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Drug Data Exclusivity in India: Innovation Catalyst or Affordability Risk for Indian Pharma?

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For over four decades, India’s pharmaceutical industry has been built on a powerful moral and economic proposition: that life-saving medicines should be affordable, accessible, and globally available from Indian manufacturing prowess. This principle transformed India into the “pharmacy of the developing world.” But as the industry now aspires to move decisively from generics to innovation, a new question has begun to unsettle policymakers, industry leaders, and public-health experts alike:

How should India protect pharmaceutical innovation without diluting its legacy of access?

It is this unresolved tension that has resurfaced sharply following a December 2, 2025, Economic Times report on the sharp divergence between the Ministry of Commerce & Industry and the Ministry of Health & Family Welfare over whether India should formally adopt Drug Data Exclusivity (DDE) norms. What appears at first glance to be a technical regulatory debate is, in reality, a defining policy moment for the future trajectory of Indian pharma.

What Is Drug Data Exclusivity—and How Is It Different from Patents?

Drug data exclusivity, as we know, protects the clinical trial data generated by an innovator company from being referenced by regulators to approve generic versions for a fixed period – typically 5–10 years, depending on the country.

This protection:

  • Exists independent of patent status
  • Can apply even after a patent expires
  • Prevents generics from relying on originator data, forcing them to repeat costly trials

In short:

  • Patents protect inventions
  • Data exclusivity protects information

This distinction is vital – because exclusivity over data can delay competition even when the patent monopoly has legally ended.

How Data Exclusivity Is Often Used to Extend Market Monopoly:

Globally, data exclusivity has increasingly been used not merely as innovation protection – but as a commercial weapon to prolong monopoly pricing.

The Humira Case (AbbVie): A Global Cautionary Tale

Humira is one of the world’s best-selling drugs, generating over USD 200 billion in lifetime revenue. While its primary patent expired in 2016, AbbVie constructed a dense patent thicket supported by regulatory protections, delaying biosimilar competition for years in key markets. During this extended protection:

  • Annual treatment costs exceeded USD 70,000 per patient
  • Biosimilars entered much later than legally necessary
  • Healthcare systems absorbed massive avoidable costs

This pattern - where regulatory exclusivities outlive patents - is exactly what concerns Indian public-health policymakers.

Why the Debate Is So Sensitive in the Indian Context:

India is not just another pharma market. It is:

  • The largest supplier of generic medicines globally
  • A key provider of HIV, TB, oncology, and vaccine supplies to LMIC nations
  • The backbone of India’s own public health programs

Any policy that artificially delays generic entry directly impacts:

  • Government procurement costs
  • Insurance claim ratios
  • Out-of-pocket patient spending
  • Export affordability for Africa, Latin America, and Southeast Asia

In India, monopoly pricing is not an abstract economic concern – it directly determines treatment access at population scale.

Does India Need Data Protection to Encourage Innovation? Yes – but Carefully:

There is no denying a fundamental truth:
Discovering new drugs is expensive, risky, and capital-intensive.

Indian pharma’s next growth phase depends on:

  • New chemical entities (NCEs)
  • Biosimilars with true differentiation
  • Complex injectables
  • Cell & gene therapies

For this shift, global investors and MNC collaborators do seek assurance that proprietary data will not be freely copied immediately. The Commerce Ministry’s argument is therefore not without merit.

The real policy question today is not whether to protect data, but:

How much protection is necessary – without crossing into long-term price monopoly?

The Hidden Danger: Data Exclusivity as the New Patent Thicket:

India has already seen how evergreening strategies can extend monopolies through:

  • Secondary patents
  • Polymorph claims
  • Incremental formulations
  • Combination patents

If long periods of mandatory data exclusivity are added on top, India risks creating:

  • Dual monopolies (patent + data)
  • Effective market lock-outs even after legal patent expiry
  • Price protection without scientific novelty

In practical terms, this could mean:

  • Cancer medicines remaining expensive 10–12 years after original discovery
  • Biosimilars delayed despite manufacturing readiness
  • Insurance penetration becoming unaffordable
  • Public procurement budgets exploding

What Kind of Data Protection Could Work for India – Without Falling into a Monopoly Trap?

This is where India must design a bespoke regulatory architecture, not copy-paste US or EU models.

1. Limited Exclusivity Window Only for First-in-Class Drugs

India could grant 3–5 years of data exclusivity strictly for:

  • First-in-class molecules
  • Novel biological pathways
  • Orphan or rare disease drugs

Not for:

  • Me-too molecules
  • New strengths
  • New dosage forms
  • Fixed-dose combinations without therapeutic novelty

This ensures protection only where real innovation exists.

2. Automatic Public-Health Override Clause

India must retain the unconditional right to:

  • Waive exclusivity during public-health emergencies
  • Apply compulsory access for national programs
  • Support Jan Aushadhi-linked drug expansion

This keeps constitutional right to health superior to commercial protection.

3. No “Back-Door” Extension Beyond Patent Life

A strict rule must apply:

If the core patent has expired, data exclusivity cannot reset monopoly.

This prevents situations like:

  • Patent expiry in Year 20
  • Data exclusivity extending till Year 28

Such structures undermine the very logic of patent law.

4. Differential Rules for Small-Molecule Drugs vs Biologics

Biologics involve:

  • Higher R&D risk
  • Greater manufacturing complexity

India could explore:

  • Short exclusivity for chemical drugs
  • Slightly longer (but capped) exclusivity for biologic drugs
    - without mirroring western 12-year biologic lock-ins.

Why Blind Western Replication Will Hurt India:

The US and EU built their exclusivity regimes when:

  • Their innovation ecosystems matured decades ago
  • Public health spending was largely state-covered
  • Insurance penetration was near universal

India’s reality is different:

  • Out-of-pocket expenditure still dominates healthcare
  • Insurance depth is expanding but not universal
  • Government health budgets remain price-sensitive

A western-style exclusivity framework would therefore:

  • Raise medicine prices structurally
  • Shrink export competitiveness
  • Weaken India’s generics leadership
  • Strain Ayushman Bharat-type programs

Strategic Risk: India’s Export Leadership Could Erode:

Nearly 40% of US generics come from India. If:

  • Indian approval timelines slow
  • Domestic generics get delayed by exclusivity
  • Costs rise due to repeated trials

Then:

  • Latin America, Vietnam, and even Africa could gradually replace India as low-cost generic hubs.

Data policy, therefore, is not just a health issue – it is a geopolitical manufacturing strategy question.

