Friday, May 23, 2008

NYT Publishes Story on Tobacco Research at VCU

New York Times published a story regarding the sponsored research commissioned by Philip Morris at VCU in Richmond.

May 22, 2008
At One University, Tobacco Money Is a Secret
By ALAN FINDER, New York Times

On campuses nationwide, professors and administrators have passionately debated whether their universities should accept money for research from tobacco companies. But not at Virginia Commonwealth University, a public institution in Richmond, Va.

That is largely because hardly any faculty members or students there know that there is something to debate — a contract with extremely restrictive terms that the university signed in 2006 to do research for Philip Morris USA, the nation’s largest tobacco company and a unit of Altria Group.

The contract bars professors from publishing the results of their studies, or even talking about them, without Philip Morris’s permission. If “a third party,” including news organizations, asks about the agreement, university officials have to decline to comment and tell the company. Nearly all patent and other intellectual property rights go to the company, not the university or its professors.

“There is restrictive language in here,” said Francis L. Macrina, Virginia Commonwealth’s vice president for research, who acknowledged that many of the provisions violated the university’s guidelines for industry-sponsored research. “In the end, it was language we thought we could agree to. It’s a balancing act.”

But the contract, a copy of which The New York Times obtained under the Virginia Freedom of Information law, is highly unusual and raises questions about how far universities will go in search of scarce research dollars to enhance their standing. It also brings a new dimension to the already divisive debate on many campuses over whether it is appropriate for universities to accept tobacco money for research.

Dr. Macrina would not specify how much money Philip Morris gave for the restricted research. Historically, the company has not been a major contributor to the university. Last year, it gave $1.3 million in research grants that included the restricted contract and a more traditional independent grant, Dr. Macrina said.

Over all last year, Virginia Commonwealth, with nearly 32,000 students, received $227 million in research grants from government and private sources, a sum dwarfed by the amounts the nation’s largest research universities take in. For example, the University of Washington received $1 billion in grants last year, while Johns Hopkins got $1.4 billion in federal money alone.

Philip Morris, based in Richmond, is a likely source for Virginia Commonwealth in its hunt for dollars from a finite number of corporations. Among tobacco companies, Philip Morris is the leader in investing in academic research. And for Virginia Commonwealth, expanding ties with its neighbor could produce other benefits like additional grants and support for other university functions.

About a dozen researchers and research ethicists from other universities were astonished at the restrictions in the contract, when they were told about it.

“When universities sign contracts with these covenants, they are basically giving up their ethos, compromising their values as a university,” said Sheldon Krimsky, a professor at Tufts University who is an expert on corporate influence on medical research. “There should be no debate about having a sponsor with control over the publishing of results.”

Stanton A. Glantz, a professor at the University of California, San Francisco, School of Medicine who has lobbied for banning tobacco money on campuses, said, “University administrators who are desperate for money will basically do anything they have to for money.”

Although Dr. Macrina would not discuss many details of the research, Philip Morris officials were less reticent.

Rick Solana, the senior vice president for research and technology, said university scientists were studying how to identify early warning signs of pulmonary disease, and how to reduce nitrogen and phosphorus drained into rivers from processing tobacco leaves.

Dr. Solana also said the contract represented a new focus on developing tobacco products with reduced risks, a shift in strategy in underwriting university research that requires more confidentiality to protect the corporation’s intellectual property rights. And he said Philip Morris had similar arrangements with other universities — although he declined to say how many or which ones.

About 15 public health and medical schools no longer accept donations from the tobacco industry, and many major research universities continue to do so only if guaranteed independence to carry out the research and publish the results.

The business school at the University of Texas at Austin decided in December to stop accepting tobacco money. The University of California system tightened its oversight of tobacco-financed research last fall, after rejecting a proposal for a ban.

Virginia Commonwealth’s president, Eugene P. Trani, declined to be interviewed. But Dr. Macrina defended the contract, saying it struck a reasonable balance between the university’s need for openness and Philip Morris’s need for confidentiality, even though it violated Virginia Commonwealth’s own rules.

“These restrictive clauses seek to protect the rights and interests of multiple parties in the agreement,” Dr. Macrina said, pointing out that Virginia Commonwealth scientists would be working with other researchers.

Virginia Commonwealth’s guidelines for industry-sponsored research state, “University faculty and students must be free to publish their results.” The guidelines also say the university must retain all patent and other intellectual property rights from sponsored research.

Under the agreement, though, Philip Morris alone decides whether the researchers can publish because the contract defines “without limitation all work product or other material created by V.C.U.” as proprietary information belonging to the company.

“We would have discussions, and there could well be agreements that could ultimately result in the publication of proprietary information,” Dr. Macrina said.

Dr. Solana agreed, saying that once the company determined that its competitive interests were protected, it could permit researchers to publish.

“We have to start out with is anyone’s intellectual property going to be compromised?” Dr. Solana said. “Once the intellectual property is protected, then it’s usually O.K. to publish.

“Something being proprietary does not mean something cannot be published. We try to be very supportive in the health area of work being published.”

The contract also includes a longer than usual time for Philip Morris to review any possible publications by the researchers for potential patent or other proprietary problems — 120 days, with the option to continue for 60 days more. Again, this violates university guidelines, which call for reviews of no more than 90 days.

“When you have multiple parties involved at the level of the sponsor, we’re willing to agree to more time than we usually would,” Dr. Macrina said.

Dr. Macrina also defended the requirement that the university decline comment and tell the company if asked about the agreement by news organizations and other third parties.

“Language like that occurs in agreements like this because the sponsor wants to be sure there are no slip-ups, that things will not be released inadvertently,” he said.

Dr. Solana said the prohibition was intended to prevent participants in the research, both at the university or at other companies, from using the relationship with Philip Morris to promote themselves.

At Virginia Commonwealth, few professors appeared to know about the contract; when told about it, a number of them said they were concerned about its secretiveness.

“It’s a controversial area, and I personally prefer transparency,” said Richard P. Wenzel, chairman of the department of internal medicine at the university’s medical school, who had not heard of the contract before a reporter’s call.

Dan Ream, the president of the Faculty Senate, said he, too, knew nothing about the contract.

“It hasn’t come up as an issue of debate in the Faculty Senate at all,” said Mr. Ream, who works in the university’s library. “I’m highly committed to open access to information. That’s one of the tenets of librarianship.”

A tenured scientist at Virginia Commonwealth, who would not be interviewed for attribution because he said he feared retribution against his junior colleagues, called the contract’s restrictions, especially the limitations on publication, “completely unacceptable in the research world.”

For most of the decade, Philip Morris financed conventional research grants, using a scientific panel to select worthy research proposals from professors. The company granted independence to the professors whose work it sponsored and left them free to publish.

Even so, opponents of smoking opposed the grants, arguing that universities should not take money from tobacco companies because of the public health impact of smoking and what they viewed as the industry’s misuse of scientific research.

Last fall, Philip Morris began phasing out this program to switch to developing new products, said Dr. Solana, the company vice president. Some of the new research will be conducted internally, he said, at a new company research center in Richmond, and some will be contracted out to universities and corporations case by case.

The restricted contract with Virginia Commonwealth, Dr. Solana said, was part of what he hopes will be a new and different relationship between the company and universities. But scientists said such restrictions — especially the constraints on publication and what university officials can say publicly — are contrary to the open discussion essential to university research.

“It’s counter to the entire purpose and rationale of a university,” said David Rosner, a professor of public health and history at Columbia University. “It’s not a consulting company; it’s not just another commercial firm.”

Monday, May 19, 2008

Cary Pharma Seeks $14M in First Round

Great coverage for Doug Cary in the WBJ:

A Northern Virginia biotech is beginning its first funding drive with an ambitious road map. Despite sluggish life sciences investments for this region, the company wants to raise $14 million by the summer to launch two clinical drug trials later this year.

Executives for Cary Pharmaceuticals Inc., currently based out of its founder's Great Falls home, are taking to hours-long plane rides in their attempt to nail down what would be its first institutional round of funding. To date, the company's cashbox has been composed of $688,000 from its principals, family and friends, nearly $625,000 in federal grants and $1.3 million from a manufacturing partner.

By adding another $14 million to that pot, Cary Pharmaceuticals said it would not need any more funds to reach profitability by the end of 2009 -- and perhaps an initial public offering or acquisition beyond that.

But for the six-person company, which has ducked under the radar for its 14-year lifetime, that's hardly easy in a region that garnered a measly 3 percent of last year's record-breaking national biotech venture capital.

Company leaders argue they have graduated from their biotech rookie years. Cary Pharmaceuticals plans by this winter to file its first request to market a drug, an oral antidepressant that it bought equal rights to with a Canadian drug developer partner, and aims to begin the first phase of clinical trials on a new hypertension pill and second phase of trials on a smoking cessation pill before the end of the year.

"It all has to do with your definition of 'early stage,'" said Doug Cary, a former Abbott Laboratories executive and president and founder of Cary Pharmaceuticals, which hired New York-based investment banking firm Bio-IB to introduce it to investors.

Cary, which licensed the hypertension drug candidate from Georgetown University, patented the antismoking drug by combining an antidepressant pill by GlaxoSmithKline PLC and hypertensive pill by Merck & Co. Inc., both federally approved drugs. The company is gearing up to test the resulting once-a-day tablet, which blocks nicotine receptors and calms cravings for what Cary said will be less than the price of a cigarette pack, on 500 smokers at five clinical sites around the country. Cary then will license out the product line to a larger drugmaker that can handle the monthly payments of a final third-phase clinical trial while paying the local company for its development trouble until then.

They're banking on -- and asking investors to bet on -- what analysts expect to be a $2.6 billion market for antismoking products by 2010. While the U.S. market is dominated by slightly lagging over-the-counter patches and gums sales, major drug companies are digging their heels in the prescription side, such as Pfizer Inc. with Chantix and GlaxoSmithKline with Zyban. Cary said it hopes to make a play for foreign smokers after getting patents in China, Taiwan, Singapore and Europe.

Though, Cary also will have to surpass a publicly traded neighbor with 10 times the employee directory. Rockville's Nabi Biopharmaceuticals is planning to enter its third, and final stage of clinical tests for NicVax, its smoking cessation vaccine, this year.

Meanwhile, Cary expects its first dose of revenue next year from an antidepressant that it's pushing toward the market with $2 million raised by its publicly traded Quebec partner Intelgenx Corp. The two companies would split sales proceeds equally under an agreement ratified last month -- proceeds that Cary plans to use to increase its employee count by 50 percent and, depending on incentives, shift to office space in Maryland or Northern Virginia.

VaBIO "After Hours" a Hit in NoVa


The Virginia Biotechnology Association held its spring 2008 "Biotech After Hours" in Northern Virginia at the Tower Club in Tyson's Corner on April 29. More than 75 came out to enjoy the food, drink and networking with their bioscience peers from universities, research leabs, biotech companies and medical device firms.

The event was made possible by the generous sponsorship of Foley & Lardner LLP and Appian Realty Advisors. Additional support came from the law firm of Latimer Mayberry and Mathews IP Law.

Here are some images from the event...

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