When will taxpayers have enough of spending on irrelevant science?

Irrelevant Science

By Dr. John M. Rost, Chairman of the North American Packaging Alliance, Inc.

You only have to open a newspaper or read any medical website to see continued coverage of health scares. The president just launched a new “War on Cancer” campaign, we now have Zika virus concerns and Ebola remains a major health issue around the world. What is surprising is that among all these legitimate health stories, the media continues to fixate on BPA and the seemingly endless stream of studies on the chemical that try to tie it to a variety of health concerns.

I recently attended a meeting at the National Academy of Science where BPA was a topic of discussion among the attending scientists. During that discussion, an FDA researcher stated that the levels of BPA in the human body are so low, the idea it could be causing health issues does not pass the “reasonable test.” He pointed out that it is well known that the levels of BPA in the body in a biologically active form are so low that the body’s receptors to the chemical could not possibly be activated.

So imagine my surprise today when I opened my Google News Alert to see a new study on BPA titled “Exposure to bisphenol A (BPA) in Wistar rats reduces sperm quality with disruption of ERK signal pathway.” I quickly looked to see if it correlated with the scientific discussion last week at all.  Unfortunately, it did not. As is typically the case with government-funded academia studies, this research has a fatal flaw – the doses given to the test animals were far too high to have any human relevance. Case in point: The study’s lowest dose was 100,000 times higher than actual human exposure. That doesn’t seem very reasonable to me and yet these are the studies that end up in major news outlets.

From a grant-receiving researcher’s perspective, you can see why this study approach is attractive. First, it gives the opportunity for a great headline that the university’s press office can use to show the important work being done at the school. Second, the research work showed adverse effects, which seems to be a prerequisite for publication. (Studies without any adverse effects rarely get published.) Last, and most importantly, a study with findings that require additional research are a perfect way to keep the funding coming. Just look at the final sentence in the rat study’s abstract — “However, additional research is needed to confirm our findings and to further test the suggested potential mechanisms.” If the study had showed no adverse effects or delivered conclusive results, there would be no need to keep writing checks.

Finding adverse results from excessively high doses is not unique to this study. Consuming almost anything at a dose 100,000 times higher than normal will likely cause adverse effects. For example, the typical human needs between 60-90 milligrams of vitamin C, but a dose higher than 2,000 milligrams can start to cause adverse effects, and that is just over 20 times the typical exposure.

So the question is, other than wasted taxpayer money, what is the harm? That is an important question because the researchers didn’t appear to publish bad science (I trust the results are valid and proper controls were used) but instead, irrelevant science. As the patrons of these studies, shouldn’t we, the taxpayers, ask why research such as this should be approved when the studies are so obviously flawed in their ability to add any new insights into the BPA debate? Unfortunately, few believe that this irrelevant science creates any consequences. But it does — it can create complicated regulatory and legal situations with an economic impact that consumers see on the store shelves.

In California, there is a law and regulation titled Proposition 65 (Prop 65). Under Prop 65, a chemical can be reviewed and put on a list if it has been “shown” that the chemical causes cancer, development or reproductive harm. Information on products that might contain the listed chemicals is provided to the public, often on product packaging similar to the Surgeon General warning on tobacco products. At its core, the idea seems perfectly logical in that consumes should know if they are being exposed to one of the listed chemicals. The problem is that the criteria to getting a chemical on this list do not take into account actual human exposure levels.

Back in May of 2015, BPA was added to the Prop 65 list for the stated reason that it had been shown to cause female reproductive harm. At the hearing in California, where the state’s experts reviewed the studies on BPA, they were constantly reminded that they are not to consider the actual levels of human exposure, just the potential for exposure. Given the multitude of “irrelevant science” that shows adverse effects from BPA doses many times higher than expected exposures, the unfortunate but not unexpected result was BPA’s listing as a harmful chemical under Prop 65. Starting in May 2016, companies selling products into California that contain even a trace of BPA will have to put a warning label on their products or face an onslaught of lawsuits.

The actual end result will likely be that companies, particularly in the food industry, will be forced to find other materials for their packaging. Although any new materials will need to be approved by the FDA, they will not have the safety data or performance criteria of the previous materials made using BPA. BPA exposure is not a consumer safety issue. Foodborne pathogens that cause illness and, in extreme cases, death are consumer safety issues, and ironically BPA epoxy liners provide the best protection against these foodborne illnesses. In fact, there has not been a foodborne illness case from the failure of metal packaging, most using BPA-based liners, in almost 40 years and trillions of cans.

One can hope that government agencies will be held accountable for funding research on issues that matter and on studies that add to the knowledge of the debate, testing real world conditions and not assumptions of “potential.” Meanwhile the only thing consumers in California will get is a brief statement on the side of their packaging without any indication of the irrelevant science that lead to this decision. That is until the next headline on a study about the latest scientific boogeyman comes along.