Barry Blackwell’s response to Charles Beasley’s response
Barry Blackwell: Corporate corruption in the psychopharmaceutical industry
I am grateful to Charles Beasley, an ACNP member and Distinguished Lilly Scholar, for sharing his expertise regarding the statistical nuances and economic burden on industry that derive from searching for serious side effects of investigational drugs in clinical trials, a problem akin to searching for a needle in the haystack.
The large sample sizes and costs can be viewed as both a rationale to justify the high cost of marketed drugs or a disincentive to innovative drug development. Charles comments on the recent surge of attempts to profit in the generic arena when there is no competition, by imposing exorbitant price increases. This is now curbed by legislation in Maryland; a strategy we can hope will spread to other States.
Of greater concern, but not mentioned, is the dramatic price differential and recent increases for top-selling prescribed and patented drugs in America compared to elsewhere in the world. Drug costs in America account for 12-14% of all health care spending. This averages just over a $1,000 per capita annually, the highest in the world - three times higher than UK, six times higher than Brazil and 12 times higher than India. Costs rose by 127% in America between 2008 and 2014, compared to an 11% rise in US household goods, and were higher than anywhere else worldwide. Industry defends these cost differentials by invoking the price of new drug development and the significant discounts bargained for by providers and insurance companies. However, the widely accepted major factor is that Governments in all the countries with a single payer health care system impose cost controls on drugs which America declined to do with Medicare.
Returning to the cost of discovering serious side effects Charles notes that having a prospective hypothesis as to their nature simplifies trial design and reduces cost. Personal experience suggests this is possible but unlikely. The rare but fatal consequences of interaction between tyramine containing foods and MAO inhibitors were completely predictable based on existing knowledge in the literature and the same can be said for the NSAID analgesics. Both enzyme systems are active at multiple sites in the body and a competent basic scientist could have uncovered possible risks to be investigated in pre-clinical animal studies and Phase 1 clinical trials in humans. In my experience, both as an investigator (MAOI) and patient (NSAIDS), this was not the case and even after life-threatening side effects were reported industry disputed or denied their relevance until facts overwhelmed myopia.
Charles’ final point concerns the difficulty of obtaining two consecutive positive clinical trials to achieve FDA approval. This is a reminder of how some companies dealt with this by concealing negative trials, a practice we hope remains in the past.
Since INHN posted my essay on Corporate Corruption I have become aware of profound ethical lassitude and passivity towards accepting the status quo among colleagues. Undoubtedly, this is due to a perception that the political and industry forces opposing change are insuperable. These include the vast economic resources at industry’s command which they deploy with more than 600 lobbyists who engineered and maintain ill-advised Congressional legislation that transferred scientific discoveries to industry, that weakened FDA’s integrity and oversight of new drug development and was used to establish economic dependency on industry support for medical education, so called Key Opinion Leaders (KOL’s), as well as professional and advocacy organizations.
These strategies have taken hold in a cultural Zeitgeist of greed and addiction to money along with political and public acceptance of income disparity.
I regret the need to mingle science and politics in this response especially since I respect and admire Charles Beasley’s willingness to debate the issues. I welcome whatever response he might make.
May 3, 2018