Last week, federal regulators gave the go-ahead for the nation’s first trial of embryonic stem cells in human beings. Geron Corporation will run the trial. It is designed to assess the safety of so-called GNROPC1 oligodendrocyte stem cells in treating spinal cord injuries.

Geron plans to begin testing by year-end. It will enroll about 10 patients over 2 years and follow them for 15 years after treatment. For safety reasons, Geron will space-out each enrollee by at least 30 days.

The primary purpose of the trial will be to determine whether GRNOPC1 is safe. Geron will assess efficacy as a secondary outcome.

The treatment involves injecting the stem cells into the spinal cord of injury victims 1-2 weeks after the injury occurs.

The FDA originally accepted Geron’s study application in January, 2009. It subsequently held things up after Geron reported that mice treated with GRNOPC1 had developed tiny cysts on their spines. According to Geron, many patients with spinal cord injuries develop larger cysts as the injury heals. Geron also reported that the cysts were not observed in a second animal study.

Oligodendrocyte stem cells mature into myelin-producing oligodendrocytes. Myelin forms a sheath around nerve cells that protects them and facilitates conduction of impulses via the nerves from the brain to the muscles, skin and internal organs. The hope is that the GRNOPC1 stem cells will facilitate healing of damaged spinal cord tissue and restore normal nerve conduction.

Embryonic stem cell research is controversial because in some cases, the cells are obtained from aborted human embryos. In 1996, Congress prohibited federal funds from being used to support stem cell research. Six years later, President Bush relaxed the ban by allowing federal funds to be used for research on stem-cell lines already in existence. In March, 2009, President Obama lifted the ban altogether.

A few years back, Jason Newsom, a former Army doctor returned to Panama City to oversee the Bay County Health Department. He was tasked to educate the public about health issues like swine flu and AIDS. He decided to take aim at the obesity problem as well.

He began by barring doughnuts from department meetings and threatening to trash any similar products he happened to find in the break room.

Then he removed candy bars from all vending machines in the building.

Next, he took his cause to the streets. On an electronic billboard outside the department, he ran banners like “Sweet Tea = Liquid Sugar….Hamburger = Spare Tire….French Fries = Thunder Thighs….”

But eventually, Newsome tangled with the wrong hombres.

“America Dies on Dunkin’,” read his latest creation, a slap at Dunkin’ Donuts’ iconic tag, “America Runs on Dunkin’.”

That didn’t sit well with County Commissioner Mike Thomas, who happened to own a doughnut shop in town, and a pair of lawyers who owned a Dunkin’ Donuts down by the beach.

The lawyers (what else?) threatened to sue, and before long the Florida Health Department forced him to resign.

“I picked on doughnuts because those things are ubiquitous in this county. Everywhere I went, there were two dozen doughnuts on the back table. At church, there were always doughnuts on the back table at Sunday school. It is social expectation thing,” Newsom, a lean 6-foot, 167-pounder, told the AP.

“I think he was…a zealot,” concluded Thomas. “I don’t have a problem with him pushing an agenda, it’s the way he did it. People borrowed money to go into business and they are being attacked by the government.”

“My method was…provocative and controversial,” retorted Newsome. “But there wasn’t a person in Bay County who wasn’t talking about health and healthy eating.”

Newsom now performs physical exams on inmates at the local prison.

Federal regulators have chastised Coca-Cola for inappropriate nutritional claims on the label of its popular soft drink, Diet Coke Plus.

In a letter, the FDA objected to the beverage’s tag line claiming the stuff is “Diet Coke with Vitamins and Minerals.”

Apparently, Diet Coke Plus doesn’t have enough vitamins and minerals to justify the “plus” descriptor. To qualify as “plus,” foods must contain 10% or more nutrients than comparable products, according to the Associated Press.

The FDA wants Coca-Cola to change the labeling for Diet Coke Plus and revert to the agency in 2 weeks with a plan to do so.

Coca-Cola said it will address the matter this month, but for now it seems likely to spurn the agency’s request. “This does not involve any health or safety issues, and we believe the label on Diet Coke Plus complies with FDA’s policies and regulations,” Coke spokesman Scott Williamson told the AP.

Diet Coke Plus hit supermarkets in March, 2007, trumpeted as a calorie-free cola packed with B vitamins, magnesium and zinc.

Beverages enriched with homeopathic doses of vitamins and minerals generate billions of dollars annually for soft-drink purveyors. Products range from energy drinks with ginkgo and ginseng to calcium-fortified OJ.

The FDA will endorse health claims on food labels once scientists verify they help prevent illness. For example the FDA says it’s OK for oatmeal products to state “may reduce risk of heart disease” on their labels.

When the FDA dispatches warning letters to companies for failing to adhere to manufacturing and marketing regulations, the letters are not legally binding, so for Coke officials there’s no sense getting bent out of shape so soon after the holidays.

The Senate Committee on Aging will soon hold a hearing about direct-to-consumer ads for medical devices.

Herb Kohl (D-Wisc), Chairman of the committee, indicated the hearing was necessary to decide whether the FDA ought to ramp up its oversight of device promotions to match what it already does for drug ads. “The medical device industry is just beginning to get into the game,” he said.

DTC advertising for medical devices nearly doubled between 2005 and 2007, to approximately $193 million. This is peanuts compared to the $5 billion spent annually on prescription drug promotions, but some people believe medical device advertising can have a disproportionately large impact on consumers. Surgery is after all usually required to implant medical devices and the devices remain in situ for years.

Currently, TV promos for medical devices are not required to address risks and benefits as are those for pharmaceuticals.

Johnson & Johnson promotes its artificial hips with ads featuring iconic Duke basketball coach Mike Krzyzewski. The ad shows people jumping rope and surfing, among other things. In spots for its competing product, Biomet features former Olympic gold medalist Mary Lou Retton.

Twenty years ago, we were aware that US medical school graduates tended to enter disciplines having the highest earning potential. Since then, income disparity between specialists and primary care physicians has widened, and medical student debt has ballooned to an astounding median of $140,000 per graduating senior.

So there is no reason to be surprised by the results of a recently published survey of graduating students from 11 US medical schools. Only 2% of respondents to this survey indicated that they planned to work in primary care internal medicine. That’s down from 9% in 1990. This year, 2,600 fewer US doctors enrolled in primary care training programs than did so just 6 years ago. 

The survey revealed that low income is just one reason why US medical students steer clear of general internal medicine. They are turned off by heavy workloads, continuous hassling with insurance companies and inadequate ancillary support as well.

Still, despite a lot of public hand wringing on the matter, the US health system is not acutely endangered by this trend. New primary care venues such as retail clinics are opening up in droves, and to fill the manpower void more than 3,300 foreign medical graduates have entered primary care training programs in the last 6 years.