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Jack Sisson's Life Ethics Blog

We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.


From The Hill:

Democrats in the House and Senate are looking to stop what they say are deceptive advertising practices by anti-abortion health clinics that imply they offer abortion services, but instead encourage birth and promote adoption.

The legislation is aimed at crisis pregnancy centers (CPCs), which are clinics often set up by a church or other anti-abortion groups. Democrats in Congress and other pro-abortion groups say these clinics are known to indicate they can perform abortions in order to attract pregnant women patients, and then try to convince them to carry their babies to term.

Rep. Carolyn Maloney (D-N.Y.), the House sponsor of the Stop Deceptive Advertising for Women's Services Act (H.R. 2030), said CPCs should not be allowed to deceive women who are seeking information about their pregnancy.

"Women shouldn't be deliberately misled or coerced when they seek legitimate medical services," she said when she introduced the bill last week. "While I will defend crisis centers' First Amendment rights even though I disagree with their view of abortion, those that practice bait-and-switch should be held accountable so that pregnant women are not deceived at an extremely vulnerable time in their lives."

Her bill would give the Federal Trade Commission the ability to investigate reports of misleading claims from CPCs, just as it can investigate other consumer products and services.

The bill is supported by the National Abortion Federation, whose president, Vicki Saporta, said that CPCs "have a long history of intentionally misleading women to prevent them from accessing abortion case."

Ilyse Hogue, the president of NARAL Pro-Choice America, added that she is "thrilled that Rep. Maloney is acting to hold these fake 'clinics' accountable."

Maloney's bill has 12 House co-sponsors, all Democrats, and Sen. Robert Menendez (D-N.J.) has introduced a companion bill in the Senate.

"No one should ever be subjected to misleading information when they are seeking health care, especially during pregnancy," Menendez said. "We have worked too hard to expand the availability of women's health care services to have any confusion created by those who would deliberately deceive a woman to suit their own purposes."

Link to The Hill.

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From Medical Daily:

Shocking statistics from Canadian researchers indicate that chronically homeless men who drink heavily have 400 times the number of head injuries as the general population.

What's more, the rate of traumatic brain injuries with internal bleeding is 300 times higher than among average Canadian men, and the rate of severe head injuries is 170 times as high.

In a study published in the Emergency Medicine Journal, researchers led by Dr. Tomislav Svoboda, of St. Michael's Hospital in Toronto, detail findings about head injuries in the general homeless population and among those who live in low-income housing.

"We were shocked by the number if [sic] head injuries," said Dr. Tomislav in a news release. "In medicine, we worry when something occurs two or three times more often in a particular patient group, but to talk about magnitudes of 300 or 400 is unheard of."

Analyzing Head Injury Rates Among Homeless Men
While previous research on head injuries among homeless people was based on interviews, Svoboda says this study is the first that is actually based on emergency department records, as well as the first to compare those patterns with data on the general population of securely housed people.

The researchers conducted a retrospective review of almost six years' worth of emergency department interview records from seven inner city Toronto hospitals, recruiting 170 men who agreed to have their records released.

The participants were split into three groups: those who were chronically homeless with drinking problems, those who were homeless but without drinking problems, and those in low-income housing.

They were all assessed for any instances of head injuries, from mild concussions to severe brain trauma.

The results showed that both the general homeless population and those living in low-income housing had about 23 times as many head injuries as securely housed people. Chronically drinking homeless people, in turn, had 17 times as many as than those groups-almost 400 times as many as the general population.

In addition, the more injuries homeless men with drinking problems had, the less time passed between their head injuries. The average amount of time between head injuries was 7.7 months, and that number decreased by about 12 days with each one.

The main predictors of having a head injury were previous head injuries, seizure disorders, or drug dependence.

Healthcare for Homeless People?
In the general Canadian population in Canada, about 12 in every 10,000 men might suffer a brain injury each year. Among chronically homeless people, that number shoots up to 4,800- almost half.

In a representative sample of homeless people last year, 53 percent had traumatic brain injuries in their lifetime.

It's unclear how prevalent head injuries are among homeless people in the United States, since previous studies had fairly small, non-representative sample sizes. In American samples with 60 or more members, however, anywhere from 20 to 47 percent of those surveyed had traumatic brain injuries.

Even with the most conservative estimates, this is likely to be a significant public health issue. According to estimates from the 2011 Annual Homeless Assessment Report to Congress from the United States Department of Housing and Urban Development, about 100,000 Americans were chronically homeless that year.

Homeless people are particularly vulnerable to head injuries, said Svoboda. Such injuries cause symptoms like dizziness, memory loss, impaired thinking, and mental illness, which lead to even more head injuries. In addition, homeless people are at higher risk of being assaulted.

"We need to do something for this group-we're seeing data that suggests they are in a downward spiral," said Dr. Svoboda.
He suggested that healthcare programs could help treat the persistence of head injuries, perhaps by performing CT scans on homeless people who might be at risk.

"When the brain is injured, you can't fix it," he added. "We need to identify and support these people."

Link to Medical Daily.

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From Time:

“Rock Hard” and similar so-called “natural” supplements for men often contain potentially dangerous drugs — some of which have never been tested on animals, let alone humans.

In an editorial published in JAMA Internal Medicine, Pieter Cohen, assistant professor of medicine at Harvard Medical School and a colleague collected some of the lesser known facts about an industry that produces millions of pills — and likely generates tens of millions, if not billions of dollars in profits— but is almost entirely free of government oversight.

Here’s what they found:

*  A product sold as “Rock Hard for Men” in 2012 turned out to contain not only counterfeit Cialis (tadalafil)— but also a diabetes drug that can be deadly if used incorrectly.  A similar combination killed more than a dozen men in Asia in 2009.

*  One Utah company alone produced more than a million pharmaceutically-tainted pills monthly, earning $2 million between 2007 and 2010, according to an indictment issued in one of the few cases brought against such manufacturers.

*  More than three-quarters of male enhancement supplements tested in one study in Singapore contained pharmaceuticals that were not disclosed— and half of them were present in higher doses than recommended.

*  Over 45 different versions of drugs in the same class of Viagra have now been found in male sexual supplements.  A Dutch study found that 75% of the products sold in the Netherlands contained at least one analogue, or chemical variant that has the same effect as Viagra.

* A product called “Mojo Nights” recently analyzed by the Food and Drug Administration (FDA) included not just counterfeit Viagra, but also three different analogue drugs.

* Just last week, the FDA identified three tainted supplements: “Vicerex” and “Bullet Proof,” which contain counterfeit Cialis and “Lightning ROD,” which includes an analogue of Viagra.

“We’re talking about a massive number of brands and millions of millions of pills that are tainted,” Cohen says. “Hundreds of millions of pills are being produced every month that are spiked with these prescription medications — and worse, entirely novel drugs.” The presence of the new medications is particularly concerning since there are no data to support their safety, much less their efficacy. And they are sometimes sold alongside legitimate supplements and over-the-counter medications, so consumers often assume they are safe and tested.

The products are typically manufactured in China and sold either online or in health food or convenience stores.  The FDA and Drug Enforcement Agency (DEA) have repeatedly attempted to crack down on “legal highs” that contain analogues of chemicals such as the active ingredient in marijuana — sold as Spice or K2 — or other substances marketed as “bath salts” for recreational use. But these agencies have taken little action against male sexual enhancement manufacturers and those who illegally include active drugs in what are supposed to be “natural” herbal products.“The number of people prosecuted for this is probably less than half a dozen and the number of criminals involved is countless,” Cohen says.

“It’s so common that the FDA has been testing these pretty regularly and has set up a consumer information page,” says David Kroll, a pharmacologist at the North Carolina Museum of Natural Sciences, who was not associated with the study, but has studied pharmaceutical contamination of herbal products.

Cohen urges men to simply avoid these supplements; if they contain inert ingredients, then consumers would be saving their money, but if they contain unknown drugs, they could be dangerous to people’s health. “The bottom line is that any product being sold as a natural product for male sexual enhancement should be avoided. No legal natural ingredients work and we’re seeing lots of dangerous chemicals and novel medications.”

To create these new drugs, illegal manufacturers apparently search patent applications and studies for analogue compounds that may have a similar, desired effect to the legal medication and then synthesize and sell them. Many of these agents that appear in the scientific literature may never have been studied in animal research, which makes them particularly hazardous. Some compounds may even have been abandoned for safety reasons by drug companies. And while some clearly are effective in producing arousal or sexual enhancement, their side effects are unknown.

“It’s as if they are just playing mad scientist and coming up with new chemicals and now jumping from that to popping them at pharmacological doses into these supposedly natural supplements,” Cohen says.

Such backyard drug makers might even be encouraged by the lack of enforcement of laws prohibiting improper marketing of pharmaceutical-grade agents. It’s illegal to sell prescription medications and untested compounds as herbal drugs, for example, but few are prosecuted for it. “I think it’s an enforcement issue,” he says, “The regulatory authorities are spread too thin.” He says that there are other barriers as well: those who market the products can claim that they did not know the illegal ingredients were present. “[Some] companies that import [these products] say, ‘it’s adulterated when we get it.’ I don’t know what to do about that.”

To fight the illegal market, Cohen proposes making the legal drugs easier to get. “I would be for Viagra being over-the-counter,” he says, “It’s tremendously safe if you know what you’re taking,” and are given information about risks.  He recommends that for now, doctors be more generous in prescribing them, given that the risks of unknown drugs at unknown doses are far greater. If the legal drugs are simpler and less embarrassing to access, he argues, the market for the illegal versions will diminish.

Pfizer has already moved in this direction, announcing that it will sell Viagra online, with a prescription, so consumers can avoid the embarrassment of picking the drug up at a pharmacy.  The company told the New York Times the decision was part of its efforts to fight counterfeit drugs.

As with the “legal high” market, the globalization of drug manufacturing and the anonymity and ubiquity of the internet are fueling the traffic in male enhancement pills, and generating a market for the more questionable manufacturers. But Cohen hopes the study will raise awareness of the dangers of leaving the industry with little oversight, and compel health experts and legislators to enhance their own performance when it comes to ensuring medications are safe and effective.

Link to Time.

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From The Herald in Monterey County:

Federal officials were skeptical two years ago when ProPublica asked them to release a database of prescriptions written in Medicare's landmark drug plan, known as Part D.

The data details the prescribing habits of more than 1 million doctors and other health professionals who treat Medicare patients. The Centers for Medicare and Medicaid Services had never allowed any outsider, let alone journalists, to have access to such records, which include identity codes for individual providers.

In the months that followed, ProPublica reporters argued that freeing this data could help patients assess the prescribing patterns of their health providers. The reporters pointed out that the stringent laws on the confidentiality of medical records were written to protect the privacy of patients, not doctors.

After months of high-level deliberation, CMS, to its credit, agreed to release the records — and to unveil one of medicine's biggest secrets.

In examining the data, our reporters found powerful indications that Medicare has not done all it could to oversee its drug plan.

Some of our nation's most vulnerable citizens rely on this program — the elderly and disabled. We found that some doctors were prescribing antipsychotic drugs to large numbers of seniors — an age group for which such medicines are particularly hazardous. Others were writing unusually high numbers of prescriptions for painkillers and other dangerous drugs. Reporters systematically examined these cases, interviewing the doctors about their prescribing decisions. In some cases, they could explain their conduct. In others, they could not.

They all had one thing in common: None of the doctors whose prescribing habits stood out in our analysis had ever been questioned by Medicare officials. Government overseers, our reporters found, didn't consider it their job to examine these patterns or act upon them.

The story we've published with The Washington Post is the first in a series that will delve into critical gaps in government oversight of public programs that annually spend billions of dollars in taxpayer money for prescription drugs. 

Officials at CMS, the agency that runs Medicare, contend the program is running smoothly. They have rebuffed calls by the Inspector General at the Department of Health and Human Services to tighten oversight of the drug program. Their own records offer a powerful rebuttal.

Beyond surfacing dangerous prescribing habits, the information we are making public with this story has the potential to change the doctor-patient relationship.

Until now, only insurance companies, government officials and pharmaceutical manufacturers have been able to track prescriptions written by individual doctors. Pharmaceutical companies have used such data to see how often doctors choose high-priced, name-brand drugs over generics, or pick one manufacturer's product over a competitor's.

The companies have bought this information from middlemen who collect it from pharmacies. Several years ago, ProPublica attempted to purchase this information from one of these companies. We were told it would not be available to us at any price.

The story and online news application, called Prescriber Checkup, put a significant chunk of that information in the hands of the public. You will be able to review the prescription patterns of nearly 350,000 Medicare providers, including the most prolific, and see how they compare to others in the same specialty.

Like all data, this information is just the starting point for a larger conversation. There are many reasons one health provider's prescribing patterns could vary from those of his or her peers. Doctors with sound approaches can stand apart if they have unusual patient populations, for example.

But the release of this information will give health professionals and patients new insights. A number of doctors we interviewed said they welcomed the chance to see where they stood.

Because this data is so potentially valuable to patients and doctors, we are making nearly all of it available immediately to researchers and the public on our website.

We expect that journalists, scholars and patients will find this information of use as the nation continues to debate the future of American health care.

Link to The Herald.

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From U.S. News and World Report:

Protecting our children should be our foremost concern when creating and implementing health policy. The first line of defense in protecting the health and safety of children is input and guidance from parents and doctors. The decision to allow unfettered access to the emergency contraceptive Plan B to girls as young as 15 shows an alarming lack of concern for the safety of young girls and the fundamental rights of parents.

There have been no studies on the safety of this high dose hormone on young girls. Additionally, to echo the concerns of Secretary of Health and Human Services Kathleen Sebelius and President Obama, there is good reason to believe that young girls do not understand that this drug is designed to be used only once per month and is not a substitute for oral contraception.

Finally, allowing Plan B to be available without a prescription distances those girls at highest risk for sexual abuse and sexually transmitted infections from the medical supervision they need. A 2010 study out of the United Kingdom shows a spike in the instances of sexual diseases among teens following the provision of Plan B over the counter.

The decision to exclude parents and doctors from dealing with the sexual behavior of underage girls and the administration of a serious drug is irresponsible and dangerous. Parents have every right to be informed and to consent to any decision affecting their child's health, education, or upbringing. Teenagers under the age of 17 cannot even be admitted to an R–rated movie and schools are required to obtain a parent's permission to administer any type of medication to a child or teen. Yet through this policy, the Food and Drug Administration inexplicably asserts that young teens should have access to a potentially dangerous drug without supervision of a parent or doctor.

Another of the most alarming aspects of this new policy is that Plan B will be available not behind a pharmacy counter, but rather on the store shelves where it can be picked up and purchased by anyone with identification stating that they are at least 15 years old. This is a flimsy protection, indeed. In order to fully protect the health of teens and rights of parents, the FDA's decision should be overturned.

America's girls and their parents deserve better than this ill-conceived plan.

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