Frustrated in their attempts to access information, seek compensation, and prevent future deaths, the families convinced the flamboyant lawyer, Jan Schlichtmann, to take on what was thought to be a hopeless cause. Suddenly, the case seemed to promise a multi-million-dollar settlement. Large industrial concerns, as well as government officials, began to pay close attention. Obsessed with the enormity of the apparent crime, the creative Schlichtmann amassed a huge amount of damning evidence through careful and expensive scientific research. But the accused companies also invested large sums in experienced lawyers and scientists who used other data and legal technicalities to refute the charges. The families lost their case in 1986, and Schlichtmann was financially and emotionally ruined. By that time, 21 cases of leukemia had been identified – 4 times the anticipated rate for the population. A public health report found “no significant differences” in exposure between the leukemia cases and controls, yet concluded that “it is not possible to rule out exposure to this water as a factor” (Cutler et al 1986). 

Author Jonathan Harr began work on A Civil Action in 1986 before the opening of the trial, and he accompanied Schlichtmann to almost all meetings, relied on court transcripts, and conducted many painstaking interviews with the families and opposing lawyers. The result is an omniscient yet intimate perspective on these true events that reads like an action-packed thriller, complete with dialogue. It won many awards and was on the New York Times bestseller list for 65 weeks. It stands as an interesting commentary on the nature of environmental health and on the American justice system. 

Three years later, Steve Zaillian wrote and directed the award-winning film, A Civil Action (1998), based on Harr’s book and starring John Travolta and Robert Duvall. Shlichtmann received $250,000 for the portrayal rights, but is quoted as saying, “John Travolta made more money playing me than I ever did playing me” (Kix 2009). Forty years later, now at age 75, he continues to champion environmental causes, aiming for settlements rather than court cases and recounting his “lessons learned” on the speakers’ circuit. 

Woburn and A Civil Action had coincided with other prominent environmental disasters, caused by industrial failures: Three Mile Island (1979), Love Canal (1977-1979), Times Beach, Missouri (1983), Bhopal (1984), to name only a few. The book and the film contributed to rising awareness about the health risks of environmental damage, and they added to increasing skepticism over the intentions of private entrepreneurs and the courts. They also heralded a period that saw a growing body of legislation aimed to define responsibilities and regulate industrial pollution – measures coming, alas all too frequently, after new problems arose and covering jurisdictions defined only by political boundaries, which have nothing to do with the flow of water and air. In 2022, the United Nations declared that a healthy environment is a human right. Dozens of countries, including Canada (2023) and several American states, have enshrined that ideal in law, even if practicalities and protections lag far behind. 

Less known is that fact that Woburn triggered a public-health preoccupation with “clusters” and the nature of proof (Alexander et al., 1999; Kingsley et al., 2007) Do clusters indicate important dangers or are they unfortunate but random occurrences? A decade later, the Center for Environmental Health Sciences at Massachusetts Institute of Technology reported on its vain “search for causes” in the industrial toxins of the Woburn leukemia cluster (Durant et al., 1995). In 2002, a controlled study, based on Woburn, failed to establish a causal correlation between disease and contamination; it pointed out that incidence had returned to anticipated levels, while 8 consecutive years had seen no leukemia cases at all (Costas et al., 2002). Woburn has also been cited in efforts to provide better statistical evaluation of “clusters” (Waller, 2000). Woburn prompted recommendations to incorporate qualitative methods into public heath reporting (Brown, 2003) and to recognize the value of citizen science and epistemic differences in lay and professional “ways of knowing” (Brown, 1992; Petteway et al, 2019). Woburn is still being cited in public health assessments of environmental causes of malignancy, often with ambiguous outcomes (Binczewski et al., 2026). 

A Civil Action helped prepare the terrain for these many studies with their controls, statistics, and tracking of chemicals–mind you, only those chemicals that are already recognized and detectable. We no longer question the harm in smog and smoking, while improvements in respiratory diseases proclaim the benefits of keeping air clean. It is dismaying that the idea of water pollution as a harm to human health continues to be such a hard sell, while disasters like Flint, Michigan, or Grassy Narrows, Ontario, roil on. 

