Of Buzzing Bees and Direct-to-Consumer Drug Ads

Congress is scrutinizing direct-to-consumer drug marketing, and Allison Bass (author of a new book on the deceptive marketing of Paxil) posted this interesting entry on her new blog. Researchers at Duke University have listed cognitive techniques drug-makers use to distract them from comprehending all the pesky negative information that the FDA requires be disclosed. For example, in an ad for the allergy drug Nasonex, a distracting animated bee appears during the rapid fire recitation of side effects. But when the benefits of Nasonex are described, the bee hovers quietly.

In the past, I have supported DTC ads (see here) because I have felt the public health benefits may outweigh the problems with biased drug information. After reading about this new study, I may have to revise my position!

Is Pharmaceutical Promotion Protected by Free Speech?

Recently, the New England Journal of Medicine published this interesting Sounding Board article by Aaron S. Kesselheim and Jerry Avorn, both of whom are physicians at Brigham and Women’s Hospital and Harvard Medical School. They are leading proponents of efforts to limit the use of prescription data-mining, and assisted the state of New Hampshire in its ultimately unsuccessful efforts to ban the practice (see this article for some background on various legislative actions).

At issue is whether prescription data-mining and other promotional activities are considered “free speech” and thus protected by the First Amendment. This has been a major argument of the pharmaceutical industry in its ongoing litigation in several states that are considering bans.

The authors distinguish personal speech, which is strongly protected by the First Amendment, from commercial speech. Whereas any limitation on individual free speech requires that the government have a clear interest in limiting a particular person’s speech (a high legal standard that is rarely met), limitations on commercial speech are based on different standards. The main framework used by courts is called the “Central Hudson Test,” after a 1980 case in which a utility company sued New York State over regulation of their advertising.

Based on that case, courts now allow limitations on commercial speech if three conditions are met. First, the government must have a substantial interest in the issue (in the case of prescription data-mining, the government indeed has a substantial interest in the relevant issue, which is public health); second, the proposed regulation must directly advance those interests (banning data-mining reduces the potential for non-scientifically based physician prescribing behavior); and third, the proposed regulation must not be more extensive than necessary to achieve its goals (the New Hampshire courts ruled against the ban partly because it agreed with Pharma arguments that there are less restrictive ways to counteract drug company misinformation, such as programs to better educate doctors about evaluating promotional claims).

I found this a valuable article for understanding some of these issues. Happy reading!

The King of Industry Supplements and I

John Shelton, PhD, may well be one of the most influential people in the field of psychiatry—though he is not a psychiatrist, and you may never have heard of him. He is the publisher of the Journal of Clinical Psychiatry, and is thus, in my mind, both Dr. Jekyll and Mr. Hyde. Jekyll-wise, he produces an excellent journal, brimming with clinically relevant articles covering topics that front-line psychiatrists care about (as opposed to, for example, Archives of General Psychiatry, which is filled with basic science articles).

But in his Mr. Hyde persona, he publishes dozens of industry-supported CME Supplements, each of which is an advertisement for a product marketed by the sponsoring company. I’ve never been shy about criticizing these supplements (here), and nor have other critics (here).

As I walked by the J Clin Psych booth at the APA meeting earlier this week, I saw Dr. Shelton in the flesh, and went up to him and introduced myself. He is a slim gregarious man with white hair and a ready smile, but when he looked at my name tag, he frowned. “The blogger!” he exclaimed. “There he is.” Surprised that he knew me right off the bat, I was a little flustered, and said, “Yep, that’s me….and I wanted to thank you for accepting my letter.” (I was referring to a soon-to-be-published letter in which I complain about bias in this recent BMS-funded supplement). “Look,” he said, “we put your letter through our review process, which is what we do for all our articles.”

The conversation was brief but cordial. I reiterated that I have no problem with the main journal but that the supplements appear to be promotional, almost without exception. He and Jane Eckstein, who is the director of their CME operation, maintained that the content is developed completely independently of drug company input. This is the standard bone of contention between those on different sides of the commercial CME divide, and both arguments are predictable, so I didn’t tarry long at the booth.

As I left, I realized that it all depends on what you define as “bias.” If you define it as inaccurate information, then Shelton and Eckstein are correct, since their supplements are carefully vetted for accuracy. But if you define it as manipulating the choice of accurate information to serve a promotional objective, then Team JCP is guilty as charged, since each supplement covers a topic of commercial benefit to the sponsor, and information is chosen to highlight advantages of the sponsor’s product.

To argue that the information is accurate and helpful to readers is not relevant. The information in drug ads is also accurate (the FDA makes certain of that) but nobody would argue that they are not also promotional.

Dr. Shelton mentioned that commercial CME covers important off-label uses, which FDA forbids companies to discuss (although recent guidelines may change this). But, in fact, doctors who don’t participate in industry CME are also free to teach about off-label uses, and they do so, frequently.

The debate will continue. And while I believe that you are doing the wrong thing, Dr. Shelton, I applaud you for being willing to engage with the “enemy”!

More APA Notes: Conversations with the "Enemy"

About 20,000 psychiatrists attend the APA annual meeting, and as you wander around the convention center, you bump into people you wouldn't ordinarily be rubbing shoulders with. Even people you might go out of your way not to rub shoulders with. This is a good thing, because you find out quickly that your "enemy" is no monster, but a person just like you. And possibly not an enemy at all.

Two examples from the 2008 meeting stand out; I'll describe one today and one tomorrow.

As I was browsing the publisher's exhibit area, I saw Stephen Stahl at the Cambridge University Press booth, signing copies of the latest edition of his immensely popular textbook, Essential Psychopharmacology. Apart from being a prolific author, Stahl is the head of NEI (Neuroscience Education Institute), a medical education company specializing in industry-funded CME. I mentioned him in this prior post, when I put him in the company of Charles Nemeroff as one of the more industry-conflicted psychiatrists in the profession.

Well, I went up to him and introduced myself, and we got talking about industry influence in psychiatry. "We're moving away from pharma funding," he said. For example, he said that he plans to stop participating in industry-supported symposia. "I consult with industry," he said, "and so I shouldn't be doing these symposia." I told him that I was on an APA work group tasked with adapting to future loss of industry funding. I asked him how he thought the organization would manage. "We're not going to make as much money," he said, "and maybe we shouldn't. Sometimes we just have to do the right thing."

I was impressed. But it was ironic that our short conversation was just then interrupted by a Pfizer employee asking him to sign her copy of his book. "We'll be seeing you tonight, Dr. Stahl," she said graciously. I don't know what event she was referring to, but I do know that the Pfizer was giving away his book at their display in the exhibit hall, and had scheduled him to sign copies for the dozens of psychiatrists happy to stand in line for a freeby.

Nonetheless, I believed Dr. Stahl was sincere in his plans to reduce his spigot of industry money, and I hope that we'll start seeing changes in NEI's business model over the coming year.

Tomorrow: Close encounters with John Shelton, publisher of Journal of Clinical Psychiatry.

Notes from the APA Meeting

Here I am at the No Free Lunch booth in the Exhibit Hall of the annual meeting of the American Psychiatric Association. The Pristiq coffee lounge is buzzing with caffeine-seeking psychiatrists a few yards away. Beyond that, a quarter mile of exhibits, small and large, some from drug companies, publishing companies, software companies, and physician placement firms.

We offer a No Free Lunch Pen Amnesty program, in which doctors can exhange their drug company pens for our No Free Lunch pens.

Hundreds of psychiatrists have strolled by, amused and intrigued. Many are skeptical, believing that lunches and pens do not influence their prescribing habits. Others tell stories about having prescribed Invega after the Risperdal rep came by and later wondering why on earth they did so. Another doctor said that, as an intern, he prescribed nothing but Zoloft because the Pfizer rep got to him before the other reps.

These are great discussions, often coming back to the question of "so what?" Are patients actually harmed by drug company gifting? These are difficult questions. My own feeling is that patients want me to make my prescribing decisions based on scientific grounds, and not based on the giving of gifts. I don't need the gifts, and I can get much more reliable information about drugs by reviewing the journals checking internet websites.

Time to sign off--the exhibit hall just closed, and they are turning the lights on and off. More stories later this week!

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.

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, many 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.