There is probably not a person alive in the United States today that doesn’t know how quickly the pharmaceutical industry moved to develop a COVID-19 vaccine. When President Trump and Dr. Fauci announced that a vaccine could be developed and approved within a year, many were skeptical. It had never been done.
By early 2021, nursing home patients and healthcare workers were rolling up their sleeves for Pfizer-BioNTech’s coronavirus vaccine.
Medical News Today tells us that it typically takes 10 to 15 years to develop a vaccine. So how were several vaccines rolled out and approved in less than one year?
Much of the answer was round-the-clock research and testing by drug companies and independent labs. But no matter how quickly a vaccine may be developed, the FDA still requires extensive clinical trials to make sure the vaccine works and is safe. Those drug trials are conducted by the pharmaceutical companies themselves, often with the help of private labs and testing companies.
In the United States, along with much of the world, we rely on the pharmaceutical industry to police itself. The FDA reviews clinical trial data but doesn’t conduct the actual trials.
The official FDA drug approval process is typically as follows:
First, a pharmaceutical company develops a new drug and seeks to have it approved in the United States.
Second, the drug is often tested on animals to get some initial data on efficacy and safety. Assuming the animal trials go well, the next step is a phase 1 trial on humans, typically 20 to 80 healthy people volunteer. We say healthy because the phase one trial is focused on safety.
Next comes a phase 2 trial that usually involves hundreds of volunteers. While every trial always focuses on safety and any reported side effects, the phase 2 trial is most concerned with efficacy. Does the new drug work?
Assuming the risks are acceptable and the drug appears to work, the final phase of human testing, phase three, involves thousands of volunteers. Here the drug company looks at dosage and interaction with other medications.
At all times, the companies involved with the testing are required to report to the FDA which scrutinizes all aspects of the trials.
Once the clinical trials are complete, the drug company and FDA will work together on a complex new drug application process and review.
The central element to the entire process is accurate clinical trial results. While there have been very few documented cases of fudged results, these incidents do happen. And when they do, patient lives are at stake.
Today it can cost over a billion dollars to roll out a new drug. For a few companies, the temptation to cut corners is simply too great for. Either they lie about the effectiveness of the drug or worse, hide / minimize adverse reactions. This week a federal judge sent two people implicated in a false clinical trial data scheme to prison.
Justice Department / FDA Prosecutes Two Clinical Trial Workers
Eduardo Navarro, a Miami nurse practitioner, and Nayade Varona, a study coordinator from Port St. Lucie, were sentenced to prison on August 11th. Both men were convicted of falsifying results in a clinical trial of a drug being developed for irritable bowel syndrome.
The case began in February when a federal Grand Jury indicted four men including a physician. All four were associated with a company called Tellus Clinical Research. According to the Justice Department, the defendants “knowingly enrolled subjects in clinical trials when those subjects failed to meet eligibility criteria, falsified subject laboratory results, falsified subject medical records, and falsely represented that subjects were taking the drugs being studied when in fact they were not.”
In announcing the indictments, the Justice Department said, “The public must be able to rely on the accuracy and honesty of clinical trial data, which is essential to ensuring the safety of drugs approved for patient use. The defendants undermined that process and put patients at risk. The Department of Justice will pursue and prosecute those who put personal profit before public health.”
The indictment does identify the pharmaceutical company associated with the drug or the complicity of that company.
Whistleblower Rewards for False Clinical Trial Data
Although the FDA maintains a tip line for people wishing to report fraud, they have no formal whistleblower reward program. That doesn’t mean whistleblowers can’t receive a reward, however.
If the drug being developed is actually on the market and is approved for reimbursement by Medicare, Medicaid or Tricare, there may be rewards based on the amount of federal spend. Assuming the whistleblower reports the fraud before the FDA approves the drug, there may be a reward from the SEC if any of the companies are public companies or subject to the SEC’s jurisdiction. Obviously, an SEC reward is a bit more tenuous but no shareholder or investor wants to be associated with a company that is putting lives at risk.
While the prosecution of the four Tellus Clinical research employees is important, even more important is the FDA’s statement that they intend to vigorously prosecute anyone who produces or submits false clinical trial data to the FDA.
Do You Have Inside Information About False Clinical Trial Data?
Both the Justice Department and SEC can pay rewards of up to 30% of whatever monies are collected from wrongdoers. To qualify for a reward, one generally must be the first to file (meaning don’t wait) and have inside or “original source” knowledge of the fraud.
To learn more, visit our Pharmaceutical Fraud and SEC Whistleblower Program information pages. Ready to see if you qualify for a reward? Contact is online, by email or by phone at 202-800-9791. Pharmaceutical whistleblowing cases accepted worldwide. All inquiries protected by the attorney – client privilege and kept strictly confidential.