Fixing Scientific Funding
One of the biggest challenges that has led to the crisis in science is funding. We as a society collectively spend a tremendous amount on funding science, however, when considering the lofty goals and expectations in place, science is incredibly underfunded. Federal funding of science peaked in 1964 at 1.86% of the GDP in the USA, and by 2014 had fallen to 0.77%. Private industry and philanthropy have filled in the gaps, with total spending on science only falling from 2.79% in 1964 to 2.69% in 2014,  but realistically funding should have increased to match the increases in infrastructure and PhDs granted. Exacerbating matters of funding is exploitative behaviour by private corporations, including but not limited to, the publishing industry, private sector drug and equipment manufacturers utilizing public funds, and even private university administrators.
No More Corporate Free Rides
Probing the implications of publicly funded NIH grants to private corporations, a team from MIT published in Science found, after extensively reviewing 365,000 grants over a 27 year period, that 31% of NIH grants were utilized in patent grants for the private sector, and 8% of the grants directly resulted in a patent grant for the private sector.  This has been confusingly reported in a positive light, trumpeting the effectiveness of NIH grants, without questioning the use of public funds to patent developments for private profit. 
First, I want to say that often private industry is best suited to make advances, and as a society, we should be putting our best foot forward in order to solve many of the challenges we are facing. I am not against using public funds to benefit private business, when said businesses are taking on risk in order to positively impact society, I am simply against having this resource available on no, or limited, restrictions. If private industry is going to profit from public funds, it needs to be ensured that the public profits from this investment in private industry. Any programs developed need to be a win-win scenario, not a free ride with massive winners at the expense of the public coffers.
The NIH does have some requirements for funding private research, such as requiring results to be published regardless of the outcome and requiring published results to be open access. These reasonable and quite limited strings are enough to deter many private corporations from choosing to utilize NIH grant funds, which in of itself is quite telling on these companies’ dedication to the truth.  The NIH defends their decision to fund private science, however, sometimes this backfires. In 2018, they ended up with egg on their face over funding for research conducted on behalf of the alcohol industry, having to promise to “clean up their ethics.” The research was so compromised, the NIH had to render it entirely untrustworthy. 
“But recent projects have put the NIH in the spotlight for the wrong reasons. The most controversial was a much-publicized partnership with alcohol manufacturers, which was canceled in June after the NIH concluded scientists had so thoroughly involved alcohol industry figures in planning as to render the science untrustworthy.”
There are some easy safeguards to this issue. First, Canada has a great program that I have utilized and written about previously called the Scientific Research & Experimental Design tax credit program. Rather than issuing grants for businesses to use as they wish, SR&ED works as an evaluation of work already conducted, and when found to be appropriate, issues tax credits for future years to offset the funds spent on advances in science, engineering, and technology. Basically, private corporations are tasked with first raising their own funds, and conducting the work, and then are credited back. This is a fantastic model, as the private corporations are taking on the risk, and then rewarded appropriately, both in terms of tax credits and ability to monetize on their findings.
Another scenario exists in which the public may benefit from funding private corporations, without that corporation first needing to conduct the work, or raise external funding. In this scenario, the public is taking on considerable risk through funding and should be appropriately compensated for this risk. As it stands, a private corporation can utilize public funds to make a discovery, patent that discovery, and then charge whatever exorbitant, borderline criminal, mark-up they please with no recourse. There are two options I see as potentially being able to fix this issue, with a hybrid option likely the most sensible.
- The NIH, or other nation’s grant issuing authorities, become equity investors in the start-up or receive royalties off of any commercialization of projects funded by grants. These royalties, or equity interests, would contribute towards funding more and more projects.
- Mark-up is controlled, or input heavily considered and negotiated by, the original grant funding source such as the NIH. This would ensure that exploitative tactics are not utilized by private corporations looking to charge obscene margins to the population and insurance companies, a horrendous practice greatly contributing to the dismal state of the US Healthcare system.
I am typically not in favour of the government stepping into private business. In my younger years, I was far more in support of a free-market economy, however, with age and experience, I am becoming more and more sensitive to the corruption and exploitation that exists in this model. Immediately it is thought by most in support of a free-market economy that government is incompetent and ineffective, which unfortunately is often the case. The question becomes, what would we rather try to fix; unchecked fraud, exploitation, and corruption, or ineffectiveness and incompetence. The latter seems like an easier task, particularly when considering this would be more of a mixed system.
Private corporations would still be completely within their rights to fund projects completely by themselves without public grant fund assistance, and if they pursue their business on their terms they would not be held to these restrictions. This is simply a solution for the legal, but ethical misappropriation of public funds towards the private sector. Private corporations, and proponents of a free market, cannot have their cake and eat it too. They cannot utilize public taxpayer funds given to them by the government, and then bemoan government involvement in relation to the money that the government, by way of the public, has given them.
