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

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