The legal right to medical decision-making

Hi, readers!  Long time, no blogging.

In the few years, there has been a huge push to legalise assisted suicide. Brittany Maynard became a national figure for the right to assisted suicide before she took her life.  Several states have legalised it.  Proponents of assisted suicide have argued that dying individuals, not the State, have a right to determine their medical care, and that swift death can be a compassionate alternative to prolonged, hopeless suffering.  (For the record, I do not find these arguments to be persuasive.)

Given that Americans are embracing this logic, it’s ironic that the same logic does not apply to the F.D.A.’s approval and clinical trial process for experimental, potentially life-saving, drugs.  The New York Times (hat tip) reported that the FDA is streamlining the process after its oncology chief, Dr. Richard Pazdur, lost his wife to ovarian cancer.

The F.D.A. has a notoriously slow approval process for new drugs.  This is largely a result of the thalidomide crisis in the 1960s, when pregnant women who took an anti-nausea drug gave birth to children with severe deformities (including flippers instead of arms).   F.D.A. medical officer Dr. Frances Kelsey refused to approve the drug after he found that it had not been tested on pregnant animals.  As the drug was never approved in the United States, American babies avoided the devastating harm that other children faced in countries where thalidomide had been approved.  The F.D.A.’s cautiousness in approving the drug has been used to justify its slow approval process in the half-century since the crisis.

Much of the problem with thalidomide was that its costs were out of proportion with its benefits: it reduced nausea, but could cause lifelong severe deformities.  As a general rule, we are more willing to approve drugs that cause a lot of harm if they also do a lot of good (e.g. a drug that has chemotherapy’s side effects would never be approved to reduce headaches, but is fine when it could save someone’s life). As such, the F.D.A. has a “compassionate use” programme, wherein severely ill people can apply to take unapproved drugs in the hope of saving their lives.  The rationale is that the patient will probably die anyway, so the additional risk of taking the unproven drug is minimal.  As the NYT explains,

That decision was made in a separate category of “compassionate use” drug approvals for individual patients. Every year, the F.D.A. receives about 1,000 similar applications from terminally ill people seeking experimental medications, and agency officials say they approve 99 percent of them. The approvals are distinct from those for drugs that have gone through clinical trials and that are for broad distribution.

So every year, about a thousand people apply for “compassionate use” drugs.  Every year, over a half-million people die from cancer.  Obviously, many of those people pass away from types of cancer that are not the target of any drugs in clinical trials or the approval process; but whatever that percentage of cancer patients who could benefit from a drug in the pipeline is, it is probably higher than 0.5%.  In fact, the number of people who apply for and receive permission for “compassionate use” of an experimental drug is approximately equal to the number of people who undergo euthanasia every year in America (even though assisted suicide is limited to a small number of states).

In effect, we are a country wherein a cancer patient is just as likely to commit suicide via a lethal dose of legal drugs as he is to receive experimental, potentially life-saving medical treatment.  Analytically, the laws governing each are different: the “drug cocktail” that is used for assisted suicide is an off-label use and therefore not governed by the F.D.A., and state law, not federal law, governs assisted suicide.  But in a discussion about the policy that governs the approval process for potentially life-saving medication and the availability of compassionate use, it is damning that Americans are just as likely to use legal drugs to kill themselves as they are to apply for life-saving ones.

 

BAMF, Senior Citizen Edition

An elderly North Carolina gentleman, Joseph Sapienza, heard two robbers trying to pry open his door.  He put his gun in the holster on his walker, moseyed to the front door, threw it open, and yelled out that he was armed.  The two robbers fled.  (Story.)

The sheer awesomeness of having a holster on a walker aside, this serves as a reminder that the Second Amendment protects the elderly, the weak, and the frail far more than it protects big burly men (who are protected by the fact that they are big, burly men). As the saying goes, God made young men and old men, but Smith & Wesson made them equal.

Tuesday Pop Quiz

Who said this?

 Corporations, “separate and apart from” the human beings who own, run, and are employed by them, cannot do anything at all. [….]

While it is certainly true that a central objective of for profit corporations is to make money, modern corporate law does not require for-profit corporations to pursue profit at the expense of everything else, and many do not do so. For-profit corporations, with ownership approval, support a wide variety of charitable causes, and it is not at all uncommon for such corporations to further humanitarian and other altruistic objectives.

a. John Mackey, CEO of Whole Foods
b. Elizabeth Warren
c. Samuel Alito
d. Pope Francis
e. Steve Jobs

Crunching some numbers regarding the IRS’s priorities

As anyone who watched CSPAN’s coverage of the Congressional hearings involving IRS Commissioner John Koskinen knows, the IRS allegedly did not back up its emails because of lack of funds.  It would have cost between $10 million and $30 million (out of a $1.8 billion IT budget) to upgrade their server systems.  (This is, of course, refuted by one Congresscritter who asked why they couldn’t have bought those terabyte hard drives off of amazon.com for about $80 per employee, total cost: $7 million.) According to a national archivist, the IRS violated the law on preservation of documentation and emails.

It’s not just that the IRS claims it didn’t have enough money to upgrade its IT systems; it has also been mis-allocating the money already budgeted it it.  Via TaxProfBlog, a discussion of how the IRS acted outside of its statutory authority to require licensing of tax preparers, and then, when such a scheme was deemed unlawful, started a voluntary licensing programme in its place.

To state the obvious: if you have the time and money to do stuff outside of your statutory authority, you have the time and money to fulfill your statutory obligations. Why the IRS was spending its time licensing tax preparers, rather than insuring that it met its basic record-keeping requirements, is a mystery.

McCullen: unanimously for free speech!

The McCullen decision came out this morning (opinion here). It was a unanimous opinion stating that it is not constitutional to establish buffer zones that exclude even consensual, calm speech on public sidewalks in front of abortion clinics. (Typically, the Boston Globe commetariat are very upset about this and blame it on “right wing zealots,” as if that is an apt description of Justices Breyer, Sotomayor, Kagan, and Bader Ginsburg.)

I’m reading the decision now and have only a few points to make before more detailed blogging later. The Supreme Court’s pair of unanimous decisions today (the other one being Noel v. NRLB) seem to be driven by a desire by both sides to give up a bit of their wins to ensure that the other side has less power when the other side is in power. The liberals on the court would not want a President Palin making such recess appointments, nor a conservative Congress outlawing labour protests outside of businesses under the rational set forth by the Commonwealth in the buffer zone case (see, AFL-CIO amicus brief).

I also think it’s hugely important that this was a consensual speech case, not a protest case.  You can adequately scream at people from thirty-five feet away (more if you have a megaphone), but you can’t offer literature, solace, a place to live, or financial help. Eleanor McCullen has saved hundreds of babies by offering real, concrete help to women in a crisis pregnancy, and she is not able to do so from shouting distance.

Market forces matter

The latest revelation in the VA scandal again highlights why governments are inherently incapable of doing private-sector jobs as well as the private sector: psychiatric patients received no evaluations for years.  (Hat tip.)  It gets better: “[The Office of Special Counsel} is reviewing even more cases — approximately 60 — of allegations that those who came forward with concerns about scheduling, understaffing, and patient care faced retaliation by their superiors.”

The private sector is not perfect, but this stuff would not last nearly as long in the competitive marketplace.  A competitive industry would take customers away from the one that performed poorly; those companies that retaliate against their employees, treat their patients/clients like dirt, and cook the books will lose people to other businesses.  Falling profits force such companies to either root out the problems or go out of business.

The government can also intervene: when aggrieved clients, patients, and customers can sue the offending company, the government is a neutral arbitrator.  However, when normal citizens attempt to seek redress through the court systems against a government institution, they are either outright barred by suing due to sovereign immunity, or they are seeking justice in a system wherein the defendant is on the same team as the judge. It would be like suing one of the Koch brothers, walking into the courtroom, and finding that the other brother is the presiding judge. See the problem?

See the problem?

What (not) to do when pulled over by the police

boston.com has an interesting (read: trite) slide show of how to behave when you are pulled over by the police. Most of the advice falls into the “behave reasonably” category, but I object to one part: the idea that you should leave your registration in the glove compartment until asked for it.

Usually, the police run your license plates before approaching your vehicle.  You can use that time to get your registration out of your glove compartment and your driver’s license out of your tote bag or back pocket. First off, you’re a grown adult and presumably know that you’re going to be asked for those items; having them at the ready is normal. Moreover, that saves you from having to grovel to the police officer that you’re going to be reaching into your glove box (where some people keep their guns) or your back pocket/tote bag (ditt0). Obviously, have your hands in plain sight when the police officer approaches the car, but there’s nothing wrong with having those items at the ready.

A note about the Facebook “Ban guns because of these gun deaths” meme

I’m  a lawyer who used to be an engineer, so when I see the Facebook meme that demands that we restrict guns because “24,000 people are murdered every  year!”, my law nerd and stats nerd self almost can’t help but issue a few clarifying remarks.

That statistic relates to homicide, not murder.  Homicide is when you have a dead body from non-natural causes; murder is a deliberate killing without adequate justification. If an 80-year-old wheelchair bound woman shoots an attacker and kills him, that’s homicide but not murder. If a woman who is all of a hundred pounds, soaking wet, shoots her 6’5 bruiser of a husband as he’s coming at her with a baseball bat, that’s homicide and not murder. If someone breaks down your door in the middle of the night and charges at your kids with a knife, it’s not murder when you shoot him dead.

