20 Years of pharmaceutical company fraud

How much longer will big pharma be allowed to get away with it?

Something’s got to change, because along with all the settlements shown below, the pharmaceutical industry is responsible for killing thousands of patients each year.

You’ll see from the chart that the last few years have been the worst for settlements – the reason is that the pharmaceutical companies that are all too happy to create drugs (and aggressively market those drugs) in the knowledge that the drugs are unsafe – putting their wealth before patients’ health.

The age of the truly innovative blockbuster drug is over – Big Pharma knows this but continues to market sub standard products to the public. This is also the reason why we have seen marketing and advertising spend leap ahead of (by two to three times) the R&D spend at every major drug maker in the world.

Here’s a great article from ED Silverman at Pharmalot:

Once upon a time, defense contractors were considered the biggest hucksters. You know, the US Defense Department would pay $10 for a pencil. Now, though, drugmakers have surpassed every other industry when it comes to defrauding the US government, according to a new analysis by Public Citizen, which calls for stiffer penalies and increased criminal prosecution of pharma execs.

The findings: Of 165 settlements comprising $19.8 billion in penalties during the past 20 years, 73 percent of the settlements and 75 percent of the penalties – representing $14.8 billion – have occurred in just the past five years. And four drugmakers – GlaxoSmithKline, Pfizer, Eli Lilly, and Merck’s Schering-Plough -accounted for 53 percent, or $10.5 billion, of all financial penalties. The chart below shows there were 10 deals in 2006, 27 in 2008, and 38 last year. Through Nov. 1, 32 settlements have been reached this year, but there have been more recent deals (see here and here).

Off-label marketing was responsible for the largest amount of financial penalties, although Glaxo recently agreed to pay $750 million fine to settle charges over numerous production problems at a former facility in Puerto Rico, signaling the feds are now eyeing manufacturing fraud as another avenue of pursuit (back story).

qui-tam-pharma-settlements-chart

The most common violation against state governments was deliberately overcharging state health programs, primarily Medicaid, and this was responsible for the largest amount of financial penalties levied by the states. And former pharma employees and other whistleblowers initiated the largest number of federal settlements over the past 10 years. From 1991 through 2000, such cases comprised 9 percent of payouts to the government, but from 2001 through 2010, they accounted for 67 percent.

The report goes on to list all violations that led to settlements: overcharging government health programs; illegal promotion; anti-trust violations; kickbacks; concealing clinical trial findings; poor manufacturing practices; environmental violations; financial violations and illegal distribution.

 

Chuck Nemeroff – really, really pissed off… but still really, really rich!

Did I mention the textbook that Chuck Nemeroff wrote, oops – or rather he didn’t, but he might have done, or at least he might have seen some drafts and approved them… who knows?

Probably not Chuck  because his memory is so bad – maybe that’s why he forgot to disclose all that cash he got from drug companies (wasn’t it about $1.5 million?).

That’s one poor memory!

Anyway, now he’s really pissed off and wants to sue POGO because they ran a story about the ghostwritten Nemeroff textbook – and so did the the New York Times in their story: Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say

Here are some downloads for you while away the long winter hours with – thanks to 1 Boring Old Man

POGO Letter to NIH on Ghostwriting Academics
November 29, 2010 – Revised December 9, 2010
Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say
November 29, 2010
APA Statement: Psychiatric Book Not Ghostwritten
November 30, 2010
Ghostbusters at POGO
December 1, 2010
Letters from Drs. Nemeroff’s and Schatzberg’s Lawyers to POGO
December 2, 2010
NYT Corrections
December 8, 2010
POGO’s first reply to letters from Dr. Schatzberg and Dr. Nemeroff
December 8, 2010
Nature Editorial
December 8/9, 2010
Letters from Drs. Nemeroff’s and Schatzberg’s Lawyer to POGO
December 9, 2010
POGO’s second reply to letters from Dr. Schatzberg and Dr. Nemeroff
December 9, 2010

Interesting that Nemeroff thinks his reputation has been damaged by these revalations, rather than by what he has actually done in his long and chequered career.

