Response to the FDA Opiods REMS

Response to Docket No. FDA - 2009-N-0143
May 6, 2010


The National Foundation for the Treatment of Pain has responded previously to this REMS proposal . The previous submission provided extensive analysis of the data proposed by FDA in support of the claimed need for REMS activity regarding oxycodone and other opioids, both sustained and immediate release. This analysis clearly established that there is no defensible statistical basis for restricting the already inadequate treatment of pain in America because of the statistically insignificant incidence of overdoses from the abuse of illicitly obtained prescriptive medications.

NFTP urges FDA to revisit this analysis of the data we have previously submitted. It is plainly obvious to any individual trained in statistics and statistical analysis that the occurrence of overdoses and abuse of prescriptive medications, particularly the opioids, has increased over the last few years, as drug abusers have redirected their activities toward prescribed medications in addition to illicitly drugs of abuse. However, simply stated, there is a profound difference between the concept of "occurrence" and that of "incidence".

A recent article by the editor of Science News
http://www.sciencenews.org/view/feature/id/57091/title/Odds_Are%2C_Its_Wrong
brilliantly addresses the short-comings and pitfalls of statistical arguments in support of conclusions, policies and egulation. The burdens upon the health care system of any proposed REMS must be minimized. y objectives and beliefs. It is strongly recommended that FDA consider it carefully.

While the unfortunate and sometimes tragic consequences of misuse of prescribed medications has increased, the incidence of such events is statistically insignificant when calculated against the total number of prescriptions and legitimate ingestions of these drugs is considered. For example, while almost 8,000 overdose deaths in 2009 from the illicit diversion and ingestion of opioids is a tragedy to the families and friends of the individuals involved, compared to the hundreds of millions of doses safely ingested out of medical necessity, these fatalities are not statistically significant. Simply stated, while NFTP recognizes the political pressure directed at the FDA by the sensationalized media focus on overdose deaths, a Draconian REMS response by FDA would be a clear example of throwing the baby out with the bathwater.


Related to this issue, NFTP strongly supports the views of other interested parties who have responded to this docket matter. Specifically: The burden of any proposed REMS upon the health care system must be minimized. Opiophobia is already a cancer upon the body of American medicine. Adding any additional barriers and burdens upon medical practitioners will only further increase the shameful lack of willingness of physicians to accept responsibility for the adequate treatment of pain. There are 40 million chronic pain patients in America, the vast majority of whom suffer needlessly and endlessly from lack of pain medication. The deaths of even 8,000 drug abusers hardly justifies giving physicians an additional incentive to avoid them.

1. Any proposed REMS elements should be proven to reduce the risk of abuse, misuse or diversion. The concept of the "cost/benefit ratio" for these elements must be carefully examined and researched, prior to their imposition upon the health care system.

2. The REMS should not impose a patient registry upon intractable pain patients. They are already demonized, stereotyped, abused, avoided and abandoned by their families, society, the medical community and policy-makers. Requiring them to register will impose burdens, vulnerabilities and opprobrium upon them far beyond their current suffering, which is already a national disgrace. State and national data systems to track schedule II prescriptions are more than adequate to contain diversion and abuse. Pain patients are not sexual offenders and should not be treated as though they are.

3. Existing DEA registration mechanisms should be used to track and confirm prescriber competency. The skillful and competent management of pain should be an absolutely essential component of every physician's medical skills. Doctors who refuse to treat, and who avoid pain patients, should be identified and re-educated as to their professional, moral and ethical responsibilities. Additional burdens and barriers to prescribing will only worsen the already catastrophic unavailability of effective pain treatment.

4. Any proposed REMS must include all classes and types of opioids, so that regulatory forces don't distort the practice of medicine. The vast majority of abuse of opioids, including fatal overdoses, occur from the abuse of hydrocodone and oxycodone products combined with acetaminophen, ibuprofen or aspirin. REMS directed only at sustained release opioids will drive physicians to prescribe precisely the medications that already cause the vast majority of abuse and overdose problems. Again, however, when one contrasts the hundreds of millions of doses of short and sustained acting opioids that are safely and appropriately ingested each year, to the few thousand instances of overdose from illicit use, there is no reasonable basis for any such change in public policy other than a chimerical need generated by tabloid-driven hysteria.

