A Calculation of the Relative Risk of Pharmaceuticals Versus Nutrition Supplements

Last Updated on December 30, 2021 by Shaun Snapp

Executive Summary

  • Health authorities point to the risks of nutrition supplements, without calculating the relative risk versus pharmaceuticals.
  • We perform this calculation in this article.

Introduction

This article performs a calculation to compare the relative risk of pharmaceuticals to nutrition supplements.

Our References for This Article

If you want to see our references for this article and related Brightwork articles, visit this link.

Comparison #1: Comparing All Supplements to Just Vioxx

If we take just the drug Vioxx, it will take a nearly infinite number of years for health supplements to match the death toll…

Actually, this is a complete guess, as the American Cancer Society did not state the death toll from heath supplements every year.

…of Vioxx by itself. 

Comparison #2: Comparing Tylenol to Supplements

Even Tylenol, which is not a prescription drug, records close to 500 deaths per year, as is explained in the following quotation.

Analysis of national mortality files shows about 450 deaths occur each year from Acetaminophen-associated overdoses; 100 of these are unintentional. Analysis of national databases also show that Acetaminophen-related overdoses account for about 50,000 emergency room visits and 25,000 hospitalizations yearly. – Addiction Center

I can barely find any mortalities from supplements, yet in a single year Tylenol (Acetaminophen) accumulates 450.

Furthermore, Tylenol complications, which again is not prescribed medication, have as nearly as many ER visits and more many times as many hospitalizations as all nutrition supplements.

However, there is no similar set of warnings about Tylenol on the websites of the health authorities. 

How the Drug Companies Continually Get Dangerous Drugs Approved

The following quotes from the article Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs paint a picture that is mostly hidden from the public.

CopyCat Drugs Clogging Up the FDA Approval Pipeline

Second, largely as a result of industry pressure, Congress has underfunded FDA enforcement capacities since 1906, and turning to industry-paid “user fees” since 1992 has biased funding to limit the FDA’s ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages. Finally, industry has commercialized the role of physicians and undermined their position as independent, trusted advisers to patients.

Institutional corruption consists of distortions of these responsibilities, such as approving drugs that are mostly little better than existing medications, failing to ensure sufficient testing for serious risks, and inadequately guarding the public from harmful side effects. These distortions serve commercial interests well and public health poorly.

The industry measures “innovation” in terms of new molecular entities (NMEs), but most NMEs provide at best minor clinical advantages over existing ones and may lawfully be approved by the FDA even if they are inferior to previously approved drugs. The preponderance of drugs without significant therapeutic gain dates back at least 35 years.

From the mid- 1970s through the mid-1990s, multiple assessments have found that only 11 to 15.6 percent of NMEs provide an important therapeutic gain.

Millions of patients benefit from the one out of six drugs that are therapeutically significant advances; but most R&D dollars are devoted to developing molecularly different but therapeutically similar drugs, which tends to involve less risk and cost for manufacturers. These drugs are then sold through competition based on brand name, patent status, and newness, rather than on their therapeutic merits.

Patenting Non Innovative Drugs

An analysis of data from the National Science Foundation by Donald Light and Joel Lexchin indicates that patent- based pharmaceutical companies — often deemed by Congress, the press, the public, and themselves to be “innovative” — in fact devote only 1.3 percent of revenues, net of taxpayer subsidies, to discovering new molecules.15 The 25 percent of revenues spent on promotion is about 19 times more than the amount spent on discovering new molecules.16 In short, the term “R&D” as used by industry primarily means “development” of variations rather than the path-breaking “research” that onlookers might like to imagine.

The number of products put into trials has actually increased as the number of clinically superior drugs has decreased.21 These facts provide evidence that companies are using patents and other protections from market competition primarily to develop drugs with few if any new therapeutic benefits and to charge inflated prices protected by their strong IP rights.

Companies claim that R&D costs are “unsustainable.” But over the past 15 years, revenues have increased six times faster than has investment in R&D

The FDA’s Approval of Higher Risk Drugs

Most new drugs approved and promoted since the 1970s lack additional clinical advantages over existing drugs and — as with all drugs — they have been accompanied by harmful side effects. A systematic review of the 39 methodologically strongest studies performed in the U.S. between 1964 and 1995 examined patients who were hospitalized due to a serious adverse drug reaction (ADR) or who experienced an ADR while in the hospital.

The public health impacts are even greater when milder adverse reactions are taken into account. Given estimates that about 30 ADRs occur for every one that leads to hospitalization, about 81 million side effects are currently experienced every year by the 170 million Americans who use pharmaceuticals.

The FDA’s Approval of Low Benefit Drugs

In his review of new pharmaceutical products in the 1940s and 1950s, Dr. Henry Dowling, an AMA senior officer and expert, found that companies launched 200-400 a year but only three on average were clinically useful.38 Physicians, swamped with far more drugs than they could know much about, relied on sales reps to brief them, entertain them, and leave an ample supply of free samples as gifts that the physicians could then give to their patients — a two-stage economy of reciprocation.39 In effect, through political pressure and lobbying, companies minimized the role of the FDA as the protector of public health for its first 56 years.

First, three criteria used by the FDA contribute to the large number of new drugs approved with few therapeutic advantages. New drugs are often tested against placebos rather than against established effective treatments, and the use of surrogate or substitute end points, rather than actual effects on patients’ health.

The Rigged Trial to Journal Pipeline

Third, companies have created what can be characterized as the trial-journal pipeline because companies treat trials and journals as marketing vehicles. They design trials to produce results that support the marketing profile for a drug and then hire “publication planning” teams of editors, statisticians, and writers to craft journal articles favorable to the sponsor’s drug.48 Articles that present the conclusions of commercially funded clinical trials are at least 2.5 times more likely to favor the sponsor’s drug than are the conclusions in articles discussing non-commercially funded clinical trials.49 Yet, journal approval is deemed to certify what constitutes medical knowledge. Published papers legitimate the pharmaceutical products emerging from the R&D pipeline and provide the key marketing materials.

