A British Medical Journal editorial this week projects that the United States will be the ONLY industrialized country allowing full direct-to-consumer prescription drug advertising.
The editorial explains that New Zealand's health minister has decided that the potential benefits of drug ads do not justify the harms, and so will ban the ads in 2005.
Legislators in Australia and Canada and the European parliament have all come up with unfavorable reviews of DTC ads in recent years.
Once again, the U.S. stands alone. Nothing to be proud of.
Cleveland Clinic cardiologist Eric Topol says the problems with Vioxx, Bextra and Celebrex should make the government rethink its policy of allowing direct-to-consumer prescription drug advertising.
Topol says, "Unbridled promotion exacerbated the public health problem. The combination of mass promotion of a medicine with an unknown and suspect safety profile cannot be tolerated in the future."
The folks who publish PRWatch.org have named the winners of the 2004 Falsies Awards, "to remember the people and players responsible for polluting our information environment."
The top award goes to the government's video news release promoting the new Medicare reform law at the start of 2004. The VNR ended with the sign-off, "In Washington, I'm Karen Ryan, reporting." But Karen Ryan was paid by a production company hired by a PR firm hired by the government. To the shame of the television news business, the VNR aired on dozens of TV newscasts.
Ryan wasn't done. In October she "reported" on the president's No Child Left Behind law. PRWatch.org says that "a Freedom of Information Act investigation revealed that the U.S. Education Department paid $700,000 to the PR firm to produce two VNRs as well as to rate newspaper coverage according to how favorably reporters described No Child Left Behind."
Ryan and the government deserve the top Falsie award. It was a memorable year for false and misleading news and information.
The Los Angeles Times reports that at least six big drug companies have sent internal notices to employees preparing them for "potential ambushes" from Michael Moore, whose next film will be on health care and the pharmaceutical industry.
The Times quotes a big pharma spokesman: "We have an image problem -- not only with Michael Moore, but with the general public."
Moore told the paper, "Being screwed by your HMO and ill-served by pharmaceutical companies is the shared American experience. The system, inferior to that of much poorer nations, benefits the few at the expense of the many."
The movie, tentatively entitled "Sicko," is just entering production, yet Moore says "already people are freaky-deaky."
Why is a government task force spending time on analyzing what the cost savings would be from a large-scale commercial system to reimport low-cost Rx drugs from Canada? Is there any surprise in the finding that the cost savings would be negligible?
Senator Byron Dorgan (D-N.D.) said, "I never had much confidence that this study was going to be objective. Millions of Americans obtain prescription medicines from Canada and other countries and do so safely. The federal government itself is buying flu vaccine from abroad right now. The only thing endangered ... is the incrredibly large profits of the drug companies."
Meantime, why must all reform proposals travel the twisted road of Canadian reimportations? Why doesn't the federal government take DIRECT action to negotiate with drug companies?
Stories like today's about naproxen causing "a 50 percent greater risk of heart attacks and stroke than placebo" can be meaningless if they don't provide the ABSOLUTE risk. The 50% figure is the relative risk -- naproxen's rate relative to placebo. But we're not told the ABSOLUTE rate: how many people actually had heart attacks and strokes in each group. The difference could be very small if the ABSOLUTE numbers are small.
But it's not just journalists who fail to give the absolute risk figures. The New York Times reports that those making the naproxen announcement yesterday would only say that 70 people out of 2,500 in the study experienced heart attacks and strokes. They would not give the numbers for each group. You can do the math to figure it out, but consumers shouldn't have to do the math. Government officials and journalists should help.
Mea Culpa Disclosure: I violated the absolute risk tenet myself in my Dec. 17 entry when I wrote, "Pfizer has stopped a clinical trial for its blockbuster drug Celebrex because it was shown to cause 2.5 times more heart attacks than did placebos."
This week President Bush set up a health savings account. The president gets his health care at no cost and his family has private insurance similar to that offered to all federal employees. Nice options.
A White House spokesman said the president, in setting up the account, wanted to set an example.
What example does the president's action set for the nation's 40+ million uninsured? What options do they have?
