The FDA Flexes Its Muscles on Testosterone

by Karen Solomon, Bioethics Program Student

In 2002, Solvay Pharmaceuticals developed a new marketing strategy that characterized the natural decline in testosterone production associated with normal male aging as a medical problem, termed low-T. The ultimate objective was to encourage physicians to prescribe testosterone to otherwise healthy patients to combat the effects of normal male aging, such as low energy and libido.

This marketing strategy worked. In the last decade, testosterone use in men has increased by over 300%. Over 2 million men are now being treated with testosterone in the US, earning pharmaceutical companies a great deal of money. In 2012, US testosterone sales hit $2 billion, up from a “mere $324 million” in 2002. Although the US leads the world with testosterone prescribing, a significant and steady increase in testosterone use has been seen across the globe.

However, safety concerns over testosterone use by otherwise healthy men are mounting. One observational study revealed that within three months of starting testosterone, heart attacks doubled in men over 65, and in younger men with heart disease. Another study found that among older men with low testosterone undergoing coronary angiography, many with heart disease, there was a 30% increase of “stroke, heart attack, and death” among those being treated with testosterone.

Earlier this year the FDA took notice, asking an Advisory Committee to provide recommendations on licensing and use of testosterone as an anti-aging panacea. That committee has since recommended that the Agency place additional restrictions on the ability of pharmaceutical companies to promote testosterone for low-T. The panel also recommended that researchers conduct additional clinical trials designed to better understand the frequency and severity of side effects associated with testosterone use.

It is encouraging to see an FDA Advisory Panel argue for greater caution with the use of prescription drugs in otherwise healthy individuals. As demonstrated with testosterone, FDA drug approval does not mean that all potential safety issues had been vetted. When drugs are prescribed with larger and more diverse populations than those studied in clinical trials, new safety concerns can arise. Once physician prescribing habits become established for off-label uses, drug manufacturers may not have an incentive to pursue additional studies to demonstrate whether such use is effective or safe.

Hopefully this will change. Until recently, manufacturers profited from increased sales while questions about whether off-label use was safe or effective were left unanswered.

In 2007, however, the FDA was given new authority under the Food and Drug Administration Amendments Acts (FDAAA), to require manufacturers to conduct post-marketing studies, as new safety information becomes available. The FDA now has the option to flex new regulatory muscles, as they have done with testosterone manufacturers, instead of negotiating for voluntary action with little promise of an end game. This can only be a win for patients.

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

Tackling the Problem of Domestic Violence

by Sean Philpott-Jones, Director of the Center for Bioethics and Clinical Leadership

The National Football League is in for a rough season, both on and off the field. In the past month, for example, America’s most popular sport has been rocked by allegations that league officials and team owners willfully ignored evidence that the Baltimore Raven’s star running back Ray Rice beat his then-fiancée unconscious in an Atlantic City elevator.

All-pro defensive end Greg Hardy of the Carolina Panthers and defensive lineman Ray McDonald of the San Francisco 49ers face similar allegations. Most recently, Minnesota Vikings’ Adrian Peterson was charged with criminal child abuse after whipping his four-year-old son with a wooden switch and a leather belt.

In response, beleaguered NFL Commissioner Roger Goodell promised to overhaul the organization’s policies on personal conduct, making it easier to penalize players harshly for egregious off-field behaviors, including domestic violence and child abuse. Commissioner Goodell also introduced a new initiative that would require all players and league staff to participate in regular educational programs on domestic violence and sexual abuse.

Unfortunately for Mr. Goodell, much of this is “too little, too late.” A growing number of women’s organizations and domestic violence advocacy groups are calling for his resignation. A number of commercial sponsors are also distancing themselves from the NFL, which makes Roger’s continued tenure as NFL Commissioner increasingly unlikely.

A number of pundits have also weighed in, not just on the question of Mr. Goodell’s career prospects but also on whether or not the recent spate of domestic and child abuse causes is directly linked to misogynistic and violent culture of professional football. Some of these armchair quarterbacks have linked the so-called “epidemic” of domestic violence in the NFL to increasing awareness of the physical and mental toll that football takes on professional (and even amateur) athletes.

