Monday, April 28, 2008

Post-Deception Medicine

I'm on vacation and snatched an hour or so of internet time to check email, but I couldn't resist a quick entry alerting readers to a couple of hot items. First, today's New York Times published this article by Gardiner Harris reporting that the major association of medical schools has unveiled its new policy on drug company gifting. And the news is tremendous. The Association of American Medical Colleges now recommends that "drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff and students in all 129 of the nation’s medical colleges...." In addition, "the report recommended that medical schools should 'strongly discourage participation by their faculty in industry-sponsored speakers’ bureaus,' in which doctors are paid to promote the benefits of drugs and devices."

And in a feat of good timing, the Prescription Project has released a series of "toolkits" to help hospitals and academic medical centers create the conflict of interest policies that the parent organization now recommends. You can read more about this here.

The era of post-deception medicine is finally here.

Thursday, April 24, 2008

Massachusetts Senate Passes Drug Company Gift Ban

On April 18, the Massachusetts State Senate unanimously passed a law that included a complete ban on any gifts from the pharmacetical industry to doctors in the state.

This ban was only a small part of a larger bill to control health care costs in the state, but it is the provision inciting the most controversy by far. At this point, the bill is headed to the state House of Representatives, and then to the governor, so the ban is not yet a fait accompli.

It’s been highly entertaining to see how the issue has been playing out in the blogosphere and in local papers. The first salvo came in the form of this op-ed in the Boston Globe by Christopher R. Anderson, president of the Massachusetts High Technology Council.
Among other things, Anderson argued that a gift ban would hurt the state’s biotech industry by “undercutting biopharmaceutical employers that are expected to create jobs here.”

Boston’s conservative paper, the Boston Herald, then chimed in with this editorial, which quoted a letter from four drug companies complaining that the gift ban would hurt business and implying that drug companies would take their money to other states if it were enacted. The Herald said that the gift ban would “kneecap” the life science industry in Massachusetts.

Wow. How demeaning to both drug companies and doctors. Apparently, the only way to succeed as a pharmaceutical company in Massachusetts is to bribe doctors to use your products. And here I thought business success depended on creating valuable medical treatments that offer real advantages over competitors.

By the way, if companies believe they can flee regulation of their marketing practices by leaving Massachusetts, they’re wrong. Minnesota bans gifts worth more than $50, and Vermont requires public disclosure of gifts over $25. And according to this legislative round-up from The Prescription Project, in 2007 over half of all state legislatures considered bills addressing various aspects of bribery-based pharmaceutical marketing.

Furthermore, m
any of the country's premiere academic medical centers have already banned drug company gifts in their facilities, including Yale, Stanford, University of Michigan, University of Pennsylvania, Boston Medical Center, Vanderbilt University, University of Pittsburg, and University of Massachusetts. The huge University of California system is now in the process of formulating its own gift ban.

There truly is no place for drug companies to hide. A better solution is for the companies to scale back their marketing to traditional and legitimate practices, such as advertisements in medical journals.

At any rate, the Herald then published this perplexing op-ed written by two Boston physicians, supposedly arguing against the gift ban. The perplexing part of the article is that they actually claim to support gift bans in academic medical centers, and furthermore, they readily admit both that the reason drug reps call on doctors is to get them to prescribe more of their drugs, and that cheaper generics are often just as effective as newer, expensive agents, which, they say, "may add only incremental value." Thus, they don’t seem to be arguing against the gift ban per se, but rather they appear to believe that this bill is the first step in a darker liberal agenda: “The real intent of these critics goes far beyond food and trinkets, and its true purpose is to curtail strictly or even eliminate all contacts between physicians and private industry.” Talk about conpiracy theories. There's nothing in the bill eliminating, or even discussing, payments for CME activities or industry funding of research. Come on people, enough with the straw man arguments.

The credibility of the editorial was severely damaged by the conflicts of interest of the writers, which were only partially disclosed in the article. The disclosure noted that Dennis Ausiello is a director of Pfizer, but did not also note that he is on the advisory boards of three other drug companies. Tom Stossel disclosed no COIs at all, despite the fact that he is on Merck’s advisory board and receives payments for various speaking and marketing activities from four other companies. No wonder their editorial, ultimately, fell on deaf ears in the State Senate. You can read more details in two articles in Pharmalot and the Wall St. Journal Health Blog.

Meanwhile, the battle for public opinion has been spiced up by several letters to the editor, including here and here by yours truly, these two pro-bribery letters (one by a physician's husband and the other by the CEO of a promotional products company), and here by Lisa Kaplan Howe of the Massacusetts Prescription Reform Coalition, which is a group I work with.

The fact is that our patients want us to base our prescribing decisions on an objective reading of the medical literature, rathet than a hard sell from professional salesmen. And bribery? It’s time to delete the term from the pharmaceutical industry’s lexicon.

