Pharmaceutical Industry Influences Practice and Guidelines

Larry Hand

September 14, 2012

September 14, 2012 ( UPDATED September 20, 2012 ) — Individuals with financial conflicts should be excluded from involvement with medical practice guideline writing, regardless of disclosure, and physicians should be discouraged from meeting with drug company representatives, according to an article published in the September/October issue of the Annals of Family Medicine.

Linda M. Hunt, PhD, from the Department of Anthropology, Michigan State University, East Lansing, and colleagues analyzed the management of patients with type 2 diabetes and hypertension in 44 primary care centers in Michigan during 2009 and 2010. They conducted interviews with 58 physicians, nurse practitioners, and physician assistants, observed 107 clinical consultations with 12 clinicians in 6 clinics, and interviewed 70 patients treated by those 12 clinicians.

Sixty-two (89%) of the patients said they took multiple medications, with 36 (51%) of the 70 taking 5 or more medications, which is a threshold commonly used to define polypharmacy. Such medication use reflects a US trend of prescription drug use that has increased 6-fold since 1990. Adverse drug reactions reported by the Food and Drug Administration tripled between 1995 and 2005, the researchers write. In addition, lower diagnostic guideline criteria introduced over the years has resulted in an increase in the number of people diagnosed with and being treated for chronic diseases such as diabetes and hypertension, and even prediabetes, they write.

"We noted a common scenario: patients began medications after having moderately elevated test results (often at levels considered normal just a few years ago), developed additional symptoms, were found to have values falling outside reference ranges on other tests, and were prescribed more drugs," the researchers write. "They were expected to continue these medications permanently: their target laboratory levels could be achieved only through continued use of these drugs."

The clinical consultations the researchers observed "focused heavily on" medication prescriptions with little or no discussion of other treatment paths including diet and exercise, the authors write.

Of the 58 clinicians involved, 39 (67%) said they relied on clinical guidelines when prescribing, and only 4 (7%) questioned the clinical soundness of guidelines. All clinicians reported prescribing combinations of at least 2 drugs for hypertension or diabetes, and 25 (43%) often combined 3 or more drugs. "Furthermore, once a patient has a diabetes diagnosis, the goal numbers for hypertension and cholesterol are lower, so additional medications will be prescribed, quickly multiplying prescriptions," the researchers write, saying this illustrates a so-called "prescribing cascade."

Heavy Marketing by Pharmaceutical Companies

The authors also note that clinicians are exposed to heavy marketing efforts by pharmaceutical companies, and that this, combined with pay-for-performance programs, may be contributing to the emphasis on medication prescriptions. Of the 53 clinicians willing to discuss pharmaceutical marketing, 38 (72%) reported having regular contacts with pharmaceutical representatives, with 33 (62%) of these clinicians seeing 10 representatives weekly and 41 (77%) finding the representatives' information useful.

The 70 patients in this study were taking an average of 4.8 medications, with 42 (60%) taking medications for disorders in addition to hypertension or diabetes, and 24 (57%) of those patients "taking additional medications for respiratory or gastric symptoms — well-known adverse effects of hypertension and diabetes medications," the researchers write. Almost 70% (47) of the patients said they had experienced symptoms of adverse drug reactions from diabetes or hypertension medications, yet all but 1 physician in the study mentioned prescribing fewer drugs, most concentrating on either adding or changing prescriptions.

Patients also voiced many concerns about affordability of such medication prescriptions.

In addition to influencing clinicians' decisions, pharmaceutical companies may also have influence on the establishment of guidelines physicians consult when making medication decisions, the researchers write. "[T]he committees and organizations setting the standards often have substantial pharmaceutical industry support and include many individuals with industry ties," the researchers write.

At a minimum, they write, such industry-tied individuals should be excluded from guideline writing, physicians should be discouraged from seeing industry representatives, and pay-for-performance programs should be monitored for "evidence of unintended negative effects on patients."

They conclude, "Together, these policy changes may slow the disturbing trends our findings illustrate."

In an interview with Medscape Medical News, Kenneth Thorpe, PhD, chairman of the Partnership to Fight Chronic Disease, praised some of the study's findings, saying they provide, "more proof of...the silos in which the current system operates and how that fragmentation fails people coping with chronic conditions."

However, Dr. Thorpe continued, "I believe that the research for the article is observational and small in nature, and the article includes a fair amount of speculation and conjecture, as the authors acknowledge. Despite those limitations, the conclusions they draw are sweeping. I do not agree that answers lie in shutting off information and communication; we need more of both."

Dr. Thorpe acknowledged that diabetes and high blood pressure are primarily related to personal behaviors and that lifestyle changes are important in preventing and treating those conditions. "[B]ut for many [patients this is] not the only solution — medications also play an essential role in slowing or preventing disease progression and helping patients avoid disease complications. For example, research on diabetes has shown that each 1% drop in blood glucose control lowers the risk of nerve damage–related complications by more than 40%. Too few people achieve the recommended levels of blood glucose control and blood pressure control, for that matter, without using medications."

Dr. Thorpe continued, "With medications, the emphasis should be on appropriate use: making sure the patient is prescribed the right medicine or medicines for her, at the right doses, and for the right duration to achieve both clinical improvements and [feeling] better. Studies evaluating the effectiveness of comprehensive medication management, for example, have shown significant results in resolving polypharmacy issues and improving the quality of outcomes for patients with chronic diseases."

Regarding the composition of guideline committees, Dr. Thorpe said, "When developing medical guidelines you want the best, credible information available and to have that information vetted by leading medical experts in the field. Conflicts of interest, financial and otherwise, certainly should be considered in the selection of experts to develop and review medical guidelines, but some balance is needed to avoid issues of undue influence without excluding the leading experts in a particular medical field."

This study was supported by a grant from the National Institutes of Health, National Center for Human Genome Research. The authors have disclosed no relevant financial relationships. Dr. Thorpe serves as a consultant to Vivus.

Emerg Infect Dis. 2012;10:452-460. Full text

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