Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices or The Rothman’s Efforts to Undermine Public Health
Patients dying of cancer or suffering from diabetes often do not have the means to advocate for more research or treatments to help them survive. Individuals suffering from rare diseases are frequently unable to get treatment because medicines are unavailable or stalled by regulatory tape. Additionally, millions of Americans each day must forego treatment or receive inadequate care because the latest technology and medicines are not covered yet by government programs or insurance companies.
To address the inability of individuals to find solutions for their health problems, Health Advocacy Organizations (HAOs) were created as a way to organize thousands of people concerned with a widespread disease such as diabetes or cancer or with a narrower focus such as Weil Disease. Consequently, HAOs have had a significant impact in helping Americans fight their diseases by pursuing an agenda that includes expanding government support for medical research and the availability of health care services. In addition, HAOs advocate for members’ unrestricted access to all drugs, devices, and diagnostic tools relevant to their health conditions. Helping to push a bureaucratic Food and Drug Administration (FDA) to streamline and approve life saving medication for diseases such as AIDS.
Typically, HAOs conduct campaigns to promote disease awareness, update members about new diagnostic tests and drugs, facilitate physician referrals, deliver health care services, and advocate for policies that they believe are in their members’ best interests. HAO leaders and members testify at congressional and state hearings, lobby legislators, negotiate with regulators, serve on federal advisory panels, and inform the media. As a result, HAOs are among the most influential and trusted stakeholders in US health policy.
While the positive impact HAOs play in improving access to care for patients and advancing treatment for diseases is clear, some are skeptical of HAOs because their positions “closely correspond to the marketing aims of pharmaceutical and device companies: increase product sales.” The concern, according to a recent paper published in the American Journal of Public Health, is that despite “the overlapping interests of HAOs and the pharmaceutical industry, the financial relationships between them have remained relatively unexplored.”
As a result, Sheila M. Rothman and David J. Rothman, et al. from Columbia University, carried out a study to explore the relationships between HAOs and the pharmaceutical industry.
It should be noted that Shelia and David Rothman served as consultants to the Office of the Attorney General of the State of Texas in litigation against Johnson & Johnson related to Risperidone.
The study received funding from the May and Samuel Rudin Family Foundation. It also was funded by the Pew Charitable Trusts (Prescription Project) and the Institute on Medicine as a Profession which receives the bulk of their funding from George Soros. All these organizations are anti-industry and frequently fund research and promote stories to discredit the pharmaceutical and device industry.
Background
In the early 20th century, philanthropic citizens joined with public health officials and civic minded physicians to spearhead campaigns against deadly diseases. Although each organization targeted a specific disease, they allied to advance sweeping social changes. For example, John D. Rockefeller and Jacob Schiff supported the establishment of The National Tuberculosis Association in 1904.
However, the authors believe that “organizations that once served the public interest have now become devoted to their members’ interests.” One reason for this change according to the authors is that companies, not private individuals and charitable foundation, are now funding the campaigns. As a result, they assert that “contemporary HAOs advocate almost exclusively for members’ special interests.”
They point to “AIDS activists who inaugurated the new HAO model in the 1980s. They advocated to make AIDS research a priority; to make experimental drugs available to all AIDS patients, not only those in clinical trials; and to speed up the Food and Drug Administration (FDA) drug approval process for AIDS drugs.” The authors also described theses activists as “confrontational, aggressively picketing the FDA and holding marches and vigils.”
Accordingly, “a circumscribed angle of vision and hard-line tactics soon became the hallmarks of other HAOs, including those focusing on breast cancer, mental illness, and epilepsy. So what exactly is wrong with this kind of approach? Should people remain silent as millions die from cancer and heart disease each year? What is wrong with Americans confronting the government so that people with AIDS and diabetes do not have to suffer? Since the efforts from these groups began:
- The death rate from HIV/AIDS dropped more than 75% from its highest point in 1995
- Since 1970, the death rate from heart disease has dropped nearly 60%
- Deaths from stroke are down 70% since 1970
- The death rate from cancer has dropped 16% since 1990; and
- The average life span of Americans increased from 69.7 years in 1960 to approximately 80 years in 2007.
