Hypocrisy concerning the Federal Drug Adminstration FDA Approach to Drugs

The Food and Drug Administration is typical of a governmental organization: politically driven, slow, and staffed poorly. You get what you pay for? In this case, perhaps we’re getting even less than that.

The FDA is too diverse, in an area where specialization is the only way to handle the increasing influx of work that they have. Their jurisdictions include food, drugs, medical devices, biologics, animal feed and drugs, cosmetics, radiation-emitting products, and anything that is a combination of the above.

They are responsible for inspecting fresh meat. However, they are only able to inspect 2% of all imported fresh seafood.* They are not even able to enforce restrictions on the cattle feed supply, which can cause bovine spongiform encephalopathy (BSE, or mad cow disease) in cattle which is easily passed on to humans (that’s right; our beef is still not safe). Their attempt at preventative inspections for cattle with BSE is criminally negligent.* And Consumer Reports Agency researchers ruffled feathers in January 2004 when they reported in Environmental Health Perspectives that young chickens contain three to four times more arsenic than other poultry and meat.

But the FDA is also supposed to regulate the drugs on the market. They are expected to keep questionable drugs out of the country, and make sure that what is available is relatively safe for the consumer. But because they move at the pace of a severely constipated, crippled horse, the United States is way behind other countries in modern medicine.

For instance, when my son was born in 1993, the Chicken Pox Vaccine was already widely used and accepted in Europe, where it had a marvellous success rate for over 10 years. However, the FDA had continued to drag it’s feet in approving it. The only thing that kept me from flying my baby out to another country to receive the vaccine was my doctor’s reassurance that it would finally be available in the U.S. within a year (and it was).

Consider those 10 years that children suffered because the FDA couldn’t move faster to approve that vaccine. And don’t forget the rare deaths that were a result of Chicken Pox. Too bad the FDA can’t be held responsible for withholding treatment.

In March 2006, it was reported that “Nearly two-thirds of more than 1,200 post-approval drug studies promised by the manufacturers have yet to start”; which should have caused a much greater outcry than it did. But this sort of story lacks the glamor of celebrity break-ups or serial killers and it’s hard to communicate to a viewing public with the attention span of an average 2 year old.

What does this mean? It means that drugs which you are using may not have been proven to be safe or effective. However, complaining about it may be the wrong tactic to take, when the FDA is so atrociously hesitant to even approve drugs which have been proven to be effective in other countries.

Additionally, the FDA is rather busy lately in it’s attempt to shut down the import of safe, legal drugs from Canada. The reason is political, of course: Bush wants to force senior citizens to get on-board the new Medicare Part D bandwagon.

I don’t have the time or ability to discuss Part D today, but it baffles many senior citizens (and we’re not talking the senior citizens of yesteryear – these people are intelligent, active members of society).

The main reason that Bush is so gung-ho for it is that it’s a way to privatize Medicare. Private companies are making great money this way, and I’ve been to conferences where it’s touted as a sure-fire way for insurance agents to make big bucks, fast. Being as Bush is in the pocket of Big Business and special interest groups, this has his attention. And when cheaper drugs are available from Canada, and that impacts the pocketbook of Big Business, Bush’s interest is increased. Sales of Canadian drugs to US citizens alone have skyrocketed over the billion dollar mark in the past few years. Who doesn’t want a piece of that action?

So, the FDA is doing what it can to seize the shipments and muscle out the competition. While the vast majority of our food supply remains uninspected. While no one follows up on the drug studies. While we remain behind the rest of the world in advanced medicines. And Nero fiddles while Rome burns.

*Consumer Reports, Jan. 2005