Welcome to the November issue

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

Since 1996, DTCA has existed only in the USA and New Zealand , but recent declarations from the European Commission (EC) suggest that the rules governing pharma communication with patients may be loosened.

In October, both the Wall Street Journal (WSJ) and the Financial Times (FT) reported intriguing recommendations from the “High Level Pharmaceutical Forum”, a 3-year programme run by the European Union to address specific public health considerations regarding pharmaceuticals and to promote industry competitiveness while sustaining national healthcare systems. The Forum was the brainchild of Günther Verheugen, the Vice President of the European Commission and Commissioner for Enterprise and Industry. The FT also reports that Mr Verheugen is drafting legislation to formally ease marketing rules for pharma.

Concerns about DTCA in Europe emerge from one of the Forum's three mandates: that patients and citizens need access to better information on disease states and available drugs. But who should provide that information? Both the WSJ and FT report that proposed new rules would weaken the existing strict limits on pharma-provided information to patients. Under the new proposed rules, “objective and unbiased” print and on-line information about drugs would be permissible, but direct advertising would not.

But who determines what is objective and permissible? Where is the line drawn between information and advertising? What role would the European Medicines Evaluation Agency (EMEA, a European equivalent of the US Food and Drug Administration) play?

Efforts to have Mr Verheugen answer those questions were unsuccessful. Queries to his press officer were unanswered and his spokesman stated that “our experts are still working on this and will not be available for the coming weeks.”

The published final conclusions and recommendations from the Forum clearly state that “the ban on advertising of prescription medicines to the general public should continue”, but it also names the industry as one of the relevant players in healthcare that should ensure high quality information for patients.

Thus, it is not clear exactly what the EC is proposing and, if agreed to, when the changes would be implemented. But this discussion does suggest a possible change in attitude toward the role of pharma in providing healthcare information in Europe.

back to top

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

Drug company Eli Lilly has said that it will start disclosing the amounts of money over $500 that it pays to physicians – and other firms are likely to follow suit one jump ahead of a US Congress that is planning to mandate such transparency.

Research has shown that payments to doctors can influence behaviour. As Dr. Arthur L. Caplan (pictured left), director of the University of Pennsylvania's Center for Bioethics, puts it: “[Disclosure] is a good thing because we have a great deal of evidence that gift-giving can influence behaviour in terms of prescriptions, publishing positive findings but suppressing negative findings, and generating enthusiasm for new drugs.” He cites the extreme example of Emory University 's Dr Charles Nemeroff, a psychiatrist who, according to Health Care Renewal, raked in hundreds of thousands of dollars as a paid speaker on behalf of drug marketers, and denied these earnings while running a government-funded project meant to evaluate some of the products of his commercial sponsors.

Dr. Caplan believes that “the ethical handwriting is on the wall.” In an interview with HOC , he said that even small gifts can sway doctors, and he cites articles in the Journal of the American Medical Association and the New England Journal of Medicine underscoring that. His own article “All gifts great and small”, which appeared in the American Journal of Bioethics (3, 2003:39–46), gives further weight to that contention – and policy makers, he says, are starting to pay attention. Caplan believes that Congress will enact disclosure legislation shortly after the new president is sworn in on 20 January.

So what can pharmaceutical companies do if legislation shuts the door on how they can forge useful relationships with the medical profession? Dr Caplan believes there are four ways:

1. Rethink the traditional approaches of sponsoring dinners and trips, and focus on building useful websites for physicians; perhaps something similar to the SERMO approach (see HOC December 2007) – a social networking initiative involving physicians whose real life clinical experiences can be made available to pharma.
2. Hold conferences and peer-reviewed public meetings for healthcare associations.
3. Maintain registries of research, which would be a useful service for both physicians and patients.
4. Think ahead to putting medical information on YouTube, etc, and make sophisticated information advertisments for doctors – turn DTC into DTDoc

Is $500 a suitable threshold for disclosure? Dr Caplan believes it is; he also thinks that device manufacturers should be included in any disclosure mandates.

With legislators and even medical associations such as the AMA and the Association of American Medical Colleges looking for a zero tolerance approach to drug company handouts to physicians, the industry would be well advised to develop a Plan B if it wants to influence physicians and stay within ethical boundaries. Otherwise, recipients of drug company gifts might decide to do what one Minnesota hospital chain did. They swept them all up in 20 shopping carts and shipped them off to the West African nation of Cameroon .

back to top

By Laura Goldman (laura.goldman@rxcomms.com)

The pharmaceutical industry knows only too well the dire statistics of expiring patents. According to Forbes Magazine , $160 billion of drugs will lose patent life by 2016. Midwest Business (midwestbusiness.com) reports that drugs with $19.7 billion of revenue went off patent in 2008. $12 billion of pharmaceutical sales revenue was lost in 2006 due to patent expiration.

Dr Kevin Schulman, a professor of medicine at the Fuqua School of Business of Duke University , estimates that “Drug companies typically lose 80% or more of their revenue stream within a quarter of a patent expiring. In the US , generic competition is very rapid.” If you extrapolate these percentages, Pfizer will lose $10.4 billion in revenue when its best selling drug, Lipitor, goes off patent in 2011.

Herman Saftlas, pharmaceutical industry analyst at Standard & Poors, said that his research showed that the conversion to generics is occurring at a slightly slower pace. “Generics are rapidly gaining market share. Currently, they account for 55% of all prescriptions filled in the United States.”

Dr Schulman still does not foresee a bailout for the industry: “I don't think there would be much support on the public side for a bailout of the pharmaceutical industry. From a larger perspective, there would not be an apparent impact on the broader market the way there is with the banking industry. From a narrower perspective, there is not much that additional financial infusions can do to help erase the lack of new products coming through the pipeline. The public (through Medicare and Medicaid) is already a significant supporter of this industry.”

Mark Bard, president and cofounder of Manhattan Research, concurs. “While you saw banks incur significant losses which required government intervention to save the system from a systemic meltdown, the ‘impact' of generic switch within pharma is known and very predictable in the coming years. How do companies react to the coming wave of patent expirations? They do it through selective sales force reductions where needed (and which are happening now), increasing operating efficiency, reducing administration costs, and cutting costs to reflect in what many cases may be a smaller revenue base in the coming years.”

John Paul, research analyst at Frost and Sullivan, agreed: “The pharmaceutical industry is biting the bullet and making the cuts necessary to their survival. Merck just announced a restructuring that will generate savings of approximately $4 billion over the next five years. Pfizer will make $800 million in cuts this quarter which will most certainly include layoffs. Schering Plough is cutting 10% of its work force and closing plants in a bid to reduce costs by $1 billion over the next two years. Many pharmaceutical companies have been closing down manufacturing facilities in Europe and the US and turning to outsourcing to save costs.” Many expect this year to set a record for layoffs in the pharmaceutical industry.

Short of a cash bailout, there are other things that can be done which would benefit the pharmaceutical industry. Michael Cannon, director of health policy studies at the Libertarian Cato Institute, advocates for a patient driven solution for pharma's problem. “Rather than throw more money at the pharmaceutical industry, Congress should do something to help patients, like shorten the length of time it takes to get new drugs to market, which now averages some 15 years. I would like to see the process go back to the 1960's model when the FDA only ruled on safety. Let the private market determine the efficacy of the drugs.”

During the bailout talks in the Senate that resulted in a $700 billion dollar bailout for the financial industry, the pharmaceutical industry was not ignored. John Mack, the independent publisher of Pharma Marketing News , noted, “There were special tax breaks for R&D dependent industries such as pharmaceutical and high tech.” (The tax breaks were not included in the final version of the bill.)

Some would say that the pharmaceutical industry already received their bailout. Michael Cannon said, “Medicare Part D, the programme's new prescription drug benefit and the largest expansion of the entitlement state since the creation of Medicare itself, was essentially a bailout of the drug companies.”

