The poster child for corporate crime

While RFK Jr. peddles false claims about vaccine safety, an eye-opening new book reveals the real culprits behind unsafe medical products.

No More Tears: the dark secrets of Johnson & Johnson

By Gardiner Harris

Random House, 444 pp., $32

Critics of the pharmaceutical industry can be divided into two camps: Those angry and financially harmed by outrageously high prices; and those angry and physically harmed by horrific safety lapses. Over the course of the 20^th century, the political system has occasionally responded to the concerns of the safety advocates. Those hoping to harpoon the white whale of drug company pricing power have less to show for their efforts.

Congress created the modern Food and Drug Administration in 1938 after the sulfanilamide disaster, where a Tennessee company used a sweet-tasting antifreeze in a children’s formulation of the first antibiotic. The tragic deaths of more than 100 children later, Congress passed a law requiring all new drugs undergo safety testing before entering the market.

In the late 1950s, the Sen. Estes Kefauver held numerous hearings lambasting the high prices charged by “the antibiotic cartel.” Congress failed to act. But in 1962, an eagle-eyed FDA scientist named Frances O. Kelsey prevented thalidomide from being widely distributed in the U.S. after noticing tens of thousands of European newborns had serious birth defects because their expectant mothers had taken the drug for morning sickness.

The ensuing uproar forced Congress to enact legislation requiring all drugs be tested for efficacy before entering the market. Since then, those two questions – Is it safe? Is it effective? – have been the sole focus of the FDA’s decision-making process when weighing approval of new drugs. In 1976, Congress gave the agency similar authority to regulate the approval and marketing of new medical devices, from high-tech imaging equipment to hip and knee implants to surgical tools.

While the agency has been given limited power to police marketing of drugs and devices, pricing remains outside its purview. So has pricing’s first cousin, comparative effectiveness. FDA reviewers have all the information they need to determine whether a new drug for a particular disease or condition is the same, better or worse in terms of efficacy, side effects and potential patient harm compared to other drugs for the same condition already on the market. But it has never been given the authority to analyze that data or publish the results, which would provide much-needed guidance to physicians and patients as well as a powerful tool for public and private payers hoping to drive down prices.

Despite these limitations, domestic press accounts routinely refer to the FDA as “the gold standard” of global regulatory agencies, a reputation based solely on its acumen in evaluating new products. Despite the FDA’s single-minded focus on safety and efficacy, and this stellar reputation, this century has witnessed some of the worst drug safety disasters in U.S. history.

In 2004, Merck, which was frequently rated as the most admired corporation in America, withdrew the pain reliever Vioxx from the market after an estimated 40,000 people died from heart attacks and strokes. The Titanic of drug disasters, the opioid epidemic, to date has caused an estimated 750,000 overdose deaths, most from the illegal use of FDA-approved products that contain the powerful opioids fentanyl, oxycodone and tramadol.

The roots of the opioid disaster

The company most closely associated with this public health fiasco is Purdue Pharma. Over several decades, the FDA repeatedly failed to control its aggressive and illegal marketing tactics. It took public protests and thousands of lawsuits filed by devastated families, backed by state and local governments, to bankrupt the company and make its majority owners – the Sackler family – a household epithet in every corner of America.

But there is a hidden but equally culpable villain in this ongoing drama. The company is a household name with well-regarded brands. Like Merck before its downfall, it is ranked among the most respected companies in America. Yet no company has been less deserving of that honor, veteran reporter Gardiner Harris writes in his scathing new book, “No More Tears: the dark secrets of Johnson & Johnson,” published earlier this month by Random House.

J&J is a New Jersey-based conglomerate that produces everything from baby shampoo to surgical robots. It has long been associated with combatting pain. Tylenol (acetaminophen) is one of its best-selling over-the-counter medicines. In the early 1990s, the company’s drug division began marketing a fentanyl-laced, time-released skin patch called Duragesic to cancer patients. This was four years before Purdue entered the market. J&J made as much money from those skin patches as Purdue made on its oxycodone pills. Both products were equally prone to abuse. Both products have been widely abused.

J&J was the first company to promote the widespread use of opioids to treat pain. It began in the 1980s when it added codeine (an opioid) to acetaminophen to create Extra Strength Tylenol. When used in young children, the capsules slowed breathing, damaged livers and posed a serious risk of death. Dozens of children died after being overdosed by parents confused by the frequently changed formulations.

In the early 1990s, J&J provided the initial financial backing for launching the American Pain Society, a physician group that promoted the use of opioids to treat chronic pain. The group shut down in 2019 in the face of numerous lawsuits and a Senate report calling it a “cheerleader for opioids.” J&J also provided generous funding to physicians belonging to the American Academy of Pain Medicine, whose studies touted the beneficial uses of opioids.

