Just the Facts, Please: Doctors Start Company to Improve Drug Information

Sunday, February 09, 2014
Lebanon — Partly out of frustration with government lethargy and red tape, and mostly with a desire to improve the lives of patients, two professors at the Geisel School of Medicine at Dartmouth have founded a company they hope will soon provide patients with clear, concise and unbiased information about prescription drugs.

Physicians Lisa Schwartz and Steven Woloshin started Informulary Inc. a year ago, believing doctors, patients and pharmacists need an accurate understanding of what prescription drugs can and can’t do — and with that information, lives could be improved and, in some cases, saved.

After more than a decade of research, and of prodding the Food and Drug Administration, the husband-and-wife team decided to take a sabbatical from their clinical practice at the Veterans Affairs medical center in White River Junction and devote their energies to improving the kind of information the public has about prescription drugs.

There’s a vast and growing market for this kind of information: Nearly half the U.S. population takes at least one prescription drug every day. On average, those over 65 take at least three drugs a day. Prescription drug spending in the U.S. in 2012, the latest figures available, was $325.8 billion, or $898 per person, according to a recent study by the IMS Institute for Healthcare Informatics.

But even with that huge market, Informulary Inc.’s founders say, it is hard for consumers and health care providers to find good information about the benefits, harms and uncertainties of those drugs.

Schwartz and Woloshin, who study medical communication, realized there was a wide gap between the “half-truths” used to sell many medications and the critical, useful information the FDA had developed in the process of approving the drugs for market.

That problem, they reasoned, could be fixed with a simple, one-page sheet of information boiled down from the FDA data that would allow consumers and doctors to compare drugs and make informed choices — a “drug fact box.” The idea came to them over breakfast one morning, they say, while looking at the nutrition facts on a box of Cocoa Krispies.

“Finding out about the drugs you’re taking should be as easy as looking at the nutrition facts on a box of cereal,” Woloshin said last month during an interview in the Dartmouth Regional Technical Center, where the offices of the seven-person company occupy an open space with floor-to-ceiling windows and a handful of chairs, small tables and computers. “But in many cases that information is not available on drug labels (the package inserts that come with prescriptions) or presented in ads,” he said. The information provided to the public, reprinted in the Physician s’ D esk Reference and excerpted online, doesn’t contain independent, understandable facts about the medications, he said.

When pharmaceutical companies want the FDA’s approval for a new drug, they are required to perform studies and clinical trials and submit the results to the FDA, Schwartz and Woloshin wrote in a 2009 article in The New England Journal of Medicine. The FDA reviewers evaluate the evidence that supports or questions the drug’s effectiveness, and they determine whether the drug does “more good than harm,” Schwartz said. The reviews take about a year, and the results are documented, providing insight into how the reviewers deliberated before deciding to approve the drugs.

Many people believe a drug must be safe and effective if it has been approved by the FDA, but all FDA approval does is indicate that the agency is convinced the medication will do more good than harm. Many don’t realize that uncertainties about the medication remain.

Those uncertainties, data about the harms, and detailed results of clinical trials and studies often don’t appear on drug labels. The information also usually doesn’t make it into relevant journal articles, they said. That can lead to overprescribing or other problems that could be harmful to patients.

What does appear on drug labels is a long litany of possible side effects. This information is provided by the drug companies and approved by the FDA, but it is designed specifically to shield the pharmaceutical firms from lawsuits, Woloshin said.

At the same time, pharmaceutical companies spend a great deal of money advertising their drugs to the public — $4.3 billion a year, about 10 times the FDA’s budget for evaluating new drugs, according to a 2012 presentation Woloshin made to the National Academy of Sciences, which is posted on the company’s website (www.informulary.com).

As a rule, the benefits of the medications are asserted with vague qualitative statements. Only about 13 percent of the advertisements contain data from studies and trials, and that data typically is presented in an exaggerated format.

The message is appealing and seems easy to understand, but it’s very misleading, Woloshin said.

For example, Rozerem, a drug that was approved in 2005, was aggressively promoted to consumers to solve chronic insomnia, the Journal article says. Newspaper and magazine ads for Rozerem show Abe Lincoln and an owl sitting at a breakfast table with the catch line, “Your dreams miss you.” The ad contains no data on how well the drug works.

The FDA-approved language on the label notes, somewhat cryptically, that “both doses of Rozerem reduced the average latency to persistent sleep at each of the time points when compared to placebo.”

