US Attorney General Eric Holder and the Revolving Door

Covington - DOJ - Covington

I'm not really into American politics, not really into British politics either, I'd sooner read knitting patterns as politics, in general, bores me rigid.

That's not to say that every now and again something pops up that is of interest. None more so than the recent news surrounding US Attorney General, Eric Holder.

Holder was part of the legal team for the Department of Justice (DOJ) - the same team that fined GlaxoSmithKline a staggering $3 billion for promoting its best-selling antidepressants (Paxil and Wellbutrin) for unapproved uses and failing to report safety data about its top diabetes drug, Avandia.

Bizarrely, Holder had previously worked for the law firm, Covington, who specialize in representing (defending) pharmaceutical companies in litigation.

It was quite a turnaround. One minute Holder is defending pharmaceutical companies, the next, he's prosecuting them.

Strange then that, after just 6 years with the DOJ, he should return to Covington as a partner.

So, what input, if any at all, did Holder have regarding the negotiations of the $3 billion settlement figure, and, more importantly, could the original figure, said to be a lot more than $3 billion, have been whittled down by Holder? Furthermore, who was exactly behind the Wellbutrin promotion, was it, as some sources suggest, the current CEO of Glaxo, Andrew Witty, who, at the time of the illegal promotion, was Vice President General Manager of Marketing for Glaxo?

I'm just throwing the question out there because this revolving door between Covington and the DOJ seems, to me at least, to be bordering on being incestuous.

News of Holder's double u-turn came via Melayna Lokosky who has wrote a quite brilliant blog post where she raises many questions regarding Holder's latest "unethical move."

Her blog can be read, in full, here.

Lokosky also tweets about it via her Twitter account, here.


One to keep an eye on.


Bob Fiddaman.

Hey Glaxo, Guess Who's Been Talking?

GSK Whistleblower Blair Hamrick & Bob Fiddaman

I started writing this blog back in 2006. I had some issues with the antidepressant drug manufactured and marketed by British pharmaceutical giant GlaxoSmithKline. I also had some issues with the way drugs were regulated in this country by the British drug regulator, the MHRA.

Eight years on and I have learned so much about GlaxoSmithKline... I learned more about them yesterday evening as I sat down to dinner with Blair Hamrick, one of the whistleblowers who blew the lid on Glaxo's fraud in the US, a blow which, after 11 years of legal wrangle, Glaxo settled for a record breaking $3 billion.

Blair is a very brave soul for going up against the company that he once worked for. His life is now back on track after Glaxo sacked him then muddied the waters so he couldn't get a job elsewhere in the pharmaceutical field. Yes, he was paid handsomely for his bravery and is now living a life that most could only dream of. 

Despite the publicity, fame and riches Blair is one of the most down to earth people you could ever wish to meet, a trait that became evident when he just couldn't bring himself to promote the antidepressant Wellbutrin off-label to doctor's.

Wellbutrin is an antidepressant and indicated to treat adults that are depressed. Blair, whilst working for GSK, was prompted by senior management to promote it off-label to doctors for treating children. He just couldn't bring himself to do that. One of the side effects of Wellbutrin is seizures and Blair envisaged kids going into seizure. "It was wrong, it wasn't indicated for kids and I just couldn't bring myself to tell doctor's it was okay for kids to take," Blair told me over a glass of wine in the plush settings of one of Westminster's finest hotels in London. "They also tried to market it as the happy-horny-skinny pill because they had learned through post marketing that patients taking it for depression were losing weight and reporting high sex drives." [increased libido] Wellbutrin was not indicated for this but the Glaxo marketing team came up with the "happy-horny-skinny pill" line so reps could convince doctors to prescribe it to patients who were overweight and also those who were experiencing a low sex drive [decreased libido]

Blair also spoke about the doctors who were paid by GlaxoSmithKline, a staggering 48,000 doctors were paid speaker fees, attendance fees and given lavish gifts, all in an attempt to get them to prescribe more of Glaxo's drugs.

"We'd pay doctor's between $2-4000 to give a talk to other doctor's.

"6 or 7 doctors would be invited out for dinner, sometimes with their spouses in tow, they'd be wined and dined and then the speaker would talk about the wonders of drug a or b, of course these were off-label "wonders" - that's how Glaxo rolled.

"Our marketing team would send them a slide-show and a carefully scripted narrative so they could convince other doctor's that it was okay to prescribe a number of drugs off-label.

"Some doctor's, whose basic annual salary was around $150,000, could give 2 or 3 talks in a week, giving them a potential to earn up to an extra $12,000 per week.

"I was also given luxury private box tickets for sporting events, these would be given to doctors as a 'thank-you' or incentive to prescribe more and more of Glaxo's drugs."

Glaxo, at some point during these wanton violations, caught wind that their off-label promotion had been leaked and reps were told to be careful what they added to their call-notes.

Call-notes are what pharmaceutical reps use to familiarize themselves with a doctor.

"The way it worked was that a doctor would be visited by a rep who would  then add notes to a hand-held device.

"It was useful because we knew what these doctor's liked, be it a particular football, baseball team or if he had a sweet tooth - on the next visit we would bring in a small token of gesture, be it tickets to the game or sweet tasting delicacies - it was just a way to keep them prescribing more drugs."

Blair recalled a meeting where reps were told to be careful what they wrote in the call-notes, the crux of the meeting was basically to tell reps to "write right", in other words write down the legal stuff and not the violations.

I asked Blair about Glaxo's recent announcement that they are going to be more transparent.

"The whole transparency thing wasn't a conscious decision by Glaxo, their hand was forced, it was all part of the settlement - it makes me laugh when I now read how they are claiming to offer up the results of their clinical trials, they were told that's what they had to do as part of the agreement they entered into with the Department of Justice."

Regular readers of this blog will note the tagline I use, "It's perverse when GSK claim that they are going to be more transparent when they do not offer transparency when writing about their transparency."

I could have listened and talked to Blair all night, alas I had a train to catch back home, a train that I almost missed due to losing track of the time.

Blair Hamrick, along with the other whistleblowers in this particular case, should be applauded for their efforts. It's no coincidence that Glaxo are now being investigated for the same type of violations in other countries. 

Blair blew the whistle and it almost took the roof off GSK, for that he deserves a future of happiness. His conscience not to promote a drug that could cause kids to have seizures was frowned upon by senior management at GSK - what kind of human being could promote a drug that could be potentially harmful to children, moreover, what type of human being could sanction such a promotion?

On a side note, I wasn't just in London yesterday to meet Blair. Earlier on I met with a film-maker who is in the process of making a documentary about antidepressants. The film-maker also dined with myself, Blair and his partner. More about the documentary in a future post.

I now have something to tell my grandchildren.

I once had dinner with Blair.

Bob Fiddaman

Whistleblower Cases Under Federal and State FCAs

Whistleblower Cases Under Federal and State FCAs Settled with Prescription Drug Manufacturers as of September 30, 2004 [Source]

AstraZeneca
Settlement Date: 6/20/03
Product: Zoladex (prostate cancer)
Total Recovey: $355 million
Type of Alleged Fraud: Marketing the spread Concealment of “Best Price”
Whistleblower: Sales executive of competitor TAP Pharmaceuticals


Bayer I
Settlement Date: 1/23/01
Product: Kogenate, Koate-HP (hemophilia) Gamimune (immune deficiency)
Total Recovey: $14 million
Type of Alleged Fraud: Marketing the spread Concealment of “Best Price”
Whistleblower: Specialty pharmacy (same as Dey, Schering-Plough I)


Bayer II
Settlement Date: 4/16/03
Product: Adalat CC (blood pressure) Cipro (antibiotic)
Total Recovey: $257 million
Type of Alleged Fraud: Concealment of “Best Price”
Whistleblower: Bayer marketing executive


