Medical ethics expert discusses concerns about transparency of clinical trials

Dr. Jennifer Miller spoke at Augusta University about drug ethics in Augusta, Ga., Wednesday afternoon December 6, 2017. MICHAEL HOLAHAN/STAFF

Dr. Jennifer Miller asked who considered pharmaceutical companies honest and ethical and in the room full of medical residents and students at Augusta University not a single hand went up.


“Zero?” said Miller, who has given her presentation many times. “I’ve never gotten zero.” She is trying to change company behavior by grading them on how well they adhere to ethical standards in clinical trials and transparency.

Miller, an assistant professor of medical ethics at New York University and president of Bioethics International, created the Good Pharma Scorecard to grade those companies initially on how transparent they are in making clinical trial data public. The scorecard was published online Tuesday and two companies – Johnson & Johnson and Sanofi – tied for first with a perfect 100 percent score while Valeant was last with a 50 percent score.

“You’re really seeing a change in the industry,” she said.

Miller and colleagues published an accompanying article in BMJ Open on their data. They looked at 19 new drugs from 11 large companies approved by the Food and Drug Administration in 2014 and examined 505 trials associated with them.

While 65 percent of the trials were disclosed at FDA approval, that rose to 96 percent of the trials that involved patients 13 months after approval. That could vary widely based on the drug, however. After initially finding that half of the drugs approved in 2012 lacked information on a phase 2 or phase 3 clinical trial, which are usually large and important trials involving a greater number of patients, that number shrank to about a third of drugs approved in 2014. FDA requires companies to make trial data public but no one has ever been fined for not doing so and the language requiring it was “incredibly unclear” and open to different interpretations, Miller said.

Still, there were “striking” differences between drugs in terms of transparency, according to the study. For the insomnia drug Belsomra, for instance, six out of 37 trials used for its approval were done in patients and all of that data was publicly available but only 20 percent of the rest of the trials were available. There could be a reason for that – the drug has been denounced by Consumer Reports after medical experts it hired concluded the data shows the drug only helps patients fall asleep faster by six minutes on average and stay asleep 16 minutes longer compared to a placebo while also carrying significant potential side effects and expense.

Miller said she was not surprised by the skepticism of pharmaceutical companies. The percentage of people who trust those companies has decreased from 79 percent in 1997 to just 10 percent this year.

“This distrust has been getting steadily worse,” she said. About 9 out of 10 people believe the industry puts its profits ahead of its concerns for people, Miller said. By making the scorecard, she not only gives the industry a chance to show off its efforts at transparency but puts a public spotlight on them.

“No one want to look bad in the public space,” Miller said, and there is a truism that “what gets measured gets done.”

She would like to next take a look at the design of clinical trials, particularly since most of the early clinical trials use healthy young white males that are not representative of the patients that will eventually use the drug.

“We want to make sure there is more inclusivity in clinical trials, more access,” Miller said.

each Tom Corwin at (706) 823-3213




Fri, 02/23/2018 - 19:39

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