Ex-employee Testimony to the Hawai'i Department of Agrigulture on Pharm Algae

By Mark Bilan
Contact: Dr Brian John
Press Notice
May 25, 2005

Hello,

My name is Mark Bilan, an ex-employee of Mera Pharmaceutical when it was known as Aquasearch Inc. and I wish to offer some comments on the proposed introduction to our island of a GMO algae to be grown at Mera Pharmaceutical. I have done a little researching about this algae and in it's natural form it is a very hardy and prolific strain in nature, able to survive in a fresh or salt water environment.

I read in the article in West Hawaii Today about the assurances by Mera that it will be safely grown in their enclosed growth modules. I helped to design and built [sic] those modules. In my 5 years of employment at Aquasearch my job as a lead technician and maintenance person involved me in helping design and build every aspect of the facility including the growth modules and the processing plant. I worked directly with all the scientists and engineers who proposed a design and then gave it to me to build so please trust me when I say that I know what I'm talking about as far as their system capabilities and limitations.

In my opinion, there is no way for Mera to guarantee that they can grow anything there and it will absolutely not end up in the groundwater, out in the nearby shore or carried away by unknowing employees to who knows where. Let me tell you about a few of the biggest concerns. The growth module end sections are made of Schedule 40 PVC plastic. The polyethylene tubing that makes up the length is joined to the ends by means of foam tape as a seal and then the outer layer of the polyethylene tubing is wrapped with duct tape to keep it from tearing and then held on with stainless steel clamps. The system is sterilized after building with a sodium hydrochloride solution and rinsed before being filled with culture. This same sterilizing procedure is used after harvest. A module may be used for up to 4 times before it is disassembled. When it is, the ends are cleaned and the tubing is discarded.

A major concern during the development and design of these module assemblies is to ensure that there are no pockets that algae can accumulate, die and cause bacteria or other contaminates to grow. This problem has never been fully solved but at least reduced to a point of acceptability for the growth of the product we had then. This of course means that as of now Mera cannot claim that when a module is taken apart, all remaining algae cells will be dead. This is a minor concern, a few pockets of living cells that may end up in a landfill somewhere and maybe work their way into the ground water table.

What is a bigger and more serious concern is that during the growing cycle, the module sits on the module pad semi-submersed in a constant bath of cold sea water used for temperature control. When a module springs a leak (which is often enough as the tubing is only polyethylene and can be punctured by tiny lava rocks or any pointy object) the only way it is known is if someone noticed the volume of the module is much lower or if they happen to spot the leak while tending to the module's shade cloth or whatever. In the meantime, gallons and gallons of culture have run into the drainage system which leads directly to an untreated hole in the ground not more than 100 yards from the shore and is below sea level. Mera may tell you this is not really a problem because this same hole is used for the dumping of the sodium hydrochloride mixture used to sterilize all the systems. I seriously doubt there is always chlorine in that hole especially at night when there is no one there but the module may still be leaking.

Another major concern is the harvesting and processing of the algae. When harvested, the culture is sent to a large holding tank where the algae is allowed to settle out. Most of the algae will sink to the bottom and then the top water is drained off to reduce the volume to be centrifuged. This drained top water is once again sent to the big hole in the ground still full of live cells and more will join it as it is further processed. If the product is dried on site, even if it is ruptured first, the belt drier used can cause dried (and still alive cells) to become airborne by it's exhaust which can be carried across the street to Cyanotech and contaminate their ponds growing algae for their products Spiralina or BioAstin.

Aside from the methods mentions so far there is also the very real possibility that this algae will end up in the clothing and on the bodies of the employees and carried far off the premise. Washed cloths will then carry the algae into the local water table and water treatment plants. Remember this is a very robust strain of algae nicknamed "the cockroach" of the algae kingdom for it's survivability in adverse conditions.

Mera has in the past been dealing with growing alga's that were not a threat to the environment and were in fact natural occurring species. Now however, we are talking about a genetically modified version of something that is a nightmare to deal with in it's natural form. What precautions have been taken to ensure this will not survive on it's own and cause irreversible damage to out environment here in Hawaii? I urge you to consider the possible outcome of letting this into out home andthe permanent damage it may do. Mahalo

Mark Bilan

Creating 'Human-animals' for Research

May 1, 2005

Ethics report endorses mingling human cells with lesser beings

RENO, Nevada (AP) -- On a farm about six miles outside this gambling town, Jason Chamberlain looks over a flock of about 50 smelly sheep, many of them possessing partially human livers, hearts, brains and other organs.

The University of Nevada-Reno researcher talks matter-of-factly about his plans to euthanize one of the pregnant sheep in a nearby lab.

He can't wait to examine the effects of the human cells he had injected into the fetus' brain about two months ago.

"It's mice on a large scale," Chamberlain says with a shrug.

As strange as his work may sound, it falls firmly within the new ethics guidelines the influential National Academies issued this past week for stem cell research.

In fact, the Academies' report endorses research that co-mingles human and animal tissue as vital to ensuring that experimental drugs and new tissue replacement therapies are safe for people.

The National Academies -- private, nonprofit agencies chartered by Congress to provide public advice on science and technology -- consist of the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine and the National Research Council.

Doctors have transplanted pig valves into human hearts for years, and scientists have injected human cells into lab animals for even longer.

But the biological co-mingling of animal and human is now evolving into even more exotic and unsettling mixes of species, evoking the Greek myth of the monstrous chimera, which was part lion, part goat and part serpent.

In the past two years, scientists have created pigs with human blood, fused rabbit eggs with human DNA and injected human stem cells to make paralyzed mice walk.

Particularly worrisome to some scientists are the nightmare scenarios that could arise from the mixing of brain cells: What if a human mind somehow got trapped inside a sheep's head?

The "idea that human neuronal cells might participate in 'higher order' brain functions in a nonhuman animal, however unlikely that may be, raises concerns that need to be considered," the Academies report warned.

In January, an informal ethics committee at Stanford University endorsed a proposal to create mice with brains nearly completely made of human brain cells.

Stem cell scientist Irving Weissman said his experiment could provide unparalleled insight into how the human brain develops and how degenerative brain diseases like Parkinson's progress.

Stanford law professor Hank Greely, who chaired the ethics committee, said the board was satisfied that the size and shape of the mouse brain would prevent the human cells from creating any traits of humanity.

Just in case, Greely said, the committee recommended closely monitoring the mice's behavior and immediately killing any that display human-like behavior.

The Academies' report recommends that each institution involved in stem cell research create a formal, standing committee to specifically oversee the work, including experiments that mix human and animal cells.

Weissman, who has already created mice with 1 percent human brain cells, said he has no immediate plans to make mostly human mouse brains, but wanted to get ethical clearance in any case.

A formal Stanford committee that oversees research at the university would also need to authorize the experiment.

Living factories

Few human-animal hybrids are as advanced as the sheep created by another stem cell scientist, Esmail Zanjani, and his team at the University of Nevada-Reno.

They want to one day turn sheep into living factories for human organs and tissues and along the way create cutting-edge lab animals to more effectively test experimental drugs.

Zanjani is most optimistic about the sheep that grow partially human livers after human stem cells are injected into them while they are still in the womb.

Most of the adult sheep in his experiment contain about 10 percent human liver cells, though a few have as much as 40 percent, Zanjani said.

Because the human liver regenerates, the research raises the possibility of transplanting partial organs into people whose livers are failing.

Zanjani must first ensure no animal diseases would be passed on to patients.

He also must find an efficient way to completely separate the human and sheep cells, a tough task because the human cells aren't clumped together but are rather spread throughout the sheep's liver.

Zanjani and other stem cell scientists defend their research and insist they aren't creating monsters -- or anything remotely human.

"We haven't seen them act as anything but sheep," Zanjani said.

Zanjani's goals are many years from being realized.

He's also had trouble raising funds, and the U.S. Department of Agriculture is investigating the university over allegations made by another researcher that the school mishandled its research sheep.

Zanjani declined to comment on that matter, and university officials have stood by their practices.

Ethical boundaries

Allegations about the proper treatment of lab animals may take on strange new meanings as scientists work their way up the evolutionary chart.

Human stem cells have been injected into mice and now sheep. Such research blurs biological divisions between species that couldn't until now be breached.

Drawing ethical boundaries that no research appears to have crossed yet, the National Academies recommend a prohibition on mixing human stem cells with embryos from monkeys and other primates.

But even that policy recommendation isn't tough enough for some researchers.

"The boundary is going to push further into larger animals," New York Medical College professor Stuart Newman said. "That's just asking for trouble."

Newman and anti-biotechnology activist Jeremy Rifkin have been tracking this issue for the last decade and were behind a rather creative assault on both interspecies mixing and the government's policy of patenting individual human genes and other living matter.

Years ago, the two applied for a patent for what they called a "humanzee," a hypothetical -- but very possible -- creation that was half human and chimp.

The U.S. Patent and Trademark Office finally denied their application this year, ruling that the proposed invention was too human: Constitutional prohibitions against slavery prevent the patenting of people.

Newman and Rifkin were delighted, since they never intended to create the creature and instead wanted to use their application to protest what they see as science and commerce turning people into commodities.

And that's a point, Newman warns, that stem scientists are edging closer to every day: "Once you are on the slope, you tend to move down it.

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