Tuesday, July 3, 2012

NHS & Banks: Regulation & Failures

Lehman Brothers Building New York now Barclays Capital ©2009 Am Ang Zhang
As Barclays was singled out amongst a number of UK banks in the so called Libor price fixing scandal, heads might indeed fall on the side of Bank of England.

Is it a failure of the regulators? Only time will tell. At least Mr Bob Diamond is handing the government a neat £290 million. Nobody dies as a result.

In Health Care, regulatory failure tells a different story. Failure of regulation often means death, and unnecessary death at that. Worst if you have an organisation such as NICE that actually set up protocols and made recommendations for treatment instead of leaving it to doctors, the deaths are in-excusable.

In my book The Cockroach Catcher:             

.....The trust between the doctor and the patient has been responsible for, as long as medicine is in existence, that mysterious force that brings about healing and often cures. That is all but gone. Now doctors have to act according to guidelines, protocols and rules, written or otherwise. Interestingly there is as yet no guideline for guideline writers. Two of the most commonly used drugs recommended by NICE for diabetes, which were taken by hundreds of thousands of mostly overweight people in the U.K. last year, were shown to cause widespread heart failure[1]. The embarrassing alarm was raised by a “maverick” doctor[2]. 

When I last visited Costa Rica, I met a fellow traveler form the US. When he realized that I was a child psychiatrist cornered me to ask if I used Paxil. Luckily for me, I was not converted to it. He then went on to tell me his sad story. His only son suffered depression of sorts and was prescribed Paxil. Within six weeks or so he had a call from his son’s College: he hanged himself.

Well, GlaxoSmithKleine has just been fined $3 Billion for Avandia, Paxil & Wellbutin.

The Guardian:

GSK targeted the antidepressant Paxil (Paroxetine) at patients under age 18 when it was approved only for adults, and promoted the drug Wellbutrin for uses it was not approved for, including weight loss and treatment of sexual dysfunction, according to a US justice department investigation.

The company went to extreme lengths to promote the drugs, such as distributing a misleading medical journal article and providing doctors with meals and spa treatments that amounted to illegal kickbacks, prosecutors said.

"The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts," said US attorney Carmin Ortiz.

In a third case, GSK failed to give the US Food and Drug Administration safety data about its diabetes drug Avandia, in violation of US law, prosecutors said.

The misconduct began in the late 1990s and continued, in the case of Avandia's safety data, through to 2007. GSK agreed to plead guilty to three misdemeanour criminal counts, one each related to the three drugs.

Guilty pleas in cases of alleged corporate misconduct are exceedingly rare, making GSK's agreement especially unusual.

Remember my post in 2008:

Seroxat and Ribena
Now the story of Ribena has to be one of those sweet (sorry) stories one remembers for a long, long time. Nobody died either.

In Health Care, death unfortunately is irreversible.

GSK: Paroxetine: in the UK marketed as Seroxat and in the US as Paxil.

[1] Diabetes drugs recommended by National Institute for Health and Clinical Excellence (NICE)  were linked by scientists to heart failure.  Last year 1.8m prescriptions were written across the UK, which scientists say equates to several hundred thousand patients taking the drugs which are  recommended for use across the NHS by NICE.  But researchers today call on NICE to think again, revealing that as many as one in every 50 patients taking the drugs Avandia (rosiglitazone) and Actos (pioglitazone) over a period of 26 months will have to be hospitalised for heart failure.

[2] Dr Steven E. Nissen - Drug Safety Critic Hurls Darts From the Inside
     Dr. Nissen is shaking up the nation’s pharmaceutical industry.  His questioning of the safety of the Avandia diabetes medication in late May, for example, prompted a federal safety alert and led to a sales decline of about 30 percent for the drug, which brought in $3.2 billion for GlaxoSmithKline last year. Now, with a federal panel soon to decide whether it can remain on the market, Avandia’s future is uncertain.
    The drug is the latest example of why Dr. Nissen, 58, whose day job is chairman of cardiovascular medicine at the Cleveland Clinic, has emerged as a Naderesque figure and the nation’s unofficial arbiter of drug safety.

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