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As Castellani Takes PhRMA's Helm, Where Does Personalized Medicine Advocacy Stand?

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Originally published Aug. 10.

By Turna Ray

The resignation of Billy Tauzin as the head of the Pharmaceutical Research and Manufacturers of America may be welcomed by those in the drug industry who feel he failed to represent the interests of drugmakers during healthcare reform. However, the former congressman from Louisiana and outspoken cancer survivor will certainly be missed by personalized medicine advocates for his vocal support of their cause.

Upon Tauzin's departure in June, the drug industry trade group named John Castellani, former CEO of Business Roundtable, as its leader. Industry observers have noted that the move from the outspoken Tauzin, also known as the "Swamp Fox," to an insider business lobbyist-type like Castellani represents a shift in PhRMA's advocacy style. Where that leaves PhRMA's backing for personalized medicine, a pet cause of Tauzin's, is hard to determine in the post-healthcare-reform climate in Washington.

"Castellani is very effective as a trade group leader, but I don't know how high personalized medicine will be on the PhRMA agenda," said Robert Goldberg, co-founder and vice president of the Center for Medicine in the Public Interest.

Castellani will begin his term as the CEO and president of PhRMA Sept. 1. He joins PhRMA after more than nine years at Business Roundtable, an association representing the interests of corporate CEOs. Prior to Business Roundtable, Castellani served in leadership positions at Tenneco, National Association of Manufacturers, and TRW. His first job was with General Electric, where he was an environmental scientist.

"Personalized medicine was personal to Tauzin," Goldberg noted. "Castellani doesn't have a personal tie and it will be interesting to see how PhRMA's position will translate into actual support for policies."

Tauzin was a member of the House of Representatives for Louisiana's third district from 1980 to 2005. For most of his time in public office, Tauzin was a Democrat with conservative leanings. In 1995, after the Democrats lost control of the House, Tauzin became a Republican, saying he had long felt marginalized by the Democratic Party for his conservative views.

During his time in Congress, Tauzin chaired the House Committee on Energy and Commerce and backed the Medicare Prescription Drug Bill, which critics said heavily favored the pharmaceutical industry. After being diagnosed with stomach cancer in 2004, Tauzin left Congress to join PhRMA.

As a lobbyist for one of the most powerful industry groups on Capitol Hill, Tauzin pushed for lifting barriers to drug development, urged for increased incentives to industry for research and development, and supported policies to delay entrance of generic drugs to market. In every advocacy effort, Tauzin always recalled the story of his battle with cancer, where he spotlighted the role of researchers, doctors, and most importantly, the work of drug companies in developing innovative and targeted cancer drugs, such as Gleevec.

"I have a very personal reason to be deeply grateful to the thousands of men and women who work every day to bring these new medicines to patients. Because I too have been a patient," Tauzin told the Senate Committee on the Judiciary during a 2007 hearing titled, "Paying off Generics to Prevent Competition with Brand Name Drugs."

"Today, with support from family and friends and the help of some amazing doctors and nurses, I am now a cancer survivor. I also know that I would not be here now without the help of the innovative medicines made by America's research-based biopharmaceutical companies," Tauzin said at the hearing. "Because of those medicines, I am cancer free and living a healthy, full life."

Gleevec, developed by Novartis and approved by the US Food and Drug Administration as a treatment for chronic myeloid leukemia ten weeks after submission, was often upheld by Tauzin as an example of the drug industry's innovative power and contribution to the healthcare system. Gleevec, an inhibitor of the tyrosine kinase enzyme ABL that is also a treatment for gastrointestinal stromal tumors, represents one of the early examples of personalized medicine and "rational drug development" through high-throughput screening.

While Tauzin was at PhRMA, the lobbying group put its name behind personalized medicine efforts such as the Biomarker Consortium and the FDA's Critical Path Initiative, projects that envisioned an era of molecularly-guided medicine while drug developers were saying that pharmacogenomics wasn't ready for prime time.

Pharmaceutical companies, once seen as averse to applying pharmacogenomic strategies to develop agents that benefit small subpopulations of patients, have recently begun focusing on gene targets as a mainstay of their drug development strategy. Most big drug firms have embraced PGx strategies just as blockbusters such as Lipitor and Plavix are about to lose patent protection and as much as $142 billion worth of drugs are slated to face generic competition in the next five years.

