More about money in health care.
The New York Times reports: "As the Guidant Corporation came under scrutiny last spring for not telling doctors about potentially fatal defects in its heart devices, the company's public message was upbeat and insistent: concerns about the safety of its products were overblown, it said, and perhaps even irresponsible. But newly released documents show that, inside Guidant, executives were struggling to contain a mounting crisis. The records illustrate how a series of miscalculations by Guidant, like its misreading of doctors' tolerance for being kept in the dark and its initial decision not to recall the devices, put the company on the defensive. "
According to the Times, in 2004, Guidant's heart device division accounted for about half of Guidant's $3.8 billion in sales. Defibrillators, which cost up to $35,000 each, have a profit margin of about 75 percent.
One physician says in the story, "I will not work with a company that put profit and image in front of good patient care and honesty in device manufacturing."
The Star Tribune reports that UnitedHealth Group CEO Dr. William McGuire sold about 6 percent of his stock and options Friday for $135.7 million. Subtracting what he paid to exercise his options, the paper speculates, may drag his net gain down to $123 million.
Past sales of stock and options reported by the paper have netted McGuire:
$114 million in 2004
$84 million in 2003
$50 million in 2001
$46 million in 2000.
The Milwaukee Journal-Sentinel reports that WTMJ-TV in Milwaukee dismissed its medical reporter Kimberly Kane last week. Kane had worked at the station for seven years. The station’s news director did not respond to the newspaper’s e-mails asking about the reporter’s status.
The TV reporter told the newspaper in an e-mail: "When the most recent administration took over leadership of our newsroom, it was made clear to me their commitment to health was different. I was told to take my stories in a different direction: more controversies, more excitement . . . "
She said some of these changes made her "uncomfortable."
No one on the outside can judge a personnel matter. But her statement that management was pushing her toward more controversies and more excitement certainly aligns with what most of us receive in local TV health news – an abyss for consumers who need fact more than flash, who need evidence-based reporting more than emotion, who need health policy news more than breathless breakthrough gee-whiz gushing.
Incidentally, the station in question, WTMJ, is where I began my journalism career 34 years ago. The newsroom then had a bunch of veteran newspeople. Many were much older than anyone you see on the air today. They were much more than pretty faces. They knew the city and they knew its people and politics and budgets. They knew what viewers cared about and they reported what they needed to know – not what some consultant told them people wanted to see. They knew B.S. when they heard it. And they never – NEVER – followed what was in the newspaper. They originated their own stories. Show me a TV station that matches that description today. And never would someone have been canned because he/she didn't generate enough controversy or excitement in the news. But that was a long time ago.
University of Minnesota researchers announced Sunday that they were able to reverse diabetes in monkeys by transplanting insulin-producing cells from pigs.
The Star Tribune's sub-head read, "A new study raises the potential for an endless supply of insulin-producing cells to cure the disease that affects 20 million Americans." Mind you, this work was done on a few monkeys. Yet the headline trumpets a potential impact on 20-million Americans. At least the first line of the story read, "They're not ready to try this with people yet. "
KMSP TV wrote "Scientists at the U of M are closing in on a cure."
WCCO TV wrote this was a "breakthrough that could lead to the end of injections for tens of thousands of diabetes patients."
KARE TV wrote "While many consider pigs a cure for hunger, they could also harbor the key to curing Type 1 diabetes."
The Pioneer Press headline read, "U finds pig cells can treat diabetes." Treat? Yeah, in monkeys. The story went on to say this development gives "renewed hope that a better treatment, or even a cure, may soon be available." Soon? The researcher says human trials are three years away. How would you define soon?
Read my "Seven Words You Shouldn't Use in Medical News.". Cure, breakthrough, and hope are all on the list. And I didn't create the list. Sick people provided the impetus. This important piece of diabetes research could have been told with a lot less sensationalism. The story didn't need it. Neither do sick people.
A physician writes about concerns over the fast track approval of new drugs in this week’s BMJ.
Three months after the Food and Drug Administration gave the drug natalizumab accelerated approval for treating relapsing multiple sclerosis, its makers withdrew it after three patients developed life-threatening conditions. Two of them died. The author lists the things that went wrong on the fast track: cumulative safety data weren't available, the trials' end points were dubious, the drug’s mechanism of action was always risky, and the animal model was not suitable.
The drug was licensed by the FDA in 2004 on the basis of short term results from two unpublished trials. The FDA granted approval before final trial and cumulative safety data were available. Natalizumab was predicted to be the leading drug for multiple sclerosis, with estimated annual sales in excess of 2 billion dollars.
The author says this case highlights the potential risks for patients in trials of new drugs where knowledge of long term efficacy, outcome measures, and safety is lacking.
According to the New York Times, the Harvard Center for Risk Analysis accepted a half million dollars from the Tuna Foundation to study the risks and benefits of hypothetical changes in fish consumption, but didn’t disclose Big Tuna as the primary funder of the work.
The study appeared in the November issue of the American Journal of Preventive Medicine.
The Times reports that “Critics say the failure to identify the source of the funding is a conflict of interest. Edward Groth, an environmental health expert retired from Consumers Union, said: ‘No matter how well they did their analysis, since an affected industry paid for it, its credibility is suspect.’ “
Last week, Dr. Jerome Kassirer of the Tufts University School of Medicine, and author of ''On The Take: How Medicine's Complicity With Big Business Can Endanger Your Health,” had an op-ed piece under the headline above in the Boston Globe.
He wrote about what he called “corruptive influences in medicine.” For example: “The settlement of the $185 million class action lawsuit against Bristol-Myers Squibb announced at the end of January is a lesson in how physicians paid by the pharmaceutical companies as speakers and consultants can be hazardous to your health. While most of the attention of this suit focuses on how company officials defrauded investors by overly flamboyant predictions for the sales of the highly touted ''blockbuster" drug Vanlev, documents prepared for the suit show that behind the scenes, Bristol-Myers Squibb-paid physicians in major medical meetings were shamelessly exaggerating the benefits of the drug for patients with high blood pressure and heart failure and failing to report publicly on substantial numbers of life-threatening drug complications which they knew, from their close relationship to the company, to exist. Fortunately, the FDA saved hypertensive and cardiac patients from ever receiving Vanlev because it knew about the potentially fatal events, determined that they were excessive, and Bristol-Myers Squibb was eventually forced to withdraw its application to market the drug.”
Kassirer concluded: “It's about time that pharmaceutical companies cut back on their massive campaign to influence doctors and to use paid ''experts" to influence other doctors. It's about time physicians, academic medical centers, and professional medical organizations wean themselves away from the deep pockets of companies whose principal goal is not education but marketing.”
Meantime, USA Today last week reported that “at least nine states are considering bills that would require drugmakers to publicly report how much they and their sales representatives give to doctors, hospitals and pharmacists each year. A few proposals go further: A bill under debate in Massachusetts would ban all gifts to medical professionals from the drug industry. … Four states — Vermont, Minnesota, West Virginia and Maine — and the District of Columbia have laws requiring gift reporting by drugmakers. California requires that drugmakers declare they are compliant with federal and industry gift guidelines.”
The NY Times had a gut-wrenching story this week, "A Cancer Drug Shows Promise, at a Price That Many Can't Pay."
The drug is Avastin, which, as the Times reports, is "a drug already widely used for colon cancer, as a crucial new treatment for breast and lung cancer, too. But doctors are cringing at the price the maker, Genentech, plans to charge for it: about $100,000 a year. That price, about double the current level as a colon cancer treatment, would raise Avastin to an annual cost typically found only for medicines used to treat rare diseases that affect small numbers of patients. But Avastin, already a billion-dollar drug, has a potential patient pool of hundreds of thousands of people — which is why analysts predict its United States sales could grow nearly sevenfold to $7 billion by 2009. Doctors, though, warn that some cancer patients are already being priced out of the Avastin market."
The Times profiled how one man with cancer was forced to do his own cost-benefit analysis regarding a new cancer drug, and chose to decline a drug that he thought might only have marginal benefit for him. The drug would have cost him $1,000 a month even though he's covered by Medicare. He is quoted in the story: "If anybody came out and said, 'By God, this is the stuff. You want to get well, find a way to buy it,' that would be one thing. But that isn't the case. The forecast of how much it's going to do is not that wonderful."
How many other Americans are facing those decisions and making those choices?
On his blog this week, Merrill Goozner reflected on a Wall Street Journal story headlined "Oil Hits a Gusher." The story had an interesting bar chart that showed that fourth quarter profits for U.S.-based oil companies rose a stunning 66.4 percent over a year ago, and accounted for nearly two-thirds of the entire $20 billion increase for all corporations.
But Goozner writes that "what also caught my eye was the other really long bar in the Journal chart. Health care corporations increased their profits in the same quarter by 68.5 percent -- two full percentage points more than Big Oil! And that accounted for another 30 percent of the increase in total corporate profits in the fourth quarter. In other words, Big Oil and Big Health got it all (utilities accounted for most of the rest)."
Yet the U.S. has 45-million people without health insurance, and an administration trumpeting the merits of a market-driven solution to health care (disingenuously marketed as a "consumer-driven" solution!). Americans, who have already been told they are "addicted to oil, " clearly can't afford to also be addicted to health care.
The Los Angeles Times reports that "President Bush talked on Wednesday about good health, and his plan to help America pay for it, at the home office of the nation's third-largest purveyor of hamburgers and French fries. Speaking in the lobby at the headquarters of Wendy's International, Bush urged Americans concerned about healthcare costs to consider a fledgling government program built around high-deductible insurance for catastrophic illness or accidents and tax-free personal savings accounts to pay for routine medical needs."
The Times quoted the President saying "If patients control how their healthcare dollars are spent, the result is better treatment at lower cost." But the President then used the absurd example of what he said was the decrease in the cost of laser eye surgery, which is usually not covered by insurance. As a result, he said, patients sought the best price because they paid for the procedure themselves.
The president needs to look beyond price. Why aren't insurance companies covering laser eye surgery. Perhaps evidence (efficacy and safety) and quality concerns come into play - something true health care reform should care about.
Some critics questioned the speech being given at Wendy's. The Center for Science in the Public Interest asked, "Was the lobby of Philip Morris unavailable?" But the White House chose Wendy's because of how the company has embraced health savings accounts.
In the 80s, Wendy's ran a famous ad mocking its competition with the tagline, "Where's the beef?" (Walter Mondale also used the line as a presidential candidate mocking a competitor's platform.) Today, many people question "Where's the beef?" in the president's health plan.
Bloomberg News reports that the medical device industry is fighting the FDA over the use of the word “recall.” Companies such as Medtronic, Boston Scientific and Guidant have had to deal with the FDA a lot lately over reports of problems with devices such as implantable defibrillators. The FDA calls it a recall when a company has to repair or replace such defective products.
But the industry says “recall” is misleading because faulty device implants don’t have to removed like faulty car parts. So industry wants to replace “recall” with “field corrective actions.”
An industry spokesperson said “We want to communicate clearly with our users and our patients on how to manage our products, and the word ‘recall’ gets in the way.”
Hmmmm. And the words “field corrective actions” help with clear communication?
The Center for Science in the Public Interest offers a newsletter called “Integrity in Science Watch.”
You can subscribe by writing to: science@cspinet.org.
Last week’s newsletter had this item:
New York Times Fails To Disclose Researcher's Ties to Antidepressant Makers
A new study published this week in The New England Journal of Medicine showed an increased incidence of lung disease in children born from pregnant women taking antidepressants like Paxil, Prozac, Celexa and Zoloft. While the New York Times report quoted a Food and Drug Administration official calling the results "very worrisome," it countered with study co-author Christine Chambers of the University of California at San Diego, who downplayed the risks. "We don't know for certain that the drugs actually caused persistent pulmonary hypertension, and that if they did, the risk is still low, about one in a hundred," she said. The Times failed to report that Chambers and her co-authors have numerous ties to pharmaceutical firms, including Barr Laboratories, Par Pharmaceutical, Teva Pharmaceuticals, Sandoz, and GlaxoSmithKline, all of which make at least one of the drugs in the test.
Princeton health economist Uwe Reinhardt published an editorial in last week’s BMJ examining claims made about “consumer empowerment” via health savings accounts.
He wrote: “Not ever mentioned in the marketing of this ‘consumer empowerment’ are two important side effects. Firstly, the approach inevitably delegates most of the expected belt tightening in health care to families in the lower half of the nation's income distribution, whose decisions on health care are most sensitive to high out of pocket costs. In effect, the proposal seeks to ration health care by income. Secondly, the approach would shift more of the financial burden of health care from the chronically healthy to the chronically ill.”
Promoters of health savings accounts talk about giving consumers the information to make smarter purchasing choices. “How readily, however,” Reinhardt writes, “can the ambitious infrastructure for information envisaged by the president be constructed?”
There’s a thoughtful news criticism piece on the CJR Daily website. It’s headlined, “A Heaping Serving of Baked Kolata, Hold the Caveats.”
It questions why the New York Times put on its front page Gina Kolata’s story on a study questioning the impact of low-fat diets on postmenopausal women. Meantime, the piece explains that the Wall Street Journal put the story “deep, deep, deep inside the paper. Specifically, under a one-column headline on page D5. And even though the Journal's article about the federal study was less than half as long as the Times' piece, it managed to bring to the topic twice the skepticism.”
The criticism concludes: “what a paper such as the Times chooses to include on its front page is at least as important as what it excludes. On this one, we recommend a little less Kolata in the diet, and a few more caveats.”
Veteran health journalists have not forgotten the Kolata page one hype of a “cancer cure” in 1998. For that background, see another Columbia Journalism Review piece. It provides one more piece for the archives of questionable editing at the Times (Judith Miller? Jayson Blair?).
The Washington Post reports on an FDA advisory panel recommendation to add warnings on attention-deficit hyperactivity disorder (ADHD) drugs because of reports they may have caused sudden deaths or other serious problems.
The Post quotes Dr. Curt Furberg of Wake Forest University Medical School: "On the surface, it is hard to believe. What is also interesting is this condition is not really recognized in other countries -- you wonder what we are treating. I am sure there are patients who need these drugs, but it is not 10 percent of all 10-year-old boys."
This blog continues to chip away at some of the myths surrounding "consumer-driven health care." It seems appropriate to inject some other perspectives into the discussion, since the President has portrayed this approach of heath savings accounts as a health care reform solution.
Last week the Government Accountability Office reported that Federal Employees Health Benefits Program members enrolled in high-deductible health plans associated with health savings accounts on average are younger than those enrolled in traditional plans and more likely to have annual incomes of $75,000 or more. Rep. Pete Stark (D-Calif.) said the report "verifies" that HSAs "are designed for healthy, wealthy people," adding, "Despite this reality, President Bush is pushing them on low-income workers -- not to provide them with better health insurance, but to meet his long-term goal of dismantling employer-provided health care."
Also last week, the Wall Street Journal examined how HSAs "are generating savings on payroll taxes for companies that adopt them, and they could hasten a shift of health care costs from companies to employees."
This week, some Knight Ridder newspapers ran an article headlined "Bush's HSA proposal hinges on dubious premise." The article states that "President Bush's proposed expansion of Health Savings Accounts depends on a premise that research shows is questionable: that Americans want more financial choices in their lives." It quotes a Columbia University behavioral economist: "It's the chicken-and-egg problem. On one hand they want more choice, but on the other they have problems choosing. With health care, the obvious issue is that unlike chocolates and jams, no matter what option you pick, it has serious consequences."
Jessie Gruman, Executive Director of the Center for the Advancement of Health, offers an essay on “consumer-driven health care” on the Center’s website.
She writes that:
“Consumer-driven health care tells you it will pay 100 percent for your screening and early detection costs because you can’t be trusted to go to the doctor on your own when you feel healthy. But when you are sick and least able to make a rational decision, it tells you to make your own call on which expensive drug to take or whether to opt for surgery.
It tells you to spend only when necessary and only on the best treatments. But it gives you no real information on which measures are the best.
The incentives in consumer-driven health care are backwards. …
The belief that the consumer is at fault for excessive health care spending will just lead to solutions that not only don’t work but also result in more cases of preventable illness. It adds insult to injury - it’s your own damn fault you are in the hospital or grave….”
Freelance writer Tinker Ready delivers a terrific piece in the Washington Post about the ties between drug companies and nonprofit health advocacy groups.
She begins the piece: "Diabetes patients anxious to weigh the pros and cons of an experimental diabetes drug called muraglitazar might expect some help from the American Diabetes Association (ADA). But they won't find much on the ADA Web site.
For example, there is no information about research linking the drug to possible increased risk of fatal heart problems. Also, the Web site has yet to report that the Food and Drug Administration (FDA) approved the drug only on the condition that its maker, Bristol-Meyers Squibb -- which last year donated more than $1 million to the ADA -- produce additional safety data first. The diabetes group acknowledges financial support from the drug maker in its annual report and on a Web page called 'Corporate Health Ambassador Case Study,' but not the precise amount of the donation.
Similarly, if patients have questions on drugs for bone loss, they might think the National Osteoporosis Foundation (NOF) would help sort things out. But the NOF Web site doesn't get into the scientific debate over the long-term effects of Fosamax, the most popular osteoporosis drug on the market. Merck, the maker of Fosamax, is a longtime NOF donor, and it's named in NOF's annual report. But the organization does not disclose how much it gets from Merck and other supporters."
Read the whole piece. It highlights another example of the entanglement of conflicts of interest in the dissemination of health and medical news and information in this country.
The Star Tribune reports that “Minnesotans buying mail-order prescription drugs from Canada are having medications confiscated by U.S. Customs in escalating numbers….It is unclear why federal authorities have increased confiscations now.
Charlotte Bystrom of Crane Lake, Minn., was expecting a package of six medications in mid-January. Instead, the 69-year-old got a letter from U.S. Customs and Border Protection telling her the $600 shipment had been ‘intercepted.’ …
‘I thought I would be in jail,’ Bystrom said. ‘I could order a dress from Canada or shoes from Canada. I could order nearly everything I wanted from Canada -- except drugs.’
‘I felt like the drug companies are [calling] the shots here,’ she added. ‘They're controlling our government. I felt violated, like something was stolen from me.’ “
Think about this. Seniors are rejecting the feds’ Medicare prescription drug plan in surprising numbers. Many who accept the plan are terribly confused by how to use it. In designing the plan, the feds gave up the chance to negotiate with drug companies for lower prices. But now when a 69-year old woman (and many others like her) pursues what she thinks is a better approach for her own health and purse, her shipment is seized – like she’s a criminal.
This is one little example of why I feel ill when I hear medical marketers call this the era of consumer-driven health care.
Spurred on largely by recent problems with implantable cardioverter debrillators (ICDs) and pacemakers, the FDA held a rare "media briefing" to discuss the problems the agency faces in tracking the safety of medical devices after they've been approved for use.
The Star Tribune reports the FDA acknowledged it is "challenged by the size and growth of the device industry, the complexity of devices, increased home use of devices and the tension between safety and cutting-edge technology that could improve people's lives."
You could cut and paste those words into a description of the challenges faced in drug monitoring.
The newspaper reports that last week the FDA sent "an unusually harsh and broad warning letter" to the Boston Scientific corporation. "The FDA cited serious quality-control problems -- and inadequate responses to earlier warnings -- at numerous factories operated by Boston Scientific, whose products include the best-selling Taxus stent."
More critics are weighing in with the opinion that the President's push for expanded use of Health Savings Accounts is blind to the reality of the current health care environment.
In USA Today, Drew Altman of the non-profit Kaiser Family Foundation research group says, "We're a solid decade away from being anywhere close to consumers having the price and quality information they need to really shop for health care."
An Albany Times Union editorial asks, "How many of the more than 45 million people without insurance are helped by such a plan?"
The Wichita Eagle writes in an editorial that while HSAs are a valuable tool, they are "likely too modest to make much difference to the 45 million who are uninsured and the others dealing with rising costs and declining access."
Diane Stafford, in an opinion piece in the Kansas City Star wrote: "If you ... wanted a solution to our nation's rising health care cost woes, you didn't get it from the State of the Union address."
Zanny Minton-Beddoes, on the "Marketplace Morning Report," said that the health care proposals that Bush announced in his State of the Union address allow ideology to "triumph over good sense."
Herb Field, wrote in an opinion piece in the Harrisburg Patriot-News: "Better that you bear more of your own medical costs so that you see the doctor less, allow your sniffle to turn into pneumonia, and stay home and die" based on the health care proposals that Bush announced in his State of the Union address.
Robert Goldberg, in the Washington Times wrote that although "making Medicare choices on your own is scary, just try using" HSAs.
Wall Street Journal columnist Alan Murray wishes President Bush would read the work of Harvard Business School professor Michael Porter. According to Murray, Porter, like Bush, "believes competition can solve much of what ails the health care industry," but Porter believes that "the president is making a big mistake by focusing mostly on cost." Porter believes that the "real problem in health care ... is a lack of good information on quality and outcomes" and that, "without that information, any effort to drive down costs through competition will backfire," Murray writes. In addition, Murray says, Porter believes that the "focus ... should be on value" because the "scandal of today's health care is that the quality is often shoddy." Porter also believes that, although "much of the effort to drive up value needs to happen in the private sector," the "government should take the lead in measuring health care quality and outcomes," according to Murray. He concludes, "If competition is going to rescue the U.S. health care system, it will have to be competition on price and quality" (Thanks to American HealthLine for the excerpts).