The pharmaceutical industry, previously one of the major contributors to the Republican Party, has been veering left this election cycle. The Center for Responsive Politics reports that the employees and political action committees of the pharmaceutical industry have split their donations evenly between the two parties this elections cycle. Traditionally, the Democrats garner only 30% of the industry's donations.

Ken Johnson, Senior Vice President at the Pharmaceutical Research and Manufacturers Association of America ( PhRMA), the pharmaceutical industry's lobbying group, wanted to emphasise the organisation's bipartisan giving. “Although today's political and economic climate may pose unique challenges for US pharmaceutical companies, we will continue to support sound policies that encourage innovation of new therapies and encourage patient access to medicines. We will also continue to support policymakers on both sides of the aisle who value the important and life changing work that America 's pharmaceutical companies do every day to enhance the lives of patients around the world.”

back to top

“ While medicine is a science, in many particulars it cannot be exact, so baffling are the varying results of
varying conditions of human life.”
Charles Horace Mayo, American physician and co-founder of the Mayo Clinic

American Medical Writers Association (AMWA) Annual Conference 2008

By Robert Hand (robert.hand@rxcomms.com)

Under the title “Setting the Pace,” the American Medical Writers Association (AMWA) held its 68th Annual Conference on October 23–25 in horse country, Louisville , Kentucky . More than 1000 medical communicators with a wide range of expertise and interests attended. This year, AMWA offered a full programme of 97 certificate and non-certificate workshops, as well as 38 open sessions in which panels of experts addressed issues of concern to present and potential medical writers.

The Walter C. Alvarez Award, for excellence in communicating healthcare developments and concepts to the public, went to T.L. (Tedd) Mitchell , MD , President and Medical Director, The Cooper Clinic, Dallas Texas . His witty and entertaining address was, “Move Yourself: Getting Americans Back on the Path to Good Health.” Mitchell tweaked the host state for the conference, noting that it has the highest tobacco consumption in the United States . In an illustration of absurdity, he showed a picture of men using the escalator rather than the stairs on their way to a gym, ostensibly for exercise. Another showed before-and-after pictures of Michelangelo's David; “before” was the familiar slim young man, and “after” was an electronically altered image showing a chubby, middle-aged man with voluminous love handles. Mitchell presented a series of charts documenting the epidemic of obesity and other health problems. His message was clear: we all need to take individual action to maintain our physical fitness and reduce the risk of serious, preventable health problems.

AMWA's highest award, the Harold Swanberg Distinguished Service Award, for major contributions to medical communication and the medical profession, went to Norman Grossblatt, the man behind the Board of Editors in the Life Sciences (BELS) exam for editors. Grossblatt's speech was a reminiscence called, “A Life in the Day of a Manuscript Editor” (no, that's not a typo!) that recounted the many technological changes that have advanced the editing process over recent decades. From the days of handwritten mark-ups of paper manuscripts he recalled the development of early copy machines yielding pages that were of questionable quality and quickly became brittle and discoloured. (And how many people remember the purple mimeograph?) Since those days, tremendous technological advances, such as the replacement of typewriters by computers, have eliminated much of the paper and speeded the review process, with reviewers able to review manuscripts entirely on screen and circulate their comments instantly via e-mail. The result is a process that is vastly different from that of a few decades ago. On the other hand, the current process still requires real human beings to do the actual editing.

Further information about AMWA can be found at www.amwa.org .

Editors note: Robert Hand is a former president of the Delaware Valley Chapter of AMWA.

back to top

back to top

back to top

HOC is your publication, so please send us your requests or comments to duncan.dibble@rxcomms.com

If you missed any earlier issues of HOC , email duncan.dibble@rxcomms.com for a copy. Just a few of our previous articles are Getting drugs accepted , Healthcare blogs and How to make the most of conferences . A full list is available at http://www.rxcomms.com/hocezine.asp

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.

back to top

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.
Produced by Beaumore Publishing Solutions