Schwitzer health news blog

Canadian "drug policy reform" effort driven by Pharma funds

A CanWest news report shows how a "drug policy reform" push from a self-described patient advocacy group is actually totally funded by drug companies.

The story begins:

"Louise Binder is HIV-positive and chairwoman of a coalition that fights for drug-policy reform in Canada. During a recent visit to the nation's capital she urged members of Parliament to rewrite the rules governing prescription drugs that would increase the access patients have to new, expensive medications and require the government to foot the bill.

One thing she didn't mention during that visit is the fact her association, the Best Medicines Coalition, receives 100 per cent of its funding from Canada's pharmaceutical companies - the very industry that stands to profit most from a governmental decision to approve new and expensive drugs for use and coverage in Canada."

Pharma-funded nurses in UK - backdoor drug marketing?

The Wall Street Journal reports on a new drug company scheme in the UK.

Under the guise of "disease management programs," the paper says that drug companies are paying for nurses in doctors' offices to study patient charts to find people with chronic illnesses - which may often lead to a new prescription of a drug made by the company funding the nurses.

Drug Industry Gifts Make Gastro-Conference Easier to Digest

From Caroline Rodriguez at the Integrity in Science Watch project of the Center for Science in the Public Interest:

"More than 15,000 doctors visited Washington, D.C. last week to attend the largest ever gathering of gastrointestinal physicians. Integrity in Science Watch paid a visit.

As soon as each doctor walked onto the convention floor, they were handed purple-pill backpacks advertising Nexium from AstraZeneca. The Shire Pharmaceuticals’ booth offered weary physicians a park-like atmosphere complete with gently rolling grassy hills, stone paths, park benches, and free hot dogs. The Abbott booth contained a mini-movie theater. On every aisle, companies provided free slushies, gourmet espressos, coffee, tea, sweets, hot dogs, and fresh pretzels. They also offered beach towels, blankets, movies, free internet access, and, the most popular gift of all, a comfortable place to sit and chat with colleagues or the model-like sales representatives who prowled the convention floor.

Most of the doctors surveyed did not express concerns about the potential influence of the gifts. Some said they expect free knick-knacks at conferences, but would oppose them at schools or hospitals. Others said it was important for companies to promote themselves. Almost no one favored cutting out free gifts at physician conventions and offices, but perhaps that was because this informal survey only included doctors clutching blankets, towels, key chains, or pens.

The quietest space on the convention floor was the corner reserved for the small booths of patient advocacy groups, text book sellers, and scientific journals. “We don’t get any sponsorship from corporations for our meeting booths,” said Crohn’s & Colitis Foundation of America representative Laura Hitchens, eyeing the towering Fuji stereo sound system blaring a description of a colonoscopy camera. Thelma King Thiel of the Hepatitis Foundation says they wouldn’t say no if a company was to offer to fund their booths, but not many companies are interested in prevention, she said."

All-drugs-all-the-time-TV

A story out of the UK reports:

"Four of the world's biggest pharmaceutical companies are proposing to launch a television station to tell the public about their drugs, amid strenuous lobbying across Europe by the industry for an end to restrictions aimed at protecting patients. Pharma TV would be a dedicated interactive digital channel funded by the industry with health news and features but, at its heart, would be detailed information from drug companies about their medicines."

Remember: Europe doesn't allow direct-to-consumer drug advertising as we wise Americans do. And drug companies have been fighting that European ad ban. The story explains:

"The industry has been lobbying in Europe to be allowed direct access to patients. It argues that lifting restrictions would help its competitiveness and has hinted that companies may relocate to the US, where they can advertise to patients who then demand drugs from their doctors. Profits have soared there as a result."

I would look forward to such Pharma TV specials as "Adventures with Avandia," "The Virtues of Vioxx," and "Everybody Loves Statins."

The more we hear about Avandia the worse it gets

The New York Times reports:

A leading diabetes doctor sent the Food and Drug Administration a letter seven years ago that warned of the heart risks of the drug Avandia. And in the next year, the F.D.A. reprimanded the drug’s maker for playing down safety concerns, according to documents from 2000 and 2001.

The documents, found in a reporter’s search of the F.D.A.’s database, indicate that the agency had been warned of safety concerns with the Type 2 diabetes treatment Avandia, and that the drug’s maker, GlaxoSmithKline, was seeking to minimize Avandia’s risks, before some of the same cardiovascular concerns were brought to public attention on Monday in an article and an editorial in The New England Journal of Medicine. ...

In his letter to the agency, dated March 15, 2000, Dr. (John) Buse (incoming American Diabetes Association president) was highly critical of the drug maker’s marketing of Avandia, accusing the company of “pervasive and systemic” efforts to play down the drug’s risks and overstate its benefits.

In the Wall Street Journal, Buse is quoted as warning of "rampant abuse of clinical trial data" by then-maker SmithKline Beecham, saying the company "may have overstated the safety of the drug."

This is why I howl when I read stories from all over the country that seem to downplay long-term safety issues with new drug approvals - as with yesterday's glowing news all over the country about approval of Lybrel - a new oral contaceptive that promises to stop menstrual periods. Some newspapers (the Washington Post and the Minneapolis Star Tribune were two I saw) made this front page news. Many stories just flat failed to mention that many women dropped out of the Lybrel trials because of breakthrough bleeding or spotting. So, as some experts have pointed out, women may be trading scheduled bleeding for unscheduled bleeding. Perhaps we should ask those dropout women which they would rather have. There's a reason they dropped out. That didn't show up in much news coverage and that won't show up on Lybrel's labeling or TV ads.

How gullible we are. When will we learn?

HealthNewsReview.org honored again

One of my day jobs - as publisher of HealthNewsReview.org - has been rewarding and the work has also been awarded - again.

The site has been named a finalist in the first-ever Mirror Awards honoring excellence in media industry reporting. There are 22 other finalists, including the New York Times, the Washington Post, National Public Radio, The New Yorker, The Economist, The Wall Street Journal and others.

Is Avandia the heart risk sequel to Vioxx?

For a good wrapup of issues surrounding the New England Journal of Medicine article by Steven Nissen of the Cleveland Clinic showing that the heavily marketed diabetes drug Avandia from GlaxoSmithKline increases heart attack risk in the millions of patients who have taken it, go to GoozNews.com.

The Wall Street Journal headlined it "Sequel for Vioxx critic" - referring to Nissen who also raised some of the early red flag warnings about Vioxx.

No surprise: Americans confused about cancer

A study in the journal Cancer Epidemiology, Biomarkers and Prevention reports widespread confusion in America about cancer and cancer prevention.

Nearly half of respondents (47.1%) agreed that "It seems like almost everything causes cancer," 27.0% agreed that "There's not much people can do to lower their chances of getting cancer," and 71.5% agreed that "There are so many recommendations about preventing cancer, it's hard to know which ones to follow."

I'm a journalist so I always look in the mirror first and I blame journalists for creating much of this confusion. The "cure" or "killer" emphasis in many stories - in order to compete for space or airtime - shows no appreciation for public understanding. Fulltime health, medical and science reporting jobs are being slashed all over the country.

Just look at how some top news organizations recently handled cancer screening stories.

And then we have health insurance marketing people shoveling "consumer driven health care plans" at us. This study is further evidence of how far away many Americans are from understanding how to be in the driver's seat of their own health care - admirable though that goal may be.

Stop calling it the best health care system in the world

Dr. Zeke Emanuel, a bioethicist at the National Institutes of Health, published a rant on the U.S. health care system in the Journal of the American Medical Association this week.

Emmanuel wrote:

"Many no longer believe the United States has the best health care system in the world. The statistics are damning. The United States has the most expensive system, by far. In 2005 health care cost more than $6000 per person or in excess of 16% of the gross domestic product (GDP). The nearest rival, Switzerland, spends $4077 per person per year, or 11.5% of its GDP (in purchasing power parity). Norway spends $3966 (9.7% of GDP); Germany, $3043 (10.6% of GDP); and South Korea, a mere $1149 (8.2% of GDP). However, Americans are increasingly aware that all of this money is not buying very much. Life expectancy in the United States is 78 years, ranking 45th in the world, well behind Switzerland, Norway, Germany, and even Greece, Bosnia, and Jordan. The US infant mortality rate is 6.37 per 1000 live births, higher than almost all other developed countries, as well as Cuba. Even for white individuals, the numbers are not world class—5.7 infant deaths per 1000 live births—more than double the rate in Singapore, Sweden, and Japan. Even at the individual hospital level, Americans are realizing the care they receive is not of the highest quality. The idea put forth in the Institute of Medicine report To Err Is Human that 100 000 Americans die each year from medication errors in the hospital has taken hold in the public consciousness as emblematic of the problems with the quality of health care.

Furthermore, Americans are becoming aware that in such an unreliable system even money cannot guarantee outstanding care.

...Increasingly, Americans are beginning to be skeptical about whether new health care technologies are better. The tipping point probably came with the withdrawal of rofecoxib from the US market. Today, the list of drugs and technologies for which new might not be better (and may be even worse) has expanded rapidly: postmenopausal hormone therapy, bare-metal stents, megadose antioxidants, selective serotonin reuptake inhibitors for adolescents, Swan-Ganz catheters, gabapentin for bipolar disorder, erythropoietin for anemia, and the list goes on."

Should women be downing statins? Online debate.

Last week’s BMJ, the May 12 edition, carried a debate about whether women should be offered statin drugs to prevent cardiovascular disease.

Dr. Scott Grundy of the University of Texas Southwestern Medical School supports the idea. He lists the fact that he has been a consultant to the following companies that market statins: Merck, Pfizer, Bristol Myers Squibb, and Astra Zeneca.

Malcolm Kendrick of the UK hates the idea. He writes:

"To date, none of the large trials of secondary prevention with statins has shown a reduction in overall mortality in women.Perhaps more critically, the primary prevention trials have shown neither an overall mortality benefit, nor even a reduction in cardiovascular end points in women. This raises the important question whether women should be prescribed statins at all.

I believe that the answer is clearly no. Not only do statins fail to provide any overall health benefit in women, they represent a massive financial drain on health services. This money could be diverted to treatments of proved value.

In addition to the lack of benefit and expense, statins carry a substantial burden of side effects. Lifetime drug treatment can also create other problems. Firstly, women may falsely believe that they are being protected and may therefore be less likely to make beneficial lifestyle changes. Secondly, mass medicalisation is a dangerous road with many psychological and societal consequences."

Good debate, with some passionate responses from readers available online.

Sorting Out Good Science From the Bad

An article under the headline above was written by Sharon Begley and published in the May 7 issue of Newsweek.

It's important.

She reminds readers: "For us civilians, it's hard to grasp how much of science is subjective, and especially how much leeway there is in choosing how to conduct a study. No one is alleging that scientists stack the deck on purpose. Let's just say that depending on how you design a study you can practically preordain the outcome."

Read the article to learn some of the study design tricks of the trade.

Unhealthy advocacy: journalists and screening tests

The Poynter Institute website has published my overview of some journalists' apparent pro-screening bias in coverage of some screening tests. The incidents I've tracked involve screening for cancer (prostate, breast, lung, colon) but also for cardiovascular disease and diabetes.

The piece documents more than a dozen incidents of pro-screening stories and gets perspectives from some health journalists about why this is happening.

Michael Moore's "SICKO" has 'em on the edge of their seats already

Documentary producer Michael Moore's new film, "Sicko," will be in theaters this summer, he promises. But it's already getting lots of publicity, some of which he's drumming up around a Treasury Department investigation of Moore. It involves Moore's team taking some sick Sept. 11 rescue workers to Cuba for one segment in the film.

Moore's letter to Treasury Secretary Henry Paulson is on Moore's website. In it, he writes:

"The health care and insurance industry, which is exposed in the movie and has expressed concerns about the impact of the movie on their industries, is a major corporate underwriter of President George W. Bush and the Republican Party, having contributed over $13 million to the Bush presidential campaign in 2004 and more than $180 million to Republican candidates over the last two campaign cycles. It is well documented that the industry is very concerned about the impact of SiCKO. They have threatened their employees if they talk to me. They have set up special internal crises lines should I show up at their headquarters. Employees have been warned about the consequences of participating in SiCKO. Despite this, some employees, at great risk to themselves, have gone on camera to tell the American people the truth about the health care industry. I can understand why that industry's main recipient of its contributions -- President Bush -- would want to harass, intimidate and potentially prevent this film from having its widest possible audience."

An Associated Press story has many more details on the reason for the Treasury Department investigation.

Advisers urge curb on EPO use; Ads slammed, too

Merrill Goozner reports that an FDA advisory panel has called for "new warnings that will dramatically scale back the use of anti-anemia drugs if the warnings are heeded by the nation's oncologists. You've seen those television ads. They show beaming older cancer patients playing with their grandkids. Why? Now they have the energy because of J&J's Procrit and Amgen's Aranesp."

One FDA reviewer said: "Improved quality of life, fatigue and other symptoms associated with anemia has not been established in properly conducted, randomized, double-blind, placebo-controlled trials." On top of that, two trials were ended early because of concerns over increased mortality. Another trial showed increased mortality and signs of cancer spreading.

The FDA heard patient stories such as this one Goozner cites: "How is it possible that something that was supposed to help me might have made things worse?" asked Lilla Romeo, a 60-year-old breast cancer patient who's been battling the disease since 2000. The false hope offered by the ads run by the companies was "both insulting and cruel," she said.

He also quotes Richard Pazdur, head of the FDA cancer drugs division: ""They (the FDA) have to give the American people a good explanation for why these ads were allowed to continue."

Drug whistleblower on Procrit promotions

The Wall Street Journal reports on a whistleblower lawsuit against Johnson & Johnson, with allegations about how the company tried to push sales of the anti-anemia drug Procrit "by offering contracts that fattened doctors' profits and urging its salespeople to push higher-than-approved doses." More:

"Dean McClellan, who worked for 12 years at J&J's Ortho Biotech unit selling Procrit, saved 15,000 pages of company memos, contracts and other work-related documents in a storage unit and shed he built off his garage. He says he was forced to retire in 2004 because the company told him his sales increases weren't high enough. He believes the company wanted him out because of his age, which was 55 at the time. Angry, he agreed to join a whistleblower lawsuit by another former Procrit salesman, Mark Duxbury. A brief filed by J&J says Mr. Duxbury was fired in 1998 for racial and sexual harassment. Through his attorney, Jan Schlichtmann, Mr. Duxbury says he was a star salesman for Ortho whom the company turned on after he told the truth about their business practices at a court-ordered deposition."

An FDA advisory committee meets today to reconsider the risks and benefits of Amgen’s Aranesp and Johnson & Johnson’s Procrit for cancer patients on chemotherapy.

The Wall Street Journal Health Blog reports: "The deliberations and recommendations of the panel could exert a powerful effect on use of the anemia drugs, whose side effects in some patients have raised questions about how broadly and aggressively they should be prescribed. A bunch of briefing documents appeared online today, and they show that the drugs could face a tough go of it."

The true harms of a false positive test

The London Daily Mail reports on a man diagnosed with cancer who was told he had less than a year to live.

"The 62-year-old council worker quit his job, sold his car, stopped paying his mortgage and dug into his life savings so he could treat himself and relatives to expensive restaurant meals.

He even sold all his clothes but for the black suit in which he expected to be buried.

A year later, however, with no sign of the Grim Reaper coming to call, he went for tests - which gave him a clean bill of health. He had never had cancer at all."

I've written before on this blog about journalists who seem to have a pro-screening test bias, never mentioning the harms that can occur from some tests. While this story was about a diagnostic test, not a screening test, it nonetheless should serve as a reminder that there are harms of false positives - which occur often in mass screening campaigns which some journalists endorse in the absence of the best evidence.

Student project on clinical trials registry

And now for something completely different on this blog.

I'm flattered that some University of Pittsburgh graduate students in a seminar on rhetoric and science policy controversies have asked me to "host" their final project, the video that follows.

For this seminar, rather than write a final paper, students were asked to create a role-play that highlights important communicative aspects found in their assigned case-study. This group worked together to examine the controversy surrounding a clinical trials registry and created scenes depicting arguments based in the literature. After drafting scenes, students wrote character sketches and then rehearsed and refined each scene. The role-play was then videotaped, and groups of two or three edited the video for time and content. Finally, students were asked to search out public audiences for their work in order to inspire dialogue and debate in the world outside the classroom. That's where my blog comes in.

