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India’s Drug Quality Concerns: Is Light At The End of The Tunnel In Sight Now?

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A brief chronology of some recent events on issues pertaining to patient-health-safety with drugs, as captured below, would possibly generate a mixed feeling for many. This includes a serious concern about, especially generic drug quality safety standards in India, on the one hand, and a ray of hope in the tools available to patients to know more about drugs that they have been prescribed. In this article, I shall dwell on this area. My intent is to bring to the fore the vital point – Is the beginning of the end of a long dark tunnel in sight now?

 A chronology of some recent events:

As reported on July 16, 2023, while talking on the subject, “Pharmaceutical Quality — What are we missing?”, the Drug Controller General of India (DCGI) made a notable comment. He, reportedly, said that the poor quality of drugs exported from India to foreign countries had tarnished the image of the country in the international market. The DCGI further added, pharmaceutical quality has become a subject of discussion on the global platform and the international community has started doubting whether India is capable of making quality pharmaceuticals for the global population.

He underscored, “We boast of our country as the pharmacy of the world, but it seems that it is too difficult to maintain the top position for long. If the position is lost, it will be painful and difficult to restore the faith of the international community. Further, we will lose the opportunity to serve the whole humanity of the world. The responsibility of the loss will not only fall on the manufacturers, but equally on all the stakeholders.”

Alongside, a news report on August 01, 2023, brings some hope in this regard, which I shall elaborate in course of this deliberation.  

A long saga of events: 

Yes, as it appears from the following backdrop:

Over the last several decades, there have been many instances where international drug regulators, including the U.S. FDA, expressed concerns about the quality standards of Indian manufactured drugs. These concerns have generally been related to specific manufacturing facilities – ranging from top domestic manufacturers to smaller ones, raising an uncomfortable apprehension – does India produce ’World-Class’ medicines, for all? 

About a decade ago, one of the most well-known cases was in 2013 when the U.S. FDA issued an import alert on products from the Ranbaxy Laboratories facility in India due to data integrity and manufacturing quality issues. This led to significant scrutiny of other Indian pharmaceutical companies as well. Issues related to data integrity, product quality, and good manufacturing practices lead to inspections, warning letters, import alerts, or other regulatory measures.

It continued. For example, around that time, even Sun Pharmaceutical Industries, one of India’s largest pharmaceutical companies, received a warning letter from the U.S. FDA in 2015 (Source: U.S. FDA). Similarly, Wockhardt, another top Indian pharmaceutical company, faced regulatory scrutiny in 2013 when the U.S. FDA issued an import alert and seized products manufactured at their facility in India. The FDA raised concerns about violations of good manufacturing practices and data integrity issues at the facility. This led to recalls of several products and affected the company’s reputation. (Source: Reuters).

As the juggernaut kept moving, on  December 08, 2016, I wrote in this blog, “Even Smaller Countries Now Question Indian Drug Quality Standard.” On March 04, 2023, the Mint reported, “Death of children in Gambia linked to consumption of India made cough syrups, as the US CDC report states.”  

As I write, the veracity of impact of such incidences remains as serious, if not more, although instances seem to be much fewer. For instance, as reported by Reuters on August 01, 2023: “India has directed Riemann Labs, a manufacturer linked to cough syrup deaths in Cameroon, to stop manufacturing activities, the country’s health ministry said in a statement on Tuesday.”

Thus, On May 27, 2019, I again wrote about: “Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India” in this blog– and that was not the first time I flagged this menace in the country against patient safety.

Even big Indian pharma continued to be struggling with GMP issues:

Big Indian pharma companies are also involved in issues related to lapses in high drug quality standards even recently. Such as, even in 2021, Dr. Reddy’s Laboratories, received a warning letter from the U.S. FDA after an inspection of their manufacturing facility in India. The letter cited violations of good manufacturing practices, data integrity issues, and inadequate investigations of product complaints. Source: The Economic Times). Just a year before, in 2020, the U.S. FDA noted several observations related to good manufacturing practices and quality control. (Source: Moneycontrol).

Drug regulators fight the fire as and when it comes up:

Both the state drug regulators and the Drug Controller General of India (DCGI) fight the fire at the respective manufacturing locations, as and when these come up. No significant actions on the ground for patient safety against such drugs were visible on the ground.  

For example, as reported on August 03, 2023: “Following recent incidents of several countries reporting deaths allegedly linked to “contaminated” India-manufactured drugs, the government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) which were revised in 2018, bringing them on par with World Health Organization (WHO) standards.”

The government ponders making technological interventions for patients:

There are early signs of the government trying to embrace technology for patients’ safety. For example on November 17, 2022, the Union Health Ministry released a gazette notification no 823Eimplementing the Drugs (Eighth Amendment) Rules, 2022, making it mandatory for pharmaceutical companies to affix a QR code on the pack of top 300 formulations from August 1, 2023. A QR code, as reported, will contain the unique product identification code, generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacture, expiry date and manufacturing license number.

This was part of the Ministry’s ‘track and trace’ mechanism, and of course, an intent at that time. However, a specific timeline for implantation has now been clearly enunciated.

This time it’s a two-pronged action:

For the first time, I think, a two-pronged action has been announced by the government – an enabling action for patients on the one hand against a strong punitive measure for the errant drug manufacturers on the other:

According to the above gazette notification of the Union Ministry of Health, on August 01, 2023, the central government announced stricter regulations for drug authentication and transparency by imposing mandatory QR codes on drugs. This will be effective from the same day. Patients will now be able to check the QR code on their medicines to ensure their authenticity. 

On August 03, 2023, the government set a deadline for adopting WHO-standard good manufacturing practices for drug manufacturers. Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year. 

Conclusion:

Besides all important patient safety, there are, at least, three other important factors for manufacturing high quality drugs for all and on an ongoing basis, sans lapses, as below:

  • Patients’ trust in the healthcare system relies on the availability of reliable medication. When patients have confidence in the drugs they are prescribed, they are more likely to comply with treatment regimens, leading to better health outcomes. 
  • A strong pharmaceutical sector that focuses on safe and effective drugs can foster economic growth by generating revenue, creating jobs, and attracting investments. It can also stimulate research and development efforts.
  • A reputation for producing quality drugs can boost India’s position as a global leader in pharmaceuticals, attracting international collaborations and partnerships.

Which is why, from the entire perspective, as above, amid India’s drug quality concerns, I reckon, one may still tend to wonder now – Is a light in sight now at the end of the dark and long tunnel? 

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.

 

UCPMP: Vacillating Between ‘The Perfect’ And ‘The Real’ World?

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In the ‘perfect world’ one takes ‘perfect decisions’, while in the ‘real world’ one takes a ‘real decision’ – as the saying goes. In tandem, a raging debate continues on what is ‘perfect’ and what is ‘real’, in the world we live in today. This may cause a dilemma to many, which seems to be all pervasive today. Understandably, many critical industry practices and processes are also a part of this quagmire. The pharma industry, the world over, including India, is no exception, where such dilemma and debates span across virtually all the business domains of the industry.

However, in this article, I shall focus only on one specific issue – alleged pharma marketing malpractices that continue unabated, regardless of severe punitive measures in many cases, from several parts of the world. Has it then become a universal ‘culture’ in this area? For greater clarity, let me start the ball rolling by trying to understand the line that differentiates ‘the perfect world’ norms from ‘the real world’ ones.

Understanding the ‘line’ between the ‘Perfect World’ and the ‘Real World’:

I reckon, in ‘the perfect world’ people develop ideal values, ethical standards and practices. The social, business and economic environments also encourage and promote an uncompromising value system that culminates into perfect and desirable behavioral traits for all. Consequently, there are no grey areas in the ethics and value judgement, especially regarding what is ‘right’ and what is ‘wrong’.

Whereas, in ‘real world’, the surrounding social, business and economic environment usually encourages and promotes self-serving interests, mostly from the shelter of ‘perfect world,’ as we shall see later. There also appears to be a flexibility in the overall value system – drawn around different guidelines, for preferred behavior and practices in most spheres of life. Consequently, one can spot many grey areas in that space, which are subject to different interpretation by different people. ‘Exceptions’ to the preferred behavior are also many.

As construed by many, one contemporary and broad example could perhaps be, the ethics, values and governance – enshrined in the Indian Constitution, arguably belong to the ‘perfect world.’ The same for ‘the real world’ is, what the majority of the population, including those who are governing the country demonstrate through words, deeds and action on the ground.

Living in ‘the real world’ – most expect others to practice ‘the perfect world’ norms:

Although, most people, including several different entities, actually prefer to live in ‘the real world,’ following commensurate practices and exceptions – generally expect others to practice ‘the perfect world’ norms – following commensurate ethics and values. Governments usually, try to exhibit that they want all citizens to be in ‘the perfect world’. However, under pressure of different nature, their policy enforcement arms keep maintain the status-quo of ‘the real world.’

Let me illustrate this point from the Indian perspective, with some recent examples related to the prevailing Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in the country. Here itself, we shall find, even the Government machinery vacillating between the both worlds.

Government vacillating between ‘both worlds’:

A recent media report related to the ongoing allegation on pharma marketing malpractices in India raised a controversy. It reported, on January 13, 2020 – ‘PM Modi warns pharma companies not to bribe doctors with women, foreign trips and gadgets,’ during his meeting with the senior officials from top drug-makers. This move was, reportedly, triggered by the report of “Support for Advocacy and Training to Health (SATHI)” – an NGO.