In summary, NFTP supports the position of every pain advocacy organization that:

1. The problems FDA is seeking to solve with a class-wide opioid REMS, as well as obvious potential consequences (such as, fewer prescribers and reduced access to care) need to have clear definitions and baseline measurements to adequately assess the effectiveness of any REMS.

2. The REMS elements should be proven to reduce the defined problems before finalizing them as regulations, including the use of phased-in testing if no such evidence exists.

3. Any opioid REMS should include ALL classes of opioids, not just extended release opioids.

4. The REMS should not include a patient registry.

5. The REMS should include comprehensive, interoperable State Prescription Drug Monitoring Programs and FDA should appeal to Congress and the Administration for expansion of these programs, through greater funding of the NASPER law or other means.

6. Appropriate opioid education, developed by professional associations, should be voluntary for all prescribers of controlled substances until a system can be put in place that can verify education without disrupting the access to these important medicines and without disrupting the delivery of care. Any system should have minimal administrative burdens on both prescribers and dispensers. DEA should utilize its existing registration procedures to track and confirm the completion of such education. Any such system should make it absolutely clear that the effective management of pain is the ethical duty of every physician, and that Opiophobia is a form of pharmacological racism - irrational, unacceptable and contemptible.




PREVIOUS NFTP RESPONSE TO PROPOSED REMS:

The potential harm that is the object of these concerns actually presents an extremely low risk to pain patients who utilize opioids to contain their suffering sufficiently to give them a reasonable quality of life. Even 8,000 opioid deaths in a single year is a minuscule number, compared with the 150 million doses of opioid safely prescribed in the same year. Further, when these deaths are examined objectively, most occurred as a consequence of what doctors call "polypharmacy" - the combining of alcohol, sedatives, illicit stimulants and often many other drugs, with the opioid. These deaths are the consequence of the abuse of drugs - out of ignorance, peer pressure, compulsive behavior and addictive disorders. They are never the result of use as prescribed. Therefore, the supposition that reducing the availability of opioids will effect a reduction in this kind of overdose death is either naive, or a cynical strategy for generating support for a new extension of the "War on Drugs".

Indeed, as with the lessons learned from the Prohibition of alcohol, the consequences are only greater harm. Restricting the legitimate provision of opioids drives patients to illicit sources. Illicit drugs are not only potentially contaminated and of unpredictable potency, but they also support crime and international criminality. Addicts have never had their disease mitigated by the restriction of supply. Criminal suppliers always find means to meet their demands.

Finally, the current proposal, to restrict the prescribing of opioids by imposing more requirements on physician prescribers, is a dreadful folly.
1. The real crisis regarding opioids is the unavailability of medical management of pain - there are almost 4,500 untreated pain patients for every abuser dead of polypharmacy involving an opioid.
2. Physicians are already dysfunctionally opiophobic - imposing further requirements upon them would catastrophically further reduce the number available for the medical management of pain.
3. EVERY physician's training should make them completely competent to treat pain - acute and chronic. Establishing a special category and training requirements for opioid prescribing would defeat this essential goal.
4. Instead, medical schools should be required to adequately train EVERY physician in pain management as a requisite for obtaining a license to prescribe.
5. The mythologies of opiophobia must be eliminated by competent clinical training in pharmacology. Any physician who practices opiophobia is de facto pharmacologically incompetent.
So, in summary, practicing evidence-based medicine unavoidably leads us to the conclusions that:
1. The need for the proposed REMS is unproven and factually unprovable.
2. The imposition of what is proposed would not only be a national folly, but have horrendous negative consequences for both pain patients and the general public.
3. Criminals would be the primary constituency to benefit from the proposals.
4. What is proposed would have no impact, whatever, upon the incidence of accidental overdose deaths involving opioids of substance abusers.
5. The resources wasted on the proposal would be far more wisely invested in the education of ALL physicians, and ALL young people, and in providing medical treatment for the addictive disorders as an alternative to the criminal justice system..
J.S.Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org