Is the FDA Really Our Protector?

A recent television news show featured a controversial artificial fat that the Food and Drug Administration (FDA) had approved.  When a woman in a grocery store was approached by the news commentator and asked what she thought about this new product, her comment was probably what many people were thinking at the time: "Well, if the FDA has approved it, it must be safe."

While the FDA is supposed to an impartial government watchdog organization, an automatic vote of safety can often be far from the truth.  Consumers expect to be protected from the greedy corporations out there who are trying to make huge profits as food and drug manufacturers. 

In truth, the FDA is a politically-driven machine that is largely controlled by these same manufacturers.  The drug approvals given by this group sometimes have more to do with political maneuvering  and power and less to do with the how effective or safe a food or drug may be. 

The bottom line here?

It may be unwise to assume that a label of "FDA Approved" means the product can be taken without concern.

Those FDA-approved drugs are said to be killing at least 140,000 people a year - and that is just in hospitals!  At the same time, the FDA is spending millions of dollars interfering with the firms that sell natural supplements, products that have not harmed or killed anyone. 

Tales exist of armed FDA agents charging through the doors of alternative health practitioners with their guns drawn.  Files are confiscated and the owners are taken to court.  Why?  Because these people were selling a vitamin in a manner not approved by the FDA.

Researchers claim that absolutely no people have been killed by taking nutritional herbs and supplements which were prescribed by their alternative health care practitioners.  Yet 384 people die every day (and remember, this is just in medical institutions) because they took drugs approved by the FDA. 

Then again, one might want to recall how many thousands of women have children with reproductive cancers because the mothers took the drug known as DES during their pregnancy.  Or the children who have missing limbs because their mothers willing took thalidomide.  And there are the women who took estrogen in the 50s and 60s thinking they would remain young longer.  In truth, the grim reaper is knocking on their doors as they struggle with reproductive cancers.

One recent example of the FDA's level of concern for the general population's health is the drug combination known as fen-phen (fenfluramine/Pondimin and phentermine or dexfenfluramine /Redux), which was prescribed to millions of women to aid in weight loss.  This was despite the fact that this combination was not approved by the FDA.  Phentermine is an amphetamine-like drug (also known as speed) while dexfenfluramine and fenfluramine are Prozac-like drugs that raise serotonin levels, offsetting the jitteriness caused by the phentermine.

This under-studied drug combination was being handed out like candy to women who needed to lose some weight while the FDA chose to look the other way.  When evidence came out of Europe (where the combination had been used for a longer period of time) that the drug could cause pulmonary hypertension in a small percentage of women, the FDA simply held press conferences that reassured women their "obesity" was more of a risk than the fen-phen.

Eventually the Mayo Clinic discovered that a certain group of women were stricken with an odd and potentially deadly heart valve damage had all been taking fen-phen.  Even then it took the FDA months to request that the manufacturers pull this deadly product off the shelves.

A sad reflection on this commentary is that when fen-phen was under consideration by the FDA for approval, it was almost not approved because in high doses the drug was causing brain damage in laboratory animals.  The FDA also knew at that time that it could cause pulmonary hypertension. 

After the fen-phen episode the diabetes drug Rezulin came on the scene.  This product is implicated for the deaths of 391 people due to liver damage.  The number of people who now have non-0fatal cirrhosis of the liver because of this drug has not been tallied.  One can guess it is probably significant.  Before the drug was finally banned in 2000, the FDA eventually told doctors in the U.S. to monitor the liver functions of their patients when they were prescribing this drug.

A popular statin drug called Baycol (used for cholesterol control) was recalled in 2001 after causing at least 31 deaths through a deadly, muscle-wasting disease. 

The FDA has recently been under pressure from drug companies and their Washington lobbyists to "speed up" the drug approval process.  To accommodate, the FDA has initiated a "fast track" approach to drug approvals whereby new drugs are making their way more quickly to people suffering from AIDS and other diseases which have no conventional cures through current medications.

The downside of this new FDA mandate is that dangerous drugs have even more potential for slipping through for approval.    The number of post-approval drug recalls has recently risen from 1.56 percent to 5.34 percent of all approvals. 

How serious is this?

A study published in the May 2002 edition of JAMA states that 20 million patients were exposed to five drugs that were withdrawn between September 1997 and September 1998 because of the possibility of serious side effects.  Again, that is ONE YEAR - and 20 million people.

Your best bet?  Do not use a drug that has not been on the market for at least 10 years.  Of course, alternative health care practitioners believe you are healthiest when avoiding prescription drugs altogether.

It is also important to know that all products labeled "natural” or "alternative" may not be safe or effective.  There is a lot of good information on the internet regarding supplements.  Be wary of any product that claims to cure just about anything without any history or biochemistry to back it up. 

Also, what works for one person may not work for another.  If you take a product and feel worse instead of better, or if you have a negative side effect, stop taking it and consult a health care professional. 

Each person is unique.  Listen to your body.


Posted in Is the FDA Really Our Protector?

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