– The FDA Approves Provenge, a Prostate Cancer “Vaccine”

Summary: Today, the news broke that the FDA has approved a drug that could extend the lives of some patients suffering from late-stage prostate cancer. For Wall Street, it’s a big story. For cancer researchers, it could represent a break-through. For some of today’s patients, it may be good news—if they can afford the drug.

The headlines are everywhere:

“Dendreon Hits the Jackpot” 

“FDA approves breakthrough cancer therapy Provenge”

“Dendreon (DNDN) is trading at $53.50 after last trading at $45.50 before the halt“

“Dendreon: Provenge boosts survival 40 pct”

What does Provenge actually do? The company calls it a “vaccine,” but it doesn’t prevent prostate cancer. Nor does it cure prostate cancer. Contrary to what you may have read, it doesn’t “save lives.”

 It extends the lives of men suffering from late-stage prostate cancer by an average of 4 months. The patients in a trial of 512 men lived a median time of 25.8 months if they received Provenge, compared to 21.7 months if they got the  placebo. (I have no idea why Reuters claims that Provenge boosts survival by 40 percent.)

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Summary: Earlier this month, an FDA committee voted on whether it should tighten the rules for generics to make certain that they are exactly the same as brand-name drugs. Medical research says that they are equivalent in all of the important ways. But critics have been raising questions, stirring controversy in the media. HealthBeat’s Naomi Freundlich took a look at the problem in January. Recently, Merrill Goozner, who is a member of the FDA committee, reported on its decision. Why did the committee decide not to jack up the requirements for generics? What is it doing to ensure that generic manufacturers are meeting safety standards? Why is the FDA’s decision politically important at this point in time? A final question : Is the generic version of the anti-depressant Wellbutrin really as effective for all patients?

Imagine that you are taking a medication that works well for you. But the monthly co-pay is $75.  This is more than you can afford. A generic is available, and the co-pay is only $10. The FDA says that it is just as good. But when you take it, you’re not sure. It sometimes seems that the pain is worse—or that you are more tired, or more depressed than you were when you were taking the brand-name drug. How can you be certain? When you try to think about how you feel, you realize that your mind is trying to diagnose your mind.  It’s a standoff that leaves you totally flummoxed.

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Pity poor Marc Siegel, a hard-working, primary care doctor who is facing hard times. “As the months drag on, and my office expenses continue to increase, my patients will find that I am barely able to continue to keep my office open. Many will grow more disappointed as my carpeting grows worn and my wallpaper begins to peel,” he writes in a commentary this week for Forbes.

Struggling to survive on dwindling reimbursement from Medicare, routinely having to tell patients that insurance won’t cover their name-brand prescription drugs and batteries of diagnostic tests, Siegel, who is based in Manhattan, says he can’t even think about accepting Medicaid patients.

For him, health care reform offers no salvo for this sad state of affairs; he might have to close up shop. In fact, in Siegel’s view, health reform is not only an unmitigated disaster, it’s something more sinister as well; “the government is plotting to spread expensive insurance to pay for low-tech care for the entire population.” Government plots, low-tech care for the entire population? Hmm, who is this Marc Siegel after all?

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Summary: An exceptional essay in the April issue of Lancet explores why even healthy, asymptomatic people are terrified when they hear the word “cancer.”  Robert Aronowitz, an internist and professor of the history and sociology of science at the University of Pennsylvania, describes “cancerphobia,” a term coined in the 1950s by a Cleveland Clinic surgeon who suggested that our “fear of cancer can cause even more suffering than cancer itself . . . public health campaigns with their constant calls for surveillance and aggressive treatments combine to increase cancer fears, which in turn has led to demands for increasingly aggressive intervention and more surveillance.”  Over-testing leads to over-diagnosis and over-treatment. A study just published in the Journal of the National Cancer Institute offers disturbing numbers on the magnitude of “over-diagnoses,”  defined as “the diagnosis of a ‘cancer’ that would otherwise not go on to cause symptoms or death.”

Even when we are told that tests are ineffective or of little benefit, testing gives many patients a false sense of control over their fears. Meanwhile, cancerphobia has spawned an enormous, lucrative industry.

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The very word “cancer” inspires a degree of fear that “heart attack,” “stroke” or even “kidney failure” do not. Any of these conditions can kill. Even worse, in rare cases, a stroke can leave a patient “locked in” — conscious and able to think, but unable to speak or move.

Yet, somehow, to many of us, the idea of cancer seems more horrifying.  Perhaps it is because the word calls up an image of something evil invading the body, and then spreading. It is a growing, living thing, crawling inside one’s own body, preying on the tissue.

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Note: The “summary” below is a HealthBeat pilot project. Some readers have noted that HealthBeat posts are, well . . . a tad long. At the same time, many seem to appreciate comprehensive, in-depth coverage of a topic. HealthBeat has a niche, and I wouldn’t want to desert those readers.   So I’ve decided to experiment with offering what a medical journal would call an “abstract” at the beginning of each post. Since HealthBeat isn’t a medical journal, I’m just calling it a “summary”. Many thanks to friend and fellow blogger Joanne Kenen  for this suggestion. Please let me know what you think about the change. mm.

