Drug Makers Are Patient Advocacy Groups' Biggest Donors

Iowa Senator encourages other patient groups to publicly disclose the extent of their pharmaceutical income

Gardiner Harris for The New York Times (10/22/09)

Hmm... why does this all sound like some big déjà vû?

The close ties between the alliance and drug makers were on stark display last week, when the organization held its annual gala at the Andrew W. Mellon Auditorium on Constitution Avenue in Washington. Tickets were $300 each. Before a dinner of roasted red bell pepper soup, beef tenderloin and tilapia, Dr. Stephen F, president of the alliance’s board, thanked Bristol-Myers Squibb, the pharmaceutical company.

“For the past five years, Bristol-Myers has sponsored this dinner at the highest level,” Dr. F said.

He then introduced Dr. Fred G, chief of antiviral research at Bristol-Myers, who told the audience that “now, more than ever, our enduring relationship with the AIDS foundation must remain strong.”

Documents obtained by The New York Times show that drug makers have over the years given the HIV health alliance — along with millions of dollars in donations — direct advice about how to advocate forcefully for issues that affect industry profits. The documents show, for example, that the alliance’s leaders, including Mr. F, met with Gilead sales executives on Dec. 16, 2003.

Slides from a presentation delivered by the salesmen show that the company urged the alliance to resist state efforts to limit access to HIV drugs.

“Solutions: Play Hard Ball,” one slide was titled. “Hold policy makers accountable for their decisions in media and in election,” it continued.

The alliance’s own slides concluded by saying, “We appreciate Gilead’s strong support of our work.”

Mr. F said that the alliance frequently had such meetings and that the organization would fight for better access to mental health drugs “even if we had no relationship with pharmaceutical companies.”

...

Drug makers are natural allies in these pursuits since cures may come out of corporate laboratories and the industry’s money can help finance public service campaigns and fund-raising dinners. But industry critics have long derided some patient organizations as little more than front groups devoted to lobbying on issues that affect industry profits, and few have come under more scrutiny for industry ties than the mental health alliance.

Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry’s influence on the practice of medicine.

Mr. Grassley’s scrutiny has been unnerving for patient and disease advocacy groups, which are often filled with sincere people who are either afflicted with serious illnesses themselves or have family members who have been affected. Many join the groups in the hope of making sense of their misfortune by helping to find a cure or raising awareness of a disease’s risks and frequency.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private.

But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.

Even the group’s executive director, Michael F, said in an interview that the drug companies’ donations were excessive and that things would change.

“For at least the years of ’07, ’08 and ’09, the percentage of money from pharma has been higher than we have wanted it to be,” Mr. F said.

He promised that the industry’s share of the organization’s fund-raising would drop “significantly” next year.

“I understand that our patient research and advocacy group gets painted as being in the pockets of pharmaceutical companies, and somehow that all we care about is pharmaceuticals,” Mr. F said. “It’s simply not true.”

Mr. F said Senator Grassley’s scrutiny, which he described as understandable given the attention paid to potential conflicts of interest in medicine, had led his organization to begin posting on its Web site the names of companies that donate $5,000 or more. And he predicted that other patient and disease advocacy groups would be prodded by Mr. Grassley’s investigation to do the same.

“Everyone I talk to wants to have more balanced fund-raising,” Mr. F said.

In a statement, Mr. Grassley praised the alliance for its disclosures. “It’d be good for the system for other patient groups to do what NAMI has done,” he said.

...

For years, the alliance has fought states’ legislative efforts to limit doctors’ freedom to prescribe drugs, no matter how expensive, to treat mental illness in patients who rely on government health care programs like Medicaid. Some of these medicines routinely top the list of the most expensive drugs that states buy for their poorest patients.

Mr. Fitzpatrick defended these lobbying efforts, saying they were just one of many the organization routinely undertook.

Thai ALVAC-AIDSVax study published in NEJM this week.

From accompanying editorial (Raphael Dolin):

"The most important contribution of the study is most likely the opportunity to investigate possible host-response correlates of protection against infection. The establishment of such correlates is the central question in HIV vaccine development and will have a profound effect on the designs of vaccines andclinical trials to assess their efficacy.

Given the lack of detection of conventional immune responses in earlier studies of these vaccine components, as well as the divergence between the vaccine's effect on the infection and the effect on viral load, the correlates of protection may, indeed, reflect new concepts of host response. This should be the focus of intense research using the most current research techniques. Ultimately, it is the results of such studies that will most likely determine the significance of this clinical trial to the field of HIV vaccine development."

Kudos to Dr. Bob Siliciano and his Hopkins team for their persistence in pursuing this reservoirs issue

(Even if it is said that top retrovirologists view the eradication grail as unlikely ever to succeed)

Journal of Clinical Investigation (10/01/09)

From the Discussion section:

"Because of the high cost and potential toxicities of long-term HAART and the disappointing results from the clinical trials of HIV-1 vaccines and microbicides, there is still a pressing need for pursuing the goal of eradication.

To cure HIV-1 infection is exceptionally challenging and will likely require combining HAART with agents that can purge latent virus.

The identification of 5-hydroxynaphthalene-1,4-dione (5HN) not only expands the number of classes of latency-reversing agents but also demonstrates the possibility of utilizing pathway(s) further downstream of TCR stimulation to avoid global T cell activation.

Although the toxicities of 5HN raise concerns for its clinical application, this is a proof of concept for this approach to finding novel strategies to reactivate latent HIV-1 without inducing global T cell activation."