A Push to Spell Out a Drug’s Risks and Benefits

[Pharma Newshound]

Source: NY Times

By NATASHA SINGER

WHAT if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbs and calories of an Oreo cookie?

Inspired by the nutrition fact panels on food packaging, researchers at the Dartmouth Medical School are urging federal regulators to adopt a similar concept — numerical tables that quantify the benefits of taking a drug compared with a placebo, and that list the odds of having side effects.

These drug fact boxes or benefit boxes, as the Dartmouth team calls them, would appear on magazine advertisements for drugs as well as on the Food and Drug Administration’s Web site, if the researchers have their way.

“We thought, if you could do it for Cocoa Krispies or Diet Coke, why couldn’t you do it for Lunesta or other drugs?” said Dr. Steven Woloshin, a general internist and researcher at the Dartmouth Institute for Health Policy and Clinical Practice.

On Friday, Dr. Woloshin and Dr. Lisa Schwartz, also of the Dartmouth institute, plan to present their case to the F.D.A. during a meeting of the agency’s advisory committee on “risk communication.” That panel is examining how best to provide consumers with data about prescription drugs using printed matter like package inserts.

Dr. Woloshin and Dr. Schwartz are scheduled to present the results of two randomized trials, published last week in Annals of Internal Medicine, in which they examined how well drug fact boxes worked on several hundred people. The studies indicated that most people presented with comparative risk and benefit information were able to identify the more effective of two drugs.

The F.D.A. would not comment on the merits of the Dartmouth proposal before the hearing on Friday, Sandy Walsh, an agency spokeswoman, wrote in an e-mail message to a reporter. The hearing is focused on improving drug information for patients, she said.

But on its Web site, the agency acknowledges receiving complaints that drug ads provide inadequate information for consumers. Ms. Walsh said the agency was studying how to improve drug advertising.

At least one executive involved in drug marketing said he agreed with the Dartmouth effort and was enthusiastic about the prospect of the public’s knowing how well a drug works and the odds of having side effects.

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That marketing executive, Robert Ehrlich, the chief of DTC Perspectives, a publishing and consulting company specializing in pharmaceutical marketing, said he also had urged the F.D.A. to ask for risk statistics in ads.

The Dartmouth researchers, in one example, used data from a published study of the insomnia drug Lunesta to create a benefit box showing that volunteers who took the sleeping pill nightly for six months typically fell asleep 15 minutes faster than people on a placebo. The table, e-mailed to a reporter, also indicates that volunteers taking Lunesta typically slept for six hours and 22 minutes — or only 37 minutes longer than the placebo group. There was no difference in life-threatening side effects among the groups.

In 2007, Sepracor, the maker of Lunesta, spent about $293 million on advertisements for the sleeping pill, the highest ad spending that year among drug brands, according to Nielsen.

The doctors’ sample drug box is based on a study from 2003 in which patients themselves reported on how long they had slept, Amy Trevvett, a spokeswoman for Sepracor, wrote in an e-mail message. A subsequent study, using a more scientific method of measuring sleep duration, reported that patients taking Lunesta slept for seven hours or more, she wrote.

Federal law requires that drug ads include a brief summary about the possible side effects of a medication and about who should not take a certain drug. In television and radio commercials, this summary often takes the form of a hastily read list of hazards that can run the gamut from dizziness to death. The back side of print ads typically provides the material in small print, sometimes in dense medical language.

But ads are not required to — and seldom do — spell out how well a drug works or how often volunteers in clinical studies had side effects. In a highly anecdotal sampling of a dozen current issues of glossy magazines, a reporter found only one pharmaceutical ad, for the smoking cessation drug Chantix, that quantified its advantages over a placebo.

The pharmaceutical industry spent nearly $4.8 billion last year on television and print ads, according to Nielsen Media Research.

Critics, including some doctors, legislators and health advocates, have called the current format of drug ads misleading. In the absence of effectiveness statistics, critics say, ads may influence people to seek prescriptions for drugs that are of only marginal benefit. Meanwhile, the lack of data on the likelihood of side effects could scare consumers into avoiding highly effective drugs if they overestimate the risks.

