Secrets, Secrets are no fun: Is it unethical to leave dead end research unpublished?

          Have you ever thought of a great concept or joke and later found out that someone else thought of the exact same thing earlier than you? You may feel dejected if your idea was a joke, but what if it was a plan for taking certain courses, or to try making a certain type of food in an unorthodox manner? Chances are you could benefit greatly from the experiences of the person who tried it out before you – if the method of cooking ended in disaster, you can save yourself and whoever you are cooking for a lot of time and stomachache by avoiding it and trying something else. Now imagine, if your predecessor decided not to tell anyone about his failure – whether out of shame or because he intended to try again – the result would be that you would never get the chance to learn from him, and would be doomed to the same fate.

            This is the current state of affairs in the world of Clinical Trials. A law passed by Congress in 2007 requires that clinical researchers release most of the detailed results of their trials to the public. However, they are only required to do so once their product becomes approved by the FDA – meaning if they terminate the study early, or it fails for some other reason, they are never legally required to release the information. Even if it isn’t illegal, is invoking this loophole unethical? The hypothetical situation above shows how sharing can lead to benefit for a group of people, even if the result was not as expected. Additionally, it could help clear up current medical assumptions that we don’t even know are problematic. Science Daily uses the example that Michael Rogawski, Chair of the UC Davis School of Medicine Neurology Department, presents. He says new antiepileptic drugs are tested on mouse models, which are assumed to be effective simply because there is no contradictory evidence. However, if it is being withheld by the companies that failed, then this evidence could exist somewhere.

            The article in Science Daily concludes that when researchers fail to publish failed results, they are violating “an implicit moral contract between sponsors and study participants.” While I agree that it should become standard practice, if not law, for research companies to release all of their results – failed or successful – I would not go far as condemning those that have not chosen to as of yet. Research dead ends for a number of reasons – dangerous side effects, running out of funding, or simply a change in the market. It is understandable that in some of these cases, a company may want to keep their methods secret in case they want to return to the research at some point, and there is no strongly suggestive evidence to say they are harming anyone by doing so. For this reason we should avoid condemning anyone for what has been done up until now. Nevertheless, I think it is time for a change. The law should be changed in order to require that all results be published, just in case we are missing something that could benefit everyone.

http://www.sciencedaily.com/releases/2011/09/110928142444.htm

Trust Me, I'm a Neurochemist

Paul Zak claims to have found the reason that we trust others: a complex molecule called oxytocin. Zak, a professor at Claremont Graduate University in Southern California and a self-described “neuroeconomist,” investigates the factors that make people more generous and trusting towards others.

In a recent study, he found that people who had been exposed to the chemical oxytocin, a neuropeptide that has been shown to be related to social attachment in other mammals, chose to give about one and a half times as much money to charity as a control group who had been exposed to a placebo.

In another study, Zak found that subjects who had been exposed to oxytocin were twice as likely to donate all of their money to an anonymous trustee, trusting that that other participant would give them some back.

While it may not be a trust serum quite yet, Zak’s research serves as a reminder that the black box surrounding the functioning of our brains is ever-shrinking. As we become more capable of manipulating feelings and even thoughts by using chemicals, we must ask ourselves what the appropriate uses of these chemicals might be.

For example, one could easily imagine the dangers that a trust-inducing substance might produce in the hands of a con man or corrupt politician. But one could also see applications that are less morally clear-cut. Would a doctor be justified in prescribing oxytocin to an autistic person to allow him or her to more easily empathize with others? Would caretakers of a mentally deranged person be justified in giving that person oxytocin in order to reduce the risk of violent outbursts?

It seems a fundamental tenet of morality that we should never change another person’s thoughts without that person’s consent. After all, what privacy do we have if not that of our own mind? But what if the patient is incapable of giving consent? Our idea of personhood is so intimately tied up with our thoughts that I believe that traditional methods of proxy consent (parents for children or caretakers for the mentally disabled) may not be strong enough to justify the application of a drug capable of creating significant and lasting mental change.

