Home Politics Anti-Cannabis, Big Pharma Companies Tied to FDA Nominee

Anti-Cannabis, Big Pharma Companies Tied to FDA Nominee

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AP

If cannabis were a federally approved drug, it would be regulated by The Food and Drug Administration (FDA). The agency falls under the U.S. Department of Health and Human Services and is tasked with setting federal guidelines for not only food and drugs but also medical devices, cosmetics, and tobacco.

That said, the most important federal agency for the cannabis industry is about to get a new commissioner, Dr. Robert Califf – and he’s been widely criticized for his financial ties to big pharmaceutical companies known to pay big money in Washington D.C. to keep their own interests intact.

Califf, the agency’s current deputy commissioner was nominated by President Obama for the top spot after Margaret Hamburg’s resignation in March.

On Tuesday, Califf won the overall approval of the Senate Committee on Health, Education, Labor and Pensions. However, not every lawmaker on the committee was happy about it.

There were two exceptions at Tuesday’s hearing on Capitol Hill, Alaska Senator Lisa Murkowski (R-AK) and Democratic Senator and democratic presidential candidate Bernie Sanders (I-VT) opposed the nomination.

Sen. Murkowski threatened to block his confirmation, insisting upon reassurances from the FDA that the agency will write the rules for labeling genetically modified salmon – a coveted industry in her home state and a $270 million dollar industry, according to the National Oceanic and Atmospheric Administration.

“I want to make sure the FDA knows voluntary labeling guidelines is not sufficient… I will vote to move him out of committee today but I want my friends and colleagues to be on notice that I have these concerns and I would like to get these resolved before his name moves forward to the floor,” said Sen. Murkowski prior to the final tally of committee votes.

Chairman of the committee, Senator Lamar Alexander (R-TN) asked for a quick resolution between the two before they adjourned. “If there are issues I hope those conversations can be speedy because of the size of the responsibility that he has at the FDA, we need an impressive leader in a confirmed position over there,” said Sen. Alexander.

Senator and Democratic presidential candidate Bernie Sanders was not in attendance on Tuesday but did voice his objections.

 

“We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government. Dr. Califf is not that person,” Sanders said in a statement. “His extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than pharmaceutical industry CEOs.”
The Independent from Vermont planned on sending in his ‘no’ vote by proxy, however, the committee changed to a voice vote before he could submit his answer.

 

The nomination passed unanimously and now awaits final authorization by the Senate.

Dr. Califf and Big Pharma

Prior to his involvement with the FDA, the prominent cardiologist founded the Duke University Clinical Research Institute. The institute helps run clinical studies for some of the largest pharmaceutical companies in the world, which, in turn, fund more than half of the center’s budget. Between 2009 and 2015, he was paid more than $200,000 in consulting fees as documented by the Duke Clinical Research Institute report on conflicts of interest.

The lucrative consulting relationships he had with big pharmaceutical companies before his involvement with the federal government has historically been reserved for FDA commissioners after they leave public office.

“I think if you look at my record you’ll find I’ve never been a proponent of lowering standards,” Califf said during his nomination hearing on Tuesday.

The list of pharmaceutical companies that have paid him for consults prior to his federal tenure is impressive: Johnson & Johnson, Merck & Co., and GlaxoSmithKline PLC, and AstraZeneca.

The Department of Health and Human Services has gone on the record saying that all Califf’s consulting fees since the mid-2000’s have been donated. Califf adds that he has since severed ties with many of those companies to avoid any conflicts of interest.

But concerns remain as many big pharmaceutical companies are spending big money lobbying for their industry’s interests.

The Center for Responsive Politics, a non-partisan, independent, and nonprofit research group, wrote about the dichotomy in an analysis titled Money, Not Moral, Drives Marijuana Prohibition Movement.

“Retired police officer Howard Wooldridge, now an anti-drug war lobbyist, told the anti-corruption blog Republic Report in 2012 that one of the biggest opponents to marijuana legalization is the Pharmaceutical Research and Manufacturers of America (PhRMA), given that marijuana can replace drugs from “Advil, ibuprofen all the way to Vicodin, pills for nausea – I mean expensive store-bought pills.” PhRMA is certainly an organization to be reckoned with: In 2014 alone, PhRMA spent about $16.6 million on lobbying, ranking it 11th in spending among all lobbying clients that year. And the drug manufacturing industry as a whole poured $14.7 million into the 2014 election cycle.”

The article also points to other industries like big alcohol, prison guard unions, private prison companies, and police unions spending tens of millions oo lobbyists and other anti-cannabis efforts.

The FDA and Marijuana

A recent study published in the Journal of American Medical Association (JAMA) says there is a lack of evidence that medical marijuana works.

On their website, the FDA says they are open to more research:

“The FDA also has an important role to play in supporting scientific research into the medical uses of marijuana and its constituents in scientifically valid investigations as part of the agency’s drug review and approval process. As a part of this role, the FDA supports those in the medical research community who intend to study marijuana. The FDA also supports research into the medical use of marijuana and its constituents through cooperation with other federal agencies involved in marijuana research. Conducting clinical research using marijuana involves interactions with other federal agencies.”

The JAMA study conducted by international researchers found that cannabinoid drugs failed to show statistical significance in all 79 of their trials and suggests “further large, robust, RCTs are needed to confirm the effects of cannabinoids… using standardized outcome measures at similar time points to ensure inclusion in future meta-analyses.”

The good news for cannabis enthusiasts is that JAMA recommends more research and has outlined specific scientific methods by which to compare future findings. But until researchers can prove the medicinal properties of the plant work in two randomized clinical trials, legalizing medical marijuana will remain a state-by-state issue.

A Controversial Nominee

The embattled doctor has seen his share of hurdles as a public servant. In December, the nonpartisan public health group, Public Citizen, called on the Senate to reject his nomination over conflicts of interest. In a press release, Dr. Michael Carome, Director of the group writes, “the attitudes he has developed over his decades-long history of extensive financial ties to pharmaceutical and medical device companies leave him all too willing to promote the interests of regulated industries over those of public health and patient safety. This is not compatible with being the FDA commissioner.”

Califf does have at least one big name behind him, like the President of the United States. In a White House press release announcing his nomination and a handful of other appointments, President Obama said of all his choices, “I am confident that these experienced and hardworking individuals will help us tackle the important challenges facing America, and I am grateful for their service. I look forward to working with them.”

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