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."

Forest's Promotional Objective: Use CME to Sell Lexapro

We have known for some time that the actual purpose of industry-sponsored CME (continuing medical education) is to increase prescriptions of the supporter's product. But few will admit it. The ACCME says that it accredits only CME that is unbiased and objective, even though half of it is paid for by the pharmaceutical industry. Leading medical societies appear to be willing to fight to maintain their God-given right to industry funding of CME until the world ends.

Finally, a major drug company--Forest Laboratories--has confirmed that CME is, in fact, advertising.

In today's New York Times, Gardiner Harris describes a smoking gun document that outlines in stark fashion how Forest has created CME programs for physicians in order to increase market share for Lexapro. The document, entitled "Fiscal Year 2004 Marketing Plan," can be read in all its inglory here.

Here are a couple of my favorite excerpts.

"PROMOTIONAL OBJECTIVES

• Achieve first place in detail dollar share of voice in the SRI market
• Maintain SRI category leadership in number of journal ad inserts
• Maintain SRI category leadership in total number of medical education events (Including CME symposia, speaker programs, teleconferences, and peer selling programs.)
• Generate significant Lexapro specific news coverage to both consumers and healthcare
professionals
• Have Lexapro included in all depression/anxiety related round up articles/stories that
discuss treatment"

Yep, there it is, number three on their list of strategies: CME symposia. But like any successful company, Forest leaves nothing to chance. In order to make sure that Lexapro-friendly CME got in front of potential prescribers, they came up with a variety of tactics, such as:

"A reporter from publications like CNS News, Psych Times, and the Journal of Clinical Psychiatry will be sent to cover key Lexapro data presented at important medical meetings. Data from ADAA (Anxiety Disorders Association of America), APA (American Psychiatric Association), AAFP (American Academy of Family Physicians, and AAGP (American Association for Geriatric Psychiatry) will be reported in the journal as a CME supplement.

Quantity:4
Cost per unit:$75,000
Estimated Cost: $300,000"

In other words, rather than waiting for doctors to decide to write their own articles singing the praises of Lexapro, Forest decided to hire reporters from journals to cover the CME symposia they already paid for. Based on the reporting, ghostwriters would then scribble the articles, and plant some psychiatrists' names as authors. The articles would be packaged as "CME supplements" with the journals.

It's so much more...efficient this way!

There's more in this document, much more. Please give it a read, but I suggest you do so on an empty stomach.

Thoughts on Orthogate

I haven't had much to say about orthogate, the ongoing scandal involving Medtronic, Dr. Tim (the forger) Kuklo, and Dr. David (the consultant) Polly.

It's pretty clear that Dr. Kuklo is a bad apple, assuming that it's true that he made up data regarding the Medtronic bone growth product Infuse, including forging the names of colleagues who later said they had no involvement in the study. (See Doug Bremner's particularly colorful review of these events here). Outright fraud can happen in any system, no matter how well regulated, so the Kuklo disaster is not necessarily grounds for calling for systemic reform.

The David Polly case is a tougher call. Obviously, Polly, a professor at the University of Minnesota and the former head of orthopedics at Walter Reed, made a barrel-full of money consulting for Medtronic on Infuse. In fact, between 2003 and 2007, Polly received more than $1.14 million in fees and expenses from Medtronic. According to the Wall St Journal, the main "bad" thing that Polly did was failing to disclose at a May 2006 senate hearing that Medtronic had funded his trip. Polly was at the hearing to drum up more government funds for research on treating wounded soldiers, and he and his colleagues in Minnesota evenutally won a $466,644 Department of Defense grant for a study on Infuse. Obviously, Polly should have told the Senate that he was speaking on behalf of Medtronic; instead, he claimed to be speaking on behalf of the American Academy of Orthopaedic Surgeons.

To his credit, Polly didn't run and hide behind a veil of "no comment." In fact, he went on the radio program All Things Considered and said that he was a "rookie" that day. He said it didn't appear there was a forum or venue to make such disclosures at the hearing. "If there had been, certainly I would have been delighted to disclose," he said. "And if I was asked to testify before Congress tomorrow or currently, I would probably do things differently to be a little more clear about who I have financial ties with."

Is this believable? Who knows? In my experience, people who rise to the rarified ranks of academia like Polly are extremely shrewd about regulations and paperwork. I'd be surprised if it didn't occur to Polly that the Senate would have wanted to know that Medtronic was paying him $6000 to testify, according to the New York Times account.

Subsequently, the WSJ and others had a field day going over Polly's detailed consulting and billing records:

His consulting log indicates that on one occasion he spent one minute to wake up a Medtronic executive, although he listed "no charge" for that service. He did bill Medtronic for the 30 minutes he spent in the car with that executive after waking him up.

