Close this search box.
Close this search box.

Falsified Drug Testing Data No Hurdle For FDA Approval

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

An investigation at the Houston Laboratory of Cetro Research by FDA agent Patrick Stone uncovered activities of misconduct, tampering of files, and manipulation of five years worth of test data. The FDA agent was made aware of the alleged prohibited activities after an employee raised the alarm. On arrival at the Houston Lab, Stone informed the testing facility’s President China Pamidi of the gravity of the inquiry resulting in employees at the lab producing years worth of data from corrupt test trials.

The result of such a discovery means that over one hundred drugs currently available on the market are for sale without any assurance of their safety or efficacy. The FDA chose not to disclose which drugs were approved for sale based on the Cetero Houston’s drug tests and trials. This action is in contrast to the European Medicines Agency (EMA) which removed seven Cetero tested drugs on learning of the practice violations.

Reliability of such testing is essential in order to determine specific dosages required which is essential for those patients who use anti-seizure and blood thinning medication. Data is also used to maximize effective treatment whilst also playing an important part in minimizing side effects of already debilitating drugs such as chemotherapy medication. It has recently been revealed that one drug which used data from the Houston Lab trials was the chemotherapy drug Temodar. Crucial tests were carried out at the Lab to determine the dosage to be administered with regard to its injectable version. If the dosage is underestimated patients could be administering levels of the drug which allow the cancer to continue to grow.

In response to discovering Cetero’s violation of the FDA’S Good Laboratory Practice Guidelines, the FDA demanded drug makers reanalyze and repeat Cetero’s tests. However, without a directive to recall or stop manufacturing, deadlines were disregarded with only 53 drugs making submissions, 6 months past the deadlines set. What’s more is only 21 of the 53 submissions made have been reviewed by the FDA leaving a gap on the market where drugs are being sold without any scientific evidence supporting their claim to treat various ailments. In refusing to release the names of the Cetero tested drugs, the FDA is failing in their obligation to US consumers to provide a transparent drug approval service. While the EMA assured European consumers by producing evidence of why they believe certain medicine’s benefits greatly outweigh their potential risk, the FDA has allowed labels containing data from Cetero testing to remain on drugs being sold.

Marc Scheineson, attorney for the defendant Cetero referred to the FDA’s actions as “overkill,” leading to the demise of the testing laboratory when it was forced to file for Chapter 11 bankruptcy in 2012. The Laboratory opened under new name ”Pracs Institute,” which soon also had to close due to bankruptcy.

In spite of the relief caused by the closure of the Houston Lab, data from the laboratory still remains in scientific journals and is relied upon by the medical community with co-editor in chief of “Cancer Chemotherapy and Pharmacology” admitting he was only made aware of the laboratory’s tampering when a reporter contacted him.

Related Posts