Nidel's Paper on Drugs in the Environment Wins FDLI Competition

Chris Nidel said the FDA and drug manufacturers should do more to limit the environmental impact of pharmaceuticals.

What happens to those two Advil pills after you take them? Hopefully a portion of the drug will make you feel better, but some takes the eventual route of the food you eat — down the toilet. Recent studies have shown that human and animal pharmaceutical drugs don't disappear once the drugs are ingested — the drugs make their way through waste treatment facilities and into the environment. The FDA, responsible for monitoring drug safety, testing and approval, should also monitor the environmental safety of drugs, according to third-year law student Chris Nidel, a former chemical engineer.

Nidel's paper on the subject, "Regulating the Fate of Pharmaceutical Drugs: A New Prescription for the Environment," won the Food and Drug Law Institute's (FDLI) annual H. Thomas Austern Writing Awards Competition, open to all enrolled law students. The award's $1,500 prize comes in addition to the paper's publication in the Food and Drug Law Journal and the publication of Nidel's abstract in FDLI's Update magazine.

"Municipal waste treatment is not designed to get rid of those organic compounds [in drugs], so many end up being dumped back into the environment," Nidel said. As much as 70 to 80 percent of an active drug can be excreted after ingestion.

In his paper, Nidel examined recent scientific research that shows drugs have not only infiltrated the environment, but can affect the environment. For example, he highlights a theoretical link between the hormones in waste effluent and the sexuality of fish near treatment facilities. Many fish populations near treatment sites have become sexually dysfunctional, Nidel said, and rivers throughout the United States show an increased antibiotic resistance in their bacteria.

"Under the National Environmental Policy Act (NEPA), the FDA has a responsibility to assess the environmental impact of their actions — their approval of a certain drug," Nidel said.

Historically, scientists did not see this kind of build-up of pharmaceuticals in the environment, due mainly to a lack of concern and a lack of technical ability, Nidel said. However, new technology has helped measure levels once too low to be detected.

Nidel says his paper examines a couple of ways the government might deal with the problem. One route, adapting waste treatment facilities to eliminate drug residue, is "unrealistic" because of the expense and the administration involved, even if it's technically feasible, according to Nidel.

A more likely solution, and one he supports in his paper, is requiring the FDA and drug manufacturers to do a more thorough evaluation of a proposed drug and its downstream impact. The FDA could recommend that the effectiveness of lower drug dosages be investigated, which may decrease the concentration of drug eventually released into the environment.

"One of the problems is that when they're doing an assessment, they're not going to have data on the impact of the drug on the environment prior to its approval and use," he said. Nidel said the FDA may be able to estimate the environmental bearing of a drug by looking at the impact similar drugs have made on the environment.

Nidel, who worked for five years at pharmaceuticals-maker Merck in Harrisonburg, Va., before starting law school, earned his M.S. in chemical engineering at M.I.T. and his B.S. from U.Va. He originally wrote his paper for professor Richard Merrill's Food and Drug Law class; Merrill encouraged his students to submit their papers to the contest, Nidel said.

"Chris tackled a subject about which — so far as I am aware — no other scholar has written," Merrill said. "His treatment of the 'science' was superior and may be a reflection of his engineering and work-experience background." Merrill said the Law School had a history of producing winning papers from students who took his class or who wrote under his supervision. At least two have won first place before, and several others have placed second or third in the competition in recent years.

Nidel said his education and work experience give him a special interest in plaintiffs' work in environmental/toxic tort, an area he may one day pursue as a career. Although he's mulling several job offers, last summer he worked for the best-known toxic tort firm in the country, Baron & Budd, which at the time took a case that Erin Brockovich's firm began. With roughly 1,000 individual plaintiffs, the case was too large for her firm to handle alone.

While Nidel sees the FDA as the primary regulator of drugs' environmental impact, manufacturers can also help by taking proactive measures themselves. For example, in 2000 3M ended production of Scotchguard — which degrades to form a chemical called PFOS, or perfluorooctane sulfonate — after discovering that PFOS was found widely in people and in the environment at low levels. Although it's disputed by some how much 3M knew about the contamination before 2000, the company took steps to correct the problem and this year released a more environmentally friendly Scotchguard. Nidel hopes such proactive moves are imitated by other drug and chemical manufacturers and will become a standard for corporate responsibility and forward thinking. Until that day, "increased regulation may be a necessary evil," Nidel said.