Weapon Against Bioterrorism: Life Sciences Code of Ethics

"Unprecedented advances in the life sciences and the potential for the misuse of the scientific enterprise for bioterrorism or biowarfare have created a pressing need for an international consensus on the steps that must be taken to reduce this grave threat to humanity.

Counterbioterrorism measures must include providing ethical guidance--especially for scientists, physicians, scientific institutions, and others engaged in research and development in the life sciences throughout the world. In this Policy Forum [from Science Magazine], an ethical code is proposed that captures the essential aspiration that research and development in the life sciences will seek to do no harm and, where possible, to benefit humankind; extends the prohibitions of the Biological Weapons Convention (BWC) to the broader scientific research community; specifies actions that scientists and others must take to protect against the misuse of biological agents and dual-use information; and addresses areas of contentious research by incorporating ethics and safety reviews."

The Proposed Code:

"CODE OF ETHICS FOR THE LIFE SCIENCES

All persons and institutions engaged in any aspect of the life sciences must

1. Work to ensure that their discoveries and knowledge do no harm (i) by refusing to engage in any research that is intended to facilitate or that has a high probability of being used to facilitate bioterrorism or biowarfare; and (ii) by never knowingly or recklessly contributing to development, production, or acquisition of microbial or other biological agents or toxins, whatever their origin or method of production, of types or in quantities that cannot be justified on the basis that they are necessary for prophylactic, protective, therapeutic, or other peaceful purposes.

2. Work for ethical and beneficent advancement, development, and use of scientific knowledge.

3. Call to the attention of the public, or appropriate authorities, activities (including unethical research) that there are reasonable grounds to believe are likely to contribute to bioterrorism or biowarfare.

4. Seek to allow access to biological agents that could be used as biological weapons only to individuals for whom there are reasonable grounds to believe that they will not misuse them.

5. Seek to restrict dissemination of dual-use information and knowledge to those who need to know in cases where there are reasonable grounds to believe that the information or knowledge could be readily misused through bioterrorism or biowarfare.

6. Subject research activities to ethics and safety reviews and monitoring to ensure that (i) legitimate benefits are being sought and that they outweigh the risks and harms; and (ii) involvement of human or animal subjects is ethical and essential for carrying out highly important research.

7. Abide by laws and regulations that apply to the conduct of science unless to do so would be unethical and recognize a responsibility to work through societal institutions to change laws and regulations that conflict with ethics.

8. Recognize, without penalty, all persons' rights of conscientious objection to participation in research that they consider ethically or morally objectionable.

9. Faithfully transmit this code and the ethical principles upon which it is based to all who are or may become engaged in the conduct of science."

Digital Signature Trials to Start

"The first pilot projects testing a digital signature standard that's being developed for worldwide use by the pharmaceutical industry are due to be launched within the next three weeks, according to officials involved in the effort.

The standard, called Secure Access for Everyone (SAFE), is designed to enable the use of legally enforceable electronic signatures over public-key infrastructure (PKI) networks. Backers envision the digital signatures being used in business-to-business transactions and communication with government regulators.

Among other benefits, the SAFE credentials are expected to make it faster and more cost-efficient for pharmaceutical companies and researchers to submit applications and get approval for drug trials than with current paper-based processes, said Guy Tallent, SAFE's program director."

From this BioITWorld article.

Supreme Court Hearing Set on Experimental Use Safe Harbor Statute

"Party and amicus briefs have been filed and the stage is now set for the April 20 hearing of Merck KGaA v. Integra LifeSciences at the Supreme Court.

Merck v. Integra is slated to determine the scope of 35 U.S.C. �271(e)(1), the safe harbor statute that permits a drug manufacturer to perform potentially infringing experiments needed to obtain FDA approval without incurring liability for patent infringement. A major question will be how attenuated an experiment may be and still fall within the protection from infringement liability offered by the statute."

For summaries and PDF copies of the various briefs filed in the case, please see this post from Patently-O from which the foregoing quote was taken.

Evolution Can Occur Quickly

"In a stunning example of evolution at work, scientists have now found that changes in a single gene can produce major changes in the skeletal armor of fish living in the wild.

The surprising results, announced in the March 25, 2005, issue of journal Science, bring new data to long-standing debates about how evolution occurs in natural habitats.

'Our motivation is to try to understand how new animal types evolve in nature,' said molecular geneticist David M. Kingsley, a Howard Hughes Medical Institute investigator at the Stanford University School of Medicine. 'People have been interested in whether a few genes are involved, or whether changes in many different genes are required to produce major changes in wild populations.'

The answer, based on new research, is that evolution can occur quickly, with just a few genes changing slightly, allowing newcomers to adapt and populate new and different environments."

From this Biology News article.

The US Drug Pricing System is Broken

"The pricing system for drugs in the United States is broken, said David Brennan, executive vice president of the North American division of AstraZeneca, the drug maker with headquarters in the U.K. and Sweden. Trouble is, no one, including the drug companies themselves, has any clear idea how to fix it.

Brennan, who was also appointed to AstraZeneca's board last week, made these remarks at a Wharton healthcare conference in February. Not surprisingly, he doesn't advocate a radical overhaul: Such a move could hurt the productivity of an industry that has contributed substantially to advances in human health and longevity during the last three decades, he said. What's needed is realistic cooperation among all the players -- drug makers, insurers, consumers, doctors, hospitals and employers."

Read more in this Kowledge@Wharton article.

How to Make Money in Bioinformatics

"This report from a recent Harvard Business School panel discussion about business models for bioinformatics presents the complex answer to a vexing question for bioinformatics firms - How can you make money selling bioinformatics? The short answer: 'You have to pick a big enough niche, and you really have to understand the customer.'"

Via this about.com post.

Agrobacterium-mediated transformation of plants patent dispute settled

From this post from Navigating the patent maze:

"In November 2004, I reported the conclusion of a long running dispute in the U.S. Patent Office on who first invented Agrobacterium-mediated transformation technology (previous post). A few weeks ago, a joint press release from Bayer CropScience, Max Planck Society, and Monsanto announced that the interference ended by settlement among these parties. Under the agreement, the organizations will cross-license their respective Agrobacterium-mediated transformation technologies; Bayer (the exclusive licensee of Max Planck's technology) and Monsanto will provide each other non-exclusive licenses related to R&D and sale of transgenic crops; Monsanto will give Max Planck a license in the U.S. for research purposes...

If the technology is not licensed to anyone else - neither of these companies is known to widely license technology - then they are able to effectively stifle other companies from entering the transgenic plant field. Agrobacterium is the most widely used method for transforming plants; there are very few other means of transformation, only bombardment (owned by Cornell and licensed to duPont) is frequently used. With luck new transformation technology developed at CAMBIA using non-Agrobacterium strains will break the stranglehold."

The Stem Cells Patent Landscape

Stem cells have been in the news a great deal recently, both for their medical promise and the difficult ethical questions the use of embryonic stem cells present. This article from Goodwin Procter LLP via Mondaq discusses some of the science, medical treatments, ethics, politics and the IP status of the business of stem cells, stating:

"The patent landscape for both adult and embryonic stem cells is very crowded, with hundreds of issued patents having claims to methods of isolating stem cells, methods of propagating stem cell lines, methods of differentiating stem cell lines, and methods of using stem cells in treatment.

On the embryonic stem cell patent front, the University of Wisconsin holds the dominant patent position in primate embryonic stem cell line production. The Wisconsin Alumni Research Foundation ("WARF"), founded to handle the University’s patents and technology transfer, holds patents affecting 64 stem cell lines, including extensive rights to five lines.

Among companies, Geron Corporation is a significant player that to date has a portfolio of 240 stem cell patents. Geron obtained an exclusive license from WARF for its human embryonic stem cell technology, which ultimately ended up in litigation that was settled in 2002. Under its present license from WARF, Geron holds exclusive rights to develop certain therapeutic and diagnostic human embryonic stem cell products.

WARF and Geron have agreed to grant research rights to their existing human embryonic stem cell patents and applications to academic and governmental researchers without royalties or fees. Third-party for-profit companies may form collaborations with Geron or obtain licenses to Geron’s intellectual property on market terms. WiCell Research Institute, a WARF subsidiary, distributes the cell lines. WARF and WiCell Research Institute agreed to reasonable terms for such distribution in a Memorandum of Understanding with the NIH on September 5, 2001.

The adult stem cell patent landscape is also very crowded, with hundreds of patents directed to various aspects of the technology. For example, Osiris Therapeutics, a clinical stage biotechnology company founded to commercialize adult stem cells derived from bone marrow, has 42 issued patents directed to certain technologies, including methods of isolating and differentiating such cells, and methods of using the cells as immunosuppressants, for cartilage regeneration, and for repair of connective tissue."

UN votes to ban human cloning

"By a vote of 84 in favor, 34 against and 37 abstaining, with 36 absent, the UN today approved a declaration calling on all UN Member States to ban all forms of human cloning, including cloning for medical treatment, as incompatible with human dignity and the protection of human life.

While in general agreement, some delegates said they opposed banning therapeutic cloning. The Declaration, negotiated by a Working Group last month, also banned 'genetic engineering techniques that may be contrary to human dignity' and called for a prevention of the exploitation of women and adequate protection for human life in the application of life sciences. The Declaration has been welcomed by many as a clear expression of the ethical norms that should guide scientific research."

From this Biology News post.

Getting Beyond Fear of GM Crops

"GM crops are created in laboratories, using highly precise techniques. They have been tested repeatedly, and they are regulated by the EPA, FDA, USDA and other agencies. Americans have collectively eaten over a trillion servings of food containing one or more GM ingredients, without a single case of harm. Indeed, as Greenpeace co-founder Patrick Moore and others have demonstrated, every single claim of risk to people or the environment -- from monarch butterfly deaths to destabilized insect ecology and diminished biodiversity -- has been refuted by scientific studies.

And still Dr. John and his fellow radicals place ultra precaution against minor, distant, theoretical risks to healthy, well-fed Westerners above the very real, immediate, life-threatening risks faced by our Earth's poorest and most malnourished people.

Farmers the world over are increasingly turning to GM technology, planting 200 million acres last year. They don't for a minute believe ag biotech is a magic bullet that will make them rich and solve the world's hunger problems. But they know it dramatically increases crop yields, farm profits and family nutrition -- while reducing pesticide use, crop losses to drought, insects and disease, and the amount of land that will be needed to feed a world population that is expected to hit 9 billion by 2050, before leveling off.

Bt cotton has let Chinese farmers reduce their pesticide use by 50 to 70 percent -- while increasing their yields by 25 to 66 percent, and their incomes by US$300 per hectare (US$120 per acre). Since most of these chemicals were applied via hand spraying, they've also slashed accidental pesticide poisoning. Farmers in other Third World countries have had similar experiences."

From Ethis March 7, 2005 article

BioBlast Scheduled

Join the Pittsburgh Biotech community for the first BioBlast of the year! -- The Common Ground for Science and Business

Come to BioBlast, and interact with fellow life scientists. Over drinks and food, share tidbits about research, start-ups, and discoveries. Meet venture capitalists, entrepreneurs, scientists, and business people from the life sciences industry.

Date: Wednesday, March 9, 2005
Time: 6:00 p.m. - 9:00 p.m.
Venue: WQED, Studio A - 4802 Fifth Ave, Pittsburgh

From more information click here.

The Patentability of Biotechnology

"Since the 1970s particular attention has been paid to the patentability of biotechnology focused on genetically modified organisms and other products derived from living systems. Does patent law protect such subject matters? Can biotech patenting be harmonized? How can the traditional principles of patentability be applied to new forms of technology? Should biotechnology be regarded as subject matter for patent protection? [3] The Aim of this analysis (based mainly on US law) is to highlight biotechnology patent novelties and compare them to established principles of patent law."