Eli Lilly's "Pain TV": Are they serious?

Sometimes in the CME field you come across something that seems so embarrassing for everybody involved that you just have to shake your head and wonder what they were thinking. So here is the link to Medscape's ACCME Accredited Category 1 CME activity called "Pain TV", supported by an "unrestricted educational grant" from Eli Lilly, manufacturer of Cymbalta, which recently won the FDA indication for chronic musculoskeletal pain--in addition to its indications for depression, generalized anxiety disorder, diabetic neuropathic pain, and fibromylagia. According to Pharma Marketing Blog, each new indication means another $500 million in the bank for the company.

To ensure that it will gain its windfall, Lilly has teamed up with Medscape, several academics on speakers bureaus for multiple companies, and lord knows what other ancillary production and medical writing companies, to produce a lavish 12 part series called "Pain TV" in which they will "educate" doctors about how to diagnose lots of patients with chronic pain, and how important it is to treat it. Will they blatantly push Cymbalta as the very best treatment? Of course not, since that would reveal the promotional intent of this CME program. Instead, they will teach us about the horrors of pain, the dangers of opiates, and about a new non-addictive treatment with a recent FDA approval for the condition that Lilly is paying millions to educate doctors about.

Maybe Cymbalta is, indeed, a miracle drug for chronic pain. Maybe all pain patients would benefit enormously from it. I'm not a pain specialist, and therefore I am in no position to judge the relative advantages or disadvantages of Cymbalta for pain. I'm certain there are thousands of complicated studies in the medical literature that have some bearing on whether Cymbalta is the go-to medication for this condition--and I am also certain that reasonable doctors would disagree about the relative merits of these studies. Accredited CME is supposed to be a way for doctors to learn about best medical practices from unbiased and credible colleagues. Unfortunately, I'm assuming that doctors who are paid by Lilly (indirectly via Medscape in this case) will have an overwhelming financial incentive to emphasize the strengths of Cymbalta and the weaknesses of its competitors--which is the very definition of commercial bias. It doesn't mean that Pain TV isn't of some educational value--many promotional activities can be quite educational. Just don't pretend that it meets ACCME's criteria for accredited CME.

I am certain that this is not the kind of CME that the AMA's new ethics guideline condones: "For the most part, accepting support from a company or permitting participation by an individual when there is an irreducible financial interest would not be ethically acceptable."

But then again, maybe I'm misreading the intent of these guidelines. Perhaps the AMA would be all for a CME activity in which Lilly funds a 12 part TV show highlighting a disease state for which it happens to have a treatment all dressed up and raring to go.

"Performance Improvement" CME, Brought To You By Medscape and Eli Lilly

Performance Improvement CME has become all the rage in the world of continuing medical education. Otherwise known as PI CME, it is being touted by the AMA as the next big thing in medical education. You can read an AMA white paper about it here.

Not all medical specialty organizations actually require that physicians complete PI CME, but they are moving toward this. The American Board of Psychiatry and Neurology now requires something similar, which they call "self-assessment" CME, and it requires a robust program of medical learning to doctors, along with a minimum of 100 CME questions. There's more to it than that--I had to learn about it in order to get Carlat Publishing approved for it.

It's fine with me, thought it is another annoying hurdle for CME providers and for doctors, but maybe in the end it will force doctors to keep their knowledge more up to date. The problem is that there are no regulations regarding who can support these new and elaborate programs. Obviously, as you can see from the screen shot above, or by following this link, Medscape is already exploiting commercial funding. This is a PI CME program called "Diagnosis and Treatment of Major Depression: Performance Improvement." It is funded by Eli Lilly, maker of the antidepressant Cymbalta. I haven't gone through the program yet, but I'm willing to bet that there will be a lot talk about pain in depression. 


I hope someone out there can investigate this Lilly/Medscape joint endeavor to see whether it is biased or unbiased. Let me know your thoughts!

Two more from Dollars for Docs: Psychiatrists Rule the Hired Guns, and "Thought Leaders" are Cash Cows

Psychiatrists are at the top of the Hired Gun list

According to Medscape, psychiatrists accept more money from drug companies for promotional speaking than any other specialty listed on ProPublica's Dollars for Docs database.

"Of the 384 physicians in the $100,000 group, 116 are psychiatrists. Leading all psychiatrists was Roueen Rafeyan, MD, in Chicago, Illinois, who received $203,936 from Eli Lilly, AstraZeneca, Johnson & Johnson, and Pfizer, mostly for professional education programs."

While discouraging, this does not surprise me, since American psychiatry has fallen into a practice style that relies on medication at the expense of getting to know patients. The slogan of the modern psychiatrist has become "I prescribe, therefore I am," and drug companies are quick to approach them with offers of cash payments in return for prescriptions. While this deal is never made explicit (it would be considered an illegal kickback), in fact the expectations underlying these financial relationships are painfully clear.

NPR Shows how "Thought Leaders" are really "Prescription Writers"

NPR ran a nice piece (which can be read here) scrutinizing whether drug companies hire speakers because they are experts, or rather because they prescribe a lot of their drugs and are good at getting other docs to follow suit.

First, they interview child psychiatrist Lance Clawson. According to this entry on the Dollars for Docs website, Dr. Clawson has spoken for Eli Lilly, which paid him $56,800 in 2009 and $7,661 in the first three months of 2010. Clawson tells NPR that he feels no guilt about these talks: "I'm going out there and trying to educate other doctors about how to treat ADHD appropriately and safely," he explains. Since Clawson said he is talking about ADHD I assume he is promoting Strattera, which is Lilly's only FDA approved ADHD medication. Strattera is, indeed, effective for ADHD, but is significantly less effective than stimulants. During Dr. Clawson's talks, I therefore wonder how much time he devotes to educating his audience about this study, which showed that Strattera is significantly less effective than Concerta, or this study, showing that Strattera is much less effective than Adderall XR. Since hired guns are forced to use only the company's slides, I suspect that Dr. Clawson educates doctors the Lilly Way, rather than the Evidence-Based Medicine Way

NPR then interviews a current drug rep who knows exactly why doctors such as Clawson are chosen as "thought leaders"--because they have lots of patients to whom they will prescribe lots of the company's drug.

According to the rep: "I think nowadays a thought leader is defined as a physician with a large patient population who can write a lot of pharmaceutical drugs. Period." Furthermore, according to NPR's sources, reps very closely monitor the prescriptions of speakers after they are paid to give talks, and, according to one rep, paying a speaker $1500 to give a talk may well yield $100,000 or more in extra prescriptions.

I'd be curious to get the prescription reports for Dr. Clawson's practice after he gives his talks! I'm sure his rep has the data squirreled away in the company laptop.

WebMD's Big Lie

In order to provide quality web-based health content, you need money. The question is how you choose to make that money. WebMD, like many web sites, makes money from advertising, but it consistently goes several steps further, allowing its content to be transformed into one long stream of stealth advertising.

The incredibly successful company was just caught red-handed by Senator Chuck Grassley, who saw a WebMD television commercial encouraging viewers to log on to the site in order to take a depression screening test. When Grassley navigated over to the test, he found that it was funded by Eli Lilly—information that was apparently omitted from the TV commercial.

What's the big deal? At first blush, this looks like business as usual. I read through the test, which appears to simply go through the DSM-4 criteria for depression, one at a time. Nor is the test actually written by Lilly. In fact, at the top of the page is the statement “This content is selected and controlled by WebMD's editorial staff and is funded by Lilly USA.” So it would appear that Lilly paid WebMD staff to encourage people to discover whether they have depression, and to seek appropriate treatment from their doctors. Yes, some of these patients might end up on Lilly’s antidepressant Cymbalta, but others would be prescribed competing antidepressants. Looked at this way, this isn’t particularly deceptive or nefarious. In fact, it might be interpreted as a public health service--enhance awareness of depression, and everybody benefits.

But of course this story isn't quite that benign. Let’s take a closer look at Web MD’s depression screening test. DSM-4 lists nine possible symptoms of depression, yet WebMD’s test lists ten. Here is WebMD’s extra item:

“I'm having frequent headaches, stomach problems, muscle pain, or back problems.

