Cosmetic Implantables Theres More Beneath The Surface

Thinking about Life Sciences: Cosmetic Implantables: There’s More Bene...

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Thinking about Life Sciences http://blog.aesisgroup.com Tuesday, October 31, 2006 Cosmetic Implantables: There’s More Beneath the Surface

Medical technology and, indeed, medicine more generally, has been increasingly moving into the cosmetic sector. The aging baby boomer demographic is essentially the defining factor in this trend. The US anti-wrinkle market alone grew about 20 – 30% yearly as baby boomers came of “wrinkle age” during the 1990’s. With a little faith in the continuation of this trend, the world of anti-aging medications, supplements, and even cosmetic implantables could hold nearly unlimited potential for doctors and medtech companies. However, like an investor shorting a stock, investing in these companies could also mean nearly-unlimited risk, beyond just the funds invested. New Medical Applications: New Safety Expectations The reason for the high-gain, high-risk relationship is that the baby-boomer demographic– as discussed in my previous columns (for example: Drug Safety Debate to Yield Big Changes, Grow More Controversial) – is also driving changes in the safety expectations of post-modern drugs and devices. As I wrote in that column: it’s not that previous generations did not expect quality medical care, but well known among medical practitioners, baby boomers have higher expectations than ever before of service, outcomes, and safety. In many ways, the healthcare system is being driven by the, sometimes unrealistic, needs and expectations of these aging baby boomers. The “miracles of medicine” are now taken for granted and patients want the perfect medical solution to all that ails them…now! Thus, there are two simultaneously-occurring trends, whose reconciliation might be difficult: the growing ranks of the aging wrinkled represent an ever growing demand for products and treatments from the cosmetic market, yet these consumers’ idealistic expectations for results and safety are nearly unachievable. They want what they can’t have, so, in trying to give them something just to satisfy their demands, we may be taking a huge risk in delivering disappointing results or even worse, setting ourselves up to pay millions in lawsuits if even one mistake is made or medical complication occurs. The Guidant defibrillator situation (in which a number of defibrillators malfunctioned) is a case-in-point. Cardiac defibrillators are life-saving devices and the safety malfunctions represented only a small fraction of all the devices implanted and lives saved. As many know, there are other complicated circumstances behind how these safety problems developed. I won’t comment on these, but only want to stress the point that this controversy demonstrates that consumer standards (and thus scrutiny) are very different today than even just a decade ago. They are largely not willing to accept even minimal medical risk and simply want a certain outcome. Essentially, the doctor (and the companies that provide the drugs and device tools of the trade) is taking risks and making “tough-call decisions” that of which the patients are no longer empathetic. Cosmetic Medicine: Even more Risk-Averse When it comes to cosmetic medicine – where lives are not at stake - patients are rightly even more risk averse. While the market potential is huge, even a few deaths or adverse outcomes may mean a complete loss of investment on the doctor and/or medtech company’s part. In addition, depending on whether any malfeasance was involved (however slight)—any divergence from the baby-boomers’ elevated expectations may even mean greater penalties if legal actions are taken. That’s why I see investments in cosmetic

11/17/2008 12:51 AM

Thinking about Life Sciences: Cosmetic Implantables: There’s More Bene...

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implantables as exceptionally high reward/high risk, with an emphasis on the high risk. Just yesterday, the FDA approved a new cosmetic implantable from Artes Medical, Inc. (based in San Diego) which represents the first permanent antiwrinkle injectable. The current antiwrinkle procedures involve injections of biodegradable dermal fillers such as collagen, which require repeat visits every four to six months. The ArteFill dermal filler actually combines conventional collagen with microscopic synthetic beads. The collagen is eventually absorbed by the body, but the beads serve as a scaffold around which the patient’s natural scar tissue grows. The ArteFill product is certainly controversial as previous incarnations were seen to have “significant” adverse effects in trial runs. Though, given the safety-expectation trends outlined, “significant” could actually mean “minimal.” That is to say, even “minimal” adverse effects could be significant in affecting patient and physician adoption of the technology, when it comes to use in the face, that is. Extending Applications to Build Value and Mitigate Risk Medicine is a delicate balance between risks and benefits. While the cosmetic market is huge and growing, I believe that the real benefits for these permanent tissue-fillers will be in other (non-cosmetic) medical applications that require restorative tissue bulking, where “minimal” adverse affects may be tolerated in exchange for the benefit to a patient in need of reconstructive surgery. While not perfect, implants of this sort have been used, for example, to improve the “tightness” of the lower esophageal sphincter to prevent stomach contents from regurgitating upwards and thus causing the symptoms of gastro-esophageal reflux disease, more commonly known as “heartburn.” It is also more likely that combining these permanent or semi-permanent tissue bulking agents with various drug-delivery systems will be the sweet spot for their medical application. Another possible application may be with radical cancer surgery in which large amount of malignant tissue is removed; in this case an inert tissue filler can be placed in the empty area along with a slow-release cancer therapeutic. That would be a true drug-device combination. The question then, is what business models will support such cross-industry collaborations? Will drug companies bring out such implantables? Will they come from the device sector? Or will they come from somewhere else? Only time will tell, but for now we should carefully weigh the risks and benefits of using them in cosmetic procedures, especially when baby boomers (many of whom we can count among ourselves) are involved. Ogan Gurel, MD MPhil [email protected] http://blog.aesisgroup.com/ Convergent Medical Technology Cancer Cosmetic Implantables Cosmetic surgery plastic surgery Aesis Research Group Ogan Gurel MD

11/17/2008 12:51 AM