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https://www.commondreams.org/views/2020/09/17/invent-our-way-beyond-covid-19-we-need-open-science

Published on Thursday, September 17, 2020 by Common Dreams
<https://www.commondreams.org>
To Invent Our Way Beyond COVID-19, We Need Open Science

It is time for our government to put science and public health ahead of
private profit.
by Christopher Morten
<https://www.commondreams.org/author/christopher-morten>
16 Comments
<https://commons.commondreams.org/t/to-invent-our-way-beyond-covid-we-need-open-science/82276>
[image: "Big pharma's secretive, profit-driven model of science is making
the invention and dissemination of COVID treatments and vaccines more
difficult than it needs to be," writes Morten. The industry, he warns,
"generally prefers to keep its scientific advances on COVID-19 as secret as
possible, even though this secrecy needlessly slows down the process of
developing effective treatments and vaccines. And our law currently lets
them." (Photo: Skynesher/Getty Images)]"Big pharma's secretive,
profit-driven model of science is making the invention and dissemination of
COVID treatments and vaccines more difficult than it needs to be," writes
Morten. The industry, he warns, "generally prefers to keep its scientific
advances on COVID-19 as secret as possible, even though this secrecy
needlessly slows down the process of developing effective treatments and
vaccines. And our law currently lets them." (Photo: Skynesher/Getty Images)

All of us desperately await the day when we can send our children to
school, spend time with our grandparents and grandkids, and live without
fear of COVID-19.

An ad campaign from the pharmaceutical industry’s largest lobbying group
promises us that “science is how we get back to normal
<https://catalyst.phrma.org/in-combating-covid-19-science-is-how-we-get-back-to-normal>.”
They’re right that science can defeat COVID-19, but they’re wrong about the
kind of science we need most.

Big pharma’s secretive, profit-driven model of science is making the
invention and dissemination of COVID treatments and vaccines more difficult
than it needs to be. Big pharma generally prefers to keep its scientific
advances on COVID-19 as secret as possible, even though this secrecy
needlessly slows down the process of developing effective treatments and
vaccines. And our law currently lets them.

For example, in the spring, Gilead announced that the drug remdesivir is
the first antiviral proven effective against COVID-19 but declined, at
first, to share
<https://www.statnews.com/2020/05/13/wheres-the-data-in-a-pandemic-now-is-no-time-to-sit-on-covid-19-trial-results/>
its clinical trial results, leaving doctors and researchers in the dark.
AstraZeneca recently halted a major trial of its COVID-19 vaccine candidate
because of safety concerns—which might conceivably affect other vaccines,
too—but has so far refused to disclose any details
<https://www.nytimes.com/2020/09/13/science/coronavirus-vaccine-trials.html>.
If and when we do have a working vaccine, knowledge vital to scale up
manufacturing and distribution around the entire world is likely to be held
as trade secrets
<https://www.statnews.com/2020/07/10/covid-19-reexamine-trade-secrets-information-stranglehold/>,
slowing the global public health response
<https://science.sciencemag.org/content/369/6506/912?rss=1> and
perpetuating the pandemic.

(As I’ve co-written elsewhere
<https://medium.com/@MSF_access/we-need-strings-attached-b51952795e6b>, big
pharma’s efforts through the COVID-19 pandemic to keep scientific knowledge
proprietary are particularly galling given that the U.S. and other
governments have invested billions of dollars of public money to create
that knowledge.)

There is a better way: open science. Open science means broad, ready,
equitable access to scientific knowledge, and to the data that generates
that knowledge, across drugs’ and vaccines’ entire lifecycles, through the
pandemic and beyond.

Open science is essential to focus research and development activity on the
most crucial health needs, accelerate R&D, expand competition and prevent
monopolization, reduce costs, and ensure affordable, equitable access. We
must provide access to the “means, methods, and materials”
<https://www.treatmentactiongroup.org/statement/treatment-action-group-celebrates-new-guidance-on-the-right-to-science-by-global-human-rights-body/>
of biomedical innovation, including various preclinical, clinical, and
financial data that is <https://ebm.bmj.com/content/24/2/53> currently kept
mostly hidden
<https://law.yale.edu/sites/default/files/area/center/crit/crit_white_paper_november_2017_best_promoting_transparency_in_clinical_research_why_and_how.pdf>
by industry—and too often by government and academia, too.

This could be done in two phases. In phase one, the National Institutes of
Health (NIH), the Food and Drug Administration (FDA), and other public
agencies should begin discretionary sharing
<https://journals.sagepub.com/doi/abs/10.1177/1073110517750615> of
preclinical
<https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options>
 and clinical data
<https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2686147>
 they hold
<https://www.law.nyu.edu/sites/default/files/Clinical_Trial_Cost_Transparency_at_the_NIH-Law_and_Policy_Recommendations.pdf>.
Government-held results of experiments and clinical trials, and information
on the costs of this research, can and should be shared regardless of
whether the results are generated by government, industry, or academia.
Such data sharing would make it easier for researchers to replicate
research findings, reduce redundancy and other inefficiency, and speed the
development
<https://www.statnews.com/2019/11/18/data-sharing-clinical-trials-lessons-yoda-project/>
of
new therapies.

Phase one could be achieved immediately, through agency discretion, without
changes to existing law. However, Congress could maximize public benefit by
making this data sharing mandatory.

Phase two would extend open science to manufacturing. Sharing data and
know-how on manufacturing processes would accelerate development of new
drugs, especially biologics and biosimilars. This would break
anti-competitive monopolies and lower sky-high prices
<https://www.forbes.com/sites/theapothecary/2019/03/08/biologic-medicines-the-biggest-driver-of-rising-drug-prices/#283a757f18b0>
.

To achieve this, Congress should amend federal statute (such as the Food,
Drug, and Cosmetic Act
<https://illinoislawreview.org/online/volume-2018/follow-on-biologics-are-set-up-to-fail/>
or
the Biologics Price Competition and Innovation Act
<https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.1285>) to
require manufacturers and the FDA to share information that is currently
protected as trade secrets once the appropriate exclusivity period has
passed. Congress should also provide the FDA and Department of Health and
Human Services (HHS) discretion to share manufacturing information—and
clinical data, too—sooner, before the exclusivity period expires, to
accelerate competition in the event of anticompetitive conduct or pressing
public health needs.

The Patent Act should also be reformed
<https://www.ted.com/talks/priti_krishtel_why_are_drug_prices_so_high_investigating_the_outdated_us_patent_system?language=en>
to
require patent owners to disclose more useful information
<https://scholarship.law.vanderbilt.edu/vlr/vol69/iss6/9/>.

The COVID-19 pandemic has confirmed that we must change our laws to prevent
drug companies from keeping valuable medical knowledge secret for years,
even decades. It is time for our government to put science and public
health ahead of private profit, by passing new laws to ensure broad, ready,
equitable access to scientific and medical knowledge, from test tube to
pharmacy.

*This op-ed is part of an ongoing series on public medicines. View the
first in the series here
<https://www.commondreams.org/views/2020/08/20/reclaim-public-medicine-public-health>,
the second here
<https://www.commondreams.org/views/2020/08/26/its-time-take-big-pharma-and-reclaim-medicines-public-health-we-need-public-option>,
the third here
<https://www.commondreams.org/views/2020/09/02/break-glass-case-emergency-we-must-break-pharma-monopolies-lower-drug-prices>,
and the fourth here
<https://www.commondreams.org/views/2020/09/10/we-must-take-vaccine-industry-public-ownership-ensure-its-products-are-available>.*