Let the Lawsuits Fly

From a press release from Prescription Access Litigation...

A U.S. District Court judge today issued a decision allowing to go forward a class action lawsuit that alleged that Eli Lilly & Co. (NYSE: LLY) fraudulently marketed the atypical antipsychotic drug, Zyprexa, for uses not approved by the FDA. Judge Jack B. Weinstein, of the U.S. District Court, Eastern District of NY, denied Eli Lilly’s motion for summary judgment, as well as a summary judgment motion filed by the plaintiffs.

The 14-page order highlighted the importance of the Courts in protecting the public in the arena of prescription drugs. The Judge stated:

"Under the present organization of the pharmaceutical industry, the official federal Food and Drug Administration (FDA), and the plaintiffs' bar, the courts are arguably in the strongest position to effectively enforce appropriate standards protecting the public from fraudulent merchandising of drugs." (Opinion, pp. 3-4)

The entirety of the judge's latest ruling can be seen here. This is a potentially big story, but I have little time to discuss it now. Maybe later...

Most Prescribed Drugs

And the winner of the most prescribed category of drugs is below...

Hospital and doctor visits in the United States have surged by 20 percent in the past five years and the most commonly prescribed medications are antidepressants, according to statistics published on Friday.

This according to Reuters, which based its numbers on stats from the Centers for Disease Control and Prevention. Full report available here. Of course, I'm sure they are rarely prescribed to patients who don't need them, right?

Payola Part Two

In an article that will shock roughly none of my readers, New York Times reporter Gardiner Harris reports that

"As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: psychiatrists earn more money from drug makers than doctors in any other specialty."

You may recall that Harris reported on this payola issue in an earlier article, focusing on the state of Minnesota. The story discussed the payments from drug companies to doctors – the results indicated that drug companies paid Minnesota psychiatrists large amounts of money to stump for their products. I added my commentary as well as a description of how this process is important in creating “key opinion leaders” who serve as both physicians and talking advertisements for drugs.

This time, Harris wrote about Vermont, and the results are unsurprising. In the Green Mountain State, Vermont officials reported that

…drug company payments to psychiatrists in the state more than doubled last year, to an average of $45,692 each from $20,835 in 2005 (see update below). Antipsychotic medicines are among the largest expenses for the state’s Medicaid program.

Later in the story, Harris writes that

Officials in Maine and Vermont said they would try to compare reports of payments to doctors with Medicaid records to explore how marketing practices might influence prescribing in ways that increased costs to taxpayers.

Well, when the analyses that are pending in Maine and Vermont were run in Minnesota, they found what appears to be a strong relationship between receipt of drug company money and prescription rates of atypical antipsychotics to kids.

The Vermont report appears to not have provided as much information as the Minnesota report, but the similarities are notable. The article also reported that several states are considering similar legislation that would require disclosure of drug company payments to doctors. The big question is how much money drug companies will invest in sinking such legislation.

Thanks to Gardiner Harris and the New York Times for the reporting. Keep it up.

Hat Tip: Mind Hacks

UPDATE (6-28-07): A helpful reader comment noted accurately that the NYT article cited above only refers to a group of top recipients of funding, so the average Vermont psychiatrist made much less than $45k in drug company funds in '06. My apologies that this point was not made clearly in my original post.

Burying Data, Chapter 317

In the sad yet unsurprising category, Ed at Pharmalot has two reports (1, 2) on Pfizer burying negative data about Lipitor. How would they do such a thing? Well, Pfizer conducted a study comparing Lipitor to Zocor and found positive results. Naturally, a favorable press release was issued, which opened by stating...

A retrospective analysis of a large U.S. managed care database showed that patients who took Pfizer's cholesterol-lowering medicine Lipitor® (atorvastatin calcium) Tablets had a significant 14 percent reduction in the risk of cardiovascular events, including heart attacks and strokes, compared with patients who took simvastatin.

An "independent" academic was also featured in the press release, stating...

"This analysis is important for physicians, employers and formulary directors at managed care companies who are making real-world treatment decisions for patients," said Dr. Robert Vogel, an author of the study and professor of medicine at the University of Maryland. "This further supports the cardiovascular benefits previously seen with Lipitor."

Well, turns out the analysis was wrong. The difference between Lipitor and Zocor was not statistically significant -- someone made an error during data analysis. No big deal that someone screwed up the analysis in my book -- it happens from time to time. Ed noted that, of course, there was no press release accompanying the new, less favorable data analysis. Though Lie-Zer, er, Pfizer has issued platitudes regarding its commitment to transparency, this behavior does not exactly engender faith in their commitment to honesty, eh? Here's Ed Silverman's rant...

So Jeff [Kindler, Pfizer CEO], what happened? If the marketing team is no longer in charge of everything, why hasn’t Pfizer gotten around to issuing that bad news press release? Your company has had 11 days to correct its mistake. Will that happen, or are accountability and transparency just convenient buzzwords?

Well said. I'd like to ask similar questions regarding the convenient release of study results that found Zoloft was ineffective for posttraumatic stress disorder ten years after the study was conducted, yet positive trials for Zoloft in PTSD took much less time to get published. How Pfizer handled other data regarding Zoloft is also dubious.

Golden Goblet Reincarnated

Danny Carlat has issued a nomination for the "Doctors for Dollars" Award. He discusses how a medical education communication company hired by a drug company got academic "key opinion leaders" to place their names on a piece of advertising that passes off as education for physicians. You'll be shocked to read that Joe Biederman is one of the nominees.

I'd strongly suggest reading Carlat's post and providing suggestions as to how the Docs for Dollars Award can be integrated with the Golden Goblet award (1, 2) and the Krusty the Klown award in a truly outstanding awards ceremony later this year.

WTF? I'm G-Rated

There is now a site that will issue movie-like ratings to blogs, and as you can see, I'm G-rated. I've never been called G-rated in my life! Not sure if this is a sign of my site being "family friendly" or if this means that I need more profanity, nudity, and cocaine on my site...

Hat tip to the R-rated Scientific Misconduct blog and the PG-13 rated Pharmagossip. I'd like to congratulate Philip Dawdy at Furious Seasons for his NC-17 rating.

Antipsychotics for Kids Update

I posted hastily earlier regarding a story in the Edmonton Journal on a survey of Canadian child psychiatrists. The article previously cited was based on a paper in the June issue of the Canadian Journal of Psychiatry. This survey investigated the frequency of prescription of newer antipsychotic medications for patients under 18 years of age.

As part of the survey, psychiatrists were asked for which disorders they prescribed atypical antipsychotic medications. Among those who prescribed atypicals (Risperdal, Zyprexa, Seroquel, etc.), here's the percentage who reported prescribing them for various conditions

• 81.8% bipolar (Go Team Biederman?)
• 30% depression
• 25.9% eating disorders
  
• 51.2% ADHD
• 74.7% poor frustration tolerance
• 35.9% insomnia
• 89.4% pervasive developmental disorder
• 51.2% oppositional defiant disorder
• 59.4% conduct disorder

The list goes on, but the above interested me the most. Apparently, the child bipolar paradigm is winning favor in Canada (as it obviously is here in the U.S.), and there are a variety of (how do I say this nicely?) not well-supported prescribing practices occurring. I'd add a rant, but the numbers speak for themselves. It's not clear precisely how often the medications are being prescribed, but it is clear they are fairly common. The survey further noted that 12% of these prescriptions were for children under age nine. Read the full-text of the study here.

Good News for Biederman?

To quote from a report in the Edmonton Journal [all emphases added]…

Ninety-four per cent of 176 child psychiatrists in Canada surveyed are prescribing powerful drugs known as atypical antipsychotics for a variety of disorders and symptoms, including anxiety, attention-deficit hyperactivity disorder and "poor frustration tolerance."

While most prescriptions were for children 13 and older, a "surprising" number were for the very young: 12 per cent of all prescriptions were for children aged eight or under, including three-year-olds.

None of the drugs has been officially approved for use in children. Risperidone (brand name Respirdal) was the most commonly prescribed atypical antipsychotic to children, followed by olanzapine (Zyprexa) and quetiapine (Seroquel).

Later, the reporter writes (providing no supportive evidence)

Atypical anti-psychotics are considered a significant improvement over older antipsychotics that were used in both adults and children.

Apparently the reporter never heard of CATIE, CuTLASS, or some of the other trials to recently compare newer and older antipsychotic meds. Oh, and if a kid has “poor frustration tolerance,” I suppose that means he/she is bipolar? Better ask Joe Biederman.

Hat Tip: Pharmalot

Child Bipolar Wars Continue

As reported on Furious Seasons, it looks like Joe Biederman is getting attacked by psychiatrist Lawrence Diller, who goes pretty far in his accusations. I’m glad someone in psychiatry is questioning the child bipolar frenzy, though I don't necessarily agree with Diller entirely.

