FDA - Harming People and Getting Drug Seller Profits High
Opioids, Psychedelics, and Marijuana
Executive Summary:
Sadly, it’s not difficult to find instances when the U.S. Food and Drug Administration (FDA) has put corporate interests ahead of the people’s health even when the evidence of injury and/or death is clear. This pattern is evident again when examining the FDA actions around the expansion of Opioid use, approval of the first psychedelic medication for depression, and the enthusiastic support for rescheduling marijuana. In each instance, the FDA has acted on little or no science, weakened or abandoned protocols, and downplayed or ignored known or potential outcomes or side effects, including injury and death.
Government/regulatory agencies are supposed to play a critical role in the people’s health and safety but are failing in many areas. In my last blog, I highlighted how FDA and HHS have blocked regulatory action for more than a decade regarding the removal of menthol flavoring from cigarettes. Menthol has played a critical role in attracting and addicting youth and almost all Black youth and adult smokers. Compare this lack of action to what you are about to read about how the FDA promotes and protects the drug industry.
FDA’s Reckless Behavior is Far Reaching
While I will just focus on opioids, marijuana, and psychedelics in this blog, the FDA’s reckless behavior is occurring in other areas beyond their oversight of drugs. I recommend watching The Bleeding Edge, a disturbing 2018 Netflix documentary on medical device injuries, lack of FDA oversight and action by FDA once injuries were known, and the brave work of patients and advocates that held drug makers and the FDA accountable. Two instances of note involved Bayer’s Essure sterilization device and Johnson and Johnson’s pelvic mesh implant. Bayer had stopped selling Essure outside of the U.S. in 2017 but continued in the U.S. in 2018 despite over 27,000 adverse event reports since Essure was approved in 2002. Bayer, not the FDA, withdrew Essure a week before the Bleeding Edge was to air. Johnson and Johnson stopped selling the implant in 2012 and the FDA did not order mesh implants off the market until 2019. Since the airing of the documentary, Johnson and Johnson has been ordered to pay out more than $400 million in settlements for its pelvic mesh implant. Lawsuits targeting Johnson and Johnson and other mesh makers have resulted in more than $8 billion in settlements.
We won’t have time to go into all the financial ties between FDA and the drug industry but in a December 2021 statement opposing the nomination of Dr. Robert Califf to head the FDA, Senator Bernie Sanders (D-VT) noted that 9 of the last 10 FDA Commissioners have gone to work for the Pharmaceutical Industry. In addition, Dr. Califf received funding from the pharmaceutical industry and owned “up to $8 million in the stocks of major drug companies.” Dr. Califf was confirmed and is the current head of FDA.
Opioids – FDA Opens the Flood Gates – Without Science:
The National Institute on Drug Abuse (NIDA) has stated that, “Prescription opioids and heroin are chemically similar and can produce a similar high.” Based on what was known about prescription opioids, one might ask why the FDA allowed the use of this drug in the first place. And if they were going to approve it you would think they would use excessive caution. Nah.
This 2019 60 Minutes story exposes FDA’s role in the birthing of the opioid epidemic. Opioids were only to be used in very narrow circumstances such as end of life care and a few days following a serious accident or surgery. Oxycontin, an opioid drug, was approved in 1995 for short term use. In 2001, Purdue Pharma, maker of Oxycontin, met secretly with the FDA to get them to change the guidance for opioids to treat things like chronic pain and permit use to “around the clock…for an extended period of time.'' Despite there being NO science to support the change, the FDA changed the guidance. “There are no studies on the safety or efficacy of opioids for long-term use,” said Dr. David Kessler in the 60 Minutes story. Dr. Kessler is a former head of the FDA who left before the labeling change. In summary, a drug that behaves like heroin is approved for long-term use by the FDA with ZERO scientific evidence supporting the decision. In one Internal Purdue Pharma document, released due to legal action, they said the FDA action “…has created enormous opportunities.” Purdue Pharma opioid sales would soon triple.
And it gets worse.
In August 2020 in the American Medical Association (AMA) Journal of Ethics, Dr. Andrew Kolodny (featured in the 60 minutes story) authored an article on “How the FDA Failures Contributed to the Opioid Crisis.” In his piece, he notes that a 2017 Presidential Commission found the FDA partly responsible for the opioid epidemic due to its “inadequate oversight” and National Academy of Sciences called on FDA to overhaul its opioid policies. Dr. Kolodny went on to write “FDA policies for approving and labeling opioids remain largely unchanged,” and that the FDA … “has not undertaken a root cause analysis of its regulatory errors…let alone instituted any major reforms.” This was as of August 2020, and hundreds of thousands of people had died from opioid use, and the FDA felt no need to act. Wow.
As the many legal settlements have shown, the horrific actions of the pharmaceutical companies and others involved with sales and distribution is well documented. Unfortunately, their actions did not move the FDA to act and, in fact, those same companies are still on the good list at the FDA. On the list is Johnson and Johnson who has paid hundreds of millions to settle lawsuits around its pelvic mesh implant and will be “contributing” $5 billion for its role in the opioid epidemic. Knowing this, guess which company the FDA approved to administer the first psychedelic drug for depression? Yes, Johnson and Johnson.
FDA and Psychedelics: Weak Evidence/Bad Side Effects Didn’t Stop the FDA – Sound Familiar?
Ok – I did not know FDA approved its first psychedelic medication – a nasal spray – for depression in 2019. I began to research and found this detailed analysis of the drug and FDA process in the May 2020 British Journal of Psychiatry. The title of the article is “Are we repeating mistakes of the past? A review of the evidence for esketamine (the new nasal spray). Looking at how the FDA approached opioids (and medical devices), let’s see if we can find some similarities.
The authors of the article point out that in January of 2020, the UK’s National Institute for Health, and Care Excellence (NICE) issued draft guidance recommending against Esketamine due to lack of evidence and cost effectiveness. Esketamine is derived from Ketamine.
Ketamine:
For decades, Ketamine has been used both as a prescription anesthetic agent and also as a club/street drug (special K, psychedelic heroin, etc.). The authors note several things about Ketamine:
· Ketamine induces a trance-like state (often called dissociation)
· Patients recovering from Ketamine may experience delusions, hallucinations, delirium, and confusion, and sometimes ‘out of body’ or ‘near death’ experiences.
· Ketamine raises blood pressure and heart rate and has been associated with heart attacks and stroke, more often in those with pre-existing factors.
· As a street drug – between 1993 and 2016 there were at least 117 deaths in England and Wales attributed to the drug (likely more since ketamine is not always tested for in unexplained deaths)
· Deaths from ketamine include accidental poisonings, drownings, traffic accidents and suicide.
· Ketamine is also addictive with withdrawal symptoms including anxiety and depression.
· Ketamine as a long-lasting anti-depressant has not been established in randomized trials.
· Esketamine is twice as potent as Ketamine.
FDA and Approval of Esketamine – weak science, FDA weakened protocols
· The appearance is that Esketamine is for a narrow population – treatment resistant persons who have tried two different anti-depressants, but the authors note “which is likely to encompass many current antidepressant users.” Think bigger sales/market.
· The FDA normally requires two positive efficacy trials to license a drug, ‘each convincing on its own’. Some believe this standard is not strong enough. However, Esketamine did not even meet this standard.
· The FDA loosened its rules and allowed for the submission of a discontinuation trial that had a flawed study design.
· FDA downplayed side effects of the drug, “including an increase in depression and suicidality was also observed during esketamine treatment, compared with placebo.”
The authors conclude:
“It would seem that themes from history are repeating: a known drug of misuse, associated with significant harm, is increasingly promoted despite scant evidence of efficacy and without adequate long-term safety studies.”
Remember the joy Purdue Pharma had when FDA greenlighted greater use of its opioid drug? In the 4th quarter of 2023, sales of J and J’s Esketamine (brand name Spravato) increased 73% with sales expected to reach $1.5 billion plus! Read this article to see just how excited pharma is about FDA’s love of psychedelics.
And earlier this month (May 2024), the British Medical Journal published an Expression of Concern regarding a previously published study that had promoted the benefit of a psychedelic drug’s ability to treat depression. Turns out the methodology used was flawed and that the study was “…likely to have overestimated the benefits of psilocybin.” Confident the FDA is monitoring science on psychedelics and harms of psychedelic drugs to patients/users? Me neither.
Marijuana Rescheduling: FDA Again – Weakening Protocols/Weak Science
Understanding Marijuana Rescheduling:
As you will see, the rescheduling of marijuana is supposed to be based on science and data but what you are seeing and reading is more about politics and the marijuana industry’s future profits. In today’s news (May 21, 2024), you will see that Biden Administration is working to ignore the Drug Enforcement Agency’s request to further time review the scientific evidence around marijuana as medicine – a critical piece to rescheduling. The FDA is not supposed to be the decision maker. The FDA sends their recommendation to the Drug Enforcement Division (DEA) and the DEA examines the evidence and makes a decision. Rescheduling does not mean marijuana is legal, but it is a strategy to increase industry profits and move the PR needle to help the marijuana industry’s friends at the state and federal level pass policies to allow the sale of marijuana.
