Midodrine: keep taking the tablets

Photo: Steven Saltzberg's Genomics blog

What happens to patients when a drug they have relied on for years is suddenly due to be taken off the market?  This was the situation for users of Midodrine in 2010, when the US regulator the FDA announced that the drug's licence was to be withdrawn.  Goldacre (2012: 138-140) tells how the drug had been developed and patented, and had been approved in 1996, but with only limited clinical data to support its therapeutic claims.  Fourteen years later, the patent owner had still failed to provide this evidence (although the company disputed this). The FDA's announcement provoked a public outcry from some of the 100,000 US users of the drug, triggered in part by anecdotal evidence from patients published in the national and international press.  

Backing up the stories of patients desperate that something which, regardless of the trials, worked for them (there was no other clinically proven alternative on the market), was a Facebook campaign which helpfully linked supporters to their representatives in Congress.  When the FDA reversed its decision after just a month of lobbying, some of the same publications which had earlier criticised the FDA for ignoring the voices of patients (for example Miller 2010), now derided the same agency for ignoring its own stated principles of evidence-based decision making.  More bizarrely, the owner of the Midodrine patent), which had announced that it was to cease manufacturing in any case, changed its corporate mind and decided to continue to market the drug (Star Tribune, citing Associated Press 2010).  

The original action of the FDA I call 'third party demarketing', which is where an outside body - goverment, regulator, judge, etc. - intervenes to try and ban or restrict a product or service. This action often results in boosting demand, as the principle of psychological reactance kicks in. This theory states that withdrawing something that people have enjoyed the freedom of causes them to like it still more. In the case of Midodrine, patients felt this was something they could not do without. The flurry of press activity just after the FDA's original intention to withdraw the product licence may have been spontaneous, or may have been triggered by PR agencies hired by the manufacturers. The outcome was the same, though: the FDA backtracked and, despite the lack of clinical data, patients continued to be prescribed Midodrine.


References

Goldacre, Ben (2012), Bad Pharma: How drug companies mislead doctors and harm patients, London: Fourth Estate

Miller, Henry I. (2010), “Agency dithers, reputation withers - Ditsy decisions make for dizzy bureaucrats”, The Washington Times, 29 September 
Star Tribune (2010), “FDA backs off plan to withdraw Shire low blood-pressure drug midodrine from market”, Star Tribune citing Associated Press, 6 September