The San Francisco Chronicle reports on how "the painkillers Vioxx, Celebrex and Bextra may go down in history as a classic example of the danger posed by aggressive industry promotion of prescription drugs to both patients and doctors."
But some say that if the FDA tries to block consumer advertising for the drugs permanently, it could be headed for a showdown based on a First Amendment challenge.
A former FDA deputy commissioner said, "You don't have a First Amendment right to lie, to say false and misleading things."
For those worried about a single-payer health care system introducing too much big government into health care -- wake up -- it's already happening.
A report in Health Affairs this week projects that public programs will pay for half of total health care costs by 2014. Much of that will be rung up to the new Medicare prescription drug benefit.
Another report of conflicts of interest in FDA drug deliberations may not be surprising.
Ten of the 32 government drug advisers who last week endorsed continued marketing of the pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs' makers, according to disclosures in medical journals and other public records. Take away their votes and the committee would have voted to keep Vioxx off the market and to withdraw Bextra.
The Associated Press reports that speakers at the national meeting of the American Association for Advancement of Science expressed the latest concern that some scientists "are being ignored or even pressured to change study conclusions that don't support (Bush administration) policy positions."
One scientist said, "This administration has distanced itself from scientific information."
The director of the CDC said yesterday that the bird flu virus may mutate to human form and said her agency is preparing for a possible pandemic next year.
But my local paper, the Minneapolis Star Tribune, didn't have a word in this morning's paper.
I don't get it.
But there was the big spread about the woman whose goal is to walk every mile of the city's streets!
That's the quote from FDA safety officer David Graham, on the decision by an agency advisory committee to recommend that COX-2 inhibitors remain on the market
The Associated Press reports that governors of both parties are uniting to oppose the President's proposed cuts to Medicaid, which provides health care to 52 million poor, elderly and disabled.
"If we don't get Medicaid solved, what you basically do is put governors in the position where they've got to pick between grandchildren and grandparents," said Iowa Gov. Tom Vilsack, a Democrat.
Bush's budget proposes reducing federal spending on Medicaid for states by $40 billion.
The Bush administration faces questions about the bizarre story of Jeff Gannon/Jim Guckert "pimping for the White House," as the Minneapolis Star Tribune puts it, about paying columnists to promote or advise the administration, and about creating an Office of Strategic Influence to provide "news" to foreign media.
And now the U.S. comptroller general has issued a blanket warning that reminds federal agencies they may not produce "newscasts" promoting administration policies without clearly stating that the federal government is the source. That's happened twice in two years -- once for the government's spin on a video news release promoting the Medicare reform legislation. And you, the taxpayer, paid for it.
The comptroller general, chief of the Government Accountability Office (GAO), Congress' investigative arm, wrote: "Agencies may not use appropriated funds to produce or distribute prepackaged news stories intended to be viewed by television audiences that conceal or do not clearly identify for the television viewing audience that the agency was the source of those materials."
The FDA advisory panel that looked at the safety of Cox-2 inhibitors and walked away with a mealy-mouthed, back-door endorsement of this class of drugs -- in the face of strong evidence of risks -- is troubling.
Journalist Merrill Goozner writes about the label you won’t read on Celebrex, Bextra and Vioxx (if Merck decides to bring Vioxx back):
"WARNING: This drug increases your risk of a heart attack or stroke. This drug provides no more pain relief than generic and over-the-counter painkillers. There is no reason to take this expensive, prescription drug unless you are among the 1 to 4 percent of people who suffer from gastrointestinal side effects from other
painkillers, which are available at one-tenth the price at your local supermarket or drug store without a prescription. Nearly half of all heart attacks are fatal and those who survive must deal with the consequences for the rest of their lives. Only one in 20 ulcers are fatal and the vast majority of gastrointestinal problems are easily treated with few long-term effects."
The Associated Press reports that the Vatican says Pope John Paul's suffering with Parkinson's disease is an antidote to the mentality that modern medicine must cure all, calling this a "religion of health" that is taking hold in affluent countries.
