Drug Makers Fight Stimulus Provision


WASHINGTON -- The drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing.

The fight over the provision is highlighting the tensions behind President Barack Obama's plan to overhaul the health-care system. The administration hopes to expand coverage while limiting use of treatments that don't work well, but any efforts that might reduce coverage are politically sensitive.

The House version of the stimulus package sent shudders through the drug and medical-device industry. In a staff report describing the bill, the House said treatments found to be less effective and in some cases more expensive "will no longer be prescribed."

A Senate version backed by Finance Committee Chairman Max Baucus (D., Mont.) doesn't mention cost as a subject to be studied. And the industry won a battle to add the word "clinical" in describing the research -- adding to the implication that the comparison studies won't look at bang for the buck. The final language is likely to be hammered out later this week in a House-Senate conference committee.

Mr. Obama is under pressure to find long-run health-cost savings as projections show that Medicare spending is on track to severely deplete the federal budget. "Without question, we're headed for more of a public and private push for which medicines work best at the lowest cost in particular patients," said Mark McClellan, former Medicare and Medicaid chief under President George W. Bush.

The $1.1 billion in research funding would be doled out to the National Institutes of Health and other government bodies. "We should focus on producing the best unbiased science possible," said Rep. Henry Waxman (D., Calif.), a strong proponent of the House language.

Mr. Obama supported research into comparative effectiveness during his campaign. Administration officials and leading Democrats in Congress say the idea will help government programs direct their dollars to treatments that are worth the money.

Officially, drug and device makers don't object to that sentiment. But they warn of a slippery slope where the government ends up axing useful treatments just because they cost too much. They have lined up patient groups that get industry funding to lobby Capitol Hill.

A coalition called the Partnership to Improve Patient Care includes the lobbying arms of the drug, device and biotechnology industries as well as patient-advocacy groups and medical-professional societies. Coalition spokesman David Di Martino says the research envisioned in the House bill may be used "in an inappropriate manner that may limit treatment options for patients."

A public-relations firm that is part of one of Washington's most influential lobby shops, Barbour Griffith Rogers, is representing the coalition. A major goal is to give industry a seat at the table when federal officials decide what to research with the $1.1 billion.

Companies "want to control the data, how it is reviewed, evaluated, and whether the public and government find out about it and use it," said Harry Selker, a Tufts University professor who directs its clinical-research program.

That also worries Jerry Avorn of Harvard Medical School, a frequent drug-industry critic. Comparative research "has the potential to tell us which drugs and treatments are safe, and which ones work," he said. "This is not information that the private sector will generate on its own, or that the industry wants to share."

Michael Cannon of the libertarian Cato Institute said comparative effectiveness research "isn't going to do any good because the industry will defund it as soon as it presents a threat."

When the government's Agency for Health Research Quality suggested in 1995 that there were too many unnecessary back surgeries, doctors and industry groups attacked the conclusion. Mr. Cannon noted that Congress at the time slashed the agency's budget and stripped its authority to make medicare-payment recommendations.

"They almost killed AHRQ," said Dr. Avorn. "The memory of their near-death experience hasn't been forgotten."

Dr. McClellan, the former Medicare chief, said effectiveness research can be useful but shouldn't assume pricey medicines are automatically bad. "The goal isn't to avoid expensive drugs, it's to get more value for our health-care spending," he said.

—Jacob Goldstein contributed to this article.
Write to Alicia Mundy at alicia.mundy@wsj.com

Faculty positions at University of Utah College of Pharmacy

Tenure Track Outcomes Research Faculty Position

Research Faculty Position
Assistant/Associate Professor
Pharmacotherapy Outcomes Research Center
Department of Pharmacotherapy
College of Pharmacy, University of Utah

This position provides opportunity for Pharmacotherapy Outcomes Research scholarly activity in a research-intensive, interdisciplinary health sciences center.

Review of applications will begin immediately and will continue until the position is filled.

Scholarly Activity:
The individual’s primary focus will be to conduct scholarly activity in health economics and outcomes research in collaboration with Pharmacotherapy Outcomes Research Center faculty and staff. The successful candidate will also be expected to pursue and direct independent outcomes research as well as seek research support from both the public and private sector. The individual will be expected to interact with individuals from the health care industry on a regular basis.