"PhRMA’s support for personalized medicine … has been growing in keeping with the industry’s increased commitment to and investment in targeted therapeutics," said Ed Abrahams, President of the Personalized Medicine Coalition. "PhRMA understands that the ability to say to patients, providers, and payors that this drug is not for everyone but it is for you is a very powerful and compelling message."

Castellani, although described as a quiet industry operative with an advocacy style quite different from Tauzin's, will most likely continue to support the industry's move toward personalized medicine strategies.

"Whether Tauzin accelerated the industry's shift to personalized medicine I don't know, but certainly in public comments he was an advocate of personalized medicine and made it part of the PhRMA brand," Goldberg noted. "The new president will likely continue to do the same, but the question remains how that lip service will translate into reimbursement policies and clinical trials criteria" that advance the discipline.

Despite growing industry investment and support of personalized medicine, it remains to be seen whether genomically guided drug development efforts will receive continued funding and backing from politicians in the post-healthcare-reform climate in Washington.

"Everyone's giving personalized medicine lip service, but money is still being divided up to fund retrospective analyses and they're not doing squat to look at molecularly informed studies," Goldberg told Pharmacogenomics Reporter.

The healthcare reform bill, signed into law this March by President Barack Obama, provided for the creation of the Patient-Centered Outcomes Research Institute, an independent entity that would conduct research on the comparative risks and benefits of marketed drugs, devices, and medical products (PGx Reporter 03/24/10). Specifically, with regard to personalized medicine, the institute will also examine the utility and effectiveness of medical products and services in "various subpopulations" differentiated by race, ethnicity, sex, age, co-morbidities, as well as genetic and molecular subtypes.

While Tauzin believed that personalized medicine should be used to differentiate the effectiveness of drugs in people, he also felt that the cost of treatments should not be used to make coverage decisions. At a meeting on CER hosted by the PMC in 2009, Tauzin emphasized that while it’s important to figure out which drugs are most effective to advance personalized medicine, cost should not be the deciding factor in which therapies are most effective.

The CER provisions in the health reform law allow data from such research to be used for coverage decisions as long as it is not the only data being used, and the determination is made "through an iterative and transparent process which includes public comment and considers the effect on subpopulations."

Also, as part of the American Recovery and Reinvestment Act, Congress granted a total of $1.1 billion for comparative effectiveness research: $400 million to the NIH, $300 million to the Agency for Healthcare Research & Quality, and $400 million to the Office of the HHS Secretary to create the Federal Coordinating Council for Comparative Effectiveness Research.

Even with the increased funding, personalized medicine proponents have pointed out that the majority of CER proposals are for looking at treatments for the general population, and there are limited opportunities for research on genetically defined subpopulations. Indeed, the Federal Coordinating Council issued a set of priorities to HHS for CER research last year in which the council mentioned the need to look beyond randomized-controlled studies to advance personalized medicine; but most of the priority areas for funding described traditional clinical trials for interventions for the average population (PGx Reporter 07/08/09).

In Washington, "we're in a different phase now," Goldberg noted. "November may be a reboot of healthcare reform." According to Goldberg, depending on which party takes control of Congress this fall, there could be a reshuffling of AHRQ's priorities in terms of CER.

Funding considerations for the FDA will be another important issue for legislators this fall, Goldberg said.

In a letter to HHS Secretary Kathleen Sebelius last week, Senator Tom Harkin (D – La.) and Representative Henry Waxman (D – Calif.) asked the secretary to boost FDA's congressional request for funding for the 2012 budget. The congressmen feel that flat funding over past years has left the agency unprepared to meet its growing oversight responsibilities. In 2010, FDA received $3.2 billion; in 2009, $2.7 billion; and in 2008, $2.4 billion. In 2011, FDA has sought $4.03 billion, which Waxman and Harkin say is not enough. The need to increase FDA's funding was also discussed at a recent congressional hearing on the marketing and oversight of direct-to-consumer genetic testing firms (PGx Reporter 07/28/10)

"So, we'll see how PhRMA proceeds on these issues," Goldberg said, adding that in general, PhRMA will likely "push forward the message of personalized medicine." PhRMA did not respond to an interview request for this article.

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