Miracle drug???

Novartis 3Dr. Michael J. O’Connell, New Hampshire, commented that yet another product has been rolled out by Novartis, a Swiss pharmaceutical giant, and as is becoming common-place, the media is eager to do the company’s bidding.  Morning news shows, CBS’ This Morning and NBC’s Today Show, as well as the Wall Street Journal and NY Times carried word of the latest ‘miracle drug’ LCZ696, a novel treatment for congestive heart failure.  Currently, so called ACE inhibitors are the gold standard for this malady, as this drug group makes it easier for a generally weak heart muscle to pump blood, ergo less congestion.  The new drug was in fact compared to enalapril (Vasotec), one of the gold standard group, in this multicenter, blinded and randomized study.  LCZ696 performed so well in this comparison analysis that the ‘study was halted,’ for purposes of getting the drug to market faster.  This is a high visibility, high drama maneuver built into study design, which grabs the attention of the media, and did so with mind blowing efficiency again.  After all, if a drug works so well as to demand no more ‘fiddling with research, let’s get it out to the public at large,’ it must be obvious gold.  And it will be, for Novartis, as the projected market price is about $2,500 per year vs. under $100 a year for the generically available ACE inhibitors.  Novartis 6

Dr. Michael J. O’Connell noted that there are a couple of sobering problems with this study.  Closer inspection quickly reveals it to be totally funded by Novartis.  This has become expected fare in the pharma industry—so nothing new about that.  But what biases are built in by accepting such exclusive funding?  Can researchers be motivated to fudge/tweak/improve results by hacking into the code to determine whether a specific patient was given enalapril or LCZ696?  Could researchers be encouraged to withdraw patients from the study if they appeared to be reacting unfavorably to LCZ696, in other words burying these withdrawn subjects into obscurity?  What a dreadful thought, that the integrity of a clinician could be violated by money.  Could it happen?  Drs Russ Portenoy, David Haddox, Scot Fishman and Lyn Webster come to mind, as clinicians whose endorsements of opioids for chronic pain has fueled the overdose deaths of hundreds of thousands of Americans over the past 14 years.  Can compromise occur?  You bet it can.

Another striking aspect to the Novartis study is the art with which the study was designed.  Novartis knew that ACE inhibitors have performed remarkably well in controlling the symptoms and reducing mortality of CHF.  So if they set out to conquer the market for ACE drugs, Novartis recognized the margin of victory would likely be slight.  So a clever way of making the data appear more dramatic is to not simply examine CHF patients given LCZ696, but compare it with enalapril so that ‘absolute improvement’ is minimized and the more startling ‘relaNovartis 5tive improvement’ is highlighted.  For example, if a new cholesterol lowering agent, drug A, reduces LDL (the so called ‘bad cholesterol’) by 15%, one might say, hmmm significant though not earth shattering.  But if the gold standard drug, drug B, is known to reduce the LDL by 10%, then pharma can claim its drug A is 50% better than the gold standard.  An astounding figure that will grab the media far more pervasively than 15%.  These are the games big pharma plays.  There are many more.

LCG696 is not a miracle drug!

About Dr. Michael J. O'Connell, New Hampshire
Dr. Michael J. O'Connell of Barrington, New Hampshire, has forged a distinguished career spanning over three decades, as entrepreneur, physician, businessman, philanthropist and healthcare consultant. As former owner, administrator and CEO of a 225+ employee multi-specialty medical practice, Dr. O'Connell has dedicated his entire professional life to helping patients with family medicine and especially those experiencing chronic pain and all aspects of addiction. Since selling his family of healthcare businesses, he has never once contemplated retirement despite his rich and fulfilling journey, but instead has turned his focus to consulting in an industry starved for courage and creativity. Having weathered many political, technological and legal challenges, there is hardly a storm he has not confronted, a tempest he has not quelled, an urgent need he has not met. While the talking heads and self-proclaimed experts in the field have assumed the conventions and standards of the times, Dr. O'Connell does not believe in merely reflecting the herd mentality, but rather in leading the charge. Eschewing political correctness, Dr. O'Connell says and does what needs saying and doing, and not what the mindless masses expect. In addition to the continual education afforded by his variegated life experiences, Dr O'Connell earned his BS in Biochemistry at the University of NH in 1975, his Medical Degree from Dartmouth College in 1981, interned at Walter Reed Medical Center in 1982, Residency/Fellowship at UCSF in1986, and finished his Masters in Healthcare Administration at UNH in 1995. Dr. O’Connell enjoys many outdoor activities, including rock climbing, snowboarding, hiking, and golf. Through the decades Dr. O'Connell has supported many non-profit charities to include the St. Charles Home in Rochester NH, the Tri City VNA and Hospice, Hyder House, and Cocheco Valley Humane Society. To the latter organization alone Dr. O'Connell has donated over $180,000 and pledged another $250,000 in the “Bring-Us-Home” campaign for a new building. His “Matching Donations Christmas drive” has generated over $175,000 in charitable giving from the community. In addition Dr. O'Connell has participated in many dozens of other volunteer and donation efforts locally as well as in Africa and the Dominican Republic. For a listing of how I gave back to the community during my career and continue to do see: https://michaeloconnellmdnh.wordpress.com/

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