In the January 19, 2008 issue of the British medical journal The Lancet, author Samuel Lowenberg brings up a number of serious questions relating to ethics and drug trials done by the pharmaceutical industry. After reading his brief two page review, it is apparent that a major overhaul in the way clinical trials are done is in order. The trail of abuse is international in scope and has possibly caused the deaths of innocent children.
According to Tikki Pang, the World Health Organization’s director of Research Policy and Cooperation, “The trials that are being done overseas by drug companies are in a sense secret, because they do not share the information, they site confidentiality and patient protection.” He further goes on to say “Anecdotally, we have heard many, many instances in India, China and other countries of the possibility of ethical safeguards not being followed.” In Nigeria, a number of children died of an experimental anti-meningitis drug Trovan and Pfizer, according to a lawsuit, destroyed data from the trial and gave some of the children a dangerously low dose of Rocephin, a known treatment for meningitis.
It is time for Congress to enact a bill demanding that all drug trial, in the U.S. or abroad, be registered and the results must be shared with the FDA regardless of outcome. The data then must be shared with the public without prejudice and in a timely manner. The nonsense that is pharmaceutical research has got to change. People’s health is at risk and lives are at stake. They are treating third world people like lab rats and this has got to stop.
Now with the scandal involving Scheering-Plough and Merck, two pharmaceutical giants becoming the biggest news story of the day I have to comment. Do you really think that the study that Vytorin is not beneficial is an isolated incident? If you do, you are sadly mistaken. When I worked for a company that sold clinical trial software to the pharmaceutical and medical device industry, I was involved in talking to a number of researchers employed by these companies and some of the things I heard made me realize that the focus of these companies was not your health but their profits.
Here are some of the details of the Vytorin story you may not know about.
The data that showed that Vytorin was not beneficial in the lowering of the risk of heart disease was known almost 2 years ago by people at Merck and Scheering-Plough.
The CEO of Merck ??? sold $29 million dollars worth of stock in her company last year, after she had to have known the results of the drug trial. 800,000 prescriptions a week are written for Vytorin which provides billions of dollars of profit to these two companies.
Worst of all, and something that Congress will be looking into is the fact that after the drug companies found out that Vytorin wasn’t showing up as well as expected they tried to manipulate the data to change the end points which would hopefully show the drug actually worked.
It is this last issue I have my greatest concerns about. When I taught a class to a medical device company in Cleveland, Ohio, I was asked by one of the primary investigators whether they could change the data once it was entered into the program. I made sure they understood that this would be illegal and immoral as well. Often times, I found out that many researchers (not all) in the pharmaceutical industry manipulate data end points and use other statistical machinations to create findings that are positive instead of properly studying results and reporting good and bad regardless of the financial ramifications.
With the recent research saying that there is no link between autism and thimerasol in mercury it was apparent that the researchers manipulated the end points to come up with a result they wanted to come up with. They claim that there was no relationship because there is no change in autism rates recently since thimerasol was removed from vaccines. Problem is that the number of years since the mercury laden vaccines have been removed are not sufficient to see a change in autism rates. Most autism is diagnosed at 4-5 but the removal of thimerasol was only done 2-3 years ago so how could they see a difference. This is known as changing the end point to create a result you want. It is immoral and dangerous.
It is time the FDA and our government do what they are charged with doing, protecting the citizens from dangerous drugs. The pharmaceutical industries money first attitude needs control and must be stopped. It is time for a major overhaul of the drug research and approval system.