A great consumer safetyÂ concern with theÂ FDA (Federal Drug Administration)Â drug approvalÂ process is the sheer number of manufacturer products coming to market.
Before pharmaceuticalsÂ come to market there is an extensive FDA safety-approval processÂ whereÂ billions of R&D (Research & Development) dollars are spent to ensure consumer safety.Â Â However,Â It is also true thatÂ much of the FDAâ€™s budget is greatly dependent upon the pharmaceutical products and services industries.Â TheÂ pharmaceuticalÂ industryÂ also sustainsÂ 10â€™s of thousands of other government, private sector and special interest jobsÂ throughout our health care system.Â Is there a conflict of regulatory and product interestÂ over consumer protections?Â Only you can make that determination based on your medical condition and needs.
Are drugs that createÂ health risk conditions with â€œlittle-to-noâ€ health benefits really necessary?Â Â Is our drug approval processÂ regulatingÂ an acceptable life extension vs. death rate scenario asÂ aÂ cost-of-doing business?Â Â Have the drug companies and the FDA caused an unacceptable level of illness, disease, death and class action lawsuits as aÂ cost of doing business?Â The answer to these questions really depend on who’s shoes your standing in.
It would appear, â€œpatientsâ€ have becomeÂ part of an animalÂ experiment. Â Human studies are now disguisedÂ as aÂ â€œfree pass to marketâ€ process that incorporates reuse of the same drug(s), previously pulled from consumer use and then relabeled Â under differentÂ brands known asÂ â€œOff-Market Labelsâ€ to treat conditions that were not initially approved by the FDA.
Have we become the little white ratsÂ for Off-Market Label drug trials?Â Â Are Off-Market Label drug policies part of what’s breaking our healthcare systems back?Â Since there are too many ways in which these questions could be answered, it is best to list and identifyÂ drugs that haveÂ caused significant healthÂ problems for the consumer and then you decide.
Listed below is 5 of the 41 most dangerousÂ prescription drugs with class action lawsuits .Â Â These drugs have caused serious health problems for patients and even death.Â Â As long asÂ 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 allowsÂ bad drugs into the marketplace.Â If this â€œbusiness as usualâ€ approach does not change, further erosion ofÂ our health careÂ industries and consumer safety problems willÂ continue.Â Â Â ToÂ move forward with suchÂ relabeling drug practices and policies willÂ cost everyone moreÂ if oversight does notÂ include the rightÂ types of checks and balances.
Five out of 41 Most Dangerous Drugs in Class Action Lawsuits.Â See following Link: http://www.legallawhelp.com/safety_and_health/defective_drugs.html
â€œAccutane:Â Â Lawsuit 2010-09-30 â€“ This was an approved FDA, â€œaward winningâ€ 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.Â There are now many problematic side-effect and deaths as a result of use.Â Some of the serious side-effects include but not limited to:Â Bowl disease, psychosis, hepatitis, pancreatic, myalgia, raised blood glucose, etc., And birth defect rates are extremely high when proper screening before prescription occurred. Â Â 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.â€ Â http://accutanelawsuit2010.net/
â€œVioxx and Bextra:Â Approved by the FDA – A new study links certain painkillers to High Cholesterol, 13 Feb 2007.Â 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.Â This increased the possibilities of blood clot and stroke.Â Lipid loads in the body when using this anti-arthritic pain alleviation drugs were shown to increase leading to cardiovascular issues with pain patients.â€Â http://vioxx.pharmaceutical-lawsuits.com/
â€œKetek:Â An anti-biotic was linked to liver failure and other problems.Â Originally Ketek was approved by the FDA to treat sinusitis and bronchitis.Â Because of the problems it was no longer allowed for use by the FDA as originally intended.Â However, in 2004 was approved to treat pneumonia outside of a hospital or nursing home.Â 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 â€œhis superiors forced him to soften his unflattering review of the drugs.â€ http://www.newsinferno.com/legal-news/ketek-lawsuit-filed-in-illinois-says-sanofi-aventis-knew-of-liver-failure-side-effects/
â€œZyprexa:Â Approved in 1996 and has been used for years to treat schizophrenia and bipolar disorder.Â Clinical trials have shown this drug to cause weight gain and diabetes.Â The CDER is known by prominent medical clinical research professional(s) regards the pharmaceutical industry as the FDAâ€™s(agency) main client.Â 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.Â However there is evidence that off-label marketing is not as strong as it use to be.Â 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.â€Â http://www.coreynahman.com/atypical-antipsychotic-lawsuits.html
â€œRosiglitazon (Avandia):Â Â Approved by the FDA â€“ A type 2 diabetes drug approved for diabetes 2 use in 1999 caused some patients to have heart attacks.Â Â Rosiglitazon is an oral anti-diabetic drug that increases insensitivity to insulin.Â After patients experienced, heart problems, liver failure, weight gain, low blood sugar and fractures the FDA put out a warning on the drug.Â In 2005 the Canadian Medical Association Journal reported that Rosiglitazon caused partial blindness in 7 patients.Â In 2007 a press release stated women that used Avandia showed increased signs of upper arm, feet and hand fractures.Â In 2009, there is â€œno increaseâ€ in hospitalizations or death in comparison to those taking metformin with sulfonylurea.Â Â But there were increases in heart failure and deaths for those taking Avandia.Â The drug is still in use today and some patients are beginning to file lawsuits.â€Â http://www.avandia-injury-lawyer.com/index.php?gclid=CKbgwZyUr6QCFQsSbAodPibP0w
It appears the drug industries are now focused on â€œOff-Label Plusâ€ meaning to reduce or minimize false statements, or kickback incentives that would cause serious risk to patients.Â 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 â€œwithout FDA approval!â€
The individual drug companies run these off-label research programs in a research setting funded by our government.Â This creates quite a lengthy mess during off-label prosecutions. Â Research programs are causing our government to pay for more uses of drugs than it should through numerous individual Medicaid State agencies.Â This off-label product-to-market channel is creating a complicated medical lawsuit nightmare for all parties involved.
There areÂ multiple-billion dollar; multi-national CompaniesÂ withÂ millionsÂ of â€œOff-Label Plusâ€ claims throughout our nation.Â AÂ major consideration in lawsuit cases is if research and development experts, physicians andÂ pharmaceutical sales reps have mislead the public trust, or the FDA in any serious way.Â 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:Â 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 Iâ€™ve provided aboveâ€¦ Â Learn all you can about the drug(s) and lawsuits, talk to your doctor and determine if there are better alternatives out there.Â 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:Â Marc T. Woodard, MBA, BS Exercise Science, USA Medical Services Officer, CPT, RET.Â 2010 Copyright, All rights reserved.Â Revised: 24 November 2013.Â Mirror AthleteÂ Corp., Publishing @: www.mirrorathlete.org, Sign up for your free eNewsletter.
Have we become the little white rats supporting the Off-Market Label drug trials as drug products are expedited for use in the marketplace? And is this why our prescription drugs have a ridiculously high cost: â€œFactor cost of class action lawsuits; off-label product marketing costs and FDA blind-eye policy and underwriter kickbacks to give a green light on a free pass to market.â€ Are Off-Market Label drug policies breaking our healthcare systems back? Is there anything that can be done about it?
I suppose we are all somewhat in a national experiment when it comes to the pharmaceutical world. I mean, there’s a drug for everything and it cures absolutely nothing. There’s so many brand names, it’s no wonder we’re all confused with what is doing what. Out with the old, in with the new. This industry is a money maker at our expense.
Clancy you are right on target. Also, don’t forget the other industry player in all of this “attorney class action law suits.” Too much money to be made in all directions. Don’t think the Off-Market Label drug policies are going to change anytime soon.
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 Iâ€™ve provided aboveâ€¦ 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.