Contrary To The Views Of Naysayers, Covid-19 Pandemic Is Showing The Importance Of Biopharma

As the seriousness of the Covid-19 became apparent, big pharma and biotech companies to their credit immediately explored ways they could find vaccines and therapeutic agents that could be developed to benefit as many as a billion people around the world. The first out of the box was Gilead’s remdesivir. Originally developed as a potential treatment for Ebola in 2013, remdesivir was shelved as it proved inferior to other antiviral drugs that were being advanced. However, when a new coronavirus emerged, remdesivir was resurrected and found to reduce the impact of the disease in Covid-19 patients. Working closely with the FDA, Gilead was able to obtain an Emergency Use Approval for remdesivir in a mere two and a half months. Gilead is now in the process of gearing up global manufacture of this antiviral in order to deliver it globally – at a cost in excess of $1 billion.

Gilead was not alone in acting quickly. Pfizer, working with BioNTech, identified four different mRNA vaccine candidates and immediately put them into clinical trials to identify the most promising for advanced human testing. Pfizer has already begun shifting production at four manufacturing plants to make 20 million vaccine doses by the end of the year and hundreds of millions more in 2021. CEO, Albert Bourla, estimates that Pfizer will spend $1 billion to develop and manufacture a vaccine BEFORE it knows if it will work, saying “Speed is of paramount importance.”

Gilead and Pfizer are not alone. J&J, Merck, AstraZeneca, GSK, Moderna and a number of others have committed hundreds of millions of precious R&D dollars to attack this virus. In just a matter of months, at least a dozen vaccines and therapeutic agents have already entered development with more to follow. The alacrity with which the industry has responded is stunning. Furthermore, it is not as if there is a “pot of gold” waiting for whoever comes up with successful Covid-19 treatments or cures. Companies are already signaling that they don’t expect to realize significant profits as a result of these efforts.

One would expect that people would be impressed by such progress and thankful that the biopharmaceutical industry has stepped up to this challenge. Yet, in an article entitled “Covid-19 has exposed the limits of the pharmaceutical market model” , authors Amin and Malpani take an opposing view.

“If anything, remdesivir is the poster child for why we need a new model of drug development for pandemics and neglected diseases that isn’t restricted by the current market based model…… Since 2002, epidemics caused by severe acute respiratory syndrome (SARS), swine flu (H1N1), Middle East respiratory syndrome (MERS), Zika, Ebola, and other viral diseases have killed nearly 600,000 people worldwide. Yet, in the aftermath of these outbreaks, and despite clear warnings that another viral pandemic could emerge, the pharmaceutical industry failed to sustain investment into new treatments and vaccines.”

First of all, no research could have been done in advance of the Covid-19 pandemic as the virus, SARS-CoV-2, had yet to emerge. It’s hard to discover a cure for a disease that doesn’t yet exist. But, independent of that basic fact, work in new platforms for vaccine development such as the mRNA vaccines being used by Moderna and Pfizer, were certainly being worked on well in advance of Covid-19. And, as mentioned earlier, the work that Gilead did on Ebola laid the foundation for remdesivir. The authors continue.

“In today’s capital-driven market, investments in pandemic preparedness and in neglected diseases like tuberculosis and malaria are not, and have never been, a priority for pharmaceutical company drug development even though neglected diseases cause more than 2 million deaths per year, almost seven times the number of deaths caused so far by Covid-19.”

There is no doubt that neglected diseases are not a priority in biopharma. These companies have to work in areas that generate significant profits in order to survive and so they work on diabetes, depression, arthritis, cancer, etc. Yes, these are not neglected diseases but they are suffered globally. However, companies do have philanthropic efforts that do address neglected diseases such as efforts in Sub-Saharan Africa to eradicate two leading causes of preventable blindness (Pfizer’s azithromycin for trachoma; Merck’s ivermectin for river blindness). In fact, companies like Gilead, Merck and Pfizer routinely appear on lists of the most philanthropic companies in the world.

“A company executive deciding between investing in a novel treatment to address a potential pandemic threat or buying back company shares to boost a company’s stock price will probably choose the latter.”

Actually, this is a bogus point. Biopharmaceutical companies have a fixed R&D budget, usually 15% of top-line sales. This is important to note: the higher a company’s sales, the more money for investment in R&D. These funds are separate from those used building new production facilities, or increasing a sales force and yes, buying back stock. So the decision that an executive will face is: “Do I invest in the possibility that a new virus could emerge (for which we have no idea how to attack it as the virus is currently unknown), or do we invest in new ways to treat Alzheimer’s disease or heart disease?” I can assure you that the latter will win out – and rightly so.

“Gilead recently announced that it is exploring the possibility of developing an oral or inhaled form for remdesivir instead of the current intravenous application, which must be administered in a hospital. Had Gilead collaborated earlier and more broadly, scientists could have explored the viability of these delivery forms sooner, making the drug easier to use and more readily available (to) those in poor countries who have less access, or sometimes no access, to hospitals.”

So, let’s get this straight. Gilead should have been using R&D resources to develop alternative delivery forms of a failed Ebola drug that was going nowhere. And researchers would have been clamoring to do this. Really?

The real issue that the authors have with the pharmaceutical market model is not the model itself. Rather, they don’t believe in intellectual property.

“Governments are ultimately responsible for the system that incentivizes the pharmaceutical industry to behave the way it does. The last 40 years has seen a rapid global expansion of intellectual property. This has resulted in longer monopolies and progressively more privatization of scientific research and knowledge, including government-funded research done by universities. It is past time to address the proprietary issues within science and re-balance intellectual property regimes that stand in the way of public health progress.”

First of all, the rapid expansion of intellectual property over the past decades is the result of billions and billions of dollars invested by the private sector into R&D. Furthermore, there aren’t “longer monopolies” now than existed 40 years ago. Patents have always had a finite length and that hasn’t changed. Intellectual property does not stand in the way of public health progress. Without it, there IS NO public health progress. If investors don’t get an ROI, they won’t invest and R&D based industries will dry up.

If anything, the coronavirus pandemic shows that the biopharmaceutical industry is vibrant and can be very responsive to pandemics. Is it perfect? No. But, we should all be thankful we have it in times like these.