Author Archives: Maggie Mahar

The FDA: What Happens When You Starve the Beast

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In October, I talked to a source inside the FDA who suggested that the agency was having a hard time keeping up with work-flow.  I quoted him on this blog as explaining that since the FDA has committed to reviewing applications for approval of a new drug within 10 months, drug-makers have been submitting “shabbier” applications that contain less evidence about risks and benefits.

“For the drug-maker it’s a gamble. The company is betting that, because we want to make the 10-month deadline, we won’t send the application back,” said the source. And often, he acknowledged, the drug-maker is right. “If you find a problem or there is something missing and it doesn’t seem terribly material, there is a tendency to overlook it. Because if you don’t it will just delay the whole process.”

In the past, he added, a company submitting an application knew that if the application wasn’t up to snuff, the FDA would send it back. But those standards have fallen: “Now we send it back [only] if it’s really crappy.”

Yesterday the FDA Science Board dropped a bombshell in the form of a report which suggests that standards at the FDA haven’t just fallen—they’ve fallen off a cliff. The title of the report says it all: FDA: Science and Mission At Risk.
The problem, according to the report: a lack of funding. The Coalition for a Stronger FDA,  co-chaired by the last three secretaries of Health and Human Services (the department that oversees the FDA), says the FDA needs a 15 percent boost in funding per year for the next five years. 

Here are just a few highlights from the report:

  • “The Information Technology situation is problematic at best—and at worst it is dangerous.”
  • “The FDA has substantial recruitment and retention issues”.
  • “Critical data…including valuable clinical trial data…are sequestered in piles and piles of paper documents in large warehouses."
  • “The FDA has an inadequate and ineffective program for scientist performance."
  • "The FDA has inadequate funding for professional development to ensure that staff maintain scientific competence."

William Hubbard, a former FDA associate commissioner who supports the Coalition for a Stronger FDA, told ABC News that the report stands out because of the "intensity of the feelings" expressed by the subcommittee.

"These people were horrified by what they found," he added.

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Obama Says No One Should Be Forced to Sign up For Insurance; Edwards Says If You Don’t, He’ll Garnish Your Wages—Who is Right?

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John Edwards’ declaration that under his health reform proposal anyone who refuses to sign up for health insurance will be subject to having their wages garnished has led to a blogstorm of often confusing debates.  Under national health reform, should everyone be required to enroll? The Edwards and Clinton plans have mandates insisting that all Americans purchase insurance; the Obama plan has a mandate for children, but not for adults

New York Times columnist Paul Krugman stirred controversy Friday by defending Edwards, and criticizing Barack Obama: “Under Obama’s health care plan, healthy people could choose not to buy insurance—then sign up for it if they developed health problems later,” Krugman observed. “As a result, people who did the right thing and bought insurance when they were healthy would end up subsidizing those who didn’t sign up for insurance until or unless they needed medical care.”

On Sunday former FCC Commissioner Reed Hundt called Krugman out on TPM Cafe in a post headlined “Ease up, Dr. Krugman.” According to Hundt: “The very idea of government mandates directed to individuals evokes a command-and-control model that disturbs citizens who want to enjoy certain freedoms in choosing health care.” As of yesterday, Hundt’s post had drawn some 60 comments—some on point, others muddying the waters.

Meanwhile, at TNR Jonathan Cohn weighs in with a long discussion of just how many people Obama’s plan might leave uncovered—and suggests that one of Obama’s advisers has information showing that under Edwards’ plan, even more Americans would be left “going naked.”

Because the conversation in the blogosphere has become such a mix of good information, misinformation and false assumptions, I’ve decided to try to spell out, as clearly as possible, why we need a mandate. Very simply, it addresses a serious defect in our health care system:  under existing rules, you don’t have to buy insurance, but you can be priced out of the insurance system if you are sick.

After examining that problem–and looking at how requiring insurance solves it– I’d like to answer a sensible question that observers like the Washington Monthly’s Kevin Drum have raised: Why force people to buy insurance? Why not just tax everyone, put the money in a pool similar to the Medicare Trust Fund, and use it to buy universal insurance?

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How the Media Covers Health Care

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Sometimes health care reporters remind me of the financial journalists who helped hype the bull market of the 1980s and 1990s. I began my career as a journalist at Money magazine, and I remember sitting in an editorial meeting where we talked about an upcoming cover story: “The Ten Best Mutual Funds NOW.”  One intrepid reporter asked: “What if there aren’t ten great mutual funds that you really should invest in right now?”

“Let the fact-checker worry about that,” someone else quipped, referring to the person who would be double-checking the details of the story just before it went to press. Almost everyone sitting around the table laughed.

And Money was generally a pretty responsible magazine that tried to warn investors against the risks of the market. Still, “good news” cover stories sold magazines—just as “breakthrough” medical stories on the local evening news keep viewers from changing the channel.

