People living with pain sustained another jolt last week at the hands of a Food and Drug Administration advisory panel. The panel voted 19 to 10 to recommend that Vicodin and other hydrocodone products be reclassified from Schedule III controlled substances to Schedule II drugs, thus making these much used and needed medicines for pain patients harder to obtain.
Much of the information in this column came from an email sent to me by Cindy Steinberg, a pain care activist who attended and testified before the FDA panel last week.
In 2008, the FDA turned down a request from the Drug Enforcement Administration (DEA) to reschedule Vicodin form schedule III to schedule II. The DEA requested that the FDA look into the matter again, leading to last week’s decision.
The most disturbing element in this recommendation is that much of what was used in support of the change was based on little evidence or wrong assumptions.
At no time was there any evidence introduced that the recommended schedule change would reduce diversion, illegal use, addictions or deaths. The chair of the advisory panel and deputy director of the FDA, Dr. Douglas Throckmorton, cited this lack of evidence as his reason for voting against the recommended changes.
The rescheduling decision was also tainted by the fact that there was only one pain doctor among the 29 panelists. And the number of parents testifying about the loss of a child through prescription medicines far exceeded the number of people with chronic pain who testified.
This might be explained by two primary factors; people living with chronic pain usually have more employment problems because of their disabilities. They have less money to spend on going to hearings and paying for hotel rooms. People with pain also have much more difficulty with travel. This by itself should have alerted the panel members to the very real deficits with which people in constant pain must cope daily.
While it’s impossible to predict the long term effects of rescheduling, I believe it will hurt pain patients rather than protect them.
Rescheduling will limit patients released from hospitals and emergency rooms to a three day supply of Vicodin, which a majority of the panel thinks will be enough for pain patients to see their prescribing physicians. This is an unfortunate cul de sac for people with pain who will likely suffer from abrupt withdrawal from their opioid medicines.
The three day supply seems reasonable on the surface, but it is the launch pad for yet another attack on pain patients. How many of us are able to secure an appointment with our physicians in three days? Those with a decent income and health insurance often have a working relationship with their physicians and may be able to see them in three days.
But if you are poor and have no access to decent health insurance, your chance of landing an appointment in three days is problematic at best. Many have to rely on overworked and overbooked community health centers or have no standing relationship with a physician on whom they might rely.
Those on limited income but who have insurance through their employer will also be hit hard financially, as they will have to see their prescribing doctors every month to obtain a prescription because Vicodin prescriptions will no longer be given over the phone, mailed or faxed.
Those patients will have to pay a monthly copayment and those without insurance will have to pay anywhere from $85 and up for their monthly appointments. This will increase the traffic in medical practices, thus making it even harder to obtain the required prescription in three days.
These problems will likely be even more severe in rural areas where all medical services are harder to obtain. Many poor and those with limited incomes will have to travel long distances to see their physicians. This in itself will increase the pain with which many struggle. And in an increasing number of states this will lead more people to join the unconscionable “pharmacy crawl” that causes so much suffering in states like Florida.
Even patients in nursing homes and assisted living facilities will have to visit their physicians monthly. This, of course, will aggravate the painful conditions for which they seek the relief of opioid medicines.
If these recommendations are approved by the FDA we might likely see in increase in the diversion, addiction and deaths from other Schedule II medicines, as well as an increase in the use of illegal drugs, such as heroin, by pain patients who won’t be able to adhere to the new policy or be able to afford increased medical bills.
This leads to a point I’ve been making repeatedly since the Spring of 2012: The war on drugs disproportionately targets the least powerful among us; those on limited or fixed incomes, the poor and the disabled living with chronic pain.
It seems likely to me, barring other developments, that these recommendations will be approved by the FDA. With political pressure growing and a recommendation by their own panel the FDA’s likely decision won’t augur well for those living with pain. Those of us in this category, while we have some sympathy from politicians, realize we have little power in the political arena.
We have to remember that there’s huge money swirling around this problem, not the least of which is the DEA whose budget for 2011 was over $2 billion. This, combined with nearly $650 million for the treatment of pain and the billions of dollars the pharmaceutical companies make manufacturing and selling these medicines, points to the kind of power brought to bear on the panel’s deliberations.
The only power we have is our voices, voices that need to cry out from the depths of the hell in which millions of us live, millions of law-abiding citizens in need of care, not unsubstantiated “facts” underpinning governmental repression.
Though time is running out, pain patients, their families and friends can still post statements on the FDA docket until Friday, February 1.
Comments can be posted at this link. We can still have an impact. Our voices, regardless of the opposition, need to be in raised in the public square.
Mark Maginn lives in the east bay of San Francisco where he is a poet, writer and social justice activist. Mark suffers from chronic pain and was a longtime volunteer with the American Pain Foundation. His blog can be found here.
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