Week of August 20-24, 2001
 In The News:

Biotechnology Patents Stalled Over Ethical Concerns; France and Germany Want Ban on Reproductive Human Cloning

In the U.S., patent applications in the areas of cloning and embryonic stem cells jumped 300 percent in the last year. But ethical prohibitions - such as the 13th Amendment to the Constitution, which forbids ownership of humans - are preventing scientists from securing patents on certain medical uses of human cloning technology. And the European Patent Office has embryonic stem cell patents in suspended animation until an ethics committee established by the European Commission issues recommendations that include the definition of a human. According to The Wall Street Journal, "Patent records indicate that a cat-and-mouse game has emerged between scientists and patent examiners. Scientists want to make the broadest claims they can. Patent offices want to restrict them. So, top cloning groups have filed strings of applications to probe for loopholes that would allow them to protect some useful aspects of human cloning … These applications are testing legal limits and setting the stage for what many e xpect will be an eventual legal challenge to allow patents to cover human reproductive cloning a s well." In a separate development, the French and German governments have joined forces to request that the United Nations to approve a measure seeking worldwide ban on human cloning for reproductive purposes.
Ethical Concerns Block Patents Of Useful Embryonic Advances, The Wall Street Journal, Aug. 20, 2001

France and Germany Jointly Seek a Ban on Cloning Humans, The New York Times, Aug. 22, 2001


Do Doctors Ignore the FDA's 'Dear Health Care Professional' Letters?

Baycol (cerivastatin) was taken off the market worldwide after 31 patients died from kidney failure caused by rhabdomyolysis, a disorder in which muscle cells break down, overwhelming the kidneys with cellular waste. Baycol had been tested on more than 3,000 patients, and no serious problems had turned up. When muscle problems and deaths linked to the statin were reported, Bayer and the Food and Drug Administration warned doctors to be cautious in prescribing it, but the warnings failed to stem the problem, and Baycol finally had to be taken off the market. A paper by FDA scientists published in JAMA last week concluded that the agency's warnings about Rezulin (troglitazone) -- which was pulled from the market in March 2000 after reports of more than 60 deaths caused by liver failure - repeated 'Dear Health Care Professional' letters to physicians were ineffective and that different strategies should be pursued to alert doctors to drug side effects and problems. Experts say the kind of communication failure that has occurred with Rezulin and Baycol may well occur again with other drugs.
Drug's Problems Raise Questions on Warnings, The New York Times, Aug. 21, 2001


Prosecutors File Charges Against Man Identified Only by DNA Profile

Macon County prosecutors have filed burglary and sexual assault charges against a John Doe, after matching DNA samples found at the scene of an August 2000 burglary and at the scene of a July 1999 sexual assault. This is the first time prosecutors in Macon County have asked for a warrant using a person's profile, though this practice has been used in other jurisdictions to prevent the statute of limitations from running out before an arrest is made. Illinois authorities hope to match the unknown suspect's DNA profile to one in a DNA database of about 18,000 convicted sex offenders compiled by the state.


 Business Inteligence:

CHI Report Details Key Pharmaceutical Industry Trends and Opportunities

Cambridge Healthtech Institute's (CHI's) latest report, "Transforming the Pharmaceutical Industry: Adapting to Change in Technology and Markets," focuses on competitive pressures in the pharmaceutical industry brought about by genomics, microarray analysis, high-throughput screening, and other technologies. The CHI report highlights specific tools and tactics, including: "Fail fast" policies that eliminate problematic compounds before clinical trials are initiated; outsourcing and CROs to accelerate drug development; and the role pharmacogenomics will play to transform research, clinical trials, marketing, and health care delivery. The report also finds that, in some cases, it is possible to re-engineer a business based on well-defined metrics to track the success of strategic initiatives.


The "Holy Grail"

Business 2.0 describes the convergence of the biotechnology and information technology fields, describing it as an as-yet unattainable dream of "one seamless superscience that could crack the molecular code of disease and yield a gold mine of new treatments and cures. … Some very big names in tech … have been placing bets on so-called convergence companies … mostly obscure companies that use words like 'genomics,' 'bioinformatics,' and 'proteomics' to describe what they do. This industry is so new it hasn't settled on a single name yet."
6,160,717,289 Cures for Cancer, Business 2.0, August 1, 2001


Report: Visitors to Pharmaceutical Product Websites More Likely to Request Brand

When pharmaceutical companies air direct-to-consumer (DTC) advertising on radio or television, FDA regulations require that consumers receive labeling and additional product information on a particular product. Whereas pharmaceutical companies traditionally complied with regulatory requirements by running companion advertising in print publications, they are increasingly turning to a toll-free number or an Internet site. According to the Cybercitizen Health Trend report by Cyber Dialogue visitors to product-specific websites are more likely than the average consumer - as well as consumers who called toll-free information hotlines -- to request the product from their healthcare provider. And, the company's research suggests that consumers who visit these websites are younger, and tend have more discretionary income as well. While noting that consumers still turn to physicians, nurses and pharmacists as their primary sources of healthcare information, Cyber Dialogue says this data argues strongly in favor of pharmaceutical companies developing informational websites.