This project explores the debate surrounding the establishment of a national clinical trials registry. Recent controversies highlighting the possible dangers of popular pharmaceuticals such as Vioxx and Prozac have renewed debate over the underreporting of negative clinical trials. Legislation such as the Waxman-Markey "Enhancing Drug Safety and Innovation Act" of 2007 has attempted to address the problem of underreporting by requiring that federally or privately sponsored drug researchers register their trials with the publicly accessible database www.clinicaltrials.gov . The role-play asks, in the age of increasing media saturation, is access to information empowering? Or will information without context undermine, rather than bolster, public confidence? The students seek to inspire discussion and welcome all feedback - through this site.

Take a look and weigh in at the COMMENTS link below.

Medicare rejects depression device the media helped hype

Wish I had a nickel for every story about vagus nerve stimulation that trumpeted it as a treatment for depression.

This week, Medicare rejected Cyberonics’ implantable nerve stimulator, saying the device, the VNS Therapy System, hasn't been shown to be necessary. The $25,000 device is already approved for epilepsy. Cyberonics wanted to expand its use.

Bloomberg News reports “The Food and Drug Administration approved the device in 2005 to treat depression, overruling 20 agency advisers who urged rejection.”

On the Cyberonics website the company boasted of dozens of news stories from across the country over the past two years, with headlines such as:

"Implant can relieve depression: VNS Therapy is proving beneficial."

"Omahan says she's proof device zaps depression."

"Emerging from the depths of depression."

"The Pacemaker for the Brain" is Saving Lives."

"Up from hopelessness."

"Implanted device helps fight drug-resistant depression - Giving new hope"

Among the media reporting the potential for the device:

U.S. News & World Report
Saturday Evening Post
Redbook
Reuters Health
Arizona Daily Star
San Antonio Express News
El Paso Times
Corpus Christi Caller Times
Toledo Blade
Omaha World Herald
Chicago Tribune
KSAT, San Antonio
WMUR Manchester, NH
WCCO, Minneapolis
KETV, Omaha
KUTV, Salt Lake City
KSL, Salt Lake City,
WBZ, Boston
WCBV Boston
WISN, Milwaukee
WKYC, Cleveland
KTBS, Shreveport
KOMO, Seattle

Each one of those news organizations owes it to their audience to play up the Medicare rejection of the device as prominently as they promoted the potential in the giddy glory days.

NH law protecting prescription data overturned

In a story that didn't get much attention this week - but should have - a federal judge overturned a New Hampshire law that made doctors' prescription-writing habits confidential.

The Associated Press reported: "The law made New Hampshire the first state to try to block pharmaceutical companies' hard-sell ptiches by restricting access to data that identifies doctors and other prescribers. Pharmaceutical company salespeople prize doctors' information because it profiles prescribing habits. They can learn which doctors favor brand names or generics, and who is more willing to prescribe new drugs."

The judge said the law violated the First Amendment. (Huh???)

The NH legislator who sponsored the law told the New York Times, "I feel that corporate interests took precedent over the needs of people in New Hampshire. I think it's like having a drug rep peering over a doctor's shoulder when he is writing a prescription."

Lack of sustained coverage of health care crisis

Former Philadelphia Inquirer executive editor Gene Roberts, whose paper won 17 Pulitzers in his 18 years in that job, was asked in an interview, “Are there any beats you would suggest the mainstream press is missing today?”

Roberts: “One of those is the medical crisis in the country. People write about it, but I don't see the kind of sustained week-in, week-out coverage that the situation calls for.

You read now and then about the crisis in the emergency rooms and how many Americans are uninsured, but it isn't really set up as a beat, so you have different reporters switching in and out of a story and you don't get the expertise and the continuing coverage that would have if more reporters covered it as a beat. …

The FDA, the Food and Drug Administration, is another one not well reported by newspapers. The whole question about how rapidly and safely drugs get out to the public is another thing that is going uncovered.”

Roberts is now a journalism prof at the University of Maryland. He won a Pulitzer of his own last month for his book, “The Race Beat.”

News coverage of a new prostate cancer test

For a look at how two different news organizations covered the news of a potentially more accurate test for prostate cancer, see the HealthNewsReview.org review of a weaker ABC News story in contrast with the review of a stronger Baltimore Sun story.

However, neither story adequately addressed the fact that while a more accurate test may tell who has prostate cancer better, it still does not tell which men need treatment in their lifetime and which men don't, which is the real problem in prostate cancer screening. So, both stories left readers and viewers with an overly optimistic view of what screening can do.