The Dartmouth researchers said their benefit boxes could provide an answer to such criticisms at a time when some members of Congress have vowed to restrict drug advertising, even as the industry argues that such marketing is a valuable consumer education tool.

Dr. Schwartz said it would not be onerous for F.D.A. experts to fill out a form containing statistics for use in drug fact boxes. The agency regularly vets clinical trials, submitted by manufacturers seeking drug approvals, which contain data necessary for such information tables.

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The general idea of a drug fact box is not new, said Alan Goldhammer, the vice president for science and regulatory affairs for PhRMA, a pharmaceutical industry trade group. Although packaging for over-the-counter drugs like Claritin does not typically include statistics on efficacy, Dr. Goldhammer said packages contained information panels with facts about active ingredients and directions. He added that drug makers over the last few years had greatly improved the medical explanations in print ads.

But Mr. Ehrlich, of DTC Perspectives, said he thought current ads were too vague about risks. “If you mention fatality in an ad, what does it mean to a consumer — one in 100, one in 1,000, one in 100,000?” Mr. Ehrlich said. “If you mention fatality, you owe the consumer some kind of odds of occurrence. I am not talking about a sneeze.”

Consumers armed with more numerical information might avoid less effective drugs, he said, but the new approach might be good for the industry.

“If there is high benefit and low risk, doctors will prescribe more of the drugs,” Mr. Ehrlich said. “If there is low benefit and high risk, the drugs probably should not be on the market.”

[Pharma Newshound]

Source: Dartmouth Medicine Magazine

By Matthew C.Wiencke

'Peaceful, restful sleep" promises an ad for the sleep drug Lunesta. Yet nowhere in the fine print of the ad (or the drug's package insert) is there any data about howmany people who take the drug are helped by it or how much sleep they get when taking it. Such "benefits data" is not currently required by the Food and Drug Administration (FDA).

The ad, says DMS's StevenWoloshin, M.D., suggests that popping a Lunesta leads to eight hours in dreamland. "But if you actually look at the data, and this is real data, you fall asleep 15 minutes faster and sleep 37 minutes longer than [with a] placebo."

Common: He and other DMS researchers are also concerned that the information on side effects in drug ads can be confusing. Ads have "huge laundry lists of side effects, and oftentimes they're not highlighting the ones that are more common than placebos' [side effects]," notes DMS's Lisa Schwartz, M.D. Ads also don't make it clear which side effects may be life threatening and which are merely bothersome.

So Woloshin, Schwartz, and H.Gilbert Welch, M.D., created a "drug facts box," to help patients (and physicians) better understand drugs' capabilities. The top part of the box describes what the drug is designed to do, who should consider taking it, and what monitoring is recommended.

In the middle is a table with study data showing the drug's benefits and side effects compared to a placebo. At the bottom is its FDA approval date.

Facts: The DMS team then recruited 274 volunteers and presented them with a drug facts box about tamoxifen (a breast cancer preventative) and a survey to test their comprehension of the data.

"People did quite well," says Woloshin. "That was very gratifying." The vast majority, 89%, correctly determined what percentage of women given tamoxifen got a blood clot in their legs or lungs; 71% calculated the absolute difference in the proportion of women who got breast cancer in the tamoxifen group versus the placebo group. Over 66% chose the better drug in two scenarios that called for comparing percentages. Half of those with only a highschool degree and two thirds of those with some college correctly answered at least four out of five questions based on the study data table. The results were published in Medical Decision Making.

FDA reviewers have expressed interest in the concept and are now working with Schwartz and Woloshin. The researchers' goal is to have the box included in drug package inserts, says Woloshin. They're optimistic about the prospect. The FDA reviewers "really are dedicated public servants," says Schwartz. The researchers are all affiliated with the Center for Medicine, the Media, and the Public at the Dartmouth Institute for Health Policy and Clinical Practice.

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