EXECUTIVE SUMMARY

About a third of 103 cancer patients who spoke at advisory committee meetings in a 15-year period reported financial ties to industry, found a recent analysis.

  • In two instances, speakers failed to disclose their financial ties.
  • Only six speakers — none with financial ties — presented negative opinions.
  • Some advisory committees have patient representatives who vote.

Much attention has been paid to clinicians with financial ties to industry and resulting conflicts of interest, but patients who speak at public meetings also have financial ties, found a recent analysis.1

Researchers analyzed speakers at all 49 meetings of the FDA’s Oncologic Drugs Advisory Committee from 2009 to 2014. Some key findings include the following:

  • More than 90% of the 103 public speakers who were cancer patients supported approval of the drug. About 30% reported financial ties to the drugmaker.
  • In two instances, speakers failed to disclose their financial ties. The researchers discovered through online searches that the speakers represented organizations that had received money from the drug company.
  • Only six speakers — none of whom reported financial ties — presented negative opinions. These speakers generally called for better safety and efficacy data.

Genevieve Pham-Kanter, PhD, assistant professor in the department of health management and policy at Drexel University School of Public Health in Philadelphia, didn’t find it particularly surprising that some of the public speakers had ties to industry — either as individuals or through organizations.

This is because individuals who are sufficiently motivated to expend the effort, time, and money to participate as public speakers in these hearings are typically those who feel very strongly about advocating for access to a particular drug.

“Their interests, and those of the sponsor of the drug, are aligned,” she explains. Pham-Kanter is also a senior fellow at the University of Pennsylvania’s Leonard Davis Institute of Health Economics.

What was somewhat surprising to Pham-Kanter was the relatively small proportion of public speakers who highlight potential safety issues and oppose approval.

“Consumer safety advocates are strongly motivated to keep drugs they perceive to be unsafe off the market,” she notes. “We would have expected to have seen greater representation of these types of advocates.”

Some Patients Do Vote

Joseph Golec, PhD, a professor of finance at the University of Connecticut, co-authored a 2015 report examining FDA advisory committees and conflicts of interest.2 The report analyzed only individuals on the advisory committee who vote, not those who simply speak at the meetings. The authors concluded that conflicts of interest don’t unduly influence voting patterns on FDA advisory committees.

“Many, but not all, committees have a patient representative who votes. So the sample of these members is relatively small,” notes Golec. That subset of members voted to recommend drug approval more frequently than other members. “Because of the small sample, the statistical significance of the difference in voting between conflicted and unconflicted members is weak,” says Golec.

Golec believes the effects of conflicts on voting are not significant. The report found that members with conflicts have more expertise. This is possibly because they are sought out by drug companies to run clinical trials. “To get the top specialists, one may have to accept that they will have ties to drug companies,” says Golec.

Patient representatives who serve on advisory committees as voting members are required to disclose their ties and abide by conflict-of-interest rules. Pham-Kanter says, “Because many patients are interested in increasing access to therapies, they are natural allies with drug companies, who also want more drugs on the market.”

As long as patients’ financial ties are being disclosed and managed appropriately, Pham-Kanter doesn’t see these as particularly problematic.

Other public speakers don’t have a formal voting role on committees, but present as independent commentators. These speakers do not have to abide by conflict-of-interest rules.

It’s possible that public speakers from patient advocacy organizations are substantially supported by industry. “But because the industry financial ties of these organizations do not have to be disclosed, advisory committees could be presented with a misleading picture of the role the public speakers are playing,” says Pham-Kanter. She sees the following three ethical concerns:

  • if the advisory committee doesn’t know about the full scope of the speaker’s — or his or her organization’s — financial ties,
  • if the roster of public speakers is dominated by those who are funded by industry and representing industry interests, and
  • if the roster doesn’t sufficiently represent consumer groups concerned about safety, which are generally less well-funded.

Currently, advisory committees incorporate public speakers’ concerns in different ways. “My understanding is that the FDA has been seeking to formalize and standardize the process for including patient concerns in its decision-making,” says Pham-Kanter. “Standardization would represent progress.”

REFERENCES

  1. Abola MV, Prasad V. Characteristics and conflicts of public speakers at meetings of the oncologic drugs advisory committee to the U.S. Food and Drug Administration. JAMA Intern Med. 2016; 176(3):389-391.
  2. Golec J, Cooper JC. Searle Civil Justice Institute Report. FDA advisory committees: Conflict of interest and voting relative to benchmarks. January 2015.

SOURCES

  • Joseph Golec, PhD, School of Business, University of Connecticut, Storrs, CT. Phone: (860) 486-6327. Email: Joseph.Golec@business.uconn.edu.
  • Genevieve Pham-Kanter, PhD, Assistant Professor, Department of Health Management and Policy, Drexel University School of Public Health, Philadelphia. Phone: (267) 359-6163. Email: gpkanter@drexel.edu.