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Covid-19: Perils Of Haste In Scientific Decision-Making Process

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Multifaceted threats posed by Coronavirus to the humanity, are getting increasingly complex, every day. Currently, Covid-19 cases in India are ‘the highest that any country has ever recorded on a single day since the start of the outbreak.’ Alongside, the hopes of billions of people – for its predictable and dependable remedies are also soaring sky high. But, despite full throttle global endeavor of scientists, the world continues waiting for scientific-evidence-based, well-proven, safe, and effective Covid-19 drugs, vaccines and other treatments.

It is expected, each of these cures and antidotes should be duly authorized by drug regulators, according to global norms – without any outside non-scientific interference – not even from the very top. Nevertheless, the reality is, as on date, besides some ‘emergency use authorizations’, all scientific pursuits in this area are Works in Progress (WIP) – some are with great potential, though.

The catastrophic impact of Covid-19 pandemic is all pervasive. So is the competition between media publications to attract maximum eyeballs, with details on many aspects of the disease and related scientific development. These include reports on intense, non-scientific pressure on scientists and regulators to make drugs, vaccines or other Covid-19 treatments immediately available for use. In this article, I shall dwell on the perils of haste in the scientific decision-making processes, while combating Covid-19.

A quick research outcome is important – based on ‘rational’ – but not ‘rash’ decisions: 

In pursuit of a quick disease treatment outcome, a rational and ethical approach in any scientific discovery process, is non-negotiable. It has always been so – while dealing with many different health crises, and should remain that way for Covid-19, as well. In my view, for achieving a prompt and desirable treatment outcome – a quick, but rational decision should always be favored – over highly influenced, contentious, non-scientific and rash decisions.

Many wise men believe, a quick decision is one, made quickly supported by irrefutable inputs of an accepted quality and scale. Whereas, a rash decision is one, made with limited, questionable or even no inputs – just based on gut feel, as it were. This broad concept is applicable to Covid-19 drugs, vaccines and other treatments, including -plasma therapy.

In the space of Covid-19 pandemic, there are several such examples, starting from hydroxychloroquine to the most recent plasma therapy – both in India, and also beyond its shores. Without being judgmental, this article will try to join some critical dots, for the readers draw their own conclusions on this issue. Let me start with two examples of this drug regulatory quagmire – the very first, and the most recent ones.

Perils of haste in the Hydroxychloroquine saga:

As I wrote in this blog that the US President Donald Trump, on March 21, 2020,  proclaimed Chloroquine and Hydroxychloroquine as potential game changers against Covid-19 global pandemic, despite doubts from the US-FDA. Interestingly, on March 28, 2020, the US drug regulator granted the emergency use authorization of these two drugs for treating Covid-19. However, it was subsequently revoked on June 15, 2020. The agency justified this action by saying:

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The World Health Organization (W.H.O) also announced: “Studies show Hydroxychloroquine does not have clinical benefits in treating COVID-19.” However, as published by JAMA on May 28, 2020,following President Trump’s naming these drugs at a press conference, Hydroxychloroquine prescriptions shot up by over 200 percent, over the previous year. Nonetheless, the prescriptions returned to normal as news highlighting the lack of enough evidence to support its use started spreading, across the globe.

Soon, India followed the same… a strange coincidence?

As stated above, on March 21, 2020, the US President Trump proclaimed Chloroquine and Hydroxychloroquine as potential game changers against Covid-19 global pandemic, despite doubts from the US-FDA. Curiously, on March 23, 2020, Indian media also reported:

‘Amid rising Coronavirus cases in the country, the national task force for COVID-19 constituted by Indian Council for Medical Research (ICMR) has recommended hydroxy-chloroquine as a preventive medication for high-risk population. According to the advisory, it should be given to high risk population — asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19 and asymptomatic household contacts of laboratory confirmed cases.’

The above protocol, recommended by the National Task Force, has been approved by the Drug Controller General of India (DGCI) for restricted use in emergency situations. This seems to have happened even before the US-FDA granted similar authorization. Intriguingly, US-FDA subsequently revoked it on June 15, 2020, for lack of enough scientific evidence, unlike the Indian drug regulator.

