Someone once defined insanity as ‘doing the same thing over and over again and expecting a different result.’ For whatever reason, the phrase stuck with me over the years. It just seems so simplistic, yet the accuracy of the concept is spot on. When you view people and/or groups and their actions through this prism, a different and unique picture develops. Take for example the FDA.
The U.S. Food and Drug Administration (FDA) began with the Pure Food and Drug Act of 1906 and strengthened in 1938 with the passage of the Federal Food, Drug, and Cosmetic Act. The purpose of the FDA was, and is, to protect Americans from profiteers selling questionable and often dangerous and deadly drugs to unsuspecting consumers. Their mission statement reads; “The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” The statement would lead anyone to believe the FDA is looking out for your best interests; but their actions tell a different story.
Just last month (October 2018), while Americans are in the throes of a ravaging drug epidemic that claimed over 73,000 lives last year, the FDA approved yet another incredibly deadly opioid, Dsuvia. The FDA advisory board recommended approval (10-3) as well as the head of the FDA, Scott Gottlieb, over the concerns of healthcare critics.
For those unfamiliar with Scott Gottlieb, he was nominated by the current administration, approved by the senate and assumed the top spot in the Food and Drug Administration (FDA) on May 11, 2017. His bonafides are many and diverse. The introduction on his Wiki page paints a clear picture of his professional life stating that he is ‘an American physician and investor who serves as commissioner of the FDA. Among Gottlieb’s highlights prior to his appointment as FDA Commissioner in 2017, he worked as a healthcare analyst at the investment bank Alex Brown & Sons, the FDA between 2005 and 2007, and following his departure from the FDA, Gottlieb became a partner at New Enterprise Associates (NEA), one of the largest venture capital firms in the world, serving as an active investing partner in the firm’s healthcare division.
Dsuvia is a brand name owned by a publicly traded California company called AcelRx Pharmaceuticals. The drug itself is not new. Sufentanil, which is sold under the brand names Dsuvia and Sufenta, is a synthetic opioid analgesic first synthesized in 1974. Its use has been primarily for pain management after major surgery and extensively for patients who have built up a tolerance to opioids including but not limited to the Medicated-Assisted Treatment (MAT) approved drugs, Buprenorphine and Methadone.
Up until last month, Dsuvia has been administered intravenously to patients. But that has changed with the FDA approval of Dsuvia sublingual, an under the tongue formulation. It is delivered in a disposable, pre-filled, single-dose applicator.
Critics are concerned that the FDA’s approval of a sublingual sufentanil – the strongest opioid painkiller available for use in humans – will open the door for the drug to be diverted and find its way onto the streets. They say it is bound to hit illegal markets. And there is good reason for their reservations. Sufentanil is approximately 10 times more potent than its parent drug, fentanyl, and 1,000 times more potent than morphine.
Fentanyl is one of the most potent opioid painkillers on the market. A tiny amount approximately the size of the head of a pin can and will kill you. Moreover, just coming into physical contact with this dangerous opioid can be absorbed through the skin and cause an overdose and death. Addicts use fentanyl because the highs are stronger than heroin. But with that come the crippling lows that, more time than not, keep people using. Detox is very difficult with this drug.
According to the National Institutes of Health, synthetic opioids, primarily illegal fentanyl, have recently become the most common drugs involved in overdose deaths in the United States.
So why the rush to add another opioid painkiller, 10 times more potent than the leading drug causing overdose and death, to an already oversaturated market? It sounds a bit insane to many healthcare professionals including myself. AcelRx Pharmaceuticals spokespeople claimed the U.S. military have an interest in a sublingual painkiller for environments such as battlefields where IVs cannot be used.
In a statement, Gottlieb said “The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds. The military application for this new medicine was carefully considered in this case.”
This may sound all well and good until you visit AcelRx Pharmaceuticals website (www.acelrx.com) and their product site Dsuvia (www.dsuvia.com). On both sites you’ll find this announcement; “For U.S. Residents Only NOW APPROVED DSUVIA (sufentanil) sublingual tablet 30 mcg.” So what is the take away? It is painfully obvious that Dsuvia is available to all Americans, both civilian and military. Is the whole “the military wants it” characterization just a ruse? Did AcelRx wrap a flag around Dsuvia so it could get broad FDA approval?
Dr. Andrew Kolodny seems to think along these lines. He heads the Opioid Policy Research Collaborative at Brandeis University and is executive director of Physicians for Responsible Opioid Prescribing, an education and advocacy group. Upon hearing of approval, Kolodny stated; “There is absolutely no need for this product. Claiming we need it on the market to help soldiers on the battlefield is ridiculous. We already have sublingual fentanyl product available for use on the battlefield.”
Dr. Kolodny also inferred that he and his group were mislead by Gottlieb when he took-over as head of the FDA. According to Kolodny, the nonprofit National Academy of Sciences prepared a report in July 2017 calling upon the FDA to complete a review of the safety and effectiveness of all approved opioids and to revise the opioid policies accordingly.
“More than a year ago Commissioner Gottlieb endorsed a National Academy of Sciences report that called on FDA to overhaul its opioid policies. In particular, NAS urged FDA to utilize a new risk vs benefit analysis for opioid approval AND removal decisions. If Gottlieb meant business when he endorsed the report—if he was speaking truthfully when he promised Congress that he would fix FDA’s past mistakes, then he would not have allowed this product on the market. Rather than approving new exceptionally dangerous opioid formulations, he would be pulling the most dangerous opioids off the market.”
If this makes you feel like you’ve been betrayed by the Food and Drug Administration, I can assure you that you are not alone. There has been a pattern of situations like this one dating back to the late 80s and early 90s. It was a challenging time for Americans. Thousands of people were dying every year from the AIDS epidemic. There was a public outcry for a cure for the disease and everyone started pointing their fingers at the FDA.
No one was happy. The pharmaceutical industry rightfully claimed the FDA was taking too long to approve drugs. The FDA rightfully claimed they didn’t have the manpower or resource to move any faster than they already were. Congress men and women were under quite a bit of pressure from their constituents to resolve the issue. Then, the pharmaceutical industry made an offer congress could not refuse. They suggested user fees on new drugs they were ready to market.
In 1992, congress passed The Prescription Drug User Fee Act (PDUFA). This allowed the FDA to charge fees on new drugs as a way to diffuse some of the cost associated with drug approval. It was a huge win for people with AIDS. New drugs became available and thousands of lives were saved.
It was also a win for the pharmaceutical industry at the expense of the American public. PDUFA became the albatross hanging around all of our necks. Anyone who has been involved in corporate America will tell you there is nothing altruistic about the way they go about their business. They won’t hand over so much as a nickel without some condition that benefits them.
According to the FDA website, their budget for FY 2018 is $5.4 billion. About 55 percent, or $3 billion, of FDA’s budget is provided by federal budget authorization. The remaining 45 percent, or $2.4 billion, is paid for by industry user fees. The money the pharmaceutical industry pays to the FDA continues to give them the power to influence the approval process and much more.
They’ve also placed ‘their people’ in key positions throughout the agency. In fact, the FDA has a revolving door. The same people work in the industry and the agency at different times. The list is simply too long to go into right now, but if your interest is piqued, just Google “the revolving door between the FDA and industry.” But in the mean time, ask yourself: Does this person currently working at the FDA, that before joining the agency worked for XYZ Pharmaceuticals and plans to again, really have my best interest at heart?
So, are the actions of the FDA insanity or pure economics? Are they ensuring your safety with the efficacy and security of human drugs, biological products, and medical devices as their mission statement suggests? It’s hard for me to believe that anyone could feel confident that the FDA is looking out for you after the approval of Dsuvia sublingual and others like it that preceded this approval.
If you are as dissatisfied as I am with how the FDA is approving opioid painkillers and other medicines and medical devices, you need to take action. Doing the same thing, like sitting on your hands and holding back waiting for things to change, just will not cut it. You have to hold your elected officials accountable. They have the power to turn this epidemic around but they need to be persuaded. All the information you need can be found online. Call them, email them and sit with them when they come into your community. It worked for the AIDS epidemic and it will work for the drug epidemic. Remember, nothing happens until you take action.
John Giordano is the founder of ‘Life Enhancement Aftercare & Chronic Relapse 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 Beach 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 websites: