Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, June 25, 2015

GSK's Product Placement - Channel 5 Respond!

Last week I wrote about how I had learned that, in 2013, GlaxoSmithKline and bosses at Channel 5, a UK terrestrial TV channel, had struck a deal to have GSK's product, Maximuscle, placed into the popular TV show Big Brother (Back story)

Here's the email I wrote...

Dear Sir/Madam,
I'd be grateful if you could pass this along to the relevant department at CH 5.
It recently came to my attention that GlaxoSmithKline's product, Maximuscle, was used as a  product placement deal for a Celebrity Big Brother task in 2013.
Whilst I understand, to a small degree, business and advertising revenue, I cannot understand why Channel 5 would agree to placing a product marketed and manufactured by GlaxoSmithKline given that the British pharmaceutical giant, one year previous to collaboration with Ch 5, were fined a record $3 billion in a fraud settlement in the United States.
The criminal charges involved the illegal marketing of the antidepressants Paxil and Wellbutrin and the withholding of data on the health risks of the diabetes medication Avandia.
Paxil (Known as Seroxat in the UK)
Although the antidepressant Paxil is not approved for patients under 18, Glaxo illegally marketed the drug for use in children and teens, offering kickbacks to doctors and sales representatives to push the drug. Many children and teens who took the drug went on to self harm and/or carry out acts of violence on other and/or kill themselves.
Glaxo used the help of PR firms and the appeal of lavish vacations to convince medical professionals to prescribe the antidepressant Wellbutrin for weight loss, sexual dysfunction, drug addiction and ADHD, even though the drug is FDA approved only to treat depression. 
For seven years, Glaxo failed to report data to the FDA showing that its blockbuster diabetes drug, Avandia, approved in 1999, increased heart risks in patients.
In 2007, the drug was banned in Europe. The European Medicines Agency concluded that the heart risks of Avandia did not justify its blood sugar benefits.
I'd be grateful if a representative of CH 5 could explain why they endorsed a GlaxoSmithKline product on one of its most popular TV programmes given that they (GSK) had one year previously plead guilty and paid $3 billion to resolve fraud allegations and failure to report safety data.
I look forward to you reply.

I also sent a copy to Viacom, the owners of Channel 5.

Earlier today I received a response. It's priceless.

Date:  25th June 2015
Dear Bob
Thank you for your recent enquiry regarding Celebrity Big Brother. 
We were sorry to read your concerns regarding a GlaxoSmithKine product being featured in the 2013 series of this programme. Irrespective of any past legal action involving this company in the United States, they are a legitimate company and although some people may have concerns about their business practices, we do not believe that this should preclude them from placing products in a television programme in accordance with the relevant guidelines.
As a commercial television channel we fund our programming and engineering costs through advertisements and programme sponsorship opportunities. However, this does not mean that we will accept advertising or sponsorship from companies or products making misleading or false claims.
Nevertheless, we do appreciate your concerns and we would like to thank you for taking the time to contact us. Your comments on this issue have been logged in our Viewer Enquiries Report for the attention of all relevant personnel.
Thank you for your interest in Channel 5. 
Yours sincerely


I've wrote back the following. You will note where I have highlighted what Channel 5 appear to have missed when doing their homework on the British multi-million pharmaceutical company.

Thank you for your reply.
However, I am somewhat baffled by the line, "this does not mean that we will accept advertising or sponsorship from companies or products making misleading or false claims."
Did you read the Department of Justice Department's verdict?
Here's what GlaxoSmithKline agreed to plead guilty to.

  • GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.

Civil Settlement Agreement
As part of this global resolution, GSK has agreed to resolve its civil liability for the following alleged conduct: (1) promoting the drugs Paxil, Wellbutrin, Advair, Lamictal and Zofran for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex; (2) making false and misleading statements concerning the safety of Avandia; and (3) reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.
Off-Label Promotion and Kickbacks: The civil settlement resolves claims set forth in a complaint filed by the United States alleging that, in addition to promoting the drugs Paxil and Wellbutrin for unapproved, non-covered uses, GSK also promoted its asthma drug, Advair, for first-line therapy for mild asthma patients even though it was not approved or medically appropriate under these circumstances. GSK also promoted Advair for chronic obstructive pulmonary disease with misleading claims as to the relevant treatment guidelines. The civil settlement also resolves allegations that GSK promoted Lamictal, an anti-epileptic medication, for off-label, non-covered psychiatric uses, neuropathic pain and pain management. It further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. It also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex. The United States alleges that this conduct caused false claims to be submitted to federal health care programs.
GSK has agreed to pay $1.043 billion relating to false claims arising from this alleged conduct. The federal share of this settlement is $832 million and the state share is $210 million.
This off-label civil settlement resolves four lawsuits pending in federal court in the District of Massachusetts under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.
Avandia: In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleadingrepresentations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. The federal share of this settlement is $508 million and the state share is $149 million.

Not to mention the fact that GSK are also the subject of UK litigation regarding the antidepressant Seroxat. How do you think the plaintiffs in the case against them feel when they see GSK products advertised on your programme? 
Is it possible to make a request under the terms of the FOIA to Viacom or Channel 5? The answer you gave me, to be honest, is quite shocking and someone at Viacom or Channel 5 obviously did not do their homework on GlaxoSmithKline.
Bob Fiddaman.

For me, the above correspondence is of public interest, hence the publication of it on this blog.

I will endeavor to keep readers updated should Channel 5, or indeed Viacom, wish to further answer my query.

Bob Fiddaman.

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