FDA Approves Devices Without Scrutiny, Putting Patients At Risk

There was real excitement two weeks ago among some FDA officials and drug and medical device lobbyists when reports came out that Senator Charles Grassley (R-IA) might leave his position as leader of the Senate Finance Committee to take over Arlen Specter’s spot as ranking member of the Judiciary Committee. Grassley has been a tenacious critic the Food and Drug Administration’s oversight of food, drug and medical device safety. He’s also fought to curtail industry payments to physicians and researchers who conduct trials on new drugs and devices.

 As it turns out, the cheering was premature. The FDA—and its new leadership—will still have to answer to Chuck Grassley, at least for the near future: The Judiciary position was given to Senator Jeff Sessions (R-Ala), although Grassley is likely take over leadership at the end of next year.

Advice to Insurers on How to Capture Customers -- Appeal to Emotions, Not Reason

As more and more employers back out of the health benefit business, more and more individual consumers are shopping for health insurance these days. Yet sales have remained relatively flat The McKinsey Quarterly reports in its most recent issue. “What,” McKinsey asks, “is preventing health insurers from effectively addressing pent-up demand?”

My first thought was that the answer might have something to do with the fact  that consumers are having a hard time finding insurance that offers good coverage at a price they can afford. But apparently I’m wrong. The article’s authors suggest that insurers just don’t know how to advertise their product: “Our research suggests that a primary barrier is [insurers’]  belief that consumers make economically rational decisions about health benefits. It’s a misguided view. Faced with more choice, complexity, and financial exposure for their health care in an increasingly uncertain world, what consumers are really seeking is peace of mind.”

Spinning Health Care Reform: Why Liberals Shouldn’t Learn to “Frame” Issues

Frank Luntz, a master manipulator of language who helped create the rhetoric that conservatives used throughout the 1990s, is now offering Republicans advice on how to talk about health care reform.

First, they must embrace the idea: “You simply MUST be vocally and passionately on the side of REFORM,” Luntz advises in a confidential 26-page report that Politico.com obtained from Capitol Hill Republicans.

Most Americans want health care reform, and so Republicans should forget about simply opposing President Obama on this issue. But they can redefine what reform means, says Luntz, author of Words that Work: It’s Not What You Say, It’s What People Hear.

Health Care Industry Promises to Slow Spending on Health Care

Why?

You’ve seen the headlines: “Health Care Industry Offers to Rein in Spending”; “Stakeholders to Obama: We’re Ready to Cut Costs”?

What does this mean? I think it means that the industry—and in particular the insurance industry—is afraid, very afraid that the healthcare reform train is going to leave the station without them. They’re desperate to have “a seat at the table.” 

And so they are admitting what President Obama, White House Budget Director Peter Orszag and bloggers like yours truly have been saying for more than a year: we must rein in health care spending.  Over the weekend, the Wall Street Journal announced that the president would be receiving a letter signed by leaders of of Pharma, Advamed (device manufacturers), the American Medical Association (doctors), the American Hospital Association, America's Health Insurance Plans, and the Service Employees International Unions.  In that letter, the signers pledge “to do our part to achieve your Administration’s goal of decreasing the annual health care spending growth rate” by 1.5 percent a year, “saving $2 trillion or more . . .  we are developing consensus proposals to reduce the rate of increase in future health and insurance costs through changes made in all sectors of the health care system."  Today the president announced the industry’s promise.

A Mother’s Day Present That Only a Blogger Would Love

Blog-bioethics reports that drug giant Merck has gone into the publishing business, creating a fake “peer-reviewed” medical journal to tout its products. (Hat-tip to reader and son Michael Klotz for calling my attention to this story yesterday—an unexpected Mother’s Day gift).

Summer Johnson writes: “It's a safe guess that somewhere at Merck today someone is going through the meeting minutes of the day that the hair-brained scheme for the Australasian Journal of Bone and Joint Medicine was launched, and that everyone who was in the room is now going to be fired. [ I’m afraid Johnson may be little optimistic about how Merck makes firing decisions—mm]

Provider Backlash

Fifteen years ago, insurers were trying to put a brake on healthcare costs by “managing care”—which often meant saying “no” to patients. Too often, insurers denied coverage for care that patients needed. Then came the backlash against managed care, and insurers relented.  They began to say “yes” to more treatments, and passed the cost along to customers in the form of higher premiums, co-pays and deductibles. 

