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BIO 2000 Opening Plenary Speech / Boston

We meet here in Boston at a truly remarkable moment in the relatively short but dramatic history of the biotechnology industry.</p>

By Carl B. Feldbaum, President

Ladies and Gentlemen, I'm Carl Feldbaum, President of the Biotechnology Industry Organization, otherwise known as BIO. I want to welcome you here to Boston, and to BIO 2000, which is by far our largest, and hopefully our best event ever.

Already, over 7,000 individuals have registered for this meeting. This represents an enormous increase over last year's success in Seattle. Here in Boston you come from six continents: from Singapore to Scotland; Lebanon to Luxembourg; India to Iceland; New Zealand to Nigeria; Cuba to Hong Kong. And everywhere in between.

For those of you not familiar with Boston, we meet here in a cradle of both liberty and innovation. Boston and Massachusetts led the fight for U.S. independence. In 1773, a mere 227 years ago, the so-called Boston Tea Party, where revolutionaries dumped 340 chests of tea into Boston Harbor, sparked a mass protest against colonialism. More about protests and protesters later. Just two years after the Boston Tea Party, the American Revolution began with the "shot heard round the world," in the first battle between the colonists and British at Lexington and Concord.

Boston is also home to many educational and technological firsts: Harvard, founded in 1636, was the first American university. Imagine, the first public school was established here in 1639 and the first public library in 1653.

The first American railroad was built in Quincy, Massachusetts, in 1826. It followed the world's first railroad, which was built in England about 10 years earlier. Modern surgery began with the first public demonstration of ether as an anesthetic in 1846. Alexander Graham Bell demonstrated the first telephone right here in 1876. The world's first subway was built in Boston in 1898. The first liquid fuel rocket was launched by Robert Goddard in 1926 in Auburn, Mass., and the first computer, a non-electronic "differential analyzer," was developed at MIT in 1928 by Dr. Vannevar Bush. And today, Boston's "Big Dig," which you may have seen on your way here from Logan Airport, is the largest, most complex and technologically challenging highway project in American history.

Boston and Massachusetts residents also are known for their fondness of sports; basketball was first played in Springfield in 1891 and the first volley ball game was played in Holyoke in 1895. While the beloved (but not by me!) Boston Red Sox may not have to wait another 100 years for another World Series win – the last one was 1918 – they have some of baseball's real heroes, such as Babe Ruth and Ted Williams.

Boston also is home to some famous foods, like Boston Baked Beans, Boston Cream Pie, Fenway Park Franks and, of course, New England Clam Chow-DAH. While you're here, you should try some of this stuff.

More seriously, the television ad you witnessed just a minute or two ago "Biotechnology, a Big Word That Means Hope" is part of BIO's growing effort to spread "the word" about our industry -- starting with our lineage of pioneers and risk-takers like Thomas Edison, the Wright Brothers, and Amelia Earhardt; our heritage of progress and success -- people like former President John F. Kennedy – from Boston - who called upon and brought out the best in many of us.

We meet here in Boston at a truly remarkable moment in the relatively short but dramatic history of the biotechnology industry. In the next few minutes, I want to talk briefly about two things: First, our industrys progress and new prominence. Second, the ethical and social responsibility that comes with such progress and prominence.

First regarding progress and prominence. Like it or not, and ready or not, the biotechnology industry is now front and center on a national stage and increasingly on a global stage. When I first came aboard as President of BIO in 1993, there were articles about our technology appearing on an average of twice a week, usually in a small science column and once in a while on the business page. Three to four years ago, articles began appearing more regularly, say twice a week in the main news sections. Now articles appear on the front page everyday somewhere in the nation and somewhere abroad.

Several events have raised biotech profiles since we met last year in Seattle.

The huge run up in stock prices, beginning in November 1999, and continuing into this year has raised the biotech industry's profile dramatically. For a while, biotech has taken the place of Internet stocks as Wall Street’s favorite high growth investment. As a result, in the first three months of 2000 the industry has raised more than $8 billion, more money than in any previous full year. On March 13 the Wall Street Journal even carried a story saying some biotech companies may have turned the tables on big pharma and now were wealthy enough to acquire a drug company of their own.

Let me put this in a little perspective for those of you who may not follow the money side of our business as closely as some in our industry. This a moment that deserves to be acknowledged if not savored. In New Orleans they say (and pardon my Creole), Laisse les Bone Temps Roulez. Let the good times roll!

Only 18 months ago the financial markets romance with internet stocks was in full flower. Even high-tech investors largely ignored biotechnology companies. In the bleak fall of 1998, BIO took the extraordinary step of issuing press releases, and publishing op-eds and letters to the editors of newspapers throughout the Nation to remind people about the benefits of biotechnology in health care, agriculture and the environment, and the enormous scientific progress our industry was making. But stories about biotech back in 1998 focused bleakly on how many companies were operating on so little cash. Our small, entrepreneurial companies' initial public offerings were put -- and left -- on the shelf.

That September the NASDAQ biotech index dipped below 300. How fortunes have changed: Earlier this month, the NASDAQ biotech index topped 1,600, a 433% increase from that moment, not so long ago.

So, what happened between September 1998 and today? There's more to this Wall Street story than the whimsy of investors who tired of Internet stocks. The biotech industry has earned it. After 25 years, our industry has arrived: there were a record 22 new drug approvals in 1999; more drugs have been approved in the last five years than the previous 13 years combined; nearly 100 biotech medicines are now on the market helping hundreds of millions of people worldwide. Another 350 drugs are in late-stage clinical trials. These are not just numbers. The record 22 drug approvals by the FDA in 1999 included breakthrough new treatments for ovarian cancer, rheumatoid arthritis, hemophilia, influenza and hepatitis C.

Our industry has proved that biotechnology works.

There are other factors contributing to our industry's progress and prominence. For example, we have new legislation to help manage the risk and expense of biotech drug development: the FDA Modernization Act, which speeds reviews of new drugs and vaccines and gets them to patients faster; extension of the R&D tax credit and reform of patent laws, which help our companies attract investment dollars.

Our new high profile, however, can have some frustrating consequences as well.

One thing that attracts as much news media and public attention as a stock boom, is a stock bust, such as the one that hit March 14 after White House spokesman Joe Lockhart mistakenly said a joint statement by President Clinton and British Prime Minister Tony Blair, to be released later that day, called for restricting gene patents. The statement actually endorsed the vital role played by patents on gene-based inventions in development of new health-care products. Clinton-Blair called for unencumbered public access to raw DNA sequence data, which already are freely available and are not patentable. The damage caused by the misstatement was real, however. The NASDAQ biotech stock index plummeted more than 12 percent March 14.

Which brings us to a third example of biotech’s soaring profile: the Human Genome Project. We are nearing completion of the complete DNA sequence of the human genome, an achievement that has been described as the most significant advance ever in our understanding of biology. Completion of the full DNA sequence of the human genome not only will help speed development of new drugs, but also help create new strategies for disease prevention. The fact Clinton and Blair even felt compelled to issue a statement on gene-based research demonstrates how biotechnology has moved from being just a science and business story to a front page story of interest to a mass audience.

This heightened public interest, in many respects, dates to the arrival three years ago of Dolly the cloned sheep. Since then news of biotech research breakthroughs and gene discoveries are reported daily. The day before the Clinton-Blair statement, many television stations and newspapers carried photos of five cloned pigs, which are part of the research effort to find new sources of organs for human transplant. Last year, 4,000 people died in the United States because there were not enough donor organs. The same company that cloned Dolly cloned the pigs: One, by the way, is named Dotcom, which may put bioinformatics in a whole new light.

Progress and prominence for our industry were inevitable. But so is the second thing I want to talk about: the ethical and social responsibility that comes with progress and prominence. We must continue to be sensitive and responsive to the impact our innovative technologies have on our social and ethical traditions.

BIO's internal organization reflects our respect for these bioethics issues. We have an active bioethics committee composed of representatives of our member companies. This committee considers bioethical issues, such as those surrounding cloning, xenotransplantation, gene patents, and gene therapy. All our member companies have adopted a Statement of Principles for the responsible and ethical practice of biotechnology. A number of our member companies have formed bioethics committees of their own to advise them on the implications of their research. Geron is a good example of this. Company officials formed an advisory ethics committee to explore issues as they progressed in their stem cell research.

BIO also works closely with the National Bioethics Advisory Commission, the National Institutes of Health's Recombinant DNA Advisory Committee and members of Congress.

We also are proactive in reaching out to patient groups, the news media, educators, students, and private citizens to discuss a whole range of issues from informed consent for patients participating in clinical trials to the safety of biotech crops and foods.

At BIO 2000 we have expanded our Teacher Professional Development Program. We sponsor the BIOGenius Awards to encourage high school students to learn more about biotechnology. Patients and patient groups participate throughout the conference. And many other sessions this week will include discussions of the bioethical issues surrounding biotechnology.

Progress and prominence will always require more, not less, attention to ethical and social responsibility. Which brings me back to protesters; not those who participated in the Boston Tea Party, but those outside our conference. Because of our accelerating progress and prominence and the bioethical issues raised by our technology, protests likely have become a fact of life, not just for BIO 2000, but for years to come. That's not all bad. Peaceful protest is a tradition in our country.

I used to be a constitutional lawyer. We have a treasured First Amendment right to protest and demonstrate.

Here are some excerpts from U.S. Supreme Court cases: In Sweezy v. New Hampshire, Justice William Brennan wrote, "Our form of government is built on the premise that every citizen shall have the right to engage in political expression and association. This right was enshrined in the First Amendment of the Bill of Rights."

Justice John Harlan wrote in the 1958 case, NAACP v. Patterson, "Effective advocacy of both public and private points of view, particularly controversial ones, is undeniably enhanced by group association, as this Court has more than once recognized by remarking upon the close nexus between the freedoms of speech and assembly."

We are sensitive to the concerns of those who disagree with us and we want to engage them in peaceful discussion.

There are, however, limits to First Amendment rights. You can't yell FIRE in a crowded building to start a stampede when no fire exists. You can't incite people to riot. We worked closely with the Boston authorities to take prudent precautions against irresponsible protesters. Just as the protesters have a right to assemble and voice their concerns, we also have a right to conduct our meeting.

I'm happy to note that these demonstrators have conducted themselves peacefully.

The protests we face now and in years ahead represent the growing challenge of maintaining public acceptance for biotechnology. In the long-run, public acceptance will determine the pace of our progress in all applications of biotechnology. We cannot risk slowing down our efforts to find new therapies and cures; to help developing nations feed their people; to conserve limited natural resources; and to keep cleaning up our environment.

Henri Termeer, the chairman, president and CEO of Genzyme Corporation here in Cambridge and the co-chairman of the BIO 2000 steering committee, helped me put our industry's progress in perspective. He said: "If this were a Boston Marathon, we'd just be at the point of lacing up our shoes."