This matters because the “so many gun deaths!!” meme does NOT take into account defensive use of guns: it assumes that everyone who winds up with a bullet between the eyes is an innocent victim. The question is not how many people die from being shot; the question is how many people die who were not the initial aggressors.

Please remember that as you put up that statistic, it includes people who saved their own lives with guns. Many of us understand that your “regulations” will take away the only meaningful avenue of self-defense for the most vulnerable in our society. Little old ladies with fractured hips, abused women, people who live in crime-ridden cities – these people are toast without a gun. Yet when they kill their attackers, opponents of the Second Amendment claim those deaths as a justification to ban firearms.

A tragic end after the loss of all good sense

The story of Daniel Kopin and Lena Sclove, both students at Brown University when the latter accused the former of rape, is rife with issues for discussion. But I would like to focus on this vignette:

The woman also wrote that she voluntarily took off most of her clothes and that, while she almost immediately began to regret the encounter, she never told Kopin she wanted to stop. Her grievance against him boiled down to the claim that he “moved [her] body around into whatever positions he felt best in” and seemed interested only in his own pleasure, and that he pushed her head down too forcefully while she was giving him oral sex, causing her to stop and tell him that “that was rude.”

Any crime has an objective element to it: we do not throw people in jail (or, in the instant case, throw them out of school) for not being mind readers or for relying on objective signals of acquiescence. Imagine with theft: “May I have a dollar?” “Okay….” Ten minutes later: “He stole my dollar! Charge him with theft!”  Certainly, there are issues with this as the repeated asking, combined with other signals, approaches coercion, but receiving a “yes” in response to a question is an objectively reasonable standard of consent.

I loathe being in the position of defending cads, but the particular cad in question should be defended against charges of rape.  Her problem with the encounter is that a man barely out of his teens was screwing her for his own pleasure and not her empowerment – so she accused him of rape.

At this point, I feel the need to channel my inner acerbic, chain-smoking aunt: Honey, of course he had sex with you for his own gratification. He’s a healthy young man. If you wanted a man to make love to you instead of fucking you, then don’t have sex with a man who isn’t in love with you.

As a raging conservative, I can explain to Lena Sclove why she felt so crummy after that encounter and everything that is wrong with it, starting with the premise that it’s a good idea to be sexually intimate with a man who doesn’t put your best interests first. (Here’s a hint: if he doesn’t do that outside of the bedroom, it won’t happen in the bedroom.) But I wonder if she can cogently explain the problems with it and why she was so upset after what was apparently a consensual sexual encounter. I wonder if she – or anyone on the Brown disciplinary panel – can explain the difference between being a selfish cad and a rapist.

I suspect that until our society can explain to young women that “consent” is a necessarily, but certainly  not sufficient, condition for a sexual encounter that will not make them feel crappy, we can only expect more of this – more men thrown out of school, more heartbroken women who can’t understand their pain.

It’s a Greek letter! It’s a transcendental number! It’s trademarked!

An artist has trademarked the Greek letter π with a period after it, i.e. “π.”  He has now sent copyright [sic] cease-and-desist letters to manufacturers of nerdy t-shirts. From wired.com (link previous):

At issue is U.S. trademark registration 4,473,631, issued to one Paul Ingrisano, aka “Pi Productions Corp” of New York. In January, the U.S. Patent and Trademark Office gave Ingrisano a trademark on the symbol π.—pi followed by a period—a design Ingrisano uses on T-shirts sold at some brick-and-mortar stores.

Obviously, the USPTO has been falling down on the job.  While trademarks have encompassed sounds (e.g. the NBC chimes), colours, and common words (e.g. Wendy’s or Burger King for hamburger chains). In theory, Ingrisano could have used the trademark “pi” for something completely unrelated to either the Greek letter or mathematical symbol – for example, “Pi Candy” or “Pi Movie Productions.” But it is patently (get it? patently?) absurd for him to trademark something that is both a letter in a foreign language and a mathematical symbol.  It would be like trademarking “e.”

Furthermore, the touchstone of trademarks is to reduce or eliminate confusion as to the source of goods in a marketplace.  T-shirts and such with “pi” on them have been ubiquitous long before Ingrisano was born.  As “π” does not signify to consumers that goods purchased in interstate commerce came from Igrisano’s company, it is not a valid trademark.

The trademark application only states that this is the letter pi, followed by a period, that is trademarked.  While some companies may temporarily stop production of their “pi” products, the far more likely result is that someone will happily take on the lawsuit – because Ingrisano had the lack of wisdom to do this at almost the exact time that a patent troll was ordered to pay costs to the defendants in a lawsuit.

Okay, and I’m still laughing about the fact that one Ronald Millett, Esq. of West Islep, New York, not only took this “case,” but cannot tell the difference between trademark and copyright infringement.