Everybody's a critic.
We published a post last month analyzing Gunvalson v. PTC Therapeutics (here's a link), in which a federal judge ordered a company to provide an experimental drug to a dying patient who did not qualify for a clinical trial. We wrote:
"Basically, a drug company would be crazy to open a compassionate use program for just one person – nor could one person afford to pay the 'cost' of all the overhead compassionate use requires.
"The court dismissed these cost considerations as 'trivial.' Slip op. at 8. They’re not."
And what do we hear in response?
One of Herrmann's kids -- we'll call him "Jeremy," because, well, that's his name -- accused us of being heartless brutes.
Jeremy said that drug companies have a ton of money, and sick people usually don't. He said that the drug company possessed the only chance for a person to live. He said that he'd watched the movie "Lorenzo's Oil" in high school and, in that movie, parents had to fight to convince someone to produce the product that ultimately saved their child's life and the lives of many others.
How could the two of us be so heartless?
Where's our moral compass?
How could I be his dad?
Buck up, kid. You're stuck with me.
But we're not heartless; we're realists. (Maybe there's a thin line there.)
(Hey, Jere! It gets even worse -- at least from your perspective. PTC has hired Bexis' firm to handle the appeal in this case, so Bexis now has a conflict of interest. He couldn't participate in drafting this post; Dad wrote it alone.)
Here's why courts should not distort the "compassionate use" regulations by compelling companies to give experimental drugs to anyone those drugs might theoretically help.
First, by definition, the drug that Judge Martini ordered PTC to provide to Gunvalson was not proven to be either safe or effective. It might save him; it might kill him. No one knows -- that's what "experimental" means.
Yeah, says Jeremy, but it's the only chance Gunvalson's got. Surely PTC should give Gunvalson his one chance to survive.
(Shoot -- if it were about 15 years ago, at this point I'd tell the kid to be quiet and go talk to his mother.)
Look: Drug companies develop lots of molecules that could conceivably cure diseases. Those companies are in the business of developing those molecules, and let's hope the companies succeed. But before the drugs can be sold, they must be tested and proven safe and effective. Companies can't be required to give experimental drugs to anyone who has no other hope, because that regime would effectively put drugs on the market (free of charge) before the drugs were ready for prime time.
It's not only drug companies that face questions like this one. Should a physician be required to treat any sick person who comes to his or her door? Should an insurance company be required to pay for a treatment that isn't covered by an insurance policy? Should Bill Gates or Warren Buffet be legally obligated to step in and help people who are in distress and might be helped by an existing, but terribly expensive, medical treatment?
You and I could probably debate the morality of different responses in those situations, but there's not much room to quibble about the law. In the United States, the law respects private property and certain notions of liberty; at the edges, those values may bump up against generalized notions of "always doing what's right."
We know that capitalism seems heartless to the young. People are starving overseas. Heck, people are starving right here in the United States -- but we don't confiscate the property of the rich to save the poor. Whether you approve of capitalism or not, it's created a dynamic economy in this country, and that economy develops a lot of new products (including drugs) in part because of the profit motive.
The law makes similar judgments in other situations, too. Suppose you see someone drowning in a lake. Do you have a duty to rescue him? Your heart may say yes, but the law generally says no. (Here's a link to the "duty to rescue" page of that leading legal resource for your generation -- Wikipedia.)
The absence of a legal "duty to rescue" is not without controversy. But here's how a legal scholar justifies that rule (and a link to the abstract of Alan Calnan's article at SSRN):
"To most people, the no-duty-to-rescue rule seems clearly at odds with the concept of moral fault. Instinctively, it feels wrong to stand idly by as another human being suffers harm. This instinct could be rooted in a number of possible sources. Many societies embrace values of benevolence and altruism. Most religions preach good samaritanism and denounce selfishness. Whatever their source, our sensibilities tell us that one who fails to rescue others is morally deficient.
"Because of its apparent immorality, the no-duty-to-rescue rule also seems unreasonable. However, as I will attempt to show in this brief essay, such a conclusion is by no means inescapable. . . . First, I shall demonstrate that the no-duty-to-rescue rule is actually a reasonable exception to a broader principle of cooperation, which forces people to make sacrifices for parties who take affirmative measures to defend their interests in emergencies. Second, I show how the rule satisfies the reasonable requirements of distributive and corrective justice, deftly balancing the interests of the parties and the state, while maintaining the integrity of the liberal value system of which it is a part."
Got that, kid? (I love how those guys write.)
Ultimately, if companies were required to provide drugs, free of charge, to anyone the drugs might theoretically help, then companies would become much more selective in the molecules they chose to develop.
Companies would also incur huge costs to supply drugs to anyone who might theoretically benefit from them, and that money has to come from somewhere -- probably the drug companies' research and development programs. By helping Gunvalson, you'd be using resources that might save more people if they were put to some other use.
Congress (and the FDA) has balanced these interests, created guidelines for compassionate use programs in appropriate situations, and written those guidelines into law.
If courts enforce those rules (including in ways that sometimes seem heartless), then companies will produce new medicines and help an awful lot of people. If courts distort those rules, then companies will be discouraged (or disabled) from producing new medicines, and society as a whole will suffer.
If society as a whole doesn't like the balance that the laws strike, then society should pass new laws. Maybe the government could pay for a program to provide experimental drugs to people who might benefit from them. (But then the taxpayers would start to squeal; it's easier for a court just to take the money from a drug company.)
Those truths may not tug at your heartstrings, but, with luck, the drugs those policies produce will cure what ails you if you get sick.
You're actually a pretty good sounding board for the other side of this issue, young man. The plaintiff's side of Gunvalson -- and every other case that resembles it -- is emotionally (if not legally) appealing, which is why Bexis and I are concerned that courts will be tempted to adopt it.
I'm proud of you for raising the issue.
(But what the heck are you doing reading this blog, anyway? Go back to studying.)