The Dangers of FDA Regulated/Approved Compounds vs. OTC Supplements or Homeopathic Drugs
Before a new FDA approved drug appears on the pharmacy shelf, it goes through a long process of testing that takes an 
average of 12 years. It also costs about 350 million US dollars to move that new drug from the scientific laboratory to the consumer’s reach. Once a company develops the new drug, it undergoes about three and a half years of laboratory testing before applying to the U.S. Food and Drug Administration (FDA) for further testing in humans. This strict regulatory process can be grueling and financially taxing for a company eager to get its product to market. Yet, having a mandated approval process offers consumers the reassurance of knowing that the non-prescription or prescription drug they have been encouraged to take has the FDA seal of approval, and therefore must be safe. But, is it really safe?
Americans want to trust their doctors, the medical community and the government that the drugs they are taking for treating disease, relief of medical conditions and/or for pain management are going to give them significant benefits that outweigh any health concerns. Unfortunately, there are often many associated risks with these drugs, and also many harmful side-effects that are later discovered after these drugs have gone through the lengthy, intensive FDA approval cycles…things that just are not manifested until released to the wider public. Vioxx, a non-steroidal anti-inflammatory drug (NSAID), is an example of one of these drugs that resulted in disappointment, mistrust and in some cases, hysteria after the manufacturer, Merck pulled the drug off the shelves. Marketed to treat osteoarthritis and acute pain conditions, Vioxx was approved by FDA in May 1999. The drug gained widespread recognition with over 80 million people taking the prescription drug based on their physicians’ recommendations for relief of arthritis and other conditions causing chronic or acute pain. In September 2004, Merck & Co. withdrew the drug from the market based on risks of heart attack and stroke. This had a major impact on the medical field and the public since it was one of the most widely used drugs to be charged with causing serious health risks, especially after having had a market presence for five years. Why was this health concern not detected or considered earlier in the FDA approval process?
More recent news involving Acetaminophen puts FDA and one of their “approved drugs” in the spotlight again, as well as the drug manufacturers who make Tylenol, Vicodin and Percocet, and other pain relief and cold medications with this harmful drug present in the ingredients.
As cited in a recent WSJ article by Melinda Beck, “Taking Pains with a Painkiller”, July 8, 2009, “This isn’t the first time the FDA has grappled with the acetaminophen problem. In 2002, an advisory panel recommended that over-the-counter products containing the drug be clearly labeled on the front of the package. But it took until December 2006 for the FDA to propose such a rule, and until April 2009 for it to go into effect.” Meanwhile, acetaminophen has been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s (stated by the FDA). In 2007, a report from the Center for Disease Control and Prevention estimated that the pain relief medication was also the likely cause of 1,600 acute liver failures each year. These statistics make it very difficult for the consumer, as well as manufacturers, to fully trust in the FDA approval process initially described above as being effective in determining safety.
What’s the alternative? There are natural supplement and homeopathy companies that deliver safe and highly effective over the counter (OTC) drugs for the same medical conditions and pain relief, minus the negative side-effects and health risks linked to FDA approved medications. They may not be government regulated, since such products are not currently required to receive FDA approval, but many follow best practices in safety and manufacturing, have received compliance under drug and supplement standards, and most of all, these more natural products aren’t killing people! Some of the biggest advantages to those who have made the switch to natural/holistic supplements, is the low hassle of finding a solution to your ailment(s), without needing an insurance card or written prescription from a doctor’s office, and finally due to the ease of mind knowing that the substance you are ingesting is natural, rather than of synthetic compounds with levels of high-toxicity.
However, is this enough assurance for people who are familiar with the traditional protocol? There are many Americans spending billions of dollars annually on natural supplements and natural products known as an alternative to more common FDA approved drugs. Still, some are concerned that there’s no guarantee that all of these “natural” alternatives are safe either. The consumer should review the information on packaging regarding claims and ingredients and any drug interactions with other medications. They also should investigate what type of safety and toxicity testing has been done by the manufacturer, and any QA / QC guidelines that are in place (i.e. quality assurance / quality control).
As FDA-regulated products continue to pop up in the news with harmful findings that have been discovered after-the-fact of approval, it’s a perfect time to consider safe, effective alternatives. Many who have given up on the old standards due to health concerns or because they found that the common pain meds just didn’t work as well, are now happily pain free and/or content knowing they have choices of products that are non-toxic to the body and completely safe.
1 comment July 17th, 2009