We want safe foods and drugs. But should we want the Food and Drug Administration? Or more regulation from it?
We can use third-party investigations of the nature and effects of pharmaceuticals; but a government agency doing the investigating sure has its drawbacks. The bureaucracy’s coercive regulations and costly mandates should certainly not trump individual judgments about whether one may use a drug.
The FDA exists, however, and its massive presence in modern medicine isn’t going away any time soon. Luckily, some of its decisions are better than others. And now that it has authorized sale of the painkiller Zohydro ER, we can say it made the right call here.
The rightness of the decision is highlighted rather than contradicted by mounting political pressure to reverse it.
U.S. Senator Joe Manchin, a Democrat, and U.S. Senator Mitch McConnell, a Republican, are among those demanding that Zohydro be outlawed. Their main complaint seems to be that the drug’s very effectiveness makes it more addictive, and more prone to abuse, than other painkillers. Officeholders from 29 states have chimed in to demand a ban.
I don’t know the ratio of benefits to risks in taking this drug. I know that if I’m writhing in pain, and other painkillers can’t do much to alleviate it, but Zohydro ER can, I want the freedom to decide for myself whether the benefits are worth the risks.
We have the right to make such decisions about our own lives.
In the meantime, FDA Commissioner Margaret Hamburg deserves credit for resisting political demands that the agency rescind its approval.
My prescription for her? Don’t back down.
This is Common Sense. I’m Paul Jacob.
7 replies on “FDA Chief Gets It Right”
The problem with this drug is that once it makes it’s way to the street, and it will, the druggies often crush & snort it. Knowledgable people say that if it is abused in this way it is a fatal dose for many.
The next time Senator Joe Manchin or Senator Mitch McConnell breaks a bone or is in writhing pain from some other ailment, give them what they are willing to allow the people of the United States as a painkiller: nothing.
Either the Creator, or nature,(take your choice) makes anything which is intrinsically evil.
This drug has valid utility. The fact it is dangerous and has side effects, including potential addiction, is understood and a rational and informed individual, not their government, is the only correct party to determine their personal cost/benefit ratio.
That the only known to be prescient creature on the planet is capable of abusing it, indeed that some will, is not relevant.
That the FDA is correct on this is surprising and refreshing, although that does not mean I support their continued market interference.
That the do-gooder, elitist social engineers of the nanny state, which we call elected politicians, are against personal liberty and responsibility is disappointing, but not a all surprising.
It took decades for the medical profession to get away from the totally unproved concept that opiate painkillers cause psychological addiction. (All opiates cause physical addiction, but that is minimal in patients with severe pain, and does not cause problems when the patient stops taking the opiate due to decreased pain.)
So, by the 1980s, physicians were adequately treating people with moderately severe and severe pain. Then the DEA comes into doctors’ offices and tells them to reduce opiate use or go to jail. Suddenly, most physicians in the country stop prescribing opiates. The few physicians who do are heavily scrutinized, and the DEA tries to entrap some by having actors fake symptoms to get opiates.
This was the practice environment when Oxycodone came out. I worked at a VA hospital, and the physicians were scrutinized every time they prescribed oxycodone, and the veterans often were questioned. The VA physicians gave up and prescribed methadone. Methadone isn’t scrutinized by the DEA because it’s primary use is weaning addicts off heroine. Methadone works as a pain killer, but proper dosing wasn’t known. Patients and doctors had to use trial-and-error. This is what pain treatment has come to.
Great article. For a companion piece look at LFB.org title Traffic Jams.The wonderful FDA and the efforts of one employee, Nestor, who never approved one drug. Ralph Nader loved him.
Whose little fiefdom is this medicine messing up?
McConnell shows his nature by his actions. One of those actions being his rhetoric about support for freedom, another being his support to prohibit this drug.
His nature (not unlike that of Obama) is to tell people what they want to hear, and to do as he wants regadless of what he’s said.