On a somewhat different note, Daniel Carlat urges caution before jumping on the Biederman Bashing Free-For-All. If Carlat’s writing is always going to contain as much sarcasm as appears in his most recent Biederman post, I’ll be one happy guy. One snippet: “The study [in which Biederman played a key role] was not even funded by industry, which is impressive for a department in which psychiatrists can barely find the water fountain without industry support. [my emphasis]”

Let the games continue…

My Opinion Matters More Than Yours

Over at Furious Seasons, Philip Dawdy has a long and highly recommended post on the latest in the child bipolar wars. It is regarding the recent Boston Globe interview with Dr. Joe Biederman, who clearly believes that child bipolar is relatively common and undertreated. Background on child bipolar here and here. I'm in firm disagreement with Biederman, but am more than willing to change my position should the science start to improve.

What really concerned me was how Biederman discussed his critics in the Globe article:

Biederman dismisses most critics, saying that they cannot match his scientific credentials as co author of 30 scientific papers a year and director of a major research program at the psychiatry department that is top-ranked in the "US News & World Report" ratings.

"The critics 'are not on the same level. We are not debating as to whether [a critic] likes brownies and I like hot dogs. In medicine and science, not all opinions are created equal,' said Biederman, a native of Czechoslovakia who came to Mass. General in 1979 after medical training in Argentina and Israel. He now lives in Brookline.

I really hope he was taken out of context and that he didn't get all braggy about his 30 papers per year and about the US News rating of his department. Just because you've published 30 papers per year does not mean you're right about child bipolar. Indeed, despite publishing a mountain of research, some questions still loom large...

1. Does child bipolar really exist in substantial quantity?
2. Does treatment help kids with this "disorder"?
3. Why would a leading "expert" in child "bipolar disorder" say that up to 75% of children who are "bipolar" become suicidal without citing any supporting evidence?

True, all opinions are not created equal in science -- but the idea that child bipolar is a hugely underdiagnosed and undermedicated condition is not backed by consistent data. It would seem that Biederman is confusing quantity (e.g., publishes a boatload of papers) with quality of evidence. Again, please see my above questions. If they can be answered sufficiently, then I'll be glad to jump on the child bipolar bandwagon.

Now, does this mean I'm "not on his level" because I have the audacity to ask questions and point out gaping holes in the so-called evidence base regarding this purported disorder? I suppose his opinion is more valid because he has published more articles than his critics? I'm really hoping that Biederman was quoted out of context, but if he was not, he looks pretty arrogant.

A Breath of Fresh Air

I am quite happy to introduce my readers to Daniel Carlat’s new blog, The Carlat Psychiatry Report. Dr. Carlat, as I’ve reported earlier, writes about psychiatry in a newsletter that provides continuing education for psychiatrists. He also had a recent piece in the New York Times decrying the influence of industry in continuing medical education. I’m a big fan of his work.

There are few blogs that report critically on the sneaky marketing of the drug industry in psychiatry, and I strongly suspect that Carlat’s site is going to be a welcome addition to the blogosphere. I expect his writings will help detail the farce that medical education has become, where doctors are exposed to thinly veiled drug advertising which passes for education in order to keep doctors apprised of the “latest and greatest” in medical research. See earlier posts here and here for my observations on medical advertising, er, education.

Advertising as Education: Carlat Hits Home Run

Daniel Carlat is the chief of the Carlat Report, a newsletter which provides CME credits for physicians and is (gasp) sometimes critical of the drug industry and its marketing practices.

Carlat has an op-ed in the New York Times where he presents several examples of how drug companies, in the name of education, have misled physicians. I'd like to summarize what he wrote, but he really said it best. Please check it out. It covers a lot of important material in relatively few words. He also has a simple solution -- any CME paid for by drug companies should not count for educational credit for physicians. I couldn't agree more!

As y'all know, I am highly critical of current CME practices, which allow physicians to maintain their medical licenses based upon their soaking up sugarcoated drug company advertising which masquerades as education. For examples, please read an earlier post on a pro-Geodon piece and a puff piece pushing transcranial magnetic stimulation for depression. I am very pleased that the Times ran Carlat's piece.