The amounts of money seemed excessive, and while there's nothing wrong with a company paying an expert lots of money to help them develop products for patients care, even Medtronic shareholders were rattled by the scope of the payments. At the Medtronic annual meeting, shareholder John Burbidge was quoted in the Twin Cities Pioneer Press as saying that while he understood the need for input from physician consultants, he was "taken aback" by the sums of money involved.

"Is it really necessary to pay that kind of money to doctors in order to get good information?" he asked. "Can you rely on information that you pay that much money for?" added Burbidge, who said he is a longtime Medtronic shareholder. "Obviously, nobody is going to want to tell you anything you don't want to hear and jeopardize his relationship with the company."

Eventually, although Polly denied any malfeasance, the heat was too much for him and he resigned his post as a board member of the American Academy of Orthopedic Surgeons, saying that the issue had become a "distraction" for the organization.

What to make of orthogate? Kuklo, apparently, is just a unethical doctor/researcher who allowed his greed to influence his professional decisions. Polly, on the other hand, seems like a good guy who made a mistake in disclosure. In some ways, it's surprising to me that he even quit the orthopedics organization. I'm willing to bet that many of his colleagues on the board do the same kinds of lucrative consulting gigs. Are they all supposed to resign now?

Perhaps the lesson here is that when physicians decide to work with industry, and when the amounts of money become astronomical, they will inevitably teeter on the brink of greed. Once greed takes over, they may start to do bad things. That's why transparency of such payments will be helpful, so that we can closely monitor doctors who seem to be making just a teensy bit too much money from industry.

A MECC that BLISSfully keeps Promotion in Medical Education

Recently, medical writers from across the country have been forwarding me blatant examples of how medical education companies are currupting the basic tenets of continuing medical education. Although I've become jaded, this particular company astonished even me with their willingness to do away with the pretense that industry-funded medical education is anything other than advertising.

The company is called Brand(x) and they are based in the United Kingdom. They are mainly an advertising firm but they have a robust medical education department. Here is a screen shot from their website in which they explain their conception of "medical education."


If you can't quite make out the small print, you can reach this page by going to the home page, clicking "enter" then "services" then "med ed." Here is the definition of CME, Brand(x)-style:

In today's business environment clients increasingly recognize that to get the best results, medical education must be led by a clear understanding of what the brand stands for and be closely integrated with the promotional strategy. At Brand(x), we are uniquely placed to provide the exceptional skills, which will help shape your educational strategy and implementation so that your brand's business objectives are met.

The company has developed its own process for making sure CME promotes a drug company's brand. It's called "BLISS," an acronym for "Brand Led Integrated Support Service." Here's a screenshot showing how they make CME more BLISSful:

Recently, Dr. Murray Kopelow assured the Senate Special Committee on Aging that his organization, the ACCME, has everything under control. In fact, here is what ACCME's standards for commercial support has to say about the content of CME:

The content or format of a CME activity or its
related materials must promote improvements
or quality in healthcare and not a specific
proprietary business interest of a commercial
interest.

But here is what Brand (x) has to say about CME:

BLISS ensures that your medical education programmes and strategies are synergistic with your brand's promotional strategy and execution.

I guess ACCME will need to hire a few more compliance officers.

Industry-Funded Medical Writers vs. Health Care Reform

Recently, a former staff medical writer at a MECC (Medical Education Communication Company) anonymously alerted me to a particularly sleazy advertising tactic used by a medical writing company. This person had worked as a pharma-supported medical writer for several years, but recently quit because, “I really couldn't stomach the ethical problems associated with writing for the pharma industry." Recently, looking for medical writing jobs, this writer came across a company called "Emron--" no, not Enron, although the ethical standards of the sound-alike companies appear to be similar.

Here is how Emron advertises its writing services to the pharmaceutical industry:

When you’re looking to compete on quality, set your sights on Emron for top-flight healthcare marketing communications and brand management. We drive sales, access and reimbursement in competitive markets: our clients achieve sustained competitive advantage by creating product demand and reducing price-sensitivity.

Now, if Emron were simply an advertising company, I would have no problem with this. Ad copy writers specialize in the craft of helping companies gain market share. As a newsletter publisher, I appreciate the magic of good marketing copy when I am periodically forced to send out those annoying promotional mailers that most people toss into recycling.

But Emron does much more than advertising. It produces accredited CME programs in order to help their clients "achieve sustained competitive advantage." As the medical writer pointed out to me, the worst part of Emron's statement is the phrase "reducing price sensitivity." With healthcare costs being foremost in the nations' consciousness right now, this attitude is unconscionable. Emron is saying to pharmaceutical companies "To heck with healthcare costs! The pharmaceutical industry should not do anything to compromise their profit margins. And we will offer you our professional staff of writers (for a hefty fee) to write your CME so that doctors will prescribe more of the most expensive drugs."

One example of Emron's work is the The Contraception Report, a Wyeth-funded newsletter whose underlying purpose is to get doctors interested in Wyeth's latest birth control products. That newsletter has expanded into a website called Contraception Online, which is also entirely funded by Wyeth, and which also provides advertising dressed up as CME. This site is shamefully produced by Baylor College of Medicine; I don't know what part Emron still plays in it, as the website does a good job of making this opaque.

Recently, Murray Kopelow provided testimony in which he assured the Senate Special Committee on Aging that ACCME is the firewall between education and promotion. Emron's toll-free number is 800-367-6613. I suggest Dr. Kopelow give them a call to help them build a better firewall.

Ghostwriting Stays in the Spotlight

With Natasha Singer's article on ghostwriting appearing in the Health section of today's New York Times, this underhanded method of drug promotion is in the public spotlight as never before. Medical ghostwriting leaches out the confidence we have in the authenticity of medical research, because the articles are conceived and written by drug company marketers and their surrogates. But when they are published in the top journals, they look like serious reports of medical science, complete with the names of prestigious doctors who are dubbed "authors."

After you read the New York Times article, I suggest you read this very clever article by William Heisel, a two time Pulitzer finalist, who blogs on Reporting on Health, a project of the Annenberg School for Communication at USC. Heisel's focus is on the self-deluded ways doctors are rationalizing their partipation in medical ghostwriting. For example, Dr. Leon Speroff, a former professor of obstetrics and gynecology at Oregon Health Sciences University who allowed DesignWrite to put his name on a paper he didn't write, defended his bad behavior by saying that it was then "standard practice" to not disclose a drug company's involvement.

Comments Heisel:

Why is it when these researchers are caught with a drug company's hand playing them like a puppet, they pull the "standard practice" line? Standard for whom? Certainly not for the patients taking the pills and presumably not for the journal editors accepting the articles for publication. Perhaps this is something Sen. Charles Grassley, R-Iowa, should ask in a hearing. Speroff told the Journal Sentinel he had nothing to apologize for:

"There is nothing dishonest about it."

Speroff was quoted in this excellent investigative report on medical ghostwriting at University of Wisconsin written by--who else?--the incomparable John Fauber and Meg Kissinger of the Milwaukee Journal Sentinel, both of whom should be on the short list at the next awards meeting of the Pulitzer committee.

Eli Lilly Posts its Grand Deception

Eli Lilly has recently posted the Grand Deception which it is calling the "Lilly Faculty Registry." You can inspect it here. Why do I call it the "Grand Deception?" Because the doctors listed as "faculty" are not really faculty at all. They are salesmen and saleswomen, with MDs after their names.

The Wall Street Journal reported that over the first three months of 2009, Lilly pumped $22 million into doctors' pockets, and most of this was categorized as "Healthcare Professional Education." This is the same kind of education you'll get if you go to a Toyota dealership and ask the salesman to educate you about which hybrid to buy. You will get some education, most of it accurate, about the Toyota Prius. You'll hear about its gas mileage, its cubic footage and its GPS system. But you won't hear anything about Honda hybrids or Ford hybrids or Chrysler hybrids. You won't be getting "car-buying professional education." You'll be getting a marketing pitch.

Lilly's Healthcare Professional Education events are no different. Doctors who go to a Lilly-sponsored talk on depression, for example, will hear plenty of information about Lilly's blockbuster Cymbalta, most of it accurate. But they'll hear nothing about Zoloft, or Celexa, or Paxil, or Effexor, or Remeron, or Nardil, or any of the dozens of other antidepressants that are as effective as Cymbalta.

Here's how Lilly defines Healthcare Professional Education: "Speaker programs are intended to enhance a healthcare professional's knowledge and patient care expertise." Excuse my calling a spade a spade here, but that's simply a lie, and every speaker on the registry list (many of whom are friends and colleagues) knows it. The speakers are required to use Lilly's slides, and are required to say what Lilly wants them to say. And what Lilly wants them to say are things that will get the doctors in the audience to prescribe more Lilly drugs.

Aren't I insulting the intelligence of doctors? Don't the doctors who go to these talks understand that it is a hard sell? Of course they do. But this knowledge does not make them impervious to the effects of marketing. Everybody knows that the billboards for Bud Light are paid for by Anheuser Busch. But that doesn't make them any less effective.

The question is, do we want our doctors to get their medical education this way? To be plied with good food, plentiful wine, and a free ticket to a colleague's joke-filled presentation singing the praises of the company's drug? Of course not.

Most importantly, do these talks lead to patients being harmed? Almost certainly. Lilly's top-selling drug, Zyprexa, led to an average weight gain of 37 pounds in a year in one study (Strassnig M et al. Schizophr Res 2007 Jul; 93:90-8.). Now that's not a study you'll be hearing much about during Lilly's Healthcare Professional Education talks!