Presidential campaigns have a way of eliciting bold and sweeping commitments from its candidates that don’t always translate into policy. It’s usually not until after cabinet and key positions are filled that the tea leaves reveal what is in store. After all; personal is policy. On the campaign trail, candidate Trump claimed that his supporters constantly spoke to him about the opioid epidemic. In response, he pledged to end the epidemic at a Columbus, Ohio town hall meeting last August; “we’re going to work with them (addicts), we’re going to spend the money, we’re gonna get that habit broken.” This promise became central to his campaign and reiterated in stump speeches throughout the remainder of the election.
President Trump seems to be making good on his pledge. In March (2017) he appointed New Jersey Governor Chris Christie to head a federal commission whose sole purpose is to identify the status of the epidemic and make recommendations for the future. Christie – who lost a close friend to an opioid overdose and has been outspoken about the need for reform – has a personal interest in ending opioid abuse and overdoses which makes him the perfect candidate for this position.
If there were a polar opposite of Governor Christie it might just be the President’s nominee to head the Food and Drug Administration, Dr. Scott Gottlieb. Looking at his CV you might think Gottlieb crafted his career – like an artist chisels a statue out of a block of stone – specifically for this appointment.
Dr. Gottlieb, 44, is very accomplished. According to his Wikipedia page, Gottlieb is a physician, internist at Tisch Hospital, clinical assistant professor at New York University School of Medicine, and conservative health policy analyst. He has held many positions in the federal government including being a member of the White House Biodefense Interagency Working Group, Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration (FDA) during the Bush Administration, and has testified as an expert witness before committees of the United States House of Representatives and Senate on issues related to FDA regulation, healthcare reform, and medical innovation. Gottlieb is also a cancer survivor who regularly writes healthcare policy op-eds for many national newspapers and magazines, and is a frequent guest on cable TV shows.
But there is another side to Dr. Gottlieb that not all have seen. Before he studied medicine, Gottlieb worked as a healthcare analyst at the Baltimore office of Alex. Brown & Sons, an investment bank. Since 2007 he has been a partner at New Enterprise Associates, which he describes as “one of the world’s largest and most active venture capital firms.” His focus at the firm has been on health care investments. In addition, he is also a senior principal at the investment bank TR Winston, and partner at the hedge fund Arcoda Capital Management; all health care–centric finance groups. He has served on five pharmaceutical companies’ boards and is currently a member of GlaxoSmithKline’s product investment board. Gottlieb is also a resident fellow at the American Enterprise Institute where he researches the FDA and the Centers for Medicare & Medicaid Services.
Due to his nomination, Gottlieb was required to provide Health and Human Services associate general counsel for ethics, Elizabeth Fischmann, disclosure statements revealing any conflicts of interest or financial ties to companies in the health industry. In his report, Gottlieb stated he has approximately two dozen healthcarerelated companies in which he has a financial interest. Gottlieb also stated he would divest his interests in those companies within 90 days of his confirmation.
Harvard professor Daniel Carpenter, an expert on the FDA, stated that; “These are not relationships whose influence just disappears once he resigns from a corporate board. If (Gottlieb) is confirmed, he would be the most interest-conflicted commissioner in American history, by far.”
Upon news of Gottlieb’s nomination, The Pharmaceutical Research and Manufacturers of America’s (Pharma) CEO Stephen J. Ubl sent out congratulations stating; “We look forward to working with Dr. Gottlieb in his new role, as they seek to modernize the drug discovery and review process and advance competition in the biopharmaceutical market.”
According to Market Watch, a Mizuho Securities USA survey found “72% of 53 drug companies polled favored Gottlieb for the position.” Gottlieb’s disclosure statements reveal a troubling relationship with opioid manufacturers and distributors. According to a federal database, he received more than $400,000 in payments from pharmaceutical companies between 2013 and 2015. From 2016 to the present Gottlieb has accepted almost $45,000 in speaking fees from firms involved in the manufacture and distribution of opioids.
Public Citizen’s Health Research Group director, Dr. Michael Carrome, had this to say about Gottlieb; “He is someone who has been an industry shill and has spent most of his career dedicated to promoting the financial interests of pharmaceutical corporations.” “He is entangled in an unprecedented web of close financial and business ties to the pharmaceutical industry and was no doubt chosen because he is well-suited to carry out the President’s reckless, ill-informed vision for deregulating the FDA’s review and approval process for prescription medications, including opioids.”
