Financial Conflicts of Interest in Health Research at the NIH

We've talked about the FDA revolving door with pharmaceutical companies, and how the agency has been completely organized around for-profit pharamceutical approval, leading to little to no research being done on natural herbs and other treatment options that aren't patentable. Thus, the issue is much larger than any one agency. If the FDA can be captured, any other agency could be as well, and the bigger problem seems to be how power struggles within committees that develop clinical guidelines often result in bias, favoring the interests of corporate sponsors over credible evidence.

Typically, pharmaceutical companies take the reins in planning, running, and reporting clinical trials, calling in reinforcements from external partners when extra muscle is required. Research sponsorship takes a backseat to financial gain. CROs receive a whopping 70-75% of clinical trial funding, leaving independent researchers with limited grant opportunities and little control over the studies they lead. Industry-sponsored trials can be misleading, making it seem like academics or other independent actors are in charge. But scratch beneath the surface, and you'll often find CROs running the show for pharmaceutical companies, with company statisticians quietly working behind the scenes to make sense of the data. By picking and choosing the right components, companies can practically guarantee the outcome of their studies. This includes selecting surrogate endpoints, trial lengths, and participant demographics that stack the deck in their favor.

At the end of the day, most published articles are outright creations of the companies, with academic or independent researchers merely lending their names to the effort. Behind the scenes, there's a subtle supervision of medical research that goes unnoticed. The PR machinery of pharmaceutical companies is a well-oiled beast. No wonder their trials get so much more attention than those led by individual researchers, who often struggle to get the word out. Thousands of influential experts are paid by these companies to give presentations to doctors, using pre-crafted slide decks to discuss the latest medical research findings.

 

Developing new drugs is lengthy and costly, requiring substantial R&D investment. This includes lab research, clinical trials, regulatory approvals, and marketing. The biggest pharmaceutical companies exemplify this. Their R&D spending is a significant portion of their budgets. A 2018 study indicated developing a single new drug costs $78 to $133 per patient annually. Pharmaceutical companies claim high drug prices reflect this investment in innovation, but various discrepancies would suggest otherwise. 

The Role of Patents and Market Exclusivity

Patents give pharmaceutical companies exclusive rights to sell a new drug. This period typically lasts 20 years from the filing date. This exclusivity lets companies recoup R&D investments and generate profits before generics enter the market. Some drug companies extend market exclusivity through practices like "evergreening". Evergreening involves minor medication modifications to extend patents. For example, slight formulation tweaks or adding external attributes. Even something minor like a stripe on a pill can renew patent exclusivity.

Marketing and advertising educate healthcare providers and consumers about new drugs. These expenses significantly impact a medicine's overall cost. Direct-to-consumer advertising grew by almost 70% in the early 2000s, according to American Progress. Some consider these advertisements educational. Others believe they raise illness awareness and prompt patient requests for specific treatments. Regardless, pharmaceutical marketing is pervasive. Many other countries are starting to adopt these controversial marketing practices.

Rising prescription drug costs significantly impact healthcare spending and public health. Americans have the highest per capita pharmaceutical spending globally, according to a 2019 report. Big pharma's high profits warrant examination, especially given potential conflicts of interest with taxpayer-funded research.

Public opinion is key to balancing industry competitiveness and innovation with affordable medication access. The government and the private sector often fund early-stage drug research. However, the biggest pharmaceutical companies subsequently earn enormous profits. 

Exorbitant Prices and Profits: Moral Implications

In 2015, Martin Shkreli dramatically increased the price of Daraprim, a life-saving drug. The price jumped from $13 to $750 per tablet, sparking public outrage. This act highlighted the ethical considerations of pharmaceutical pricing.

Pharmaceutical companies need profitability and investor returns to fund high-risk ventures. However, focusing solely on high-profit drugs can neglect other critical health needs. Many neglected tropical diseases lack effective treatments. This is often because developing drugs for these conditions isn’t as profitable as treatments for chronic conditions in wealthy markets. Research and development are expensive, costing billions and taking many years. However, publicly-funded institutions often contribute millions. This raises concerns as companies may generate high profits (near 20% over two years) while reinvesting only a fraction of the public funds received.

Factor	Description	Impact on Big Pharma
Taxpayer-Subsidized Research	Government research funding benefiting pharmaceutical companies.	Reduces company R&D costs, potentially boosting profits.
Tax Incentives	Tax breaks and credits for pharmaceutical companies.	Lower corporate tax burdens result in higher annual profits.
Drug Company Patents and Market Exclusivity	Legal protections allowing premium pricing.	Higher drug costs and limited competition to increase profits.
R&D Expense	High new drug development costs.	Justifies high drug prices but also lowers profit margins.

 

Reports reveal a close relationship between Big Pharma and Congress, potentially benefiting special interests through lobbyist donations.

Political Influence on Drug Companies: Are Big Pharma's profits influencing policy?

Healthcare policy leaders and elected officials often oppose federal negotiation of prescription drug prices. Sources like BBC Sounds offer diverse perspectives. Past campaign contributions from industry officials have fostered relationships that may influence policy decisions, blocking attempts to limit medicine price increases. Some policymakers propose banning contributions tied to committees overseeing pharmaceutical policies.

