|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 12-13-2005
The practice of having medical writers help craft or edit articles for medical journals is, as this reporter notes, “an open secret in medicine.” Still, this article is worth reading in its entirety just to show how an “open secret” can become page 1 news in the overheated debate over pharmaceuticals.
Ghostwriting is also an open secret on op-ed pages, in publishing, academia, and anywhere else where very busy and/or famous experts rely on professional writers or graduate students to publish more materials than would normally be possible for a single human being. (Politicians, for instance, hardly ever write their own speeches.)
But is ghostwriting for medical journals a cause for alarm? A sign that pharmaceutical companies have co-opted medical journals? No.
Many of the articles that appear in scientific journals under the bylines of prominent academics are actually written by ghostwriters in the pay of drug companies. These seemingly objective articles, which doctors around the world use to guide their care of patients, are often part of a marketing campaign by companies to promote a product or play up the condition it treats.
Now questions about the practice are mounting as medical journals face unprecedented scrutiny of their role as gatekeeper for scientific information. Last week, the New England Journal of Medicine admitted that a 2000 article it published highlighting the advantages of Merck & Co.'s Vioxx painkiller omitted information about heart attacks among patients taking the drug. The journal has said the deletions were made by someone working from a Merck computer. Merck says the heart attacks happened after the study's cutoff date and it did nothing wrong. …
The practice of letting ghostwriters hired by communications firms draft journal articles - sometimes with acknowledgment, often without - has served many parties well. Academic scientists can more easily pile up high-profile publications, the main currency of advancement. Journal editors get clearly written articles that look authoritative because of their well-credentialed authors. Increasingly, though, editors and some academics are stepping forward to criticize the practice, saying it could hurt patients by giving doctors biased information.
Of course, authors should fully comply with a journal’s disclosure policies when they submit manuscripts for publication. But it only stands to reason that companies (and academics) frame their data to make their research look as strong as possible - and there is nothing inherently wrong with this. Banning or mandating disclosure of the role of editorial writers won’t change that aspect of medical research and, as the article notes, having medical writers involved in the process certainly makes the articles easier to read and probably more informative.
Of course, researchers or companies that deliberately falsify or distort data should be penalized. For instance, South Korean researchers are under increasing fire over their claim last summer to have successfully cloned human embryos, and the lead researcher, Dr. Hwang Woo Suk, stands accused of falsifying data that was submitted in the June issue of Science.
The real safeguard medical journals rely on is peer review. Responsible journals insist on a strong process of peer review because that, in the end, is the best gatekeeping system we have. Doctors know that findings from clinical trials (industry-sponsored or otherwise) are inherently open to disagreement and interpretation because clinical trial protocols are artificial compared to the messy world of real clinical practice. At the same time, academics, insurers, and the government all conduct studies of their own, allowing the medical community to draw on a wide variety of sources in making their own judgments about appropriate treatments.
The bottom line is that doctors and patients are the final arbiters of what works. Medicines that can’t pass muster in the market will - and should - lose out in the end. That’s the real story. But it’s not as sexy as ghostwriters in medical journals.
More than a year after Vioxx was withdrawn from the market, researchers are still struggling to quantify the cardiovascular risks that are associated with both old and new non-steroidal anti-inflammatory drugs (NSAIDs) like Vioxx, Celebrex, or ibuprofen. Observational studies have presented some tantalizing clues, and researchers like Garrett Fitzgerald suggest that mechanistic studies in small groups of patients may help us better understand the risks.
Pfizer, for its part, is stepping up to the plate with a large, multi-year study intended to prove that “low doses of [its Cox-2 drug] Celebrex do not pose the same heart attack and stroke risk that Vioxx does.”
The big surprise: Pfizer enlisted one of Celebrex's first critics to run the 20,000-patient study. Steven Nissen of the Cleveland Clinic, who co-wrote with his boss Eric Topol a 2001 journal article that raised the alarm on both Celebrex and Vioxx, will be running the big study. It will compare Celebrex to two other popular arthritis drugs, the active ingredients in Aleve and Advil, in patients who are already at high risk for heart attacks. Says Alastair Wood, associate dean at Vanderbilt University Medical School, "That's the study Merck said couldn't be done."
The trial, dubbed Precision, may not be finished until the middle of 2009, but when it wraps, Nissen says patients will have finally answered raging questions about which arthritis drugs are safest for those in pain. "If you have arthritis, you're going to have to take something," says Nissen. "So what do you take? Celebrex, ibuprofen or naproxen?"
Daniel H. Solomon, a Harvard rheumatologist who is not involved in the Pfizer study, says, "As a physician, I'll tell you that's the decision I make. I am deciding what to prescribe in high-risk people, because those are the people who have arthritis."
Pfizer’s move is bold. Competing in today’s cost-conscious healthcare marketplace demands that companies bring products to market that can validate their safety and cost-effectiveness against their competitors. Pfizer is trying to do just that, in a patient population where there is a real need for better (and safer) therapies. We should also remember, however, that this study will cost $100 million. That should help industry critics recall just how expensive medical research is.
In the debate over drug importation, advocates for each side have been talking past each other. One side claims imported Canadian drugs are safe. The other says that they expose Americans to unwarranted health risks.
But the reality is that we need to clarify our terms. Drugs made in the U.S. or Canada in FDA-registered facilities, and sold by legitimate Canadian pharmacies, are undoubtedly safe. The problem is that the total Canadian prescription drug market is only a tiny fraction of the U.S. market—meaning that Americans who order drugs from online websites are at substantial risk of falling victim to drug counterfeiters from abroad who are selling fake, dangerous, or substandard drugs as “Canadian.”
