A great consumer safety concern with the FDA (Federal Drug Administration) drug approval process is the sheer number of manufacturer products coming to market.
Before pharmaceuticals come to market there is an extensive FDA safety-approval process where billions of R&D (Research & Development) dollars are spent to ensure consumer safety. However, It is also true that much of the FDA’s budget is greatly dependent upon the pharmaceutical products and services industries. The pharmaceutical industry also sustains 10’s of thousands of other government, private sector and special interest jobs throughout our health care system. Is there a conflict of regulatory and product interest over consumer protections? Only you can make that determination based on your medical condition and needs.
Are drugs that create health risk conditions with “little-to-no” health benefits really necessary? Is our drug approval process regulating an acceptable life extension vs. death rate scenario as a cost-of-doing business? Have the drug companies and the FDA caused an unacceptable level of illness, disease, death and class action lawsuits as a cost of doing business? The answer to these questions really depend on who’s shoes your standing in.
It would appear, “patients” have become part of an animal experiment. Human studies are now disguised as a “free pass to market” process that incorporates reuse of the same drug(s), previously pulled from consumer use and then relabeled under different brands known as “Off-Market Labels” to treat conditions that were not initially approved by the FDA.
Have we become the little white rats for Off-Market Label drug trials? Are Off-Market Label drug policies part of what’s breaking our healthcare systems back? Since there are too many ways in which these questions could be answered, it is best to list and identify drugs that have caused significant health problems for the consumer and then you decide.
Listed below is 5 of the 41 most dangerous prescription drugs with class action lawsuits . These drugs have caused serious health problems for patients and even death. As long as Off-Market Labels continue, so will an acceptable rate of death and class action lawsuits.
The FDA is under a tremendous amount of pressure from oversight committees, consumer watch dogs and other advocates against the current drug-to-market protocols and regulatory bodies that allows bad drugs into the marketplace. If this “business as usual” approach does not change, further erosion of our health care industries and consumer safety problems will continue. To move forward with such relabeling drug practices and policies will cost everyone more if oversight does not include the right types of checks and balances.
Five out of 41 Most Dangerous Drugs in Class Action Lawsuits. See following Link: http://www.legallawhelp.com/safety_and_health/defective_drugs.html
“Accutane: Lawsuit 2010-09-30 – This was an approved FDA, “award winning” vitamin A derivative to treat various forms of cancer highly effective at mitigating and killing the spread of cells in the pancreas, brain and nevoid basal cell carcinoma syndrome. There are now many problematic side-effect and deaths as a result of use. Some of the serious side-effects include but not limited to: Bowl disease, psychosis, hepatitis, pancreatic, myalgia, raised blood glucose, etc., And birth defect rates are extremely high when proper screening before prescription occurred. Legal action is the result of either party(s) wrongly prescribed, or misunderstood use of, or detailed information of potential risks/brochures, or a signed consent form of understanding of pharmacist was not accomplished per prudent protocols.” http://accutanelawsuit2010.net/
“Vioxx and Bextra: Approved by the FDA – A new study links certain painkillers to High Cholesterol, 13 Feb 2007. Pain killers known as COX-2 inhibitors (Vioxx and Bextra) at the time of the study were shown to increase excess cholesterol for lack of purging it from the body. This increased the possibilities of blood clot and stroke. Lipid loads in the body when using this anti-arthritic pain alleviation drugs were shown to increase leading to cardiovascular issues with pain patients.” http://vioxx.pharmaceutical-lawsuits.com/
“Ketek: An anti-biotic was linked to liver failure and other problems. Originally Ketek was approved by the FDA to treat sinusitis and bronchitis. Because of the problems it was no longer allowed for use by the FDA as originally intended. However, in 2004 was approved to treat pneumonia outside of a hospital or nursing home. The statements made by former physician David Ross who worked on pre-approval for FDA at Center for Drug Evaluation and Research (CDER) after 10 years stated “his superiors forced him to soften his unflattering review of the drugs.” http://www.newsinferno.com/legal-news/ketek-lawsuit-filed-in-illinois-says-sanofi-aventis-knew-of-liver-failure-side-effects/
“Zyprexa: Approved in 1996 and has been used for years to treat schizophrenia and bipolar disorder. Clinical trials have shown this drug to cause weight gain and diabetes. The CDER is known by prominent medical clinical research professional(s) regards the pharmaceutical industry as the FDA’s(agency) main client. Off-label marketing (specific falsities as to the side effects of a drug) for anti-psychotic drugs used to sedate nursing home patients kills approximately 15,000 a year. However there is evidence that off-label marketing is not as strong as it use to be. Off-label use also means that prescription drugs may be used to alleviate other symptoms or conditions but not approved for use by the FDA.” http://www.coreynahman.com/atypical-antipsychotic-lawsuits.html
“Rosiglitazon (Avandia): Approved by the FDA – A type 2 diabetes drug approved for diabetes 2 use in 1999 caused some patients to have heart attacks. Rosiglitazon is an oral anti-diabetic drug that increases insensitivity to insulin. After patients experienced, heart problems, liver failure, weight gain, low blood sugar and fractures the FDA put out a warning on the drug. In 2005 the Canadian Medical Association Journal reported that Rosiglitazon caused partial blindness in 7 patients. In 2007 a press release stated women that used Avandia showed increased signs of upper arm, feet and hand fractures. In 2009, there is “no increase” in hospitalizations or death in comparison to those taking metformin with sulfonylurea. But there were increases in heart failure and deaths for those taking Avandia. The drug is still in use today and some patients are beginning to file lawsuits.” http://www.avandia-injury-lawyer.com/index.php?gclid=CKbgwZyUr6QCFQsSbAodPibP0w
It appears the drug industries are now focused on “Off-Label Plus” meaning to reduce or minimize false statements, or kickback incentives that would cause serious risk to patients. In many cases some patients that have no other choice get treated with drugs that were originally intended and approved for a completely different use “without FDA approval!”
The individual drug companies run these off-label research programs in a research setting funded by our government. This creates quite a lengthy mess during off-label prosecutions. Research programs are causing our government to pay for more uses of drugs than it should through numerous individual Medicaid State agencies. This off-label product-to-market channel is creating a complicated medical lawsuit nightmare for all parties involved.
There are multiple-billion dollar; multi-national Companies with millions of “Off-Label Plus” claims throughout our nation. A major consideration in lawsuit cases is if research and development experts, physicians and pharmaceutical sales reps have mislead the public trust, or the FDA in any serious way. While in many other cases, if the off-label process were to be put to a halt, many patients may lose their life, while at the same time many lives may be saved. http://www.policymed.com/2010/07/pharmaceutical-marketing-lawsuits-slowing-considerably.html
Recommendation: If you are taking any prescription drugs, and especially if that drug is one of the 41 class action lawsuits drugs found at the link I’ve provided above… Learn all you can about the drug(s) and lawsuits, talk to your doctor and determine if there are better alternatives out there. All too often, many of us tend to continue taking the same drugs for many years without physician follow up consultation to determine if health risk outweighs the benefits of using any particular, or combination of pharmaceuticals.
Author: Marc T. Woodard, MBA, BS Exercise Science, USA Medical Services Officer, CPT, RET. 2010 Copyright, All rights reserved. Revised: 24 November 2013. Mirror Athlete Corp., Publishing @: www.mirrorathlete.com, Sign up for your free eNewsletter.