Prior to this, on May 03, 2018, it was also widely reported, “Prime Minister Narendra Modi recently opened a Pandora’s box by condemning the allopathic doctors of the country during an interaction called ‘Bharat ki Baat, Sab ke Saath’ with the diaspora in London. The PM condemned the Indian doctors on charges of corruption and malpractice. He emphasized on the doctor-industry nexus and shared concerns on the fallout of such a relationship.”

The above statements, as reported, reflect deep anguish of the Prime Minister for violation of ethics and values in pharma marketing practices – as expected in the ‘Perfect World.’ Following this outburst at the top echelon of the country’s governance hierarchy, the logical general expectation is, commensurate action by the Department of Pharmaceuticals (DoP), at least, to contain those contentious practices.

But, the Government seems to be vacillating: 

Instead, just after a few weeks from what was quoted in the above January 2020 report – on February 09, 2020 another media report highlighted something that confirms vacillation of the Indian Government from ‘the perfect world’ to ‘the real world’, albeit too frequently, on this issue.

Despite UCPMP being in force for all drug companies to abide by, voluntarily, since January 2015, the situation in this area hasn’t improved a bit, which the DoP also seems to be well aware of. The obvious question, therefore, that follows: Is the DoP on the same page as PM Modi?

Interestingly, despite the PM’s assertion in this regard, the DoP Secretary, reportedly, kept playing the same old tune even after 5 years of the UCPMP’s unsuccessful implementation. He again repeated: “We have strictly instructed all the stakeholders to follow the code voluntarily. If not complied seriously, the department will bring in stricter regulations at the time to come and also think about making it mandatory for effective compliance.” This threat, from the ‘perfect world’ perspective, continues with the ‘real world’ understanding for action.

The possible reason for the above vacillation:

Many consider, intense lobbying by the pharma associations as the possible reason for vacillation of the Government. This is vindicated by another report of January 17, 2020 that claimed, a powerful Indian industry association has sought multiple tweaks in the current UCPMP – meant for voluntary implementation by the drug industry in India. Two of these, among several others, were reported as follows:

  • Relaxed rules for the distribution of free samples.
  • Permission for doctors to work at pharmaceutical companies.

As reported, this proposal of the industry has been floated among pharmaceutical companies, for comments. ‘Once approved by all member companies, it will be sent to Department of Pharmaceuticals secretary P.D. Vaghela.’ However, it appears, there doesn’t seem to be anything new in it, as news archives reveal, similar proposals were submitted by the Indian drug industry associations, in the past, as well.

At this stage, let me hasten to add that the above January 2020 report, quoting the Indian PM’s anguish, was denied by a domestic industry association by a statement.

The first report was denied – albeit vaguely – by an industry association:

Curiously, the January 2020 report was denied by the domestic Industry Association - Indian Pharmaceutical Alliance (IPA) by releasing a statement. It said, the meeting convened by the Prime Minister Narendra Modi with the healthcare industry on January 01, 2020 was to discuss future road map for growth of the industry.

It further emphasized, the focus of the discussion was to promote research and development, build an innovation ecosystem, improve access to high-quality medicine and strengthen global competitiveness of the industry. The purpose was to take the industry to the next level and leverage opportunities going forward in the pharmaceutical sector. “There was no discussion on uniform code of pharmaceutical marketing practice in the meeting,” the statement added.

However, this statement appears rather vague to many, as it doesn’t emphatically deny that the PM did not say or mean those words, regardless of the context. Neither, the PMO, reportedly, has done so, as yet.

Probably because of this reason, another news article reported on January 15, 2020 that the Indian Medical Association, the country’s largest body of doctors, urged Prime Minister Narendra Modi to “prove, deny, or apologize (for)” the purported statement attributed to him asking pharmaceutical companies ‘not to bribe doctors with foreign trips, gadgets and women.’ I am still not aware of any response from the PMO on the same. Hence, some people find the industry association’s statement, especially considering the core issue under discussion today, albeit vague.

Some key findings on UCPMP:

Be that as it may, as I indicated in one of my previous articles in this blog, a survey report by Ernst and Young titled, “Pharmaceutical marketing: ethical and responsible conduct”, was released in September 2011 on the UCMP and MCI guidelines. It highlighted some of the following points:

  • More than 50 percent of the respondents are of the opinion that the UCPMP may lead to manipulation in recording of actual sampling activity.
  • Over 50 percent of the respondents indicated that the effectiveness of the code would be very low in the absence of legislative support provided to the UCPMP committee.
  • 90 percent of the respondents felt that pharma companies in India should focus on building a robust internal control system to ensure compliance with the UCPMP.
  • 72 percent of the respondents felt that the MCI did not stringently enforce its medical ethics guidelines.
  • Just 36 percent of the respondents felt that the MCI’s guidelines would have an impact on the overall sales of pharma companies.

Although, this report may be a bit dated, its key findings don’t seem to have changed much as on date. It is also worth noting that there are umpteen examples of similar malpractices in the pharma industry, globally.

Conclusion:

“Compared to a strictly controlled manufacturing environment, the marketing environment for the pharmaceutical industry in India is less regulated, but will move towards greater regulation in times to come”, predicted ‘The Global Guide to Pharma Marketing Codes,’ a few years ago. The situation remains unchanged.

Alongside controversy over pharma firms allegedly ‘bribing’ medical professionals, the Alliance of Doctors for Ethical Healthcare (ADEH), a network of doctors from across the country has demanded that the UCPMP framed five years ago be made mandatory, as another media report highlighted on January 21, 2020.

But the reality is, the Government wants the drug industry to follow ‘the perfect world’ ethics and values in marketing practices to safeguard patients all round interest. Whereas, the drug industry wants the policy makers to appreciate the business compulsions of ‘the real world’ and introduce exceptions to the rules.

Both the stances are unlikely to meet a common ground, because general population expects the Government to adhere to ethics and values of ‘the perfect world’, in health care. Whereas, in public, pharma industry leaders often take vows of practicing so, but seem to act differently in ‘the real world’ situation, expanding the credibility gap.

In the perceivable future, it appears unlikely that the Government’s ‘perfect world’ expectations, and the ‘real world’ actions of most pharma players will be in sync with each other. Unless, of course, either the Government moves away from ‘the real world’ marketing ethics and values – safeguarding patient interest, to meet ‘real world’ expectations of the industry, or make pharma players to fall in line with ‘the perfect world’ expectance, by making the UCPMP mandatory.

Is the question, therefore, how to take a ‘perfect world’ decision for the people’s health interest, in the ‘real world’ of the pharma industry? Till this issue is resolved, UCPMP will continue to exist, but no more than a ‘toothless tiger’, as it were.

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.

 

 

Uniting Pharma With Business Ethics: A Bridge Too Far?

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Operating ethically not only is the right thing to do but also is fundamental to success in business. Poor governance and poor ethical business practices can lead to fines, public scrutiny and distrust – overshadowing good performance, destroying reputation, and undermining the morale and engagement of employees. …We must act in ways that build and maintain the trust of patients, healthcare professionals, governments and society. This was articulated in the Novartis Corporate Responsibility Report 2017, highlighting how important it is to unite pharma operations with business ethics for each company. But is it happening in reality?

The same question haunts yet again with the announcement of a new Code of Marketing Practice by the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA),effective January 2019. The pronouncement prescribes ‘a global ban on gifts and promotional aids for prescription drugs wherever the association’s member companies operate.’

However, the overall scenario gets more complex to comprehend, when on January 03, 2019  Bloomberg Law reported: ‘The change is causing concern among both U.S.-based and multinational companies like Astra Zeneca, Bristol-Myers Squib, Johnson & Johnson, and Pfizer Inc. about how to balance appropriate business behavior with respect for cultural norms in other countries.’ Interestingly, the IFPMA membership virtually covers all MNC drug companies, operating across the world. Thus, any concern on its implementation, especiallyamong some of the bigger names, raises more questions than answers about its effectiveness. What exactly has been the outcome of all such actions being taken, especially by the multinational pharma industry associations, from time to time. Have the patients been benefited – at all?

Keeping this recent development as the backdrop, I shall try to gauge in this article, is the bridge still too far to mitigate the widening gap between overall pharma operations and the standard of business ethics -voluntary code of practices of pharma associations notwithstanding?

Why pharma ‘business-practices’ and ‘business-ethics’ are so important?

Before charting onto the sensitive areas of ‘business practices’ and ‘business ethics’, let me recapitulate the meaning of these two terminologies to fathom why these are so important in pharma to protect patient health interest.

  • Business practice is defined as a method, procedure, process, or rule employed or followed by a company in pursuit of achieving its objectives. Itmay also refer to these collectively.
  • Similarly, Business ethics is defined as a form of professional ethics that examines the ethical and moral principles and problems that arise in a business environment. It applies to all aspects of business conduct on behalf of both individuals and the entire company.

Thus, ethical business policies and practices for pharma industry, when worked out both by an industry association or an individual company, aims at addressing potentially controversial issues, such as corporate governance, insider trading, bribery, discrimination, corporate responsibility and fiduciary responsibilities.

Ironically, despite well-hyped announcements of voluntary codes of practices from time to time, no commensurate changes in patients’ health interest are visible in real life. Thus, the very relevance of such edicts is now being seriously questioned by many.

What do reports reflect on ongoing pharma business practices?

To get an idea in this area, let me quote below from three reports, out of which one is specifically on the Indian scenario, which has not changed much even today:

“The interaction between physicians and medical representatives (MRs) through gift offering is a common cause for conflicts of interest for physicians that negatively influence pre- scribing behaviors of physicians throughout the world.” This was articulated in an article titled, “Gift Acceptance and Its Effect on Prescribing Behavior among Iraqi Specialist Physicians”, published by Scientific Research Publishing (SCIRP) in June 2014.

A couple of years before that, on September 07, 2012, Reuters also published an article with the headline: “In India, gift-giving drives drug makers’ marketing.” Thereafter, many similar articles were published in various newspapers and magazines, possibly to trigger remedial action by the regulators in the country.

Very recently, on January 18, 2019, The New York Times (NYT) came out with a mind boggling headline – “Study Links Drug Maker Gifts for Doctors to More Overdose Deaths.” Elaborating on this JAMA study, the NYT wrote: “Counties where the doctors got more meals, trips and consulting fees from opioid makers had higher overdose deaths involving prescription opioids.”

The point I want to drive home here is that freebies in the form of gifts, travel to exotic places with free meals and stay, fees of various types clubbed under a mysterious nomenclature ‘consulting fees’, purported to influence doctor’s prescribing behavior, are now rampant. These are adversely impacting patients, as they are often compelled to buy high-priced drugs, unnecessary drugs, including antibiotics, sedatives and opioids, to name a few.

Are big pharma companies following the codes – both in letter and spirit?

The doubt that surfaces, are these changes just for displaying to the stakeholders how well and with stringent measures, drug companies are self-regulating themselves, on an ongoing basis? Before jumping to any conclusion, let us try to make out whether, at least the big pharma players are following these codes in both letter and spirit.

To establish the point, instead of providing a long list of large pharma settlements with governments for various malpractices, I shall cite just the following two relatively recent ‘novel’ examples related two top global pharma companies, for you to have your own inferences.

  • The first one is related to reports that flashed across the world in May 2018 related to Novartis. One such article described, “Congress demands info from Novartis about its USD 1.2m in outflows to Michael Cohen, just as it was negotiating payments for its cancer drug.” The report further elaborated, Novartis’ USD 1.2 million payment was made in the shell company of Michael Cohen, President Donald Trump’s personal lawyer and so-called ‘fixer’.
  • The second one is the September 13, 2018 report of The New York Times. It revealed: ‘Dr. José Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, resigned on Thursday amid reports that he had failed to disclose millions of dollars in payments from health care companies in dozens of research articles.”

The report also stated: “Dr. Baselga, a prominent figure in the world of cancer research, omitted his financial ties to companies like the Swiss drugmaker Roche and several small biotech startups in prestigious medical publications like The New England Journal of Medicine and The Lancet. He also failed to disclose any company affiliations in articles he published in the journal Cancer Discovery, for which he serves as one of two editors in chief.”

Indian companies aren’t trailing far behind, either:

Many Indian companies are, apparently, sailing on the same boat. Let me illustrate this point by citing an example related to India’s top ranked domestic pharma player.

What it said: Way back on November 13, 2010, Sun Pharmain a communication expressed its concern by saying: ‘Over four decades since Independence, the government nurtured a largely self-sufficient pharma industry. But the entry of MNCs is putting most drugs beyond the reach of millions.’

The communique further added: ‘Even as the domestic industry begins to feel the heat of an unprotected market, public health experts are examining why drug prices in India are higher than in Sri Lanka, which imports most of its drugs. The MNC takeover raises the specter of an MNC-dominated pharma sector selling drugs at un-affordable prices, a throw ‘back to the scenario just after Independence, which the government painstakingly changed over four decades. Are we setting the clock back on the country’s health security?’

The reality thereafter: It’s a different story that today, the same Sun Pharma, despite alleged ‘high price drugs of MNCs’, occupies the top ranking in the Indian pharmaceutical market. Be that as it may, the point to note that the same company is now facing similar charges from other countries, almost a decade after. On March 2017, a media report came with a headline: ‘Sun Pharma, Mylan face price fixing probe in US.’

Incidentally,the company is mired with allegation on governance related issues, as well. A media report dated November 20, 2018 carried a headline: ‘Governance cloud over Sun Pharma, stock at 6-month low.’ This example is quite relevant to this discussion, as well, for its link with ethical business practices, as discussed earlier.

Additionally, class-action lawsuits in the United States for alleged business malpractices, including ‘pay for delay conspiracies’, against Indian pharma companies are also on the rise – Sun Pharma and Dr. Reddy’s top the list in terms of those who face most class-action litigation, reported a leading Indian business daily on September 02, 2017.

Pharma malpractices continue, DOP is still to make UCPMP mandatory: 

In this quagmire, where self-regulation doesn’t work, the government usually steps in, as happened in the United States and Europe. Whereas, in India, no decisive government action is yet visible to curb this menace, especially for protection of patients’ health interest. Let me try to illustrate this point with the following chronology of four key events:

  • On May 08, 2012, the Parliamentary Standing in its 58th Report, strongly indicted the DoP for not taking any tangible action in this regard to contain ‘huge promotional costs and the resultant add-on impact on medicine prices’.
  • Ultimately, effective January 01, 2015, the Department of Pharmaceuticals (DOP) put in place the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) for voluntary implementation, despite knowing it has not worked anywhere in that format.
  • When voluntary UCPMP did not work, on September 20, 2016, the then secretary of the DoP reportedly said, the mandatory “UCPMP is in the last leg of clearance with the government. The draft guidance has incorporated suggestions of the pharma industry and other stakeholders.”
  • After another year passed by, on April 16, 2018, a news report reconfirmed: ‘4 years on, code to punish pharma firms for bribing doctors still in works.’ Its status remains unchanged till date.

Conclusion:

Even after Prime Minister Modi’s comment on April 2018 regarding the alleged nexus between doctors and pharmaceutical firms and doctors attending conferences abroad to promote these companies, decision paralysis of DOP continues on this important issue.

Pharma companies continue practicing what they deem necessary to further their business interest, alongside, of course, announcing their new and newer voluntary codes of practices. But, patients keep suffering, apparently for the apathy of the DOP to curb such malpractices forthwith.

Coming back to where I started from, when the malice is so deeply rooted, would any global ban ‘brand-reminders’, such as gifts, even if implemented religiously, work? Thus, the doubt lingers, for uniting pharma operations with corporate business ethics is the bridge still too far?

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.

Is The Department of Pharmaceuticals On The Same Page As The Prime Minister?

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“The open secret is that pharmaceutical companies throw all manners of inducements on doctors to prescribe their medicines. The victim of their misdemeanors is the unsuspecting patient. Mr. Modi clearly wants to break this self-serving chain” – highlighted a media report on April 20, 2017.

“Prime Minister Modi wants to end the unholy doctor-drug industry nexus” – echoed another media headline on the same day.

In a step towards this direction for the benefits of patients, the PM hinted at making prescriptions in generic names of drugs mandatory through a legal framework. There could be many challenges ahead to achieve this objective, but the fact remains just the same. A study published in a well-acclaimed medical journal, even after the PM’s much talked about pledge, re-establishes the adverse impact of this alleged nexus through a bioequivalarge research study.

In this article, I shall not go into the details of what the PM had said in this regard and the impact of the same on patients, pharma companies, different types of service providers to the branded-generic business, and the Indian Pharma Market (IPM), as I have already done that. Neither shall I focus here on the action expected from the Union Ministry of Health, as they have, at least, amended the statute making the bioequivalence studies mandatory, though several other action steps need to follow. Today, I shall deliberate only on one question: Is the department of pharma on the same page with the PM on effectively addressing the alleged ‘doctor-drug industry nexus’?

A recent study:

The following very recent study elegantly highlighted the criticality of snapping this unholy link, as many believe, for the patients’ sake.

The May 2, 2017 JAMA editorial titled, “Reconsidering Physician – Pharmaceutical Industry Relationships” articulated, physicians need to balance the risk and benefits of treatments, especially when inputs come from companies whose interests may conflict directly with those of patients. Drug costs, though revenue to their respective manufacturers, are high out of pocket expenditure to patients, many of whom seriously struggle to afford their medical treatment.

The above editorial comment was based on an ‘Original Investigation’ study titled, “Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing”, published on the same day in the same esteemed journal.

This large study was aimed at measuring the outcome of an effort by some Academic Medical Centers (AMCs) in the United States to regulate physicians’ conflict of interest in this area. These AMCs enacted policies restricting pharmaceutical representatives’ visits to physicians for product detailing, between 2006 and 2012. Accordingly, the paper analyzed the association between detailing policies enacted at these AMCs and the physicians’ prescribing of actively detailed and not detailed drugs. This study included 16,121, 483 prescriptions, written between January 2006 and June 2012, by 2126 attending physicians, at the 19 intervention group AMCs, and by 24, 593 matched control group physicians.

The authors concluded with a fresh reaffirmation that the implementation of policies at AMCs, which restricted product detailing by the respective company medial representatives, between 2006 and 2012, was associated with a modest but statistically significant reduction in prescribing of detailed drugs across 6 of 8 major drug classes.

Significant cost reduction, with important economic implications:

It’s worth noting, the patients did not suffer at all, in any way, with such restrictions, on the contrary were probably benefitted with this policy, though individual pharma player’s sales revenue might have been adversely impacted.

Quoting the researchers, a Public Release of May 2, 2017 titled, “Restricting sales visits from pharmaceutical reps associated with changes in physician prescribing” also reiterates: The reduction in the prescribing of detailed drugs and the increase in the prescribing of non-detailed drugs potentially represent a large reduction in costs, with important economic implications.

Why aren’t the erring players brought to justice in India?

