Health Headlines:

A. The FDA does no testing of its own but did approve lead acetate as a "progressive" hair dye. That means it gradually darkens hair with repeated use.

The FDA concluded in 2002 that according to safety tests it received, "No significant increase in blood levels of lead was seen in the trial subjects and the lead was not shown to be absorbed into the body through such use."

Despite this reassurance, questions remain about the safety of lead-containing hair dyes. Canadian and European Union health authorities have banned lead from hair dyes and personal care products.

A study published in the Journal of the American Pharmaceutical Association (Jan/Feb, 1997) revealed that some lead residue is left on hands even after washing. Rubbing hands through hair may contaminate hands again.

The researchers noted that, "Given the requirement to continually reapply these hair coloring agents, the user becomes a living purveyor of lead contamination."

These new guidelines triggered a firestorm of outrage from some quarters. The American Cancer Society and the American College of Radiology objected to them. Some women who have had breast cancers detected through mammograms were distressed at the idea of forgoing them. Most women have been told that any sign of cancer requires surgery or other aggressive treatment. But there is growing awareness that some breast tumors do not warrant heroic measures because they don't threaten the woman's life. Just as with prostate cancer, some breast cancers just sit there so women die with them but not as a result of them. Our current screening methods do not allow doctors to determine which is which.

[Annals of Internal Medicine, November 17, 2009]

Too bad doctors and patients can't do the same thing when it comes to medications. Unfortunately, the information that they need to make critical decisions that can affect health may not be readily available.

That's what two experts on drug safety concluded in the New England Journal of Medicine (Oct. 29, 2009). Lisa Schwartz, MD, and Steven Woloshin, MD, point out that doctors rely on the drug "label" to learn about effectiveness and safety. This official prescribing information is "written by drug companies, then negotiated and approved by the FDA."

What many people don't realize is that these drug labels may leave a lot of crucial information out. Perhaps that why Drs. Schwartz and Woloshin titled their perspective "Lost in Transmission--FDA Drug Information That Never Reaches Clinicians."
Imagine trying to decide which washing machine to buy without knowing any comparative data about various brands and their efficiency or repair record. It would be next to impossible to make an informed choice.

Doctors are in a similar situation when they try to choose which sleeping pill to prescribe, for example. The article discusses Lunesta, a highly advertised prescription sleeping pill. Its television commercials feature a Luna moth flitting in through an open window to bring sleep to restless insomniacs.

Those ads and other promotions cost the manufacturer of Lunesta $750,000 a day in 2007, but the expense really paid off. In 2008, sales of Lunesta were nearly $800 million.
With sales like that, you might conclude that Lunesta works really well. The label says only that the drug is better than placebo. How much better? In the biggest, longest clinical trial, Lunesta helped insomniacs fall asleep about 15 minutes faster (on average) than those on placebo. They slept a bit more than half an hour longer. According to data the FDA has, there was "no clinically meaningful improvement in next-day alertness or functioning," but you won't find that statement anywhere in the drug label.

Another prescription sleeping pill, Rozerem, was no more impressive. As Schwartz and Woloshin note, "there were no subjective improvements in total sleep time, sleep quality, or the time it took to fall asleep." An FDA review before approval concluded that the drug had "marginal clinical significance." In other words, Rozerem just barely made it through the FDA approval process, but the label did not reflect this. Television commercials (many involving Abe Lincoln and a badger) implied that Rozerem was a new advance for fighting insomnia.

Some side effect information may also be lacking in the official label. That means doctors may not know about certain serious adverse reactions before prescribing a new drug.
Perhaps it's time to get as much information about our prospective medicines as we can about a new TV. Doctors and patients deserve an easy-to-read summary of the true benefits and risks of prescription medications.