Monday, December 22, 2008

Current Psychiatry CME: Looks like an Ad, Smells like an Ad...Yep, It's an Ad

In Dr. Goldberg’s response to my “Guess the CME Sponsor” parlor game, he is defending the accuracy and balance of his article. However, I never questioned the accuracy of the Current Psychiatry supplement.

The supplement is both accurate and is a veiled advertisement for the use of Seroquel in the treatment of bipolar depression.

Commercial bias and accuracy of content make excellent bedfellows, because accurate and academic presentations of material give the articles exactly the aura of legitimacy that the sponsor is purchasing.

The Current Psychiatry supplement was entitled “Diagnosing and Managing Psychotic and Mood Disorders,” which is an extremely broad topic. There are hundreds of approaches one might use in covering the topic.

For example, one could focus specifically on depression with psychotic features, in which you’d emphasize the overall superiority of ECT, while also covering a variety of combinations of antidepressants and antipsychotics.

You could focus on treating mood problems as they arise in schizophrenia, most commonly depression and suicidal ideation. Such an article (here is one example) would focus primarily on antidepressants.

You could focus on treating psychosis in patients with risk factors for cardiovascular disease, in which case you would talk about Abilify over and over again, as happened in this recent CME supplement sponsored by Bristol-Myers Squibb, and published by the Journal of Clinical Psychiatry.

You could focus on the treatment of acute mania, in which case you’d pretty much have to give equal airtime to all the atypicals and the mood stabilizers.

But, in 3 of the 4 cases presented, Dr. Goldberg and colleagues chose to focus their attention on the treatment of acute bipolar depression. It just so happens that Seroquel is one of two treatments FDA-approved for bipolar depression. It just so happens that AstraZeneca funded the supplement.

Of course, the “it just so happens” part is the core of the problem. There was nothing random about it. The authors knew exactly who was funding the supplement, and they chose to highlight the advantages of Seroquel because of this.

If you take great care in choosing the topic, you can always find one that will inevitably highlight the sponsor’s product. This is fine, as long as it is clear to the readers that it is a promotional activity. For example, on the website, there is plenty of accurate information about the advantages of Seroquel for bipolar disorder, including a case study similar to the cases presented in this supplement. This is an excellent source of information for those interested in learning about patients for whom Seroquel is helpful. But it’s an advertisement, festooned with Seroquel logos. It is transparent, and it is honest.

The Current Psychiatry supplement is neither transparent nor honest, because it holds itself out as being accredited Category 1 CME. ACCME criteria are explicit that accredited CME cannot be crafted in order to endorse the sponsor’s product. Specifically, this supplement violates Standard 5.1 of the ACCME’s Standards for Commercial Support, which states: “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.”

This is the point in the debate where defenders of commercial CME will argue that this not conflict of interest, but rather “convergence” of interests. AstraZeneca gains by showcasing Seroquel, and the physicians gain by learning about a good treatment. But this is called advertisement and promotion, not CME. If the Current Psychiatry supplement had been preceded by the statement, "The following is a product advertisement funded by AstraZeneca," there would be no controversy about it at all.

Getting the ACCME seal of approval is supposed to mean something. It means that the educators have one single agenda in mind: helping physicians sort through the complexities of diagnosis and treatment in order to do the right thing by their patients. The Current Psychiatry supplement, however, was written with two agendas: educating practitioners and selling Seroquel.

Saturday, December 20, 2008

Dr. Joseph Goldberg Responds to our Critique of Current Psychiatry CME Supplement

Note: I just received this e-mail from Dr. Joseph Goldberg, in response to our recent critique of this AstraZeneca funded supplement of the journal Current Psychiatry. With Dr. Goldberg's permission, I am printing his letter below in its entirety. I'll comment on it when I get a chance, most likely early next week.

Dear Dr. Carlat,

Your distillation of our comments in the case presentations of our recent Current Psychiatry supplement implies that the authors' goal was to motivate clinicians to diagnose more bipolar disorder and then use a medication manufactured by the sponsor of the CME. For the sake of fair balance to your readers, you might mention our findings published elsewhere that community practitioners fail to utilize DSM-IV criteria when diagnosing bipolar disorder, and consequently over-diagnose it in as many as 2 of 3 patients with mood instability and substance abuse (Goldberg et al., J Clin Psychiatry 69: 1751-1757, 2008); in such over-diagnosed patients, mood stabilizers appear far over-used to the exclusion of rigorous substance abuse treatment. But in patients WITH DSM-IV bipolar disorder, suicide risk is significantly higher, and use of unstudied drugs or medications with negative data may lead to disastrous outcomes.

Part of our goal in these case discussions was to review the differential diagnosis of bipolar disorder. Psychiatric medications work better when the diagnosis is correct, but often fail when it is not. Your comments fail to discuss the importance of correct diagnosis, differential diagnosis, and evidence-based (i.e., well-studied) therapeutics, as expressed in our supplement.

When a diagnosis of bipolar disorder IS correct, unfortunately, few medications have robust effects. In the case of bipolar depression, for example, the controlled trial literature has far more negative than positive studies (e.g., antidepressants + mood stabilizers are no better than mood stabilizers alone [Sachs et al., NEJM 2007; 356: 1711-1722); aripiprazole is no better than placebo (Thase et al., J Clin Psychopharm 2008; 28: 13-20); lamotrigine has 4 negative placebo-controlled studies (Calabrese et al., Bipolar Disord 2008; 10: 3; 10: 323-333)). For better or worse, quetiapine and Symbiax are the only psychotropics that have demonstrated efficacy for acute bipolar depression. The academic community would greatly welcome CME-sponsorship by more organizations, but most studied agents are now either off-patent (e.g., lithium, divalproex, lamotrigine), lack FDA indications due to negative findings (e.g., divalproex for maintenance; oxcarbazepine for acute mania (Wagner et al., Am J Psychiatry 163: 1179-1186, 2006); topiramate for acute mania (Kushner et al., Bipolar Disord 8: 15-27, 2006); or lack any data (e.g., ziprasidone or risperidone for bipolar maintenance). Our case discussion reflects this literature, but yours does not. Readers deserve a more fair-balanced critique of our summary than the one you provide.

-- Joseph Goldberg MD,
Assoc. Clin. Professor of Psychiatry, Mount Sinai School of Medicine;
Deputy Editor, Current Psychiatry

Thursday, December 18, 2008

Nemeroff’s Effexor Love-Fest: It’s CME-Like!

According to the Wall Street Journal Health Blog, in 2000 Dr. Charles Nemeroff organized a Wyeth-funded supplement of a journal which he also edits, Depression and Anxiety, paying himself and 13 other academics $3000 each. This money was disbursed from an “unrestricted educational grant” given to Emory by Wyeth. The fact that the supplement was paid for by Wyeth was, unfortunately, not disclosed to the readers.

Also from the Wall Street Journal, we learn here that Emory’s defense of Nemeroff’s undisclosed hundreds of thousands from GSK is that some of the payments were not for promotional talks, but for “CME-like” talks.

Nobody seems to have an inkling what "CME-like" means. But after reading through Nemeroff's Effexor Love-fest supplement, I'm getting an idea.

Here is how Dr. Nemeroff introduces the supplement:

“There is little doubt that the introduction of venlafaxine has had a remarkable impact on clinical practice. I have had more than 25 patients who have failed multiple trials with virtually all of the antidepressants available who have responded to venlafaxine often with complete remission.”

And here are some random phrases culled from the abstracts of the 13 other CME-like articles, done up in Wyeth's green and purple Effexor color scheme:

Venlafaxine is a unique antidepressant medication with well documented efficacy and safety in the acute treatment of major depressive disorder

easy to monitor and dose

may also be effective in the treatment of dysthymic disorder and bipolar II depression

facilitate successful treatment of patients.

low potential for drug interactions

appropriate first-line medication for GAD

may be particularly effective for the severely ill

good tolerability

may be effective for conditions such as stroke, anxiety, and neuropathic pain

may be useful in children and adolescents with a variety of psychiatric disorders

effective in reducing anxiety in patients with depression several other conditions including panic disorder, social anxiety disorder, obsessive compulsive disorder, trichotillomania, ADHD, chronic pain, and fibromyalgia

an attractive choice for geriatric patients

So here is a working definition of CME-like:

--Too academic-sounding to be an advertisement

--Too commercially biased to be CME's CME-like!

Tuesday, December 16, 2008

Current Psychiatry: Guess the CME Sponsor!

Yes, it’s time for your favorite game show, Guess the CME Sponsor.

Today, we have a special treat for you, a supplement from Current Psychiatry, entitled “Diagnosing and Managing Psychotic and Mood Disorders.” It is accessible online here

The rules of this game are simple: No peeking to see which drug company has paid for the preparation of the supplement (so skip page 2).

Let’s start, shall we?

This supplement is composed of four case studies. As we know from past experience, medical education communication companies (MECCs) increasingly use case studies to communicate a marketing message in CME. Medscape did this so blatantly once that BusinessWeek published an article about it.

Both Medscape and Dowden Health Media (publisher of Current Psychiatry) love to use cases because they offer so many avenues for promoting the sponsor’s drug. There are usually three phases of promotion:

Phase 1: The case begins with a patient doing poorly on medications. This “bad” medication regimen is strategically chosen by the MECC to cast competitors in a poor light.

Phase 2: The “faculty” members (most or all of whom are consultants or speakers for the sponsoring drug company) then discuss the case, ostensibly in order to come up with ideas for how to improve the patient’s treatment. Here, the MECC can choose to highlight themes to accentuate advantages of the sponsor’s drug and shortcomings of competitors.

Phase 3: Finally, there is a dramatic denouement, in which the faculty decides on a better medication regimen. Obviously, MECCs will ensure that the rescue regimen incorporates the sponsor’s drug. If they are good at gaming this system, they will try not to make this blatantly obvious. As we’ll see below, Dowden Health Media has a lot to learn about subtlety.

Case 1: Treatment-resistant psychosis and schizophrenia

1. Initial unsuccessful medication regimen: Risperdal Consta, haloperidol decanoate, valproic acid.

2. Faculty discussion:
--Is the patient’s diagnosis of schizophrenia accurate? The faculty decides that the patient may actually have either schizoaffective disorder or bipolar disorder.
--They discuss the bad side effects of first generation antipsychotics, such as EPS.

3. Rescue medications: Start clozapine, stop haloperidol, and increase Risperdal Consta.

Comment: Janssen’s Risperdal Consta jumps out at us, because the rescue regimen involves increasing the dose as well as starting clozapine. However, it would be hard to imagine Janssen being happy about a case in which a patient starts by doing poorly on their medication. The faculty dwells on disadvantages of older antipsychotics, seemingly in order to lay the groundwork for the promotion of one of the atypicals, but at this point, we don’t know which one they will favor. Clozapine is available as a generic, so is not sponsorable. At this point, the only thing we can be fairly certain of is that Janssen is not the sponsor of the supplement.

Case 2: Psychosis with bipolar mania

1. Initial unsuccessful regimen: Risperdal and valproic acid; Risperdal was stopped because it wasn’t working, the patient was switched to Zyprexa, which helped a bit but caused 18 pounds of weight gain in one month.

2. Faculty discussion:
--The patient was initially misdiagnosed with ADHD and depression, but actually had bipolar disorder; initial use of stimulants may have precipitated a manic episode. (The message here is: “Diagnose more bipolar disorder.” This is a common industry CME tactic, in which experts harp on how the diagnosis for which the sponsor makes a drug is often missed. After all, the sponsor can’t make money unless the condition is liberally diagnosed.)
--Zyprexa is bad. To quote Dr. Pariser: “Olanzapine is a very effective atypical antipsychotic, but weight gain is a major concern for many patients receiving this drug as well as clozapine. I have observed that many patients who gain weight tend to go off the medication, and those who do may not always admit that they are nonadherent.”

3. Rescue regimen: Lamictal, topiramate, and an un-named medication that Dr. Goldberg coyly describes in these terms: “another atypical antipsychotic with a somewhat lower risk of metabolic side effects, relative to olanzapine, as well as an indication for treating bipolar depression to help lower the risk of suicide in this high-risk patient.” Which medication might Dr. Goldberg be referring to? Well, there are only two FDA-approved medications for bipolar depression: Symbyax (Zyprexa combined with Prozac), and Seroquel. Since he specifies that the best choice would not be Zyprexa, he must be referring to Seroquel.

Comment: The sponsor sure ain’t Eli Lilly. Any MECC that would take CME money from Lilly and then feature a case in which Zyprexa caused an astonishing 18 pounds of weight gain in one month would never see another dime from Lilly again.

While lamotrigine and topiramate were part of the rescue regimen, they are both generic, so unsponsorable. The rescue antipsychotic was Seroquel, so after two cases, my best guess is that the sponsor is AstraZeneca, maker of Seroquel.

Case 3: Bipolar depression and anxiety

1. Initial unsuccessful regimen: Effexor XR and clonazepam

2. Faculty discussion:
--Patient was misdiagnosed with depression; actually had bipolar disorder and OCD (diagnose more bipolar!)
--It can be difficult treating bipolar disorder when combined with anxiety. But Seroquel may actually be a good choice for both! To quote Dr. Goldberg: “Given data from studies of generalized anxiety disorder and quetiapine’s ability to reduce anxiety symptoms in the context of depression, using this drug alone might be safer than augmenting with sertraline and be just as effective as the combination.”
3. Rescue regimen: Seroquel, lamotrigine, and sertraline.

Comment: Looks like the MECC is pushing Seroquel for anxiety in anticipation of a possible indication for generalized anxiety disorder.
Both lamotrigine and sertraline are generic and unsponsorable.

Case 4: Depression and anxiety: Distinguishing unipolar and bipolar disorders

1. Initial unsuccessful regimen: Sertraline, then Effexor XR.

2. Faculty discussion:
--Yet another patient with bipolar disorder misdiagnosed with depression—I guess there’s an epidemic of this. Funny how the faculty neglects to cover the evidence indicating that bipolar disorder may now be over-diagnosed.

3. Rescue regimen: Seroquel and lamotrigine.

Comment: C’mon guys, Seroquel again? Would it kill you to be subtle?


Let’s go through the possible sponsors.

Janssen: No, because Invega was not mentioned, and in one case, Risperdal Consta was ineffective at the starting dose.

Eli Lilly: No, because Zyprexa was never used as a rescue medication, and one of the cases featured the worst example of Zyprexa-induced weight gain that I have heard of.

Pfizer: No, because Geodon is never a used as a rescue medication.

Bristol-Myers Squibb: No, because Abilify is hardly mentioned at all.

My guess is that the sponsor is AstraZeneca, because in three out of the four cases, Seroquel is the linchpin of the rescue regimen.

Now for the fun part. Go back to the supplement, turn to page 2, and you’ll find that the sponsor is………AstraZeneca, maker of Seroquel.

Winners receive a lifetime supply of Seroquel. We are not responsible for fatalities, injuries, or loss of employment due to the sedation and weight gain caused by Seroquel. Employees of AstraZeneca and Dowden Health Media are not eligible for participation in this contest.

Thursday, December 11, 2008

Massachusetts Disclosure Loophole: "Let's Keep Research Payments Secret"

In August of this year, Governor Deval Patrick signed into law a historic bill limiting drug company payments to doctors and requiring disclosure of any other payments. The pharmaceutical industry battled the law tooth and nail before their defeat. At one point, GlaxoSmithKline actually blackmailed the state, saying it would stop doing business in Massachusetts if the law were passed.

Now that it is law, the companies are back at their shenanigans, trying to water down the official regulations that the Department of Public Health will use to enforce the bill. And they've been quite successful. As covered in today's Boston Herald, the proposed regulations do not require that companies disclose research payments to doctors.

According to John Auerbach, the public health commissioner, the regulations were written this way for fear that forcing disclosure of such payments would keep clinical trials out of the state. Wait a minute--this sounds exactly like the bogus industry arguments that failed to prevent the bill from passing in the first place!

The fact is that doctors are paid millions to conduct research studies, and we have a right to know this information. If there is truly nothing wrong with doing research with industry (and I agree with this), why should the money remain hidden?

The companies argue that publishing this information gives their competitors information about their research plans. The problem with this argument is that information about clinical trials is already publically available on an
online registry of clinical trials. Beginning in 2005, the International Committee of Medical Journal Editors announced that they would only consider for publication research that was posted on this registry, in order to prevent the problem of publication bias. There are currently 65,825 trials registered. So if you are Pfizer, and you want to know what kind of research Eli Lilly is conducting, the answer is only a few clicks away.

It's time for the Department of Public Health to stop meeting with drug company lobbyists and to start writing regulations that reflect the will of the people.

Wednesday, December 10, 2008

It’s Not About Goodwin. It’s About Disclosure.

The Frederick Goodwin/Infinite Mind case has become one of the defining controversies for a crucially important health policy issue. Some of us have become hot-headed in our comments, largely because this is something we feel so passionately about. So, in this post, I’ll be keeping my cool, and will pluck some of the significant issues from the morass of accusations into which this debate has degenerated.

1. This is a debate about disclosure of potential conflicts of interest, and not a debate about Dr. Goodwin’s scientific views or his academic integrity.

Let’s not get sidetracked into a discussion of whether antidepressants do or do not cause suicidality. On "Prozac Nation Revisited," it was clear that Dr. Goodwin and his guests believed that this danger has been exaggerated. I happen to agree. But that’s not the issue here.

Nor is this about Dr. Goodwin’s scientific work over the years, which has been excellent. His writings have always struck me as scientifically fair and balanced, including his industry-sponsored CME articles, which is a tall order, given how difficult it is to keep MECCs from sweetening CME with pro-sponsor messages.

No, this debate is specifically about how, when, and where academics should disclose potential conflicts of interest with the pharmaceutical industry. And I believe that "The Infinite Mind" should have disclosed to the listeners, at the beginning of each program, all potential conflicts of interests relevant to the topic of that program.

2. I do not believe that the mere disclosure of conflicts of interest is an admission of “guilt” or “bias,” but audience-members need to be informed so they can judge for themselves.

If an academic takes money from the drug industry and then educates physicians or the public about drugs, this is, inherently, a potential conflict of interest. Here is the conflict: on one hand, the speaker has an interest in providing accurate, useful, and unbiased information to the audience. But on the other hand, the speaker has an interest in maintaining the flow of money from the company, and companies are paying out the money to improve sales.

Speakers with such conflicts may do one of three things. First, they may knowingly bias the talk in favor of the sponsor’s drug. Second, they may unconsciously bias the presentation. Or third, they may not bias the talk in any way at all.

The audience has no way of knowing what goes on in the mind of the speaker, so they have no way of knowing whether they can trust what he or she has to say. In my opinion, the best way to resolve this problem is for doctors to stop accepting money from drug companies for promotional activities. However, at a minimum, listeners needs to know what the potential conflicts are, so they can be on the alert for potential bias.

3. Many have pointed out that “we all have biases,” so why focus on those related to drug company payments?

Yes, many forces and experiences influence our opinions. As a psychiatrist, for example, I might choose drug X over drug Y because:

--A relative did well on drug X.
--A relative did poorly on drug Y.
--I don’t like company Y’s marketing practices.
--I publish a newsletter, and my readers enjoy hearing me criticize drug Y.
--I’ve made $1 million doing promotional talks for drug X, and I’d like to make another million (I haven’t!).
--I’ve done 10 years of research on drug X’s mechanism of action, and if I get one more paper into New England Journal of Medicine I’ll be promoted to full professor.

And so on. There are innumerable sources of potential bias, and we should disclose those that are most clearly identifiable. In my opinion, financial conflicts are the easiest to identify, and also the easiest to resolve. I can choose not to take the money, but I cannot choose to change the fact that a relative did poorly on drug Y, or that I have staked my career on drug X, etc….

This is why we focus on financial conflicts of interest.

4. Finally, this is not about whether Senator Grassley, Senator Kohl, or the New York Times are trying to destroy psychiatry as a profession.

Most of the targets of Grassley’s investigation have been psychiatrists. Some have been cardiologists, and some have been orthopedists.

Psychiatrists have been particularly targeted because, at least in two of the states where drug companies are compelled to disclose payments to physicians, psychiatrists have topped the list. As a profession, I believe psychiatrists are the most vulnerable to the blandishments of the pharmaceutical industry, for various reasons.

First, we psychiatrists make less money than most other medical specialties, and want to supplement our income with drug company money. Second, psychiatrists, by abandoning psychotherapy to those “lower” on the pecking order, such as social workers and psychologists, have painted ourselves into a corner in which all we do is prescribe drugs. Thus, we are exquisitely dependent on information on pharmaceuticals, information which is usually funded by drug companies. Finally, we have a chip on our shoulders in relation to the rest of medicine. Are we “real” doctors? Are we as “good” or as “scientific” as our colleagues in other specialties? Psychiatrists obsess about such questions. Working closely with the pharmaceutical industry makes us feel valued, scientific, and powerful.

Let’s keep the focus where it belongs.

Friday, December 5, 2008

Open Letter to Dr. Frederick Goodwin

Dear Dr. Goodwin,

Thank you for taking the time to respond to my blog postings regarding this unfortunate disclosure controversy.

I’ll start by apologizing for the single false statement I made: “the segment itself was partially funded by Pfizer, maker of Zoloft.” I got that wrong. Pfizer did not fund that particular segment, but it has, indeed, been one of the underwriters of The Infinite Mind. According to the producer's website, many other drug companies have funded the program, including Eli Lilly, Abbott Laboratories, Scios, Searle, Janssen, and Solvay. According to an email from Bill Lichtenstein, the last drug company grant the show received was in 2005.

However, I stand by all my other statements. Regardless of who actually invited the guests, chose the topic, or suggested questions, you were ultimately responsible for what was said. You were there behind the microphone, asking questions, making comments, and steering the discussion.

While you appear to blame Mr. Lichtenstein for the show’s failings, saying that he put it together “in a hurry,” in fact Mr. Lichtenstein tells me that he did not produce this segment at all, and had hired a freelance producer to coordinate it.

You also blame Mr. Lichtenstein for the fact that Peter Pitt’s PR work for drug companies was not disclosed. However, you are on the board of directors of Center for Medicine in the Public Interest (CMPI), a pro-industry front group which receives a majority of its income from drug companies. Peter Pitts happens to be the president and co-founder of this same organization. How could you have not known of his financial relationships with the pharmaceutical industry? And assuming you did know, how could you have not made certain that this was disclosed to listeners?

You state that I am “damaging the reputation of distinguished academic scholars such as a professor at UCLA.” I assume you are referring to Andrew Leuchter
, a professor of psychiatry at UCLA who was one of the guests on the Prozac Nation: Revisited show. In fact, I said nothing to damage his reputation. Dr. Leuchter is a brilliant researcher who I once interviewed for an article on the uses of EEG in psychiatric practice. He takes money from pharmaceutical companies for research on antidepressants, which he discloses on his website. There’s nothing wrong with that. But this information should have been disclosed to listeners—not to discredit him, but to alert listeners that these financial relationships might (or might not) have influenced his opinions about the dangers of antidepressants.

To conclude, I’m hoping that you and your supporters, such as John McManamy , will stop blaming everybody else for this mess. Don’t blame the New York Times—they were merely reporting the facts. Don’t blame scientologists—they haven’t even participated in this discussion. Don’t blame Bill Lichtenstein, Gardiner Harris, Charles Grassley, Slate Magazine, Shannon Brownlee, Jeanne Lenzer, or even Daniel Carlat.

This entire fiasco could have been averted if you had chosen to inform NPR listeners of your financial conflicts of interests at the beginning of shows focusing on pharmaceuticals.

Daniel Carlat, M.D.

Thursday, December 4, 2008

Dr. Frederick Goodwin Responds to Carlat

Frederick Goodwin, who has been under fire from various quarters for apparently failing to disclose pharmaceutical company income to the producer of The Infinite Mind, has responded to my postings about this issue in the comments section of this blog entry. I thought it was an important enough response to feature it as its own post. I print it below in its entirety, and I will respond to his concerns in a separate entry.

I was very saddened and disappointed to read Dr. Carlat’s post. While he and I may disagree on certain issues, I had always assumed that he adhered to minimum scholarly standards in his writings, standards that are expected of professionals with academic backgrounds.

While I was taken aback by the polemical over-the-top language from a colleague with whom I worked in a recent American Psychiatric Association symposium, e.g. “outrageous betrayal of the listeners trust,” I was most profoundly dismayed by statements that were simply not true. (And can easily be shown to be false.) For example, he said that “Goodwin brought together experts with clear financial interest in arguing for the drugs’ [SSRI’s] safety.” First, he ignored what I said in the statement that I had sent him before he posted this blog, namely, that the producer of the Infinite Mind, not the host, reserved for himself full responsibility for the selection of topics, selection of guests, preparation of the script, and even the questions to be asked.

If Dr. Carlat did not believe me, but still wanted to protect his own credibility, he easily could have checked this out with Mr. Lichtenstein, the show's producer, or I would have been happy to send him a copy of the contract which specifies the producer’s total control of content. The fact that he went ahead with his own version of reality, in the face of assertions to the contrary in his possession, (assertions which he apparently did not check out) is reminiscent of what the Times’ Gardiner Harris did in simply ignoring any reality that didn't fit his narrative.

(Incidentally the particular show that Dr. Carlat was discussing was put together in a hurry by Mr. Lichtenstein working alone because he wanted to get something on the air to reassure stations that he could still produce a new show now and then. I didn't even know who the guests were until I arrived at the studio and got the script that had been faxed directly to the radio station. Mr. Lichtenstein later acknowledged that he had not determined in advance that one of the guests was affiliated with a center getting funds from a pharmaceutical company. While this was not disclosed, as it should have been, it was an oversight by a vastly overworked producer. But that's a minor point.)

More damaging to Dr. Carlat's credibility is his loose throwing around of reckless charges referring to “experts with clear financial interests in arguing for the drugs’ [SSRI’s] safety.” Incidentally by referring to Zoloft in this context he seemed not to be aware that this drug has been available in a generic form for some time now. One would like to assume that the author of a pharmacology newsletter would be aware that once drugs become generic there is no further “promotion” by pharmaceutical companies and therefore no “clear financial interests” of anyone. His sweeping statement is more than naïve - it's recklessly damaging the reputation of distinguished academic scholars such as a professor at UCLA. Many of the readers of his blog may not understand how naïve it is to talk about “promotion” of a drug that's been off patent. Dr. Carlat must assume responsibility not only for misleading his readers, but also for recklessly and falsely damaging reputations. To use his phrase, “that's bad journalism.”

But he gets even more reckless. He asserts as fact that “ the segment itself was partially funded by Pfizer, the maker of Zoloft.” Where did he get this information? From a Scientology website? Unless Dr. Carlat can document this, he owes me, the Infinite Mind producer, the guests, and, especially his readers, an apology.

Dr. Carlat’s blog is, to use his own words, a “particularly outrageous betrayal of the [readers] trust,” readers who have a right to assume that his statements reflect the standards associated with professionals in academia.

Frederick K. Goodwin M. D.

Wednesday, December 3, 2008

Why Americans Hate Pharma Almost As Much as They Hate Oil Companies: The Case of Cephalon

Today, I'd like to introduce a guest posting by Harry Tracy, the writer and publisher of NeuroInvestment, a monthly online journal providing cutting edge of analysis of developments in the neurotherapeutics industry. Dr. Tracy often publishes essays evaluating the marketing tactics of the pharmaceutical industry, and in his current issue, he tackles the particularly unsavory price gouging strategy used by Cephalon in order to lay the groundwork for its newest me-too product, Nuvigil. I've published his essay below, by his generous permission.

It's not news that pharma companies try to 'switch' patients to a revamped version of a drug prior to the introduction of a generic competitor in order to pre-empt that advent. And it's not news that one of the levers available is to raise the price of the original drug, in order to shift patients to the revised edition. The assumption that they make is that prescribers are too busy to notice that the revamped drug may offer little value over the original version, and thus will keep patients on the new one even when the generic arrives, at lower cost. When a new version is genuinely better, as was the case for Adderall XR, the merit of the molecule drives the market, as it should. But as Adderall XR's patient life dwindled, Shire tried to repeat the trick with Vyvanse, whose superiority to Adderall XR is confined to slightly reduced abuse risk. They stated quite openly that, if necessary, they would raise Adderall XR's price to drive users to Vyvanse before the generic Adderall XR hit the market. We do not track Adderall XR's pricing, so we don't know to what degree Shire implemented that tactic.

But Shire possessed the subtlety of MI5 compared to Cephalon, whose SWAT-team pricing tactics for Provigil hit the Wall St. Journal on November 18. Cephalon has raised the per-tablet price for Provigil, now in billion-dollar per year revenue range, by 74% over the past four years (that's one way to get there), 24% in just the past year. And they are open about the fact that they are boosting Provigil's price in order to shift people to Nuvigil, which will not be available until 2009, (if then) and displays no significant advantages over its racemic forebear.

To summarize: In anticipation of generic competition in 2012, they are raising prices four years ahead. Since there really aren't any desirable alternatives to Provigil, they are gouging a captive audience.

Cephalon already has its picture up on the Post Office Wall as a perpetrator of the first order when it comes to regulatory reckless driving. Earlier this year, they paid a $444 million fine for violating rules on off-label marketing, which they brushed off as if it were just a traffic ticket. It's not as if it has not been obvious for years that Cephalon likes to skate on the thinnest edge of the law; when we pointed out just such an instance of skirting the rules in 2007, their response was to have their Legal Department send NI [Neuroinvestment, Dr. Tracy's journal] a letter of reprimand. If it was a threat, it was a hollow failure, since what they had done was in front of an audience of about two thousand.

NI has previously written of our disappointment with Cephalon's squandering of its potential: Greater contributions to medical care and ethical responsibility have been exchanged for hard-nosed marketing and incremental improvements. But this has implications beyond that, because of the times in which we live. Greed is no longer seen as being as good as it once seemed. The mercenary excesses of the banking industry have led to chaos in global macroeconomics, and scapegoats are welcome. Now, a new Administration is about to come to power in the US, with healthcare reform high on its agenda. Cephalon's strategy seems to be one of trying to stuff as much loot into their sack as they can before the vault door swings closed, much as some banking executives voted themselves bonuses as their corporate vessels began to founder. This is a policy of plunder which only provides ammunition to anyone who considers price controls to be a valid option for reining in healthcare expenses. Not that Cephalon is alone--the media is awash with reports of health risks concealed, benefits exaggerated. But this is another nail in the coffin of Pharma's public image.

