Despite a study showing that the Food and Federal Drug Administration has approved drugs with a higher risk of affecting human health, UW-Madison students who use University Health Service have little to fear, according to Director of Clinical Services Scott Spear.
Researchers from Cambridge Hospital and Harvard Medical School, whose article appeared in the Journal of the American Medical Association yesterday, reviewed the harmful side effects of new drugs approved in the past 25 years. The study found a full 10 percent required additional warnings posted on their packaging or total removal from the market, the majority of which were approved in the most recent years.
\Our data found that only half of all serious adverse reactions are detected seven years after a drug enters the market,"" said Karen Lasser, the study's lead author. ""Millions of patients are exposed to potentially unsafe drugs each year.""
According to Spear, UHS takes a number of factors into consideration when deciding which drugs to administer for specific ailments.
""The kind of conditions we treat, particularly with antibiotics, many of the older antibiotics work just as well as or better than new ones and are oftentimes less expensive,"" he said. ""[The new drugs] tend to be for diseases not as common in this age population. We're not trying to cure cancer or the HIV disease here.""
UHS officials have made decisions in the past regarding the administration of specific drugs based upon the needs of the student community they served, according to Spear.
""We didn't use Phen-fen, which was used for weight loss. ... We said 'You know, we're really not comfortable doing this,'"" he said, but added that UHS does provide Plan B, a new form of morning-after birth control. ""It certainly is very important for this population to have emergency contraception medication that doesn't make women sick to their stomachs.""
The report reignited the controversy within the health care community as to whether the FDA is doing its job of protecting the health of the consumer.
In a corresponding article in the journal, Robert Temple of the FDA's Center for Drug Evaluation and Research Policy wrote that the study was misleading.
""Many of the reasons described are not good reasons to avoid using a new drug,"" he said in an interview. ""Patients needn't be nervous about using new drugs prescribed by their doctors.""
Spear said the FDA should provide separate tracks of approval for life-saving and nonlife-saving drugs.
""I think we expect the FDA to do good safety work,"" he said. ""But, if the risk of finding something harmful in a drug is so much outweighed by the benefit of that medication. ... I think in those cases we want the drugs out as soon as possible.""
