No More Tears: The Dark Secrets of Johnson & Johnson

The Food and Drug Administration (FDA) is the federal agency responsible for overseeing food and product safety, including the safety of cosmetics, medications, and medical devices. In 1937, 73 people died from ingesting diethylene glycol found in a “patent medicine” called Elixir Sulfanilamide. In 1938, Congress passed the Food, Drug, and Cosmetics Act which gave the FDA the power to assess the safety of drugs for approval.

Gardiner Harris is highly critical of the FDA’s inability to effectively oversee and regulate the medical industry throughout No More Tears. Harris identifies how the FDA has been compromised by close connections with the medical industry, a process known as “regulatory capture.” For instance, he notes that as of 1992, the FDA is funded largely by industry contributions. As a result, Gardiner argues, the FDA is reluctant to intervene aggressively against medical companies when they act illegally or unethically. Further, FDA commissioners often come from the medical industry and/or go on to work in businesses connected to the medical industries. For example, he notes that Dr. Mark McClellan is a former FDA commissioner who “has served on J&J’s board of directors since 2013” (251). He also focuses on how the FDA lacks the resources, personnel, and statutory power to effectively perform its oversight role. For instance, the 510(k) loophole allows medical device companies to take new products to market without human trials as long as it is not “substantially” different from existing products on the market.

Although he focuses on criticizing the agency, Harris also notes instances where FDA intervention led to changes like dangerous products being taken off the market. For examples, he describes how FDA investigations into the dangers of vaginal mesh likely led to many of those products being taken off the market. However, he does emphasize that these interventions are too slow and often insufficient, resulting in millions of “preventable deaths” and injuries.

Medicaid and Medicare are the public health provisions in the United States. Medicaid is government-funded health insurance for very low-income people with significant health needs. Medicaid is a joint federal and state program which is administered by state and local agencies. This means that state Medicaid directors and state governments more generally have significant leeway in how they administer the program. Gardiner Harris argues Johnson & Johnson exploited this structure to lobby state Medicaid directors and governments to expand the market for the antipsychotic medication Risperdal.

Medicare is government-funded health insurance for older people or people with disabilities. This federal program is effectively the only tool the federal government has to regulate the prices of health care provision, as the Medicare program has a statutory ability to set prices for medications and services. Harris describes how Johnson & Johnson effectively committed Medicare fraud by providing its synthetic EPO to Medicare providers at low or no cost, then directing providers to claim reimbursement for the free Procrit at full market rates. This reimbursement was then shared with J&J.

Alex Gorsky is the former CEO of Johnson & Johnson. Harris focuses on Gorsky’s tenure at the company and how he oversaw some of the worst elements of the scandals covered in No More Tears. Harris contrasts Gorsky’s all-American, “tough,” “ethical” public persona with his actions while an executive for Johnson & Johnson. Gorsky is effectively the “villain” of Harris’s narrative.

Alex Gorsky first joined Johnson & Johnson as a sales representative for Janssen Pharmaceuticals in 1988 after leaving the Army. He then worked his way up to an executive position in the company. As an executive, he oversaw the “Sell the Symptoms” marketing strategy for Risperdal, which led to its excess prescription for the elderly and children. Harris reports that Gorsky was the J&J executive “most responsible for turning Risperdal into a blockbuster” (168). When the extent of Risperdal’s side effects and role in excess deaths became publicly known, Gorsky briefly left the company, only to return four years later.

Gorsky was appointed CEO in 2012. During his tenure Johnson & Johnson made billions in profits and grew as a company. Harris focuses on Gorsky’s role in a series of cascading scandals, including the attempt to mitigate the company’s liability in the asbestos-contaminated baby powder scandal by declaring bankruptcy, the failure of the Johnson & Johnson Covid vaccine, and his interventions at the FDA to protect the faulty and dangerous metal-on-metal hip replacement, Pinnacle, and vaginal mesh products.

Gorsky is portrayed as the quintessential corporate executive who pursues profit at all cost while burnishing his positive public image. This is well-illustrated in Harris’s account of Gorsky’s first shareholders’ meeting as chief executive in 2012, when Gorsky emphasized that “the credo [to never put profits before people] is so relevant and essential to who we are” (224); Harris counterposes this scene with a note that Gorsky was deposed three weeks later for his role in the Risperdal scandal. Gorsky’s close association with the government is likewise illustrated vividly in his appearance with President Joe Biden announcing the launch of the Johnson & Johnson Covid vaccine. As Harris writes, “J&J just might save the world, and Biden wanted to be sure he was close by Gorsky’s side when it did” (313).