Conventional Medicine the Right Choice?Essay title: Conventional Medicine the Right Choice?Is Conventional Medicine the Right Choice?Americans are turning to a safer, affordable, and more natural means of treating ailments due to the increased number of deaths, addictions and side effects from conventional medicine. Alternative medicine offers a wider range of natural drugs and treatments with fewer side effects than that of prescription medication. The benefit is to the consumer and not to the pharmaceutical companies that continue to make large profits off of below standard drugs. The danger lies in the misconstrued clinical trials that the pharmaceutical companies conduct and the fact that the Food and Drug Administration (FDA) uses their biased opinions to approve their “safe” drug.
The Alternative Medication Treatment Act of 2004, H.R. 437, created a regulatory framework requiring that drug manufacturers, wholesalers, and patients who sell or offer non-invasive alternative therapies and/or have purchased any of the ingredients or components of any of the aforementioned therapies or subgroups of drugs must receive a safety assessment. The federal government has not approved any new forms of treatment without FDA approval. However, the FDA has approved “prescription and unapproved medical devices,” the classification by which alternative drugs are defined. Some alternative treatment agents often cause serious psychological, neurological, or behavioral impairments, and the drug companies have attempted to ban or restrict use of certain drugs or subgroups of drugs to avoid that classification. Many of the drugs are “drug-free” because the FDA has only been able to certify the availability of a drug and not a class of drugs known as “prescription and unapproved medical devices” and not “non-prescription” drugs. While there is some disagreement among a small number of physicians what is considered safe, and the actual safety of many of them is uncertain, the lack of oversight is a massive obstacle to effective and cost-effective therapy. In this post-conventional medicine perspective, we will try to answer questions relevant to the FDA’s decision make, including: What does the FDA say about “prescription and unapproved medical device” when it has not been certified to treat a specific treatment? What does the FDA mandate with all nonmedical devices sold? And, What does the FDA do when its decisions about what to do with certain non-medical drug are contrary to its policy and the law? If you have any answers the FDA needs help with, we can provide you with a step by step guide.
The FDA’s Recommendation to Manufacturers
I first met with the FDA in 1998 for an informal meeting in Washington. I learned that they were planning on issuing a “commission document” and I asked them to approve the protocol if I would. As I read along, I learned the FDA had made several statements that stated the FDA did not regulate drugs using FDA approved substances except for certain specific types of alternatives; I also learned that they did not have a clear separation of powers. My meeting with them was of good public interest and I had the opportunity to speak with the FDA director and other employees.
I also learned that on June 10, 1998, the FDA sent an “advisory publication” to the Secretary. This advisory paper was intended to address questions of safety, efficacy, safety to the FDA, and quality of existing products. From a review of the advisory and supplemental materials, it was concluded that there was no significant difference among these three items (other than the recommendation to limit usage of certain drugs among those with the FDA’s recommendation to designate certain drugs). To put it another way, the FDA advised that the FDA was making recommendations based on clinical studies that would not necessarily be consistent with the FDA’s recommendations to prevent or treat serious medical problems.
I continued reading through the advisory papers and was then informed that most of them stated they had not been reviewed by FDA. This indicated ignorance about the substance(s) that was being used, and that the
There is a variety of complementary and alternative medicine, also referred to as CAM, available to Americans that are less risky than prescription medication. “CAM is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine . . . .” (NCCAM). Complementary medicine is often used in conjunction with conventional medicine such as aromatherapy. Alternative medicine is used instead of conventional medicine such natural herbal supplements, acupuncture, and massage. These methods of treatment are becoming more popular as the prescription of choice rather than conventional medicine.
Deaths from conventional medicine have not been brought to light. Statistical evidence has been researched to prove that there have been an increased number of deaths due to dangerous prescription drugs that should have never been put on the market to begin with. “The total number of deaths caused by conventional medicine is nearly 800,000 cases per year. It is now evident that the American medical system is the leading cause of death and injury in the U.S.” (Null, Feldman, Rasio, & Smith, 2006 p.67). With such strong statistical evidence, how can the government continue to let pharmaceutical companies bully them around? Millions of Americans are dieing and no one seems to be concerned about it.
Vioxx, a COX-2 inhibitor, is one drug that is an example of extreme negligence released by the Merck & Co. and approved by the FDA in 1999.