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Are These Dangerous Drugs in Your Medicine Chest?

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Since direct-to-consumer drug advertising was legalized 13 years ago, Americans have become a nation of pill poppers - choosing the type of drug they desire like a new toothpaste, sometimes whether or not they need it.

But if patients want the drugs, doctors and pharma executives want them to have them and media gets full page ads and huge TV flights (when many advertisers have dried up), is the national pillathon really a problem?

Yes, when you consider the cost of private and government insurance (Medicare's budget is bigger than the Pentagon's) and the health of patients who take dangerous drugs like these.

Prozac, Paxil, Zoloft, SSRIs

Selective serotonin reuptake inhibitor (SSRIs) antidepressants like Prozac, Paxil, Zoloft and Lexapro probably did more to inflate pharma profits in the decades than direct-to-consumer advertising and Viagra put together, no pun intended: over 66 million prescriptions were filled in the US in 2007.

But many say the drugs have also inflated police blotters.

antidepressants

Columbine shooter Eric Harris (1999), Red Lake shooter Jeff Weise (2005), and NIU shooter Stephen Kazmierczak (2008) were all reportedly under the influence of SSRIs. Virginia Tech shooter Cho Seung-Hui (2007) was also influenced by psychoactive drugs say reports.

In addition to 4,200 published reports of SSRI-related violence, aggression, bizarre behavior, self-harm and suicide since the drugs were introduced in 1988, the lucrative antidepressants also pack non-behavioral perks: SSRIs can cause life-threatening serotonin syndrome when taken with migraine drugs, gastrointestinal bleeding when taken with aspirin, Aleve or Advil and the bone condition osteoporosis.

The popular Paxil can reduce or abolish the effect of tamoxifen in breast cancer patients and increase deaths says British Medical Journal. It's linked to a two-fold increased risk of cardiac birth defects in infants according to its own manufacturer, GSK.

And sexually, SSRIs are so linked to dysfunction even the pharma identified web site WebMD admits many will experience impotence, delayed ejaculation or no orgasm. The solution? Add another antidepressant that's not an SSRI like Wellbutrin says WebMD.

Effexor, Cymbalta, Pristiq, SNRIs

Selective norepinephrine reuptake inhibitors (SNRIs) are like their SSRIs chemical cousins except their norepinephrine effects can modulate pain, which has ushered in your-depression-is-really-pain, your-pain-is-really-depression and other crossover marketing. But the problem with giving a psychoactive drug for pain is that you're giving a psychoactive drug for pain. "After three months of taking Savella [another SNRI], I started self-destructing and cutting myself," writes a 40 year old woman on askapatient.com. "I don't know why or anything, but it does similar to Prozac where it makes you think and do weird things."

And Cymbalta, approved this fall for chronic back pain and osteoarthritis?

Cymbalta was the drug healthy 19-year-old volunteer Traci Johnson was testing when she hung herself in an Eli Lilly dorm in 2005. It was the drug Carol Anne Gotbaum killed herself on at Phoenix's Sky Harbor airport in 2007.

SNRI's are also harder to quit than SSRIs, especially Effexor. 25-year-old Chicagoan David F. says he stood at the top of an 8-story parking lot contemplating jumping every day for weeks after quitting. It's also the drug Andrea Yates was on when she drowned her five children in 2001.

But not all SNRI side effects are behavioral. The FDA would not approve Pristiq, a newer version of Effexor, when Wyeth/Pfizer tried to market it for vasomotor symptoms, because it caused heart attacks, coronary artery obstruction and hypertension in clinical trials. That's similar to another SNRI, the diet pill Meridia, which was just withdrawn from the market for causing heart problems. Pristiq is still available.

Seroquel, Zyprexa, Geodon, atypical antipsychotics

Even though the antipsychotic Seroquel tops 71 drugs on the FDA's January 2010 Medwatch quarterly report with 1766 adverse events, even though it's linked to eight corruption scandals, even though military parents blame Seroquel for unexplained troop deaths, it is the fifth biggest-selling drug in the world and netted AstraZeneca almost $5 billion last year.

Atypicals were originally promoted to replace side-effect prone drugs like Thorazine but soon became pharmaceutical Swiss Army Knives for depression, anxiety, insomnia, bipolar and conduct disorders and other off label uses - and betrayed the same side effects as older antipsychotics. (Especially tardive dyskinesia-linked Abilify.)

Foisted disproportionately on the young, poor and disadvantaged, atypicals cause such weight gain and metabolic derangement - 16 percent of Zyprexa patients gain 66 pounds and some gain over 100 - manufacturer Lilly Eli Lilly agreed to pay the state of Alaska $15 million in 2008 for the Medicaid costs of Zyprexa patients who developed diabetes.

Atypicals carry warnings of death in demented patients but are widely used in nursing homes. And even though Risperdal maker Johnson & Johnson, Geodon maker Pfizer, Abilify maker Bristol-Myers Squibb, Lilly and AstraZeneca have all entered into government settlements that acknowledge fraudulent or wrongful atypical marketing, FDA rewarded atypical makers by approving Zyprexa and Seroquel for children last year. And approved a new atypical antipsychotic, Latuda, in October. Maybe the FDA is bipolar.