Gary Schwitzer, an associate professor in the School of Journalism and Mass Communication at the University of Minnesota, recently published a provocative piece about how the media covers health care in the American Editor. Schwitzer begins his piece by asking his reader to “Imagine a reporter filing a story from the Detroit Auto Show. She writes about one car maker’s hot new model as if it is the best thing since the ’57 Corvette. But in the excitement over the chrome and style, she doesn’t mention the cost of the new model, doesn’t compare it with other manufacturers’ offerings in the same class, and doesn’t mention anything about performance (fuel efficiency, handling, braking, safety issues, etc.)

“An editor would certainly raise questions about this kind of puffery.

“But over on the health care beat,” Schwitzer observes, “the majority of stories on new products, procedures, treatments and tests are published without including comparable information. Claims that would never be accepted unchallenged from a politician are accepted unquestioningly from physicians and researchers and company spokespersons.”

Schwitzer, who publishes HealthNewsReview.org, a website that grades health care news stories for accuracy, balance, and completeness, has evidence to back up his claim.  Below I’ve re-posted some of his data on some 400 stories from almost 60 major news organizations (available at his website) to demonstrate how many health care stories “provide a kid-in-the-candy-store portrayal of the health care system that leaves readers with the impression that most products or procedures in health care are amazing, harmless and without a price tag”:

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The Best Health Care Posts

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Check out this week’s Health Wonk Review, highlighting the best stories that have appeared on health care blogs in the past two weeks–including a post about “the sorts of people some pharmaceutical companies hire to perform clinical research . . . including one physician-researcher who managed to personally give two of his patients genital herpes . . .”

Health Wonk Review also throws a spotlight on Managed Care Matters, where Joe Paduda recently examined how US universal coverage plans could deal with illegal immigrants, but noted that meanwhile, Mexico may come up with a universal coverage system before the US does.

And on the Agonist Ian Welsh commented on John Edwards’ pledge that if Congress doesn’t pass universal health care by July 2009, “I’m going to use my power as president to take your [legislator’s]  health care away from you.” Time magazine’s Joe Klein was appalled, calling Edwards’ statement “demagogic nonsense.” Welsh disagrees. ( I would be interested in what Health Beat’s readers think.)

This week, Dr. Roy Poses picked the posts for Health Wonk Review.  The editor of Health Care Renewal, Poses specializes in “addressing threats to health care’s core values, especially those stemming from concentration and abuse of power.” 
I began talking to Poses before I started this blog, and I have the greatest respect for his work. He pulls no punches, and backs up his pieces on conflict of interest and fraud with excellent research.  Honest physicians know, better than anyone, what is going on in our health care system, and Poses is one of the guys carrying a torch.

The New York Times “Gets Cracking” on Rising Health Care Costs

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On Sunday the New York Times published an editorial that set out to analyze “The High Cost of Health Care.” The result might best be described as “muddled.”

What is exasperating is that about 85 percent of the facts in the editorial are true. But a good 15 percent are simply wrong.  And the Times’ editors managed to weave truth and error together in such a way that it would take a knitting needle to separate the two. As Matthew Holt put it on The Health Care Blog: “the piece looks entirely as though it was written by a committee that couldn’t agree with itself.”

As you read the editorial, you can almost see the editors sitting around a table, negotiating. “Okay,  we’ll let that sentence about the value we’re getting for our dollars stand—as long as well keep this sentence about  ‘skin in the game.’”  The result, a mix of propaganda and analysis, is far more dangerous than outright lies because the many true facts make the whole thing sound credible.   

Because I hate to see our paper of record disseminate disinformation, I am going to try to separate the wheat from the chaff. Begin with the truth: Near the top of the story, under a sub-head that reads “Varied and Deep-Rooted,”  the Times provides a nice summary of the main reasons why we lay out roughly twice as much as the average developed nation, without getting care that is twice as good:

“we pay hospitals and doctors more than most other countries do. We rely more on costly specialists, who overuse advanced technologies, like CT scans and M.R.I. machines, and who resort to costly surgical or medical procedures a lot more than doctors in other countries do. Perverse insurance incentives entice doctors and patients to use expensive medical services more than is warranted. And our fragmented array of insurers and providers eats up a lot of money in administrative costs, marketing expenses and profits that do not afflict government-run systems abroad.”

Spot on. If only this section of the editorial had not begun with a casual half-truth: “Contrary to popular beliefs, this is not a problem driven mainly by the aging of the baby boom generation, or the high cost of prescription drugs, or medical malpractice litigation that spawns defensive medicine.”

They first part of the sentence is correct: the aging of the boomers is not a major cause of health care inflation.  The last clause of the sentence is debatable, though probably true.
What’s troubling is the middle clause:  Why does the Times feel obliged to declare that the “high cost of prescription drugs” is not an important factor behind soaring medical bills?

