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Where Does It Hurt? – Painful Times for the FDA

The FDA Needs to
Put Pain in Perspective


Official portrait of the FDA Commissioner

FDA Commissioner Dr. Margaret Hamburg

FDA Commissioner Dr. Margaret Hamburg is under renewed pressure from public health advocates and law enforcement officials over the agency’s lax and inconsistent approach to powerful and addictive opioid painkiller medications.

This follows on the heels of appeals to repeal the FDA’s approval of a controversial painkiller up to ten times more potent than oxycontin. These include appeals by 29 state attorneys general, members of Congress, and at least one governor who banned the drug in his state only to be overturned in the courts.

Consumer Reports has also weighed in asking the FDA to reverse its approval and abide by its own scientific advisory committee’s 11-2 vote against the drug’s approval. 

And just today, the first medical society to do so – the American Academy of Neurology – issued a position paper finding that “The risks of opioids far outweigh their benefits in chronic pain conditions such as headache, fibromyalgia, and lower back pain” – conditions for which they’re commonly prescribed today.   

I discuss the FDA’s many shortcomings in Our Healthcare Sucks. Unfortunately, its handling – or rather mishandling – of this crucial healthcare issue shows there’s been no real progress since in the agency’s regulatory effectiveness.

Whatever Were They Thinking?

The latest assault on the FDA goes so far as to seek Dr. Hamburg’s replacement as FDA head. The stimulus for this ratcheting up of public pressure is the agency’s tone deaf approval last year of the opioid-on-steroids drug Zohydro ER (extended release).

The approval came literally the day after the FDA announced stronger language on opioid drug warnings in response to pressure to better combat the quadrupling in opioid deaths since 1999. While hardly a coincidence, this calculated bit of bad timing only threw into greater contrast the seeming illogic of approving its strongest opioid medication yet. The fact that it was approved without the packaging safeguards imposed on less potent opioid medications served to underscore the agency’s apparent inconsistencies.

Zohydro ER is mostly concentrated hydrocodone bitartrate – the addictive stuff found in lower doses in oxycontin – in an extended release formulation. Available only as a capsule, it fails to discourage illicit use of the drug – as most of the less-potent opioid medications now do. In brief, they can’t be crushed or injected like Zohydro ER can.

How Bad Can It Be?

But really, can the risks be that great if the FDA saw fit to approve the drug? Let’s see what the drug manufacturer itself says in its label warnings, which uses stark and ominous terminology not found in most drug disclaimers…

“Zohydro ER exposes patients and other users (other users?) to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death…serious, life-threatening, or fatal respiratory depression, especially during initiation of Zohydro ER or following a dose increase…

“Crushing, chewing, or dissolving Zohydro ER can cause rapid release and absorption of a potentially fatal dose of hydrocodone.”

The same online description containing that label information added the following…

“As modified release products such as Zohydro ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death…

Addiction can occur at recommended doses and if the drug is misused or abused…

“Overestimating the Zohydro ER dose when converting patients from another opioid product can result in fatal overdose with the first dose

“Never give anyone else your Zohydro ER. They could die from taking it (emphases added).”


Manna From Heaven – For Junkies!

The risks are great enough that an article in a journal for emergency room physicians is entitled “Emergency Physicians Urged Not to Prescribe New Opioid, Zohydro ER, Given High Potential for Abuse“. Its physician author advises other ER physicians to just “Say no to Zohydro” – advice many think the FDA should likewise have heeded.

It’s safe to say that this drug needs to be prescribed with extreme caution and vigilant supervision. Yet a physician report in The New England Journal of Medicine on the clinical and cultural conflict between chronic pain and addiction made this troubling observation:

“Many doctors have prescribed opioids for chronic pain without following best practices, understanding the risk for the development of substance abuse disorders, or recognizing the red flags that can emerge in clinical practice…

“There is now evidence from states…that some individuals whose path to addiction may have started with a prescription for pain are progressing to heroin.”

It’s the context that’s the killer here – and killing it’s doing, quite literally. Deaths from opioid overdoses have quadrupled since 1999 in parallel with looser prescribing of opioid medications – once reserved for acute post-surgical and cancer pain – for all sorts of chronic pain like back pain and arthritis.

With oxycontin, percocet, and vicodin all harder now to abuse, this more potent and simple-to-open opioid capsule must be like manna from heaven for the drug-abusing population.

Opioids Aplenty, But It’s
Medical Marijuana They Worry About

I’ve written before about the scourge of cavalier opioid prescribing and its marked contrast with the hyper-cautious medical mindset regarding relatively benign medical marijuana (see “Medical Marijuana vs. Prescription Opioids – Misplaced Perceptions and Priorities“).                      “.

One might reasonably expect an FDA willing to approve a hyper-opiate drug like Zohydro ER – over the strong objections of it own medical advisors – might see fit to at least correct its decades long role in misclassifying marijuana as a Schedule 1 drug – a vestigial remnant of “Reefer Madness” hysteria from a pre-scientific era. Doing so would enable more aggressive scientific research of medical marijuana’s clinical benefits and perhaps less an obsession with its perceived risks.

Much has changed, after all, since marijuana was originally classified as having no clinical benefit and being more dangerous than heroin or cocaine. We now know both of these assumptions to be false.

Despite the DEA’s “reefer madness”-inspired delusions, there’s compelling evidence that marijuana is relatively benign – at least for mature brains without the added risks that all drugs, including prescribed medications, pose for the still-developing brains of children and adolescents.

And on the benefits front, the discovery of the cannabinoid receptor system in the human body has helped us to better understand much of the plant’s therapeutic effects. Continuing to ignore this scientific breakthrough discovery subordinates science to political exploitation that’s rooted in ignorance.

The risk-reward ratio for medical marijuana is factually far better than its current FDA classification assumes, while the risk-reward for opioids is much worse. Indeed, there’s emerging evidence – so far only in animal studies – that prolonged opioid use may promote cancer cell proliferation (see again “Medical Marijuana vs Prescription Opioids – Misplaced Perceptions and Priorities“). There’s similar evidence that marijuana may actually fight tumor progression.

Assuming this is borne out for humans, just how stupid should we feel when we look back on this era of politically-motivated and unscientific drug classification that’s caused, and is causing, needless deaths and untold suffering by ignoring these opioid risks and marijuana benefits?

Perhaps the most exquisite irony in in this painkiller debacle is the cavalier attitude many physicians display to over-prescribing a drug proven to be a true “gateway drug” – and that itself is responsible for more deaths than heroin and cocaine combined. What makes this ironic is the constant medical hand-wringing over using medical marijuana – a drug never proven to be a gateway drug and which is responsible for no known deaths – for pain relief.

Go figure.

A Chance to Tune-Up
Obama’s Legacy?

President Obama could do far more for America’s healthcare than Obamacare ever will if he found the backbone and determination to reconcile federal drug policies for both opioids and medical marijuana with what the science now tells us.

What’s going on now with conflicting federal policies and conflicting federal and state policies about marijuana, medical marijuana, and opioids reminds me of the (fictional?) mess in the current season of  FX’s “The Bridge” in which federal FBI agents are fighting a Mexican drug cartel while the CIA protects and enables the cartel. 

Much of this apparent dysfunction is, like all our politics, driven by commerce. A recent article on the Zohydro imbroglio noted that Dr. Hamburg’s role with the FDA is unlikely to be threatened by the demands for her removal. That’s because she’s quite “Popular with key stakeholders, including committee leaders on Capitol Hill, the pharmaceutical industry, and medical groups”.

Mr. Obama’s biggest healthcare legacy needn’t be just Obamacare – whose future will remain uncertain for years to come.

A much broader and non-ideological span of the public would benefit – and with far less controversy – were he to find a way to elevate patients to that elite group of FDA “stakeholders”.

None of the current stakeholders’ vested interests are as compelling – or as urgent – as our need for more rational and compassionate federal policies on drugs permitted, and restricted, for pain management.

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