New Public Institutions

The following policy, if instituted, will end the destructive pharmaceutical industry practices I detailed in Part 3, accelerate the development of effective and safe medicines, and provide prescription pharmaceuticals to patients for no charge. It will accomplish all this while reducing current government expenditures.

I propose we end the use of drug patents to incentivize R&D and institute a  public funding system for drug discovery and trials.^[1] We will also end the patentability of “discoveries” or knowledge useful to medicine or health. The reduced drug costs resulting from my proposal will create net financial gains for the government more than needed for the public R&D funding increase and for paying 100% of patients’ costs for prescribed drugs.  

Objections to an increased government role in the drug development process may seem justified based on the dysfunction in its role in the past. The dysfunction was obvious in the Covid-19 pandemic and in many other cases I described in Part 3. But the influence of big pharma on government agencies resulted in their dysfunction. My public policy would end the corrupting influence of big pharma companies enabled by the massive resources they extract from society through monopoly pricing power. Without this corrupting influence, the government will be free to act solely in the public interest instead of as a partner in big pharma companies’ profit-maximizing process. And with the system I will detail, it will create immense social benefits.

Despite the destructive influence of big pharma on government agencies, on the whole, the NIH’s role in pharmaceutical development has been hugely positive. As noted earlier, all 210 medicines approved for market from 2010 to 2016 came out of research supported by the NIH, which spent $100 billion during this period; $64 billion helped the development of 84 first-in-class drugs.

To advance our prescription drug development system, I propose we create two institutes within the NIH, one for drug innovation and the other for clinical trials. The drug development division’s Board of Trustees will evaluate funding proposals from academic research organizations for their drug development work . These proposals could include those for their expanded research capacities. The Board will also fund NIH R&D and R&D infrastructure expansions.

Drug companies will be eligible for NIH R&D funding if they share their research findings with the academic community as soon as practical; in other words, if they have environments like academic research institutions. However, their public funding will be limited to supporting research projects they can perform with their existing infrastructure. (Of course, drug companies will be free to develop drugs independent of the publicly funded system.) We will focus public infrastructure improvement funding on multidisciplinary  academic research institutions and the NIH’s 27 Institutes and Centers.

The Board shall be composed of 8 members, including:

1. The director of the Academic Drug Discovery Consortium (ADDC)

The ADDC is a non-profit organization supporting the interactive and growing network of university centers engaged in drug discovery that has emerged in response to recent drug discovery ecosystem changes. As of August 2019, 150 ADDC Center members are in 17 countries. We will include the dozens in the U.S. in this funding system.

2. The Administrator of the Centers for Medicare & Medicaid Services
3. The Commissioner of Food and Drugs
4. The Director of the National Institutes of Health
5. The Director of the Centers for Disease Control and Prevention
6. The Director of the Health Resources and Services Administration
7. The president of the American Medical Association
8. The president of the National Academy of Medicine

Depending on the center, ADDC centers are financially supported in varying degrees by federal and state governments, philanthropy, disease foundations, their university, and pharmaceutical companies, including from the revenues from patent licensing and sales. The companies invest in ADDC members’ R&D to benefit from the resulting knowledge advancements. For ADDC members’ patented technologies, the companies receive advantageous patent licensing or sales pricing. They are then enabled to abuse the transferred knowledge with monopoly pricing power for any resulting drug they market. With the proposed system, this abuse will end along with ADDC member funds sourced from patent licensing and sales and all or most of the funds drug companies provide for academic centers’ R&D in process. According to the system detailed here, these funds will be replaced by government investments directed in the public interest, eliminating the biases introduced by industry influence. Companies can manufacture ADDC members’ created drugs or further develop them without paying any fee.

To assist the Board in carrying out its responsibilities, it will:

• Hold hearings, take testimony, and receive evidence as the Board considers appropriate. Among the hearings’ participants will be representatives of consumer and patient interest groups.
• Establish independent committees on the following:

1. Research and development priorities.
2. Economic evaluation of therapeutic benefits.
3. Financial control and auditing.

The Institute for Clinical Trials will:

• Establish and enforce clinical trial standards. It is particularly important to extend trial durations for drugs intended to be taken long-term.
• Ensure that all trials submit their detailed anonymized trial data monthly to clinicalstrial.gov, and within three months of trial completion, their summary and formal report of results.
• Ensure robust analytical tools are available for trial data.
• Establish and maintain a partnership with the open-source biomedical science journal PLOS (Public Library of Science), the world’s largest multidisciplinary peer-reviewed journal. (In the unlikely event a partnership is not possible, the institute will oversee the NIH’s work on establishing an independent open-source peer-reviewed journal of all research articles.) All peer-reviewed research reports will be accessible for no fee through PLOS and PubMed Central(an existing full-text archive that includes some articles from journals).

Prizes will be part of the funding system, which the Board will award to research organizations based on their success in creating significant advancements in drugs or the tools needed for drug development. These organizations could distribute some of their prize amount to the persons most responsible for the advancement within their research center based on their published guidelines.

The selection process for the research organization recipients of the prizes and the amounts awarded will include consideration of:

• The number of patients who would benefit from the drug, biological product, or manufacturing process involved. In cases of neglected diseases, global infectious diseases, and other global public health priorities, the number of non-United States patients will also be considered.
• The incremental therapeutic benefit of the drug, biological product, or manufacturing process involved as compared to existing drugs, biological products, and manufacturing processes available to treat the same disease or condition.
• The degree to which the drug, biological product, or manufacturing process involved addresses current, emerging, and potential future global infectious diseases (such as those that may be caused by variations of existing corona or flu viruses).^[2]

The prize amounts will be distributed over three years.

Enormous competitive forces to excel exist within academic research institutions and between them, and intrinsic rewards are researchers’ main motivating factors. However, the prize will also be a beneficial motivator, possibly also for some drug companies whose R&D was not initially funded in the system.

In addition to new standards for trial duration will be those for participant numbers and demographics.^[3] One demographic poorly represented in industry-sponsored trials now are people over 65 years old. For example, in NSAID trials, only 2% of participants were 65 years or older, despite this group being most likely to be harmed by the drugs—or because of this, from the profit-maximizing perspective of drug corporation managers.^[4]

The clinicaltrials.gov database, launched in September 2008, is the most comprehensive resource for patients to enlist for future trials. Under my proposed system, all system-funded drug trials will recruit on the site. The Food and Drug Administration Amendments Act of 2007 requires the submission of “basic results” for clinical trials to the site no later than one year after their completion date; however, compliance has been poor.^[5] We will modify the requirement (and enforce it) as described above.

Researchers’ formal reports will undergo a peer review. Those that meet or can be improved to meet PLOS standards with edits for clarity will be included in its comprehensive database of high-quality journal articles. These articles will also be included in PubMed Central. We will include reports not meeting PLOS standards in a separate section of the PubMed database with explanations of their defects.

PLOS is currently funded by article authors, who pay for each published article between $1,595 and $3,000 based on the subject. In 2018, PLOS expenses totaled $38 million and total revenue of $32 million, resulting in a $6 million loss.^[6] We will publicly support the $38 million in expenses and increase support each year in proportion to the number of articles it has peer-reviewed, not published, to avoid incentivizing publishing articles that do not meet the highest standards. In my proposed system, authors will no longer have any expense to publish their articles.

The publication of pharmaceutical research results in the many expensive medical journals now existing limits vital information flow. Under my proposed system, anyone can access research results for no charge from comprehensive databases of PLOS journal articles. And the free article database will help support libraries by eliminating medical journal costs.

Unlike under the current system, clinical trials will always determine the safest and most effective option to treat a disease by comparing the current standard of care (if one exists) with the tested drug that researchers judge may be superior. Currently, clinical trials often compare drugs to placebos, even though a drug treatment standard exists. It is unethical for researchers to give some patients an inert substance while deceiving them it could be beneficial when a treatment exists, as it is to knowingly give them an incorrect comparator drug dosage.

As I noted in Part 3, drug company researchers sometimes intentionally select too high or low a comparator drug dosage for favorable results on the tested drug. So, many drugs are approved for the market despite a superior alternative being available. And placebos in trials are almost always inactive, which biases trial results in favor of the tested drug.^[7] But when the results reveal the tested drug is either ineffective or has side effects severe enough to jeopardize the drug’s approval for the market based on other trial results, drug companies often do not publish the negative results. For example, a study reviewing data on 74 antidepressant drug trials involving 12 drugs found that 94% of the positive studies were published, but just 14% of the negative or uncertain ones were.^[8]

Biased designs of trials and not disclosing those with negative outcomes waste trial participants’ sacrifice to benefit profiteers. And as a result, hundreds of thousands of people have taken dangerous or ineffective drugs. Removing windfall monopoly profits will end all their perverse consequences, including drug trial participants’ abuse.