John Mack noted that the Drug Wonks blog (predictably) came to the rescue of Big Pharma by calling Carlat's piece "hysterical." Of course, Robert Goldberg (the Drug Wonks author in question) provided no evidence -- he also said

Oh, and if I were Carlat, I would drop the characterization "Unbiased" from the description of his expensive newsletter. He is as biased as anyone. Anyone who calls his colleagues money launderers is biased.

Oh gee, we're all biased, so who knows what's right? It's all so relativistic. Please. I think that many pharma bloggers (including myself), have marshaled sufficient evidence to indicate that Big Pharma has often placed marketing well ahead of patient benefit. For documentation, um, start reading a bunch of posts on this and similar sites. Yes, we're all biased to one extent or another -- that's why we should stick to facts rather than label industry critics as "hysterical" or worse. And the facts indicate that CME needs reform. Call me hysterical if you want.

Hat Tip: Furious Seasons

A Perfect Post on Avandia

Roy Poses of Health Care Renewal has penned a post that debunks GlaxoSmithKline's latest PR stunts regarding Avandia. Read it now. Included are our friends at Drug Wonks, a congressman, how GSK came to begrudgingly put its clinical trial data online, and much more.

Congratulations!

Both PharmaGossip and Pharmalot were listed among the top 50 business blogs by the London Times. Well-deserved! I assume that Pfizer and/or AstraZeneca rigged the voting so that Peter Rost was not also included, but I cannot confirm my suspicion with evidence.

Selling an Organization

Bob Fiddaman has an interesting post about the Obesity Society and its ties to GlaxoSmithKline, maker of the weight loss pill Alli. Yes, the Alli of I Pooped My Pants fame.

Bob noted that, in the new video promoting Alli, it is mentioned that a portion of sales of a new book that discusses weight loss will be donated to the Obesity Society. Bob connects the dots by noting that the Obesity Society needed funding, GSK provides some funding for the Obesity Society, and that GSK was about to launch a diet pill (Alli).

I also noticed that, on the Obesity Society's website, it is stated that

On February 7th, the Food and Drug Administration approved Alli, an over-the-counter version of orlistat (trade name Xenical). Alli, manufactured by GlaxoSmithKline, will be available in June. It is a 60mg version of Xenical, which has been available as a prescription product for several years. Xenical, at 120mg, will continue to be available to patients needing a higher dose and who are under a physician's care. Prescription Xenical is made by Roche. Obesity Society President Eric Ravussin was quoted on the front page of USA Today indicating that the product was safe and effective. GlaxoSmithKline's educational efforts include a paperback book on weight loss; part of the proceeds of the book's sale will go to The Obesity Society. The society has received other support from GlaxoSmithKline.

Part of GSK’s “educational” efforts as well as part of GSK’s marketing, but the Obesity Soceity wouldn’t want to draw attention to that. You can also see what’s happening with corporate sponsorship of their meeting. Here’s a snippet…

Become a Benefactor of the Obesity Society's 2007 Annual Scientific Meeting and heighten awareness of your company and product(s) among the experts and thought leaders in the obesity field. Benefactor Sponsorship provides the most economical way to reach all of the 2,000+ Annual Meeting attendees frequently before, during, and after the meeting:

Benefits:

• Sponsorship of 3 general sessions:
• One Symposium
• One Workshop/Tutorial/Debate
• One Key Lecture
• Sponsor recognition in registration area
• Sponsor logo on Learning Center Website (your choice of ONE the four Annual Meeting Tracks) OR sponsor logo on attendee registration bags
• Sponsor recognition on meeting website
• Sponsor recognition in several issues of The Obesity Society’s electronic newsletter
• Sponsor recognition in all on-site publications
• Final Program
• Abstract Supplement
• Complimentary insert into attendee registration bag
• Complimentary use of one mailing list of:
• Pre-registered attendees ( 4 - 6 weeks prior to meeting)
• Final meeting attendee list (approx 2,300 names)

Sponsorship Fee: $50,000

It’s nice that researchers pay membership dues to join the Obesity Society, then their organization sells the names of members to corporate sponsors so that members can then receive solicitations.

I understand that the Obesity Society needs money and that obesity researchers likewise require funding for their research. I wonder, however, if this is the proper manner in which to raise funds.

This works great for the sponsors. Their products (such as Alli) are featured prominently in advertising that is received by Obesity Society members. They get to recruit “thought leaders” from the Obesity Society ranks, who will then go forth and speak on behalf of their products. The Obesity Society is by no means unique. The American Psychiatric Association, for example, has long been noted for its strong ties with corporate sponsors. Yet these organizations call themselves independent.

