For Katherine Eban, the author of “Bottle of Lies: The Inside Story of the Generic Drug Boom,” there is no dilemma. In this pulpy, gripping tale of pharmaceutical scandal practiced on a vast scale, brand-name drugs and the companies that make them are good, generic drugs and the companies that make them are bad, and Americans should be afraid of any drug (especially an Indian- or Chinese-made drug) not labeled with the brand name of a European or American pharmaceutical firm.
Eban is an investigative journalist capable of processing reams of documents and scores of interviews, parsing the regulatory sciences of bioequivalence and Good Manufacturing Practice, and transforming the picayune details of regulatory compliance into the page-turning drama of potboiler detective fiction. Her reporting in Fortune on the 2013 Ranbaxy scandal exposed corruption and deception at the highest levels of one of India’s largest exporters of generic drugs, a company that knowingly provided substandard pharmaceuticals to American consumers and to HIV/AIDS medication rollout programs in sub-Saharan Africa. In “Bottle of Lies,” as the Ranbaxy scandal unfolds in blow-by-blow detail around a whistleblower who undergoes a dramatic narrative arc, amid layers of subterfuge, investigation and coverup, Eban reveals the thinning edge of U.S. regulatory power in a rapidly globalizing pharmaceutical industry.
And yet at no point in 400 pages of text does Eban adequately try to convey the other half of the socioeconomic context in which the Ranbaxy scandal must be placed. As a result, the book’s overall thrust provides reasons for consumers to fear generics but offers no program to rebuild trust. Eban has given a lopsided gift to the well-funded lobbyists of the drug industry trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), and the biotech trade association, the Biotechnology Innovation Organization (BIO). The book paints an uneven picture for readers, who should know that the willingness of pharmaceutical companies to promote substandard and potentially harmful agents is not limited to Indian or Chinese firms; it can be found just as readily among European and North American brand-name manufacturers.
The 2013 Ranbaxy scandal is a terrifying story of corporate and regulatory malfeasance that consumers and policymakers need to understand to make better decisions moving forward. But so is the 2010 GlaxoSmithKline scandal, in which the company knowingly operated a plant in Puerto Rico that produced contaminated brand-name antidepressants, and the 2008 Baxter heparin scandal in which a lax global supply chain tainted brand-name heparin products for American consumers — which Eban barely mentions. So is the 2007 Avandia scandal, in which GlaxoSmithKline failed to report findings that led to as many as 100,000 cases of stroke and heart failure, because of a disinclination to disrupt a leading product yielding $900 million in annual sales. So is the 2000 Vioxx scandal, in which executives at Merck, a company depicted in glowing terms in Eban’s account, pursued deception on a grand scale by continuing to market a drug that its executives had reason to believe caused heart attacks and strokes. So, too, is the closure of Abbot’s plant in Lake Forest, Ill., in 1999 because of a failure to follow good manufacturing practices.
And that’s just the past two decades. Eban’s book is the latest in a half-century’s worth of hard-nosed investigative critiques of the pharmaceutical industry that have now become a well-worn groove of American nonfiction writing. If most of these books — from Milton Silverman’s “The Drugging of the Americas: How Multinational Drug Companies Say One Thing About Their Products to Physicians in the United States, and Another Thing to Physicians in Latin America” (1976) to Marcia Angell’s “The Truth About the Drug Companies: How They Deceive Us and What to Do About It” (2004) — have been critical of brand-name firms and generous to generic firms, there is also a long history of exposés on the other side. When Margaret Kreig’s lurid “Black Market Medicine” (1967) detailed counterfeit practices by “fly by night” generic-drug manufacturers eluding the reach of the Food and Drug Administration, the ensuing congressional investigations played neatly into the hand of efforts by the Pharmaceutical Manufacturers of America (PMA) to forestall competition from the fledgling generic-drug industry. A few decades later, with the publication of “Patients in Peril? The Stunning Generic Drug Scandal” (1991), William Cray and C. Joseph Stetler went a step further, linking criticism of the generic industry directly to brand-name lobbying. The authors of this account of FDA corruption and bribery were both PMA executives fighting a rear-guard action as physicians and patients became increasingly comfortable with generic substitution.
The cost savings associated with the use of generic drugs in the United States in the past decade are estimated at more than $250 billion per year. This is possible only if the regulatory infrastructure that permits confidence in the quality, safety, efficacy and interchangeability of these drugs is upheld — and if the reputations of pharmaceutical manufacturers and the federal agencies charged with regulating them can continue to be trusted. From the title page to the conclusion, the white-hat/black-hat melodrama of “Bottle of Lies” works to erode that trust, and Eban offers no tools to restore it.
Perhaps it is unreasonable to ask for more. But as political scientist Daniel Carpenter notes in his “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA,” the reputation of the agency has been built step by step over the past century precisely because it has responded to successive scandals by learning, adapting and reflexively becoming a better regulator along the way. There is much for the FDA to learn in the wake of the Ranbaxy scandal. But were all readers to follow the logical implication of Eban’s book and eschew generic drugs altogether, it is far from clear who, beside the brand-name industry, would benefit — or where the funding for an extra $2.5 trillion in drug costs over the next decade would come from.
As a title like “Bottle of Lies” should remind us, deception can take place through omission as well as commission. This book, in selectively decrying the sin of the latter, risks the sin of the former. The global regulation of generic drugs is a fragile and thinly built structure, and Eban, finding a part of it vulnerable to corruption and decay, is right to sound the alarm. But at a time when we have learned to expect xenophobia and fearmongering on the part of our elected leaders, it seems a shame for one of our dwindling population of investigative journalists to be content to fan these flames as well, when she could be helping instead to mobilize an effective response.
The Inside Story of the Generic Drug Boom
By Katherine Eban
482 pp. $28.99