Emails point to ‘troubling’ relationship between drug firms, regulators.
Milwaukee Journal Sentinal, October 6, 2013
Pharmaceutical firms paid to attend meetings of panel that advises FDA.
Washington Post, October 6, 2013
FDA and Pharma: Emails Raise Pay-for-Play Concerns.
MedpageToday, October 7, 2014
Why Did the F.D.A. Approve a New Pain Drug?
New York Times, December 3, 2013hat tip to George Dawson…
I’m personally a chronic back pain person with a back full of hardware. After my first back event, I was sent home with a bottle of Percocet – "two every six hours as needed for pain" it said. I sure had pain, so I took two, and reached the following conclusion. There was never going to be a minute for the rest of my days when a couple of those wouldn’t feel like a fine idea. So I threw them away. They were too good. My point is that their addictive potential is impressive.
Later in life, I had some pain situations where I simply had to take something [after a couple of back surgeries, for a dental abscess or two, etc]. I learned that when you have big time pain, they are mostly pain pills. The euphoric effects aren’t so noticable then. But for lesser pain, they become happy pills too. I learned that with an excruciating dental abscess. The first pill after it began to get better was when I got that "uh-oh" feeling and tapered off.
After using narcotics for more than two days, I think it’s best to assume physical dependence and taper rather than stop. My assumption, by the way, is that anyone can become addicted to narcotics. It’s an equal opportunity drug.
Bob Rappaport, the director of the F.D.A’s Division of Anesthesia, Analgesia, and Addiction Products, observed at the meeting that it was reasonable to anticipate that a single-entity hydrocodone product “will contribute to the already critical public-health problem of prescription opioid abuse and misuse.” But he also chastised the expert panel for some of their more pointedly critical remarks about Zohydro ER, observing that they were “punishing this company and this drug because of the sins of the previous developers and their products” and that “from a regulatory standpoint, that’s not something we can do.” He explained that as long as the drug met F.D.A. requirements, it ought to pass muster; Zohydro ER could not be scapegoated simply by virtue of being an opioid. “We are obligated at the agency to operate within the regulatory framework,” he said, “and that includes providing a level playing field for industry. We don’t have a choice by that. It’s the law.”
Without a system like this, there’s no incentive to develop drugs and we stagnate. With such a system, double binds like this are inevitable. Rarely do we see a new drug that doesn’t have something about it that throws a monkey wrench into the equation. But the issue with Zohydro™ER seems to me to transcend the argument put forward by Bob Rapaport above. It has to do with a hierarchy of values. Zohydro™ER is not a "me too" drug. It’s a "me too much" drug.
Hydrocodone generally comes in 5.0 mg, 7.5 mg, and 10.0 mg pills. Zohydro™ER comes in capsules. "Each Zohydro ER capsule contains either 10, 15, 20, 30, 40, or 50 mg of hydrocodone bitartrate USP." Its assets are that it doesn’t have Acetaminophen and one doesn’t have to take as many pills or take them as often. The downside is that some of those pills could easily be lethal to people who are not tolerant or to children. They will be worth a mint on the street where bigger is better. I expect the drug culture people see them as something like a new iPhone – a potential blockbuster. The risk/benefit ratio is much higher than the pills on the market already. And in the hierarchy of values, surely "do no harm" trumps convenience every time.