The idea of consent itself also becomes clouded when mind-altering drugs come into play. If a patient were initially skeptical of taking an oxytocin pill, but became so trusting of his or her doctor when on the pill that he or she would not choose to go off the pill while its effects were active, can we consider that patient to still be consenting to continued treatment?

Such questions seem to border on science fiction, but it is more and more likely that they will become concrete issues within our lifetimes. I believe that we should continue to research the chemical composition of the brain for the sake of greater scientific discovery and for the potential medical applications, but that we should not allow any such chemicals to be released as publicly available drugs. They have too great a potential to compromise our humanity and we are better off without them.

Trust me.

Sources:

Barraza, JA, et al. “Oxytocin infusion increases charitable donations regardless of monetary resources.” Hormones and Behavior, 8 May 2011

Kosfeld, Michael, et al. “Oxytocin increases trust in humans.” Nature, 435: 673-676 (2 June 2005)

Zak, Paul. "Trust, Morality, -- and Oxytocin." TED Talk. www.ted.com/talks/paul_zak_trust_morality_and_oxytocin.html

Understanding the brain – courtesy of your military

        The Defense Advanced Research Projects Agency, or DARPA, is a Department of Defense agency that is known for funding research into new technologies ranging from the outlandish – flying cars – to the slightly more tractable – autonomous vehicles.   With these developments, the agency and many other military research groups have developed close relationships with the scientific world.   Recently, US national security groups have come to see neuroscience as a key frontier in the 21^st century.  The nature of neuroscience research, however, means that research of interest to the military is often begun without any interest in military applications.  This interplay between civilian and military technologies is nothing new.  The internet and GPS were originally developed for military use.

        In a paper published in PLoS Biology, an open-access journal, Michael Tennison and Jonathan Moreno explored the balance between military interests and scientific ethics.  They argue that while the goal of science is to expand knowledge via rigorous validation, the military aims to utilize new technologies as quickly as possible for national defense.  They hold that, as a result of this conflict, neuroscientists should remain conscious of the possibility of dual-uses, both civilian and military, for they research.

        Should this possibility of dual-use for new research be a real cause for worry?  The authors discuss a few technologies such as brain-computer interfaces, mental enhancement, and technologies developed toward the possibility of brain-reading.  Each military technology goes hand in hand with scientific research, yet the goals of the research that yielded each were not the creation of new military weapons.  I believe that while continued military use of neuroscience research is a cause for concern, there is not much that can be done if we hope to continue advancing our knowledge of the brain.  The nature of neuroscience research means that as we increase our understanding of the brain and develop new technologies, these new ideas will continue to play a role in military operations. 

http://www.sciencedaily.com/releases/2012/03/120320195800.htm

Unnecessary Tests and What They Mean for the Healthcare System

NPR reported today that “…as much as one-third of all procedures performed in the United States are of ‘questionable benefit’” (1). The news agency explained: “These procedures drive up cost and don’t help patients.”

This is appalling! How can a group of professionals who have sworn to “do no harm” conscience charging patients for these tests? On the face of it, this seems like it verges on criminal malpractice. But actually, I think the fact that doctors are overcharging patients for these unnecessary procedures is a symptom of a dysfunctional healthcare system. When doctors have to jack up prices (knowing that patients with insurance will not end up paying most of that sticker price) to pay for uninsured patients, we know that there’s a problem.

The good news is that some doctors are trying to change this norm: “In a move likely to alter treatment standards in hospitals and doctors’ offices nationwide, a group of nine medical specialty boards plans to recommend on Wednesday that doctors perform 45 common tests and procedures less often, and to urge patients to question these services if they are offered.”

However, there is still much to be done. And discussion of the healthcare system is particularly relevant now since the Supreme Court is currently deciding the fate of Obamacare. But no matter what happens, the most important thing is to change the incentive structure for doctors: the fee-for-service model that we have now is just not working, as indicated by all these unnecessary tests. This is where we should start.

(1) http://www.npr.org/local/stories/KQED/150023820

Not gender selection, but sexual orientation selection?

