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.

Thursday, October 15, 2015

Express Scripts Will Cover the Newest (Expensive) Cholesterol-Lowering Drugs

 I posted a blog recently about the two newest cholesterol-lowering drugs, made by Amgen and Sanofi SA (See this blog, Oct. 6, 2015). The new drugs will be very expensive; approximately $14,000 per year, compared to just a few dollars a month for the statins. I raised the question about whether insurers should cover the new drugs just because patients say they want them.

When the prices of the new drugs were announced, it seemed that the intent was to limit the use of the drugs to those patients who couldn't achieve adequate cholesterol reduction with the statins. According to FoxNews, insurers planned to "aggressively challenge" claims of statin intolerance before agreeing to pay for them. But how will insurers respond when physicians write prescriptions for the new drugs for their patients? I'm betting that patients will demand the new drugs once the drug companies start their ad campaigns, and that insurers will be pressured into paying the exorbitant bill.

At least one pharmacy benefits management company, Express Scripts, has included the new drugs in its 2016 list of approved drugs, but the company added that there would be "restrictions" on who could use them. Good luck with that! It will be interesting to see whether they actually do manage to restrict their use, or whether the costs to insurers will spiral out of control.

If you think it doesn't matter, consider this; high health insurance expenses by other insured individuals ultimately affects your insurance rates.

Monday, October 12, 2015

Governor Brown Signs California's Death with Dignity Bill

Last week California governor Jerry Brown signed the state's death with dignity bill, known officially as the End Of Life Option Act. The bill, inspired by the plight of Californian Brittany Maynard who had to move to Oregon to take advantage of a similar law there, will take effect next year. In a statement made after the signing, governor Brown said, "I do not know what I would do if I were dying in prolonged and excruciating pain. I am certain, however, that it would be a comfort to be able to consider the options afforded by this bill." Governor Brown consulted with doctors and a Catholic bishop before he made his decision to sign the bill.

Opponents of the bill have already begun efforts to have the bill repealed. They'll have an uphill battle; a recent poll showed that 65% of Californians approve of the bill, while only 27% oppose it.

Saturday, October 10, 2015

Do Some People Have a "WiFi Allergy"?

Is it possible for people to have an allergy, or at least an adverse reaction of some kind, to WiFi transmissions? Some people think so. They claim that their symptoms of headaches, itchy skin, a rash, heart palpitations and nausea are caused by what they call an "electromagnetic hypersensitivity" (abbreviated EHS; doesn't every disease have a three-letter designation these days?), which can be triggered by wireless Internet service transmissions. One couple has even sued their son's school, claiming that EHS is a disability and that the school must change their WiFi system to accommodate him.

It turns out that many cases of EHS are self-diagnosed. The condition is not a recognized medical diagnosis by any authoritative medical body. Although no one denies that some people experience symptoms, it appears that the symptoms result more from what is called a "nocebo effect" - the tendency for someone to feel unwell when they think they have been exposed to something hazardous. In a review published in 2010 of 46 published blind or double-blind studies, involving over 1,000 people who self-diagnosed themselves has having EHS, it was found that reactions similar to EHS were elicited when the persons thought they were being exposed but were not. In other words, the symptoms in these patients are most likely due to psychological factors.

Nevertheless, some people continue to push for EHS to be declared a disability, entitling them to the accommodation that such a declaration would allow. Let's hope they don't succeed.