meaningless. His only choice was to become a promotional speaker, and he checked his academic independence at the door.

This behavior is inherently unethical, because it demeans the reputation of all doctors. How can patients have faith that doctors are making independent medical decisions when they hear about the Dr. Sternthal's and Dr. McGeeney's of the world defending themselves in such ways? Such doctors are gradually undermining the public's trust in all physicians.

Priceless: Two Items from the GlaxoSmithKline PR Spin Machine

Item #1: From the GSK "Frequently Asked Questions" page:

Does GSK fund CME programs in order to influence doctors and get them to prescribe your medicine?

No, not at all. GSK is committed to supporting quality healthcare education. Our goal is to support independent medical education programs for healthcare professionals (physicians, nurses, pharmacists and other healthcare professionals) to increase their knowledge, competence, performance and ultimately improve patient outcomes. Doctors and other healthcare professionals must take CME/CE courses to maintain their licenses and hospital privileges. The Accreditation Council for CME (ACCME), Accreditation Council for Pharmacy Education (ACPE), American Nurses Credentialing Center (ANCC) and others set accreditation criteria for the programs to physicians, pharmacists, nurses and other healthcare professionals. It is also important to note that GSK does not control the content of independent educational programs and that the purpose of the programs is not to promote GSK products.

Item #2: The URL of the GSK web page for organizations seeking CME grants:

WWW.PARTNERSINKNOWLEDGE.COM

GlaxoSmithKline Will Fund MECCs Under the Table

Yesterday, I reported on GlaxoSmithKline's announcement that they would no longer fund commercial MECCs (Medical Education Communication Companies) to produce CME programs. The big question was whether the company would allow academic centers and medical societies to subcontract course production out to MECCs, an arrangement more genteelly known as "co-sponsorship."

I just received the answer directly from Mary Anne Rhyne, GSK's GlaxoSmithKline Corporate Communications Director. Rejoice, all ye MECCs, your loophole is intact!

In this earlier op-ed piece in the New York Times, I had referred to industry-funded CME as a money laundering operation, in which drug companies do not directly pay doctors to give lectures, but instead pay a MECC to hire and pay the doctors. This provides the illusion that the drug company is not involved in the program, when of course the program wouldn't happen without company funding.

With this new brand of CME "reform," both Pfizer and GSK are simply adding another layer to this laundering operation. Now the money will go from the drug company to the academic medical center to the MECC to the doctor.

Over the years, MECCs have become experts at creating a series of dog and pony shows called CME. They have the process down to a science. They know how to make the flashiest slides, hire and manage the best key opinion leaders, rent out the nicest conference rooms, and serve the tastiest food. They make the process so seamless and effortless that academic medical centers are only too happy to hire them to do the dirty work of actually putting on the courses. Under GSK's new policy, I predict that universities will get the big grants and will pass on a chunk to the MECCs, keeping a healthy slice for their own highly profitable CME departments.

Unfortunately, the actual medical education will continue to be slanted in favor of the most expensive drugs and medical devices.

By the way, I also asked for a list of the 20 favored academic centers. The GSK spokeswoman said that this will be posted soon on www.partnersinknowledge.com, their website for grant applicants.

GlaxoSmithKline Stops CME Grants to MECCs

In another piece of good news for patient care, GlaxoSmithKline has announced that they are clamping down on funding continuing medical education programs. According to their press release, "GSK will no longer fund CME by commercial providers including medical education and communication companies (MECCs)." The new policy takes effect immediately.

The company says that it will cut down drastically on the number of organizations receiving CME grants, to only about 20 academic centers that meet their criteria of having a "track record of developing and delivering high quality medical education programs that have a measurable impact on improved patient health." I asked GSK for a list of the favored 20, as well as exactly what their criteria for CME excellence are, but I have not yet heard back.

GSK posts their educational and charitable grants on the web. You can read the grants from the first and second quarter of 2009 here. I went through the Q2 grants and found that it's pretty hard to tell which are CME grants and which are patient advocacy or charitable grants. But I estimated that in the 2nd quarter of 2009, GSK made CME grants to about 90 organizations, and about 20 (22%) of these are MECCs. While this implies that cutting out MECCs is not a big deal, in fact the MECCs are the big money hogs of the bunch. MECCs received by far the largest grants, including Pri-Med Institute ($658,000), Research to Practice ($540,000), Discovery Communications LLC ($420,000), and Physician Education Resource Group LP ($363,000). MECCs are great at sponging up lots of cash from drug companies, because they have no other business plan. Some of the money goes to physicians who give lectures, but much more is sheer profit, padding the pockets of MECC executives.

Thus, cutting out MECCs will presumably save GSK a lot of money and save doctors from getting pounded over the head with the redundant marketing messages MECC-produced CME excels at.

Some of you may recall that Pfizer announced a similar policy change over a year ago. You can read coverage of Pfizer's decision in this Medical Meetings article and in my blog post. While I applauded Pfizer's decision I also noted that their policy left the door open for eligible providers to co-sponsor programs with MECCs, a rather giant loophole that lead to problems with a huge $12.3 million anti-smoking initiative the company funded. Pfizer funded University of Wisconsin to coordinate the project, but allowed UW to work jointly with a few MECCs, including CME Enterprises. The result was that the CME program was biased in favor of Pfizer's Chantix, as detailed in this article in the Milwaukee Journal Sentinel.

Nobody knows whether GSK will allow a similar loophole. Let's hope not.

Paul Thacker: The Tenacious Hero of Reform

"Never doubt that a small group of thoughtful, committed people can change the world. Indeed, it is the only thing that ever has."

Or so said Margaret Mead, and I believe it's true.

One rarely gets the chance to meet such people, but on September 3, 2008, I was sitting in a popular Washington, D.C. Mexican restaurant blocks from the Capitol building, chatting with Paul Thacker. Few have heard of him, but many have heard about his boss, Charles Grassley, the senator from Iowa who has crusaded for transparency in industry-academic relationships. As Thacker and I ate enchiladas and chatted about Grassley's investigations, it became clear that Thacker himself was the spark behind the blizzard of letters and inquiries that ultimately exposed a slew of cozy arrangements between academics and the drug industry.

Now, Meredith Wadman has published this fascinating profile of Paul Thacker in the journal Nature, and it is required reading for anyone interested in the Man Who Brought Down Nemeroff, and more generally in the process of political reform. I won't even quote from it because I want to encourage you to read the article yourself (a subscription is required to read the whole thing). And for more on Thacker, check out this PBS documentary based on his earlier investigative reporting on the manipulated science sponsored by the tobacco industry and by deniers of global warming.

Schering-Plough: Committed to Corrupting every last Psychiatrist?

Since my last post about Schering-Plough's campaign to buy off doctors with invitations to join its Speaker's Bureau, a number of my colleagues have reported receiving their own invitations. Strangely, many of them are prominent opponents of industry-funded medical education.

For example, Ivan Goldberg, creator of the popular website Depression Central, and an outspoken critic of drug industry manipulation of doctors, received this letter. Check it out, because it's a little different from the one I got. They offered me $170,000 for 125 presentations (of 45 minutes each), while they offered Dr. Goldberg more money ($179,500) for fewer (only 96) presentations. In a phone conversation with Dr. Goldberg, he suggested that the differential was due to the fact that he lives in expensive New York City, but I assumed that Schering-Plough marketers calculated that he is worth more to them than I am. After all, they also offered Goldberg the lucrative gig of up to 5 "train-the-trainer" spots at $4500 apiece. This is where they would fly him to a meeting to stand at the podium and teach the teeming hordes of wannabe hired guns how to most effectively prostitute themselves.

Why is Schering-Plough sending these corrupting invitations to all the wrong people? Maybe the company employee in charge of identifying potential hired guns simply screwed up and didn't vet the mailing list adequately. Dr. Goldberg offered a different theory. He opined that perhaps all the bad PR about drug companies buying off doctors is dissuading MD's from accepting these gigs. Therefore, perhaps Schering-Plough is now forced to send out invitations to everybody, including "B" players and industry critics, in order to achieve their critical mass of Dr. Drug Reps.

What a fiasco for the company. Talk about a bad stumble as they are about to launch their new antipsychotic. I haven't heard any official Schering-Plough comment on this matter yet, but here is how I predict the statement will read: "Speaker programs are intended to enhance a healthcare professional's knowledge and patient care expertise." Wait--they can't use that line, because it was already used by Eli Lilly. I guess they'll have to make up their own sophisticated BS.

Schering-Plough to SAPHRIS Hired Guns: Come 'n Git It!

The FDA recently approved SAPHRIS (asenapine) for the treatment of both schizophrenia and bipolar disorder. It is available only as a sublingual tablet, meaning that it is not effective if swallowed, and it must be left under the tongue to dissolve for it to be absorbed into the bloodstream. I haven’t yet reviewed the studies to see if SAPHRIS has any advantages over other antipsychotics, but I do know that Jeffrey Lieberman, MD, who is Chair of Columbia University Department of Psychiatry as well as the head of the APA's Council on Research, was quoted in this article as saying that “The studies haven’t shown that [SAPHRIS] provides any unique therapeutic advantage. The main contribution is that clinicians and patients will have yet another choice.”

Advantage or not, Schering-Plough is already poised to make aggressive use of hired guns to get psychiatrists to prescribe its new antipsychotic.

Oddly, the company just sent me a SAPHRIS Speaker Bureau invitation packet. I guess my 2007 New York Times Magazine memoir describing the tangled ethics of promotional speaking has not yet become required reading at Schering-Plough.

Their invitation packet starts with this cover letter flattering me by saying, “As a recognized thought leader and well-respected healthcare professional among your peers, we are seeking your participation as a speaker in our Schering-Plough SAPHRIS Speaker’s Bureau….”

Then there is this Speaker Bureau Agreement in which you have to promise to go to a Schering-Plough training meeting (it’s not so bad—you get $3000 plus all expenses for a day and a half meeting), and in which you promise to use only company-sponsored information for your presentations.


But the meat of the packet is called Exhibit A, (part of which is pasted above) which tells you how much you’ll be paid:

--$1,600 for a 45 minute power point presentation or informal “peer discussion group.”
--$1,000 for a 45 minute web-based live presentation (you get $600 less because you don’t have to leave the comfort of your office)
--Total maximum (called “contract total aggregate”) amount that you may receive over the course of the year is $170,000.

Evidently, Schering-Plough is confident that it can attract all the hired guns away from both Eli Lilly and Pfizer, both of which have either started posting physician payments on the web (Lilly) or have promised to do so (Pfizer). Presumably, chastened doctors will be more likely to whore for a company that will keep their payments discreet. But the impending Physician Payments Sunshine Act will prove the old maxim, "you can run, but you cannot hide."