"'The propriety of having the pharmaceutical industry develop unbiased
education for prescribers and patients is debatable,' wrote Lewis Nelson, MD,
and Jeanmarie Perrone, MD, in an opinion column published in the
Journal of the American Medical Association.
"'Although such education for prescribers will be offered through ostensibly independent continuing medical education providers, the expectation
of the FDA that this will be funded by the pharmaceutical industry
raises several concerns, including financial motivations
and creative risk/benefit messaging.'”
What Do We Have Now?
The FDA’s risk evaluation and mitigation strategy (REMS) allowed the following:
* Voluntary training courses for doctors precribing extended release opioids.
* 20 drug makers funding these training courses and creating non-promotional medical guides for patients on extended release opioids.
An FDA advisory committee recommended mandatory training for opioids, expressing concern that not enough doctors would volunteer their time; however, the FDA overruled the advisory board, saying mandatory training would be “potentially burdensome.”
"Burdensome" to whom? Possibly, the booming business of morticians.
The problem of prescription drug abuse has become so severe that drug overdose deaths attributed to opioid pain medicines such as Vicodin or Oxycontin exceed overdose deaths from heroin and cocaine combined. In 2008, 36,450 people died from drug overdoses in the United States, and 20,044 of those were due to prescription drug overdose. Opioid pain relievers were involved in 14,800 of those 20,044 deaths. (Center for Disease Control, 2011)
"Three years" with a "goal of 60 percent"? How can the FDA, in the name of a merciful God, allow three more years of spiraling death and deformity due to rx drug abuse pass as a hopeful 60 percent of doctors complete their voluntary opioid courses? If this is an example of a typical goal set by the FDA, we should be able to see now how many of their measures are grossly ineffective.
I'm not making this up. In the midst of the biggest man-made health epidemic in history, truth is much, much stranger than fiction. Let me fill you in a little more:
* There is a significant lack of pain curriculum in medical schools.
* The voluntary training will not cover powerful short-acting opioids such as hydrocodone (Vicodin) that have an equally high potential for abuse.
* Several non-profit medical organizations -- like the American Pain Society -- have already been offering educational seminars on pain management. They call this "an outstanding educational program that industry has no control over whatsoever." (Quote from Roger B. Fillingim, PhD, president of the American Pain Society)
* Purdue Pharma’s has already established an online training course for physicians under REMS. The training program for doctors covers safe prescribing methods for OxyContin, its widely prescribed and abused painkiller. The program ends with a short quiz, but physicians are not graded on their answers and are not required to demonstrate competency before being certified that they took the program. Incidentally, the Purdue website notes that “completion of the questions does not affect your ability to prescribe OxyContin.”
* And, these courses provided by those organizations are expected to play a key role in the FDA’s training program for physicians.
I know for certain that I am IN PAIN reading about the FDA training plan. At this point, it is the duty of the American public to act by petitioning the FDA to instill mandatory training for doctors prescribing opioids; training that is not funded or conducted by pharmaceutical companies. I am making this petition available to all.
Please take a minute to sign the online petition and include any comments you deem necessary. The site is included at the bottom of this blog entry. Please, click on it to sign today. Quick and easy.
I'll leave you with a couple of quotes about the FDA training from Kristina Fiore's MedPage Today report:
"'These educational programs are likely going to do more harm than good,'" said Andrew Kolodny, MD, chair of psychiatry at Maimonides Medical Center in New York City. 'Nowhere does it say that prescribers should tell patients these drugs are addictive. And these programs give the implied message that there's evidence for using opioids in long-term, noncancer chronic pain.'
"Kolodny noted that the final REMS is the same version that the advisory panel voted down 2 years ago, and called it a 'jackpot for the medical education companies (MECs).' He said there are about five MECs that currently handle much of the industry-sponsored education for opioids.
"Instead, Kolodny said, a better option is mandatory education that's either tied to DEA licensure or has a certification process similar to that for buprenorphine (Suboxone), an opiate and addiction treatment that requires completing an 8-hour class before physicians can prescribe it."
(Kristina Fiore, "FDA Finalizes Opioid Education Plan, MedPage Today, July 9 2012)
The American News Report Article: http://americannewsreport.com/15222-8815222
Please Click This Address to Sign the Petition: