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Should we beware of new drugs?

Should we beware of new drugs?

Picture of Martha Rosenberg

Quick sales to millions of people is a crucial marketing tactic to make a blockbuster drug because there is a small sales window before a patent runs out. But a sales blitz can also be dangerous because many risks don't fully emerge until millions take the drug.

Here are some blockbuster drugs that crashed and burned, some of which had a very short time on the market.

Vioxx

Perhaps no blockbuster drug executed the crash and burn of Merck's Vioxx. Billed as "super-aspirin" for everyday pain whether menstrual or arthritis, Vioxx was aggressively advertised by celebrity athletes like skater Dorothy Hamill and track star Bruce Jenner as a wonder drug.

The Vioxx saga was the first time in recent memory that the possibility of deliberate Pharma subterfuge surfaced. Even as 20 million people were using Vioxx, it was found to increase cardiovascular events and Merck was reported to have known about it.

 In Merck's 1999 annual report, the drug giant announced "Vioxx--Our Biggest, Fastest and Best Launch Ever!" predicting the drug would graduate from being a mere painkiller to preventing Alzheimer's disease and colon cancer. Instead, Merck found itself  compensating 20,591 heart attack and 12,447 stroke plaintiffs in 2010 out of a $4.85 billion settlement fund.

 

Trovan

Increasingly, Big Pharma is eyeing poor countries to market, manufacture and test new drugs and the story of Trovan is a case in point. During a meningitis epidemic in Nigeria in 1996, Pfizer administered the not-yet-approved antibiotic Trovan to children, 11 of whom died with others sustaining permanent injuries. Nigerian officials said Pfizer "unlawfully conducted a clinical trial without obtaining a valid clinical trial certificate," and failed to obtain required approvals and consent from the patients.

In 1998, Trovan was approved for adult use in the United States but, during its first year, the FDA cautioned doctors of acute liver failure cases and deaths. Less than two years later, U.S. regulators forced Pfizer to withdraw Trovan because of its liver toxicity. A year before it approved Trovan, the FDA approved the antibiotic Raxar later linked to heart rhythm problems and sudden death. Raxar was withdrawn from the market in 1999 and there were questions about its original clinical trials.

Propulsid

Direct-to-consumer advertising, which began in the late 1990s, is widely credited with popularizing "GERD" (Gastroesophageal reflux disease), a condition that was largely known as heartburn before TV drug ads. Soon an array of preparations like Nexium, Prevacid and Prilosec debuted which became blockbusters despite their links to osteoporosis and C. difficile. 

One GERD medicine that didn’t make it was Propulsid. Approved in 1993, by 1999 there were 341 reports of heart rhythm abnormalities and 80 reports of deaths. Johnson & Johnson promoted Propulsid for children as well as adults and 20 percent of babies in neonatal intensive care units received it, according to a survey. In 2000, Janssen Pharmaceutica, part of Johnson & Johnson, announced it would stop marketing Propulsid.

Seldane and Hismanal

Direct-to-consumer advertising also boosted the seasonal allegories "market." But even as Claritin, one of the first advertised drugs, became a household word, the older antihistamines Seldane and Hismanal were under safety clouds. Seldane, an early non-drowsy antihistamine approved in 1985, was linked to heart problems especially when taken with certain antibiotics or antifungal drugs. Hismanal, approved in 1988, was linked to cardiovascular events and deaths and dangerous when combined with some antibiotics, AIDS drugs and antidepressants, said the FDA. Both drugs were withdrawn.

Darvon and Darvocet

Is an opioid-linked medication that relieves pain worth the overdoses, death, addiction and abuse that are often in its wake? It is a question we hear today with drugs like OxyContin--but dates all the way back to 1957 when Eli Lilly began marketing Darvon. In 1978, Public Citizen called for a ban or severe restriction of Darvon and Darvocet due to heart toxicity and death.

In 2006, Public Citizen again called for a ban saying Darvon had been linked to 10,000 confirmed U.S. deaths. Darvon lethality stemmed from its interaction with alcohol, slow elimination and other factors said the watchdog group. In 2010 the FDA banned Darvon and all products containing Darvon.

Meridia

Debuted in 1997, as direct-to-consumer advertising was beginning, there was a cloud over the diet drug Meridia even before it was approved. In 1996, an FDA advisory committee voted 5 to 4 that the drug's benefits did not outweigh its risks. In 2002 Public Citizen petitioned the FDA to ban Meridia for its heart and cardiovascular risks. In 2010, Abbott withdrew the drug from the U.S. market under FDA pressure. Some of Meridia's quick rise stemmed from it being approved just as Fen-Phen was withdrawn for heart valve side effects.

Baycol

Baycol was an early statin that tried to compete with Lipitor for the growing, lucrative statin market. Guess who won? Approved in 1997, Baycol was withdrawn in 2001 after postmarketing surveillance revealed 52 deaths from rhabdomyolysis and 385 nonfatal cases. Rhabdomyolysis is a condition, seen with statins, in which muscle tissue breaks down and can lead to kidney failure. Made by the drug giant Bayer, Baycol made between $900 million to $1 billion a year before its withdrawal. 

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