DC Medical Malpractice & Patient Safety Blog

Watch for this buzzword to become important in health care quality and safety over the next few years: "Comparative effectiveness research."

The $787 billion economic stimulus package that was signed into law in February 2009 will fund federal research on comparative effectiveness of treatment options, according to The New York Times’ Robert Pear. The research is aimed at saving money; health care in America totaled $2.2 trillion in 2007. But it could also provide a big boost toward higher quality health care.

Too few studies have been done to compare different treatments for a given illness, and as a result, doctors don’t really have solid information about what works for which patients. The gap in evidence translates into patients’ risk of getting ineffective or unnecessary treatments at billions of dollars each year. The new research projects will seek the most efficient and cost-effective treatments available to patients, and, in the process, reduce Americans’ spending on health care.

This new government effort in healthcare reform is a step toward improving quality of care. The studies of medical effectiveness already done have punctured many myths about medical treatments, proving over and over that what seems logical and reasonable does not always translate into proven benefits for patients.

One small example from the Patrick Malone law firm's experience shows how tragic injuries can come from unnecessary medical treatment. Our 13-year-old client suffered a head injury when she fell off her bicycle. She developed bleeding on the surface of the brain which was successfully drained by drilling a small hole in her skull. She was on her way toward uneventful and complete recovery when her neurosurgeon prescribed, on her way home from the hospital, a six-month course of Dilantin to prevent possible seizures. Over the course of the next several weeks, she developed a severe allergic reaction to the Dilantin that caused permanent damage to the corneas of both eyes, leaving her legally blind. When we investigated the case, we discovered that researchers had published a comprehensive study in one of the leading medical journals, the New England Journal of Medicine, proving that Dilantin is ineffective in preventing seizures after head injury in patients who don't spontaneously develop seizures in the first place. The surgeon was following traditional practice when he prescribed the drug to our client and was simply not aware of this research showing that the drug just didn't work. (The study showed that when patients after a head injury were randomly assigned to either receive Dilantin or a dummy pill, the ones who got the Dilantin actually had a few more seizures in the following months than the ones on the dummy pill.)

With the government behind a push to expand effectiveness research and give more publicity to the results of such research, patients will benefit by receiving only treatments that are proven to work and not those that are dangerous because they are worthless and come with side effects such as the one our young client experienced.

Do large doses of vitamins really help ward off health problems, including insomnia, fatigue, digestive disorders, and impaired immune system? A number of recent scientific studies challenge the long-held popular belief in the disease-preventing power of vitamin pills, which cost Americans $23 billion a year, Tara Parker-Pope reports in a New York Times article.

A study published last October showed that taking vitamin E or selenium does not prevent prostate cancer. In a separate study in November, scientists found that neither vitamin E nor vitamin C reduces the risk for cardiovascular diseases for men. Most recently, Women’s Health Initiative released a report in February 2009 that found no connection between vitamin usage and prevention of cancer or heart disease in women.

Not only have scientists discovered that, contrary to public belief, vitamins generally do not prevent or treat diseases, they found harmful effects of vitamin pills – beta carotene users are at greater risk for lung cancer, and those who take folic acid are more likely to have precancerous polyps than those who don’t.

If high doses of vitamin pills aren’t proven to prevent diseases and can potentially be harmful to our health, where else do we turn to avoid vitamin deficiency? Dr. Peter Gann, professor and director of research at the University of Illinois at Chicago, suggests a healthful and balanced diet that includes whole fruits or vegetables, since “[there] may not be a single component of broccoli or green leafy vegetables that is responsible for the health benefits.”

The American public should not throw out their vitamins just yet. Researchers are still studying the benefits of high doses of some promising vitamin extracts, for example, Vitamin D’s potential in reducing risks for cancer. But they again warn that “[w]e should wait for large-scale clinical trials before jumping on the vitamin bandwagon and taking high doses.”

In a recent initiative against contaminated weight-loss products, the FDA finds 69 drugs to be contaminated with prescription drugs and chemicals, and expects the list of brands to grow even longer in the next few weeks, reports Natasha Singer of the New York Times. A complete list of the tainted drugs found so far is available on FDA’s website.

One of the best known drugs on FDA’s list is StarCaps, endorsed by many celebrities, which was found to be tainted with bumentanide, a powerful diuretic that can give rise to serious side effects. FDA’s Michael Levy said that many of the products “either contain dangerous undeclared ingredients or…have no effect at all.”

These weight-loss products are not only illegal – FDA considers a supplement unapproved if it contains an undeclared active pharmaceutical ingredient – they also pose dangerous risks for consumers. For one thing, the ingredients on their own can cause problems like elevated blood pressure or seizures. Worse, the hidden ingredients can have toxic interactions with other medications, making it difficult for doctors to diagnose patients or manage their illnesses.

Although many of the distributors of these 69 drugs have voluntarily recalled the products, others continue to sell them on the internet. Consumers taking weight-loss supplements should monitor FDA’s growing list of products they should avoid and consult their doctors for a healthy and safe weight management plan.

One of the less common forms of cancer, oral cancer was diagnosed in about 35,300 Americans last year and caused the death of 7,600 people. Although oral cancer is one of the easiest to detect and diagnose, the five-year survival rate is only 59%, and more than 60% of cases are diagnosed in the late, incurable stages – which may be a result of people not regularly visiting their dentists or not asking to have visual exams, reports Laurie Tarkan of the New York Times.

The most effective way to screen for oral cancer is to carefully look for it. The dentist or dental hygienist should examine the cheeks, the gums, the floor of the mouth, the area behind the teeth, the palate and the tonsil area (pulling the tongue forward), and should feel the lymph nodes of the neck. Such visual exams are found to reduce mortality by 34% in a study done in India. Emerging on the market are alternative tests and devices that may be more sensitive than the traditional visual exams. However, no decisive study has been done to prove that the more expensive tests are necessarily better.

Dentists encourage patients to get a thorough visual exam every year, and they recommend it not only to the high-risk groups (smokers and heavy drinkers) but to every adult, because oral cancer has recently been linked to oral HPV, which is transmitted through oral sex.