drugs

Regulation of the Day 98: Gastrointestinal Drugs

by Ryan Young on January 8, 2010

in Deregulate to Stimulate, Health and Illness, Healthcare, Personal Liberty, Precaution & Risk, Regulation, Regulation of the Day

Did you know that the federal government has a Gastrointestinal Drugs Advisory Committee? It’s true. If you don’t believe me, you can attend their upcoming meeting on February 23. The topic of the day will be a new drug application to treat hepatic encephalopathy.

Hopefully some hepatic encephalopathy sufferers will be there. They can ask the Committee why the FDA takes as long as a decade (and as much as $800 million!) to approve medications that could be helping people and saving lives right now.

Destabilizing Afghanistan: the Quagmire Expands

by Hans Bader on May 5, 2009 · 1 comment

in Agriculture, Economy, Features, International, Legal, Personal Liberty, Politics as Usual, Precaution & Risk, Trade

The anti-American Taliban extremists are resurgent not only in Afghanistan, where they once sheltered Osama Bin Laden, but also in neighboring Pakistan (which has nuclear weapons) as well. Thousands of Pakistanis are fleeing the Swat Valley, which is dominated by the Taliban.

But the Obama Administration stubbornly refuses to learn from the Bush Administration’s mistakes in Afghanistan. It’s stepping up efforts to wipe out the mainstay of the Afghan economy, by eradicating the opium poppies that Afghan farmers cultivate. Afghans are so poor that the poppies are 60 percent of their economy: a bigger fraction of their economy than agriculture and manufacturing combined are of the U.S. economy. Many Afghans have little choice but to grow opium: the Soviet invasion and occupation destroyed their irrigation works (and roads), making large-scale food production and transport extremely difficult. And when food prices went up in 2006 and 2007 as a result of ethanol mandates and rising demand for food in India and China, thousands of Afghan children starved to death. The Bush Administration’s attempts to eradicate the poppies turned many Afghans against America, and helped fuel the Taliban’s resurgence.

Jacob Sullum gives a number of reasons why the Administration’s anti-opium campaign will backfire and is probably doomed to failure, such as:

2. “The terrain is a guerrilla’s dream. In addition to acres of shoulder-high poppy plants, rows and rows of hard-packed mud walls, used to stand up grape vines, offer ideal places for ambushes and defense.”
3. “The opium is tilled in heavily populated areas…The prospect of heavy fighting in populated areas could further alienate the Afghan population.”
. . .
5. Opium poppies are “by far the most lucrative crop an Afghan can farm.”
6. “The opium trade now makes up nearly 60 percent of Afghanistan’s gross domestic product, American officials say.”
7. “The country’s opium traffickers typically offer incentives that no Afghan government official can: they can guarantee a farmer a minimum price for the crop as well as taking it to market, despite the horrendous condition of most of Afghanistan’s roads.”

Some will argue that the U.S. supported drug-eradication programs in Colombia, despite its civil war, so why not in Afghanistan. But the two countries are vastly different. Colombia was and is a much more prosperous country, with income levels ten times greater, and life expectancies 30 years longer, than in Afghanistan, which is one of the world’s poorest (and most warlike) countries. There are viable alternatives to growing drugs in Colombia, unlike in arid, impoverished Afghanistan.

In a war, you can’t be too fastidious about local customs. In World War II, the U.S. fought the Japanese with the assistance of Naga headhunters. We didn’t give them lectures about their practice of collecting the heads of their enemies (not that I would suggest that growing drugs is as bad as killing people). In the Vietnam War, the U.S. allied itself with tribesmen in Laos and Vietnam who grew opium and other drugs. We didn’t try to destroy their drugs. That would have made them kill us rather than support us.

If you want to win a war in a country you are occupying, sometimes you have to try to win the hearts and minds of the local people, rather than telling them what to do.

For those who think that tolerating drug cultivation is somehow an extraordinary measure: is it remotely as extraordinary as using torture, as the Government did in the aftermath of 9/11 (producing false information and bogus orange alerts in the process)? Keep in mind that for most of American history, there were no bans on drug cultivation (the federal government did not regulate marijuana until the 1930s), but torture to obtain confessions has always been illegal in the U.S.

If we can do something like torture (which I opposed) to win the War on Terror, why not something far less extreme and less historically-unprecedented, like allowing Afghan farmers to keep cultivating opium poppies?

And for those of you bleeding-heart liberals who objected when the phone companies were given protection against lawsuits for assisting the federal government in its antiterror surveillance programs (something I supported; such surveillance would be perfectly legal in many countries, like Sweden): is it not far worse to make Afghan families starve by destroying their crops?

Virginia Postrel on Her Own Brush with Cost-Effective Drug Research

by Greg Conko on April 1, 2009

in Healthcare, Insurance, Nanny State, Nano & Biotech, Personal Liberty, Regulation

In the March 2009 issue of the Atlantic, Virginia Postrel recounts her recent successful battle with breast cancer and notes that she may not have had such a happy outcome if she lived in New Zealand. Following surgery to remove several tumors, Postrel’s doctors prescribed the monoclonal antibody Herceptin, which regulates cell division and can keep some cancerous cells from dividing uncontrollably. Herceptin has a 95 percent success rate in early-stage cancers like Postrel’s. And, although it’s been just a short time since her treatment ended, it seems to have worked.

Unfortunately, despite fairly good evidence of Herceptin’s effectiveness in treating early-stage breast cancer, it was not until 2007 that the New Zealand government agency called Pharmac, which determines what medicines will and will not be covered by the country’s national health care system, agreed to cover Herceptin for early-stage cancers. Herceptin is expensive — in the neighborhood of $60,000 US per patient — and Pharmac wasn’t convinced the treatment was worth it. Ironically, Postrel points out, Pharmac had long agreed to cover Herceptin treatment for late-stage cancers, even though the likelihood of success in treating those conditions are much lower.

In part because the Obama Administration and many congressional Democrats have been pushing for a US-equivalent of Pharmac, Postrel’s article generated an overwhelming number of letters to the Atlantic‘s editors. Some will be published in a future edition of the print magazine. But, two days ago, the Atlantic published several of them online, along with a lengthy reply by Postrel. Because her original article is relatively short, Postrel could not fully examine or even touch on many items that she does address in this later response. I recommend that the two items be read together as a two-part essay.

One theme in particular that Postrel develops more fully in part 2, is very important. While it’s true that government run health plans can’t pay for all the treatments every patient would like to have, the problem is that, when a government herds large swaths of its population into public sector health plans with few realistic alternatives, this kind of rationing inevitably means that some patients will not get treatments that could cure them. One letter writer, for example, argues that Herceptin was a poor example for Postrel to highlight because “Multiple cost-effectiveness analyses have shown that, despite its high cost, Herceptin is both effective and cost-effective.” That, of course, was Postrel’s point. She replies, “I used [Herceptin] as an example not only because of my personal story but because its very cost-effectiveness makes it such a striking example. New Zealand chose to ration the drug (and not to cover it at all for early-stage cancer until July 2007) despite its significant benefits.”

An Explosion of Litigation

by Hans Bader on March 13, 2009 · 1 comment

in Bailout Watch, Economy, Employment, Healthcare, Labor, Legal, Politics as Usual, Precaution & Risk, Privacy, Regulation, Stimulus to Nowhere

Already burdened by $8 trillion in new federal spending commitments and the likelihood of higher taxes to pay for bailouts, pork, and welfare, the economy now faces an additional threat: an explosion of litigation.

Even liberal Washington Post columnist Michael Kinsley can’t stand the Supreme Court’s liberal 6-to-3 ruling in Wyeth v. Levine, which let a patient sue an innocent drug maker for an injury caused by a physician’s assistant who disregarded repeated warnings by the drug maker. (The ruling indirectly “will cost lives“). As Kinsley notes,

“Diana Levine, a professional guitarist, showed up at the hospital for the second time in one day complaining of . . . hours-long spasms of ‘retching’ and ‘vomiting.’ She was injected with an anti-nausea drug called Phenergan. The label on Phenergan says six times, in different ways, some of them in boldface capital letters, that if Phenergan gets into the arteries, the result can be disastrous. Nevertheless, a physician’s assistant used the wrong method of injection, and Levine’s arm turned gangrenous and ultimately had to be amputated.”

“The drug company Wyeth has sold Phenergan, with Food and Drug Administration approval, since 1955. The official question in Wyeth v. Levine, decided last week by the Supreme Court (the quotes above are from Justice Samuel Alito’s dissent), was whether that federal government approval “pre-empts” a Vermont jury ruling in favor of Levine. The court said no. A more interesting question is: How did we end up with such a crazy system for making important decisions? . . .”

“What happened to Diana Levine is a tragedy and a scandal. But what did Wyeth do wrong? Is there any way the company could have stayed out of trouble? It’s unlikely. Phenergan has been legal for half a century. (If you Google the word “Phenergan,” the results include pages containing an ad for Phenergan online.) So if you can’t get them for the product itself, you nail them for a “failure to warn.” The basic fiction at the heart of the whole system of regulation by lawsuits is that people read and act on warning labels. But the FDA approved Wyeth’s original warning label and every change since. “Not good enough,” said a Vermont jury, and, incredibly, a majority of the Supreme Court agreed.”

The arbitrary litigation fueled by this decision will cost lives over the long run by discouraging medical innovation, notes Gordon Crovitz in the Wall Street Journal. Jim Copland and Paul Howard call the counterproductive Wyeth decision “a ‘cure’ worse than gangrene.”

Ted Frank calls the Wyeth decision the most anti-business decision in more than 40 years. Yet, amazingly, the liberal New York Times, which wants even more lawsuits, accused the Supreme Court of “reflexive deference to corporations“!!!

Greg Conko observes that the jury’s decision was baseless and undermined the FDA’s labeling process. “The physician’s assistant injected Phenergan into Ms. Levine’s artery, in direct contravention of six label warnings against arterial injection. More or sterner warnings against arterial injection would not have prevented Ms. Levine’s injury.” “FDA made a regulatory decision that the benefits of IV injection outweighed the risks, and the agency permitted the product to be labeled accordingly. . . letting a Vermont jury penalize Wyeth for not ruling out IV injection on Phenergan’s label is tantamount to letting a group of laymen over-rule FDA’s expert opinion regarding safety.” Yale Law School’s Peter Schuck similarly criticizes the Supreme Court’s decision.

Don’t expect any help from Congress. Incredibly, it is moving to abolish what little limits there currently are on state court lawsuits that undermine federal drug-labeling requirements. The day after the Wyeth decision, trial lawyer allies like Rep. Henry Waxman (D-Cal.) proposed legislation to completely abolish any preemption of such lawsuits, even in the exceedingly narrow circumstances where the Supreme Court admits preemption is appropriate.

Drug and device lawyers explain the Wyeth decision as being partly the judiciary’s reaction to the 2008 election, when liberal politicians friendly to lawsuits, and hostile to (often mythical) “deregulation,” made big gains. As the humorist Finley Peter Dunne noted a century ago, the Supreme Court reads election returns.

Workplace lawsuits also will rise. A costly comparable-worth bill backed by the Administration, the Paycheck Fairness Act, passed the House earlier this year on a largely party-line vote. And a law that largely eliminates the statute of limitations in pay-discrimination cases, the Lilly Ledbetter Fair Pay Act, was signed by Obama in January. Obama made false claims about the Supreme Court decision the Ledbetter law overturned (and the facts of that case), and broke campaign promises he made by signing it into law without the opportunity for public comment.

Obama also backs the so-called Civil Rights Restoration Act, which would radically rewrite federal discrimination law in several ways, such as scrapping limits on punitive damages (and allowing them in situations never before permitted by any federal court), and making schools liable for many more instances of “peer harassment” by students (increasing the pressure on colleges to adopt speech codes).

Other “radical employment law changes will create lots of work for attorneys,” according to the National Law Journal.

The economy-shrinking stimulus package Obama signed also contains multiple provisions creating new grounds for lawsuits. It contains increased damages and state attorney-general rights to sue under the burdensome and expensive HIPAA law, which contributed to the Virginia Tech shootings, has impeded public safety, and causes billions of dollars in losses due to pointless red tape. The stimulus package also contains vague and expansive whistleblower provisions allowing suits over actual or perceived wrongdoing.

The Administration also shows no interest in tempering the excesses of a law Obama supported, the Consumer Product Safety Improvements Act, which has shut down thrift stores and entire industries, and gives state attorney generals and their trial lawyer allies broad new powers to bring lawsuits over toys, clothes, and books, resulting in children’s books being thrown out and pulled from library shelves by the thousands.

Did the Supreme Court “Botch” Wyeth v. Levine?

by Alex Harris on March 5, 2009 · 1 comment

in Healthcare, Legal, Precaution & Risk, Regulation

I was initially going to post this as a comment to Greg Conko’s recent post arguing against the Court’s recent decision in Wyeth v. Levine, but the comment system didn’t work correctly for me.

I appreciate the force of Greg’s argument (and I certainly agree that this particular case should have been decided much earlier on different grounds), but I think there is room for reasonable disagreement within the libertarian community about whether FDA preempting state tort law is good or bad. This is one of these questions about what to do in the real world, where first-best solutions just aren’t politically possible.

Most libertarians would likely agree that there should be only one system to deal with injuries caused by products, including drugs: the tort system. The tort system only operates once there has been an actual injury, not just some scared politician’s prediction of a harm. And it doesn’t ban anything; it just forces manufacturers to internalize the external costs of the injuries their products cause. If the benefits of the product outweigh the total (social) costs, the product will keep being made. This is the optimal outcome. And, further, the injured consumers will not simply be ignored; they get compensated for their harms, restored to a position as good as they’d be in had they not been harmed.

Unfortunately, however, we don’t just have the tort system. We also have the FDA and other prospective regulatory agencies that pass judgment on products before they hit the market, banning some and restricting how others can be marketed and sold. If the FDA isn’t going away, what should we do?

Greg’s answer is essentially the one I gave in the context of internet regulations: “multiple levels of regulation [are] always worse than… only one.” There is a difference between multiple levels of regulation and a tort system plus a regulatory system, though. If the FDA gets lots of stuff wrong, but the tort system functions ideally (a big, and admittedly untrue, assumption), then the FDA should not be able to preempt the tort system. If the FDA allows a drug that nonetheless causes injuries, the tort system has not failed or “overregulated” if it correctly assesses and assigns damages. It has internalized costs that would otherwise be external.

If the Court had found preemption, however, then there would be calls for the FDA to regulate even more heavily, banning every drug that might cause any problem. The tort system currently functions as a safety net. Remove it and politicans and voters will demand more stringent protection from the system left – the regulatory one.

However, finding no preemption emphasizes the point that the FDA is not infalible and that the tort system does a better job, at least sometimes. Unfortunately, it only does this in one direction, and does nothing to expose the much more common and deadly – but largely invisible – type I error. Still, I think though the tort system may get some stuff wrong and incorrectly over-compensate, this risk is more acceptable than the risk of further entrenched and onerous FDA regulation.