generic drug prices skyrocketing

will do a few blogs on drug company shenanigans (this one includes a blog I started a couple of years ago, below). lots of drug company blogs done in past, but i thought it was time to do a few more....

this one was inspired by a patient call to me this weekend. 63 yo woman with asthma who called saying she needed an albuterol inhaler but was told that there was a $57 copay!!  i called the pharmacy, asked them to try different inhalers (Pro-Air, Ventolin, Proventil, any other albuterol variant....) and they confirmed that the only one covered by insurance was the one with the $57 copay. And this for a drug which has been around for 40-50 years and used to cost about $5 without insurance.

a recent Washington Post article highlighted distressing price-fixing among generic drug companies (see http://edition.pagesuite.com/popovers/dynamic_article_popover.aspx?artguid=c7b7cedb-3ac0-4d16-8501-96635f0ff7f0&appid=1165 ), noting:

--a federal lawsuit last month will be looking at >1 million e-mails, cellphone texts, and other documents from these generic drug companies. this lawsuit started in 2016 in an investivation of 2 drugs, but now involves 16 companies and 300 drugs
--the antitrust lawyer from Connecticut bringing this lawsuit refers to it as most likely "the largest cartel in the history of the United States"
--he refers to albuterol (though this time the pills, not the inhaler as with my patient): Mylan and Sun (generic drug makers) "jumped the price more than 3,400 percent, from 13 cents a tablet to more than $4.70"
--generics account for 90% of prescription in the US, with sales in 2017 of $104 billion. ie, huge industry with relatively few big, economically/politically powerful players, so not so surprising that there are shenanigans leading to monopolistic pricing (though these generic drug companies were formed to combat the brand-name drug monopolies)

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There was an article in STATnews in 2016 (in particular their Pharmalot series by Ed Silverman which regularly exposed drug company malfeasance) about price-fixing amongst generic drug makers. 

--2 generic pharmaceutical executives had finally been accused of price-fixing (see https://www.statnews.com/pharmalot/2016/12/14/heritage-generics-antitrust-price-fixing/?s_campaign=trendmd ). 
    --Jeffrey Glazer and Jason Malek, the chief executive officer and former president respectively of Heritage Pharmaceuticals, were accused by federal authorities of conspiring with rivals to fix prices for doxycycline hyclate and glyburide. 
    --This is the first criminal charges of a two-year federal investigation into such price-fixing among generic pharmaceuticals. At the time of this article no other companies had been named, though Mylan Pharmaceuticals, Teva Pharmaceuticals, Actavis, Lannett Co, Impax Laboratories, Sun Pharmaceuticals, Endo International's Par subsidiary, and Taro Pharmaceuticals had disclosed receiving subpoenas in this investigation. 
    --These two executives had been fired from Heritage in in August 2016 for a seven year "long-running criminal conspiracy that severely damaged Heritage", noting that they had "looted tens of millions of dollars from Heritage by misappropriating its business opportunities, fraudulently obtaining compensation from themselves, and embezzling its intellectual property", per the court documents. 
    --Heritage Pharmaceuticals claimed that these two had redirected more than $9 million to a dummy company between 2012 and 2015.
--Prior findings had found that half of all generics had become more expensive during the prior 12 months, doubling the price of 11 generics, with one medication increasing 17,000%. 
    --This led to an investigation by Sen. Bernie Sanders of Vermont and Representative Elijah Cummings from Maryland, but the manufacturer had refused to testify (including Heritage) stifling the investigation. At that point Sanders had his formidable quote: "pharmaceutical executives must be held accountable for ripping off the American people by charging them the highest prices in the world for prescription drugs… At a time when one out of five Americans cannot afford the medication they need, we must do everything we can to stop the greed and illegal behavior of the drugmakers. Fraud can no longer be an acceptable business model for the pharmaceutical industry."
    --Also as reported by a prior issue of STAT and on a PBS news hour blog on November 4, 2016 (http://www.pbs.org/newshour/rundown/bernie-sanders-requests-federal-investigation-insulin-makers-price-collusion/ ) Sanders and Cummings wanted an FTC investigation into Eli Lilly, Sanofi, and Novo Nordisk, since their price for insulin had been going up in tandem over several years. The cost of insulin from 2000 to 2013 more than tripled from $231 to $736 a year per patient, despite the fact that the original insulin patent had expired 75 years ago. [a recent survey found that the cost of the commonly used insulin glargine is about $300 per bottle for those without insurance, closer to $4000/yr for many patients, according to https://www.goodrx.com/ ]

--and, as a recent addendum: 75 protestors, organized by the Brookline-based Right Care Allance, a patient advocacy coalition, were at Sanofi pharmaceuticals, where 2 mothers delivered the ashes of their diabetic children who died because of the high price of insulin (see https://www.bostonglobe.com/business/2018/11/16/protesters-sanofi-cambridge-decry-high-price-insulin/MeEajamQHARWqDTQKXqPVL/story.html ).  Sanofi is one of 3 insulin manufacturers that marked up insulin prices by as much as 5,000 percent

--there have been many blogs in the past on drug company shenanigans (see http://gmodestmedblogs.blogspot.com/search/label/drug%20companies  ). One (http://gmodestmedblogs.blogspot.com/2015/09/and-drug-company-shenanigans-continue.html  ) commented on the increase in price of doxycycline from $20 for 50 tablets in October 2013 to $1849 in April 2014, an increase of 8000%.

--the whole push for generics (leading to a law in 1984 to establish the FDA rules for generics) was an attempt to lower the excessive costs of meds, especially in the US.  In the past, this has generally worked, with major decreases in cost. but over the last few years, many drug companies have devised ways to subvert the whole intention of the law, as above. or, even going so far as to use an old FDA requirement that all new drugs be proven to be safe and efficacious prior to getting onto the market, and then going after some common and likely highly profitable drugs that predated this FDA pronouncement in 1962 (see http://www.slate.com/articles/health_and_science/medical_examiner/2011/03/a_giant_pain_in_the_wallet.html ). a few highlights:
    --colchicine has been around since at least the 6th century, had cost a few pennies per pill, but URL Pharma won exclusive FDA approval to sell its now brand-name drug at >$5/pill. this was based on a really inexpensive study they did of 184 patients who got placebo vs colchicine at higher or lower dose levels. and now this really important and useful drug regularly requires a prior approval, and in many of my patients, this approval has been denied. a recent case of someone with recurrent gout being put on allopurinol but needed colchicine both to treat his gout and prevent recurrences with allopurinol uptitration. the insurance required me to use the much more toxic 2 drugs of NSAIDs and prednisone prior to getting that approval.
    --or, 17 alpha-hydroxyprogesterone caproate in pregnant women used to prevent preterm birth, also around for eons, going from $15 to $1440 per treatment (and women "typically require 20 injections in the course of their pregnancy") after a drug company was given exclusive approval to sell their now brandname product (along with open company threats that they would sue any pharmacy compounding this generic med, as they had done for decades)

--there was a really great article in the BMJ in 2012, showing that the bulk of drug development is largely targeted on look-alike drugs (yet another ACE-inhibitor) and not new drugs which actually do something different from the old ones; and the R&D costs of drug company development are grossly overstated: see drug co research devel bmj2012 in dropbox, or doi:10.1136/bmj.e4348 

so, in this age of increasing corporate greed and its attendant huge increases in income inequalities, it really is not so surprising that the generic drug companies are doing whatever shenanigans they can pull off to increase their already exorbitant profits. in this case, there are direct adverse health consequences to their greed....

geoff

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