Ritalin, Concerta, Strattera, Adderall and ADHD drugs

When it comes to the epidemic of 5.3 million US children between 3 and 17 diagnosed with ADHD, suspicions of pharma pushing the disorder are exceeded only by pharma's admissions thereof.

During an August conference call with financial analysts, Shire specialty pharmaceuticals president Mike Cola credited the "very dynamic ADHD market" to Shire's globalization efforts and "investments we have made in new uses for our existing products."

Those uses, a.k.a. diagnoses, for Shire products like stimulants Adderall, Vyvanse and Intuniv include adult ADHD, cognitive impairment, depression and excessive daytime sleepiness.

Still, Cola says despite the 10 percent ADHD "new starts" that are helping Shire "grow the market," and the "co-administration market" of add-on prescription drug$, the ADHD franchise suffers from patients who drop out when they quit seeing their pediatrician. "We don't see those patients show up again until their mid-to-late 20s," laments Cola.

ADHD drugs, in addition to "robbing kids of their right to be kids, their right to grow, their right to experience their full range of emotions, and their right to experience the world in its full hue of colors," as Anatomy of an Epidemic author Robert Whitaker puts it, are also deadly.

A 2009 article in the American Journal of Psychiatry called Sudden Death and Use of Stimulant Medications in Youths found 1.8 percent of youthful stimulant users died sudden deaths from cardiac dysrhythmia or unexplained causes versus 0.4 percent who were not on stimulants. Though it helped fund the study, the FDA said the results proved no "real risk" and kids should keep taking their meds.

Meanwhile, says Robert Whitaker, kids on ADHD meds "are told they are going to be on these drugs for life. And next thing they know, they're on two or three or four drugs," a phenomenon also known as the co-administration market.

Foradil Aerolizer, Serevent Diskus, Advair and Symbicort

How could asthma drugs that increase the chance of dying of asthma become pharma's top sellers? The same way antidepressants that cause depression and antifracture drugs that cause fractures become top sellers: good consumer marketing.

Still, unlike drugs that look safe in trials and develop safety signals postmarketing, the long-acting beta agonists (LABA), salmeterol and formoterol, found in many asthma products, never looked safe. In fact it was their links to deaths and adverse events that led to studies in the 1990s and 2000s which showed more deaths and adverse events: LABAS increase death in users, say the studies, especially African-Americans and children.

Original safety trials were also marred with major fraud

Pharma doctors, when reviewing the study results at FDA hearings in 2005 and 2008, blamed LABA deaths on patients' underlying disease and non-compliance and dismissed hospitalization as a side effect less serious than death. They danced around FDA testimony, including from Dr David Graham of Vioxx fame, that there is no scientific evidence that the inhaled corticosteriods found in Advair and Symbicort make the products safer and that LABA's modest clinical benefit does not justify their 28-fold increase in mortality risks. (5,000 deaths in ten years estimated Graham.)

While many regard LABAs as a medical mishap, marketing for "step up" asthma treatment is no mistake. Though inhaled corticosteriods are still considered the best asthma treatment, millions have been convinced they need two drugs to control their asthma and that the combination is keeping them out of hospitals. Except when it isn't.

Singulair and Accolate, leukotriene receptor antagonists

How did Merck convince Americans to use an allergy drug that works no better than over-the-counter antihistamines but costs eight times as much?

A drug in which "asthma control deteriorates when switched from low dose inhaled corticosteriods" according to original FDA reviewers in 1998 - but was approved anyway?

How did Merck convince pediatricians and mothers to give kids such a drug on a daily basis for seasonal allergies, runny noses and minor wheezing? Even though FDA reviewers cautioned that adult trials "may not be predictive of the response" in children in the New England Journal of Medicine? And infant monkeys given Singulair had to be euthanized because "infants may be more sensitive" FDA reviewers wrote?

Last month, the saga of Singulair mismarketing continued when Fox TV reported that Merck's top selling allergy drug is suspected of producing aggression, hostility, irritability, anxiety, hallucinations and night-terrors in kids, symptoms that are being diagnosed as ADHD.And that Singulair is being huckstered to parents by the trusted educational service Scholastic, Inc. and the American Academy of Pediatrics.

Eight-nine parents on the drug site askapatient.com report hyperactivity, tantrums, depression, crying, school trouble, facial tics and strange eye movements after their children, some as young as one, were put on Singulair. Similar reports appear on medications.com and parentsforsafety.org. Most symptoms subside when Singulair is stopped.

"Do NOT recommend this drug to other parents," writes one mother. "4 year olds that suddenly talk about killing themselves are influenced by a DRUG!!

"THE GOVERNMENT SHOULD BE ASHAMED OF THEMSELVES FOR APPROVING THIS!!!!" writes another mother, though the shame may well not stop there.

Martha Rosenberg is a columnist and cartoonist, who writes about public health

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