Hearing minutes now posted: http://www.fda.gov/downloads/
The hearing started PROMPTly at 9AM with an introduction by the FDA Deputy Center Director Dr. Douglas Throckmorton, Center for Drug Evaluation and Research. The first four presenters were from downtrodden PROPagandist parents that lost loved ones to a drug overdose, in each case due to inappropriate prescribing by a licensed medical doctor, misuse, or a combination of both – but in each case it involved opioid addiction. I think we can all agree that such tragedies are very sad and our hearts go out to all families that continue to suffer from these losses.
Multiple practitioners that included medical doctors, pharmacists, social workers, and others presented following these first four; some in favor and some against relabeling of opioids (more specifics to come in a later blog post).
On 4-5 occasions, PROPagandists likened oxycodone to heroin. I can allow such a comparison by non-medically or pharmaceutically trained people, but it remains unconscionable that medical people bias this factor in presentations. For example, not a single one said oxycodone is chemically similar to heroin, but, dextromethorphan (found in Robitussin® Cough Syrup) is also structurally similar. See paindr.com blog post, Heroin, Hydrocodone, Buprenorphine & PROPaganda comparing heroin to buprenorphine
So here I am after half the day and the questions and comments that loom in my mind are as follows:
- Many medical presenters started by saying, “I have no conflicts of interest to disclose with any pharmaceutical firms”. I don’t much care, unless all presenters are required to disclose any and all third party funding whether it is funded by the pharmaceutical industry or not – this would serve to expose who is financially fueling this fire (Worker’s Comp, Health Insurance Industry)? For the record, I funded my own travel expenses.
- Many spoke about the maximum daily dose of morphine, and one presenter displayed data suggesting that there are more deaths from patients that are in the category of receiving greater than 100mg of oral morphine or equivalent per day. That may be true, but could it be because of all patients that fall into that category, there are sicker patients compared to those on lower doses? That certainly would make sense.
- During Dr. Kolodny’s presentation, he suggested that third party payers would not deny payment for opioids off-label if the indications were changed, yet another presenter sited evidence that this has already occurred. Dr. Koldony used an example of how Lyrica® is FDA approved for fibromyalgia, yet many third party payers refuse payment in lieu of Neurontin® because it’s less expensive, even though it does not have the FDA approval. What he failed to mention is that both of these drugs have an identical pharmacological mechanism of action to uptake the alpha-2-delta subunit receptor that affects intraneuronal voltage-gated calcium channels. Yes, they both work the same way, so it is understandable that third party payers require failure on Neurontin® before paying for Lyrica®. When directly questioned if evidence exists to support that third party payers will not deny payments, Dr. Kolodny did not offer a yes or no reply. For the record, no such evidence exists.
- Perhaps the most compelling, well-organized, carefully balanced, patient-clinician directed and truthful presentations this morning were from Doctors Amy Abernethy (American Academy of Hospice and Palliative Care), Robert Twillman (American Academy of Pain Management), and Charles Argoff (American Academy of Pain Medicine). Dr. Abernethy’s perspective was particularly enlightening because she spoke about terminally ill patients or some that have had “terminal” illnesses that are not cancer-related, all of which required chronic opioids beyond 90 days and often exceeding 100mg or oral daily morphine or equivalent for quality of life. Dr. Twillman discussed three “Logical and Philosophical Considerations in the Use of Opioids for Chronic Pain”, perhaps the most compelling that “The absence of evidence does not constitute evidence of absence”. Dr. Argoff aptly outlined the physiological differences of various pain syndromes and how and why we might expect to see a response from one agent versus another, but also the importance of appropriately combining various pharmacological agents for a rational polypharmacy approach to pain.
- Items that were not discussed in detail yet are the following:
- Prescription monitoring systems across states and how we might work collaboratively across all states and with the DoD and VA systems to tighten up collaborative monitoring among prescribers and pharmacies.
- Who’s data will the FDA use to establish what the oral morphine 100mg conversion should be? See paindr.com blog post, The Answer is Morphine 100mg Equivalent – Morphine Jeopardy.
- When establishing a maximum daily dose, how will one account for patient variability?
- When establishing a maximum daily dose, how will one account for the lowering of morphine (or other opioid) serum levels specifically due to drug interactions? See paindr.com blog post, Rifampin Lowers Oral Morphine Absorption, The Path to Publication in Healthcare.
I’m glad I could provide this quick update during lunchtime. More to come!