Guest Author - Gary King

I have been doing some extensive research on the Food and Drug Administration (FDA) and their concern for the safety of all persons in the U.S. who buy their drugs from any source not approved by the FDA, and I sincerely believe they are not the big bad wolf!

The FDA is and has been warning the public about counterfeit versions of the drugs Zocor (simvastatin) and carisoprodol that were imported from Mexico by individual Americans. Tests indicate that the counterfeit Zocor did not contain any active ingredient and that the counterfeit carisoprodol differed in potency when compared to the authentic product. Carisoprodol is a drug used in the treatment of painful musculoskeletal conditions and Zocor is a cholesterol lowering drug. The counterfeit versions were reportedly purchased at Mexican border town pharmacies and sold under the names Zocor, 40/mg, (lot number K9784, expiration date November 2004 and lot K9901, exp. date December 2006), and Carisoprodol, 350/mg, (lot number 68348A). Patients who rely on these counterfeit versions of the drugs could develop serious health risks (with the counterfeit Zocor) or have insufficient pain relief (with the counterfeit carisoprodol).

FDA has repeatedly expressed its concern about the purchase by Americans of drugs from foreign countries. As demonstrated by the incident above, purchasers cannot assume that the products meet the quality, efficacy, and safety standards of FDA authorized products or that FDA is assuring the quality, safety, and efficacy of products purchased from outside the United States.

Medications purchased within the U.S. system for prescription drugs have undergone rigorous testing and review to verify their identify, potency, and purity and to ensure that they are safe and effective for their intended use. In addition, there are safeguards to help maintain the integrity of the products while in shipment to pharmacies and prior to dispending to patients.

Anyone who may have purchased the above described versions of Zocor 40/mg and Carisoprodol 350/mg from Mexican pharmacies should consult with their physician as well as notify their local FDA office.

FDA is investigating this matter and working with the Mexican authorities to ensure that further sale and importation of these products is halted.

A Food and Drug Administration (FDA) analysis of three commonly prescribed drugs purchased from a Web site advertised as Canadian showed that so-called "Canadian Generics" bought from the Web site were fake, substandard and potentially dangerous. One was a controlled substance. In light of these findings, FDA reiterates its strong concerns about purchasing prescription drugs online from unknown sources.

FDA investigators recently purchased three commonly prescribed drugs from a Web site advertising "Canadian Generics," which had been sending "spam" emails promoting its products. The products purchased were so-called "generic" versions of Viagra, Lipitor, and Ambien. None of the three products has a U.S.-approved generic version, and so all three drugs were unapproved.

"The test results of our analysis offer proof positive that buying prescription drugs online from unknown foreign sources can be a risky business. As was the case here, even where a website looks legitimate, FDA has clear evidence that the Web site is dispensing misbranded drugs that are not the same quality as those approved by the FDA for sale in the United States. Consumers who believe they are getting equivalent products from reputable sources are being misled and putting their health at risk," said an FDA spokesman. "This firm shipped drugs that were the wrong strength, including some that were substantially super-potent and that pose real health risks as a result, drugs that didn't dissolve properly, drugs that contained contaminants, and drugs that should not have been given because of potentially dangerous drug interactions."

Ambien, a controlled substance (schedule IV), is approved for the short-term treatment of insomnia in the U.S. The product FDA obtained online contained too much active ingredient, including one tablet that was nearly double the labeled potency. Taking "superpotent" Ambien puts patients at risk for central nervous system depression, especially in elderly or debilitated patients.

The so-called "generic" Lipitor FDA purchased was subpotent and failed standard dissolution tests, providing on average only 57 percent of the active ingredient claimed on the label. It also failed FDA's purity testing. Clinically, subpotent product could present a long-term risk for the various complications of high cholesterol, such as heart disease. In addition, the so-called "generic" Lipitor product was furnished to FDA's online purchaser, even though the purchaser said that he was taking the antibiotic Erythromycin. Lipitor's label warns against taking Lipitor and Erythromycin at the same time.