Water degradation is bad for flora, for fauna, and for the planet. Therefore, it is bad for us too. But for industry, the courts, and even some epidemiologists in their many ways of knowing, it remains an unproven hunch. 

References 

• Alexander, Freda E. 1999. Clusters and clustering of childhood cancer: A review 
• European Journal of Epidemiology 15: 847-852.
• Binczewski, N.R., Morimoto, L.M., Wiemels, J.L., Richardson, D.B., Bartell. S.M., Metayer, C., Vieira, V.M. 2026. Spatial analysis of residential location at birth, PFAS in public water, and childhood cancers in Southern California (2000-2019). Journal of Exposure Science & Environmental Epidemiology 2026 Mar 5:10.1038/s41370-026-00850-1. doi: 10.1038/s41370-026-00850-1. Epub ahead of print. PMID: 41781477; PMCID: PMC13032745. 
• Brown, Phil. 1992. Popular epidemiology and toxic waste contamination: lay and professional ways of knowing. Journal of Health & Social Behavior 33(3):267-81. 
• Brown, Phil. 2003. Qualitative methods in environmental health research. Environmental Health Perspectives 111(14):1789-98.  
• Costas, K., Knorr, R.S., Condon, S.K. 2002. A case-control study of childhood leukemia in Woburn, Massachusetts: the relationship between leukemia incidence and exposure to public drinking water. Science of the Total Environment 300(1-3):23-35. 
• Cutler, J.J., Parker, G.S., Rosen, S., Prenney, B., Healey, R., Caldwell, G.G. 1986. Childhood leukemia in Woburn, Massachusetts. Public Health Reports 101(2):201-5. 
• Durant, J.L., Chen, J., Hemond, H.F., Thilly, W.G. 1995. Elevated incidence of childhood leukemia in Woburn, Massachusetts: NIEHS Superfund Basic Research Program searches for causes. Environmental Health Perspectives 103 Suppl 6:93-8. 
• Kingsley, B.S., Schmeichel, K.L., Rubin, C.H. 2007. An update on cancer cluster activities at the Centers for Disease Control and Prevention. Environmental Health Perspectives 115(1):165-71.  
• Kix, Paul. 2009. In the shadow of Woburn, Boston Magazine, City Life, 22 September:  https://www.bostonmagazine.com/news/2009/09/22/in-the-shadow-of-woburn
• Lagakos, S. W., Wessen, B. J., Zelen, M. 1986. An analysis of contaminated well water and health effects in Woburn, Massachusetts. Journal of the American Statistical Association 81(395):583–596.  
• Petteway, R, Mujahid, M., Allen, A., Morello-Frosch, R. 2019. Towards a people’s social epidemiology: Envisioning a more inclusive and equitable future for social epi research and practice in the 21st century. International Journal of Environmental Research and Public Health 16(20):3983. 
• Waller, L.A. 2000. A civil action and statistical assessments of the spatial pattern of disease: do we have a cluster? Regulatory Toxicology & Pharmacology 32(2):174-83. 
• Jonathan Harr discusses A Civil Action on C-Span 

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In her 2011 book Blood Feud (also published as Blood Medicine), award-winning journalist Kathleen Sharp describes a wrenching example of whistleblowing in the pharmaceutical industry about a drug designed to promote the growth of blood cells.  

Beginning in 1992, Mark Duxbury and Dean McClellan became high flying salesmen for Johnson and Johnson, Ortho branch – happily promoting the anemia drug Procrit (or Epogen — erythropoietin). (Yes! that’s the same hormone sometimes abused by high-performance athletes.) Developed by fledgling Amgen, Procrit was licensed to Ortho for specific uses. The two salesmen rejoiced as their careers took off; during 1993, they earned bonuses and their stature rose. Soon however, Duxbury was being encouraged to promote the drug for off-label uses and in high doses—all to enhance sales. He began to realize that the drug was not safe when used in these situations: people were dying because their unnaturally thickened blood resulted in strokes and heart attacks. He was appalled by the fact that the company was giving kickbacks to prescribers who were making false claims to Medicare. 

