It goes without saying that the drugs you take for a headache, or high blood pressure, or even depression should work better than a Tic-Tac. That’s what drug trials are for: researchers give a group of subjects either the drug under investigation or a placebo to check that the medicine is significantly more effective than a sugar pill. Plus, the trials can reveal any potentially harmful side effects. In theory, this is a great way to weed out useless or actively harmful drugs. But it fails when drug manufacturers cherry-pick their data, publishing papers on the positive trials and sweeping the unsuccessful ones under the rug. And this behavior is completely legal.
Science writer and medical doctor Ben Goldacre wrote a book, with a long excerpt published at the Guardian, about how this process leads to approval for drugs that don’t actually work. And as he explains, when widely used drugs—such as the diabetes medication rosiglitazone—have harmful side effects, they sometimes remain in common use.
The synthetic marijuana product Spice
Synthetic, or designer, drugs are chemical compounds that imitate the effects of marijuana, stimulants, and other recreational drugs. Unlike illegal substances, synthetics are easily accessible to users who want to get high without risking legal repercussions. Although the Federal Analog Act of 1986 prevents the sale of chemicals with structures that are “substantially similar” to those of illegal drugs, it only applies to drugs intended for human consumption. Manufacturers easily leap this hurdle by labeling their synthetic drugs as non-ingestible products such as incense, potpourri, or bath salts. Taking a different tack, the government recently passed the Synthetic Drug Abuse Prevention Act of 2012, which makes some of the popular designer drugs illegal. But did this really make synthetics less available?
Marijuana, long known as a recreational drug, has earned some respectability with its growing reputation as a pain reliever for those who suffer from cancer, multiple sclerosis, and other ailments. And now, cannabis’s seedy reputation may go entirely to pot: a new strain called Avidekel preserves the drug’s medical properties but does not get users high.
The effects of various breeds of marijuana depend on their balance of the chemicals called cannabinoids. One cannabinoid, called tetrahydrocannabinol or THC, acts on the brain’s cannabinoid receptors to create the sensation of being high. While this feeling is the goal for recreational users, it can be an unwanted side effect for patients who smoke medical marijuana to relieve their pain and then find themselves unable to work, run errands in a car, or function normally until the drug’s effects wear off. The primary reason these users turn to marijuana in the first place is a different cannabinoid, called cannabidiol, which reduces inflammation without any psychoactive side effects.
Last April, we reported on the failure of Truvada, an oral anti-HIV pill, to prevent infection in African women. The results of the trial were disappointing, and surprising, because Truvada had been found to prevent infection in 90% of gay men who took it religiously. We pointed out at the time that the researchers had yet to analyze blood samples they’d taken from the women in the study. Those samples would show whether the women had been taking the drug as prescribed, which would suggest that its failure was due to some biological factor, or whether they had been failing to take the drug.
It looks like it’s the latter. This week, the NYTimes reports, the researchers announced at an AIDS research conference in Seattle that of the women who got infected, only a quarter of them had any Truvada at all in their blood. Read More
Amyloid beta deposits in brain of Alzheimer’s patient.
What’s the News: A drug used to cure skin cancer is also a possible treatment for Alzheimer’s, according to a new study in Science. The drug not only reduced levels of amyloid beta—a protein whose elevated levels are a hallmark of the disease—but also reversed cognitive decline. In mice, dramatic effects were evident after just 72 hours.
Doctors long believed that patients who remained in a coma weeks or more after a brain injury would never regain consciousness. But recent research has shown that consciousness isn’t a binary, awake-or-not state; it’s a spectrum. While some brain injury patients are in a vegetative state, without any conscious awareness, others are in what’s called a minimally conscious state, still partially aware of—and at times even able to respond to—their surroundings. From the outside, it can be difficult to tell the two apart, though new methods, such as EEGs that pick up on subtle differences in brain waves, are starting to help clinicians gauge a patient’s level of consciousness.
From these hinterlands of consciousness comes another astounding—and mysterious—discovery: Ambien, the prescription sleep medication, and zolpidem, the drug’s generic form, can help some minimally conscious patients wake up. Jeneen Interlandi delves deep into this seemingly paradoxical treatment in the New York Times magazine:
What’s The News: Three 16-year-old teenage boys in Texas had heart attacks shortly after smoking a product called k2, or Spice, according to a study published this month in the journal Pediatrics. The report highlights a growing public health problem: the increased availability and use of synthetic cannabinoids, which when smoked mimic the effects of marijuana but typically can’t be detected in drug tests. While the U.S. Drug Enforcement Agency secured an emergency, one-year ban of five synthetic cannabinoids in March of this year, most of the hundreds of such chemicals remain basically legal, widely available, little understood, and potentially harmful.
An experimental drug causes obese monkeys to lose weight and improves their metabolic function by depriving their fat of its blood supply, researchers reported yesterday in Science Translational Medicine, offering hope that such drugs could help battle obesity in people, as well.
President Barack Obama will sign an executive order today aimed at reducing the number of drug shortages; between 2005 and 2010, the number of such shortages jumped from 61 to 178. Most of the drugs reported as coming up short are generic, injected medications like cancer drugs, antibiotics, and nutritional shots for hospitalized patients. Many of the shortages are due to manufacturing delays or quality control problems, like syringes found to contain glass particles or to be contaminated with microbes. The executive order will require the Food and Drug Administration to speed review of applications for changes in manufacturing protocol or to use new or different drugs in certain circumstances.
The order also instructs the FDA to work with the Department of Justice to report possible instances of price gouging, which could lead to prosecution of companies that illegally horde certain medications or overcharge for certain drugs in times of shortage. In one instance, a company charged $990 per vial for a leukemia drug that normal fetches only $12—an 80-fold markup.
When rats were injected with a chemical similar to marijuana’s main ingredient, THC, shortly after a undergoing a severely stressful event, they showed a significant reduction in symptoms like those seen in people with post-traumatic stress disorder. The study tested a synthetic cannabinoid called WIN 55,212-2, which was injected directly into the animals’ amygdala, a brain region involved in the regulation of emotions like fear and anxiety. Timing was important. Rats given the drug two and 24 hours after the stressor—being forced to swim for 15 minutes—appeared less “traumatized” when tested a week later, compared with those given the drug 48 hours later or given no drug at all. While the study adds to the already large and complex pile of evidence that the cannabinoid system has a vital role in regulating emotions like anxiety, it’s far from proving that cannabinoids will be useful for treating PTSD in humans.