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| Is pharma's time in the spotlight running out in terms of treating heart disease? |
Recent reports indicate a potential shift in healthcare as researchers and doctors are increasingly just saying no to drugs and instead embracing medical devices to treat certain conditions. The notion of passing over drugs in favor of devices is growing in popularity in the treatment of such conditions as Alzheimer's disease, while new drug development for heart disease seems to be slowing down. So, as minimally invasive surgeries increase and researchers turn to medical devices in instances where drugs aren't working, are medical devices stealing the spotlight from Big Pharma?
Last week, for example, Reuters reported on a noticeable change in the air at the American College of Cardiology's scientific meeting in New Orleans. The article notes that Medtronic dominated local advertising this year in terms of plastering its new pacemaker on the sides of buses and on hotel keys, whereas these spots have traditionally promoted pharmaceutical products such as Pfizer's Lipitor and AstraZeneca's Crestor.
In addition to advertising, the conference, according to Reuters, focused heavily on minimally invasive surgeries and innovative treatment methods while drugs took a backseat. Allowing for minimal scarring and recovery time with fewer risks, minimally invasive surgeries and devices are broadening treatment options and promising exciting outcomes for various heart-related issues. Several such technologies were prominent at the show while little fanfare was dedicated to new drug development, the article notes. The efficacy of existing drugs designed to treat high cholesterol and high blood pressure, according to the article, has tempered the drive for new drugs in these areas.
"We have learned that mechanical problems are fixed by mechanical devices," David Holmes, president of the ACC, told Reuters. "Devices have been brought along because they sometimes result in more reliable, reproducible outcomes."
But medical devices aren't just on the rise thanks to minimally invasive surgeries; they're also regarded as having potential for the treatment of Alzheimer's disease. As I recounted in a blog post a few weeks ago, researchers are actively exploring light-based therapies and medical devices to treat the devastating disease. Drugs are considered by many to be relatively ineffective in treating Alzheimer's disease, and medical devices offer an interesting alternative worth investigating.
While drug makers probably aren't too threatened by these advancements, the rise of medical devices and slowing of drug dominance in certain areas is an interesting trend to observe. It will also be fascinating to watch how emerging minimally invasive procedures and combination devices impact the medical device and pharmaceutical industries. Soon enough, the impending era of personalized medicine could likely spur a resurgence in drugs for the aforementioned applications. But until then: Enjoy your time in the spotlight, medical device makers. --Shana Leonard
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Comments
Innovation, Convergence, Combination Products and the Elixir of Life........
Lo and behold…..challenges and changes galore for the medical device industry at global and some key local levels (the need for glocal “Current” Good Regulatory Practice to successfully “dance” in tune with the regulators cannot but be overemphasized):
• US-FDA’s Innovation Initiative and CDRH’s assurance of the safety and effectiveness of medical technologies
• GHTF disbanding & regrouping with regulators only (without industry participation – while the Asian Harmonization Working Party (AHWP) web site is sponsored by industry stalwarts)
• Recast “legal framework” initiative of (possible repeal) Directives 90/385/EEC, 93/42/EEC & 98/79/EC by Q1 2012 – led by Health and Consumer Protection Directorate General of the European Commission (DG-SANCO) [while the industry is yet to catch up with the last technical revisions per Directive 2007/47/EC]
• Health Canada’s Summary Technical Documentation (STED) implementation effective July 2011 for non-in vitro diagnostic Class III and IV Premarket Medical Device Licence Applications
• Status of ASEAN Medical Device Directive (AMDD) given the glaring lack of information from ASEAN Consultative Committee on Standards and Quality (ACCSQ) Medical Device Product Working Group (MDPWG).
………………………………..Amarjit S. Jowandha