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Health Care Reform: What Do Americans Want? (Or Think They Want?)

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On the surface, it seems that American voters have made their will clear.  Poll after poll shows that they are calling for a major overhaul of our health care system.

But when you look closer, their responses bristle with contradictions, contradictions that I think the reform-minded presidential candidates will have to consider when deciding how to approach health care reform. 

In a poll reported in Health Affairs at the end of last year, sixty-nine percent of respondents rated the US system as “fair” or “poor.” Yet in the same survey, when asked about their own experience with receiving medical services or with their own physician, 80 percent who had received care in the last year ranked their care as “excellent” or ”good.”

Other polls reveal the same pattern.

According to a survey released by Greenberg Quinlan Rosner in July, voters express doubts about the quality of the American health care system (with 49 percent dissatisfied), while 74 percent were dissatisfied with the cost.   Yet, “at another, more personal level,” the pollsters note, “a slightly different picture emerges. Fully eight in ten (82 percent) describe themselves as satisfied with the quality of the health care they receive personally. This number jumps to 90 percent among seniors (64 percent very satisfied), but includes impressive majorities of nearly all groups…”

Nevertheless, when the pollsters asked the same group about health care reform, three-quarters called for “major changes” or “completely rebuilding” the system. 

If they are satisfied with the care they are receiving, why would they want radical change? Because they don’t feel secure that they will be able to keep what they have:  “There’s a precariousness to Americans’ contentment with their own health insurance coverage,” the Kaiser Family Foundation reported after looking at a number of polls at the end of last year.  “Among the insured, six in ten are at least somewhat worried about being able to afford the cost of their health insurance over the next few years, and nearly as many (56 percent) said they worry that by losing a job, they or their family might be left without coverage.”

This, then, is why so many Americans want universal health care: it would guarantee that they and their families would always be covered.

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How Wall Street Reacts to Fraud in Our Health Care Industry

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This appeared on Bloomberg News today:

“WellCare Shares Jump After Analyst Calls Fraud Probe `Limited’

Nov. 20 (Bloomberg) – WellCare Health Plans Inc., the U.S. health insurer under investigation for possible government overpayments, rose the most in two weeks in New York trading after an analyst upgraded the company.

“The analyst, Carl McDonald of CIBC World Markets in New York, called the probe ‘limited’ and raised his rating of WellCare to ‘sector outperform-speculative’ from ‘sector perform.’ WellCare rose $2.38, or 6.8 percent, to $37.39 at 9:40 a.m. in New York Stock Exchange composite trading after touching $38.14.

“A U.S. government raid of WellCare’s Tampa, Florida, headquarters on Oct. 24 yielded thousands of records, including papers pulled from a shredder bin and files on offshore bank accounts, according to court filings. McDonald said the filings suggest the probe is focused on Florida’s Medicaid program for the poor.

“’It’s possible that the Florida Medicaid investigation spreads into other areas, but the document seems to rule out widespread, systemic fraud,’ the analyst said in a note to clients today.”

Bloomberg also reveals that: “The agents seized records from the desks of Chief Executive Officer Todd Farha and Chief Financial Officer Paul Behrens, according to the court records. From Behrens’ desk, agents grabbed a document called the ‘Stairway to Heaven Plan,’ according to the inventory.

“Also taken were wire transfers, tax returns, bank accounts in the Grand Cayman Islands, a calendar of political visitors and contributions, and phone lists. One seized document was labeled ‘Re: Possible Kickback,’ according to the court records”.

Yet none of this seems to bother the analyst who upgraded the stock or the many investors who followed his upgrade–pushing the share price up 6.8 percent this morning.  The analyst predicts that “that WellCare [will] settle, pay a fine, but remain in all its businesses, rather than being put out of business.”

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Herzlinger’s Meme on Switzerland and Consumer Driven Medicine

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In today’s Wall Street Journal, Harvard Business School professor Regina Herzlinger offers an upside-down account of what’s right and what’s wrong with Switzerland’s health care system.  A leading advocate of “consumer driven” health care, Herzlinger assumes that because the Swiss pay for so much of their care out of their own pockets, consumer choice drives their system. 

But the truth is that Swiss patients have relatively little say over either the cost or the quality of the care they receive. Prices are regulated by the government, which also tries to make sure that consumers are getting value for their health care dollars by selecting which drugs, devices and tests insurance will cover. In fact, it is the very visible hand of a smart, largely efficient government that accounts for Switzerland’s relative success.

Before explaining how Herzlinger gets so much so wrong, let’s look at what she gets right. “The Swiss have achieved universal coverage,” Herzlinger points out “at a far lower cost than the U.S.”  In 2003 Switzerland spent 12 percent of GDP on health care while we laid out “a staggering 15 percent of GDP” while leaving roughly 14 percent of our population uncovered. Switzerland also has “far better health outcomes than the U.S., even when Switzerland is compared to socio-demographically similar U.S. states such as Connecticut and Massachusetts,” Herzlinger acknowledges. Moreover, while U.S. insurers in most states can shun sick customers, either by refusing to cover them—or by charging them astronomical premiums—in Switzerland you are not penalized for having cancer. The sick “can afford health insurance and pay the same price” as everyone else.

Finally, while the cost of care continues to snowball in both countries, the Swiss seem to have a better handle on health care inflation. From 1996 to 2003 health care spending in Switzerland rose by an average of 2.8 percent a year, Herzlinger says, versus 4.1 percent in the U.S.  Meanwhile “Switzerland boasts substantially more in the way of health-care resources and . . . tops the world in most measures of user satisfaction.”

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Does the U.S. Have Too Many Doctors?

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On the Buckeye Surgeon blog, a general surgeon from Cleveland, Ohio, questions what he calls “the almost dogmatic assumption that the United States is facing a physician shortage is the coming years…We’re always reading that we need to train more doctors, that with the aging population there won’t be enough physicians to satisfy demand. But then I was waiting for the elevator the other day, reading the names of all the doctors on the peg board who practice at one of my hospitals. The board is 4×4 feet and just crammed with names, names, names. It’s unbelievable how many doctors there are.”

“There’s two large GI groups,” Buckeye Surgeon continues. “There’s three general surgery groups. There’s three separate pulmonary groups. The ID group has 7 doctors. (Don’t get me started on ID again). And on and on. What we have isn’t a physician shortage, but rather a physician overabundance. And I don’t think it’s too different at most suburban hospitals across the country. The scenario isn’t one of overworked doctors struggling to keep up with the demands of patients waiting in line for care. Rather, it’s a hyper-competitive world of doctors in the same specialty fighting over a limited supply of patients.”  (Thanks to Kevin, M.D. for calling my attention to Buck Eye’s post.)

Buck Eye Surgeon is offering an anecdotal view of physician supply, but rational research backs up his claim. When the Council on Graduate Medical Education (COGME) warns that we need to train more physicians to meet the demands of aging baby boomers, the Council assumes that the current national physician-to-population ratio is optimal.  Those who call for more physicians “never examine the relationship between physician supply and the health of patients and population” notes Dartmouth’s Dr. David Goodman in a 2005 Health Affairs article, “The Physician Workforce Crisis: Where Is the Evidence?” (For more about Dr. Goodman, his background and his evidence, see "David
Goodman, M.D.: Counting All Doctors" in Dartmouth Medicine )

Take a look at the evidence, and it’s clear that the conventional
wisdom is wrong. As I’ve discussed in the past, in areas of the country
that boast more specialists, patient outcomes are worse—even after
adjusting for differences in age, race and the overall health of the
population. (I have written about this for both Health Beat and Dartmouth)
A greater supply of primary care physicians, on the other hand, leads
to better outcomes. So, Goodman quite sensibly concludes: “If improving
the health and well-being of the population remains our goal we need
more generalists and fewer specialists, today and in the future.”

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Desperate, Drug Makers Court Doctors in Developing Countries

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In the U.S. we are accustomed to seeing exceptionally well-dressed drug company reps strolling into doctors’ offices bearing trinkets: coffee cups, note pads and pens. We also know that they take doctors to expensive dinners, and host “continuing education” junkets to warm climes. Device-makers have been known to ferry doctors to strip clubs after dinner.

But in the developing world, drug makers are pulling out all of the stops. Often there is not even a pretense that the gift will help the doctor do his job. In Kashmiri, a physician confides, “representatives of pharmaceutical  companies offer cash, refrigerators, color televisions, laptops, PCs, mobile phones, ovens, phone bills, [and even to pay school] tuition [for your] children.”

In India, a doctor from Mumbai reports:  “On sale of 1,000 samples of the drug, you get a Motorola handset. On sale of 5,000 samples you get an air cooler. On sale of 10,000 samples get a motor bike.”

In Pakistan, a survey of 149 doctors, 100 medical information officers (sales representatives) and 99 medical store personnel, found that gifts may include included air conditioners, cars, cash, home appliances and domestic cattle.   Murad M. Khan, professor & chairman of the department of psychiatry at Aga Khan University, describes the latest practice: For writing 200 prescriptions of a company’s high-priced drug, a doctor is rewarded with the down payment on a brand new car.

These are just a few of the enticements documented in a November 2007 Consumers International (CI ) study, "Drugs, Doctors and Dinners: How Drug Companies Influence Health in the Developing World." (Thanks to Gary Schwitzer, at Schwitzer Health News Blog, for calling attention to this report.) A global voice for consumers, CI is an independent not-for-profit boasting over 220 member organizations in 115 countries.

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