Welcome to the March issue

By David Woods (david.woods@rxcomms.com)

There has been much written lately about the perceived failings of the FDA. The Wall Street Journal claims that “the place is a mess,” and a physician who served in the FDA from 1979 to 1994 commented in a letter to the New York Times: “the agency's most significant problems are mismanagement and a culture that is excessively risk-averse.”

That same physician went beyond this diagnosis to offer a potential cure. What the FDA needs, he suggested, is competent management, discipline in the ranks, more effective risk-benefit balancing, a commitment to permitting patients to assume more responsibility for the risk of medicines, and the banishment of politics from regulatory decisions and policy.
One of the FDA’s advisory panels, the Science Board, notes that the Agency is in a precarious position because it's chronically under funded. And the US Government accountability office asserts that at the FDA’s current pace of operations, it would take 13 years to inspect every foreign drug plant exporting to the US.

The under funding issue comes into sharp focus when one realises that the Agency’s mandate has increased exponentially over the past decade or so. In fact, the Science Board states that “while the world of drug discovery and development has undergone revolutionary change, the FDA's evaluation methods have remained largely unchanged over the last half-century.” The Board proposes that the FDA modernise current regulatory pathways, especially the narrowness with which it balances risk and benefit for the most promising new therapies before they are allowed to reach the public.

The FDA was founded in 1906 with the laudable objective of protecting the populace against ingesting harmful or dangerous substances. It has grown into a bureaucratic monster, employing some 10,000 workers, and with a budget of more than $1.5 billion.

And the role of Commissioner has not been an entirely happy one. Since Dr. David Kessler, the so-called ‘scourge of the tobacco industry,’ stepped down after a record six year tenure, his three successors have lasted an average of two years. The present incumbent, Dr. Andrew C. von Eschenbach, has filled the role since last December. In an interview I conducted with Kessler for the British Medical Journal shortly after he resigned, he said that he had achieved his three major aims: developing and mandating the nutritional labels that now appear on all foodstuffs sold in the US; shortening the time for approving new drugs; and bringing about the legal definition of nicotine as an addictive drug and therefore subject to FDA regulation.

Often accused of zealotry and of politicising the Agency, Kessler also became the object of a congressional investigation of his allegedly padded expense accounts. But if you want to be liked, don’t be a regulator, he told me, noting that “it’s no secret that if you take on difficult issues in this town you'll be attacked. You learn to live with criticism; you don't confront it.”

Is there a case for privatising the Agency? Despite the 1992 scandal of some FDA scientists accepting bribes... and some dubious drug approvals, it might be that this is one area where public enterprise might be a preferable guardian of the public interest. Under the Prescription Drug User Fee Act (PDUFA) some privatisation is already occurring, with drug companies paying user fees to the FDA in order to reduce approval times. Another suggestion, put forward by Henry Miller, MD, a former head of the FDA’s Office of Biotechnology, is to appoint a powerful, independent Agency ombudsman with the authority to impose sanctions on FDA employees responsible for flawed decisions or policies.

In Europe, several countries use ‘notifying bodies’ to approve drugs and devices. A two-pronged system under which drug companies could hire private labs to certify the results of testing for safety and efficacy … with the FDA regulating the labs and retaining authority to accept or reject their findings, might be a sensible middle of the road option.

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By Mary Gabb (mary.gabb@rxcomms.com)

Obnoxious, annoying, Big Pharma strikes again – these are just some of the sentiments heard when encountering a direct-to-consumer (DTC) advertisement, the myriad commercials on radio or television, or adverts in magazines, newspapers, or on the internet, promoting prescription drugs to consumers. The pros and cons of DTC advertising have been bandied about since the inception of this marketing platform more than a decade ago. DTC advertising is currently permitted only in the United States and New Zealand, but Canada and/or Europe may follow suit as pressure to allow this form of advertising increases.

Arguments against DTC advertising are familiar – it increases the cost of medications, it has created a society of hypochondriacs, it reinforces that “quick fix” so many in modern society seek, instead of the lifestyle changes necessary to address some diseases, and it reinforces the sinister concept of Big Pharma.

The arguments in favour of DTC advertising are less well known, but still important to consider. First, DTC advertising helps to make patients aware of their treatment options, such as new drugs for a particular disease, and the potential side effects of taking the drug. DTC adverts also help to destigmatise and raise awareness of certain disorders, prompting patients to seek medical attention when they might not have otherwise. In short, patients become more motivated to take control of their healthcare and become more active partners in the patient-doctor relationship.

The extent to which the pros outweigh the cons (or vice versa) has been argued in recent years, as long-term studies have followed the effects of DTC advertising – the percentage of marketing budgets spent on DTC advertising, the effect on the number of prescriptions written, surveys of physicians on the extent to which DTC has affected the doctor-patient relationship and prescribing habits, the spread of costs across healthcare delivery (eg, fewer hospitalisations with increased use of prescription drugs). Supporters of DTC advertising are also facing criticism of poor oversight of the ads by the FDA. The recent decision by Pfizer to pull their Lipitor ads featuring Dr. Robert Jarvik only highlight such scepticism. (With pressure from the US Congress, the Jarvik Lipitor ads were deemed to be misleading, for several reasons: Dr. Jarvik is not a licensed physician, he is not a cardiologist, and some of his colleagues are debating whether he should receive sole credit for [or even be credited at all with] inventing the artificial heart.) Although the ads may seem to be ubiquitous, the number and type of drugs advertised to consumers is small, and the ads focus on new drugs to treat chronic diseases and diseases for which patients can recognise the symptoms (eg, depression, dyslipidaemia, obesity, allergies, osteoporosis, arthritis, asthma, and diabetes). Also, DTC advertising still occupies a relatively small portion of marketing budgets for those drugs that are advertised. The New England Journal of Medicine reported that while spending on DTC advertising rose 330% between 1996 and 2005, it made up only 14% of total promotional expenditures in 2005. Advertising to doctors is still one of the biggest drivers in marketing budgets.

Ultimately, the effect of DTC advertising will depend on the individual patient – his interest in and capacity to understand his disease and the drug, including its benefits and risks.

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By Julie Stauffer (julie.stauffer.rxcomms.com)

Sustaining staff morale is about much more than delivering a wage slip at the end of the month. If the past few years of restructurings, closures, and layoffs in the pharma industry have taken a toll on the office mood, perhaps it’s time for a little shot in the arm.

The following nine-point guide can help you boost workplace satisfaction – and reap the rewards of a more motivated workforce, lower staff turnover, and a positive environment

Know your staff

Some employees are driven by results, others by process; some focus on the big picture, while others love details; some are introverts, and others wilt without lots of interaction. By taking the time to understand what makes each person tick, you can keep them motivated and create the conditions to help them thrive.

Communicate

Closed doors breed rumours and fear, so make a point of keeping everyone in the loop about corporate decisions and impending issues. Make sure your employees know how their work is having an impact. Finally, remember that communication is a two-way street. Ask for input, and take it seriously.

Offer support

When you provide training and mentoring, you’re sending employees the message that they’re worth investing in – and giving them the tools to succeed. Programmes can be formal or informal, in-house or external, just so long as they fit the specific needs and interests of your staff.

Give and get feedback

Employees shouldn’t have to wait for their annual review to find out how they’re doing. Give feedback regularly: praise an accomplishment or nip a problem in the bud before it becomes a big issue. At the same time, ask questions. Are they happy? Is there anything you could do to help them work more effectively?

Recognise good work

Who doesn’t like to be acknowledged for a job well done? Whether it’s an accolade at the weekly departmental meeting, a simple thank you in the hallway, or a formal corporate award, recognition lets people know that their efforts are appreciated.

Crank up the challenge

Boredom creates a breeding ground for discontent, so give your employees work they can sink their teeth into: a new project, for example, or the autonomy to make more decisions.

