According to Merriam Webster, the transitive verb "outsource" first entered the English vocabulary in 1979 -- a scant 35 years ago. It's hard to believe that the term -- if not the business strategy it describes and defines -- is of such recent vintage. For by now, it seems like everything in our cabinets, closets, garages and medicine chests is the product of cheap labor doing its thing in places like China, Bangladesh, Vietnam, India, Malaysia or Honduras. Precisely why American manufacturers move millions of jobs offshore isn't too difficult to figure out: lower production costs equal higher profits which equal much, much happier stockholders. Why Congress has not -- and apparently will not -- do something about it is even easier to understand: American manufacturers kick back a percentage of their increased profits in the form of campaign contributions.
As a result, almost everyone and everything is the product of outsourcing these days:
- Johnson & Johnson gauze pads and Purina dog treats are made in China (along with just about everything else);
- Rawlings baseballs are stitched in Costa Rica; Mattel's iconic Barbie doll is manufactured in Hong Kong;
- Converse Allstars hail from Thailand;
- Levis are made in Lesotho, Cambodia, Turkmenistan and the Philippines;
- Even my beloved Brooks Brothers shirts are manufactured in Malaysia.
And of course, this doesn't include what might be termed "Call Center Purgatory -- all those Indians, Pakistanis, Malaysians and Filipinos named "Mark" or "Betty" who handle our questions, requests and complaints about defective products we've purchased at Wall Mart, Best Buy or Big Lots.
Although both maddening and occasionally stupefying, none of the above-referenced forms of outsourcing are illegal and heretofore rarely -- except in the case of our pets -- lethal.
One form of outsourcing that has been flying well beneath the radar for the past several years is lethal: this involves the outsourcing of medical ethics. According to federal law all clinical trials -- medical research trials involving human subjects -- must first be brought before an Institutional Review Board (I.R.B.) which both oversees and protects the rights of these human subjects. The creation of I.R.B.s finds its genesis in the post-war Nuremberg Doctors' Trial, which considered the fate of 23 German physicians who either participated in the Nazi program to euthanize persons deemed "unworthy of life" or who conducted experiments on concentration camp prisoners without their consent. The need for such review boards -- peopled by physicians, scientists and public representatives -- was given even greater impetus when the truth of the "Tuskegee Syphilis Study" was made public. This "experiment" was an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service to study the natural progression of untreated syphilis in rural African American men who thought they were receiving free health care from the U.S. government.
Today, by law, anyone participating in a clinical trial -- whether it be for the creation of a new drug or medical device or the collecting of medical data -- must be fully cognizant of what they are signing up for. They must be apprised in easily understandable lay terms (in their native language) what they are about to undergo, what the possible risks and benefits (if any) are, and then give what is called "informed consent." If the subject is a minor or an individual otherwise unable to give consent, they must be represented by a "legally appointed representative" (LAR).
(Note: Over the past 19 years, I have served as a public representative on two different IRBs; from 1995-2012 with Cleveland Clinic, Florida, and since May 2013 with Schulman Associates IRB. It is the most intellectually challenging -- and rewarding -- position I have ever held. Over nearly 2 decades, I have poured through, sought to understand, edited (when necessary) and voted on more than 1,000 research protocols. Yes, it's a lot of work, but protecting human beings in the name of medical advancement is terribly worthwhile . . .)
Bringing new pharmaceuticals and medical devices to market is a lengthy, exhaustive, incredibly expensive proposition. It involves reams and reams of reports filed at virtually every step along the way, and an unbelievable amount of clinical and federal oversight. However, if and when a new drug or device is granted Food and Drug Administration (FDA) approval, it can earn literally billions for companies like Bristol- Meyers Squibb (Abilify), Astra Zenica (Nexium), Perdue Pharma (OxyContin) or Pfizer (Celebrex).
This last drug, Celebrex, is a non-steroidal anti-inflammatory drug that has been aggressively promoted in television commercials for a decade. Its manufacturer, Pfizer, the world’s largest drug company, has spent more than a billion dollars promoting its use as a pain remedy for arthritis and other conditions, including menstrual cramps. Without getting into too much boring detail, it turns out that many of the clinical trials Pfizer ran during the creation of this incredibly profitable drug were held in places like Estonia, Croatia, Ukraine and Lithuania -- places where the F.D.A., due to financial and staffing limitations, simply could not monitor research trials. In many cases, doctors were paid hundreds of dollars for each test subject they enrolled, while the subjects, many of whom had little or no knowledge of what they were about to undergo, were paid as little as $3.50 for their participation. This is precisely the sort of unethical behavior an IRB is on the lookout for. Turns out that Celebrex ran into a world of difficulty.
First, it was disclosed that patients taking the drug were more likely to suffer heart attacks and strokes than those who took older and cheaper painkillers. Then it was alleged that Pfizer had suppressed a study calling attention to these very problems. Meanwhile, Pfizer was promoting Celebrex for use with Alzheimer’s patients, holding out the possibility that the drug would slow the progression of dementia. It didn’t. And yet, Celebrex is still on the market, still making a fortune for Pfizer (more than half-a-billion dollars in sale in the first quarter of FY 2013 alone).
Believe me, this is just the tip of the iceberg . . . the tip of the tip of the iceberg.
It has become frighteningly commonplace for big pharmaceutical companies to engage in test protocols in third world countries. By outsourcing trials, they not only save millions upon millions of dollars; they evade the long arm of an already overworked and understaffed FDA. Frequently they take advantage of poor, illiterate men, women and children -- some reportedly as young as 6 months. Besides being thoroughly unethical, this creates an intolerably dangerous situation. A pair of Levis or Converse Allstars made by cheap labor won't kill you; a drug created under less than pristine clinical conditions can.
It is horrifying to note that in 2009, the American death toll from prescription drugs considered "safe" was in excess of 200,000. According to an exhaustive investigative piece by Vanity Fair's Donald L. Bartlett and James B. Steele, ". . . [this] is three times the number of people who die every year from diabetes, four times the number who die from kidney disease. Overall, deaths from F.D.A.-approved prescription drugs dwarf the number of people who die from street drugs such as cocaine and heroin. They dwarf the number who die every year in automobile accidents."
On the bright side, the budget passed by Congress last week did increase FDA funding: $85 million in industry-provided user fees, and an additional $91 million above FY 2013 funding levels. What is truly needed above and beyond increased funding and the beefing up of the FDA are hearings; hearings in which the heads of big pharma will be forced to answer two straightforward questions:
Why in the world are you outsourcing medical ethics?
Have you no shame?
Hopefully, Congress won't accept additional campaign contributions in lieu of answers . . .
©2014 Kurt F. Stone