Tuesday, December 2, 2008

More Frederick Goodwin Developments

There have been a few developments regarding The Infinite Mind scandal since yesterday. Pharmalot posted a statement from Dr. Goodwin rebutting the New York Times piece. This statement had originally been published on an APA listserv, and was apparently leaked to Pharmalot--though not by me. I wrote directly to Dr. Goodwin to ask him if this statement was actually his, and whether I could post it, and he wrote back saying that he would send me a shorter version of the statement, which I'll post when I receive it.

Meanwhile, NPR's show On the Media aired this interesting 8 minute segment on the issue, which is worth a listen, because it brings these issues into perspective. Specifically, the host David Folkenflik points out that NPR is by definition a source of unbiased news, being the only major radio network which does not accept advertising. Thus, for it to air a show hosted by a psychiatrist who did not disclose $1.3 million in industry payments was a particularly outrageous betrayal of the listeners' trust.

Finally, you must check out this elegant essay by Jonathan Leo, which deconstructs, quote by quote, the notorious "Prozac Nation Revisited" show, during which Goodwin interviewed guests who shared his belief that the antidepressant-suicide connection is overblown. As it turns out, I mostly agree with Goodwin on this issue, but that's irrelevant. Whether antidepressants cause suicidality is a controversial point, with very complicated data on both sides of the argument. Goodwin brought together experts with clear financial interests in arguing for the drugs' safety (Nada Stotland is an exception, since she was there representing the APA and has no current pharma ties). Furthermore, the segment itself was partially funded by Pfizer, maker of Zoloft. The point is that the public was offered only one side of the debate, without having been informed of the fact. That's bad journalism.

Goodwin has been arguing that his pharma ties were available to anybody who chose to Google him, but this doesn't meet basic journalistic standards. Listeners should be able to trust NPR, and should not feel the need to rush to the internet to check up on every expert featured. That's why we suffer through those pledge drives!

Monday, December 1, 2008

Biederman, Goodwin, Greed, Arrogance

Thanksgiving week was a busy one for revelations of greed among two of our top academics in psychiatry: Dr. Joseph Biederman and Dr. Frederick Goodwin.

Apparently, in 2002 Dr. Biederman solicited hundreds of thousands of dollars for a "Johnson & Johnson Center for the study of pediatric psychopathology." One of the publically stated goals of the center was to “move forward the commercial goals of J.& J.” I'm shocked, just shocked. Actually, this is not really as horrendous as it seems. Researchers like Biederman are always on the hunt for research funding. They prefer NIH funding, but that is increasingly scarce, so they hold out their hats to industry.

When you take research money from industry you are always making a deal with the devil. Your intentions are to produce serious research, but you know that your funders are not in the business of charity. They want to "move forward the commercial goals" of their companies, and you know that going in. Ideally, this represents a "confluence of interests," using buzz-phrase popular among advocates of academic-industry collaboration.

In theory, there's nothing inherently wrong with such collaborations, as long as the nature of the relationship is disclosed, and as long as the principal investigator takes great care to play by all the rules, both legal and ethical. Unfortunately, the New York Times article and a follow-up posting in Pharmalot imply that Biederman did not play by the rules. For example, Harvard and MGH rules stipulated that researchers doing company-funded trials are not allowed to get paid more than $10,000 in consulting or speaking income from the funding company. Biederman made much more than this and did not disclose it.

Basic ethical guidelines dictate that if a company doesn't pay you a requested grant, you should not respond by pressuring colleagues not to use that company's drug. But e-mails unearthed in court documents imply that Biederman did just that:

Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson rejected a request that Dr. Biederman had made for a $280,000 research grant. “I have never seen someone so angry,” Mr. Bruins wrote. “Since that time, our business became non-existant (sic) within his area of control.” Mr. Bruins concluded that unless Dr. Biederman received a check soon, “I am truly afraid of the consequences.”

Dr. Biederman comes across as petty and retaliatory. Is he also a brilliant, productive researcher who cares about children? Of course. But there is no excuse for this level of arrogance and greed.

Next up: Frederick Goodwin. Another brilliant, smart researcher who cares deeply about people with mental illness. He is former chief of NIMH, and co-writer of the major textbook on bipolar disorder.

He is also a passionate defender of the free enterprise system and an enemy of those who criticize the pharmaceutical industry. For example, he is on the board of directors of the rabidly pro-pharma organization, Center for Medicine in the Public Interest (CMPI), and has teamed up with its Vice President Robert Goldberg (not one to be tangled with--see this earlier slimefest on my blog) on articles such as this diatribe against Marcia Angell and Arnold Relman which is posted on the website of the conservative Manhattan Institute.

Okay, but so what? He's a conservative, I'm a liberal, this tent is big enough for both of us.

My main beef with Goodwin stems from his participation in a May 2007 symposium at the annual meeting of the American Psychiatric Association. The symposium was organized by my friend and colleague Nassir Ghaemi, and was entitled "Uneasy Partners: The Pharmaceutical Industry and the Psychiatric Profession." There were five speakers. Dr. Ghaemi reviewed the landscape of the controversies, I did a talk showing that 46/46 industry-sponsored symposia at the the 2006 meeting promoted a drug made by the sponsoring companies, David Healey discussed disease mongering, and both Howard Kushner and David Osser talked about the need for evidence-based medicine. Finally, Dr. Goodwin came to the podium as the "discussant," presumably to comment on our presentations.

But instead of discussing our talks, Goodwin decided to use Marcia Angell's book, The Truth about Drug Companies, as target practice. Angell was not on the program, and her book was only mentioned in passing by one of the presenters. But Goodwin seemed to despise her and her book. He went through her main points, rebutting them systematically, arguing that pharmaceutical companies are wonderful, that medications are very helpful, that there is nothing wrong with making money, and that drug companies are not as profitable as everybody thinks. Then, he went on a bizarre tangent about how one of the major networks is filled with scientologists.

I must say, I was amazed, dumbfounded, and profoundly embarrased for my profession. I had never met Goodwin before, but, like other psychiatrists, I revered him as a legend in the field. That all came crashing down as I watched him make a series of strident statements that were largely irrelevant to any of the points made during the symposium. He entertained the audience by being charismatic and at one point got a very cheap laugh by ridiculing the non-industry sponsored symposia at the meeting.

So when I heard about Goodwin's lack of disclosure regarding The Infinite Mind, I was not surprised--only saddened. He, and Biederman, and Nemeroff, and many other less well known hired guns are bringing the profession of psychiatry to its knees.

Tuesday, November 25, 2008

A Thanksgiving Break

Yes, there has been an embarrassment of riches in terms of revelations of pretty awful behavior on the part of some of psychiatry's key opinion leaders. Next week, after a Thanksgiving break, I will have plenty to report, including my impressions of Dr.
Frederick Goodwin based on his fairly outrageous comments during an APA symposium in which he and I were co-participants.

Until then--happy turkey day to all.

Friday, November 21, 2008

AMA's U-Turn on Industry Funding

As reported in Medical Meetings, the AMA's Council on Ethical and Judicial Affairs (CEJA) will reverse its earlier position, and will recommend that industry support of CME be allowed to continue. Just last May, CEJA had prepared this report urging the AMA to adopt a stance against allowing commercial support of CME, concluding that:

To promote continued innovation and improvement in patient care, medicine must sustain ongoing, productive relationships with the pharmaceutical, biotechnology, and medical device companies. However, industry support of professional education has raised concerns that threaten the integrity of medicine’s educational function....Existing mechanisms to manage potential conflicts and influences are not sufficient to address these concerns. Recognizing the profession-defining importance for medicine of achieving its educational goals, the Council recommends that:
Individual physicians and institutions of medicine, such as medical schools, teaching hospitals, and professional organizations (including state and medical specialty societies) must not accept industry funding to support professional education activities.