"While millions of people in the world struggle to survive hunger and disease, lacking even minimal health care, in rich countries the concept of health as well-being figures in creating unrealistic expectations about the possibility of medicine to respond to all needs and desires," said the Rev. Maurizio Faggioni, a theologian and morality expert on the Vatican's Pontifical Academy for Life.
A Vatican psychiatrist said the Pope is "the living alternative to the prevailing health-fiend madness." Vatican officials stressed that all people should have access to basic health care.
But "it is difficult to establish what a decent minimum is," Faggioni said, when asked about unaffordable health care for many in the United States.
You almost have to pinch yourself to be sure you're not dreaming your way through the health policy deliberations that take place in this country.
Today's Minneapolis Star Tribune gives details of a "doomsday scenario" that Governor Tim Pawlenty is considering if the FDA stops the state's online program to buy cheaper prescription drugs from Canada. Pawlenty says he's had preliminary talks with leaders of northern Minnesota Indian bands to see if they'd use their sovereign status "to act as wholesalers and distributors of prescription drugs."
The Star Tribune paints this scenario: "Imagine this: You go to a casino in Minnesota to play the slots and pick up your prescription drugs at the same time."
The casino setting may be appropriate. After all, we're gambling with the future with the haphazard nature of our health care reform movement, with states scrambling to fill the void left by a federal government that has taken on Social Security rather than Medicare.
The Wild West analogies keep creeping into this story. Pawlenty refers to the cost of drugs as "a prairie fire spreading across our nation." Now the cowboys of health care reform may take advantage of the Indians once again.
The Newhouse News Service has a terrific story about Medicare requiring seniors who receive a new government-funded "Welcome to Medicare" exam to have electrocardiogram (EKG) tests that some say are a waste of time and money.
Dr. Gil Welch of Dartmouth says, "It's a great test for someone who had chest pain or an irregular heartbeat." But would he give it to someone age 70 and apparently healthy? "Absolutely not."
The U.S. Preventive Services Task Force says the evidence is incomplete to endorse EKGs for those at some risk, including seniors. The task force wrote, "Harms from false positive tests are likely to occur."
But the article explains that the feds now mandate the test for seniors in taking the Welcome to Medicare exam, and physicians won't be reimbursed for doing anything if they don't include the EKG.
Now that's evidence-based medicine! How this got into the Medicare reform bill is not clear.
Larry Altman, in today's New York Times, discusses the New York City health commissioner's decision last week to announce that one man had shown the first diagnosed strain of HIV that was resistant to several antiretroviral drugs and rapid progression from infection to AIDS.
Some have criticized the announcement as "too hasty, alarmist and unscientific." Altman recalls that not long ago, single case reports were common in medical journals. He quotes the commissioner saying, "I don't know whether this is of tremendous scientific importance but I do know that from a public health standpoint it is of great concern."
This is an important issue as scientists, public health experts and journalists think about how they communicate information to the public. Read Altman's story for more complete perspectives.
Health Canada has stopped sales of Adderall XR, a commonly prescribed drug for attention deficit hyperactivity disorder, because of concerns that it could cause sudden death . The agency cited data indicating there have been 20 sudden deaths - many in patients who had serious cardiac abnormalities -- related to Adderall XR and immediate-release formulation Adderall, both of which are approved for sale in the United States. FDA reviewed the same data last year and concluded merely that the drug required additional warnings.
This isn't the first time that Canadian regulators have acted more swiftly and strictly than U.S. regulators. Let's see how this one plays out.
Merrill Goozner's essay this week, "Protecting the View From Mt. NIH," is a good read.
He writes about NIH director Elias Zerhouni’s decision to ban agency scientists from having outside financial ties with drug, biotechnology and medical device companies -- a decision that "was actually rammed down the agency’s throat by the Office of Government Ethics and the determined reporting of David Willman in the Los Angeles Times."