Not included are results of lab trials that showed the drug induced sleep seven minutes faster for younger adults, and 14 minutes faster for older people, compared with a placebo. Nor are the results of real-life trials, in which Rozerem showed no difference in younger adults and induced sleep eight minutes faster in older people. All trials showed that the drug had no effect on the ease of falling back asleep, the number of sleep awakenings, total sleep time or sleep quality.

The FDA reviewers’ comments, which also weren’t included in the ads or on the label, are succinct: “Rozerem has a statistically significant treatment effect that is of marginal clinical significance … the treatment effect does not seem robust. Patients who are currently being targeted by the proposed indication do not seem to recognize any benefit from treatment with Rozerem.” The reviewers also expressed concern about the safety of the drug and its side effects.

“Doctors need to know how well a drug works, not just what it does, or just what side effects it can and can’t cause,” Schwartz said.

All the information is on the FDA’s website and can be found with relative ease, but it’s poorly organized and weakly summarized. Nevertheless, it’s still a wealth of information, Woloshin said. “We start out with thousands of pages, a box full, and boil that down to the pertinent facts.”

Woloshin and Schwartz developed a prototype of the “fact box” and met with 20 FDA officials. They’d come up with a good idea, FDA officials said, warning, however, that to include the fact boxes on drug labels and in advertisements would require an act of Congress. That was in 2002.

The FDA officials challenged the medical school professors to conduct studies that would show that consumers really want to know the information and understand the benefits of the data.

With the help of the Robert Wood Johnson Foundation, the nation’s largest philanthropy organization devoted solely to public health, Schwartz and Woloshin conducted three randomized studies — in Boston, in Vermont and nationwide — to see if the drug fact boxes helped people understand the differences between two competing drugs, one that was more effective than the other.

Half the participants received a brief summary of the FDA-sanctioned drug label. The other half got a one-page drug fact box instead of the summary label. In the fact box group, almost 70 percent picked the better drug. Only about 31 percent of the label-only group picked the more effective medication.

The FDA’s Risk Communication Advisory Committee proposed in 2009 that drug facts boxes become law, and the 2010 Affordable Care Act stipulated that the federal Department of Health and Human Services decide within a year whether to adopt the boxes.

When in 2011, Health and Human Services said it would take three more years to deliberate, the decision changed the doctors’ thinking — and the course of their lives.

“We were incredibly disappointed when we found out that it was going to be delayed again,” Schwartz said last week.

They had demonstrated the need for the fact boxes, and Health and Human services had the evidence. A handful of U.S. senators, including Jeanne Shaheen, D-N.H., added their support and wrote letters to get the agency to move quickly, but to no avail, Swartz said.

“We wrote an op-ed piece for Th e New York Times. We thought that might put pressure on them, but it didn’t seem to. I really believe that getting this information out there could really make a difference and will help a lot of people.”

At the encouragement of the Robert Wood Johnson Foundation, they met with a business councilor in New York and began to explore developing a for-profit company.

A few months later, they got together with Gregg Fairbrothers at the Dartmouth Entrepreneurial Network, and they took his introduction to entrepreneurship course at the Tuck School of Business at Dartmouth.

“This is a whole new world for us. We’re researchers, physicians. Business is something we’re having to learn about,” Woloshin said.

Being in business and doing significant research is a balancing act that requires full disclosure and maintaining high ethical standards, “something we are very aware of,” Schwartz said.

To launch the company, Robert Wood Johnson provided Informulary with a grant, and Dartmouth-Hitchcock made an investment. “Dartmouth-Hitchcock is a principal investor in Informulary, given its mission of improving health by helping providers and patients make wise decisions about prescription drugs, (which) is entirely consistent with Dartmouth-Hitchcock’s goals of population health and informed decision making in health care,” said Dartmouth-Hitchcock spokesman Clarence R. Adams Jr. in an email last week.

“Our investment was appropriate to support the initial startup of the firm, and we look forward to working with them as they continue to develop the product and business model.”

A contract also has been signed with Consumer Reports, and the company is providing information for articles in the nonprofit organization’s magazine.

Informulary is on track to build a database that is large enough to be marketable to consumers and health providers by the end of the year, Schwartz said.

“It’s a changing landscape, but we’re on the way to getting that done.”

Warren Johnston can be reached at wjohnston@vnews.com or 603-727-3216.