Many players, for example, use anabolic steroids illicitly in order to get a competitive boost. It is well known that abuse of these drugs can lead to uncontrolled aggression and violent behavior (colloquially called ‘roid rage’).

Similarly, head injuries – particularly concussions – are also a common occurrence in high-speed contact sports like football. Players with a history of repeated concussive head injuries are at increased risk of developing a progressive neurodegenerative disease known as chronic traumatic encephalopathy (CTE), symptoms of which include mood and behavioral changes, dementia, tremors, impaired speech, and deafness. Actuarial experts hired by the NFL itself now estimate that as many as one-in-three professional football player will develop CTE or other long-term cognitive problems in their lifetime.

But it is important to remember that correlation is not causation. For instance, there is no definitive link between CTE and domestic violence in the NFL or other sports leagues. More importantly, despite the current spotlight on Ray Rice and Adrian Peterson, there is no link between professional football and domestic violence.

This is not to say that domestic violence is not a big problem in the NFL. Since 2000, nearly 100 players have been arrested or changed with domestic violence or child abuse. But this rate is actually slightly less than the US national average.

So despite what most Americans think, the NFL is not suffering from a “widespread epidemic of domestic violence”. Rather, it is the country overall that is in the midst of an outbreak.

At some point in their life, nearly a quarter of all women and 8% of all men will be the victim of a physical or sexual assault by a romantic partner or personal acquaintance. Many more will be the victim of more insidious forms of violence, including verbal, emotional and psychological abuse. Rates of abuse are particularly high among racial, ethnic and sexual minorities.

Similarly, over 10% of children will be abused or neglected by the time they are 18 years old. Over 6% will be raped or sexually assaulted by a family member. An estimated 1,500 children in the US die annually as a result of abuse or neglect.

This is the real tragedy, and the one that we need to address. In many ways, the spotlight on the NFL may do just that. In the past couple of weeks we’ve seen an increase in public discussion and debate about the problem of domestic violence. Victims of abuse – including celebrities like Meredith Vieira and Sarah Hyland – have also gone public with their stories on television, in the press, and via Twitter chats using the hash tags #WhyIStayed and #WhyILeft.

But increasing public awareness and discussion of the problem is just the start. We also need to reform relevant local and state laws to make the perpetrators of domestic violence or child abuse more accountable for their crimes. In many states, for example, a man can go to jail for up to five years for abusing his dog, but spend less than a month in jail for beating his wife, girlfriend or daughter. Existing abuse laws also often lack protections for gay, lesbian or transgendered individuals, even though these groups are at higher risk for physical abuse or sexual assault.

The epidemic of domestic violence and child abuse in the US will not end until the nation as a whole tackles this rampant problem head on.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on September 25, 2014, and is available on the WAMC website. The contents of this post are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Extending the Zadroga Act

by Sean Philpott-Jones, Director of the Center for Bioethics and Clinical Leadership

Thirteen years ago today, Americans watched in horror as planes hijacked by Al Qaeda-backed terrorists slammed into the World Trade Center, the Pentagon and a vacant field outside of Shanksville, Pennsylvania.

Many of us lost friends and family. Nearly 3,000 people were killed that day, including 2,753 who died when the World Trade Center’s Twin Towers fell. The actual death toll associated with 9/11, however, is much higher.

When the Towers fell, they released a cloud of pulverized cement, shards of glass, asbestos, mercury, lead, PCBs, and other carcinogenic and poisonous materials into the air. That cloud lingered for months, with hundreds of rescue workers, thousands of construction workers and millions of New York City residents breathing in a witches’ brew of cancer-causing chemicals.

Rates of asthma, obstructive pulmonary disease and other respiratory illnesses are sky high among those who were exposed to the foul air or toxic dust that lingered over Lower Manhattan in the days and weeks the followed 9/11. A study of police who responded to the terror attacks found that more half have diminished lung function and chronic shortness of breath.

