1 Boring Old Man

UK Charges Glaxo With ‘Market Abuse’ For Pay-To-Delay Deals
Pharmalot
by Ed Silverman
04/22/2013

In the latest instance in which drugmakers have been accused of reaching?’pay to delay’ deals that harm consumers, the UK Office of Fair Trading late last week charged that GlaxoSmithKline colluded with three generic drugmakers to forestall the introduction of low-cost versions of its Seroxat antidepressant, which is known as Paxil in the US.

The agreements included "substantial payments" made by Glaxo to Alpharma, Genericks UK and Norton Healthcare in return for a commitment to delay plans to market generic versions of the antidepressant. In announcing its charges, the anti-trust regulator noted that if drugmakers?conspire to delay the potential emergence of generic competition, the UK’s National Health Service may be denied significant cost savings.

‘The introduction of generic medicines can lead to strong competition on price, which can drive savings for the NHS, to the benefit of patients and, ultimately, taxpayers. It is, therefore, particularly important that the OFT fully investigates concerns that independent generic entry may have been delayed in this case," Ann Pope, Senior Director of Services, Infrastructure and Public Markets at the OFT, said in a statement…

In the enduring chronicles of the pharmaceutical industry, SmithKlineFench cum GlaxoSmithKline deserves special mention for corporate criminality with their Paxil [Seroxat] antidepressant at every level from the early approval process to even beyond the end of their patent. Their launch meeting in 1993 moderated by Emory’s Dr. Charlie Nemeroff and organized by STI’s Sally Laden paired these two icons with this SKF [GSK] medication for a trip through every black art in the PHARMA compendium. Now we read that it lasted beyond the grave of patent expiration. If this were sports, we would retire the number as a testimonial to their persistence and hubris in slithering between the cracks of regulations and the law.

Sir William Osler said in antiquity that one could learn all of medicine from the study of one disease – namely Syphilis. Well one could learn all of PHARMA’s tricks by studying GSK’s Paroxetine: ghost writing, data manipulation, suppression of adverse effects, KOL corruption, off-label promotion, indication creep, experimercials, etc., and now patent extension payola. They wrote the book [literally – Recognition and Treatment of Psychiatric Disorders].

The problem is that it was the worst of drugs, and the worst thing about it was that it had enough efficacy to get it on the market and for people to continue taking it. Very early on, my friend’s wife took it and found it helpful. After a time, she tried to stop it and discovered that it can have a now well-known malicious withdrawal syndrome in some. It took her forever to discontinue it no matter how slowly she decreased the dose. At the time, I had never prescribed the drug and could find nothing in the literature about withdrawal. As I was on the Emory faculty, I called a colleague still on the full-time faculty who was studying the drug. He suggested that my friend’s wife was having a return of her depression. That wasn’t right, and I never prescribed the drug myself. So Paroxetine was particularly good at causing akathisia up front, and had a show-stopping withdrawal profile. Oh yeah, it’s apparently not so good for the yet unborn either.