Down's Syndrome Prenatal Test Found Fraudulent

I have written a number of articles on the fraudulent clinical trials performed on drugs. They are released out into the marketplace, only later to recall them because of serious and deadly side effects. It is not only drug manufacturer's that are involved in fraud and deception. The Sequenom Company is another example of research fraud.

The Sequenom Center for Molecular Medicine: This company is based in San Diego, CA. SCMM designs and manufactures tests involving genotyping, prenatal screening tests, methylation detection, and clinical tests. Clinical tests are used to determine the effectiveness and safety of drugs and procedures. The prenatal testing market is worth 2 billion a year and more to companies like Sequenom.

The Down's Syndrome Pre-Screening Test Hailed As Amazing Technology.

This companies research was focused on a test that pre-screened for Down's syndrome. Once that test was passed by the government, their next step was to design new tests using the same technology to pre-screen for Edward's and Patau Syndrome. In January, 2009 the clinical trial for the test was hailed to be 99 percent effective to pre-screen for Down's Syndrome. There were press releases and lots of stir in the scientific community. Share holders came on board with their support and checkbooks. Money flowed and everyone was happy. This test would have been used by parents to determine if the child they were carrying had the birth defect of Down's syndrome. In some cases, finding out this information would have led to abortion of the baby. I just really want to drive home, how drug clinical trials and testing procedures impact lives and cause death.

Hailed Test and Company Executives Falls into Disgrace

Someone blew the whistle on the research, and investigators found significant flaws in the effectiveness of the test. The shareholders, in response to the uncovered fraud fired the President, CEO, the Senior Vice President of Research and Development, and three employees. The CFO resigned on his own. Most of the top people were involved. They were found to have failed to supervise the test properly. The effectiveness and results of the test overall were in serious question as well.

This year, Sequenom paid 14 million to settle the lawsuit instituted by its shareholders who lost a fortune on the deal. Then more trouble came with the Securities and Exchange Commission. The company executives are in trouble for insider trading. They knew the stocks would fall once fraud was discovered. Another company, Xenomics, is also suing them. Xenomics is involved in the licensing procedures for these tests. They are suing them for $300 million dollars, saying the test was never real just a scam. This allegation still has to be proved but considering the investigations already, they have a good chance for winning their suit as well. As consumers, we were blessed that this fraud was discovered before it was released and used by trusting patients. In many cases, it is months or years before the fraud and deception is discovered. This is usually after the company has made billions off of the product.

How would you have felt if you had aborted your child on the findings of this test? You would never know for sure whether your child was affected with Downs or not. This is the problem of abortions based on genetic testing. Sometimes it is based on reliable technology and sometimes it may not be. These tests are basis for couples making moral and ethical decisions that impact their unborn child's life, their life, and heart forever. Those decisions may cause guilt, grief, and remorse for years to come. These company executives ought to be put in jail, not just lose their jobs. The fraud they perpetrated could have resulted in unnecessary abortion and grief to the family involved. If you are going to have genetic testing, ask questions about the testing procedure and how long it has been used. Ask if there is information on how reliable it has been. Research the company and see what you can find. Give it all the due diligence you can before accepting the results.

References:

www.signonsandiego.com/news/2010/mar/16/sequenom-cites-progress-problems-key-test/

http://www.signonsandiego.com/news/2009/jan/29/1b29sequenom00582-sequenom-hails-its-prenatal-diag/

San Diego Union Newspaper, Business section, page C3, March16th, 2010