Furthermore, companies are much less likely to publish negative results, and they have threatened researchers who break the code of secrecy and confidentiality about those results.50 Positive results are sometimes published twice — or even more often — under different guises. This further biases meta-analyses — a method of statistically combining the results of multiple studies — and clinical guidelines used for prescribing. The result is “a massive distortion of the clinical evidence.”

The Problem With User Fees for the FDA

In 1992, after years of underfunding and cuts in the 1980s that contributed to drug review times ballooning from 6 to 30 months, Congress passed the Prescription Drug User Fee Act (PDUFA), authorizing the FDA to collect “user fees” from drug companies that would allow it to hire 600 more reviewers and thereby speed up drug review.52 Supporters claimed that fees would increase incentives for innovation and improve health; but aside from clearing the backlog of NMEs waiting for approval, industry fees have not increased innovation as measured by clinically superior drugs. In return for paying user fees, companies required the FDA to guarantee that it would review priority applications within six months and standard applications within 12 months of submission. Shortened review times led to substantial increases in serious harms. An in-depth analysis found that each 10-month reduction in review time — which could take up to 30 months — resulted in an 18.1-percent increase in serious adverse reactions, a 10.9-percent increase in hospitalizations, and a 7.2-percent increase in deaths.54 Now, 20 years later, what Carpenter calls “corrosive capture” has set in — a weakened application of regulatory tools and a cultural capture of rhetoric about saving lives by getting new drugs to patients more quickly.

For the FDA, the reduction in review time combined with the fear that missing review deadlines will jeopardize continued PDUFA funding has also led to an increase in “up against the wall” approvals as review deadlines approach. Carpenter and his colleagues found that “the probability of a drug approved in the two months before the deadline receiving a new black-box warning (the most serious safety warning that the FDA can issue) is 3.27 times greater than a drug approved at some other time” and the likelihood of a drug being withdrawn from the market because of serious adverse events is 6.92 times greater.

Large and growing user fees, with a sunset expiration every five years and a threat of nonrenewal that would severely cripple the FDA, have intensified the classic principal-agent conflict.66 Marcia Angell, former editor-in-chief of the New England Journal of Medicine, observed that, “[i]n effect, the user fee act put the FDA on the payroll of the industry it regulates [and]…has drastically changed the way it operates.”

A Decline in Vigilance and Unwillingness to Move Forward on Claims

A 15-month investigation by the Committee on Government Reform of the U.S. House of Representatives found “a growing laxity in FDA’s surveillance and enforcement procedures, a dangerous decline in regulatory vigilance, and an obvious unwillingness to move forward even on claims from its own field offices.”76 The resulting 2006 report also documented a 53.7-percent decline in warning letters. Since then, FDA leadership has shifted to talking about being a “partner” with industry to get more drugs to patients more quickly. For the reasons we explained above, the proportion of new products with clinical advantages seems to have moved from about 1 in 8 down to 1 in 12, while the proportion with serious harms has gone up from 1 in 5 towards 1 in 3 as the number of drugs given priority status increases.

Things the FDA Needs To Do

First, while research companies play important roles in discovering and developing superior drugs, they should play no role in testing them.77 Over the years, expert bodies and prominent scientists have called for an independent institute to test drugs because commercial trials were so poor, biased, and conflicted.78 Yet this bedrock reform has never been accomplished, as the industry’s lobbying of Congress and its contributions to Congressional campaigns have soared.79

Second, the FDA needs new leadership to restore public trust and build a new culture focused on safety through enforcement of its existing rules. Hearings through the 1960s and 1970s documented how frequently the FDA fails to adhere to its own rules and protocols.80

Third, user fees must end, and the FDA must be entirely funded by taxpayers-as-consumers. The FDA should be entirely clear about whom it serves.

Fourth, while approval criteria should allow for a sufficient number of therapeutically equivalent drugs in a class to give clinicians a range of choices,81 they should also require patient-relevant evidence of superiority. Limiting the number of drugs in the same therapeutic class worked successfully in Norway but was stopped when Norway harmonized its regulatory requirements with those of the European Union in 1995.82 Non-inferiority trials should be allowed only if one can ethically justify entering patients into a trial in which there can be no benefit for them.83 All adverse events, including those occurring among subjects who drop out, must be reported with follow-up for two years.

Fifth, Congress needs to restore trust by creating a National Drug Safety Board with adequate powers, funds, and mandates to independently investigate and report on drug safety issues. The creation of this board would support the position that all data related to how drugs and vaccines affect people are a public good and that access to this data is a human right. Both the inadequacy of pre-approval safety testing and the lack of systematic post-approval monitoring need urgent attention.84 None of this is likely to happen until third-party payers, politicians, and the people decide they want to stop paying so much for so many drugs of little value and then for treating the millions harmed by those drugs. Nor is it likely until the campaign to restore institutional integrity to Congress through funding elections by the 99 percent, rather than by the one percent, is successful.85

How can the FDA be taken seriously when one learns how they actually function?

Conclusion

The comparative risk of nutrition supplements versus pharmaceuticals is so extreme, that it makes one question either the financial bias, math skills, or sanity of entities that are part of the medical establishment that spend are more time warning of the dangers of nutrient supplements and close to no time warning of the dangers of pharmaceuticals. I cover in the article The Medical Establishment Resents People Checking Covid Adverse Reactions in VAERS, that the medical establishment, and their media pawns, like Science.org, opposed people informing themselves on the adverse reactions from pharmaceuticals.