Rates of prostate cancer, thyroid cancer, and multiple myeloma are also elevated; one study looking at nearly 10,000 firefighters found that those who were at the World Trade Center were 20% more likely to develop cancer than those who were not there. Over 2,900 people who worked or lived near the World Trade Center on 9/11 have been diagnosed with cancer, including nearly 900 fire fighters and 600 police. Many of these cancers are likely associated with exposure to chemicals in the air and debris at Ground Zero.

Under the James Zadroga 9/11 Health and Compensation Act, passed by Congress in 2010 after a prolonged partisan fight, first responders, recovery workers, and survivors of the terror attacks can seek free testing and treatment for 9/11-related illnesses. Nearly 50,000 people are currently being monitored and over 30,000 are receiving medical treatment or compensation for illnesses and injuries associated with the World Trade Center’s collapse.

These numbers are expected to rise in the coming years. The incidence of cancer and chronic respiratory illnesses continues to increase at an alarming rate among survivors and responders of the terror attacks. At the same time, two of the key programs created by the Zadroga Act are due to expire. Unless Congress extends the Act, the World Trade Center Health Program, which provides free screening and treatment for 9/11-related illnesses, will end in October 2015. The September 11th Victim Compensation Fund, which provides financial support to the victims of 9/11 and their families, will close in October 2016. Desperately needed medical care and social services will be cut off for thousands of sick patients whose only crime was to survive the attacks or to provide care and aid for those who did.

A bipartisan group of New York politicians – including New York City Mayor Bill de Blasio, US Senator Kirsten Gillibrand, and US Representatives Peter King and Carolyn Maloney – want to prevent this. Just this week, they called upon Congress to extend the Zadroga Act for another 25 years. But they and other supporters of the Act face an uphill battle.

One of the key reasons that it took nearly 10 years to get this legislation passed in the first place is that many prominent (largely conservative) Congressmen opposed its passage, including Representatives Michele Bachmann and Paul Ryan. House Speaker John Boehner and Majority Whip Kevin McCarthy voted against it repeatedly. Senator Tom Coburn also filibustered its passage, arguing that the federal government simply cannot afford provide treatment and care for the victims of 9/11 in an era of record budget deficits. Should the deficit hawks of the Republican Party retain control of the House and recapture the Senate in the upcoming mid-term elections, the fate of the Zadroga Act is likely sealed.

The heroes and victims of 9/11 deserve better. I believe that we have a moral obligation to provide lifelong medical care and treatment for illnesses linked to the terror attacks. It is shameful that the same politicians who used these attacks to justify hundreds of billions of dollars in military expenditures are suddenly crying poor when asked to help the victims themselves. I urge you to call your Senator and Representative and urge them to support the Zadroga Act. More importantly, I urge you to use the power of the ballot box in the upcoming midterm elections to send a message to those who do not support an extension of the James Zadroga 9/11 Health and Compensation Act.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on September 11, 2014, and is available on the WAMC website. The contents of this post are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Can Social Media Save Us from the “Spiral of Silence?”

by Karen Solomon, Bioethics Program Student

Studies suggest that, before the advent of the Internet, we are unlikely to share minority or unpopular viewpoints with our co-workers, friends and relatives. This inclination creates, in essence, a “Spiral of Silence.”

But does the Internet provide a remedy to the “Spiral of Silence,” by encouraging online discussion of viewpoints that may be unpopular? Contrary to the hopes of social media advocates, new research finds that social media may not provide a voice to those who feel uncomfortable expressing minority viewpoints in face-to-face relationships.

Scientists at the Pew Research Center surveyed 1801 adults regarding a political issue over which public opinion was divided: Edward Snowden’s leak of the US government’s extensive surveillance program. The survey examined three areas: subjects’ opinions about the leaks, subjects’ willingness to express their opinions about the leaks in both online and face-to-face contexts, and subjects’ perceptions of others’ opinions in online and face-to-face settings.

They found that those who were not comfortable discussing their opinion about the Snowden leaks in face-to-face discussions were also unwilling to use social media as an outlet to post their viewpoints. Among the 14% who would not discuss the leaks in face-to-face discussions, only 0.3% of these were willing to post their opinions on social media.

In fact, researchers found that the “Spiral of Silence” also applied to social media. Those on Facebook were twice as willing to share their views with their Facebook network when they believed their network was in agreement.

Several factors may explain our continued unwillingness to share controversial opinions, including concerns that online posts may be viewed by future employers or by those in authority. It could also be that social media users, exposed to a wide range of opinions via their social networks, are less willing to speak up because they are “especially tuned into” others’ opinions.

But what would it mean if use of social media does not provide a voice for discussing viewpoints we believe are unpopular? What if social media does not encourage more diverse outlooks on topics we care about? What if instead of encouraging discussions, it turns out that use of social media does the opposite and actually stifles expressing opinions our face-to-face interactions, even when we feel others would agree?

Social media is still relatively new, despite its far-reaching impact on how many of us communicate. If we accept that our willingness to share opinions and reactions to events and information is important to how we learn, understand, and think about what is important for us in managing work, school, and our relationships, then this study provides plenty of food for thought. Online learning is ever more important for higher education, which is increasingly provided online and integral to the training and education of professionals, including tomorrow’s bioethicists.

Discussions that nurture diversity of opinion foster sound ethical decision-making. Research into group decision-making cites diversity of opinion as an essential quality of “wise groups.” Diversity of opinion allows for the consideration of all relevant information, surmounting the “herd mentality” that can rob groups of their independence when tackling ethical dilemmas. Recognizing and addressing obstacles to deliberative decision-making is integral to the consistent application of ethical principles across domains, including social media and ethics blogs, discussion boards in online bioethics courses, and hospital ethics committee meetings.

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

The Boys in the Ban

by Sean Philpott-Jones, Director of the Center for Bioethics and Clinical Leadership

For over 30 years now, the United States Food and Drug Administration (FDA) has banned blood donations from gay and bisexual men. It is a lifetime ban. Currently, no man who has ever had sex with another man can donate blood in the US.

The same is true for tissue donations. Just last year, for example, the FDA refused to accept for donation the eyes of an Iowan teen after learning that the boy was gay. When 16-year-old Alexander Betts committed suicide after months of bullying at the hands of classmates because of his sexual orientation, just a few months after he signed up as an organ donor, his family honored one of his last wishes by donating his organs and tissues. But while his heart, lungs, kidneys and liver were used to save the lives of six other people, the donation of his eyes was rejected because “tissue from gay men carries an increased risk of sexually transmitted diseases, including HIV/AIDS.”

The ban on blood and tissue donation from gay men was put in place in 1983, shortly after HIV, the virus that causes AIDS, was first isolated. It made sense at that time. Along with other socially or economically marginalized groups like injection drug users and commercial sex workers, during the early years of the AIDS epidemic gay men were — and still are — at increased risk of acquiring HIV. Banning donations from groups who were more likely to be infected with the virus, particularly when there were no effective treatments, was a logical step to protect the blood supply from contamination with HIV.

This was in part because the first tests to detect the virus in the blood of infected individuals were notoriously inefficient. In fact, these first tests didn’t — and many modern HIV tests still don’t — test for the presence of the virus itself. Rather, they test for the presence of antibodies to HIV.

Antibodies are proteins produced after the immune system encounters a foreign body like a virus, a bacterium or an allergen. They specifically recognize and bind to these pathogens, hopefully neutralizing them before they can infect a person and cause disease. Most vaccines are designed to trigger an antibody response to common infectious agents, such as those cause measles, chicken pox or hepatitis, in order to protect people exposed to those diseases.

Unfortunately, the antibodies produced by the human body against HIV are not protective. But they are a marker that a person has been exposed to HIV, and likely been infected. But an antibody response to HIV can take days or even weeks to develop after infection. So tests that look only for the presence of antibodies to HIV can miss those individuals who are recently infected. If these people give blood in the interval between when they were infected and when they develop an antibody response to HIV, testing their blood will suggest that it is clean even though it may contain live virus that can be spread to transfusion recipients.

But as a team of researchers as Harvard Law School point out in a recent article in the Journal of the American Medical Association, times have changed. HIV testing technologies have dramatically improved in the three decades since the virus was found. Modern antibody tests are much more sensitive, detecting anti-HIV antibodies much earlier in the infection process. We also have inexpensive and reliable tests that look for the presence of the virus itself. Used in combination, these tests can determine if a person has been infected within just a couple of days of exposure. They are a quick, cost-effective and largely infallible way to screen the US blood supply.

Given this, it seems rather unconscionable that the FDA continues to maintain a lifetime ban on blood donations from gay men. This is particularly true when you consider that other groups at high risk for HIV do not face a similar ban. For example, the ban on blood donations from men who have had unprotected sex with women who are known to be HIV-positive is only one year in duration, not life. The same is true for women who have had sex with an HIV-positive male partner. So it’s not the gender of the infected partner that matters, only their sexual orientation.

Moreover, in countries that have lifted the lifetime ban on donations from men who have sex with men, no concomitant increase in the incidence of transfusion-acquired HIV has been seen.

Finally, in 2010 an FDA advisory committee concluded that the lifetime ban keeps many low-risk men from donating to the nation’s blood supply. But despite this, the committee voted to keep the ban in place.

So why does the lifetime ban on blood donations by gay and bisexual men? It is sexual behavior not sexual orientation that determines whether or not an individual is at increased risk of HIV. A promiscuous heterosexual college student is a far greater risk than a gay man who has been in a long-term monogamous relationship.

Quite simply, the ban is purely discriminatory in nature. It does little more than perpetuate outdated and homophobic stereotypes. It also contributes to widespread stigmatization of sexual minorities, leading to the open hostility and institutionalized violence that lead young men like Alexander Betts to end their lives.

We can do better. It’s time to end the lifetime ban on blood and tissue donation by gay and bisexual men.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on August 28, 2014, and is available on the WAMC website. The contents of this post are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

The Early Bird Get the Ethics?

by Karen Solomon, Bioethics Program Student

Does early to bed and early to rise, make a man healthy, wealthy and more ethical? Earlier research suggested a “morning morality effect”: that people are more ethical early in the morning, becoming less so as they “wear out as a day wears on.”

Not so fast, researchers now say. New research casts doubt on conceptions that night owls are less ethical than their early rising lark counterparts. Instead, a better predictor for ethical behavior takes into account the “fit” between one’s chronotype — night owl or morning lark — and the time of day when ethical behavior is implicated.

Consider the night owls who have more energy as the day wears on, with peak energy levels in the evening. Researchers postulated if internal body clocks supply the energy for ethical behavior, then the body clocks of night owls, people who have more energy as the day wears on, should overcome the morning morality effect, and demonstrate more ethical behavior in the evening.

To test this hypothesis, researchers asked participants to complete a matrix task or a die role and report the outcome, for the opportunity to earn a nominal monetary reward or tickets toward a raffle. What researchers evaluated, however, was the participant’s honesty in reporting the actual task outcome. Researchers found morning larks more likely to report task outcome honestly in the morning, during the larks’ peak energy hours. Conversely, night owls were more likely to behave ethically in the evening, confirming researchers’ belief that the fit between chronotype and time of day are better predictors of ethical behavior than chronotype alone. (Gunia, Barnes, & Sah, 2014)

Future research is needed to uncover the underlying mechanisms involved in the “chronotype morality effect” and the impact of interventions that boost the match or aggravate the mismatch between chronotype and time of day. However, these results clearly have broad implications, particularly for shiftwork in the workplace.

For example, understanding how body clocks inform ethical decision-making by health care professionals, particularly those involved with hospital emergency rooms and critical care units, may become a valuable tool in responding to the intense and often unpredictable nature of ethical dilemmas that characterize medical ethics. Such decision-making encompasses a range of highly personal and emotional health care decisions, including end-of-life care, organ donation, starting and stopping life-sustaining treatment, and informed consent. Such medical ethics decision-making also reflects the untimely nature of accidents, illness, and other tragedies.

In the future, health care administrators and professionals who understand the importance of aligning those involved with ethical decision-making with processes that take into account optimal times for ethical decision-making may provide the best opportunity for ethical decisions that stand the test of time. For example, scheduling ethics consultations and professional staffing consistent with optimal times for sound ethical decision-making may confirm the conventional wisdom that timing is, in fact, everything.

[The contents of this blog are solely the responsibility of the author and do not represent the views of the Bioethics Program or Union Graduate College.]

Taking the Icy Plunge (Or Not)

by Sean Philpott-Jones, Director of the Center for Bioethics and Clinical Leadership

There’s an epidemic that is sweeping this country. It’s not Ebola, despite all of the hype and misinformation about that disease that has dominated the news in the past two weeks. Rather, I’m talking about the ice bucket challenge.

Anyone who has watched television in the last couple of weeks has seen this: newscasters, celebrities and athletes like Matt Lauer, Martha Stewart and Nick Swisher being doused with a bucket of ice water in the name of charity. The goal of the ice bucket challenge is to raise money and awareness about amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease).

ALS is a neurodegenerative disease that affects nearly 30,000 Americans. It primarily affects people in their mid-40s to mid-60s, and is characterized by an increasing loss of motor function. Initial symptoms include muscle weakness or slurred speech. As the disease progresses these symptoms become increasingly pronounced. Patients with ALS gradually lose the ability to walk, speak, eat and (eventually) breathe. They slowly become prisoners in their own bodies, fully aware but trapped in an increasingly uncooperative shell.

The root cause of the disease is still unknown, and there is no known cure. Treatments can slow the onset of symptoms, but most patients succumb to the disease rather quickly. The majority of people living with ALS die within 3-5 years of their initial diagnosis, although there are notable exceptions like famed physicist Stephen Hawking, who has lived with the disease for over 50 years

The federal government spends about $60 million on ALS research. Private organizations like the ALS Association also spend money, both to develop new treatments and to provide care for those affected by the disease. As a non-profit organization, however, the ALS Association depends on contributions from people like you and me, and that’s where the ice bucket challenge comes in.

The challenge is simple. A person either donates $100 to the ALS Association or agrees to post a video of them getting doused with ice water on a social media site like Facebook (usually with a hash tag like #IceBucketChallenge or #StrikeOutALS). That person then challenges three of their friends to do the same: donate or get doused.

The campaign has been remarkably successful. In the past month, the ALS Association has raised over $1.5 million. Donations are up nearly a hundredfold since the campaign began. That’s a good thing, so what I’m about to say is likely to be surprising and even a little upsetting to some.

I think the ice bucket challenge is a crock, and I want no part of it. To all my friends who have called me out on Facebook to participate, my answer is ‘no’.

This isn’t to say that I don’t believe that ALS is a terrible disease. It is. I have seen the effects first hand, when the brother of a close friend contracted the disease. I have also donated to the ALS Association in memory of a former student’s father, who died from complications related to ALS last year

I am opposed to the ice bucket challenge for a number of reasons. First, I don’t believe that it does anything to raise awareness of ALS in the long term. Most of the videos that I have seen posted on Facebook, Vine and other social media sites say little to nothing about the disease and its impact on the families affected by ALS. They also don’t discuss why monetary donations are desperately needed, where to donate to, or how the money will be used.

Second, I have a real problem with a fundraising campaign in which public humiliation or exhibitionism seems to be the primary goal, with donations to a charitable cause an afterthought. Consider the rules of the ice bucket challenge: you either film yourself getting doused with ice water or you donate $100 to a charity. Charitable donations are the consolation prize in this extortive game.

In fact, what most people don’t realize is that the ice bucket challenge predates the ALS Association campaign. It was actually started as a game among pro athletes like golfer Greg Norman, with those who refused asked to donate to a charity of the challenger’s choice. The original challenge was never about raising money or awareness of a charitable cause, and now we have thousands or millions of Americans who feel like they’ve contributed to ALS research without actually doing anything.

If you want to help those living with ALS, dunking a bucket of cold water over your head is not the way to do it. Rather, you should visit the websites of organizations like the ALS Association and learn more about the disease. You should donate money to the cause and encourage your friends and family to do the same (without subjecting them to hypothermia). You should write your Congressional representatives and encourage them to increase funding for ALS research. Finally, you should consider donating your time to help those with the disease and their families.

Save the ice for your drinks.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on August 14, 2014, and is available on the WAMC website. The contents of this post are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]