Yes

No”

Now, nobody would insist that the nine DSM criteria are the be-all and end-all of depression. Depressed patients often experience problems that are not specifically included in DSM-4’s list. These include symptoms and behaviors like lowered sex drive, irritable mood, excessive use of drugs or alcohol, and, yes, various physical aches and pains. There are many more. So why, out of the dozens of possible depressive symptoms not listed in DSM-4, did WebMD decide to ask about one, and only one, in particular: aches and pains?

Because Lilly markets Cymbalta as the "go to" antidepressant for patients who have both depression and physical pain. This is not really a "depression screening test" at all. Instead, it is a "Cymbalta-requester" screening test.

WebMD is telling the public a big lie. The say that “this content is selected and controlled by WebMD's editorial staff” when in fact the crucial aches and pains questions was selected by Eli Lilly’s marketing team to encourage patients to ask their doctors for Cymbalta.

The company's blatantly deceptive techniques are particularly ironic given that WebMD's CEO, Wayne Gattinela, likes to talk up "transparency" in interviews about his company. Clearly, WebMD would never allow transparency to get in the way of an Eli Lilly payday.

Indianapolis Star Reports on CVS Caremark-Eli Lilly Marketing Scam

For most of us, blogging is a labor of love, and our payment is the possibility of having a positive impact in the world. So it was gratifying to see that the Indianapolis Star published this story prompted by my prior post about how Eli Lilly is paying CVS Caremark to sell doctors on Cymbalta for fibromyalgia.

Reporter John Russell did an excellent investigation, finding that the practice is more widespread than I realized. For example, he interviewed Dr. Matthew Mintz, an internist in Washington, D.C., who said he too had received a deceptive pharmacy drug ad, this one funded by Merck and encouraging Dr. Mintz to switch one of his diabetes patients from a different company's drug to Merck's Januvia.

The Star's Russell also revealed that Lilly had used the pharmacy-whore technique to sell Zyprexa in 2002, when it apparently paid another drug benefit manager, AdvancePCS, to send out 120,000 letters promoting Zyprexa to doctors nationwide. AdvancePCS hawked its services for $5/letter, meaning that they stood to make $600,000 from the scam. In documents forced public in the context of a trial, AdvancePCS officials wrote that this direct-mail campaign was "designed to influence key prescribers" as part of a "tactical plan for Zyprexa."

Lilly declined to say whether it took AdvancePCS up on the offer. Translated from PR speak, this means, "Yes, we did pay them the $600,000 but it was such an obviously slimy marketing technique that we will not admit it."

An Eli Lilly spokeswoman told the reporter that the latest CVS Caremark letter was simply meant to "share medically accurate and relevant information with health-care professionals," and denied that it was deceptive at all. I guess we'll have to wait for another trial to find out that this, like the earlier Zyprexa letters, was designed as a "tactical plan," this time for Cymbalta.

At any rate, the debacle may have a silver lining for us all, since Lilly told the Star that they are "re-evaluating the entire practice" of using pharmacies to market their drugs to doctors.

That's great. Lilly is quite proud of its good corporate citizenship. Last year, John Lechleiter, Lilly's CEO, crooned in this press release that "With each of our industry firsts, from launching our clinical trials registry to the public reporting of educational grants, Lilly is striving to be a leader in improving transparency across our industry. As Lilly continues to look for more ways to be open and transparent about our business, we've learned that letting people see for themselves what we're doing is the best way to build trust."

Dr. Lechleiter failed to mention that Lilly's decision to become a leader in transparency was done with a gun to its head--it was part of a corporate integrity agreement that was bundled with $1.4 billion fine for illegal off-label marketing of Zyprexa.

Details, details.

Eli Lilly Hires CVS Caremark to Push Cymbalta

Eli Lilly has discovered a new advertising strategy: your pharmacy.

Check out this package of material I just received from CVS Caremark, a prescription benefit plan associated with CVS pharmacy. Pure and simply, it is an advertisement for Cymbalta, Eli Lilly's antidepressant which was recently approved for the treatment of fibromyalgia.

