Biotech Values

[DewDiligence]

Patients Fear Rapport With Genentech Is in Danger

http://online.wsj.com/article/SB121866949810638715.html

›By MARILYN CHASE
August 14, 2008

While Roche Holding AG's recent bid for Genentech Inc. cheered investors, it had a more chilling effect on the patient advocates who have developed unusually close ties to the pioneering biotechnology company.

Despite contentious battles over the price of the cancer drugs it has developed over the past 15 years, Genentech has invited activists to confer on clinical-trial planning, peek at early study data, and sit in on meetings about manufacturing and pricing strategy. Arthur Levinson, the company's chief executive officer, and other top managers regularly host meetings and lunches with patient groups. Indeed, just days after the Swiss pharmaceutical giant's takeover offer, an advocacy group for colon-cancer patients gathered for a meeting inside the walls of Genentech's South San Francisco campus.

Now activists worry that with Roche poised to acquire the 44% of the company it doesn't already own, their access to Genentech and its leadership is in jeopardy. Yesterday, Genentech announced that its outside directors rejected the $44 billion bid, but they invited a higher offer -- suggesting the company's days as an independent concern may be numbered.

"Genentech has actually gone out of its way to engage conversations with the activist community," says Barbara Brenner, executive director of Breast Cancer Action, a San Francisco advocacy group. "We rarely agree, but at least we can talk to them. I have trouble imagining that will continue if Roche owns the company."

Genentech's rapport with patient advocates is unusual among pharmaceutical companies, and uniquely close, say many advocates. The hard-won relationship was born of a long, fractious history with patients dating back to the early era of AIDS activism. Today, while many drug manufacturers work with patient groups -- for instance, to provide low-cost or free drugs to needy patients -- it is rare for companies to bring patients into the company's culture to the extent that Genentech has.

In part, advocates say, that is because Genentech has been relatively small and nimble, compared with the behemoths of big pharma, where responses to patient inquiries can be slow in coming. In an era where large old-line drug companies are gobbling up small biotechs to feed their pipelines, activists see this move as a broader threat to the influence and access patients have with top drug executives.

"It isn't that big companies are evil and small companies are good. But with big companies, everything moves slower," says activist Robert Erwin, who had battled Genentech in the past over access to a breast-cancer drugs for his late first wife.

For its part, Roche maintains it would preserve Genentech's creative independence and says patients would benefit from an acquisition. "Our relationship with patients would be strengthened by this transaction," a spokesman said in an email statement. "Our combined much larger development organization would facilitate the management of a very broad portfolio of clinical trials, improving patients' access to new drugs." He said it is too early to provide a more specific response.

Beneficial Dialogue

Relations between Genentech and patient groups have often been prickly, but both sides say there have been tangible benefits to the dialogue. The company says input from activists has prompted important changes in the design of clinical trials and helped establish programs to improve access to new medicines. Patient groups say their efforts to recruit patients for Genentech trials and to put pressure on the Food and Drug Administration helped hasten approval of the breast-cancer drug Herceptin -- a boon for the company and patients alike.

"They welcome feedback," says Carlea Bauman, president of the Colorectal Cancer Coalition, the Washington, D.C.-area nonprofit whose board met at Genentech shortly after Roche announced its bid. "Our concern is that [with Roche] we could lose that relationship with Genentech, that give-and-take." Her group gets funding -- $225,000 for its fiscal year ended June 30 -- from Genentech.

Fostering Access to Drugs

The patient-advocacy movement was spearheaded by AIDS patients, whose confrontation with drug companies and the FDA in the late 1980s and early 1990s is widely credited with fostering access to AIDS drugs in advance of their FDA approval -- and saving lives in the process.

In 1994, the San Francisco AIDS activist group ACT UP joined forces with cancer patients to put pressure on Genentech to similarly make the drug that became Herceptin available to desperately ill patients, even though it was years away from the market. After the company turned down Mr. Erwin's request for the drug for his wife, Marti Nelson, who was suffering from breast cancer, the groups laid siege to the company, periodically jamming its fax machines and staging demonstrations at its headquarters, where some protesters chained themselves to doors.

Ms. Nelson died in November 1994 without getting the drug, triggering further demonstrations and an enduring tide of bad publicity. Shortly after a second high-profile patient died the following August, the company announced a policy to provide early access to the drug. Because its supply of the medicine was limited, it worked with activists to set up a lottery system to select patients who would get the drug.

'Unique Insights'

"There were many difficult challenges," says Susan Desmond-Hellmann, now Genentech's president for product development, who handled the early-access talks. "In that moment of inexperience, we [listened]. We faced their anger. We saw they had unique insights...that complement ours."

Says Mr. Erwin: "From this point on, the relationship between Genentech and the advocacy community has steadily improved."

The FDA approved Herceptin in September 1998, just three weeks after an advisory panel recommended the drug -- an unexpectedly fast turnaround by the agency that activists claimed credit for helping to accomplish.

Now, Genentech doesn't wait for protests, but engages activists at scientific meetings and at Genentech's campus. Activists, in turn, often testify at FDA hearings -- frequently helping the company make its case for approval. Mr. Erwin says he believes current FDA leadership now looks favorably on expanded access, perhaps as a result of positive interactions between companies and advocacy groups.

Seeking a Meeting

Even so, Genentech and the activists still battle over prices and other issues. Last January, Breast Cancer Action's Ms. Brenner, a lawyer and breast-cancer survivor, sought a meeting with a Genentech executive on her own turf to discuss her concerns about the company's blockbuster Avastin, then under consideration at the FDA for treating breast cancer.

She says a top oncology official met her at a cafe in San Francisco to hash out issues over the risks and benefits of the drug. She complained that Avastin's high cost -- as much as $100,000 a year -- and lack of significant survival benefit didn't justify its approval. The official argued otherwise. The FDA eventually green-lighted the drug for breast cancer.

High Marks for Openness

Despite the disagreement, Ms. Brenner, whose organization doesn't accept donations from drug companies, gives the company high marks for openness.

Mr. Erwin, who doesn't own Genentech stock and currently gets no financial support from it, says the company's style of engaging the cancer community is different from other companies he has worked with.

The foundation he runs in his late wife's name, as well as other groups, have managed to get early access to the cancer drug Erbitux from ImClone Systems Inc. and Bristol-Myers Squibb Co. But he says there was no rapport established with top management, as there was with Genentech. Another big pharma company recently took several months to answer a request for early access to an experimental cancer vaccine before responding with a "very polite" no, he says.

"They're likely to keep cards close to their vest," he says of such companies.‹


“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”