The Latest Advisory Committee at FDA

Merrill Goozner

Posted 12/7/11 on Gooz News

Is the Food and Drug Administration stacking the deck against a negative decision at tomorrow’s safety hearing for oral contraceptives that contain drospirenone, include Bayer’s Yasmin? Or is it laying the groundwork to combat lawsuits by Bayer should the agency decide to pull the drug, which the FDA has already warned increases the risk of blood clots?

The agency took two actions this week sure to anger safety advocates, especially in the women’s health community. First, it ruled that Public Citizen’s Sidney Wolfe could not take his usual post as consumer representative on the Drug Safety Advisory Committee because his widely read newsletter, “Best Pills, Worst Pills,” has already called for pulling Yasmin from the market. The agency accused Dr. Wolfe of an intellectual conflict-of-interest.

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Scary Predictions

Merrill Goozner

Posted 11/26/11 on Gooz News

Writing in next week’s New England Journal of Medicine, Harvard professor David Blumenthal, former head of Medicare’s health information technology division, forecasts the following scenario should the Republicans win the White House and both houses of Congress next year and repeal most of the Affordable Care Act:

By 2020, 20% of Americans may be uninsured, even as 20% of our gross domestic product is devoted to health care.

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Medical Homes – A Boost To Primary Care

Merrill Goozner

The following appeared 11/24/11 in The Fiscal Times:

Amerigroup Inc., the health insurer for Medicaid patients in Nashville, has a serious problem. Many of its 50,000 inner city, low-income beneficiaries go for their routine care to local hospital emergency rooms, which is the most expensive place for such treatment.

So a year ago, without government help, the company instituted a so-called medical home program, paying extra money to local physicians who care for Medicaid patients. They were asked to hire outreach workers to call patients to make sure they keep appointments, take their medication or simply to check up on how they were doing. The insurer also encouraged physicians to establish same-day scheduling and keep extended hours for patients who call with immediate problems.

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On the FDA’s Decision To Withdraw Avastin’s Breast Cancer Indication

Merrill Goozer

Posted 11/18/11 on Gooz News

They did the right thing. Two clinical trials showed no improvement in mortality among women with metastatic breast cancer. Those trials didn’t even replicate the delay in progression of disease that had been shown in the original trial that led to accelerated approval in 2007.

Now comes the firestorm from patient advocacy groups, who will use anecdotal stories to claim the drug works for some women. The drug industry’s flaks and sycophants will suggest the FDA’s overweaning regulatory apparatus is stifling innovation.

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Supreme Court Goes Beyond Individual Mandate

Merrill Goozner

Posted 11/14/11 on Gooz News

The Supreme Court, as expected, will consider the constitutionality of the individual mandate in health care reform. But as Tim Jost, a Washington and Lee University professor of law, noted today on theHealth Affairs blog, the high court will also hear arguments on the constitutionality of using Medicaid to expand insurance coverage to people earning up to 138 percent of the poverty line. States are challenging this mandate under what the attorneys general in the 26 states challenging the law call “the coercion theory.” Noted Jost:

The coercion theory calls into question a multitude of federal government programs. Many federal programs, and not just health care programs, operate through conditional grants to the states. Were the Supreme Court to hold that the Medicaid expansions are unconstitutional, it would open every one of these programs to judicial challenge. New programs, or changes in existing programs, could be tied up for years as litigation proceeded. Such as decision could pose a much greater threat to the power of Congress to address national problems than might a decision holding that Congress exceeded its authority under the Commerce Clause in enacting the individual mandate. It would be a truly radical decision.

I don’t know that this cases yet rises to the level of a Dred Scott decision for the 21st century. But its framing by the states challenging the law has all the hallmarks of the southern states that challenged the 1964 civil rights act, claiming states had the right to nullify federal laws that prohibited local laws condoning segregation, impeding voting and the like. The stakes in this spat over the individual mandate have suddenly grown significantly larger.

Ending Pay-For-Delay Deals Could Raise over $5 Billion

Merrill Goozner

Posted 11/08/11 on Gooz News

The deficit reduction “super committee” charged with coming up with $1.2 trillion in budget reductions over the next decade shouldn’t let this one pass. The Congressional Budget Office today estimated that ending drug industry “pay for delay” deals with generic manufacturers will save the federal government over $5 billion over the next decade.

The “Preserve Access to Affordable Generics Act,” sponsored Sen. Herb Kohl, D-Wis., with eight co-sponsors, including two Republicans, requires that any deal between two companies that delays production of a generic drug after a patent has expired must show that the deal is “pro competitive,” which would effectively ban the practice. The Federal Trade Commission issued a report a year ago that found 66 of these deals reached over the past half decade were costing consumers about $3.5 billion a year.

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Conflict-Free Panels Are Possible and Necessary

Merrill Goozner

Posted 11/3/11 on Gooz News

Duff Wilson of the New York Times this morning puts the spotlight on three National Institutes of Health panels deliberating new clinical practice guidelines for managing cholesterol, hypertension and obesity and finds significant conflicts of interest among the panel members. No surprise there. Most guideline-writing committees in most specialties across the medical profession are laced with physicians on the payrolls of companies with a financial stake in the final product of the committees’ deliberations. Just put the phrase “conflicts of interest” in the search engine on this website, and you’ll see more than 200 articles I’ve written in the past few years documenting and lamenting this phenomenon.

