Monday, November 27, 2006


Today the hunt for the vulnerable plaque will begin in earnest. It's not a new adventure, but one I like to think of a "Plaquequest."

"Vulnerable plaque" is the plaque within an artery that can suddenly "rupture" and stimulate the rapid formation of clot within a coronary artery, compromising blood flow to a portion of heart muscle, and leading to a heart attack. Cardiologists have long recognized that tightly narrowed arteries are not necessarily the ones that suddenly occlude during a heart attack; sometimes only modestly narrowed arteries become abruptly occluded. This has lead to a search for ways to identify which plaques are vulnerable to rupture before rupture occurs, potentially saving lives and heart muscle.

A consortium of researchers are assembling to attempt to identify vulnerable plaque. To the tune of $30 million. It is a huge undertaking, but the pot of gold at the end of the rainbow is just too tempting for industry to ignore. It is not surprizing that Merck and Astra Zeneca, two large pharmaceutical companies have joined the hunt. But BG Medical? Who are they? Described as a new "start-up company" in the New York Times, it's really a consortium of pharmaceutical and imaging industry interests including Astra Zeneca, Boehringer Ingelheim, Biorosettex, GlaxoSmithKline, Philips, Mitsubishi Pharma Corporation, the "Global Alliance for TB Drug Development" (what has tuberculosis got to do with this? I wonder if their membership is happy about this investment, but I digress) and...

..the FDA.

Really? The Food and Drug Administration is now a "Partner" with BG Medical? Maybe so. At least they're listed on BG Medical's "Innovative Paths to a Trusted Partner" page on their website. Certainly, there have been concerns regarding conflicts of interest with the FDA's "Special Government Employees" that advise the FDA having conflicts of interests with the pharmaceutical industry and what needs to be disclosed to the public. But to this doctor, the FDA itself has a responsibility to the public at large to maintain objectivity in its oversight of new drugs during the approval process. Certainly this partnership of the FDA itself with BG Medical violates the public's trust.

Oh, but we needn't stop here.

Look who else is "partnering" in Plaquequest: Humana, a manager of health care insurance plans.
The centerpiece of the research will be a study of 4,000 to 6,000 Humana patients with at least two known risk factors for heart attacks. As the outcome for the patients becomes clear over the next few years, researchers hope the profiles that emerge from the study will, in hindsight, show patterns pointing directly to the high-risk patients who actually suffered heart attacks. That in turn could help the companies create new therapeutic products.
I'm not sure of their motivation here, but I wonder how much revenue and "best practices data" they receive for supplying the patients for this trial. Hmmm. It seems only Humana patients will be participating in this "research." Why?

Plaquequest is a noble goal indeed. Going after arteries already blocked is a $6 billion stent market. $20 billion more are spent for statin drugs for primary and secondary prevention of coronary disease presently. It seems clear that the drug and device industry wants to know if they can boldly grow this market so cardiologists can place stents in asymptomatic arteries cloaked under the "vulnerability" guise. Interesting, but will this work?

Lets say this research succeeds at Plaquequest. How do we apply this finding to John Q. Public? Do we then place a stent there knowing it could thrombose as a result of the stent being there? Or should we place everyone on a statin drug as we've already been recommended for anyone with significant hyperlipidemia. Doctors haven't historically been so good at even this simple recommendation. And imaging to screen for vulnerable plaque is expensive: who is going to pay for massive screening tests? (Take a guess) So what have we gained?

It's hard to know. Maybe some new drugs or insights to the mechanism of acute coronary syndromes will be discovered, leading to new research paths for these great companies. But I hope Plaquequest is more than a means for Humana to get more best practice and cost analysis data while doctors get to feel good that the pharmaceutical and medical imaging industry has "given back" to research centers, and maybe the FDA.



CardioNP said...

Even if they are able to figure out how to accurately predict vulnerable plaques, I am wondering how they will determine who gets IVUS'd and who pays.
Will be interesting to see how this plays out.
A former EP attending joked that in the 80s the indication for an EP study was groin access and a heart.
Sounds like the indication for vulnerable plaque screening might be any cardiac risk factor, access and a heart!

DrWes said...

Sounds like the indication for vulnerable plaque screening might be any cardiac risk factor, access and a heart!

IVUS (intravascular ultrasound) will never be a long-term option as a screening test (I'm not even sure of its utility in this study). Eventually, I doubt you'll even need access (for IVUS) since CT's, MRI's, (external) ultrasound machines and PET scanners will hopefully provide answers... but, as you say, who's gonna pay for all of this when (if) this hunt is found to be legitimate???

Unless an economical, non-invasive, reliable measure to identify vulnerable plaque in the masses of patients out there (and its application to those patients clarified), the hunt for this "Holy Grail" will die a slow, expensive death.