Despite the hype, some new drugs aren’t effective for patients
Editor’s Note: This column by Dr. Christopher Lillis will appear in Sunday’s Healthy Living section.
BY DR. CHRISTOPHER LILLIS
Let’s confront our human nature—we all like things that are shiny and new. Research even shows that the more a product costs, the more likely we are to think highly of it, whether it be an electronic gadget or a new car.
This particular quirk in human nature is wonderful for retailers, but it can be harmful for patient care.
Patients and doctors need to be cautious about new, pricey drugs that may be aggressively marketed but not live up to the hype.
New pharmaceuticals must jump through certain hoops before they become available. First, animal testing will occur, and if that goes well, a drug manufacturer can ask the Food and Drug Administration to allow human clinical trials.
Phase I clinical trials are conducted on a very small number of healthy individuals to ensure that the drug is safe. Then come Phase II trials, treating a very small number of individuals with the condition the drug is expected to treat.
Finally, Phase III trials are conducted in a larger number of patients with the condition the drug targets. The drug’s effect is usually compared to a placebo or sometimes to another available treatment. Phase III trials can include thousands of patients, and the results determine if the FDA will allow a drug to come to market.
So you might feel pretty good about FDA-approved drugs, surviving years of research to earn the ability to be prescribed in the United States. But today I present a cautionary tale.
HYPE AND OUTCOMES
The blood pressure medicine Tekturna (aliskiren) was approved for marketing by the FDA in 2007. A new class of medicine, it blocks a key enzyme in our body—renin—that regulates blood pressure. The first renin-blocker available, it works on a different chemical in the same system as other generic drugs that have been around for decades.
Tekturna won FDA approval after being shown in Phase III clinical trials to lower the blood pressure of patients with hypertension (high blood pressure).
For the past three years, our office has been visited almost weekly by the marketing representatives of the manufacturer of Tekturna.
Hypertension drugs earn drugmakers billions of dollars a year since so many Americans have high blood pressure. Week after week, doctors are given glossy presentations lauding the virtues of drugs like Tekturna, with fairly aggressive sales techniques, to entice physicians to write prescriptions for the drug.
For years, I frustrated the Tekturna representative who came to my office. I refused to write even one prescription. Our conversations each week were identical. I would argue that there are generic high blood pressure medicines that are cheaper and just as effective, but much more importantly, I would argue that Tekturna did not have any proof that it was truly beneficial.
To this claim, the representative was astounded that I did not agree with the glossy graphs that showed how much blood pressures were lowered for people on the drug. For me and my patients, though, lowering blood pressure is not nearly enough; we need to know that the drug protects against the problems, such as strokes, that are linked to high blood pressure.
Despite showing that Tekturna lowered blood pressures, no research trial ever documented that it reduces the risk of heart disease, stroke and death.
We treat high blood pressure to reduce the risk for heart attacks and strokes. Period. Lowering the numbers we see on the blood pressure cuff is nice, but stopping a stroke is what counts.
Dozens of generic blood pressure medicines reduce the risk of stroke, heart attack and death, but Tekturna had no such research evidence.
A FULLER PICTURE
In the past, there have been many instances of drugs that move numbers (like blood pressure), but that can worsen clinical outcomes. Alpha-blockers, for example, were shown decades ago to cause increased numbers of deaths in heart failure patients despite powerfully lowering blood pressures.
Last month, a clinical trial of Tekturna (the ALTITUDE trial) was stopped before it was completed. In trying to measure if Tekturna reduced the risk for heart attack and stroke, researchers discovered that Tekturna significantly increased the risk of stroke, kidney complications and problems with blood potassium levels.
The drug actually caused patients harm in comparison with generic alternatives, so the manufacturer recently stopped marketing it.
This is not the first time an expensive drug was found to improve some measurable number yet not affect important outcomes.
Another recent example is Zetia (ezetimibe). Zetia reliably lowers cholesterol but has never shown the ability to prevent heart attacks or deaths. Thankfully, Zetia does not cause any harm (unless you count the harm to your wallet), or its manufacturer might have stopped marketing the drug altogether, as Tekturna’s manufacturer did.
WHAT TO DEMAND
To protect yourself from being a guinea pig for new drugs, beware of television ads for pharmaceuticals; they often influence prescribing behavior.
And the next time your physician takes out the prescription pad, make sure you ask if there are generic alternatives to the drug being prescribed.
But much more importantly, ask about the outcomes research for a given drug. Will the drug prevent a heart attack, or just make your blood pressure numbers look better? I know which drug I prefer when I am the patient. How about you?
Dr. Christopher Lillis can be reached at healthyliving@freelance star.com.