Dartmouth Doctors say Drug Labels Leave Out Essential Information

Dartmouth doctors Lisa Schwartz and Steven Woloshin have an article in the recent New England Journal of Medicine.

They write that neither patients, nor doctors, are getting the information they need to make smart decisions about medicine.

The FDA has reams of clinical trial data showing how well or poorly new drugs work compared to placebos.

And the FDA also has information on the probability that a new medication will cause harm or death.

But Woloshin and Schwartz, who work for the Dartmouth Institute for Health Policy, say much of this information never makes it to drug labels.

Woloshin: "The drug label, which is the most direct way the FDA communicates what it knows about drugs to doctors, is kind of haphazard, so important information can be lost."

The doctors reviewed hundreds of pages of clinical trial data provided to the FDA for the drug review process.

For example, they report that trials of the sleeping pill Rozerem showed the drug makes little if any difference to insomniacs.

Woloshin: "In the sleep lab, people fell asleep seven minutes longer…good enough to pass the bar for approval."

In fact, some FDA reviewers doubted whether they should approve it.

The drug label says nothing about just how effective, or ineffective, Rozerem was shown to be in clinical trials.

Nor does it say anything about the reviewers’ doubts.

Steven Woloshin says this missing information misleads patients and doctors.

Woloshin: "Once a drug is approved, people may not think it was a close call, they just think, oh, drugs are approved because they work really well, which is not the case."

For drug companies, keeping key information off of labels and out of drug ads could mean the difference between a blockbuster drug and a bust.

Schwartz: "Lunesta typifies this."

Dr. Schwartz is talking about another sleeping pill – this one sold by Sepracor to the tune of more than $600 million last year.

Schwartz says in clinical trials, Lunesta helped patients fall asleep just fifteen minutes faster than patients who took nothing.

Schwartz: "There’s this tremendous advertising campaign, it’s just not that easy for either docs or patients to see how well the drug works…It’s our feeling that if people started to see that they might be less willing to have higher copays for taking these new medicines."

For the last several years, Schwartz and Woloshin have been trying to convince the FDA to adopt a drug fact box that would present research results in an easy to read way.

They’ve tested the box with average patients.

It’s similar to the nutritional information boxes on packaged foods.

And it turns out that when presented with basic data about the effectiveness of one drug versus another, consumers can easily tell which one works better.

In February, two FDA risk advisory committees voted that the FDA should employ the drug fact box or something like it.

Sidney Wolfe of Public Citizen is a doctor and a member of the FDA risk management advisory committee.

He says such a box would help reduce one of the leading causes of death -- adverse drug reactions.

Wolfe: “Underlying this problem is a grossly inadequate amount of information by doctors or patients about the real evidence-based assessment of benefits and risks of drugs.”

The FDA says it is interested in the Dartmouth doctors’ work.

But so far it has been slow to commit to the proposal, despite the advisory committees’ recommendations.

John Jenkins directs the FDA’s Office of New Drugs.

Jenkins: “We are working with Drs. Woloshin and Schwartz, we’ve been involved with their development of this drug fact box…we’re continuing to work with them to try to understand where their model fits into FDA communication vehicles.”

Part of the difficulty lies in the fact that the FDA doesn’t write the drug labels.

The drug companies do, under FDA guidelines.

And they are in no hurry to print bald, numerical statements about the relative effectiveness and risks of their drugs – on the labels or in their ads.

Jeff Francer is with Phrma, the industry trade group.

Francer: “People have to understand the appropriate role of the FDA. The appropriate role of the FDA is not to tell people what will work best in them. That’s the appropriate role of the physician.”

That, say Schwartz and Woloshin, is exactly the point: without the facts on drugs, a physician can’t prescribe intelligently.

The issue has risen to the halls of Congress.

Senators Jack Reed of Rhode Island and Barbara Mikulski of Maryland have written legislation that would require the FDA to study the fact box – and if it works, to adopt it soon.

That provision is included in the Senate HELP Committee health care overhaul legislation.

Mikulski’s staffers say it will be part of a merged health care bill.

Woloshin and Schwartz aren’t waiting for legislation.

On Thursday, Woloshin says, FDA leadership asked him and Schwartz to help the agency research better ways to communicate drug risks and benefits.

For NHPR News, I’m EG.