But he chides some media coverage that stated "this will set back the commercialization of NIH knowledge...drive the best and brightest into the private sector and hamper industry by cutting off access to NIH’s cutting-edge science."
He concludes: "I hope our culture hasn’t become so crassly commercial that there are no longer young scientists who want to climb to the top of the mountain, or veteran scientists who won’t stick around to enjoy the view."
The New York Times reports that ABC Television will produce a reality program featuring a "team of physicians" that will "scour the country seeking people who urgently need medical care but do not have the wherewithal to obtain it."
It shouldn’t take much scouring.
What a commentary on our times: the one way commercial network television devotes prime time to a discussion of health policy issues is in a non-journalistic, entertainment-based format. Maybe you'll get kicked off the island if you are a senior or if you lose your job and your insurance along with it.
The KaiserNetwork.org posted the following excerpts from editorials around the country about the news that the Medicare drug benefit is now projected to cost far more than the Bush administration first estimated.
* Boston Globe: "This society ought to marshal the resources to keep Medicare a bedrock of affordable protection" for the elderly, a Globe editorial states, concluding that a tax increase "spread throughout the population would safeguard Medicare and spare millions from an old age of increasing hardship" (Boston Globe, 2/10).
* Chicago Tribune: The Medicare prescription drug benefit "was sold with false numbers, is badly designed and is far, far too expensive for the federal government to absorb," according to a Tribune editorial. The Tribune states that Congress "has to repeal this program" (Chicago Tribune, 2/10).
* Denver Post: The Bush administration's explanations for the "'lowball' projection" it gave for the cost of the new Medicare law "doesn't wash," a Denver Post editorial states. According to the editorial, "Congress should approve bulk purchasing" of prescription drugs for Medicare, and "lawmakers should ... remember the story of the Medicare cost estimates when they review Bush's plan to partially privatize Social Security" (Denver Post, 2/10).
* New York Times: With regard to cost estimates for programs the Bush administration "wants to sell," the "math isn't just fuzzy ... it is often downright misleading and deliberately so," a New York Times editorial states, adding that the cost estimate for the Medicare prescription drug benefit is the "latest example." According to the editorial, "Americans have to choose" whether they want a "social safety net that ... makes sure [the elderly] can afford adequate health care" or a "small government with a tax code" that protects "the wealth of the richest Americans at the expense of the middle class and the working poor" (New York Times, 2/10).
* Philadelphia Daily News: A bipartisan bill in the Senate that would repeal part of the new Medicare law to allow the government to negotiate lower prices with pharmaceutical companies and "introduce other protections for seniors ... might salvage some of the current mess" with Medicare, a Daily News editorial states (Philadelphia Daily News, 2/10).
* Providence Journal: As Medicaid and Medicare costs "are rising much faster than inflation" and governors become concerned that more costs might be shifted to states, "making nonessential medicines available to the elderly" -- such as those for erectile dysfunction -- "should be off the table," a Journal editorial states (Providence Journal, 2/10).
* USA Today: Medicare's prescription drug benefit is "unaffordable" without "an infusion of new tax revenue," a USA Today editorial states. The editorial continues, "Congress ought to revisit the law before it kicks in ... and figure out a way to target benefits to those who need them the most." The editorial adds that the "greater need is to abandon piecemeal approaches to the nation's mounting health care crisis and face up to the politically unpalatable need for a comprehensive solution" (USA Today, 2/10).
* Washington Post: The "phony, or at the very least unwarranted, outrage over Medicare costs underscores a real outage: the continuing, repeated brazenness of the Bush administration and its congressional enablers in manipulating budget windows to their liking," a Washington Post editorial states. The editorial concludes that predicting the cost of government programs and "the trajectory of the deficit is always inexact," but developing the "most honest assessment possible is a necessary ingredient of responsible policy-making" (Washington Post, 2/10).
