This week, the Second International Symposium on Green Processing in the Pharmaceutical and Fine Chemical Industries was held at Yale University in New Haven. The event brought together some of the finest minds working in green chemistry today, from industry, academia and government. Several speakers came from Japan and Europe, while an expert from Dr. Reddy's (based in the U.S.) discussed using green chemistry to develop generic drug products. Lunch keynote speaker was Connecticut DEP Commissioner Gina McCarthy.
The next few posts today will talk about Day 1 of the conference.
But wrapping up the first day was a panel discussion on "Greening the Pharmaceutical Lifecycle: Turning Challenges into Opportunities." A fairly vague title, it wound up focusing on exactly what I'd hoped it would: the issue of pharmaceuticals in the drinking water (touched on in previous posts here and there), and what that means to the public, industry and regulators. Moderating the session was none other than Berkeley Cue, Jr, who was so instrumental to Pfizer's Green Chemistry program.
Discussing the problem were Peterson Myers, CEO at Environmental Health Sciences and coauthor of "Our Stolen Future," Nicholas Anastas, a scientist from Massachusetts DEP, and Duane Huggett from the University of North Texas' Institute of Applied Sciences.
Several attendees noted that some drug companies, notably Pfizer, AstraZeneca and Merck, have already come up with detailed databases and that this work is ongoing. (Yes, but it's also voluntary...and we cynics know what can happen with voluntary industry programs that aren't universally embraced) Concerns were aired that this may ultimately prove to be a "non-issue," and wouldn't it be a shame if overly prescriptive measures were taken. Panelists also discussed new ways of analyzing impacts that could form the basis of future regulations.
One audience member concluded that the greatest need was to optimize bioavailability and to develop new delivery systems, but potential end-of-pipe treatments were also discussed.
Looming Water Shortages and the "Tamoxifen Effect"
Mr. Myers sees the issue becoming "a perfect storm" for the industry, driven by global water shortages and the fact that "21st century endocrinology is beginning to replace 16th-century toxicology" as the method for gauging impact. "It won't go away," ne noted. As Nicholas Anastas later asked, channeling Rumi, "Do you [industry] want to be the moth or the flame?" (He was asking the wrong crowd, though. These were scientists, who generally pursue the truth, however unpalatable it may be. Perhaps the question should be directed to the C-level at top executive meetings. )
He then mentioned non-monotonic dose response curves, and what some studies have seen with Tamoxifen, the breast cancer drug. At the right concentration levels, the drug can destroy cancer cells, but at lower concentrations, some studies have found that it may stimulate the growth of tumors! "The regulatory system is blind to this type of effect," he said. "And we may find that some pharmaceuticals in our drinking water follow these same curves."
Mr. Hugget from Texas noted the strains on Dallas' water system, and the Trinity River which, at one point is 90% effluent. Given that the local population is expected to double by 2050, people will eventually have to use recycled water. He also mentioned a recent Warsaw meeting in which 89 presentations focused on pharmaceuticals in the environment, as well as the data from India, published in Chemical Week and C&EN, which found extremely high levels of drugs in manufacturing effluents.
EMEA in Europe is far more involved in this issue than FDA, Hugget said, singling out Sweden for its work in assessing and addressing the problem. In the U.S., he said, FDA and EPA are planning to partner to look at "mode of action" guidelines
(Great---two resource-strapped agencies, one of which (FDA) is now somewhat in crisis, working together without top level government or industry support or funding on an extremely complex, challenging and important issue. How much progress can be made? What kind of time-line are we looking at, and how much money would be involved....wanted to ask that question, but why ruin the party, especially since it's pretty much unanswerable...Data are already being collected by industry, Mr. Hugget noted, but are they the right type of data?
Environmental Pharmacy Needed in Curricula
Once data on drugs' persistence, bioaccumulation and toxicity are available, and made available to physicians, nurses and the public (and these groups educated to make better prescription choices----he suggested that courses in Environmental Pharmacy be included in curricula), it will be necessary to look into applying newer techniques such as molecular modeling, added Mr. Anastas from Massachusetts DEP (brother of the Yale professor Paul, director for the Center for Green Chemistry and Green Engineering).
He noted the "Nocebo" effect, and the fact that, when told there may be a contaminant in the water, some people suddenly develop symptoms <ribshot----this was a serious crowd> He also mentioned end of pipe treatment options, some of which are being developed by Terry Collins at the University of Massachusetts (formerly of Carnegie-Mellon), which include UV and other forms of biofiltration.
Audience members brought up the fact that drug metabolites in the environment can be far more toxic than the drugs themselves, a fact that all panelists and Mr. Cue agreed was very important. They also mentioned the fact that the drug industry already possesses vast amounts of clinical data on each of its drugs. "We know what the knowns are. What worries me are the unknown unknowns," one attendee asked. Panelists agreed that mixtures of drugs topped the list.
In general, Europe is ahead of the U.S. in examining these issues and requiring industry to provide more data.
Clearly this issue will take many years, much science and $ to assess and mitigate. I was pleased to see it being openly debated, and hope that the discussion is advanced, and facts shared by experts, at industry management meetings.
As DEP Commissioner McCarthy noted, we're in an age where the market is driving political decisions and the market is clearly demanding safe, environmentally sound solutions. That same market can also drive policies that are based on bad science, if industry fails to take the public's concerns seriously.
An industry that's already lost favor with the public doesn't need to lose any more good will.
From 'On Pharma'