Why is the US pharma lobby still opposing clinical trial transparency?
The American lobby group PhRMA has long fought to preserve impunity for pharmaceutical companies that hide clinical trial results.
New data suggest that its stance is outdated and runs counter to the majority of its members’ interests.
In 2018, patients, doctors and medical researchers called on the US Food and Drug Administration (FDA) to impose fines on companies that undermine patient safety and public health by making their clinical trial results public.
Together with the medical device lobby group AdvaMED, PhRMA was the only player that opposed such sanctions, despite overwhelming evidence that keeping clinical trial results hidden can harm patients and undermine public health. Over 2,000 trials of drugs and medical devices are currently missing results.
In the end, PhRMA got its way. The FDA recently refused to systematically enforce a 2007 law that requires companies (and universities) to make clinical trial results public. De facto, for the foreseeable future, pharma companies can continue to hide clinical trial results they do not like – and get away with it.
Data collected by TranspariMED suggest that PhRMA scored an own goal by lobbying in favour of medical opacity and continued impunity for law-breaking companies.
While PhRMA’s actions reinforced negative stereotypes about the drug industry, the companies that make up its membership had long since moved on.
To pharma critics, the results will come as a surprise: 32 out of 33 PhRMA members have made all of their clinical trial results public as required by law.
UPDATE 07 Oct 2020: This blog originally stated that two PhRMA members were not fully compliant with the law, which was accurate at the time. In the days since the blog appeared, one of the companies uploaded its final missing clinical trial result. As of today, only Bristol-Myers Squibb remains non-compliant - but it too has already uploaded one of the results listed in the image below. This blog has been updated to reflect the current status quo.
Only one PhRMA member company has failed to disclose some of its trial results:
Bristol-Myers Squibb has failed to make public the results of five trials [see update above], including several cancer trials and a trial that involved chronically ill children. This is completely unacceptable, and is an example of how one major company’s failings can drag down the reputation of the sector as a whole.
The vast majority of PhRMA members are already in compliance with transparency laws and have nothing to gain from opposing transparency.
However, law-abiding members of PhRMA have a lot to lose:
PhRMA’s stance poses a reputational risk for member companies and the entire sector
PhRMA’s stance gives law-breaking companies an unfair competitive advantage over PhRMA’s own law-abiding members
TranspariMED urges companies that are members of PhRMA to contact their trade association and ask it to stop opposing the full implementation of the transparency provisions of the FDA Amendments Act.
Note on methodology: TranspariMED searched the FDAAA Trials Tracker for the names of PhRMA member companies, working from a public list on the PhRMA website, on 30 September 2020. TranspariMED reviewed companies’ current performance to see whether required trial results were publicly available on ClinicalTrials.gov at the time of assessment. TranspariMED did not assess whether those results had originally been posted within the timeframe set out by US law. The FDAAA Trials Tracker was developed by CEBM at the University of Oxford. CEBM was not involved in data extraction or the writing of this blog.