Foxes in the Henhouse

© Juan Auni’n | 123rf.com

© Juan Auni’n | 123rf.com

On February 24, 2016, 2015 the FDA announced that Robert Califf MD was confirmed as the new Commissioner of the FDA by an 89 to 4 vote in the Senate. There seems to be opposing opinions regarding his role as the new FDA Commissioner. Presidential candidate Bernie Sanders opposed his appointment because of his extensive ties to the pharmaceutical industry and lack of commitment to lowering drug prices. Writing for Forbes, Matthew Herper said: “Any senators who slow his path to the job he [Califf] deserves should be accused of practicing the basest kind of partisanship.”

Herper said it was no shock that Califf was nominated. His nomination seems to have been the culmination of a leadership transition at the FDA beginning before Califf was appointed as the FDA Deputy Commissioner for Medical Products and Tobacco in January of 2015. Herper said Califf’s departure from Duke University was a clear sign this transition was already in the works. Herper wasn’t alone in seeing this potential nomination and appointment.

Also writing for Forbes, David Kroll commented that Califf’s position as Deputy Commissioner for Medical Products and Tobacco was second in scope to being commissioner of the FDA. Massimo Calabresi, in his article for Time in February of 2015, also suggested Carliff could be the next FDA Commissioner. Then the serving FDA Commissioner, Margaret Hamburg announced she would step down at the end of March 2015. According to Herper, Califf’s name had been in circulation six years ago when Hamburg was nominated. But he was widely seen at the time as having too many links with industry. So instead, the Obama administration went with Hamburg.

Herper acknowledged Califf’s ties with the medical industry, but felt he worked with drug companies “in the best possible way”—convincing them to do large, expensive clinical trials. Not only were these trials profitable for Duke, but they helped prove the effectiveness of major medicines like Plavix, Vytroin, and Zarelto. But he hasn’t been a pushover. “His goal has always seemed to be to make sure that doctors and patients have the best evidence possible for deciding what drugs to give to patients. He has not always been easy on industry.”

Massimo Calabresi gave a more nuanced portrayal of Califf. At Duke, he was the founding director of the Duke Clinical Research Institute, which is considered to be one of the world’s largest academic research organization, with an annual budget of $320 million. Califf himself estimated that 50 to 60% of this annual research funding comes from industry. Calabresi captured the controversy nicely about Carliff when he noted that Carliff sees collaboration between industry, academia and the government as the way of the future: “The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors.”

Carliff went on to say there was a tension that cannot be avoided between the industry and creating the conditions where the industry can thrive. “The FDA’s got to do both.” He thought it would be useful to have someone leading the FDA who understood how companies operate, “because you’re interacting with them all the time.” Calabresi said the tension over Callif’s collaboration with industry gets at the heart of the FDA at a pivotal moment. “While FDA defenders see the collaboration as a threat to its independence, others see close relationships between government, industry and academia as the model for the future.”

Diana Zuckerman, President of the National Center for Health Research, which advocates for FDA regulatory authority, says such ties “should be of great concern.” Dr. Califf is “a very accomplished, smart physician who’s been an important name in the field,” Zuckerman says, but his “interdependent relationships” raise questions about his “objectivity and distance.” She cites several studies suggesting the medical products industry uses such ties to influence the behavior and decision making of doctors and researchers, even when the scientists don’t realize it.

Senator Sanders said he strongly believed “We need a leader at the FDA who is prepared to stand up to the drug companies.” Someone who will strive to substantially lower drug prices, to develop rules to safely import brand-name drugs from Canada “and hold companies accountable who defraud our government.” Carliff’s extensive ties to the pharmaceutical industry did not give him reason to believe he would make “the FDA work for ordinary Americans rather than the CEOs of pharmaceutical companies.”

Whether or not Senator Sanders’ reservations about Robert Carliff come true remain to be seen. But there is a more troubling tie between the pharmaceutical industry and our government to consider. Reporting for The New York Times, Nicholas Kristof said the pharmaceutical industry spent $272,000 in campaign contributions per member of Congress in 2015. And there are more pharma lobbyists than there are members of Congress. One of the key issues at stake is to keep the government from bargaining for lower drug process with Medicare. “That amounts to a $50 billion annual gift to pharmaceutical companies.”

Reporting for STAT News, Sheila Kaplan and Ike Swetliyz said that around 30% of US Senators and 20% of US Representative hold assets in biomedical and health-care companies. Johnson & Johnson, Merck and Pfizer were favored investments for members of the House and the Senate. Some of the most aggressive congressional investors in the biomedical sector served on key committees. The House Energy and Commerce Committee for example, which oversees the FDA and works on issues of importance to the industry such as drug regulation, research funding and taxes on medical devices.

Members of Congress owned more stock in health-related companies last year than in the defense and construction sectors combined, according to the Center for Responsive Politics. Their investments in the sector topped $68 million.

They described legislators who had financial investments and even ownership stakes in companies that Congress was regulating. One Congressman who sits on the Energy and Commerce Committee co-sponsored a bill to repeal taxes on medical devices. If passed, this bill would help two companies in which he has heavily invested. He also proposed that the FDA loosen requirements for drug companies to track the safety and effectiveness of their products once they are on the market. Not only would that provision help many drug companies, it would benefit a biotech company in which he is the largest single stockholder.

Dr. Michael Carome, the director of a nonprofit health advocacy organization, Public Citizen’s Health Research Group, said: “Even if the lawmakers aren’t personally picking and choosing each stock, knowingly holding stocks in pharmaceutical and medical device companies creates obvious financial conflicts of interest.”

Members of Congress are not required to recuse themselves from voting on bills that could effect their personal finances, unless they would be the primary beneficiary of the legislation.

Yet across most of the federal government, employees are required to recuse themselves from working on issues that could influence the value of their investments. Within the Department of Human Services, employees are barred from owning stock in drug companies or other industries that the agency closely regulates.  STAT said they called dozens of lawmakers for their story, but none would comment in detail about their investments.

Matthew Herper’s opening comment about partisan politics blocking Califf’s appointment seems to have been baseless. He almost had unanimous support. Whether or not he will be tough on the industry remains to be seen. And with regard to partisanship, it was Democratic Senators who held up his nomination; and three of the four opposing votes were from Democrats. So only 20 to 30 percent of U.S. Member of Congress have a financial stake in biomedical and health-care companies. But it is disturbing that several of those legislators are on committees making regulatory decisions for those companies. And when you consider that the number of pharma lobbyists outnumbers the sitting legislators, it seems we have a situation where the foxes have been invited into the henhouse.