Instances of serious marketing malpractices of several pharma companies in India are also being widely reported from time to time, both by the international and national media, including expressions of serious concern in the Parliament, and a reported Public Interest Litigation (PIL) pending in the Supreme Court.

Any instances of levying massive fines, or other punitive measures taken by any competent Indian authority for such delinquency by many pharma companies operating in the country, have not been reported, just yet, in my view. This is because, India doesn’t have in place any specific regulatory mechanism with built-in legal teeth that would deter, detect, investigate and take exemplary punitive actions against the erring players, wherever justifiable.

Is the department of pharma on the same page as the PM?

Much before this recent development, the Department Related Parliamentary Standing Committee on Health and Family Welfare in its 58th Report, placed before the Parliament on May 08, 2012, strongly indicted the Department of Pharmaceuticals (DoP) for not taking any tangible action in this regard. The committee observed that the DoP should take immediate action in making the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ mandatory to contain ‘huge promotional costs and the resultant add-on impact on medicine prices’.

It has just been reported, soon after the Prime Minister’s hint for a legal framework mandating doctors to prescribe in generic names, 73 percent doctors surveyed across the country opposed the PM’s initiative, raising concerns about the quality of all non-branded generic drugs. The report further stokes the apprehension of a concerted effort by this alleged nexus to further strengthen the make-believe perception, sans requisite credible favorable evidence, that branded-generics as a category is superior in quality to non-branded generics, which is not the fact.

Unfortunately, nothing substantive has yet happened on the ground regarding this issue, except the announcement of voluntary implementation of the DoP’s ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’, effective January 1, 2015 for six months for its assessment. Thereafter, the date extension process on the voluntary implementation of the UCPMP has become a routine exercise for the DoP on various pretexts, such as continuing discussion with the pharma trade associations and other stakeholders or to give legal teeth into it with penal provisions.

This situation prompts an important question: Is the DoP on the same page with the PM to contain, if not eliminate, the alleged unholy doctor-drug industry nexus?

Scope of mandatory UCPMP goes beyond prescriptions with generic names:

The scope of several intricate types of marketing malpractices, goes well-beyond influencing prescriptions for brand name drugs, due to various reasons. Hence, what Prime Minister Modi recently hinted at is not an alternative or a replacement for UCPMP, which will fall within a legal framework and be applicable to all the concerned players. Although, there could possibly be some degree of overlap with the prescriptions in generic names, mainly from the perspective of protecting patients’ health interest, the scope of both these initiatives is mutually exclusive, in many respects.

This would also encourage, especially the millennial generation, for innovative strategic thinking to work out cutting edge pharma marketing game plans with active patient engagement, while charting the uncharted frontiers, despite prescriptions in generic names, as and when it comes, if at all. As a result, new warhorses with proven cerebral power and agility would get newer opportunities to hold the leash and occupy the center stage in the pharma marketing warfare.

But…the indefinite wait continues:

Although the DoP apparently maintains a radio-silence on this important issue, a media report of February 26, 2017 indicates that the department will ‘soon’ issue an order making UCPMP mandatory for the drug manufacturing industry, bringing all doctors, chemists, hospitals and states in its ambit, and a blanket ban on expensive freebies such as cruise or vacation tickets. Intriguingly, no one seems to know how ‘soon’ would this ‘soon’ be – hence, the agony of an indefinite wait for justice continues.

Conclusion:

For the last three and a half decades, ‘Code of Pharmaceutical Marketing Practices’, prepared by various global pharma trade associations and many large global pharma companies individually, has come into existence for ‘strictest’ voluntary adherence. These are being relentlessly propagated by them as a panacea for all marketing malpractices in the drug industry.

Squeaky clean ‘pharma marketing codes for voluntary practices’ can be seen well placed in the websites of almost all large global pharma players and their trade associations. Although, its concept and intent are both commendable, a regular flow of media reports on such malpractices raises a relevant question: Do the votaries, sponsors and creators of these codes “walk the talk”?

If yes, why then mind boggling sums in billions of dollars are being paid as settlement fees by a large number of global pharma companies for alleged colossal marketing malpractices in different countries of the world.

This scenario prompts many stakeholders believe, though over-hyped by the global pharma industry, ‘Voluntary Practices’ alone of Pharma Marketing Code’, has never worked anywhere in the world. Thus, India needs a legally binding UCPMP for all concerned.

Prime Minister Modi has hinted at an effective pathway to mitigate this malevolent nexus for the benefit of patients. Understandably, that way can’t be construed as an exhaustive one, nor a cure-all. A slew of other effective steps should follow from different Government authorities, in tandem. The Union Ministry of Health has, at least, taken a related measure falling in their space. Nevertheless, an intriguing apathy of the DoP, as it were, in this area would encourage many to ponder: Is this important Government department on the same page as the PM in containing the alleged ‘doctor – pharma industry nexus?’

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.

 

Prescriptions in Generic Names Be Made A Must in India?

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Would prescriptions in generic names be made a must in India?

Yes, that’s what Prime Minister Modi distinctly hinted at on April 17, 2017, during the inauguration function of a charitable hospital in Surat. To facilitate this process, his government may bring in a legal framework under which doctors will have to prescribe generic medicines, the PM assured without any ambiguity whatsoever.

“In our country doctors are less, hospitals are less and medicines are expensive. If one person falls ill in a middle-class family, then the financial health of the family gets wrecked. He cannot buy a house, cannot conduct the marriage of a daughter,” he reiterated.

“It is the government’s responsibility that everybody should get health services at a minimal price,” the Prime Minister further reinforced, as he referred to the National Health Policy 2017. His clear assurance on this much-debated issue is indeed music to many ears.

Some eyebrows have already been raised on this decision of the Prime Minister, which primarily include the pharma industry, and its traditional torch bearers. Understandably, a distinct echo of the same one can also be sensed in some English business dailies. Keeping aside these expected naysayers, in this article, after giving a brief backdrop on the subject, I shall argue for the relevance of this critical issue, in today’s perspective.

Anything wrong with generic drugs sans brand names?

At the very outset, let me submit, there aren’t enough credible data to claim so. On the contrary, there are enough reports vindicating that generic drugs without brand names are generally as good as their branded equivalents. For example, a 2017 study on this subject and also in the Indian context reported, ‘93 percent of generic and 87 percent branded drug users believed that their drugs were effective in controlling their ailments.’

Thus, in my view, all generic medicines without any brand names, approved by the drug regulatory authorities can’t be inferred as inferior to equivalent branded generics – formulated with the same molecules, in the same strength and in the same dosage form; and vice versa. Both these varieties have undergone similar efficacy, safety and quality checks, if either of these are not spurious. There isn’t enough evidence either that more of generic drugs sans brand names are spurious.

However, turning the point that generic drugs without brand name cost much less to patients than their branded generic equivalents on its head, an ongoing concerted effort of vested interests is systematically trying to malign the minds of many, projecting that those cheaper drugs are inferior in quality. Many medical practitioners are also not excluded from nurturing this possible spoon-fed and make-believe perception, including a section of the media. This reminds me of the famous quote of Joseph Goebbels – the German politician and Minister of Propaganda of Nazi Germany till 1945: “If you tell a lie big enough and keep repeating it, people will eventually come to believe it.”

The lower prices of generic drugs without brand names are primarily because their manufacturers don’t need to incur huge expenditure towards marketing and sales promotion, including contentious activities, such as, so called ‘Continuing Medical Education (CME)’ for the doctors in exotic locales, and several others of its ilk.

Thus, Prime Minister Modi’s concern, I reckon, is genuine to the core. If any doctor prescribes an expensive branded generic medicine, the concerned patient should have the legal option available to ask the retailer for its substitution with a less expensive generic or even any other branded generic equivalent, which is supposed to work just as well as the prescribed branded generic. For this drug prescriptions in INN is critical.

Provide Unique Identification Code to all drug manufacturers:

When in India, we can have a digitally coded unique identification number, issued by the Government for every individual resident, in the form of ‘Aadhaar’, why can’t each drug manufacturer be also provided with a similar digitally coded number for their easy traceability and also to decipher the trail of manufacturing and sales transactions. If it’s not possible, any other effective digital ‘track and trace’ mechanism for all drugs would help bringing the wrongdoers, including those manufacturing and selling spurious and substandard drugs to justice, sooner. In case a GST system can help ferret out these details, then nothing else in this regard may probably be necessary.

Past initiatives:

In India, ‘Out of Pocket (OoP) expenditure’ as a percentage of total health care expenses being around 70 percent, is one of the highest in the world. A study by the World Bank conducted in May 2001 titled, “India – Raising the Sights: Better Health Systems for India’s Poor” indicates that out-of-pocket medical costs alone may push 2.2 percent of the population below the poverty line in one year. This situation hasn’t improved much even today, as the Prime Minister said.

Although, ‘prescribe drugs by generic names’ initiative was reported in July 2015, in the current context, I shall focus only on the recent past. Just in the last year, several initiatives were taken by the current Government to help patients reduce the OoP expenses on medicines, which constitute over 60 percent of around 70 percent of the total treatment cost. Regrettably, none of these steps have been working effectively. I shall cite hereunder, just three examples:

  • On February 29, 2016, during the Union Budget presentation for the financial year 2016-17 before the Parliament, the Finance Minister announced the launch of ‘Pradhan Mantri Jan-Aushadhi Yojana (PMJAY)’ to open 3,000 Stores under PMJAY during 2016-17.
  • On August 04, 2016, it was widely reported that a new digital initiative of the National Pharmaceutical Pricing Authority (NPPA), named, “Search Medicine Price”, would be launched on August 29, 2016. According to NPPA, “Consumers can use the app before paying for a medicine to ensure that they get the right price.”
  • In October 2016, a circular of the Medical Council of India (MCI), clearly directed the medical practitioners that: “Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs”

A critical hurdle to overcome:

Besides, stark inefficiency of the MCI to implement its own directive for generic prescriptions, there is a key legal hurdle too, as I see it.