On April 5, 2017, Gottlieb appeared before a Senate panel for a confirmation hearing. Gottlieb was quoted as saying that “the opioid addiction is the biggest crisis facing the agency and will ’require dramatic action,’ including finding ways to spur development of nonaddictive alternative painkillers as well as addiction treatments.” He said tackling the crisis would be his first priority.
At the conclusion of the meeting, the ranking Democrat on the Health, Education, Labor, and Pensions Committee, Senator Patty Murray (Wash.), said she believed the panel needed to slow down the vetting process, to give time to review Gottlieb’s “unprecedented financial entanglements in the industries he would regulate as commissioner.”
The most important question still unanswered is which Dr. Scott Gottlieb will we get? Will it be cancer surviving internist with compassion for others suffering from disease, a man who is determined to quickly expedite the approval of generic and orphan drugs? Or will we get the Washington insider venture capitalist hell-bent on getting more drugs approved at a faster pace with ambivalence towards drug efficacy and public safety? This almost feels like election season all over again – a lot of talk and promises made by people who will never be held accountable for their statements once their appointment is approved by congress. If there is one thing that I’ve learned watching our political process, it is that person is policy. The President is going to fill key positions with the people who will carry out his vision.
That being said, perhaps a look into the President’s recent activities will give us better insight to the new direction of the FDA. One of the first groups Trump met with after becoming president in January was the pharmaceutical industry. Trump, who stressed on the campaign trail that “pharmaceutical companies are getting away with murder,” threw caution into the wind by telling big pharma execs that he plans to cut the FDA’s regulatory playbook. “Instead of it being 9,000 pages, it’ll be 100 pages. We’re also going to be streamlining the process so that from your standpoint so that when you have a drug, you can actually get it approved — if it works — instead of waiting for many, many years.”
In early April (2017) insiders reported that Trump intends to tap former lawyer and current Rep. Tom Marino for the position of U.S. Drug Czar (Office of National Drug Control Policy – ONDCP). Marino, who is currently serving his third term as the U.S. Representative for Pennsylvania’s 10th congressional district, is not without controversy.
In 2016, Marino authored and supported the Ensuring Patient Access and Effective Drug Enforcement Act. The bill’s supporters claim it struck the right balance between the needs of patients, the pharmaceutical industry, and law enforcement. However, detractors of the bill claim the legislation undercuts the DEA’s ability to hold pharmaceutical drug distributors accountable for the diversion of large amounts of opioid pain relievers. More specifically, Joseph Rannazzisi, JD, RPh, head of the DEA Office of Diversion Control, cautioned the bill, backed by a pharmaceutical industry lobbying campaign, would protect corporations engaged in criminal activity. “This bill passes the way it’s written we won’t be able to get immediate suspension orders, we won’t be able to stop the hemorrhaging of these drugs out of these bad pharmacies and these bad corporations. What you’re doing is filing a bill that will protect defendants in our cases.”
If you look at Christie, Gottlieb, and Marino’s appointments independently, you might not think much about any one of them. However, when you take into consideration that Christie’s job ends in November and Gottlieb and Marino serve at the President’s pleasure, the tea leaves begin to reveal their secrets.
The FDA is the most important government agency to our economy in that it regulates industries that account for nearly 25 percent of consumer spending in the U.S. That represents a lot of jobs and prosperity, something else former businessman and current President Trump promised on the stump. He can only keep one of his promises, end the opioid epidemic or open the flood gates at the FDA. Which promise he intends to keep will be reflected by the actions Gottlieb takes as head of the FDA.
I have not given up hope because we still have a voice in this discussion. Make your thoughts known by calling your congressmen and senator. Phone calls matter. There is a new app called 5calls.org that makes it easy to find your representative and their contact information. Exercise your rights and give it a try.
John Giordano, Doctor of Humane Letters, MAC, CAP, is the
founder of ‘Life Enhancement Recovery Center,’ an Addiction
Treatment Consultant, President, and Founder of the National
Institute for Holistic Addiction Studies, Chaplain of the North Miami
Police Department and is the Second Vice President of the Greater
North Miami Chamber of Commerce. He is on the editorial board
of the highly respected scientific Journal of Reward Deficiency
Syndrome (JRDS) and has contributed to over 65 papers published
in peer-reviewed scientific and medical journals. For the latest
development in cutting-edge addiction treatment check out his