Tag: FDA

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folly free trade & free markets general freedom ideological culture too much government

Bitter Pill

Martin Shkreli, Turing Pharmaceuticals, Daraprim, greed, FDA, ilustration, Common Sense

When Martin Shkreli, CEO of Turing Pharmaceuticals, announced his August acquisition of Daraprim, the only available version of the anti-parasitic pyrimethamine, and his plan to raise its price from under $14.00 to $750 per dose, I did not comment. Everybody else seemed to know exactly how evil the man was, and how awful the system that allowed his machinations.

I knew only that I didn’t know enough.

After reading Mary J. Ruwart’s “The $750 Pill: Corporate Greed, Excessive Regulation—or Both?,” I’m glad I waited. According to Dr. Ruwart, who has worked in the pharmaceutical industry, even the barest facts in the case incite suspicion:

Daraprim was patented in the 1950s, and is used for treating parasitic infections in fewer than 13,000 people a year in the U.S.  Turing bought exclusive rights to distribute the drug in the U.S. from Impax for $55 million; drug sales are less than $10 million/year. Impax itself bought daraprim several years earlier. It upped the price from $1 to $13.50/pill, causing the number of prescriptions to drop about 30%.

As Ruwart explains, the drug is no longer patent-protected, and “any generic company could make daraprim. . . .” So, what gives?

A company cannot just jump into the market. It has to prove — to the Food and Drug Administration — that its new generic would enter the bloodstream exactly as the old one. With the FDA’s red tape, this costs millions.

Which allows companies like Turing to effectively reclaim a monopoly for a little-used generic. Blame the FDA.

Still, there is some competition, from a company with a similar drug, priced at $1 per tablet.

This is Common Sense. I’m Paul Jacob.

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Martin Shkreli, Turing Pharmaceuticals, Daraprim, greed, FDA, ilustration, Common Sense

 

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Common Sense crime and punishment general freedom nannyism privacy responsibility

Pain Economies

Pain Medicine Police

Looking for a new doctor, a colleague of mine called his friend’s primary care clinic, and was told, “We are taking all patients except pain management cases.”

He was thankful his health issues were not pain-related.

After reading Leslie Kendall Dye’s Salon piece, “But what if I actually need my painkillers?” you will easily understand: America doesn’t make it easy for those who must fight constant pain.

Ms. Dye’s story is harrowing. Her chronic pain, the residue of a ballet injury, makes her personal, day-to-day experience not primarily about economizing pleasures, but economizing pains.

So she takes Tramadol. Regularly. Even with the drug, her agony too often returns. What she tries to do is carry on with as little relief as possible while living an active, normal life, always risking excruciating pain levels.

And she’s constantly harassed and inconvenienced and probed and lectured. “Each time I take my painkiller prescription to a pharmacy, I can’t help feeling suspected of a crime.”

She’s not paranoid.

The government is out to get her. And her doctors.

All to “save” the lives of people who “abuse” the drugs.

I read about cases of lost souls, overdoses, suicides, black market pills, portions of towns laid waste by narcotic abuse, and I worry. I worry for the addicts, but I also worry for those of us who would not be able to carry on without responsible pain management.

She admits to feeling “conflicted” about this.

My prescription? Feel less conflicted. Were today’s standard individual responsibility, not societal responsibility, responsible patients would suffer less.

This is Common Sense. I’m Paul Jacob.

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Pain Medicine Police

 

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folly free trade & free markets nannyism

A New, Freer Sector

Food Folly

Current trends in public policy and law seem to be pointing not to consistent principles, but contradictory ones.

Wyoming just made it legal for farmers to sell directly to local customers, in such venues as farmers’ markets — without government inspection and conformity to the usual, clunky set of regulations that apply when selling to other businesses for resale.

The bill, recently signed into law by the governor, also allows neighbors to sell homemade foods to one another informally and at special community events like bake sales.

An obvious win for freedom. Who can argue against a free market in foodstuffs at the community level, where normal transactions tend to be customary and casual, and also obviously subject to regulation by reputation?

But government regulations still apply maximally to farmers and supermarkets and grocery chains. And yet, many of the arguments for local free markets apply equally to these currently controlled ones. Free competition would likely lead to the re-introduction of reputation economies into big agribiz markets. Could very well be transformative.

For our health.

After all, it’s not as if government has really helped us in this realm. We are right now working our way out of a government-sponsored health and diet paradigm that we are learning was exactly wrong.

The official “anti-fat” hysteria made us fat.

A more competitive approach, allowing for different philosophies to operate — as they can at the community level, with old recipes co-existing with the new-agey ones, as well as with non-pasteurized milk and organic farms and local cheese and everything else — would encourage new ways of meeting old food fears as well as accommodating new food fads.

Extend freedom. (Not waistlines.)

This is Common Sense. I’m Paul Jacob.

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Food Folly

 

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national politics & policies too much government

FDA Chief Gets It Right

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.

Categories
free trade & free markets too much government

This Is the Government We Pay For

We live in a time when the governing political party and the dominant strain in the major media constantly harp on two themes:

  1. Capitalism is wasteful, not environmentally sound, and
  2. We need more regulation from government.

So, it is especially droll to witness the Food and Drug Administration pounce upon an age-old recycling practice between breweries and farms. In the name of “better regulation,” and “safety,” of course.

For well over a century beer brewers have disposed of their spent grain product — the non-beer product of the beer-making process — by giving or selling it cheaply to farmers, who feed it to livestock.

It would cost a lot to dispose of this in landfills, so brewers save money by letting farmers take the dregs off their hands.

But now the FDA, in a new set of proposed rules (proposed not by Congress, by the way), wants to protect cattle’s food supply by requiring brewers to dry the spent grain before shipping it off.

That’s a killer cost. One Oregonian brewer referred to it as an “enormous burden,” and warned that higher consumer prices would be the result.

I’m with Oregon Senator Ron Wyden (D), who demands that the agency go back to the drawing board.

“I don’t know everything about beer,” Wyden has been quoted, “but I do know when a federal agency acts like it has had one too many.”

For my part, I don’t see this as aberrant behavior from a federal agency. I see it as typical.

Typically drunk on power.

This is Common Sense. I’m Paul Jacob.

Categories
free trade & free markets too much government

Good FDA, Bad FDA

You’re sick and need medicine that has proved its benefits to you. Will the Food and Drug Administration let you use it?

The FDA recently extracted $600 million from Allergan, makers of Botox, for promoting uses for Botox different from those for which it was approved. It’s not illegal to use the drug for unapproved uses; it’s just illegal, sometimes, to tell you about those other uses. This, despite the fact that the First Amendment doesn’t exclude members of the pharmaceutical industry.

Now we’re hearing that the FDA has flip-flopped about letting people use midodrine, which quells dizziness. Back in 1996, midodrine was approved under “an abbreviated process,” one too brief to determine whether it really helps with dizziness. So, recently the agency outlawed sales of midodrine until its effectiveness could be shown. But — oops! — during the intervening 14 years, patients have come to depend on it. These patients swamped the FDA with complaints. So now the agency, in good-cop mode, says, okay okay, you can use it.

Thus, if you can persuade bureaucrats to let you medicate yourself as you and your doctor see fit, you get to do so. If not . . . sorry.

The New York Times talks about the “tough choices” facing the FDA, since banning a drug can mean “stranding desperate patients.” Congress should represent patients by stripping the agency of any power whatever to dictate when and how we may act to improve our own health.

This is Common Sense. I’m Paul Jacob.