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A Mission (mis)statement

Would pharma's image improve if companies were clearer on their safety commitments?

According to Wikipedia, in marketing, branding refers to the sum total of a company's value proposition: products, services, people, advertising, positioning and culture.

A brand is a collection of feelings towards an economic producer; feelings created by the accumulation of experiences with the brand and related directly to its use, as well as through the influence of advertising, design and media commentary.

Brands are symbolic embodiments of all the information connected to a company, product or service, and serve to create associations and expectations among products made by a producer.

The pharma industry is, in essence, a business and not an academic institution. However, it is a very specific type of business, occupying itself with science, in the context of determining unmet medical needs, generating data, transforming data into information, and sharing the knowledge with patients, prescribers, payers and shareholders.

Sharing the knowledge should be translated into sales so that there is a source from which one can reinvest in future research and development (R&D).

Of course, this source of income is also used for marketing, related activities and the general administration of the business. The smaller the difference between investment in R&D, and marketing and general administration, as a percentage of sales, the easier it may become to convince the general public that we are different from other businesses.

One way to 'translate' this is to aim for patients, presribers and payers to have a positive feeling towards your company and your company's products, based on efficacy, safety and quality. Or is it?

Real world relevance?
Traditionally, the purpose of randomised, controlled clinical trials was to determine whether a product works and whether it is safe to man.

In the 21st Century, we should be able to accept that quality products, in the manufacturing sense, are the minimum expectation anyone should have. The question has been asked for many years whether efficacy and safety are enough. We know that this is the minimum needed for getting a product registered.

However, we also know that clinical trial populations are usually a homogenous group of participants, due to their strict entry criteria.

The development of health economic views, probably driven by the cost of healthcare, gave rise to the notion of effectiveness: ie, does the product work in the real world?

We know, too, that there is no product without side effects. These differ between patient populations, but also between patients in a specific patient population.

Yet, how do patients know what pharma's obligations are to safety management?

Of course, we understand it, but what is in place to help patients understand?

These obligations are summarised very clearly on the GSK website:

  • To collect, investigate and proactively evaluate information relating to side effects of medicines for the purpose of protecting patients and advising on drug safety, and

  • To fulfil its legal obligations to the regulatory authorities by reporting individual adverse events (AEs) on an expedited basis and/or periodically, according to the drug safety regulations of each country.

Having side effects, however, does not mean that the product is not effective; and so, over time, the concept of benefit-risk analysis was born: ie, do the benefits of a product for a specific indication in a specific patient population outweigh the risk associated with that product for the same group?

This is important not only from a payer perspective, but also from a patient and public health perspective. Yet, it is not possible to collect this data from traditional randomised, controlled clinical trials and, hence, health outcomes/observational research has become more and more popular. But how do our customer groups know that we care about this?

Current mission statements
Looking at mission statements from a random sample of pharma companies, one finds references to 'healthier, happier and longer lives', `quality of life', `curing disease and ease suffering', `satisfying customer needs', `innovative solutions of high quality for unmet medical needs', `extending human life', and so forth.

But is this explicit enough? Does this really tell our customers anything? Does it tell them that we not only care about our patients, but that we also keep ourselves busy with the continuous gathering of data - information on our products that we can use to continually assess and evaluate the changing benefit-risk profile of our products? Are we indeed doing this?

One company's mission statement refers to `well-tolerated products' and another's to `reduced side-effects'. Although more explicit, this is probably still not adequate.

Due to technological advances, our patients now have much increased access to data on a variety of health-related issues, including disease and product information.

Yet, current regulations see information in the public domain conforming to specific guidelines. Our package information leaflets and patient information leaflets may not be particularly helpful to put benefit-risk in perspective. A letter once published in The Times newspaper gave a good summary of what patients may contemplate:

`Sir, my wife has been prescribed pills. According to the accompanying leaflet, possible side effects are: sickness, diarrhoea, indigestion, loss of appetite, belching, vertigo, abdominal cramps, dizziness, stomach ulcers, bleeding from intestine or blood diarrhoea, ulcerative colitis, sore mouth and tongue, constipation, back pains, inflammation of pancreas, mouth ulcers, skin rashes, hair loss, sensitivity to sunlight, drowsiness, tiredness, impaired hearing, difficulty with sleeping, seizures, irritability, anxiety, depression, mood changes, tremor, memory disturbances, disorientation, changes in vision, ringing in ears, bad dreams, taste alteration, allergic reactions, swelling due to water retention, palpitations, impotence or tightness of the chest. Should she take them?


What can we do to help?
The Food and Drug Administration (FDA), on its website, attempts to explain the importance of the benefit-risk assessment (see Fig 1, opposite). While the EMEA's mission statement does not refer specifically to benefit-risk, we know from the Clinical Trial Directive and other guidance documents that it is interested and indeed expects pharma to comment (see Fig 2, left). The question is, what can we do to help?

Prospective observational safety research: evaluation of safety data in pharma is currently dependent largely on the collection of adverse events during clinical trials and via spontaneous reporting by healthcare professionals or patients.

It is well-known that there is gross under-reporting of adverse events in a so-called spontaneous setting. However, the data is analysed and integrated into the annual report and/or Periodic Safety Update Report (PSUR). Of note is that many companies complete annual PSUR reports, rather than cumulative reports, although they are expected to complete a benefit- risk statement on the cumulative data.

In order to be more proactive from a safety information perspective, pharma should start considering, as a matter of course, the use of observational research after marketing authorisation, including post-marketing surveillance studies, post-authorisation safety studies, prescription event monitoring, registries, and the like.

There would be more active safety signal surveillance/detection, with more current benefit-risk analyses. This notion already works in Japan and some Asian countries.

Package inserts and patient information leaflets: through trade associations, there should be more active partnership with regulators, advocacy groups, academic institutions and payers to develop package inserts and patient information leaflets that are helpful and reflect the benefit-risk assessment of a product, rather than just listing possible adverse events, even those that are unlikely to be product related.

Sharing of information: should become more scientific and robust. The medical rep's traditional sales aid may contain all the information as per regulations, but who will focus on a list of side effects with only 2 minutes in front of a physician? Whether it is a rep or medical liaison, focus should shift from efficacy and safety to benefit-risk. The messenger should then be able to go into detail of how the benefit and risk evaluations were derived.

Similarly, medical or scientific information departments should be allowed to include this in their communications, and medical journals can ensure that this is included in scientific publications. Corporate affairs colleagues should educate the media.

Partnerships: even assuming that patients' wellbeing remains central to what academia, regulators, advocacy groups and payers are engaged in, the future will look no different unless more successful partnerships can be established.

I am not suggesting that this is the only way to do it, but it is time that pharma united to change its image.

The Author
Dr Danie du Plessis is director, clinical operations & information sciences, Europe, Middle-East, Africa & CIS, at Lilly. The opinions in this article are not necessarily representative of Lilly's policy or strategy

2nd September 2008


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