| May
1, 2005 |
| By:
Anthony
J. Sinskey, Stan
N. Finkelstein, Scott
M. Cooper |
| Pharmaceutical
Discovery |
|
Anthony J. Sinskey
|
In the 1913 edition, Webster's Dictionary defined scientific
research as "diligent inquiry or examination in seeking facts or
principles" — a definition more than suitable for today. Within
the broad definition of scientific research, scientists generally
acknowledge three types: basic, the primary purpose of which is
to discover new facts or test theories about natural phenomena; experimental,
in which conditions are varied to test effects and applied, where
the investigation is conducted with a view to obtaining information
directly useful in producing something with practical utility.
Testing theories through basic research has brought about tremendous
advances too numerous to elaborate here. It also often comes with
something we suspect most scientists would acknowledge as a constant
by-product — the potential for opposition on what are stated as moral
or religious grounds.
Today's touchstone for opposition to scientific research is the stem
cell issue. That's unfortunate; as Hans Keirstead, head of the
Reeve-Irvine Research Center at the University of California at Irvine,
has stated, "Every hundred years, there are one or two major
turning points in science akin to the discovery of penicillin, and stem
cells is one of them" (1).
Stan N. Finkelstein
|
In 2001, President George W. Bush issued an executive order limiting
federal funding of stem cell research to existing stem cell lines — a
textbook case of ideology trumping science. His decision was denounced
by nearly every foundation and society dedicated to research into curing
diseases. In June, 2004, 58 U.S. senators (including 14 from Bush's own
party) sent the president a letter urging him to expand the available
lines, joining 206 of their fellow lawmakers in the U.S. House of
Representatives (including 26 Republicans) who had issued the same call
the previous April.
In California, voters took more direct action. Last November's
election saw the passage of Proposition 71 in that state, a
groundbreaking measure allowing some $3 billion in state funds to be
used for embryonic stem cell research — effectively bypassing the
federal ban.
Why does this matter? Estimates suggest that more than 3000 people
die every day in the United States from diseases that could be treatable
as a result of stem cell research, including Alzheimer's, Parkinson's,
diabetes, multiple sclerosis, heart disease, stroke and spinal cord
injury. "It is not too unrealistic to say," suggested Harold
Varmus, then director of the National Institutes of Health (Bethesda,
Maryland, USA), "that [stem cell] research has the potential to
revolutionize the practice of medicine and improve the quality and
length of life" (2).
Scott M. Cooper
|
Now Massachusetts — where we live and work — is entering the fray.
In early February, the president of the state senate, Robert Travaglini,
introduced a bill that would make it state policy to support human
embryonic stem cell research (without providing funding), while at the
same time banning human reproductive cloning and creating an advisory
committee to establish safeguards for stem cell donation and address
ethical issues regarding the research. According to Travaglini,
"Our research community stands on the threshold of great advances
in the fight against disabling childhood and degenerative diseases but
has been held back by cloudy legal policy on stem cell research"
(3).
Massachusetts Governor Mitt Romney took exception. Expressing his
moral objections to the Travaglini bill, he announced that he would
propose legislation to criminalize some aspects of stem cell research.
The immediate consequences aside, this could have an adverse effect on
the future of scientific research beyond that strictly related to stem
cells.
One of Gov. Romney's specific
targets is the method of obtaining stem cells by creating new ones
specifically for scientific experiments. This is the approach being
taken by the Harvard Stem Cell Institute (HSCI) at Harvard University
(Cambridge, Massachusetts, USA), a bold scientific enterprise, announced
in April 2004, to use private funds in order to circumvent the Bush
Administration ban.
HCSI will "coordinate the
teaching, training and research of about 25 principal investigators and
64 affiliated member scientists and will engage seven Harvard schools
and six affiliated hospitals, focusing their research and clinical
efforts on a singular goal: the use of stem cells to correct organ
failure" (4). The Institute is co-directed by Douglas Melton, a
Harvard professor in the natural sciences, and David Scadden, a Harvard
professor and director of the Center for Regenerative Medicine at
Massachusetts General Hospital (Boston, Massachusetts, USA).
The Institute may well be a
scientific and economic boon for the Boston area.
Economic Considerations
Those who counter the positions of Bush, Romney and the others who put
politics before science and health sometimes leave out the economic
factor and often fail to make the decisive link between economics and
long-term healthcare advances.