For example, in the current situation, the only way the JAS can sell more of essential generic drugs for greater patient access, is by allowing the store pharmacists substituting high price branded generics with their exact generic equivalents available in the JAS. However, such substitution would be grossly illegal in India, because the section 65 (11) (c) in the Drugs and Cosmetics Rules, 1945 states as follows:

“At the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed. 20 [(11A) No person dispensing a prescription containing substances specified in 21 [Schedule H or X] may supply any other preparation, whether containing the same substances or not in lieu thereof.]”

A move that faltered:

To address this legal issue, the Ministry of Health reportedly had submitted a proposal to the Drug Technical Advisory Board (DTAB) to the Drug Controller General of India (DCGI), for consideration. In the proposal, the Health Ministry reportedly suggested an amendment of Rule 65 of the Drugs and Cosmetics Rules, 1945 to enable the retail chemists substituting a branded drug formulation with its cheaper equivalent, containing the same generic ingredient, in the same strength and the dosage form, with or without a brand name.

However, in the 71st meeting of the DTAB held on May 13, 2016, its members reportedly turned down that proposal of the ministry. DTAB apparently felt that given the structure of the Indian retail pharmaceutical market, the practical impact of this recommendation may be limited.

The focus should now move beyond affordability:

In my view, the Government focus now should move beyond just drug affordability, because affordability is a highly relative yardstick. What is affordable to an average middle class population may not be affordable to the rest of the population above the poverty line. Similarly, below the poverty line population may not be able to afford perhaps any cost towards medicines or health care, in general.

Moreover, affordability will have no meaning, if one does not have even easy access to medicines. Thus, in my view, there are five key factors, which could ensure smooth access to medicines to the common man, across the country; affordable price being one of these factors:

1. A robust healthcare infrastructure
2. Affordable health care costs, including, doctors’ fees, drugs and diagnostics
3. Rational selection and usage of drugs by all concerned
4. Availability of health care financing system like, health insurance
5. Efficient logistics and supply chain support throughout the country

In this scenario, just putting in place a legal framework for drug prescription in generic names, as the Prime Minister has articulated, may bring some temporary relief, but won’t be a long-term solution for public health care needs. There arises a crying need to put in place an appropriate Universal Health Care (UHC) model in India, soon, as detailed in the National Health Policy 2017.

Brand names aren’t going to disappear:

Prime Minister Modi’s assertion to bring in a legal framework under which doctors will have to prescribe generic medicines, probably will also legally empower the retailers for substitution of high priced branded generics with low priced generic or branded generic equivalents.

This promise of the Prime Minister, when fulfilled, will facilitate making a larger quantum of lower price and high quality generic drugs available to patients, improving overall access to essential medicines. Hopefully, similar substitution will be authorized not just for the JAS outlets, but by all retail drug stores, as well.

Brand names for generic drugs will continue to exist, but with much lesser relevance. the Drugs & Cosmetic Rules of India has already made it mandatory to mention the ‘generic names or INN’ of Drugs on all packing labels in a more conspicuous manner than the trade (brand) name, if any. Hence, if a doctor prescribes in generic names, it will be easier for all retail pharmacists and even the patients, to choose cheaper alternatives from different available price-bands.

Possible changes in the sales and marketing strategies:

If it really happens, the strategic marketing focus should shift – from primarily product-brand marketing and stakeholders’ engagement for the same, to intensive corporate-brand marketing with more intense stakeholder engagement strategies, for better top of mind recall as a patient friendly and caring corporation.

Similarly, the sales promotion strategy for branded generics would possibly shift from – primarily the doctors to also the top retailers. It won’t be unlikely to know that the major retailers are participating in pharma company sponsored ‘Continuing Pharmacy Education (CPE)’ in similar or even more exotic places than the doctor!

There are many more.

International examples:

There are enough international examples on what Prime Minister Modi has since proposed in his speech on this issue. All these are working quite well. To illustrate the point with a few examples, I shall underscore that prescribing in generic name or in other words “International Nonproprietary Name (INN)’ is permitted in two-thirds of OECD countries like the United States, and is mandatory in several other nations, such as, France, Spain, Portugal and Estonia. Similarly, pharmacists can legally substitute brand-name drugs with generic equivalents in most OECD countries, while such substitution has been mandatory in countries, such as, Denmark, Finland, Spain, Sweden, Italy. Further, in several different countries, pharmacists have also the obligation to inform patients about the availability of a cheaper alternative.

However, the naysayers would continue saying: ‘But India is different.’

Impact on the pharma industry:

The March 2017 report of ‘India Brand Equity Foundation (IBEF)’ states that Indian pharmaceutical sector accounts for about 2.4 per cent of the global pharmaceutical industry in value terms, 10 per cent in volume terms and is expected to expand at a Compound Annual Growth Rate (CAGR) of 15.92 per cent to US$ 55 billion by 2020 from US$ 20 billion in 2015. With 70 per cent market share (in terms of value), generic drugs constitute its largest segment. Over the Counter (OTC) medicines and patented drugs constitute the balance 21 percent and 9 percent, respectively. Branded generics constitute around 90 percent of the generic market. In my view, if the above decision of the Prime Minister is implemented the way I deliberated here in this article, we are likely to witness perceptible changes in the market dynamics and individual company’s performance outlook. A few of my top of mind examples are as follows:

  • No long-term overall adverse market impact is envisaged, as ‘the prices of 700 essential medicines have already been capped by the National Pharmaceutical Pricing Authority (NPPA). However, some short-term market adjustments are possible, because of several other factors.
  • There could be a significant impact on the (brand) market shares of various companies. Some will have greater exposure and some lesser, depending on their current sales and marketing models and business outlook.
  • Valuation of those companies, which had acquired mega branded generics, such as Piramal brands by Abbott Healthcare, or Ranbaxy brands by Sun pharma, may undergo considerable changes, unless timely, innovative and proactive measures are taken forthwith, as I had deliberated before in this blog.
  • Together with much awaited implementation of the mandatory Uniform Code of Pharmaceutical Marketing Practices (UCPMP) sooner than later, the sales and marketing expenditure of the branded generic players could come down significantly, improving the bottom-line.
  • Pharma marketing ballgame in this segment would undergo a metamorphosis, with brighter creative minds scoring higher, aided by the cutting-edge strategies, and digital marketing playing a much greater role than what it does today.
  • A significant reduction in the number of field forces is also possible, as the sales promotion focus gets sharper on the retailers and digitally enabled patient engagement initiatives.

The above examples are just illustrative. I hasten to add that at this stage it should not be considered as any more than an educates guess. We all need to wait, and watch how these promises get translated into reality, of course, without underestimating the quiet lobbying power of the powerful pharma industry. That said, the long-term macro picture of the Indian pharma industry continues to remain as bright, if appropriate and timely strategic interventions are put well in place, as I see it.

In conclusion:

It is an irony that despite being the 4th largest producer of pharmaceuticals, and catering to the needs of 20 percent of the global requirements for generic medicines, India is still unable to ensure access to many modern medicines to a large section of its population.

Despite this situation in India, Prime Minister Modi’s encouraging words on this issue have reportedly attracted the wrath of some section of the pharma industry, which, incidentally, he is aware of it, as evident from his speech.

Some have expressed serious concern that it would shift the decision of choosing a specific generic formulation of the same molecule for the patients from doctors to chemists. My counter question is, so what? The drug regulator of the country ensures, and has also repeatedly affirmed that there is no difference in efficacy, safety and quality profile between any approved branded generic and its generic equivalents. Moreover, by implementing an effective track and trace system for all drugs, such misgiving on spurious generic medicines, both with or without brand names, can be more effectively addressed, if not eliminated. Incidentally, reported incidences of USFDA import bans on drug quality parameters and breach of data integrity, include many large Indian branded generic manufacturers. Thus, can anyone really vouch for high drug quality even from the branded generics in India?

Further, the expensive branding exercise of essential medicines, just for commercial gain, and adversely impacting patients’ access to these drugs, has now been questioned without any ambiguity, none else than the Prime Minster of India. The generic drug manufacturers will need to quickly adapt to ‘low margin – high volume’ business models, leveraging economies of scale, and accepting the stark reality, as was expressed in an article published in Forbes – ‘the age of commodity medicines approaches’. Even otherwise, what’s wrong in the term commodity, either, especially when generic medicines have been officially and legally classified as essential commodities in India?

Overall, the clear signal from Prime Minister Modi that ‘prescriptions in generic names be made a must in India ‘, well supported by appropriate legal and regulatory mechanisms – is indeed a good beginning, while paving the way for a new era of Universal Health Care in India. God willing!

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.

‘Indian Drug Control World’s Weakest: Pharma Trade Bodies Working At Cross Purposes’

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“In the entire world, I think our drug control system probably is the weakest today. It needs to be strengthened,” said the Secretary of the Department of Pharmaceuticals (DoP) – V K Subburaj at an event in New-Delhi on April 19, 2016. 

In his speech, the Secretary also singled out the pharma industry associations for working in opposite directions, adding that “if we take one decision, it is appreciated by one but the other one criticizes us”.

This is indeed an irony. Such scathing comments from an important and a top Government official indeed stand out. This is primarily because, in the midst of the prevailing scenario, where a large section of the Government is saying ‘we are the best’ or ‘best among the worst’ or, at least, ‘fast improving’, a seemingly helpless key decision maker for the pharma industry was constrained to publicly say, what he had said, as above.

Nonetheless, public expressions, such as these, coming from a top Government official well-captures the sad and pathetic scenario of the systemic failure of pharma industry regulators to bring order in the midst of continuing chaos. Virtually free-for-all business practices, blatantly ignoring the patients’ health and safety interest in the country, continue to thrive in a self-created divisive environment.

Unsparing remarks in two critical areas:

As reported by the ‘Press Trust of India (PTI)’, the DoP Secretary, with his unsparing remarks, publicly expressed his anguish for the delay in taking remedial measures, at least in the two critical areas of the pharma industry in India, as follows:

  • Questionable quality of drugs
  • Questionable pharma marketing practices 

He also highlighted, how just not some Government Departments, but the pharma trade associations, which are formed and fully funded by the pharma players, both global and local, are working at cross-purposes to perpetuate the inordinate delay in setting a number of things right, to satisfy the healthcare needs of most patients.

I briefly dwelled on this critical conflict in my article in this blog of March 28, 2016 titled, “Ease of Doing Pharma Business in India: A Kaleidoscopic View”

A. Questionable quality of drugs:

There wasn’t enough debate in the country on the questionable drug quality in India. It began when the US-FDA started banning imports of a number of medicines in the United States from several drug manufacturing facilities in India. These pharma plants are of all sizes and scales of operations – large, medium, small and micro.

Almost on a regular basis, we now get to know, both from the national and international media, one or the other pharma manufacturing facility in the country, has received the ‘warning letter’ from the US-FDA on its ‘import ban’.

Dual drug manufacturing quality standards?                                            

The spate of ‘Warning Letters’ from the US-FDA have brought to the fore the existence of two different quality standards of drug manufacturing in India:

  • High quality plants dedicated to exports in the well-regulated markets of the world, such as, the United States, following the US-FDA regulations.
  • Other plants, with not so stringent quality standards of the Drug Controller General of India (DCGI), cater to the needs of the Indian population and other developing non-regulated markets. 

In this situation, when many Indian manufacturers are repeatedly faltering to meet the USFDA quality standards, the following two critical questions come up:

  • Are the US-FDA manufacturing requirements so stringent that requires a different compliance mindset, high-technology support, greater domain expertise and more financial resources to comply with, basically for protection of health and safety of the American patients?
  • If so, do the Indian and other patients from not so regulated markets of the world, also deserve to consume drugs conforming to the same quality standards and for the same reason? 

Answers to these questions are absolutely vital for all of us.

Pharma associations working at cross-purposes? 

Considering this from the patients’ perspective, there lies a huge scope for the pharma associations, though with different kind of primary business priorities, to help the Government unitedly in resolving this issue.

It appears from the deliberation of the DoP Secretary that the health ministry is already seized of the matter. The concerned departments are also apparently batting for quality, and trying to strengthen some specific capacity building areas, such as, increasing the number of inspectors and other drug control staff.

Reports also keep coming on the poor quality clinical trial data in India, including data fudging, as was recently detected by the foreign drug regulators. Intriguingly, nothing seems to be changing on the ground. In these areas too, the industry can unitedly try to protect the innocent patients from the wrongdoers, demonstrating enough credible and publicly visible real action.

From the anguish of the DoP Secretary on the critical quality related issue, it appears, there is a huge task cut out for the Indian drug regulators to ensure uniform and high drug quality standards for health and safety of all Indian patients’, just as their counterparts in America.

It is unfortunate to note from his observation that pharma industry associations are not visibly working in unison on many such issues in India.

B. The UCPMP:

The Edmund J. Safra Center for Ethics of Harvard University, while deliberating on “The Pharmaceutical Industry, Institutional Corruption, and Public Health” dwelled on the legal, financial, and organizational arrangements within which the pharmaceutical industry operates. It said, this situation sometimes creates incentives for drug firms and their employees, that conflict with the development of knowledge, drug safety, the promotion of public health, and innovation. More importantly, they also make the public depend inappropriately on pharmaceutical firms to perform certain activities and this leads to institutional corruption.

Illustrating from Professor Marc Rodwin’s project, the article said pharma players provide substantial discretionary funding for important medical activities, such as, continuing medical education, medical research, medical journals, and professional medical societies, which can encourage unwanted and undesirable compromise and bias in favor of their interests.

The same sentiment was also well-captured in an editorial of the well-reputed international medical journal BMJ of June 25, 2014. It unambiguously articulated, “Patients everywhere are harmed when money is diverted to the doctors’ pockets and away from priority services. Yet this complex challenge is one that medical professionals have failed to deal with, either by choosing to enrich themselves, turning a blind eye, or considering it too difficult.”

The editorial underscored the point that success in tackling corruption in healthcare is possible, even if it is initially limited, as anti-corruption bodies in the United Kingdom and US have shown to a great extent. With this, BMJ planned to launch a campaign against ‘Corruption in Medicine’, with a focus on India.

The DoP initiative:

Initiating a step in this direction, on December 12, 2014, the DoP announced details of the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’, which became effective across the country from January 1, 2015. The communique also said that the code would be voluntarily adopted and complied with by the pharma industry in India for a period of six months from the effective date, and its compliance would be reviewed thereafter on the basis of the inputs received.

Not a panacea:

It is worth noting, since the last three and a half decades, ‘Code of Pharmaceutical Marketing Practices’, prepared by various global pharma trade associations and most of the large global pharma companies individually, have come into existence purported for strictest voluntary adherence. These are being relentlessly propagated by them and their trade associations, as panacea for all marketing malpractices in the drug industry. Squeaky clean ‘pharma marketing codes’ for voluntary practices can be seen well placed in the websites of almost all large global pharma players and their trade associations.

The concept of a pharma marketing code and its intent are both commendable. However, the key question that follows: are all those working in practice? If the answer is yes, why then mind boggling sums in billions of dollars are being paid as settlement fees by a large number of global pharma companies for alleged colossal marketing malpractices in different countries of the world?

Mandatory UCPMP:

As happens with any other voluntary pharma marketing code of a global drug company or their trade associations, however mighty they are, similar non-compliance was detected by the DoP with voluntary UCPMP.  This gross disregard on the code, apparently prompted the DoP making the UCPMP mandatory, with legal implications for non-compliance, which could possibly lead to revocation of marketing licenses. 

A move in this direction, obviously necessitated meaningful discussion of the DoP with all stakeholders, especially the pharma trade associations. According to the Secretary, the discussions got unduly protracted, crippling his decision making process to put the mandatory UCPMP in place, soon.

Divergent views of pharma associations?

Thus, it is now quite clear that one of the reasons for the delay in making the UCPMP mandatory is the divergent views of various pharma trade associations.

In the Secretary’s own words, “To take an example of uniform marketing code, we thought we could arrive at a common solution. But even after 7-8 meetings, we failed to come to a conclusion. It’s only now that we have arrived at a code.” 

However, the bottom-line is, as on date, we don’t know when would the mandatory UCPMP come into force in India.

Conclusion:

The reverberation of virtual helplessness in the recent utterances of the Secretary of the DoP, has naturally become a cause of great concern, especially for the patients. There is still no sign of early resolution of the critical issue of dubious quality, both in the drug manufacturing and clinical trials in India.

The concerned ministries would require to demonstrate unwavering will and unflagging zeal for good governance with accountability, to set things right, without any further delay. When US-FDA can, why can’t the DCGI succeed in doing so? The Government is expected to ensure that justice prevails in this area, for the patients’ sake, soon enough.

Similarly, wrong doings in pharma marketing practices also need to be addressed by the DoP, initially making the UCPMP mandatory having strong legal teeth, to start with, notwithstanding the fact that the trade associations mostly work at cross-purposes, in this area too.

As I hear from the grapevine, especially the MNC trade associations, both inside and outside the country, are trying hard to take, especially, the owners of the large Indian pharma companies on board, in several ways, basically to further their crusade on various self serving issues, such as dilution of Indian Patents Act.

That said, taking serious note of the observation of the DoP Secretary that the Indian drug control is the “weakest in the world”, together with the challenges that he is facing in containing pharma marketing malpractices, I hope, the honorable Prime Minister’s Office (PMO) may wish to intervene soon, in order to promptly contain these snowballing public health menace.

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.

Against Pharma Marketing Malpractices: A Gutsy Step

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January 7, 2016 edition of ‘The Financial Times (FT)’ reported that responding to escalating pressure on the drug industry, related to its ‘Conflict of Interest’ with the doctors and other related professionals, GlaxoSmithKline (GSK) has decided taking a very unorthodox step.

According to this news report, GSK has decided not to promote its brands by making payments to doctors in any form. The company also strongly expressed its belief that to refurbish the dented image of the industry, in general, its competitors, as well, would start following the same steps, sooner than later.

Whatever it may be, GSK has apparently decided to avoid the above ‘conflict of interest’ and not to ride on the trendy wave for drug promotion, any longer.

Although, many restrictions have already been put in place by different countries, to curb these practices to the extent required, many pharma companies always find effective ways to circumvent those restrictions, as many report highlights.

In this scenario, GSK has taken a bold and calculated decision to swim against the tide. Respecting public outcry and sensitiveness on the subject, it has decided against engaging paid physician speakers, as an integral of the brand marketing strategy, any longer. More importantly, this decision of the company is absolutely voluntary, transparent, and its faithful implementation level can also be monitored externally. 