Duxbury raised objections with his employer. For voicing concerns, he was ostracized and then fired in 1998. Along with the stresses of his work, the financial difficulties, and emotional turmoil, Duxbury’s home life collapsed, his marriage fell apart, and he worried about his daughter, Sojourner. He developed multiple health problems, including sleep apnea and dependency on drugs and alcohol. 

Duxbury enlisted the help of the famous lawyer Jan Schlichtman featured in the 1995 book, A Civil Action, by Jonathan Harr (also the famous 1998 film starring John Travolta). In 2003, they launched a qui tam lawsuit under the False Claims Act against his former employer. A qui tam case allows an individual to sue on behalf of the government (i.e. the people); if successful, the individual will be entitled to a portion of the proceeds. The process stalled but was revived in 2009. However, Duxbury died suddenly of a heart attack in October 2009 at age 49 with the case still unresolved. The potential value of his qui tam was unknown but was estimated to be 150 million dollars four years later.  

Contacted by Duxbury in 2004, author Kathleen Sharp, initially hesitated to take up the project. After the FDA issued increasingly alarming warnings about the dangers of Procrit in 2006-7, she began to take his concerns more seriously.  Relying on interviews and many documents from courts and private papers, Sharp reconstructed the events in a narrative that resembles a novel, with direct quotes and even the inner thoughts of the players. Duxbury’s death intestate comes as a shock to the reader, as it may well have been to the author. Reference notes support the unverifiable claims made in her narrative—placing it somewhere in-between “recreative” journalism and fiction. 

Since the publication of Blood Feud, the case was referenced in an unsuccessful suit by Duxbury’s daughter Sojourner against her stepmother in 2013 and an appeal of the same year, which gave judgement to the defendant (i.e. not Duxbury). Duxbury v. Ortho Biotech has become an important precedent cited in other qui tam cases into the present. 

Blood Feud raises concerns about the behavior of pharmaceutical companies in duping their own salesmen to generate income even at the cost of human life. But it also invites consideration of the too-often-neglected responsibilities of the health care profession and the government. The thorny legal aspects of the pharma industry and its regulation result in multiple lawsuits that contribute to the ever-higher costs of drugs. 

Blood Feud: The Man Who Blew the Whistle on One of the Deadliest Prescription Drugs Ever 
Kathleen Sharp 
Dutton, New York, 2011: 432 pages 

Web image by Medhum.org

When the Food and Drug Administration (FDA) was created in 1930, its mission was to ensure the safety of prescription medications. In 1962, with the passage of the Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, the FDA also became responsible for certifying drug effectiveness. Positive results in one or more randomized double-blind clinical trials became the gold standard for approval. Thus, patients were assured that when their doctor prescribed a “hot” new drug that had appeared on the market, it had met the FDA’s rigorous safety and effectiveness criteria.  

Yet, sixty-three years later, near the beginning of Rethinking Medications (2025), Dr. Jerry Avorn writes:  

“In 2021, the Food and Drug Administration (FDA) gave its approval to Aduhelm, a new drug for Alzheimer’s disease that didn’t work, could cause brain damage, and was poised to cost the nation each year a sum the size of NASA’s annual budget. How did the world’s once best prescription drug regulatory body fall so low” (p. 31) 

The FDA not only approved Aduhelm but did so over an almost unanimous negative vote of its scientific advisory panel. What had happened to the promise of safety and effectiveness? Jerry Avorn MD, founder and director of Harvard’s Division of Pharmacoepidemiology and Pharmacoeconomics, argues that the Aduhelm approval resulted from a longstanding decline in the FDA’s regulatory standards, a slippery slope greased by social, political, and especially pharmaceutical industry pressures. Rethinking Medications is a comprehensive assessment of the pharmaceutical industry, the FDA, and their complex relationship in the 21^st century. Much of the book addresses three core issues: Does a new drug work? Is it safe? And what should it cost? Other chapters deal with education, patient empowerment, and the specific examples of psychedelics and pain killers. 

