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o reach the small, but lucrative hemophilia market, some drug makers have tried an unusual and high-intensity promotional strategy — building lifetime relationships.

Companies start early by giving children toys and comic books. One sponsored summer camps and another offered grants for music and sports classes. Teens have been awarded college scholarships. Young adults and parents were offered jobs to advise families about treatment. In some cases, sales reps have been assigned to individual patients to ensure long-standing use of specific medicines.

Such moves exceed the usual sort of industry promotion aimed at consumers, and, in fact, more closely resemble the tactics used by the pharmaceutical industry to sway physician prescribing, according to a paper published Tuesday in PLOS Medicine. And the authors argued that the web of ties can foster a culture of dependency that may undermine effective decision-making and requires more regulatory oversight.

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“This particular community is entirely enmeshed with the pharmaceutical industry,” said coauthor Dr. Adriane Fugh-Berman, who heads PharmedOut, a project that examines the influence drug makers have on the practice of medicine. She noted that companies aggressively pursue these patients because industry research indicates they are very organized, well connected, and savvier than most consumers.

“This is all about buying brand loyalty to expensive drugs that will be used for a lifetime … This is a creepy situation,” she added. “It’s a clear illustration that pharmaceutical companies go after whoever controls market share. And in this case, it’s the patient. But the relationships are so entangled that it can get in the way of a rational assessment of the different therapies. And it flies under the regulatory radar.”

Moreover, the authors argue that the blurred lines extend to patient advocacy groups, some of which are funded, in part, by drug companies. As the authors see it, these close relationships may be used to pressure payers and legislators to cover certain medicines or distort discussion of treatment options, including more research that would compare the effectiveness of the different medicines.

The paper highlights an important issue, according to Arthur Caplan, who heads the division of medical ethics at New York University. “You shouldn’t talk to children, period. It’s an ethical no-no. No dinners, no forming relationships with kids, at all. They’re too vulnerable to understand what’s going on. And they don’t determine which medication to use or who their healthcare provider would be.”

The issue is also noteworthy because hemophilia, while a small market, involves big dollars.

About 20,000 people in the United States have hemophilia, a condition in which blood fails to clot and causes someone to bleed severely from even a slight injury. The global market is worth about $10 billion and the hemophilia A market, the classic form of the disease, is worth about $3.5 billion in the US, according to Sanford Bernstein analyst Ronny Gal.

Average annual costs were $59,100 for mild hemophilia and $84,300 for moderate hemophilia, according to a study published last year in the Journal of Medical Economics of six federally supported treatment centers. For severe hemophilia, the costs were $201,400 for treating periodic episodes of bleeding and $301,400 for preventive care that involves two to three doses of a treatment each week.

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Moreover, the study found that medications accounted for 94 percent of the total cost of care, including hospitalization, for patients with severe hemophilia and 54 percent for those with mild hemophilia. And the PLOS paper noted the market is moving toward preventive care. Meanwhile, Medicare and Medicaid cover about two-thirds of hospitalizations associated with hemophilia.

For this reason, the PLOS authors maintain that the unusual industry promotion raises questions about the extent to which payers are influenced to cover medicines for which there is no scientific evidence of any difference in outcomes among the various medications. And they recommend increased federal funding of comparative effectiveness of hemophilia treatments.

The companies that sell treatments include Pfizer, Novo Nordisk, Bayer, Biogen, and Shire, which recently bought the Baxalta unit spun off by Baxter.

A Novo Nordisk spokesman wrote us that its support programs attempt to fill needs not met through public or private insurance, and its consumer advisory board, whose members are compensated for their time, creates programs for patients. Its educational grant program was administered by third parties and available to any patient, regardless of their treatment. And a coloring book given to children helps them understand the disease and how to talk about bleeds.

A Bayer spokesman wrote us that the company “adheres to a strict code of conduct that governs all interactions with patients, health care providers, payers, and other external parties.” He added that Fugh-Berman has served as a paid expert witness for plaintiffs in lawsuits filed against drug makers over marketing practices, which she disclosed. We should also note that another of the PLOS authors, Philip Kucab, serves on the Multidisciplinary Advisory Board for Bayer. The Bayer spokesman later wrote us to say this board has not met for more than a year.

A spokesman for Biogen, which plans to spin off its hemophilia business, sent us this: “To help us better understand the hemophilia community and its needs, many of [our community relations team] has previous experience in this disease area including, in some cases, direct personal experience.  We’ve carefully created these positions to ensure that all their activities are conducted in adherence to applicable laws, regulations, and appropriate guidelines, and encourage patients to keep an open dialogue with their own health care teams.”

A spokeswoman for the National Hemophilia Foundation, a leading patient advocacy group, told us that NHF, “under no circumstances, recommends particular treatment for specific individuals, and in all cases recommends that people with bleeding disorders consult their physician or local treatment center before pursuing any course of treatment. NHF does not advocate to payers or legislators for any single product.”

A spokesman for Shire wrote that the company is “firmly committed to compliant patient relationship practices and have stringent ethical polices for how we engage with all members of the hemophilia community. We strongly believe that engaging with patients in a compliant and educational manner enables them to become more active and informed participants in their care.”

A Pfizer spokesman wrote us that all applications for its scholarship program, which began in 1997, are sent to “independent third-party reviewers” through a public relations firm that aggregates and collects the information “to ensure an unbiased review of every application based on merit.” And its patient assistance program provides “eligible patients” with various services, including insurance counseling, co-pay assistance and access to medicines for free or at a reduced cost.

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  • If I had a child with hemophilia I would want by loyalty bought and paid for with a any company that manufactured safe synthetic clotting factors, which are expensive to make. Or perhaps to save money and avoid the appearance of being “bought off” we should return to the days of yesteryear where commercial clotting factors were obtained from the pooled plasma of paid donors, about half of whom were HIV positive.

  • Hemophilia is a rare condition, frequently not understood or treated properly except, for the most part, at the approximately 140 federally designated Hemophilia Treatment Centers (HTCs) in the United States. These HTCs are often understaffed and underfunded and/or under-supported by their parent institutions. With this in mind, is it exceptional that pharmaceutical manufacturers step in to fill a void and also market their products, especially when patients frequently need to be educated so they can advocate for their proper treatments when needed? This is a difficult ethical situation, although the excesses have been gradually reduced somewhat over the last few years.
    Note that there are also scholarships for people with other conditions, such as cancer, sickle cell disease, etc., administered through disease-based foundations, along with co-pay assistance programs, free trials/samples and quick-start programs, patient education booklets, etc., also. So, the question is: do pharmaceuticals approach patients with these and other chronic and/or high cost conditions like they do in Hemophilia/Bleeding Disorders? I think not, although there are increasing numbers of consumer conferences, for example, Brain Tumors, Multiple Myeloma, etc, and I am certain that pharmaceutical reps attend these to spread the word about their products to consumers.

    • Its nice to see a reply from someone familiar with hemophilia treatment and the hemophilia community. Because hemophilia treatment centers are underfunded and understaffed, much of the educational material and “extras” provided by pharmaceutical companies, as well as home health care companies, fills important gaps. When the educational materials are provided to hemophilia treatment centers to make available to their patients, when people with hemophilia can apply for scholarships or other assistance programs through a third entity that keeps their identity private, or when assistance is offered whether or not the person uses that companies medication — that can be very helpful. However, when these pharmaceutical companies contact hemophilia families directly, things get pretty potentially unethical, and certainly inappropriate and “sticky.”

  • You couldn’t be more wrong. There is nothing wrong with the way these companies market. We ask them to do it.

    • Hi Josh,

      Thanks for the note. And I understand your point. I’m familiar with the reasons for, and reactions to, the marketing beyond what was noted in the PLOS paper. There are different perspectives, of course, on the extent to which the marketing is, nonetheless, appropriate. I highlighted what the researchers believe is problematic.

      That said, I’ve asked the lead researcher to consider responding directly, since it’s her name on the paper. Hopefully, she will reply.

      Regards,
      ed

    • Factor manufacturers are happy to fund anything the hemophilia community asks for. Whatever they spend is a bargain because it buys silence from the community on high factor prices, lack of comparative effectiveness research and other issues for which unconflicted advocates would be demanding action.

  • It may cost up to $1000/week/camper for these medical specialty camps although families are charged a fraction of the cost while the balance is subsidized by the national foundation. Being able to defray the costs and thus send more kids to camp by partnering with a pharmaceutical company- I don’t see a problem.

    • It’s well-established that exercise and fitness reduce hemophilia bleeding events.

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