Thank goodness for the courts. A federal judge has now done what the Obama administration had failed to do — make the “morning-after pill” available without prescription to all girls of reproductive age, including those younger than 17.

The emergency contraception pill works to prevent pregnancy up to 72 hours after sexual intercourse. The Food and Drug Administration, which had begun dragging its feet during the Bush administration over approval of this proven safe medicine, had finally cleared it for over the counter sale after a decade of hemming and hawing about nothing.

But, for reasons having everything to do with politics and nothing to do with science, public health or logic, U.S. Department of Health & Human Services Secretary Kathleen Sebelius overruled FDA’s approval in December of 2011 and said it could not be sold to girls under the age of 17 without a prescription.

The court has now righted that grave wrong.

Sebelius' decision made no sense. The pill is safe and it works. It will reduce unwanted pregnancies and be of particular help to young women who are raped, abused or coerced into sex.

Critics have made two key arguments against the pill—that it is an abortion agent and that it will encourage sex.  Neither claim holds a thimble-full of science or logic.

Scientifically, emergency contraception works by prohibiting ovulation or by prohibiting the implantation of an embryo into the lining of the uterus.  If an embryo has not implanted it cannot be aborted since it never had a chance to become anything.  Emergency contraception is only an abortion in the eyes of those blind to how reproduction works.

And as for encouraging sex, there is no reason to think that girls, some of whom are already sexually active, will be joined by hordes more who will feel free to fool around because there is a pill anymore than there is to think that condoms lead to more underage sex.

The battle over the "morning-after pill" has done nothing to solve the real problem about teenage sex -- the inability of this country to talk about sex. We don’t have enough sound sexual education in our schools, too many of our religious leaders are not effective or credible in spreading wisdom about virtue, responsibility and sex and, a lot of parents fail when it comes to engaging their kids about sex if for no reason other than what they were themselves doing at 14, 15 and 16.

As the judge noted, there is no reason whatsoever to hold this pill hostage to politicians’ whims.  It is safe, it works, and it gives a woman who has no other choice, due to contraceptive failure, abuse or rape, a way to avoid an unwanted pregnancy.  It ought to be stocked in every emergency room, pharmacy, and police station.  And your politicians and clergy should try harder to figure out how to teach our children about sexuality and sexual responsibility without making fools of themselves over a pill.

Arthur Caplan, Ph.D., is the head of the Division of Medical Ethics at NYU Langone Medical Center.

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Judge: Make 'morning-after pill' available to all girls without prescription

India’s top court ticked off Big Pharma this week when it denied a patent to the pharmaceutical giant Novartis on a modified version of its blockbuster cancer drug Glivec.

Novartis has been making ominous noises about ever doing business in India again. Other Big Pharma companies are making similar bellicose noises. The U.S Trade Representative’s office noted that 40 other countries had granted the patent and that it might be time to pay a little more attention to India’s emerging renegade status when it comes to enforcing international property law.

But the Indian court decision has its admirers, especially those agencies who seek to advance the health of the poor in developing countries. They noted that by declining to honor the patent, the Indian court had guaranteed continued access to low-cost copycat versions of drugs for diseases like HIV and cancer. India is the world’s biggest provider of cheap, knock-off generic medicines.

The actual case that the Indian court ruled on was not a hugely strong one for Novartis. The company had tried to defend a patent extension on its highly profitable drug by slightly tweaking its chemical composition — a standard maneuver by Big Pharma when patent protection on a blockbuster drug is wearing out but one that the Indian court found entirely unpersuasive.

The whole brouhaha over patent protection misses the key moral point. Few but lawyers will shed many tears over Big Pharma’s lament that they cant possibly do research for tomorrow’s drugs if they cannot use patents to accumulate buckets of money today by enforcing patents no matter how needy patients may be. And who really wants to join the NGOs, patient advocacy groups and some governments in poor nations in celebrating the parasitic generic industry which profits by copying name brand drugs while merely pocketing their profits with no interest in making anything new or better for tomorrow?