Trial participants risk their health to benefit humanity. In the current drug development system, managers use them to boost corporate profits and the income and wealth of relatively few people; participants are rarely among them (even more rarely or never are any major owners). If trial participants had a choice, they would make their sacrifice in a system that would not make a tiny percentage of our population rich off people who are ill. But if they want to participate, they don’t have a choice.

Human rights include the rights to be treated with justice, have their wishes considered respectfully and not be exploited. Since the current drug trial process ignores considerations of what is just and fair, disrespects the participants’ desires regarding their sacrifice, and exploits them for drug company profits, it is designed for human rights violations even when a beneficial drug is discovered.

In my proposed drug development system, besides the best-known drug for treating a disease, clinical trials will also include the most promising herbal alternative. For many conditions, dietary and specific nutrient interventions and exercise are therapeutic; where any might be, we will include them in clinical trials as well. Not only will we sometimes discover these interventions to be as good or superior to pharmacological ones, they commonly have beneficial “side effects.” For example, based on a review of the research literature comparing exercise to antidepressants, they were equally effective. So exercise, with only positive side effects, unlike antidepressants, is generally the superior option by far.^[9]

Exercise results in many health benefits. It protects against heart disease and diabetes, improves sleep, and lowers blood pressure. High-intensity exercise releases the body’s feel-good chemicals called endorphins. Low-intensity exercise sustained over time releases proteins that cause nerve cells to grow and make new connections. The improvement in brain function improves mood. In depressed people, neuroscientists have found that the hippocampus in the brain, which helps regulate mood, is smaller. Exercise supports nerve cell growth and connections in the hippocampus, which helps relieve depression. No drug can match all these benefits.^[10]

Studies have shown that lifestyle changes that include a plant-based whole-food diet reverse heart disease.^[11] More studies on the effect of lifestyle on disease reversal and prevention are warranted, as is doctor education on these outcomes. Doctors are now mainly trained in the use of pharmaceuticals or surgery to treat disease. Our healthcare system irrationally and harmfully ignores treatment and prevention options far less costly and more beneficial. Herbal and lifestyle treatments are mostly ignored because they don’t involve the monopoly profits of drug companies.

As I described in Part 3, many patients prefer marijuana over pharmaceutical alternatives, and it is not the only good herbal substitute for pharmaceuticals, which often have serious side effects. Although herbs can be harmful, most reported harm resulted from contaminants, including pharmaceuticals, in the herbal medicines.^[12] Trials that include herbs will reveal some as good as pharmaceuticals or nearly so and that are safer and less expensive.

Herbs have a complex combination of compounds, some of which may act synergistically, enabling them to have superior clinical value to drugs dependent on the action of an isolated molecule. And drugs’ isolated molecules are often derived from plants.

Of the top 150 prescription drugs in the United States, at least 118 are based on natural sources. A child with leukemia in 1960 faced a 10% chance of remission; by 1997, the likelihood of remission increased to 95% thanks to two drugs derived from a wild plant native to Madagascar.^[13] When a good herbal alternative is discovered, its analysis may reveal a component that could be developed into a more effective drug that would otherwise not have been created.

We will select the comparator herb in each drug trial by a vote of ethnobotanists and herbalists teaching at accredited institutions. Of course, they could collaborate before their vote. Prominent examples of institutions with qualified staff for the purpose include the University of California, Berkeley, Medical and Nutritional Ethnobotany department; the University of Arizona, Andrew Weil Center for Integrative Medicine; the University of Illinois at Chicago, Department of Medicinal Chemistry and Pharmacognosy; and the University of Hawaii, Ethnobotany department. Among the tools these herbal medicine experts will likely use to select herbs is the massive phytochemical and ethnobotanical database produced by Dr. James Duke, former Chief of USDA’s Economic Botany Laboratory in the Agricultural Research Service.^[14]

 To produce all covered drugs in the system, we will establish long-term contracts with drug manufacturing facilities organized as domestic non-profit businesses. As noted in Part 3, low manufacturing standards and poor regulatory oversight of overseas production facilities, which are far more difficult for the FDA to inspect, have created a hazardous drug supply. And relying on getting over 80% of our active pharmaceutical ingredients from overseas manufacturers is a significant national security risk.