Together, the two groups produced a joint statement entitled “The Use of Opioids in the Treatment of Chronic Pain,” which came out in 1996. Andrew Kolodny, one of the nation’s top experts on the opioid epidemic, tells Harris it was “one of the single most damaging documents … (in) the history of the opioid crisis.”

In 2001, J&J bought the small company that produced its fentanyl patch for over $10 billion in stock, considered at the time one of the largest acquisitions in drug industry history. By mid-decade, Duragesic was generating $2.4 billion a year in sales for J&J, nearly equal to the $3 billion being racked up annually by Purdue Pharma’s Oxycontin. Both drugs – one a patch; the other a pill – were designed to release their doses over time. Both were easily swallowed or crushed by addicts looking for an ever more powerful fix.

Even after three of Purdue Pharma’s top executives pleaded guilty in 2007 to misleading regulators, doctors and patients about Oxycontin’s risks, J&J introduced a new time-release opioid pill called Nucynta. The company continued to use the same marketing talking points – it was less prone to abuse – that it and Pursue had used to promote Duragesic and Oxycontin. The company continued selling Nucynta until 2020 despite repeated warnings from the FDA that the drugs were addicting and easily abused.

“Fifteen years into one of the worst public health disasters in American history, and J&J was aggressively pushing a marketing plan for a new opioid with all of the same elements that had started and accelerated the epidemic in the first place,” Harris writes near the end of his chapters on Duragesic and Nucynta. “Company executives knew exactly how deadly their actions were, but they went on with them anyway because they also knew just how profitable they might be.”

It’s not just opioids

J&J’s central role in the iatrogenic opioid epidemic is just one of many shocking revelations in this masterwork of investigative research and reporting. Harris, who covered the drug industry for the Wall Street Journal and the New York Times, spent five years delving into the voluminous court cases lodged against J&J over the past two decades, including transcripts from secret grand jury proceedings that he managed to obtain.

He covers nine J&J products from each of its four major divisions: consumer products, over-the-counter medications, drugs and devices. They range from its asbestos-ridden baby powder to a cancer-spreading anti-anemia drug to an infection-promoting hip transplant to a sex-life destroying vaginal mesh. Each eventually proved dangerous, fatal or both to thousands of patients.

Harris introduces the book by recounting how J&J built its stellar reputation through its response in 1982 Tylenol murders, where at least seven people died after someone inserted cyanide into capsules sold in Chicago area stores. J&J quickly issued a recall of every bottle on store shelves and replaced them with tamper-proof seals at a cost of $100 million, a significant sum in those days. The Harvard Business School uses J&J’s response to the terrorizing incident as a case study for teaching budding executives how doing the right thing and doing well financially go hand in hand.

But in his dissection of the event, Harris reports how J&J knew prior to the murders that its over-the-counter medication packaging was unsafe because it had already received hundreds of complaints about contamination. It was considering tamper-proof packaging when disaster struck, enabling the company to move quickly. The company also covered up evidence that the likely perpetrator worked for a local subcontractor whose employees lined grocers’ and pharmacies’ shelves, the final link in the supply chain the FDA is supposed to monitor. The FDA played almost no role in investigating the case. “The sad truth is that the FDA ignored, enabled or encouraged every Johnson & Johnson disaster in this book,” Harris writes.

In case after case recounted in the book, this supposed gold-standard of regulatory agencies took years to document risks that were killing people. When it finally acted, it issued warning letters that were ignored by the company. When it slapped black-box warnings at the top prescription drug labels (those small print, folded white sheets inserted in packaging) or in the device instructions, too many prescribing physicians and operating surgeons inappropriately used the products after being plied by company sales with free meals, gifts and reprints of company-funded studies touting their products.

Agency capture

While the book is structured as a takedown of a single company, its subplot is the incestuous relationship between the FDA and all the companies the agency is supposed to regulate. J&J is emblematic of how the FDA polices the entire industry when it comes to safety: Too little and too late. All too often, by the time the FDA cracks down on a dangerous drug or device it has allowed onto the market, it has either lost patent protection or seen product liability suits and bad publicity drive sales into insignificance.

The book’s two medical device case studies are textbook examples of the FDA’s failure to provide post-marketing safety oversight. But they also call into question the pre-marketing approval process itself. The 1976 law allowed companies to introduce new products that are “substantially equivalent” to a previously approved product without conducting comprehensive safety and efficacy testing in human subjects. It is the FDA’s job to determine if design changes submitted by a company are so minimal they meet that lower standard.

Both J&J’s metal-on-metal hips for arthritic joint replacement and a plastic pelvic mesh used as a protective wall to prevent sagging bladders from causing female urinary incontinence used this regulatory approval pathway with forbearance from the FDA. Both contained significant design change from prior products. Harris uses court records to show that company officials were well aware the new designs caused significant problems even before submitting the applications.