The current frenzy about patents obscures the much more important question which is prices. Patent or not why isn’t Novartis selling its cancer drug to poor people at prices they can afford? Why does the fact that a drug company holds a patent on a vaccine give them license to ripoff the rich to get these medical goods, which they most certainly do, to Americans? The important question which battling about patents does nothing to address is how to come up with a reasonable pricing scheme for medicines that makes sense in a world with a wide variation in purchasing power.

Lawyers who make their money litigating about patents may try to convince courts and the rest of us that patents that are the key to the availability of better drugs, but they are not. When Big Pharma holds the patent on their new discoveries, access to them is not a function of their legal right to go after anyone who tries to clone or copy them. Access is a function of what is being charged, not who owns the patent. And what is being charged—the price of drugs, vaccines, and devices --is what ought to command attention from those concerned both with access to current drugs, the overcharging of rich countries for a lot of drugs and the financial incentives needed to get companies to make new and better ones.

Pharma execs who are frothing at India’s hubris in telling them that the much favored monkeying around with the composition of a drug have nothing to say when they sell that very same drug at huge price differences where their patents are honored. And agencies and foundations like the Gates Foundation have to pony up to make sure that the drug companies and vaccine manufacturers will see it in their interest to make their patented drugs available to those staggeringly poor people who need them.

Instead of creating yet another profiteering industry—the generic drug industry—which lives by trying to poach can't we all agree that drug companies have a moral duty to make their drugs available free or at minimal cost to those who have no money to pay for them at all? And shouldn’t the very rich be wondering why it is fair that the subsidize the prices of drugs for the sort of rich so Pharma can lumber on in pursuit of more medicines? That is the policy debate that the world needs to have.  Leave the patent wars to the lawyers – they do the rest of us little good! 

Arthur Caplan, Ph.D., is the head of the Division of Medical Ethics at NYU Langone Medical Center.

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Novartis loses landmark drug patent battle in India 

A top-level commission has just released a new report on the morality of studying the safety of an anthrax vaccine in children, with an eye toward treating kids in the event of a terror attack.

The report, issued Tuesday by the Presidential Commission for the Study of Bioethical Issues, is quite thoughtful. It concludes that no testing should be considered unless the risk to kids is minimal. But it also represents a study of an experiment that has no chance of happening -- ever. The commission has wasted its time. There is not a chance that a sufficient number of American parents are going to sign up their kids for the safety testing of an anthrax antidote.

The reasons for asking the question are sound enough: In 2011, the U.S. government conducted a bioterrorism preparedness exercise to study the likely results of a large-scale release of weaponized anthrax spores in a major city Officials estimated nearly 8 million citizens would be affected, nearly a quarter of them children.

If such a terror attack happened, current federal plans call for immediate distribution of antibiotics and a follow-up widespread vaccination program using anthrax vaccine adsorbed or AVA. Vaccination is necessary because anthrax spores would likely pose a threat long after their initial release.

The vaccine has been administered to more than a million adults in the military. The problem, of course, is that no one knows what effect anthrax vaccine might have in children. Some have been in favor of testing the vaccine on children, arguing that it’s better to know the effects than not to know.

The National Biodefense Science Board -- a group of scientists and doctors who advise the feds -- recommended that the government conduct a study to test the safety and effectiveness of anthrax vaccine with children in case an attack occurs, contingent upon ethical review. The new review calls for strictly limiting pediatric anthrax research risk in any study to a minimum.

That sounds reasonable until you think about what a study actually involves. Anthrax vaccination requires five -- count ‘em -- five shots. According to a safety review completed a year ago by the Military Vaccine, or MILVAX, Agency of the US Army Medical Command, 30 percent of men and 60 percent of women in the military who were vaccinated experienced a wide range of minor side effects, including soreness, redness, itching, swelling and or lumps at the injection site, plus ailments like rashes, headaches and joint and muscle aches. There were no deaths or serious long-term harms found.  

As medical interventions go anthrax vaccine is very safe. But it’s one thing if you’re a soldier heading somewhere where bad guys might lob an anthrax-loaded shell your way. In that case, a little itching, swelling and joint soreness would hardly matter.
If it’s your kid, it’s another thing. And if your kid has asthma, allergies, depression, cystic fibrosis or cancer, the risks seem even greater. The whole notion of a trial in children of anthrax vaccine is, quite simply, ludicrous.