Read more about Professor Charles Nemeroff and his links with big pharma – if the price is right he’s your man.

WikiLeaks – big pharma revelations next…?

In a rare, two-hour interview conducted in London on November 11, Julian Assange said that he’s still sitting on a trove of secret documents, about half of which relate to the private sector. And WikiLeaks’ next target will be a major American bank. “It will give a true and representative insight into how banks behave at the executive level in a way that will stimulate investigations and reforms, I presume,” he said, adding: “For this, there’s only one similar example. It’s like the Enron emails.”

“You could call it the ecosystem of corruption. But it’s also all the regular decision making that turns a blind eye to and supports unethical practices: the oversight that’s not done, the priorities of executives, how they think they’re fulfilling their own self-interest. The way they talk about it”.

Let’s just walk through other industries. What about pharmaceutical companies?

“Yes. To be clear, we have so much unprocessed stuff, I’m not even sure about all of it. These are just things I’ve briefly looked at or that one of our people have told me about”.

Let’s all hope that WikiLeaks will be throwing its spotlight on the pharmaceuticals indiustry sooner rather than later.

Read the entire interview here.

1 Boring Old Man… & Chuck Nemeroff

A retired Doctor (the 1 Boring old Man) writes about Nemeroff and Ghostwriting:

Like Dr. Healy, I have some personal reasons for being upset about all of this. In 1974, I changed careers from Internal Medicine to Psychiatry and Psychoanalysis because of an interest in the mind, and I never looked back. I was in academic medicine at Emory University after retraining. In the early 1980’s, a new Chairman arrived, and it was clear that my interests were not compatible with the wave of Biological Psychiatry that was sweeping the specialty, and I left for private practice, continuing to teach in the Psychoanalytic Institute, but no longer involved with the Psychiatry Department. At that time, I wasn’t bitter and enjoyed my private practice. A few years later, Dr. Nemeroff became Chairman. I had little to no contact with him, but heard plenty. During the decade that followed, Psychiatry changed so much I hardly recognized it. The journals were filled with drug research and meetings became monotonous and boring.

I learned about the new drugs, and found that the SSRI’s were effective in controlling depressive and obsessive compulsive symptoms in certain cases, and so I prescribed them, but my main work was as a psychotherapist and psychoanalyst. I personally thought that the “Biological Wave” was something of a fad that would pass in time – finding its appropriate place. But then I began to realize, along with lots of other colleagues, that the “Biological Wave” was more than a fad, it had a motor – the Pharmaceutical Industry looking for profit. I resented the intrusion of Drug Companies into the practice of Psychiatry and into academic medicine – the place where practitioners looked for guidance. As time went on, I further learned that the intrusion had reached criminal proportions with university physicians in on the the game. That is absolutely infuriating! And a lot of it was centered at my University [Emory], in my town [Atlanta, Georgia], where I practiced – so I’m hardly unbiased in this matter. That is my own conflict of interest statement in toto.

Read the entire post here.

Thanks to Soulful Sepulcher for this… and keep with all the latest news from Stephany on Twitter: @soulflsepulcher

Keller, Nemeroff: more on the ghostwriting they put their names to

According to documents, Glaxo began to push sales of Paxil in the early 1990s with an extensive ghostwriting program run by the marketing firm Scientific Therapeutics Information (STI). For instance, STI wrote a proposal to organize GlaxoSmithKline’s Paxil Advisory Board Meeting in 1993 at the Ritz Carlton Hotel in Palm Beach, Florida.

STI chose good ol’ Chuck Nemeroff as their speaker to lay out the meeting’s agenda and objectives.  Nemeroff apparently led discussions on how to “evaluate clinical research/promotional programs” and “generate information for use in promotion/education.”

STI’s ghostwriting included editorials, journal articles, and even a textbook that was widely used by primary care physicians to treat psychiatric disorders. Further details here.

[Thanks to Bob Fiddaman for this story].

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