Turning plaque into profit

3. February 2008 William Davis (7)
For reasons unknown to me, I received a solicitation to invest in a company called Prescient Medical, with a slogan that caught my eye:


Detect and treat heart attacks before they occur.


The glossy brochure details their technology development strategy:

Predict(TM) Optical Catheter System--A catheter introduced into the coronary artery during a catheterization procedure to determine whether a specific plaque or vessel area is "vulnerable," i.e., prone to rupture in future.

Protect(TM) Luminal Shield--A stent-like metal device deployed into the coronary artery at the region of vulnerable plaque to prevent future plaque rupture.

The company anticipates FDA approval for their systems by 2009 and sales to begin by 2010. They predict sales of $7 billion.

Let's stop and think about this for a moment. It seems to me that, rather than pursuing the market of another stent for a "severe blockage," this company is going after the untapped procedural market of vulnerable plaque. In other words, their technology (an optical sensor technology that emits and analyzes light wavelengths to map specific plaque characteristics) identifies plaque that may rupture in months or years, followed by implantation of stent(s) that presumably prevent plaque rupture.

Thus, conceivably, many 20%, 30%, 40% etc. "blockages", atherosclerotic plaques that do not block flow and thereby pose no need for a conventional stent, will end up with this new type of stent. One patient could therefore receive multiple "Luminal Shields" in a single procedure.

When would these devices be employed? One pathway I could conceive of that my colleagues will be sure to exploit is 1) identify plaque by CT angiography, then 2) bring patient to the catheterization laboratory and perform this procedure for whatever hot, vulnerable plaques are identified. In other words, symptoms are no longer necessary. Reduced blood flow is no longer necessary. An abnormal stress test is no longer necessary. All that is required is that you have plaque. If the plaque is then determined to be vulnerable, then it is stented.

What bothers me about all this is the emerging effort to exploit this untapped market--a big one--of early heart disease as identified by coronary atherosclerotic plaque. As heart scans have demonstrated, there is an enormous amount of hidden heart disease in this world. This company has discovered a way to turn plaque into a profit opportunity, much as the statin drug industry found a way to "turn cholesterol into money."

The conventional stent market has plateaued and now has been, to some degree, battered by the drug-coated stent argument. Prescient has found a new and significant market for procedures and stents.

Is this really necessary? Why does plaque have to become a procedural disease? Doesn't it make more sense that, if vulnerable plaque is identified, that clinical trials are then designed to develop treatment strategies that modify vulnerable characteristics? Shockingly, this has not been done to any significant extent. Instead, the easiest path to a profit opportunity is to implant a "Luminal Shield."

You and I are able to inactivate, disempower, and essentially shut down plaque, while others are working furiously to convert it into a procedural profit opportunity. I personally find this so distasteful that I would sooner endorse a high-dose statin strategy than this approach.

You can view a video of my colleague, Dr. Martin Leon, on the Prescient Medical website, (or click here to go directly to the video), talking about how this technology will "change the treatment paradigm of the interventionalist from reactive to proactive." Scary stuff. Dr. Leon has made millions of dollars (probably more like tens of millions of dollars) from his support of technology companies for the interventional coronary device market.

My hope is that word of the sorts of techniques we use in the Track Your Plaque program disseminate before this sort of luminal coating idiocy gets off the ground.

(In actuality, a different version of this approach has been available for years using intravascular ultrasound (IVUS), another procedure that involves threading a catheter down each coronary artery during a catheterization procedure. IVUS can also cross-sectionally map a plaque's anatomy and identify "vulnerable" features, like a thin cap overlying a collection of semi-liquid fat ("lipid pool"). There has been some discussion of using this approach to identify vulnerable plaque followed by stent implantation, but it has never gotten off the ground and has certainly not found validation in any clinical study. By the way, any stent prevents plaque rupture, since by their very nature, the plaque contents are compressed, modified, and excluded to the exterior of the stent. Plaque rupture within a stent is very rare in its few millimeters of length. It may therefore not require some new technology to prevent plaque rupture.)
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Comments (7) -

  • Cindy Moore

    2/4/2008 1:38:00 AM |

    Well, I've heard of some, diabetics all I think, who have had a cath done and ended up with stents simply because they are diabetic.  No symptoms, just high cholesterol and diabetic.  

    I know one woman who has 2 50% blockages and has been told she needs a bypass ASAP....and completely asymptomatic. (her's was diagnosed by ultrasound, external ultrasound too, does that sound right? can they see that degree of detail?)

  • Dr. Davis

    2/4/2008 1:10:00 PM |

    Hi, Cindy--

    No, ultrasound cannot visualize coronary arteries. But they can visualize the left ventricle. Perhaps she had an abnormal left ventricle that provided presumptive evidence of poor flow. But that's just my guess.

  • Anonymous

    2/4/2008 3:36:00 PM |

    This post reminds me of how trusting people can be with hospitals and magazine articles, even when they suspect something might be wrong.  

    When it comes to investments it always amazes me how people can trust strangers to invest their hard earned money.  A person might read a magazine article about a "hot investment", or maybe a stock broker mentions the companies latest recommendations from their company "research experts".  And without much thought and no research of their own people will happily hand over cash with out really knowing what investment they are buying into.    

    It is a different reaction if a stranger off the street came to you and said he/she knows of a fantastic investment you should buy into.  If that happened, you would naturally be cautious.  If you did not dismiss the stranger outright, you would ask questions, want to know what kind of success the stranger had in the past, details about the investment, and what was their definition of success?  

    I've been talking with a lady who's husband has heart disease.  She learned of my heart healthy diet and felt a need to give me her negative unsolicited thoughts.  She reads magazines and tells me of the latest procedures or drug possibilities being developed.  She does not think highly of her husbands doctors. Up until the other day I had not heard her say a kind word about any doctor.  "They don't know what they are doing!" she would tell me.  I told her about TYP and the great information she could learn from the web sight,and the success many are having with reversing heart disease, but TYP did not interest her.  Her doctor had not told her of CT scans, lipoprotien testing.  Even learning from me about heart healthy supplements and diet held little to no interest for her.          

    The other morning she told me her husband had a check-up and the doctor told him he was doing "fantastic".  I nodded and said that was great, I hope he has continued success.  I walked away thinking what I really wanted to say - why do you still trust so much?  Did you ask for your husbands doctors definition of fantastic?  Is it fantastic because he has enriched the hospital with procedure after procedure?

  • Dr. Davis

    2/4/2008 5:44:00 PM |

    Yes. Well said.

    As you point out, most people regard the absence of symptoms the same as health. Of course, that's not even close to the truth.

    The emerging phenomenon of self-empowerment in health will make for great confusion as well as great opportunity.

  • Thomas

    2/5/2008 1:00:00 AM |

    Dr. Davis,

    A little bit off the main thread, but what do you think are the chances of having completely clear coronary vessels if you have a heart scan score of zero?

  • Dr. Davis

    2/5/2008 1:24:00 AM |

    Thomas--

    The chances are excellent. The likelihood of uncalcified plaque and the risk of coronary events like heart attack is exceptionally low.

    There are exceptions when symptoms are present or certain forms of lipid (cholesterol) abnormalities are present, but they are indeed exceptional. Please read the Track Your Plaque Special Report, What if my heart scan score is zero?

  • Anonymous

    3/22/2008 3:25:00 PM |

    Sad but its all about the money now. After my 3rd visit to er room last dec 04 I had them unplug me and walked slowly out of the cath lab...Dr. said I needed bypasses etc., but I refused...plus the 10,000 for all the drugs was a bit much...3 bags of morphine was the cheapest........read your book after scan and have been doing good so far so guess 2 of the 4 stents from 03/1999 are not blocking anymore plus nitro use is way down now going into the 4th yr.

    Was going to make appt. but with the weather so bad I'm just staying put and reading all this stuff. Would like to say my BP is lower now that am low carbing and no atenolol or altace needed so what you eat does make a big difference.

    Hope you keep this site going as its really helping me a lot. I'm so far keeping the right neck flowing at 50% after operation, the left still no flow and not operatable now. Good luck and keep the info coming....Roaming

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