May 11, 2017 – San Diego, CA — A new American Medical Association study released on May 9, 2017 illustrates that, in our opinion, the FDA is either broken or fails to study new drugs adequately before being sent to the market.
The study looked at new drugs approved by the FDA from the years 2001 through 2010.
The study found that 32% of these new drugs had some type of post-market safety event (side effect). Three drugs were pulled from the market in recalls, and 61 were assigned FDA Black Box warnings, which is the most severe warning from the FDA. Many times after a black box warning is issued, the next step is a recall.
71 drugs approved by the FDA were later found to have 123 safety events. This is simply absurd. Why must the American people be the testing ground for these new drugs?
The FDA is trying to fast track these new drugs to the market. Is it pressure from Bug Pharma looking to increase its ever growing revenue? Or is the FDA so bloated as a bureaucracy that it simply can’t keep up?
Regardless of the politics on the issue, the bottom line is that we the people are now being the guinea pigs for drug companies. Our safety is at risk. The public should demand that all drugs being reviewed should have longer testing periods and or a larger study group to insure that these new drugs are indeed safe for the public at large. 
It usually takes a drug company 5 years to get a new drug to the market. Drug companies perform their own clinical trials then submit to the FDA. This may seem like a long period of time, but when the study points out the 32% of new drugs have problems, maybe this is too short of a development process. Now our new administration lead by President Trump wants to make this process even faster!
What is the FDA GRAS list? (Generally Recognized as Safe)
Just reading the Generally Recognized as Safe makes me wonder what this actually means. So let’s get the answer from the FDA website:
“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.
In my mind this entire GRAS system is simply a well let’s just wait and see if something happens to people. Again this illustrates that the FDA isn’t truly serving the American people. Given that people tend to trust the medication that they take, most are not completely aware of the risks that they may be facing.
Marketing to Doctors versus Research and Development.
Another problem that most people don’t know is the fact that Big Pharma spends more money marketing to doctors, than on research and development. What’s wrong with the picture?
Examples of Drug Marketing Cost versus Research and Development include:
- Johnson & Johnson spent $17. 5 billion on marketing in 2013 versus $8.2 billion in R&D
- Pfizer spent $11.4 billion versus $6.6 billion in R&D.
- GlaxoSmithKline spent $9.9 billion versus $5.3 billion in R&D.
Most of these marketing dollars are directed at doctors, and not the general public.
As noted on Last Week Tonight with John Oliver on this topic, Oliver puts it this way:
“Ask your doctor today if he’s taking pharmaceutical company money. Then ask your doctor what the money is for, ask your doctor if he’s taken any money from the companies who make the drugs he just prescribed for you. Then ask yourself if you’re satisfied with that answer.”
Another study released a few days ago mentioned that when teaching hospitals don’t allow pharmaceutical sales reps in the building, the doctors don’t prescribe those drugs. Are we seeing a pattern here?
Every drug recalled by the FDA was once approved by the FDA.
Drug recalls can be by a company’s own initiative, by an FDA request, or by the FDA under statutory authority. Recalls by the FDA are classified as either: Class I, Class II and Class III.
Class I recalls means there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
There have been numerous drugs over the years that have not only had severe side effects, but many that have in fact led to a person’s death. A quick view of Wikipedia shows a large list of drug recalls dating all the way back to 1960.
Examples of recent large drug recalls includes:
- 2010 Darvon/Darovcet – risk of heart attacks and stroke.
- 2010 Mylotarg – risk of death.
- 2010 Avandia recalled in Europe – risk of heart attack and death, still sold in US!
- 2010 Meridia – risk of heart attack and stroke.
- 2008 Trasylol – risk of death.
- 2007 Zelnorm – risk for heart attack, stroke, and unstable angina.
- 2004 Vioxx – risk of myocardial infarction and stroke.
- 2004 Bextra – risk of heart attack and stroke.
Who stands up for the People’s Rights? Who fights Big Pharma?
It’s well known that Big Pharma is collectively a massive and powerful group of companies with combined earnings in the billions. They are the number one lobbying group in Washington DC and they continue to pressure or government to ease back regulations pertaining to them.
Consumers who are harmed by the use of defective medications and who attempt to stand up for themselves soon realize that they are up against a corporate behemoth with billions of dollars at their disposal. These resources are often put to use by way of retaining extremely skilled defense attorneys and other professionals whose job is to protect the legal and financial interests of their clients. Simply put, an individual consumer working without legal help against a worldwide corporation is not a fair fight.
Lawyer Richard Hood
The defective drugs lawyers at the Hood National Law Group have been leveling the playing field for consumer clients in these matters across the United States for decades. We have taken on several enormous corporations and earned positive results because we understand how to hold wrongdoers accountable.
If you or someone you love has suffered as a result of trusting any of these medications, contact the defective drugs lawyers at the Hood National Law Group, today to schedule a free initial consultation.
Sources:
http://jamanetwork.com/journals/jama/article-abstract/2625319
https://www.fda.gov/drugs/drugsafety/drugRecalls/default.htm
