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Mike Mitchel and I are attending one of the most interesting conferences about life science in the country. It’s the BioAgenda Summit near Palm Springs. It covers a wide range of issues about where life science is going–or is "taking us"–and about the industry of biotechnology. There are amazing people here.

Well, to get ready for the conference we had–groan!–homework. We were supposed to write little essays about issues to be discussed the next two days. Topics:

  1. Are drug prices too high?
  2. Human-directed evolution: how far do we go?
  3. Is biotech working?
  4. How do we get benefits of science to the world?

I’ve posted my responses below. I’ll report any more views that come up.

BIOAGENDA SUMMIT HOMEWORK: DAVID COLLIN

DRUG PRICING

For the question, “Are drug prices too high?” almost
immediately you are compelled to ask also, “Too high for whom?” Patients and
family? Insurers, HMOs or other care providers? Employers and premium payers? Federal or state program managers
and policy makers? The US economy? Not a simple proposition.

In mid-February an article in the NYTimes reported that the
cost of a year’s lung cancer treatment with Avastin will be in the neighborhood
of $100,000. That isn’t the most expensive therapy around, but it evidently
sets a new high water mark high for treatment of common diseases like breast
and lung cancer. Genentech spokespersons also said that the price is based on
the value returned in extended life. I’m unaware of the calculus they used to
arrive at that figure, but I’m sure it will make for an interesting
socio-political dialog, especially if that approach is to become a standard for
pricing future complex biologics as some expect. No doubt some rationalization
of the process for setting value of treatment is helpful, but I’d guess
decision makers mentioned above have their own gut-level formula for making the
decision.

It seems to me we have reached a threshold where some
process for rationalizing decisions to say “yes” or “no” to drugs and other
technologies is essential. It is very hard to say “no” in a society where our
ideals—at least in the past—held that no price is to high to pay for a human
life. However, the expense of health care in the US is breaking families,
government budgets, competitive positions of companies, and the projected
expenditures of entitlement programs. Drugs are only one part of that dilemma,
but at some point setting limits will become rational and not inhumane. With scarce
resources—and even the US does not have unlimited resources—all decisions are a
trade off of one benefit vs. others.

It is already evident that extravagant expenditures for new
treatment technologies do not necessarily result in better overall population
health when compared to societies where less is spent. So, while some
individual cases lives may be shortened to some degree, the overall impact on
societal health of curtailing high-priced therapies will be low. While drug
costs are just one component of a continuously inflating health care costs in
the US, they contribute to the situation where costs continue to go up and the
proportion of the population with essential health coverage goes down. I doubt
that there will be much outcry if limits are exercised.

It seems to me there are ways of mitigating the cost of new
drugs. One is broadening the market for return on investment. The US cannot
continue to be the primary market in which return on investment for private
drug development is recouped. Drug developers and governments must join in some
arrangement to distribute expenditures more broadly, or major US sources need
to start saying no.

Another way to affect overall cost is to have the agencies
that fund publicly supported research and research institutions be better
managers of public IP investments. Taxpayers are investors taking a risk on
allocating scarce dollars to research. If the result is products they can’t pay
for or technologies that beggar families and the economy, where’s the investor
incentive to continue doing that? Products that you don’t have access to are
effectively nonexistent. I think taxpayers who have funded research through NIH
and other federal agencies and through excellent public research universities
have not gotten adequate return on the IP in which they have invested.
Investment-based private companies do a good job of realizing return on IP;
federal and state agencies should do the same.

Decades ago it was assumed—perhaps somewhat naively—that
research would eventually result in widespread benefits to public wellbeing.
Increasingly it is evidently that that is not necessarily the case. This is
changing. A new model is developing with the California with the Institute for
Regenerative Medicine. Steps are being taken to assure that the $3 billion
invested by the taxpayers of California in stem cell research will result in
greater control of resulting IP and participation in revenues from resulting
products. The $3 billion could result in an awesome IP position for the state
of California. The “CIRM Intellectual Property Policy for Non-profit
Organizations” is worth reading. (http://www.cirm.ca.gov/meetings/pdf/2006/02/021006_item_8.pdf)

The life science industry argues rather persuasively that
private investors need high ROI to motivate continued investments in risky life
science research. Well, so does the public. It needs to be a partnership
between private and public investors. The incentives for investors—private and
public—need to be balanced. Success with well-managed IP and shared revenues
could provide funds to subsidize the purchase of drugs so they are within the
reach of all.

HOW FAR DO WE GO?

I do not hold any personal beliefs that lead me to say there
is any defined line for how far modification of the human form should go. Human
beings have been through many transformations and modifications in the
evolutionary process, many that made us smarter, faster, stronger and freer
from disease. I doubt we’d roll any of those changes back. In my view,
evolution is an open-ended process, including human-directed evolution.

When I ask myself if I’d like to be smarter, faster,
stronger and disease free, I have to say, “yes,” to all. I assume most people
would say the same. My observation is that the arc of human medical effort has
been to rid humanity of everything that compromises or shortens life. The
result is a drive for immortality by default. I don’t think medical progress
will stop until life is absolutely extended to the last possible moment.

Given that I think the vast majority of people would avail
themselves of the gains suggested, I don’t see how any consensus can be arrived
at about limiting possible enhancements. Having said that, my concern is with
the pace at which it proceeds. In The Singularity is Near, Kurzweil
anticipates the transformations to be extreme and to happen soon, driven by
synergistic advances in information technology, nano-science, and genetics.
Dramatic reengineering of the body is foreseen by 2030. I’m skeptical that that
will be so. Developing interventions affecting humans is a slow process for
good reason. We cannot foretell the short term effects well, much less the long
term and unintended consequences of interventions. It’s currently taking a
decade or more to develop and test modest treatments for the maladies we’ve
endured for millennia. I’m not convinced Kurzweil’s “law of accelerating
returns” works with human biology and medicine.

It seems to me the social and economic disruption of the
fundamental revisions to biology suggested by Ray Kurzweil will result in
monumental turmoil. If augmentation of intelligence and other qualities are
demonstrated to be beneficial and reasonably side effect-free, then huge issues
of access and opportunity arise dwarfing the dilemmas mentioned in question
four of this survey. So, while I think the thrust of human longing is toward
self-betterment and a tangible resolution to the existential fright of
mortality, I think it’ll be a long, difficult road.

IS THE BIOTECH INDUSTRY PAYING OFF?

The privatization of life science research and development
beginning some 30 years ago initiated a whole new way of moving science
findings out of the lab for public benefit. At the current level of biological
knowledge it’s little wonder that biotech is risky business. Of the total space
of biological knowledge, where are we? Fifty percent? Thirty? Twenty percent?

There are questions about whether or not the management of
so-called Big Pharma is efficient and effective enough to succeed in the
development of complex molecular therapies. However, it’s no surprise to me
that the results in biotech so far are mixed. Until three decades ago there was
no private investor sector in complex biological research. Now it’s in a
precarious time of experimentation and developing fundamental techniques. I
certainly don’t believe that anyone can judge that biotech a failure at this
point. The small company granularity of biotech may turn out to be an asset if
it enables them to be more focused units of production.

There are ideas about bio-system development that are only
partially developed. “Rational drug design” has been around for some time
without the payoff anticipated. And “systems biology” is still primarily a
concept with varying definitions. It’s a lot easier to coin buzzwords than to
bring those concepts to maturity. One would presume that the greater the
accumulated knowledge in these areas, the more efficient the drug production
process will be. Ray Kurzweil in Singularity projects great advances in
applying modeling and information technologies to biological design. He expects
that to reach breakthroughs in the next decade. That remains to be seen.

I suggested in my response to question one, we have embarked
unwittingly on a private/public investment process for life science R&D.
The value relationships have yet to mature and so has the science. Perhaps
we’re at the linear stretch of what Kurzweil calls the law of accelerating returns
in life science. It may be quite some time before the curve of progress goes
ballistic.

THE HAVE AND HAVE NOTS OF LIFE SCIENCE

One billion people have access to the fruits of scientific
life science progress? Hmm, I wonder. I’m assuming that the population of the
US would be counted among that one billion. However, given the low percentage
of the population in the US fully covered by health insurance of some kind, my
guess would be that a significant portion of the population of this country do
not have full access to the fruits of life science. My thoughts on making it
more equitable in the US and industrialized nations are contained in the answer
to question one.

Making benefits more widely distributed worldwide is a
complex matter. If you look at the varied situations of the five billion
mentioned in this question, one issue is getting developing the appropriate products. In the most recent
issue of Wired Magazine, there is an article reporting on the great shift of
clinical trial testing to India. One of the most prominent points of the
article is that Indians are involved in testing drugs that are of little direct
benefit to them. Dr. SP Kalantri, a physician with patients enrolled in cardiac
drug trials, notes that the biggest health problems faced by people in his
vicinity are viper bites and insecticide poisoning. Bill Gates has invested
hundreds of millions of dollars to develop third-world treatments not
forthcoming from the western world market. Impoverished populations—whether in
the third-world or subpopulations of the US—have little effective market
demand. The market-driven biotech world is unlikely to provide solutions for
those populations.

One possibility for improving the situation is to bring
R&D closer to indigenous populations. Perhaps philanthropist and
international consortia that serve as agents of those populations could look at
giving incentives to biotech companies in India and China where drugs might be
developed at lower cost. Perhaps IP could be purchased and managed by agents to
be directed more toward the needs of those populations.

Another aspect of greater access is the overall
infrastructure of the societies in which the bulk of the population lives. In
some respects distribution of drugs and therapies needs to parallel the
development of the society as a whole. Behind the drug therapies for wealthy
nations there is an elaborate health care infrastructure and a culture amenable
to that form of health care. More equitable access to the fruits of life
science needs to be linked to overall economic and social development.

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