Hormone Replacement Therapy Safer for Younger Women?

A best evidence review by Medscape indicates that "perspectives on hormone replacement therapy have undergone a dramatic change in the last decade, and current recommendations call for using hormone therapy at the lowest dose and shortest duration possible in order to treat menopausal symptoms. While many women have grown reticent to use hormone therapy even in the presence of severe menopausal symptoms, the current study suggests that the cardiac risk associated with hormone therapy may not be as significant among younger women." For the Medscape article, click here. (registration required). For the original article in the Journal of the American Medical Association (JAMA) that analyzes the longer term stats, click here.

Federal Guidelines for Newborn Screening of Genetic Disorders Recommended

From Science Daily (hat tip to James Hughes of IEET.org)

Most Babies Receive Recommended Newborn Tests, But Half A Million Still Not Screened For Serious Genetic Disorders

Science Daily - Nearly 90 percent of all babies born in the United States -- more than double the percentage in 2005 -- live in states that require screening for at least 21 life-threatening disorders, according to the latest March of Dimes Newborn Screening Report Card.

For the whole enchilada, click here.

Pharma Feeding Ads Directly to Consumer Debate

Should the Food & Drug Administration should be able to forbid companies from advertising directly to consumers until new drugs have been on the market for at least three years? Representative Henry Waxman says so -- from Business Week:

"If Representative Henry Waxman (D-Calif.) had his way, the little butterfly used to advertise the insomnia remedy Lunesta might not be allowed to flutter all over our TV screens, as it has incessantly since the drug was approved in late 2004. Waxman believes the U.S. Food & Drug Administration should be able to forbid companies from advertising directly to consumers until new drugs have been on the market for at least three years. He tried to mandate such a restriction by attaching it to a drug-safety bill. But on July 11 he came up short. After a debate centered on drug companies' right to free speech, the bill passed with virtually all restrictions on drug advertising stripped out.

The end of Waxman's proposal, however, may be the beginning of a fierce new debate over drug advertising..."

Access the rest of the article here.

Being without health insurance is no big deal --

From the NY Times today, an op-ed from Paul Krugman:
"Being without health insurance is no big deal. Just ask President Bush. “I mean, people have access to health care in America,” he said last week. “After all, you just go to an emergency room.”

This is what you might call callousness with consequences. The White House has announced that Mr. Bush will veto a bipartisan plan that would extend health insurance, and with it such essentials as regular checkups and preventive medical care, to an estimated 4.1 million currently uninsured children. After all, it’s not as if those kids really need insurance - they can just go to emergency rooms, right?

O.K., it’s not news that Mr. Bush has no empathy for people less fortunate than himself. But his willful ignorance here is part of a larger picture: by and large, opponents of universal health care paint a glowing portrait of the American system that bears as little resemblance to reality as the scare stories they tell about health care in France, Britain, and Canada.

The claim that the uninsured can get all the care they need in emergency rooms is just the beginning. Beyond that is the myth that Americans who are lucky enough to have insurance never face long waits for medical care.

Actually, the persistence of that myth puzzles me. I can understand how people like Mr. Bush or Fred Thompson, who declared recently that “the poorest Americans are getting far better service” than Canadians or the British, can wave away the desperation of uninsured Americans, who are often poor and voiceless. But how can they get away with pretending that insured Americans always get prompt care, when most of us can testify otherwise?

A recent article in Business Week put it bluntly: “In reality, both data and anecdotes show that the American people are already waiting as long or longer than patients living with universal health-care systems.”

The rest of article has been reprinted at the CommonsDreams.Org website.

Well said, Paul -- Anybody who has seen Sicko knows the movie starts out with the story of man who accidentally had two of his fingers lopped off and had to choose which finger to get sewn back on because he didn't have health insurance. But, what the hey, no big deal, right? -- Who needs fingers?

Merit-Based Payment of Pharmaceutical Treatments

Drug companies are beginning to putting their money where their mouths are — by offering a money-back guarantee. From the NY Times today:

"Johnson & Johnson has proposed that Britain’s national health service pay for the cancer drug Velcade, but only for people who benefit from the medicine, which can cost $48,000 a patient. The company would refund any money spent on patients whose tumors do not shrink sufficiently after a trial treatment.

The groundbreaking proposal, along with less radical pricing experiments in this country and overseas, may signal the pharmaceutical industry’s willingness to edge toward a new pay-for-performance paradigm — in which a drug’s price would be based on how well it worked, and might be adjusted up or down as new evidence came in.

“I think payers will say, ‘If the product works and it creates value, we will reward you for it,’ ” said Anthony Farino, a pharmaceutical industry consultant at PricewaterhouseCoopers. “ ‘If not, we won’t reward you.’ ”

It is far too soon to tell whether such a pricing paradigm can actually work, in particular because it can be difficult in many cases to measure how well a drug is working. And the approach would probably be most feasible in countries, like Britain, where the government is the primary payer."

Rest of the article here.

Ordering a Pizza in the 2012

Alright, so this is not strictly bioethics, but it is an amusing cautionary tale from the ACLU about guarding your privacy. Check it out -- and don't even think about ordering a double meat pizza.

The Holy Grail of Regenerative Medicine

Embryonic Stem Cells have been dubbed the "Holy Grail of Regenerative Medicine" because of their ability to give rise new tissue in every part of the body — from the liver to the heart to the bones and the brain. And scientists around the world are working to harness these incredibly potent and malleable cells to cure a wide variety of diseases -- ranging from growing whole new organs to replacing damaged brain cells.

In a paper published online Wednesday in the journal Nature, researchers at McMaster University say they have discovered that "stem cells have a far more complex relationship with the cells around them — and that knowledge could open up entirely new avenues of research....
Previous studies in mice have shown that various types of stem cells hole up in little nests of cells known as niches, and these niches are located in specific spots within various tissues..."

Rest of the article here.

[Editor's note, added July 17, 2007: In an exclusive interview with The UK Times, Japan’s leading genetics researcher, Shinya Yamanaka, claims it will could be only “a matter of months” from reaching the Holy Grail of biotechnology – producing an “ethical” human stem cell without using a human embryo, he has said. For the full article, click here.]

NIMBY (Not-In-My-Back-Yard) and Assisted Suicide

For nine years, the headquarters of Dignitas, the assisted-suicide organisation has been the centre of Switzerland's alleged "suicide tourism"; a total of 700 people have taken their lives here.The residents of the housing block where Dignitas is located have called for a halt to the practice of assisted suicide:

"Gloria Sonny, 55, who has lived in the building for six years - or, as she calls it, "under the same roof as death" - headed a petition calling for Dignitas to go. "I'm not against assisted suicide," she said, "but this is a place where people live. It's the wrong place to help people die. I don't see why I should pay with the quality of my life because Switzerland deals with the topic in a more liberal way than other countries."

She said the building smelt of death and that she suffered nightmares that she would be forced into one of the "death flats" against her will and made to drink a fatal cocktail."

To read on, click here.

Are We Alone?: Alternative Life in the Universe

Life with an alternative biochemistry to that of life on Earth may be possible elsewhere in the universe, according to a new report from the National Research Council. The report recommends that the search for extraterrestrial life be broadened to consider this possibility and recommends research and missions in which the federal government should invest to increase our knowledge in this area.

The committee that wrote the report found that the fundamental requirements for life as we generally know it -- a liquid water biosolvent, carbon-based metabolism, molecular system capable of evolution, and the ability to exchange energy with the environment -- are not the only ways to support phenomena recognized as life. "Our investigation made clear that life is possible in forms different than those on Earth," said committee chair John Baross, professor of oceanography at the University of Washington, Seattle.

The report emphasizes that "no discovery that we can make in our exploration of the solar system would have greater impact on our view of our position in the cosmos, or be more inspiring, than the discovery of an alien life form, even a primitive one. At the same time, it is clear that nothing would be more tragic in the American exploration of space than to encounter alien life without recognizing it."

The tacit assumption that alien life would utilize the same biochemical architecture as life on Earth does means that scientists have artificially limited the scope of their thinking as to where extraterrestrial life might be found, the report says. The assumption that life requires water, for example, has limited thinking about likely habitats on Mars to those places where liquid water is thought to be present or have once flowed, such as the deep subsurface. However, according to the committee, liquids such as ammonia or formamide could also work as biosolvents -- liquids that dissolve substances within an organism -- albeit through a different biochemistry. The recent evidence that liquid water-ammonia mixtures may exist in the interior of Saturn's moon Titan suggests that increased priority be given to a follow-on mission to probe Titan, a locale the committee considers the solar system's most likely home for weird life.

"It is critical to know what to look for in the search for life in the solar system," said Baross. "The search so far has focused on Earth-like life because that's all we know, but life that may have originated elsewhere could be unrecognizable compared with life here. Advances throughout the last decade in biology and biochemistry show that the basic requirements for life might not be as concrete as we thought."