This individual may participate in team-taught courses for PharmD and MS students and serve as a preceptor on PharmD elective outcomes research clerkships. The individual may assist in the training of post-doctoral residents and fellows in pharmacotherapy outcomes research.

A PhD degree, PharmD degree, pharmacy practice residency or equivalent experience, and fellowship or equivalent experience in health economics and/or outcomes research are preferred. Clinical practice experience and/or research experience are preferred. Excellent verbal and written communication skills and proven ability to work with other health professionals in an interdisciplinary environment are required.

Rank and Salary:
Appointment as a research track assistant or associate professor within the Department of Pharmacotherapy and a salary commensurate with qualifications and experience plus benefits will be provided. This is a calendar year appointment.

This position provides an excellent opportunity for collaboration with practitioners and faculty in a broad range of clinical and scientific disciplines in an interdisciplinary clinical environment. Interested individuals are invited to send their curriculum vitae and the names of three references to provide letters of recommendation to:

Joseph Biskupiak, PhD
Research Associate Professor, Department of Pharmacotherapy
Director, Pharmacotherapy Outcomes Research Center
Department of Pharmacotherapy
University of Utah College of Pharmacy
421 Wakara Way; Suite 208
Salt Lake City, UT 84108

The University of Utah is an EEO/AA employer and encourages applications from women and minorities.

Assistant Professor Rank
Department of Pharmacotherapy
University of Utah College of Pharmacy
Salt Lake City, Utah

The Department of Pharmacotherapy is seeking to fill a 12-month, tenure track faculty position at the minimum rank of Assistant Professor within the disciplines of outcomes research including health economics, biostatistics, and clinical outcomes. Applicants must possess a graduate degree in a health services research-related field such as behavioral science, pharmacoeconomics, health economics, pharmacoepidemiology, or public health. An undergraduate or professional degree in Pharmacy is preferred to facilitate teaching within the PharmD curriculum. The ideal candidate will possess demonstrated potential as an outstanding researcher, a strong interest, competence and commitment to excellence in teaching in the professional and graduate programs and a commitment to academic service.
The successful applicant is expected to complement the strong research program in the College of Pharmacy. The College of Pharmacy is situated in the foothills of the Wasatch Mountains in L.S. Skaggs Hall, which is part of the Utah Health Sciences Center, the University of Utah Hospital and Clinics, the School of Medicine, the Colleges of Health and Nursing, the Eccles Health Sciences Library and a state of the art Health Sciences Education Building. The Health Sciences Center is an environment conducive to interdisciplinary and translational research. The University of Utah College of Pharmacy is consistently ranked in the top five pharmacy schools nationally receiving National Institutes of Health funding for research. The Department of Pharmacotherapy consists of a strong foundation of clinical, tenure track faculty and research faculty, the Pharmacotherapy Outcomes Research Center, the Utah Poison Control Center and a Continuing Education Program.

Qualified applicants should send by mail and email a letter of intent, current curriculum vitae, and the names and addresses of three references to:
Diana Brixner, PhD, RPh
Chair, Outcomes Research Faculty Search
c/o Sara Ray, Administrative Officer
Department of Pharmacotherapy, University of Utah College of Pharmacy
30 South 2000 East – Room 258
Salt Lake City, UT 84112-5820
(801) 581-5984
sara.ray@pharm.utah.edu or diana.brixner@pharm.utah.edu

The University of Utah is an EEO/AA employer and encourages applications from women and minorities.


Health Economics Position - Grapevinerecruiters

this just came in, please contact Darren (see below)

Associate Director of Health Economics and Outcomes

REPORTS TO: Strategic Affairs


• Develop timely, appropriate health economic data to support reimbursement initiatives for all products
• Manage economic and outcomes research projects in support of international and local pricing and reimbursement programs
• Provide interpretative expertise for economic/outcomes research data as needed by internal/external customers
• Mentor junior associates to improve skill sets
• In-depth understanding of outcomes research and epidemiological study design.
• Working knowledge of biostatistics and data analysis
• Capabilities in health economic modeling
• Advanced communication capabilities
• Experience in government and patient advocacy lobbying
• Masters Degree in epidemiology, health economics, health policy
• 10 years work experience in health industry

