A century ago, a distinction was drawn between the ethical pharmaceutical industry and the patent medicines industry. Ethical companies specified what was in their medicines, whereas the patent industry kept the details hidden.
The Birth of Pharma
The patent medicines industry flourished on the back of a promise that some Secret Health Ingredient in their Treatment (SHIT) would transform us. SHIT allied to the development of modern advertising and marketing gave rise to Pharma, then the most profitable enterprise on earth.
Driven by hope, or need or fear, millions flocked to patent remedies made by companies like Glaxo and Beecham and were injured as a result. These deaths and injuries led to the first efforts at reform the 1906 Act that set up the Chemical Bureau, later the FDA. This Sunlight Act forced the patent medicine companies to spell out the ingredients on the label of their secret potions.
A tightening of the regulatory noose in 1938 that coincided with the development of the Sulpha drugs, the first of a series of Magic Bullets, led to an apparent triumph of the ethical industry over the patent industry. An industry that claims to be ethical, made of companies formed from mergers between companies like Glaxo and Beechams, is still trading on the glories of the 1950s and 1960s.
Pharma is Dead. Long Live Pharma!
But the ethical companies have been body-snatched by Pharma. Its the formerly ethical pharmaceutical companies who now engage in the most sophisticated marketing and advertising on earth and make the greatest profits.
A modern medicine is made of a chemical and information. The hiding these days happens in the information domain with companies like GlaxoSmithKline indicted for misrepresenting the information component of their blockbusters
These modern drugs are also available on patent but in this case a patent means that in return for the sole right to manufacture a product a company should be completely transparent about the ingredients or processes involved so that the market develops to the benefit of all.
But far from doing this, we have recently had the specter of AbbVie supported by all pharmaceutical companies including GSK taking an action against the European Medicines Agencys (a European successor to FDA) policy of open access to clinical trial data. AbbVie specifically want to keep Adverse Event Data from their clinical trials of Humira hidden, with other companies seeking the same for their drugs.
When something goes wrong for someone on their drug, they want doctors and governments and the media to shrug and say Shit happens, rather than ask any questions about the role SHIT may have played in what happened.
The current strategies companies are adopting to maintain their ability to have SHIT in their treatments by refusing access to clinical trial data was first trailed in November 2012 in Wont Get Fooled Again and a series of further posts.
Wont Get Fooled Again was immediately followed by Access to RxISK Data. We called on anyone with a view to tell us what we should do with the data being generated by people reporting adverse events. For instance if there was data on GlaxoSmithKlines Paxil Seroxat Aropax Deroxat what should we do vis-a-vis GSK?
Perhaps inspired by Arthur Shafers vigorous input saying we should have nothing to do with Pharma, there were more comments (73) in response to this post than to any other post ever put up on this blog.
A majority of respondents seemed to see some place for some dealings with pharmaceutical companies. Arthur held out.
SHIT Hits Anne
The second most commented on post on this blog (65) has been Anne-Maries Out of My Mind: Driven to Drink. This is a compelling portrait of how SSRIs in some individuals can trigger a life-destroying alcoholism. The comments offer further telling accounts from others similarly affected that should leave no-one in any doubt but that SSRIs can cause alcoholism.
This led RxISK to come out and state just that that SSRIs can cause alcoholism. We are the only organization or forum that has done so.
One of the surprises to date has been that so few lawyers or others who might be interested have picked this issue up. Britains Daily Mail is full of stories of women being left by husbands because of developing alcoholism that make it clear the women are also taking an SSRI.
Once locked in a drink cycle no-one will believe you if you suggest it might be your SSRI causing the problem not your partner, not your doctor, not AA, not the probation service or the Courts, not the regulators. As Lord Denning would likely have put it if given half a chance:
If their story is right, it is such an appalling vista it cannot be. People drinking after they go on SSRIs should be regarded as alcoholics and if need be should stay in jail rather than be freed and risk a loss of public confidence in the law and pharmaceutical companies.
Accessing RxISK Data
Anne-Maries case was written up and published in the International Journal of Risk and Safety in Medicine - http://davidhealy.org/wp-content/uploads/2013/10/2013-SSRIs-and-alcohol-IJRSM-803091338-002-14-Aug-2013.pdf']);" href="http://davidhealy.org/wp-content/uploads/2013/10/2013-SSRIs-and-alcohol-IJRSM-803091338-002-14-Aug-2013.pdf" target=_blank>HERE.
Following the publication of Anne-Maries article, we have had enquiries from two companies who make generic versions of paroxetine Ranbaxy and Nolem. Both asked whether the paroxetine involved in this case was made by them. These companies appear to be taking seriously their ethical duty to track adverse events and inform regulators. Whether they should just concern themselves with their version of paroxetine is a moot point.
We mentioned to each of them that we then had 31 other reports on Rxisk of SSRI induced alcohol problems 9 on citalopram, 3 on escitalopram, 4 on fluoxetine, 3 on duloxetine, 5 on sertraline, 6 on paroxetine and 2 on venlafaxine. We have had many more since.
Somewhat to our surprise neither company came back asking for more details on any of the other cases, as to whether their drug might be involved.
But the really interesting omission has been the lack of interest from GlaxoSmithKline. Anne-Marie began treatment at a time when most of the paroxetine used in the United Kingdom was manufactured by GSK.
So who is ethical in the ethical pharmaceutical industry?
It takes time to track down details. Arthur should we or should we not hand over details like this? Do we charge for the time involved in tracking them down?