According to Avorn, the FDA’s rigor began to break down during the late 1980s when the agency initiated an accelerated or “fast track” review process in response to the AIDS epidemic, a reasonable change in light of the rapid spread of this incurable and deadly disease. (pp. 30-32) Initially, “fast track” approval involved greater FDA monitoring and quicker action but still required evidence of clinical effectiveness. In the case of AIDS, a hematological marker, CD4 T-cell count, was highly correlated with clinical outcome, which made it an excellent index of effectiveness. 

However, not long afterward, the FDA opened its accelerated approval pathway to medications for chronic, progressive diseases and to use a favorable change in such surrogate markers (e.g. blood tests or images) as substitutes for clinical improvement. For example, in the case of Alzheimer’s disease, reduction in the number of amyloid plaques was considered a sufficient reason to approve Aduhelm, though the study had not documented symptom reduction or slower decline in functioning. While some surrogate markers are good predictors of outcome (e.g. Hb A1c in diabetes), most markers used for chronic disease drug approvals lack strong predictive evidence.¹ 

However, the accelerated track includes a presumed fail-safe mechanism. The pharmaceutical company is required to complete a long-term confirmatory study to confirm clinical effectiveness. By 2022, more than half of new drug applications were being processed in the expedited track, and over 80% of these were approved. (p. 77) The confirmatory study requirement, even if honored by the companies, allowed medications to be prescribed for years before a negative finding might cause approval to be revoked. According to Avorn, the increasing use of surrogate markers as endpoints tells the industry, “You can market your drug if it makes a lab test look better in a short study, compared to a placebo. We won’t be on your case too much about those confirmatory follow-up studies.” (p. 37) [Avorn engages in hyperbole here. Aduhelm was shown to be ineffective and withdrawn from the market in 2024.]² 

Avorn next addresses the safety of newly approved drugs. Serious side effects must be recognized, if possible prior to approval. However, according to the author, the profit motive sometimes outweighs evidence of significant harm. He discusses the case of Vioxx (Merck Pharmaceuticals, 1998), a COX-2 inhibitor approved because it had fewer GI bleeding side effects than other NSAIDs. Several studies subsequently showed that patients taking Vioxx had almost double the number of myocardial infarcts and strokes of those taking other NSAIDs. Nonetheless, Merck rigorously disputed this evidence for several years before finally removing Vioxx from the market in 2004. Largely as a result of the Vioxx scandal, Congress passed the FDA Amendments Act in 2007, which introduced several safeguards for ensuring drug safety. These included (a) creating a nationwide system for monitoring adverse effects, (b) preventing companies from hiding clinical trial results by requiring that all trials be registered in a federal registry, and (c) insisting that companies complete follow-up studies after the drug has been approved. (pp. 167-170) 

In 2007, a far more widespread safety failure was still a decade from being revealed. When Oxycontin was approved in 1995, the FDA believed the long-acting form of oxycodone would result in less abuse potential, since the drug would be absorbed slowly without an immediate “rush” to promote abuse. This belief had a theoretical basis, but there were empirical findings that strongly suggested otherwise. Over twenty years later, a presidential commission (2017) “concluded that the FDA’s mishandling of the evaluation, approval, and use (of oxycontin) was an important cause of the nation’s opioid crisis” (p. 393). 