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Xigris Pulled – $1 billion Later

Merrill Goozner

Posted 10/26/11 on Gooz News

Another over-hyped and over-marketed drug bites the dust. Eli Lilly earlier this week pulled Xigris from the market after a clinical trial showed it provided no benefit for hospital patients with septic shock. From the start, critical clinicians questioned the efficacy of this drug, which is used to treat sepsis, a hospital-acquired systemic infection that often strikes the elderly in the wake of major operations. The Food and Drug Administration approved the drug in 2001 after a single, small trial showed a 28-day survival benefit. The FDA approval came despite half the members of an advisory panel voting against the drug.

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Anti-RUC Suit Challenges Process for Setting Doc Pay Scales

Merrill Goozner

Posted 10/25/11 on Gooz News

Whither CMS? That’s the issue raised by Brian Klepper and David Kibbe in their post on the Health Affairs website this morning. The Center for Medicare and Medicaid Services faces a November deadline for answering a complaint by six Georgia physicians that claims the American Medical Association’s Relative Value Scale Update Committee (RUC) violates the Federal Advisory Committee Act. The RUC periodically sends recommendations to CMS on how it should reimburse different physician services. As Klepper and Kibbe point out, this specialist-dominated committee, after what are the medical equivalent the early 20th century factory efficiency studies conducted by Frederick Winslow Taylor, decides that the value of cataract surgery, for instance, is 12.5 times the value of a primary care office visit.

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Bracing for More Medicare Cuts

Merrill Goozer

Posted 10/19/11 on Gooz News.

I attended a depressing forum this morning on cost-saving ideas for Medicare to present to the Congressional “Super Committee” charged with coming up with $1.2 trillion in budget savings by the end of the year. The tone was ominous, best summed up by Mark Smith, president of the California HealthCare Foundation. “In times of crisis, meat-axes are taken to whole sectors. If you don’t believe me, ask the people who used to work for Lehman Brothers,” he said.

Here’s the backdrop. President Obama in his mid-September budget reduction plan called for coming up with an additional $320 billion in Medicare savings over the next decade, which would be on top of the half trillion dollars in Medicare cost reductions contained in the Affordable Care Act. The president would get there largely by cutting payments to hospitals and other providers, although the president also called for higher premiums on wealthier seniors for physician and drug coverage.

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Memo to USPSTF: Hire a PR Pro

Merrill Goozner

Posted 10/18/11 on GoozNews

Last Friday at 3 p.m., the Agency for Healthcare Research and Quality held a telephone briefing to inform the press and public about the U.S. Preventive Services Task Force recommendation against routine screening of prostate specific antigen (PSA) levels in middle-aged men. The “D” recommendation, now open for public comment, said the harms from false positives and overtreatment of prostate cancer identified by elevated PSA levels outweighed any benefits that would be achieved by the early identification of the relatively small percentage of cases that would lead to metastatic disease and early death.

They posted no slides to go along with the three presentations made at the briefing. They didn’t spell out the names of the men who spoke (I scribbled down Moyer, Chou and LeFebre). And, when they concluded their presentations, they didn’t take questions.

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AMA: Pay Docs For Care Coordination

Merrill Goozner

Posted 10/10/11 on Gooz News

The little-known American Medical Association committee that recommends physician pay scales to Medicare’s fee-for-service program today asked the agency to reimburse physicians for coordinating care for their chronically-ill patients. In a letter to administrator Donald Berwick, the Relative Value Scale Update Committee (better known as the RUC) recommended the Center for Medicare and Medicaid Services pay for phone calls, counseling sessions and other services that help their patients wend their way through the complicated health care system.

Good idea, and long overdue. But what I didn’t see in the letter from RUC committee chairwoman Barbara Levy was any reference for how to pay for these new services. How about a reduction in the “relative value” of back surgery or conducting angioplasty on patients complaining of persistent chest pains? These are among the most expensive and overused procedures in medicine, incentivized by the extraordinarily high fees earned by the surgeons who do them. These surgeons often earn two or three times what primary care physicians earn.

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Rising Premiums Do Not Square With Costs

Merrill Goozner

First posted 9/28/11 on Gooz News

The press releases flew from various House committees yesterday afternoon (which double as Republican Party campaign offices). The charge: rising health care premiums are due to “Obamacare.” The latest Kaiser Family Foundation employer survey of health care insurance costs, which was reported on the front page of all this morning’s newspapers, showed premiums rose 9 percent this year, substantially more than the 3 percent they went up last year.

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Spare the Knife. Keep the Rod.

Who will tell the men?

That’s what I wondered last week when I read the abstract about prostate cancer patients’ grim prognosis for normal sexual activity after surgery or radiation for their disease. The study appeared in the Journal of the American Medical Association. Tara Parker-Pope in the New York Times’ Well blog gave it a shot today, and led with an anecdote about a surgeon who blithely told one patient that 98% of his robotic surgeries turned out fine. Not exactly.

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