Proposed Solutions and Future Directions

Drug manufacturers benefit significantly from government support. This includes R&D subsidies, tax write-offs, and publicly funded healthcare systems that finance their innovation. Often, this lacks cost caps, potentially leading to unregulated pricing. While new drugs generate substantial revenue, affordable pricing and societal benefit should be prioritized, like with Insulin.

Since 2002, insulin prices have quadrupled despite decreasing manufacturing costs. Some estimates indicate drug pricing costs in single digits versus retail prices in the hundreds. This enormous price difference for a life-sustaining medication raises concerns. Experts worry that even during health emergencies, patent and government monopoly powers may prevent access to affordable medicine, leading to price gouging.

Exponentially higher costs for drugs in the U.S. compared to other nations, has made big pharma profits an even more contentious issue, drawing public and regulatory scrutiny. Prescription medication development often relies heavily on taxpayer dollars. Finding a balance between fostering innovation and ensuring affordable treatment options is crucial. This balance prevents patients from foregoing needed medications due to cost. But is the innovation created through R&D investment even helping the public, or mostly private, often foreign multinational, companies?

Financial Conflicts of Interest in Health Research

The preferential treatment given to drug companies by the FDA is no surprise, but even in NIH research, conflicts of interest abound and it appears that the agency has been captured by chemical companies wanting exclusive control over health policy. Since 2012, federally-funded health researchers have reported over 8,000 "significant" financial conflicts of interest worth at least $188 million, according to filings in a government database obtained by ProPublica. However, the total is likely much larger. The database, which has not been made public before, details the financial relationships of researchers at universities, hospitals, and nonprofit organizations. These outside interests include:

• Stock holdings in companies that may benefit from the outcome of research
• Payments for royalties, consulting work, and speaking engagements

The total value of the conflicts is likely much higher than $188 million, as 44% of the disclosures did not place a dollar value on the investigator's financial relationship. The NIH requires disclosures of "significant" financial conflicts — because outside income from interested parties can potentially affect researchers' objectivity and influence the design and findings of their taxpayer-subsidized work. Even though the NIH collects the filings in a central database, the agency does not post the information online and has not released the database to an outside party before. ProPublica is providing public access to the data through its Dollars for Profs lookup tool.

"This is critically important," said Lisa Bero, a University of Sydney professor who studies the impact of corporate interests on health care research. "Many people over the years have been calling for it. We need this kind of data available."

Types of Financial Relationships

Most of the financial relationships with a value of $600,000 or more resulted from researchers taking equity stakes in, or licensing patents and copyrights to, drug and biotech companies. These companies range from small, private startups to large pharmaceutical concerns such as Bristol-Myers Squibb, Eli Lilly and Co., and Novartis. Most of the researchers who reported conflicts of interest work in academia. The top three institutions with the most conflict disclosures are:

• University of Wisconsin-Madison (1,015 disclosures)
• University of North Carolina at Chapel Hill (358 disclosures)
• University of California, Los Angeles (294 disclosures)

The U.S. Department of Health and Human Services inspector general reported last year that the value of NIH grants associated with such conflicts was $1 billion in fiscal 2018. In total, about 3,000 researchers accounted for the 8,101 significant conflicts disclosed to the NIH. The dataset includes some of the best-known names in medical research.

As published in the National Academies of Sciences Health and Medicine Division:

• Approximately $455 billion of the $7.35 trillion spent on health care annually worldwide is lost each year to fraud and corruption. 
• 45 percent of global citizens believe the health sector is corrupt or very corrupt.
• Globally, 1.6 percent of annual deaths in children under 5—more than 140,000 deaths—can be explained in part by corruption.
• Chronic government underfunding, insufficient regulatory oversight, and lack of transparency in governance can breed corruption and reduce the quality of health care.

Is Change Coming to the NIH?

At the EarthX environmentalist conference in Dallas, Robert F. Kennedy Jr. was asked about the alarming issue of cancer-causing chemicals in Texas drinking water. Specifically, the reporter inquired about glyphosate, a herbicide in RoundUp that has led to multi-billion-dollar class actions against its manufacturer. When asked about his plan to keep Texas waters clean of carcinogenic chemicals as HHS head, Kennedy emphasized the need for significant reform at health agencies, particularly the National Institute of Health (NIH).

"The NIH, because it is captured by the chemical industry, does not do the kind of studies [and] does not require the kind of studies that need to be done to determine the safety of these products –– and because of that, the manufacturers get to keep poisoning people and animals, etc., without any consequences."

Kennedy proposes a crucial shift in NIH's priorities to address this issue. He plans to:

• Conduct thorough studies to determine the safety of products
• Empower lawyers to litigate against chemical companies
• Allow the market to shut down harmful chemicals quickly

"I am going to shift NIH's priorities to do those studies," he assured. "I cannot tell you that we are going to ban every bad chemical, but I can put enough science out there that the lawyers can now litigate against the chemical company and let the market shut down that chemical very quickly...We need to revamp our health agencies, with the NIH taking the lead in the fight against cancer-causing chemicals."

 

Sources

https://www.ncbi.nlm.nih.gov/sites/books/NBK535646/