As a side note, how well does Alli work? According to one abstract of a trial comparing low-dose orlistat (Alli) to placebo over 16 weeks, Alli patients lost 3.05 kilograms compared to 1.90 kgs lost by those taking placebo. Pretty small difference, yet the president of the Obesity Society (quoted above) seemed impressed. I wonder why?

Great Slate of Republican Candidates

Why we're screwed if a Republican candidate wins in 2008...



Not that any of the likely Democratic nominees are particularly wonderful. The only good news is that Jon Stewart will apparently have fodder for many more years.

Billy Tauzin for President!

No more political chatter for a long time on this blog, I promise.

Science and PR Declare Merger

The firms Science and Public Relations will officially merge today. As Science has exponentially increased its contracts with Public Relations over the past 30 years, this comes as little surprise to investors. It is rumored that Universities will soon end their "independence" to create a megaconglomerate: Science-PR-University Inc.

Billy Tauzin, CEO of the Pharmaceutical Research and Manufacturers of America, expressed optimism, saying, "Hey, when Science, PR, and Universities team up on a project, the results can be incredible. When the three firms aligned for the Paxil in Kids campaign, that was amazing. There was obvious synergy that was able to take what was, frankly, a mediocre product, and really slap some lipstick on that pig."

Of what do I speak? In the parallel universe known as reality, Aubrey Blumsohn has detailed what seems to be a rather odious merger of science and public relations. It involves a an "independent" academic researcher, Procter & Gamble, and much more. His post is well worth reading.

Creativity Crisis: Cartoon Version

I just noticed that the creativity crisis in drug development I've written about previously may best be illustrated with a couple of cartoon videos. The analogy is simple. Think of He-Man as Effexor, Risperdal, and Celexa and think of She-Ra as Pristiq, Invega, and Lexapro.

Enjoy.





And when you put the originals and the copycats together, you've got...

Astroturf: Welcome to the Machine

I welcomed y’all to the PR Machine yesterday, where I discussed the Drug Wonks blog and the general topic of how pro-industry speech is magnified while dissenting voices are generally muffled.

I’m not the only blogger who has noticed this trend. Philip Dawdy at Furious Seasons noted recently that Lilly, maker of Doggie Prozac (aka Reconcile), is now supporting a patient support group (Support Partners) that touts the benefits of dog ownership for people with depression. Wonderful. I wonder if this new support group will ever discuss Reconcile? Nah, too obvious, you think? We’ll see.

On the page that discusses treatment options for depression, it is stated…

Some of your questions may include the different medications used to treat depression. If you want to learn more about a medication for the treatment of depression from Eli Lilly and Company, click here

As you probably guessed, it links to the lovely Depression Hurts website. The page also states:

Therapy typically means that you spend about an hour a week talking with a mental health professional. Treatment can continue for several weeks or up to one to two years. Every person's situation is different.

What does it say about antidepressants, besides linking to Cymbalta?

Taking medication to treat depression doesn't change your personality; you'll simply start to feel better. You may begin to feel improvement in your symptoms in the first couple of weeks of taking an antidepressant. Typically, within four to six weeks, you should notice a significant improvement.

So with medication, “you’ll simply start to feel better,” usually within four to six weeks, whereas with psychotherapy, you might spend several weeks or up to two years and who knows if you’ll feel better. Who cares that the evidence on treating depression does not support Lilly’s marketing?

Oh well. At least the website for Support Partners is obviously sponsored by Lilly, with the Lilly logo on the bottom of the page.

Sneaky Sponsorship: Some groups are not nearly as blatantly sponsored as Support Partners. That is why I am so pleased that Seroxat Secrets has been keeping an eye on patient support groups that, by sheer coincidence, happen to recite marketing talking points from industry. The posts on the Diabetes Monitoring Forum (1, 2) are well worth a read.

A patient support group known as Depression Alliance has also been dissected at Seroxat Secrets. Rather than copy his words, I’ll just refer interested readers to the posts on the link between the patient advocacy group Depression Alliance and public relations firms that helped with the UK launch of Cymbalta (1, 2).

Other astroturfing posts include:

• Seroquel on Turf
• Astroturfing Is Not NICE
• Grassroots or Astroturf?
• Astroturfing Down Under
• Astroturf Education

Once again, Welcome to the Machine

Welcome to the PR Machine

The conflict of interest Tilt-A-Whirl continues at breakneck speed. Yet it's even more than a conflict of interest. After reading a few great posts by fellow bloggers recently, I've become somewhat discouraged at how dissenting voices are rarely heard amidst a buzz of industry-funded cheerleading.

What am I talking about?

Drug Wonks: The blog Drug Wonks frequently defends drug companies and their practices, while heaping derision upon those who challenge the drug industry. I'm not saying that Dr. Steve Nissen, of recent Avandia meta-analysis fame, is perfect, but MAN, the scorn they are heaping upon him is over the top. Here are a couple comments about Nissen made on their site:

1. "Dr. Nissen was alternately defensive, evasive and hesitant" in Congressional hearings.
   
2. "Diedtra Henderson interviews Steve Nissen who responds -- sort of-- to my blog calling him 'small and craven' as he shifts positions and engages in self promotion in a campaign to become defacto FDA commissioner"
3. Drug Wonks blogger Robert Goldberg has also stated that Nissen's true interest is in becoming FDA commissioner, and that this current Avandia is essentially a publicity stunt to help him move up the ranks of FDA commissioner contenders.

Who are the Drug Wonks? To steal, er, borrow from Health Care Renewal's fine post on this topic of PR,

The President of the Center for Medicine in the Public Interest, where Goldberg works, and which runs the blog called DrugWonks, is Peter J Pitts, whose day job is to be Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvage and Lee has many big pharmaceutical accounts.

Okay then. So drug companies hire a firm to help them manage their reputations. The president of the PR firm runs a blog on the side that just, by sheer coincidence, happens to cast dispersions on those who criticize the drug industry.

There is still more to the story. Robert Goldberg, who blogs regularly at Drug Wonks, was a fellow at the Manhattan Institute, and he is now Vice President of the Center for Medicine in the Public Interest. What is the Manhattan Institute? It is a thinktank that advocates for free-market reforms. It would be fair to say that the Manhattan Institute favors a more limited role for the FDA. So who funds this Manhattan Institute? They're not telling. But it would appear that they receive the lion's share of their funding from a variety of corporations and foundations that advocate for laissez-faire capitalism.

So it's like this... The Manhattan Institute advocates for the "free market" to save health care. But behind the scenes, the Manhattan Institute exists only because a variety of interests, from highly rich individuals to large drug companies, need to push their message. The Institute is created to give an outlet for their message. I don't know who funds the Center for Medicine in the Public Interest. I'm betting it's not the Tooth Fairy.

The Point: Because they have money, corporate interests can buy the time of people like Peter Pitts and Robert Goldberg, who can be counted on to reliably talk in a friendly manner about big corporations. I'm not saying that Goldberg, Pitts, and company advocate for reforms that happen to support the interests of their sponsors just because they are paid to do so. Far from it. My guess is that these folks had their free-marketeering views long before they signed on with any sort of thinktank. They likely honestly believe what they are writing, but it also can't hurt that they are being paid by these corporate interests -- most people won't offend their sponsors, as there can be untoward consequences for doing so (1, 2).

The Golden Rule of Speech: He/She Who Has the Most Gold Has His/Her Message Heard Most Frequently.

People from industry friendly thinktanks are frequently featured on TV newscasts, in newspaper stories, on on op-ed pieces. They are cited as "experts" -- why are they considered experts? Well, gee, the person came from an "Institute" -- he/she MUST be well-informed!

Those of us in the healthcare media world who are more skeptical of the behavior of drug companies are typically not nearly as well-funded. In fact, if you look around the healthcare blogosphere, you'll find that most of us ain't getting a nickel for our work (Rost, Dawdy, Jack Friday, myself, Roy Poses, Aubrey Blumsohn, and many more). Yes, Rost wrote a book, but nobody was paying him to say anything. Anyway, does our working for peanuts make us masochists? Maybe, but that's a topic for another day. It's great that Rost was featured in Fortune (as was PharmaGossip), but such publicity is rare. While the industry-funded folks are regularly featured in higher-profile media (1, 2, 3), the rest of us are left writing for a smaller (but growing) audience. Sure, folks at Public Citizen get press regularly, but as a general rule, the frequently-cited "experts" are those with some connection to industry or industry-related public relations. Is this going to change?

Additional Reading: If you really want your socks to be knocked off regarding the huge role of public relations firms in American society, you really should read Toxic Sludge is Good for You.

