Acetaminophen overdoses are the main cause of liver failure in the U.S. Accidental acetaminophen overdoses kill about 100 people and send some 56,000 people to emergency rooms annually. The FDA said that while the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines means patients don't realize they are ingesting far more than they should. One study found that 19% of adults in the U.S. take the drug in a given week.

The FDA advisory panel consisting of 37 doctors, pharmacists and researchers voted on the recommendations yesterday after spending two days discussing steps the FDA should take to reduce the number of acetaminophen overdoses.

The FDA panel recommended a series of measures, including banning a number of well known and commonly prescribed prescription pain relief products, such as Vicodin, Ultracet and Percocet. These pain relievers combine acetaminophen with narcotic painkillers.
That recommendation could also affect 240 pending drug applications.

The panel recommended that prescription products containing acetaminophen should include strong warnings about potential liver damage. And they also strongly advised that only one concentration of over-the-counter cold medicines should be available, citing concerns about liver damage in children. That could affect products such as Theraflu and NyQuil.

The panel did not recommend banning over-the-counter cough and cold medicines and other products that combine acetaminophen with other ingredients. The panel cited data showing liver damage occurs most frequently in patients using prescription products.

If accepted by the FDA, which generally follows suggestions of its expert panels, the recommendations could result in major changes in labeling and packaging.

Many of these victims would have to turn to public assistance for needed medical services. The taxpayer would be left to fund these items.

Consumer groups, several state’s attorney generals, and several individuals with pending claims against objected. Now, as part of a deal brokered by the current Administration, GM has agreed to take on responsibility for future product liability claims. In a concession to the consumer groups and state officials who had threatened to block the sale because of product liability concerns, the new company will now assume responsibility for future claims involving vehicles made by the old company, according to documents filed in federal bankruptcy court in last Friday. A hearing on the proposed sale of assets is scheduled for tomorrow.

Under the previous plan, the new GM would not have assumed any liability for future claims related to GM vehicles made before the sale and creation of the new company. That meant that consumers who wanted to file a lawsuit related to a defective GM vehicle would have had to seek compensation from old GM. However, the old GM will most likely consist of unprofitable assets left over after the sale. In that case there would be nothing left to pay the claims.

Under the new proposed plan, the new company will not assume liability for already pending claims and those victims will still be forced to seek compensation from old GM.

However, Biogen recently reported the ninth confirmed case of progressive multifocal leukoencphalopathy (PML) in a patient taking Tysabri. PML is a rare and often fatal viral disease that is characterized by progressive damage or inflammation of the white matter of the brain at multiple locations.

According to reports, the patient with the latest confirmed PML case took 35 doses of the monthly medication. Only two of the nine cases since last July were located in the U.S.
In 2005, a link between Tysabri and PML led to the drug being pulled off the market for 18 months. But, due to its effectiveness in fighting MS, it was relaunched in 2006.

It is reported, however, that the long-projected risk of developing the PML infection while on Tysabri is well below 1 in 1,000 patients. However, there is no way to predict who will get PML, and there is no known treatment, prevention, or cure.

In a common treatment for prostate cancer, doctors implant dozens of radioactive seeds in the prostate to attack the cancerous cells. But, according to reports, when Dr. Gary D. Kao treated one patient at the VA hospital in Philadelphia, his aim was more than a little off.

Most of the seeds, 40 in all, were implanted in the patient’s healthy bladder, not the prostate.
It was an egregious error, but according to the report, with the help of federal regulators Dr. Kao, was able to conceal his mistake. He was allowed to rewrite his operative note to match the number of seeds in the prostate.

The patient had to undergo a second implant which also failed, resulting in an unintended dose to the rectum. Regulators knew nothing of this second mistake because no one reported it.
The report disclosed that two years later, in 2005, Dr. Kao again changed an operative note after putting half the seeds in the wrong organ. Once again, regulators did not object.

This was only the tip of the iceberg. The Cancer unit at the VA Philadelphia hospital operated with virtually no outside scrutiny and botched 92 of 116 cancer treatments over a span of more than six years , and then concealed the errors.

The physicians in the unit continued implants for a year even though the equipment that measured whether patients received the proper radiation dose was broken. The radiation safety committee at the Veterans Affairs hospital knew of this problem but took no action.

The Times concluded that the 92 implant errors resulted from a systemwide failure in which none of the safeguards that were supposed to protect veterans from poor medical care worked. Peer review, in which physicians examine one another’s work, did not exist in the unit. The V.A.’s radiation safety program; the Nuclear Regulatory Commission, which regulates the use of all nuclear materials; and the Joint Commission, a group that accredited the hospital, all failed to intervene.

Virtually none of the substandard implants in Philadelphia were reported to the nuclear commission, meaning errors went uninvestigated for weeks, months and sometimes years. During that time, many patients did not know that their cancer treatments were flawed.

Many of the patients, all veterans, suffered severe pain and other problems, such as incontinence, as a result of these errors.

This report comes on the heels of another disclosure some months ago that VA Hospitals were failing to properly sterilize medical equipment, exposing veterans to the risk of infectious diseases such as hepatitis and AIDS. Surely, our veterans deserve better.