Recalled Dietary Supplements Return to the Shelves

Unlike pharmaceutical drugs, dietary supplements do not have to be proven safe and effective before they can be sold. All the FDA can do is to force specific products to be pulled from store shelves (recalled) after it receives complaints about the product's safety.

A study published in JAMA shows how ineffective the FDA's recall power really is. The authors of the study examined 27 dietary supplement products that had been recalled by the FDA. Some of the products were recalled for containing anabolic steroids or prescription drugs such as Viagra and Prozac. Several weight-loss products contained an amphetamine-like drug not approved in the U.S. The authors found that within an average of three years after recall, approximately 2/3 of the products were being sold again - under the same name and with the same ingredients. Even the manufacturers and distributors were the same! Most of the manufacturers are U.S.-based.

Why can't the FDA put a stop to this? In part, their hands are tied because dietary supplement manufacturers have the right to sell their products without any proof that they are safe and effective. Tainted products are only identified after they have hit store shelves and after complaints are received. And even then, recall can be difficult because many of these products are sold over the internet from unknown physical addresses.

Until the dietary supplements regulatory environment changes and the FDA is given more power to punish unscrupulous companies, it remains "buyer beware" when it comes to dietary supplements. Unfortunately for us, the authors did not name the manufacturers, distributors, or products in their study. That's a shame.

Canada Opens First Carbon Capture Power Plant

Canada recently completed the first commercial-scale coal-fired power plant designed to capture and sequester greenhouse gases. The plant will capture around 90% of the CO2 that the plant generates - about a million tons a year. The CO2 will either be sold to a nearby oil company to enhance oil production or buried deep underground.

The new plant, called Boundary Dam, demonstrates that it is possible to burn coal without damaging the environment in the process. But don't expect the more than 1,000 coal-fired power plants in the planning stages worldwide (most of them in China) to adapt the technology any time soon. The technology is economically feasible at the Boundary Dam plant because the plant received substantial subsidies from the Canadian government and because the plant is located in an area in which the CO2 could be sold to oil producers, who use the CO2 to enhance oil production.

And there's the irony. Some of the CO2 not released into the atmosphere by the coal-fired power plant will be used to enhance the production of oil, which of course is also a fossil fuel that releases CO2 when it is burned. I suppose there's still a net reduction in CO2 released into the atmosphere, but it's not the full million tons a year.

Another Artificial Sweetener

There's a new artificial sweetener about to hit the market that's more than 30 times sweeter than saccharine (Sweet-n-Low), aspartame (Nutrasweet and Equal), or sucralose (Splenda). The new sweetener, called advantame (it does not have a catchy brand name yet), is made by Ajinomoto, a Japanese company.

Although it's entering a crowded and competitive field, Advantame will probably find a niche in the marketplace because it doesn't break down as readily as other sweeteners under heat. That means that it'll probably become the artificial sweetener of choice in baked goods.

The FDA approved the new sweetener in May. It's not clear how long it'll be before it's found in the products you buy.

Antibiotic Use in Farm Animals is Still Increasing

According to an FDA report issued recently, the amount of antibiotics sold for use in food-producing animals increased 16% between 2009 and 2012.   The use of cephalosporins, a class of antibiotics widely used in humans, increased by a whopping 37% over the same time period.   Health officials, of course, are worried that the overuse of antibiotics leads to the rise of antibiotic-resistant strains of bacteria, threatening human health.

The FDA issued new guidelines in 2013 that are meant to restrict the use of antibiotics in food-producing animals, but it's too early to tell whether they will work.   Basically, the new rules prohibit the use of antibiotics in healthy animals for the sole purpose of increasing weight gain.  Instead, antibiotics may used only in sick animals to treat disease, and only when prescribed by a veterinarian.  The new rules will take effect over the next three years.

Ranchers know that antibiotics cause even healthy animals to gain weight.   That means that ranchers have a big financial incentive to use antibiotics indiscriminately, and veterinarians who work in farm communities will have a financial incentive to write the prescriptions.  The FDA is trying to (gently) nudge the livestock production industry toward practices that are better for society as a whole, but not for the food-producing industry.  So you think the new rules will reduce antibiotic use in food-producing animals very much?  If they don't, what would you suggest we do next?

FDA Approves Home Test for Colon Cancer

The FDA has approved a new home test for colon cancer. The new test, called "Cologuard", tests not only for hidden blood in the stool, but also for changes to DNA that may signal the presence of colon cancer.

Current recommendations by the U.S. Preventive Services Task Force for screening for colon cancer are that persons aged 50-75 should have an occult blood test every year and a colonoscopy every 10 years. Whether the Task Force will include Cologuard as an option in future recommendations is unknown. Nor is it clear yet whether Medicare or most insurance companies will pay for the test. That's critical to its acceptance because Cologuard costs nearly $600; much more than the standard occult blood test.

With any test, it's important to consider how accurate the test is. Cologuard appears to be better than the occult blood test at detecting cancers when they are present (92% of cancers detected, versus 74% for the occult blood test). However, Cologuard also has a higher "false positive" rate (reporting that cancer may be present when in fact it is not) of 13% versus 5% for the occult blood test. A positive result with Cologuard should be followed up with a colonoscopy, just to be sure.

Cologuard isn't perfect. But if it is used by people who refuse to go to the doctor for a blood test or especially for a colonoscopy, then it will serve a purpose.

First U.S. Ebola Case

A man who traveled to the U.S. from Liberia via Europe is now the first person to be diagnosed with Ebola while within the U.S. At least one of the major news services is giving this one "event" continuous coverage all day, which of course raises our fear level; it makes it sound like this one case of Ebola could lead to an epidemic in this country.

Nothing could be further from the truth. According to the CDC, Ebola is transmitted primarily in bodily fluids such as urine, saliva, or blood. In addition, Ebola patients can only infect others when they are actually sick - not before and not after. The patient in question didn't feel sick until several days after he arrived in the U.S. And four days after he began to feel sick, he was isolated in a hospital prepared to deal with diseases such as this. That means, for example, that he did not infect anyone on his incoming transatlantic flight, and he's probably not going to infect anyone else after the time he was hospitalized. At most, he could have infected some of the people with whom he had close contact in the four days during which he felt sick before he was hospitalized.

Public health officials certainly have their hands full finding all the people with whom the Ebola patient had direct contact, and monitoring them for 21 days. Surveillance is tedious, but it works. So relax; at least one expert doesn't think an Ebola epidemic is likely in this country. Ebola is just not transmitted easily enough.

Sensationalism sells. But the news services should dial back their continuous coverage of what is probably a non-event.