Friday, April 11, 2008

Montville ban threatens state's economic development plan

Activists, desperate for a win after a series of setbacks in their drive to rid Maine of biotech-enhanced crops, have found a new venue — town meetings. At town meeting (March 29), the residents of Montville voted overwhelmingly to ban the planting of genetically engineered plants within the town. The selection of town meetings to carry on the fight is no accident. The message is easily controlled. Outsiders, who might have some knowledge are unwelcome at town meetings. Debate is limited. And the populist appeals of the anti-biotechnology crowd, built on a distrust of corporations and science, resonate with the residents of Maine’s small towns, hard hit by the state’s flagging economy.

In the grand scheme of things, the action in Montville won’t amount to much. The
ordinance clearly violates Maine’s right to farm law which plainly states “A method of operation used by a farm or farm operation located in an area where agricultural activities are permitted may not be considered a violation of a municipal ordinance if the method of operation constitutes a best management practice as determined by the Department of Agriculture, Food and Rural Resources.” (17 M.R.S.A., 2805) The Department of Agriculture, which considers biotech crops to be part of best management practices, has said it will ask the Attorney General for an opinion on Montville’s ordinance. The Maine Farm Bureau, which in the past has aggressively defended farmers’ rights to farm as they see fit, will undoubtedly join the fight. Other Maine farm organizations can be expected to follow suit.

The problem for Maine officials, though, is this isn’t a fight over what may or may not be grown in Montville. It’s a battle over the public’s acceptance of science in shaping the future of agriculture. Many Mainers have bought into the organic farming mystique, which is rooted in the unscientific premise that nitrogen from cow manure is better for plants than nitrogen from the air, or that chemical pesticides synthesized by plants are safer than chemical pesticides synthesized by man. Framing the contest as one between organic farming and biotech farming neatly sidesteps the scientific debate. In fact, the path to victory for opponents of biotech lies in an outright rejection of science. As Diana George Chapin, who led the Montville ban effort
wrote, “While many answers to securing our future lie in the investigations and developments of science, I believe GMOs do not improve the quality of our lives.” (Oddly enough, Chapin has a master’s degree in soil and environmental science.)

The rejection of science in the debate over biotech crops should be setting off alarm bells in the statehouse and at campuses across the state. Maine has hitched its economic future to the triumph of science. State officials have upped spending on research and development and repeatedly urged voters to pass R&D bond issues. All of this is based on solid research showing higher incomes in states that spend heavily on scientific research. A rejection of science on the local level threatens the very heart of the state’s economic development plan.

State officials, from the governor’s office to the chancellor’s office in Orono, are betting that setbacks like the one in Montville won’t chill the voters ardor for R&D spending. They may be right. But Maine’s spending on R&D is not based on the premise that the state can spend its way to prosperity. It is based on the expectation that private investment will flow into the state to leverage state spending. And venture investors, who invested over $9 billion last year in life science companies, do pay attention to little things like Montville. Who wants to risk their money in a state that rejects the very thing they are investing in? No matter how many R&D bonds the voters approve, without private investment the state’s plan will fail.

And private investors will be hearing about Montville soon, if they haven’t already. What Maine’s public officials have failed to grasp is that the real goal of the anti-biotechnology activists in Maine is PUBLICITY. Who cares what is or isn’t grown in a Maine town with a population of 1,000. But when a Maine town becomes the “First town outside of CA to pass moratorium on GMOs,” as the activists spun it, the world will take note. As Rob Fish, the founder of GE Free Maine (since renamed Food for Maine’s Future) crowed in an e-mail to me, “Did you see the national media on Montville?”

What should Maine officials do? First, they should end their silence on this issue. For years, activists have disparaged biotechnology and the farmers who use it without a peep from elected officials or scientists in the state who know better. Then, Maine officials, starting with the Governor, should role up their sleeves and start defending biotechnology. Here’s a to do list:
  • 1. The governor’s science advisor should issue a statement denouncing the action in Montville as being unscientific and contrary to the best interests of Maine farmers and the state.
  • 2. The governor should convene a blue ribbon panel to make recommendations on how best to integrate biotechnology into the state’s economy.
  • 3. The University of Maine should update its biotechnology White Paper series issued between April and December 1999.
  • 4. The University of Maine should convene a panel of experts on agricultural biotechnology and host a series of public debates at locations around the state.
  • 5. Then the university should publish and distribute the proceedings of the expert panel.
  • 6. Individual scientists around the state, in both the public and private sectors, should engage in the public debate through public lectures, panel discussions and in newspaper columns and letters to the editor.

If leaders around the state undertake even a portion of the steps outlined above, the recent action in Montville will fade into obscurity as Maine claims its rightful place in the 21st century. If state officials and scientists remain silent, the residents of Montville will get their wish as the state slips quietly back into the 19th century.

Tuesday, April 8, 2008

Looking for a job? Maine's truth squad has openings.


  • Help Wanted: Anti-sales representatives to travel the state of Maine to talk with doctors and health care providers in order to counter what pharmaceutical sales representatives are telling them. Competitive salary, generous fringe benefits, state car and credit card. Position reports to Winston Smith in the Ministry of Truth.


I’m making this up, right? NOT! (Well, I did make up the part about Winston Smith and the Ministry of Truth. That came from George Orwell’s novel 1984.) According to LD 839, which was passed by the Maine legislature last year, the state is supposed to have an “academic detailing” program up and running by January 1, 2008. The purpose of the law, according to the preamble, is to “enhance the health of the residents of the State” and “improve the quality of decisions regarding drug prescribing.”


The program components include “outreach and education” including “personal visits from program staff.” There it is, the smoking gun. The state is going to hire people to go out and PERSONALLY visit doctors in order to “improve” the decisions they make. Just what we patients are looking for, a doctor whose decision making has been “improved” by the Maine Department of Health and Human Services. For those who have forgotten, these are the same people who engineered the Medicare billing fiasco that sent $56 million of your tax dollars into a black hole.


Who’s paying for this Orwellian scheme? Pharmaceutical manufacturers doing business with the state must pay a $1,000 annual fee. The Pharmaceutical Research and Manufacturers of America list 65 member companies on their Website. Assuming all of these companies do business in Maine (which they don’t) that’s $65,000 into the kitty each year. With salary, benefits and expenses, that would support about one truth teller a year. Where’s the rest of the money going to come from? You guessed it, the General Fund — your tax dollars at work. So, not only is DHHS sending out a truth squad to “improve” you doctor’s decision making, but you are footing the bill!


There are two messages here, one for business owners in Maine, the other for consumers. If you are a business owner pray that your sales practices don’t catch the attention of a legislator. Should you run afoul of the legislature, you could find your sales representatives being shadowed by a taxpayer-funded truth squad to “improve” the decisions made by your customers. And for consumers, the next time you see your doctor ask yourself, is the decision your doctor just made guided by that Harvard Medical School diploma on the wall or did it originate in the Ministry of Truth in Augusta?


When we moved our public relations business to Maine we were astonished when CEO after CEO told us they didn’t want the name of their company to appear in newspaper stories. “It only brings the regulators from Augusta to mess around in our business,” they told us.
Maine has the 48th worst business climate in the nation. A well deserved ranking from the look of it.


Postscript Before posting this article I called DHHS and asked to talk with someone familiar with this program. I was promised a call back. Four days later nobody has called. Either they don’t know what is going on or they don’t want to talk about it. My money’s on the latter.
February 6 Update I received a call from Jude Walsh in Governor Bladacci’s Office of Health Policy where she is Director of Pharmacy Affairs. Walsh said the program startup has been delayed because Maine is working with Vermont and New Hampshire, where similar programs are in the works. The three states have received a planning grant and will be meeting next Monday (Feb. 11) with an expert from Harvard Medical School to begin working on a curriculum for the academic detailers. The academic detailing program in Pennsylvania will serve as a blueprint for the three-state initiative. Rules for Maine’s program have been drafted but are not yet available to the public.

(Originally posted 1/25/2008)

Will biotech get mugged (again)?

Nine years ago the Maine Board of Pesticides Control turned thumbs down on several registration applications for insect-resistant corn containing the naturally occurring pesticide Bacillus thuringiensis or Bt. The reason: the applicants failed to demonstrate a need for the products as required by law. The hearings were contentious and messy with biotech opponents sounding off about technology run amok, corporate greed and all manner of things unrelated to the technology. Seed manufacturers were so disheartened by the process that a full nine years would pass before they could be persuaded to resubmit their applications. Meanwhile, the opponents of agricultural biotechnology claimed bragging rights when the action made Maine the only state in the nation to prohibit the planting of Bt corn.

Fast forward to 2007. In July, the BPC reversed itself and approved seven varieties of Bt field corn. Need for the products was documented by field trials and thoughtful testimony from farmers who claimed they would plant the corn. Scientific questions were addressed by a Technical Committee which submitted a 34 page report to the Board. Though testimony from opponents was as wild and wooly as ever (
Rep. David Miramant claimed modern farming methods were the cause of all the cancer we see), against the backdrop of the Technical Committee’s report, the unsubstantiated claims of harm from Bt corn couldn’t gain any traction. The BPC voted unanimously (with one abstention) to approve the registrations.

Now the process seems poised to come unglued as the BPC tackles rule making for the use of the products. The draft rule is a hodgepodge of initiatives that lack not only a scientific underpinning, but make no sense. For example, the rule proposes that farmers who plant Bt corn be licensed as pesticide applicators, never mind that the same farmer could buy unlimited amounts of Bt itself and apply it without any license. The draft rule also defines the plant itself as a pesticide, not just the active ingredient. That’s like calling a bottle a pesticide because it happens to contain one. Some of the rule, training for farmers who plant Bt corn, for example, seems reasonable, but the jury is very much out on how the final rule will read.

The public hearing on the draft rule, held November 16, was a spectacle. BPC members politely listened to four hours of testimony, much of it redundant and most of it completely unrelated to the draft rule. The same familiar faces stood before the board and made the same wild and unsubstantiated claims about biotechnology. Someone even launched a gratuitous attack on the Board claiming they were on the take for having granted the registrations in the first place. Supporters of the registrations stayed focused and narrowly commented on the draft rules. It was as if the two opposing sides were from different planets.

How did we get here? How do we find ourselves deep in the middle of a very serious governmental process where an elected official states (unopposed) that our farmers are killing people. Or where a person levels a charge of corruption against public officials without a shred of evidence and is not held accountable.

WE GOT HERE BECAUSE WE LET IT HAPPEN. Reasonable, knowledgeable people have left the process. Scientists no longer testify at legislative hearings or rulemaking sessions because no one listens to them. And they are tired of taking abuse from unhinged critics in public meetings. An agronomist who has volunteered considerable time to help the BPC told the Board at the last meeting he would no longer donate his time because nobody was listening to him. Business people have also left the room. A plea to the Biotechnology Association of Maine to engage in the rulemaking process went unanswered.

It remains to be seen whether the rulemaking process will spin out of control or whether reason and science will prevail in the end. But which ever way it goes, Maine has lost. For a state that touts the “Creative Economy” and courts biotechnology as a “targeted economic sector” the public flogging of agricultural biotechnology throughout this process is an embarrassment.


(Originally posted 12/03/2007)

Of butterflies and caddisflies -- what's a regulator to do?

Yoggi Berra called it “deja vu all over again” — the feeling that you’ve been there done that. For biotech supporters, the recent study published in Proceedings of the National Academy of Sciences is causing flashbacks to 1999. That’s the year when a paper published in The Lancet showed you could kill Monarch butterfly larvae by feeding them gobs of pollen from Bt corn — corn genetically engineered to express a naturally occurring pesticidal protein. To activists it was the “smoking gun” they desperately needed to end the advance of biotechnology in agriculture. Soon, Monarch butterflies were everywhere, marching in front of supermarkets, flying around Web pages — the Monarch butterfly quickly became the symbol of the anti-biotechnology movement.
There was only one problem. John Losey, the researcher who published the study, fed the pollen to the Monarch larvae in the laboratory. Critics of the study said the levels of pollen needed to kill the larvae were way higher than those found in corn fields. Sure enough the critics were right. After several years of actual field studies, researchers at the USDA’s Agricultural Research Service concluded “There is no significant risk to monarch butterflies from environmental exposure to Bt corn.” To this day there is
a USDA Website devoted to the controversy.

The study just published in PNAS claims that Bt corn byproducts and pollen are toxic to caddisflies, small insects that live in streams. When these streams flow near corn fields planted with Bt corn, some of the stalks end up in the streams where they are eaten by the caddisflies. This led the authors to conclude that “Bt corn byproducts may have negative effects on the biota (read caddisflies) of streams in agricultural areas.”

The parallels between the 1999 study and the recent PNAS study are eerily similar. Both the Monarch larvae and the caddisflies were killed by pollen administered in the laboratory. Both authors qualified their results with words like “may have” or “potentially” when suggesting Bt corn was harming the environment. Experts in the field were strongly critical of both studies. Both times, the media ignored the qualifiers and the critics when reporting on the studies. And both times the activists seized on the studies as the long sought “smoking gun” they were looking for.
The criticism of the caddisfly study is persuasive. The concentrations of Bt needed to cause mortality were way higher than that found in the field. From the way the study was designed, you can’t know for sure what was killing the insects. And most importantly, the study didn’t look at the effect of Bt on caddisflies under actual field conditions.

Several things we know for sure. More work will be done, but this time it will be carefully done under actual field conditions, just as with the Monarch butterfly. We can be certain that activists, undaunted by their past embarrassments, will seize on the research to press their case with regulators and legislators. What we won’t see is activists parading in front of supermarkets dressed as caddisflies — they are ugly little devils.

It will take some time to resolve this issue. Good science takes time. In the meantime, Maine regulators and legislators can do little but wait and watch. Taking action on the basis on one scientific study is not only bad policy, it shows a profound lack of understanding of science itself.

(Orginally posted 11/09/07)

Maine R&D spending: Mid-course correction

By all accounts, for the past ten years Maine has been on a research and development spending binge. The start of the spending spree can be traced back to Joel Russ when he headed the now defunct Maine Science and Technology Foundation. In 1998, Russ talked the legislature into floating a $20 million R&D bond that, when passed by voters, funneled research money into the University of Maine and the MSTF. Russ’s argument: R&D spending boosts incomes.
Two years later, Evan Richert, Governor Angus King’s choice to head the Maine State Planning Office, upped the ante with his “30 and 1,000″ plan. Richert’s vision was that by the year 2010, 30 percent of Maine’s adults would have college degrees and R&D spending would reach $1,000 for every working person in the state. The legislative spigot opened further and a succession of R&D bonds followed.


But something happened on the way to the party: the way those R&D funds were allocated changed. The 1998 bond earmarked $3 million for the private, industrial sector and $1.5 million for Maine’s nonprofit research sector: two-thirds industry; one-third nonprofits.
Following the 1998 bond, the next legislature escalated R&D spending spree with a $10 million appropriation, but it dedicated the money to a newly created Maine Biomedical Research Fund. To get money out of the fund you had to be a “Maine-based private nonprofit biomedical research institution or academic medical center or medical school.” With that, Maine’s nonprofit R&D institutions had a lock on the funds. In 2003, Maine voters plowed $20 million into the fund and in 2005 added another $8 million. Since its inception, $52.5 has passed through the Maine Biomedical Research Fund.


Meanwhile, the private sector was receiving far less. For example, from the $60 million R&D bond that added $20 to the Biomedical Research Fund, the private sector got $2 million through grants to various “technology sectors.”

Shortly after the spending spree began, the legislature commissioned a study to look at R&D spending to see if the state was getting a proper bang for its buck. The first study was encouraging, though not enough time had passed to draw meaningful conclusions. The law required the study be repeated in five years. The first five-year analysis was published on February 6, 2007. And it was an eye-opener.

Not surprisingly, the study found that the $297 million Maine has spent on R&D since 1996 has “contributed to consistent growth in Mane’s economy and has increased competitiveness relative to other states.” The study also found R&D spending has created jobs and boosted incomes. Maine’s median income has been creeping up relative to the rest of the U.S., due in part to better paying R&D jobs.

But four paragraphs into the report the tone turns sour. “There is, however, a serious mismatch between the investment in R&D and the resulting performance,” the report states. R&D spending on the nonprofit sector caused it to grow by 211 percent, while nationally the nonprofit sector grew only 89 percent. Meanwhile, despite investing 22.5 percent of the R&D funds in private industry, the sector shrunk by 30 percent.

“The question is, do we care about these allocations? The answer is we do. While increased R&D is in and of itself a good thing, its real impact on the economy is when the knowledge produced is commercialized. The overwhelming finding from this report is that the academic and nonprofit sectors are not commercializing much of the new knowledge acquired through the state-funded R&D, while industry is commercializing at a high rate. Therefore, the state’s investment is not creating the maximum possible impact.”

Ouch!

The good news is that legislators apparently read the report. This November voters will decide on a $55 million R&D bond issue. If it passes, $50 million will go to the Maine Technology Institute to be parcelled out to private industry and nonprofits on a competitive basis, with no earmarks! This means the private sector and the nonprofits will be on an equal footing when they line up for state R&D funds.

Under the new system, the winners will be the researchers with the best ideas . . . and the people of Maine.

(Originally posted 10/26/2007)

Sunday, April 6, 2008

Pesticide Board Threatens to Undercut Insect-Resistant Corn Registrations


Maine farmers scored a huge victory on July 27 when the Maine Board of Pesticides Control voted to register seven varieties of biotech-enhanced, insect-resistant field corn. Nine years earlier, the BPC turned thumbs down on similar applications claiming there was no need for the products in Maine. This time the farmers were prepared. A study showing that the bugs the corn resists are active in Maine was presented to the BPC. At the hearings, farmers came out in numbers to testify that the corn was in fact needed and without it Maine farmers would lose access to better yielding varieties of field corn. The BPC listened and voted unanimously (with one abstention) to register the products.

Now, the BPC seems poised to take all that away.
Draft rules for the regulation of insect-resistant corn are so burdensome that manufacturers of the products are likely to withdraw their registrations and write off the Maine market. If this happens Maine’s dairy farmers, who need the corn to feed their cows, will be the losers. Their competitors in every other state in the nation can plant the higher-yielding varieties, and thus will have an economic advantage.

What’s going on? The health and environmental safety issues have long been resolved in favor of insect-resistant corn. Even the BPC itself found nine years ago that the products posed no dangers to health and safety in Maine.

What’s happening is that a well organized lobby of organic farmers and backyard gardeners are trying to gain through rulemaking what they could not achieve in the approval process.
A letter from Russ Libby, executive director of the Maine Organic Farmers and Gardeners Association, to the BPC contains a blueprint for the rules. The draft rules published after Libby’s letter was received follow his recommendations, almost to the letter: required pesticide licenses for farmers who plant the corn, mandatory buffers between insect-resistant corn and other corn and pesticide licenses for seed dealers who sell the corn seed.

The requirement that seed dealers who sell and farmers who plant the insect-resistant corn obtain a pesticide license is regulatory overkill. The 191 page manual, on which the licensing exam is based, contains not a single piece of information relevant to the planting of the corn. The mandated 660 ft. buffer between insect-resistant corn and other varieties ignores the findings of the BPC’s own technical committee and the research of one of its members who found that beyond 100 ft., cross-pollination by corn was minimal.

But all of this misses the point. The Board of Pesticides Control is charged by Maine law with “assuring to the public the benefits to be derived from the safe, scientific and proper use of chemical pesticides while safeguarding the public health, safety and welfare, and for the further purpose of protecting natural resources of the State.” The BPC has already determined there are no public or environmental health or safety issues with insect-resistant corn. The pursuit of a burdensome rulemaking effort at the urging of activists who failed to make a scientific case sufficient to block registration should stop. Otherwise, the BPC will fail in its responsibility to provide to the public the benefits to be derived from the safe, scientific and proper use of the seven, insect-resistant strains of corn it already has approved.


(Originally published on October 11, 2007)