In case you ever wondered, October 20th is World Osteoporosis Day. In preparation, two advocacy groups — the National Osteoporosis Foundation and the National Bone Health Alliance — have joined forces with Medtronic, the world’s largest medical device maker, to raise awareness about what they consider to be an “under-diagnosed” problem: vertebral compression fractures (VCF) from osteoporosis. (This news was brought to our attention via an emailed announcement from a public relations company.) This should raise eyebrows for a few reasons. First, there’s growing concern amongst some health care professionals that osteoporosis is already over-diagnosed and over-treated. Second, many bone experts feel VCF (when bones in the spine weaken and get squished) is a self-limiting condition that often only requires temporary pain management. Finally, these two advocacy groups are conflicted by financial relationships with Medtronic, and yet they … [Read more...] about Osteoporosis and vertebral compression fractures: Advocacy groups and medical device maker spin misleading message
Drug and device development
Verbeck bears a resemblance to Bryan Cranston's Walter White character from the TV series Breaking Bad, in which a high school chemistry teacher — chasing fast money — begins making meth with a former student.Verbeck embraces the look and once dressed up as White for a lecture. But Verbeck says he and Kiselak's aims are more noble than just making money. He said he primarily wanted to help solve the opioid crisis that has hit communities across the country. He said if someone on opioids or other drugs was unresponsive and needed medical treatment, they could breathe into the device so doctors could diagnose them quickly and give them appropriate treatment. Public safety uses could be in the offing as well. In Texas, it's illegal to drive under the influence of drugs. While an officer can perform a field sobriety test, they have no means to confirm the person is impaired because of drugs other than alcohol. They would have to order a blood or urine sample to … [Read more...] about Breaking Breath: University of North Texas professor makes meth in his lab for drug test device
A study published yesterday in the Journal of the American Medical Association (JAMA) raises important questions about the implications of widespread screening for atrial fibrillation — our most common abnormal heart rhythm (or, “arrhythmia”). Atrial fibrillation (“AF” or “AFib” for short) is an irregular beating of the heart’s two upper chambers, and is considered a risk factor for stroke. The study looked at diagnosing AF — not by the traditional electrocardiogram (ECG) performed during an office visit — but by using a wearable, self-applied ECG patch; specifically, in people over age 55 at high risk for developing the arrhythmia. The study found that at 4 months Afib was diagnosed in 53 out of 1,366 patients wearing the patch (3.9%) compared with 12 out of 1,293 patients (0.9%) in the control group; an absolute difference of 3%. After a full year the rate of AF diagnosis more than doubled in the monitored group (from 2.6 to … [Read more...] about Screening for atrial fibrillation with a wearable patch: Seek and ye shall find … and then what?
The Food and Drug Administration is threatening Bayer with civil and criminal penalties if it doesn't better inform women about risks from one of the company's contraceptive devices.Bayer's device, Essure, is a permanent contraceptive developed by the German drugmaker as an alternative to surgical techniques like tying or severing the fallopian tubes. U.S. regulators found that some doctors weren't always telling women about the Bayer's device's risks, which can include bleeding, pain and organ perforation.The move by the FDA signals the agency's increasing oversight of health products already on the market."Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information. That is simply unacceptable," FDA Commissioner Scott Gottlieb said in a statement. "Every single woman receiving this device should fully understand the associated risks."After noticing an increase in side effects, the FDA … [Read more...] about FDA threatens Bayer with penalties over permanent contraceptive device
An investigation has been launched after the drugs trial being carried out in the western city of Rennes went tragically wrong. Some media reports in France claimed the drug was a cannabis-based painkiller and AFP quoted a source "close to the case" who said the drug contained cannabinoids - an ingredient found in cannabis plants. However a spokesperson for France's health ministry has told The Local this information is false. "This medication did not contain cannabis and was not a cannabis-based drug," said Health Minister Marisol Touraine. According to France's Minister of Health Marisol Touraine the trial has been called off after one person was left brain-dead and five others hospitalised after taking the drugs. However some reports suggest the victim has been left in a coma, which would mean the brain damage may not be permanent. It is believed eight people were taking part in the trial, but of two of them had been given a placebo. "A serious accident took place," the … [Read more...] about Volunteer left brain-dead as French drug trial goes wrong