Does Pharma 'Highjack' FDA Public Comment on Cancer Drugs?

Nick Mulcahy

February 05, 2016

UPDATED February 8, 2016 // About one-third of "public" speakers at US Food and Drug Administration (FDA) advisory committee meetings on yet-to-be-approved cancer drugs in recent years had financial ties to the pharmaceutical industry, according to new research.

In other words, public testimony, which is mostly from patients and the staff of nonprofits, and can be emotionally compelling, is regularly supported by private interests.

"The industry has hijacked that microphone; they're using it as their second presentation at advisory committee meetings," senior study author Vinay Prasad, MD, MPH, from the Oregon Health Sciences University in Portland, said in a press statement about the findings, which were published online February 1 as a research letter in JAMA Internal Medicine.

Dr Prasad's strong words are based on the study, which looked at all 103 public speakers at 28 meetings of the FDA Oncologic Drugs Advisory Committee (ODAC) from 2009 to 2014. The committee's recommendations are usually followed by the FDA.

The agenda at an ODAC meeting includes presentations from a drug company and the FDA itself, plus public comment.

Public comment at ODAC was overwhelmingly in favor of the drugs under discussion, the study indicates: 95 of the 103 (92%) speakers supported marketing approval; only six (5.8%) speakers did not (two were neutral).

This occurred even though ODAC meetings are typically reserved for drugs "where the risk–benefit [ratio] is even more questionable than usual," Dr Prasad explained.

Notably, 31 (30%) of the public speakers reported financial ties to the drug maker, including financial support for travel to the FDA meeting or broader organizational support.

This is unfair, Dr Prasad suggested. "The industry already gets a chance to make its case at ODACs. In my mind, any percentage more than 0% is too high," he told Medscape Medical News about the proportion of industry-supported public comment.

But a former chair of the ODAC defends the process.

"The public speaking portion of ODAC meetings is an example of our democracy at work — literally anybody can register to speak," said Mikkael Sekeres, MD, MS, from the Cleveland Clinic Taussig Cancer Institute.

"That some speakers have financial ties to pharma is expected and taken into account as testimony is considered," he told Medscape Medical News.

Dr Sekeres acknowledged that public comment is overwhelmingly positive, but argued against regulating it. "Attempts to balance testimony are antithetical to the purpose of an open speaker portion," he said.

Another expert said that even when advisory committee members have financial ties to pharmaceutical, their voting has not been found to alter decisions.

Thomas Stossel, MD, from Harvard Medical School in Boston, pointed to a study that showed that excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied study (JAMA. 2006;295:1921-1928).

He also asserted that public comment is not hoodwinking the FDA.

"The public testimony, in contrast, is overt advocacy, and the FDA knows it," Dr. Stossel told Medscape Medical News.

However, Dr Prasad and his coauthor, Matthew Abola, BA, a medical student at Case Western Reserve University in Cleveland, also discovered, after some Internet sleuthing, that two speakers did not disclose their financial ties to industry.

Testimony from patients and patient advocates can be a powerful influence, argued Dr Prasad.

Of the 103 public speakers, 46 (44.7%) were patients with the cancer in question, and 32 (31.0%) had used the drug in question.

"Some of the stories are really compelling," Dr Prasad said, "but it's a mistake to assume that people who speak at these hearings represent the average patient or express what the average patient wants."

We're likely hearing more of the upsides.

"We're likely hearing more of the upsides. Patients who suffered real side effects — they are not the ones able to travel to these meetings," he added.

To even out this disparity in public testimony, Dr Prasad proposes a lottery system, of sorts.

"I think the ideal solution would be for patients on pivotal trials to record video diaries describing how things are going and how they feel," he said. At the ODAC in such a scenario, the FDA could play randomly chosen videos, potentially including deceased patients. ODAC needs to hear from "a representative set of patients, not a stacked deck," Dr Prasad asserted.

He also said that his cancer patients in Oregon want drugs that have benefits and risks clearly described. But you won't likely hear from them at ODAC, he pointed out.

"No one is sponsoring patients who don't want drugs that only slow disease progression and who want to know if the drug improves overall survival and, if so, by how much, with what side effects, and at what price," Dr Prasad said.

Dr Prasad, Mr Abola, and Dr Sekeres have disclosed no relevant financial relationships.

JAMA Intern Med. Published online February 1, 2016. Abstract


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