Monday, April 21, 2008

Pentagon Borrows Techniques of Commercial CME

While this blog generally focuses on how physicians sometimes manipulate information in response to financial incentives, last Sunday's New York Times covered another category of corrupted information brokers: military analysts hired to interpret the news. In a devastating expose, David Barsow details the ways in which the Pentagon has groomed former military men to deploy the official White House message to national TV audiences.

Any reader of this blog will immediately recognize the same techniques used by hired gun M.D.'s—the highlighting of the positive while downplaying the negative, the hidden conflicts of interests, the rationalizations, and, ultimately, the damage done to our nation’s sense of morality.

Television networks have long hired retired generals and colonels to serve as “independent” military analysts, brought on to help the public understand the meaning of the latest developments in war. Yes, they were once part of the military establishiment, but we assume that in their retirement they no longer have to answer to anyone, and they can provide a clear-eyed interpretation of confusing war-time events. At least, that’s the theory.

The truth is very different. “Hidden behind that appearance of objectivity,” says the Times, “is a Pentagon information apparatus that has used those analysts in a campaign to generate favorable news coverage of the administration's wartime performance….”

As a result of a lawsuit, the Times forced the Defense Department to release 8000 pages of e-mails and meeting transcripts detailing how these analysts are paid to say nice things about the army. According to newspaper, “internal Pentagon documents repeatedly refer to the military analysts as ‘message force multipiers” or ‘surrogates’ who could be counted on to deliver administration ‘themes and messages’ to millions of Americans ‘in the form of their own opinions.’”

The parallels to the industry-sponsored CME industry are eery. In both cases, “key opinion leaders” are paid to deliver the company message (the Pentagon uses the term “key influentials”); old boy networks ensure that friends reward friends; and e-mail trails of damning communications eventually expose the sham.

Unfortunately, military analysts and industry-sponsored CME are not the only examples of our country’s burgeoning culture of deceptive information-brokers. In the last couple of years, we’ve read about college loan officers referring students to banks in return for kickbacks (1) ;
financial analysts entrusting their customers’ money to certain stock brokers in return for golf and gambling vacations (2) ; and government officials accepting lavish gifts from lobbyists for decisions that enrich their clients (3).

The moral? As information becomes more complex and specialized, it becomes more valuable to stakeholders. And where there is value, there is the opportunity for corruption, whether in medicine, the military, or any other field.

Friday, April 18, 2008

A Bad Week for Professional Liars

This was a very bad week for those whose careers depend on the use of deceptive marketing tactics.

1. JAMA (the Journal of the American Medical Association) published this article written by Joe Ross and colleagues exposing Merck’s use of ghostwriters to disseminate studies in support of Merck’s ill-fated arthritis drug, Vioxx.

2. The same JAMA issue reported that Merck had hidden its knowledge of the Vioxx dangers in studies of the drug in Alzheimer's disease
. Those still looking for evidence that relying on industry sources of information can lead to bad outcomes—in this case, death—need look no further than this article.

3. The editor in chief and deputy editor of JAMA wrote this scathing commentary in response to these articles, which began with the following statement: “The profession of medicine, in every aspect—clinical, education, and research—has been inundated with profound influence from the pharmaceutical and medical device industries. This has occurred because physicians have allowed it to happen, and it is time to stop.”

4. The New York Times published this article by Gina Kolata interviewing three high profile academic doctors who have relinquished industry ties and feel better about themselves and their profession as a result.

5. The current issue of the Journal of Nervous and Mental Diseases contains this paper by Speilmans and colleagues showing that only half of drug ads in psychiatry cite sources for their marketing claims, and of that half, only 65% of the cited sources support the claims. Steven Sharfstein, former president of the American Psychiatric Society, wrote an accompanying editorial. He urges both the FDA and the journals themselves to better evaluate drug advertising claims. He concludes: “The doctor-patient relationship should not be a market-driven phenomenon. If patients are to trust their physicians, they need to know that their interests are paramount and that the physicians’ knowledge base is up-to-date and accurate.”

6. Prescribing for Better Outcomes, a website devoted to educating physicians about inappropriate marketing tactics, released a journal supplement and a webinar helpful for those who are interested in a non-industry perspective on the use of epileptic medication in bipolar disorder.

It looks like the era of post-deception medicine is finally dawning.

Tuesday, April 15, 2008

For Relief from Pharma Influence, Visit Vermont

I suppose I should not be surprised that Vermont is doing so much to combat inappropriate drug company influence. After all, the state is famous for liberal physicians, including, most prominently, the current chairman of the Democratic National Committee, Howard Dean.

I recently gave a talk (as part of my “Dirty Thirty” tour) to the Vermont Psychiatric Association. What an impressive group. These are psychiatrists who are in the profession to help their patients, no matter what it takes, and are refreshingly unwedded to the medication solution. For example, Alice Silverman, one of the association's representatives to the APA, no longer starts with antidepressants when treating mild depression, because she has found therapy to be just as helpful. Her patients are happy because they don't have to deal with either sexual dysfunction or a higher risk of osteoporosis.

Also present was David Fassler, the incoming secretary-treasurer of the APA. I look forward to working with him on the newly formed APA Work Group to figure out who to wean ourselves off of industry money.

Vermont is absolutely at the forefront of the growing movement to wrest control of medicine away from the pharmaceutical industry. The legislature has passed a law restricting prescription data-mining; the University of Vermont Medical School has banned drug company gifts or meals; and the Vermont Association of Mental Health has just said "no" to industry support. To read more about what Vermont is doing, read this excellent overview article in the Barre Montpellier Times Argus.

Thursday, April 10, 2008

Drug-Rep Free Zone

I've had it. As of today, I am no longer allowing drug reps into my office.

Yes, until today, I was seeing reps a few times a month for 5 minute visits in order to keep up on trends in drug company marketing techniques. But today, an Astra Zeneca rep and his district manager came in to push Seroquel for bipolar depression. They came armed with the two studies that won Seroquel its FDA approval. The studies have their limitations, but somehow these reps didn't bring these up.

Instead, what I got was a ridiculous hard sell: "Dr. Carlat, given this data, would you choose Seroquel over the other atypical antipsychotics for bipolar depression?" I asked them if Astra Zeneca had done any head-to-head studies comparing Seroquel with the others. The rep adopted a pseudo-confused look, and said, "I'm not even sure that kind of study would be ethical--would the FDA even allow you to compare an approved drug with an unapproved drug?" I pointed out that the FDA, in fact, requires that drugs be compared with placebo, the ultimate in "unapproved" drugs, and that they deem this ethical enough.

He tried another tack. "What are the symptoms of bipolar depression that you have the hardest time treating?" I said that all the symptoms are hard to treat--that, in fact, bipolar depression is a very difficult illness to treat. Out came his computer, with a slide showing that Seroquel successfully treated every one of the depressive symptoms in one study. "Now doctor, if you had a patient come into your office with suicidal ideation, and you had an agent that would help those symptoms in a week, wouldn't you want to use that agent?"

Of course I would, and there are many other agents that will work better than placebo in a week. But my rep wasn't interested in talking about the alternatives. The focus, as always, was on his product, and on his bonus.

I've printed out the National Physicians Alliance's brochure, "Why Doesn't My Doctor See Drug Reps?" and will put it in my waiting room. I'll let you know how my patients respond. For now, I'm still accepting samples (making me the most despised of doctors among drug reps, a "sample-grabber") but that will be the next to go.

Monday, April 7, 2008

Wyeth Reps Trash Pristiq

Read this message board over at Cafe Pharma for an interesting though rather alarming thread about Wyeth's newly approved antidepressant, Pristiq. Cafe Pharma is a site frequented by drug reps, although because postings are anonymous, one never knows whether a given comment is actually from a rep or from an outsider with an agenda. Nonetheless, this particular thread sounds real, because it involves Wyeth reps grousing about upcoming layoffs (layoffs which the company has, in fact, announced) and about the new Pristiq sales force tag line: "People, Passion, Performance...Pristiq!"

Here is one rep's snide take on his company's upcoming campaign:

"PEOPLE - 1/2 of you will be gone in less than 27 days

PASSION - There is no passion now, but for those that remain with Wyeth, we will bribe the passion out of you by taking you to Vegas for 4 days.

PERFORMANCE - You thought it was hard to reach your performance incentive before? Wait until 2nd quarter

PRISTIQ - Good luck selling both Effexor XR and Pristiq at the same time. So Dr., would you like to hear about my antidepressant that has been around for 12 years, with proven efficacy with the ability to titrate the dose as need to better care for each patient's needs that will have generic competition in 4 months, or would you like to hear about my brand new antidepressant with one dose, less indications and less evidence of efficacy? You want me to choose, let me check with my bonus plan to see which one pays more."

If this is the typical attitude within the Pristiq sales force, Wyeth may end up a little shy of the blockbuster they were hoping for!

Friday, April 4, 2008

The Unbranded Doctor

The National Physician's Alliance (NPA) just announced the kick off of its "Unbranded Doctor" campaign. For those who have never heard of the organization, the NPA is to the AMA (the American Medical Association) as the Prius is to the Ford Explorer--namely, a progressive group of relatively young doctors who are more concerned with ethics and patient care than with ensuring a fat income stream. I am a proud card-carrying member, and I urge you to join as well.

