When something goes awry with a particular vehicle and it’s recalled, every consumer who bought one gets a notice in the mail. The way Hugo Stephenson sees it, prescription drugs should work much the same way.

But they don’t.

That’s why Stephenson, a drug safety expert, and Quintiles Transnational, where Stephenson worked until just recently, are officially launching iGuard on October 1. It’s open for new users now, and allows consumers to register on the site (for free) and record all the drugs they’re taking, along with their general health profile. When the FDA issues advisories and other safety notices for some 20,000 different marketed drugs, or when new research emerges about drugs or drug interactions that may affect them, iGuard members taking those drugs will get an e-mail alert.

The warning system uses a scale of 1 to 5 and is color-coded in a way that was inspired by the U.S. government’s homeland security alerts.
It’s impossible to gauge how many drugs will be given a “1,” which means suitable for widespread use, or a “5,” which iGuard says should be more carefully considered. Lipitor, for the record, gets a “2” rating from iGuard.

All drugs on the market are in iGuard’s system, and the public can get access to information on them after signing up and becoming a member.  If one goes to the site as a non-member and tries to look up specific drugs, many won’t come up. “We really don’t want to get into the actual risk rating for a drug until a person’s health profile and other prescriptions have been factored in,” explained Stephenson.

iGuard—which was funded by Quintiles but is now independent—has worked to ensure that its warning system is objective, said Stephenson. Two pharmacists gather the data. Then two safety experts place it into the five categories. The process will be completely transparent, he says, for anyone who wants to get a closer look at it.

‘Drug Safety is Tough’

“Keeping up with the whole drug-safety debate is tough for people,” said Stephenson. “We found there was huge frustration on the consumer’s behalf. When consumers find out that a drug they thought was working isn’t, it causes a lot of stress. Think Vioxx, Avandia. We saw a huge need to create a consumer-oriented service to give people quick updates about the products they’re taking.”

And so about a year ago, Stephenson began concentrating on the iGuard concept. In April, it really went into development. In August, he left his post as Quintiles’ senior vice president of strategic research and safety services to officially head up iGuard. He’s now its president.

Friends and Family First

The site was unveiled to a small friends-and-family audience this summer and caught on quickly, said Stephenson. It had more than 1,500 active users within a month. The goal? To sign up 100,000 patients in 12 months.

The cost to Quintiles is “a few hundred dollars per member,” Stephenson said.

Yeah, But Why?

What’s in it for Quintiles? Or the pharmaceutical industry? A better way to conduct post-approval research, says Stephenson. As part of their involvement with the site, iGuard members fill out surveys to report serious adverse events, and a form also goes to their physician. This helps reveal more adverse events than the typical 1 to 6 percent that are reported by the general population. If the iGuard users turn out to be representative of the U.S. population, the company’s database could evolve into an important early warning system for physicians and regulators.

Crucially, iGuard has the ability to provide context. “We are able to then look back and get a denominator,” Stephenson explained. “If we have 3,000 patients on Lipitor and three adverse events, we have context there where there normally isn’t. And we can look at: was their health profile different?”

Big Improvement, Potentially

This is an improvement over how most drug development companies currently do their post-approval research: running observational studies or using registries, which, in the end, often amount to “enormous money spent and getting very little,” Stephenson says. 

For example, he says, “For the 100 doctors we’d ask to participate in a registry or commitment study, maybe four would agree, then only one would actually do it, and that one would enroll one patient, who would drop out within 12 months. Companies spend millions [on this type of post-approval research] and get maybe a quarter of the data they need.”

Providing an Incentive

To improve on that, Stephenson—who had founded Health Research Solutions, an Australian contract research organization (CRO) that Quintiles acquired in 2002—began experimenting with a post-marketing research model he called the “patient-directed, doctor-reported approach,” in which patients reported adverse events to drug companies, with their doctor’s sign off. This involved a sponsor nudging a patient, instead of the doctor, for updates. It proved cheaper, and more effective, Stephenson found—but still, he puzzled over how to get patients to participate if there wasn’t anything in it for them.

And that’s how the idea for iGuard was hatched: it offers an upside for consumers willing to stay active with the site and report adverse events. And it’s a vast improvement over registries or looking at health insurance data, as iGuard members can be called and asked additional questions about their drug reactions if the need be, and if they have given the proper consent.

Go for a Blood Draw, Please

Researchers will be able to ask patients to get extra blood work or other diagnostics done at specific intervals, if it would help a trial. So far, 95 percent of iGuard members have checked yes when asked whether they would agree to participate in a trial in this way.

“How nice would it be if you could go back to patients who have been on Nexium for a year or longer and find out what their hemoglobin looks like?” said Stephenson, adding that iGuard, if it really takes off, will make this possible.

Free to Stakeholders

Stephenson said iGuard is already starting to collect interesting data on the back end—all of which is being made available to any researchers whose work would be enhanced by it. Epidemiologists, risk-management folks, anyone “on the stakeholder continuum,” he said. (The data has been anonymized, of course, to comply with HIPAA regulations.)

Stephenson is so excited about the info-harvesting promise he sees in the iGuard concept, he just wishes he and his team would have come up with it a long time ago.

Preventing Another Vioxx

“If we could wind the clock back, there may have been a possibility that patients on Vioxx could have been asked to go in for blood work at three months and six months, and so on,” thus avoiding the disaster that occurred.

Already, pharmaceutical companies and even the government have approached iGuard about helping them customize post-marketing research using the iGuard concept, but Stephenson said they’re not going there—not yet. He wants to focus on growth of the site and working out any kinks in communication with consumers. After all, lack of communication with consumers was what has made the site necessary.

But after that’s all in place, he says, who knows?

—by Suz Redfearn

_Editor’s note: Since this article was published, iGuard has been renamed MediGuard._

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