Methodology
To carry out the study, the authors used Eli Lilly and Company’s grant registry to examine its grant-giving policies. They also examined 161 HAO Web sites to determine their grant disclosure patterns. The authors were able to carry out this investigation because some drug and device companies now report publicly on their Web sites the precise dollar amounts of the grants and gifts they make to HAOs as a result of US Department of Justice criminal prosecutions and state legislative mandates. Essentially, the authors used a ProPublica strategy of publishing Lilly grant payments as an attempt to discredit HAOs who are using such grants to help physicians and patients.
The authors selected Eli Lilly and Company for analysis because the Lilly Grant Registry (LGR) was the first to make its grant registry public in 2007. The Lilly registry identifies the HAOs receiving support, the exact level of support each HAO receives, and provides specific information about the company’s grant-giving policies and practices. The authors examined Lilly’s grant giving and the grants it awarded to HAOs during the first 2 quarters of 2007
Results
Examination of the LGR information revealed that during the first 2 quarters of 2007, Lilly gave over $3 million to HAOs, representing 10.22% of its total grant giving. The funding was closely aligned with the company’s therapeutic areas of interest. HAOs active in Lilly’s 3 main therapeutic areas (accounting for 87% of its total US sales)—neurosciences, endocrinology, and oncology—received 94% of Lilly’s grants to HAOs.
The match of therapeutic area to HAO was not consistent; neuroscience and oncology HAOs received proportionately more grant funds than Lilly’s sales percentages in these therapeutic areas, and endocrinology received less. But overall it was evident that the company targeted HAOs concerned with its areas of therapeutic interest.
Lilly’s grants to HAOs also mirrored its therapeutic areas with the strongest sales. In 2007, Lilly reported annual US net sales over $10 billion. Of this total, 45% came from neurosciences, 31% from endocrinology, 11% from oncology, and 13% from miscellaneous health. During the first 2 quarters of 2007:
- 66% of Lilly’s HAO grants went to organizations concerned with neurosciences.
- 21% of Lilly’s HAO grants went to organizations concerned with oncology.
- 8% of Lilly grants went to HAOs concerned with endocrinology.
Of the 161 sample HAOs that received Lilly funding, 137 (85%) were in neurosciences (n=114), endocrinology (n=6), and oncology (n=17). In terms of geographic scope, endocrinology and oncology HAOs were predominantly national organizations.
Additionally, the authors found that 25% of HAOs that received Lilly grants acknowledged Lilly’s contributions on their Web sites, 18% percent acknowledged Lilly in their 2007 annual report, 1% acknowledged Lilly on a corporate sponsors page, and 10% acknowledged Lilly as the sponsor of the grant event. No HAO disclosed the exact amount of a Lilly grant.
However, it should be noted that HAOs are not legally required to disclose the names of their corporate sponsors and it is doubtful that the Rothman’s did anything more than a cursory review of websites which we all know no matter where you put something on a website the information can be easily overlooked.
Consequently, the authors recognized that “before industry-wide and HAO-wide conclusions are drawn, further research is necessary to establish whether other companies and HAOs fit the patterns described in their study of Lilly.”
Discussion
While the disclosure of grants reflects an intensified commitment to transparency, the use of this information by the authors to suggest that HAOs and industry should be heavily scrutinized is problematic. Without fully explaining the benefits industry grants provide to patients, industry critics such as Dr. David Rothman, who believe that HAOs are operating under a ‘‘veil of secrecy’’ and are dependent on drug company funding, underscore the significant impact HAOs have in the lives of patients and physicians.
First, the grants that Lilly provided are ethical and not related to marketing. Specifically, as the authors recognize, Lilly’s “Principles for Interacting with Health Care Professional Associations’’ states that organizations receiving grants are not ‘‘obligated or directed to use these funds in a manner that benefits the company or its products.’’ But the authors disregard this statement by pointing to the data which show that Lilly funded organizations that covered Lilly’s three main therapeutic areas. However, by taking a closer look at the programs, it is clear that Lilly funded such programs because of the positive impact they have on patients and physician training.
For example, Lilly gave the National Alliance on Mental Illness (NAMI) $450,000 for its Campaign for the Mind of America. The authors are concerned because NAMI advocates for the most severely disabled “to get access to the newest medications such as atypical antipsychotic and anti-depressive agents.” Doesn’t it seem a bit ridiculous that the authors are criticizing an HAO that wants doctors to “utilize the latest breakthrough in medical science . . . without bureaucratic restrictions to the access for life-saving medications?’’
