Friday, December 13, 2013

Los Angeles to Regulate E-Cigarettes as Cigarettes

Back in November of 2011 I reported that a federal judge had blocked the FDA’s proposal to regulate e-cigarettes in the same way as drugs and drug delivery devices (this blog, Nov. 15, 2011). The judge’s argument was that if e-cigarettes are to be regulated at all, they should be regulated in the same way as cigarettes, not as drugs or drug delivery devices. The judge’s ruling effectively opened the way for the importation and sale of e-cigarettes in the U.S.

Two years later, the FDA is still not requiring that e-cigarettes be regulated as cigarettes. But there’s nothing from stopping states or even cities from doing so.

Last week Los Angeles did just that. The city council of Los Angeles voted unanimously to regulate e-cigarettes as cigarettes, with all the same restrictions on sale and use. The L.A. city council felt it was better to err on the side of caution, given that the health effects (if any) of e-cigarettes are not yet known and that e-cigarette use is on the rise among high school students.

E-cigarettes were developed primarily as a product that could help smokers quit smoking cigarettes, which we now know increases cancer risk. Their primary active ingredient is nicotine, which is supposed to satisfy the craving that cigarette smokers experience. However, the e-cigarette companies soon realized that young non-smokers might also be attracted to e-cigarettes, and they were right. Some people worry that e-cigarette use by teens who never smoked could lead to a whole new generation of people addicted to nicotine, even if they are unlikely to get lung cancer. And that’s probably not a good thing if it could be avoided.

Presumably, L.A.’s restrictions would not deter current smokers who wish to use e-cigarettes to quit smoking. They are already accustomed to the rules for cigarette use, such as minimum age for purchase and where cigarettes can be smoked).

Score one for the regulators - this time, at least. (See this blog Nov. 16, 2013).

Wednesday, December 11, 2013

The FDA Approves an Oral Medication for Hepatitis C

The FDA has just approved the first oral medication (a pill) for the treatment of hepatitis C.  Hepatitis C is a liver disease caused by a virus.   It is usually transmitted by direct blood-to-blood contact.  For a primer on hepatitis C, see the CDC’s “vital signs” on the subject.

Doctors will soon be recommending this new drug, called Sovaldi, to their patients with hepatitis C.  But here’s the catch; treatment with the pill is expected to cost $1,000 per day.  Since the drug is supposed to be taken for 12-24 weeks, a full course of treatment will cost $84,000 to $168,000!   The stockholders of Gilead Sciences, the medication’s manufacturer, hope the drug will earn big profits for the company.  There are approximately 150 million people with hepatitis C worldwide.  Stock analysts think that annual sales of the drug could top peak annual sales of the best-selling drug of all time, Lipitor.   Patient advocacy groups have voiced concern that some patients will not be able to afford the drug, but there’s not much they can do.  We can complain that pharmaceutical companies are greedy, but it’s not that simple.   They have huge development costs and they have a right to make a profit.

But as health care consumers, we do have choices.  If I had hepatitis C, before I opted for the new oral treatment over any other treatment option I’d try to compare convenience, cost, and effectiveness.   Granted, the oral pill will be more convenient than the current standard of treatment, which requires intravenous injections.  What’s the difference in cost, and could I afford it?   And most important, what’s the difference in effectiveness?  I wouldn’t pay a lot more simply for convenience or for a marginal difference in effectiveness, for example.  But that’s just me; you might make a different decision.

Monday, December 9, 2013

New Clues to Archaic Human Evolution

The evolutionary history of humans just gets more interesting every day.

Last month (see "How Many Species of Primitive Humans Were There?") I reported on an anatomical analysis of a series of archaic human skulls that challenged the “multiple species” theory of archaic human evolution. The authors of the study concluded that despite marked anatomical differences between the skulls, they could in fact all have belonged to one species.

New evidence using DNA analysis seems to support the notion of interrelatedness of seemingly distinct groups of archaic humans. The oldest sample of human DNA ever analyzed comes from a fossil of an ancient human ancestor who lived in Spain nearly 400,000 years ago. As expected, this DNA shares many features with the DNA of the Neanderthals who lived on the same continent. However (and surprisingly), it most closely resembles the DNA of a group of ancient humans called the Denisovans, who lived in Siberia nearly 4,000 miles away and more than 300,000 years later.

In light of the new DNA findings, scientists are going to have to think seriously about how far archaic humans might have traveled, and about how much they might have interbred when they came in contact with each other. If in fact they did come in contact with each other and interbreed, it may be time to consider that archaic humans all belonged to one species, and not the multiple species generally described by most paleoanthropologists.

Thursday, December 5, 2013

FDA Warns 23andMe

The FDA has sent a letter to a company called 23andMe, warning the company to stop selling its popular genome testing service to directly to consumers. For just $99, the company had been promising to analyze samples of saliva for nearly 300 different gene alleles, many of which are associated with increased risks of known genetic diseases.

People certainly have the right to their genetic information if they wish. The problem is that because the results could indicate that the person may be at an increased risk for specific genetic diseases, the results are more like medical tests than just interesting information, meant to satisfying ones curiosity. Any references to increased risks of genetic diseases associated with the results are tantamount to medical advice. The FDA is concerned that people may make medical or life-style decisions based on the unproven tests and unknown or inaccurate risk assessment. Risk of genetic disease, for example, may depend on family history and environmental factors, in addition to just the genetic component. Discussions of risk generally include a thorough medical history and discussion with a physician or genetic counselor, all of which are lacking when a test (and subsequent risk assessment) is done by mail order.

There are companies, such as, that offer to test your DNA so that you can trace your ethnic origins or potentially identify specific ancestors. That’s not an issue for the FDA because it is essentially for entertainment, not medical diagnosis.

Monday, December 2, 2013

The FDA Moves Closer to Banning Trans Fats

The popular press was full of reports last month that the Food and Drug Administration (FDA) is likely to ban trans fats as ingredients in foods.  What the FDA actually did was make a preliminary determination (yet to be finalized) that partially hydrogenated oils – a major source of trans fats in foods – are no longer “generally recognized as safe” (GRAS).  Practically speaking, that is close to banning them, since anything not GRAS would have to go through all kinds of testing (at great expense) to prove its safety before it could be marketed and sold.

Trans fats (including margarine and shortening) have been around for over 100 years.  Their popularity soared in the late 1900s when it was discovered that they improved the taste, texture, and shelf life of many foods, including French fries, donuts, pizza, and coffee creamer.  In the past several decades, however, scientific evidence has accumulated to show that trans fats are linked to an increased risk of heart disease.  As a result, many food manufacturers have already taken steps to eliminate trans fats from their products.  McDonald’s, for example, hasn’t cooked its French fries in trans fats in over 10 years.

According to the FDA, the average American consumer’s consumption of trans fats has already declined to less than a quarter of what it was just nine years ago.  The recent FDA ruling is just the final nail in the trans fat coffin.  Hopefully, trans fats will continue to be phased out, and consumption in the U.S. (and elsewhere) will continue to decline.

To learn more about some of the alternatives to trans fats in foods, click here.