Another report of April 09, 2020 summed it up well. It wrote, the hype of Hydroxychloroquine – pushed by the US President Trump as a COVID-19 treatment, has now been joined by many other countries, despite inconclusive medical evidence on the efficacy and safety of the drug. Is this just a strange coincidence?

Be that as it may, India’s decision on the emergency use of Hydroxychloroquine had its rub-off financial impact in the country, in terms of increase in its export demand, which may not be an intended one, though.

Its rub-off financial impact in India:

As the world’s largest manufacturers of Hydroxychloroquine are located in India, many of these companies reaped a rich harvest in the April-June quarter, mostly, based on media reports on its use in treating Covid-19. For example, Ipca Laboratories Ltd, reportedly, garnered ₹259 Crore in additional sales, with consolidated net profit for the quarter soar threefold to ₹454 Crore, from the drug in that period.

Notably, Ipca also acknowledged, ‘HCQ sales were a one-time boost for the company. With the hype waning, after various clinical trials showed the drug did not provide any significant benefit, the company now expects sales to ease to earlier levels,’ as the report goes. Let me now move over to the most recent example.

Perils of haste in the plasma therapy saga:

Since, the third week of this month, a series of incidents related to plasma therapy highlighted the ongoing perils of haste in the scientific decision-making process. These were generally prompted by powerful non-scientific external influences, as reported below:

  • On August 23, 2020, the US President announced that the US-FDA has granted emergency approval of blood plasma from recovered Coronavirus patients as a treatment for those battling the disease. President Trump called the development “a historic breakthrough.”
  • According to Reuters, the US-FDA had authorized its use after President Donald Trump blamed the drug agency for impeding the rollout of vaccines and therapeutics for political reasons.
  • The very next day of President Trump’s announcement, on August 24, 2020, the World Health Organization advised caution about endorsing the use of recovered COVID-19 patients’ plasma to treat those who are ill, saying evidence it works remains “low quality.”
  • American scientists, including researchers at the Mayo Clinic also challenged a key statistic cited by U.S. officials as grounds for emergency approval of the treatment.
  • On August 25, 2020, US-FDA Commissioner Stephen Hahn, publicly apologized ‘for overstating the benefits of plasma for treating Covid-19 patients.’ 
  • “The US-FDA’s emergency use authorization for plasma for Covid-19 looks questionable. If this presages an early vaccine nod, we should be very afraid,” reported another article.

Similar controversy was also witnessed in India. Just days after the Drug Controller General of India (DCGI) gave its go-ahead to a proposal of ICMR for the clinical trial of convalescent plasma therapy in COVID-19 patients, the Ministry of Health said, ‘there is not enough evidence to claim plasma therapy can be used for treatment of COVID-19. Interestingly, several states, such as, Delhi, Gujarat, Maharashtra and Uttar Pradesh, have already started clinical trials for plasma-based treatment. Meanwhile, media reports, such as, ‘India sees black market boom for plasma from recovered Covid-19 patients,’ started pouring in.

Conclusion:

As recorded in the morning of August 30, 2020, total Coronavirus cases in India have reached a staggering figure of 3,542,733 with 63,657 deaths, despite all measures taken by the country. No signs of flattening of the curve are visible, just yet. In this situation, many experts believe, the way prescriptions are written for Covid-19 patients, based on anything but robust considerations, needs to be re-looked. The headline of an article, written by Richard L. Kravitz, Professor of Health Policy and Internal Medicine, University of California, Davis on July 09, 2020, vindicates this point. It said:‘When Trump pushed Hydroxychloroquine to treat COVID-19, hundreds of thousands of prescriptions followed, despite little evidence that it worked.’

Another interesting article, tried to ferret out the truth behind such haste. It voiced, ‘the truth is that researchers, academic institutions, medical journals and the media all face powerful incentives to portray the latest research findings as more earthshaking than they actually are’. The authors spotlighted, under normal circumstances, numerous mechanisms exist to blunt some of the worst over-hyping and many sources of medical information do their best to be accurate in what they report.

It is possible that in the midst of a pandemic, the urgency of the moment may overwhelm these good intentions. The above paper also cautioned, ‘Bad science can be spread far and wide by normally credible sources.” However, the bottom-line is, the scientific research community, under no circumstances, be made to comply with the thoughts and beliefs of non-scientific, but powerful decision makers. It happened in the oldest democracy in the world, as it also happened in the largest democracy on the planet earth.

The above two instances are just illustrations to highlight an important point – without becoming judgmental. The discussion spotlights the perils of haste in the scientific decision-making processes, while combating Covid-19. As many experts believe, it could be counterproductive for non-scientific power sources to influence the robust medical value creators for a quick remedy. Mainly because, patients will continue to be at the receiving end for the net outcome, of such unproven, and scientifically fragile hypes.

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.

Stem Cell Therapy in India: A Potential Game Changer in Disease Treatment

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Stem Cells (SC) offer an incredible potential to instill a new lease of life virtually to any organ of the human body, bringing them back to the pre-disease state through its own biological repair mechanism. Intensive research initiatives are on across the world to harness this unique possibility that will be able to successfully address a plethora of serious and chronic ailments for mankind. The good news is, the global scientific community is taking rapid strides in understanding the complex stem cell biology to give shape to a game changing medical treatment blue print for tomorrow.

Capturing one such pursuit, on February 21, 2017, well-reputed British news daily – ‘The Telegraph’, reported the outcome of a path-breaking medical study for freezing the progression of yet another complex and crippling ailment – Multiple Sclerosis (MS). This research followed a unique SC transplantation process. Intriguingly, both such diseases and the treatment are not generally much talked about, particularly in India. If done, it would increase public awareness and help many patients fetch greater benefits from the available and approved SC therapy in the country. Probably, considering the unfathomable scope of the body’s own repairing toolbox with SC, Prime Minister Narendra Modi reportedly called on Indian biologists to motivate school children for pursuing a career in stem cell research.

Let me now go back for a moment to Multiple Sclerosis (MS) as I am aware of this this disease condition rather closely. One of our close family friends who was a very senior official in one of the top multinational corporations of the world, had to give up his job prematurely being a victim to this serious illness. In that sense, this particular news item rekindles a new hope for many to look for a better quality of life while managing many other diseases of such kind, all over the world, including India.

‘The Telegraph’ reported: in so far, the largest long-term follow-up of SC transplantation treatment study of MS, which was spearheaded by Imperial College London, established that 46 per cent of patients who underwent this treatment did not suffer a worsening of their condition for five years. The treatment works by destroying the immune cells responsible for attacking the nervous system. This is indeed a very significant development in the space of medical research.

This new treatment, called autologous hematopoietic stem cell transplantation (AHSCT), was given to patients with advanced forms of MS who had failed to respond to other medications. However, the researchers noted that the nature of the treatment, which involves aggressive chemotherapy, carried “significant risks”.

It’s worth recapitulating here that MS is caused by the immune system malfunctioning and mistakenly attacking nerve cells in the brain and spinal cord, leading to problems with movement, vision, balance and speech. It’s a lifelong condition and often causes serious disability, with no cure still in sight. The disease is most commonly diagnosed in people in their 20s and 30s, although it can develop at any age.

A new hope with a game changing potential:

The above study of SC transplantation conducted by Imperial College London in MS, is just a recent example, among scores of major steps being taken in this frontier of medical science in preparation of a decisive battle against many more life-threatening and serious debilitating diseases.

No doubt that various treatments involving stem cells are generally considered a novel and rapidly advancing medical technology. However, in a small number of developed countries, such as the United States (US), a number medical procedures with stem cells are being practiced since around last three decades. Bone marrow transplant is the most widely used stem-cell therapy in this area, which was first performed in 1968.

According to California Institute for Regenerative Medicine (CIRM) and various other medical literature, SC treatment has the game changing potential for successful use to:

  • Replace neurons damaged by spinal cord injury, stroke, Alzheimer’s disease, Parkinson’s disease or other neurological problems
  • Produce insulin that could treat people with diabetes and heart muscle cells that could repair damage after a heart attack, or
  • Replace virtually any tissue or organ that is injured or diseased

Thus, stem cells offer limitless possibilities, such as tissue growth of vital organs like liver, pancreas. Today there are many diseases for which no effective treatment still exists, besides giving symptomatic relief, such as Multiple Sclerosis, Parkinson’s disease, Alzheimer’s, severe burn, spinal cord injury. There is a host of other diseases, including several chronic ailments, such as diabetes, heart ailments, rheumatoid arthritis, or some types of cancer, which can’t just be reversed, however, could be managed with a lifelong treatment. For most of these diseases, and several others involving tissue degeneration, SC therapy has the potential to be a huge life and a game changer. It may involve, besides patients, several industries, including pharmaceuticals and biotech sectors.

Major stem cell sources and some key milestones:

Medical scientists and researchers have conclusively established that stem cells are the master cells of any human body. These are undifferentiated cells of the same lineage, retaining the ability to divide throughout life and grow into any one of the body’s more than 200 cell types. Some of the major sources of stem cells in the human body are bone marrow, cord blood, embryonic cells, dental pulp and menstrual blood.

As captured by ‘ExploreStemCells’ of UK, some key events in stem cell research include:

  • 1978: Stem cells were discovered in human cord blood
  • 1981: First in vitro stem cell line developed from mice
  • 1988: Embryonic stem cell lines created from a hamster
  • 1995: First embryonic stem cell line derived from a primate
  • 1997: Cloned lamb from stem cells
  • 1997: Leukemia origin found as hematopoietic stem cell, indicating possible proof of cancer stem cells
  • 1998: University of Wisconsin isolated cells from the inner cell mass of early embryos and developed the first embryonic stem cell lines.
  • 1998: Johns Hopkins University derived germ cells from cells in foetal gonad tissue; pluripotent stem cell lines were developed from both sources.
  • 1999 and 2000: Scientists discovered that manipulating adult mouse tissues could produce different cell types. This meant that cells from bone marrow could produce nerve or liver cells and cells in the brain could also yield other cell types.

All these discoveries were exciting for rapid progress in the field of stem cell research, along with the promise of greater scientific control over stem cell differentiation and proliferation. Currently, many more research studies are underway in globally acclaimed institutions and other boutique laboratories exploring the possibility of wide scale use of SC therapy, even in the treatment of several chronic diseases, including diabetes and heart disorders.

A controversy:

The controversy related to SC research mainly involves Embryonic Stem Cells (ESC) and raises several difficult questions for a speedy resolution. As articulated by the ‘Genetic Science Learning Centre’ of the University of Utah, these are mainly:

  • Does life begin at fertilization, in the womb, or at birth?
  • Is a human embryo equivalent to a human child?
  • Does a human embryo have any rights?
  • Can destruction of a single embryo be justified to provide a cure for a countless number of patients?
  • Since ESC can grow indefinitely in a dish and can, in theory, still grow into a human being, is the embryo really destroyed?

However, in 2006 scientists learned how to stimulate a patient’s own cells to behave like embryonic stem cells. These cells are reducing the need for human embryos in research and revealing exciting new possibilities for stem cell therapies, according to this Centre.

Stem cell research in India:

India has pursued SC research since over a couple decades reasonably supported by the Government, especially the Department of Biotechnology (DBT), besides several remarkable initiatives from the private sector. Ethical guidelines in this regard are also in place, so also are the National Guidelines for Stem Cell Research in India. These guidelines are aimed at obtaining licenses from the Drug Controller General of India (DCGI).

Further, in a major move to regulate and oversee the activities by streamlining SC research in the country, the Government has also set up an Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) and the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT). This necessitates the researchers on human stem cells, both institutions and the individuals, to be registered with NAC-SCRT through IC-SCRT. To ensure that the concerned companies and individuals follow the National Guidelines, these committees will review, approve and monitor each research project in this area. It now calls for even greater focus from all other stakeholders to help accelerate growth of this niche segment of medical science for patients’ benefits.

SC transplantations using umbilical cord blood and bone marrow for treating neurological, hematological, hepatic and cardiac disorders are being pursued by some well-known medical institutions, such as, AIIMS, PGI Chandigarh, CMC Vellore, AFMC Pune, Manipal Hospital Bangalore. For example, AIIMS, reportedly, undertook a major multi-center trial to look at the role of stem cells in repairing tissue damaged during acute heart attacks, where other treatment process, including a cardiac bypass surgery fails to adequately improve the heart function. Similarly, Shankar Netralaya in Chennai has successfully carried out limbal stem cell transplantations for restoring vision to several patients.

That said, this is a cost intensive area of research, which involves expensive equipment, reagents and other consumables. Moreover, ensuring continuous training for SC researchers and clinicians also poses a major problem. Greater international collaboration in this area, and increasing number of Public-Private-Partnership (PPP) could accelerate the progress of India in this hugely promising area of medical science, reaping a rich harvest for a large patient population of the country.

Stem cell banking:

SC banking is a fast-developing area in this field, especially designed for SC therapy. As not many patients are not currently as much aware or interested in SC therapy as they ought to, it may not appear as an immediate requirement for many. However, an encouraging trend is fast catching up, especially within some enlightened persons, to have in a bank a large reserve of their own or their baby’s stem cells that would be available for any medical emergencies or more effective treatment options, in the future.

It assumes increasing importance because, as we age, illness and the natural process of aging could reduce the number of stem cells available to regenerate organs, muscles and bone. At that time, while treating a serious illness or a grave injury, a person may have fewer adult stem cells that have the collective power to make an effective healing response to SC therapy.

In that context, SC banking provides a great opportunity to store, multiply and utilize a newborn’s or even an adult person’s younger and healthy stem cells for SC therapy during any medical emergency, such as a serious accident or a crippling illness, at a later stage in life.

There are broadly the following two types of SC banking facilities are now available in India:

A. Cord blood stem cell banking:

This is type of SC banking is the process of collecting, processing, cryogenically freezing and preserving the ‘Cord blood’ that remains in the vein of the umbilical cord and placenta at the time of birth, for potential future medical use during SC therapy. Stems cells extracted from the umbilical cord blood have been shown to be more advantageous than those extracted from other sources such as bone marrow. These banked stem cells are considered as a perfect match for the lifetime of the donor baby, and for other family members, as well. This is significant as there exists a greater chance for success in a stem cell transplant between siblings than with unrelated donors and recipients.

B. Adult stem cell banking:

Some state-of-the-art adult stem cell banking services are either already available or in the process of coming up in many places of the world, including India. As an individual’s fat (adipose tissue) is an important source of adult stem cells, with the application of a high precision medical technology of separating, multiplying, and storing adult adipose tissue-derived mesenchymal stem cells for autologous use by physicians, ‘Adult stem cells are stored in these banks.

The good news is, increasing awareness in this area has now started prompting many parents, and also some adults to bank or store their own SC and the baby’s cord blood rich with a specific types of stem cells, that can be utilized, at a later date, in a variety of SC therapy while treating many life-threatening and debilitating diseases, if required.

Types of stem cell therapy:

There are two major types of SC therapies, and both are available in India:

  • Autologous stem cell therapy: uses the adult patient’s own stem cells obtained from the blood, bone marrow.
  • Allogenic stem cell therapy: uses donated stem cells, but faces chances of donor stem cell rejection.

As articulated in the revised stem cell guidelines, stem cells can’t be offered to patients in India as ‘therapy’ unless these are proven effective and safe supported by unequivocal clinical trial data and approved by the DCGI. Otherwise, these can be used only in ‘clinical trials’ as will be approved by the DCGI. The only exception to this is the use of haematopoietic (blood forming) stem cells for treating blood disorders, which is considered as ‘a proven therapy,’ according to available reports.

