Keeping tabs on pharma: Pfizer aims for clinical trial diversity and EMA urges public to be aware of falsified medicines in face of Covid-19 pandemic

Pfizer’s pursuit to diversify clinical trials

Pfizer has aired a TV ad in the US with an aim to undo underrepresented diversity in clinical trials.

The narrator in the ad stressed, “The Covid-19 pandemic has highlighted deep racial and ethnic disparities across the US.

“Black community’s health concerns have [long] been ignored, under-resourced, underappreciated and undervalued.”

For people of color and indigenous groups, there has typically been a number of barriers to participating in clinical trials including language barriers, distrust in the healthcare system, poor health awareness and limited access to trials.

In the US, African-Americans represent 12 per cent of the population but only five per cent are likely to take part in a clinical trial. Similarly, the Latino community makes up 16 per cent of the population but just one per cent participate in clinical trials, according to the US Food and Drug Administration (FDA).

To ensure that diverse populations are aware of and have the opportunity to participate in clinical trials, Pfizer’s ad promotes that the design of their clinical trials incorporates as much patient input as possible.

Rod MacKenzie, Chief Development Officer at Pfizer, said: “Ensuring diversity in clinical trials is a matter of equity. We've made a commitment to design clinical trials so that enrollment can reflect the racial and ethnic diversity of the countries where we conduct clinical trials and the epidemiology of the diseases we intend to treat or prevent.”

In addition, multiple efforts focused on recruiting more diverse communities into Covid-19 trials have been made by the FDA, “specifically [toward] racial and ethnic minorities, as well as adequate representation in late phase trials of elderly individuals and those with medical comorbidities”.

Covid-19 crisis boosts threat of counterfeit medicines

Restricted workforces, rationing supplies and implementing new testing protocols are just some of the effects the Covid-19 pandemic has had on pharma supply chains. These additional barriers in the supply chain have made it harder for legitimate healthcare products to be shipped out, making it easier for illegitimate goods to slip through the net.

As India is engulfed by a second wave of coronavirus infections, for example, the rate of counterfeit drugs are increasing with arrests being made in Maharashtra for fake vials of remdesivir sold for Rs35,000 (US$464), far above the official Rs2,000 ($27) price cap for the genuine product, reported the Financial Times.

Similarly, Pfizer confirmed fake versions of their vaccine were circulated in Poland and Mexico in April 2021. Polish authorities confirmed counterfeit doses of Pfizer’s vaccine were seized at a man's apartment. Meanwhile, Hugo Lopez-Gatell, Mexico's government spokesman on Covid-19, told the BBC: “Fake vaccines had been detected by cyber police after being offered on social networks for up to $2,500 a shot. Several people have been arrested.”

In response, the European Medicines Agency (EMA) has urged the general public not to buy medicines from unauthorized websites and other vendors, stating: “Vendors may claim that their products can treat or prevent Covid-19 or may appear to provide easy access to legitimate medicines that are otherwise not readily available. Such products are likely to be falsified medicines.”

To protect against fraudulent vendors the EMA has advised all legally registered online pharmacies have a common logo that confirm if a site is safe.

The EMA has said they are continuing to work with governments, law enforcement, healthcare providers and others to combat this illegal trade.

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