A top health fraud prosecutor recently said that clinical trial fraud will be a priority of the DOJ. At a Food and Drug Law Institute conference last month, the deputy assistant attorney general characterized the DOJ's enforcement of clinical trial fraud cases as aggressive.
He noted that.
Clinical trials pose significant risks to the American public. The FDA relies on clinical trial data to make drug approval determinations, with the ultimate goal of ensuring that all FDA-approved drugs are safe and effective.
The Consumer Protection Branch of the DOJ brings criminal and civil actions to enforce health and safety related laws.
There are many sham clinical trials, such as the Gonzalez Regimen for cancer, Burzynski's antineoplastons, and what seems like thousands of acupuncture trials.
The research that was done was called the "Unlimited Medical Research".
According to the DOJ, a Miami, Florida, company was hired by a pharmaceutical firm to conduct a clinical trial to investigate the safety and efficacy of an asthma medication in children. Employees of the company faked records to make it appear as though children made scheduled visits to the research center, received physical exams from a clinical investigator, and received payments for their participation. Children were not given exams, they did not take the study drugs, and they were not paid. There were no children in the trial and the employees faked it to get the pharmaceutical company to pay them more money. The doctor used patients' personal information from her private medical practice to create false information for the trial.
The purpose of the study was to measure the long-term safety of the asthma medication Advair Diskus. The results were published in a journal. The prosecutions were due to the fact that after it became aware of possible misfeasance by Unlimited Medical Research, it excluded the fraudulent data from studies and reports and reported its suspicions to the FDA and Institutional Review Boards.
You will see that there is more than meets the eye in the published study and response to the fraud.
Five people were charged in the scheme. The medical doctor was sentenced to 60 months in prison and ordered to pay $174,000 in forfeiture after pleading guilty to one count of conspiracy to commit wire fraud. The study coordinators was sentenced to 30 months in prison after pleading guilty to conspiracy to commit wire fraud. One person is scheduled for trial this year.
A Coral Gables, Florida, medical doctor, a nurse practitioners, and two others were indicted last March on charges of wire fraud and money-laundering. The defendants fabricated clinical trial data while working at a Miami medical clinic. Opioid drugs were the subject of fraudulent trials.
The indictment charges that the defendants lied about the trial participants taking the drugs when they weren't, and that they knowingly enroll subjects that failed to meet eligibility requirements. Drugs under study were tossed and fake profiles were created using personal information from friends and family.
The nurse practitioners was sentenced to 46 months in prison and his co-conspirator to 30 months. They were ordered to pay over two million dollars. The third person will be sentenced next week.
Two additional recent incidents of alleged criminal clinical trial fraud not mentioned in Rao's speech came to light in researching this post, courtesy of an international group of experts who run Rxisk.org.
There is an independent website where you can research prescription drugs and report drug side effects when it is still possible to find a solution.
A 19-count indictment was returned by an Ohio federal grand jury in July of 2020 against eight defendants who worked for a company called Clinical Research Solutions. A trial is going to be held in July.
According to the DOJ, the defendants, one of whom is an MD specializing in allergies and immunology, agreed with pharmaceutical companies to conduct clinical trials of various drugs. The defendants broke the law.
The defendants are accused of faking medical records, faking informed consent forms, and other documentation for fictitious study subjects.
The schemes are despicable, but they pale in comparison to the fraud carried out by the man, who was sentenced to death for his part in the trial fraud.
He directed his companies to pose as legitimate human clinical research trial sites and provide false clinical research trial data to dozens of drug companies and the FDA. The false clinical research data included safety data on dozens of different drugs and medicines designed to treat a wide variety of diseases and conditions.
The doctor who trained as a doctor in Pakistan but was not licensed in the U.S. forged the signatures of the doctors he employed to admit ineligible research subjects. They stole blood from patients of his medical center, obtained blood from employees, and fabricated diary entries. The employees of Anwar and his company stole the study drugs and recorded them as having been given to study subjects.
A three-year-old girl with atopic dermatitis was participating in a study for a new medication. She was scarred permanently by the medication. A teenager was hospitalized for attempting to kill himself after being involved in a study of a smoking cessation drug. A man died while participating in two trials.
Employees testified at his trial that he directed the fraud but also engaged in threats, retaliation and intimidation to hide his crimes. They testified that they were threatened at their homes and at work, and that they slashed their tires in order to prevent them from cooperating with the authorities.
A federal jury found Anwar guilty of 47 counts of wire fraud, mail fraud, conspiracy, fraudulently obtaining controlled substances, and giving false material information to the Drug Enforcement Administration. He was sentenced to over 28 years in prison and his companies were ordered to pay more than $7.5 million in forfeitures and compensation, the judge remarked that the fraud was "astounding" and that he had "endangered countless lives". He has appealed his conviction.
How did they get away with it?
The website I mentioned earlier, Rxisk.org, offers an interesting insight into how egregious fraud can happen in the first place.
The kind of research that gets published in top peer-reviewed journals is what these people were doing.
The frauds went undetected for a long time, as the Ohio firmCRS worked for seven companies before the eighth noticed something wasn't quite right. The CEO of Tellus Research used the company account to buy herself a Range Rover.
When the FDA closed down the Zain Research, Sami Anwar opened a new research center in the same town and was hired again.
How did that happen?
Johanna Ryan wrote that the answer is "Contract Research Organizations: the Ubers of clinical research". She says that most pharmaceutical giants rely on Contract Research Organizations (CROs), large commercial brokers that recruit and manage the hundreds of local sites and doctors in a "gig economy" of medical research. CROs offer help with everything from designing the studies to writing up the research papers and pitching the newly-approved drug to doctors.
She compares the doctors who work as independent contractors to drivers who work for companies like Door Dash and Deliveroo. If the drive is dangerous or the pizza arrives cold, the pizza parlor can deny responsibility and claim it was the driver's fault. Contract doctors provide similar plausible deniability for pharmaceutical companies. Thus.
When Dr. Bencosme was arrested, the system allowed the company to place themselves as victims not suspects.
The asthma drug trial was conducted by Parexel and Dr. Bencosme, who was charged with fraud, in the first place.
Ryan points out that it is unlikely that any of the authors in the NEJM article are in academic medicine.
They gave an inhaler to a patient and watched what happened.
It is good to know that the DOJ is focused on clinical trial fraud, but if Ryan is correct, the drug trial system is ripe for abuse by unethical players. The DOJ can only come in and clean up the crime scene if the system is reformed.