The Unbranded Doctor campaign is a godsend for physicians who are eager to make their offices drug rep-free and sample-free, but would like some logistical help and moral support. After all, nobody wants to be impolite to drug reps, who are by nature friendly and convivial. And how do you break it to patients that there will be no more drug company pamphlets around, not to mention not-truly-free samples?

The website offers downloadable brochures to keep in your waiting room, such as "Why is my doctor restricting the use of promotional samples?" and "Why doesn't my doctor see drug reps? Information for patients." Even more fun, there is an Unbranded Doctor Store, where you can purchase buttons with choice slogans like, "Data, not doughnuts" and "Lower your cholesterol, say NO to drug lunches!" While you're there, don't forget to pick up some unbranded t-shirts, sweat-shirts, coffee mugs, mouse pads, bibs, tote bags, journals, and clocks. They make great gifts for drug reps!

Wednesday, April 2, 2008

The Wall of Commercial Bias Keeps Crumbling Down

It's rare for an industry-friendly magazine like Medical Meetings to feature an article opposed to commercially-sponsored CME. And rarer still for the editor-in-chief to preface the issue with an editorial in support of this position. But we are seeing a historic sea change in public opinion, and the unpredictable is becoming commonplace.

First, read Tamar Hosansky's editorial, Fast-Track CME Reform. In it, she discusses the recent annual conference of the Alliance for CME, a trade group that supports commercial CME. After mentioning another trade group's announcement that it will start collecting data to audit bias in commercial CME (calling all hens--leave henhouse immediately!), Hosansky states her own opinion: "First, I believe the move toward curtailing commercial support is inevitable." Hardly naive, Hosansky appreciates "CME providers' reluctance to limit funding. But it's only by making fundamental changes to the financial and accreditation enforcement models that the CME community will begin to establish its credibility and reduce the threat of government regulation."

But the jewel of this issue comes later on, in Donna Beales' article entitled "5 Steps to Building Real Firewalls." Beales is the CME Coordinator at Lowell General Hospital in Massachusetts. It's unusual for a CME professional who stands to benefit from industry funding to take such a strong ethical stance. Or, as Upton Sinclair once said, "It is difficult to get a man to understand something when his job depends on not understanding it."

Beales argues, among other things, that physicians with commercial interests should be ineligible to present CME programs. I'll quote at length from this part of her article, but please go to the original to read the whole thing (I have bolded some passages in the second paragraph; the bolding in the third paragraph is in the original text).

"Increasingly, it's becoming a standard across all industries to disclose commercial interests. On most boards, if an individual has any conflicts, it's expected that he or she will be recused from voting on any issues that might involve personal gain.

Choosing to be a physician is a noble calling. Choosing to be a drug company representative may have lucrative financial returns for a doctor who is burned out with medical practice. Both are free enterprises. It's time to choose between one or the other — teaching, or hawking. They are not one and the same. In fact, education and enterprise are mutually exclusive. It's time for doctors to get back to the business of doctoring, and for those with aspirations toward the world of commerce to depart the profession for greener pastures.

If we're worried that we won't attract anyone to teach due to the lack of financial gain, then it's time to look at the whole structure of CME. No other educational program in the U.S. is free of charge to participants. Perhaps it's time to entertain the possibility that participants themselves should defray some of the increasing costs that will inevitably result from a real split between industry and medical education. Attorneys and accountants often pay for their own continuing education course work. If lawyers can afford to do it and bean counters can afford to do it, surely doctors can manage too."

Tuesday, April 1, 2008

Epocrates + iPhone = Cooler, Richer CME Bias

Epocrates is the premier PDA-based medical software, extremely popular with doctors because the basic version is free. Of course, in a world of no free lunches, Epocrates comes with its own price, namely various drug ads offered in the guise of "doc alert" messages. All in all, not a bad product, and I gave it a pretty good review in this past article in The Carlat Psychiatry Report.

Now that Apple has opened up the iPhone software to third party developers, Epocrates has created an iPhone version. Unfortunately, Epocrates' CEO, in a recent interview with Pharmaceutical Executive Magazine, has tilted the company's hand, and it's all about pharmaceutical CME/advertising. To quote from the article:

"It's getting harder for sales reps to meet with doctors, and we provide a tool to establish a relationship with a physician and deliver messaging," Kirk Loevner, chairman and CEO of Epocrates, told Pharm Exec on Monday. Programs such as Doc Alerts transmit key pharma studies or journal articles straight to a physician's device. With the iPhone, pharma companies can also create richer mobile continuing-ed programs, including video and graphics branded with pharma messaging.

The company's inspiration, Socrates, once said, "The unexamined life is not worth living." I'm sure he would have had some wise counsel for Kirk Loevner, new champion of pharma messaging.