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Posted at 8:01 p.m. PDT Sunday, April 1, 2001 Q&A: Biotech lobbyists have their hands full The biotechnology industry has more than its quota of controversy these days, with the prospect of human cloning, a dispute over embryonic stem cell research, anger over the high cost of drugs, and concern about the potential misuse of genetic information. And the Bush administration is considering key appointments that affect the health care industry, including Food and Drug Administration commissioner and National Institutes of Health director. Mixing it up in all these debates is the Washington, D.C.-based Biotechnology Industry Organization, or BIO, and its president, Carl B. Feldbaum. With more than 960 members, including most of the publicly traded biotech companies, BIO lobbies for an industry that includes fragile start-ups with big ambitions as well as established firms with products on the market and profits on the balance sheet. Feldbaum, 57, is well-positioned to do battle. He's former chief of staff to Sen. Arlen Specter, R-Pa., and held positions in the departments of energy and defense. Early in his career, he was an assistant to Watergate special prosecutor Archibald Cox and can talk with authority about that famous 18 1/2-minute gap in President Nixon's White House tapes. Feldbaum was recently in the Bay Area and Silicon Valley -- what he calls the ``biotech heartland'' -- visiting member companies. This is an edited transcript of his interview with Mercury News reporter Paul Jacobs. QThis year biotech stocks are way off; what's your sense of the health of the industry? A The last several years have been very, very good to the biotech industry in terms of the ability to access capital. Most if not all of the CEOs and companies I talk to really took that period of access to raise money for research. We've been through these ups and downs before and this does not even begin to approximate what the industry went through in 1993 to 1995, when companies just had months of capital available, given their burn rates. We were at CV Therapeutics (in Palo Alto). They have several hundred million dollars in cash reserves. It wasn't like this when the droughts occurred five and seven years ago. QGive me a sense of what this industry has accomplished. Why should someone care about biotech? A As I came into the industry in 1993, products were just beginning to trickle through the FDA. You already had some significant ones like Amgen's EPO and you had human insulin for diabetics. From the period of 1993 through the present you see a real acceleration of products coming out. Right now what we're looking at is more than 350 biologics in late stage clinical development at the FDA. That is a fuller pipeline then we've ever had before. QWhat are you doing to influence the Bush administration on embryonic stem cell research? A We met with members of the administration (on March 16) on the issue of stem cell research and had with us some experts on the possibilities and also limits of using adult stem cells, as opposed to embryonic stem cells, so that all the science was laid clearly on the table. We discussed not only science but the emerging field of regenerative medicine, the ability to grow cardiac cells and pancreatic cells and neurons and other cells to help people regenerate spinal cord tissue and heart tissue and, for diabetics, pancreatic tissue. And I think we had a very useful, helpful meeting. It's clear that the president is under some pressure, and members of the White House staff certainly feel it, from some of the religious conservative groups that helped elect him, to take into consideration a broad agenda of which this is a part. QWhat's your position on the cloning of a child? AFrom the beginning when the issue was raised with the advent of Dolly the sheep back in February 1997, we've been clear that the safety issues and the moral and ethical issues have certainly not been resolved. It took 274 attempts to get a healthy sheep, Dolly, back in 1997. Those kinds of odds, even if they were reduced to one in 20, reduced by 90 percent, are just unacceptable when applied to an attempt to create a healthy child. Also, we have not sufficiently thought through the moral and ethical questions raised. While we're used to identical twins in our daily lives in the same generation, we really have not thought through some of the familial complexities of having identical twins of different generations, a grandmother and a granddaughter, for example, or a grandfather and grandson that would be genetically identical. Not in any way that they'd be identical people, but those are issues we think have not been resolved. So I wrote a letter to President Bush about six weeks ago reiterating our stand that we do not think that cloning to produce a human child is the right thing to do. QIs there a Frankenstein image that grows out of this talk by an Italian- led team to clone a child? A What concerns me right now is not the economic situation of the biotech industry. That doesn't concern me. That's a cycle we've been through many times before, and we're stronger than we've ever been to get through this one. What does concern me is what I will gently refer to as scientific grandstanding -- experiments where the average lay person hears about it and asks what are they up to? That raises doubt about a great deal of legitimate research. I've heard about putting jellyfish genes in monkeys to test the viability of certain gene therapies. The idea that anybody would be so politically tone deaf is frankly a mistake and it causes lay people, who don't particularly understand what the experiment was about, to doubt the legitimacy of the rest that is going on to cure Alzheimer's, Parkinson's, breast cancer, ovarian cancer and all the other diseases that need treatment. QExtending Medicare coverage to prescription drugs should be a good thing for pharmaceutical and biotech companies, but it may come at a cost -- some sort of price-setting. A We think now with a whole arsenal of biotech products as well as other pharmaceuticals, plus the pipeline at the FDA -- more than 350 new products -- that Medicare needs to be re-examined in a fundamental way and that ultimately a prescription drug benefit needs to be afforded seniors, particularly with the boomer generation. How that happens is very important to the biotech industry. A great many of the biotech companies are developing drugs for age-related diseases that are inordinately suffered by the Medicare population -- such as Alzheimer's, Parkinson's, osteoporosis and age-related cancers. So those are our markets. We need to move forward. But politically how it's done is of great interest, because there are ways to do it where you don't impose a one- size-fits-all government system that threatens to squelch investment or rate of return in the biotech industry. QThe health of this emerging industry seems sensitive to politics. A We're super-sensitive to political developments. About three years ago I noticed a sea change in the way members of Congress regard us. They may respond to public or media pressures on any issue, and they may introduce a piece of legislation. But if you can go to them and very, very clearly indicate that their piece of legislation can adversely affect biotech research into Alzheimer's or diabetes or whatever the disease, they don't want to go there. They say help us rewrite it and we do. Going to the politics of the industry, our politics are not only local, our politics are purely personal. We talk to members of Congress who have histories of various conditions and they quite explicitly want to find out what the biotech industry is researching. And we certainly go in and lead with those examples. Contact Paul Jacobs at [log in to unmask] or (530) 756-0236. http://www.siliconvalley.com/docs/news/depth/qa040201.htm ******** ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn