Patient Safety Blog

Nearly every week, we hear more evidence that American children are over-medicated, especially with drugs that affect mood and behavior. Most recently, a panel of experts has denounced the overuse of Risperdal, a powerful antipsychotic drug, for attention deficit disorder. The drug has too many side effects, including potential development of permanent muscle twitching, to justify its use in mild conditions like ADD for which other options exist, according to the expert panel convened by the Food & Drug Administration to advise it on labeling changes.

What is behind the explosion in use of antipsychotic drugs in children (besides Risperdal, they include Zyprexa, Seroquel, Abilify and Geodon) is a drumbeat of support from leaders in child psychiatry. But that leadership is tainted by their ties to the drug industry -- ties that frequently don't get mentioned in public when these same doctors are lecturing their colleagues and advising worried parents. One leader, Dr. Joseph Biederman, a child psychiatrist at Harvard, was revealed by a Congressional investigation to have accepted $1.4 million from manufacturers of antipsychotic drugs that he did not disclose to his university. Another psychiatrist leader, Dr. Charles B. Nemeroff of Emory, had to step down as chair of psychiatry after it was revealed that much of his consulting pay from drug makers, which totaled over $2.8 million in seven years, had been hidden from his university.

Now another influential psychiatrist has been exposed for his secret ties to the drug industry. He is Dr. Frederick Goodwin, former chief of the National Institute of Mental Health, who hosted a popular show on National Public Radio, "The Infinite Mind." Senator Charles Grassley of Iowa released data to the New York Times showing that Dr. Goodwin received $1.3 million from drug manufacturers from 2000 to 2007 for giving marketing lectures to other doctors. The money was never mentioned on his radio show, and NPR now says the show has been canceled and all reruns will stop soon.

According to the Times' Gardiner Harris, on one day in 2005, Dr. Goodwin received $2,500 from GlaxoSmithKline to give a talk about its mood stabilizer drug Lamictal at a Ritz Carlton resort in Florida. On his radio show broadcast the same day, Dr. Goodwin said that children with bipolar disorder who did not get treatment could suffer brain damage (a controversial prognosis) but he reassured his listeners that mood stabilizer drugs were a safe and effective way to treat the problem.

Senator Grassley has sponsored legislation to require drug makers to post publicly all the payments they make to doctor consultants. That would help the public to know whether the recommendations they see from doctors for medicating their children are truly unbiased or should be taken with a grain of salt.

Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Disclosure , Doctor-Patient Relationship , Medications

Bookmark:

Millions of people with normal cholesterol levels in their blood could be started on cholesterol-lowering statin drugs based on a new research study, but if patients understood the numbers behind the study, they might not move so fast to put statins in their medicine cabinet. Every patient can benefit from a closer understanding of how statistics work in medicine to push people toward treatments that they may or may not really benefit from.

The latest study involves people who were put on cholesterol-lowering statins because they had a high result on a blood test called C-Reactive Protein, even though the same people did not have high cholesterol.

As reported by Tara Parker-Pope in the New York Times' "Well" blog, here are the key numbers:

* The researchers reported an impressive sounding 50 percent reduction in heart attacks in the group treated with statins, as compared to patients in the same study who got a sugar pill (placebo) instead.

* But the real numbers of actual patients helped by the statins were only around nine in every 1,000 people treated -- less than one percent.

How do those numbers fit together? In the placebo group, 18 of every 1,000 patients suffered a heart attack or some other serious heart event during the study. In the group taking the statin drug, nine of every 1,000 patients had a serious heart event. That's how the researchers could report that the risk had been cut in half -- from eighteen to nine -- although the actual numbers of patients were few. Comparing eighteen to nine is called a relative risk ratio. Comparing 18/1,000 to 9/1,000 is called comparing the absolute risk. The absolute risk number is usually more meaningful.

Another important number for patients to understand in figuring out if a new medicine is for them is called the "number needed to treat." How many patients need to be treated with the new drug for one patient to benefit?

According to a New England Journal of Medicine editorial which analyzed the new study, 120 patients would need to be treated with statins over two years for just one of those patients to benefit.

That number might be enough to persuade some patients to take the drug. But it's a lot different than fifty percent. Bottom line: to make intelligent choices about treatments, patients need to understand how many patients like them are really expected to benefit from the treatment.

Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Communication , Disclosure , Doctor-Patient Relationship , General , Medications

Bookmark:

A recent medical malpractice lawsuit prosecuted by Patrick Malone & Associates for the victim of a delayed diagnosis of skin cancer highlights the need for annual skin checks by a qualified doctor. Anyone who is fair-skinned, sunburns easily, or has a lot of moles on their skin should see a dermatologist or a good primary care doctor for annual skin checks. These can be part of a routine physical exam. The doctor should measure and do sketches of the moles' location and appearance on your skin, or should take good photographs. A change in a mole is one of the key indicators of potential for malignant melanoma, a skin cancer which is deadly once it gets into the bloodstream but is 100% curable when still confined to the skin. Patients and their families often don't notice subtle changes in a mole -- getting bigger, changing color, etc. -- that health care providers can pick up.

In the legal case of Semsker v. Lockshin, a benign mole on the patient's lower back turned into a deadly melanoma over an eight-year period, during which time the mole's presence and change in size was documented by the dermatologist. The lawsuit alleged the dermatologist should have removed the mole two years before it finally was removed, when it had already invaded the patient's lymph nodes. Mr. Semsker died 14 months after the diagnosis.

In their defense of the malpractice lawsuit, the dermatology practice of Norman Lockshin, M.D., P.A., contended that they would have told the patient to get skin checks even more often than he was (every few years from either his primary doctor or his dermatologist), although this recommendation was not documented in their records.

Regardless, every patient needs to know about the dangers of melanoma and the need for regular skin exams. Exams should focus on the ABCDE's of skin cancer: A for Asymmetry of the mole; B for irregular Borders; C for variegated Color or unusual color in the mole; D for diameter greater than 6 millimeters, and E for Evolution or changes in the mole's size, shape or color.

Posted by Patrick A. Malone | Permalink | Email This Post

Posted In: Cancer , Communication , Doctor-Patient Relationship , Medical Error

Bookmark: