2009 brings a move toward ending pharma freebies

January 1, 2009 – typically a day of new beginnings – marked the beginning of the end of SWAG (stuff we all get, or freebies) for doctors from pharmaceutical companies in the United States . This change was the result of new voluntary industry guidelines published by the industry group, Pharmaceutical Research and Manufacturers of America (PhRMA). As of 15 January 2009, 41 companies have signed on to abide by the code.

Pharma swag has typically come in the form of free pens, notepads, soap dispensers, coffee mugs, and the like, all with the company and drug name prominently displayed. These “reminder items” serve a purely promotional purpose – to reinforce the brand. More recently, swag has also taken the form of more medically useful or educational items, such as anatomy displays or posters for doctor’s offices, or patient educational pamphlets or DVDs – all with the pharma company, drug name and logo in plain view.

The new guidelines ban the distribution of “items for healthcare professionals’ use that do not advance disease treatment or education – even if they are practice-related items.” Items that can be given away should be “designed primarily for the education of patients or healthcare professionals… are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities.” Thus, other freebies such as DVD players or free sporting event tickets are now verboten.

While some doctors bemoan such blatant promotion, others insist it does not affect their prescribing habits, that they make prescribing decisions based on the individual patient. Given the billions of dollars spent by pharma on advertising each year, one imagines that the swag must have had some effect or the companies wouldn’t have bothered.

But what impact will the swag vacuum have on physicians’ practice balance sheets? For those in private practice, having to buy their own pens and notepads may not throw their budgets into the red, but free clinics and practices that serve predominantly Medicaid/Medicare or uninsured patients and operate on more strict budgets may be feeling the pinch.

Shannon Ortiz, the office manager for the Free Medical Clinic in Iowa City , Iowa , says her office will now rely on donations for such office supplies; such items are included on a “wish list” for donors. The pharma sales reps who visit her clinic don’t typically bring medical items (eg, branded tongue depressors, exam table paper) as swag but if they need such items, other doctors’ offices typically donate them.

By contrast, Carle Clinic in Urbana , Illinois , (which employs more than 330 physicians) has had some form of non-solicitation policy for the last few years and has actively discouraged both pharma reps from distributing swag and physicians from accepting them. This new pharma policy was not formally announced to the clinic and, according to Jennifer Hendricks-Kaufmann, Public Relations and Communications Manager for Carle Clinic, should have “minimal, if any, impact” on their budgets, because the office items and even patient education materials are already provided directly by the clinic.

The impact of this swag reduction remains to be seen – for both physician practices and pharma profits. It does show, however, that pharma is paying closer attention to appearances of undue influence on prescribing habits.

Drug makers gift disclosures: the ethics issue

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.

Regulating DTC ads – Are we attempting to herd cats?

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

In a previous issue of HOC , we outlined some of the commonly expressed pros and cons of direct-to-consumer advertising (DTCA), which is currently allowed only in the United States (US) and New Zealand but under consideration for Europe .

On May 5, 2008, three executives, from Pfizer, Schering-Plough/Merck and Company, and Johnson & Johnson, appeared before the US Congress Subcommittee on Oversight and Investigation, to answer questions regarding three specific “potentially misleading and deceptive tactics” used in DTCA for Pfizer’s Lipitor, J&J’s Procrit, and Vytorin, which is sold by Merck and Schering-Plough. The congressional subcommittee asked whether the three companies would be willing to commit to six guidelines:

• Follow the American Medical Association’s guidelines regarding the use of actors and health professionals in DTCA.
• Not market products in DTCA until a valid outcomes study of the product is completed.
• Place a 2-year DTCA moratorium on new prescription drug products, as recommended by the Institute of Medicine .
• Not market off-label uses for prescription products in DTCA.
• Add the FDA toll-free MedWatch phone number in all DTCA.
• Include “black box” warnings in DTCA for products that contain such warnings.

All three companies agreed to only two of the six guidelines (following AMA guidelines on use of physicians in DTCA and placing a 6-month moratorium on DTCA for new products). Some of the companies also agreed to specific guidelines, or more often, agreed to work with FDA guidance or seek advice from the FDA on the proposed guidelines. The trade association for the pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America (PhRMA), also participated in the congressional hearing. In 2005, PhRMA had developed its own guiding principles on DTCA.

DTCA are reviewed by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC). The reviews are for the most part voluntary, except for specific categories of drugs, such as cancer drugs, where the risk-to-benefit ratio may be weighted on the risk side. In the latter cases, the advertisement must be submitted ahead of time – but the pharmaceutical manufacturer does not have to heed the DDMAC advice nor even wait for the comments before it releases the ad.

Nonetheless, PhRMA maintains that DTCA is one of the most highly regulated forms of advertisement in the US . To date in 2008, the FDA DDMAC has issued 5 warning letters outlining regulation violations in promotional advertisements.

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The changing face of DTCA

The New England Journal of Medicine reports on a new form of DTCA of which we may be seeing more – for medical devices. (NEJM 2008;358:21). The article also describes the differences in DTCA requirements based on format – television ad, web site, and patient-education brochure. For example, the FDA requires that only “major risk information” be disclosed in broadcast DTCA, but these ads must direct viewers to other sources of information on associated risks.

Print advertisements, by contrast, must include all information about associated risks (ie, major side effects, contraindications, and precautions contained in the FDA’s label). As an example, a television ad for a drug-eluting coronary stent listed 4 potential adverse events related to use of stents in general, but none associated with the product. The web site listed 10 device-related adverse events, and 5 that were product-specific. The patient education brochure listed 31 device-related adverse events, and 13 product-specific adverse events. So, patients must do their homework, depending on the type of DTCA they see. A spokesperson from the FDA said that all ads – for devices and drugs – are required to not be false or misleading and to present information that is in accord with product label

Pros and cons of direct-to-consumer advertising

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.

How to select a healthcare agency

There are hundreds of healthcare agencies and trying to find one that will suit your needs is difficult and potentially time-consuming. The key is to limit your choice, and these simple steps will help you develop a shortlist of suitable prospects:

First, try to decide what you want from an agency and then categorize this need into one of the following types of services:

• General medical communications;
• Public relations;
• Medical education;
• Training; and
• Specific modeling or other tasks that require a full understanding of health economics processes.

Then decide whether you need a full-service agency, or a more specialized one that will tailor its approach to individual projects. Even if you want a full service agency, it’s better to ‘pilot’ a specific task first since working with an agency on a day-to-day basis will be the best test of compatibility.

Also, restrict your choice of agency by deciding what features are important to you – for example, you might decide that an experienced agency with a reputation for quality is of high priority or you might want to go for a new agency with some exciting approaches.

Geographic location might be unimportant, but how the agency works with the client might be critical. Once you have a list of key needs, ask colleagues for personal recommendations before you try the internet. Finally, search websites; often, these will give you an immediate feel for an agency and allow you to include or discard it.

By now you should have a much shorter list. The final factor that can limit the choice will be experience within your specific area of need; not all agencies have experience in health economics and not all have generalized experience. Decide how important this might be to you.

Lastly, try speaking on the phone with an agency – this can be an important and direct way to find out how an agency operates; sometimes, agencies that pride themselves on their PR record can have poor PR themselves.