Not so on the "left
coast," though. Some supporters of Proposition 71 claimed that the
measure would "make California, already the United States' leading
hub for biotech industries, a world hub of stem cell research too"
(5). As Paul Berg, a professor at Stanford University Medical Center
(Stanford, California, USA), said, "It is extremely likely that
researchers in other areas of the country, and the world, whose work is
hamstrung by funding or regulation, will move to California, which would
become a new hub in this realm" (5).
Our institution, Massachusetts
Institute of Technology (MIT), has a long and proud history of making
great scientific breakthroughs — as does our friendly rival up the
street, Harvard University. Entrepreneurship is also a big part of MIT,
and thousands of businesses have been created based on MIT research.
Innovation from MIT has spurred local, regional and even national
economic growth. Investments lead to products, which lead to profits and
new investment in the next generation of advancements. This is true for
biotechnology and other research-driven industries (6).
A recent article in Nature
Biotechnology (New York, New York, USA) gives a very clear picture
of just what's at stake financially. Citing a U.S. Department of
Commerce (Washington, DC, USA) report, the article notes that, "In
2001, biotech companies nationally reported net sales of $567 billion,
operating income of $100.5 billion, capital expenditures of $29.5
billion and the employment of approximately 1.1 million people"
(7).
In California, the economic impacts
of Prop. 71 promise to be felt in many ways. "Much of the initial
funding, for example, will be earmarked for lab construction and
equipment, which will generate revenue for California companies and send
sales tax money to Sacramento. Beyond that, stem cell research could
foster other medical technologies because stem cells can be used to
create disease cultures for drug testing. Today, if a researcher wants
to test a new drug on, say, a cancer cell, he or she must obtain one
from a patient or buy a cancer line. But using stem cells, researchers
can explore their own disease-related genes more quickly and more
cheaply" (1).
In Massachusetts, Governor Romney's
attempt to ban stem cell research could have a devastating impact on the
cycle of research (discovery → commercialization → further
research). The immediate losers in our region will be scientists and
entrepreneurs, but in the longer-term it will be those who suffer from
the diseases that stem cell research might cure. Romney's actions
prompted Irving Weissman, director of Stanford University's stem cell
institute, to comment: "This could have a very unfortunate effect
nationwide, leading other governors to follow suit and precipitating a
national division we do not need" (8).
We agree with Weissman.
At stake is whether society will
have the chance to benefit from scientific progress and future medical
treatment, and also from sound economics. Our region, for instance,
already has "a large biomedical research infrastructure, a ready
source of capital and a critical mass of companies at various stages of
development" (7). This combination bodes well for the kinds of
advances we would like to see from stem cell research — as well as for
helping fuel an engine of economic growth and create good jobs that are
socially useful.
Doing the Right Thing
The Massachusetts legislature has an opportunity to put scientific
progress before politics by supporting research that could save the
lives and ease the suffering of tens of millions of people throughout
the world. Ethical guidelines can be crafted to ensure that scientific
research is appropriate — something every serious researcher embraces
— but at the end of the day it is the science that must come first.
Failure to take advantage of the
promises stem cell research offer is an unacceptable alternative.
References
1. P.J. Sauer, Inc. Magazine February, 19 (2005).
2. Statement to U.S. Senate
Appropriations Subcommittee on Labor, Health and Human Services,
Education and Related Agencies, December 2, 1998.
3. State House News Service, "Travaglini
files measure supporting stem-cell research," The Boston Globe,
February 10, 2005.
4. J. Shaw, Harvard Magazine 106(5),
59 (2004).
5. M. Lavine, "$3bn for
California stem cell research," Agence France-Presse, November 3
2004.
6. See MIT: The Impact of
Innovation, a 1997 report by BankBoston with the support of the
Massachusetts Institute of Technology. Available online at http://web.mit.edu/newsoffice/founders).
7. K.H. Wilan, Nature
Biotechnology 23(2), 175-179 (2005).
8. M.L. Brandt, Stanford Report
February 16, (2005). Available at http://news-service.stanford.edu/news/2005/february16/med-stem-021605.html.
Anthony J. Sinskey and Stan
N. Finkelstein are co-directors of The Program on the Pharmaceutical
Industry (POPI) in Cambridge, Massachusetts, USA. Finkelstein is also a
senior research scientist at MIT Sloan School of Management in
Cambridge. Sinskey is professor of microbiology at MIT in Cambridge. Scott
M. Cooper is an affiliate and frequent collaborator of POPI
researchers.
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