The consequences of this ‘Conflict of Interest’: 

Available reports indicate that the consequences of alleged marketing malpractices of any kind, attract some serious financial consequences for the pharma players, provided of course, if one gets caught, especially in the United States or Europe.

A February 24, 2014 article highlights that in the last few years alone, pharmaceutical companies have agreed to pay over US$13 billion to resolve only U.S. Department of Justice allegations of ‘fraudulent marketing practices’.

Dwelling on the subject, a November 6, 2014, BBC News commented, “Imagine an industry that generates higher profit margins than any other and is no stranger to multi-billion dollar fines for malpractice.”

It is worth noting, all those pharma players paying hefty fines due to alleged marketing misadventures of humongous proportion, also prominently display their well-crafted code of ethics of pharma marketing practices in their respective websites, vowing for strict voluntary adherence. Nevertheless, the (mal)practice goes on, unabated.

Did a recent deterrent work in America? 

Despite recent enactment of “Physician Payments Sunshine Act”, such practices of pharma companies continue unabated even in the World’s largest pharma market – the United States.

As is known by many, the ‘Physician Payments Sunshine Act’ is a healthcare law enacted in the United States in 2010 to increase transparency of financial relationships between health care providers and pharmaceutical manufacturers.

This Act requires manufacturers of drugs, medical devices and biologicals that participate in US federal health care programs to submit annual data on payment and other transfers of value that they make to physicians and teaching hospitals. The data submission period is followed by 45 days for physicians to review their ‘Open Payments’ data and dispute errors before the public release.

On July 1, 2015, ‘ProPublica’ – an independent, non-profit newsroom that produces investigative journalism in the public interest, published an article titled, “Dollars for Docs: How Industry Dollars Reach Your Doctors.” Quoting the public database, it reported that in 2014, 1,630 pharma companies in the United States disclosed a hefty total payment of US$ 3.53 billion to 681,432 doctors. The maximum total payment received by a single doctor during this period was US$ $43.9 million. 

Published names of ‘Top 20 Companies’: 

According to ‘ProPublica’, the money that the following 20 companies spend on interactions with doctors in the United States, excluding research and royalties, is as follows:

  • Pfizer: $30M,
  • Janssen Pharmaceuticals: $20.5M
  • Astrazeneca Pharmaceuticals: $19.1M
  • Forest Laboratories: $17.2M
  • Allergan: $15.5M
  • Otsuka America Pharmaceutical: $15M
  • Sanofi and Genzyme: $14.6M
  • AbbVie: $13.5M
  • Genentech: $12.9M
  • Intuitive Surgical: $12.8M
  • Novo Nordisk: $12.4M
  • Depuy Synthes Sales: $12M
  • Bristol Myers Squibb: $11.9M
  • Eli Lilly: $11.7M
  • Teva: $11.6M
  • Novartis: $11.5M
  • Boehringer Ingelheim: $10.8M
  • Stryker: $10.3M
  • Merck Sharp & Dohme: $10.3M
  • Takeda: $9.68M
GlaxoSmithKline not featuring in the list: 

Interestingly, I could not locate GlaxoSmithKline (GSK) featuring in this specific list of the top 20 companies in the United States. Some industry watchers comment that this could well be an outcome of other unorthodox measures taken by GSK earlier to revamp its reputation, dented by the widely reported Chinese bribery scandal and also a huge settlement of US$3 billion with the Government of the United States, for alleged marketing malpractices. Whatever it is, GSK has now initiated some tangible policy decisions in this regard, unlike most of its counterparts.

Alleged pharma malpractices are rampant in India too:

Frequent reports of Indian media have already triggered a raging debate in the country on the same subject. It has also been reported that a related case is now pending before the Supreme Court against a Public Interest Litigation (PIL) for the hearing.

On May 08, 2012, the ‘Department Related Parliamentary Standing Committee on Health and Family Welfare’ presented its 58th Report to both the Lower and the Upper houses of the Indian Parliament. The committee, with a strong indictment against the Department of Pharmaceuticals (DoP), observed that the DoP should take decisive action, without any further delay, in making the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ mandatory, so that effective checks could be ensured on ‘huge promotional costs and the resultant add-on impact on medicine prices’.

Unfortunately, nothing substantive has happened on the ground regarding this issue as on date, excepting announcement of voluntary implementation of the DoP’s ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’, effective January 1, 2015 for six months for its assessment. Thereafter, the date extension process on the voluntary implementation of the UCPMP has become a routine exercise for the DoP, on the pretext of continuing discussion on the subject with the pharma trade associations and other stakeholders.

Nevertheless, incidences of alleged marketing malpractices are still unfolding today and getting dragged into the futile public debate. In a situation like this, I reckon, the Government is expected to play a more proactive role by all, instead of maintaining the status quo, any longer.

‘Voluntary practice’ concept alone, has not worked, anywhere:

Strong internal and external business performance pressures, while navigating through turbulent business environment with strong headwinds, could temporarily unnerve even the seasoned managers with nerves made of steel, as it were. It has been happening all the time, now more frequently, despite having stringent ‘voluntary pharma marketing practices’ codes in place, for many different reasons.

This  has been vindicated by a recent research published by ‘PLOS Medicine’ on January 26, 2016.

The study states that European Union law prohibits companies from marketing drugs off-label. However, in the United Kingdom (UK), as in some other European countries, but unlike the United States, pharma industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and also) shedding light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion.

The paper provided credible evidence of the limited capacity of the UK’s self-regulatory arrangements to expose marketing violations. It recommended that the UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions.

Thus, all-weather ‘voluntary practice of ethical pharma marketing code model’ alone, is either failing or has failed, almost everywhere in the world. GSK’s is a novel, but solo attempt and may not necessarily be imbibed by others.

Appropriate regulations and robust laws, instilling not just the ‘fear of God’ to the violators, but also promising justice to all, would always be a strong deterrent in those trying situations, especially in countries like, India, unless of course, any person or a legal entity is a hardcore manipulator with its key focus just on profiteering.

Restoring tarnished image:

GSK has taken the above bold step to restore its tarnished image, after receiving body blows related to several scandals, as it were. Commendably, it did not continue doing the same, unlike many others. Instead, the leadership of the Company demonstrated sensitivity to public outrage.

GSK won’t be a solitary example of pharma marketing malpractices. There are other large drug companies too, who even after meeting with similar public disgrace, keep charting the same old path to maximize brand sales by paying for the doctors, either directly or in several other forms, as many reports have alleged.

To offset all such marketing related expenses, and thereafter earn a huge profit, many of them keep the new drug prices exorbitantly high, adversely impacting the access of those drugs to many of those, who need them the most. This is besides taking hefty annual increases on existing brand pricing, even when inflation is very low to moderate.

Access to drugs for all needy patients is ‘Government responsibility’: 

To justify access barrier to high priced drugs for a large number of patients globally, most pharma players and their trade associations have a ready answer in their advocacy toolkit. It says, ensuring access to drugs for all needy patients is the responsibility of the Government, not of the drug companies.

As a result, the trust deficit between the pharma industry and the general public is increasing, further denting its image. At present, when many national Governments are initiating action or are contemplating to do so, to contain such insensitive practices, the industry probably would require to pause for a while, take a step back and ponder – what next? 

Restoring the tarnished image of the drug industry is a challenging ball game, far beyond the capabilities of even the richest pharma associations of the world, and their over-paid lobbyists. Crafty creation of any facade to hoodwink all, is no longer working to achieve their self serving purposes. Today, the public, in general, seems to understand much more about their reasonably affordable healthcare needs and wants, than what these trade associations’ possibly think about them.

Otherwise, why would Hillary Clinton ‏@HillaryClinton – one of the strongest contenders for American Presidency this time, would tweet on January 28, 2016 addressing her voters and admirers with the following vow:

“We will go after pharmaceutical companies that gouge patients with pricing. They are wrong, and we will stop them.”

My experience tells me that astute pharma CEOs, by and large, still command much higher credibility than their trade associations. Thus, the top leadership of the respective organizations would require taking the ‘image revamping exercise’ in their own hands, directly. It is essential to publicly demonstrate that most of them are aligned and in sync with the emerging new paradigm of changing aspirations, needs and wants of the patients and other key stakeholders. Future business excellence would demand inclusive growth. GSK is just an example of a CEO’s bold response to address this challenge of change – ‘a small step but a giant leap’ in this direction.

Conclusion:

In my view, all these contentious practices are basically being prompted by the strong intent of most of the pharma CEOs to ‘play safe’, in order to deliver expected shareholder value.

Any unorthodox approach to rebuild the tarnished image is usually risky, generally frowned upon and discouraged by the industry. Other vested interests often join them too. All these retarding forces express grave apprehensions on any fresh look by a company to mend fences with its key stakeholder – the patients and the public, in general. 

The recent GSK example is no exception. Apprehensions have already been expressed, whether this untested fresh thinking, against a widely perceived corrupt practice of paying physician speakers for indirect brand promotion would really be able to boost its image, without cutting into revenue. Some would take a step further and question, would a rejuvenated image ultimately fetch expected growth in sales revenue and profit? 

Only time will tell us the consequences of this uncommon and unorthodox decision taken by a courageous leader in the pharma industry.

In India, even the Government seems to have gone into a deep slumber on this issue. Despite reported discussions with the stakeholders several times, Government’s UCPMP still remains voluntary, with the DoP holding the same old ground, where it started from on January 1, 2015. It is difficult to fathom, whether intense industry lobbying is influencing a long overdue decision in favor of the patients’ overall interest.

