Monsanto, Henry Miller, and the FDA

I have been reading with interest various articles reporting on the trove of internal documents obtained from Monsanto during the discovery phase of a federal multidistrict litigation against that company that is currently pending in the United States. (The documents, and a list of articles from all over the world that have been written about them, can also be found on the website of the NGO US Right to Know.)

Attorneys with Baum, Hedlund, Aristel & Goldman, the firm representing hundreds of plaintiffs across the US in the case, indicate that these so-called “Monsanto Papers” “tell an alarming story of corporate malfeasance. They reveal that Monsanto has been manipulating the science…ghost-writing scientific literature…bullying scientists that publish anything negative…and colluding with regulators to ensure ‘positive’ assessments.”

I was especially intrigued to learn that Henry Miller, who was described in The New York Times as “an academic and a vocal proponent of genetically modified crops,” is implicated in the ghost-writing scandal, albeit in regard to a non-academic journal. As reported in The Times, Dr. Miller “asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015.” Forbes has since taken the article in question down from its website and ended its relationship with Dr. Miller.

What was not mentioned in the article in The Times, and the reason for my intrigue, is the fact that Dr. Miller was the founding director of FDA’s Office of Biotechnology from 1989 to 1994. During that timespan, Calgene Inc., was seeking approval from FDA to commercialize what turned out to be the first genetically engineered (GE) whole food to enter the marketplace, the Flavr Savr™ tomato. Back then I was part of a team of scientists at Calgene conducting safety studies, explaining to FDA scientists how the genetic engineering process we were using worked, and participating in a dialogue with those FDA scientists about what possible risks might be associated with crop genetic engineering technology.

I have always felt that the timing of the release of FDA’s policy for dealing with GE food and feed products (not to mention the policy itself) made no sense. And now I am wondering how long the relationship between Dr. Miller and Monsanto, which appears to have included ghost-writing in support of that company, has been going on.

Initial safety data on the first GE whole food had been submitted to FDA, but not yet evaluated by the agency, when the May 1992 FDA policy was established

We at Calgene had submitted a large package of data that we hoped demonstrated the safety of our GE tomato to FDA in August of 1991. We had submitted a similarly large package of safety data related to use of a gene conferring resistance to the antibiotic kanamycin, a gene Calgene and most other biotech companies insert(ed) into crops during the genetic engineering process, some 10 months earlier.

But before FDA had responded to these data packages, first by asking questions about their scientific contents and then by asking for more data to support our safety claims—which the agency ended up doing on at least five occasions, FDA came out with its policy for how to “regulate” GE food and feed products in May of 1992. That FDA policy was simple. With only a couple of exceptions, it called for developers of GE food/feed products to voluntarily consult with the agency about them.

The timing of the May 1992 policy just didn’t make sense to me. Why hadn’t the agency waited until it had thoroughly evaluated the safety of (at least) the first GE food product, Calgene’s Flavr Savr™ tomato, before it came out with its policy for “regulating” all GE food/feed products? And, because FDA had not completed evaluation of Calgene’s—or any other developer’s—safety-related data prior to publishing its policy for “regulating” GE foods, how could that policy be based on science?

Thorough evaluation of Calgene’s safety data revealed scientific “surprises” that I feel are relevant to FDA regulation of GE foods

As it turned out, FDA scientists, and we Calgene scientists as well, continued to discover and deal with scientific issues related to the genetic engineering process in general, and the Flavr Savr™ tomato in particular, for some 18 months after the May 1992 FDA policy was published.

For example, FDA contacted Calgene multiple times between December 1992 and September 1993 about concerns they had with one scientific experiment in which minor gastric lesions developed in the stomachs of 7/20 female rats fed one particular variety of Flavr Savr™ tomato. In response, Calgene conducted multiple, various additional studies on that GE tomato variety until FDA was satisfied as to its safety.

And some six months after the May 1992 FDA policy was published, FDA scientists also asked Calgene to carry out experiments to demonstrate that only the foreign DNA we intended to insert into our tomatoes was, in fact, inserted into them. I, for one, was flabbergasted to find out that in about 20% of our GE tomatoes (and other GE crop plants transformed using the Agrobacterium method), much more foreign DNA—and DNA that was not well characterized at that—had been inserted than we had intended. To my knowledge, this “extra DNA” problem still has not been solved and so crop genetic engineers just have to look for extra DNA in each GE plant and throw out those that contain any.

What might FDA’s policy for regulating GE foods/feeds have looked like had the agency waited until after it had concluded evaluation of Calgene’s safety data to set its policy?

If FDA had waited until after it had reviewed all of Calgene’s data, and until after the scientific issues that surfaced during that review had been resolved to its satisfaction—i.e. until a point at which it could base its policy on some actual science—its policy for regulating GE crops might have been very different. FDA might have required that developers check their GE crops for DNA that was not intended to be inserted into them, for example, and/or required animal-feeding studies of new GE crops as is required in the European Union.

So why didn’t FDA wait until it had evaluated all of (at least) Calgene’s data, and then establish its policy based on that relevant science?

Could FDA’s failure to wait until after it had completed evaluation of the relevant data it had in hand before publishing its policy for “regulating” GE foods have had anything to do with a relationship between Henry Miller, Director of FDA’s Office of Biotechnology at that time, and Monsanto?

Back when Henry Miller was serving as the first director of FDA’s Office of Biotechnology (1989-1994), we at Calgene had heard rumors that Monsanto was not happy that Calgene, a little start-up company, might set regulatory precedence with FDA by being first to commercialize a GE whole food. And we knew that Monsanto employees were also in dialogue with FDA during the years leading up to publication of the FDA policy in May of 1992.

I have read many of Miller’s writings since then and often wondered how much he might have been influenced by Monsanto as the 1992 policy was being set. Especially since, as Monsanto’s Vice President for global strategy, Scott Partridge, told The Nation recently, “the [regulatory] process requires a tremendous amount of contact and interaction with the government.”

Now that it has come to light that Monsanto has apparently ghost-writen for Miller about RoundUp/glyphosate, I am even more curious about what kind of influence that company might have had over Miller back when the FDA policy was being formed.

Monsanto’s influence on EPA

After all, the “Monsanto Papers” suggest that Jess Rowland, a (now former) deputy director of the EPA’s pesticide division, had the kind of relationship with Monsanto that caused Congressman Ted Lieu to ask the Justice Department to investigate the possibility of collusion between Monsanto and EPA employees reviewing glyphosate, the herbicide-active ingredient in RoundUp. (And, as reported in The Nation, the EPA’s Office of the Inspector General has claimed to be looking into that.)

So I wonder: how might Monsanto have influenced Henry Miller, back in the early 1990s when he was director of FDA’s Office of Biotechnology (1989-1994), on the subject of how genetically engineered foods should be regulated by FDA?

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3 Responses to Monsanto, Henry Miller, and the FDA

  1. Ed Regis says:

    Re: “We at Calgene had submitted a large package of data…” Can you give us some idea of the size of this package, as for example an approximate page count? When in February of this year, PhilRice and IRRI submitted an application for a biosafety permit for Golden Rice to the Philippine Department of Agriculture, the application totaled about 1,000 pages. Was Calgene’s comparable to that?

    • Belinda says:

      Sure. And yes, Calgene’s data package(s) was comparable to that.
      The original data package that Calgene submitted to FDA on November 26, 1990, which covered the gene conferring resistance to the antibiotic kanamycin, comprised three volumes: one of 272 pages, a second of 596 pages and a third that contained a list of references. The original data package that Calgene submitted to FDA on August 12, 1991, which covered the Flavr Savr tomato itself, was 574 pages long (not counting the list of references).
      But, as I mentioned in this post, AFTER the FDA published its policy for voluntary consultations with developers of GE foods/feeds, the agency asked Calgene for more data on multiple occasions, and Calgene responded to all of these requests with more data.

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