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Saturday, August 15, 2015

Oxy For Hurting Kids and What You Probably Don't Know


"In a question-and-answer posting on the FDA’s site, the head of the agency’s painkiller division stressed that OxyContin’s new pediatric approval 'was not intended to expand or otherwise change the pattern of use of extended-release opioids in pediatric patients,' but to better inform prescribing that was already taking place in children. Doctors are allowed to prescribe medicines any way they see fit, including for uses not approved by the FDA, a practice known as off-label prescribing.

“'Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients,' Sharon Hertz, director of the FDA’s division of anesthesia, analgesia and addiction products, said in the posting. 'This program was intended to fill a knowledge gap and provide experienced health care practitioners with the specific information they need to use OxyContin safely in pediatric patients.'”

(Jeanne Whalen. "FDA Approves OxyContin for Kids as Young as 11."
The Wall Street Journal. August 14, 2015.)

So says the FDA to support their decision to approve the use of the painkiller OxyContin in children, as young as 11, for "severe pain that can’t be adequately treated with other medications." A caring and safe decision you say? I say it is a decision with significant risks to public health.

Let me begin with an old FDA decision. Who remembers 2013 and the FDA's Risk Evaluation and Mitigation Strategy (REMS) for extended release/long acting opioid analgesic drug products? Then, the FDA refused to make training for all doctors who prescribe these substances mandatory. Instead, they chose to make the instruction voluntary with the following highly questionable, pitifully low goals.

According to the FDA, there were about 320,000 prescribers of long-acting opioid analgesics in the U.S. then, and the agency expected 25% of them to be trained at the end of the program's first year. Their goal was to have 60% of prescribers trained by year three.

I believe establishing mandatory training within reasonable time limits is necessary to prevent addiction and to save lives.

In fact, in 2013, many top dogs supported mandatory training. The FDA's own appointed expert panel including Dr. Margaret A. Hamburg, the F.D.A. commissioner, and R. Gil Kerlikowske, President Obama’s top drug policy adviser, said that mandatory training was essential for the following reasons:
  • To reduce the abuse of strong painkillers, or opioids, and
  • To make sure that pain patients were treated appropriately with them.

Yet, in their own words, the FDA overrode the panel's evaluation and even OKed opioids like OxyContin as useful in "moderate pain." Here is the Risk Evaluation and Mitigation Strategy (REMS) for all extended release/long acting opioid analgesic drug products due to their risks of misuse, abuse, addiction, and overdose:

"Extended‐release and long‐acting (ER/LA) opioid analgesics are approved for the management of chronic moderate-to-severe pain in the U.S., and can be safe and effective in appropriately selected patients when used as directed. However, opioid analgesics are also associated with serious risks and are at the center of a major public health crisis of increased misuse, abuse, addiction, overdose, and death."

Even though the new FDA guidelines for prescribing OxyContin to adolescents say "doctors should only prescribe OxyContin in children who have already been treated with opiate painkillers and who can tolerate at least 20 milligrams a day of oxycodone," how can safety be assured when so many prescribers have not been trained in the use of long-acting opioid analgesics?

In fact, pain levels are usually gauged by patients and depend largely on subjective evaluation. Several widely used instruments let patients rate pain on a scale of one to 10. The one-to-three range is described as mild, nagging pain that does not greatly interfere with a patient’s daily life. The four-to-six range ismoderate pain” that significantly interferes with a patient’s ability to perform activities of daily living such as working, cooking and doing chores. The seven-to-10 range is “severe pain” that is disabling and renders a patient unable to perform daily-life activities.

I believe the FDA should not approve OxyContin for management of moderate pain. Evidence of long-term efficacy for chronic non-cancer pain (≥16 weeks) is limited and of low quality. For many patients with chronic pain, analgesic efficacy is not maintained over long time periods. These opioids can be dangerous. With daily opioid use, physical dependence and tolerance can develop in days or weeks.

Who's Training What?

Who is "providing experienced health care practitioners (but also largely untrained prescribers of long-acting opioid analgesics) with the specific information they need to use OxyContin safely in pediatric patients"? The manufacturer -- Purdue Pharma. They are the company entrusted to do the job of "filling the knowledge gap" as phrased by Sharon Hertz. Not only are Purdue employees in charge of providing the information, but also they are the ones chosen to conduct the research on the effects of prescribing the substance to adolescents.

Please understand that the FDA does no testing on new pharmaceutical products itself, but relies on the reports produced from the testing carried out by the drug manufacturers. In too many cases the drug manufacturers ignore or down play possible side effects in these reports in order to get permission to put their drug on the market.

Industry-sponsored medical education cannot be trusted. When the very pharmaceutical companies that manufacture opioids are in charge of funding and administering REMS programs, there is a distinct bias. Pharmaceutical companies are actually using REMS for a marketing tool to convince consumers of their utmost concern for public safety as they continue to push for higher profits and higher distribution.

Lobby groups boast of their ability to “craft” legislation with the FDA. Along with the financial lobbies, the pharmaceutical and health products industries have historically been one of the biggest and most powerful lobbies in Washington. Drug companies enjoy more power and influence in America than with any other government in the world.

But, if you trust Big Pharma ... Purdue’s chief medical officer, Gail Cawkwell, said of the FDA's approval: “For the first time, physicians prescribing OxyContin for patients 11 years and older who have already been receiving opioids will be guided by FDA-approved dosing and safety information.”

(Jeanne Whalen. "FDA Approves OxyContin for Kids as Young as 11."
The Wall Street Journal. August 14, 2015.)

The FDA has been lobbied into submission and now willfully accepts the opinion of pharmaceutical companies as fact instead of demanding that unbiased, independent studies be used as trustworthy research to determine the safety of drugs.

I absolutely want OxyContin to be available to young patients in severe pain, especially those who suffer from terminal cancer. Still, the way the system works now is irresponsible. Without significant public pressure, untrained prescribers will continue to get their information from drug companies whose bottom line is making bigger and bigger profits.

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