One Person Brain-Dead After French Drug Trial
Five others hospitalized after a 'serious accident' occurs during testing of an oral medication.
One person has been left brain-dead and five others hospitalized after a "serious accident" during a drugs trial in France, Health Minister Marisol Touraine said Friday.
She said the six volunteers had been taking part in a "trial of an oral medication being developed by a European laboratory" in the northwestern city of Rennes.
According to a source close to the case, the drug was a painkiller containing cannabinoids, an active ingredient found in cannabis plants.
A separate source said the research company Biotrial had been carrying out the drugs trial for Portuguese pharmaceutical company Bial.
"A serious accident took place," the minister said, adding that the study had been halted and all volunteers taking part recalled. The incident occurred on Thursday.
The study was a Phase I clinical trial, in which healthy volunteers take a prototype medication to "evaluate the safety of its use, tolerance and pharmacological profile of the molecule", the minister added in a statement.
It was not clear how many people were taking part in the study.
Clinical trials typically have three phases to assess a new drug or medical innovation for safety and effectiveness. Human participation in such trials and scrutiny by outside watchdogs are essential for obtaining market authorisation.
Phase I entails a small group of volunteers, and focuses only on safety.
Phase II and Phase III are progressively larger trials, typically involving hundreds or thousands of volunteers, to assess the drug's effectiveness, although safety remains paramount.
Touraine was set to hold a press conference later Friday alongside a manager from the Biotrial company which has its French headquarters in Rennes.
The company conducts its Phase I trials at a 150-bed facility in Rennes and also in Newark, New Jersey, from where it carries out "a large variety of early clinical studies," according to its website.
Biotrial says it is able to fast-track early patient studies by "combining the favourable regulatory environment in Western Europe with fast and efficient patient recruitment in Eastern Europe."
The Paris prosecutor's office said an investigation had been opened.
Touraine vowed to "shed light on" what happened and has called for an inspection of the research site.
Every year thousands of volunteers, often students looking to make extra money, take part in such clinical trials which are seen as safe.
Mishaps are relatively rare, but in 2006 six men were hospitalized in London after taking part in a clinical trial into a drug developed to fight auto-immune disease and leukaemia.
In gene therapy, setbacks have included the death of an 18-year-old US volunteer, Jesse Gelsinger, in 1999, and the development of cancer in two French children treated for "bubble baby" syndrome, a chronic lack of immune defences.
Medical marijuana gets all the headlines, but many legal weeds have traditions as medicines too. Although homeowners often consider these plants as lawn outlaws, weeds can serve as a floral pharmacy. However, would-be patients of the plants should consult a doctor before self-medicating.
Cichorium intybus, the light blue flower frequently seen along roads, provides the main commercial source of the compound inulin. Patients take inulin to fight high blood fats, including cholesterol and triglycerides, according to WebMD. Research published in Diabetes & Metabolism Journal suggests that inulin intake benefits women with type-2 diabetes by reducing the rate of blood sugar increase after eating. Inulin promotes the growth of certain bacteria in the intestines. While some believe this can help digestion, others suffer serious flatulence when the inulin-fed bacteria build up.
Some people add the dried and roasted root to coffee. Chickory coffee is especially popular in New Orleans.
Trifolium pratense contains chemicals known as isoflavones. These chemicals can act like the female hormone estrogen in the body. Doctors have examined the clover chemicals as a treatment for hot flashes and other symptoms of menopause. However, doctors warn that women with a history or risk of breast cancer should avoid isoflavones, since estrogen-like chemicals have been associated with increased incidence of some cancers.
Silybum marianum has a 2,000 year history as a liver medicine. Modern research has looked at thistle extracts as a treatment for alcohol-induced liver damage. Substances in milk thistle, particularly the chemical silymarin, may protect the liver from damage after a person takes an overdose of other medications, including acetaminophen (Tylenol). Milk thistle may also be an antidote to poison from the deathcap mushroom (Amanita phalloides). Animal studies found that milk thistle completely counteracted the poison if given within 10 minutes of poisoning, according to the University of Maryland Medical Center.
Native Americans used the milkweed (Asclepias sp.) as a contraceptive, according to the U.S. Department of Agriculture. The milky, white sap that gives the plant its name served to remove warts. However, milkweeds also contain chemicals known as cardiac glycosides. These chemicals can cause severe illness in humans and livestock. Monarch butterfly caterpillars eat milkweed and build up high concentrations of glycosides, which makes the insects nasty tasting to predators.
Ancient Greeks and Romans used horsetail (Equisetum arvense) to stop bleeding, heal ulcers and wounds, and treat tuberculosis and kidney problems. My wife drinks horsetail tea to flush out her body’s system and help lose weight. The tea has a mildly bitter flavor, similar to chamomile. Research published in Ethnopharmacolgy found that horsetail tea increases urination which corroborates my wife’s contention that the plant is a diuretic, or a substance that increases urination. However, doctors recommend taking a multivitamin when drinking significant amounts of horesetail tea, because it can flush nutrients, such as vitamin B1, thiamin and potassium, out of one's system as well.
In the past, Europeans used remedies made from dandelion (Taraxacum sp.) roots, leaves and flowers to treat fever, boils, eye problems, diabetes, and diarrhea, according to the University of Maryland Medical Center. Practitioners of traditional Chinese medicine take dandelions for stomach ailments and breast problems, such as inflammation or lack of milk flow. Dandelion leaves taste similar to spinach and contains vitamins A, B, C, and D, along with iron, potassium, and zinc.
Urtica dioica can put the hurt on an hiker in shorts, but historically the plant has served to treat aching muscles and joints, eczema, arthritis and gout. People still use the plant to treat joint pain, and some studies have suggested that the plant can treat arthritis. Another study found that capsules of dried stinging nettle may reduce the symptoms of hay fever. Europeans frequently use stinging nettle root to treat bladder problems. Boiled nettle makes a side dish similar to collared greens.
For those who brush alongside stinging nettle, a remedy to the sting is often found growing nearby. Applying crushed up dandelion, horsetail, Aloe vera, jewelweed or the leaf of a dock or lock plant can counter the acid in the sting.
Like many of the medicinal weeds in this list, purslane (Portulaca oleracea) also makes a healthy snack. The plant contains a high content of omega-3 fatty acids. I ate some that grew in my yard and found it was somewhat sour. A little bit was good, but too much would be overpowering in a salad. In traditional Chinese medicine, purslane treats genito-urinary tract infections. Research published in Phytomedicine found that the plant reduced problems with cognition in older mice.
Since the age of the ancient Greek doctors have used plantains (Plantago sp., the weed in sidewalk cracks, not the fruit) to speed wound healing. In the training manual Survival, Evasion and Recovery, the U.S. Department of Defense recommends plantain as a poultice on wounds or as a nutrient-rich tea to treat diarrhea.
Traditionally, healers use burdock (Arctium sp.) to clear toxins from the blood and increase urination, according to the University of Maryland Medical Center. The plant also is used to treat skin ailments, such as eczema, acne, and psoriasis. The leaves and roots of burdock are edible and contains inulin, like chicory, so they may aid digestion and/or cause a nasty case of flatulence. Burdock also contains high quantities of antioxidants that can prevent damage to cells.