Dey*
Settlement Date: 6/11/03
Product: Albuterol Sulfate and Ipratropium Bromide (asthma inhalants)
Total Recovey: $18.5 million
Type of Alleged Fraud: Marketing the spread
Whistleblower: Independent pharmacy (same as Bayer, Schering-Plough I)


GlaxoSmithKline
Settlement Date: 4/16/03
Product: Paxil (anti-depressant) Flonase (nasal allegy spray)
Total Recovey: $88 million
Type of Alleged Fraud: Concealment of “Best Price”(derived from Bayer marketing executive allegations)
Whistleblower: (derived from Bayer marketing executive allegations)


Pfizer I
Settlement Date: 10/28/02
Product: Lipitor (cholesterol)
Total Recovey: $49 million
Type of Alleged Fraud: Concealment of “Best Price”
Whistleblower: National account manager for Pfizer subsidiary


Pfizer II
Settlement Date: 5/13/04
Product: Neurontin (anti-seizure for epilepsy)
Total Recovey: $430 million
Type of Alleged Fraud: Off-label marketing
Whistleblower: Medical liaison to physicians for Pfizer subsidiary


Schering-Plough I*
Settlement Date: 5/3/04
Product: Albuterol drugs (asthma inhalants)
Total Recovey: $27 million
Type of Alleged Fraud: Marketing the spread
Whistleblower: Specialty pharmacy (same as Bayer, Dey)


Schering-Plough II
Settlement Date: 7/29/04
Product: Claritin family of products (non-sedating antihistamines)
Total Recovey: $345 million
Type of Alleged Fraud: Concealment of “Best Price”
Whistleblower: Three employees at Schering-Plough subsidiary


TAP Pharmaceuticals
Settlement Date: 10/3/01
Product: Lupron (prostate cancer)
Total Recovey: $875 million
Type of Alleged Fraud: Marketing the spread. Concealment of “Best Price”
Whistleblower: HMO physician and TAP sales executive

*Settled under the False Claims Act and the Texas Medicaid Fraud Prevention Act

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Pharmaceutical companies in the news - Taxpayers Against Fraud

Source: JOINT EFFORT BLOG

Forest Laborator is charged with defrauding the goverment
DoJ has charged Forest Laboratories with defrauding the government by illegally marketing the antidepressants Celexa and Lexapro for unapproved use in children and teenagers. Prosecutors charge former top executives at Forest with concealing a clinical study that showed that Celexa and Lexapro were not effective in children and might even pose risks, including causing some to become suicidal.

Amgen -biotechnology company -Massive Amgen Fraud Case
An unidentified whistleblower has filed a False Claims Act case against Amgen, the biotechnology company which makes arthritis and psoriasis drug Enbrel, and anti-anemia drug Aranesp. Amerisource-Bergen and online health-information provider WebMD Health Corp are also named. The case came out from under seal at a judge’s directive, and DoJ is still deciding if it will join. The case involves off-label marketing, kickbacks and Medicaid best price violations.

Johnson & Johnson and Scios are alleged in off-label marketing
The U.S. Justice Department has joined two whistleblower lawsuits alleging that Johnson & Johnson and Scios engaged in off-label marketing of the cardiac drug Natrecor.

GlaxoSmithKline has reserved $400 million to settle off-label and kick back chargesGlaxo’s $400 Million Reserve
GlaxoSmithKline has reserved $400 million to settle off-label and kick back charges related to “several products” sold from 1997 to 2004, including the antidepressant Wellbutrin. Glaxo said the reserve “reflects the current status of the [DoJ] investigation.”

1- Tenet Heathcare — $900,000,000 under the False Claims Act
2- HCA — $731,400,000 under the False Claims Act
3- Merck - $650,000 under the False Claims Act
4- HCA — $631,000,000 under the False Claims Act
5- Serono– $567,000,000 under the False Claims Act
6- TAP [Taketa-Abbott Pharmaceutical] Pharmaceutical Products Inc. — $559,483,560 under the False Claims Act
7- Schering Plough — $255,000,000 under the False Claims Act
8- Abbott Labs– $400,000,000 under the False Claims Act
9- Fresenius Medical Care of North America (National Medical Care) — $385,000,000 under the False Claims Act
10- Cephalon - $375,000,000 under the False Claims Act
11- Bristol Myers Squib — $328,000,000 under the False Claims Act
12- SmithKline Beecham Clinical Laboratories Inc. doing business as GlaxoSmith Kline — $325,000,000 under the False Claims Act
13- HealthSouth — $325,000,000 under the False Claims Act
14- National Medical Enterprises — $324,200,000 under the False Claims Act
15- Gambro Healthcare — $310,000,000 under the False Claims Act
16- Schering-Plough– $292,969,482 under the False Claims Act
17- AstraZeneca Pharmaceuticals — $266,127,844 under the False Claims Act
18- St. Barnabas Hospitals — $265,000,000 under the False Claims Act
19- Bayer Corporation — $257,200,000 under the False Claims Act
20- Schering-Plough — $255,000,000 under the False Claims Act

For more info read the Joint Effort Blog

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

UK Whistleblowers Protected, It Seems?

Interesting thread over at Gianna Kali's Beyond Meds blog.

Gianna writes:

"This is old news but still quite relevant and disturbing. From the Henry Kaiser Family Foundation."

She then pastes a snippet from the aforementioned site and adds, "There is clearly simply mind-blowing amounts of illegal activities going on in pharma and medicine. So much that employees can’t stand it anymore."

What is fascinating about this particular post of Gianna's is the comment section. I'll cut and paste for you here. It's certainly food for thought.


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GSK better watch its back for whistleblowers… To cut costs, the Corporation is throwing 10,000 employees on the streets.. They are rightly going to be very angry and very disgruntled employees. And, worse still, they know exactly where their bosses in the boardroom have buried the bodies, so to speak…

So… to all soon-to-be-sacked GSK staff: it’s time to spill the beans! Go on! You know you’ve always want to! Well soon you can, without any risk of censure.. In fact, the law today in England & Wales prohibits discrimination against corporate whistleblowers…. So the time is ripe to sing like canaries!

And as an added bonus (if a whistleblower should ever need one) there is now a criminal offence of Corporate Manslaughter on the British statute books.

The Courts can jail a company executive for life..where it is shown he has killed people through malfeasance or criminal negligence. And let’s be frank,, is there a single executive in Big Pharma who hasn’t killed people in that way?

Corporate Manslaughter should be an easy crime to prove of Big Pharma executives. Those rogues are gangsters. If they weren’t running the prescription drug industry, they would be running guns and narcotics around the globe.. In fact, that’s exactly what some of them have been doing at Eli Lilly…

Let’s hope the Courts have the stomach to pack the prison cells to bursting point with these monsters..

The worm is turning….

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Maybe something good did come out of Tony Blair’s government, after all?!

The Act is here.. The date of the Act commencement was 6 April 2008, so it’s live today..

To date, no successful prosecutions under the Act, SFAIK.. Plenty of time yet, though..

Corporate Manslaughter and Corporate Homicide Act 2007

An Act to create a new offence that, in England and Wales or Northern Ireland, is to be called corporate manslaughter and, in Scotland, is to be called corporate homicide; and to make provision in connection with that offence. [26th July 2007]
……

The offence

An organisation to which this section applies is guilty of an offence if the way in which its activities are managed or organised— causes a person’s death, and, amounts to a gross breach of a relevant duty of care owed by the organisation to the deceased…

An organisation is guilty of an offence under this section only if the way in which its activities are managed or organised by its senior management is a substantial element in the breach..

I think the executives of a company must get prosecuted separately through another Act or under the common law….

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Here is a bit of background on the whistleblowers’ protection under the Public Interest Disclosure Act 1998.

For those about to be sacked by GSK, whistleblowing might be the best option. You could clean up GSK as well as gouge the company at an employment tribunal if GSK tries to punish you…

There is a charity called “Public Concern at Work” that has resident experts who can find the best way to do it..

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Full article at Beyond Meds


Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING