April 9, 2008 (essay)

Every once in a while you read a news story that just so blows your mind that you can't figure out which angle about it is more disgusting. You read the article over and over and you can't even talk to anybody about it because – I mean – where do you begin?

In case you missed the New York Times article yesterday, Drug Makers Near Old Goal: A Legal Shield, let me run down the facts for you here:

In the late 1990s Johnson & Johnson expressed their intention to the FDA to create a birth control patch that would have lower estrogen levels than pill based birth control. You see, lower estrogen levels are a desirable thing because high estrogen levels can often cause blood clots and heart attack and stroke and other things that severely harm a human being – and, you know, kill human beings.

Johnson & Johnson went on to create the patch, called Ortho Evra, but found during testing that it actually released estrogen levels far greater than that of traditional birth control pills into the blood stream. Not wanting to not make a lot of money off of this invention, however, Johnson & Johnson kind of fudged the numbers a bit when they reported their testing to the FDA, but just enough to get approval for the patch – which comes out to about half of the actual levels the patch releases. After receiving FDA approval for the patch, with their false data, Johnson & Johnson went on to market the patch, reporting this same low estrogen level to the public.

For the next five or six years at the beginning of this decade report after report was filed with the FDA of cardiovascular related deaths associated with this patch. During this time Johnson & Johnson was running their own tests and finding these same dangerous results, over and over again. Of course, Johnson & Johnson didn't really think it was quite their responsibility to report these findings to the FDA – not until the FDA finally started poking their heads around. Finally in 2005 the company began to publish the actual estrogen levels of their patch on the packaging and prescriptions soon fell by about eighty percent. Not before, however, this drug had already killed around 40 people and done who-knows-what other kind of damage to the women using the medication.

Now, a bunch of those people are suing Johnson & Johnson over damages. Things aren't going well, though. Some similar cases brought before the Supreme Court last year ended up being ruled in favor of medical device manufacturing companies, holding that if the FDA has approved a device then the company cannot be held responsible for any ill effects of the device. This is a legal concept called 'pre-emption.' President George Bush and his administration, in their ever continuing effort to protect the citizens of the United States, are strong advocates of pre-emption and are fighting for drug companies to be protected by this kind of legal loopholing.

See what I mean by not knowing where to start? That took forever to write, I hope it wasn't too painful to read all that, for those of you still with me. Let's move on and talk about these facts before we go into fact-intake shock.

So, here we have a drug company purposefully lying to the government to get its drug approved, then proceeding to lie to the public about the harmful effects of the drug once they have received approval from the FDA. We have a company that obviously saw enough reason, over the years, to continue running tests on their drug to see if it is quite as dangerous as the deaths among those people taking the medication would seem to suggest, and then went on to hide the findings of these tests. This company, however, refuses to take responsibility for their actions, even going so far as to claim that they "acted responsibly" in these matters.

We have a public that wants to hold this company responsible for their actions. A public that, even if they were so inclined to do gobs of research to protect themselves from unsafe medication, could not make an educated decision about the product because the drug company did nothing short of lie about the estrogen levels of the drug and its possible side effects.

We have a court system that, in the very heart of laissez faire capitalism, refuses to regulate the destructive actions of companies and is willing to protect corporations from all responsibility for their actions. All of this in complete contradiction to the reason the courts were established: to protect the private citizens of this great nation.

All this brings us to the FDA. Why did they drop the ball on this? Well, that is a very interesting question. It doesn't take much research into the FDA (in fact, this New York Times article even talks about it) to find that even the FDA thinks they are doing a horrible job. The FDA is not a policing organization, you see. For a matter of fact, they are barely an organization at all. They themselves claim that they are underfunded, disorganized and impotent.

The FDA, my fellow citizens, actually does not do much testing of new foods and drugs on their own – they just do not have the budget. The FDA actually relies on the individual companies that create these products to do their own testing. Since the FDA does not have the man power or budget to check over all this testing there is a certain amount of trust required that those companies will accurately and truthfully report their findings to the FDA when seeking approval. This trust, it would seem, is not something we should take for granted.

So, one has to ask themselves, why is there always enough money in the Federal budget to toss bombs at foreign countries, but not enough money to actually protect the citizens of America from the dangerous and destructive actions of those companies among us that will do anything to bring in more and more money -- enough budget to ensure an FDA that can audit enough tests to keep Americans safe? Are our congress and president so blind as to not see the dangers in this situation? It would seem so – or it would seem that these people we elect to protect us are profiting from turning a blind eye in some other form.

Which brings us to our compassionate, brave, and all round upstanding President George W. Bush. A man who, it seems, at every opportunity presented to him weighs his options carefully, does some serious soul searching on what path would be the best for the people of our country, and then chooses the most morally appalling option among his choices. If this was just one incident I would not be so strong with my words. Our President, however, has demonstrated a will to cement his place as the most despicable president in the history of the United States – choosing over and over again to put the people of the United States second, and the interests of large corporations at the forefront of his policy.

Once again I am forced to come to you, fellow readers, and call on you to write your congressperson. I call on you, in all decency and humanitarianism, to use your voices to form a loud public outcry against these kinds of policies that literally sacrifice citizens of our nation on the altar of the economy. I call on you to do what our goverment cannot -- and will not ever be able to do -- to hold corporations responsible for their (im)moral actions! And I call on you to stand up and demand your voices be heard and to not surrender until we have a government for the people, by the people – instead of a government for corporate interests, by corporate whores.