The news of a bright possibility of finding magic bullets to significantly tame, if not totally annihilate Covid-19, is coming almost every passing day. As expected, these are being initiated mostly by drug companies, alongside various academia, located in several countries of the world, including India. It rekindles hope to return to some kind of normalcy in daily life, work and business.
However, the hype created around each of these, either too early or based on some anecdotal reports, apparently driven by the desire for a windfall commercial gain, may be counterproductive. That some remedial measures to tackle the notorious virus will come very soon, could influence a number of decisions of those who are engaged in managing the situation.
The pressing need to restart the economic activity – come what may, even before the first wave of Covid-19 subsides in a developing country like, India, comes along with a strong storm signal. Balancing life with livelihood has never been so difficult ever. In tandem, it poses a great challenge also for the pharma industry to demonstrate what it stands for the society, such as:
- Bringing scientifically proven, safe and effective drugs and vaccine, in a specified timeframe falling close to the realm of a genuine possibility.
- Making these drugs and vaccines available, at an affordable price and accessible to all, globally.
In this article, I shall focus on the relevance of these two critical expectations of all, where, incidentally, pharma is expected to do and deliver the very best – particularly against the prevailing and near-chaotic scenario. Let me begin with the first point first.
A great challenge:
Understandably, the above task is not a piece of cake due to many reasons. For example, according to a leading pharma trade association in the United States, ‘On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average.’
Thus, logically, a new drug molecule for Covid-19 can’t possibly be expected, by any stretch of imagination, within the next 12 to 18 months. What one can possibly expect for the same is, repurposing older drugs for the same. Quite logically, steps are being taken in this direction. However, even for such drugs, a clinical trial would take ‘six to seven years on average.’ Considering the urgency to combat the Covid-19 pandemic, can a fair clinical trial be completed in the next 12 to 18 months?
Therefore, the challenge in hand for the drug companies, even considering a super fast-track regulatory assessment and approval in 12 to 18 months, appear a pretty tough proposition. The challenge gets more complex, if Covid-19 starts changing.
A new issue is unraveling:
Recently, a new dimension got added to the mounting challenge of coming out with an effective drug or vaccine to fight Covid-19 pandemic, as evident from the Bloomberg article of May 20, 2020. It carries a headline ‘China’s New Outbreak Shows Signs the Virus Could Be Changing.’
It reported, Chinese doctors are seeing the Coronavirus manifest differently among patients in the new cluster of cases of their northern provinces of Jilin and Heilongjiang, compared to the original outbreak in Wuhan. Apparently, it indicates that the pathogen may be changing in unknown ways, complicating efforts to manage the infection. Although, more details need to be unraveled in this area, this incident could flag a fresh uncertainty over the virus mutation that may hinder current efforts of developing safe and effective drugs and vaccine for Covid-19.
Still no available drugs and vaccine for Covid-19 with proven clinical efficacy:
‘The Lancet’ article of April 02, 2020 – ‘‘Global coalition to accelerate COVID-19 clinical research in resource-limited settings’ has also emphasized the above point. It reiterated, there is still no available vaccine against Covid-19 infections and no drug with proven clinical efficacy, although there are several candidates that might be effective in prevention or treatment.
As of March 24, 2020, there were 332 COVID-19 related clinical trials, 188 of which were open for recruitment and 146 trials are preparing to recruit. These clinical trials were either planned or being carried out, mostly in China, South Korea, Europe and North America. However, not many trials were planned in south and southeast Asia, Africa, and central and South America at that time, the article pointed out. But the hype for the availability of drugs continues to reverberate, generally in the media reports. Nevertheless, the work is still in progress.
Some unproven hype as on date?
Despite so much of publicity on availability of drugs for the treatment and prevention of Covid-10, starting from Chloroquine and Hydroxychloroquine, which the US President Donald Trump called a “game changer” for Coronavirus – right up to Remdesivir, none has demonstrated scientifically proven clinical efficacy, as yet.
For example, the latest clinical trial results for Covid-19 on 15000 people, published in The Lancet on May 22, 2014 found, hydroxychloroquine and chloroquine did not benefit patients with the Coronavirus, either alone or in combination with an antibiotic. Moreover, the drugs caused an increased risk of cardiac arrhythmia. Earlier, ‘The BMJ’ article of May 14, 2020 also found that the administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard care alone in mild to moderate Covid-19 infections. This study also noted, adverse events with the recipients of hydroxychloroquine were higher than non-recipients.
On the other hand, in India, as reported on May 23, 2020, the Union Health Ministry has issued an advisory expanding the pool of people to be given the anti-malarial drug hydroxychloroquine (HCQ) as a prophylactic to prevent them from contracting the infection.
Similarly, even Gilead had stated in its Press Release of April 29, 2020: ‘Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19,’ besides some initial success reports. Notably, in India, Union Health Ministry has also recommended the use of anti-HIV drug combinations Lopinavir and Ritonavir for high-risk group patients, although there is no proven clinical evidence for its efficacy and safety in Covid-19 patients, if not against the use of this combination therapy.
Commercial activity progresses even before evidence-based regulatory approval:
Although, a single clinically proven drug is yet to come out, commercial activities for some of these drugs – in a near desperate situation – based apparently on hype created, including by the US President, have progressed or progressing. This had happened for hydroxychloroquine and has now started happening for remdesivir.
Almost every passing day one finds yet another repurposed drug being put on clinical trial by a different company, probably for similar reasons. There is nothing wrong on that, but which drugs work and which do not, must be evaluated in a more cohesive manner and sooner.
The good news is, the World Health Organization (WHO), which is concerned with recommendations for ‘administering unproven treatments to patients with COVID-19 or people self-medicating with them,’ has announced the “Solidarity” clinical trial for the new Coronavirus treatments. This is an international clinical trial, aimed at the scientific assessment of 4 treatment options to slow the disease progression or improve survival rate for COVID-19 patients.
Otherwise, a strong desire for people to survive – ‘somehow’, will prevail in this desperate situation, over what these medicines can actually deliver. Even drug companies never experienced in the past or even could even envisage such a pandemic at this humongous global scale.
A similar scenario is witnessed with some major vaccine development initiatives. For example, stock markets soared with the early signs of viral immune response of the much publicized experimental Covid-19 vaccine being developed by Moderna Inc. However, a few days later, after ‘parsing the data to gauge the company’s chances of success’ by the analysts, it was reported: ‘It’s too soon to assume success for Moderna Inc’s COVID-19 vaccine.’ Curiously, it continues to happen in the early days with almost all such well publicized initiatives. Nonetheless, the pursuit to find out safe, effective and clinically proven drugs and vaccine continues.
Which is why, bringing scientifically proven safe and effective drugs and vaccine sans the early hype, in a specified time, falling close to the realm of a genuine possibility, becomes a key deliverable of pharma players, in this situation. That said, it brings me to the second point where pharma and biotech companies are widely expected to meet the other expectations of all – making these drugs and vaccines available, affordable and accessible to all, globally.
Making Covid-19 drugs and vaccines available, affordable and accessible to all, globally:
Again, this seems to be an equally tough call for most drug players, as has been happening, generally. But Covid-19 drugs and vaccines are just not for saving life, these are also intimately related directly to the livelihood of a very large global population, especially in the developing nations, like India. Therefore, ‘Coronavirus vaccine should be for everyone, not just those who can afford it,’ as articulated in the article, published in the STAT news on March 05, 2020.
This apprehension arises among many in the United States, as well. Mainly because, as reported in the above article, vaccine coming out of the two vaccine development projects funded by the U.S. government, one by Sanofi and another by Johnson & Johnson, may not be affordable to all Americans.
Further, quite a number of countries in the world lack resources, infrastructure, and health care personnel to detect the virus and prevent it from spreading quickly and easily among populations. In which case, without drugs and vaccines, the number of cases is likely to grow exponentially, putting stress on already burdened health care workers and facilities. Consequently, it will make harder to provide timely care for those who are ill. Thus, vaccines will be an important tool for preventing such a catastrophe.
For those with resources – ‘rich countries and rich people,’ a Covid-19 vaccine will certainly be valuable to save lives. However, for most people in all countries, including India, it may be essential for the livelihood, as well. Without it, they will suffer disproportionately and unnecessarily, the article concluded. Thus, in this hour of multiple crisis of global dimension, the drug players are expected to come forward, making these drugs and vaccines available, affordable and accessible to all, globally – a task where they can deliver the best, compared to others.
Amid ‘Lockdown.4’ in India, as on May 24, 2020 morning, the recorded Coronavirus cases have mounted to 131,920 with 3,869 deaths. By the way, on the same day, the most populated country in the world – China, where Covid-19 struck first in December 2019, records 82,974 cases with 4634 deaths, so far.
That apart, Covid-19 is a very special situation for all countries, probably more than what happened during the 1918 Spanish flu pandemic, for several reasons. Comparing these two pandemics, especially during the lockdown period, has been common. Due to this pandemic, as many as 675,000 people, reportedly died only in America, many of them were previously healthy young adults. Almost similar situation is on the horizon with the Covid-19 pandemic.
Agreed, that the overall healthcare infrastructure and global scientific resources to combat these two pandemics may not be comparable. But even in the context of the 21st century, this is a very critical global situation, for both – saving life and also the livelihood. Thus, for pharma and biotech companies ‘this is not a time to make money’, as the chief executive officer of Serum Institute of India, which is helping produce a vaccine for Covid-19 developed by Oxford, puts it succinctly. Be that as it may, the answer to the two questions that I started with, still remains elusive.
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.