• Implement local health economic and outcomes research strategies that support the overall reimbursement strategies
• Design health economic and outcomes research studies that are scientifically sound and timely
• Collaborate with International medical affairs to incorporate health economic measures into clinical trials
• Analyze and report results from health economics outcomes research studies, including publication and presentation of data
• Provide input into global health economics and outcomes research studies and programs.
• Communicate results of health economic and outcomes research studies to internal and external customers
• Recruit and manage investigators/vendors to conduct health economics and outcomes research studies

• Impactful outcomes in outcomes studies
• Analysis plan for health economic and outcomes studies
• GO/NO GO decisions for health economic studies
• Health economic approach for submission/presentation to customers
• Publication strategies for completed studies

Darren Kruszynski
Grapevine Executive Recruiters
269 Richmond Street West
Suite 100
Toronto, Ontario
416-581-1445 ext 225


NICE splits renal cancer drugs assessment - "yes" for Pfizer's Sutent, "no" for Roche, Bayer, Wyeth

by Nick Smith

LONDON, Feb 4 (APM) - NICE on Wednesday split its controversial review of renal cancer drugs into two, saying 'yes' to Pfizer's Sutent (sunitinib) but rejecting three others - Wyeth's Torisel (temsirolimus), Bayer's Nexavar (sorafenib) and Roche's Avastin (bevacizumab).

In effect NICE has all but guaranteed that one product will reach patients, while pushing problematic appeals back down the appraisal process.

In a statement issued late on Tuesday for Wednesday release, NICE said in an attempt to get guidance out the NHS as quickly as possible it had published later-stage guidance recommending sunitinib as a first-line treatment option in advanced and/or metastatic renal cell carcinoma.

In a second set of guidance, bevacizumab, sorafenib and temsirolimus were not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma.

Also in the second set of guidance, the two drugs also licensed for second-line treatment of advanced or metastatic renal cell carcinoma, sorafenib and sunitinib, are not recommended for this indication.

A spokeswoman for NICE told APM the sunitinib document was a so-called Final Appraisal Determination (FAD), which in the absence of an appeal will become guidance to the NHS. The second is a first draft which is now out for public consultation ahead of a later FAD.


Initially all four cancer drugs were assessed and rejected together, leading to a huge public outcry that dying people were being denied life-extending drugs.

Following this, new flexibilities for NICE's appraisal committees were announced by the government.

This gave them a more formal freedom to exceed NICE's generally understood maximum cost per quality-adjusted life year of 30,000 pounds (33,000 euros) under certain conditions, including low incidence and end-of-life cases.

In its statement, NICE says the approval of sunitinib comes under these new flexibilities and stresses its desire to get this treatment to patients as soon as possible.

NICE said: "Having decided that one of these treatments should be recommended for use in the NHS, we felt that it was in the interests of patients to get that advice out as quickly as possible.

Although this final recommendation is subject to appeal we very much hope it will form the basis of our guidance to the NHS."

The approval for sunitinib is specifically in patients with renal cell carcinoma (RCC) who are suitable for immunotherapy with an Eastern Cooperative Oncology Group performance status of 0 or 1.

Despite the mention of an appeal it was not clear what grounds companies with rejected drugs might use. It is unusual for patient organisations to appeal an approval from NICE.

The spokeswoman confirmed that after NICE split the assessment, the sunitinib FAD only deals with the Pfizer drug. Although she insisted all consultees - which would include Wyeth, Bayer and Roche - had the right to appeal regardless of whether their product was included or not, she could not say how they might benefit from an appeal.

In the absence of a rejection of their own drugs, it seems any appealing company could only succeed in slowing down access or stopping patients accessing any drug at all.

Pfizer is one of two companies which offered "patient access schemes" - incentives to the National Health Service that in some way reduce the price paid by the service - in order to gain NICE approval in cases which would otherwise have led to rejection.

Pfizer offered the NHS the first cycle of sunitinib in renal cell carcinoma free. "The independent advisory committee concluded that sunitinib does represent a cost effective use of NHS resources when used as a first-line treatment for advanced and/or metastatic RCC," NICE said in the statement without giving its estimated cost per QALY.

NICE also noted the Department of Health said the Pfizer scheme, "does not constitute an excessive administrative burden on the NHS".

Bayer also agreed a patient access scheme with the Department of Health, in which the first pack of sorafenib is free to the NHS, NICE said.


[14114] 04/02/2009 09:31 GMT - INDUSTRY