Gender selection, whether through embryo screening, sperm selection, or, more radically, conscious pregnancy termination, has been a hot topic of debate over the past few years. But recent research is suggesting that designing babies may go beyond selecting gender, physical traits, or even mental capacities and talents: it may be possible to select a child’s gender orientation.

More specifically, dexamethasone, or dex, is a risky, class C steroid that is nevertheless given to some pregnant women who are carrying fetuses with potential congenital adrenal hyperplasia (CAH), a disorder that gives the fetus ambiguous genitalia development. In girls, CAH means an excess of prenatal androgens that can give her male physical characteristics, but some researchers suggest that these characteristics may go beyond physical ones. Maria New, pediatric endocrinologist at Mount Sinai School of Medicine, published in a paper in 2008 on the “dose-response relationship of androgens with sexual orientation” by studying women with different types of CAH. New found that “the rates of bisexual and homosexual orientation were increased above controls . . . and correlated with the degree of prenatal androgenization.” In addition, she found that “CAH women as a group have a lower interest than controls in getting married and performing the traditional child-care/housewife role.” Thus, dex may have the potential to decrease not only the possibility of developing physical traits of the opposite gender, but also that of being homosexual.

Aside from the argument that the drug dex is dangerous and that its effects on preventing homosexuality are not yet fully understood, should a “treatment” be made widely available if further research showed reducing prenatal androgens did indeed reduce possibilities of homosexuality?

While the continuation of research to develop dex for the purpose of attempting to eliminate homosexuality is controversial, researching the link between prenatal androgen and homosexuality should be allowed to continue because it could provide more specific detail for the fact that homosexuality is natural/ biological, as opposed to a conscious life-style choice.

On the other hand, using dex as a “treatment” for homosexuality should not be widely accepted because of the coercion that it could represent for pregnant women. Unlike certain kinds of enhancement, such as minor operations that improve one’s appearance, or drugs like Adderall, which allows someone to focus but not necessarily produce better work, the dex “treatment” could be viewed by those who are strongly opposed to homosexuality as not a luxury but a way to “cure” the society of homosexuals. Giving a pregnant woman with a potential CAH fetus the freedom of choice on whether to use dex is not really giving her a freedom of choice at all. Women who choose not to use dex would face stigma from society accusing them of not preventing their children of being homosexual when they could have. Homosexuality is an identity, one that is no less valid than other identities. But unfortunately, not all of society shares that view. So unless opposing views change, we should not strive to make dex a widely available “treatment” for homosexuality, even if the drug’s risks are reduced.

http://www.physorg.com/news197211098.html

http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4754&blogid=140

Human Engineering To Solve Climate Change?

We could select shorter children via PGD to create smaller children so that mankind will on the whole expend less energy.

New York University professor of bioethics S Matthew Liao argues that human engineering is a plausible way to tackle energy resource challenges. According to Liao, modifying humans to simply use less energy deserves consideration because it is less risky than other options (such as geoengineering) in the long run. Even assuming that this premise is true, are the implications and risks involved with this kind of human engineering morally justifiable?

Liao justifies his proposition by saying these policies should be optional: “a voluntary activity rather than a coerced, mandatory activity”. Sure, this is entirely plausible assuming such alteration of height entirely affects the mature human population – humans able to give consent. However, this does not address the moral problem of parents taking away the right to an open future from their children: a matter large enough to present a convincing argument against “climate bioengineering”.

Indeed, parents selecting a shorter stature for children in this way (via PGD) is obviously done without the child’s consent: the children have no choice in this matter, therefore this proposal can’t count as voluntary. Steve Clark of Oxford echoes this sentiment: “as a society, we don’t give parents an unlimited right to make decisions on behalf of their children”. Creating smaller children to combat global energy scarcity is far from ethically justifiable.

http://www.wired.co.uk/news/archive/2012-03/13/bioengineering-humans-climate-change

http://www.smatthewliao.com/wp-content/uploads/2012/02/HEandClimateChange.pdf

http://blog.practicalethics.ox.ac.uk/2012/03/planet-of-the-little-apes/

Marijuana: Recreational or Medicinal?