That report was debated in an AMA reference committee (a committee which debates issues before bringing them before the full house of delegates), and after hearing from a slew of medical education companies, the committee recommended tabling the proposal for further review. Since then, Dr. Mark Levine, the chairman of the committee, ended his term and was replaced by Dr. Regina Benjamin. Apparently, one of the committee members (not Dr. Benjamin) told journalist Dave Kovaleski that while the next version of the report will not be released until next June, an interim report makes it clear that industry funding will continue in some fashion or other. That's clear enough. But in a strange twist, CEJA is now calling for comments as they prepare the final report. They've already given us the punchline, and now they want input?

At any rate, it appears that CEJA is working on this report jointly with the AMA's Committee on CME, and this may explain why CEJA has changed its mind. The ethics of the issue have not changed over the last 6 months--after all, ethics rarely change at all. The core ethics of this issue were summarized in the original report's abstract thusly:

Medicine’s autonomy and authority to regulate itself depends on its ability to ensure that current and future generations of physicians acquire, maintain, and apply the values, knowledge, skills, and judgment essential for quality patient care. To fulfill this obligation, medicine must ensure that the values and core commitments of the profession protect the integrity of professional education.

In May, this ethical core struck CEJA as being inconsistent with industry funding of medical education. What appears to have happened is that ethics (CEJA) has married expediency (the CME Committee.) The final report will therefore be a moral compromise. This does not make me proud of my profession.

Thursday, November 20, 2008

FDA's Indictment of Psychiatric CME

As covered in the business section of Tuesday’s New York Times , an FDA advisory committee has accused the agency of doing too little to warn physicians about the dangers of prescribing newer antipsychotics to children.

The committee reviewed data showing that more than 389,000 children and teenagers were treated last year with Risperdal, the majority of them 12 years old or younger. Risperdal is one of five newer atypical antipsychotics, drugs which comprise the bulk of antipsychotic prescriptions to both adults and children in the U.S.

While the atypicals have been extravagantly profitable for drug companies, a series of recent studies have shown that they are no more effective than older generic antipsychotics, and that some incur a higher risk of weight gain and blood lipid abnormalities. The most recent of these studies focused specifically on children with schizophrenia and schizoaffective disorder. In that study, the atypical drugs Risperdal and Zyprexa were no more effective than the generic molindone, and the children on the newer agents suffered significant weight gain—13 pounds on Zyprexa and 9 pounds on Risperdal over only 8 weeks of treatment. Molindone caused less than a pound of weight gain.

So who is to blame for the excessive enthusiasm for atypical antipsychotics in children? The FDA says: “Not us.” When asked why physicians were not learning enough about side effects, Thomas Laughren, the director of the agency’s division of psychiatry
products, said that the FDA has done its job by requiring appropriate warnings on the drug labeling. According to the article:

"Dr. Laughren of the F.D.A. said the agency could do little to fix the problem. Instead, he said, medical specialty societies must do a better job educating doctors about the drugs’ side effects."

Hmmm. Now that is going to be a tall order, considering that over half of all medical education courses in the U.S. are funded by drug companies. The medical specialty societies reap millions per year in “industry supported symposia,” which are CME courses certified by the medical societies, paid for by drug companies, and which are subtle advertisements for the sponsor’s drugs.

What is the FDA doing about this corruption of medical education? Absolutely nothing. Instead, they have given this responsibility to an agency called the ACCME. The ACCME is independent of the FDA, and is funded almost entirely by organizations that have a vested interest in continued drug company funding of CME. Because of this, it has presided over an incremental approach to regulation that has moved at glacial speed. Meanwhile, children on antipsychotics are becoming obese.

It is time for the FDA to get involved in regulating doctors’ education. I suggest that they immediately form a task force to investigate why the ACCME is moving so slowly to get industry influence out of medical education.

Let’s get real about this issue. Our health, and our children’s health, are at stake.

Wednesday, November 19, 2008

Victory in New Hampshire: No More Data-Mining

Yesterday, in a historic victory for physicians and patients, the First Circuit Court of Appeals unanimously upheld New Hampshire’s Prescription Confidentiality Act, which prohibits drug reps from using prescription information for pharmaceutical detailing.

This is a huge victory. While both Maine and Vermont have passed anti-data mining laws, industry-funded lawyers have challenged the laws on the basis that they violate the First Amendment protections on free speech. In fact, these same lawyers were able to convince a district court to strike down the New Hampshire law in April 2007, and since then, according to this article by the Associated Press, many other states have frozen their efforts to regulate this sleazy marketing practice while they wait to see how courts rule.

Now, they have their answer. Yesterday’s decision marks the first time a federal court has upheld such laws. According to Sean Flynn, a law professor who has spearheaded efforts to ban data-mining, the federal court "refused to apply the First Amendment to the trading of prescription records for marketing purposes where ‘information itself has become a commodity.’ The court explained that applying the First Amendment to such trade in prescription data 'stretches the fabric of the First Amendment beyond any rational measure.’”

You can almost hear the great clicking sound of dominos falling as the 18 other states considering anti-data mining laws get back to work on them.

Click here for an excellent fact sheet on prescription data-mining, courtesy of the Prescription Project. I have covered this issue from various perspectives here.

Let's hope that drug companies will use the millions they were spending on data-mining for something more useful to society--like research and development.

Tuesday, November 18, 2008

Disclosure Wars: The Case of Goozner vs. Pies

Transparency has become all the rage in medical publishing these days, which is a good thing. A recent battle between the Integrity in Science Project website and the journal Psychiatric Times is a great illustration of some of the more complicated issues involved.

What makes this case especially interesting is that there is no “good versus evil” dynamic here. One on side of the ring is Merrill Goozner, a former business journalist who is the director of the Integrity in Science Project, part of the nonprofit organization Center for Science in the Public Interest. I know Merrill personally and can vouch for his ethics and passion for honesty in science.

Standing in the other corner is Ron Pies, M.D., a psychiatrist and editor-in-chief of Psychiatric Times. Ron and I are friends and colleagues, and he is one of the most thoughtful people I have met on issues of ethics. In fact, he invited to write this two part article
on conflicts of interest in psychiatry, which he published in Psychiatric Times two years ago, in November of 2006.

We have two fine individuals scrimmaging over an issue they both care deeply about. So what happened?

Here’s the sequence of events.

First, on August 1, Dr. Pies wrote this editorial
in which he discussed Senator Grassley’s investigation of conflicts of interest, and announced that his journal would henceforth begin posting the financial disclosures of its entire editorial board.

Then, on September 2, Merrill Goozner posted this short piece on his Integrity in Science Watch
in which he acknowledged Psych Times’ efforts at transparency but nonetheless added a little jab by claiming that Dr. Pies personally has industry ties, which is at odds with the recommendations of The International Committee of Medical Journal Editors' “Uniform Requirements for Manuscripts Submitted to Biomedical Journals,” which declares that “editors who make final decisions about manuscripts should have no personal financial involvement in any of the issues they might judge.”

In response to Goozner’s backhanded complement, in the current issue of Psychiatric Times there is an unusual commentary entitled “Setting the Record Straight.” It is unusual in that it is written by both Susan Kweskin, the journal’s editorial director, and by Dr. Pies, who is the editor-in-chief.