That's not a red state/blue state issue. It's coast-to-coast, in all age groups, and, increasingly, in many socioeconomic groups. And these people are looking for leadership at the federal government level. Even from the White House.
Pfizer has stopped a clinical trial for its blockbuster drug Celebrex because it was shown to cause 2.5 times more heart attacks than did placebos.
Merrill Goozner of the Center for Science in the Public Interest writes: "It is becoming increasingly clear that heart problems associated with everyday painkillers called Cox-2 inhibitors (Vioxx, Celebrex, Bextra) are what pharmacologists call a "class effect." Every Cox-2 inhibitor on the market has now been linked to increased risk of heart attacks or strokes. ... It's interesting to note that Pfizer decided to release this information on Friday. In the world of politics, that's the day when savvy politicians release bad news because Saturday's papers get the smallest readership of the week.
But no public relations strategy can rescue the drug industry or its handmaidens in government from the firestorm that is about to break. U.S. consumers have spent billions of dollars for these "super aspirins" in recent years. When they were launched in the late 1990s, it was considered one of the best marketing campaigns ever by industry insiders. Millions of arthritic seniors threw away their
over-the-counter ibuprofen bottles in favor of a $90 per month prescription medicine. ...
In news article after news article touting the new "super aspirins," reporters uncritically passed along the claim that an estimated 16,500 died each year from taking traditional pain pills. Where did they get that number? From a single academic study funded by the companies selling the newer drugs."
Columnist Robert Samuelson, in Wednesday's Washington Post, quoted outgoing health and human services secretary Tommy Thompson reflecting on his greatest accomplishment. "You got to put the complete overhaul...of the Medicare (program) pretty much at the top of the list," Thompson said.
Samuelson counters: "Far from a triumph, the Medicare drug benefit is one of the worst pieces of social legislation in decades," later calling it a "legislative atrocity."
"The appearance is terrible. A chief architect of the Medicare prescription drug legislation is now going to represent the chief beneficiary of the bill. This will only reinforce the public's disillusionment with Congress." That's what Congressman Henry Waxman (D-Calif.) says about former Congressman Billy Tauzin (R-La.) becoming president and CEO of the Pharmaceutical and Research Manufacturers of America or PhRMA.
Meantime, the Washington Post reports that almost one out of five FDA scientists surveyed two years ago said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality.
Public confidence in Congress and in the FDA? Entanglement of interests? These questions are popping up every day.
Congressional investigators have found that the Medicare toll-free help line, designed to help seniors understand the new prescription drug benefit, gives accurate answers only 60% of the time. 29% percent of callers got inaccurate answers and 10% got no answer at all -- which is probably better than an inaccurate answer.
From the Center for Science in the Public Interest:
"A group called the Center for Consumer Freedom is frequently mentioned in the media downplaying health concerns about soft drinks, restaurant meals, processed foods, and alcohol. News articles do not always identify it as such, but it is mostly funded by restaurants, tavern operators, and food companies.
So we note with interest that the watchdog group Citizens for Responsibility and Ethics in Washington (CREW) has filed a complaint with the Internal Revenue Service asking that the agency investigate the Center for Consumer Freedom, revoke its tax status, and impose large fines against it.
The Center for Consumer Freedom enjoys tax exemption as a 501(c) 3 charitable organization. But according to CREW, the CCF engaged in prohibited electioneering activities when it advocated against the presidential campaign of Rep. Dennis Kucinich (D-OH). CREW’s complaint also contends that CCF and its affiliated organizations have "made substantial, suspect payments" to its founder, Richard Berman, and Berman’s consulting firm. Those payments add up to nearly $7 million since 1997. CREW says payments that constitute "excess benefit transactions" should be subject to a 200% excise tax."
See my review article in this week's British Medical Journal.
http://bmj.bmjjournals.com/cgi/content/full/329/7478/1352
In case you missed it, United HealthGroup CEO Dr. William McGuire last week cashed in stock options worth almost $115 million. He was the second highest paid CEO in the nation last year, with total compensation of $94 million.