How Safe Is That Drug? Get A Rating!
9 CommentsBy Ed Silverman // October 2nd, 2007 // 11:05 am
Taking a page from Consumer Reports, a former Quintiles exec this week will be launching a new web site that provides consumers with risk info about their meds in the form of color-coded rankings. Called iGuard, the venture is designed to take the mystery out of the time-consuming and often confusing process of learning whether a drug is safe enough to take. The site relies on the latest medical info and a user’s personal health data to generate a ranking. A red 5, for instance, may be the equivalent of placing an Al-Qaeda pill in your body.
“The model came from the car industry. Most consumers don’t get a phone call from a pharmacist or doctor (about safety info). It’s left up to them to determine how actively they want to look up info…So if you look at drug safety in the US, it’s a big issue largely because patients and physicians don’t feel risk has been communicated very well to consumers, or in a timely fashion,” says founder Hugo Stephenson, who’s biggest backer is Quintiles, the contract-research organization.
“Let’s use the info that came out yesterday about bisphosphonates, such as Fosamax. Well, that was in the New England Journal of Medicine four or five months ago, but patients may ask why they’re not told. You turn on the TV and see everything about benefit. The challenge is that industry can’t not talk about risk. Presenting a 2-page ad in a magazine with very fine print doesn’t constitute full disclosure.”
Who’s assessing the risk info? A handful of outsiders…
…with backgrounds in medicine, biostatistics, pharmacovigilance, and evidence-based medicine, who serve as a ‘clinical review team,’ although at least two are also drug safety consultants to unnamed clients. One is Judith Jones, who heads The Degge Group, and the other is David Goldsmith.
And what happens to all that personal health info? iGuard will develop a database that can be accessed by researchers from government, academia or industry seeking to do studies. And of course, market researchers can also mine the info.
“Most patients won’t dwell on safety. I think they’ll understand it and move on. That’s what we’re trying to focus on,” he says. “It’s not designed to be sensational, though. I’d like to be the vehicle for commmuncating risk in a more low-key fashion.”
Paul Joannides
You report that iGuard’s biggest backer is Quintiles. On their website, Quintiles says, “Quintiles has helped develop or commercialize all 30 of the world’s top 30 best-selling drugs.”
Forgive me, as I don’t know about the safeguards in your industry, but how does this differ from the fox guarding the hen house?
Also, it seems like the biggest risk occurs when a patient is taking multiple drugs. For instance, Drug X by itself might not be a problem, but what is the risk if you are taking Drug X, Drug Y and Drug Z? Is this something that iGuard can help patients assess?
Reality
I’m very disappointed in the readership of Pharmalot that it took over 3 hours for someone to point out the relationship of Quintiles to pharmaceutical development, CME, etc. You guys are slipping! ;-)
Also, I have to say — and forgive the superficiality — but iGuard’s leadership team (http://www.iguard.org/help/about/leadership.html) better do something about those photos if they want their site to be taken as a serious source of pharma safety info. The lack of professionalism with their casual couch and vacation photos doesn’t exactly instill a lot of confidence.
Hank
It’s not as immediate in terms of “the latest,” but Therapeutics Initiative in BC is another great site to get good, evidence-based analyses.
Ed Silverman
Hi Paul,
You asked a good question. And there would be a problem if, for instance, a Quintiles-run trial overlooked some data, or worse. Of course, that would create all sorts of issues before we even think about iGuard.
Another question, perhaps, is whether a drug would get a more favorable rating if Quintiles was involved the trials. We don’t know, although the company is involved in so many trials that, theoretically, many drug ratings would be open to question.
This is all hypothetical. What’s interesting is the small number of iGuard’s ‘clinical review team,’ and the large number of drugs. Simply put, a larger team may be desirable. And those undisclosed consulting ties should be disclosed - at the very least.
I think the site will be interesting to watch and generate more fodder for comment as it progresses. We’ll be watching.
Thanks for writing,
ed at Pharmalot
Laurie
The fact that Iguard is spamming web based message boards, mine included, is a big red flag for me.
Chris
Paul, as I understand it people registering with iguard have to upload the various drugs they are using so each person’s profile is taken into account and the particular combo of drugs they are on is taken into account in their personalized risk factors.
And Ed, I think this topic of CROs’ impartiality was touched on before. I said then that their business is too large to jeopardise by skewing results. The trials they conduct are subject to the same guidelines, inclusion/exclusion criteria and reporting conventions as any other - academic, industry or whatever. They are expected to (and do) operate under the same ethical guidelines as any other investigator.
And I do not work at Quintiles or any other CRO. I just happen to know how it works.
Chris
sea
I don’t like the data-mining possibilities. Doctors have a hard enough time responding to reps who have their prescribing information - what will happen when pharma is able to go directly to the patient? Are we going to see scenarios where a rep is calling patients and telling them that their product will work better so ask your doctor for a scrip?
Another question - if Quintiles has “helped develop or commercialize” the top 30 best-selling drugs (as Paul says), why hasn’t “risk… been communicated very well to consumers, or in a timely fashion”? If you help develop and commercialize a drug don’t you bear some responsibility for safety?
It all sounds fishy to me. I’ll do my own research.
Reality
“What will happen when pharma is able to go directly to the patient?”
+++++++++++++++++++++
Too late. It’s called DTC advertising. Not to mention the colossally boneheaded Prozac mailing by Lilly a few years ago (http://query.nytimes.com/gst/fullpage.html?res=9C07E2DE1E31F935A35754C0A9649C8B63).
Lisa Van S
Reality,
Great response…..