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.
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.