Painkillers: Regulations and Recommendations

By Nisha Chandra

Last month, the FDA made a recommendation to change the way doctors prescribe hydrocodone
painkillers. These painkillers are the highest prescribed medications in the US and include narcotics like
Vicodin, which are legal but highly addictive. These types of painkillers have long been a problem in
America because of the potential for drug abuse. In fact, in the last ten years, more than 100 thousand
have died from overdoses of hydrocodone medication.

Drug companies claim that they have reduced the risk of addiction by adding a drug called
acetaminophen, which is found in Tylenol, to hydrocodone painkillers. However, very little evidence
exists to prove whether acetaminophen actually lowered the risk of abuse.

Efforts in the past to rectify the problem have been met by opposition from lobbyists. Drug companies,
patients-rights groups, and the AMA all oppose restrictions on hydrocodone drugs. The stated reason
for this opposition is that additional regulations will decrease access to those who truly need it. And
these lobbyists have been persuasive. A bill in the House of Representatives to restrict prescriptions
of hydrocodone medication was shut down by a representative from Michigan who had received 300
thousand dollars in campaign contributions from drug companies.

Still, public health advocates pushed for more restrictions. The FDA previously looked into the problem
in 2008, but at that time concluded that there was no need to tighten restrictions on hydrocodone
drugs. But they reversed that decision last week. Now, the FDA recommends that the pain pills should
be moved from Schedule III to Schedule II. Schedule II drugs are ones that are deemed more dangerous
and are more strictly regulated. The FDA also recommended that patients should only be able to get
refills for hydrocodone painkillers for 90 days before having to see a doctor. Previously, the limit was 6
months. Doctors are trained to see the symptoms of addition, and more frequent visits to the doctor are
hoped to cut down on prescription abuse. Additionally, patients will have to take a prescription to the pharmacy for a refill, instead of having their doctors call it in. This may have negative effects for those who live in rural areas and those without access to transportation.

Still, this is just a recommendation from the FDA, not actually law. It will become law when the
department of health and human services approve these recommendations and when the DEA adopts them. These approvals are expected to take place and will result in changes happening early next year.

References:
http://www.nytimes.com/2013/10/25/business/fda-seeks-tighter-control-on-prescriptions-for-class-of-
painkillers.html

http://www.bloomberg.com/news/2013-10-24/u-s-recommends-tighter-control-on-hydrocodone-pain-
pills.html

The Mediterranean Diet

by Nisha Sarla Chandra

A new study published in the New England journal of medicine in early February 2013 definitively shows the effect that diet can have on one’s cardiovascular health. The 5-year long study, which took place in Spain, used participants who were at high risk for heart disease. Each of the 7,447 people had at least one risk factor, such as smoking, being overweight, or having diabetes. They were then separated into three groups; one group was assigned a low-fat diet and the two others followed different variations of a traditional Mediterranean diet.

The Mediterranean diet is one that has been followed by the people of the region for hundreds of years. The diet has moderate amounts of fat in the form of olive oil and nuts. It also involves multiple servings of fish each week, lots of fresh fruit and vegetables, and a daily glass of wine. Those who adhere to the Mediterranean diet stay clear of red meat, dairy, and store-bought bakery goods. Researchers in the past have noticed a slightly lower incidence in heart disease for people who live in the Mediterranean. However, without definitive proof, it was hard to ascribe this lower prevalence to diet, rather than other factors like genetics or lifestyle. In fact, many leading experts in cardiovascular health have long recommended either low-fat diets or veganism to those with heart issues.

But it seems that a low-fat diet is not the solution. The group assigned to a low-fat diet had a hard time sticking to it, despite intensive nutritional counselling. As a result, the study ended up comparing the Mediterranean diet with a modern, moderate-fat diet. The end result was astonishing – a 30% decrease in heart attacks, strokes, and deaths from heart disease in those following the Mediterranean diet. In fact, the study was supposed to run for a longer period of time, but researchers could not in good conscious allow a study to go on that showed such a large health disparity between groups.

Of course, as with any study, there are detractors. But the majority of experts are impressed with the parameters researchers used and the ensuing results. The study only explored the effects on the diet on those with risk factors for heart disease, but it is expected to have preventative benefits for those at low risk.