In 1972, Congress made marijuana into a Schedule I controlled substance claiming that it has, “no accepted medical use”.  However, since then marijuana has been found to be a, “safe and effective treatment for the symptoms of cancer, AIDS, multiple sclerosis, glaucoma, epilepsy, and other conditions” and numerous studies have been published on this matter.  Consequently, 16 states have already legalized marijuana, but it is still a controversial topic around the US.  Interestingly, if marijuana is examined from an objective standpoint, meaning that we consider it as just another prescription drug and not associate it with recreational use and drug abuse, then the medicinal use of marijuana becomes apparently justifiable.  So why then is the topic still so controversial?

It is because people are unable to change their paradigm of looking at marijuana from that of a recreational drug used by drug addicts.  This becomes evident from the arguments critics against medical marijuana use.  The arguments primarily lie on three fronts; first, the critics claim that the medicinal properties of marijuana have not been adequately proven due to the, “lack of consistent, repeatable scientific data”.  But this is surely not the case, for instance, Jocelyn Elders, a former Surgeon General asserts that, “The evidence is overwhelming that marijuana can relieve certain types of pain, nausea, vomiting and other symptoms”.  This “evidence” takes the form of controlled studies published in reputable journals around the US – so the critics are clearly just ignoring the facts and hiding behind their inability to shift paradigms. 

Second, critics claim that marijuana poses health risks, which makes its use unethical.  First of all, this has to be put in perspective – virtually all drugs that treat serious illnesses like cancer or AIDS have dangerous and potentially lethal side effects, so just because marijuana could have certain side effects does not immediately preclude it from medicinal use.  In fact, again the critics are just making assumptions about the health risks of marijuana despite the fact that numerous studies demonstrate its general safety.  Some people claim that marijuana could cause lung cancer or emphysema, but to this date not even one case of either disease has been attributed to marijuana use.  Moreover, critics also say that marijuana use can suppress the immune system, but in one study conducted on patients with AIDS, it was found that patients using marijuana had higher immune function than those on a placebo.  Admittedly, there are definite cases in which marijuana does decrease immune function, but as researchers agree, marijuana is far less toxic than drugs used in the aggressive treatments of other diseases, such as chemotherapy for cancer.  Thus, marijuana does not pose any health risks that are incomparable to other FDA approved drugs, so the critics are again, just clinging to emotional arguments and are ignoring the facts in front of them.    

Third, other critics claim that marijuana is addictive and a gateway for the use harder drugs.  Although studies have found that there can be withdrawal symptoms associated with marijuana, they are largely incomparable to those with other drugs, like nicotine.  In fact, the medicinal use of marijuana does not require use every day so addiction is far less likely.  Despite this, critics do claim that up to 10% of people who use marijuana for medicinal purposes end up getting addicted.  But again, this needs to be put into perspective, take pain killers for example, more than 15 million people use them regularly, which is a jump from half a million a decade ago.  Furthermore, morphine addiction is the 3^rd most common drug related reason people end up in the emergency room – but we still use morphine and vicoden as medicinal drugs.  Secondly, the “gateway” theory has been largely repudiated by studies which have shown that people who are predisposed to using drugs will use both marijuana and other harder drugs regardless.  The only reason that marijuana use starts first is that it is more readily available.  Hence, again, the critics’ arguments fall apart in the face of studies which they conveniently ignore.  Although they do bring up certain reasonable points about the properties of marijuana, they are still treating it as a recreational drug and are not looking at it through the larger perspective of medicine.

 All in all, there are no perfect drugs in medicine, all have potentially adverse effects but they are the best options available.  Similarly, there are no other drugs that can exactly replicate the therapeutic properties of marijuana, so despite the fact that it could have certain detrimental consequences, for the most part marijuana will be beneficial.  As a result, marijuana should be allowed for use in medical settings, where patients can be adequately monitored, minimizing any potential risks – just as all other potentially harmful drugs are administered. 

http://medicalmarijuana.procon.org/view.resource.php?resourceID=000141

http://www.morphineaddictionhelp.com/morphine-addiction-statistics