More recently, insurers have begun trying to save money by shifting their focus from patients to doctors. Increasingly, insurers have been delaying payments to physicians, and, doctors say, insurers are underpaying for many services. Physicians are now fighting back, bringing lawsuits against insurers. Doctors often complain that we live in a terribly litigious society. Now, they are hiring the lawyers. Are the suits justified?

The World Turns

Below, a guest post by Pat S. . I would add only that I share his faith that the system will change because the current paradigm is  both untenable and unaffordable. Some older doctors will resist change, but I believe that many, who have been increasingly frustrated for the past twenty to twenty-five years, will welcome it.  One paper distributed at the Mayo Clinic conference reminded everyone that when a doctor takes an oath to practice medicine, he is implicitly committing himself to “continuous improvement.”   MM

The World Turns

“What you have outlined is the usual situation when orthodoxy is replaced. Many old ideas have been difficult to discredit over the course of medical history.” – HealthBeat reader Christopher George

Back in the 60’s, Thomas Kuhn published his famous work, The Structure of Scientific Revolutions.  One of his basic models is that existing paradigms for scientific systems persist until it becomes impossible for them to continue to function because of their failure to account satisfactorily for real world data and until their explanations of that data become too complicated and cumbersome to be acceptable.  At that point the environment is conducive to replacing the old system with a new model.

The Pediatric Intensive Care Unit— The canary in the healthcare coal mine

Below, a guest post from HealthBeat reader and blogger, Dr. Chris Johnson. Formerly the head of the pediatric intensive care unit at the Mayo Clinic, Johnson is the author of Your Critically Ill Child and blogs at www.chrisjohnsonmd.com.

When you read his post, it is worth remembering that a larger share of U.S. children live in poverty than in any other nation in the developed world.

We have known for a long time that  poverty is associated with illness. Tiny Tim did not die at the end of Dickens’ Christmas Carol. The reason he lived was because, just in time, Scrooge had an epiphany and raised the Cratchit family’s standard of living. That Christmas goose brought more than good cheer to the Cratchits — it brought good health, too. Some historical studies, such as those of Thomas McKeown,   have linked the long population rise of the past century to improved nutrition. Experts still debate if this is true or not, but either way it is old news.

It may be old news, but for today’s Tiny Tims it is still very much current news. The furious debates over what to do about health care reform are often about choice — what choices Americans should have selecting their health care, what choices doctors should have in providing it, and what choices society has in paying for it. I take care of children, so that is the lens through which I see the issue. And children have no choice at all in this matter, because the family they are randomly born into determines everything, even if they will live or die. Across America we have constructed what are, in effect, a series of laboratories to test the results of what happens when different sorts of children get severely ill. These laboratories are pediatric intensive care units.

Reinventing the Way We Train Doctors and Nurses

While in medical school, students are supposed to know the answers. They spend hours cramming, memorizing arcane language and hard-to-remember numbers so that if the question appears on a test—or worse still,  if a resident decides to quiz them during rounds—they can answer it.

“I don’t know, but I know where to look it up,” is not an acceptable response.

“Looking up the answer is considered cheating,”  Dr. Denis Cortese, president and CEO of the Mayo Clinic pointed out on the opening day of Mayo’ s National Symposium on Medical and Health Care Education Reform.

Yet, Cortese observed, once the student becomes a doctor, he is supposed to “cheat”—i.e.  look things up. He is not supposed to “take a stab” at the right dosage the way he might take a stab at the right answer on an exam. His patient’s well-being depends upon him knowing where and how to look up the information he needs, or whom to consult.  A doctor who is reluctant to admit “I don’t know” is a dangerous doctor.

Today, we recognize that medicine is a team sport. No one doctor can know everything that he needs to know, even in his own specialty.

Yet, we continue to train would-be doctors as if they were going to be practicing medicine circa 1950, when “The Doctor” was supposed to have all of the answers. 

The Symposium acknowledged that today, we are educating medical students the way we always have—preparing them to work in the old, broken system that we are trying to reform.  Just as the system requires change, so does medical education.                

For instance, the symposiums’ participants recommended that “Exams should test information use and information gathering rather than memorized knowledge.”  Moreover, rather than spending all of their time in classrooms and hospital wards, students should spend more time learning to practice medicine in real-life settings.  Voting on the best solutions to improve medical care, the majority of the audience agreed that “to understand patients, students should interface with the patients in their communities, experiencing medical care through their patients’ eyes and experiences.”  

Finally, we need to change the way we choose students for admission to medical school. One speaker made a persuasive argument that today, we rely too heavily on grade point averages (GPAs) and medical college admission tests (MCATs). We need to draw medical students from a larger pool.