Viagra is sold in the U.S. to treat impotence. The so-called "generic" version of this product also contained too little of the active ingredient, failed the dissolution test, and had and unacceptable level of impurities. Although subpotent "generic" Viagra may not place patients at additional risk, the purchase informed the firm in its online questionnaire that he was taking Erythromycin. Use of Viagra in patients taking Erythromycin is contraindicated.

FDA continues to advise patients and consumers that they must use great care when purchasing prescription drugs online. Their evidence indicates that although a Web site may appear to be hosted by a reputable source and may look similar to other retail pharmacy Web sites, many of these sites in fact operate from outside the United States and are providing unapproved drugs from unreliable sources. The National Association of Boards of Pharmacy (NABP) has established a program called VIPPS designed to certify Web sites that meet industry standards. The Agency believes that consumers should look for participation in this type of certification program as one method to help minimize the risks of getting bad quality drugs from disreputable sources.

The FDA's test results are summarized in a chart that can be accessed at: http://www.fda.gov/importeddrugs/chart071304.html. Additional information about buying drugs online is available at FDA's website, http://www.fda.gov/oc/buyonline/default.htm.

The FDA, contrary to what many people believe and are saying, is NOT trying to keep you from buying drugs at a discount price! What they are trying to do is protect you and your safety and maybe even perhaps save your life.

I am aware of the high costs of prescription drugs and I am also aware of the FDA's concerns for your safety. I believe the safety concerns by the FDA far outweight the high costs. So, the question remains and seems to grow bigger -- how do you buy the prescription drugs you need at costs you cannot afford? There really is no legitimate answer to that question right now, but there are some steps that should be taken, by the government, the drug manufacturers and others to ensure that these drugs are available at prices you can afford.

The government, the FDA, the drug manufacturers, and some representatives who represent your interests need to sit down, with legislators present, and hash this out and come up with some answers and solutions that work all the way around the table. Enough of the passing the buck and not getting things done. If the drug manufacturers want to charge an arm and a leg for the cost of their medicines, then the legislators need to act to pass legislation that makes it impossible for them to do that, if that cost is beyond your reach! No if, ands or buts--hash it out and quit beating around the bush.

The high cost of medication is forcing some Americans to find a way to get their medication at a price they can afford. And it seems that the only price some of them can afford is to buy from a foreign source, which, according to the FDA is not safe. So, to put this in perspective, the FDA should do something about helping the government to pressure the drug manufacturers to lower the prices to a level consumers can afford. Instead, they continue to raise the prices, telling us how bad they need this extra money. But they look the other way when the consumers tell them they absolutely cannot afford the medication at the current price.

We need to get our act together in this nation. We have too many greedy businesses and too many people out to get what they can, when they can, at the expense of whoever. And they do not care whether you live or die, whether you can afford this or that, especially when they leave their job and hop in their Mercedes or Cadillac and tool on down to their million dollar house. Yes, it is a rough world for those who work for drug companies or those drug companies who market pills which cost pennies on the dollar but are sold for MILLIONS!

The answers to all of the above problems with prescription drugs are for people to start acting with common sense, decency, fair play, justice, integrity, and the like. But I'll bet my bottom dollar that over 90% of the people who need to do it do not even know what those words mean. And if they do know, they sure don't know how to dispense any of those ingredients. They do know how to dispense pills to the tune of thousands and millions of dollars, though, so they can buy another Mercedes and put it in the garage to drive when the other one gets dirty.

If there are any drug companies out there in this land with some ingredients we call integrity, fair play, common sense, decency, etc., please tell me where they are at. I have not been able to find any of them. Remember when gas was 17 cents a gallon (and believe it or not it was at one time) and people used to even leave their house unlocked when they went up town? That price of gas went out the window about the same time as common sense and integrity went out the same window. And in flew greed, apathy and only God knows what else. People striking and always asking for more and more money and then wondering why things are so high and why gas costs what it costs. Some people never learn and probably never will learn.

Gosh, we should be proud of our college graduates. They even know how to write commercials with words written on the stomach of a person. Or they know how to make a pop can fly. But they do not know how to lower the price of gas or to lower the price of drugs that can save lives.

Meanwhile, back at the ranch and so it goes, on and on, on and on.

Attention, America, sleep not in the silence!