There are so many things we are misinformed about and even if you do not want to believe me, at least inform yourself. Information is but a mouse click away these days. Develop an inquiring mind –ask questions and teach your children to do so. All too many of us are following mainstream media, which breeds misinformation. Be especially cautious when an industry stands to make a huge amount of money from the “life-saving” products they produce.
Like many others in academia and the medical research environment, I used to believe that the FDA looks after our best interests. They are put in place so that they can direct what food is good and healthy for us and what drugs are safe. Consumers are constantly told how complicated it is to get a new drug on the market. After all, researchers have to jump through all sorts of hoops to assure safety before new therapies are approved for the public, right? Then why are there so many drug recalls? Also, let us not lose sight of the fact that adverse drug reactions are the fourth leading cause of death in America. How is that possible with the FDA as the watchdog?
You need to understand that the FDA views the industry as the client, so they serve the industry and not the public- the very people they are supposed to protect. The documentary “Money Talks: Profits Before Patient Safety” points out exactly how much pull Big Pharma has within the FDA. “More than half of the budget of the drug approval division of the FDA is funded by the drug companies. Therefore, “the watchdog is largely drugged.” This documentary also touches on the direct level of financial dependence the FDA has on the pharmaceutical industry. Agency jobs and funding are sustained by the monetary success of new or existing drugs. This conflict of interest significantly jeopardizes public safety.
Before a drug is approved the FDA looks at efficacy and safety. When looking at efficacy, the FDA assumes that the drug doesn’t work and the drug company has to prove them wrong. When they look at safety it’s entirely the opposite. Here the FDA assumes the drug is safe and now it’s up to the drug company to prove that the drug isn’t safe. Seriously? What company on earth is going to try to prove that their drug isn’t safe? There’s no incentive for the companies to do things right. The clinical trials that are done are too small, and as a result, it’s very unusual to find a serious safety problem in these clinical trials. Safety flaws are discovered after the drug gets on the market.
The Vioxx drug safety catastrophe
A case in point when it comes to the FDA’s inability to protect the public is the arthritis drug Vioxx. The FDA approved Vioxx even though one of its researchers Dr. David Graham indicated that the drug causes cardiovascular disorders. After enduring various forms of intimidation by senior FDA officials and being accused of scientific misconduct Dr. Graham blew the whistle on Vioxx. A staggering 88 000 – 139 000 people suffered heart attacks or strokes from Vioxx before it was withdrawn from the market. The insanity however is, one week before this drug was pulled off the market, it was approved for children. So do you still think the FDA protects the public?
Efficacy means it is more effective than a sugar pill
To determine if a drug is effective the drug is compared against something called a placebo or a sugar pill. It’s something that doesn’t have a medical effect. The assumption is that the drug will be no different than the sugar pill. The FDA puts the onus on the drug company to conduct a clinical trial to show that the drug is different from a sugar pill. The drug does not necessarily have to have a very great effect to be approved. For instance, the drug might lower your blood pressure by just a few millimeters of mercury, but the FDA will say we can approve it because it does lower your blood pressure. The company then markets this drug like it is the latest breakthrough medicine and through clever and misguiding advertising many patients and doctors will use this drug.
So, my question to you is, are you willing to take, or give a drug to your child that may be slightly more effective than a sugar pill, but could be as deadly as Vioxx?
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