Beware Generic Drugs: not all are created equal

[kwillia]

Long but very, very informative article.

Just when Beth Hubbard should have been feeling great, her health fell apart.

A 34-year-old housewares designer in the St. Louis area, Hubbard had recently gotten married. She liked the creativity of her career. And she’d conquered her mild depression and fatigue with a combination of exercise, rest and medicine, including the antidepressant Wellbutrin XL. But in the fall of 2006, shortly after she refilled her prescription—her pharmacy giving her this time Budeprion XL, a generic version of the drug—her good health gave way.

Within a month, she had gained 15 pounds, couldn’t sleep well, developed gastrointestinal problems and felt such extreme fatigue and lack of motivation that she thought about quitting her job. She cried and called in sick for days at a time. “I chalked it up to exhaustion after the whirlwind of the wedding and honeymoon,” Hubbard says.

Yet she wasn’t getting better. Her doctor referred her to four specialists, but none, she complains, “were really listening to me—they were just anxious to give me another drug.” They diagnosed her alternately with severe allergies, a heart murmur, a slow thyroid, irritable bowel syndrome, gluten intolerance, mononucleosis and chronic pain. She cycled on and off different drugs: Ambien to help her sleep at night; Provigil to keep her awake during the day; Allegra, Zyrtec and Nasacort for allergies; Lexapro, Zoloft and Xanax for anxiety and depression; Zelnorm for bowel problems. And she continued on the Budeprion XL the entire time. “I was fighting for almost a year with the insurance company over all the tests and therapy I needed,” Hubbard adds.

After eight months of struggling with her mystery ailments, she was out to dinner with a friend and mentioned that she needed to refill her prescription. Her friend said she’d recently gone off Wellbutrin and had some leftover pills Hubbard could use.

Within a week, Hubbard’s troubling symptoms vanished. Her energy came roaring back. And that is when she finally connected the dots: Her problems had begun mere days after she first took the generic. Because generics had always worked well for other conditions, she says, “I never even gave it a second thought or mentioned the pharmacy’s switch to my doctor.” Until now.

She called her doctor to complain about the generic and request a new prescription for the brand name only. The nurse’s response floored her. “Yes,” the nurse said matter-of-factly. “We hear that all the time.”[/i/]

Stephanie T., a 33-year-old in New York City, never gave much thought to where her prescription drugs were manufactured. She knew only that they were helping her get healthy after years of battling schizoaffective disorder. In January 2007, she was productive again, back in school and studying for a degree in medical coding and billing. She had been taking a version of fluoxetine (the generic of Prozac) by a Croatian company, Pliva; then her pharmacy switched her to a fluoxetine made by the Indian generic giant Ranbaxy. Over the next six months, she fell into a deep depression. “I was lying on the couch all day long,” recalls Stephanie, who asked SELF not to publish her last name. “I wasn’t eating; I couldn’t get my schoolwork done. I was crying all the time.” If it weren’t for her family, she says, “I don’t think I’d be around.”

Out of the blue, Stephanie’s pharmacy switched her back to the medicine made by Pliva. “Within days, I was a brand-new person. I remember lying in bed thinking, What did I do differently?” she says. “When people are mentally ill, changing their drugs is like playing with someone’s mind. I could have committed suicide and no one would have known why.”

Between 2000 and 2008, the number of new generic drugs put forth for FDA approval went up 40 percent and approvals doubled, with roughly 600 cleared to be sold last year. “Generic companies are popular on Capitol Hill because the industry is powerful and voters are anxious for cheaper drugs. There was always pressure on us to reduce barriers to entry,” says Scott Gottlieb, M.D., deputy commissioner for medical and scientific affairs for the FDA from 2005 to 2007. (Dr. Gottlieb is now a resident fellow at the American Enterprise Institute, a conservative think tank in Washington, D.C., and also advises brand-name-drug companies.)

Because brand-name medications have already been clinically tested, generic companies applying for FDA approval don’t have to repeat that process on their versions. Instead, they must test their medicine on a minimum of 20 people; subjects take a single dose, so the drug is not tested over time. If tests show the generic contains the same active ingredient that the original does and delivers about the same dose, then the FDA considers it “bio#equivalent” and clears it to be sold.

But as Beth Hubbard discovered, patients are finding stark differences among drugs the FDA has deemed equivalent. Pharmacologist Joe Graedon and his wife, Terry, cohosts of the public radio show The People’s Pharmacy, have fielded complaints about dozens of generics for depression, hypertension, high cholesterol and more. Consumers described drugs that had no effect, caused bizarre side effects or made conditions worse. Joe Graedon says he has been “astounded” by the outpouring. “I’m not in the back pocket of the pharmaceutical companies—I want generics to be good,” he says. “But the more we dug, the more we realized nobody is monitoring the equivalence of these drugs.”

Bad Bargain: The Dangers of Generic Drugs - Page 1 - MSN Health & Fitness - Health Topics

 

[Chasey_Lane]

Daaaaaaaayum!! That's an interesting read.

 

[punjabigyrl]

Long but very, very informative article.




Between 2000 and 2008, the number of new generic drugs put forth for FDA approval went up 40 percent and approvals doubled, with roughly 600 cleared to be sold last year. “Generic companies are popular on Capitol Hill because the industry is powerful and voters are anxious for cheaper drugs. There was always pressure on us to reduce barriers to entry,” says Scott Gottlieb, M.D., deputy commissioner for medical and scientific affairs for the FDA from 2005 to 2007. (Dr. Gottlieb is now a resident fellow at the American Enterprise Institute, a conservative think tank in Washington, D.C., and also advises brand-name-drug companies.)

Because brand-name medications have already been clinically tested, generic companies applying for FDA approval don’t have to repeat that process on their versions. Instead, they must test their medicine on a minimum of 20 people; subjects take a single dose, so the drug is not tested over time. If tests show the generic contains the same active ingredient that the original does and delivers about the same dose, then the FDA considers it “bio#equivalent” and clears it to be sold.

But as Beth Hubbard discovered, patients are finding stark differences among drugs the FDA has deemed equivalent. Pharmacologist Joe Graedon and his wife, Terry, cohosts of the public radio show The People’s Pharmacy, have fielded complaints about dozens of generics for depression, hypertension, high cholesterol and more. Consumers described drugs that had no effect, caused bizarre side effects or made conditions worse. Joe Graedon says he has been “astounded” by the outpouring. “I’m not in the back pocket of the pharmaceutical companies—I want generics to be good,” he says. “But the more we dug, the more we realized nobody is monitoring the equivalence of these drugs.”

Bad Bargain: The Dangers of Generic Drugs - Page 1 - MSN Health & Fitness - Health Topics

That is not surprising at all. Sometime, last year on the news someone argued about generics causing more har than good and everyone totally disagreed with him. Generics are also being pushed because alot of people are getting cheaper meds from Canada, Isreal, India, England etc.