January 22, 2014 - New meds are rushed to the market so industry can start making money even before safety has been determined.
When a prescription drug
causes risky side effects, the word often doesn't get out for years, allowing Big Pharma to make money anyway.
The FDA and Big Pharma contend that dangerous side-effects in a prescription drug only emerge when it is used by millions instead of the relatively small group of people in clinical trials. But there is another reason the public ends up guinea pigs. Prescription drugs are rushed to market in as little as six months so industry can start making money while safety is still being determined. Both Merck's risk-laden bone drug Fosamax and painkiller Vioxx were on the market after a six-month review. In the case of Vioxx, it was because "the drug potentially provided a significant therapeutic advantage over existing approved drugs," the FDA said.
Thanks for that. And five drugs (Trovan, Rezulin, Posicor, Duract and Meridia) rushed through in 1997 because of Pharma and congressional pressure on the FDA, says Public Citizen, were subsequently withdrawn.
Here are some drugs whose risks did not did not keep them from getting their "patent's worth."
You'd think Merck would have learned from Vioxx and Fosamax that aggressive marketing can only hide emerging risks for so long. It didn't. To sell its asthma and allergy drug Singulair to children, the drug giant partnered with Olympic gold-medalist swimmer Peter Vanderkaay and Scholastic and the American Academy of Pediatrics even as the FDA warned about "neuropsychiatric events" including agitation, aggression, nightmares, depression, insomnia and suicidal thinking.
While Merck marketed Singulair, which comes in a cherry-flavored chewable formulation, to parents with slogans like "Singulair is made with kids in mind," Fox TV and over 200 parents on the website askapatient reported that children on Singulair exhibited altered moods, depression and ADHD, hyperkinesis and suicidal symptoms. Fifteen-year-old Cody Miller of Queensbury, NY reportedly took his own life days after taking the drug in 2008. Still, Singulair made $5 billion for the company in 2010. After its patent expired in 2012, Australia's Therapeutic Goods Administration, the FDA's counterpart, reported 58 cases of adverse psychiatric events in children and teenagers, primarily suicidal thinking. Who knew?
How do you sell a drug that causes 30 percent of users to gain 22 pounds and some to gain as much as 100 pounds? By burying the risks. The antipsychotic Zyprexa was supposed to be Eli Lilly's followup to its blockbuster antidepressant Prozac even though Lilly knew as early as 1995, according to the New York Times, that Zyprexa was linked to unmanageable weight gain or diabetes. Zyprexa's side effects of "weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule," wrote Lilly's Alan Breier, who later became chief medical officer, in documents obtained by the Times.
Even as Lilly settled charges that it withheld the drug's link to high blood sugar levels and diabetes and illegally marketed the drug for dementia, Zyprexa made $5 billion in 2010 and out-earned Prozac. Who says crime doesn't pay? Zyprexa was especially marketed to the poor and became one of the nation's top Medicaid drugs extracting at least $1.3 billion of our tax dollars in 2005 alone. In 2008, Lilly settled an Alaskan suit to cover the cost of Medicaid patients who developed diabetes on Zyprexa. Unbelievably, Lilly offered a "free service" to "help" states buy mental illness drugs like Zyprexa as a fox guards the henhouse and 20 states took the bait. Zyprexa's patent ran out in 2012.
Like Zyprexa, the antipsychotic Seroquel, made by the UK firm AstraZeneca, became a best-selling medication in the US, earning over $5 billion in 2010, despite frequently reported risks. It was so heavily marketed to poor children that in 2007, Florida's Department of Juvenile Justice's bought twice as much Seroquel as Advil. Seroquel's high use in the military for the unapproved uses of sleep and PTSD was also disturbing: reports of veterans' sudden deaths on the drug, thought to be cardiac-related, surfaced even as use of Seroquel soared 700 percent in the Department of Defense. In 2009, it was the number-two drug at the VA, accounting for $125.4 million in tax dollars.
