Surprising as it may seem, the way the present system works is that thousands of devices are routinely cleared for market without any of the clinical testing for safety or effectiveness that is required for prescription drugs.
"I thought that any medical device that was actually being put into people's bodies had been extensively tested before it was released to the public," said Ayers. Not exactly.
FDA urged to rethink approval of medical devices
FDA admits heart drug doubles risk of death
Regulators with the Food and Drug Administration have warned that Multaq, a cardiac drug Sanofi, has been linked with fatal heart problems in a clinical trial the company recently ended.
Multaq is prescribed to control atrial fibrillation, the most common type of irregular heartbeat which is found in about 2.2 million Americans. It is a condition in which the primary electrical impulse that causes the atria - the two upper chambers of the heart - to contract instead fires erratically, causing several other nodes, or electrical impulse points, to fire instead.
J&J cuts maximum Tylenol dose to prevent overdoses
Johnson & Johnson said Thursday that it's reducing the maximum daily dose of its Extra Strength Tylenol pain reliever to lower risk of accidental overdose from acetaminophen, its active ingredient and the top cause of liver failure.
The company's McNeil Consumer Healthcare Division said the change affects Extra Strength Tylenol sold in the U.S. - one of many products in short supply in stores due to a string of recalls.
US judge upholds federal embryonic stem cell funds
U.S. District Judge Royce Lamberth ruled the U.S. National Institutes of Health (NIH) guidelines on such research do not violate federal law and he dismissed a legal challenge to the funding.
Lamberth a year ago had halted the funding of the research. But he was reversed in a ruling by a U.S appeals court in April. His latest decision was largely based on the appeals court's reasoning and conclusions.
Psychiatric disease labeling of children exposed as scam by non-profit group
Child drugging has been a huge profitable market for Big Pharma, earning them $4.8 billion dollars a year. They have done everything in their power to convince the press, legislators and especially parents why children need to be put on drugs.
They claim that ADD/ADHD, depression, bipolar disorder, etc., are medical conditions, and consider them on par with cancer, diabetes, and heart disease. But in reality there is no actual evidence that proves that psychiatric disorders are indeed medical conditions. They simply diagnose a child by using a behavioral checklist.
Young people should not take flu vaccine, watchdog says
Its announcement comes after studies showed that young people who were given the vaccine were at increased risk of developing narcolepsy, which causes sufferers to fall asleep unexpectedly.
Pandemrix, manufactured by the British pharmaceutical giant GlaxoSmithKline, was given to 30million people across Europe after the outbreak of swine flu – the H1N1 strain of the virus - that started in Mexico early in 2009.
World Health Organization calls for TB blood test ban
Blood tests designed to detect active TB are inaccurate and should be banned, the World Health Organization has said. More than two million such tests are carried out annually, but the WHO says they are unethical and lead to misdiagnosis and the mistreatment of patients.
The organisation's review of these tuberculosis test kits says they give wrong results in around 50% of cases. The kits are mainly sold in the developing world. However, most of the 18 kits on the market are produced in Europe and North America.
More Articles...
Page 101 of 235