Taking medicine is often a gamble. You are betting that the benefits will outweigh the risks. But do you realize a payoff is far from certain?
Drug companies rarely have to prove that their pills actually produce the desired outcome. All they have to show is that the medication moves the needle on some gauge or lab test.
These numbers are called surrogate endpoints. They are things like blood pressure, cholesterol or blood sugar. If you have hypertension, elevated cholesterol levels or diabetes, it is assumed that getting the numbers down is good enough. But the real aim is reducing the risk of kidney disease, strokes and heart attacks. Few drugs are proven to accomplish those goals.
Imagine going to a casino. If you want to play poker or roulette, you buy chips. Those chips are your surrogate money. If you win, you get to cash the chips back in for real money.
Any gambler would be outraged if the casino refused to trade the chips for cash at the end of a successful night. No casino would last long if it didn’t pay up.
Drug companies, though, get away without delivering on the eventual outcome because such studies are expensive and take a long time to complete. It is far easier just to prove that your pills lower cholesterol or blood sugar — and that is all that the Food and Drug Administration requires.
Several recent studies suggest that such surrogates are no longer adequate. A huge diabetes study financed by the federal government was halted prematurely because the results were so disappointing.
The ACCORD trial (Action to Control Cardiovascular Risk in Diabetes) was designed to lower blood sugar aggressively in high-risk diabetes patients. To everyone’s surprise, those who got the most intensive treatment with insulin and oral medications were more likely to die than those on standard therapy.
Researchers were shocked that better blood-sugar control did not result in an improved outcome as expected. In fact, just the reverse occurred. It would be like winning the lottery and discovering you had to pay money instead of taking your winnings.
Another study, ALLHAT, shocked the cardiology community when it revealed that an inexpensive diuretic outperformed newer, fancier drugs in preventing heart attacks and heart failure. All the drugs lowered blood pressure, but most doctors expected the more expensive drugs to provide a survival advantage. Some of the most popular pills actually increased the risk for heart failure.
These disappointments are reminiscent of another recent setback. The ENHANCE study was supposed to prove that lowering bad LDL cholesterol aggressively with a combination pill called Vytorin (Zetia plus simvastatin) would reduce clogging of carotid arteries. Vytorin did work better than simvastatin alone to reduce LDL. But to everyone’s surprise, the lower cholesterol numbers did not lead to cleaner arteries.
The study was not large enough to tell scientists whether the drug would reduce the likelihood of heart attacks or strokes. Those studies will take years to complete. In the meantime, the unexpected outcome of the ACCORD trial should make everyone wary of just assuming that lower numbers by themselves mean better health and longer survival.
Q. I have very sensitive skin that reacts badly to everything. I have used Listerine for years to clear up small blemishes. I apply a dab to the area at night, and usually by morning the spot is clear. It doesn’t irritate the surrounding skin, either. My husband has started using it for shaving bumps, too.
A. The herbal extracts and alcohol in Listerine that are supposed to “kill germs by millions on contact” may be useful in helping your blemishes heal. We have heard from other readers who have used Listerine in this way.
Q. I am taking naproxen for pain in my lower back, hands and knees. It seems to do the trick for the pain, but I am having lots of flatulence. There is probably no connection, but I would like to know for sure if the naproxen is causing it. Also, are there any other complications of naproxen that I should be aware of?
A. Naproxen (available as Aleve over the counter and as Anaprox, Naprelan or Naprosyn by prescription) is a nonsteroidal anti-inflammatory drug (NSAID). Like ibuprofen and similar pain relievers, naproxen can cause flatulence. A surprising number of medications can contribute to gassiness.
NSAIDs like naproxen can cause digestive distress including ulcers, high blood pressure, fluid retention, dizziness, drowsiness, ringing in the ears, rashes and kidney damage. You may want to consider some natural approaches to easing pain and inflammation such as boswellia, turmeric or fish oil.
You can find out more about such approaches as well as a number of causes and treatments for flatulence in “Best Choices From The People’s Pharmacy.” It is available from your local library or bookseller, or online at www.peoplespharmacy.com.
Q. I’ve read that people, especially older folks, should be out in the sun for at least 10 minutes per day to get vitamin D. What if the person has had skin cancer? I am conscientious about sunscreen, but someone told me using sunscreen negates the beneficial effects of sun exposure for vitamin D.
A. Everyone needs vitamin D, and most of us don’t get enough, especially in winter. This vitamin is crucial for a healthy immune system as well as strong bones. Older people who get adequate vitamin D are far less susceptible to falls.
Vitamin D is found in a few foods such as oily fish and fortified milk, but the primary source is sunshine. Sunscreen can keep skin from making vitamin D, so a supplement of 1,000 to 2,000 International Units daily might be advisable for someone like you who has had skin cancer. This is quite a bit more than the 400 IU in multivitamins, but corresponds to the latest research.
Q. A guest on your radio show mentioned an experimental use for a drug that had been used for inflammation and is now being looked at for diabetes prevention. It was “sawcelate” or something like that. What is the correct spelling, please?
A. The drug is salsalate. It is related to aspirin and fights pain and inflammation as aspirin does. It is far less irritating to the digestive tract, however.
Scientists at the Joslin Diabetes Center have found that salsalate can help people with diabetes and pre-diabetes lower their blood sugar and may be useful in preventing diabetes (Diabetes Care, February 2008). Like aspirin, salsalate has been used for more than a century. Unlike aspirin, however, it is available only by prescription.
Q. My daughter had three stubborn warts on the bottom of her foot that hurt her terribly. We tried salicylic acid tape from the pharmacy. It always burned off all the good skin and left the wart intact.
Duct tape didn’t work, and neither did freezing them off at the doctor’s office. They kept coming back.
I made a paste of fresh-scraped turmeric root and taped it on the warts. The warts were completely gone in three applications.
Bright-pink, fresh, smooth skin grew in the black-specked holes left behind after the bandage was removed. After they fell off following the turmeric treatment, the warts never came back.
I bought the turmeric from the health-food store. I taped a little lump the size of a pea on each wart and changed it each night. (I had her wear a sock to bed. Turmeric is neon-yellow and stains bedding.) I have no idea why it works, but someone at work said it worked for him.
A. No one knows much about why any wart remedy works. Warts are caused by a virus, though. Curcumin, a compound found in turmeric, has antiviral activity (Virology online, Jan. 14, 2008), so perhaps that explains your success.
Q. Our grandchild has had a bout with lice, picked up in her first-grade class. Her mother has purchased lice shampoo and all the stuff to spray, but the lice keep returning. That is despite washing all the linens and getting new pillows.
Can you give us any home-remedy advice? She is getting desperate!
A. Although it is important to wash and dry bedding at high heat when treating a child for lice, it should not be necessary to replace the pillows.
Lice have developed resistance to some commonly used lice shampoos. We do have a home remedy to suggest, though. Wet the hair thoroughly with Cetaphil cleanser, then blow it dry. This will form a hard shell on the hair. Leave it on overnight, then wash it out in the morning. The Cetaphil “shrink-wrap” suffocates the lice, and it is easier to remove than Vaseline!
Another trick is to rinse the hair with Listerine (original amber color). Leave the Listerine on for two hours and then use a lice comb.
Q. My husband says that his magnetic bracelet helps his arthritis pain. What do you have to say about that? Would it also help fibromyalgia? Are there side effects?
A. A few randomized studies suggest that magnets may help arthritis pain. Many scientists are still skeptical, but some people who have tried magnets agree with your husband. Magnets are not appropriate for pregnant women, people wearing pacemakers or those using electromagnetic equipment such as insulin pumps or sleep-apnea machines. We’re not aware of other side effects.
We discuss this approach among others in our Guide to Alternatives for Arthritis. Anyone who would like a copy, please send $3 in check or money order with a long (No. 10), stamped (58 cents), self-addressed envelope to: Graedons’ People’s Pharmacy, No. AA-2, P.O. Box 52027, Durham, NC 27717-2027. It also can be downloaded for $2 from our Web site: www.peoplespharmacy.com. Go to “Buy In Depth Guides.”
There are no studies to show whether a magnetic bracelet would help fibromyalgia. We think it is unlikely to do harm, though.
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