A Balanced Policy Can Actually Strengthen Indian Innovation:

If calibrated well, data protection can:

  • Encourage Indian NCE discovery
  • Attract selective global R&D alliances
  • Improve valuation of Indian biotech assets
  • Keep public programs protected
  • Preserve generics growth

But if miscalibrated, it can:

  • Lock patients into long-term high-price regimes
  • Shut MSME generics out
  • Increase healthcare inflation structurally
  • Damage India’s moral leadership in access to medicines

Conclusion: 

India Must Choose Smart Protection, Not Blind Protection

The current Commerce–Health Ministry divergence reflects a deeper ideological conflict:

  • Commerce protects capital
  • Health protects citizens

India’s answer cannot lie at either extreme.

The country must refuse both:

  • Data anarchy that disincentivizes innovation
  • Data absolutism that entrenches monopoly

The correct path, in my view, lies in:

Time-bound, novelty-linked, override-protected, India-specific data protection.

If India gets this balance right, it can become:

  • A true bio-innovation hub
  • Without ceasing to be the pharmacy of the poor

That, I reckon, is the real opportunity before Indian policymakers today.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors

Sources:

  1. The Economic Times, December report on Commerce & Health Ministries split over Drug Data Exclusivity
  2. US FTC & Senate hearings on AbbVie–Humira patent thicket strategy
  3. WHO reports on TRIPS, data protection & access to medicines
  4. Indian Patents Act, 1970 – Section 3(d) & compulsory licensing provisions
  5. National Pharmaceutical Pricing Authority (NPPA) publications

 

When Pills Betray Trust

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Why India’s Drug Quality Crisis Demands a Mindset Reset?

A Familiar Headline, a Fading Sense of Shock:

It happened again.
According to The Economic Times (October 24, 2025), 112 drug samples failed quality tests in September — one even found spurious.

If that didn’t startle you, you’re not alone. These headlines have become as routine as morning tea. Public outrage brews for a moment, then cools before the next edition hits the stands.

But imagine if 112 aircraft failed safety checks in a single month — would anyone dare call that a “batch-specific issue”?
When it comes to medicines that enter human bodies and decide between sickness and survival, such excuses sound absurd. Yet, we’ve come to accept them.

That quiet acceptance is where the real danger begins.

When Data Lies, Patients Pay the Price:

As reported by The Economic Times on October 30, 2025, in a separate and alarming development — “Drug cos forging data for approval, mislabeling brands to be barred.”

If the first report showed what went wrong, this one revealed why - Forged data. Mislabeled brands. Corners cut in dossiers. It’s not just a lapse in manufacturing — it’s a collapse in ethics.

Let’s be honest: you can’t market “Make in India, Trust Globally” when the fine print whispers “Data Forged, Labels Fudged.” Somewhere between speed-to market and responsibility-to-patient, we’ve misplaced our moral compass.

And when that happens, it’s not just a regulatory failure — it’s a betrayal of trust.

Quality: Built In, Not Inspected In:

Each time such headlines appear, the reflex is predictable — emergency reviews, press statements, promises of stricter enforcement. All necessary. Yet, all reactive.

Because quality cannot be inspected in after production — it must be built in before it begins.
And that calls for something no checklist or audit can enforce: a fundamental change in mindset.

  • A corporate mindset that values patient safety above quarterly profits.
  • A regulatory mindset that prizes prevention over post-mortem.
  • A leadership mindset that refuses to normalize mediocrity when human lives are at stake.

This is not a question of capacity or compliance — it’s a question of conscience.

“You can’t inspect quality into a pill — it has to be built into the process, the mindset, the culture.”

From Blame Games to Shared Accountability:

Every time this issue resurfaces, the blame carousel spins:

  • Regulators point to resource gaps.
  • Companies point to complexity.
  • Everyone points to the system.

But systems don’t act — people do.

A regulator’s vigilance cannot replace a company’s integrity. Nor can corporate SOPs mask ethical indifference.

India’s recurring quality crises demand not louder warnings, but shared accountability — an honest partnership between regulators and industry that treats every tablet as a promise, not a product.

If we achieve that, the next set of headlines won’t read “112 Drug Samples Fail.” They’ll read: “India Sets New Global Benchmark in Drug Quality.”

A Dose of Humor — and a Hint of Hope:

Someone once quipped, “In India, we don’t recall drugs — we recall excuses.”
Clever. Painfully accurate.

But here’s the hopeful twist: India has achieved the impossible before.
We built vaccine networks the world now depends on.
We made medicines affordable to millions who once had none.
We can certainly lead in quality — if we decide to make integrity non-negotiable.

The prescription isn’t complicated:

  • Less denial, more diligence.
  • Fewer circulars, more conviction.
  • And a mindset that views every patient not as a market opportunity — but as a moral responsibility.

Because every failed sample isn’t just a number — it’s a risk to a trusting patient who believed the system would protect them.

It’s time it truly did.

“When data lies, patients pay the price.”
“Quality in pharma isn’t a regulatory requirement — it’s a moral one.”

Conclusion:

The Bottom Line

India has earned its title as the pharmacy of the world.
Now it must earn another — the pharmacy the world can trust.

That journey doesn’t begin with another inspection or circular.
It begins with a mirror — and a mindset.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors.

 

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.


Sources & References

  1. “112 drug samples fail quality tests in September 1 found spurious: Govt” — PTI / ET Manufacturing (The Economic Times), October 24, 2025.
  2. “Drug cos forging data for approval, mislabeling brands to be barred” — The Economic Times, October 30, 2025.
  3. Background: Business Standard reports on CDSCO alerts and enforcement updates, 2024–25.

 

India’s Push for Affordable Mental Health Meds: Triumphs and Challenges in 2025

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In June 2025, a small clinic in rural Ghana celebrated a milestone: it provided affordable antidepressants to 500 patients, thanks to India’s generic sertraline, costing just $2 a month per person. This was unimaginable a decade ago, when branded versions cost $30 – far beyond reach for most. As the world grapples with a mental health crisis, with 1 in 8 people facing disorders like depression or anxiety, India’s role as the “pharmacy of the world” is saving lives. Its affordable generic medications are a beacon of hope for millions in low-income countries. Yet, while India has made remarkable strides, significant hurdles remain.

Since long, I have been deliberating on this growing concern in this Blog. For example, on January 17, 2017, I wrote: ‘Mental Health Problem: A Growing Concern in The Healthcare Space of India’. However, in today’s article, let’s explore what India has achieved, what’s left to do, and why this matters to us all.

India’s Game-Changing Achievements:

India’s ability to deliver mental health medications at a fraction of global prices is nothing short of revolutionary. Supplying 40% of the world’s generic antidepressants and antipsychotics, companies like Cipla and Sun Pharma make drugs like fluoxetine (Prozac’s generic) and risperidone accessible to millions. For example, a month’s supply of fluoxetine costs under $1 in India, compared to $15-$20 in the US or Europe. This affordability transforms lives, like that of Priya, a fictional but representative single mother in rural India, who manages her depression with generic escitalopram for $3 a month, allowing her to work and support her family.

The backbone of this success:

The backbone of this success is India’s 1970 Patents Act, which blocks “evergreening” – minor drug tweaks by big pharma to extend patents and keep prices high. This policy ensures generics hit markets fast, benefiting not just India but countries like Nigeria and Bangladesh. In 2022, during UK-India free trade agreement talks, leaked drafts suggested “data exclusivity” clauses that could delay generics for years. Health policy researcher Kavya Shah, reportedly warned, “Such rules could choke access to mental health drugs.” India’s firm rejection of these clauses in the 2023 FTA ensured that drugs like quetiapine, used for bipolar disorder, remained affordable globally. Another report highlighted – Dr. Kanica Rakhra, an Asia Global Fellow, calls this “a masterstroke for health equity,” cementing India’s role as a global health champion.

India’s recent efforts go beyond generics: 

The 2025 Mental Health Mission, launched with a $300 million budget, has boosted production of psychotropic drugs and trained 10,000 community health workers to identify and treat mental health issues early. Public awareness campaigns, like nationwide ads featuring relatable stories of recovery, are chipping away at stigma. Partnerships with the World Health Organization have also scaled up access to drugs like aripiprazole for schizophrenia, reaching patients in Nepal and South Africa. These steps show India’s commitment to leading the global mental health conversation.

The Challenges India Still Faces:

Despite these triumphs, India’s work is far from done. Domestically, the country’s mental health infrastructure is strained. A 2025 Indian Council of Medical Research study reveals only one psychiatrist for every 130,000 people, leaving millions without specialized care. Over-the-counter sales of psychotropic drugs, often misused due to lax regulation, fuel risks like dependency. For instance, in urban India, easy access to unprescribed benzodiazepines has led to rising misuse cases, a problem the government is yet to tackle effectively.

Globally, trade pressures loom large. The EU’s 2024 imposition of a 15% tariff on Indian pharmaceuticals has raised costs for African nations reliant on India’s generics, making drugs like sertraline less affordable. Ongoing EU-India FTA talks in 2025 still carry risks of stricter intellectual property rules that could limit generic production. Developing new mental health drugs is another hurdle. With global investment in psychotropic medications lagging – only 10 new drugs approved since 2015, per WHO – India’s R&D sector needs more funding to innovate.

Access gaps persist even within India. Rural areas, where 70% of the population lives, often lack pharmacies stocking mental health meds. Take Raj, a fictional farmer in Uttar Pradesh, who travels 50 kilometers to find generic citalopram for his anxiety, only to face stockouts. Scaling up distribution and enforcing stricter regulations on drug sales are critical steps India has yet to fully implement.

Conclusion:

India’s leadership in delivering affordable mental health medications in 2025 is a global triumph, transforming lives from rural Ghana to urban India with generics like sertraline and risperidone. Yet, challenges like strained infrastructure, trade tariffs, and innovation gaps demand action. By strengthening domestic systems and resisting restrictive trade policies, India can solidify its role as a health equity pioneer. Join the movement – share these stories, advocate for access, and use #MentalHealthForAll to amplify India’s promise of hope for a healthier world.

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.

Regulatory Failures Are Still Risking Patient Lives

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India’s pharmaceutical industry faces renewed scrutiny as the Drug Controller General of India (DCGI) flagged numerous substandard drugs in September 2024. At the same time, an October 02, 2024, Business Standard report highlights an ongoing crackdown on such drugs by regulators. This article explores these contrasting developments, beginning with the September findings.

On September 22, 2024, multiple reports revealed that the DCGI, through the Central Drugs Standard Control Organization (CDSCO), identified 195 instances of substandard drugs, devices, and vaccines over three months. Popular brands like Shelcal 500, NICIP MR, and Pantocid were among the flagged drugs, affecting treatments for common ailments like hypertension and acid reflux. Major companies like Alkem, Sun Pharma, and Hetero Labs were implicated. The DCGI ordered the withdrawal of these drugs and called for stricter vigilance, highlighting ongoing issues despite regulatory frameworks being in place, which is known to all drug manufacturers, but still happening all over the county.

Industry Response: 

After the DCGI’s September 2024 report on substandard drugs, responses from pharmaceutical companies were mixed. Many large firms cooperated, taking corrective steps to comply with Good Manufacturing Practices (GMP) and tightening quality control. Some acknowledged the need for stricter oversight and preventive measures.

As happens mostly, there has been notable pushback from a portion of the industry, particularly smaller and mid-sized manufacturers. These companies argue that the stringent audits and frequent shutdowns due to non-compliance are creating significant financial and operational pressures.

Interestingly, some large manufacturers claimed that the faulty products were counterfeit or spurious. This makes the scenario even more complex. Although, both endanger patient lives.

Decades of regulatory failures persist, but at what cost? 

Back in June 2015, I highlighted that “Fake Drugs Kill More People Each Year Than Terrorism Over the Last 40 Years.” Shockingly, little has improved since then.

The problem is deeply rooted in nations with weak enforcement - India being a prime example. Alarmingly, the Ministry of Health has long downplayed this threat, as it appears now.

For example, even prior to that, in 2009, their “Report on Countrywide Survey for Spurious Drugs” grossly underestimated the issue, claiming only 0.046% of spurious and 0.1% substandard branded drugs. This underreporting reflects a dangerous “Ostrich Syndrome” among regulators, who continue ignoring this life-threatening crisis, leaving millions at risk.

The question I raised in this blog on October 12, 2015 2015 still haunts me today: “Does India produce ‘world-class’ medicines for all?” Effective checks and accountability are crucial to address this crisis.

