2011 FDA Reviews

In October 2011 ABC reported that ultra violet rays have long been used to treat depression. Tanning addiction can cause skin cancer, premature aging and wrinkles. According to the Medical Journal Addiction Biology, the brain activity of those that tan 3 times a week or more mimics drug addiction. During a recent study, a group of frequent tanners agreed to be injected with a radio-isotope and the brain responded in the same areas associated with reward, the same areas that respond to drugs and sugar. Nearly 30 million Americans tan indoors a year. Professionals call it Tanorexia and doctors say if you’re tanning to get more vitamin D, take a supplement do not go tanning. According to the World Health Organization, melanoma kills 65,000 people a year. Per the National Cancer Institute one American dies of skin cancer every hour, 8,700 per year. Our government has known about UVA rays for a long time and Europeans made a change 5 years ago while our government said nothing. Fortunately, per ABC News, a new drug was approved by the Food and Drug Administration (FDA) to treat melanomas. It is estimated that 70,000 new cases and 8,800 deaths would occur in 2011. The drug targets the specific gene mutation that makes the cells grow out of control and attaches itself to the mutant protein and kills it quickly. Dr. Paul Chapman, Oncologist at Memorial Sloan Kettering, said this is the first pill you can take that will shrink your melanoma; it kills only cells that were dependant on the mutation and it’ll help approximately 50% of the patients. Dr. Besser said this mutation is also seen in thyroid and leukemia cancers; researchers need more time to determine long term results and it gives hope that understanding what makes cancer cells tick will lead to new treatments.   

There was a new study regarding migraines; the patient shown on TV was taking 40 pills a day. Dr. Stephen Silberstein of the Jefferson Headache Center is studying the use of a neuro-stimulator that acts like a pacemaker. It’s implanted below the hip and uses 2 wires that run up the spine to the nerves at the base of the neck. The use of a remote control sends tiny electrical impulses to interrupt the pain signals. The stimulator is widely used in Europe but the FDA has not approved it for use here. On October 15 we’re told that the FDA is reopening an investigation on the birth control pill ‘Yaz’ as there are several lawsuits pending. Yaz is under scrutiny for possibly causing blood clots, breathing problems, strokes and blindness as it contains drospirenone. Approximately 2 -4 women suffer blood clots out of 10,000 (way less than 1%) with ALL birth control pills. Bayer’s study shows Yaz is just as safe as other pills while several other independent studies showed the risks are 2 to 3 times higher (still less than 1%). There are a couple more stories regarding the dangers of Yaz and lawsuits and on December 9 the FDA just called for stronger warnings on the birth control pill.

On November 2 the American Pet Products and Pet Association said the money spent on medical products for dogs has gone up 47% and for cats 73% over the last decade. Yet, on November 3 the FDA launched an investigation into pet food that is giving people (not animals) salmonella (never heard the results of the investigation). November 3 federal officials approved a first-of-its-kind artificial heart valve that can be implanted without major surgery. November 15 according to the Center for Disease Control & Prevention, 5.8 million Americans have heart failure and a study at Louisville, Kentucky of 16 patients has found that stem cells can rejuvenate the heart; there still needs to be more research and larger studies.

On November 18 the FDA issued a warning to factory farms Sparboe Farms (5^th largest egg supplier in the US) as an animal rights group video found insects, rodents and dead birds in cage after age. The FDA said it’s a threat to public health as conditions can spread salmonella; McDonald’s and Target looking for a new supplier. November 20 it was reported that the USDA is targeting stores in food stamp trafficking. December 8 the Health and Human Services Secretary overrules the FDA and says girls under 17 will not be able to buy the morning after pill over the counter.

The saga on Dr. Oz’s September report on arsenic in juice (see December 1 blog) had the juice industry on November 30 say it’s up to the government to set the standard for arsenic levels. Dr. Oz said he believes that chronic alleviated exposure to arsenic can cause heart problems, cancer, skin disorders and developmental delays. Dr. Besser said that until standards are set and testing is done we don’t know the safe level; the FDA responded with they’ll do just that. December 19 it was reported that consumers pay about 25% more for premium orange juice (not from concentrate) but because of the way it’s processed the natural ingredients are taken away (flavor is added before shipment so the product is not one found in nature). The Florida Citrus Processors Association says the FDA doesn’t require the flavor pack to be put on the pasteurized juice label because the product is made from oranges. December 18 the FDA recommended we use about 2/3 of a teaspoon of salt a day and it is threatening new restrictions on salt in restaurants and packaged products at the supermarkets; a survey shows the average American uses 2 ½ days of salt in one meal or 11 cups in a year.  There were other medical stories but they had nothing to do with the federal government.