Would e-Marketing Replace Medical Representatives?

Many people within the pharmaceutical industry cannot simply visualize a drug marketing environment without Medical Representatives (MRs) detailing their products to doctors for ever increasing prescription support. This much traditional sales force, for face to face interaction and transaction with the customers, is considered virtually indispensable and has formed the backbone for organic growth of the global pharma industry since decades.

It has emerged this way because, pharmaceutical industry sells drugs predominantly through doctors’ prescriptions, where MRs play a pivotal role to influence them directly or indirectly in various ways.

Therefore, for greater success through effective increase in customer focus, as compared to competition, pharma companies are engaged in expanding the size of their respective field-forces on an ongoing basis, though in varying numbers. However, over a period of time, this process has become very expensive, costing on an average around 17 to 20 percent, if not more, of the total expenditure of a company.

As a result, many companies have now started experiencing that their business return on ever increasing number of MRs is not commensurate to investments made on them, mainly in terms of productivity growth per headcount.

This overall scenario has now prompted many pharma players, across the world, to take a hard look at the evolving drug marketing scenario and expeditiously address the consequent issues, as I shall deliberate in this article.

MRs historical role:

Most of the pharma players use their MRs to implement predominantly the following time-tested strategic game plans to generate more and more prescriptions for their respective brands:

  • Detailing product features and benefits
  • Distributing free samples and gifts
  • Developing Key Opinion Leaders (KOL) for identified products
  • Arranging product oriented seminars, conferences and Continuing Medical Education (CME) programs
  • Monitoring doctors prescriptions and incentivizing them in various company specific ways
  • Giving necessary feedbacks to their respective companies

Productive ‘doctor calls’ becoming increasingly difficult:

According to an article titled “Are Sales Reps Necessary?” published in ‘The Pharma Marketing News’, the following details, besides others, were captured in the United States:

  • MRs’ average only 2 quality details per day (quality details include discussion of features, benefits, and data).
  • Only 43 percent of MRs ever gets past the receptionist
  • Only 7 percent of pharma rep visits last more than 2 minutes
  • Only 6 percent of physicians think representatives are very fair balanced
  • The physician remembers only 8 percent of MR calls

Optimal MR productivity – the key issues:

The issue of desired MR productivity is thus becoming a cause of great concern globally for the pharma players. This is mainly because, while the number of patients is fast increasing, the doctors are trying to see all these patients within their limited available time. As a result, each patient is getting lesser doctors’ time, even though the doctors are trying to provide optimal patient care in each patient visit.

In tandem, other obligations of various kinds, personal or otherwise, also overcrowd physicians’ time. In a situation like this, increasing number of MRs, which has almost doubled in the past decade, is now fiercely competing with each other to get a share of lesser and lesser available time of the doctors. Added to this, inflow of new doctors not being in line with the increasing inflow of patients, is making the situation even worse.

According to another study of CMI Communication Media Research, about half of physicians restrict visits from MRs in one-way or another. It reported, about half of cancer specialists (oncologists) are now saying that they would interact only on new products with MRs, while 47 percent of them indicated email as a preference to MR calls.

Surveys found that the oncologists are the most restrictive specialists, with only 19 percent allowing MRs without restrictions. Moreover, 20 percent of them would not see MRs at all and another 40 percent either require prior appointments or limit visits to particular hours of the day/week.

Downsizing sales force with e-marketing:

A paper published in the WSJ titled,Drug Makers Replace Reps With Digital Tools” states that pharmaceutical companies in the United States are downsizing their sales force with increasing usage of iPad apps and other digital tools for interacting with doctors.

Such widespread layoffs do signal to many that digital tools and technology have started replacing the MRs, at least in the United States, may be in a limited way to begin with.

Building relationship:

However, other group of industry watchers believe that eliminating MRs from the pharma marketing process could lead to a serious set back in the doctor-pharma company face to face relationship that is very important for success While rebutting this point, the pro e-marketing proponents  raise a counter question: Does such relationship now exist with most MRs so far as the high value target doctors are concerned?

e-marketing gradually taking roots:

Many fascinating experiments with e-marketing have now started in several places of the world with considerable success, in tandem with germination of even bolder and brighter ideas in this area. However, the above report mentioned the following:

  • AstraZeneca tracks what doctors view on the website and uses that information to tailor marketing content for the doctor during subsequent interactions. The company had reportedly said in 2010, that it plans to eliminate 10,400 jobs by 2014, including thousands of sales positions in Western markets amounting to around 16 percent of its work force. This step was to help the company saving around US$1.9 billion a year by 2014.
  • When German drug maker Boehringer Ingelheim GmbH launched the cardiovascular drug Pradaxa in the US, it reportedly put together a digital-marketing package to target doctors, including organizing webcasts for leading physicians to speak to other physicians about the drug, with considerable success.
  • Novo Nordisk in 2010 launched a website and iPad/iPhone application called ‘Coags Uncomplicated’, which offers tools to help doctors diagnose bleeding disorders. The site and app include a plug for Novo Nordisk’s drug NovoSeven, which helps stop bleeding related to acquired hemophilia. It has several other applications available on iTunes, including one that helps doctors calculating blood-sugar levels.
  • Some other companies offering iPhone and iPad based apps for doctors include among others, Sanofi, Merck, Pfizer, GlaxoSmithKline, Novartis and Eli Lilly.

Advantages of e-marketing:

As I had indicated earlier in my blog post, ‘e-marketing’ would help creating customized, more impressive, self-guided by doctors and more focused presentations with significant reduction in the detailing cost/ product with improved productivity.

Moreover, ‘e-marketing’ would:

  • Make expensive printed promotional aids redundant
  • Eliminate time required and cost involved to deliver such material
  • Have the flexibility of change at any time
  • Ordering of just required samples online would help eliminating wastage

Fast increasingly number of doctors using Internet enabled computers/tablets and smart phones for professional purposes, especially in the urban areas, would facilitate this process.

Conclusion:

Keeping in mind this changing scenario, mindset and behavior of the doctors, as lesser and lesser time is available with the high value target customers for interaction with the MRs, the pharma players would require to take afresh a hard look at their own strategic marketing vision and principles to zero-in on the most effective mix. This approach, I reckon, is applicable more to the domestic players in India.

For high value target customers a combo-strategy would probably be more effective now. In this strategic game plan, MRs would continue to remain as the basic fabric of a drug marketing process, though in reduced numbers and augmented by increasing focus on new technologies/applications through iPad, smart phones, various Internet enabled tools, social networking sites and real time analytics. Formidable differential marketing thrust that would be created through skillful execution of this combo-strategy, is expected to be more effective in making both top and bottom line performance of a pharma player sustainably impressive to the stakeholders.

The name of the game is, therefore, impactfully delivering the core tangible and intangible product values to the doctors for desired outcome in their prescriptions decision making process, keeping in pace with the changing demand of time with a long-term ability to innovate.

That said, would e-marketing then replace MRs to a considerable extent in the years ahead?

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 Fraud or Negligence in Drug Quality Standards Not a Fraud on Patients?

As we know, a substance is called a drug when it has scientifically proven and well documented efficacy and safety profile to reduce both mortality and morbidity of patients. Any fraud or negligence in the drug quality standards, for whatever may be the reasons or wherever these take place, is a fraud on patients and should warrant zero tolerance.

A perception survey on drug quality:

According to a poll released in 2010 by the ‘Pew Charitable Trusts’s Prescription Project’ of the United States:

  • More than three out of four voters are confident that prescription drugs made in the USA are free from contamination
  • While less than one in 10 feel confident about medications made in India or China.
  • 54 percent of Americans distrusted Indian drugs and 70 percent distrusted Chinese drugs.
  • “When you buy a shirt, it will say right on the label where it was made, but when you get a pharmaceutical, you don’t know.”

Despite all these, the survey points out that in 2007, 68 percent of the ingredients of all drugs sold worldwide came from India or China, as compared to 49 percent in 2004.

Experts comment that USFDA does not have either people or resources required to monitor manufacturing in the geographically widespread locations, as these are today.

Recent spate of charges against Indian pharmaceutical companies – a vindication?

Recent spate of charges against some top ranked Indian companies, will further dent the image of India not just in the United States or Europe, but also as a pharmacy of high quality yet low cost generic drugs for the developing countries of the world.

In May 2013, well known India-based pharma major Ranbaxy reported to have pleaded guilty to criminal charges of manufacturing and distributing some adulterated medicines, produced at its Paonta Sahib and Dewas, facilities and agreed to US$ 500-millon settlement. Can this be considered as a vindication of the above perception on the quality of ‘made in India’ drugs?

The view of WHO:

Interestingly the World Health Organisation (WHO) even after the above USFDA indictment has commented that at present it has no evidence that Ranbaxy manufactured medicines that are currently prequalified by WHO are of unacceptable quality.

Indian drug regulator initiates action:

It is good to know that the Drugs Controller General of India (DCGI) and the Ministry of Health will reportedly decide the way forward in this matter on completion of a fact-finding study initiated by the Central Drugs Standards Control Organization (CDSCO) on the subject.

Other incidents in India:

Following are examples of other reported serious regulatory violations involving the domestic pharmaceutical companies:

No.

Year

Company

Issue

Status

2009 Lupin USFDA warning for Mandideep plant Resolved in 2010
2010 Claris Life Sciences USFDA ban products for manufacturing norms violations Ban revoked in 2012
2011 Zydus Cadila USFDA warns Co. over Moraiya, Gujarat Facility Ban revoked in 2012
2011 Dr Reddy’s USFDA bans sale of drugs from Mexico facility Ban revoked in 2012
2013 Jubilant Life Sciences Gets USFDA warning for Canada facility Company taking corrective steps
2013 Wockhardt Banned from exporting products from its Aurangabad factory to the US due to quality concerns In discussion

Source: The Economic Times (May 22, 2013), Financial Express (May 25, 2013)

Though some other countries also have faced bans from exporting products, it cannot be taken, I reckon, as any consolation by anyone.

A Mumbai Hospital demonstrated the mood of zero tolerance:

The above expression of good intent should not just remain as a ‘lip service’. Indian drug regulator is expected to take a leaf out of all these allegations and initiate appropriate audit as required. Otherwise, exhibiting zero tolerance, like Jaslok Hospital of Mumbai, many other institutions will ask their doctors not to prescribe products of these companies to protect patients’ interest. More hospitals reportedly are mulling similar action against Ranbaxy.

IMA expresses apprehension:

Even ‘The Indian Medical Association (IMA)’ has reportedly asked the DCGI to investigate quality of medicines manufactured by Ranbaxy.

It happens in the ‘heartland’ too just as in the ‘hinterland’:

Contrary to the above poll released in 2010 by the ‘Pew Charitable Trusts’s Prescription Project’, pointing accusing fingers, in this respect, exclusively to India and China, may not be just fair. Incidents of such regulatory violations are not just restricted to Indian pharmaceutical companies either. Unfortunately, these happen with the global majors too.

None of these should be condoned in any way by anyone and attract as much global publicity, public wrath and zero tolerance, as all these would possibly deserve.

Following are some examples:

No

Company

Issues with USFDA

Consent decree signed (year)

Issue status

Penalty amount

Schering-Plough GMP violations affecting four manufacturing sites and 125 products

Yes (2002)

Closed (2007)

$500 Mn.
GlaxoSmithKline Manufacturing deficiencies found at Puerto Rico facility

Yes (2005)

Pending

$650 Mn. Bond
Wyeth GMP violations at plant in Pennsylvania and New York which were producing FluShield

Yes (2000)

Pending

$297 Mn. Plus 18.5% of sales of FluShield
Abbott Labs Non-conformance with quality system regulations for in vitro diagnostic products at an Illinois facility

Yes (1999)

Pending

$212 Mn.
Boehringer Ingelheim To bring its Ohio facility into compliance with regulatory requirements

Yes (2013)

Pending

Not specified

Source: Financial Express (May 25, 2013)

Further, in December 1998 the US FDA reportedly had stopped shipments of Abbott Laboratories’ clot-busting drug Abbokinase till the company had resolved undisclosed manufacturing problems at its plant. Abbott subsequently resolved this to the satisfaction of the drug regulator.

Even end May 2011, the USFDA reportedly raised concerns about contamination of drugs of the American pharmaceutical major – Hospira, at its Indian manufacturing facility.This issue was highlighted as the latest in a string of manufacturing and quality problems dogging the company since 2010.

American lawmakers demand thorough review of USFDA oversight procedures:

Pressure has reportedly started mounting in the United States for a thorough review into the effectiveness of oversight procedures for all bulk drugs and formulations manufactured in foreign facilities.

Simultaneously, there is also a specific demand for an in-depth review of all actions of the US regulator for so many years, which allowed Ranbaxy’s ‘massive fraud to remain unchecked’.

Beyond regulatory oversight, need robust internal system driven model as a fire-wall:

To address such issues only drug regulators interventions may not be just enough, maintaining total integrity of ‘Supply Chain’ of an organization proactively in a well structured, fool-proof and a system-driven way, will continue to play the most critical role. This will help creating ‘fire-wall’, which will be difficult to breach.

The scope of Supply Chain:

The scope of ‘Supply Chain’, which is comprised of the entire network of entities from vendors who supply raw and packaging materials, manufacturers who convert these materials into medicines, together with warehouses, distributors, retailers and healthcare centers who will reach these medicines ultimately to patients exactly the way these will deserve.

