Pro-life vaccine company created?

Embryonic Stem Cell Research Foe, Tracy Deisher, Seeks to Market Pro-Life Vaccines
Luke Timmerman 10/1/10
The woman who helped bring the U.S. embryonic stem cell research enterprise to a standstill for a couple weeks this summer is also a Seattle biotech entrepreneur who wants to create what she calls the first pro-life vaccine company.

Theresa “Tracy” Deisher, a Stanford-trained molecular physiologist, made national news in late August as one of the co-plaintiffs who successfully challenged the Obama Administration’s year-old policy that provided additional funding for embryonic stem cell research. The big news broke when a U.S. District Court judge agreed to block the Obama Administration’s executive order, saying it violated a federal ban on embryo destruction dating back to the 1990s. The Obama Administration is appealing the judge’s ruling, and an appeals court judge has since allowed federally funded stem cell research to continue while the legal argument continues.

The latest chapter in the stem cell research controversy has rekindled this decade-long debate that has the classic ingredients of a big story—religion, science, politics. Deisher, along with co-plaintiff James Sherley of the Boston Biomedical Research Institute, were at the center of it all, appearing in a flurry of stories from the Associated Press, New York Times, Los Angeles Times, Wall Street Journal, and other media outlets.

While most of the attention focused on the legal and political storylines, not much has been written about Deisher’s career or her for-profit and non-profit ventures here in Seattle. So naturally I wanted to know more. And as luck would have it, her lab and office is one floor downstairs from my office on Seattle’s First Hill, so she came over a couple weeks ago to talk about it.

Deisher made clear that her goal is to create a new kind of biotech enterprise, Ave Maria Biotechnology, built to serve a moral purpose. The idea is to provide vaccine alternatives for people with strong religious beliefs, who reject standard commercially available vaccines that were derived via cells from aborted fetal tissue.

“We are clearly unique in that we are open and upfront about our pro-life mission,” Deisher says. “Our pro-life work is our top responsibility. For most companies, fiduciary return is the top priority. We hope our investors will make lots of money, but that’s not our first objective. We won’t compromise our pro-life mission for economic returns.”

Deisher, 47, was born and raised in Seattle. She got her scientific training at Stanford, and received a PhD in molecular and cell physiology in 1990. She ended up coming back to Seattle to work as a scientist at some of the region’s best known companies—ZymoGenetics, Immunex, and then Amgen. After that came a stint at CellCyte Genetics, a company that ran into trouble with federal securities regulators when it made exaggerated claims about stem cell research. Deisher had a public falling out with that company over their exaggerated claims, which the SeattlePI wrote about in February 2008.

Deisher’s political leanings changed dramatically over the course of her life, according to the Wall Street Journal. Deisher told the Journal she was once a “radical feminist” but changed her mind after seeing the negative effects of abortion on some of her friends. She has moved on to speak at antiabortion rallies.

Now Deisher is in an unusual position to apply her scientific background in a way that’s consistent with her beliefs. After she left CellCyte, Deisher decided to set on out on her own. She founded the for-profit Ave Maria Biotechnology, also known as AVM Biotech, and the nonprofit Sound Choice Pharmaceutical Institute.

Ave Maria Biotechnology was registered as a for-profit company with the Washington Secretary of State’s office in June 2008. Ave Maria has mostly been financed by Deisher herself, and has relied heavily on young scientific staff who are willing to donate their services for the cause, Deisher says. About 11 months after the company was founded, it raised $175,000 in equity, debt, and warrant securities out of a financing round that could potentially be worth $1 million, according to a filing with the Securities and Exchange Commission.
The company, on its website, says it objects to the use of cell lines from aborted fetuses in biomedical research, a practice that has become increasingly common in the pharmaceutical industry over the past decade. While many scientists have argued these cell lines are necessary to provide realistic conditions in the lab, Deisher rejects that idea.

“It has not held up empirically,” Deisher says, adding that pharma and biotech companies have haven’t been able to improve their success rate at creating new drugs and vaccines by using fetal cell lines in research.

Vaccines are a particular point of interest: Two mandated childhood vaccines (measles/mumps/rubella and chickenpox) are derived from fetal cell lines, Deisher says. Those vaccines alone generate about $1.2 billion in revenue for pharma companies each year, or a little more than one-fourth of the vaccine market. AVM notes that there are just over 4 million live births in the U.S. each year, and about one-tenth of those children don’t get vaccinated because their parents have religious or moral objections.

So the company’s plan is to make new vaccines that are produced without any fetal cell lines, not just for the 400,000 that morally object, but for others who take existing vaccines but would prefer to take those not derived from fetal cells.

“As a pediatrician, if you object morally to the current vaccine, you have no choice,” Deisher says.

Of course, no bootstrapped biotech like AVM has the wherewithal to finance and conduct clinical trials of a new vaccine. Instead, AVM is hoping to obtain commercial rights to a measles/mumps/rubella vaccines derived from animal cell lines that Merck, the pharmaceutical giant, has taken off the market. That vaccine is already cleared for sale by the FDA, it just isn’t currently being marketed by Merck, Deisher says. Vaccine makers have been shifting toward vaccines derived from fetal cells because they thought they would be slightly cheaper to produce, and that’s important for low-margin commodity products, she says. “The primary driver was economic,” she says.

If AVM can get ahold of this license, it would have something it could market to the many parents who choose not to vaccinate their children on religious grounds. AVM, on its website, says it “will provide commercial vaccines produced using morally acceptable cell sources and methods. We hope to be an answer to these parents’ prayers.”

While the for-profit venture hasn’t yet secured such a commercial asset, Deisher’s nonprofit venture has found better fortune. The Sound Choice Pharmaceutical Institute, which was registered in Washington as a nonprofit the same day as AVM was formed and is located in the same office, picked up a two-year $500,000 grant earlier this year from the MJ Murdock Charitable Trust, a Vancouver, WA-based foundation that supports faith-based initiatives. The Murdock grant is set aside to perform research that looks for a connection between traces of human DNA in childhood vaccines and autism.

Deisher, who announced the Murdock grant in a newsletter in April, said she was “thrilled” to get the new funding. “Shouldn’t we determine whether injecting residual human fetal DNA into our children is safe, or not?” she wrote. She added: “The grant is a major step forward for Sound Choice Pharmaceutical Institute, however, we are left with a funding gap. Please consider joining the Trust to help fund this critical research.”
The effort, based on Deisher’s July newsletter, appears to be struggling to gain momentum. The nonprofit institute has seven employees, and has sought to put them to work with basic equipment like a centrifuge, a biologic safety hood, pH meters, and incubators, Deisher wrote. After paying rent and buying lab supplies, “we have $25,000 for our employees, before mandatory taxes. We can’t retain our scientific talent with these wages,” Deisher wrote.

But research isn’t the only activity at the nonprofit institute. Deisher hopes to hire a marketing person to help with a program that will label various pharmaceuticals as “Pro-Life Produced” or “Pro-Life Approved.” This would be a certification label, like organic produce, that says whether or not a pharmaceutical or vaccine was developed using any human fetal DNA or proteins. There’s a need for certification, the nonprofit says, because 10 vaccines and three biotech drugs were produced in the U.S. with aborted human fetal cell lines. About 85 additional biotech drugs produced in this manner are “coming soon,” according to the institute.

Deisher has certainly made her share of enemies in the stem cell research field through her legal case, and any widespread effort to challenge the ethical basis of new biotech drugs is sure to run into well-financed opposition. A couple of scientists I sought comment from about Deisher politely declined to say anything on the record. Deisher didn’t have anything to say about her critics, either, but she made clear that she believes very strongly in what she’s doing, and gives no hint of backing down.

“This is a country founded on respect for the morals of others,” Deisher says. “Parents and pediatricians who object to existing vaccines should have another choice.”
Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle.

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