But it doesn't look like an ad. It looks like a letter from a pharmacy that is deeply concerned that my fibromyalgia patients receive the best treatment. Here's how the letter starts:

Dear Doctor:

CVS Caremark administers the prescription benefit plan for one or more of your patients. We are committed to providing health care professionals with information about drug therapy. As part of this commitment, we are providing you with this issue of RXViewpoints®, which focuses on the management of fibromyalgia with Cymbalta® (duloxetine HCI). Cymbalta is a therapeutic option on the CVS Caremark preferred drug lists. Patients may have a lower copayment for medications on these drug lists. Some prescription benefit plans may limit quantities or require prior authorization.

The letter came in a 9 X 12 inch envelope proclaiming "Confidential--May Include Protected Health Information." Along with the letter is a newsletter called "Rx Viewpoints" that appears to be written by Eli Lilly staff extolling the benefits of Cymbalta for fibromyalgia.

How touching that CVS Caremark is, in their words, so "committed to providing health care professionals with information about drug therapy." At the end of the letter, in small print, the source of all this benevolence becomes a tad clearer:

How much is Eli Lilly paying CVS Caremark to perpetrate this deception? Which executive at CVS became so overcome with greed that he or she approached Eli Lilly about this joint venture? Has CVS Caremark informed its patients that it is selling their pharmacy information to a drug company?

Whatever amount of money CVS is making on this scam, it had better be a bundle, because the pharmacy is going to have to spend at least that much dealing with the PR fiasco certain to be triggered by this foolish business decision.

I've called doctors who speak for drug companies "drug whores," a term that offends some readers. CVS Caremark has added another flinch-worthy phrase to the lexicon of medicine: "Pharmacy whores."

The Ethics of Speakers Bureaus under the Spotlight

Eli Lilly's publication of a registry revealing all payments to doctors has opened up an overdue conversation. Is it ethical for a doctor to become a member of a drug company speaker's bureau? Or is it inherently deceptive for a doctor to pose as being an independent source of information while at the same time being under contract to speak for specific drugs?

In today's Boston Globe, Liz Kowalczyk does some investigative reporting based on information gleaned from the Lilly Registry. She found that two physicians at Boston Medical Center (BMC), neurologist Brian McGeeney, and endocrinologist Elliot Sternthal, were each paid thousands of dollars by Lilly during the first three months of 2009 to give education talks to other physicians. But according to Kowalczyk, for the past two years BMC has officially barred doctors from giving industry-sponsored talks unless the “lecture’s content, including slides and written materials, are determined by the clinician.’’

In fact, drug companies never allow doctors to determine their own content for promotional talks. As I described in a prior post, for example, Schering Plough's contract (view it here) for its asenapine speaker's bureau was explict in this regard: "You will used only the Schering approved materials for all presentations performed under this Agreement." While I have not seen Eli Lilly's speakers' contracts, on their website they describe their "healthcare professional education" in the following way: "The information presented in these programs is provided by Lilly alone, is closely regulated, and must conform to U.S. Food and Drug Administration (FDA) requirements."

I think this is pretty clear. The content is produced by Lilly, and not by the doctor giving the talk.

Given all this, it sounds very much like Drs. McGeeney and Sternthal did, indeed, break their employer's rules regarding allowable industry activities. Unfortunately, rather than admitting this, they defended themselves in e-mails to Kowalczyk in the most unconvincing terms:

Sternthal said he determines “the structure of the presentation by my choice of disease state and clinical trial slides, order of presentation and emphasis of teaching points. This is in compliance with BU/BMC policy.’’

Whaaaat? We know what disease state Dr. Sternthal chooses for his talks--it is diabetes, for which Lilly markets a plethora of products, including Byetta. We also know what "clinical trial slides" he chooses--those slides showing research conducted by Lilly to show that its diabetes products are effective. The fact that he chooses the order of his Lilly-boosting slides hardly constitutes compliance with BMC's policy that the "lecture’s content, including slides and written materials, are determined by the clinician.’’ Sternthal might argue that he follows the letter of the rules because he, in fact, determines which among a menu of Lilly slides he uses in his presentation. But this is a hollow argument, because he didn't write the menu.

