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Public Citizen’s Dr. Michael Carome describes the thousands in consulting fees new FDA commissioner Dr. Robert Califf received from pharmaceutical manufacturers and why only four senators voted against his confirmation

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JESSICA DESVARIEUX, PRODUCER, TRNN: The Food and Drug Administration just got a new commissioner. The Senate confirmed Dr. Robert Califf to head the FDA despite deep opposition from a few senators concerned about his past ties to the pharmaceutical industry. At his confirmation hearing in November, Vermont Senator Bernie Sanders questioned Dr. Califf about making drugs more affordable. BERNIE SANDERS: And do you support the re-importation of brand name prescription drugs from major companies from Canada and from other major, industrialized companies? Yes? No? ROBERT CALIFF: Senator, as you’re aware from our previous discussion, we have major concerns about re-importation. The system it would take to make sure that the drugs are adequate [inaud.]… SANDERS: In other words, you think we can bring in fish products and vegetables from farms all over the world, but we cannot bring from across the Canadian border brand name drugs. DESVARIEUX: But in the end, only four other senators opposed Dr. Califf’s confirmation, a fact that the director of the health research group and think tank Public Citizen, Dr. Michael Carome says is alarming, given the new commissioner’s record. MICHAEL CAROME: Over his more than 30-year career at Duke University, Dr. Califf amassed an intricate web of numerous ties to mainly pharmaceutical companies, but also some drug companies. He’s accepted consulting fees, money for research, and other activities from multiple companies, and, indeed, in the most recent three-year period he accepted personal consulting fees from 19 different major pharmaceutical companies. And what this tells us is that over this career he has developed attitudes and biases that align with the interests of industry, and when push comes to shove, those biases are likely to come into play in his decisions as commissioner of the FDA and will [tell] favorably towards industry interests, rather than the interests of patients and public health. DESVARIEUX: Putting the interests of the public’s health under the pharmaceutical’s interests is exactly why a group of Democratic senators stood in opposition of Dr. Califf’s nomination. They’re especially concerned about how he would handle regulating opioids, like painkillers. In 2014 the Center for Disease Control found that doctors wrote 259 million prescriptions for painkillers in a single year, which is enough for every US adult to have a bottle of these pills. CAROME: Since the late 1990s, these drugs have been heavily promoted by those companies, and that promotion activity has contributed to the overprescribing, by physicians, of opioid drugs, and have contributed to the opioid epidemic this country now faces. For example, Perdue, which makes, is the maker of [Oxycontin], it, that company and three of its executives in 2007 pled guilty to criminal misbranding charges in their promotional activities of their opioid drug [Oxycontin], and that type of over-promotion by drug companies has been a significant contributing factor to drug abuse in this country. The company downplayed the risks of its drugs. They led physicians to believe that they were less addictive than other opioids, and that’s simply not true. And that was the basis for the criminal charges brought against the company and three of its executives. More broadly, in terms of the FDA, the FDA’s regulation of opioids has, in comparison to other drugs, has been poor. They have been too lenient in allowing these products to come to market, and allowing them to be labeled in a way that allows them to be overused and overprescribed by physicians. So, the FDA also has played a role in the opioid epidemic, unfortunately. DESVARIEUX: But what about personal responsibility? Some argue that the pharmaceutical industry cannot carry the burden of the blame, but Dr. Michael Carome says they do, because it comes down to access. CAROME: It’s important to remember that many people who become addicted to opioids started because they received a prescription from a physician for pain, either acute pain following surgery or chronic pain, and so the problem is not, while obviously there are multiple people who play a role in the addiction crisis, and patients to some degree play a role, many of these patients would not have become addicted had they not been overprescribed the drugs in the first place by their health care providers. So, physicians as prescribers have played a key role in the opioid epidemic. DESVARIEUX: Some states have taken the opioid epidemic to federal courts. For example, the state of Kentucky is filing a total of 12 claims against [Perdue Pharma], the maker of OxyContin. They’re suing for false advertising, Medicaid fraud, and unjust enrichment. In the end, the suit could cost Perdue Pharma 1 billion dollars. But without more FDA oversight, Dr. Carome says the states cannot solve this problem alone. CAROME: Because, ultimately, many of the rules that affect prescribing and that affect what drugs come to market and how those drugs are labeled, and what uses the labeling says they should be used for, that’s really a decision of the Food and Drug Administration. The other agency that plays a role is the Drug Enforcement Agency, which schedules these drugs, and the various schedules, each of those schedules what restrictions are to be put in place when prescribing opioids. So, the federal government has a key role in regulating opioids in this country. DESVARIEUX: Regulating opioids may be challenging when you look at which senators get pharmaceutical manufacturers to contribute to their campaigns. It turns out it’s virtually all of them. For the Real News Network, Jessica Desvarieux, Washington.


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