Big Pharma Rushes New Drugs to Market before FDA Approval

Most people assume when they are given a prescription from their doctor, it has received prior approval from the U.S. Food and Drug Administration (FDA), whose purpose is to protect the consumer. This is not always the case.

The FDA and ‘Big Pharma’ contend that dangerous side effects from a prescription drug emerge only after being taken by millions of people, as opposed to the relatively small group of people participating in clinical studies. Once again, the public is being used as guinea pigs because the pharmaceutical companies cannot wait to start seeing profits, so they rush their drugs to market, sometimes in under six months, while the drug’s safety is still being determined.

Years ago, Merck manufactured the bone drug, Fosamax and the painkiller, Vioxx after a mere six-month review. The FDA said, in the case of Vioxx, it was because “the drug potentially provided a significant therapeutic advantage over existing approved drugs.”

Many serious injuries, as well as death, resulted from use of Merck’s drugs. However, Merck continued its aggressive marketing when it brought asthma and allergy drug, Singulair to children. To help sales, they 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 thoughts. Merck used slogans like “Singulair is made with kids in mind,” but Fox TV and more than 200 parents reported via a website that this drug was exhibiting altered moods, ADHD and suicidal symptoms in their children. Just days after taking the drug in 2008, 15-year-old Cody Miller of N.Y. took his own life. Singulair reportedly made $5 billion for the company in 2010.

According to the New York Times, even though manufacturer of antipsychotic Zyprexa, Eli Lilly, allegedly knew as early as 1995 that Zyprexa was linked to unmanageable weight gain or diabetes, they concealed the risks. It was reported that 30 percent of patients gained between 22-100 pounds from use of Zyprexa. Despite Lilly settling charges for withholding the drug’s link to high blood sugar levels and diabetes, as well as illegally marketing the drug for dementia, Zyprexa made $5 billion in 2010, topping Prozac’s earnings.

Another antipsychotic drug, Seroquel, manufactured by AstraZeneca of the UK, became a best selling drug in the U.S., earning more than $5 billion in 2010, despite the reported risks. Seroquel’s high use in the military for the unapproved uses of sleep and PTSD was disturbing; the reports of veterans’ sudden deaths on the drug, believed to be cardiac related, surfaced even as use of Seroquel soared 700 percent in the Department of Defense. In 2009, it was the #2 drug at the VA, accounting for a shocking $125.4 million in tax dollars. Months after Seroquel’s approval in 1997, the South Dakota Journal of Medicine’s article raised questions regarding the drug’s unsafe interaction with 11 other drugs. Soon after, Cleveland Clinic questioned Seroquel’s effect on the heart’s electrical activity. In 2011, the FDA issued new warnings that Seroquel and its extended release version “should be avoided” in combination with at least 12 other drugs, as well as avoided in the elderly and people with heart disease.

Fluoroquinolone antibiotics are one of the biggest selling drug classes. Many people were given fluoroquinolone Cipro during the anthrax attacks. Big Pharma would hope we don’t recall the fluoroquinolones Trovan that was withdrawn due to liver damage, and Raxar, withdrawn for causing cardiac events and sudden death. Johnson & Johnson’s fluoroquinolone Levaquin was the best selling antibiotic in the U.S. in 2010 with sales of more than $1 billion a year, now the subject of thousands of lawsuits. 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 cardiac rhythm disturbances. The FDA did warn of tendon ruptures on fluoroquinolones, especially Achilles tendons in 2008, and issued a black box warning on the label. However, it had a serious new warning two years after Levaquin went off patent. In 2013, the FDA warned about the “serious side effect of peripheral neuropathy” in fluoroquinolones, a type of nerve damage impairing sensory pathways. Fluoroquinolones are also linked to Clostridium difficile, also known as C. Diff, a serious and potentially fatal intestinal microbe.

Johnson & Johnson’s seizure drug, Topamax, made $1 billion a year before its patent expired in 2009, and still made $538 million a year after its patent expiration. Topamax was such a favorite drug for pain conditions in the military, it was dubbed “Stupamax” for the way it slowed reaction times and impaired motor skills, attention and memory, according to Army Times. Not a great choice.

One year before Topamax went off patent, the FDA warned that it and other seizure drugs are linked to suicide and required the manufacturers to add label warnings. Four patients on the drugs committed suicide vs. none on placebo, as reported by the FDA after reviewing clinical trials. Then, in 2011, the FDA announced that Topamax could cause cleft lip and cleft palate in babies of mothers who took the drug. Although the FDA warned, “before starting topiramate, pregnant women and women of childbearing age should discuss other treatment options with their healthcare professional,” the risks did not stop the FDA from approving a new diet drug containing generic Topamax in 2012.

Despite the known lethal side effects of Purdue’s Oxycontin, it is a huge moneymaker. Oxycontin, as well as other prescription opioids, accounted for 17,000 deaths last year, four-times the number of opioid deaths in 2003. The American Geriatrics Society used Pharma-linked experts to re-write 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. When crushing, snorting and shooting this drug became more popular than cocaine on the street, Purdue finally came out with a tamper-resistant Oxycontin in 2012 and began fighting for state and federal laws to require opioids are tamper-resistant. Although Purdue claimed that public health was its main concern, many question why that concern only became heard as Oxycontin’s patent was expiring in 2013.

The FDA is an agency within the U.S. Department of Health and Human Services. They are charged with protecting the public, assuring the safety, effectiveness and security of human drugs, vaccines and other biological products for human use and medical devices. But are they protecting the financial interests of the industry over the safety of the public?

Feel free to comment on this blog post. If you or a loved one have been injured as a result of a bad drug or medical device, you may be entitled to compensation for your damages. Contact one of our experienced Gacovino Lake attorneys at 1-800-246-HURT (4878) for more information.

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