Here's an analogy. If my son comes home and says that for lunch he ate a cheeseburger and french fries, I might express my dispeasure and ask him to make healthier choices in the future. "But there was nothing else on the menu," he might respond. "Where did you go for lunch?" "McDonalds!" If you choose to go to McDonald's for lunch, your "choice" of food is severely limited. Similarly, if Dr. Sternthal chooses to go to Lilly for his medical information, every slide on the menu will be Lilly-friendly, meaning that his defense that he "chooses" what to teach is meaningless. His only choice was to become a promotional speaker, and he checked his academic independence at the door.

This behavior is inherently unethical, because it demeans the reputation of all doctors. How can patients have faith that doctors are making independent medical decisions when they hear about the Dr. Sternthal's and Dr. McGeeney's of the world defending themselves in such ways? Such doctors are gradually undermining the public's trust in all physicians.

American Psychiatric News: Guess the CME Sponsor!

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

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

Shall we have some fun?

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

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

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

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

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

The article is built around these two case studies:

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

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

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

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

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

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

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

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

Eli Lilly: Ethical Confusion Continues

Eli Lilly just became the first drug maker to announce that it will voluntarily disclose payments to physicians of $500 or greater. (See this coverage in Pharmalot.)

This is the latest in a series of Eli Lilly firsts in transparency. They were the first company to disclose their educational grants, and the first to endorse the Physicians Payments Sunshine Act. This is all good stuff.

So why do I say Eli Lilly is "ethically confused"? Because they still shamelessly participate in marketing deception. They hid risks of Zyprexa from doctors long after they knew about them, and still deny that this was wrong. They continue to fund a malpractice insurance company, PRMS, to provide sham risk management education to psychiatrists in an effort to prevent them from switching patients to less toxic antipsychotics. In this particularly ugly marketing tactic, they are paying attorneys to do their "education," payments which would remain hidden even under their new disclosure policy.

So, to borrow a phrase from Merrill Goozner's Integrity in Science Project, Lilly deserves both cheers and jeers for their efforts to reform themselves.

Eli Lilly and Physician Malpractice Education: The Outrage Continues

Eli Lilly & Co. is continuing to pay a major insurance company to provide sham education to psychiatrists about the liability risks of prescribing potentially toxic medications like Zyprexa.

The courses, entitled "GET THE FACTS: Understanding Professional Liability Risk Associated with Prescribing Medications,” are being heavily promoted to thousands of U.S. psychiatrists via mailings, and are offered both online and in the context of lavish free dinner programs. Although funded by Lilly, they are taught by PRMS, Inc. (Professional Risk Management Services), a risk management company that manages The Psychiatrists’ Program, a malpractice insurance policy tailored for psychiatrists.

The central message of these “educational” programs is that psychiatrists are unlikely to be sued for prescribing medications that may have toxic side effects. According to the course, “there are effective ways to decrease risk related to prescribing, and if a lawsuit is filed, the risk of a plaintiff prevailing is low.” While Zyprexa is never actually mentioned in the programs, it is clear that the intent of the courses is to convince psychiatrists that they are unlikely to be successfully sued by patients claiming that Zyprexa has caused obesity or diabetes.

There are numerous veiled allusions to Zyprexa in the course. In the introductory section, for example, they state that “Advancements in medicine usually add to the complexity of treatment and at the same time increase patients’ unrealistic expectations about treatment outcomes. Patients may be less likely to accept that unexpected and adverse outcomes are a part of treatment. Even in the absence of negligence, there are always risks of medical treatment that must be weighed against the benefits.” This mirrors the common theme of Eli Lilly promotional material for Zyprexa, namely, that it is more important to focus on the clinical benefits of the medication rather than the risks associated with it.

Lilly’s extraordinarily deceptive marketing tactic takes on new relevance with the unsealing two days ago of internal company documents in the State of Alaska’s suit against the drug-maker. According to Bloomberg News, an instruction sheet given to Lilly sales reps in 2002 stated that: “We believe it is essential to weaken this link to neutralize the diabetes/hyperglycemia issue. Neutralizing any concern from our customers will be essential to the future growth of Zyprexa in the marketplace.” Meanwhile, the company’s own data showed that patients taking Zyprexa had 3.5 times the rate of high blood sugar as patients taking a placebo.

