What lies beneath

The Health Select Committee (HSC), as was prior to the election period, has produced its official report on the, formerly ambiguous, influence of the pharmaceutical industry over the country's medicine prescribers. A list of 43 brawny recommendations for a reconstituted government to digest, muse over and, ultimately, act upon.

It leaves no stone unturned, with recommendations reaching from pharma's marketing efforts, side effect reporting activities and commercial interests, to issues affecting the work of the industry's service companies - disease awareness campaigns, heavyweight drug launches and promotion to junior doctors.

Indeed, "the report is full and leaves no evidence we took unreported," notes Dr Richard Taylor, the only physician and independent member of Parliament on the former HSC panel. The full committee comprised seven Labour MPs, two Conservatives, a Liberal Democrat, plus Dr Taylor: nine men and two women.

Since it was released in early April, the report has generated an array of reactions, ranging from "this is not good news, there is no comfort here" to "it could have been worse" and "they may have a point".

Talking to several pharma firms, early reactions seem to be calm and controlled, yet, understandably, defensive in nature.

Admittedly at first glance, some of the recommendations and comments from the HSC to the government look to be a foretaste of gruelling times ahead: 'The pharmaceutical industry's promotional efforts are relentless and pervasive... it seems that intensive marketing has worked to persuade too many professionals that they can prescribe with impunity', and 'people are being prescribed too many drugs, before the full consequences of adverse side effects are known'.

There have been very few prisoners taken in this report. However, whether you perceive this to be more of a truss, than an opportunity, depends a good deal on your sentiment towards it. One notable issue to arise from the investigation is that while the blunt truth about the way in which drugs are promoted may be uncomfortable for some, there are recommendations that could be described as `criticising' in nature yet which appear to be supported by industry, as well as the service sector.

There is a case for more restrictions on promotion and education in the first year or two from a product's licence being granted, notes Margot James, European president of Ogilvy Healthworld. "Industry has an effective code of practice, but it needs to be strengthened in some areas."

Fiona Hall, MD of Weber Shandwick's European practice, adds: "We are constantly bombarded with marketing messages on a daily basis and we are rapidly moving towards the moment when customers take control of the marketing they receive.

"The industry has always been very cautious when communicating with patients and the general public, and I believe the HSC report reinforces this and encourages industry best practice."

Ray Rowden, independent health policy analyst and former specialist adviser to the HSC, believes the committee has "not done such a bad job" and that it makes a number of salient points. "It has reflected some legitimate concerns relating to the sector, not helped by some negative press around antidepressants in recent months."

He notes the HSC's suggestion that 'too many drugs are prescribed before the full consequences of adverse effects are known' - "true, but there is no such thing as a totally risk free drug. We do not fully understand the longer-term effects of atypical antipsychotics, or of the combination therapies in HIV/AIDS, but we do know they offer better quality of life for millions. Does the HSC suggest that in such circumstances, products should not be available?"

Dr Taylor believes that useful drugs should remain on the market, and could do so if their roll-out was better tempered. "My hope is that by slowing down the rate of prescribing of new drugs we can avoid large scale problems for patients from side effects and, hence, the loss of potentially useful drugs for selected patients who could really benefit from them."

Andrew Hotchkiss, managing director of Lilly UK, refutes the HSC's claim that drugs are handed out to patients overzealously before side effects are discovered. "New medicines are licensed only if data demonstrate that the benefits of taking them outweigh the risks. Detecting side effects, particularly rare ones, can only be achieved by monitoring the drug's effects on large numbers of patients."

He adds: "Routine NHS use of new drugs is more likely than clinical trials to do so, yet uptake of new medicines per person in the UK is among the lowest in Europe."

The Early Bird
The risks of running a significant marketing campaign to support a new drug entering the arena form the focus of one of several areas where pharma can clean up its act, according to the HSC's 43 recommendations, which are summarised at the end of the full 126-page document.

'The aggressive promotion of medicines shortly after launch, the sheer volume of information that is received in its many forms by prescribers and the "promotional hospitality masquerading as education" in the absence of effective countervailing forces, all contribute to the inappropriate prescription of medicines,' it reads.

"I feel there should be a reduction in the marketing activity at the initial launch of a new drug," Dr Taylor notes. "Although I realise that this goes against the need to sell as much as possible to begin to recoup the enormous investment involved in the development of a new drug."

In the HSC's opinion, the potential consequences of a significant early marketing push are two-fold: that many patients may encounter dangerous side effects before the medical world really understands what they are; and that otherwise useful drugs are subsequently pulled off the market almost with immediate effect, depriving some patients of an effective therapy.

"We did feel that there should be some control on a new drug like Vioxx when it first comes out, so that it would initially be reserved for patients requiring the drug's specific benefits, rather than used as a first choice NSAID [non-steroidal anti-inflammatory drug], which happened with this drug. If hospital and GP drug formularies were all of high quality and adhered to, this would be the place to control initial prescribing."

He adds: "With this control, the side effect profile would be discovered more slowly and in patients who really had needed the drug."

Steve Poulton, director of strategy and business development for Pfizer UK and Ireland, retorts: "If a medicine is licensed as effective and safe then qualified practitioners should be able to prescribe it. Delaying wider prescribing rights would greatly delay the development of a fuller understanding of the risk to benefit ratio of the product in clinical practice."

Hotchkiss adds: "UK prescribers are already among the slowest in Europe to adopt new medicines. Further restricting their ability to prescribe new medicines would slow patients' access to innovative drugs. Lilly believes strongly in the commitment of all doctors to act in the best interests of their patients, and in fact reducing disproportionate business regulation was a commitment of the Chancellor's [Gordon Brown's] Budget statement."

The pharma industry's desire for early and effective marketing is perhaps behind one of the more scathing comments in the HSC's report: 'Priorities for research into medicines inevitably reflect the interests of pharmaceutical companies and are not necessarily well aligned with the medical needs of all patients.'

"Well, what would they expect!" asserts Rowden. "Commercial organisations in a tough global market are in a high cost R&D environment and are going to put their R&D bucks into programmes that help generate business. Surely, the answer is to ensure that government funding for pure research should be more available to UK universities, so that commercial interest can be better balanced by the scientific community being able to access 'untainted' funding at a more generous level."

"I wonder if this [cost scenario] could be made more tolerable by agreement between major pharma companies, and perhaps lengthening the duration of patents," Dr Taylor muses.

Disease Awareness
Further to the HSC's concerns over inappropriately heavy pre- and early post-launch tactics is the sticking point of disease awareness.

The role and value of disease awareness campaigns was a sore point during the HSC panel sessions, with one notable exchange between the MPs and Margot James, of Ogilvy Healthworld. James rebutted the idea that disease awareness initiatives were merely sales tactics thinly veiled under the heading of 'education' - and hence tantamount to so-called 'disease mongering' (as was implied in a question from the HSC). During one evidence session, she voiced clear displeasure that she detected in the HSC panel an "inability and reluctance" to see that one action can have two consequences.

Rowden does not accept the accusation put to the industry of `hospitality masquerading as education'. "I would like to see their [the HSC members'] hard evidence," he says. "In the past year, I have worked with Wyeth, Pfizer, Shire and Janssen-Cilag on a variety of programmes. No reputable company has ever tried to inappropriately influence the content of such programmes. All have provided quality controls on educational content that are rigorous, all have safeguards in place to ensure that educational content and attendance is properly recorded and all have been cautious that any hospitality is appropriate and within ABPI rules. So, why would a commercial company not market a new product robustly?"

Pfizer's Poulton is quick to point out the benefits of even-handed promotion: "Pfizer is proud to have initiated disease awareness campaigns that encourage appropriate patients to seek treatment for life threatening, asymptomatic conditions (for example high cholesterol). In doing so, the company is partnering the NHS to achieve its objectives as set out in the Cardiovascular National Service Framework, and helping GPs to achieve the targets outlined in the GMS contract."

He adds: "Marketing initiatives can help prescribers to understand the value of medicines, and to determine which patients may benefit from taking them. We have never set out to mislead, or to encourage inappropriate prescribing."

However, one of the HSC's chief gripes over disease awareness pertains to the barrage and intensity of promotional material aimed squarely at UK prescribers, and particularly at new and inexperienced prescribers.

'We recommend that limits be set as to the quantity of material prescribers receive, particularly in the first six months after launch. Less experienced doctors are ill-equipped to cope with the promotional material.'

