“Substantially Unsafe”: 30 disturbing facts about medical devices

Warning: you might need to go have a little lie-down after you take in the facts contained in a new Public Citizen report called Substantially Unsafe. You’d think that a medical device that’s  implanted inside your body should be at least as safe as a pill that you swallow, wouldn’t you? But this report warns that medical devices (such as pacemakers, heart valves, insulin pumps, cardiac defibrillators and orthopedic hip or knee implants) can actually pose a serious threat to patients, and that existing safeguards must be strengthened.

As a heart patient, I’m particularly alarmed by disclosures about cardiac devices – a category that’s been associated with significant problems. Implantable cardioverter-defibrillators (ICDs) are just one example.  Since 2009, the FDA has received reports of close to 29,000 deaths or injuries from implanted ICDs, by far the most for any medical device type, according to a Consumer Reports Health analysis of a federal database. The most troublesome aspect of the devices are the leads – the wires that connect them to the heart. See also: ICD Warning: Defective Defibrillator Leads Recalled.

Here are 30 highlights, or lowlights, of the Public Citizen report:  Continue reading

FDA panel that approved Yaz and Yasmin had ties with industry

Dr. Sidney Wolfe is the founder and Director of Health Research at the consumer advocacy group Public Citizen, and is also the author of the  consumer guide called “Worst Pills/Best Pills” Among the drugs mentioned in this guide under the “worst” section are birth control pills containing the synthetic hormone called drospirenone, listed with cautionary warnings “due to the increased risks of blood clots, heart attack, stroke, sudden cardiac death, or gallbladder injuries”.  An article posted on the Worst Pills website revealed that studies funded by the drug industry found lower risks of blood clots than did studies that were publicly funded.

There are, in fact, over 10,000 individual lawsuits pending over injuries and deaths related to drospirenone/ethinyl estradiol tablets. You may know them better as Yaz (or Yasmin in Canada), as well as Ocella (generic Yasmin). New safety warnings published last April in the British Medical Journal now suggests a two to five-fold increased risk of thromboembolic or blood clot-related injuries in women taking birth control medications that contain drospirenone, which generally provide no greater benefits than those seen with older, safer birth control pill formulations without drospirenone.   Continue reading

Google forfeits $500 million for illegal Canadian pharmacy ads

The New York Times has published a report announcing that Google will pay $500 million to settle U.S. government charges that it has been running illegal ads for online Canadian pharmacies in the U.S. It’s the first time an Internet search engine is being held responsible for the illegal distribution of drugs.

The fine, which the U.S. Justice Department said is one of the largest such penalties ever imposed, covers revenue that Google earned from the illegal advertisers and revenue that the Canadian pharmacies received from United States customers.

As part of the settlement, Google acknowledged that it improperly aided the Canadian pharmacies – which operate illegally by failing to require a prescription or selling counterfeit drugs – in advertising through its AdWords program. This ad network is a major moneymaker for Google, expected to generate more than $30 billion in revenue this year.

So perhaps this new $500 million penalty is not as painful as it seems at first blush?  Continue reading

How a new drug gets approved

alarm clock boyPity the poor schmuck who has no trouble falling asleep at bedtime, but is then wide awake in the middle of the night, staring bleakly at those evil green numbers on the clock radio for the next four hours. Have you been there yourself?  What if there were a magical pill we could take in the middle of those nights that would help us drift off to sleep again for just a few more hours until morning?

Enter the drug Intermezzo, a potential treatment for people suffering from this specific form of insomnia that involves difficulty falling asleep after waking up in the middle of the night.  Continue reading