Dr. Woodcock and the FDA's Attempt to Curb Drug Abuse

It’s practically a thankless job. Worse than that, the good people at the United States Food and Drug Administration are frequently under pressure from all sides of many a heated debate. Patent holders want to sell more drugs and prefer that the FDA make all plants illegal. Well-intentioned promoters of natural health like Dr. Mercola and others regularly accuse the FDA of only looking out for the interest of Big Pharma. Some bureaucrats are innocently stuck in the crossfire.

The government does seem to push the patented synthetic drugs–each with its own unenviable list of horrible side effects–when there are certainly better, less harmful solutions out there. But certainly not all of its officers are corrupt. Let us not lose sight of the fact that  the FDA is charged with no easy task. And let us never be slow to recognize the great work of the few outstanding officials that are legitimately fighting for the health and wellness of all.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, well deserves a round of applause for her efforts to reduce the number of fatal drug overdoses in the United States and beyond.

Roughly 22,000 Americans die each year due to drug overdoses. And federal data confirms that prescription drugs cause a full 75% of these deaths, roughly 16,500. Also, the number of deaths from opioids has increased by 400% since 1999. Dr. Woodcock has recommended a measure that will surely reduce the number of opiate overdoses: tighter controls on the most commonly-prescribed opioid, hydrocodone. Specifically, Dr. Woodcock recommends raising hydrocodone up one class level, from “Schedule 3” to “Schedule 2”.

Controlled Drugs are divided into five schedules, based on their medical use and their potential for abuse and addiction. These schedules are enforced by the D.E.A.

  1. Schedule I includes the drugs with a high potential for abuse that cannot be legally prescribed. Included are Heroin, LSD, Ecstasy and (absurdly) Cannabis.
  2. Schedule II lists the drugs with the most potential for abuse, but can be legally prescribed. Included in Schedule II are: Cocaine, Morphine, Oxycodone, Methadone, and Ritalin.
  3. Schedule III controlled drugs are considered less dangerous than the above lists, and are among the most available to abusers. Roughly 70% of opioid prescriptions contain hydrocodone, which is currently classified under Schedule III.
  4. Schedule IV includes Xanax and Valium.
  5. Schedule V drugs include tiny doses of narcotics, for relief of diarrhea, cough, etc.

The drugs that contain a combination of hydrocodone and a painkiller like acetaminophen or aspirin are most frequently prescribed to treat pain from injuries, arthritis, and dental extractions. Most patients take such medications for just fourteen days, while the law currently allows that a six-month supply be given to such patients, and the excess (up to 92.3%) is often sold on the black market to abusers.

In 2011, the government estimates that 131 million prescriptions for hydrocodone-containing medications were written for 47 million patients. That’s around five billion pills.  If patients only use 7.7% of the maximum allowable dose, the 92.3% surplus would leave up to 4,615,000,000 (4.6 billion) extra pills ‘on the street’. And that is one staggering figure that surely contributes to the thousands of accidental deaths by drug overdose.

Dr. Woodcock‘s recommendation to reclassify the drugs containing hydrocodone as Schedule II would reduce the maximum prescription to three months. If the patient still requires the drug, his or her doctor must then write a new prescription. Although this recommendation seems abundantly reasonable (and the D.E.A. appears to be on-board since last decade), it does not go into effect without the rubber stamp of  the Department of Health and Human Services. Even if the bureaucracy finally comes to its senses, expect the approval to take several months.

And expect the drug pushers to do everything in their power to halt the measure. The  American Medical Association, the National Community Pharmacists Association and other drug lobbyists are citing “significant hardships and delayed relief for vulnerable patients”.

Dr. Woodcock said that F.D.A. is aware that the rescheduling will affect some patients. But the impact on public health caused by the abuse of the drugs had reached a tipping point. “These are very difficult trade-offs that our society has to make,” she said. “The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.”

The epidemic that she is referring to, is the needless death of thousands of Americans per year. Let’s do the math together, based on the official government estimates:

22,000 deaths by drug overdoses per year.

75% of these are by prescription drugs = 16,500, of which Opiates account for the largest portion.

Roughly 70% of the opiates contain the target hydrocodone = 11,550

Since we are not eliminating this drug, but rather, simply going to check in with patients two extra times per year, it is probably unrealistic that we could eliminate all 11,550 needless deaths per year. But I would venture a guess that Dr. Woodcock’s recommendation may save upwards of 5,000 lives per year.

Dr. Woodcock correctly pointed out that “If you are needing chronic therapy of this magnitude,” she said, “you should be seeing your prescriber… after three months, rather than six.”