This week saw the biggest ever settlement involving the pharmaceutical industry. Glaxo Smith Kline (GSK) agreed to pay the US government 3 billion dollars in fines and penalties relating to the marketing of three drugs. Whilst this is a massive amount of money it is worth noting that combined sales of the threes drugs has been nearly $30 billion or ten times the penalty.
According to the Financial Times GSK has cash flow of around $9 billion in both 2010 and 2011. In simplest terms the penalty whilst big in absolute terms is not huge in terms of dollars generated by the company!
The three drugs involved were Avandia (for diabetes), Wellbuturin and Paxil (both antidepressants). The major issue was about the promotion of the drugs to doctors for conditions other than which they are “approved for”. Whilst doctors are allowed to prescribe medications “off label” companies are not allowed to promote drugs for these purposes.
In the case of Paxil prosecutors claimed it had been promoted for use in children and adolescents. Allegedly clinical data had been misrepresented. Previously it had come out that trials showing negative findings on Paxil had been not published whilst only favorable ones were.
Wellbuturin was allegedly promoted for weight loss and sexual dysfunction despite being only approved as an antidepressant. In Australia the drug is marketed as Zyban and is only approved as a stop smoking aid! With Avandia the issue was about non-reporting of major safety issues. The diabetes drug had been shown to increase the risk of heart attack.
The CEO of the company did a mea culpa saying that changes had been made on his watch and that these problems represented the past at GSK.
Some of the fine print is fascinating. Apparently Dr Drew Pinsky (who had a syndicated radio show called Loveline) was paid $275,000 for two months to promote Wellbuturin for sexual dysfunction in 1999. And of course there were a series of junkets to tropical locations for prescribing doctors and opinion leaders.
The Financial Times in an opinion piece noted that the public and politicians got very irate over interest rate allegations at Barclays Bank but not the issues at GSK, which it (and I agree) regarded as much worse. To quote the Financial Times GSK “has pleaded guilty to criminal conduct to settle charges of selling unsuitable drugs, including to adolescents. People caught doing that in nightclubs go to jail. People caught doing it to generate extra sales get a telling off from the US Attorney’s office”.
So what are we to make of this? The FT has nailed an issue which rarely gets airplay and that is how we treat drugs quite arbitrarily. Some substances we take to boost our mood are legal and others are not. There is far less rhyme or reason to this than you might believe.
Whilst the substances are different, the reasons they are taken and the net result is often not that different. The evidence base around antidepressants is dodgy. In mild to moderate depression they are no better than placebo. Irving Kirsch in his book “The Emperors New Drugs” argues quite convincingly that all effect of antidepressants is placebo. In other words they work but not because of the active substance but because we believe they work!
Certainly the SSRI antidepressants have been a heavily marketed class of drug and there has also been a pattern of looking for other uses as the GSK case showed. Sales of the medications have skyrocketed over the last 15 years but with no notable improvement in people’s mental health.
There are major problems, which a fine does not fix. Firstly is the problem with trials and data including what gets studied and gets published. Secondly is the problem of medical “opinion leaders” who are paid by companies, and hence are not independent when it comes to the information they provide to other doctors.
And finally is societies love affair with pills. Collectively doctors have become too eager to prescribe medications and patients too eager to take them. Life problems such as relationship hassles, financial strain and even grief are real and need to be dealt with, but they are NOT medical diseases needing a tablet.
Change needs to occur at multiple levels. For the individual patient the question is do I really need a pill?