Besides the possibility of alternative biosolvents, studies show that variations on some of the other basic tenets for life also might be able to support weird life. DNA on Earth works through the pairing of four chemical compounds called nucleotides, but experiments in synthetic biology have created structures with six or more nucleotides that can also encode genetic information and, potentially, support Darwinian evolution. Additionally, studies in chemistry show that an organism could utilize energy from alternative sources, such as through a reaction of sodium hydroxide and hydrochloric acid, meaning that such an organism could have an entirely non-carbon-based metabolism.

Researchers need to further explore variations of the requirements for life with particular emphasis on origin-of-life studies, which will help determine if life can exist without water or in environments where water is only present under extreme conditions, the report says. Most planets and moons in this solar system fall into one of these categories. Research should also focus on how organisms break down key elements, as even non-carbon-based life would need elements for energy, structure, and chemical reactions.

The report also stresses that the future search for alien life should not exclude additional research into terrestrial life. Through examination of extreme environments, such as deserts and deep under the oceans, studies have determined that life exists essentially anywhere water and a source of energy are found together on Earth. Field researchers should therefore seek out organisms with novel biochemistries and those that exist in areas where vital resources are scarce to better understand how life on Earth truly operates, the committee said. This improved understanding will contribute greatly toward seeking Earth-like life where the conditions necessary for its existence might be met, as in the case of subsurface Mars.

Space missions will need adjustment to increase the breadth of their search for life. Planned Mars missions, for example, should include instruments that detect components of light elements -- especially carbon, hydrogen, oxygen, phosphorous, and sulfur -- as well as simple organic functional groups and organic carbon. Recent evidence indicates that another moon of Saturn, Enceladus, has active water geysers, raising the prospect that habitable environments may exist there and greatly increasing the priority of additional studies of this body.

To read the full report or download the podcast, click here.

More on the Candidates Positions on Health Care

Considering that 45 million Americans do not have any health coverage and that 41% of adults are personally worried about health care or insurance costs, topping concerns about paying their rent or mortgage, being a victim of a terrorist attack or a violent crime, losing their job, or losing money in the stock market, and considering the popularity of the movie Sicko (which we've blogged about), it should come as no surprise that health care is a top domestic issue that the public wants presidential candidates to address, trailing only Iraq.

Recognizing the need to be fully informed and having the health care debate influenced by the public, two more informational articles and sites have popped today -- first, the Kaiser Family Foundation today launched a new website – health08.org – that will provide analysis of health policy issues, regular public opinion surveys, and news and video coverage from the campaign trail. Secondly, the New York Times has also compiled quotes and positions of all the candidates, and differs a bit than than the Huffington Post analysis mentioned in this blog earlier
-- I found it particularly interesting and encouraging that many of the candidates have held off on the details of their plans, citing that they want to hear from the public. After all, although it may not have felt much like it in the last few years, we do live in a democracy -- by the people, of the people, and for the people -- and our representatives are there to heed our voices, so make your voices known -- If this is important to you, let your representatives know!

Male Pregnancy Revisited...

The Empathy Belly is something couples rent so that the man can understand what the woman is going through when she's pregnant -- but Jen Graves want her partner, Patrick, to carry their child: "Scientists say it could be done. And my better half is the perfect candidate. All I have to do is convince him."

To read on, click here.

A Side by Side Comparison of the U.S. Presidential Candidates' Prescriptions for a Healthier Future

Finally, someone has done it: Prepared a Side by Side comparison, complete with charts and links, of the US presidential candidates positions on what to do about healthcare in the future. A hearty thank you to the Susan Blumenthal and her team at the Huffington Post for creating this helpful visual tool:

"The next president of the United States will confront major health policy decisions that will affect the lives of all Americans. With the first of the presidential caucuses and primaries only six months away, the pressure is on for the candidates to provide Americans with their plans to improve the nation's health care system -- and rightfully so. Despite spending over $2 trillion a year on health care -- 18% of the U.S. GDP and twice as much as any other nation -- the United States ranks only 45th in life expectancy and 37th in a World Health Organization study on the performance of national health systems." To read on, click here.

Considering that Michael Moore's film, Sicko, is emphasizing and bringing to public attention the advantages of a universal health care system, it will be interesting to see if any of these positions will change or be modified over the next few months.

Mom freezes her eggs as insurance policy for grandchildren

The annual meeting of ESHRE is taking place in Lyon France this week. Any time there is an annual meeting of fertility providers, there's bound to be a controvertial use of new reproductive technologies announced. The McGill Reproductive Center at Royal Victoria Hospital announced that they have frozen the eggs of a 35 year old woman. This wouldn't be newsworthy except that she did this to give her 7 year old daughter a chance of having a biologically related child one day. Her 7 year old daughter has Turner's Syndrome and will be infertile. If the girl actually does decide to use the eggs to have a child, biologically, it would be her half sibling. This isn't completely without precident. Women have already served as surrogate mothers, gestating their future grandchildren. Most psychologists are more comfortable with the mother in the giving role because "giving" has always been part of mothering. They tend to be less comfortable when a mother asks her teenaged (or older) daughter for eggs or to be a gestational carrier. The mother, in this case, insists that this is simply to give her daughter reproductive options when she grows up. Her child won't be pressured to use the eggs. Apparently, the announcement caused quite a stir in the audience, offending the Americans (go figure) while the Europeans seemed more comfortable with the idea.

The Good, the Bad, and the Silly: News about Chocolate

A research article in the Journal of the American Medical Association reported that dark chocolate is so rich in the class of biochemicals called flavonols that it actually produces favorable effects on the cardiovascular system. Just 30 calories worth -- about the size of a Hershey's Kiss -- not only helped lower blood pressure but raised levels of nitric oxide, which relaxed blood vessels.

The researchers emphasize that it's a small amount that they're talking about -- not enough to justify overindulgence.

And David Leibovitz (who is living the sweet life in Paris), thinks this was a just silly marketing strategy.

I say, let them eat chocolate!

The latest excuse: HIPAA made me do it!

Mark Rothstein, chair of a privacy committing advising HSS on HIPAA, said that unnecessary secrecy promoted by HIPAA is a "significant problem." "It’s drummed into them that there are rules they have to follow without any perspective," said Rothstein. "So, surprise, surprise, they approach it in a defensive, somewhat arbitrary and unreasonable way."

Susan McAndrew, of HSS, said "Either innocently or purposefully, entities often use this as an excuse. They say 'HIPAA made me do it' when, in fact, they chose for other reasons not to make the permitted disclosures."

Some dismaying examples:

-Birthday parties in nursing homes in New York and Arizona have been canceled for fear that revealing a resident’s date of birth could be a violation.

-Nurses in an emergency room at St. Elizabeth Health Center in Youngstown, Ohio, refused to telephone parents of ailing students themselves, insisting a friend do it, for fear of passing out confidential information, the hospital’s patient advocate said.

-State health departments throughout the country have been slowed in their efforts to create immunization registries for children, according to Dr. James J. Gibson, the director of disease control in South Carolina, because information from doctors no longer flows freely.

These cases were from a recent NY Times article, which also documented instances where adult children caring for elderly relatives were arbitrarily excluded from access to information in life-threatening situations.

Have we forgotten the old age "The road to hell is paved with good intentions?"

[Hat tip to HR Moody, thanks!]

Good Medical Care and Aging

Playing defense is a skill rewarded in sports, but not so much in health care. Instead, we prefer "victory" in our "battle" against cancer, heart disease, etc. Is that why it's so hard to recruit students for the geriatric health professions?

A recent study from the University of Cincinnati showed that the number of certified geriatricians in the U.S. has declined 19 percent over the past decade to 7,100. At the same time, every 8 seconds a Boomer turns age 60 and the number of Americans over 65 is expected to reach 70 million by the year 2030. Yet the U.S. certifies only 315 new geriatricians each year, not enough to replace those headed into retirement. As the New Yorker points out, we're in danger of lacking good medical care for the last stage of life:

"Good medical care can influence which direction a person's old age will take. Most of us in medicine, however, don't know how to think about decline. We're good at addressing specific, individual problems: colon cancer, high blood pressure, arthritic knees. Give us a disease, and we can do something about it. But give us an elderly woman with colon cancer, high blood pressure, arthritic knees, and various other ailments besides an elderly woman at risk of losing the life she enjoys and we are not sure what to do." To read more, click here.

[Hat tip to H.R. Moody for bringing our attention to this]

Preimplantation genetic diagnosis makes it harder to get pregnant

For some time now, women who are undergoing in vitro fertilization (IVF) procedures have had the option of using preimplantation genetic diagnosis (PGD) to screen for disease. To perform PGD, a single cell is taken from a three-day-old embryo and tested for known genetic conditions. Only those embryos that pass inspection would be implanted.

Some women who seek PGD have a family history of genetic conditions (such as Huntington disease) that they wish to avoid passing on. Others may simply figure that--since IVF procedures generally produce more embryos than will be implanted--they might as well choose the healthiest ones they can. Either way, the idea behind PGD is that it increases the odds of a woman having a healthy baby.

Turns out, however, that it may decrease the odds of a woman having a baby at all. A study published in the New England Journal of Medicine today reports that PGD reduces older women's (defined in the study as women age 35 to 41) chances of becoming pregnant by about one third. It isn't known why this happens. It had been believed that removing one cell didn't harm the embryo, but it looks like that may not be the case.

So--it might be the end of the road for PGD as a routine screening process for IVF patients. . . but stay tuned. At the very least, women who are heading down this road need to be fully informed about the possible risks and benefits of PGD before they decide to proceed with testing. . . or maybe even before they decide to pursue IVF.

New Focus on Easing the Pain

Only about a third of U.S. hospitals now offer some form of palliative care, so it was with significant interest that I read this article in Washington Post this morning:

Palliative Care Helps The Very Ill. It May Also Keep Costs Down

By Joanne Kenen

Special to The Washington Post
Tuesday, July 3, 2007; Page HE01

David Thibault grows orchids as a hobby, but the elegant flower on his bedside tray did little to lift his spirits. He stared out the window of his room at George Washington University Hospital, waiting for lab results that could tell him if he had months, weeks or maybe only days to live...
to read on, click here.

[Editor's note, added July 17, 2007 at 6:37pm] -- Diane Meier, Director of the Center to Advance Palliative Care at the Mount Sinai School of Medicine, explains on Medscape why she thinks that given the evolving demographics of our aging population, hospital palliative care programs are a necessity for every hospital, not just an option:

Advances in modern medicine have resulted in unprecedented gains in human longevity. But the fact is that eventually most adults will develop chronic illnesses with which they may live for years. Research indicates that for most people, advanced disease is characterized by big trouble: inadequately treated symptoms^[1-7]; fragmented care systems; poor communication among physicians, patients, and families^[8,9]; and enormous strains on family caregivers.^[10-13]

An artificial dichotomy still exists in the very fabric of our healthcare system -- cure vs comfort. This dichotomy ignores the fact that the overwhelming majority of people living with advanced illness require both life-prolonging and palliative treatments. Forcing a choice between cure and comfort until the end-of-life predictably results in preventable suffering during all other stages of a serious illness.^[14,15]

^{To read on, click here (registration required)}

Call for Papers

Special Issue of the International Journal of Feminist Approaches to Bioethics:
Transnational Dialogues in Feminist Bioethics

Guest-Edited by Arleen L. F. Salles and Constance Perry

Feminist thought has provided a fresh approach to the discussion of a broad range of issues in the health care context. Feminist bioethicists have reflected on the gendered, class, and racial aspects of euthanasia, resource allocation, the patient-physician relationship, and the use of biotechnology in healthcare. More recently, the debate has been enriched by the presence of feminist voices from different countries.

In this issue, the International Journal of Feminist Approaches to Feminist Bioethics seeks to encourage debate across national boundaries around issues in bioethics. We invite submissions that explore how differences between feminist thought in developing and developed countries can shape and contribute to the discussion of bioethical issues. Authors could choose to address this from a broad context or a specific issue of interest. We encourage collaborative submissions and papers and responses. The goal is to create a dialogue between diverse cultural, experiential, and national perspectives.

The deadline for submission is May 1, 2008. Papers should be no more than 8000 words. All submitted papers should be prepared for anonymous review, with any identifying references deleted. Authors should submit a separate title page, including contact information, as well as a statement that the paper has not been published previously and is not under consideration for publication elsewhere. Papers should include an abstract (under 250 words) and 3-5 key words. Papers should be submitted in Microsoft Word, as email attachments to Arleen L. F. Salles at sallesa@stjohns.edu or Constance Perry at cp28@drexel.edu

Sicko weekend continues...

The movie Sicko asks "Who are we?" - What kind of people force someone to make choice between body parts because they can’t pay their medical bills? Or choose to turn away when and do nothing when it has been documented that our country has among the worst infant mortality rates in a modern country? And racial disparities? And what does it say about us as a people when the prisoners enjoy a more meaningful right to health care than our 9/11 rescue workers? The tragedy is not that the prisoners get health care, but that our rescue workers don't; it says we don't value life or care to promote human dignity.

Mahatma Gandhi once said, "The best test of a civilized society is the way in which it treats its most vulnerable and weakest members"... by this measure, the United States does not do well, because we have chosen to allow the healthcare industry to become profiteering, no longer about serving, no longer about treating individuals with respect. Care about restoring human dignity? Let's make sure basic healthcare is a right, not a privilege -- This is an issue that cuts across party lines and affects all of us -- and it's time we let our government and our representatives know how we feel about this -- and that we will come out in droves and will vote our conscience. This is a major step towards restoring our national reputation as a caring and compassionate country.