However, there is good news also. According to a February 6, 2016 media report, ‘The Medical Council of India (MCI), for the first time ever, is set to notify specific punishments for errant doctors based on the value of favors or freebies received from drug players, under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2015. 

That apart, to revamp its dented image, the decision of GSK against paid physician speakers as an integral part of brand promotion, is not just a gutsy step with a sharp focus on restoring business ethics and values, but more laudably a voluntary one. Would others follow it too, including in India? 

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.

Cancer Cure: Inching Towards The ‘Holy Grail’?

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In a Press Conference on August 20, 2015, the 39th President of the United States, now 90-year-old  Jimmy Carter, revealed (video) that during a liver surgery earlier this month the doctors diagnosed that he has cancer. The type of cancer that he is suffering from is called melanoma, which has already spread to his liver and brain. Medical jargon would term it as deadly metastatic cancer.

Though the surgeons have removed the liver tumor, and well-targeted radiation treatment for four other small tumors in his brain has already been initiated, the original site of the melanoma, the lethal skin cancer, has reportedly not been found, as yet.

Mr. Carter’s medical treatment has started with an infusion of a new class of drug that uses the human immune system to fight cancer cells. The drug has been reported to work not only in advanced metastatic cancer, but also in the old age of patients. The former American President appears optimistic about the treatment outcomes with this new therapy, ‘placing his fate in the hands of God’, though initially he thought that he had just weeks to live.

I shall deliberate in this article, in an easy to understand language, though briefly, the promises offered by two latest options for cancer cure. One of these two, has just become available to patients and the other one, after an initial jaw-dropping success, is undergoing further tests in a renowned research laboratory of the United States.

Two novel pathways for cancer treatment:

Until recently, surgery, radiation and chemotherapy used to be the three common options for cancer treatment. One breakthrough option has just been launched and more in the offing.

In search of a cure for cancer, pathbreaking outcomes of medical research, especially in the following two areas, are significant:

A. Immunotherapy: It is a revolutionary approach to cancer treatment. The first of this novel class of drugs has just come to the market, with which Mr.Jimmy Carter is now reportedly being treated.

B. Re-programming cancer cells back to normal: Success has just been achieved in laboratory studies with this technique. It holds a strong promise to cure cancer, universally.

A. Immunotherapy:

On June 1, 2015, in an article titled, ‘Cure for terminal cancer’ found in game-changing drugs, “The Telegraph” – well-regarded international news daily, reported on anti-cancer immunotherapy drugs, as follows:

“Terminally ill cancer patients have been ‘effectively cured’ by a game-changing new class of drugs. In one trial, more than half of patients who had just months to live saw deadly tumors shrink or completely disappear.”

“In recent days, the results of trials of a number of treatments which harness the body’s immune system have been announced at the American Society of Clinical Oncology’s annual conference in Chicago. They show promise in the fight against skin cancer and lung disease.”

As we know, most of the cancers are deadly. All these grow and spread, as they manage to hide from the immune system, disguising the life-threatening danger. Thus, medical research scientists pondered that the human immune system could play a critical role in the fight against cancer and even cure, by harnessing its ability to fight the deadly disease, effectively and decisively.

To achieve this goal, this class of new cancer drugs work by allowing the body to recognize and attack cancer as any other harmful invader to the body. It effectively blocks a cellular pathway that hinders the ability of the human immune system to attack cancer cells.

At present, to treat different types of cancer, more number of immunotherapy drugs are undergoing clinical investigations.

Brilliant treatment outcomes, but not universal:

It has been reported, about one third of patients taking immunotherapy for the treatment of cancer experienced positive results. Those who responded to this therapy, showed immediate effect with their tumors shrinking or vanishing in a matter of weeks. As a result, the patients who had no more than weeks or months to live, just as former US President Jimmy Carter, have gone into remission for years and continuing with their normal lives.

It has also been reported, otherwise such patients could expect to live just nine months, if given standard treatment of cancer. Researchers said, they were hopeful that half of the patients responded to immunotherapy would end up “living disease-free”.

These drugs are expensive, costing roughly US$150,000 per year, which is a part of a different debate altogether.

Not a ‘magic bullet’:

Besides its high cost and outstanding quality of results, it is worth noting that immunotherapy is not a ‘magic bullet’ for all types of patients and in all cancer. It, therefore, throws a challenge for the oncologists to understand, why immunotherapy benefits only to some cancer patients, and who are those patients?

Moreover, there is a possibility of immunotherapy sending immune system of some patients to overdrive, precipitating auto-immune disorder that may attack also the healthy cells.

Thus, immunotherapy is not the ‘Holy Grail’ for the treatment of cancer, neither it is nowhere near a perfect drug for the treatment of all types of cancers in all patients.

Two key findings:

In this regard, two key findings of the researchers on immunotherapy are as follows:

  • Roughly around 15 to 20 percent of patients could experience shrinkage or remission of cancer
  • Half of the patients who responded found it lasting for at least six months

Thus, immunotherapy can at best be a cure for only some terminally ill cancer patients, mostly for some time, but not for all.

“In the hands of God”:

All these factors on immunotherapy probably would help us to understand, why an erudite person like Mr. Jimmy Carter said, though optimistic about the new treatment, he is placing his fate ‘in the hands of God’.

B. Re-programming cancer cells back to normal: 

The question, therefore, comes up now, if immunotherapy is not the ‘Holy Grail’ for cancer treatment that the research scientists have been intensively searching for, is there anything else coming up for cancer cure?

It appears so. A totally different approach to re-program the cancer cells back to normal has very recently been reported by Mayo Clinic’s Florida Campus in the United States. With this, cancer researchers’ dream of making the tumor cells morphing back to normal cells, they once were, would probably come true.

The research findings, published in Nature Cell Biology on August 24, 2015, represents ‘an unexpected new biology that provides the code, the software for turning off cancer,’ said the senior investigator of this study.

In the normal process, cells in the human body divide constantly to replace themselves and stop dividing when they have replicated sufficiently. However, unlike the normal cells, cancer cells do not stop dividing, they go out of control, leading to huge cell reproduction and tumor growth.

For the ultimate cure of cancer, scientists at Mayo Clinic have now reportedly succeeded in reversing the process responsible for the normal cells from replicating too quickly.

Possible cure now within sight?

This could ultimately lead to a newer class of breakthrough treatment that would be able to reverse cancerous growth in the human body, possibly curing cancer, without the need of surgery, chemotherapy, radiation or even immunotherapy.

Scientists at the Mayo Clinic have said that their initial experiments in some aggressive types of cancer are quite encouraging. They have successfully done this in very aggressive human cell lines from breast and bladder cancer.

Towards the ‘Holy Grail’:

In pursuit of finding a cancer cure, research scientists have been making commendable progress, over a period of time.

In the last few years, spectacular breakthroughs in treatment of cancer have been possible from the increasing genetic and biological understanding of the researchers, especially in ascertaining exact defects in the DNA code of human genes that cause cancer.

Ability to sequencing human genome has offered a key tool to the researchers to compare the DNA codes of cancerous and normal cells and identify the differences.

From within the 20,000 human genes, around 500 cancer genes have been reportedly discovered and are being catalogued. Clear understanding of what happens precisely when the cells divide uncontrollably and cancer spreads in different parts of the patients’ body, is taking place with commendable progress of various research initiatives in this area.

Based on the current knowledge on human genome, a number of new drugs have been and are being developed to target the cancer-causing genes with great accuracy. Such types of drugs are called ‘personalized medicines’, as these act on specific gene abnormality of patients related to certain types of cancer. Sophisticated laboratory tests facilitate treatment with ‘personalized medicines’. These are more effective with lesser side-effects, as compared to generally used anti-cancer drugs, prescribed to all cancer patients.

However, the question keeps lingering, ‘Is the Holy Grail for cancer cure has now come within sight?’

Conclusion:

Medical scientists continue to take rapid strides towards better and more effective treatment for cancer, if not cure, with fewer side-effects.

Claims for long remissions with immunotherapy, are being reported for some patients with even metastatic cancer and also in old age, just like former President of America – Mr. Jimmy Carter.

The success achieved by the scientists of ‘Mayo Clinic’ in re-programming rogue cancer cells back to normal, is stunning.

Being successful in this effort, the researchers have compared cancer with a complex software program of life. When it goes out of control, ‘instead of the code for normal cells, a code for making abnormal cells is executed’. This new study signals a strong possibility of bringing the cancer cells back to normal.

Medical experts keep their fingers crossed. Although, some of them do apprehend that there may never be a single ‘Magic Bullet’ to cure all types of cancer in all patients. This is mainly because cancer involves a large number of different disease areas, such as, breast, lung, bowel, prostate, blood and so on.

But hope refuses to fade out, as science continues to keep unravelling spectacular breakthroughs in this direction, at a fairly brisk pace. All these researches may be cancer types or patient types specifics, but the progress is taking place in the right direction.

Even in the ‘Mayo Clinic study’, scientists have been, so far, successful in re-programming the breast and bladder cancer cells back to normal, though they believe that this success sends a strong signal of an “early and somewhat universal event in cancer.”

Immunotherapy is undoubtedly a path breaking step that ensures cure in some types of cancer and in some categories of patients. However, if re-programming the cancer cells back to normal, eventually becomes an ‘universal event’ in the treatment of this generally frightening disease, no doubt, the medical science is now slowly but surely inching towards the ‘Holy Grail’ for cancer cure…at long last.

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.