What You Should Know About Drug Studies

November 19th, 2009. By Kristine B

In light of the recent release of the results from the ARBITER 6-HALTS trial regarding Zetia and Niaspan, there may be questions about what drug studies are and why they are important. This week, Pleading Ignorance examines drug studies: what they do, what they don’t do and what you should know about them.

Drug Studies: What They Do (Timing is Everything)

The names of the drug studies are impressive, aren’t they? Names like ARIBITER 6-HALTS, ENHANCE, RECORD and so on. The fancy thing is that all the letters in the names mean something (an acronym!)—but no one ever remembers what the heck they mean, save of course the folks conducting the test. So the catchy name is fine for the rest of us. (By the way, ARBITER 6 HALTS stands for “Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6–HDL and LDL Treatment Strategies“—say that fast 6 times). Once you’re beyond the name though, it’s important to know at what point in time the study is being done—after all, the studies are designed to show something. The timing in which the drug is tested will clue you in to what information the researchers are looking for.

Drug studies that are done before the drug is approved by the FDA (known as clinical trials), are done to prove…

• that a new drug is at least as effective as an older drug
• that the new drug is more effective than just standard therapy alone, or
• that the benefits of the new drug outweigh the risks (see, they’re watching out for you!)

If the studies are done after the drug is approved, they may be done to…

• study side effects or safety of the drug
• compare the drug to a different one that treats the same health problem, or
• determine new uses for the drug

What Drug Studies Don’t Do

Unless there is overwhelming evidence that a drug is specifically linked to a serious condition that no other factor could possibly be responsible for—like if a person were to spontaneously combust immediately after taking the drug and had no previous history of spontaneously combusting—drug studies will not tell you for certain whether or not you should take a drug. Rarely do researchers come out and say, “No one should ever take this drug again because it is a terrible, deadly drug and anyone who takes it will certainly die.”

More likely, should there be a direct causal relationship shown between a drug and a serious side effect, the FDA will either require a black box warning (we talk a lot about those on LawyersAndSettlments.com) on the drug’s label or, based on a variety of research, the FDA might come out and request that a drug be removed from the market. Of course, if it gets to that poing, you probably shouldn’t be taking that drug anymore.

What You Might Not Know About Drug Studies

Read the fine print with drug studies (ALWAYS read the fine print). In some cases, a company who stands to benefit from the results of the study may have actually funded it. Or that company may have offered grant support or financial funding to researchers working on the study. That’s not illegal. But, it’s important to keep in mind any possible conflicts of interest when reading a drug review, good or bad.

Company Responses to Studies

Predictably, whenever a study produces negative results about a drug (ie, it is linked to an increased risk of some bad side effect—aka, “adverse effect”), the drug companies will attack the study. They’ll make criticisms like that the sample size was too small (meaning, too few people were included in the study, not that people included in the study were too short), or the study was too short (in duration, not in stature) to draw conclusions, or that the researchers failed to take certain factors into account (like that some of the participants were already dead before the trial started—hey, don’t think it can only happen with registered voters).

The drug companies will then release a statement in which they stand by their profit machines. The statement will go something like this: “We realize that the study shows that 99 percent of patients between the ages of five and 95 who use this drug experience the unfortunate side effect of [fill in the blank]. However, researchers are overlooking the important benefits that this drug provides to the one percent of people over the age of 95 who do not experience [fill in the blank with aforementioned side effect]. Therefore, we believe that the benefits of this drug outweigh the risks.”

At the end, it is up to each individual to determine whether or not the results of a study will change his or her medication decisions, even if that means a risk of, say, potentially losing your sense of smell for the sake of treating nasal congestion (hello, Zicam!). That’s probably a risk I wouldn’t take, but that’s just me.

Tags: Drug Studies, Drugs, FDA, Pleading Ignorance

This was posted on Thursday, November 19th, 2009 at 9:11 pm and is filed under Drugs/Medical, Pleading Ignorance . Feel free to respond, or trackback. Read our comments policy.