* Washington Times: "In light of [the] considerable and mounting sum" of Medicare's prescription drug benefit, "lawmakers will have to broadly review the potential for waste" under the law and "consider if new legislation is needed to rein it in, even if this means more narrowly defining the meaning of 'medically necessary,'" according to a Washington Times editorial (Washington Times, 2/10).
The Bush administration now says that the Medicare drug benefit will cost an estimated $720 billion between 2006 and 2015, up from the $400 billion originally estimated for the period between 2004 and 2013. In addition, a new 10-year chart prepared by the Medicare actuaries estimates that seniors' drug premiums will increase from $35 per month in 2006 to $68 in 2015 and that annual deductibles will increase from $250 to $472 during the same period.
Don't expect the government to send out another video news release to the nation's TV stations with this news.
That's the title of an editorial this week in the Los Angeles Times. It argues that the push for health savings accounts might make sense "if healthcare were really like tomatoes or Toyotas." Princeton health economist Uwe Reinhardt is quoted: "It's difficult to imagine how any informed patient can effectively shop around for cost-effective care because of the now widespread price discrimination practiced by the providers of healthcare....with the highest prices charged individual self-pay patients who have no market clout."
American Health Line, a service of the National Journal, summarizes four newspapers' editorial responses to the Medicare decision to cover erectile dysfunction drugs.
* The Atlanta Journal-Constitution (registration required): It "seems a stretch that government programs should pay to maintain or invigorate a lifestyle when health care costs are going through the roof and the money could be better spent to treat more critical medical conditions," a Journal-Constitution editorial states. The editorial concludes that "there's nothing charming about subsidizing someone's love life at taxpayer expense"
* Rochester Democrat and Chronicle: The decision to add "sexual performance prescription drugs" to the Medicare drug benefit formulary is the "most recent indication that the government is not thinking deeply enough about the impact of this benefit," according to a Democrat and Chronicle editorial. If Medicare "is to keep its drug costs below the stratosphere," it "has to cast a very critical eye on drugs that do more to brighten lifestyles than to treat illnesses."
* San Francisco Chronicle: A "ban" on "lifestyle drugs" from the Medicare drug formulary "would be ill-advised; it could become a dangerous precedent," a Chronicle editorial states. However, "at the very least, the administration should adopt some reasonable cost controls on impotence drugs, such as those adopted by HMOs -- by limiting the number of prescriptions per beneficiary and by bargaining hard for discounts."
* Washington Post: Instead of "genuine reform" that would use "evidence-based medicine and ultimately ... reform ... the wasteful health care delivery system ... a drug benefit was simply tacked onto the existing [Medicare] program," the Post writes in an editorial. According to the Post, the result is that "taxpayers may wind up paying not only for Viagra but for a whole host of other expensive, and not always necessary, drugs as well."
Parody is funniest when it is closest to reality. As in this week's the ONION.
In the piece, one fictitious journalist says, "Listen, I'm no disease expert. But I know that people should be warned about global devastation any time a devastation scenario can be extrapolated from an actual news report. And for the 16th consecutive month, that time is now."
Robert Pear in today's New York Times provides a preview of what the federal government may do with Medicaid. In the words of new Health & Human Services secretary Michael O. Leavitt, "Medicaid must not become an inheritance protection plan."
As emphasized on this site earlier, journalists should be following the fed action, and the states' response to it on management of Medicaid.
Back on December 21, 2004 on this site, I questioned the government and news reports about the risks attributed to naproxen in a trial that was stopped.
In today's Washington Post, Dartmouth and VA researchers Steve Woloshin, Lisa Schwartz and Gil Welch submit a thoughtful review reaching the same conclusion. Many journalists, the FDA and the NIH overstated the evidence against naproxen. The authors conclude, "It was too soon to frighten the public."
This is a terribly important issue for journalists and for the public to understand.
Woloshin, Schwartz and Welch did a great public service by explaining it better than the government and most journalists.