Tuesday, May 24, 2016

The 'Textalyzer' Can Prove You're Texting While Driving

It's illegal to text while driving in nearly all states now. But people do it anyway, perhaps because they think the likelihood of getting caught is slim, and perhaps because in some states its still a relatively minor infraction.

If you drive and text, you should know that the likelihood of getting caught and punished may soon go up. That's because now there's a device called a 'textalyzer' that can test your phone for recent use. In addition, the state of New York is now considering a bill that would put the offense of texting-while-driving on a par with driving-while-drunk.

The textalyzer is a product of Cellebrite, an Israeli company that is a leader in "mobile device forensic solutions". The textalyzer is a portable device that can 'read' your phone to tell exactly when it has been in use. The device could provide detailed information down to the level of content of the text itself, but for reasons of privacy its use will probably be restricted to just determining the precise timing of the phone's use. In an accident investigation, that would be enough for a conviction.

New York may be the first state to use the textalyzer to tell if drivers have been texting while driving and to establish stiff penalties for the offense. If they're successful you can expect other states to follow suit.

Tuesday, May 17, 2016

Do NSAIDs Speed the Rate of Healing of Tendinitis?

Many athletes routinely use nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen and ibuprofen to blunt pain and hopefully shorten the recovery time from acute tendon injuries, called tendinitis. But are the NSAIDs really helpful other than that they blunt the pain? Do they speed the healing process?

Apparently not, according to an editorial in the British Journal of Sports Medicine. For starters, tendinitis is actually a misnomer; "-itis" means inflammation, and researchers have found that although tendon injury generally is characterized by pain and swelling, it is actually not accompanied by the appearance of the immune cells normally associated with inflammation. Therefore, what we tend to call tendinitis should probably be called tendinopathy ("-pathy" means injury). And while the NSAIDs do block the pain associated with tendinopathy, they also inhibit the release of prostaglandins which are normally involved in the production of collagen, thought to be necessary for tendon repair. So if anything, NSAIDs are more likely to slow the healing process than speed it up.

So, what to do? It's probably okay to take NSAIDs over the short-term (up to a week) to relieve acute pain. In the long term, gentle stretching and light weight-bearing exercise of the injured tendon will do more good than continued use of NSAIDs. Consult your doctor or physical therapist for the final word on your particular situation.

Wednesday, May 11, 2016

The FDA Bans E-Cigarette Sales to Minors

Last week the U.S. Food and Drug Administration (FDA) finalized new rules that lump e-cigarettes in with tobacco products, in effect giving the FDA full regulatory authority over e-cigarettes. As a consequence of that change, sales of e-cigarettes to persons under the age of 18 will now be banned. The new rules take effect in 90 days.

E-cigarettes don't contain tobacco. Nevertheless, health authorities have long argued that because they contain nicotine and other toxins they are not completely safe, and in any case they should not be available to children. Calling e-cigarettes tobacco products for purposes of regulation was an interesting move, because in addition to the ban on the sale of e-cigarettes to minors, it means that manufacturers will be prevented from making misleading claims about their products and will need to disclose all ingredients to the FDA.

E-cigarette use among persons under 18 has risen dramatically in the past few years. Over the same time period the use of tobacco cigarettes by persons under 18 has declined slightly. Cause-and-effect? No one knows for sure, but there is some tantalizing evidence to suggest that it might be. One study reports that there was a small but statistically increase in smoking among underage teens in states that banned e-cigarette sales to minors, compared to states that have not banned e-cigarettes.

So, are e-cigarettes a good thing, or a bad thing? If they help current smokers to quit and/or reduce the rate at which young people begin smoking, that would be good. If they lead to a whole new generation of nicotine addicts or if we find that e-cigarettes' other ingredients are harmful to human health, that would be bad. It may be a few more decades before we know for sure

Wednesday, May 4, 2016

Stent Retrievers Improve the Odds of Recovery From a Stroke

A device called a stent retriever can improve the odds of recovery from an ischemic stroke, brought on by a clot that blocks blood flow in an artery in the brain. The stent retriever is a tube-shaped wire mesh device similar to the stents that are used to open blocked arteries in the heart. In the case of a stroke, however, the device is inserted into the blocked artery in the brain, where it enmeshes and entraps the clot so that it can be pulled out.

Stent retrievers (and the surgeons trained to use them) have been available for a while now in hospitals with state-of-the-the art endovascular treatment units. Generally that does not include your local clinic or small hospital; more likely it's a large regional hospitals. That may prove to be important, because new findings show that the stent retriever technique is highly effective IF it is done soon after the stroke. Using "functional independence" as the definition of recovery from a stroke, 91% of stroke patients recover if the stent retriever technique is performed within 2 1/2 hours of the onset of stroke symptoms. However, recovery percentages decline rapidly if treatment is delayed. The recovery percentage declines an additional 10% if treatment is delayed another hour, and another 20% for each additional hour after that. By 5 1/2 hours after the stroke, recovery after the stent retrieval procedure is only about 40%.

Stent retrievers are shaping up to be a lifesaver for stroke victims with quick access to a well-equipped health care center. But burn this into your brain; in the case of a stroke, getting to treatment (any treatment) quickly is absolutely essential. Like the stent retrieval procedure, clot-dissolving drugs also are more effective when they are administered soon after a stroke.

Monday, May 2, 2016

First Child Born Without Kidneys

The first child ever to survive a condition called bilateral renal agenesis (the failure of kidneys to develop in the fetus) will be three years old this July. Young Abigail Beutler is the daughter of Congresswoman Jaime Herrera-Beutler from Washington state and her husband, Dan.

Bilateral renal agenesis occurs in about 1 in 5,000 pregnancies. In the past, such fetuses always died before birth. That's because the urine produced by the fetus's kidneys is the source of most of the amniotic fluid that bathes a fetus; without adequate amniotic fluid, the fetus's lungs fail to develop normally. Representative Herrera-Beutler's fetus (the future Abigail) was kept alive during gestation by an experimental procedure in which Rep. Herrera-Beutler received intra-abdominal injections of saline throughout late pregnancy, simulating amniotic fluid. The technique worked, and Abigail was born successfully on July 15, 2013.

But that was only the beginning of young Abigail's survival story. Because she was born without kidneys, she was on dialysis from birth until she was old enough for a kidney transplant. Fortunately, both of her parents were good matches for the transplant. On Feb. 8 of this year when she was 2 1/2 years old, Abigail received one of her father's kidneys. Both father and daughter are doing well.

Call it yet another lifesaving advance in medicine. We can probably expect the saline injection technique used in this case to become the standard treatment for fetuses diagnosed with bilateral renal agenesis.

Thursday, April 28, 2016

Whatevever Happened to Filbanserin, the "Female Viagra" Drug?

Last year we were talking about a new libido drug for women, called filbanserin (see this blog, July 2, 2015.). The drug was supposed to improve women's sex lives, giving them the same options men have had for years with Cialis and Viagra. The drug was poised for approval by the FDA, even though there were concerns that it wasn't very effective. Whatever happened to it?

The story of filbanserin (trade name Addyi) is one of hype, greed, and mismanagement. filbanserin was originally under development as a drug to treat depression. Then it was discovered that it seemed to improve some women's satisfaction with their sex lives. Sensing that there might be a really big market for the drug, a small company called Sprout Pharmaceuticals bought the rights to the drug. Twice they tried get it approved by the FDA. When filbanserin was finally approved last August, the company's sales force of 14 national/regional sales managers and 150 sales representatives was all set to promote and sell the drug.

But just one day after FDA's approval of filbanserin, Sprout Pharmaceuticals was bought by an even bigger pharmaceutical company, Valeant Pharmaceuticals for (wait for it...) a whopping $1 billion. (Big fish swallows helpless little fish.) Valeant was making a name for itself on Wall Street by buying up other smaller pharmaceutical companies with patented drugs and immediately raising the drugs' prices. Yes, that's the same Valeant Pharmaceuticals that is now under federal investigation for predatory drug pricing practices.

Valeant's stock price has plummeted 85% since last year. As part of its efforts to save itself, Valeant dismissed the entire Sprout Pharmaceuticals sales force and shelved all plans to sell the drug, saying they might reintroduce the drug later this year. We'll see.

Only a few thousand prescriptions for the drug were ever written. Forget about it: it wasn't a very effective drug anyway.

Monday, April 25, 2016

Determining Who Can't Tolerate Statins

For years now, a class of drugs called statins have been the treatment of choice for lowering LDL cholesterol levels. They're cheap (pennies a day), effective, and safe. The problem is that 5-20% of patients say they can't tolerate the statins because of muscle-related side effects, including muscle pain and weakness.

A new class of class cholesterol-lowering drugs, called PCSK-9 inhibitors, avoids the muscle-related side effects. However, the big downside to the PCSK-9 inhibitors is that they are very expensive - approximately $14,000 a year. For that reason, insurance companies would like the PCSK-9 inhibitors to be used only by the few people who are truly intolerant of the statins. But how is intolerance to the statins to be defined, other than by the patients and their physicians?

A recent study showed how big a problem this is. Researchers wanted to explore the effectiveness of several newer LDL cholesterol-lowering drugs in statin-intolerant patients with very high cholesterol levels. To find such patients, they recruited more than 500 patients who had tried two or more statins and claimed that they could not tolerate them because of muscle pain or weakness. The patients were randomly assigned to take a statin (atorvastatin) or a placebo for ten weeks. Then the drugs were switched for an additional 10 weeks. It turned out that only 43% of the patients could be defined as statin-intolerant; that is, they reported muscle-related symptoms while they were on the statins but not while they were on the placebo. 26% of the patients reported muscle pain only while on the placebo, 17% never experienced muscle-related symptoms on either the statin or the placebo, and 10% complained of pain on both the statins and the placebo.

The bottom line is that fewer than half of all patients who say they are statin-intolerant actually are statin-intolerant. Because the PCSK-9 inhibitors are so expensive, some insurance companies are suggesting that patients who request them should be tested for statin intolerance (as the patients in the above study were) before insurance will pay for the new drugs.

What do you think? Should patients be required to submit to several months of testing before their (and your) insurance company agrees to pay for a $14,000-a-year drug for them?