Asbestos, lead, and tobacco are classic examples of very profitable products causing a great deal of misery and death [unger1]. Their detrimental effects were not immediately obvious to those exposed, and it took years of study to establish clearly the harm they caused. Those who profited from them went to great lengths to cast doubt on research revealing harmful effects. Even after their harmfulness was well established, they succeeded for decades in fending off regulatory action and keeping their products alive.
In our technologically advanced society, new devices and materials are introduced almost daily. There is no effective system for ensuring that they are free of harmful side effects not immediately obvious, or which manifest themselves only after long-term use. The implicit rule is that a device or substance can be freely introduced into the stream of commerce unless there is ironclad proof that it is harmful. Even then, corporations profiting from those items are likely to resist efforts to take them out of the marketplace, often with considerable success.
The list of possibly hazardous products and substances is long and growing almost daily. Let's see how our current regulatory system is failing for several of these, and then conclude by considering what might be done.
There are over 80,000 chemicals used in various commercial products. Only a few hundred have been tested for detrimental effects on people or the environment [NRDC][Kristof]. Of those researched, very few have been rigorously tested, particularly with respect to long term effects. Very little has been done to look for detrimental synergistic effects and other less obvious problems. The situation is exacerbated by the fact that an obscure federal law, ostensibly to protect trade secrets of manufacturers, allows them to keep secret the use of over 16,000 chemicals, some produced in quantities exceeding a million tons per year [Layton]. Believe it or not, many chemicals on this list have, under different regulations, been reported to pose a "substantial risk" to public health or the environment!
If you google Bisphenol A (BPA), the first item on the list is the Bisphenol-A Website, a sponsored website at http://www.bisphenol-a.org/about/faq.html?gclid=CPLVvI25mqkCFeURNAodNFj5vw. It is operated by the Polycarbonate/BPA Global Group, an arm of the American Chemistry Council, an industry association. Bisphenol A (BPA) is described as "a chemical building block that is used primarily to make polycarbonate plastic and epoxy resins". Regarding safety, the claim is made that:
Safety assessments of bisphenol A (BPA) conclude that the potential human exposure to BPA from polycarbonate plastics and epoxy resins is more than 400 times lower than the safe level of BPA set by the U.S. Environmental Protection Agency. This minimal level of exposure to BPA poses no known risk to human health.
You won't have much trouble finding links to websites presenting rather different views. BPA is indeed a very useful chemical in the plastics industry. One of its most important uses is in the plastic used to line the insides of the cans containing foods and beverages. It is also used to make plastic beverage bottles. Unfortunately, BPA can leach out of these containers into the contents. BPA is also used for some types of thermal paper (roughly half of all cash register receipts, airline boarding passes, cash machine receipts, library receipts, etc. use these types), from which the BPA transfers to our skin which it can easily penetrate. So what?
A number of studies both in the US and elsewhere have indicated that BPA is a hormone (endocrine) disrupter [Matsushima]. This can have many deleterious consequences. Specifically, BPA has been linked to heart disease [Ehrenberg], diabetes, mammary and prostate cancer, genital defects in males, early onset of puberty in females, obesity and even behavior problems such as attention-deficit hyperactivity disorder [Hinterthuer]. It is widely believed that BPA is particularly harmful to children and risky for pregnant women [World-Wire]. Due to the use of BPA in so many products, people are exposed to it via multiple sources and the result is levels of BPA in our bodies that often exceed the quite low levels that have been shown to be harmful [Vaidyanathan].
Given the wealth of studies showing BPA to be posing serious risks to so many people, why is it still in use? The relevant regulatory agency is the FDA. After having denied for years that there was any problem with BPA, the FDA's current position is that BPA is hazardous, at least for children, but it is powerless to take action because, in 1963, BPA was classified as "an indirect food additive" and included on a list of about 3,000 chemicals declared (without testing) to be safe [Kissinger]. Sales of BPA last year exceeded 6 billion dollars, which may have something to do with the fact that The American Plastics Council staunchly maintains that BPA is perfectly safe. It is now up to the Congress to take effective action, and appropriate legislation is pending. Meanwhile, don't eat canned food or drink canned beverages or beverages in plastic bottles, and minimize your handling of cash register receipts.
The BPA story resembles that of tetra-ethyl lead. Both featured excellent scientific and engineering work. The innovators did not anticipate the harm resulting from biological processes that had nothing to do with their work and areas of expertise. Such situations, not unique to these two examples, are very painful in that they nullify significant accomplishments. The likelihood of such disappointments would be minimized to the extent that engineers and scientists considered the range of possible consequences of their work at every step—not an easy thing to do. (Sadly, Thomas Midgley, inventor of tetra-ethyl lead, stubbornly refused to acknowledge the harmful nature of his creation even after it became evident.)
Next we look at the pharmaceutical industry, an apt pupil of the tobacco industry, adding some clever new techniques for keeping hazardous or worthless products in the marketplace.
It is important to understand that, as is the case with every other for-profit company, a company manufacturing prescription drugs is not in business to help people. It has an obligation to its stockholders to maximize profits. So, for example, it is not likely to invest a lot of money to develop a drug that will cure some serious disease afflicting a small fraction of the population. Potential sales would be small. The most profitable medications are those that alleviate the symptoms of, not cure, a chronic, nonfatal, disease with a great many victims. This would result in huge sales, as each victim would have to buy the medication regularly for many years. Such drugs have annual sales of billions of dollars. When they develop a drug of this type, they will do everything they can to get it approved and to keep it on the market.
The pharmaceutical industry has developed a broad array of tactics to bias the process of evaluating drugs for efficacy and safety and to promote the sales of questionable products. These include corrupting prominent physicians and researchers via consulting arrangements, research grants, lecture fees and the like to endorse their products, and even to let their names be used as authors of medical journal articles ghost written by people paid for this service by the companies. Drug companies cozy up to universities via generous contributions and research contracts, and by paying them for licenses to manufacture drugs developed in university laboratories (usually under federal research grants). They influence medical journals via advertisements and the purchase of large quantities of reprints of articles they find useful [Elliott][Petersen].
Thru large campaign contributions and armies of lobbyists they dominate the legislative and regulatory processes pertinent to the industry. They exert enormous influence at the doctor-patient level by deploying large numbers of drug reps to court physicians with "educational material" and all sorts of goodies to create good will. They have insinuated themselves into the development of courses that physicians take to stay current, using them to promote their products [Vergano].
Until a few years ago, I believed, and I don't think I was alone in this, that a drug couldn't be marketed in the US unless it has been thoroughly tested and approved by the FDA. Actually, the FDA does little, if any, testing of drugs. A company wishing to market a new drug chooses a commercial laboratory to test the drug and report back to the company. If the company likes the report, it submits it to the FDA (and will probably give that laboratory more business in the future.) Negative reports are simply buried, and a favorable report sought elsewhere. So FDA approval means very little.
Our health care system and the basic regulatory process is so corrupt that using any pharmaceutical product, especially one that has been on the market for only a few years, is a gamble [Calabresi]. In the great majority of cases, neither efficacy, nor safety has been reliably established. It is not uncommon for an approved drug to be withdrawn from the market after many people have obviously been harmed by it [Rubin].
It would be easy to add numerous additional accounts of materials and products, or families of products, that were put on the market after only token investigations of their safety and/or efficacy. Following are a few:
There are many other items that have not received enough attention to be reported on. Few, if any, are likely to cause immediate, obvious harm to the great majority of people at initial exposure. Presumably such obviously pernicious products would have been identified easily and taken out of circulation. It may very well be that many, perhaps most, of them are essentially harmless. On the other hand, it is also likely that some, perhaps many, are exceedingly harmful if exposure is substantial. The point is that we don't know. There are surely many probably harmful items that have not received enough attention to be reported on. It is interesting that the Minnesota Department of Public Health recently compiled a list of over 1700 chemicals found in consumer products, or which are widespread in the environment, that they consider potential health risks [Gunderson]. This list is certainly not comprehensive.
Determining if a product or substance is safe is not a simple matter. A well done study might clearly prove that some particular harm can be done to users with probability at least equal to some value p. But a negative result, showing that, under the conditions of the test, there is no measurable harm, merely eliminates one specific problem or set of problems detectable by that test—assuming it was done properly. Changing one or more parameters of the study might reveal a serious issue. No matter how many studies fail to unearth harmful effects, it is always possible that a different study might reveal some unexpected harm, perhaps only after longer exposure to the product. In principle, it is impossible to prove that a product is absolutely safe.
The best we can do is to task unbiased expert red teams to search for possible harms associated with the use of a product. They should employ a variety of appropriate approaches such as computer simulations, in vitro and in vivo experiments, and epidemiology. Consideration should be given to synergetic effects, i.e., how the effects of the tested substance might be enhanced by the presence of certain other materials. Long term effects must be considered. Where early work reveals possible mechanisms for harm, these should be carefully followed up with further studies. Only when there is a consensus among the investigators that the subject material is almost certainly harmless, should it be released for limited marketing to the public. There should be careful monitoring of the results by a follow-up team to look for unexpected harmful side-effects. After some period deemed reasonable by the investigators, if no problems have surfaced, then the item should be certified for normal use. The basic criterion is that the product must not be released for general use until it is deemed by an unbiased panel to be safe beyond any reasonable doubt.
Under certain circumstances it might be appropriate to modify this approval process. An example would be a drug intended to cure some usually fatal disease for which there is no generally successful treatment. If early testing of a new drug indicates that it has real promise, and that it is deemed not likely to be excessively dangerous, then it might be released for use by people considered likely to die of the disease who, after being fully informed of the uncertainly, are willing to risk using it.
It is critical that the investigations and the decisions to clear a product be executed by unbiased people. They must not have any financial stake in the outcome. Companies seeking to manufacture or market the product should not be involved beyond supplying full information to the investigators. Clearly, what is done today, with company-controlled product testing, and where a product is deemed to be acceptable unless there is irrefutable evidence that it is harmful, bears no resemblance to this process.
The above described procedure, if applied to the large number of new products and materials, as well as to the huge backlog of untested or inadequately tested items, would be enormously expensive. But, given the cost of exposing the entire population to the growing number of devices and materials that expose people to a myriad of harms ranging from diabetes to death, it would be a great bargain. It would make sense to treat the screening process as an essential part of our national defense. If we are willing to spend hundreds of billions of dollars annually on such items as nuclear attack submarines and wars in remote places, it should not be considered unreasonable to invest similar sums to protect ourselves against harmful chemicals, and other assaults on our health.
There might be ways to offset a substantial part of the cost by special taxes or fees imposed on the companies associated with the products, but this would have to be done very carefully to ensure that it did not, on the one hand give the companies leverage to bias decisions, and, on the other hand, unduly discourage research or product development. It should also be understood that making the approval process a public function under the aegis of the federal government would not be very effective if the government is largely controlled by corporate interests, which, to a large extent, is the case today.
Massimo Calabresi with Alice Park, "After Avandia: Does the FDA Have a Drug Problem?", Time, Aug. 12, 2010
Rachel Ehrenberg, "A 2008 study examining human fat tissue found that BPA suppresses a hormone that protects people from heart attacks and type 2 diabetes", Science News, February 13, 2010
Carl Elliott, "White Coat, Black Hat: Adventures on the Dark Side of Medicine", Beacon Press, 2010
Dan Gunderson, "New MDH list shows hundreds of potentially harmful chemicals", Minnesota Public Radio, July 1, 2010
Bette Hileman, "Debate Over Health Hazards of Putting Antibiotics in Animal Feed Heats Up in the USA", Chemical & Engineering News, October 25, 1999
Adam Hinterthuer, "Just How Harmful Are Bisphenol-A Plastics?", Scientific American,September 2008
Meg Kissinger, "FDA says it's unable to regulate BPA", The Milwaukee Journal Sentinel, Jan. 17, 2010
Nicholas D. Kristof, "Do Toxins Cause Autism?", NY Times, February 24, 2010
Lyndsey Layton, "Use of potentially harmful chemicals kept secret under law", Washington Post, January 4, 2010
Ayami Matsushima et al, "Structural Evidence for Endocrine Disruptor Bisphenol A Binding to Human Nuclear Receptor ERR", The Journal of Biochemistry, Volume142, Issue4, October 4, 2007
NRDC, "Toxic Chemicals", Natural Resources Defense Council
Melody Petersen, "The Case for Another Drug War, Against Pharmaceutical Marketers' Dirty Tactics ", NY Times Book Review by Janet Maslin, March 17, 2008
Andrew Pollack, "F.D.A. Hearing Focuses on the Labeling of Genetically Engineered Salmon", NY Times, September 21, 2010
Rita Rubin, "How did Vioxx debacle happen?", USA Today, 10/11/2004
Andrew Schneider, "Andrew Schneider Investigates Federal (In)Action on Nano Risks", The Pump Handle, March 25, 2010
Stephen H. Unger-1, "Pioneer Killer Products: Asbestos, Lead, and Tobacco", Ends and Means, August, 14, 2010
Stephen H. Unger-2, "Cell Phones: Not Definitely Dangerous?", Ends and Means, 6-19-08
Gayathri Vaidyanathan , "Study: Human Exposure to BPA 'Grossly Underestimated'", NY Times, September 20, 2010
Dan Vergano, "Who's teaching the doctors? Drug firms sponsor required courses - and see their sales rise", USA Today, March 9, 2000
World-Wire, "Protect Children's Health From Toxic BPA",World-Wire, May 7, 2010
Comments can be emailed to me at unger(at)cs(dot)columbia(dot)edu
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