50 Ways to Leave Big Pharma

Check out this new song by Adriane Fugh-Berman, physician extraordinaire and possibly the next American Idol. Courtesy of Pharmed Out and PharmaGossip, and apologies to Paul Simon.


The problem’s over-promoted meds, she said to me
You know we’ve got to treat our patients carefully
I'd like to help you to become pharma- free
There must be fifty ways to leave drug companies

She said it isn’t education reps provide
And what they know about you they’re unlikely to confide
What they want to do is to control what you prescribe
There must be fifty ways to leave drug companies
Fifty ways to leave drug companies

Have the reps take a hike, Mike
Buy your own pen, Jen
You don't need a free meal, Neil
Just get yourself free
Throw the samples away, Kay
You don't have to use new drugs
Pay your own CME, Lee
And get yourself free

Oooh, Have the reps take a hike, Mike
Buy your own pen, Jen
You don't need a free meal, Neil
Just listen to me
Throw the samples away, Kay
You don't have to use new drugs
Pay your own CME, Lee
And get yourself free

She said it grieves me so that you’re a KOL
Masking marketing as education doesn’t serve us well
I said I resent that but would you please explain
About the fifty ways

She said we owe it to our own integrity
Together we can throw industry out of CME
And then she pinched me and I realized she probably was right
There must be fifty ways to leave drug companies
Fifty ways to leave drug companies

Have the reps take a hike, Mike
Buy your own pen, Jen
You don't need a free meal, Neil
Just get yourself free
Throw the samples away, Kay
You don't have to use new drugs
Pay your own CME, Lee
And get yourself free

Oooh, Have the reps take a hike, Mike
Buy your own pen, Jen
You don't need a free meal, Neil
Just listen to me
Throw the samples away, Kay
You don't have to use new drugs
Pay your own CME, Lee
And get yourself free

I'm a physician. I deserve nice things.

Medscape and my sometimes nemesis Dr. RW got a nice smackdown in this blog entry on “Billy Rubin’s Blog.”

I had never heard about this blog until my Google alert sent me the link under the keyword “industry-sponsored CME.”

I encourage you to read the entire article, which is well argued, and does a great job of being indignant without sounding mean or strident, a skill in which I could use some tutoring.

One excerpt:

Oddly--well, actually, not oddly at all--the real argument running beneath these rationalizations is virtually never spoken of. It's pretty simple, actually, and Doctor Rubin, despite his immense respect and affection for the vast majority of his colleagues, has heard that silent-yet-powerful argument since his early days in med school. The "argument," such as it is, is this: I am a physician and that entitles me to nice things. Trinkets, such as free hors d'oeuvres at the cocktail hour following the day's professional meetings, fancy dinners on the tab of the local drug rep, tax-deductible trips to "educational conferences" in the Bahamas--all this is part of the trappings of the lifestyle of a doc. Such is the mentality that resists seeing the obvious conflict-of-interest in industry sponsorship of CME; the defense of the indefensible rests on an emotional response, not a rational one. Until that mentality, that sense of entitlement changes, you can count on organized physician opposition to the meek suggestion that, you know, perhaps we might want to reconsider our relationship with groups whose job it is to make money, given that our job is theoretically to heal patients.

University of Wisconsin + Wyeth = Biased CME

In the fall of 2002, the Women’s Health Initiative stopped its NIH-funded clinical trial of hormone replacement therapy, because women randomized to receive hormone therapy (estrogen + progesterone) had more breast cancer, heart disease, and strokes than those not taking the drugs.

This presented Wyeth, the manufacturer of the implicated drug Prempro, with a problem: a potentially catastrophic loss of income.

They responded the way drug companies generally respond when their product is shown to be hazardous. They ramped up their marketing. They criticized the methods of the study. They emphasized the need to weigh risks vs. benefits.

And, according to this riveting article from the Milwaukee Journal Sentinel, Wyeth deployed an army of ghostwriters and academics to create a one-sided $12 million CME program which is under investigation by the Senate Finance Committee.

