John Giordano, DHL, MAC


David Jolly (U.S. Representative, Florida’s 13th congressional district) thought he was going to Washington to do the people’s work but quickly found out otherwise. He quickly learned that his highest priority as an elected official was to continue to get himself and others in his party elected. Upon arriving at the capital, Jolly was informed his job description changed to telemarketer. His responsibilities as such required him to spend 4 hours per day; 5 days a week along side other congressman calling small individual donors in a cramped, boiler room styled call-center filled with phones. That’s 20 hours a week, he and his colleagues spent dialing for dollars when they could have been writing bills and working on issues important to their constituencies.

According to ‘The Hill’ Magazine, the 2016 presidential election could cost as much as $5 billion, more than double the 2012 campaign’s price tag. Some political pundits are predicting that the totals per presidential candidate might surpass $1.5 billion and go as high as $2 billion. By the end of 2015 the pharmaceutical industry ranked 15th as the most generous industry in terms of campaign contributions with no way of telling how much money PhRMA has given to the faceless super-pacs.

Small individual donors are important to both parties, but getting over the hump is going to be difficult with only small contributions; leaving candidates with just one option – the flush pockets of big money donors such as the pharmaceutical industry and their super-pac dark money. The question of just how much influence powerful corporate interest money buys has been raised – but is yet to be answered.

Self-funded Donald Trump claims he is the only Republican in the race not beholding to any special interest group. Senator Sanders has been attacking Secretary Clinton for what he infers as her indebtedness to big money supporters and ties to Wall Street. In their defense, Secretary Clinton along with the entire Republican field, sans Trump, all claim that money does not influence their vote. Should we, the addiction and its treatment community, be concerned about how much influence campaign contributions and political action committee (PAC) dark money buys?

Perhaps a look at our recent history could give us an indication. It was in 1962 when President John F. Kennedy signed into law landmark legislation – Kefauver-Harris Amendments – that established the framework requiring drug manufacturers to prove scientifically that a medication was not only safe, but effective. The signing represented the culmination of years of political wrangling. This single piece of legislation gave the FDA the teeth they’d been sorely missing to effectively regulate drugs.

But not everyone was happy with the legislation – especially the pharmaceutical industry. At about the same time of the Kefauver-Harris Amendments, a new trade group was formed: Pharmaceutical Research and Manufacturers of America (PhRMA). Their presence was felt at the FDA almost immediately.

Dr. Herbert Leonard Ley, Jr. was a highly regarded physician and academic and appointed Commissioner of the Food and Drug Administration by President Lyndon B. Johnson on July 1, 1968. He served in that capacity for only a year and a half. Dr. Ley denied being fired, telling reporters he preferred the phrase “eased out.”

In an interview with the New York Times after his resignation in December 1969, Dr. Ley warned the public about the FDA’s inability to safeguard Americans. He was critical of Congress, the Nixon Administration and the drug industry. Dr. Ley told the newspaper that the drug company lobbyists, combined with the politicians who worked on behalf of their patrons, could bring “tremendous pressure” to bear on him and his staff, to try preventing FDA restrictions on their drugs. Ley could not be any more concise than he was at the conclusion of his interview stating “the entire issue was about money, pure and simple.”

The 70s brought even more scrutiny upon the fledging agency. Senator Ted Kennedy opened an investigation into charges by FDA employees which stated that “FDA was dominated by the pharmaceutical industry and was inadequately protecting the public against unsafe and ineffective new human and animal drugs.” After an internal investigation and an extensive probe by
a review panel seated by the Department of Health, Education and Welfare (HEW) – renamed as the Department of Health and Human Services (HHS) – the allegations found to be unsubstantiated.

Experts have said that the infusion of politics into the Commissionership is one reason for high turnover of FDA Commissioners in the 70s and 80s. In 1988 congress passed the Food and Drug Administration Act (1988 Act) and established the FDA as an agency of HHS. The FDA commissioner would be appointed by the President but was now required Senate confirmation.

The 90s were summed up best by Sidney Wolfe, M.D. and Director of Public Citizen’s Health Research Group. In a FRONTLINE interview (2003) he stated: “The industry’s [pharmaceutical] influence has been allowed to grow considerably in the absence of congressional oversight. Up until 12 years ago [1991], whenever the FDA would make a mistake — such as the series of mistakes they’ve made in the late 1990s — there would be a congressional hearing. They would have to explain to the legislative branch of the government what went wrong. They would be — properly, and in the best public health sense — on the defensive to try and explain what went wrong. No one is there in the Congress [now]. There have been essentially one or two days of oversight hearings in 12 years, as opposed to maybe the previous 12 years with dozens and dozens of oversights. So they’re getting away with no congressional oversight.”

Gene Haislip, the number three man at the DEA Office Of Diversion for seventeen years, made a similar disclosure after his retirement from the agency in 1997; “For a DEA official to put his or her neck on the line to block a company’s requested quota increase takes an awful lot of guts and a lot of hard work, particularly if that company is supporting members of Congress who have the power to block the agency’s funding.”

It’s important to note that Dr. Wolfe’s and Mr. Haislip’s observations regarding the shift in congresses attitude towards the FDA – the lack of oversight – and the beginning of the FDA’s cozy relationship with PhRMA correlate chronologically with the The Prescription Drug User Fee Act becoming law. The timing also corresponds with the origins of America’s Second Opiate/Opioid Epidemic.

The PDUFA is a law passed by the United States Congress in 1992 which allowed the FDA to charge fees from drug manufacturers for new drug approval applications. The money generated by PDUFA now accounts for nearly half of the FDA’s annual budget and many experts – myself included – believe the fees corrupted the agency.

So just how much does it cost to influence our federal elected officials? Between April 1, 2009 and March 31, 2015 the pharmaceutical manufacturing industry gave a total of $7,869,406 in campaign contributions to 100 senators; and in the two years between Apr 1, 2013 and Mar 31, 2015 – $6,095,087 to 343 house lawmakers with key committee chairs in both house and the senate receiving the lions share. For all intent and purposes, nearly every lawmaker in Washington DC has accepted pharmaceutical manufacturing money. Is this enough money to influence a vote?

But congress is a small player compared to the President of the United States. At the conclusion of 2015, the latest statics available showed the pharmaceutical manufacturing industry has already injected nearly $1,000,000.00 into the presidential race. Expect that number to grow substantially. In the last presidential election cycle (2012), the pharmaceutical and health products industry spent over $50.7 million in campaign contributions and nearly $32 million in the 2014 elections, according to the Center for Responsive Politics.

This year’s top five recipients of PhRMA money are: Secretary Hillary Clinton with more than one-third of total contributions to both parties at $336,416.00 followed by Jeb Bush $152,350.00, Marco Rubio $133,638, Chris Christie $95,350.00 and Ted Cruz $87,364.00.

Congressman Jolly recently proposed The Stop Act bill which would make it illegal for any member of Congress to personally ask voters for money. I applaud his recognition of a small part of a much bigger problem. But I can’t help feeling that, unless his bill is incremental and leading to bigger campaign finance reform, he is missing the target.

Average people make campaign contributions to candidates they like or feel best represent their ideas on governance. Big money donors will never be accused of being so altruistic. Corporations don’t shell out a single nickel without an expectation welded to it. As a society, we’ve seen the results of powerful big money interests creeping into our everyday lives. Did the pharmaceutical industry and their trade group’s campaign contributions and dark money influence the growth of America’s Second Opiate/Opioid Epidemic? Visit open secrets dot org and make your own informed decision. From what I’ve seen, it is long past time to review the influence money has in politics.

John Giordano DHL, MAC is a counselor, President and Founder of the National Institute for Holistic Addiction Studies and Chaplain of the North Miami Police Department. For the latest development in cutting-edge treatment check out his website: http://www.