Summary: Short-term, at least, hospitals are winners. When it came to negotiating with reformers, they “got into the tent early,” and the reductions in Medicare increases that they accepted will be offset by an influx of paying patients. Granted, government payments to hospitals that take a disproportionate number of uninsured low-income patients will be slashed, but because there will be many fewer uninsured patients, most hospitals will come out ahead. Those that continue to care for larger share of those who can’t pay will receive additional payments.

Fear-mongers fret that cuts in Medicare spending will threaten the financial health of the nation’s hospitals: they argue that hospitals already lose money on Medicare patients. The truth is that, today, more efficient hospitals make money or break even on Medicare beneficiaries. Hospitals that run a tight ship save money and offer better care. Unfortunately, waste remains an enormous problem in many U.S. hospitals, and waste and poor quality care go hand in hand.

Medicaid’s expansion also will help hospitals. True, Medicaid payments to hospital are low, but in the past, hospitals were treating many patients who didn’t qualify for Medicaid, but were too poor to pay their bills. Low payment beats no payment.

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Since 1992, the federal government has spent close to $1 billion on abstinence-only sex education, despite growing evidence that these ideology-based programs are ineffective in delaying the onset of sexual activity, preventing teen pregnancy and the spread of sexually-transmitted disease among teens. Meanwhile, comprehensive sex education—the kind where teens are given information about both abstinence and contraceptives—has received virtually no federal funding.

That’s why it was so encouraging when President Obama released his budget earlier this year and the $50 million per year since 1996 that’s been devoted to abstinence-only programs was missing. It looked like this ill-conceived emphasis on “Just Say No” sex education had finally ended.

Except it hasn’t. It turns out that Senator Orrin Hatch attached $50 million a year for 5 years into the health care bill; it made the cut to the final version, and funding for abstinence-only sex education has been reborn. It’s not clear why the funding stayed in the final legislation—reports are that it was used as a sweetener to score the votes of socially-conservative Democrats—but now $250 million is once again available for states that agree to offer only the most restrictive no-sex-before-marriage curriculum.

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In his latest post on GoozNews,  Merrill Goozner asks; “Why Is Tom Friedman Championing Higher Health Care Costs?” Goozner is referring to a recent op-ed piece in the New York Times in which Friedman gushes about a medical device start-up called EndoStim that he says “is the epitome of the new kind of start-ups we need to propel our economy: a mix of new immigrants, using old money to innovate in a flat world.”

This new-style start-up has no headquarters and keeps expenses low by depending on “teleconferencing, e-mail, the Internet and faxes — to access the best expertise and low-cost, high-quality manufacturing anywhere,” according to Friedman. EndoStim also plans on conducting clinical trials for its experimental implantable device in India and Chile where expenses are low. “[O]nly by spawning thousands of EndoStims — thousands — will we generate the kind of good new jobs to keep raising our standard of living.”

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 Twenty-eight states are now engaged in a heated debate over the difference between a doctor and a nurse: Legislators in these states are considering whether they should let a nurse practitioner (NP) with an advanced degree provide primary care, without having an M.D. looking over her shoulder.  To say that the proposal has upset some physicians would be an understatement. Consider this comment on “Fierce HealthCare”:

 “An NP has mostly on the job training…they NEVER went to a formal hard-to-get into school like medical school,” wrote one doctor. “I have worked with NPs before, and their basic knowledge of medical science is extremely weak. They only have experiential knowledge and very little of the underpinning principles. It would be like allowing flight attendants to land an airplane because pilots are too expensive. HEY NURSIE, IF YOU WANT TO WORK LIKE A DOCTOR…THEN GET YOUR BUTT INTO MEDICAL SCHOOL AND THEN DO RESIDENCY FOR ANOTHER 3-4 YEARS. NO ONE IS PREVENTING YOU IF YOU COULD HACK IT!” [his emphasis]

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Lobbyists representing the many who profit from our $2.6 trillion health care industry spent millions in the war over healthcare reform. Yet National Journal Contributing Editor Eliza Newlin Carney suggests that “it's unclear whether all that lobbying, advertising and check-writing yielded much.”

No question, the reform legislation that finally passed falls short of many reformers’ hopes. The public option is gone. Private sector insurers will scoop up all of the new business.  Meanwhile, by agreeing to support reform—and make some financial concessions—Pharma bought protection from generic competition, plus  a promise that it can continue to set prices, without worrying about Medicare trying to bargain for discounts.

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No doubt you have seen some of the numbers about the assault that corporate lobbyists mounted to try to block health care reform: In 2009 spending on health-care-related lobbying and TV advertising topped $700 million. The Center for Public Integrity reports that much of that money funded the 4,525 healthcare lobbyists who swarmed the capitol– eight for every member of Congress. You couldn’t beat them off with a stick. Of course, many legislators didn’t want to.

Yet despite that extravagant effort, National Journal Contributing Editor Eliza Newlin Carney questions whether the health care industry’s lobbyists got good value for their dollars.

 “For health industry players . . .  it's unclear whether all that lobbying, advertising and check-writing yielded much,” Carney writes. “At bottom, partisan rifts and fickle political winds have done more to derail proposed health care changes than any lobbying campaign. That stands in contrast to President Clinton’s failed health reform plan 16 years ago, which ran aground in part because of deft insurance industry lobbying.”
That last sentence made me pause. I remember 1994, and it’s true. Lobbyists played a much, much larger role in maiming, and then killing reform.

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