PRMS’s psychiatry insurance program is the only malpractice program receiving an official endorsement from the American Psychiatric Association. While the APA neither endorses nor participates in this educational exercise, the fact that it endorses PRMS means it may have leverage in curtailing the company’s unethical activities. Psychiatrist and APA member Dr. David Port originally alerted me to these shenanigans, and we have jointly sent a letter to the APA requesting that the organization ask PRMS to cease this program immediately. I will keep you informed of any developments.

Deceptive Surveys: Latest Marketing Tactic in the Antipsychotic Wars

You probably don't receive the throwaway journal called "Psychiatry 2008," but if you did, and if you turned to page 61 of the February issue, you would read about a new survey on treating schizophrenia. Entitled "Communicating About Health: A Mental Health America Survey of People with Schizophrenia and Providers," the survey was released by Mental Health America, a patient advocacy groups that receives funding from drug companies. (For some background on the influence of industry on patient advocacy groups, see this excellent study in New Scientist magazine.)

At any rate, this survey was conducted with 250 people with schizophrenia, and 250 psychiatrists, who were selected from two online "panels" created by a marketing research company called "International Communications Research."

The results of the survey? 1. Psychiatrists don't pay nearly enough attention to the physical health of their patient as they should. 2. Most patients have at some point stopped their medications because of side effects. 3. The potential side effect of antipsychotics of most concern to psychiatrists was diabetes.

I know what you're thinking: "This survey could not have been funded by Eli Lilly." And you'd be right, because Lilly markets Zyprexa, an antipsychotic associated with weight gain, elevated cholesterol, and diabetes. Nor would such a survey be underwritten by either AstraZeneca (Seroquel) or Janssen (Invega, Risperdal), because these antipsychotics are also implicated in the metabolic syndrome, though not as severely as Zyprexa.

Actually, this survey was funded by both Wyeth and Solvay, the companies which teamed up to market bifeprunox, an antipsychotic in development whose main marketing point is that it doesn't cause diabetes or weight gain.

Next question: If Eli Lilly decided to fund its own survey, what would they make certain the results would be? It would have to be something downplaying Zyprexa's bad side effects.

Well, we have an answer in this new Lilly-funded survey about schizophrenia that was released by yet another industry-funded patient advocacy group, The World Federation for Mental Health. This survey of 982 caregivers concluded that: 1. Relapse is a terrible thing in schizophrenia; 2. Efficacy is the top treatment priority; and 3. You have to focus on the long-term management of patients. The words "side effects," "diabetes" or "weight gain" are not even mentioned in this survey.

File this one under: Addicted to deception.

Spinning and Spinning for Cymbalta

I was browsing the January issue of the Journal of Clinical Psychiatry in order to get ideas for the "Research Updates" section of The Carlat Psychiatry Report, and I happened upon two articles, one for those intrepid counter-detailers out there, and the other for Lilly drug reps.

The first one, "Time to Rehospitalization in Patients with Major Depressive Disorder Taking Venlafaxine or Fluoxetine," is an article important for evaluating the long term usefulness of Effexor, but one which, I can guarantee you, will not show up in the hands of your Effexor rep. In this study, depressed patients in a Taiwan psychiatric hospital were discharged with instructions to continue either Effexor or Prozac, depending on which medicine made them better in the hospital. The two groups were compared to see whether Effexor would better protect patients from rehospitalization than Prozac. The results? About 45% of patients in both group were eventually reshospitalized. For patients on Effexor, the average time to rehospitalization ("survival time") was 223 days, and for patients on Prozac, it was 222 days. What does this prove? Not much, since patients were not randomly assigned to treatments. However, it's certainly no endorsement of Effexor's vaunted superiority over SSRIs. As the authors (who have no pharma relationships) state: "Our findings do not support the notion that venlafaxine, a dual reuptake inhibitor, is associated with less relapse/tachyphylaxis."

