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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.”

Caffeinated Energy Drinks Linked to Diabetes

Peter Russell

December 07, 2015
Young people who consume caffeinated energy drinks can experience a spike in their blood insulin levels. This could make them more prone to a condition which increases their susceptibility to type 2 diabetes later in life, according to early results from a small Canadian study.

However, one UK expert says linking caffeinated energy drinks to diabetes is premature.

Insulin Resistance

Canadian researchers who tested the effects of these popular drinks on adolescents say caffeine inhibits the body’s ability to deal with a high load of sugar. They say this could lead to ‘ insulin resistance’ in which the body has to produce increasing amounts of insulin to clear blood sugar circulating in tissues.

Young people are more vulnerable to these effects because they are smaller than adults and therefore likely to consume relatively larger quantities of caffeine per drink, they say.

Heidi Virtanen from the University of Calgary, who led the study, explains in a statement: “Results show that consumption of a caffeine-containing energy drink results in a 20 to 30% increase in insulin and glucose levels in response to a glucose load.

“Since caffeine persists in the system for 4 to 6 hours after consumption, continuous insulin resistance associated with regular caffeine-containing energy drink consumption in adolescents could contribute to increased metabolic risk in susceptible individuals later in life through persistent interference with their regular glucose metabolism.”

Metabolic Risk

The study was overseen by Jane Shearer from the University of Calgary who says: “Elevated glucose and insulin responses may contribute to increased metabolic risk, including type 2 diabetes and cardiovascular disease in susceptible individuals later in life.”

The researchers note that despite warning labels on caffeinated energy drinks that say they are not suitable for children, their marketing often makes them appealing to children, adolescents and young adults. They estimate that in Canada, around 30% of adolescents regularly drink them, while 50% of athletes in full-time education report using them.

The study involved 10 males and 10 females aged 13 to 19 with an average age of 17. After fasting for 24 hours, abstaining from caffeine and taking no exercise, the adolescents were randomly assigned to have either a caffeinated energy drink or one without caffeine. Both energy drinks were sugar-free in order to determine the effects of the caffeine in the drink.

Blood samples were taken periodically during a 2 hour period and a standard oral glucose test was administered 40 minutes after drinking.

The results displayed a 25% increase in blood glucose levels over a 2 hour period for those who had been given the caffeinated drink compared to those having the decaffeinated version.

Elevations in glucose with the caffeine containing energy drink were accompanied by a 26% increase in insulin levels. The researchers say that, since the half-life of caffeine is in the range of 4 to 6 hours, these results suggest that consumption of a caffeine-containing energy drink in adolescents could affect glucose regulation for hours after it is drunk.

The results, presented at the World Diabetes Congress in Vancouver, should be treated with caution as they have not yet been published in a peer-reviewed journal.

Further Trials

The researchers are planning a follow-up trial in which energy drinks will be given to adolescents containing both caffeine and glucose. Participants will then be followed for 3 days.

Commenting on the findings in a statement, Tom Sanders, professor emeritus of nutrition and dietetics at King’s College London, says: “The measurement made in this study does not really predict diabetes. Caffeine stimulates the release of non-esterified fatty acids which may transiently influence insulin sensitivity.

“It is a jump too far to suggest caffeine containing beverages increase the risk of [type 2 diabetes] based on acute measurement in such a small sample… especially as there can be marked variation in women with the menstrual cycle.”

He adds: “This is also a pilot study, so further studies will be needed to corroborate the findings.”

SOURCES:

‘Energy drink consumption impairs oral glucose tolerance in adolescents: a randomized, double-blind, crossover pilot study’, H Virtanen et al, poster presentation, World Diabetes Congress.

Science Media Centre.

Reviewed on December 03, 2015

‘Female Viagra’: Libido pill Addyi approved by US drug agency

The US Food and Drug Administration has approved a libido-enhancing drug for women dubbed the “female Viagra”.

Flibanserin, a drug produced by Sprout Pharmaceuticals and marketed as Addyi, recently passed an FDA advisory committee meeting.

It has been criticised as having only marginal benefits.

Unlike Viagra, which affects blood flow to the genitals, Addyi is designed to help women regain their sex drive by boosting levels of brain chemicals.

Sprout said trials had shown an increase “in the number of satisfying sexual events”, although experts suggest the test results were modest.

‘An unmet need’

Versions of the pill have been submitted for approval in the past but never passed.

It was rejected by the FDA twice for lack of effectiveness and side effects like nausea, dizziness and fainting.

But an FDA advisory meeting on 4 June concluded by 18 votes to six that it should be approved.

The FDA said strict measures would be put in place to ensure patients were aware of the risks, including a warning not to drink alcohol with the drug.

It will be made available through certified health care professionals and pharmacies from October.

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What is hypoactive sexual desire disorder (HSDD)?

