06Jun

The publicity around the current COVID vaccine clinical trials has done much to make the public aware of the difficulties researchers face to ensure the safety and effectiveness of the therapy being tested.

Besides the now well-known need to recruit participants representing all age groups, races, and other demographics, clinical trial managers also have to be on the lookout to avoid what the pharma community has come to call “professional study subjects.”

These individuals are so eager to participate in a clinical study they lie about their medical condition, misrepresent their lifestyle, fail to disclose medications they take and may participate in more than one, even several studies simultaneously.

Eric Devine, PhD, assistant professor of psychiatry at Boston University School of Medicine, says, “I was doing clinical trials and I was running into people who were just lying to me. It was blatant when I looked at their medical records.”

Money is what motivates most professional study subjects, according to a Medscape report. Many trials pay participants, enabling some to earn thousands of dollars. One man who entered an Alzheimer’s trial legitimately earned $31,000.

Others may be driven to participate because of free medical treatment. The Medscape report mentions one woman who lied to get into a trial involving botulinum toxin. “I wanted to get into the study. I wanted free Botox, so I participated. And I got paid — so why wouldn’t I?”

study of the problem published in 2013 found 75% of the subjects who had participated in at least two trials in the previous year admitted concealing some important medical information:

  • 32% hid health problems
  • 28% concealed their use of prescribed medications
  • 20% failed to disclose their recreational drug use
  • 14% reported pretending to have a health condition in order to qualify.

Even when these professional study subjects have more altruistic motives, their deception can skew trial results. If enough of these types of study subjects manage to enroll – and the estimate is that as many as 25% of volunteers apply in a way that violates trial criteria – the results can be skewed.

Medscape says misrepresentation can be serious enough to “invalidate outcomes and even halt further research.”

Subject registries exist to attempt to catch the professional subjects. When detected, these individuals can be entered in a registry. Recently, these registries have begun to incorporate biometric data to foil the professional subjects who have used fake identification.

“That can sound very ‘Big Brother-ish’,” Devine says. “But think about the quality of our information — it can either be lifesaving or not. Do we really want to take a chance with medicine as a science, and leave it up to ‘Well, I hope we didn’t have too many professional subjects in this trial?’ “

Photo by Mehmet Turgut Kirkgoz on Unsplash

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Jun 6, 2023

What’s the Difference Between the COVID Vaccines?

With the approval last month of the Moderna vaccine by the Food and Drug Administration, we now have two COVID-19 vaccines available. Two more – one from Johnson & Johnson the other from AstraZeneca – are on the way and could be approved as soon as February.

Healthcare workers, residents of nursing facilities and some first responders have already received the Pfizer vaccine, the first one approved by the FDA. Moderna has begun shipping its vaccine with the first of the 25 million initial doses administered last month.

People eager to be immunized have inundated doctors’ offices and clinics asking when the vaccine will be available. The best answer is soon.

Which one, though, will you receive? And does it make any difference?

The answer to the first question is whichever vaccine can be obtained the quickest or, in some cases, whichever your health plan recommends. It really doesn’t make any difference to you.

Both vaccines require two separate doses to reach maximum effectiveness 21 days apart for Pfizer and 28 days for the Moderna version. Both protect about equally well. The FDA data shows Pfizer is 95% effective after both doses. Moderna is 94.1%.

Unlike most other vaccines, these two vaccines use pieces of protein from the SARS-CoV-2 virus to prompt the body to create antibodies. Conventional vaccines, like the annual flu shot, are manufactured from viruses typically grown in chicken eggs. These chicken grown viruses are then killed or weakened to become vaccines.

The COVID vaccines employ messenger RNA (mRNA), a newer technology. These vaccines “teach” the body to replicate the little bit of the CoV-2 protein, which, in turn, creates an immune response causing the body to make the antibodies that provide the protection against the virus.

The most significant difference between the Moderna and the Pfizer vaccines is how they must be stored. Both can survive for a few days in standard refrigeration. For longer periods, the less stable Pfizer vaccine must be kept in ultra-low temperatures below -94 F. That makes shipping and storing Pfizer’s vaccine somewhat more complicated, especially outside urban areas where the low temperature refrigeration is not easily available.

“At the end of the day, these two vaccines are pretty similar,” Dr. Thomas Russo, professor and chief of infectious disease at the State University of New York, tells Health. “Grab it while you can.”

Photo by Hakan Nural

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