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Anti-Cocaine Vaccine

A vaccine developed at Weill Cornell Medicine and NewYork-Presbyterian to blunt the effects of cocaine has advanced to clinical trials for testing in humans. After demonstrating that the vaccine prevented cocaine from reaching the brain in earlier animal studies, investigators are now enrolling active cocaine addicts in a Phase I randomized control study to test how it works in people.

“Cocaine addiction is a huge problem that affects more than 2 million people in the United States, and results in more than 500,000 annual visits to emergency rooms,” said principal investigator Dr. Ronald Crystal, chairman of the Department of Genetic Medicine at Weill Cornell Medicine and a pulmonologist at NewYork-Presbyterian/Weill Cornell Medical Center. “While there are drugs like methadone designed to treat heroin, there aren’t any therapeutics available to treat cocaine addiction. We hope that our vaccine will change that.”

While most drugs that target addiction are designed to disrupt some process in the brain, this vaccine, called dAd5GNE, is meant to absorb cocaine in the bloodstream—well before it has had a chance to pass the blood-brain barrier and later produce a dopamine-induced high.

The dAd5GNE vaccine works by linking a cocaine-like molecule called GNE to a disrupted protein of an inactive adenovirus virus that typically causes cold-like symptoms, and is highly likely to produce an immune response. The immune system then unleashes antibodies that attack both the virus and the cocaine-like molecules connected to it. Once the body sees cocaine as the enemy, if the drug enters the bloodstream, the body will respond with a flood of anti-cocaine antibodies, each meant to gobble up cocaine like a Pac-man, Dr. Crystal said. This means that if someone who has received the vaccine uses cocaine, within seconds it passes from the lungs to the bloodstream, and once there, the antibodies attack.

“The goal of this vaccine is to prevent cocaine from reaching the brain,” said Dr. Crystal, who is also the Bruce Webster Professor of Internal Medicine at Weill Cornell Medicine. “While we know that this works very well in animals, now we need to find out if the vaccine will cause enough anti-cocaine antibodies to be produced so that it works in humans, too.”

Investigators are looking to enroll 30 subjects who are active cocaine users in the study, which is funded by the National Institute on Drug Abuse and the National Institutes of Health. The participants in this randomized, double-blind study will be divided into three consecutive, 10-person cohorts. Once the subjects have passed through an extensive screening process and are chosen, each cohort of 10 will be randomly split into seven receiving the vaccine and three receiving the placebo.

Before getting the vaccine, each participant will have to give up cocaine for at least 30 days, during which time they’ll undergo frequent urine screens to test for cocaine use. Their first vaccine dose is administered as an injection in the shoulder. Additional boosters will be given every four weeks until the participant has received six total injections. After the final booster is given in week 20, subjects will undergo monitoring for another three months, until the study’s conclusion after 32 weeks.

Each participant will have to meet with investigators two or three times per week to assess safety and efficacy. These meetings will include regular urine drug screens, EKGs, complete blood counts, and other measures of safety, as well as the review of any anti-cocaine antibodies in the participants’ systems, self-reports on cocaine cravings and subjects’ desire for other drugs and alcohol. Every subject will undergo standard drug dependency therapy throughout the study.

After the first group of 10 is finished, the second group will commence, followed by the third group. In total, 21 subjects will get the vaccine in escalating doses; nine subjects will get the placebo. The entire Phase I clinical study is expected to take about three years.

“Most people who become cocaine addicts want to give it up, but struggle to kick the habit in the long-term,” Dr. Crystal said. “If this vaccine works, it could represent a lifetime therapeutic for addicts.”

What Casual Drinking Does to Your Body Over Time

The effects of having a few drinks can differ person to person, but often people may not realize just how risky their drinking patterns are, or what that alcohol is doing to them under the hood.

There are two definitions for “safe” drinking. The U.S. Dietary Guidelines say moderate alcohol consumption is OK, which means having up to 1 drink per day for women and up to 2 drinks per day for men. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) has its own recommendation it calls “low risk” drinking, which sets limits for what levels of drinking will put you at a low risk for developing an alcohol abuse issue later on. This comes out to no more than three drinks on any single day and no more than 7 drinks per week for women, and no more than four drinks on any single day and no more than 14 drinks per week for men.

According to Dr. George Koob, director of the NIAAA, the current body of evidence doesn’t show whether there are significant differences between someone who drinks at this level versus someone who never drinks. In some cases, there’s strong evidence to suggest that moderate wine consumption could actually benefit the heart. Though Koob says some studies have been controversial and it’s not determined what it is about wine or other parts of a person’s lifestyle that could be at play. There are also individual patterns and sensitivities that people should take into consideration at this level. Some people can handle the amount better than others.

If you genuinely stay within the healthy drinking limits, you’re likely at a low risk for alcohol-related health problems down the line.

