Some modern drugs, such as aspirin, are “grandfathered in” even though they have enough negative side effects that they would never be approved today. Some former wonder drugs are now simply illegal. Such is the case with cocaine, an alkaloid stimulant derived from the coca leaf. Cocaine was initially used in the West as a topical anesthetic, but soon found uses in many products, including the original Coca-Cola formula from 1886 to 1906. Parke-Davis, which marketed cocaine in various forms in that era, promised the drug would “supply the place of food, make the coward brave, the silent eloquent and ... render the sufferer insensitive to pain.” One problem: Cocaine was found to be highly addictive, and was outlawed in 1914. Even the father of psychoanalysis, Sigmund Freud, got hooked on coke. It’s fascinating to read Freud’s journals as he realizes his own descent into addiction.
A psychedelic drug that induces altered states of reality, lysergic acid diethylamide (LSD) is synthesized from ergotamine, a fungus known to infect grain supplies. In fact, outbreaks of hallucinogenic ergotism were known as “St. Anthony’s Fire” in the middle ages. LSD gained vogue in the 1960s in the emerging counterculture. Studies were also conducted in the early 1960s for the drug’s use in everything from psychotherapy to treatment for alcoholism. Such studies bared little fruit, however, and today LSD is classified as a dangerous and illegal Schedule I substance.
More familiar to most by its street name, Quaaludes, methaqualone was patented in 1962 and has been prescribed under various brand names as a muscle relaxant and a sedative, as well as a treatment for insomnia. Producing a similar effect to a blackout induced by binge drinking, Quaaludes were frequently used and abused by teens and young adults in the 1970s before the drug’s dangers became apparent. Methaqualone was removed from the U.S. market in the 1980s and became a Schedule I drug in 1984. In addition to overdose, abuse of methaqualone can cause renal failure, respiratory depression and delirium.
7. Diethylstilbestrol (DES)
Diethylstilbestrol, better known as DES, was prescribed to pregnant women as a synthetic form of the hormone estrogen from 1940 to 1971 to prevent complications during pregnancy such as premature birth and miscarriage. The FDA became aware of a link between DES and breast cancer and banned its use, although the drug remained on the market in Europe until 1978. Daughters exposed to DES in the womb have a 40 times greater risk of developing a type of cancer known as clear-cell adenocarcinoma, although only 1 in 1,000 “DES daughters” will go on to develop this rare form of cancer.
Warner-Lambert Co. gained FDA approval to market its new diabetes drug, Rezulin (troglitazone), in early 1997. Although hailed as a new blockbuster drug, approval had been riddled with problems from the start, with several researchers warning against increased risk of heart and liver damage for users. As the death toll mounted, Rezulin was cited in 1999 as one of the most dangerous drugs on the market, leading to a full recall in March 2000. By then the drug had been cited as the cause in hundreds of deaths.
A situation involving the pharmaceutical company Pfizer and its drug, Bextra, illustrates how modern marketing tactics can maintain the illusion of safety in a drug whose dangers have become apparent. In a huge settlement announced in 2009, Pfizer agreed to pay out $2.3 billion, including a record-breaking $1.3 billion in criminal fines, for fraud surrounding the promotion and downplaying of safety concerns about its drug. Bextra was originally approved as treatment for menstrual cramps and arthritis, but Pfizer actively promoted its use for applications and in doses not approved by the FDA. The company had also been aware that Bextra increased the risk of heart disease and stroke before pulling the drug off the shelves in 2005. As for the record fine, it represented only a small percentage of Pfizer’s $48.3 billion in revenue the previous year, and critics questioned whether drug companies might continue to find it simpler — and more profitable — to pay fines rather than follow scientific and ethical guidelines.
Approved by the FDA in 1999, Avandia soon became the best-selling drug treatment in the world for Type 2 diabetes. Yet the drug’s manufacturer, GlaxoSmithKline, had apparently known since at least 1999 that the drug increased the risk of heart attacks. When an independent study surfaced in 2007 outlining those risks, sales plummeted. In late 2011, the British-based GSK agreed to pay a $3 billion settlement in the United States for deceptive marketing practices involving Avandia. The drug has been pulled from the market in many countries, but remains available in the United States under heavy restrictions.
A painkiller used in the treatment of arthritis and other inflammatory diseases, Rofecoxib was marketed by Merck under the familiar brand name Vioxx. Merck pulled the drug in 2004, however, when a study found that use doubled the risk of strokes and heart attacks. Merck ultimately established a $4.85 billion settlement fund for the families of the 3,468 users who died after taking the drug.
A combination of the drugs penfluramine and fentermine, fen-phen was introduced to the market by Wyeth in the early 1990s. Once hailed as a wonder drug in the fight against obesity, by the mid-1990s, several studies had shown a connection between fen-phen and heart disease. The FDA issued a recall of the drug in late 1997. At the time, many fen-phen users who had experienced weight loss were upset not at the drug’s risks coming to light, but at the recall itself. Tens of thousands of lawsuits have been filed against the manufacturer, and as of 2005 Wyeth — now a subsidiary of Pfizer — had set aside $21 billion to settle lawsuits.
The story of thalidomide is a textbook case of a wonder drug gone bad. In 1957, a German company, Grünenthal, began marketing thalidomide as a miracle painkiller, and more ominously, a treatment for morning sickness. The hideous side effects of this poorly tested drug soon became apparent, as babies were born with malformed limbs and other terrible congenital defects. Thalidomide was linked to around 2,000 deaths, and birth defects in more than 10,000 children worldwide. Only a small percentage of those birth defects occurred in the United States, however, as the FDA repeatedly denied applications for approval to sell the drug in the U.S. In an odd twist, the FDA approved the sale of thalidomide in 1998 as treatment for leprosy.