January 15, 2020

Science and Business: Imperfect Partners

By admin

For those of you that read this blog (thank you!) and those who just started (thank you!), you’ll know from previous entries that I don’t question science.

Science is an ever-expanding, quantifiable universe of facts.

Motives, however, clog and obfuscate the results of scientific research.

Profit motives make the situation even more grotesque, delivering monstrous results and companies become excellent saboteurs of their own objectives.

This recent article about clinical testing proves my suspicions about the blurring of lines between pure science and the companies and institutions that oversee the results that are derived from research.

And that ultimately drives public policy.

For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.

Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline. As of that date, those habitual violators had failed to report any results for 67% of their trials and averaged 268 days late for those and all trials that missed their deadlines. They included such eminent institutions as the Harvard University–affiliated Boston Children’s Hospital, the University of Minnesota, and Baylor College of Medicine—all among the top 50 recipients of NIH grants in 2019.

Let that sink in for a second. Take a minute. Hell, take an hour if you want.

2 of out 3 scientific results were NOT reported, even though required to do so.

Three years later, TrialsTracker conservatively estimates that FDA could have collected more than $6 billion in ClinicalTrials.gov penalties so far. The agency has yet to demand a single dollar. And despite more than 2600 trials for which results are overdue or were filed late, NIH has yet to withhold a single grant as a result or post a single violation notice on ClinicalTrials.gov. No “wall of shame” exists.

“Public-facing websites run by the government should be accurate. That’s not asking much,” Senator Chuck Grassley (R–IA), who advocated for the 2007 law, wrote in an email after reviewing a summary of the Science findings. “It’s a question of basic management and agency competence. The government has a duty to police its work product, especially because the public trusts .gov websites will be accurate and reliable.”

To physician Ben Goldacre, who directs the Oxford program behind TrialsTracker, “The lack of urgency is really troubling.”

When tests, data runs and analysis fail to deliver results – IN A BIG WAY – we as the public need to be very concerned about what this means, especially when the vast majority of these tests relate to products and prescriptions that are delivered every single day in our over-medicated community.

Please understand again when I say I don’t doubt the science.

I doubt the organizations that hide the truths that the science reveals simply so that they can make a buck.