I'll be taking a "safe, gentle psychotropic" while I ponder how our small blogger voices can somehow reach maximum amplification.

Are You Faruk-in’ Kidding Me?

Sorry for my delay in jumping on the latest New York Times story (courtesy of Gardiner Harris and Janet Roberts) detailing how drug companies hire doctors to carry out clinical trials despite their questionable backgrounds.

Much discussion of this sordid tale has already occurred at such outlets as:

• Furious Seasons
• Health Care Renewal
• Psych Central
• Pharma Marketing Blog
• AHRP
• Pharmalot

Most of what I wanted to say has already been said by the above writers. However, I have a bit to add.

Quote of the Week: Hell, this might be quote of the year, really. In the out of touch with real people category, I submit, from the New York Times [emphases added]…

Dr. Ronald Hardrict, a psychiatrist from Minneapolis who pleaded guilty to Medicaid fraud. In 2004 and 2005, he collected more than $63,000 in marketing payments from seven drug makers. In an interview, Dr. Hardrict said it was “insulting” and “ridiculous” to suggest that income from drug markers might influence doctors’ prescribing habits. [and on to the quote of the week…]

“I bought the Mercedes because it has air bags, and I use Risperdal because it works,” Dr. Hardrict said, referring to an antipsychotic medicine for schizophrenia. Johnson & Johnson, the maker of Risperdal, paid Dr. Hardrict more than $30,000 in 2003 and 2004.

SNIP

Asked why other drug makers continue to hire him despite a fraud conviction, Dr. Hardrict responded with an email message stating only, “I will pray for you daily.”

I think I speak on behalf of my readers when I say that we’ll likewise be praying for Dr. Hardrict and his Mercedes.

Are You Faruk-in’ Kidding Me? Sometimes a person’s name makes for a catchy headline, so I thank Dr. Faruk Abuzzahab for that. I was reading through the Minnesota Board of Medical Practice’s lengthy document that detailed the alleged misdeeds which resulted in a suspension of Abuzzahab’s medical license. Very interesting document.

We all make mistakes. Occasionally we make large mistakes. That’s okay. But a pattern of making similar mistakes, errors that lead to significant anguish and, in some instances, may contribute to the death of people – that’s not okay. I’ll run a trio of quotes from the report…

In a number of cases (including but not limited to patients #35, #36, and #40, for example), Respondent [Abuzzahab] enrolled psychiatrically disturbed and vulnerable patients into investigational drug studies without ensuring that they met the eligibility criteria to be in the study and then kept them in the study after their conditions deteriorated.

Respondent's documentation regarding patient #36's participation in the sertindole study differed from the staff's documentation. While Respondent documented at more than one point that patient #36 was much improved and mildly ill, staff consistently noted her deterioration throughout the study. It was also documented that patient #36 made several references indicating that she did not want to take the medications. Respondent failed to document his rationale for continuing investigational medication under these circumstances.

The pattern that emerges from Respondent’s treatment of the approximately 46 patients at issue in the contested case proceedings is that he regularly fails to substantiate his diagnoses, monitor whether the combination of drugs is appropriate for the symptoms being treated and is having the desired effect, and evaluate whether the benefit outweighs the adverse effects noted in the chart. This fundamental failure shows a reckless, if not willful, disregard of the patients’ welfare, exposes the patients to an unnecessary risk of harm and contributes to their deterioration while under his care.

A few years back, here’s a couple slices of what Morris Goldman from the University of Chicago’s psychiatry department had to say about the drug trial research field and about Abuzzahab, whom he investigated:

There are ''people drawn into this field because they are interested in dollars,'' Goldman added. ''They are very profit-conscious. And that combination of a lot of money, plus the added ethical dilemma you face in human research, that is a bad combination. And there are particular risks with psychiatric patients, with the whole issue of informed consent. It can really go wrong.''

''He [Abuzzahab] would have the patient's diagnosis called one thing in the regular chart, and then the person would be put on a drug study and the person's diagnosis would be called something else to fit the criteria''

Journalist Robert Whitaker (in the Boston Globe) said the following about Abuzzahab, and the transcript from the Board of Medical Practice (pgs. 21-22) appears to back his reporting.

In another instance, the psychiatrist took a woman off clozapine, a newly approved drug that had led her to make a remarkable recovery, and enrolled her in a drug trial. The woman had previously spent 13 years as an inpatient at a psychiatric institution, but while on clozapine she had been able to go into the community and even hold a job. One day she approached Abuzzahab with questions about clozapine's side effects; he immediately stopped the drug that had helped her so much and put her into an olanzapine trial. She deteriorated until she found her way to another physician, who put her back on clozapine.