If you have listened to the news or the President or and Vice President, about the proposal to reschedule marijuana from a Schedule 1 to a Schedule 3 drug, you have reason to be confused. You are being led to believe that the current Schedule 1 designation for marijuana means marijuana is as dangerous as fentanyl and caused our prisons to be filled with low level marijuana users. Actually, scheduling is not a harm index and is not directly used for penalties of drug use (our prisons are not filled with persons only caught for marijuana possession). Scheduling has to do with science and data (crazy).
Schedule I substances are defined as having no accepted medical use and a high potential for abuse. Schedule III substances are defined as drugs with accepted medical use, meaning they may be prescribed, dispensed, or administered; and have a moderate to low potential for physical and psychological dependence. The DEA will initiate a rulemaking process to allow for public input, review the evidence and information and make a ruling. Of note, in 2016, the Obama administration conducted a review of marijuana and determined it needed to remain a Schedule 1 drug.
Current FDA Actions Around Re-Scheduling Marijuana – Weakening Protocols and Avoiding Science.
Important to note: The FDA has not approved marijuana to treat any medical condition. Marijuana as a whole (which is being considered for rescheduling) is different than constituents in marijuana like CBD. For example, even though marijuana remains schedule 1, FDA has approved Epidiolex, which contains CBD, to treat two rare forms of epilepsy. Epidiolex is a Schedule 5 drug.
The FDA is an agency of the U.S. Department of Health and Human Services (HHS). In August 2023, HHS recommended reclassifying marijuana as a Schedule 3 drug. As you will see in this summary of the HHS/FDA actions, there is a lot to be concerned about:
· Even though HHS submitted a recommendation for rescheduling in August – it would take four months after that for HHS to release that recommendation for the public to see thanks to the threat of legal action.
· In the past, the FDA used a five-factor analysis to determine if a drug has “currently accepted medical use” – a key component to re-scheduling. As a reminder in 2016, when there was consideration of rescheduling marijuana, the FDA found marijuana did not meet any of the five criteria.
· This time, the FDA altered its approach and did not use the five-factor analysis. Instead, they made up a two-factor test!
· One factor to determine medical efficacy was the FDA used the existence of “medical” marijuana programs as evidence of efficacy. Yes – those medical marijuana businesses with no medical protocols – any marijuana for any of the qualifying medical conditions, no duration, no dosage, etc. That is evidence to the FDA that marijuana is medicine.
· The other attempt to prove marijuana is medicine was the FDA said marijuana treats pain, nausea, vomiting, and anorexia. They backed up that assertion with 3 studies – yes only 3. One study concluded its findings were “inconclusive or mixed,” another relied on study results that were not statistically significant, and the third showed minimal evidence but noted concerning side effects “may limit its effectiveness.” Over 20 years of “medical marijuana” shops/industry and this is all the FDA could provide.
· The FDA cherry picked data on Marijuana’s harm and addiction.
As you can see, just like it had done with opioids and its approval of a psychedelic drug for depression, the FDA weakened its protocols and relied on weak scientific evidence. What rescheduling would do is open doors for current marijuana business to make certain deductions such as advertising – increasing the promotion of marijuana. While rescheduling won’t legalize marijuana, it is absolutely part of the strategy by the marijuana industry and their friends to build national support for greater commercialization (legalization).
The science on the physical and mental health harms to those who use has only grown since the Obama administration rejected rescheduling in 2016. Just as the tobacco industry has done for decades, the marijuana industry is working to deceive the public about the harms of marijuana and its policy agenda. And they are doing it with the help of the media, federal health authorities, and policymakers. We need more people, health and safety professionals, advocates, and organizations to speak out. Far too many are silent while drug sellers look to expand the menu of harmful drugs available and promoted in our communities. A big thank you to those who are taking action around the country.
One last item to summarize the absurdity of FDA’s rationale that marijuana is medicine. Remember, they said the existence of state “medical” marijuana policies as proof marijuana is medicine. Well – here is a “medical” ad from Trulieve who operates “medical” marijuana businesses in Florida and who has spent $50 million bankrolling their current ballot measure to legalize marijuana in Florida.
Does this look like a medical ad to you? It apparently does to the FDA. Do you see any direction as to which marijuana treats which medical condition? Any recommendations for dosage and duration (how much to take and for how long)? Of course not. And the national media remains silent on this issue. It’s all profit, not patient, focused and FDA and CDC are ok with that.
“Medical” Marijuana Ad - FDA Believes This is Medicine