Months after Seroquel's 1997 approval, an article in the South Dakota Journal of Medicine raised questions about the drug's unsafe interaction with 11 other drugs. Within three years, researchers at the Cleveland Clinic were questioning Seroquel's effect on the heart's electrical activity. But even as the families of deceased veterans testified at FDA hearings in 2009 and demanded answers from officials and lawmakers, the FDA maintained Seroquel's safety. Then in 2011, with little fanfare, the FDA issued new warnings that corroborated the swirling suspicions: both Seroquel and its extended release version "should be avoided" in combination with at least 12 other medicines, said the FDA. The drug should also be avoided in the elderly and people with heart disease because of clear cardiac risks. Oops. Seroquel's patent ran out the following year.
Fluoroquinolone antibiotics are among the biggest-selling drug classes. Many people remember the fluoroquinolone Cipro (given for 9/11-era anthrax attacks) but Pharma hopes we don't remember the fluoroquinolones Trovan, which was withdrawn for causing liver damage, and Raxar, which was withdrawn for causing cardiac events and sudden death. Johnson & Johnson's fluoroquinolone Levaquin was the US' best-selling antibiotic in 2010 with sales over a $1 billion a year but is now the subject of thousands of lawsuits.
In 2012, a year after Levaquin's patent expired, a cascade of side effects began to emerge with Levaquin and the whole class of fluoroquinolones that casts doubt about their safety. The Journal of the American Medical Association reported that of 4,384 patients diagnosed with retinal detachment, 445 (10 percent) were exposed to a fluoroquinolone in the year before diagnosis. The New England Journal of Medicine
reported the same year that Levaquin was linked to an increased risk of cardiovascular death, especially sudden death from heart rhythm disturbances.
While the FDA warned of tendon ruptures on fluoroquinolones, especially Achilles' tendons in 2008, and added a black box warning on the label, it had a serious new warning two years after Levaquin went off patent. In 2013, the FDA warned about the "the serious side effect of peripheral neuropathy" in fluoroquinolones, a type of nerve damage in which sensory pathways are impaired. Peripheral neuropathy caused by fluoroquinolones like Levaquin can "occur soon after these drugs are taken and may be permanent," warned the FDA. Fluoroquinolones are also linked to Clostridium difficile, also called C. Diff, a serious and potentially deadly intestinal microbe.
Before its patent expired in 2009, the seizure drug Topamax made Johnson & Johnson a billion a year and it still made $538 million a year after its patent expiration. Topamax was such a favorite for pain conditions in the military it was given the nickname "Stupamax" for the way it slowed reaction times and impaired motor skills, attention and memory, according to Army Times. Not too great for combat.
A year before Topamax went off patent, the FDA warned that it and other seizure drugs are correlated with suicide and asked their manufacturers to add label warnings. Four patients on the drugs killed themselves versus none on placebo reported the FDA after reviewing clinical trials. Then, in 2011, the FDA announced that Topamax can cause the birth defects cleft lip and cleft palate in babies of mothers who take the drug. "Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their healthcare professional," the FDA warned, though the risks did not stop the FDA from approving a new diet drug containing Topamax' generic drug in 2012.
Purdue Pharma's Oxycontin is the granddaddy of drugs that make money despite lethal side-effects. Along with other prescription opioids, it accounted for an astounding 17,000 deaths last year - four times that in 2003. "The increase [in use] has been fueled in part by doctors and pain advocacy organizations that receive money from drug companies and make misleading claims about the safety and effectiveness of opioids, including that addiction is rare," reported the Journal Sentinel.The American Geriatrics Society used Pharma-linked experts to rewrite clinical guidelines in 2009, says the Journal Sentinel, which specified opioids for all patients with moderate to severe pain as opposed to Aleve or Advil. Ka-ching.
Oxycontin, because it is a long-acting formulation, was supposed to reduce toxicities and addictiveness - at least until its crush, snort and shoot potential made it more popular than cocaine on the street. (All the pill's 80mg could be taken at once.) In 2010, responding to the addictions, overdoses, deaths and diversions associated with the drug, Purdue rolled out a tamper-resistant Oxycontin and began to push for state and federal laws requiring opioids to be tamper-resistant in 2012. Purdue said public health was its main concern but many are asking why that concern only surfaced as Oxycontin's patent was expiring. Its patent expired in 2013.
Martha Rosenberg is an investigative health reporter and the author of Born With a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Random House).