The concept of binge drinking is often associated with college students and drinking to get “drunk.” But evidence suggests that people beyond college age also maintain those heavy drinking behaviors. The NIH defines it as five or more drinks for men and four or more drinks for women within two hours. Some of the risks associated with binge drinking are well known. It increases the risk for sexual assault, violence and self harm. But the physical effects of such behaviors on the body are often less discussed. According to the National Institutes of Health (NIH), there’s strong evidence to suggest that regular binge drinking can damage the frontal cortex and areas of the brain involved in executive functions and decision making. Alcohol slows down the pace of the neurotransmitters in your brain that are critical for proper body responses and even moods.

“Abstaining from alcohol over several months to a year may allow structural brain changes to partially correct,” the NIH says. “Abstinence also can help reverse negative effects on thinking skills, including problem­ solving, memory, and attention.”

Long term drinking can also hurt your heart muscles making them unable to contract properly. It can also harm liver, pancreas and immune system function. Heavy drinking can prevent the protective white blood cells in your body to attack bacterial invaders like they’re supposed to. Drinking too much alcohol can also increase your risk for certain cancers like mouth and breast. Regular heavy drinking also increases the risk for some alcohol dependence. “It creeps up on people,” says Koob.Social Drinking

Sleeping medication use may increase risk for car accidents

NBC Nightly News (6/11, story 9, 2:10, Holt, 7.86M) reported on “a big wake-up call for the millions of Americans who take certain kinds of sleeping” medications. Correspondent Ann Thompson explained, “A new study…finds three sedatives nearly double the risk of vehicle accidents among new users.” In addition, “the study…finds the risk of accidents increases over time and can last up to a year after you start taking the drugs.”

The NBC News (6/12, Fox) website reports that for the study, investigators “collected data on…zolpidem, sold under the brand name Ambien; trazodone, sometimes sold under the brand name Oleptro; and temazepam, brand name Restoril.” The researchers found “that people who took any one of” these “three popular sleeping aids had anywhere between a 25 percent and three times higher risk of being involved in an accident while driving.” The study was published online in the American Journal of Public Health.

Health Day (6/12) reports that physicians, “pharmacists and patients should discuss this potential risk when selecting a sleep medication, the researchers said.”

Skin Cancer Update 2015

The rate of skin cancer has doubled over the last 30 years, according to new federal data.

Melanoma, specifically—which is the deadliest kind of skin cancer—is on the rise, and according to the latest research, the yearly cost of treating it is estimated to triple to a total of $1.6 billion in the year 2030.

One way to prevent skin cancer is to cover up, and sunscreen is typically a go-to to protect skin in the summer heat. However, recent data has suggested that while sunscreens add protection, they aren’t necessarily up to snuff and often brands make coverage claims they can’t really deliver. There’s also the fact that many Americans still don’t wear it daily (and many still use indoor tanning beds).

A recent report from the Environmental Working Group showed that many sunscreens offer poor coverage or have ingredients that the organization views as worrisome. Some brands market their SPF 70 or SPF 100+ even though they don’t really have much more protection than SPF 50.

New, better sunscreen ingredients could help. Recently, legislation was passed to make the U.S. Food and Drug Administration to more quickly respond to pending applications for new ingredients to add to sunscreens. Many of these ingredients have already been available in sunscreens abroad for years. The law is supposed to make the agency act more promptly, and hopefully result in sunscreens with better protection for Americans.

The FDA also said years ago that it would crack down on sunscreen regulation, by putting a cap on SPF at a max of SPF 50, establish standards for testing the effectiveness, and enforce better labeling.

So what’s the best way to stay protected? Keep wearing sunscreen (data suggests Americans could do a better job), but abide by other measures too. Health experts recommend covering exposed skin with clothing, avoiding time in the sun between the hours of 10 a.m. and 2 p.m, and remembering to reapply sunscreen—a teaspoon per body part—at least every two hours.

Fluoride UPDATE

HHS recommends less fluoride in drinking water.
NBC Nightly News (4/28, story 7, 0:30, Holt) reported, “Federal health officials are lowering the recommended level of fluoride in drinking water for the first time in more than 50 years.”
The CBS Evening News (4/27, story 13, 0:30, Pelley) reported that on Monday, the Federal government “said that less fluoride should be added to the drinking water.” Currently, 75 “percent of Americans have fluoridated water. The Department of Health and Human Services said that fluoride is already in toothpaste and mouth wash and too much fluoride can discolor children’s teeth.”
The Washington Post (4/28, Bernstein) “To Your Health” blog reports that HHS now recommends that “drinking water contain .7 milligrams of fluoride per liter,” representing a change in the previous recommendation of “a range of .7 to 1.2 milligrams per liter” set in 1962.
The AP (4/28, Stobbe) points out that “adding fluoride was – and has remained – controversial,” with opponents of fluoride contending that “health effects aren’t completely understood and that adding it amounts to an unwanted medication.”