In the area of oncology, Lilly granted the National Breast Cancer Coalition (NBCC), which represents 25 state and national organizations, $50,000 to support its annual advocacy training program. According to the authors, a program such as this undermines public health because of Lilly’s grant. One has to wonder how can this be the case when the NBCC advocates for a ‘‘comprehensive strategy to end the breast cancer epidemic,’’ including greater access to screening, insurance coverage for participation in clinical trials, and expanded Medicare coverage for all oral cancer drugs?
In the area of endocrinology, Lilly granted the American Diabetes Association (ADA) $250,000 for its Cardiovascular Risk Initiative. Does a program that “taught patients and providers strategies for preventing cardiac disease among people with type 2 diabetes, including weight management and better drug use to control glucose level,” sound like something that undermines public health as the authors suggest?
All of these programs above and thousands of others sponsored by pharmaceutical companies are changing the lives of Americans and improving health each day. Just because HAOs are highly effective advocates does not mean their source of support is unethical. Americans want those who have gone through a disease and survivors to advocate for them because they know what it’s like to be a patient and to fight for the research and medicine they need to survive.
Recommendations
The authors believe that HAOs advocacy activities and the level of public trust that they enjoy makes transparency more obligatory. As a result, the authors recommend that HAOs should disclose all corporate grants, including the purpose and the amount because “absent this disclosure, legislators, regulators, and the public cannot evaluate possible conflicts of interest or biases in HAO advocacy.”
They also recommend amending the Sunshine Act provisions in the recently enacted US health reform law, which require companies to report gifts to physicians, to include company payments to HAOs. The authors also want federal income tax regulations to mandate public disclosure of HAO donors and sums on Form 990.
Conclusions
Given that industry has increased its transparency significantly over the past years and made payment information about grants public, using this data in a negative light as the authors do is a waste of time and money. Research should be looking at ways to encourage patient groups and HAOs to work with companies to focus their research and development budgets on diseases and new breakthroughs.
While transparency is important and it should certainly be feasible for HAOs to disclose their corporate grants, the information and data must not be used to discredit the organizations or programs described above that help improve health care for patients. However, that is exactly what Rothman’s article attempts to do. Rothman et al. assert that HAOs lack of transparency in their study is disappointing because they “pursued activities that promoted the sale of Lilly products.” But this claim is overstated. Other than an HAO receiving a grant for a particular therapeutic area that Lilly had, there is no evidence that HAOs “promoted” a Lilly product.
What is really disappointing is that the authors use their anti-industry bias to present the HAO programs as marketing endeavors, when in reality, these programs taught patients and physicians how to treat deadly and chronic diseases, create a strategy to end breast cancer, and to utilize the latest breakthrough in medical science.
In the end, if you were a patient waiting for the newest treatment, device or training to make you healthier, who would you want advocating for you? Would you want the government bureaucrat or anti-industry academic who is more worried about reducing health care costs than saving your life, or would you rather have an HAO and patients who have survived your disease fighting for your life?
Upate
According to Duff Wilson at the New York Times:
In response to this study, Senator Max Baucus, a Democrat from Montana who is the chairman of the Senate Finance Committee, and Senator Chuck Grassley, a Republican from Iowa, who co-sponsored the physician disclosure law with Senator Baucus, said in separate statements that they would consider the suggestions to increase transparency.
Mr. Baucus said in a statement that he would like to “build on” the new law, which requires disclosure of payments to doctors and teaching hospitals starting in 2013. It was adopted as part of the health care overhaul.
Mr. Grassley’s press secretary, Jill Kozeny, said the senator was open to recommendations to expand the disclosure requirements to prescribers, patient organizations, professional societies, group purchasing organizations and pharmacy benefit managers.
None of this is acidential. This is a planned activity by the Rothmans who founded the Prescription Project to expand the scope of the Sunshine Provisions in the Afforadable Care Act. Their answer to how do we stop medical innovation is more government regulation.
Disclosure
Our company the Potomac Center for Medical Education receives grants from Eli Lilly for CME activities. No one at Eli Lilly was contacted in the writing of this article.