Dangerous generics

We are all told–doctors and patients alike–that generic drugs are just like their brand-name counterparts. They work just as well and they’re just as safe. Indeed, more than 80 percent of drugs now dispensed in the U.S. are generics. This saves nearly $200 billion per year in prescription costs.

Despite ever-increasing premiums, your health insurance company makes you take the less expensive generic versions. But more and more medical professionals claim the generics just aren’t the same.

Earlier this month, Fortune magazine ran a large piece questioning the safe use of generics in medicine.

In fact, in October of last year, the FDA pulled a generic antidepressant drug called Budeprion XL from the market. This drug was also used to help people stop smoking, among many other purported uses, according to the marketing done for the original branded drug.

The agency admitted that the generic form made by Teva Pharmaceuticals was not identical or “bioequivalent” to the name-brand drug Wellbutrin. In fact, men and women who took the 300 mg tablet of Budeprion XL experienced strange symptoms. In some cases, it didn’t work at all.

Now, the FDA wants other companies that make a generic form of Wellbutrin to test their drugs as well. This unusual move by the FDA rocked the industry and has everyone questioning the use of generic drugs.

How can a generic be different from its brand-name predecessor? Aren’t they carbon copies?

No, they’re not in fact. And you can thank the FDA for that.

You see, the FDA declares a drug effective if it shows just 20 percent more efficacy that a placebo pill.

But a generic drug has even more wiggle room.

The FDA says the concentration of the “active ingredient” in a generic drug can go  20 percent lower or 25 percent higher than the original drug.

That’s a range of nearly 50 percent!

In the case of  Budeprion XL, the active ingredient in the generic form dissolved much too quickly in the blood. Tests showed that the generic drug reached only 75 percent concentration in the blood. In some cases, it only reached 40 percent concentration. As a result, patients felt sick to their stomach, woozy, or even suicidal.

So let’s back up a moment…

The FDA does not regulate how quickly the drug reaches active levels in the blood. So, a generic can attain blood levels too quickly, too slowly, or maybe even not at all, depending upon the dosages.

Plus, as the American Heart Association recognizes, there is the all-important issue of the biological matrix. This means that your digestion and metabolism affect how quickly the drug reaches your blood stream.

There are also big differences between  tablets and capsules.

Try putting a typical tablet in a glass of water. Your body and gastric fluids are mostly water. See whether the tablet dissolves quickly. Or does it just sit there? Then, try heating the water. Shake and stir the water. In most cases, the tablet will just sit there.

Now pour the contents of a gel capsule into water and see what happens. A gel capsule dissolves in the normal heat of the body and the ingredients rapidly release.

That’s why you feel better faster when you take a gel capsule pain reliever instead of a hard tablet. The active ingredient reaches your blood faster when released from a capsule.

And it can make all the difference.

That’s why I recommend taking dietary supplements in capsule form whenever possible.

Is the FDA warning doctors and patients about all of this?

No–of course not.

Much of the credit for FDA’s generic withdrawal of Budeprion XL goes to the hosts of a National Public Radio program called “The People’s Pharmacy.”

In 2008, Joe and Terry Graedon received a deluge of calls from radio listeners. The listeners said that taking the 300 mg dose of Budeprion XL didn’t alleviate their depression. Others said it made them sick. As I have often warned about antidepressants, this generic antidepressant even made patients feel suicidal!

Fortunately, Joe Graedon is a pharmacologist and an advocate. So, in 2008, he got an independent laboratory to check up on the generic drug. Turns out, Budeprion XL isn’t just like Wellbutrin. It’s not as safe. And it’s not as effective.

For five years, FDA dismissed Graedon’s complaints. In October 2012, the FDA finally acted.

Now, medical societies like the American Academy of Neurology, the Endocrine Society, and American Heart Association want a switch to generics only with a doctor’s approval.

Will the FDA listen?

Not if Big Pharma has anything to do with it.

The generic drug industry already agreed to pay $300 billion per year to the FDA to speed up the approval process for generics. Yes, $300 billion per year! Sounds like protection money to me.

Meanwhile, experts express real concerns about other generic drugs, such as thyroid medications, cholesterol medications, and others.

In October 2010, Dr. Janet Woodcock, the Director of the FDA Center for Drug Evaluation and Research said in a speech, “I’ve heard it enough times from enough people to believe that there are a few products that aren’t meeting quality standards.”

Oh, I get it.

The old Wilson Pickett song: “I heard it through the grapevine…How much longer will it be…?”

So–Dr. Woodcock heard through the grapevine that some generics aren’t meeting quality standards? Is this really the scientific method used at the FDA? Maybe the doctors and patients should start “picketing” the government to do their jobs.

Sources:
http://management.fortune.cnn.com/2013/01/10/generic-drugs-quality/?iid=SF_F_River#comments


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