From gag rule to speech at the point of a gun

In Atlas Shrugged, the apes in power try to make a productive man say what they want him to say by holding a gun to his back -- and the FDA is now doing the same thing to the makers of painkillers. (Thanks to Jared Rhoads of the Lucidicus Project, from whom I first heard about this story.)

The FDA has its knickers in a twist because prescription painkillers are often used, not for the purpose for which they are prescribed, but to get high. Because our nanny state can't possibly allow a man to make his own choice about what he puts into his own body, and to bear the consequences if he makes a mistake, the FDA is joining the DEA (and probably other alphabet agencies) in trying to stamp out prescription painkiller abuse.

The issue that FDA wants addressed is that the vast majority of prescription painkiller users do not get the drug because it was prescribed to them by a doctor. They get it from a dealer, or because someone they know was prescribed the pills and passed them on.

So FDA's solution is to force the manufacturers of opioid painkillers to develop anti-abuse education materials. These materials are supposed to persuade the patient for whom the drugs are actually prescribed not to give them away, and to educate the doctor on how to talk to patients and/or recognize that a drug he's prescribing may not be going to the patient it's being prescribed for.

Never in this process is it assumed that a) the patient has a brain, probably knows that opioid painkillers have addiction potential (duh!), and knows exactly what he is doing if he decides to supply drug to someone else; b) the doctor wasn't born yesterday (but also is under huge time constraints imposed by our current healthcare system, itself the result of government regulations, and therefore may not have time to ask all the questions required to determine whether a patient is really in pain or is a "drug seeker"); and c) that all parties involved, including the drug abuser, have a right to enter into whatever mutual agreements they please, including agreements that result in someone getting high on pain pills!

Instead, the FDA is holding a gun to manufacturers' backs and telling them they have 120 days to produce educational materials (which, according to the agency's logic, will surely cause patients, sheep-like, to stop handing drugs to their friends and family) and submit them to the agency. (The gun, of course, is the unspoken but palpable threat that FDA will force manufacturers to pull these products from the market.) As Jared Rhoads has pointed out, 120 days is just about enough time, should the manufacturers start working feverishly right now, to get the materials reviewed by their internal legal and regulatory personnel. Then the FDA gets to look at the materials and force the manufacturers to make additional changes as it sees fit.

Unfortunately, unlike in Atlas Shrugged, the manufacturers are not reacting by pointing out the gun at their backs for what it is, and proudly standing up for their right to sell their products without government interference. In fact, one manufacturer's representative meekly says, "We really support [FDA] efforts...we think education is the right way to tackle this issue," as the Wall Street Journal reports. Not that I can condemn them for it -- as Ayn Rand said, morality ends where a gun begins, and these producers recognize that they risk losing their entire operations should they fail to comply with the FDA's demands. But I can condemn the FDA for trampling on the rights of producers and patients alike.

Another gag rule from the FDA

I've already posted many times about how FDA gags pharmaceutical companies -- preventing them from making many kinds of claims, even if true, about their products. But I didn't know until today that the FDA's coercive power extends to journalists as well -- the agency forbids reporters from consulting outside experts with regard to embargoed news.

Let's talk about what a news embargo is, first. A company or organization wants certain news released, but it wants to control the timing of when that news is released. So it enters into voluntary agreements with reporters: You get the scoop in exchange for promising not to release that news until an agreed-upon date. So far, so good; we have a voluntary agreement between reporters and companies or trade groups. (We'll leave aside the case that the need for an embargo may have arisen because of an FDA requirement that a company not publicize its offerings prior to a certain date; in that case, the FDA is clearly violating rights, but the embargo itself remains a voluntary agreement.)

But the FDA has decided to meddle with this process, forbidding reporters to consult with third-party experts about embargoed news. This means that the reporter, who is likely a well-educated layman with respect to the drug or device he's reporting on, is not allowed to verify the story he's about to print with someone who is more qualified to evaluate the claims being made. As the Association of Health Care Journalists puts it, "Reporters who want to be competitive on a story will essentially have to write only what the FDA wants to tell the world, without analysis or outside commentary." That's a clear violation of free speech.

The FDA needs to butt out of healthcare communications entirely. It's scary that the arm of the state reaches beyond forcing pharmaceutical companies and medical device makers to denounce their own product, and into making the press say what it wants.

How insurance encourages us not to ask questions: An example

[Warning: slightly icky medical details follow.] I have a plantar wart. If you've never had the pleasure of dealing with one (I've read that about 15% of Americans have), allow me to inform you that a plantar wart is what happens when HPV decides to take up residence somewhere on the sole of your foot. The warts HPV causes in this way are not really painful, but they can be uncomfortable. They are also tenacious as all get out. All kinds of over-the-counter remedies exist for getting rid of plantar warts. Often, as has been the case with me, they don't work. After trying and failing to kill the little bastard son of a bitch darn thing for six months with OTC salicylic acid patches, I finally gave up and headed to a podiatrist.

Podiatrist has a look at my foot, confirms that I indeed have a plantar wart, and informs me of the stronger options available to treat such things when there's a prescription involved. Fine. (Well, except for the hour and a half beyond my scheduled appointment time I had to wait to see him, which is an example for a different argument against government regulation in health care...but that's for another day.)

At this point, the doctor told me he would shave off part of the wart so that the medication he prescribed me to put on it would be absorbed more efficiently. He took out his scalpel and scraped for about 30 seconds. I thought nothing of this at the time. But, a few days ago, I got my insurance company's "explanation of benefits," a statement I receive any time I visit a doctor or hospital. The EOB, as they abbreviate it, explains what services I received from the doctor, how much the doctor billed the insurance company, how much the insurance company actually paid out (since, frequently, they negotiate lower rates than the doctor initially bills), how much of a copay I had, and if there's any further obligation on my part to pay the doctor. (Usually, since I have a pretty generous insurance policy, there isn't.)

When I got the EOB for the podiatrist visit, I saw that the doctor had billed about $150 for a "visit" and gotten paid the negotiated rate of $75. He also billed the insurance company $100 for "surgery," and got paid $53. It took me several minutes to figure out that this "surgery" was the 30 seconds' worth of shaving he'd done to my foot in the office! Would I have paid $53 for this service, let alone the requested rate of $100, if I were paying for my medical care directly? Oh, hell, no. It's something I easily could have done myself, at home, for the price of an Xacto knife. I'll admit, I probably wouldn't have thought to ask the doctor the price of such a simple "operation" before he performed it, but if he had had the nerve to try and charge me that much for it, I would have argued and, if he insisted on charging me in the end, I could have refused to see him for any further care and posted a negative review on one of the many ratings websites out there.

In any case, there would have been much more pressure on the doctor -- whether from me or from patients who'd seen him before me -- to put a much lower price on such a small service. Instead, there was no incentive at all for the doctor to charge a low price, or for me to question the bill afterward. After all, I'm not paying it -- my insurance company is. Except that, when this kind of decision is made by millions of people, guess what? Premiums go up!

Remember, we owe this distorted system to the tax policy that makes it advantageous for our employers to buy us generous health benefits rather than raising our salaries. In a free market -- free of coercive taxation -- most of us would likely buy far less comprehensive health care policies in order to save money, and then we'd scrutinize our health care expenses far more closely in order to save more money.