It’s a New Year and time to turn the page, or so I thought. It only took a headline before I was brought back to reality and reminded of the challenges we face. Late last year the Food and Drug Administration (FDA) approved yet another dangerous pure hydrocodone painkiller. Purdue Pharma L.P., makers of Oxycontin, was granted a Priority Review in July and final approval in November 2014 of Hysingla ER, a once a day extended-release hydrocodone bitartrate tablet. Hysingla ER will be available in 20mg, 30mg, 40mg, 60mg, 80mg, and 120mg dosages in January 2015. Hysingla ER is expected to pose a direct commercial challenge to Zohydro ER made by California drug maker Zogenix, which is banned in most modern countries. Neither Hysingla ER nor Zohydro ER contains acetaminophen, a chemical that improves efficacy and also serves as an abuse deterrent.
In March 2014 the FDA was highly criticized by elected officials, law enforcement and anti-addiction groups for its approval of Zohydro ER because of the product’s potency – 10 times stronger than Vicodin – and susceptibility to abuse. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, made up of opioid experts, voted 11 to 2 with one abstention to not approve the drug application. In their view Zohydro ER had only met narrow targets for safety and efficacy. In addition they felt the painkiller could be used by people addicted to other opioids, including oxycodone and voiced concern for the resulting potential impact on public health. Yet with all of the caveats, FDA officials decided to over rule the committee’s recommendation and approved the drug.
This is a dangerous trajectory that the FDA has put us in considering we’re in the world’s largest opium addiction epidemic since the opium wars of the 1800s. Eight out of ten opioid painkillers are consumed in the U.S. That equates to 80% of the worlds production of opioids are consumed in a country with less than 5% of the global population. Last year an estimated 16,000 people died from prescription drug overdoses, more than heroin and cocaine combined. Emergency room visits related to prescription painkillers has sky rocked. More than two-thirds of emergency department visits for opioid overdoses involve prescription drugs – 348,000 emergency room visits for prescription drug overdoses in 2011 alone. How many more people have to be harmed or die before the FDA recognizes their historic duty as the protector of the American people and exercise their authority to prevent these dangerous drugs from killing our own?
So just when did the FDA morph from fierce watchdog and protector to the proud lapdog on the end of Big Pharma’s tight leash? In the mid to late 80’s the AIDs virus caused a national panic resulting in a public outcry for a quicker turn-around by FDA in approving life- saving drugs. At the time, the U.S. lagged behind other modern countries in drug approval by a year or more. The FDA, who is financed by the treasury, claimed that due to budget restrictions they were short staffed and were reviewing new applications as fast as humanly possible. As a way to fund the expansion for the FDA to meet the new challenge and avert additional treasury funding, the 102nd congress passed the “The Prescription Drug User Fee Act (PDUFA)” and was signed into law in 1992.
The PDUFA granted the FDA authority to charge user fees to pay for a newly expanded regulatory review. The new revenue source was intended to supplement – but not replace – direct appropriations from Congress. The PDUFA had the desired effect and a few unforeseen. In a review of the program, the U.S. Government Accountability Office (GAO) reported in 2002 that PDUFA funds allowed the FDA to increase the number of new drug reviewers by 77 percent in the first eight years of the act. In addition they found the median approval time for non-priority new drugs dropped from 27 months to 14 months over the same period.
On the surface, everything about the PDUFA seemed fine. It has been reauthorized by congress five times since its inception – surely a sign of success. In 2010, a grand total of $529,276,543 in PDUFA fees was collected. According to the FDA, this total almost covered all of the expenses associated with New Drug Application (NDA) reviews. Keep in mind that PDUFA was intended to supplement the FDA (NDA) review budget, not replace it. So what could possibly go wrong with a government institution tasked with the protection and safety of the American public being nearly 100% funded by the very corporations seeking their approval for toxic drugs? Has the integrity of FDA been compromised by Big Pharma payments of over half a billion dollars per annum and growing?
One person seems to think so. Donald W. Light, a Residential Fellow (2012-2013), Edmond J. Safra, Center for Ethics, Harvard University, wrote a scathing review of this unholy union. The article is entitled “Risky Drugs: Why the FDA Cannot Be Trusted” (a summary of a more in-depth article entitled “Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs”) was published in the Journal of Law, Medicine and Ethics (JLME) in July 2013. It’s available online and truly an unapologetic eye-opening read; I strongly recommend you check it out.
Among the many highlights of Light’s article is this: “The forthcoming article in JLME also presents systematic, quantitative evidence that since the (Pharmaceutical) industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulation, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths. New FDA policies are likely to increase the epidemic of harms. This will increase costs for insurers but increase revenues for providers.”
Light also points out:
• One in every five drugs approved ends up causing serious harm, while one in ten provide substantial benefit compared to existing, established drugs.
• Prescription drugs are the 4th leading cause of death.
• This evidence indicates why we can no longer trust the FDA to carry out its historic mission to protect the public from harmful and ineffective drugs.
Dr. Bob Rappaport is the director of the FDA’s division of anesthesia, analgesia and addiction products. One of his many duties is to over-see all of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee’s panel discussions.
During the Zohydro ER application panel review, Rappaport repeatedly attempted to steer the distinguished panel to approve Zohydro’s application through narrow regulatory framework. He zeroed in on fairness to applicants while completely ignoring the basic premise and obligation of the FDA – “Protecting and Promoting Your Health” as their slogan states. Dr. Rappaport cited narrow objectives such as: “the FDA’s obligations to operate within the regulatory framework that includes providing a level playing field for industry” as reasoning to approve Zohydro’s application. He clearly staked out his genuinely frightening position when he was quoted telling the panel: “you’re punishing this company and this drug because of the sins of the previous developers and their products. And from a regulatory standpoint, that’s not really something we can do.” Apparently the FDA is not allowed to learn from their mistakes.
Observers of the discussion said the conversation got a little spicy. “It seemed like Bob Rappaport was getting frustrated with the panel,” says Andrew Kolodny, chief medical officer of Phoenix House Foundation, “He actually started to scold the committee at one point.”
The panel wasn’t buying what Rappaport was selling. They returned a lopsided 11-2 vote recommending that Zohydro ER application not be approved. One of the panel’s members, Dr. Judith Kramer of Duke University, eloquently summed up the panel’s reasoning this way: “It’s striking me, as I’m listening to people give their reasons, that this drug is, in a way, held to a lower standard because of all the other drugs that we’ve accepted [with] this kind of profile … This drug will almost certainly cause dependence in the people that are intended to take it. I realize there has to be a level playing field in terms of business practice, but the primary thing has to be the public health.”
In late October 2013 the FDA announced they had approved Zohydro ER application. “I firmly believe that the benefits of this product outweigh its risks,” Rappaport wrote in the summary review.
The more I see the more I agree with Donald Light in that we can no longer trust the FDA to carry out its core mission of protecting the public health while there is no barrier between this federal regulation body and the corporate interests it is supposed to be supervising. It seems to me the roles have reversed with the FDA doing the bidding of the makers of drugs that have already killed hundreds of thousands of Americans. We’ll put an end to this opioid epidemic when we dissolve this Godless “wink and a nod” relationship between the makers of the poison and the organization that is supposed to be regulating them.
“Mercy to the guilty is cruelty to the innocent.” ― Adam Smith; author of “The Wealth of Nations” (1776) and considered to be the father of modern day capitalism.
John Giordano DHL, MAC is a counselor, President and Founder of the National Institute for Holistic Addiction Studies, Laser Therapy Spa in Hallandale Beach and Chaplain of the North Miami Police Department. For the latest development in cutting-edge treatment check out his website: www.holisticaddictioninfo.com