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Berwickâ€™s Death Panel

11.16.2010

My article in the American Spectator today:

Are Medicare director Don Berwick and the Obama administration delaying or denying patients access to medical innovations? That's a question the Senate's Finance Committee should ask Berwick, who heads up the Center for Medicare and Medicaid Services (CMS), when he testifies November 17.

The timing couldn't be better. Medicare won't pay for Provenge, the first cancer vaccine, since it was approved in April. It's waiting for the Medicare Coverage Advisory Committee (MEDCAC) -- also meeting on the 17th -- to decide whether the Food and Drug Administration, the National Cancer Institute, and cancer experts are right in supporting Provenge use for prostate cancer patients.

MEDCAC was established in 1998 so CMS could ask leading scientists and doctors to recommend what information should be collected to determine the best use of new technologies. But recently MEDCAC has -- under CMS direction -- begun evaluating whether innovations are cost-effective.

In November 2008 Medicare bureaucrats asked MEDCAC: At current Medicare prices, how confident are you that CTC has a similar ratio of cost per LYS (Life Years Saved) as optical colonoscopy? In 2009 CMS asked MEDCAC: What are the desirable measures of the cost-effectiveness of screening genetic tests for the prevention or early detection of illness or disability? By 2010 CMS was simply asking MEDCAC whether CMS should cover new technologies unless there was evidence of its cost and clinical effectiveness from long and expensive studies. As one speaker at a MEDCAC hearing about genetic tests noted, "if clinical outcomes as defined… become[] a requirement for reimbursement, it will reduce investment in new genetic tests and the market introduction of these tests, and ultimately their use. "

That's the goal. But given Provenge's high profile, asking about its cost-effectiveness would be controversial. Since the one-time treatment runs about $90,000, CMS thought it could ask if Provenge was effective without mentioning cost. Hence, Dr. Louis Jacques, the director of the Coverage and Analysis Group at Medicare, told Forbes: "We've been getting questions from people," says Jacques. "'Well, what's up with Provenge? Is it a drug? Is it a biologic? Is it something else? Does it really work? It has been interesting to look at the evidence around it."

Does it really work?!

Maybe Dr. Jacques didn't get the memo about the FDA approving Provenge. The FDA said Provenge "substantially improved survival to patients with a fatal disease. The risks… are minor relative to the benefit of improved survival." Or perhaps he didn't see the May 6 National Cancer Institute statement asserting: "The field of cancer immunotherapy received an important boost last week with the FDA's approval" of Provenge. On May 29 the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium added Provenge to its list of standard therapies. On June 15 Aetna said it would cover Provenge.

Federal law requires that CMS cover any cancer drug approved by the FDA or NCCN compendium therapy. Instead, on June 30, an anonymous individual requested that CMS hold a MEDCAD hearing on Provenge before it covered the drug. CMS immediately accepted the query from the secretive party. Perhaps the Finance Committee can find out who that was.

MEDCAC will render its decision based on a just released evaluation of the FDA data conducted by the Agency for Health Research and Quality (AHRQ). AHRQ tried to pretend it wasn't second-guessing the FDA and the NIH. In October, the report name was changed on AHRQ's website from "The Efficacy and Safety of Sipuleucel T" (Provenge) to "The Outcomes of Sipuleucel T." The reviewers determined the FDA data used to approve Provenge was "adequate" but not entirely convincing. You might wonder: What expertise in prostate cancer did the authors use to draw to that conclusion? The answer is none unless you count nursing, a master's degree in statistics, or a PhD in sociology. Apparently CMS believes AHRQ's collective wisdom towers over the oncology expertise of the FDA, NCI, and NCCN.

The AHRQ report understates the impact of Provenge on survival. First, it begrudges the fact that many patients receiving chemotherapy after taking Provenge live longer. It focuses on the median survival benefit of 4.5 months (which tells you the midpoint of patient survival but not how many patients lived longer and for how long). Then it raises doubts about safety. And finally the study glosses over the finding that terminal prostate cancer patients who received Provenge were 40 percent more likely to be alive in three years than those who did not receive it. The AHRQ report is ideology masquerading as medical facts. The routine and expanding using of AHRQ to guide life or death decisions undermines the legitimacy of real science.

MEDCAC meets this week but CMS can take months to decide. This callous and possibly illegal process reflects Berwick's stated belief that only a centralized entity should decide what's best for us. People with prostate cancer have died and will die waiting. If that's not a death panel, I don't know what is.

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Mommy, where do drugs come from?

11.16.2010

Innovation? Unmet needs? Where's the action?

An interesting new paper by Robert Kneller (University of Tokyo, Research Center for Advanced Science and Technology) The importance of new companies for drug discovery: origins of a decade of new drugs.

Here’s the abstract:

Understanding the factors that promote drug innovation is important both for improvements in health care and for the future of organizations engaged in drug discovery research and development. By identifying the inventors of 252 new drugs approved by the US Food and Drug Administration from 1998 to 2007 and their places of work, and also classifying these drugs according to innovativeness, this study investigates the contribution of different types of organizations and regions to drug innovation during this period. The data indicate that drugs initially discovered in biotechnology companies or universities accounted for approximately half of the scientifically innovative drugs approved, as well as half of those that responded to unmet medical needs, although their contribution to the total number of new drugs was proportionately lower. The biotechnology companies were located mainly in the United States. This article presents a comprehensive analysis of these data and discusses potential contributing factors to the trends observed, with the aim of aiding efforts to promote drug innovation.

Some relevant facts:

* Of the 252 new drugs approved by the FDA from 1998 to 2007

o 58% from pharmaceutical companies

o 18% from biotech companies

o 16% from universities, transferred to biotech

o 8% from universities, transferred to pharma

* 123/252 (49%) new drugs approved by FDA from 1998 to 2007 were for an unmet medical need

* 118/252 (46%) new drugs approved by the FDA from 1998 to 2007 were scientifically novel

* 24/252 (21%) new drugs approved by the FDA from 1998 to 2007 had an orphan designation

The full paper can be found here.

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Paul Krugman: For Death Panels before he was against them

11.15.2010

The media’s favorite economist Paul Krugman is under fire for these comments he made this past weekend on ABC regarding federal spending on health care.

“Some years down the pike, we’re going to get the real solution, which is going to be a combination of death panels and sales taxes.”

Krugman is now trying to correct the record, or so he says:

I said something deliberately provocative on This Week, so I think I’d better clarify what I meant (which I did on the show, but it can’t hurt to say it again.)

So, what I said is that the eventual resolution of the deficit problem both will and should rely on “death panels and sales taxes”. What I meant is that

(a) health care costs will have to be controlled, which will surely require having Medicare and Medicaid decide what they’re willing to pay for — not really death panels, of course, but consideration of medical effectiveness and, at some point, how much we’re willing to spend for extreme care

This is merely a euphemistic way of saying the government must decide who lives and who dies.

Do we really want Medicare bureaucrats determining the “medical effectiveness” of any given treatment or medication?

Sounds like a very slippery slope.

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Drug Makers Brace for Possible Cuts to FDA

11.15.2010

Via this week’s edition of Ad Age:

Drug Makers Brace for Possible Cuts to FDA

After Midterm Elections, Pharma Wary of Congressional Appetite for Reduced Spending on Federal Agency

The Nov. 2 elections that reshaped the structure of the U.S. House of Representatives are causing a headache in the pharmaceutical industry, which could lose millions as a hamstrung FDA leads to a clogged up drug pipeline.

With many congressional candidates riding into office on a platform of reduced spending, drug makers are bracing for what they believe could be cuts to government agencies, particularly to the Food and Drug Administration.

Astra Zeneca CEO David Brennan and FDA Commissioner Dr. Margaret Hamburg last week both told the Reuters Health Summit in New York that cuts to the agency would be detrimental. "I don't think that would be good for our industry. It doesn't look to me like that would speed things up," Mr. Brennan told Reuters, speaking of the time it takes the FDA to review new products, where delays of several months can cost pharma companies millions.

Ms. Hamburg cautioned the new Congress to think twice about FDA cuts.

"Not every function of government can be cut to the same degrees using the same tools. I think we should proceed with real care," she told Reuters. "It should be recognized if we can't do our job and do it well, there isn't any other entity that will backstop behind us. What we do really matters to health."

