2011 FDA Rulings

Earlier in 2011 we heard that the Food and Drug Administration (FDA) wanted to revise the nutrition labels on packages so that they are easier for people to understand; they want serving sizes to be more realistic and the breakdown of sugars, fats, and calories per serving. The FDA approved a new clotting drug and I heard prescribed medicine overdoses outweigh vehicles accidents in 17 states and that Americans use 80% of the world’s pain killers. And, it’s being said that prescription and over the counter drugs stop working or become dangerous in the summer heat. Dr. Grant Fowler, Utah Health Medical School, said both temperature extremes are bad for drugs; it turns out humidity is bad for your drugs too.

Lipitor (a statin) did go generic on December 1, 2011 and it’s expected that this would cut into Pfizer’s $11 billion it was making off the drug. Dr. Christopher Cannon, Brigham & Women’s Hospital, said this is probably one of the best ways to reduce the risk of heart attack or stroke and 10s of millions of patients that could and should be treated but aren’t currently (thus saving lives). There was talk about Lipitor being an over the counter drug. Dr. Brian Strom, University of Pennsylvania, said if somebody were to take Lipitor over the counter by themselves, they’d have no idea if it was working for them. Take too little and you could still have a heart attack or stroke and if you take too much it could cause liver damage or rare fatal muscle problems and there are concerns that if it (a statin) is sold over the counter people won’t take it seriously. Dr. Strom said they’ll take it sometimes and not others. Per ABC News, the FDA has to decide if the benefits outweigh the risk; other statin manufacturers have tried and failed. Per the Kaiser Family Foundation, 8.7 million Americans take Lipitor, co-pays will drop from $30 a month to $10 with it going generic, the main ingredient is the same, the fillers will be different and most people shouldn’t see a difference in its working. (A company in India got approval to manufacture the drug.) Per the Harvard Medical School, 32 million Americans, 1 out of 4 over 45 are on a statin. The Journal of Infectious Diseases announced that statins fight the flu, based on 3,000 people in 2007 and 2008 they found that 40% of the people who used a statin are less likely to die; more research is needed to find out if you have to be on a statin already or if they can start its use when you enter the hospital; don’t take a statin only to ward off the flu. On October 25 ABC News reported that a top researcher from the University of Minnesota said the flu vaccine is not as effective as we hoped. The researcher looked at the studies done over the past 44 years. The flu shot in 18 – 65 year olds is only 59% - 60% effective; the mist vaccine (nasal spray) in children younger than 7 is 80% -83% effective. Because new strains of the flu show up every year, the vaccine cannot be 100% effective. The Center for Disease Control (CDC) said that 3,000 – 49,000 people die from the flu each year so the vaccine we have is better than nothing.

According to ABC News, lung cancer effects 200,000 people a year. Per the National Cancer Institute, lung cancer causes more deaths than any other cancer. Only 1% of patients with stage 4 lung cancer lives 5 years. A CT scan can reduce deaths among smokers by 20%. It was recommended that you get a CT scan if you smoked within the last 20 years even if you quit 15 years ago. I’m pretty sure that this is not being done much. Xalkori is a new FDA approved drug for the 3-5% of lung cancer patients with a specific mutant gene that causes tumors. Dr. Alice Shaw of the Massachusetts General Hospital says 90% will have a response and 60% will have a significant response. It’s too soon to tell the long term effects. The FDA came out with a new mandate that cigarette packages contain graphic warning labels of things that could happen and kill you or another if you smoke; manufacturers tried and failed to get it overturned.

In October the US Preventative Services Task Force said cervical cancer screening of women 21 to 65 should be every 3 years as it’s normally slow growing and no HPV tests for men under age 30; many doctors support this. However, this is the same panel that wanted reduced mammograms and later screening for prostate cancer. Per ABC News, 80% of women have the HPV virus but it doesn’t always cause cervical cancer; the same virus can cause cancer in men. Per the Center for Disease Control and Prevention 8,500 head and neck cancers this year have been caused by the HPV virus; the thinking is that men are getting it from the women through some kind of oral contact. Less than 50% of girls are vaccinated against HPV and the thinking is that boys should be vaccinated also. And, there’s a brand new study that links HPV with heart problems in women; a key advisory panel to the CDC recommended that males 11-21 and all females get the HPV vaccine to prevent cancer and heart problems.

On November 18 the FDA withdrew its approval of Avastin, the best selling breast cancer drug but said it can be used for other cancers (On December 28 2 new studies showed Avastin may extend the life of those with advanced ovarian cancer for 4 months and it comes with side effects so it’s not really effective).