I Want My MTV PC ...

According to a recent poll of more than 2,200 people by Harris Interactive, people love their personal computers more than their televisions, telephones, books or cell phones. Only cars and pets were seen as more important. Of those surveyed, 73 percent said they could not live without their computers vs. 68 percent who felt the same way about their telephones, 63 percent about their TVs, 46 percent about their newspapers and 48 percent about their cell phones. In the same Harris poll, which was sponsored PC manufacturer Gateway Inc., 72 percent said they were "concerned" about privacy issues while 71 percent worried about fraud on the Internet. … In a separate Harris poll conducted for the American Museum of Natural History in June, people "overwhelmingly" (84 percent) support genomics research, but want to know more about this field so that they can understand it better.


... And I'm Willing to Pay For Online Content, Too

Back when venture capital gushed to content-oriented dot-coms, it was a "fact" that users would not pay to access or download content. Now that the VCs have turned off the spigot, Web-based content services have to fact a new fact: Charging subscriptions for "premium" content or pay-as-you-go fees to view individual articles may be the only way to stay afloat. But few want to be leading the pack making this U-Turn in the Information Highway. Well, online publishers can take comfort in a recent survey suggesting that some people are willing to pay for some content on the Web some of the time. A recent survey by market research firm Lyra Research showed that 20 million people have already paid for Web content, with 27 percent having paid for industry-specific business material, 18 percent for online database services, and 10 percent for premium music and news services.
The reality of a pay-as-you-surf Web is beginning to set in, The Philadelphia Inquirer, Aug. 20, 2001


Streaming Video Finds a Niche As a Corporate Communications Tool

"Webcasting as entertainment may have been a bust," according to The Wall Street Journal, "but the technology is turning out to be a sleeper hit as a corporate communications tool - and a saving grace for the streaming-media industry." Public companies first began using Webcasts to comply with the Securities and Exchange Commission's nine-month-old Regulation Fair Disclosure, and pharmaceuticals companies are now using streaming video to promote new drugs, and to meet FDA physician and patient education requirements. Companies are also starting to develop e-training programs using Webcasting. Key software vendors include: Adobe Systems, Sonic Foundry and Media 100 Inc. (Webcasting production and editing software); Virage Inc. (applications for managing content); Convera Corp. (video archiving and search tools). Vendors that manage streaming video transmission across the Internet and within corporate intranets include, Akamai Technologies, RealNetworks' Real Broadcast Network, Yahoo!'s Broadcast.com unit, iBeam and Digital Island Inc.
Video Streaming Is a Sleeper Hit As Corporate Communications Tool, The Wall Street Journal, Aug. 20, 2001


 Deals:

Pharmacopeia and Eos Biotechnology to Merge

Pharmacopeia, Inc. (Nasdaq: PCOP) and Eos Biotechnology, Inc., a privately funded biotechnology company, have announced plans to merge in a $196M tax-free, stock for stock swap. Eos develops, applies and integrates high-throughput genomics, bioinformatics and biological processes for drug target identification and validation; Pharmacopeia has expertise in small molecule drug discovery and therapeutic antibody treatments for cancer, angiogenesis, inflammation and other diseases. The transaction is subject to regulatory and approval by the stockholders of Pharmacopeia, and is expected to close during the fourth quarter of 2001.


Genomics Collaborative Signs Agreements with GSK, Pharmacia and Other Pharmaceutical Companies For GCI AccessTM

Clinical functional genomics company Genomics Collaborative Inc. has signed agreements with five bio-pharmaceutical companies including GlaxoSmithKline, Pharmacia Corporation, and Exelixis Corporation allowing their researchers access its newly launched (in June) proprietary Global Repository™ -- which the company says is the largest database of well-characterized, properly consented DNA, sera and snap-frozen tissue samples in the world. The company says it has created "a proprietary system for anonymizing collections while ensuring data quality and protecting patient confidentiality" and that "working with international leaders in the area of informed consent for genetic research [it] has developed consent procedures appropriate to the repository context."


Medscape Finalizes Sale of Total eMed

Medscape (NASDAQ: MDLI) has finalized the sale of its transcription services segment, Total eMed, Inc., to a new entity funded by Parthenon Capital, a Boston-based private equity firm. Medscape received $5 million in cash at the closing of the transaction and will receive an additional $1 million during the next 12 months. The Company plans to use the proceeds from the sale to fund operations of its digital health record and Internet healthcare portal businesses. Medscape is a leading provider of clinical healthcare data and peer-reviewed medical information and continuing medical education to healthcare professionals and consumers. More than 15 million patients now have digital records hosted on Medscape systems; some 625,000 physicians and 1.8 million allied health professionals are registered users.


 Privacy:

Buyers of PCs from Dead Dot-Coms Get An Added Bonus

Consumers buying computer equipment from failed dot-coms don't just get a top-of-the-line machine for peanuts. In many cases, they also get priceless proprietary and competitive information lurking in e-mails, internal communications and presentations left on the computer's hard drive. It seems that soon-to-be unemployed dot-commers are too shell-shocked to purge files and wipe hard drives. Some companies rely on auction houses to restrict access to proprietary data before selling the computers - but auctioneers say that responsibility should rest with the liquidating company.
Ghost in the Machine: Sold Computers From Failed Dot-Coms Tell Their Tales, The Wall Street Journal, Aug. 20, 2001


Judge Yanks Woman's Photo, Medical Records Off Anti-Abortion Web Site

An Illinois judge ordered three anti-abortion activists to stop publishing the photograph and medical records of a woman's who was treated at St. Elizabeth hospital in Granite City in June after suffering complications from an abortion at the Hope Clinic for Women.
Judge Keeps Women's Records Off Net, Find Law-AP, Aug. 22, 2001


 People:

Genome Therapeutics has elected venture investor and former biotechnology analyst David K. Stone to its Board of Directors. Stone is a founding partner of AGTC Funds, a venture capital group focused on start-up and early stage companies that apply genomic information and technologies to develop products or services. Genome Therapeutics has partnered Schering-Plough, AstraZeneca, Wyeth-Ayerst and bioMerieux, to develop genomics-based pharmaceutical, vaccine and diagnostic products.


Mina Patel Sooch has joined venture capital fund North Coast Technology Investors as an Entrepreneur-in-Residence (EIR) to develop new business opportunities in the life sciences sector. She is the second person to join North Coast's EIR program, which is designed to attract, support and fund technology entrepreneurs. The program typically lasts between six months and one year. The EIR program provides entrepreneurs with a platform from which to view industry trends, evaluate early-stage companies and launch their own enterprises. North Coast is a $100 million early stage venture capital fund that invests in technology-driven companies throughout the Midwest.


GeneProtTM has appointed investment banker Bertrand Damour CFO reporting to CEO Cedric Loiret-Bernal, MD. Stephen C. Macevicz, PhD, JD also joins the company as VP, Intellectual Property, and Diana R. Wetmore, PhD assumes the post of CTO for the company's Geneva Branch. Macevicz and Wetmore report to Keith Rose, PhD, Chief Scientific Officer. In April 2001, GeneProt opened a large-scale proteomic discovery and production facility in Geneva, Switzerland equipped with 51 mass spectrometers and advanced bioinformatic and computing data-storage technologies to identify and synthesize novel therapeutics proteins, drug targets and biomarkers.


LaunchCyte LLC has appointed seven new science and business executives to its advisory board to help evaluate new technologies and to review commercialization strategies: Geneticist Ben Bowen, DPhil., VP of application development for Lynx Therapeutics; inventor and entrepreneur S. Thomas Emerson, PhD, director of the Donald H. Jones Center for Entrepreneurship at Carnegie Mellon University; George Fechter, associate vice chancellor for External Relations of the Health Sciences at the University of Pittsburgh; Jack Kincaid, CEO of Business Strategies Group and former president of technology incubator Milcom; Henri Lipmanowicz, former chief of international operations for Merck & Co.; Alan J. Russell, PhD, executive director of the Pittsburgh Tissue Engineering Initiative Inc. and director of the McGowan Institute for Regenerative Medicine; Robert Shapiro, former CEO of Monsanto Company and recently retired chairman of Pharmacia Corporation; and Mohamed A. Virji, MD, PhD, director for the Division of Clinical Chemistry in the Department of Pathology, University of Pittsburgh School of Medicine and director for Tumor Marker Laboratory, University of Pittsburgh Cancer Institute. Tom Petzinger is co-founder and CEO of LaunchCyte, which has raised $2.7 million of private funds to acquire, launch and develop new bioinformatics startups; its most advanced portfolio company is Morewood Molecular Inc., which owns a proprietary technology for accelerating the drug-discovery process.


 Events:

Oct. 11-12, 2001

"E-Health: Future or Folly"/University of Michigan's School of Public Health Department of Health Management and Policy in Ann Arbor, Michigan.

This E-Health conference will explore ways the Internet shapes health care, including the doctor-patient relationship, medical records keeping, purchasing, and insurance administration. Speakers include Victor Strecher, chief scientific officer of HealthMedia; Karl Bartscht, managing director of Epsilon Health Group; Marianne Udow, senior vice president at Blue Cross Blue Shield of Michigan; Marc Hallee, a health care consultant at Hewitt.com; and Marshall Rozzi, president and CEO of Planlinx.com.


Oct. 25-26, 2001

Harvard Medical School/3rd Nat'l HIPPA Summit at the Grand Hyatt in Washington, D.C.>

On Oct. 25, the 3rd National HIPAA Summit features a day-long plenary session town meeting on regulating healthcare privacy and data security. Representatives of DHHS, FTC, DOJ, NCVHS and state government will be available for questions, comments and discussion, including: William R. Braithwaite, MD, PhD, Sr Advisor on Health Information Policy, DHHS; L. Arnold Johnson, CISSP, Deputy Director, NIAP CCEVS Validation Body, National Institute of Standards & Technology; and Alan F. Westin, LLB, PhD, Professor Emeritus of Public Law and Government, Columbia University, and Publisher, Privacy & American Business.


 Web Resources: