Who benefits from treating prehypertension?BMJ 2010; 341 doi: http://dx.doi.org/10.1136/bmj.c4442 (Published 24 August 2010) Cite this as: BMJ 2010;341:c4442
When health authorities in the United States were developing new guidelines for the treatment of hypertension in 2003, they decided to create a new diagnostic category. The new category would not be used to diagnose sick people; rather it would label those people whose blood pressure was towards the upper reaches of normal. The problem was what to call this new entity: should it be borderline blood pressure, high normal, or perhaps prehypertension? That’s when market research came to the rescue. “We did focus groups to solidify which one would resonate most with the public,” says George Bakris, professor of medicine at the University of Chicago and a member of the committee that described the new entity. “Prehypertension was a clear winner so we went with that.”
The 2003 guidelines made clear that prehypertension was “not a disease category.”1 Rather it was a new classification for people with normal systolic blood pressure levels of 120-139 mm Hg or diastolic blood pressure of 80-89 mm Hg. The justification for creating it was simple. The higher the blood pressure, said the guideline writers, “the greater is the chance of heart attack, heart failure, stroke, and kidney disease,” while the risk of death and disease “increases progressively and linearly” from within the normal range. They were also clear that people labelled prehypertensive should not be treated with drugs but urged to adopt lifestyle changes to reduce their risks.
Global goldmine or useful classification?
Yet in the wake of the classification—and estimates that up to one in three adults has prehypertension (more than 50 million people in the United States alone)—the new entity is looming large as a possible goldmine for the drug industry. Organisers of a major international conference on prehypertension and cardiometabolic syndrome planned for Vienna next February claim baldly that “pharmaceutical companies are active in testing the place of novel antihypertensive drugs on patients with prehypertension.”2
One of the aims of the Vienna conference is to honour Stevo Julius, active emeritus professor of medicine at the University of Michigan, who has been working on prehypertension for more than three decades. “It’s my life’s work,” he says, describing hypertension as a self accelerating disease. “Waiting to see if a patient will develop hypertension, and recommending non-pharmacological treatment, is not likely to affect the public health problem of hypertension.”
Professor Julius is not part of the team organising the Vienna meeting; nor is he helping to raise funds for it, but he was the lead investigator of one of the first trials of drug treatment for prehypertension, published in 2006.3 The feasibility study included around 800 patients with blood pressure just below levels classified as hypertensive. Its results suggested that taking candesartan for two years could modestly reduce the chances of developing hypertension. Some have criticised its methods and questioned its results,4 but Professor Julius stands by the findings. Of the 11 authors of the published study, seven declared multiple ties to drug companies and one was an employee of Astra-Zeneca, the maker of candesartan. Professor Julius, the paper’s lead author, declared financial relationships with four drug companies, and another author disclosed ties to 15 drug companies.
Stressing that his 2006 paper did not recommend drug therapy, Professor Julius says he wants to see much bigger trials conducted among people with prehypertension to assess whether drugs can prevent the harmful consequences of hypertension. Ideally such trials would be run by volunteers from professional societies rather than companies, which he believes are unlikely to fund the long term studies required. So in his view, should prehypertension be called a condition? “I don’t know,” he answers.
Others are more certain about their answer. “I don’t use the word. I don’t like it. It’s a pseudosyndrome,” says Jay Meltzer, a hypertension specialist and emeritus professor from Columbia College of Physicians and Surgeons in New York. “These are healthy people, coming in to their doctor’s offices not feeling sick and being told they have a new disease. It’s outrageous.” Professor Meltzer has argued that the candesarten study did not prove the drug was beneficial.4 He also points out that the committee that first described prehypertension in 2003 was heavily populated by experts with financial ties to the drug industry. He believes that many people classified as prehypertensive will not develop hypertension, so treating them could do more harm than good. In his view the Vienna conference in February is a “terrible idea” because there is a danger of “creating a hundred million new patients, as targets for drug treatment.”
The conference is being organised by a Geneva based company called Paragon Conventions, whose spokesperson confirmed sponsors would include drug companies. Its latest call for abstracts—sent to doctors around the world, including Professor Meltzer— offered those submitting abstracts the chance to receive a “special award” during the conference. Chair of the committee organising the Vienna conference is Reuven Zimlichman, vice dean of Tel Aviv University Medical School, who has no financial ties to the drug industry. He says sponsors will have no say in the content of the conference and that the aim is to start the development of treatment guidelines for prehypertension, which will in turn be sent to professional associations like the American Society for Hypertension for possible endorsement.
The first international conference on prehypertension was originally being organised by another convention company to take place in Prague in 2008, but it had to be cancelled because the company couldn’t raise enough funding. Professor Zimlichman is hopeful of securing major sponsorships for the Vienna conference but says it will go ahead even without it. “We will have the conference anyway,” he said, but “maybe with fewer coffee breaks.” He says the gathering will help solve the dispute over whether to treat patients with prehypertension. Asked about his current views on this dispute, he says that if a patient has prehypertension and other risks seen as part of the metabolic syndrome, then they “probably have to be treated.”
Critics claim it’s not a condition
“It’s not a condition,” says Curt Furberg, professor of public health at Wake-Forest University. “It’s a way of increasing markets for pharmaceutical companies.” Although people with blood pressure towards the high end of normal are at raised risk of future adverse events, Professor Furberg does not think the level warrants the new classification or the treatment of millions more healthy people. “I don’t see it as a public health problem,” he says.
Professor Furberg was on the committee writing the United States hypertension guidelines in the 1990s, but he resigned after the government authorities overseeing the process refused to require mandatory disclosure of members’ financial ties to drug companies. Ultimately, the growing push for transparency meant such disclosures became inevitable, and when the committee published its guidelines in 2003 creating prehypertension, conflict of interest statements available on the web show that 11 of the 12 members had multiple ties to industry.5 For Professor Furberg, these ties reinforce his view that too many leading health professionals, and their societies and associations, are financially too close to the manufacturers of the products they prescribe.
One of the authors of the 2003 guidelines, Professor Bakris, declared at the time that he had worked as a speaker, adviser, or consultant for 13 drug companies. He told me in July that prehypertension was not a disease entity but could be described as a “diagnostic category” that does not require drugs but lifestyle changes. Arguing that testing the benefits of medicines could be a “potential dead end,” he said, however, that drugs could be tried in people with prehypertension who did not want to adopt lifestyle changes.
Professor Bakris recently became president of the American Society of Hypertension, which like many similar societies has been financially dependent on industry. Of the 13 voting board members listed in the society’s website, nine disclosed ties to drug and device makers in the 2010 annual meeting programme, with its president declaring he has served as a consultant or adviser to nine drug or device companies.6
In the decade before Professor Bakris became president of the society, it was at times wracked by a bitter and complex conflict. One of the battle lines was financial relationships with industry, with one camp calling for tight limits on the ties between board members and drug companies. That call was unsuccessful, but in response to growing public scrutiny of professional ties with industry the society has introduced some modest changes, replacing the tradition of “satellite symposiums” at their annual conference with new “society coordinated symposiums”—these are still funded by sponsors but with speakers and content chosen by society committees. According to a written statement from Professor Bakris, funding for the society will now be sought from a wider variety of sources, including “not only Pharma but the food, beverage, and nutrition industry, as well as other companies, with a commitment to improve the health of our country.”7
Move towards predisease
Whether the creation of the diagnostic category prehypertension is going to improve the health of any country is an open question. It is just one of a growing array of “pre-conditions,” including prediabetes and pre-osteoporosis, generating debates within medicine. Many of the base “conditions” can be regarded as risk factors for future illness, rather than diseases in their own right, suggesting that these new pre-conditions will give a medical label to people who are at risk of being at risk. Over a decade ago David Armstrong, then a doctor at Guy’s hospital in London, described the inexorable rise of what he called surveillance medicine, saying that it is reconstructing the nature of disease so the problem becomes “less the illness per se but rather the semi-pathological pre-illness at-risk state.”8
Until now the definition of what constitutes a condition, or pre-condition, and the guidelines for treating it, have been left largely to senior members of the medical profession and their esteemed societies, often meeting in drug company sponsored forums like the coming Vienna conference. But for people like Professor Furberg, the profession has become too close to industry. He wonders whether it may be time for society at large to take more of a role in deciding who should be classified as sick. Clearly, preventing the devastating effects of heart attack, strokes, and hip fractures is in everyone’s interest, but whether medicalising billions of healthy people with a predisease label is the best way to go requires vigorous debate among a much wider group of voices. How to constitute more independent and broadly representative panels that can deliberate well outside the long shadows of the drug industry, may be a question worth pondering.
Cite this as: BMJ 2010;341:c4442
Competing interests: The author has completed the unified competing interest form at www.icmje.org/coi_disclosure.pdf (available on request from him) and declares no support from any organisation for the submitted work; no financial relationships with any organisation that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work. Ray Moynihan is the author of several books and articles about issues relating to pharmaceutical marketing.
Provenance and peer review: Commissioned; not externally peer reviewed.