FDA Advisors on Opioid Dosing Limits: We Dunno

FDA Advisors on Opioid Dosing Limits: We Dunno

Too little data to go on, members say


If FDA panelists reached one consensus at the end of a two-day meeting this week, it was that there’s not enough information to know just what regulatory action — if any — the agency should take about higher-dose opioids for outpatients with constant or chronic pain.

“We need much better-quality data to help inform us,” summed up panelist Sean Mackey, MD, PhD, of the Stanford School of Medicine.

Questions about the needs of chronic pain patients and the role opioids play in their lives remain unanswered, members of the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesia Drug Products Advisory Committee said. “To get at those uncertainties we need better, high-quality data in real-world patients,” Mackey stated. “This is an incredibly vulnerable patient population.”

The FDA held the public meeting Tuesday and Wednesday to discuss the risks and benefits of strong opioid doses — defined loosely as 90 morphine milligram equivalents per day or more — and whether the agency should consider action to reduce access to high-strength products. Just what that action might be was unclear: “We’re talking about the impact of any possible action you think we should or shouldn’t do,” an FDA official told the committee. “Nothing’s on or off the table.”

The meeting was announced in April, just weeks after the advocacy group Public Citizen called for a moratorium on new opioid drug approvals until a new regulatory framework, such as the one proposed in a 2017 National Academies of Science, Engineering, and Medicine report, is developed.

It also came on the heels of a Risk Evaluation and Mitigation Strategy (REMS) launched in September for immediate-release opioids, expanding the FDA’s REMS for extended-release and long-acting opioids for outpatients established in 2012.

Some groups have asked the FDA to withdraw the approval of higher dosage strength oral and transmucosal opioid analgesics due to safety concerns, said Judy Staffa, PhD, RPh, associate director for the Public Health Initiatives Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research (CDER), in introductory remarks.

“Higher dosage strength products may be more harmful in cases of accidental exposure and overdose, and may also be more sought out for misuse and abuse,” she noted. In recent years, federal, local, state, and payer efforts have evolved to encourage more judicious prescribing of opioid analgesics, she said: “It is in this complex and changing environment that we need to consider potential regulatory actions that would impact the availability of higher dosage strength products to vary degrees, depending on the action taken.”

But without more data, the value or harm of new FDA action is unclear, panelists said. “We don’t know what would happen with misuse and abuse and what would happen with public health,” acknowledged Moon Hee V. Choi, PharmD, of CDER’s Division of Advisory Committee and Consultancy Management. And many committee members voiced concerns that any action to limit high opioid doses could destabilize pain patients and lead to lower quality of life and suicidality.

“I see a lot of risks associated with that, for patients particularly,” said panelist Joseph O’Brien, president of the National Scoliosis Foundation in Stoughton, Massachusetts. “Probably the best example of that is the misuse and misunderstanding of the CDC guidelines.”

“We have now shifted the opioid epidemic to a patient-care crisis,” O’Brien stated. “There is now more feedback from patients and concern and alarm that they’re not getting what they need.”

Others at the meeting, including guest speaker Adriane Fugh-Berman, MD, of the Georgetown University PharmedOUT project, called for high-dose opioids to be removed from the market completely.

“I can’t think of another self-administered class of medications where doubling a dose has potentially lethal consequences,” Fugh-Berman told the advisory committee. “A handful of pills is a visual reminder that you’re taking a lot of medicine, and that’s a good thing.”

But taking a handful of opioids opens up greater risks for patients who aren’t sure how many they have taken in a day and poses hardships for those who have difficulties swallowing, some panelists argued. It also makes it difficult to spot whether others are diverting pills for their own use.

Clearer education about high-strength opioids and proper disposal is needed, most panelists urged. Using specialists to follow patients with high-dose prescriptions more closely also could minimize patient risks — and that doesn’t necessarily mean physicians, pointed out panelist William Becker, MD, of Yale School of Medicine. “Consider a model like a Coumadin clinic, where pharmacists do the requisite monitoring and make decisions on dose titrations,” he said. “This is the kind of distributed model that might work to help preserve access, yet ratchet up the amount of appropriate monitoring and specialization that will increase safety.”

To encourage further discussion, the FDA has established a docket for public comment about this issue, which remains open until June 30. To date, more than 1,000 comments have been registered.

The agency will not issue a final determination until input from the advisory committee process has been considered and all reviews have been finalized. That determination may be affected by issues not discussed at the advisory committee meeting.

If the FDA can’t/won’t make opiate dosing recommendations because  there’s not enough information to know just what regulatory action — if any — the agency should take about higher-dose opioids for outpatients with constant or chronic pain.

One has to ask… what sort of data does the DEA and CDC have to come to rather specific limits on opiate dosing and/or what combination of meds have NO VALID MEDICAL USE ?

Could it be that the DEA is just coming up with OPINIONS to try to justify their activities ?

4 Responses

  1. The lack of data is deliberate! They left out key data indicators form the ICD by design. Physicians wanted to avoid liability, a topic at most medical conferences. They were told by industry insiders that were protecting the big healthcare corporations, the codes were designed to protect them. The industries did not want physicians recording chronic intractable pain, especially after surgeries. The industries did not want “Big Data or Big Government” tracking them or any ability to apply fact based science to the data. Meaningful data could cut into profits.

    Back in the seventies there was a saying, that appears to be forgotten or forbidden in all of the hype about algorithms and big data, G.I.G.O. That means Garbage In Garbage Out! A casual glance at the created controversy about the EHR, an Electronic Health Record, shows clearly how certain industries misled the public, and distorted data collection. It was a relatively simple matter, yet all of these years out, it was an expensive con game. None of them are interoperable, and there is no way to pick out meaningful data and trends.

    I will point to one of the real profiteers in the so called opioid epidemic, the device industry. The FDA hid years of data, report of complaints, adverse events and even deaths. The created opioid crisis, was a jack pot for the device industry. People with serious pain were denied their medications, and sought relief with dubious, and deceptively marketed devices. These were marketed to people seeking information on pain, or people in pain groups online, with no adverse event warning.

    Another industry, fly by night spine surgery clinics, advertised constantly on TV, as people with crippling back pain, were denied medications, sought relief through dubious surgeries. These clinics have suddenly and mysteriously disappeared, often with a string of lawsuits. Any person seeking any information on outcomes was sorely out of luck. A glimpse of factual reality breaks through in the content marketing, https://khn.org/news/walmart-charts-new-course-by-steering-workers-to-high-quality-imaging-centers/ Hidden in the PR release, is the Fact that 50% of the back surgeries were unnecessary or had bad outcomes. They chose to blame the imaging, instead of the Mayo Clinic.

    We are in an Orwellian world of alternative facts, one where the data, collected for marketing purposes, is so intrusive and manipulated. There is big money in marketing data, yet no effort at all has been made to collect basic data on healthcare or certain medical procedures. Data on brand name medications is often proprietary, or not collected. The deliberate lack of data, partially from corporate interference, or fear of “Big Government” is all by design. Tracking outcomes of pain patients, or even people in drug treatment programs, could be bad for business. We should be asking how we got here.

    Right now Congress is grilling the Pharma Industry over drug prices. There are no penalties, for price fixing or causing deaths, by over pricing, and the media has been protecting the industry. Those terrible “progressives’ want laws and penalties, or accountability. No one will discuss the marketing, or how that is impacting it all. Media propaganda repeats the phrase, “Innovation” as they repackage old drugs and peddle them at whatever the market might bear. The created opioid crisis, was boon for overpriced addiction medications. No one at the CDC even considered the unintended consequences, they were looking at industry profitability.

    Phrases like Regulatory Capture come to mind, when they put industry insiders in charge of federal agencies. We have the apex of Market Based Healthcare, where they use their positions at the regulatory agencies to ensure profits at any cost. History and data tell us that the market cannot police itself, yet that is what they are doing. They created a healthy market for the drug cartels too, anyone could have predicted that, except for the CDC or the FDA. Perhaps one day they will recognize that the entire reaction was Genocidal. It was not based in science or facts.

  2. The silence, obvious non-commital position of the FDA and HHS is deafening. At least Kolodny takes a stand. The most recent release by the AMA too is a study in the very best ‘fence-sitting’.

  3. Just another intentional delay tactic by the Fed alphabets and more foot dragging as the usual methodology.

    I smell another multi million $ “study” as if there haven’t been enough to gag the planet. Ought to be good for wasting another several more years. Then, the fda will announce, as last yr. ” Oops, we hired a 3rd party Contractor and they didn’t use the proper algorithm.” Then, another few yrs., then another smokey mirror ” We need another study.” By then, we’ll all be dead which was the Fed’s mission since inception…

  4. This whole post would be funny if the subject wasn’t so serious and dire! These puppets are talking like pain medication was just invented. “we have to do this study and be careful with this dosage ” what the hell? I’m 66 yrs old.. I don’t have any more time to waste waiting for these empty suits to decide whats OK for me. I’m laying on a couch or bed AGAIN because my medication was taken away!! This whole article is absurd!! They talk like they are dealing with people that have no brain or aren’t capable of knowing when to take the medication. They had better come to a reasonable conclusion,like Get ALL of these agencies out of the Dr.s office and let the Drs. take care of their patients!! You have Drs. that are afraid to prescribe for fear of going to prison or losing their license to practice!! This B*** S*** has got to end NOW!!

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