Back to the Standard Form Letter: Abbott Settles for $1.3B

In a recent post I was unable to employ my standard form to report legal settlements for corporate wrongdoing, due to the fact that many different drugs and several different allegations were all lumped together. Last month Bloomberg News reported--
http://www.bloomberg.com/news/2011-10-21/abbott-said-to-agree-to-pay-1-3-billion-to-end-depakote-suits.html#
--the following, which allows me to return to the standard format:

Drug Company: Abbott Laboratories
Drug: Valproic acid (Depakote)
Settled Federal charges of: Off label marketing (as well as state civil actions for inappropriate payments)
Fine paid: $1.3B
Fine as % of Annual Sales of Drug during Peak Year: 93%
Company Admits Guilt?: Can't tell from news report (the settlement was reported by "people familiar with the accords" and has not yet been officially announced)

What's notable about this settlement is both the fact that it topped $1B, though it's still only the third largest settlement; and the high percentage of annual sales the fine represents--we've seen from previous such reports that it's typical for the fine to be a mere 10% of annual sales.

Abbott is alleged to have heavily marketed valprioc acid, which is basically a drug to prevent seizures, for treating agitation and aggression in patients with dementia, autism, and various other disorders.

GSK To Set Record with $3B Settlement, and More on Avandia

I usually use a standard form to report the latest drug firm settling with the Feds for wrongdoing, without admitting any wrongdoing, as in:
http://brodyhooked.blogspot.com/2011/09/same-song-i-lost-count-of-which-verse.html

The most recent report, however, won't fit my standard form for a couple of reasons. First, GlaxoSmithKline has apparently not yet actually settled, there are just rumors of a settlement. Second, they are settling three different actions on three different drugs, according to the reports. But in any event, if the rumors are correct then GSK will set a new record by settling for $3B, almost twice as much as the previous high, as Dr. Roy Poses reports over at Health Care Renewal:
http://hcrenewal.blogspot.com/2011/11/to-sir-andrew-with-settlement.html

The issues that got GSK into this much trouble are: alleged improper marketing of 9 of its best-selling drugs, including Avandia, Wellbutrin, and Advair; cheating under the Medicaid rebate program; and alleged improper promotion of Avandia for diabetes.

The settlement is tentative and reportedly would be concluded in 2012, so one might wonder why it is being announced now. The speculation Dr. Poses passes along is that GSK's UK CEO, Andrew Witty, is being pushed for a knighthood, and so the company wished to clear the decks and not have embarrassing news coming out later when it could interfere with Mr. Witty becoming Sir Andrew.

Along the way Dr. Poses cites a nice review by Deborah Cohen in the British Medical Journal (BSJ) on the ins and outs of the entire Avandia debacle:
http://www.bmj.com/content/341/bmj.c4848

Ms. Cohen's piece reviews the skimpy evidence presented to both the FDA and the European drug review agency that Avandia was safe and effective, even at the time it was first approved and before later evidence emerged on the extent of the heart disease risk that it posed. The reasons why it made it through approval on such a slim basis? Clearly smart drug company promotion and lobbying played a role. But at least a part of the problem was the diabetes-endocrinology community. The glitazone drugs represent a new pharmacological approach to diabetes treatment, unlike any existing class of drugs. They promise not to replace what insulin does, but rather to treat the insulin resistance of other body tissues that is a big part of type II diabetes. The first glitazone, troglitazone (Rezulin) had to be withdrawn when patients started dying of liver failure--though its maker, Warner-Lambert, lobbied like heck within the FDA to keep its drug on the market, as I recounted at length in HOOKED. So having another glitazone as an alternative was a big priority for endocrinologists. Apparently it was such a big priority that these smart specialists forgot to ask if there was any evidence that Avandia actually improved the long-term outlook of people with diabetes, instead of just making their numbers look better right now, and especially whether it actually prevented the heart and vessel disease which is the primary serious complication of Type II diabetes.

And here we return to another theme I harp on--why many within the FDA say they must ignore conflicts of interest because if they excluded all "experts" with COI from their scientific advisory committees, there would be none left to serve. My reply to this has often been that it depends on who you call an "expert," and why more of my own colleagues in primary care fields are not asked to serve on an FDA committee. I think here you have a case in point. Who is more likely to get all misty-eyed over the fact that Avandia works by a novel pharmacological pathway? An endocrinologist. Who is more likely to be skeptical and demand proof that it really helps patients? A primary care physician. I rest my case.

ADDENDUM 11/21/11: I erred above in saying that the GSK settlement was nearly twice the previous high settlement. I had thought that the most recent Pfizer settlement was in the middle $1B range, but according to the Bloomberg News coverage of another recent settlement, Abbott Labs (see post just above), Pfizer settled its charges over the marketing of the painkiller Bextra for $2.3B in 2009.

Will Brown University Investigate Keller?

We've previously on this blog discussed the case of Dr. Martin Keller at Brown University and his study of Paxil (paroxetine) in children:
http://brodyhooked.blogspot.com/2008/06/alison-basss-side-effects-another-hall.html
http://brodyhooked.blogspot.com/2011/02/universities-corporate-influence-and.html

Now, thanks to our esteemed colleague Dr. Roy Poses from Health Care Renewal blog, we're provided with this article from the Brown newspaper in which he's quoted:
http://www.browndailyherald.com/prof-s-study-linked-to-child-suicide-1.2673693#.TsZ44VbfWSo

Seems that our other esteemed colleagues at Healthy Skepticism have been after Brown to get the University's help to withdraw the Study 329 claiming that Paxil was safe and effective in children. They argue that the article continues to be cited and can be implicated in suicides in children prescribed Paxil. Brown basically has gone into hiding and has not responded to these overtures.

Thanks to the exposes noted in previous posts on this blog, we know that Dr. Keller received huge sums of money from Pharma; that Study 329 was originally by scientific standards a negative study of Paxil in kids and was spun to make it sound like a positive study when it was published; and that the published version was essentially ghostwritten by a company hack. At least that's what's now on the public record (Dr. Keller routinely refuses to comment), and if Brown knows a different version, it's about time they let us hear it.

What Could Penn State Scandal Have To Do with Pharma?

If you're tired of reading abbout the scandal at Penn State's football program (and the university that's a small branch of that program) and you came to this blog for a moment of respite, sorry to disappoint you.

As the extremely talented former NPR reporter Snigda Prakash writes in Slate:
http://www.slate.com/articles/health_and_science/medical_examiner/2011/11/sandusky_cover_up_why_is_kenneth_frazier_leading_the_investigation_at_penn_state_.html

--there is an unfortunate link between Penn State and Merck's Vioxx debacle, through the intermediary of Merck CEO and former chief legal counsel, Kenneth Frazier. Frazier is now a member of the Penn State board of trustees and was selected by his fellow trustees to head the University's internal investigation into the scandal involving the failure to report a former football coach for allaged child sexual abuse. The University has put out the usual word as to how this investigation will leave no stone unturned, let the chips fall where they may, and whatever the cliche of your choice.

So would you select Mr. Frazier to lead such an investigation? As Ms. Prakash reports in detail, let's follow his track record at Merck. First the company did its best to conceal the cardiac risks associated with its blockbuster drug rofecoxib (Vioxx), leading to an estimated 80-140K excess cases of serious heart disease during the years that the drug was on the market and after clear evidence of serious risk had emerged (as I discussed in detail in HOOKED). And Merck didn't just leave it on the market; they promoted the holy heck out of it (remember Dorothy Hamill skating on the TV ads?), milking it for every last penny before they finally had to pull the drug in 2004.

Now Mr. Frazier was in a top spot at Merck while this was all going down but probably he was not personally responsible. But he can take full credit for what happened next, in his post as chief counsel. Merck then went into lawsuit defense mode as all the people with heart attacks who had taken Vioxx started to sue. Predictions were that Merk would have to shell out $25 to $50B to pay all the settlements. But Merck decided instead on a bold defense strategy that Prakash describes as "scorched earth." They put out $2B to hire the best legal talent in the country and to fight every single suit. From an epidemiological standpoint it was smart. It's easy to calculate that 80-140K excess cases of heart disease were caused by Vioxx across the whole US population. It is nearly impossible to prove difinitively that any patient who took Vioxx, and then had a heart attack, had the heart attack because he took Vioxx and for no other reason at all. (If you want to read all about the Vioxx legal challenge, see Prakash's book, All the Justice Money Can Buy.)

So Merck fought every case, lost some but won a bunch of others, and in the end was able to wrangle a general settlement for a mere $5B. No doubt it was this brilliant strategy as chief counsel that Merck rewarded by making Mr. Frazier their CEO.

So Penn State wants to put its investigation into the hands of a guy who first, did his best (in company with all the corporate leadership) to conceal the truth to assure that a favored brand continued to make profits; and second, once the truth came out, fought like heck to make sure that the human beings who were harmed by those corporate actions didn't get a penny. Sounds like a great plan to restore trust in the university.

Shameless Commerce Division: New Book, THE GOLDEN CALF

A while back I mentioned a forthcoming book:
http://brodyhooked.blogspot.com/2011/07/kid-gloves-on-corporate-crime-different.html

I'm happy to report that the book is now available in paperback, and soon to be released as a Kindle edition:
http://www.amazon.com/Golden-Calf-Economism-American-Policy/dp/1463762755/ref=sr_1_1?s=books&ie=UTF8&qid=1321217138&sr=1-1

To repeat my earlier brief description:
I have been spending time studying the origins and nature of a belief system that I think is most appropriately called economism. Economism is the belief in the all-powerful "free market," and the prescription that every problem in human life can be solved through the market, and that the only appropriate role of government in the market is to get out of the way and let it be "free." But economism is internally self-contradictory and so always ends up talking out of both sides of its mouth. In the case of "big government," economism desires half-powerful and half-powerless government. The powerless half is the part that could stand in the way of corporate profits--like too many DOJ or SEC investigators. But economism simultaneously desires all-powerful government when it comes to those aspects of government that can be tied to its own pursuit of wealth, and can secure monopoly privileges for those corporations now at the top of the heap. So, for example, making sure that Pharma continues to get huge tax breaks, and that the US government remains vigilant to protect its "intellectual property" so that no Indian generic firm can make AIDS drugs to sell in Africa at an affordable price, is a type of "big government" you never hear economism's boosters objecting to.

The main thrust of the book is that economism pretends to be a hard-headed scientific account of the real world, with which only irrational people could disagree. Yet any logical analysis of its thought structure shows that it functions as a religion and not as a science. Historically, I try to show that that's no surprise when you see where its ideas come from. Specifically, economism draws one strand of thinking--the idea that policies that favor the rich are good--from the "Protestant ethic" that grew out of American Puritanism in the 18th century and after; and the other strand--that policies that assist the poor are bad--from the British variant of evangelicalism that was prominent in the early 19th century. So when practitioners of economism--for example, today's "austerians" who insist that the Federal deficit must consume all of our attention, and who cares if Americans are unemployed and losing their homes--our politicians and media assume we are getting scientifically based economic advice, when in fact we are getting other peoples' religious beliefs shoved down our throats.


I ended up doing the inquiry that led to this book after studying the ethical issues around health policy, including the Pharma-medicine interface and health reform, and becoming persuaded that there was a deep level of resistance to policy ideas that otherwise made good sense. It was in search of this deeper level of belief, that declared so many promising reforms off the table from the get-go, that I came to find the phenomenon of economism. (It's been out there all along, and goes under various names--my political science and historian colleagues prefer to call it neoliberalism. But like the proverbial water that the fish swim in, it succeeds so well as a belief system that it manages never to call attention to itself.)


Why is it important to identify economism (first) and to note its logical resemblance to a religion (second)? As the Occupy Wall Street people are at least dimly aware, and are finally starting to create a relevant political dialogue about, economism has a paralyzing effect on democracy. It causes, in the name of the so-called free market and everyone's right to buy and sell without government restriction, incredible economic inequality and injustice both in the US and globally. But even more important, in a way, is how it stifles democracy by suggesting that the entire country is really nothing but a market, and the only people who can run markets are technocrats who should not be answerable to either the political system nor the public. Is it just by coincidence that the new rulers now slated to take over in both Greece and Italy are regarded as economic technocrats, and their rise to authority is being greeted by the European Union as a wonderful development--regardless as to what happens to the right of the people of both countries to control their own national destinies?

That's enough for here; check out the book if you want to learn more.

Important Conference on Future of FDA

I've been asked to help publicize this conference and am happy to oblige:

http://www.ucsusa.org/scientific_integrity/solutions/agency-specific_solutions/fda-at-a-crossroads.html

FDA Commissioner Hamburg will be keynote speaker and bills in Congress regarding user fees for approval of drugs and devices will be the focus. Union of Concerned Scientists is one of the co-sponsors.

I'm happy to let all six readers of this blog know about it!

GoozNews on Guideline/FDA Panels: Yes, There Are Non-Conflicted Experts

I've commented previously on the canard that the FDA must fill their advisory panels with docs paid by the drug industry, as those guys are the only real experts:
http://brodyhooked.blogspot.com/2011/08/nih-conflict-of-interest-rules-weakened.html

Our esteemed colleague Merrill Goozner addressed this head-on (in relation to recent discussions of NIH guideline panels) in his GoozNews blog--
http://gooznews.com/?p=3319

Let me turn the mike over to him:

That [you need to accept industry-funded people or else do without the real experts] is simply not true. When the Food and Drug Administration commissioned a study to see if it couldn’t make up its advisory panels with conflict-free experts, the outside consulting firm discovered that it would take about one week to find unconflicted physicians with the skills required to analyze clinical trial and other data needed to serve. Moreover, based on the publication records of the people turned up by such a process, the unconflicted physicians would have been more highly qualified than the “thought leaders” on drug or other industry payrolls who actually got the jobs.

Gooz identifies the critical point. In "opinion leader" circles it is simply assumed that "expert" means somebody who sits at a lab bench and discovers a new molecule, or else somebody who designs and runs clinical trials. These folks are no doubt commendable and knowledgeable, but they're not the people with the skills you most need when it comes to serving on an FDA advisory committee or writing clinical guidelines. Those tasks need different experts, people with training in fields like biostatistics and clinical epidemiology, who know how to sort through and weigh evidence from various sources. So sadly, when a mucky-muck at FDA or NIH says they need to include people with conflicts because they're the experts, they're not merely defending a flawed status quo; they're admitting that they don't understand what the real task at hand is.