Fixing Grant Committee Bias
As discussed in last week’s article, grant committee bias seems to be a very real thing, with perceived “prestigious” institutions being awarded significantly more grants, at significantly higher average grant awards, than their “less prestigious” competitors, despite “less prestigious” schools having, on average, a much better track record in scientific impact per dollar spent. A typical blinding process would not work for grant committees as it would open the door for significant fraud and misrepresentation. An ambitious academic could submit an impeccable, seemingly important and highly ambitious proposal that appears to be worth funding, but realistically impossible, given available resources at their institution. A blinding process would inflame the issue of grant funding being a competitive skill, not subdue it unless appropriate safeguards are adopted.
Grant committees should evaluate proposals and be given a weighted score of the institution and department's success record, similar to the H Index, with a breakdown of the department’s current capacity and limitations. Routine audits could generate these assessments, leaving the grant committee uninvolved in this evaluation. With the report included in the grant submission, the team and institution could be removed from the grant, effectively blinding the committee of any bias, while giving them the information needed to assess the application.
By systematically addressing inherent funding bias, funds would be distributed in a more effective, and result-driven manner perhaps reducing funds to the currently perceived “most prestigious institutions.” Additionally, by improving the peer review process with suggestions I detailed last week, while simultaneously addressing funding issues, there will undoubtedly be a shift in evaluation of the most elite schools, defined by success rather than name value and perceived exclusivity. Such a shift would impact aspiring academics choices on desired institutions to study and would lead to re-evaluations of tuition costs. Without their status to fall back on, many private institutions would be forced to price their tuitions competitively with their public counterparts, with real-time results driving the value and not centuries of name recognition, PR, and marketing.
Fixing Private Industry Data Manipulation
This last proposition involves not only funding but shoring up a massive issue with the integrity of privately funded research. As it stands, private corporations utilizing CROs have tremendous input into trial design and the right to publish. Negative studies can be sat on and rerun, until a positive “replicative” result is shown. The ability to impact study design can largely impact the success of the study, which is both good and bad. Poor design can lead to something that works for a subset of the population showing to be inefficacious overall. In contrast, manipulated trial design can lead to results that indicate a drug works on the entire population, when really it only works on a subset. This can be done to increase sales and prescriptions, improving the profitability of the drug in development. Similarly, design can be skewed in order to obfuscate potential harm or adverse events that may only be present in a specific population. Additionally, as previously discussed, private corporations can cut a trial short or extend it in order to wait for a statistical “burst” that could be random and not indicative of effectiveness. They can, and will, also practice the strategy of p hacking, running various statistical models until they find the statistically significant result they want.
Practices like data manipulation and p hacking also exist in public science. This could be attributable to desires to advance careers, publish in higher impact factor journals, and obtain more grant funding. With solutions to these challenges addressed, a model utilizing public researchers for drug development would further strengthen the integrity of the scientific findings. As it stands, pharmaceutical companies typically need two phases III trials to successfully file a new drug application (NDA). Private corporations learn a lot about their molecules during development, straight from basic science all the way through phase I and II trials. This information helps them design better trials to ensure a result is shown, which can be a good thing, or as discussed above also a very harmful practice. Private corporations should be required to have their second phase III trial replicated at a public university rather than at a CRO. Moreover, public universities should be chosen by the FDA, randomly and fairly assigned based on criteria required such as the ability to enroll, mitigating the risk of bribery or subtle corruption via competition to be awarded the work.
Public teams would be tasked with ensuring reasonable parameters are in place for trial design, and results would be immediately published regardless of results. This would create a massive funding addition to public researchers and would create more jobs in academia for those wanting to conduct primarily their own research, not interested in working in the private industry. If a drug is only effective in a subset of the population or dangerous to another subset, this would strongly motivate pharmaceutical companies to relay this information upfront, rather than risk having their entire drug development project derailed by the public team’s findings. It would undoubtedly be a hit to pharmaceutical companies and would reduce the number of drugs that make it to market.
This type of regulatory action would be one of the pharmaceutical industry would heavily protest. I am not against the pharmaceutical industry or drugs to treat specific conditions, I just want transparency. We need to know what works, who it works on, and what is safe. If a drug is dangerous to a certain population or only effective to a fraction of the population a company hopes to market to, this information needs to be known. With one subtle change to the drug development process, results could become far more honest and transparent, while simultaneously assisting in solving the public research funding crisis.
There are many issues plaguing science, from the process required to publish, lost time, costs associated with publication and peer review, exploitation of researchers and corruption, both from private entities and individuals. There are many solutions to these challenges, however, the solutions will more than likely open new challenges and shortcomings. The institution of science and the pursuit of knowledge needs to be considered an evolving model that is constantly learning, not devolving into a private enterprise at the sacrifice of the very goals it purports to accomplish.