The next article, on the other hand, will be parlayed into a "teaching point" by your Eli Lilly rep, although there's precious little to teach. Entitled "Switching to Duloxetine from Selective Serotonin Reuptake Inhibitor Antidepressants: A Multicenter Trial Comparing 2 Switching Techniques," this Lilly-funded study identified 368 depressed patients who had not responded to at least 6 weeks of SSRI treatment. These patients were then randomly assigned to either abruptly switching to Cymbalta, or gradually switching to Cymbalta. They were then maintained on Cymbalta for 10 more weeks to see if they would respond. Before we get to the results, think carefully about the design of this study, and what questions one might reasonably be able to answer, or to not answer.

This was not a double-blind study: in fact, both patients and doctors knew that the participants were being switched to Cymbalta. Furthermore, there was neither a placebo arm, nor an SSRI continuation arm. This is crucial, because patients who don't respond to a medication after 6 weeks may well respond if continued on the same medication for an additional 10 weeks. Thus, if these patients improve after a switch to Cymbalta, we have no idea how to interpret this. It might mean that Cymbalta is better. But it might also mean that the 10 extra weeks of being in treatment worked its nonspecific placebo-related magic. After all, with enough time, many people become less depressed, no matter what treatment they receive. Thus, the design of the study allows no meaningful evaluation of Cymbalta's effectiveness. The only potentially useful information here relates to the technical issue of how to conduct a switch from an SSRI to Cymbalta. As it turns out, an abrupt switch works fine and is well-tolerated. And that's all you can conclude from the study.

However, if you read only the abstract (which is as far as most readers will venture) you'll get the uncanny sensation of having been teleported to Eli Lilly's website:

"Conclusion: Switch to duloxetine was associated with significant improvements in both emotional and painful physical symptoms of depression and was well tolerated and safe, regardless of which of the switch methods was used."

If it reads like copy written by a Lilly employee, it's because it was: Dr. Perahia, the first author, works for Lilly in England. One might have hoped that the editors of the Journal of Clinical Psychiatry would have caught this bit of blatant promotionalism before it went to press. Because of this awful oversight, now Lilly will likely end up paying the journal thousands of dollars to purchase article reprints for its drug reps--someone's head will roll!

Eli Lilly "Slashes" Hired Gun Payments in Response to Dr. Drug Rep

One of my moles in the upper echelons of the pharmaceutical industry informed me that officials at Eli Lilly are changing some payment policies to hired guns in response to the article, Dr. Drug Rep.

Prepare to be underwhelmed.

The officials involved were apparently discussing the negative publicity generated by the article, and decided to put a more stringent cap on their payments to physicans who hawk their drugs to other doctors. In the past, there was a $100,000/year maximum for regular talks, with an option of tacking on an extra $50,000 for certain "brand-specific" talks, such as talks specifically relating to Zyprexa or Cymbalta. So the maximum was $150,000 per year, and many doctors were happily maxing out at that figure. Reportedly, Lilly is worried that allowing physicians to make "6 figures" for whoring themselves appears unseemly, so as of 2009, the total cap will be slashed to...drum roll please...$75,000/year. That's only 5 figures.

The physicians affected are unlikely to be hitting the welfare rolls soon, however, as they might be able to make up this lifestyle-threatening shortfall by engaging in a novel professional activity--treating patients.

An Ethical Way to Make $750/hour?

Recently, I wrote about the anonymous physician, Hired Gun, M.D., who has made as much as $800,000/year giving talks for drug companies. Some were horrified, others may have been secretly envious. Here's a key question: Is there any way for "unbranded doctors" (to borrow a phrase from the National Physician's Alliance) to make that kind of dough?

Funny you should ask. Recently, I received a call from a large law firm specializing in securities litigation cases. The attorney explained that his firm was suing Eli Lilly for defrauding investors of stock value, because they had misled these shareholders about the negative side effects of Zyprexa. If Lilly had been honest, so the suit claims, investors would have unloaded Lilly stocks earlier, thereby avoiding losses as the stock price decreased in reaction to negative media attention, particularly this New York Times article.

So where do I come in? The attorney asked me to consult in writing a paper outlining the marketing points used by antipsychotic drug makers. This brief would be used as legal ammunition, in order to prove that Zyprexa's weight gain and hyperglycemia side effects led to loss of market share versus its competitors. If I accepted, I was promised $500-$750/hour.