Tame the bureaucracy

It’s the bane of big organisations and the number one frustration for the people who work in them. You’re guaranteed to make your employees happier by minimising red tape and running interference as much as possible.

Foster camaraderie

Promoting better staff relationships doesn’t have to be touchy-feely or involve clinging to a rope 30 feet above the ground. Rather, it simply needs to get employees interacting in new ways. The better everyone understands one other, the more effectively you can all work together.

Add a spoonful of sugar

Small perks can sweeten the workday. An indoor putting green or corporate concierge may not be in your budget, but perhaps a departmental cappuccino maker is. Or consider no-cost approaches like offering flex time, dress-down Fridays, or an iPod-friendly work policy.

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“Why did you start, what did you do, what answer did you get, and what does it mean anyway?
This seems to me to be a logical order for a scientific paper”
Sir Austin Bradford Hill (1897–1991) – British epidemiologist and statistician; pioneer of the randomised clinical trial

By David Woods (david.woods@rxcomms.com)

With this the 26th issue of HOC, we are well overdue in featuring our energetic, globetrotting CEO of Rx Communications, Ruth Whittington.

I can say this with only a minor fear of being labeled a sycophant or worse, but Ruth is a model boss: knowledgeable, hard-working, and above all nurturing and empowering towards her employees.

A native New Zealander, Ruth graduated from Auckland University with a first class honors Masters degree in biochemistry and physiology. While doing her PhD she joined Adis, a major medical communications company, first as a medical writer, and then as publications manager for the journals Drugs, Pharmacoeconomics, CNS drugs, and Health Outcomes. She quickly developed close ties with the pharmaceutical industry clientele and moved into business development with Adis, writing strategic plans and developing innovative publication programmes.

In November 2000, Ruth founded Rx Communications. A consummate entrepreneur, she has overseen exponential growth in both staff and revenue for the company; she's also a highly innovative thinker, having chosen, while most medical communications companies are located in metropolitan areas, to place Rx in a small market town in North Wales. As she puts it: “We could be located anywhere as long as it has a good road to the airport and good broadband telecommunications.” The company numbers among its clients most of the major pharmaceutical firms... and has a global network of more than a hundred experienced freelance medical writers.

The Rx CEO says that her personal business philosophy is to deal with integrity and to bring love and passion to what you do; her best quality, she believes, is her ability to pick the right people. “I look for an openness to different ideas and a certain energy,” she says. But even though she takes a kindly and benevolent approach to her staff, she is a perfectionist; moreover, she loves a good argument so long as it’s dialectical and not diabolical.

Ruth has two young daughters, and says she wants to do more travel (are you serious, Ruth? You must have enough frequent flyer points to go to the moon); and to learn Welsh. Now there’s a worthy ambition: trust me, Mandarin is much easier.

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To find out more, go to www.rxcomms.com

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If you have missed any of our earlier issues, email duncan.dibble@ rxcomms.com for a copy. See the HOC page on the Rx website for a full list of previous articles.

HOC is available for print in pdf format – free

You can of course print this e-newsletter straight from your inbox (for best results select landscape in your printer’s print set up), but HOC is also available as a professional 4-page A4 newsletter in pdf format for you to print and keep for reference. Simply email duncan.dibble@ rxcomms.com for past copies. If you would like to be sent a pdf version each month let us know and we’ll send one as soon as it is available.

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Healthcare Outcomes Communicator is designed to help you explain and enhance your role and value as healthcare economists and outcomes researchers. But we need input from you – the professionals working "in the trenches". So we encourage you to give us your feedback about how we're doing – to communicate with us so that we can better communicate with you.

Yours sincerely
David Woods and the Rx Communications team

This material is published in good faith and is subject to editorial scrutiny before publication, however no warranty or guarantee of its accuracy is expressed or implied. No liability will be accepted by Rx Communications for any loss resulting from use of this resource. Our regular readership are assured that their details will not be passed on or used in any other promotional activity without permission.
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