On this point, both James and Rowden acknowledge that the HSC has a point. "It might make sense for companies to discuss the appropriate training needs of such professionals with the statutory and professional bodies," Rowden notes.

Despite her fervour for the HSC to understand and appreciate the value to patients of disease awareness campaigns, James does concede that there is room for some tightening up of the rules. "Ogilvy Healthworld agrees with the need for more control over disease awareness. The Code of Practice was developed at a time when the vast majority of company marketing comprised advertising and representative selling. Public relations, disease awareness and medical education were minimal and the Code needs to catch up and ensure that these newer forms of communications are subject to proper controls."

However, she is very clear on the real world benefits of effective disease awareness work. "I have sat in countless research groups where GP opinion leaders have bemoaned colleagues' ignorance and lack of interest, and the resultant poor treatment and management. The market has been shaped by GPs failure to take certain conditions seriously, such as migraine and irritable bowel syndrome."

She refers to five "highly significant and beneficial advances" achieved in part through effective disease awareness campaigns - triple HIV therapy, tamoxifen for breast cancer, statins, atypical antipsychotics, and taxanes for cancer.

"We should not forget the battle patients and industry had to wage to get these medicines prescribed and perhaps if industry's marketing had been, as the HSC notes, 'relentless and pervasive', patients would have had faster access to these treatments."

Weber Shandwick's Hall makes the point that promotion to doctors is not all about quantity of information. "Quality is the key here and provision of quality information that is highly relevant will ensure key stakeholders aren't deluged by vast amounts of information. Ethical healthcare communications need to be tailored to the needs of the audience. In an age of increasing noise, dilution of boundaries and identities, the increasing expectations of the customer is to be dealt with individually.

"It's not just about targeting the message or product, it is the need for an individualised process of interaction. It is clear that there is a real distrust and scepticism of the pharmaceutical industry and there's no doubt in my mind there is much the industry can and needs to do, and the HSC report marks a line in the sand."

Going Forward
Right now, all eyes are on the political parties, albeit due to their electioneering activities rather than their power to rewrite parts of the 'how to market medicines in the UK' rule book. So what to do in the meantime until the reconstituted government, whether it be Blair's buddies, Howard's hopers or Kennedy's kinship, pieces the HSC back together and then starts working on and implementing the recommendations?

The advice on the grapevine is to not panic right now, but do ensure that your marketing department is fully briefed and comfortable with what the HSC has put forward and that your staff are ready and prepared to make adjustments here and there if, nay when, the times comes. The government may have several months to make an official response, but remember that these recommendations have sharp teeth.

"Expect the recommendations to be implemented in full. If Blair gets back in, he will be weaker and less able to resist the Health Select Committee's recommendations," notes healthcare policy commentator and broadcaster, Roy Lilley.

"Pharma has always accused the NHS of being too conservative and slow to accept new products. You ain't seen nothing yet! If the Health Select Committee has its way, launching a new product in the NHS will be as easy as launching a life-boat in the Gobi desert. The industry has to look for new ways to get its message across, deal with the tide of transparency that is dissolving its cloak of secrecy and learn to be less dependent on blockbusters."

He continues: "Pharma would do well to find out about permission marketing, how to de-merge and start lobbying for separate protection for research projects and for a new-style marketing patent once a product is in use. That way, companies don't have to be in such an all-fired hurry to recover costs and make a profit in the fag-end few years of patent life that is left to them now."

Rowden, commentator and former nurse, suggests that overall the recommendations, if implemented, will serve to refine patients' experiences and companies' activities. "The HSC suggests that post launch and marketing surveillance is weak. They might have a point here and the industry should respond and look at how this might be improved."

He adds: "The industry, policy makers and regulators need robust mechanisms to keep a constant eye on the risk/benefit analysis of any new product - and please involve patients in adult discussion about such products. Still, the HSC has offered its views on the pharma sector and it could have been worse! A calm response to the report would be wise and serious reflection, and then action when we know the government's response."

Pharma's challenge? Dr Taylor says: "Greater transparency of activities is essential, particularly with regard to early warnings of unexpected side effects. Authoritative, well-informed drug and therapeutics committees across PCTs and hospital Trusts are vital.

"Await the government's response to the report," he advises. If some of us who were on the HSC are re-elected as MPs, whether we are back on the committee or not, I expect there to be a debate on the report, and on the response.