Problem Drugs Force FDA To Sieze Manufacturers

It is not uncommon to hear the cries of how this country needs “limited government” and how there needs to be an “unfettered economy.” Usually, these cries come from the Fiscal Conservatives in the Republican Party. To many Conservatives, regulations limit the amount of money that a group of people can and will rake in; however, what regulations do is protect people from unscrupulous business practices such as adulterating the drugs people need and the food people eat. It is easy to water down drugs through adding in cheap fillers, and that does two things. It makes it cheaper to manufacture those drugs, and that raises the profit margins of the drug manufacturers. What it also does is make the drugs less effective and puts people’s lives at risk.

For those who will say that this is somehow a superfluous example, the Food and Drug Administration recently took action against two drug manufacturers. The FDA all but shut down KV Pharmaceuticals and its subsidiaries ETHEX Corporation and Ther-Rx Corp. The FDA placed KV Pharm under a Consent Decree, which prevents KV Pharm from producing or distributing pharmaceuticals of any kind until the FDA approves and they remain under a certain level of probation for six years so long as they comply with the current Good Manufacturing Practice regulations. What brought the FDA’s action upon KV Pharm was simple. KV Pharm was sending out drugs which contained the wrong amount of medication, were the wrong size, and were mislabeled. KV Pharm issued a voluntary recall of their entire run of drugs, according to the FDA, after numerous problems were discovered.

What does this mean, over all? Well, ETHEX manufactured the generic form of one of the medications known as Metoprolol, specifically the succinate form of that drug. Metorpolol is a beta blocker used to treat tachycardia (rapid heart beat) and high blood pressure. It is the generic form of Toprol and Lopressor. Metoprolol Succinate was the twenty-four hour version of the drug. A lot of people were taking Metoprolol S. When KV Pharm issued their recall, they did not tell the doctors, who had to scramble to switch prescriptions, and they were not required to do so. Since most insurance companies require the use of generics, most doctors switched their patients to Metoprolol Tartrate, the twelve hour version of that drug.

That is where the rest of the problem occurred. The FDA responding to a variety of complaints from patients who had been forced onto Metoprolol Tartrate investigated and then seized Caraco Pharmaceuticals. They ordered the Federal Marshals to seize all drugs manufactured by Caraco, including Metoprolol T. Apparently Caraco was also adulterating, or at least not adding in enough of the active ingredients to, their drugs, and releasing drugs which were considered defective.

The cost of those defective, to be kind, drugs was both the health of individuals and the money that was required to treat them when their drugs failed on them. The bill for the tests at the hospital for one individual whose Metoprolol failed was over $8,000. It cost her $1,500 and the insurance company the rest. Luckily, she was being treated only for high blood pressure and not heart disease or tachycardia. Had this been a defective batch being used to treat someone with an out of control heart rate, it is quite possible that it could have killed her.

These regulations are intended to provide for the safety of the people who use these drugs and eat the food that they buy in their stores. After all, properly enforced regulations would likely have made the salmonella and e.coli outbreaks in recent years non-existent. After all, recalls of beef, tomatoes, lettuce, peanut butter, pistachios, and dozens of other food products have become almost common place.

The FDA dates back to 1930. It was created out of the Department of Chemistry, which was formed in 1909 under the watchful eye of President Theodore Roosevelt. After the publication of The Jungle by Upton Sinclair, the public found out just what was in their morning sausage. After all, rat meat has such a wonderful flavor to it. The only event which Sinclair had chronicled that Roosevelt’s inspectors were unable to verify was that of people falling into the rendering vats and being left to be ground up into sausage. Of course it is easier to go after these regulations as being about out of control and wasteful government rather than going after things like having fifteen different Intelligence organizations or having an FDA which is so vast and complex that a complaint about one drug can result in two different letters. There is waste in the government, but the regulations is not it.

If you asked someone whether they preferred to eat salmonella tainted food or pay taxes, they would probably say that they would rather pay taxes, and yet, no one ever actually asks them that. No one ever states that these regulations are intended to protect the average person from the dangers of unscrupulous business people. Everyone focuses in on waste in government and no one ever talks about what taxes pay for. This is, of course, part of the problem. While there is a need for a system to get rid of outdated and redundant regulations, the need for those regulations is more evident now than at any time in recent memory. While the FDA is busy working out the kinks and trying to streamline, the very fact that at least two people answered one letter incompletely is a waste of money.

Unfortunately, as Governor Howard Dean essentially pointed out, it is easier to change the Vatican than it is to change Washington DC.

This has not been intended as a rant or a screaming fit, but it does serve a purpose. If you have been the victim of faulty medication, please write to the FDA at:

MEDWATCH
The FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787

Or to go

www.fda.gov/medwatc/report.htm

to report online.

Pictures

http://en.wikipedia.org/wiki/File:Tabletfailure.jpg