Hundreds of thousands of patients were harmed before the FDA finally warned patients and physicians about the dangerous side effects. These included serious infections from metallic debris in the hip transplant patients and painful sex and infections after the mesh wound up migrating through the vaginal wall in an estimated one-third of those patients. In the latter case, the FDA waited five years after becoming aware of the product’s dangers before ordering J&J to conduct a clinical safety trial. Knowing the likely outcome, the company pulled its vaginal mesh products from the market five months after receiving the order.

Despite numerous instances of regulatory failure over the past three decades, neither the FDA nor Congress has moved to curb the industry’s dangerous and oft-times illegal marketing tactics. Company sales reps still promote off-label uses of drugs to physicians. Companies still pay physician “key opinion leaders” five-figure fees to promote products at seminars in hotel ballrooms and fancy resorts, where attending doctors can still get continuing medical education credits to maintain their licenses. The companies still fund professional societies to write clinical practice guidelines that endorse overuse of their products.

The FDA, at the Supreme Court’s behest, still allows television advertising for drugs that present a clear and present danger for patients – the prime example in the book being J&J’s Procrit, the anti-anemia drug used in cancer chemotherapy. The chief medical officer for the American Cancer Society once called Procrit “Miracle-Gro for cancer.”

Prescription for reform

The book ends, as every book critical of the industry must, with Harris’ prescription for reform. He wants Congress to bar doctors from taking money or gifts from drug and device companies if they treat patients. He calls for academic medical centers and the National Institutes of Health to conduct all clinical trials of new drugs, with the corporations behind the new products paying those institutions for the privilege of having a truly independent testing of their safety and efficacy.

To reform the FDA, he would end the user fee programs that fund its drug and device divisions, which make the agency’s reviewer-scientists dependent on corporate funding for their livelihood. And he would break up the agency into two parts: one that reviews the science behind products seeking marketing approval; and one that performs post-marketing surveillance for emerging safety concerns. His model is aviation where the Federal Aviation Administration approves new airplanes while the National Transportation Safety Board investigates accidents.

“Such an agency might have prevented the opioid crisis and countless others, savings millions of lives in the process,” he writes. “The FDA has never fulfilled this vital function effectively, and unless things change radically, it never will.”

Having written a book about innovation in the drug and medical device industries, I would add two more items to Harris’ agenda. Congress should also establish a third arm of the FDA or an independent agency to analyze the clinical effectiveness of every new product compared to those already on the market. The National Institute for Health and Care Excellence (NICE) in Great Britain or the non-profit Institute for Clinical and Economic Review based in Boston are models (the latter also conducts cost-effectiveness analysis based on pricing). This new agency would issue authoritative studies that could be used by clinicians and patients to make well-informed clinical decisions, and by public and private payers to negotiate reasonable prices.

A reform package should also include a new user fee on drug and device companies to create a far-reaching post-marketing surveillance system. It should be empowered to collect de-identified medical records from all medical providers (near universal electronic health records now make this possible) to analyze both the outcomes and the adverse events from the use of drugs and medical devices.

Existing registries and adverse event reporting systems like the one lambasted by vaccine critics like HHS Secretary Robert F. Kennedy Jr. rely on voluntary reporting by companies and patients. They are clearly inadequate. A comprehensive outcomes reporting system could be used to definitively determine the health benefits and harms from the use of medical products in the real world, not just in the controlled atmosphere of pre-marketing clinical trials.

In this century, Congressional and White House efforts at reform have focused mostly on addressing the high cost of drugs with paltry results. They range from the 2003 Medicare Modernization Act, which created a Medicare drug benefit with no controls on pricing, to the Biden administration initiating price negotiations for a handful of Medicare’s most costly drugs. It is time to bring the two wings of the anti-Pharma movement together behind a common platform – one that deals scientifically with all areas of uncertainty when it comes to use of medical products: safety, outcomes, comparative effectiveness, and price.

It is unlikely the current administration will look kindly on such an agenda. When it comes to safety, the new HHS secretary has focused almost solely on issues like vaccine safety and fluoridated water, both of which have been proven overwhelmingly safe and highly effective. Indeed, in the book’s final chapter, Harris points out that the one Covid vaccine withdrawn from the market was J&J’s, which used a traditional vaccine manufacturing method, led to several unexplained deaths, and was much less effective than the alternatives. Meanwhile, Kennedy continues to raise questions about the innovative and highly effective mRNA vaccines, which have been taken by hundreds of millions of people around the globe and saved countless millions of lives.

Meaningful reform is not likely to happen soon given the chaos of oligarch-run Washington. But there’s no time like the present to begin formulating what an FDA freed from industry influence would look like and writing legislation that can be enacted quickly when the wheel of politics turns, as it eventually must if we are to remain a functioning democracy capable of protecting and improving the nation’s health.