Blown Whistles and Opportunities: 2013 in ReviewBlown Whistles and Opportunities: 2013 in Review
December 23, 2013
The December 20th edition of USA Today features an investigative piece, Unmasking the People Behind Risky Pills, that unshackles a story that may have been fueled with info by a dietary supplement company owner. Mug shots, drug cocktails, and brand names are bandied about like stats of sports stars. Spiking, tainting, and links of these felons to board seats on industry groups like AHPA are described in passing.
Even the omni-eloquent Loren Israelsen had his prehistoric judgment with the U.S government profiled (related to illegal evening primrose oil importation). Admirably, Loren did not shy away from an interview, revealing his wisdom and tempered zeal: I was much younger and breathing more fire," he said. "In retrospect, would we do it that way again? No." Most of the other individuals (with criminal records related to drugs) excoriated in the piece did not respond to requests for an interview. Perhaps some press can be bad press.
A few of my science colleagues and I have intermittently toyed with the notion of this scenario: If we elected to go rogue and jump to the other sidee.g. be engaged by the FDA, FTC, class action attorneys, or even a prime time television or national daily investigative reporterwhat would we choose to unveil, hidden microphones, spy cameras, and all?
1.) Falsification of raw materials: Just this past week a science colleague of mine, with a real Ph.D. (from a respectable institution, and a published dissertation in chemistry) told me about his recent trip: a cGMP audit of a raw materials manufacturer in China. The papers submitted to him for batch records, master manufacturing records, etc. all appeared too good to be true.
Then his eyes came upon a trash bin with highly unsettling evidence. Falsification of records. Certificates of analysis, signed, with dates into the future. Ugh.
2.) Adulteration: How do certain products, with labeled ingredients inspiring enough to garner Best Yawn of 2013, become sensations in weeks or months? Spiked with drugs that are potent and relevant is one way. Take the spy cam into a contract manufacturer, after aligning with one of the disgruntled workers, and Oscar-worthy material footage is captured. Just looking at FDAs Tainted Supplements website is enough to engender a tsunami of saliva from any investigative journalist, wanting to break the story before FDA discovers the tainting months to possibly years after entry into commerce.
3.) Unsubstantiated claims-class action connection: Arguably the greatest threat to a brand is not an FDA or FTC action, nor an NAD/NARC action. It is the modern-day sword of Damocles that rests above virtually every product that lacks substantiating evidence of efficacy or compositional analysis on the actual product offered for sale. Hallowed mega brands like Muscle Milk®, Vita Coco®, and Osteo Bi-Flex® have all had class action settlements. Despite the spuriousness or robustness of the allegations brands often elect to settle, to arrest the financial and human capital hemorrhaging, and halt further erosion of brand equity. But what about all the strong- to blockbuster-selling products that lack any evidence of efficacy or have not been assiduously manufactured to label specs, which have yet to be served up classy litigation? Many products come to mind
We thrive within an industry that is littered with abominations, deception, charlatans, duplicity, and greed (granted, no different than many other industries). We have no swift means to remove the unwanted, and very often many have no desire to perform the excision, as it threatens economic health. What is left butmore regulatory oversight and enforcement.
I look forward to a pristine 2014!
Writers note: Mr. Almada has no conflicts to disclose.
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