To tackle counterfeit drugs, India needs a comprehensive strategy, such as:

  1. Strengthen Regulation: Stricter inspections, penalties, and GMP adherence.
  2. Leverage Technology: Implement digital tracking systems.
  3. Improve Coordination: Better agency collaboration and audits.
  4. Foster Industry Self-Regulation: Internal audits and regulatory partnerships.
  5. Raise Public Awareness: Educate consumers, protect whistleblowers.
  6. Adopt Global Standards: Align with international benchmarks.

Only with strong accountability can India safeguard drug safety.

While there have been reports of some progress, concerns remain:  

A Business Standard report from October 02, 2024, highlights a regulatory crackdown on substandard drugs. However, this raises critical questions about the true effectiveness of these efforts. Upon closer inspection, the report reveals limitations that warrant deeper scrutiny. These include gaps in data coverage, inconsistent inspections, and doubts about the sustainability of the actions taken, which cast doubt on how far-reaching and impactful this so-called crackdown really is.

Some of the notable flaws that I find in the report include:

  1. Lack of Comprehensive Data: The report focuses on inspected units, which represents only a small fraction of India’s vast pharmaceutical manufacturing sector, especially considering that 80% of India’s pharma units are micro, small, and medium enterprises that often escape the regulatory radar.
  2. Limited sample size could misrepresent the true scale of substandard drug production.
  3. Inconsistent Inspection Coverage: While the CDSCO has ramped up its audits, the inspection coverage appears uneven. Many smaller manufacturers, particularly those operating in less regulated states, may not face the same scrutiny as larger companies. This could skew the perception of improvement.
  4. Global Discrepancies: Despite claims of reduced international complaints, the report doesn’t fully address concerns like the recent ban on Indian-made antibiotics by Nepal, signaling that quality issues persist in exports.. This suggests a gap between domestic inspections and international quality standards. 
  5. Sustainability Questioned: The report emphasizes short-term regulatory actions, but long-term sustainability is unclear. Temporary shutdowns and corrective actions might not be enough to ensure lasting quality improvements, especially in an industry facing systemic issues like weak documentation and quality control in smaller firms 

In summary, while the report provides some optimistic updates, its credibility is limited by incomplete data, uneven enforcement, and questions about long-term impact. 

Is entity-centric accountability grossly missing in this area? 

Absolutely. The accountability of both regulators and pharmaceutical companies regarding substandard and counterfeit drugs in India has been alarmingly deficient for years. Despite recurring reports of poor drug quality, weak enforcement, and ineffective oversight persist. 

Regulatory bodies have failed to consistently hold companies accountable, allowing dangerous drugs to flood the market and endanger public health. This systemic neglect, coupled with inconsistent audits and lax penalties, has led to a crisis that remains unresolved even today. Thus, the following two areas, I reckon, need to attract greater focus:

  • Regulatory Gaps: The Central Drugs Standard Control Organization (CDSCO) has faced criticism for being reactive rather than proactive, with irregular inspections and delays in addressing violations. The weak enforcement of Good Manufacturing Practices (GMP) and insufficient penalties for violators have allowed substandard drugs to continue circulating.  
  • Pharma Companies’ Compliance: Many pharmaceutical companies have either ignored or downplayed the issue, sometimes blaming counterfeiters rather than addressing quality control lapses. While larger companies might cooperate after being caught, the lack of strict and consistent regulatory pressure has allowed many manufacturers to evade full accountability.

This lax accountability, both in the regulatory framework and among drug companies, has created an environment where the production and distribution of substandard and fake drugs continue to pose serious risks to public health in India. The need for stricter enforcement and transparent accountability is crucial for restoring trust in the system.

Conclusion:

Despite years of scrutiny, regulatory lapses in India’s drug industry continue to jeopardize patient safety. Weak oversight and inconsistent enforcement allow substandard and counterfeit drugs to flood the market, with deadly consequences.  

Regulatory bodies have failed to take firm action, and pharmaceutical companies are often not held accountable. As a result, millions remain at risk, and trust in the healthcare system is eroding. The cost of these failures is measured in lives, and without immediate reforms, the crisis will only deepen.

This underscores the point that the time for complacency has passed – India’s healthcare system and public trust demand swift, decisive action against counterfeit and low-quality drugs, with clear accountability and stringent punitive measures for violators.

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.

 

Leveraging Data Science To Deliver Unique Patient-experience

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“Changes in consumer behavior, many of which were accelerated by the COVID-19 pandemic, are fueling a redesign of the health ecosystem.” This finding was revealed by a recent study of the PwC’s Health Research Institute (HRI). The research provided insights about how and why specific groups of consumers used health services during the pandemic – from mental health and telehealth to in-home care and other non-traditional care sites.

The study also captured ‘their willingness to use them again in the future,’ and suggested, those pharma companies that closely monitor these consumer signals and design, accordingly, will likely emerge as more customer centric, as the pandemic wanes.

From this perspective, effective application of data science for creating a unique patient experience by listening to patient voice, is now an imperative for pharma players. Which is why, this approach is nowa key business success ingredient in the changing paradigm. It helps offering a holistic disease treatment solution to patients searching for an effective and affordable disease treatment process.

This article will, therefore, focus on leveraging data science for strategic use of Real-World Evidence (RWE) based on Real World Data (RWD) – on how customer characteristics and behavior impact health outcomes. This initiative is fast becoming a key driver to excel in contemporary pharma business.

Strategic use of RWD/RWE increasing in pharma marketing plans:

RWE, as the name suggests, is the evidence derived from RWD. These are collected outside of clinical trials from various sources, such as, patients and HCP surveys on treatment outcomes, electronic health records wherever available, Wearable Health Devices (WHD), insurance claims, data from connected healthcare records, custom study and many others.

The McKinsey & Company article in this area, published on July 23, 2020, also indicated so. Although, some leading pharma companies have already been using RWE. However, recent progress in digital and advanced analytics allows it to be employed in new ways to deliver impact at scale, the article highlighted. When used by hands-on- professionals of repute in this area, RWE can help pharma marketers understand how patient characteristics and behaviors affect health outcomes.

The research paper on how Biopharmaceutical companies are embedding real-world data and evidence use across the enterprise, published in Deloitte Insights on September 21, 2022, presented an interesting contemporary example. It wrote: ‘During the COVID-19 pandemic, RWD/E played a key role in enabling Biopharma companies to innovate and bring novel vaccines and therapies against this highly contagious disease to market in record time.’id-19,

The approach gained momentum during the Covid-19 pandemic:

The above research study of Deloitte brought out this fact succinctly. It found; unprecedented challenge posed by COVID-19 pandemic prompted several drug companies to leverage RWD/E to innovate faster than ever before. More than half of the companies surveyed by Deloitte used RWD/E to understand the incidence and severity of COVID-19 and its variants for vaccine and drug development.’

The survey found: ‘Many vaccine developers, such as Johnson & Johnson analyzed RWD to predict COVID-19 hotspots across geographies to optimize site selection and collect data from diverse racial and ethnic groups.’ Besides, RWE also played a critical role for these companies in understanding vaccine effectiveness across demographics such as age, gender, race, and ethnicity and determining the need for boosters.

Improves patient experience for business excellence:

A systematic and ongoing tracking and analysis of well-identified RWD, by pharma marketing analytics professionals, can help in-depth understanding of changing pharma customer characteristics and behavior, more precisely. Such initiatives include patients, HCPs, hospitals and even the policy makers. Several drug majors have adopted this practice, immediately after absorbing the initial shock of unprecedented disruptions during the Covid-19 pandemic.

Similarly, RWD can help map the exact available space for demand where a brand is being used and potential competitive value-space for its further demand extension – based on real time customer behavior with changing characteristics. To shape customer journeys, such findings may immensely help while strategizing for more targeted content delivery, with sharper segmentation and brand positioning.

Therefore, finding such gaps in various areas of patients’ journey – in their search for an effective and affordable treatment, and appropriately filling these up with brand value delivery is critical. This will help improve patient experience manifold, accelerating business excellence, in tandem.

A recent paper titled, ‘Maximizing your role as a newly appointed real-world evidence leader,’ published by the ZS on March 23, 2022, made similar observations, as above. The study reiterated that patient-generated insights obtained through RWE, are uniquely capable of adding value at different stages of a pharma brand’s life cycle. Or, throughout a patient’s journey on the care pathway of the value delivery system. It concluded: “Carrying out a successful RWE study is a fine balancing act – but its inconveniences and risks are almost certain to be outweighed by the eventual benefits.”

Increasingly used to gain actionable insights to improve patient experience:

In the contemporary market dynamics – driven by changing customer characteristics and behavior, several pharma companies are now effectively combining and analyzing RWD to retrieve RWE. The objective is to gain actionable insights for effective customer engagement for better patient outcomes, to drive business growth. According to a recent podcast by PwC on using data to shape customer journey, the process includes the following:

  • Focusing on the value and outcomes of treatment protocols and less about specific products.
  • Gaining a better understanding of pharma customers and what drives their behavior.
  • Reaching beyond the barrier in driving differentiation amongst competitors.

Conclusion:   

The Forbes article on the Data Science trend in 2022, published on October 04, 2021, aptly epitomized its relevance in today’s business, including pharma industry. It articulated, data science encompasses the practical application of ideas generated by credible and meaningful data from various relevant sources, predictive analytics, and artificial intelligence. Our ability to use such data to our advantage across wide areas in business, would help deliver increasingly worthwhile, valuable, and enjoyable patient experience. 

The article also underscored: ‘If data is the oil of the information age and Machine Learning (ML) is the engine, then data science is the digital domain’s equivalent of the laws of physics that cause combustion to occur and pistons to move.’

Thus, I reckon, both intrinsic and extrinsic brand value creation process, driven by its effectiveness, would increasingly call for Real World Evidence (RWE) based on top-quality Real-World Data (RWD). This is increasingly becoming so critical for success – spanning right across, from product development, launch planning with value propositions – to launch and beyond.

The core purpose of leveraging data science in pharma is, as I see it, is effective decision making throughout the brand life cycle, to deliver a unique patient experience in patients’ journey – with better treatment outcomes.

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.

What Have And Haven’t Changed In Pharma’s New Normal?

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While navigating through the challenge of disruptive changes, several pharma marketers are now focusing more on creating, connecting, and leveraging all market and customer related data, across the organization. Astute ones are using state-of-the-art tools, platforms, and techniques to gain actionable insights on new demands of pharma markets. I wrote about it in my article - ‘Data: the new ‘Magic Wand’ For Pharma Business Excellence,’ published in this blog on October 01, 2018.

This process is helping them to fathom what areas the pandemic has changed and what it hasn’t. Their aim is to draw cutting-edge strategies accordingly for market effectiveness – outperforming competition. This article will explore that space with contemporary examples. Let me start with a few illustrations of some hits and misses for the treatment of Covid – as the world started learning to live with this menacing virus. This was enviable, as the requisite scientific date wasn’t readily available at that moment of truth. But the time has changed now.

Some hits and misses:

As the pandemic overwhelmed the world, and no well-documented treatment for infection caused by the brand new virus – Covid-19 was available, many drug players were given quick emergency approval by country regulators for some repurposed drugs. But most of those weren’t found effective as fresh clinical data started pouring in. For example, the World Health Organization (WHO), have, reportedly, indicated that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.

More recently, Gilead Sciences Veklury – a failed Ebola drug, repurposed for hospitalized Covid-19 patients, suddenly became a blockbuster drug, according to a September 17, 2021 report. However, in less than a year, alongside more research data - a study from Europe, published in The Lancet Infectious Diseases, showed that Veklury has no real benefit. The report also highlights: ‘Aided by a ringing endorsement from then-president Donald Trump, Veklury rang up sales of $2.8 billion in 2020, including $1.9 billion in the final quarter. But those sales slid this year to $1.5 billion in the first quarter followed by $829 million in the second quarter.’

Similarly, there are several areas that are seemingly getting transformed, triggered by the pandemic and the time for resorting to a hit or miss approach, is now virtually over. From pharma marketers’ point of interest, it will now be at one’s own peril for not challenging the pre-Covid business traditions, rules, and well-tried strategies on customer relationships and brand building models. This brings us to the question on what specifically have changed in the new normal as the pharma industry navigates thorough the Covid pandemic – for close to two years now.  

Pandemic-triggered changes in the pharma marketing area:

Changes are many and are being studied across the world. One such recent analysis, articulating how the pandemic triggered changes have redefined marketing, was published by the Harvard Business Review (HBR), on March 10, 2021. This paper came more than a year after the pandemic overwhelmed the world. This article listed some interesting macro-level changes, including the following:

  • Old normal: You are competing with your competitors.
  • New normal: You are competing with the last best experience your customer had.
  • Old normal: Customers hope you have what they want.
  • New normall: Customers expect you to have exactly what they want.
  • Old normal: Courting customers is just like dating.
  • New normal: Courting customers is just like online dating.
  • Old normal: Customers must sit at the heart of your marketing strategy.
  • New normal: Customers must sit at the heart of your customer journey.
  • Old normal: Agility is a technology process.
  • New normal: Agility is a modern marketing approach.
  • Old normal: Your brand should stand behind great products.
  • New normal: Your brand should stand behind great values.

To illustrate the point, let me now give a few examples of some micro-level changes in the same space.

Some transformation trends:

I am citing a few examples related to pharma’s traditional sales and marketing models. One such area is, quite a few companies are adopting connected data based and analytics-supported Omnichannel approach for customer engagement. The key objective is to deliver coherent and high-quality customer experience.

The need for new commercial models for the changing life sciences market, was also highlighted in an interesting article, published in the Pharmaceutical Executive on September 16, 2021. The authors identified six health care macro trends, demonstrating the value of transforming care delivery and shifting market behavior that prompt to reframe customer value propositions.

Taking a cue from this paper, I am listing below some of the current trends – as I see these and wrote before in this blog. Each one of these calls for well-connected data with analytics support:

  • Fostering a new genre of ‘customer-brand relationship’ to drive more targeted go‑to‑market strategies, enhanced agility/mobility of resources and highly personalized customer interactions.
  • Meeting the growing demand for value‑based care with novel risk‑adjusted and outcome‑based Price-Value-Models, supported by ongoing innovation in this area and sophisticated approach to value, affordability and outcomes.

Interestingly, despite Herculean constraints, many pharma players continued creating and delivering value, as the customers were expecting with changing situations.  

Drug-price sensitivity is increasing:

In the new normal, drug price sensitivity of customers is increasing manifold, for various reasons. A June 18, 2020 study, flags: ‘Nine in 10 Concerned About Rising Drug Costs Due to COVID-19.’ Although, this particular study (Gallup Poll) was conducted in the United States, general public apprehension is no different in other parts of the world, including India.

In my article of September 14, 2020, I also wrote that the concept of ‘fair pricing a drug’ is being deliberated by many experts around the world, since quite some time, till today. But it continues. Most recently, as reported on September 22, 2021, for different reasons related to its new Alzheimer’s drug - Aduhelm, including its hefty price tag of $56,000 annually per patient, ‘Biogen reps banned from D.C.-area neurology clinics.’

Regardless of such customer reactions, the pharma industry, as reported on September 17, 2021, continues to advocate – drug pricing pressure will stifle innovation, blocking patient access to needed medicines and dry up investment in important R&D on new therapies. Curiously, the Pharmaceutical Research and Manufacturers of America (PhRMA), is spending more than $1 million on TV ads as part of a massive lobbying and communications campaign emphasizing the potential harm to patients seeking cures for deadly diseases, as the report highlights.

Innovation – remained mostly unhindered from old to new normal:

Customers’ expectations can’t be ignored indefinitely. Interestingly, the world has also witnessed it with Covid drug and vaccine innovation continuing even during the most trying times during the pandemic, even in India. It is, therefore, quite understandable why unfettered access to drug innovation is considered an oxymoron, by many.

The good news is, despite shrill voices over pricing measures, the quest for adding meaningful value to the healthcare space continues unhindered. As reported on September 19, 2021, both Pfizer and Merck are advancing oral antiviral candidates targeting Covid-19 into late-stage testing. Thus, I reckon, regardless of jarring noise from pharma lobbyists, drug innovation, willy-nilly, has to satisfy the diverse demand of health care customers.

Innovation needs to satisfy demands of diverse healthcare customers:

That, increasingly, drug innovations will need to be based on their ability to satisfy the demands of life sciences companies’ diverse customer-perceived value-based, was also echoed by the Pharmaceutical Executive article of September 16, 2021.

While doing so, companies will need to structure innovation in terms of health outcomes, affordability, and personalization, as the paper emphasized. It further added, ‘broader definition of innovation means products are no longer the central driver of value.’ Instead, innovation will be powered by an increasingly diverse stream of data that resides outside the confines of the traditional health ecosystem.

Covid pandemic accelerated the transition of this process of innovation, drawing its new focus on providing a seamless and holistic customer experience in the disease treatment process – supported by advanced analytics and this deeper understanding of customer segments.

Conclusion:

Many pharma marketers have possibly undertaken a sophisticated and credible market scanning exercise in the new normal, to assess by themselves what have or haven’t changed in their customer preferences and market dynamics. If not, I would encourage them to initiate it, at least, now.

Equally noteworthy, as the above HBR article wrote, in the post pandemic period: ‘Beyond geography, marketing messages need to be personally relevant, aligned to an individual’s situation and values, as opposed to demographics, such as age and gender.’

The objective is to create a personal connection between the customer and the brand promotional content, aiming to influence the prescribing and purchasing behavior, based on their psychographic to attitudinal characteristics. This process would require creating and screening lots of customized data, supported by sophisticated analytics.

From the above perspective, I reckon, deep insight on what have or haven’t changed in the healthcare environment alongside its customers, would be of fundamental importance for pharma marketers, in the new normal.

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.

Pharma’s Digital Initiatives In India: A Missing Link

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An interesting study – designed to investigate the challenges that Health and Human Services (HHS) organizations face in implementing digital and data solutions, stands out today – for many reasons. One such being, this ‘multi-country survey’ project team had no inkling about the pandemic when the project was undertaken.

This study was conducted by a research team from Imperial College London’s Institute of Global Health Innovation (IGHI), and was sponsored by EY. The survey comprises of more than 2,000 global HHS professionals – from India, Australia, Italy, UAE, the UK and the US. 359 respondents were from India.

The research passed through the phase when Covid related disruptions was about to put HHS providers through the most extreme stress test in living memory. ‘While the outbreak was catastrophic in its effects, it presented the researchers with an exceptional opportunity to study the sector’s behavior during a pivotal moment,’ the paper noted.

From this perspective, today’s article will explore, from various different sources, across the world, how Covid-triggered rapid development and adoption of digital solutions are in the process of making a paradigm shift in the healthcare space. It spans across – health care service providers, its users, and practitioners – including pharma industry and the tech-solution developers.

Consequently, the question arises, would healthcare industry’s innovative spirit of 2020 is robust enough for taking a quantum leap in this space, as we move on. That space will span across – conceptualization and development of new health care products and services, alongside their consumption pattern and consumer behavioral dynamics. And, right up to the adoption of cutting-edge digital technology for commensurate delivery mechanisms. Let me start with some key findings in this area from the above report.

Some key findings – Global and India:

The findings of the Report titled, ‘Embracing digital: is COVID-19 the catalyst for lasting change?’ published on January 13, 2021, ferreted out some interesting facts, with details. These encompass both global and Indian scenario, in this area.

Some key findings – Global:

  • Pre-pandemic – just 18% of HHS providers had managed to embed digital tools in the way they work – mostly, due to lack of funds, regulatory restrictions, and risk aversion. However, the pandemic outbreak swept away many of these barriers, as 62% of organizations have now started using digital technologies and data solutions, globally.
  • 48% organizations are planning to continue investing in technology during the next three years, with 33% expecting more than 50%, and 19% more than 100% increase in investment.
  • While phone consultations are being offered by 81 % of HHS organizations (up from 39 % before the pandemic), 71 % of organizations offering video consultations (up from 22 % before the pandemic).
  • Respondents’ top objectives for future investment towards rapid adoption of digital solutionsinclude, transforming ways of working and service delivery, improving quality of care, reducing the administrative load, enabling better communications, and streamlining work processes.
  • However, 47% of respondents think, the introduction of digital and data solutions was a temporary measure to address challenges during the pandemic.

Some key findings – India:

The Covid-19 pandemic triggered fast acceleration of the adoption of digital technologies by the HHS in India, as well.

  • 51% of respondents from India reported that their respective organizations have increased the use of digital technologies and data solutions since the Covid-19 outbreak.
  • Increased staff productivity reported for 74 % of respondents’ organizations with 75% reporting that digital solutions have been effective in delivering better outcomes for patients and service users.
  • Remote consultations, such as, phone and video consultations have witnessed a greater increase in India than the global average. 86 % of Indian organizations are now offering phone consultation (up from 48 % before pandemic) and 83 % for video consultations (up from 33 % before pandemic).
  • Around three fourth of the respondents in India reported positive experiences with digital technologies and data solutions with the number of people using online consultations in India recording a threefold increase.

This encouraging trend and pattern needs to be consolidated, analyzed, and leveraged – for sharper actionable insights for the development of more contemporary products and services to delight the pharma and health care stakeholders.

A key missing link in India:

The digital health transformation of India’s healthcare system during Covid pandemic was also captured in another article, published by Elsevier Connect on February 23, 2021. It reiterated, although the pandemic has made an overall detrimental impact impacted on India, ‘it has brought about an avalanche of positive changes, including the adoption of digital health technologies and significant changes to the way care is delivered.’ Looking ahead, ‘With the launch of national public health initiatives, India has an incredible opportunity to become a digital health leader,’ the paper predicted.

However, the author also pointed out, unambiguously, that the health care crisis caused by the pandemic has also brought to the fore a key missing link – the need for updated and near real-time availability of trusted information. This observation is more relevant now than ever before, especially considering India’s National Digital Health Mission (NDHM).

National Digital Health Mission – a new ambition:

While addressing the nation on August 15, 2020, Prime Minister Narendra Modi announced the National Digital Health Mission of India. He said in his speech, “From today, the national digital health mission will begin. It will revolutionize the Indian healthcare sector. Every Indian will be issued a health ID that will act like a healthcare account, storing details of all the tests done, existing diseases, diagnoses, medicines prescribed.”

The objectives of the mission are to establish a core digital health database, creating a system of Electronic Health Records (EHR) based on international standards, establish data ownership pathways, so that patients become the owner of their health records, and promoting health data analytics and medical research. This initiative by any standard, is expected to be a game changer, as and when it comes to fruition.

Subsequently, on June 25, 2020, the Union Ministry of Health, reportedly, wrote to the principal secretaries (health) of all states and union territories, asking them to extend full support to the NHA to create four registries — doctors, health infrastructure, health IDs and personal health records of patients. It also instructed the states to send the required details within the stipulated timeline without breaching the norms of data privacy.

Need to avoid any possible missing link in the NDHM:

However, the Harvard Business Review article, published on June 12, 2020, asserted that the emergence of the COVID-19 pandemic not only presented a “mind-boggling array of challenges” exposed the limitations of the electronic health record (EHR) in helping physicians deliver care, especially in the United States.

It suggested: transformation of the EHR from an emphasis on a ‘person’s medical record’ – to an emphasis on their ‘plan for health’ and from a focus on ‘supporting clinical transactions’ to a focus on ‘delivering information’ to the provider and the patient, will be more meaningful.

Thus, it’s time for a new kind of EHR system in today’s perspective, as suggested by the HBR article, besides other domain experts. I am sure, competent authorities will take note of this transformation required in EHR initiatives to avoid any missing link in the new digital healthcare space in India.

As the above Elsevier Connect paper also observed, with the launch of national public health initiatives, such as, Ayushman Bharat and National Digital Health Mission (NDHM), India harbors an incredible opportunity to showcase its world class digital health ecosystem for all in the country.

To help fructify these projects, all key stakeholders – health care service providers, its users, and practitioners – including the pharma industry and the tech solution companies, need to get intimately involved with a common agenda in place. Falling behind may invite regrets, later.

Nonetheless, well before that – the common missing links in India - near real-time availability of credible data, trusted and verified information for adopting digital health for patients that will need to be provided by clinicians in a seamless manner, should be carefully identified and addressed.

New steps into digital healthcare are on the way:

Several new steps into digital healthcare have been taken in various countries of the world. One such initiative is ‘Internet Hospitals.’ These are basically an internet-medical-platform combining online and offline access for medical institutions to provide a variety of telehealth services directly to patients.

A Deloitte paper – ‘Internet Hospitals in China: The new step into digital healthcare,’ published on March 16, 2021 says: ‘Online hospitals are typically offshoots of offline medical organizations. The combination of Internet with health care will drive the medical industry’s transformation into a health service provider from a health care supplier, distributing resources equally and enhancing efficiency,’ moving ‘towards future smart health care.’

Conclusion:

Covid-19 has created a new focus on the digital health ecosystem in India, for accelerating the use of digital technology to radically advance health care systems and save lives. Today, many are experiencing that, big data, analytics, artificial intelligence, remote learning, and data inter-connectivity, can make a real difference to the work of HHS professionals in India.

Embracing digital with accelerated speed during the pandemic, has reportedly started making a significant positive impact on the cycle of the patient’s clinical assessment, treatment, and monitoring. With increasing use, it would reduce the cost of health care, improve patient access to affordable treatment and care services, when many patients’ journey for disease treatment will start online, and get directed to the optimal care setting either physically or virtually.

The article on health-tech, published in the Fortune India on February 20, 2021, has aptly concluded: ‘Eventually health technology infusion in the Indian healthcare ecosystem will be the route to enhance patient-centric healthcare accessibility, affordability, and sustainability. The advent of 5G technology in the country is poised to further catalyze this momentum.’ This, in turn, will facilitate ushering in more game changing steps into digital healthcare, creating a new ecosystem, greater awareness and a keen desire to remain healthy for all.

Thus, from the GIGO perspective, as defined by the Cambridge Dictionary, I reckon, in pharma’s digital initiatives, especially in India, a key factor needs to be carefully addressed. This is – fathoming existence of any missing link involving near real-time availability of trusted information and credible data generation, which could indeed be a great spoiler of any painstaking digital adoption project.

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.

 

 

Data Integrity Issue Haunts Again With Covid Vaccine?

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On March 22, 2021, by a media release, AstraZeneca announced that its ‘US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% in preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization.’

Quite unexpectedly, on March 23, 2021, the above claim on AstraZeneca’s Covid-19 vaccine, triggered a rare post-midnight statement by the National Institute of Allergy and Infectious Diseases (NIAID) of the United states. It rekindled a lurking fear of many, yet again, on the issue of questionable data integrity within the drug industry, in general.

This News Release articulated: “Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.”

The concern was on the possible inclusion of outdated information from that trial, ‘which may have provided an incomplete view of the efficacy data.’ It urged AstraZeneca to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as soon as possible.

Later on that very day, AstraZeneca released another statement saying: “The numbers published yesterday were based on a pre-specified interim analysis with a data cutoff of 17 February. We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis.”

The company further emphasized, “We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data.” And also added that AstraZeneca intends to issue the results of the primary analysis within 48 hours.

However, the impact of the NIAID’s announcement on the unfurling of AstraZeneca’s Covid-19 vaccine in the U.S, is yet to be ascertained. It’s also still unknown what this news could mean for the vaccine’s alleged efficacy. Be that as it may, it all happened at a time when millions of people, in many countries of the world, including India, have already taken, at least, the first dose of this vaccine.

In this article, I shall deliberate on broader aspects of this critical issue and its relevance in the present case. However, before doing so, let’s try to figure out, why data integrity still remains a major concern of many experts in this area.

Why data integrity is still a major issue:

There are many studies that raised serious concern in this area, over a period of time. For example – ‘Dozens of recent clinical trials may contain wrong or falsified data’ – was claimed by the research paper that was discussed in ‘The Guardian’ on June 05, 2017.

This study reviewed data from 5,087 clinical trials, published during the past 15 years, in two prestigious medical journals – JAMA and the New England Journal of Medicine, and six anesthesia journals. In total, 90 published trials had underlying statistical patterns that were unlikely to appear by chance (or be termed as ‘unforced error’) in a credible dataset, the paper concluded.

Even my own article of September 30, 2019 deliberated on various facets of ‘data integrity’ involving novel therapy, across the world. There, I quoted one of the top medical experts related to the above paper, saying: “It’s very scary that we may be treating patients based on false evidence.” He further added: “It may be the case that certain treatments may need to be withdrawn from use.”

The ghost of a recent example still haunts:

Not so long ago, much reported fallout from Novartis’ alleged data manipulation fiasco with its billion-dollar gene therapy Zolgensma, shook all concerned. So much so, that the Company CEO had to pledge during an investor conference that: ‘the company will be more proactive in reporting data integrity issues to the FDA.’

He also added, Novartis has responded to the FDA’s Form 483 and is making documents available as requested, while reiterating that the data manipulation uncovered at the San Diego site “does not impact the safety, efficacy or quality of Zolgensma.”

The key point to ponder, therefore, especially in AstraZeneca’s Covid-19 vaccine case – is the same ghost haunting us, yet again?

Is it happening again? 

One may, possibly, find some cue of the answer to this question while looking at what followed after ‘validation of the statistical analysis’ by AstraZeneca, as it was promised by the company. Interestingly, the following day, after apparently a thorough analysis, the data released by AstraZeneca, re-iterated effectiveness of its COVID-19 vaccine, which apparently, is broadly similar to the results released earlier.

The Company highlighted therein, ‘US Phase III primary analysis confirms safety and efficacy,’ with the following points:

  • 76% (earlier shown as 79%) vaccine efficacy against symptomatic COVID-19
  • 100% efficacy against severe or critical disease and hospitalization
  • 85% efficacy against symptomatic COVID-19 in participants aged 65 years and over.

It may continue to remain unclear to many – whether or not there was some suspected issue of data integrity – till the answers, at least, to the following questions are made public:

  • Why did the data and safety monitoring board for the trial write a harsh letter to AstraZeneca on its claim, and copied the leadership of NIAID and the Biomedical Advanced Research and Development Authority?
  • As the proof of the pudding is in its eating, why there will even be a slight downward revision in the rate of efficacy of AstraZeneca Covid-19 vaccine?

Conclusion:

I wrote in this blog, way back on August 03, 2015 that data manipulation issues are dangerously leapfrogging into clinical trial domain, even in India. As a result, many domestic drug players had to pay a heavy price – in terms of drug import bans by USFDA and other regulators. Several questions on the quality of efficacy and safety of Indian generic drugs were also raised in many developed countries. A number of best-selling books were also written on this issue.

Some may recall, just ahead Covid pandemic struck, trial data of a highly complex and very expensive gene therapy was also questioned by the US-FDA, for the same reason. However, on March 31, 2020, on completion of its review of the information, records of the inspection, the evidence collected, and the firm’s corrective actions, US-FDA stated: “Objectionable conditions were found and documented but the objectionable conditions observed during the inspection do not meet the threshold for regulatory action.”

Almost in a similar line, after the NIAID decided to make its data related concern public on AstraZeneca Covid-19 vaccine, its head, Anthony Fauci, reportedly, characterized this issue as “an unforced error.” This is indeed a cryptic comment. The root cause of this entire saga with details is still awaited.

Interestingly, the term “unforced error’ is widely used in Tennis, and means, ‘a mistake in play that is attributed to one’s own failure rather than to the skill or effort of one’s opponent.’ From this perspective, after AstraZeneca’s statement of clarification on its Covid-19 vaccine data, the concern on its phase three trial data would possibly be put to rest. At least for now, let’s not see the ghost of data integrity for this vaccine, where there doesn’t seem to be any.

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.