  • A chronic or ongoing lack of interest in sex to the point that it causes a woman relationship problems and distress
  • It can be caused physically – for example by hormonal changes or surgery, or conditions such as diabetes, arthritis or cancer
  • It can be caused psychologically – depression, stress, low self-esteem or previous sexual abuse
  • Patients will have had no previous problems with sexual desire
  • It can occur regardless of sexual activity, the situation or the sexual partner
  • Current treatments are varied. Can include changes to medication and/or lifestyle, counselling and oestrogen therapy, or a combination of these
  • An estimated 8-14% of US women aged 20-49 have the condition, surveys suggest
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There will be warnings of the possible side effects, particularly for those with liver ailments, or if taken with certain other medicines, such as types of steroid.

The FDA said the drug’s purpose was the “treatment of hypoactive sexual desire disorder (HSDD)”.

A doctor would have to determine whether a woman seeking the pill was suffering from the disorder – characterised by a lack of desire, causing her distress.

Currently, there is no drug on the US market approved for treatment of HSDD or another condition, female sexual interest/arousal disorder (FSIAD).

Sprout CEO Cindy Whitehead
Sprout CEO Cindy Whitehead has gained approval for the first drug to boost sexual desire in women

“This condition is clearly an area of unmet medical need,” the FDA said.

The dose would be daily, with some doctors cautioning it would need to be taken for weeks for any benefit to be seen.

The FDA said the treatment should be stopped after eight weeks if there was no improvement.

Sprout only has 25 employees. Large pharmaceutical companies like Pfizer, Bayer and Proctor & Gamble have all studied female sexual desire disorder treatment but abandoned plans to pursue it.

Sprout’s CEO, Cindy Whitehead, told Associated Press it would promote Addyi carefully.

“We would never want a patient who’s not going to see a benefit to take it and tell everyone it doesn’t work,” she said.

Lobbying by Sprout Pharmaceuticals was backed by the women’s rights groupEven the Score, which has accused the FDA of gender bias by approving a number of drugs treating erectile dysfunction in men without passing an equivalent for women.

Originally the drug was produced by German company Boehringer Ingelheim. Sprout bought the drug from that company after it was turned down by the FDA.

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Are you affected by the issues in this story? How would a “female Viagra” drug help you? You can share your experiences by emailing haveyoursay@bbc.co.uk.

Please include a telephone number if you are willing to be contacted by a BBC journalist.

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.”

This protein can block HIV

A novel drug candidate against HIV has been created by a joint team led by researchers at The Scripps Research Institute in Jupiter, FL. The scientists consider it to be so potent and effective that it could form the basis of a vaccine alternative.

“Our compound is the broadest and most potent entry inhibitor described so far,” says Michael Farzan, a Scripps Research Institute professor who led the effort.

“Unlike antibodies, which fail to neutralize a large fraction of HIV-1 strains,” continues Farzan, “our protein has been effective against all strains tested, raising the possibility it could offer an effective HIV vaccine alternative.”

Farzan claims that the project is the culmination of more than a decade’s work on the biochemistry of how HIV enters cells.

The results of the study, which are published in the journal Nature, demonstrate how the new drug candidate blocked every strain of HIV-1, HIV-2 and SIV (simian immunodeficiency virus), including the variants that are most difficult to block.

The new drug was also found to protect against doses of the virus higher than those that normally occur in human transmission for at least 8 months after injection.

When a cell is infected by HIV, it inserts its own single-stranded RNA into the host cell. This insert of genetic code allows the virus to transform the cell into a “manufacturing site” for HIV.

However, the Scripps researchers had previously investigated a co-receptor – CCR5 – that could be used to prevent infection by manipulating related proteins. CCR5 is the first “anchor point” on the surface of a cell that HIV binds to before it can penetrate the cell.

“When we did our original work on CCR5, people thought it was interesting, but no one saw the therapeutic potential,” says Farzan. “That potential is starting to be realized.”

Using the CCR5 work as a point of departure, the scientists designed a protein that mimics the receptor and simultaneously binds to two sites on the surface of the virus, which prevents it from entering a host cell.

Study first author Matthew Gardner explains how the protein prevents the virus from penetrating cells:

“When antibodies try to mimic the receptor, they touch a lot of other parts of the viral envelope that HIV can change with ease. We’ve developed a direct mimic of the receptors without providing many avenues that the virus can use to escape, so we catch every virus thus far.”

A delivery mechanism for the drug candidate was designed using an engineered adeno-associated virus. This is a small, relatively harmless virus that does not cause disease. The adeno-associated virus turns cells into manufacturing sites that churn out enough of the new protective protein to potentially last for decades.

The data published by the team shows that the new drug candidate binds more strongly to the HIV-1 envelope than the best neutralizing antibodies currently known to work against the virus. Although it will be years before the protein can be tested in humans, it has been successful against SIV in a macaque model.

Recently, we looked at news that a recombinant strain of HIV exhibiting unprecedented aggression has been identified in Cuba.

Scientists researching this new HIV strain found that, after binding to CCR5, the virus moves to the next co-receptor – CXCR4 – much more quickly than other HIV strains. The move of the virus to CXCR4 is typically associated with onset of AIDS symptoms.

While this transition from CCR5 to CXCR4 is normally very difficult, the recombinant HIV variant was found to contain a protease that makes this transition easier to occur and also enables the virus to replicate in greater numbers than usual.

Written by David McNamee