"I think the threat to cut FDA funding is real and it's a signal that FDA has to deliver on the promises that it made during the last PDUFA negotiations," said former FDA associate commissioner Peter Pitts, referring to the Prescription Drug User Fee Act, or the fees that pharmaceutical companies pay to the FDA. "It's a shot across the bow."

For the rest of the story, see here.

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Quote of the week

11.12.2010

Joel Ario of HHS’ Office of Insurance Exchanges comparing Mitt Romney’s health system overhaul in Massachusetts to the federal health care law:

“You could say Obamacare was Romneycare before it was Obamacare.”

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CMPI at Columbus Circle

11.12.2010

CMPI recently hit the streets of New York City to ask people if they expected the health care law to help them.

Watch the video below to hear their answers:

CMPI at Columbus Circle from CMPI on Vimeo.

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MIT enjoying NEWDIGS "over there"

11.12.2010

The European Medicines Agency (EMA) and MIT’s Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) are launching a collaborative research project with a focus on enhancing regulatory science in pharmaceuticals.

Specific questions addressed by this project include how to:

* adapt current regulatory requirements to support the efficient development of safe and effective drugs;

* incorporate patient valuation of health outcomes and benefit-risk preferences into regulatory decision-making;

* implement 'staggered' and 'progressive' approaches to drug approval;

* improve fulfillment of post-marketing regulatory requirements.

The project will explore the feasibility of, priorities for and practical considerations of implementing demonstration projects on some of the issues addressed during the course of the research.

Sound familiar? It's what the FDA's Critical Path program was designed to do -- that is until it hit Congressional treacle embodied by a certain member who will shortly lose her majority status.

The data and recommendations from this project are expected to link to implementation of the Agency's Roadmap to 2015 and the CBI's New Drug Development Paradigms (NEWDIGS) research program.

The project is scheduled to be completed by December 2011.

Hopefully with a new chair at the helm of the House Agriculture (and FDA) Appropriations Committee, funding for the Reagan/Udall Center can be released and FDA can, once again, take a leadership role in developing the tools for 21^st century regulatory science.

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Remembering Our Veterans

11.11.2010

Reagan's D-Day Speech at Normandy Beach still resonates and recalls the courage mustered by everyday Americans to preserve freedom.

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Death rates in U.S. and England

11.11.2010

A new study conducted by the Institute for Fiscal Studies in London and RAND Labor and Population offers an interesting look at both the British and American health care systems.

From the study:

In the new study, researchers examined the prevalence of illness among those 55 to 64 and 70 to 80. They also looked for the first time at the onset of new illnesses in those age groups in the United States and England during the years spanning 2002 to 2006. Finally, researchers examined trends in death rates in each country.

The findings showed that both disease prevalence and the onset of new disease were higher among Americans for the illnesses studied -- diabetes, high-blood pressure, heart disease, heart attack, stroke, chronic lung diseases and cancer. Researchers found that the higher prevalence of illness among Americans compared to the English that they previously found for those aged 55 to 64 was also apparent for those in their 70s. Diabetes rates were almost twice as high in the United States as in England (17.2 percent versus 10.4 percent) and cancer prevalence was more than twice as high in the United States (17.9 percent compared to 7.8 percent) for people in their 70s.

In spite of both higher prevalence and incidence of disease in America, death rates among Americans were about the same in the younger ages in this period of life and actually lower at older ages compared to the English.

Researchers say there are two possible explanations why death rates are higher for English after age 65 as compared to Americans. One is that the illnesses studied result in higher mortality in England than in the United States. The second is that the English are diagnosed at a later stage in the disease process than Americans.

"Both of these explanations imply that there is higher-quality medical care in the United States than in England, at least in the sense that these chronic illnesses are less likely to cause death among people living in the United States," Smith said.

"The United States' health problem is not fundamentally a health care or insurance problem, at least at older ages," Banks said. "It is a problem of excess illness and the solution to that problem may lie outside the health care delivery system. The solution may be to alter lifestyles or other behaviors."

Megan McArdle has further analysis of the study here.

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A Tangled Webb

11.10.2010

Virginia Senator Jim Webb on his conversation with President Obama about the health care bill:

"I told him this was going to be a disaster. The president believed it was all going to work out."

Yet Senator Webb voted in favor of the bill. Apparently talking out of both sides of one’s mouth never goes out of vogue in Congress.

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Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.