Nor should parents want to sign their kids up.  Of all the real challenges that children face -- think abuse, neglect, obesity, suicide -- exposure to anthrax is pretty far down the list.  Calling for this study on kids is to put a remote, tiny risk ahead of a dozen other dismal and all-to-real life-threatening dangers. It is to terrorize kids and parents with a terrorist threat that is remote at best.

The commission sees a small ethical opening through which a study might pass.  I see parents taking one look at any effort to recruit their kids to a safety study of anthrax vaccine and moving on to worry about what their children are eating, who might be bullying them, and whether they drink and drive.  Sometimes you don’t need an ethical review to tell you what is gonna happen.

Arthur Caplan is the head of the Division of Medical Ethics at NYU Langone Medical Center.

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• Bioethicist: US children suffer from vaccine exemptions
• Bioethicist: We need to treat gun violence as a public health issue

Crystal Kelley got paid $22,000 to have a baby. But that wasn’t the only offer the 29-year-old Connecticut mother of two received. After an utrasound at 21-weeks revealed significant medical issues, the parents offered her $10,000 more if she agreed to an abortion.

The gross immorality of that second offer tells us that there is a lot wrong with the first arrangement. It is intolerable that our society continues to put up with an unregulated, free market in hiring cash-starved women to make babies. 

The couple, which had two other children, "were very attentive," Kelley told NBC Connecticut. "They wanted to be involved in the pregnancy. [The biological mother] said she really felt like she was living through me in this pregnancy and she wished she could experience it.”

But after the tests revealed complex heart problems, a cleft lift and palate and other issues, the would-be parents decided that the pregancy should be terminated. Kelley refused, even after the money was offered after she was told the parents would no longer adopt the baby.

Then things went from ethically bad to ethically despicable. According to a CNN report, Crystal Kelley then got a letter from an attorney named Douglas Fishman reminding her that her surrogacy contract required her to get an abortion in the case “of severe fetus abnormality.” The lawyer told her that if she did not promptly get an abortion the no-longer-wannabe-parents would sue her to get back the money they’d paid along with the money they’d spent on Crystal’s medical bills and legal fees.

This crummy story goes on and on (for those who are curious, Kelley did eventually give birth and was able to find another couple to adopt the child), but there is enough on the ethical plate to see that there is plenty wrong with commercial surrogacy if a woman can be bribed or bullied into an abortion.

Let’s do the low hanging ethical fruit first.

No one can contract with a woman to have an abortion. Under any circumstances. For any reason. Never. A woman controls her body and no one can make her do anything she does not want to do in terms of medical intervention with her body no matter what she has said before, signed or promised. The lawyer who tried to coerce and threaten Crystal Kelley to have an abortion should be subject to loss of his license to practice law. Any surrogate agency which conveyed an offer of money to encourage an abortion is guilty of at best bribery and an attempt to crassly manipulate a vulnerable woman. And any surrogacy agency that sticks abortion language into its contracts is guilty of gross misconduct.

Now let’s go for the broader moral lessons evident from this horrific tale.

Surrogacy for money is about money -- not love, or help, or altruism or doing good. Money is most attractive to those who need it most. Young single mothers with kids to feed and bills to pay and the rent in arrears are not likely to read the small print. If we are going to put up with markets in wombs, then the least we can do is mandate by law that the potential surrogate has her own lawyer that she picks but that is paid for by the couple who want to rent her womb.

In addition, we need legislation that makes it absolutely clear that if you hire a surrogate you will legally be bound to accept and raise any child that results. Would-be parents who use surrogates must understand that if a fetus is found to have problems, it is their responsibility, not the surrogate’s, to resolve them. If you enter the genetic lottery via surrogacy, you have to live with the consequences: that is the only way to insure the interests of children made via surrogacy are protected.

Lastly, we need tighter control over those in the commercial surrogacy broker business. If Crystal Kelley’s story is any indication, there are a lot of brokers out there who are far more interested in making an easy dollar then protecting the women whose wombs they offer for sale or the children who may result from surrogacy arrangements.

Technology has given us many new and valuable ways to make babies. The free market – complete with its shady middlemen and lawyers -- is not up to the task of deciding how best to use that technology.