According to the article, Wyeth hired a marketing communications company called DesignWrite which teamed up with UW Medical School to create an organization they named “The Council on Hormone Education.” This council was composed of 40 academics in the field, 34 of whom had ties financial ties to Wyeth.

It is unclear if the members of the council actually created any course content or if they simply were paid to put their names on CME articles written by DesignWrite ghostwriters. At any rate, the council stamped its name on 16 CME newsletters, the stated goals of which were "to develop and disseminate balanced, accurate, timely and consistent information about hormone therapy" so doctors could "better serve women."
The newsletters included articles such as "A Perspective on WHI (the Women's Health Initiative)," "Choosing the Right Therapy for Postmenopausal Osteoporosis" and "Sexual Desire Disorder in the Postmenopausal Woman."

Sounds pretty academic.

But when John Fauber and Susanne Rust, the investigative reporters, showed the materials to independent experts in the field, here were the reviews:

--Jacques Rossouw, chief of the Women's Health Initiative branch of the National Institutes of Health said, according to the paper, that “the views expressed in the course are not those of the general scientific community and are not suitable for a university medical education course.” "There is a history of this kind of thing from Wyeth," Rossouw said. "The materials regurgitate lines that I have heard and read many times, and I have come to believe (though I do not know) that this is part of an overall marketing strategy to the profession. It is not good science because it fails to strive for any kind of balance."

--Raymond Gibbons, a professor of medicine at the Mayo Clinic and former president of the American Heart Association, “said he also found material relating to heart disease one-sided. He noted that the materials inappropriately gave observational data equal weight to rigorously done, randomized clinical trials. ‘It's a lot of post hoc analysis,’ he said. ‘I don't see the other side of the argument.’"

-- Marcia Stefanick, an investigator with the Women's Health Initiative, told the Journal Sentinel that “since the results of the first large clinical trial on hormone therapy were released in 1998, drug companies have been trying to minimize the concerns….They are very eager to keep coming up with ways to show it isn't harmful….There is this constant attempt to get women back into it."

--Anthony Scialli, an adjunct professor of obstetrics and gynecology at Georgetown University's School of Medicine, put it simply: "It is pure, undisguised marketing.”

And what is the University of Wisconsin, the ACCME-accredited sponsor of the program, saying and doing? First, they immediately pulled the program from their website after the Journal Sentinel started asking inconvenient questions. Second, an apparently very embarrassed George Mejicano, who is director of UW’s CME programs, is not giving the straightest of answers. For example, when asked if the course had received criticism, he is quoted as answering: “Yes and no. It’s complicated.”

It’s not really so complicated. UW took in $1.5 million from Wyeth to help them advertise Prempro in the guise of CME. Money clarifies the mind and sharpens incentives.

Meanwhile, UW is involved in several other ongoing big ticket CME initiatives. These include:

--Pfizer’s $12.3 million smoking cessation program. Pfizer happens to make Chantix, an embattled smoking cessation drug.

--Boehringer Ingelheim’s program on restless leg syndrome . The company happens to make Mirapex, a drug for RLS.

-- Bayer HealthCare Pharmaceutical’s course on premenstrual dysphoric disorder. Bayer happens to make Yasmin, an oral contraceptive being touted as a good treatment for…yes, premenstrual dysphoric disorder.

If you want to enjoy these advertisements, you’d better get on it. I’ll wager that the chastened university will be soon be shutting down these websites as well!

First, Data Mining; Now, "Patient Priming"

Thought you'd seen it all? Well, the infiltration of drug company marketing into every corner of our lives scoffs at boundaries. Now that nearly half of all states are considering laws banning prescription data mining, the industry is developing a new technique: "patient priming."

