Clinical News Roundup: Should Patient Advocacy/Private Funds Connection Raise Concerns?

By Ed Miseta, Chief Editor, Clinical Leader

Nearly two-thirds of nonprofit patient advocacy organizations (PAOs) receive private-sector funding to support their initiatives, according to a report by the Cleveland Clinic published in the Journal of the American Medical Association. Patient Engagement HIT reports this is raising questions about transparency and conflicts of interest.

PAOs play a role in shaping the overall patient experience as well as advising patients and families in managing chronic or terminal diseases. Additionally, they create patient education opportunities, shape policy decisions, promote disease awareness, and influence research programs. This leads many to believe there may be a transparency issue, as donations can influence the bottom line of many of these groups. 

In order to carry out these activities, PAOs rely on donations, including from entities within the private sector, says a team of researchers led by Cleveland Clinic bioethicist Susannah Rose, PhD. However, very little is typically known about this funding, raising questions about conflicts of interest and the influence benefactors may have over the PAOs they support that may in turn affect patients.

“Patient advocacy organizations need to secure financial support, which may come from many sources, including for-profit entities,” Rose and colleagues explained. “However, relationships between PAOs and industry might influence PAOs’ activities in ways that might not align with the interests of the constituencies they represent. There is increasing evidence that financial relationships can create bias in medical research and physicians, and PAOs may be subject to the same concerns.”

There are no formal methods for tracking donation information, making it more difficult to assess and mitigate potential conflicts of interest. According to the researchers, PAOs do not regularly or publicly disclose their benefactors and other sources of funding. Specifically, this information is missing from organization websites, annual financial reports, and 990 tax forms.

FDA Responds To Patient Diversity Article

A recent article on hurdles minority patients face in clinical trials, featured in the New York Times, solicited a response from an unexpected source: Robert Califf, commissioner of the FDA, and Jonca Bull, director of the FDA’s Office of Minority Health.    

“The Food and Drug Administration is responsible for ensuring that clinical trials of regulated medical products adequately reflect the patients likely to need them,” read the letter to the editor, which appeared on January 18, 2017. “Congress directed us to take action. We focused on three critical priorities — improving data quality, increasing participation and adding greater transparency — which are already yielding results.”

As an example, the letter notes updated guidance provides greater clarity to the pharmaceutical industry on the expectations for enrolling clinical trial participants who reflect the affected populations with regard to age, gender, race, and ethnicity. Califf and Bull note that although progress has been made, it is not enough.

“We are working with public and private partners to increase diversity in clinical trials and ensure that the medical products the F.D.A. approves are aimed at the specific needs of the patients who most need them,” adds the missive.

HHS Rules Hope To Protect Trial Participants

The outgoing Obama administration finalized new rules to better protect individuals who voluntarily participate in federally funded clinical trials. The Hill reports the rule from the Department of Health and Human Services (HHS) and 15 other government agencies updates regulations drafted in 1991. Those regulations require participants be given consent forms up front that clearly explain the purpose of the research, the risks involved, and any alternative treatments that might be beneficial.

The HHS removed a provision it first proposed in 2015 that required researchers to get a patient’s consent before using their non-identified biospecimens such as blood, plasma and urine, and decided in the final rule only to cover federally funded clinical trials.

“Over the years, many have argued that consent forms have become these incredibly lengthy and complex documents that are designed to protect institutions from lawsuits, rather than providing potential research subjects with the information they need in order to make an informed choice about whether to participate in a research study,” said Dr. Jerry Menikoff, director of the HHS Office for Human Research Protections. “We are very hopeful that these changes and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants.”

The final rule is set to take effect on Jan. 19, 2018.

2016 Sets Record For VC Funding Of Mobile Health Apps

Health IT venture funding came roaring back to life in 2016 after a slight dip in the previous year, according to a new report from market intelligence firm Mercom Capital Group. And mobile health apps drew in more cash than ever before.

Forbes reports total global healthcare IT funding crossed the $5 billion mark (not including bioinformatics or medical devices) while mobile health raised a record $1.3 billion. Volume swelled, too, with 622 deals completed in 2016 compared with 574 deals that raised $4.6 billion in 2015.

Right behind the mobile health market, wearable sensor companies raised $592 million, data analytics firms raised $574 million, and telemedicine companies raised $528 million. While the report is global in scope (encompassing 35 different countries), health IT VC was strongest in the United States, which comprised $3.4 billion of funding out of the $5 billion total across 431 deals.

The biggest players in this healthtech VC cash bonanza were Khosla Ventures, GE Ventures, and BlueCross BlueShield Venture Partners. The three biggest rounds of the year went to the Chinese medical service mobile app [Ping An Good Doctor] ($500 million Series A), telemedicine app Chunyu Yisheng ($183 million), cancer big data form Flatiron Health ($175 million), activity tracker Jawbone ($165 million), and the women's health-centered social platform Meet You ($151 million).

For Positive Trial Results, Does It Pay To Follow The Money?

Are pharmaceutical industry financial ties linked to positive outcomes in clinical trials? A new study has found links between medical researchers' financial ties with pharmaceutical companies and "positive" results in clinical trials. The study was published in the British Medical Journal and completed by researchers at several United States' universities.

The study brings more light to the broader debate surrounding financial ties between the pharmaceutical industry and researchers conducting studies, doctors prescribing such drugs, and patient advocacy groups lobbying for approval of new medicines. While financial ties are common, concerns remain about the influence of industry on study design, methods, results, and interpretations; and results from previous studies of such ties have been conflicting, triggering this latest research paper.

The study examined 195 clinical trials published in 2013 for any "association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug" and the trial's outcomes, after accounting for the sources of research funding. It focused on drug trials that centered on efficacy, or the effectiveness of a particular drug. As such, trials had a larger impact on clinical practice and healthcare costs.

The research found 67.7 percent (132) of those clinical trials examined had financial ties between the principal investigators on the trial and the wider pharmaceutical industry. Of 397 "principal investigators" on the trials studied, 58 percent (231) had direct financial ties to the industry while 42 percent (166) did not.