The Market – Global and India:

September 14, 2015 issue of ‘The Pharma Letter’ stated based on a recent report that the global stem cells market was valued at US$ 26.23 billion in 2013, and is estimated to be worth US$ 119.52 by 2019, registering at a Compounded Annual Growth Rate (CAGR) of 24.2 percent. Whereas, in India, the stem cell market is expected to be around US$ 600 million by 2017. Another report, titled ‘India Stem Cells Market Forecast & Opportunities, 2020’ of ‘Pharmaion’, states that stem cells market in India is expected to grow at a CAGR of over 28 percent during 2015 – 2020.

In terms of services offered, stem cells market in India has been segmented into two main categories, namely SC banking, and SC research. The latter dominated the market in 2014, and is likely to continue its dominance through 2020. Adult stem cells accounted for the majority share in India’s SC market in 2014, as a lot of research being carried out using adult stem cells, besides growing adult stem cell banking and other associated applications in therapeutics.

The major growth drivers for SC market are: increasing patient awareness, an increase in the approval for clinical trials in stem cell research, growing demand for stem cell banking services,

Government support, rising investments in research, and ascending trend of development for regenerative treatment to meet unmet medical needs.

The first stem cell based product approval in India:

On May 30, 2016, a Press Release of ‘Stempeutics Research’ of Bengaluru announced that for the first time in India, DCGI has granted limited approval for manufacturing and marketing of its allogeneic cell therapy product named Stempeucel® for the treatment of Buerger’s Disease – a rare and severe disease condition affecting the blood vessels of the legs, which finally may require amputation. Stempeucel® treatment is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularization. The prevalence of Buerger’s Disease is estimated to be 1,000,000 in India and two per 10,000 persons in the EU and US, as the release stated. Stempeutics Research’ is a company of Manipal Education & Medical Group and a Joint Venture with Cipla Group.

Conclusion:

Research on stem cells, across the world, is taking rapid strides. It has already demonstrated its healing power in changing many human lives either by significantly stalling the progression of several serious ailments, such as Multiple Sclerosis (MS), or reversing the disease conditions, such as serious damage to the heart caused by massive myocardial infarction.

An increasing number of stem cell banks coupled with growing public and private investments in stem cell research, positive narratives are getting scripted for this space in India. With rapidly growing middle class population and comparatively less stringent rules and regulations, India is emerging as a perfect destination for many more global and local stem cell banking companies. Consequently, the stem cell market in the country is expected to witness robust growth in the coming years.

However, only future research on stem cells will be able to unravel whether an Alzheimer’s victim will get back the stolen memory; a cancer patient won’t have to mentally prepare to die of cancer anytime soon, besides spending a fortune towards cancer therapy; an insulin dependent diabetic will no longer require insulin; an individual with damaged heart won’t have to continue with lifelong medication, and it goes on and on.

Nevertheless, if it does… and God willing – it will, ‘Stem Cell Therapy’ would not just be a life changer for many patients, it will be a game changer too for several others, including the pharma, biotech companies and many more within the healthcare sector. If any skeptic still asks, will it really happen? My counter question, in response, will be: Why not?… Why the hell not?

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.

 

“Fire in The Blood”: A Ghastly Patents Vs Patients War – for Pricing Freedom?

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International award winning documentary film, ‘FIRE IN THE BLOOD’ could possibly set a raging fire in your blood too, just like mine. It made me SAD, REFLECTIVE and ANGRY, prompting to share ‘MY TAKE AWAYS’ with you on this contentious subject, immediately after I put across a brief perspective of this yet to be released film in India.

FIRE IN THE BLOOD is an intricate tale of ‘medicine, monopoly and malice’ and narrates how western pharmaceutical companies and governments aggressively blocked access to low-cost HIV/AIDS drugs in African countries post 1996, causing ten million or more avoidable deaths. Fortunately, in the midst of further disasters in the making, some brave-hearts  decided to fight back.

The film includes contributions from global icons, such as, Bill Clinton, Desmond Tutu and Joseph Stieglitz and makes it clear that the real struggle of majority, out of over 7 billion global population, for access to life-saving affordable patented medicines is far from over. This film has been made by Dylan Mohan Gray and narrated by Academy Award winner, William Hurt.

Two trailers worth watching:

Please do not miss watching, at least, the trailer of this the sad and cruel movie by clicking on the link provided on the word ‘trailer’ above and also here. To get an independent perspective, please do watch the review of the film along with interesting interviews by clicking here.

(Disclaimer: I have no personal direct or even remotely indirect interest or involvement with this film.)

International newspaper reviews:

The NYT in its review commented as follows:

“The only reason we are dying is because we are poor.” That is the heartbreaking refrain heard twice in the documentary “Fire in the Blood,” about an urgent and shameful topic: the millions of Africans with AIDS who have died because they couldn’t afford the antiretroviral drugs that could have saved their lives. Former President Bill Clinton, the intellectual property lawyer James Love, the journalist Donald G. McNeil Jr. of The New York Times and others offer perspectives on this situation and also on the concern that pharmaceutical companies value profits over lives.”

The Guardian reviewed the film as follows:

“A slightly dry, yet solid reportage on a humanitarian disgrace: the failure of western pharmaceutical companies to provide affordable drugs to patients in the developing world. As presented, the corporate defense sounds horribly racist: that poorer Africans’ inability to read packaging or tell the time leaves them ill-suited to following any medication program… hope emerges in the form of the Indian physicist Yusuf Hamied, whose company Cipla undertook in the noughties to produce cheap, generic drugs in defiance of the Pfizer patent lawyers.”

MY TAKE AWAYS:

Discrimination between human lives?

Life, as we all have been experiencing, is the greatest miracle of the universe and most astonishing creation of the Almighty. Among all types of lives, the human lives indeed have been playing critical roles in the development and progress of humanity over many centuries. These lives irrespective of their financial status, cast, creed, color and other inequities need to be protected against diseases by all concerned and medicines help achieving this objective.

What’s the purpose of inventing medicines?

“The purpose of business is to create and keep a customer”, said the management guru of global repute,  Peter F. Drucker. What is then the purpose of inventing new medicines in today’s world of growing financial inequity? 

Further, in his well acclaimed book, “Fortune at the Bottom of the Pyramid: Eradicating Poverty Through Profits”, C.K. Prahalad, explained that the world’s over five billion poor make up the the fastest growing market in the world. Prahalad showed how this segment has vast untapped buying power, and represents an enormous potential for companies, who can learn how to serve this market by providing the poor with innovative products that they need. Do the Big Pharma players have any lesson to learn from this doctrine?

R&D is not free, has costs attached to it:

Medicines protect human lives against various types of diseases. Pharmaceutical companies surely play a critical role in this area, especially the innovator pharma players, by making such medicines available to patients.

These companies identify new products largely from academic institutions and various research labs, develop and bring them to the market. This has obviously a cost attached to it. Thus, R&D cannot be considered as free and the prices of patented products should not be equated with off-patent generic drugs. Innovators must be allowed to earn a decent return on their R&D investments to keep the process of innovation ongoing, though the details of such costs are not usually made available for scrutiny by the experts in this field. 

Discourage insatiable fetish for profiteering:

Respective governments must always keep a careful vigil to ensure that earning a decent profit does not transgress into a limitless fetish for profiteering, where majority of people across the world will have no other alternative but to succumb to diseases without having access to these innovative medicines. This situation is unfair, unjust and should not be allowed to continue.

Big Pharma – strongest propagators of innovation…bizarre?

It is indeed intriguing, when patients are the biggest beneficiaries of pharmaceutical innovations, why mostly the Big Pharma MNCs, their self-created bodies and cronies, continue to remain the most powerful votaries of most stringent IPR regime in a country, though always in the garb of ‘encouraging and protecting innovation’.

Thinking straight, who do they consider are really against innovation in India? None, in fact. Not even the Government. India has under its belt the credit of many pioneering innovations over the past centuries, may not be too many in the field of medicine post 2005, at least, not just yet. Do we remember the disruptive invention of ‘Zero’ by the Indian mathematician Brahmagupta (597–668 AD) or the amazing ‘Dabbawalas’ of Mumbai?  India experiences innovation daily, it has now started happening in the domestic pharma world too with the market launch of two new home grown inventions.

Coming back to the context, India, as I understand, has always been pro-innovation, in principle at least, but is squarely and fairly against obscene drug pricing, which denies access to especially newer drugs to majority of patients, in many occasions even resorting to frivolous innovations and evergreening of patents.

Mighty pharma MNCs are increasingly feeling uncomfortable with such strong stands being taken by a developing nation like India, in this regard. Thus, expensive and well orchestrated intense lobbying initiatives are being strategized to project India as an anti-innovation entity, while pharma MNCs, in general, are being highlighted as the sole savior for encouraging and protecting innovation in India. The whole concept is indeed bizarre, if not an open display of shallow and too much of self-serving mindset. 

This analysis appears more convincing, when genuine patients’ groups, instead of supporting the pharma MNCs in their so called ‘crusade’ for ‘innovation’, keep on vehemently protesting against obscene drug pricing, across the world. 

Obscene pricing overshadows the ‘patient centric’ facade:

Obscene pricing of patented medicines, in many cases, overshadows the façade of much hyped and overused argument that ‘innovation must be encouraged and protected for patients’ interest’. This self-created ‘patient centric’ facade must now be properly understood by all.

I reckon, India has now assumed a critical mass attaining a global stature. This will not allow any successive governments in the country to change the relevant laws of the land, wilting under intense pressure of global and local lobbying and expensive PR campaigns. 

Genuine innovation must be protected:

  • Genuine innovations, as explained in the Patents Act of India, must be encouraged and protected in the country, but not without sending a strong and clear signal for the need of responsible pricing.
  • It is also a fact, though some people may have different views, that Intellectual Property Rights (IPR) encourage innovation.
  • At the same time, the real cost of R&D must be made transparent by all innovators and available for scrutiny by the experts in this field to put all doubts to rest on the subject.

When Corporate Social Responsibility (CSR) is being widely discussed globally, which has now been made mandatory in India, these players keep arguing almost unequivocally that, thinking about ‘have nots’ is the sole responsibility of the Government.

Patents guarantee market exclusivity, NOT absolute pricing freedom:

Patent gives right to the innovators for 20 years market exclusivity, but NOT absolute pricing freedom in the absence of any significant market competition in that area.

Innovator companies do argue that patented products also compete in their respective therapeutic classes. This is indeed baloney. If patented products meet the unmet needs, how can it be ‘me too’ even in a therapy class? Unless of course, insatiated fetish of Big Pharma for market monopoly with free pricing even for ‘me too’ types of so called ‘innovative products’, becomes the key motive behind such an argument.

Who benefits more with patented medicines?

Who gets benefited more with these patented medicines? Certainly a small minority living in the developed world and NOT the vast majority of the developing world.

At the same time, huge profits earned by these companies from a small minority of these patients make them so rich and inexplicably arrogant that they do not bother at all for others without having adequate deep pockets, even in India. 

Conclusion:

I have a huge problem in accepting the pharma MNCs’ argument that ‘IPR’ and lack of ‘Access’ to IP protected drugs for ‘affordability’ reasons, are unrelated to each other. For heaven’s sake, how can they be?

As I said before, absolute pricing freedom for patented drugs is obscene, if not vulgar and must be curbed forthwith with the application of intelligent and well-balanced sensible minds and also in a way, which is just for all, both the innovators and the patients.

Big pharma MNCs can no longer afford to remain just as huge profit making entities, responsible only to their shareholders, shorn of societal needs for affordable medicines, required for around six out of over seven billion human lives of the world. 

Modern society, key opinion leaders and respective governments should not allow them to shirk their responsibility in this area any more, as we move on.

If not, will narratives like ‘FIRE IN THE BLOOD’, not keep us haunting again, again and again, on similar incidents taking place in some other countries, at some other time, involving extinction of millions of precious lives for not having access to affordable new drugs? They may be ‘have nots’, so what? 

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.