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Transparency vs. opacity
December 2018
by Peter T. Kissinger  |  Email the author

The will to understand vs. the will to obscure is not a new theme, but when blended with electronic communications it is given new intensity. Both transparency and opacity are increasingly rationalized, the first from natural rights to the truth and the second from fear the truth will be inconvenient and subject to misinterpretation or, worse, malicious purposes.
So what’s new? Bad news has always traveled fast, but today it moves at the speed of light.
Conclusions are often reached before the conscious brain has time to work. For those lucky to have them, high-quality neurons signal at perhaps 100 m/s while light travels at 300 million m/s. Given our notion that the truth seeks to be free, a lot of energy is spent on keeping it captive. This energy builds as in a pressure cooker and then escapes explosively. There are endless examples over the decades. The impact on once-respected institutions such as the Olympic movement, church hierarchy, universities, governments, politics, sports and entertainment is now in full flower daily. Healthcare-related academic science and industry are full participants.
This is not new. I take you back to 1906 and the passage of the Pure Food and Drug Act (“Wiley Act”). Harvey Washington Wiley was chief chemist at the U.S. Department of Agriculture. Since his days as the first Purdue chemistry professor and chief chemist of Indiana in the 1870s, Wiley dedicated himself to the transparency side of this struggle, believing that the public had the right to expect that what they purchased and consumed was honestly labeled and unadulterated with harmful substances. It took Congress 27 years to pass any federal statute.
Why did it take so long? The forces of opacity were intense, wrapped around the “freedom to sell anything to a willing buyer.” This included meat adulterated with formaldehyde, fruit juice fortified with industrial alcohol labeled as fermented whisky, and milk “embalmed” with boric acid and formaldehyde. The drugs of that day were largely alcohol, caffeine, nicotine and more than a bit of cocaine.
The Wiley Act did not require approval to sell. Enforcement required finding violators after the sale. Sequestering products and funding the lab work to identify mislabeling and adulteration was slow without the analytical chemistry tools we have today. The Wiley act turned out to be largely ineffective, very arbitrary and extremely political. The forces for opacity continued to show strength in numbers, while quality-conscious businesses pushed the wisdom and advantages (for them and the public) of transparency. In 1937, the now-famous pediatric formulation Elixir Sulfanilamide, using an antifreeze analog as a solvent, killed over 100 and sickened many more. The 1938 Food, Drug and Cosmetic Act was quickly signed, 59 years after Wiley and others argued that safety be established before products are sold. The challenges of how safe and, later, how effective remain not fully resolvable.
The battle is fully engaged in academia and has impacted federal funding. Multiple universities have opted for opacity when department heads, deans, provosts and presidents are confronted with unethical behavior among faculty and students. Falsified or selected data, withdrawn peer-reviewed papers, funding obtained on false pretenses (fake preliminary data) and a general arrogance up the line are damaging science. Are the “peers” an elite to be protected, or exposed? The whistles are blowing for transparency. Top people at top institutions have failed us, very recently at Sloan Kettering and Duke.
Unfortunately, reluctance to quickly adjudicate is countered by a general rush to judgment, reversing the principle of innocent until proven guilty. Social media gets tongues wagging before brains are fully engaged after all sides can be heard. Treating this malady early might have saved many institutions. Ethical problems grow if not promptly treated. There are some attempts to improve the peer-review process, with calls for more transparency in protocol details, raw data and funding sources. In this regard, Prof. John Ioannidis of Stanford is the new Wiley. He and colleagues surveyed recent trends in biomedical research papers and continue to find major deficiencies (PLOS Biology, November 20). We can’t reproduce or reanalyze what is not disclosed. We can’t properly review the exponentially increasing number of submitted technical papers.
Clinical trials disclosures remain challenging as well. We do the work and much of it is never published at all, or is published with insufficient protocol details to reveal truth. “I have not failed. I’ve found 10,000 things that won’t work,” said Thomas Edison. Given the funding by taxpayers and shareholders, what didn’t work matters and should be more widely accessible. Volunteers participate in drug trials. Their service to humanity is wasted if the data are not clearly revealed. Recently, the United Kingdom’s House of Commons and Technology Committee issued a discouraging report on the topic. They are not alone.
Healthcare pricing also appears to be all about opacity. The supply chain complexities work against patients. Patients see nothing equivalent to a menu of priced options as we do in a restaurant or on the window of a new vehicle. Until this is fixed, opacity will keep winning and healthcare will not benefit from the new productivity that informatics has brought to other sectors. The recent U.S. Health and Human Services proposal to refer to prices in public drug advertisements is as interesting as was the insistence on reference to side effects.
On the other hand, government is not an effective way to make it happen. Rattling off side effects with no reference to their probabilities is silly, as would be a comparison of prices in a dozen countries. Prices are a variable—witness holiday sales. I would prefer a blanket statement saying, “all drugs have adverse results in some people, read the product insert before swallowing and ask about pricing.” Know the price before ordering.
It’s tough in this sector because there is no quality management system used to produce consistent people as there is with a capsule, a medical device or a car. Nevertheless, we can do better with transparency. Educating the public on the biology realities can’t hurt. PhRMA says GO BOLDLY! Perhaps they can boldly set some new standards of transparency and better educate the public on the opaque knowns. Today we see more interest in involving patients earlier and in paying for results beyond physical drugs and procedures. Most will not want to know or take the time to know, but others will, and they can be ambassadors for a new way. What Harvey Wiley started in the 1870s remains a work in process. Let’s go boldly faster.

Peter T. Kissinger (who can be reached at is professor of chemistry at Purdue University, chairman emeritus of BASi and a director of Chembio Diagnostics, Phlebotics and Prosolia.



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