This FDA sting operation, for instance, found that
…nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with "Canadian" pharmacies. Of the drugs being promoted as "Canadian," based on accompanying documentation, 85 percent actually came from 27 countries around the globe. A number of these products also were found to be counterfeit.
“This operation suggests that drugs ordered from so-called ‘Canadian’ Internet sites are not drugs of known safety and efficacy,” said Dr. Andrew von Eschenbach, Acting FDA Commissioner. “These results make clear there are Internet sites that claim to be "Canadian" that, in fact, are peddling drugs of dubious origin, safety, and efficacy. We believe that these ‘bait and switch’ tactics-offering patients one thing and then giving them something else- are misleading to patients and potentially harmful to the public health.”
FDA conducted its operation, named “Operation Bait and Switch,” over a few days in August 2005 at JFK Airport in New York City, Miami International Airport, and Los Angeles International Airport. FDA examined all mail parcels suspected of containing pharmaceuticals sent from four countries-India, Israel, Costa Rica, and Vanuatu-that FDA had previously noticed were sources of drugs apparently ordered from pharmacies alleged to be Canadian in origin. Out of nearly 4,000 parcels examined, almost 1,700 or about 43 percent had been ordered from “Canadian” Internet pharmacies and were represented as being of Canadian origin.
However, only 15 percent of the “Canadian” drugs in the parcels examined actually originated in Canada.
Getting the facts straight in this debate is vital, and so everyone should be careful to explain what they really mean by “Canadian importation.”
At bottom, however, what we are really talking about is drug prices. Canadian drugs are cheaper than their U.S. counterparts because of Canadian price controls. If importation-advocates want price controls for prescription drugs in the U.S., they should have the integrity to advocate that policy -- and stop encouraging American consumers to play shell games with Internet pharmacies.
Health Care for All, Just a (Big) Step Away
The Times does an excellent job of explaining how government health care subsidies, in this case the tax deduction for employer-provided health care, distorts markets.
This exemption, which has its roots in WWII-era wage and price controls, is really a disguised form of income. Rather than paying an employee directly (which is taxed) the employer provides health benefits that are untaxed. The unintended consequence of this policy, however, is that consumers who earn more get more compensation than lower paid employees. Also, employees who work at larger companies (who have more negotiating power with providers and insurers) get better benefits than individuals or employees at small companies. In short, cheaper prices for some (often high income) employees result in higher costs for everyone else.
Last but not least, third-party coverage promotes wasteful health-care spending, because it gives employees the illusion that someone else is paying for their health benefits and encourages them to rely on insurance to cover routine expenses that could be easily paid out of pocket. The Times notes that,
Next year, the federal government expects to provide about $130 billion for Americans to buy health insurance. The amount is substantial: it is equivalent to about 11 percent of all federal income tax revenue and more than a fifth of federal spending on Medicare and Medicaid. And it is growing fast: the bill is expected to surpass $180 billion in 2010.
Nonetheless, this financing remains under the political radar because it is provided indirectly - not as direct spending but as a tax break that allows workers to receive health insurance coverage from their employers without having to pay income taxes on whatever it costs.
This provides a powerful incentive to businesses all over the country. The subsidy - supplemented by an additional $11 billion in deductions for medical expenses and billions more in similar tax breaks for health insurance from states and municipalities - helps to explain why 64 percent of Americans under 65 get health insurance through their employers. Although subsidizing health insurance may seem a worthy effort, a positive contribution to the goal of universal coverage, it is among the most inefficient spending in the nation's fiscal arsenal.
"If you had $150 billion to play with, you could come very close to universal coverage," said David Cutler, an economics professor at Harvard. One reason that we are 45 million people short of that goal is that the money isn't being spent on them. According to President Bush's advisory panel on tax reform, about half of the tax break for health insurance accrues to families making more than $75,000 a year. More than a quarter goes to families making over $100,000.
Is it politically impossible to end the tax benefit? Maybe not impossible, just very difficult. But the President and Congress can start by capping the benefit, equalizing the tax treatment for insurance bought by individuals, and creating national markets for health insurance.
FDA Risk Communication Should Include Drug Benefit Info, PhRMA says
The Pink Sheet recounts a very interesting exchange between industry and the FDA on the issue of drug warnings, which seem to be driven as much by the media cycle as by sound science on the real risks and benefits facing patients. One company, DataBank, put the problem into context by highlighting the FDA’s risk communications for antidepressant drugs:
First DataBank Manager Nicholas Ratto presented examples of how FDA’s drug risk communications fail to put safety concerns into proper context. An FDA medication guide regarding the increased risk of suicide risk with antidepressant use in children was “almost completely devoted to this uncommon suicidality issue to the exclusion of other adverse effects, and to the exclusion of the proven benefits of the drug,” Ratto said. …
Ratto said First DataBank’s update to consumer medication information for antidepressants instead presented benefit information. The First Databank CMI states that “while antidepressants can provide great benefits, a small percentage of people taking these medications for various psychiatric conditions have had a worsening of depression or other symptoms including suicidal thoughts or attempts.”
Putting the drug’s main risks and benefits into context in plain English would be very helpful for individual patients, especially those struggling to decide if a particular medicine is right for them. Another advance would be to find a way to communicate drug risks in both absolute and relative terms. For instance, research suggests that Vioxx doubles the risk of adverse cardiovascular events in patients vs. placebo, but the absolute risk for any given patient still remains very small.
A patient with severe arthritis at low risk for heart disease, but who wasn't responding to other NSAIDS, could then weigh the pros and cons of different treatments (like Cox-2 drugs) in context. As it stands today, drug warnings are so complex and abstract that they tend to confuse rather than inform. The FDA is in the process of reforming its risk communications, but more can still be done to help patients make better therapeutic choices.
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