Arthur Caplan, Ph.D., is the head of the Division of Medical Ethics at NYU Langone Medical Center.

Last week, 87-year-old Lorraine Bayless collapsed at Glenwood Gardens, an assisted living facility in Bakersfield, Calif., and later died.

While it’s not unexpected that an elderly person would die, what’s troubling is that after she collapsed, a nurse called 911, yet wouldn’t administer CPR or look for someone else to do it, despite the request of the emergency dispatcher. 

The management of Glenwood Gardens backed up the staffer’s decision to not start CPR. 

“Our practice is to immediately call emergency medical personnel for assistance and to wait with the individual needing attention until such personnel arrives,” Jeffrey Toomer, executive director of Glenwood Gardens, said in written statement. “That is the protocol we followed.”

Toomer was not the only one backing the decision not to start CPR. Bayless' daughter told a reporter for KGET, the NBC affiliate in Bakersfield, that she was also a nurse and was satisfied with the care her mother received. It seems unlikely that a lawsuit will follow.

So why might the staffer and the facility balk at using CPR to try to save the life of a dying woman? One reason is that the woman who called 911 may not have felt comfortable trying CPR for some reason or perhaps felt out of practice. Another might be that since the facility had a call and wait policy, perhaps she worried for her job. One possible reason for Glenwood Garden’s policy is that there is always a nagging worry that no good deed will go unpunished — if CPR is given but it is done improperly will there be liability for the assisted living facility. As it happens, none of these reasons are good ones not to try CPR.

Even without training someone might be able to help if guided by a knowledgeable person. The dispatcher offered to walk the caller through what to do but the caller still declined.  And liability is not really much of a worry unless you do something extremely absurd every state shields those who try to be Good Samaritans against lawsuits.

It is true that CPR does not work as well as we might wish. Even when someone sees a heart attack happen or a patient collapse, as was true in this case, the odds of preventing death in someone that age are not great.

Still, I can’t help thinking that unless there is some medical fact about the patient that we don’t know—she had terminal cancer or a Do Not Resuscitate request in place —there is no ethical justification for calling 911 and then waiting until they come before starting CPR. Anyone of us could be confronted with this choice. 

Every one of us should think hard about what we ought to do when someone needs our help to live.

Arthur Caplan, Ph.D., is the head of the Division of Medical Ethics at NYU Langone Medical Center.

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Policy questioned after nurse refuses to do CPR

Would you eat horsemeat?  A lot of people would not. Should you have the right to know if the meat you are eating contains horsemeat?  The answer to that question is a resounding yes – and that’s why the current scandal in Europe over horsemeat reveals a lot about the push to get better labels on the food we eat.

If you don’t want to eat horse – why? What is the problem?  If you eat meat, then why not horse? After all, many people around the world do eat it. Horse is on the menu or in the kitchen in many nations including Kazakhstan, Indonesia, Japan, South Korea, Mongolia, Tonga, Iceland, Germany, Sweden and Holland. So whatever you think about eating horse, it isn’t safety that makes you disgusted at the very idea. 

Still, Europe is in the midst of a huge scandal involving horsemeat showing up in a lot of the wrong places. Testing has revealed that much of what has been sold as beef or pork in restaurants, schools and hospitals as well as in frozen meat products in grocery stores such as lasagna contains horsemeat.  Even the furniture giant Ikea had traces of horsemeat found in the meatballs they were selling in their restaurant stores in some parts of Europe.

Why is the discovery of horse meat in food such a big deal?  What is so troubling to Europeans that there have been protests and outrage against food companies in many nations where mislabeled meat has been found?  To understand the furor generated by consumers finding out there is horse in there you need to look elsewhere.  The South Philadelphia restaurant Monsu provides a clue.

The head chef of BYOB Monsu announced last week that the restaurant's menu would soon include some selections of the equine variety. But the day after announcing horse was going on the menu, the restaurant received a serious threat. “They called into the restaurant and said, ‘You guys start cooking horses, I am going to blow up your restaurant,’” Andrews said to NBC10.com.  Clearly, some folks feel very strongly that horses belong in a paddock, not a plate.