The Payout: Two disclaimers first: 1) I cannot verify the accuracy of the following information, though I have no reason to doubt its veracity. 2) I am not disclosing the source of the information, as I believe it could lead to untoward consequences in the wrong hands.

I found that Abuzzahab lives (or recently lived in) a house described in the following manner:

Built in 1931. The structure is a 2 1/2 story, 7569 square foot, eight bedroom, six bathroom, 17 room, single family dwelling, with a partially finished basement.

I found that a home on his street recently sold for about $2.7 million dollars. The other home appears to be significantly smaller than Abuzzahab’s pad – I’m no realtor, but it my relatively uninformed guess is that Abuzzahab is living large in a three to four million dollar crib. Not bad. Who says forging records and prescribing inappropriately does not have its rewards?

My Take: Granted, the NYT report on Abuzzahab paints a very negative picture, as does the Boston Globe article, as does the Minnesota Board of Medical Practice document. Certainly, all of the above selectively examined negative evidence, and did not have a chance to see the patients who had benefited under his care. That being said, there seems to be more than enough evidence to indicate that there is no way Abuzzahab should ever be involved in clinical research again, and it is a bit scary to me that he is practicing medicine, though perhaps he has reformed his ways.

He’s also listed as an instructor for the University of Minnesota as recently as 2005. I’m not sure if he’s still employed at the university, but it seems quite odd that they would select him as an instructor.

For all I know, Dr. Abuzzahab is the nicest guy in the world. I wish him no ill. We all make mistakes, but there are some missteps, especially when they happen repeatedly, that should disqualify people from teaching university students, conducting research on the latest drugs, and caring for patients.

Lilly, Organon, Roche, GlaxoSmithKline, Pfizer, Janssen, Abbot, Merck, Boehringer Ingelheim, Bristol-Myers Squibb – who is going to run your clinical trials?

University of Minnesota – who is going to teach your students?

Fairview Clinic, who is going to treat your patients?

Reality Impresonates Art

For those of you who have seen The Constant Gardener, you are now allowed to wonder if the movie was really fictional. Criminal charges have been filed against Pfizer for allegedly setting up a clinical trial in which they misled African child participants badly and used a very weak comparison drug, which may have led to the demise of some participants. Here's one piece from the lawsuit, courtesy of Pharmalot...

“The families of the children who [Pfizer] used as laboratory guinea pigs were led to believe and in fact understood that the Defendants were providing their children with volunteer relief, clearly focused humanitarian medical intervention and nothing more,” the lawsuit says. Parents were not told that alternative treatments were available, it adds.

UPDATE: Please see comments.

Shooting the Messenger

Health Care Renewal has taken the wind from my sails with an excellent post on the Wall Street Journal editorial from Scott Gottlieb (from the American Enterprise and formerly the FDA). If you've been living under a rock lately, you might have missed the controversy stirred up when an analysis by Steve Nissen and Kathy Wolski indicated that GSK's drug Avandia increases heart attack risk by about 40% (video here).

Not everyone has been impressed with Nissen and Wolski's findings. Some have pointed to potential conflicts of interest, but nobody has really done much to challenge their findings. Nissen has defended himself against charges of his detractors.

The WSJ: Unsurprisingly, the Wall Street Journal ran an editorial blasting Nissen's findings. Who better to write such a piece than Scott Gottlieb of the American Enterprise Institute? Scott's discussion of the study consisted of irrelevant discussion, vague and unsubstantiated attacks on the study findings, and stating the following regarding the New England Journal of Medicine (among other journals), which published the latest study...

There is a problem when some journals let antipathy for business interests and left-leaning views interfere with the medical decisions that they make, bending standards or stepping outside their mandate, using their prestige and influence in ways that distort medical facts in the aim of influencing political outcomes.

This would be fine if Dr. Gottlieb had bothered to point out how the "medical facts" were distorted in this case. But he didn't. It is an attack that completely misses the point. And if Nissen is being accused of having conflicted interests, his conflicts appear to pale in comparison to those of Gottlieb.

See Health Care Renewal for an extensive discussion as well as AHRP. I know I'm really late to the game on Avandia and I'll refer interested readers to a plethora of postings on PharmaGossip and Pharmalot if you want to catch up.