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medical device fraud and evidence-based medicine


Medical Device Fraud

  Earlier this month, writers from the NYT and Probublica teamed up for a Medpage Today exposé titled Fault Found (Again) with Conflict-of-Interest Disclosures in Journals.  The gist of the piece was just as I’ve shown you before; in a huge percentage of cases, EVIDENCE-BASED MEDICINE cannot be trusted.  Studies are tainted by FINANCIAL CONFLICTS OF INTEREST (plural), for the express purpose of providing conclusions that have been gently (or in many cases, not so gently) massaged and guided to an industry-agreed-upon endpoint.  And the cherry on top is that the funding comes from the very organizations who stand to gain the most (see AMERICAN HEART ASSOCIATION & AMERICAN COLLEGE OF CARDIOLOGY, although there are hundreds of others).

“One is dean of Yale’s medical school. Another is the director of a cancer center in Texas. A third is the next president of the most prominent society of cancer doctors.  These leading medical figures are among dozens of doctors who have failed, in recent years, to report their financial relationships with pharmaceutical and health care companies when their studies are published in medical journals.”

Just how bad is the problem?  Not only were some of these doctors and researchers paid millions (often in round-about and circuitous manner), but in quoting the authors of a recent study from JAMA Surgery (Association of Compensation From the Surgical and Medical Device Industry to Physicians and Self-Declared Conflict of Interest), Medpage revealed that, “of the 100 doctors who received the most compensation from device makers in 2015, conflicts were disclosed in only 37% of the articles published in the next year.” The JAMA authors put it this way; “A high level of inconsistency was found between self-declared conflict of interest and the Open Payments Database (OPD) general payments data among the physicians receiving the highest industry payments.”  What this means is that 2/3 of the biggest financial conflicts in the medical device research community never see the light of day.  Is this a big deal?

For one commentor on the Medpage article, apparently not.  The Editor-in-Chief of a journal I have quoted from on occasion (CUREUS) made excuses for these high-rolling fact-fudgers by telling us how busy the “worst offending authors” really are.  He even went so far as to refer to the investigative journalists who wrote this story (Charles Ornstein and Katie Thomas) as “ambitious muckrakers” before mentioning the “trust” required at every level of the process, saying that “the suggestion that journals need to run extensive background checks on authors, naive and ludicrous.”  Ludicrous it may be, but my earlier link on EBM reveals that it became necessary a long time ago.   Ornstein and Thomas explained just how necessary by stating…..

“Calls for transparency stem from concerns that researchers’ ties to the health and drug industries increase the odds they will, consciously or not, skew results to favor the companies with whom they do business. Studies have found that industry-sponsored research tends to be more positive than research financed by other sources. And that, in turn, can sway which treatments become available to patients.”

If you’ve been following the recent scuttlebutt surrounding the massive fraud seen within the medical device industry, you not only realize that this is true, but that it’s arguably a massive understatement.  I Googled ‘medical device manufacturer fraud’ and got nearly 13 million hits.  Even though I’m not a fan of what our DOJ has been doing in recent years (how could anyone say that Hillary’s purposefully-hidden server or the destruction thereof was not illegal?), I looked at a recent article on PolicyMed titled DOJ Enforcement Panel Focuses on Medical Device Companies, which dealt with a meeting by a governmental healthcare fraud enforcement panel.  One of the panel members, Jacob Elberg of New Jersey, had this to say

“Based on the cases his office and other prosecutors have seen, they ‘continue to have the feeling that there is more misconduct that isn’t being addressed.’ The medical device industry breeds a ‘whole range of misconduct,’ he noted, including improper payments, kickbacks, and off-label activity.”

Honestly, this is barely even scratching the surface.  The day after Christmas, John Commins wrote a piece for Health Leaders Media titled Top 5 Healthcare Sector Fraud Settlements for 2018.  Although he provided numerous examples of what’s going on in the device industry, allow me to give you a CHERRY-PICKED overview.

“The federal government collected $2.8 billion in False Claims Act settlements across all sectors of the economy in 2018, but the bulk of it came from the healthcare sector.  Healthcare fraud accounted for $2.5 billion in fraud recoveries for the federal government in 2018…..”

Although not all of these monies had to do with device manufacturers, what I want you to grasp is that this 2.8 billion is the tip of the tip of the iceberg.  What would make me say that?  I can assure you that in similar fashion to what we’ve repeatedly seen concerning the REPORTING OF DRUG SIDE-EFFECTS, the actual numbers are far different than what are reported — by almost 100 times (not a misprint and not 100%, but 100 times).  In other words, for every serious side effect reported, there are 100 that are not.  Might the numbers be similar concerning medical device fraud?  Almost surely.

Proof can be found via the headline of a May 2014 issue of The Economist (The $272 Billion Swindle: Why Thieves Love America’s Health-Care System). Granted, this 100x increase over the stats from the previous paragraph was not the sole result of medical device fraud, but for those clamoring for GOVERNMENT-RUN HEALTHCARE, just realize that no one has a worse track record in the fraud department than Medicare / Medicaid.  Case in point, the 2012 RAND study that estimated over 10% of government spending for healthcare services is outright fraud, and which has only gotten worse over the past six years.  And now we are finally starting to see how this fraud has infused the very governmental watchdog organizations created to protect us (HERE).  What are we supposed to do?

The solution may be simpler than you imagined.  Knowing that the vast majority of the huge financial burden of American healthcare is paid out for lifetime management of diseases of lifestyle, wouldn’t it make sense that you (yes, the person in the mirror) do everything in your power to get off the MEDICAL MERRY-GO-ROUND?  For most of you, it’s actually easier than you may have been led to believe.  I have created a protocol (not all of it will pertain to every person) for the express purpose of reducing systemic inflammatory load (HERE). 

Sure, some of you will require a DEEPER APPROACH, but for many of you —- probably the vast majority of you —- making some changes in the way you live and think could be the very thing to put you over the top in 2019 (better than SILLY RESOLUTIONS).  If you know people who could benefit from this info, be sure to like, share, or follow on FACEBOOK as it’s a great way to reach the people you love and care about most.  I wish you and your family a healthy, happy, and blessed New Year!


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