Archives of Internal Medicine: Transparency – Lack of Patient Interest Interpreted to Mean More Need for Regulation

While the Archives of Internal Medicine tackles important public health issues such as the chocolate consumption of depressed individuals. (Apparently depressed individuals eat more chocolate).  They also take time to focus on industry relationships with health professionals.

Archives recently published an review article and accompanying editorial on “The Impact of Disclosing Financial Ties in Research and Clinical Care,” they discuss that despite a lack of usable evidence that “An overwhelming body of evidence shows that financial relationships between physicians and drug and device companies are ubiquitous in medicine today” they have the answers to unanswered questions.

The systematic review article attempts to gain more knowledge about patients’, research participants’, or journal readers’ attitude toward financial ties (FTs). 

The authors reviewed original studies of patients’, research participants’, or journal readers’ views about FTs to pharmaceutical and medical device companies. Of over six thousand articles on the subject, they were only able identify 244 potentially eligible abstracts and of those only 20 met their inclusion criteria (reporting quantitative data), all of which used survey research with relatively small sample sizes, and few studies utilizing survey respondent randomization.    In fact, the authors note that the study did not do a quantitative synthesis of the data largely because the studies all asked very different questions.

 

Additionally, the research was particularly weak because it used findings that had extremely large ranges. For example, although studies showed that research equity ownership was the most important FT to disclose, it ranged from 28% on phone surveys  to 67% from an internet survey.

 

Accordingly, this data was hardly an authoritative source to make generalizations from.  Of course this did not stop them from doing so anyway despite the fact that their data failed to match their conclusions.

 

The weakness of this data and research was also discussed in an editorial by Eric Campbell, Ph.D, who noted that “public reporting of quality data will require extensive research to figure out exactly what information consumer’s need to have and how this data should be made available.” He further recognized that “it will not be easy” to collect and present industry relationship data in a way that will make such judgments possible. With this kind of doubt being placed on the research itself, and such a small and unreliable set of data, it is no wonder that the authors selectively chose data to portray a negative association with FTs.

 

Findings

 

A closer look at the data reveals that “patients were more likely to view personal gifts to physicians as unacceptable, compared with professional gifts.” For example, various studies showed that less than 10% of people thought drug samples were unacceptable. In fact, a 2009 study of 903 patients contacted by telephone, 9% disapproved of physicians receiving free drug samples. As professional gifts, drug samples allow doctors to test treatments on patients to gauge their effects and patients preferences, which is probably why so many people do not view them as unacceptable.

 

In a survey of cancer trial participants conducted in 2006, researchers found that researcher equity ownership was most often judged unacceptable (27% of patients), followed by patent royalties (23%) and speaking and consulting (13% each). In other words, only about one quarter or less of patients had a problem with researchers partaking in the activities previously listed.  In fact these activities are seen as a positive by an overwhelming number of patients.

Seemingly, with the number of people waiting for cancer treatments, and the timely and expensive process it takes to make such treatments, it should come as no surprise that the other three quarters find it acceptable for researchers to engage such activities—probably because they know collaboration will lead to results quicker, and a longer and healthier life.

 

This kind of support for collaboration between physicians, researchers and industry could also be seen in the same study by the fact that only 34% of respondents believed equity ownership should be prohibited in institutions. Additionally, fewer thought per capita payments (17%) and patent royalties (21%) should be prohibited. The notion that patients are concerned about FTs seems to go against what one study found, where only 7% of participants were “worried” by researcher FTs when presented with a 4-point scale (“very worried” to “not worried at all”).

 

Another study showed that only 23% of respondents thought lunch was an unacceptable personal gift—try telling that to restaurants in Boston. With over 75% feeling lunch is acceptable, patients must be seeing the value that doctors get from meeting with companies to discuss clinical data, research, and new treatments so that doctors can stay up to date.

 

With regards to disclosure, a 2009 study showed that approximately 80% of patients believed that disclosure would lead to increased confidence in their physician’s decisions and would help patients make better decisions about their care. On the other hand, one study in 2009 showed that only 27% of patients believed it was important to disclose “any FT.” Once again, the mixed results are hard to compare.

 

The authors noted that none of the studies assessed the impact of physician FT disclosure on patients’ willingness to receive clinical care. In other words, there was no research conducted to see whether a FT disclosure changed the mind of a patient to participate in a clinical trial. Interestingly though, the authors found that despite FTs, if clinical trials helped patients, they were willing to participate in them regardless.

 

One problem in measuring willingness was due to the difficulty of comparing patient populations ranging from outpatients with chronic diseases to patients with cancer enrolled in clinical trials. As a result, the authors noted that in clinical settings, the impact of disclosure on patient decision-making was less clear.

 

Discussion

 

While the push for transparency has grown over the years, the recent passage of the Sunshine Act and companies disclosing payments has given patients access to a lot of information.

 

If patients and research participants are truly able to distinguish between different types of FTs as well as the relative importance of disclosure of each, the new system of transparency will provide more trust between patients and doctors.

 

In fact, when clinical care physicians disclose information about financial incentives in their managed care plans, there is evidence that trust is unaffected or may even increase, according to the study. This means that disclosure of FTs with industry might strengthen their relationship with their provider.

 

Conclusion

 

The problem with this study was that it created an ascertainment bias.  The researchers selected what they wanted to analyze, and, they claim to have found what they were looking for, despite the fact that they did not.

 

What is more problematic is that they use this contradictory evidence to suggest that  because patients think  financial ties increase costs of care, and decrease quality of care, it therefore must be the case. This claim is not supported by any real or substantial evidence from this ‘study and even the editorial on the study predicts the need for future research. (Hope for a stimulus package for Eric Campbell and other anti innovation researchers).

 

The editorial reveals their ultimate goal “Public disclosure is a first step toward a more active role by government and health care institutions in evaluating and managing physician-industry relationships”  and companies “may well see this as the slow death of of the current model of marketing drugs and devices to physicians by plying them with gifts, meals, trips ect…” (with the exception of meals for talks on their drugs, paid gifts and trips are a thing of the past)

 

Consequently, the authors noted that “most research participants were not concerned about physician FTs with industry, with as few as 7% reporting concern in one study.” With such a small number of patients concerned with FTs with industry, more research is obviously needed before these types of claims can be taken seriously.

 

P.S.  Occasionally reading these endless diatribes twisting every word to describe our industry as evil, I can succumb to bouts of depression.  Perhaps I should eat more chocolate.