I respectfully declined his offer, because I believed it would create an unacceptable conflict of interest. After all, in both this blog and in The Carlat Psychiatry Report, I write about antipsychotics all the time, and I was loathe to open myself up to a criticism like, "You're being paid to say bad things about Zyprexa."

While I'm comfortable with my decision, I know that there are several prominent critics of the pharmaceutical industry who accept this type of work, including David Healey and Adriane Fugh-Berman, both of whom I know personally and who are utterly ethical people. Aside from the money, I believe they do this legal work because it is fascinating, and because it contributes to our shared cause of greater transparency in the drug industry.

So, is consulting with legal firms an ethical way to make $750/hour? Probably so, but for me, having already had my own first-hand experience with the corrupting influence of money, it's just not worth the risk of it happening again.

From Embarrassment to Scandal: Lilly + APA + The Psychiatrist's Program + Lots and Lots of Money

What began as an embarrassment of Eli Lilly, PV Updates, and PRMS is gradually becoming a full-fledged scandal. The Indianapolis Star picked up the story last weekend (read it here), and psychiatrist David Port, M.D. wrote me a letter alerting me to an expanding crisis of trust in psychiatry. Here is an excerpt:

"Whatever Lilly's justification for sponsoring a course ostensibly to help the psychiatrist to better deal with professional liability risks, I am outraged that PRMS has accepted money from Lilly and has chosen to offer its authority and reputation toward this Lilly effort. PRMS is the American Psychiatric Association-endorsed entity which directs APA members to a selected malpractice insurance agency. PRMS is thus the agency many or most of us psychiatrists turn to for guidance and direction as to liability exposure and malpractice coverage. For PRMS to work for Eli Lilly is a glaring conflict of interest between their psychiatrist clients and a pharmaceutical corporation whose interests do not necessarily coincide with those of the psychiatrists with whom they have a professional relationship. This is analogous to the same law firm representing two individuals opposing one another in a law suit; in that situation we assume that there cannot be fair representation of either client, and we may imagine that the client with an attorney who has more clout in the law firm may well prevail in the action. How can we trust PRMS, or the APA for that matter, to provide us with the best liability support? David Port, M.D."

Yes, it's true. PRMS runs The Psychiatrist's Program, a malpractice carrier that is officially endorsed by the APA.

I know, it can get very confusing. Let's follow the money. Eli Lilly gives the APA at least $1.3 million in 2007 (so far) for industry-supported symposia and fellowships. Lilly then gives PRMS a bunch of money (Lilly refused to tell John Russell at the Indy Star how much) to produce a web-based slide show teaching psychiatrists how to prescribe potentially toxic medications like Zyprexa without being sued. The APA officially endorses PRMS' psychiatry malpractice insurance for its members. Does APA receive any type of kickback for this endorsement? I assume that would be illegal, but who knows?

Look, I get as annoyed by conspiracy theorists as the next guy. But the web of money and influence here is so murky and repugnant that it leaves me wondering what's going on. I officially invite both the APA and PRMS to respond. And I'd love another diplomatic letter from Eli Lilly!

Zyprexa: Lilly Tweaks the Risk

Although Eli Lilly's Zyprexa is an effective antipsychotic, it causes more weight gain, hyperglycemia, hyperlipidemia, and overall metabolic havoc than just about any other medication known to medicine. Because of this, Lilly has been sued by patient groups, and recently settled with 18,000 patients who alleged they were never properly warned about Zyprexa's side effects.

Now Lilly's fighting back. Its weapon: educating doctors about risk management. I recently received this flyer in the mail. Published by PV Updates, a medical education company favored by Lilly, the title of this educational activity is "GET THE FACTS: Understanding Professional Liability Risk Associated with Prescribing Medications." You can watch the slide show here.

Here's the bottom line educational message: You can prescribe whatever medication you want, no matter how toxic, as long as you clearly document your rationale. So go ahead, prescribe Zyprexa--you won't be sued.

This strikes me as one of the more devious drug marketing campaigns in recent memory.