The gist of this article is that, in fact, Dr. Pies has accepted no money from drug companies since becoming editor in January 2007. When Dr. Pies wrote to Goozner to correct the error, Goozner’s response was that “We use a 5-year-look-back period for conflicts of interest. This is the same look-back period used by the Journal of the American Medical Association.”

Fair enough, responded Dr. Pies, but it seemed to him that Goozner has chosen JAMA’s particularly long look-back period to “single out specific editors-in-chief and their publications” for subtle accusations that they are allowing conflicts of interest to bias the content. Furthermore, Dr. Pies scolded Goozner for failing to contact him directly to find out if he, indeed, had conflicts of interest that would continue to be relevant to his current responsibilities.

Goozner has yet to respond to this latest installment of the drama.

So who’s right and who’s wrong? Both.

Goozner is right to be concerned about editors who have had recent financial relationships with companies related to their editorial work. While there is nothing magic about a five year vs. a one year look-back, it is probably true that editors who have received money relatively recently from a company are more likely to have their judgment affected than those who left the entanglements behind many years ago.

However, in his zeal to root out the rascals, Goozner went overboard and skipped some of his due diligence. Dr. Pies in particular was not the person to go after, and Goozner could have learned about his reputation for honesty by asking anybody in the field. Furthermore, Goozner claimed that Robert Freedman, editor in chief of the American Journal of Psychiatry, also has drug company ties, but in his slap-dash web search he linked to the wrong person: a “Robert R. Freedman, PhD,”
who is a professor of psychiatry and obstetrics and gynecology at Wayne State University School of Medicine, and who has no connection to the Psychiatry Journal’s Robert Freedman. As it turns out, the “real” Dr. Freedman indeed has had some connections to pharma, but it’s not clear what they are, or whether they are ongoing—this was a confusing issue that I once tried to clarify in correspondence with Dr. Freedman, described in this blog entry.

Dr. Pies is right to be peeved about Goozner’s “broad brush approach to disclosure,” as he put it. I have certainly been guilty of this practice as well. The fact is that those of us involved in blogging and the media feel a constant pressure to publish something, and we really need to be more cautious about the claims we make.

On the other hand, Dr. Pies has chosen to edit a journal more dependent on drug company funding than most. Unlike JAMA and the American Journal of Psychiatry, Psych Times is a “controlled circulation” journal. This means that doctors don’t have to subscribe to get it. In fact, every month it is sent for free to over 40,000 psychiatrists. Just about every last dime of the journal's income comes directly from the pharmaceutical industry. Companies pay extremely high prices for their ads (here is the journal's rate card) precisely because the journal can guarantee that ads will be viewed by 40,000 sets of prescribing eyes. Furthermore, the parent company, CMP Medica, presides over a veritable industry CME empire, including the U.S. Psychiatric Congress, and produces industry supplements packaged with Psychiatric Times. (Dr. Pies has no editorial control over these supplements.) I reviewed one of these supplements last year, and found it to be a subtle advertisement for Bifeprunox, an antipsychotic made by the supplement’s corporate sponsors, Wyeth and Solvay.

This is not to impugn Dr. Pies’ reputation, but rather to point out that he has an exceedingly challenging job of ensuring unbiased reporting in a journal that must, to a greater degree than many others, keep the drug companies happy to survive.

Bottom line: Watchdogs like Merrill Goozner (and myself) are crucial during a time when medicine is finally taking a close look at its relationships with drug companies. But we need to be careful not to take an indiscriminate shotgun approach in our investigations. On the other hand, there are some ethical editors like Dr. Pies who have decided to work within an industry-supported environment, but who are trying to keep their journals’ noses clean. May the Force be with us all!

Wednesday, November 12, 2008

An Insider Tells All

Tom Nesi used to be the director of public affairs at Bristol-Myers Squibb. He quit, and now he is a whistle-blower. Welcome aboard, Tom!

Last week's issue of U.S. News and World Report carried this
interview with Nesi about his new book, Poison Pills: The Untold Story of the Vioxx Drug Scandal.

Here is an excerpt from the interview:

You argue that in the context of pharmaceuticals, new is not always better. Why?

It's extremely important that people understand that, as extensively as a drug is tested before it's approved [by the Food and Drug Administration], it's still tested on a very small population. It's also tested on a very select population. Drug companies don't go out to try to find the sickest patients to test their drugs on.
[With older drugs], not only is there more data but more usage experience. Doctors know how to use it—they become familiar with it. An example in the pain market: When some of these non-steroidal anti-inflammatories were released, like
Motrin and Aleve, they were actually given at doses that were too high. As the years go by, [drugs] can actually become safer.

As a veteran drug marketer, you warn consumers to beware huge marketing campaigns for new drugs. In fact, you urge people to ask their doctors for proof that new drugs are superior to older ones before accepting a prescription for the newer medicine.

I would say the larger the marketing campaign, the more you should use caution. I would also say if there are good drugs in a category—in a type of illness that you suffer from—that have been out there for a while, there's no reason not to use those first.

If you are interested in a more in depth discussion of Vioxx in particular, read this interview with Ed Silverman at Pharmalot.

Monday, November 10, 2008

Funniest Medical Blog

Looking for relief from the litany of economic bad news? Then visit the Placebo Journal Blog, which I just discovered. Especially appreciated are Dr. Farrago's drug ad send-ups, two of which, "Scambien" and "Dioxx," are reproduced below.

Thanks for keeping us laughing, Dr. Farrago!

Wednesday, November 5, 2008

How Drug Companies Hid Millions in Physician Payments in Vermont

Vermont is one of a handful of states that requires drug companies to disclose their payments to physicians. But the law contains a loophole as big as the Ritz—companies are allowed to withhold information on payments that they consider “trade secrets.”

Ever since the Vermont law was passed, many have wondered what on earth these “trade secrets” might be. A research letter published in this week’s edition of JAMA (Journal of the American Medical Association) finally provides the answer.

The non-profit group Public Citizen sued to obtain information on the trade secret payments, and here it is. During the two year period from the summer of 2002 to the summer of 2004, drug companies made 21,409 payments, primarily to doctors, totaling $4.90 million. 42.9% of these payments, totaling $2.72 million were labeled “trade secrets.”

The researchers, led by Dr. Joseph Ross at Mt. Sinai School of Medicine in New York, focused their analysis on those payments to physicians of more than $100 (the Vermont law requires disclosure of all payments of at least $25). There were 4743 payments that exceeded $100, totaling $3.2 million. 49% of these larger payments were trade secrets. The median trade secret payment was $500 per doctor, far greater than the median non–trade-secret–designated payment of $177.

What kinds of payments were considered trade secrets? One would assume these would be for consulting arrangements in which doctors give advice about secret new products in the pipeline. But “consulting” constituted only 8.2% of trade secret payments.

By far the majority of trade secret payments were for promotional speaking (43.2%) and for “educational” activities—presumably CME (41.7%). Most such gigs are well-publicized by mailings to doctors' offices, and they are typically for products that are already FDA-approved.

Calling promotional speeches and CME events “trade secrets” is Orwellian double-speak at its finest. Luckily, the Physician Payment Sunshine Act, likely to be passed by Congress in the coming year, does away with this loophole.

Friday, October 31, 2008

Carlat Psychiatry Blog Supports Barack Obama for President

Yes, it’s time for everybody to choose sides.

I support Barack Obama for president, because his positions on mental health care and the pharmaceutical industry make the most sense for the American people.

Positions on Mental Health Care

The National Alliance for the Mentally Ill (NAMI) sent questionnaires to the candidates about their views on mental health issues. You can view the responses of both Obama
and McCain on the NAMI website.
What is most striking immediately is that only Obama bothered to answer the questionnaire, providing specific responses to each of 24 questions crucial to mental health care in America.

McCain, on the other hand, issued a four paragraph generic position statement with few specifics. His mental health plan revolves around controlling costs and calling on Americans to take more “personal responsibility.” For example, he states:

“I have stressed the central role of personal responsibility in leading to lower health care costs. Personal fitness and better lifestyles, especially reduction in addictions of all types – food, narcotics, or cigarettes – can yield dramatic improvements in the cost of chronic illness and high cost medical care. We can do a better job of treating addictions, but we also have an obligation to do a better job of teaching our children the benefits of good lifestyles and the perils of addictive activities.”

Who can argue against personal responsibility? Unfortunately, treating mental illness is a wee bit more complicated than telling patients to "just say no."

Obama has tangibly demonstrated support of mental health treatment by:

--Strongly supporting mental health parity legislation. While both Obama and McCain voted for the federal Mental Health Parity Act, only Obama co-sponsored the legislation. In addition, he actively supported mental health parity in Illinois as a state senator.

--Calling for mental health screening of veterans to treat PTSD and prevent suicide, two growing problems among vets. Ironically for a war hero, McCain has voted repeatedly against increased funding for veteran’s outpatient services, and specifically voted against a provision that would have allocated $500 million for VA mental health services.

Positions on the Pharmaceutical Industry

While McCain has the reputation of being “tough” on drug companies (see this pharma marketing network forum), in reality, Obama supports proposals that would more substantially bring the costs of drugs down.

Both candidates support allowing re-importation of medications from Canada, and both support eliminating loopholes in generic drug law that allow companies to pay generic manufacturers to delay the release of cheaper drugs by 6 months.

But only Obama wants to allow Medicare to negotiate drug prices with companies, which was the crucial element missing from Medicate Part D. McCain has taken no position on this issue.

To summarize, Barack Obama has demonstrated greater leadership on measures ensuring that psychiatric patients receive the care they deserve, and will fight to decrease the inflated costs of prescription medications.

Tuesday, October 28, 2008

Marketing Drugs for Unapproved Uses: A How-To Guide

The open access medical journal PLOS Medicine just published this fascinating article detailing how drug companies promote off-label uses of drugs.

Co-authored by Georgetown University's Adriane Fugh-Berman, M.D., and by Douglas Melnick, M.D., a former medical liaison for a major drug company (see his YouTube interview here), this article is notable because it provides insider information about the nasty little marketing techniques used to promote off-label indications.

In general, I am not against off-label uses of drugs. In psychiatry, many, if not most patients are taking something off-label, such as an SSRI for an unapproved indication or trazodone for insomnia. However, off-label uses should be promoted and discussed by physicians unaffiliated with drug companies. We don't need drug companies, drug reps, or industry-funded hired guns to educate us about off-label uses, because legitimate uses are published in peer-reviewed journals, which generate a buzz among physicians and a gradual rise in evidence-based off-label prescribing. We've seen many cases in which drugs, such as Neurontin, have been promoted by companies for unapproved conditions based on anecdotal data, only to find that they were completely ineffective once controlled data were published.

At any rate, this PLOS article describes a variety of methods used to market drugs off-label, including:

--The "decoy indication." "In development, drugs may be promising for several uses, and companies must choose one or two conditions on which to focus research. Ease of approval is the most important factor in this decision. If extensive off-label use is anticipated, a company may seek approval for just a narrow indication in order to speed a drug to market. In other words, a drug may be approved for this very narrow "decoy indication" while an extensive off-label campaign is not disclosed to drug regulators."

--Use of Key Opinion Leaders to skirt regulations. "Nationally known, influential academic physicians help “word-of-mouth” or “buzz” marketing. These “thought leaders” or “key opinion leaders” (KOLs) support labeled marketing efforts as well, but they are considered crucial for the promotion of off-label uses. Industry-paid KOLs are never company employees. Rendering purportedly independent opinions, via articles and lectures, KOLs are able to elude laws against off-label promotion."

There are many more interesting tidbits in this article--but I'll stop here, because I don't want to spoil your fun!

Monday, October 27, 2008

Post-Deception Medicine: Reform Picks up Steam

Last week’s announcement by the Wisconsin Medical Society that they are asking their 12,000 physician members to end marketing relationships with drug companies is part of a tidal wave of reform sweeping in a new era of what I call post-deception medicine.

The wording of their new ethics policy is straightforward:

Physicians shall accept no gifts from any provider of products that they prescribe to their patients such as personal items, office supplies, food, travel and time costs, or payment for participation in online CME. A complete ban eases the burdens of compliance, biased decision making, and patient distrust.

In their press release, they elaborated that their policy will follow the guidelines in the influential JAMA article published in 2006 which outlined policies for minimizing financial conflicts of interest in academic medical centers. Subsequently, the American Association of Medical Colleges formally endorsed these proposals, and a slew of medical centers have followed suit.

Steven Bergin, MD, an obstetrician/gynecologist who is the president of the Society, had some powerful things to say about the new policy.

“This policy is strong and clear. It leaves no doubt that the Society’s physicians want to prevent even the impression that a gift–no matter how small–could get in the way of a physician’s decision-making.”

As pressure builds in the various medical specialties to implement gift bans, many physicians have resisted, the most common argument being that physicians are too ethical and smart to allow small gifts to influence their decisions, despite a body of research pointing to many examples in which prescribing behavior is, indeed affected by gifts.

This debate will go on and on, and is unresolvable, because there is no conceivable study that could definitively answer this question. Cutting to the chase, Dr. Bergin believes that “individual physicians should take a bright line approach to accepting items from companies that make products or drugs that the physician might end up prescribing or recommending to his or her patients.”

In an interview with the Wall Street Journal Health Blog, Dr. Bergin made this point even more eloquently:

WSJ: What’s the point in banning gifts such as pens, whose value is trivial?
Dr. Bergin: There are certain people who would say a small gift wouldn’t affect someone’s judgment. But then again, maybe it would. And if there is no gift, there can be no question about it.

And that really is the point, isn’t it? Doctors make enough money to afford their own pens, books, and CME. As patients, we can all rest easier knowing that there is no possibility of commercial influence in their decision making.

But what about the specific issue of CME? The short version of the policy explicitly bans “payment for participation in online CME.” I’m not quite sure what they are driving at here, since I haven’t seen any CME providers actually paying physicians to take CME. Perhaps they mean that free CME is in itself of form of payment, and if so, I certainly agree. More clear is their official endorsement of AAMC’s policy, phrased in their press release in this way:

“CME providers should not accept support from health product companies directly. A CME provider may create a fund for medical education that may accept unrestricted donations from health product companies that is then dispersed according to institutional policy; this policy, financial contributors and the amount of their contributions shall be disclosed as public information on an easily accessible Web site.”

While this policy allows industry to indirectly fund CME, it would forbid the vast majority of commercially funded activities, in which companies support a specific course focusing on a topic area in which they sell a product. Instead, they would have to agree to donate educational funds into a pool of money, and the CME director would have sole discretion over how the money is used.

While I would prefer to keep accredited CME completely pure, and allow drug companies to provide product information in the context of promotional events only, I could certainly live with a pooled arrangement. The problem is that I don’t think drug companies will accept it, precisely because it provides a much more effective firewall between educational grants and promotion. While drug companies are enamored with the phrase “unrestricted educational grant” as a way of pretending that CME is not promotional, when grants become genuinely unrestricted, the companies balk. Why? Because they want to make sure that the CME they support will benefit their products.

Advocates of industry-CME, such as the blog Policy and Medicine, scoff at these pooled funding arrangements, calling them “blank checks” and “charity.” To be consistent, they should also point out that the word “unrestricted” when used with “educational grants” is a deception.

Kudos to Wisconsin. Which medical society will be the next to do the right thing? Let's hope it's the AMA.