Chairman and Founder of MJH Life Sciences

Mike Hennessey Sr.

As we know, the pandemic brought the topic of clinical trials to the forefront of the general population. Never before have people been exposed to daily news from the mainstream media on clinical trials, the therapies in trials for COVID-19 and the need to have data that supports efficacy and safety of these therapies, which are generated from clinical trials. Further, when Moderna briefly halted its vaccine trial to ensure that data from broad, diverse populations was included, did people understand the importance of trials including all population groups. The clinical trials industry itself has struggled with the inclusion of underrepresented groups for some time and is not blind to this multi-faceted problem.

 explores what the term "diversity" can mean when studying different populations. It also points to technologies used in decentralized trials as a way to reach underrepresented populations and allow them to participate in a clinical trial. If we struggle to include an underrepresented population in clinical trials, then those who suffer from rare diseases could certainly be a part of such a discussion. In another article, we learn that rare disease patients were disproportionally affected with healthcare access during COVID and that technologies could improve both their access to healthcare, as well as clinical trials. We have also included an article that informs on the five ways that decentralized trials can positively impact clinical trial diversity.

We applaud industry stakeholders—sponsors, CROs, investigative sites, and technology providers—on focusing their attention on the diversity and inclusion issue. Many have come forth with important programs and resources to improve the situation. However, as Pfizer executives penned in a 

, "Racial and ethnic disparities in clinical trial populations remain unacceptably abundant, and trust in the health-care system among those who suffer racial injustice is low. It is difficult to find a trial and the requirements for participants are often burdensome, contributing to unacceptably high dropout rates." They call on the stakeholders "to find common solutions that build trust and address the socioeconomic barriers to clinical trial participation." They elaborate on the specific commitments to improve clinical trial access and build trust, and to improve awareness. Hopefully, the articles in this issue will help industry in these endeavors.

, Chairman and Founder, MJH Life Sciences

Articles

Chairman and Founder of MJH Life Sciences, Mike Hennessy Sr. explores the main discussion points covered in the June issue of ACT. 

Clinical Trials Diversity and Inclusion

In March 2020, the United States was in the early stages of the COVID-19 pandemic. We shut the entire country down and grounded the economy to a halt in an effort to slow the spread of the virus. Think back to March, and how much uncertainty we were living under.

Nine months later, the FDA approved two COVID-19 vaccines under emergency authorization. Before New Year’s Day, millions of Americans had received the vaccine, including frontline physicians, healthcare providers, and nursing home patients—our most vulnerable citizens.

Nine months. Take a moment to let that sink in.

The mainstream media has crafted a narrative around the COVID-19 pandemic that’s almost entirely negative. For the purpose of ratings, they have described the US response to the pandemic as blundering from one mistake to the next. This narrative is false.

There is another way—a more accurate and underappreciate way—to tell the story of the last nine months. It is a story of heroism, innovation and precise science, performed under unbelievable pressure.

Let’s not mince words: The United States, and the world, need to appreciate the role of the pharmaceutical industry—the researchers, physicians and business leaders—who are rescuing the world from COVID-19. It’s the medical breakthrough of our lifetime.

Instead of dwelling on why many in the media are ignoring this, let’s review some facts.

Since the discovery of COVID-19, here is what scientists have accomplished: They identified a novel virus, unlocked and sequenced its genetic code, created new therapies to save lives, and developed two safe and effective vaccines using messenger RNA technology, a technology hopefully applicable to future vaccine development. Margaret Liu, MD, a member of the MJH Life Sciences COVID Coalition, called it a breakthrough for mRNA vaccines.

The United States has two vaccines approved for emergency use, one from Pfizer/BioNTech and another from Moderna. The AstraZeneca/Oxford vaccine has been approved for emergency use in the UK. In addition, there are 64 vaccines undergoing clinical trials at the moment, including 20 in Phase III trials. In the United States and around the world, the pharmaceutical industry has answered the call and invested heavily in this effort.

This was the fastest vaccine development program in history, and it’s not even close. David Pride, MD, a microbiologist at the University of California San Diego, estimates that vaccines typically take 10 to 15 years to develop. Until the COVID-19 pandemic, the fastest development timeline was four years, for the mumps vaccine.

Many government systems moved quickly to lessen the burden of onerous regulations and provide funding so that vaccines could be developed quickly but with still rigorous standards. Perhaps it should be a lesson to all of us that regulation/innovation can be calibrated more effectively during “normal” times as industry races to develop new therapies for our world’s other pandemics—cancer, diabetes, heart diseases, and more.

The next step of the process—distribution of the vaccine—will be as challenging as the development phase, if not more so. But again, the pharmaceutical industry is rising to the occasion. Factories around the world are working in overdrive to produce hundreds of millions of vaccine doses.

Already, less than a month after the Pfizer vaccine was approved, more than 15.4 million doses of vaccine have been distributed across the country, and more than 4.6 million people have received their first dose, according to CDC data. Many patients are already receiving their second dose.

While 15.4 million doses are impressive, some expected 20 million doses. But even that is moving the goal line a bit, as six months ago many observers didn’t think we’d get a vaccine until 2021.

Members of our COVID Coalition told us that the holidays slowed the rollout considerably. Nancy Messonnier, MD, a physician with the National Center for Immunization and Respiratory Diseases at the CDC, expects a rapid jump in administered vaccines during these first few days of 2021. 

Every day, more people will be vaccinated. After health care workers and our most vulnerable citizens, other frontline workers will be next. Teachers will be vaccinated so our children can return to school. And soon, all Americans will be able to go to their doctor or walk into a CVS or Walgreens and receive the vaccine.

Remember, we did all this in nine months, with the help, dedication and expertise of our pharmaceutical industry heroes. Next time you turn on the TV and see negativity, turn it off and imagine instead where we will be nine months from now.

Mike Hennessey Sr., Chairman and Founder of MJH Life Sciences, pushes for the celebration of the pharmaceutical industry after nine grueling months of fighting COVID-19.

Mike Hennessey Sr.

Articles

Clinical Trials Diversity and Inclusion

How Pharmaceutical Innovation is Saving the World