Food is much more than safety, and it is much more than nutrition – we see this  when we get into fights about labeling genetically modified food, or requiring that meat from cloned animals be clearly marked or that organic food really be organic to merit the description the European scandal over horse meat.  Food is culture.  Food is family.  Food, in short, is values.

Those who get into fights about labeling food thinking it is just an issue of safety never tried to put horse on the menu in South Philadelphia or deal with an outraged customer in England whose beef stew was more than that.  The ethical and policy lesson for regulators, industry and farmers of putting horse meat where it is not supposed to be is very simple--when it comes to food we should be able to find out anything and everything we want to know about what we eat.  To do otherwise is to deny informed choice about a subject -- food -- that is too complicated to permit any other standard.

Related: 

Horse meat found in Ikea meatballs, Czech officials say

Kevin Frayer / AP, file

Former Israeli Prime Minister Ariel Sharon in June 2005, just over six months before he suffered a massive stroke.

Ariel Sharon, the former prime minister of Israel, has been in a permanent vegetative state since suffering a massive stroke on January 4, 2006. For the past seven years, a respirator and a feeding tube have kept him alive at Sheba Hospital in Tel Hashomer, Israel. He has never shown any reliable signs of awareness or consciousness – until last week.

The stroke left the man once dubbed by Israelis as “the Lion of God” bedbound and technologically dependent on machines for his existence.

In the past, some of his family felt that he was able to slightly move a finger and show some signs of responsiveness but his doctors believed that the strokes so damaged his brain that both recovery and any serious mental activity were impossible.

But last week, a team of doctors and neuroscientists from Israel's Soroka University Medical Center subjected the 84-year-old Sharon to a series of sophisticated brain scans. They were surprised at what they saw.

They showed him pictures of random houses, which he would not be expected to know. Then they flashed a picture of his own house before his eyes. When the images of his own home were shown, areas of his brain "lit up" with activity. Similarly his brain ”fired up” in response to hearing the voices of family members but did not when nonsensical gibberish sounds were presented to him.

Sharon is not the first person to surprise doctors who doubted that anything could be going on in a brain located in a body that was otherwise unresponsive for years. Other patients with massive brain injuries have shown some brain activity included one case in which a 23-year-old woman, when asked to imagine different scenarios including playing tennis, showed strikingly similar patterns of brain activity to those found in scans of healthy volunteers.

So what are we to make of this? Can doctors say with certainty that he won’t recover?  Is Sharon really “in there” unable to move but alert and awake?  Should we ever remove life-support from someone who has been severely brain injured by a stroke or traumatic injury or asphyxiation? These questions are hardly trivial since families and health care teams face them every day all over the world.

Can Sharon come back? Many Israelis and his family fervently hope so but older patients, especially 84-year-olds who have been through two strokes and remained unresponsive for seven years, do not come back.

Is he “in there”? Let’s hope not. Being trapped in your own body year after year unable to move anything or communicate in any way would be horrific.

What about the brain activity? The data that the doctors and scientists see is very hard to interpret.  Something is going on in Sharon’s brain when he sees or hears familiar things. But is he really aware of what he sees or are well-worn neural pathways firing up when familiar stimuli are present without anyone home to appreciate them? No one really knows for certain, but it seems fair to say that a very damaged brain is not ”thinking” or aware or self-conscious in a manner similar to healthy human brains.

So what is the case for keeping Sharon alive?  He is not dead—he has brain activity. Still, he may be suffering if he has any awareness of being trapped inside his own body. Prolonging his life may be causing incredible misery to him and others like him. 

The best we can do is to let families try to decide what to do as long -- as they understand the facts and the uncertainties. And as long as they are willing to help pay the bill.  Keeping Sharon or others like him alive in a very damaged, extremely limited state with no hope of recovery is not something that the government should pay for without some support from those who want life to go on.

The choice to keep Ariel Sharon alive is one that deserves respect but is also one that demands involvement—emotionally and fiscally. The choice to let him go also deserves respect. In this case, uncertain medical science can only give way to well-intentioned ethics.

Arthur Caplan is the head of the Division of Medical Ethics at NYU Langone Medical Center.