Monday, November 23, 2015

First Uterus Transplant in the U.S.

If all goes according to plan, surgeons at the Cleveland Clinic will perform the first U.S. transplantation of a uterus within the next few months according to an article in The New York Times. Eight women are currently being evaluated as the possible first candidate for the procedure. All eight are women who were either born without a uterus, or whose uterus was surgically removed or damaged at some point.

Why hasn't it be done before, you might ask? The primary reason is that extensive and risky procedures such as organ transplants have traditionally been done only to save the life of the patient. But the women who want this uterine transplant are medically healthy, except for the inability to have the experience of having a baby. The procedure will be risky, both for the mother and the baby. The surgery itself will be extensive. And the mother will most likely have to take tissue rejection drugs throughout pregnancy, which could affect the fetus. In the worst case scenario, if the uterus is rejected during pregnancy, there goes the fetus as well.

I'm not against the procedure necessarily; if a woman wants to pay hundreds of thousands of dollars and take the risk, that would be her choice. What I am against is having uterine transplants become so routine that eventually you and I are asked to pay for them via health insurance. Let's face it, uterine transplantation would be a selfish act by an otherwise healthy woman who simply insists on experiencing pregnancy and childbirth. It has very little to do with wanting to raise a child; for that there is adoption, or surrogacy if the couple insists on raising a child with only their genes.

That's just my opinion. What's yours?

Thursday, November 19, 2015

China To Allow Two Children Per Couple

Back in 1979, China introduced a one-child-per-couple policy in order to curb what it saw as too high a rate of population growth. The country offered government subsidies for only the first child; levied fines for having more than one child; in some cases even resorted to sterilizations and forced abortions in an effort to enforce the rule. The policy was so effective that by 2000 the national fertility rate was only 1.5, well below the fertility rate of 2.1 at which a population stabilizes. Even worse, the policy has led to a newborn sex ratio of 116 boys to 100 girls; if they are only allowed to have one child, most Chinese couples would prefer that it be a boy.

In recent years China has begun to realize that the country will face a shortage of workers to support an aging population if current trends continued. In 2013 China relaxed the one-child policy somewhat by allowing people who were an only child to have a second child. And last month, China revised its policy to allow all couples to have two children, according to a CNN news article. However, it may be a case of too little, too late; even if the fertility rate does rise to 2.0 by 2050, the overall population will rise increase only 2% - hardly enough to take care of all those over-65 retired people.

One thing the new policy may do, however, is reverse the trend toward an over-abundance of male children. And that may ultimately improve marriage prospects for young Chinese males, who currently find it hard to find a suitable mate.

Monday, November 16, 2015

The First Amendment and Off-Label Drug Marketing

Should a pharmaceutical company be allowed to actively promote and market a drug for off-label (unapproved by the FDA) use? Consider, for example, a drug that lowers triglycerides, called Vascepta. The FDA has approved it only for patients with extremely high triglyceride levels, because in these patients the drug has been proven to lower the risk of heart disease. However, the drug is not approved for patients with "only" very high or high triglycerides, because there is no proof that it actually lowers the risk of heart disease in these patients.

Understandably, the drug company wants to sell the drug to as many patients as possible, and there are at least 10 times more patients with lesser elevations of triglycerides than there are patients with extremely high triglycerides. So the company sued the FDA, saying that under the First Amendment (freedom of speech), they have the right to promote the drug to patients as a triglyceride-lowering drug, even though there's no evidence that it would benefit them in terms of reducing the risk of heart disease. The FDA disagreed, arguing that under a 1962 law, drugs are only approved when they have been proven both safe and effective at reducing the risk of a medical relevant condition.

In August a federal District Court judge ruled that the drug company could promote the drug as a triglyceride-lowering agent because it's a true statement, and therefore is protected by the First Amendment. Requiring additional evidence of clinical effectiveness, according to the judge, would be suppression of free speech. The ruling in effect ties the FDA's hands in terms of requiring that drugs actually do something important before they can be marketed.

If the court ruling stands, we may be entering an era where drugs are promoted directly to the public because they do something measurable (in this case, lower triglycerides), without evidence that they are clinically effective (in this case, reduce the risk of heart disease). Rest assured that in their marketing campaigns, the drug companies will do everything in their power to imply that their drugs do something useful, without actually saying it. Even though we might agree that protection of free speech is important, is this truly in the public's best interest?

It's not clear whether the FDA will appeal the ruling to the Supreme Court, but this one is worth watching.

Sunday, November 8, 2015

Mortality Trends in the United States, 1969-2013

For all the money spent on health care research, are we making any progress towards reducing mortality from some of the major health problems? Where might more research be needed?

To find out, researchers affiliated with the American Cancer Society analyzed trends in age-standardized mortality rates from 1969 through 2013 for six major killers; heart disease, cancer, stroke, chronic obstructive pulmonary disease (COPD), unintentional injuries, and diabetes mellitus. ("Age-standardized" mortality rates take into account the changing age structure of a population over time.)

The data show that we are indeed making progress overall. From 1969 to 2013 the overall age-standardized death rate per 100,000 fell from 1278.8 to 729.8; a decline of 43%. For specific conditions, the mortality rate from stroke declined 77%; from heart disease 68%; from unintentional injuries 40%; from cancer 18%; and from diabetes mellitus 16%. However, the change in mortality rate from COPD was a real shock; it increased over 100% over the same time period.

The 100% increase in COPD is troubling, but this research doesn't provide any answers regarding the reason. One possibility is that we may be seeing the delayed consequences of the much higher popularity of smoking in past decades. But that's a question that would need to be examined by further research.

Tuesday, November 3, 2015

23andme Gains FDA Approval

Remember 23andme, the genetic testing company that got chastised by the FDA for providing what the FDA called a "medical device" without the proper documentation? (See this blog, Dec. 5, 2013.) Well, they're back in action again, this time with FDA approval.

Back in 2013, 23andme was offering to analyze samples of saliva and provide "health reports on 254 diseases and conditions" for just $99. The sticking point for the FDA was that the company was providing estimates of a person's risk for developing various genetic diseases and conditions, such as Alzheimer's disease; information that the FDA said was tantamount to offering a medical device without proof of the accuracy of the risk estimates the device provided. The company was ordered to stop providing risk estimates until proof of their accuracy was provided.

Against what seemed like formidable odds, the company stayed in business, providing information on ancestry instead. And they went to work to satisfy certain requirements of the FDA. Now they're back, this time providing information that IS acceptable to the FDA. For just $199 (notice that the price has doubled!) the company now provides basic information about a person's genetic "carrier" status for just 36 conditions, including cystic fibrosis and sickle cell anemia. While that may not seem like much, such information could be useful to prospective parents who want to know their chances of passing these genetic mutations on to their children before they make the decision to have children.

The company says that they still hope to provide accurate, defensible personal risk information for certain diseases (such as the risk of developing Alzheimer's disease later in life) in the future. And who knows, maybe they will. I didn't think the company would ever survive the debacle of 2013, but they did.

Sunday, November 1, 2015

New American Cancer Society Guidelines for Mammograms

The American Cancer Society, which traditionally has taken an aggressive position towards screening for breast cancer, has softened its stance on the need for mammograms to detect breast cancer. The new guidelines are published in the Oct. 20 issue of JAMA, along with an editorial summarizing the new recommendations.

Previously, the cancer society had been recommending yearly mammograms after the age of 40. The new guidelines recommend that women have annual mammograms starting at the age of 45, and then only every other year after the age of 54 provided that they are healthy and not at high risk of breast cancer. That brings the cancer society's recommendations more in line with the United States Preventive Services Task Force (USPSTF), which recommends biennial mammograms only after the age of 50. In addition, the ACA no longer recommends clinical manual breast exams (in which the health care provider feels for lumps) at any age.

The new guidelines reflect the latest scientific evidence that annual mammograms are not very useful in younger women and that they can result in false positive results, leading to unnecessary additional tests, including biopsies. However, don't expect physicians or patients (who've been conditioned for decades to fear cancer and to take any possible action against it) to immediately accept the new guidelines. There will still be those who take a "better safe than sorry" approach and continue with their yearly mammograms.

Wednesday, October 21, 2015

Natural Defenses Against Cancer

We now know that cancer is a disease of a loss of control over cell division. A commonly-held belief is that larger animals such as humans (with more cells and hence more cell divisions) and animals that live a long time (with more opportunity for cell damage to occur over time) should be more prone to cancer than smaller, short-lived animals.

A recent study shows that the size-and-time belief is incorrect. In a study of 36 mammalian species, the authors found no evidence of increased incidence of cancer in larger or longer-lived animals. Elephants live much longer than humans and have many more cells, but fewer than 5% die of cancer, compared to a cancer death rate of 11-25% in humans. And a particular strain of rat called the naked mole rat lives up to 30 years - much longer than other rats - without being prone to cancer. So the question becomes, why is that?

It turns out that nature has developed defenses against cancer. During evolution, elephants developed extra copies of a cancer-fighting gene called p53. (Humans have one copy; elephants have more than 20.) The p53 gene causes damaged cells to commit suicide, effectively preventing them from becoming cancerous. The naked mole rat developed a protein that blocks the growth of fast-dividing (potentially cancerous) cells.

Researching the natural defenses against cancer in other long-lived or large animals might help us better understand how cancer develops in humans and how best to fight it.