Anyone who watches broadcast television today will find it difficult to believe that prior to 1997, essentially no prescription drug advertising appeared on television. In 1997, the Food and Drug Administration approved a new rule allowing pharmaceutical companies to state only “major risks” in their ads, rather than its previous requirement of a full list of all possible risks, contraindications, and side effects, which had effectively precluded direct-to-consumer advertising. The industry quickly learned how to package major risks into brief statements aired sotto voce at the end of their commercials under images of smiling patients picnicking in a park. Since then, ads for expensive new pharmaceuticals have spread like wildfire.  

Aggressively promoted new drugs are mostly treatments for chronic, malignant, or degenerative diseases that require continued use over many months or years. The producers, in essence, have monopolies on these products because they are protected by patents from competition for a certain number of years. Without competition, companies are able to charge very high prices, which they justify as necessary to compensate for costs of research and development.  

Avorn identifies several reasons to doubt that excessive R & D costs are a determining factor in pricing new drugs. First, many Big Pharma companies spend more on marketing, most of which is direct-to-consumer advertising on TV and other media, than they do on research and development. Thus, much of the actual “investment” is spent in devising ways to convince consumers that new is better.  

Secondly, most newly approved medications are not innovative, but rather modifications of existing drugs for which the patents will soon expire. The manufacturer seeks to have a replacement drug with a claimable advantage (e.g. fewer side effects, fewer daily doses) sufficiently different to be patented and approved before it loses patent protection on a profitable product. When generic versions of the product appear on the market costing up to 60% less than the original, the manufacturer attempts to maintain profits and market share by heavily promoting its “new, improved version.”  

Third, “breakthrough” medications that employ a newly discovered mechanism, or work dramatically better than available alternatives, are generally the result of NIH-funded basic science and clinical trials performed by university faculty. While the Bayh-Dole Act (1980) allows universities to patent promising new drugs, only pharmaceutical companies have the ability to develop and market the drug commercially. When a company purchases the patent from its home university, the scientists and the university profit from the purchase, but lose control over the medication that results. Although Big Pharma does invest significantly in developing these drugs and bringing them to market, the basic research and initial clinical trials are supported by federal grants. “The largest engine driving the nation’s prodigious ability to bring new drugs to market is the hundreds of billions of taxpayer generated dollars in the National Institutes of Health and other public and philanthropic of biomedical discovery.” (p.197) Not Big Pharma.  

Finally, retail prices for the same drugs in Canada, Europe, Australia, and Japan average about 60% lower than in the United States, even though their manufacturers presumably still make a profit. The real reason they set prices much higher in the United States is simply because they can. Most other countries have mechanisms to control drug prices based on realistic cost/benefit estimates.  

Rethinking Medications is a compelling analysis of today’s pharmaceutical industry and its regulation by the FDA. Big Pharma is clearly the “heavy” in Avorn’s analysis. The FDA failures result from some combination of responsiveness to the need for new therapies in chronic diseases, inadequate resources and personnel to enforce the requirement for confirmatory studies, and the withholding of critical data by pharmaceutical companies. The FDA Amendments of 2007 corrected many of these problems, although the FDA’s fate under the Trump administration is yet to be seen. The prospects are not promising because the Department of Health and Human Services is directed by a man who aggressively promoted hydroxychloroquine as a treatment for Covid and doubts the effectiveness of vaccines.  

Despite Dr. Avorn’s focus on failures and deficiencies, the reader should keep in mind that the American pharmaceutical industry does have a remarkable track record of producing innovative and effective medications. This, of course, does not justify the industry’s rampant profiteering and deceptive practices. It would require strong federal regulation, especially regarding pricing, to address these problems. Here again, the current administration’s anti-regulatory stance makes progress in the near future improbable.  

Notes 
1, Wallach JD, Yoon S, Doernberg H et al. Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments. JAMA, 2024; 331 1646-1654. 
2, Two anti-amyloid monoclonal antibody medications, Legembi and Kisunla, have now been approved for treatment of early Alzheimer’s disease. Both have been shown to slow its progression by several months.  

RETHINKING MEDICATIONS
Jerry Avorn MD 
Simon & Schuster, 2025: 512 pages 

Web image by Jaretuz