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    Out-of-control drug pricing requires creative solutions

     

    The government has at least acknowledged this problem and in 2012 passed a law called “The Food and Drug Administration Safety and Innovation Act,” which required pharmaceutical companies to post on their websites any anticipated drug shortages. While this doesn’t address the root cause, namely that excessive regulation creates barriers to entry for competition in the generic medicine market, it at least gives physicians on the front lines of medicine time to find alternatives when shortages arise.

    Blog: Is bigger better in today’s urology practice?

    Let’s be honest. Developing a new drug, winning FDA approval, and bringing it to market is an incredibly expensive and financially risky endeavor. According to a study from the Tufts Center for the Study of Drug Development, it costs $2.56 billion to develop a new drug and win FDA approval. As such, the press coverage of Gilead Science’s hepatitis C pill, ledipasvir/sofosbuvir (Harvoni), which costs $94,500 for a 12-week course (yes, that is $1,125 per pill), is not all favorable. But I would argue that as this innovative pill cures 90% of cases of hepatitis C type 1 with almost no side effects and hence significantly reduces the burden of disease including its long-term medical problems such as liver failure, it is likely ethically priced.

    Further, Gilead went to extensive length with direct involvement from the FDA to price this pill, which is in direct comparison to Turing’s almost randomly chosen price of Daraprim, based on the documents released by the Congressional Committee on Oversight and Government Reform.

    And while Shkreli is certainly becoming the poster boy of pharmaceutical executives gone bad, the concept of buying drugs already on the market and dramatically increasing their costs for no apparent reason isn’t new and isn’t limited to Turing. Valeant, for example, purchased isoproterenol) (Isuprel) and nitroprusside (Nitropress) in 2015 and then increased their prices by 525% and 212%, respectively, resulting in increased profits of $351 million. According to a report by Elsevier, out of 4,421 drug groups, 222 had increased in price by 100% or more between November 2013 and November 2014 and 17 had increased by 1,000%.

    Also see: My six-digit mistake with a new health insurer

    Further, this isn’t even Mr. Shkreli’s first-go around at this. How about for our own patients? In a urology-related move in 2014, as CEO of a company named Retrophin, Shkreli purchased the marketing rights to a drug named tiopronin (Thiola) from the FDA and promptly increased the price from $1.50 per pill to $30 per pill. Starting to hit a little closer to home, isn’t it?

    Next: Personal experience

    Henry Rosevear, MD
    Dr. Rosevear, a member of the Urology Times Clinical Practice Board, is in private practice at Pikes Peak Urology, Colorado Springs, CO.

    2 Comments

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    • Anonymous
      You seem surprised/perturbed that Synagis costs more than a prostate removal operation? It took scientists years to develop that drug; anyone can train to cut out a prostate. Also, Turing just did what any capitalist would do; increase price to what the market will tolerate. If people complained urologists charged too much, would you lower your rates?
    • Anonymous
      Duplicate post, delete please.

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