What is it, exactly? It's so breathlessly new that I'm not entirely certain what it is. But it can't be good. You can certainly learn more if you register for this webcast to take place February 5, produced by Medical Marketing & Media magazine and sponsored by HealthGrades. Here's how they describe the event:

"Understanding and Priming the Pre-Visit Patient

The point at which a patient plans and schedules a visit to their doctor represents a significant window of opportunity for promoting treatment options and maximizing the growth of specific brands. Experts in patient engagement and marketing from the pharmaceutical, agency and media fields discuss pharma's role in priming the pre-visit patient for a more beneficial dialogue with their physician.

Featured speakers:
Jan R. Rutherford, Jr., Senior Vice President, Sponsorship and Advertising, HealthGrades
Robert Palmer, Managing Partner, S&H Digital, Sudler & Hennessey Company"

I'm guessing this is a scheme cooked up by HealthGrades to convince more drug companies to advertise on their site. I just went to the HealthGrades page evaluating me as a doctor, and noticed a banner ad for Concerta. I assume Mr. Rutherford will entice companies to use HealthGrades to prime "pre-visit patients" and encourage them to demand specific brands from their physician. Yes, this is just another version of direct-to-consumer advertising, but the Orwellian language makes it all sound particularly insidious.

Signed,

Your Pre-Visit, Pre-Primed Physician

Physician Disclosure Tipping Point

The public is increasingly demanding real disclosure of doctors’ ties to the pharmaceutical industry. Here is a run down of some recent events.

In Texas, two lawmakers have files disclosure bills that would require drug manufacturers to report all payments to Texas health-care providers – including consulting fees and honoraria, gifts and travel perks. The Texas Medical Association has already declared its support of the bill. Dr. Josie Williams, the association’s president, said her organization "supports transparency in health care, and favors transparency in this area as well."

In Wisconsin, the Milwaukee Journal Sentinel has published this remarkable two-part series by John Fauber spotlighting the activities of hired gun physicians in the state. Sifting through disclosure records of the University of Wisconsin-Madison, Fauber found that 114 university physicians had moonlighting jobs as hired guns for drug companies in 2007 and 2008.

Dr. Barry Fox, an infectious disease specialist, received particular scrutiny in the article. The Joseph Biederman of Wisconsin, Dr. Fox had side jobs with 7 different companies in 2007, including various speaking and consultation gigs. Among other drugs, Fox has promoted Avelox, and antibiotic that causes tendon ruptures and tendinitis in some patients. Did Fox discuss the dark side of Avelox in his talks to doctors? Fauber tried to find out the details of his stump speeches, but was stymied in his efforts:

Reached by phone in March, Fox initially agreed to listen to questions.
"I have nothing to hide," he said.
When asked what kind of work he did for a drug company, he said, "I'm not very comfortable with this conversation," and hung up. Several attempts to reach him since have been unsuccessful.

Dr. Robert Golden, the dean of the University of Wisconsin Medical School, is taking disclosure issues seriously:

[Golden] said an overhaul of the conflict-of-interest policy is being considered, including disclosing the actual amount paid by a drug or device company.
"We want to know if someone is getting $20,000 rather than $200,000," he said.
He said the change could be in place by April, when the disclosure forms must be filed.

In my home state of Massachusetts, hearings have been held to decide how to implement the gift ban and physician payment disclosure law passed last year. The Department of Public Health has made a preliminary judgment that physician payments for research need not be disclosed, but others disagree. You can find good coverage of one of the hearings in the Health Care for All blog.

Drug Wonks’ arch conservative Peter Pitts has chimed into the debate with this op-ed in the Boston Globe. As usual, Mr. Pitts, in arguing for less disclosure, neglected to disclose his own conflicts of interests. He designated himself "president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA." But as Dr. David Egilman pointed out in a comment, “he failed to mention that this is a front organization set up to represent the pharmaceutical manufacturers not the public's interests. He was too modest and forgot to mention that he was also "Senior Vice President for Health Affairs at Manning, Selvage & Lee.” Which is a PR firm representing drug companies.

American Psychiatric News: Guess the CME Sponsor!

Last July, I blogged on a CME conference at the New York Marriott called the “Third Annual American Conference on Psychiatric Disorders.”

The bottom line was that McMahon Publishing was using the conference to make boatloads of money from pharmaceutical companies, charging them $85,000 for each 90 minute symposium, and offering to write up articles based on each symposium for a mere $103,000 each. Well, the conference took place in September, and now, 4 months later, the first of the $103,000 articles have been published.

Shall we have some fun?

Yes, it’s time to play that always entertaining game of commercial CME corruption, "Guess the CME Sponsor!"

We’ll focus on the article entitled “Differential Diagnosis and Management of Bipolar Disorder.” It is published in a "Special Edition" of American Psychiatry News, December 2008, Vol 1, No. 12. I haven't found this article online yet, but here is the journal's website.

First, who wrote the article? We have no idea. Although the “faculty” are listed as Glenn J. Treisman, MD, PhD, and Jennifer L. Payne, MD, the article was presumably ghostwritten by a medical writer hired by American Psychiatry News.

And what about disclosures? There’s already a problem here. Under “faculty disclosure”, Dr. Treisman reports “no financial interests to disclose.” Must be a typo. Because at this December 2008 Pri-Med conference, Dr. Treisman reported being a speaker for both Boehringer Ingelheim and Abbott, and in this May 2007 CME program, he said he was on Pfizer's speakers bureau as well. In the past, Dr. Treisman apparently spoke for so many companies that he simply disclosed that he was on the “Speakers Bureau for most pharmaceutical companies” according to this Drexel University CME program.

Let’s move onto the article itself. But remember the rules: no peeking at which drug company sponsored the article until we’re done!

The article is built around these two case studies:

1) Chelsea, a 20-year-old college student, uses alcohol and marijuana and presents to a doctor with symptoms of mania. Her psychiatrist diagnoses her with bipolar disorder and comorbid substance abuse, and starts her on valproate. Over the next 1 ½ years, however, Chelsea does quite poorly on valproate, and has four manic episodes with psychotic features. Eventually, she is admitted to the hospital, and Zyprexa (olanzapine) is added to valproate. Four weeks later, Chelsea has improved: her sleep is better and her mood is stable.

2) Greta is a 40 year old married school teacher who presents with symptoms of depression. Her psychiatrist prescribes fluoxetine, but 5 weeks later she has racing thoughts, poor sleep, and her diagnosis is revised to bipolar disorder II. At this point, her psychiatrist switches her from fluoxetine to Symbyax (Zyprexa-fluoxetine combination capsule) and lithium. Three weeks later, according to the article, “Greta has improved. She is sleeping better, is less irritable, is finding it easier to focus at work, and has begun marriage counseling with her husband. Generally, she is statisfied with her treatment.”

Now let’s do our analysis. In the world of bipolar treatment, the major branded players are: Abilify, Geodon, Seroquel, and Zyprexa. Risperdal, valproate, lithium, tegretol, and lamotrigine are also used, but they are all off-patent, and therefore drug companies would be unlikely to support education featuring them.

Would Bristol-Myers Squibb support this program? Doubtful, because Abilify is not mentioned in either case, though it is mentioned in passing as a treatment option in some of the smaller-print commentary. Pfizer or AstraZeneca? Certainly not, because neither Geodon nor Seroquel appear to have entered the treating psychiatrists’ minds.

Eli Lilly? Hmmm. Chelsea finally got better after she was started on Lilly’s Zyprexa. Greta got better on Lilly’s Symbyax. I think we have a real candidate here.

Let’s flip to page 25 of the journal: “Supported by an educational grant from Eli Lilly and Company.”

We have a winner! Those of you in the audience who correctly Guessed the CME Sponsor will receive a $100 gift certificate to McDonalds, which you will tear through during your first day on Zyprexa en route to an average weight gain of one pound per week—but of course we heard nothing about either Chelsea or Greta gaining any weight. Contrast this with Current Psychiatry’s AstraZeneca’s CME advertisement for Seroquel, in which Dr. Goldberg’s patient, Mr. S, gained 18 pounds in one month of Zyprexa treatment.

As usual, nothing inaccurate was said in this article, and I'm sure Symbyax is a perfectly delightful medication for someone out there, although I would never prescribe it because I hate turning patients into blimps. But this article is an advertisement, and should not have qualified as accredited medical education. Shame on Dr. Treisman, the journal's editor, and McMahon Publishing.

Charles Nemeroff, Unleashed

It looks like Dr. Charles Nemeroff has found a way to wriggle out of the already loose leash clapped around his neck by Emory University.

For those who have forgotten about Dr. Nemeroff’s recent trials and tribulations, here’s a brief recap. He was the principal investigator of a $3.95 million NIH grant to study several drugs by GlaxoSmithKline. But he was at the same time making hundreds of thousands of dollars doing promotional talks for the same company, orders of magnitude higher than the NIH maximum allowed. In order to skirt these regulations, Nemeroff simply lied to Emory officials. According to the New York Times, he signed a letter dated July 15, 2004, promising Emory that he would keep his earning from GlaxoSmithKline to less than $10,000 per year. But that same day, Nemeroff was at the Four Seasons Resort in Jackson Hole, Wyoming, where he was earning $3000 for a talk for GSK, part of $170,000 in income he earned from the company that year—17 times the figure that he had agreed to.

Emory removed him as department chair shortly thereafter, but inexplicably kept him on as full professor and allowed him to re-apply for more NIH grants within two years. Nemeroff’s public statement revealed an alarming lack of remorse: “I regret the failure of full disclosure on my part that has led me to the current situation. I believe that I was acting in good faith to comply with the rules as I understood them to be in effect at the time.” Translation: “I’m bummed out that this is happening to me. I didn’t do anything wrong.”

Meanwhile, Emory’s “punishment” still allows Nemeroff to take drug company money for promotional talks in the guise of ACCME accredited activities. According to Emory’s letter: “He will be limited to accepting payment for ACCME-accredited speaking engagements sponsored by academic institutions or professional societies.”

But Dr. Nemeroff has already found a way to escape from this restriction. In February, Dr. Nemeroff will co-chair this CME series supported by Bristol-Myers Squibb called “Measurement Based Care Strategies for Depression.”

It is “jointly sponsored” by the University of North Texas Health Science Center (UNTHSC) and an obscure outfit called “Letters & Sciences.” Letters & Sciences (L & S) is presumably a MECC but a Google search shows that they have no website. They are listed as being an “approved provider” of CE credit for nurses by both the New Jersey State Nurses Association (NJSNA) and the California Board of Registered Nursing.

It is clear that L & S is on a Bristol-Myers Squibb gravy train, making their money by producing promotional CME encouraging doctors to prescribe plenty of Abilify for bipolar disorder and depression. They teamed up with UNTHSC to produce this recent CME series as well, which presumably pushes the use of Abilify for kids.

By teaming up with this shadowy MECC, Nemeroff is complying with the letter of his punishment but is playing fast and loose with its spirit. In specifying that Nemeroff is limited to CME events “sponsored by academic institutions and professional societies,” Emory is asking that legitimate institutions create and control the content. But in this case, we see the usual CME shell game in which a private MECC is creating the content and is paying a nominal “co-sponsor” to provide CME credit.

If I were Senator Grassley, I’d be sending letters to L&S, UNTHSC, ACCME, Nemeroff, etc…, asking:

--How did L & S obtain the grant from BMS for this program?
--What is L & S? Where are they? Who is on their staff? Which medical writers are creating the content? How much money are they making from BMS? What percentage of their total income comes from events supported by BMS?
--What, exactly, is UNTHSC doing as “co-sponsor” of the event? Are they simply extracting a healthy fee from L & S, in return for a cursory review of their paperwork and disclosure forms? Or are they actually managing the event and producing content?

Leashes always chafe, especially when the wearer feels no guilt. Sometimes, however, loosening the leash is precisely the wrong thing to do.

Hat tip to Bernard Carroll.