The pandemic made other reasons clear that relying on profit-maximizing enterprises for our drugs can result in devastating consequences:

During the SARS outbreak in 2002-04, caused by a coronavirus similar to one involved in the Covid-19 pandemic (SARS-CoV-2), several vaccine candidates were identified, but the research petered out when the epidemic died down because drug companies no longer saw prospects for short-term profits. If research had continued, we might have been better prepared to control the related Covid-19 before it became a pandemic.^[15] Also, if research continued in reliable, low-cost home testing methods for coronaviruses to track infections in the community to enable isolating and treating infected people, we could have stopped the widespread infection.

During a pandemic, the world urgently needs to disperse the knowledge and technology to end it. Profit-maximizing patent holders want the opposite; the longer they can exclusively sell their massively profitable ways to prevent and treat a disease, the better. If patents did not exist on the vaccines, and we had systems to facilitate the transfer of relevant knowledge and technology, we could have more effectively controlled the spread of SARS-CoV-2 with better vaccines, and superior treatments would likely also have been available. When knowledge is widely dispersed, advancements in it occur more rapidly. Also, PMPDs’ capture of public health organizations and their media influence suppressed knowledge on effective but inexpensive existing treatments or ways to prevent serious illness from SARS-CoV-2 infection.

An FDA-approved drug for parasitic infections, ivermectin, has robust anti-viral action towards many viruses; dozens of randomized and observational controlled trials have demonstrated this.^[16] This inexpensive drug has proven effective in preventing and treating SARS-CoV-2 infection. The Front Line COVID-19 Critical Care Alliance (FLCCC), a group of highly published, world-renowned critical care physicians and scholars, have accumulated substantial evidence in support of ivermectin’s use in the treating and preventing Covid-19 on their website, https://covid19criticalcare.com/ Despite this evidence and an excellent safety record after four billion doses of ivermectin administered since 1998, the FDA recommended against its use.^[17] Clinical trials that found ivermectin ineffective were designed to fail by administering ivermectin too late in the course of the disease and using too low a dose.^[18]

Besides the clinical trial evidence, substantial epidemiological evidence exists on ivermectin’s effectiveness. All countries that have promoted its widespread use as an early treatment for Covid-19 have seen large drops in Covid deaths and even cases. The most dramatic successes have occurred in India.  A house-to-house test, treat, and prevention program with medicine kits that included ivermectin, vitamin C, zinc, and vitamin D3 in  India’s state, Uttar Pradesh, resulted in the 7-day moving average of the number of cases dropping from 35,000 to near zero.^[19] Uttar Pradesh has a high-density population of 204 million, and only 5% were fully vaccinated.^[20] Since the program involved many factors, ivermectin’s role in their success is uncertain. However, the program’s success and other evidence suggest ivermectin’s role was likely significant.

As noted earlier, Vitamin D deficiency strongly correlates with poor Covid outcomes.^[21] It also makes it more likely to contract the disease.^[22] Oddly, our public health officials did not mention or emphasize this fact. That they didn’t is consistent with some people’s view that an information blackout on inexpensive, effective treatment and preventive measures was intentional to create panic from learning of those getting severe disease to motivate everyone to get vaccinated. This is unlikely; incompetence at the top of our public health system and a kind of groupthink established based on it is the more likely cause of our public health system’s massive pandemic response failure. But if the information blackout were intentional, considering the resulting number of unnecessary deaths, it would be an atrocity of historic proportions. 

If the FDA solely acted on the evidence, it would have given ivermectin emergency-use authorization for Covid-19. Our public health officials only advocated for using highly profitable vaccines for Big Pharma despite their failure to stop Covid transmission. August 2021, Israel had one of the world’s highest vaccination rates with the Pfizer vaccine and had one of the world’s highest daily COVID-19 infection rates.^[23]

Another promising treatment that received too little attention was studied in a randomized controlled clinical trial in Pakistan.^[24] The study found that the combination of honey and nigella sativa seeds (black cumin) significantly hastens recovery, decreases viral shedding, and reduces mortality in patients with both moderate and severe Covid-19 infection. Both honey and Nigella Sativa have anti-viral, anti-microbial, anti-inflammatory, and immune-modulatory effects and are safe.

The policies of the Food and Drug Administration (FDA), the National Institute of Health (NIH), the Center for Disease Control (CDC),  the World Health Organization, and other public health agencies worldwide have been influenced by Big Pharma dedicated to protecting their profits even if it jeopardizes the health and lives of many millions of people. And mass media parrots officials’ statements rather than play their intended investigative and adversarial role, also due to Big Pharma money’s influence. As a result, the pandemic was more widespread and destructive than necessary. The vaccines reduce Covid severity, but this benefit comes with significant risks.^[25] Some studies indicate the world may have been better off without them. Using data from 31 countries one study found all-cause mortality during the first nine months of 2022 increased more the higher the 2021 vaccination uptake.^[26] The near-exclusive focus on the novel and inadequately tested vaccines by top public health officials in response to the pandemic was inappropriate.

In the United States, Big Pharma’s capture of our regulatory agencies, public health system, and mass media has resulted in 18.52% of the world’s Covid-19 cases and 15.02% of the deaths though we have only 4.3% of the world’s population. The pandemic provided another alarming demonstration that we must radically reform our pharmaceutical industry.

[1] The Value of Everything: Making and Taking in the Global Economy, Mazzucato, M., 2018, pg. 204

[2] Some Board members and prize criteria in my lists come from Medical Innovation Prize Fund Act, S.495

115th Congress (2017-2018) Sponsor: Sen. Sanders, Bernard [I-VT] (Introduced 03/02/2017)

[3] For details on why we need new standards see Deadly Medicines and Organized Crime, Peter Gotzsche, pg. 270

[4] Deadly Medicines and Organized Crime, Peter Gotzsche, pg. 269

[5] https://www.bmj.com/content/344/bmj.d7373

[6] https://www.plos.org/financial-overview

[7] https://www.clinicaltherapeutics.com/article/S0149-2918(17)30116-9/fulltext

[8] https://www.nytimes.com/2008/01/18/health/18iht-17depress.9318417.html

[9] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5430071/

[10] https://www.health.harvard.edu/mind-and-mood/exercise-is-an-all-natural-treatment-to-fight-depression

[11] https://pubmed.ncbi.nlm.nih.gov/9863851/

[12] https://www.technology.org/2018/10/26/herbal-medicine-may-be-causing-more-deaths-than-we-know/   

[13] https://www.biologicaldiversity.org/publications/papers/Medicinal_Plants_042008_lores.pdf

[14] https://data.nal.usda.gov/dataset/dr-dukes-phytochemical-and-ethnobotanical-databases

[15] https://www.immunology.org/sites/default/files/BSI_Celebrate_vaccines_report_2020_FINAL_0.pdf

[16] https://covid19criticalcare.com/wp-content/uploads/2021/08/SUMMARY-OF-THE-EVIDENCE-BASE-FINAL.pdf

https://www.wsj.com/articles/fda-ivermectin-covid-19-coronavirus-masks-anti-science-11627482393

[17] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8088823/

[18] https://covid19criticalcare.com/wp-content/uploads/2022/03/Statement-on-Together-Trial-WSJ-Article-Mar-18-1.pdf

[19] https://covid19criticalcare.com/ivermectin-in-covid-19/epidemiologic-analyses-on-covid19-and-ivermectin/

[20] https://www.thedesertreview.com/opinion/columnists/indias-ivermectin-blackout—part-v-the-secret-revealed/article_9a37d9a8-1fb2-11ec-a94b-47343582647b.html

[21] https://pubmed.ncbi.nlm.nih.gov/34684596/

[22] https://pubmed.ncbi.nlm.nih.gov/33512007/

[23] https://www.businessinsider.com/israels-covid-19-infection-rate-is-rising-despite-vaccine-uptake-2021-8

[24] Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multi-center placebo-controlled randomized clinical trial

[25] https://assets-global.website-files.com/606d3dece4ec3c3866cc798a/60a5ff1fd9f50f42f696aec6_23%20Fifty%20Seven%20Top%20Scientists%20and%20Doctors.pdf

[26] https://www.researchgate.net/publication/369204376_Is_There_a_Link_between_the_2021_COVID-19_Vaccination_Uptake_in_Europe_and_2022_Excess_All-Cause_Mortality