Thus, just not in the manufacturing process, any breach of security at any place of the supply chain can cause serious problems to patients. 

Accordingly, pharmaceutical companies need to adequately invest along with appropriate staff training programs to ensure that the Supply Chain Integrity is maintained, always.

Supply Chain Security (SCS) is critical:

SCS, therefore, deserves to be of prime importance for the pharmaceutical companies across the globe. Recent high profile SCS related cases, as mentioned above, have exposed the vulnerability in addressing this global menace effectively.

All pharmaceutical players should realize that not just ‘show-off’, an effective integrated approach is of paramount importance to eliminate this crime syndicate, which is taking lives of millions of patients the world over.

Mixing-up counterfeit drugs with this menace may not be prudent:

Shouting for counterfeit drugs involving mainly intellectual property related issues, may be  important, but will in no way help resolving self-created menaces arising out of breach of supply chain integrity endangering million of lives, in another way.

Though an expensive process, can’t be compromised:

It is worth repeating, securing pharmaceutical supply chain on a continuous basis is of critical importance for all the pharmaceutical players across the globe. However, the process will no doubt be expensive for any company.

Like other industries, in the pharmaceutical sector, as well, cost effective procurement is critical, which entices many pharmaceutical players, especially, in the generic industry not to go for such expensive process just to maintain the SCS.

A serious SCS related tragedy:

I would like to reinforce my argument on the importance of SCS with the following example of the ‘Heparin tragedy’ where the supply chain integrity was seriously violated with ‘ingeneuity’.

In the beginning of 2008, there were media reports on serious adverse drug events, some even fatal, with Heparin, a highly sulfated glycosaminoglycan of Baxter International. Heparin is widely used as an injectable anticoagulant. Baxter voluntarily recalled almost all their Heparin products in the U.S. Around 80 people died from contaminated Heparin products in the U.S. The US FDA reported that such contaminated Heparin was detected from at least 12 other countries.

A joint investigation conducted by Baxter and the US FDA ascertained that the Heparin used in batches associated with the serious adverse drug events was contaminated with Over Sulfated Chondroitin Sulfate (OSCS). It was reported that Heparin Scientific Protein Laboratories, Changzhou, China supplied Heparin to Baxter.

The cost of OSCS is just a fraction of the ingredient used in Heparin. Being driven by the criminal profiteering motive the manufacturers in Changzhou, China had reportedly used OSCS for highly sulfated glycosaminoglycan, as the former could not be detected by the pharmacopeia test in use, until 2008. This is because OSCS mimics Heparin in the pharmacopeia test. Post this criminal event, at present, all over the world more specific pharmacopeia test methods have been adopted for Heparin.

Stakeholders need to be extremely vigilant:

Considering all these, pharmaceutical players and the drug regulators from across the world should put proper ‘fool proof’ systems in place to eliminate the growing menace of criminal adulteration of APIs, drug intermediates, excipients entering in the supply chain together with preventing any breach in their logistics support systems.

Apprehension against generic drugs as a class:

Taking advantage of the situation, one can possibly say, as some vested interests have already started propagating that generic equivalents of the branded drugs are really not quite the same in quality.

However, the point that cannot be ignored is the comment of a senior USFDA, who was quoted in the same article saying, “I have heard it enough times from enough people to believe that there are a few products that aren’t meeting quality standards.

Generic drug manufacturers should make serious note of such comments and act accordingly to allay prevailing lurking fear on the use of generic medicines, in general, though small in number.

Conclusion:

Following the recent series of incidents including that of Ranbaxy, the image of India as a low cost generic drugs manufacturer of high quality could get adversely impacted. Although there are enough instances that such things happen in the developed world, as well, including the United States.

Moreover, in the backdrop of high decibel quality concerns raised by USFDA, the level of apprehension regarding effectiveness of generic drugs made in India may increase significantly, unless some tangible, well thought out and highly publicized remedial measures are taken forthwith.

The decision of Jaslok Hospital, Mumbai advising their doctors for not using Ranbaxy products to patients on the same ground, will further strengthen the public apprehension.

Whatever may be the reason, as long as any company is in the business of manufacturing medicines, there should be demonstrable zero tolerance on any compromise, fraud or negligence in the drug quality standards. Any fraud and negligence in drug quality, I reckon, is virtually a fraud against humanity.

That said, changing mindset towards a strong corporate governance by walking the talk, all pharmaceutical companies must guarantee safe and high quality medicines to the society, come what may.

This, I believe, could be achieved by putting in place a robust SCS system and ensuring that this is not compromised in any way… anywhere…ever… for patients’ sakeboth globally and locally.

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.