Latest Drugwonks' Blog
Let me be blunt: The current political assault on direct-to-consumer advertising of pharmaceuticals is absurd, in that the essential “insight” underpinning such criticism is the preposterous premise that patients can be made better off by withholding information from them. But that eternal truth has not prevented those convinced that ordinary people are morons from arguing that the recent Vioxx fiasco (the public discussion, not the drug itself) would have been tempered had advertising not misled people into “overuse” of the drug. Oh, please. Consider an adverse drug effect that shows up in, say, three people in 100,000. In a clinical trial of 20,000 patients, it easily might not show up at all; that is the basic nature of the inference (“type 1/type 2” error tradeoff) problem afflicting all statistical analyses. Is it due to “negligence” that unknown problems might emerge in the general population of consumers? Or is it more fundamentally the result of the harsh reality that clinical trials are not free, and that larger ones would engender even greater costs, and thus fewer medicines and more human suffering over the long term? Only within the Beltway and among the plaintiffs’ bar is “a” the correct answer. And probably also in California.
There is a ballot initiative to be decided by the voters of California this fall — Proposition 79 — that would attempt and fail to deliver steep pharmaceutical price discounts to over half of the state population, even as it would enrich the lawyers. Call it the “Fewer Medicines and More Lawsuits” initiative. It would attempt to force those discounts for the middle class by excluding from the MediCal (California Medicaid) formulary drugs from producers refusing to accept the California price controls imposed by the bureaucrats and politicians. So much for the actual health interests of the poor and near-poor. In any event, the federal government (the Centers for Medicare and Medicaid Services) will not allow benefits for the poor to be mortgaged in favor of attempts by the political class to subsidize the middle class. That is what actually happened (or failed to happen) in Maine. What will emerge is an avalanche of lawsuits, because the initiative allows any citizen (that is, any lawyer) to sue on grounds of “profiteering” whenever a prescription is filled at an “unconscionable” price or at a price yielding a profit “unjust” or “unreasonable.” By the way, none of those terms is defined, and, no, the attorney needs no actual client. And the “antidiscrimination” provisions would force the price controls onto the entire market, and other states would find themselves unable to resist the pressures to impose a similar program, lest consumers in other states pay less. Presto! The long run collapse of the pharmaceutical sector would be upon us. Such are the wages of left-wing compassion.
This just in from the London Daily Telegraph, “Illegal sales of counterfeit medicines are booming, fuelled by a combination of the arrival of lifestyle drugs for ‘embarrassing’ conditions such as impotence, hair loss and obesity and their easy marketing on the internet, Britain’s drugs watchdog said yesterday.” Is this the first step towards blaming pharmaceutical companies for the frightening increase in global ethical drug counterfeiting? I’m sure there are some who will make that argument (hello Marcia!), but that’s not going to help address the problem. It’s like the old story about the police asking famous bank robber Willy Sutton why he robbed banks. His reply, “Because that’s where the money is.” The solution to drug counterfeiting isn’t fewer medicines, it’s increased vigilance. But, somehow I feel there are will be others who are ready and willing to blame pharmaceutical firms. How about this for a solution, no new drugs.
FDA Commissioner Lester Crawford has just announced that he and other members of senior agency management will travel to Miami, Boston, and Phoenix to hold open public meetings, according to the Wall Street Journal, “on any area the agency regulates, which includes drugs, medical devices, dietary supplements and most food products.” Well, that should certainly make for an interesting trip. Hopefully Les and crew will hear from some real people and not just politicians, “advocates,” and other sundry usual suspects. If you’d like to get on the agenda, visit http://www.grad.usda.gov/vision.
When Pfizer Vice Chairman Karen Katen appeared alongside Billy Tauzin at PhRMA’s recent announcement of the trade organizations DTC “Guiding Principles,” there was a lot of doubt as to whether her comments were anything more than supportive rhetoric. Well, today Pfizer proved they are willing, ready and able to really make a difference to DTC advertising and, more importantly, to truly advancing the public health.
At present risk information in DTC ads is neither designed nor delivered to be user-friendly. At present it is designed to be “in compliance” — and to truly advance the public health these things cannot be mutually exclusive. One of the things that Pfizer announced today is that they will undertake research (with input from the FDA and third parties) to help improve risk communication in DTC TV advertising, and will adjust risk communications accordingly. And, as far as the so-called “brief summary” is concerned, Pfizer has submitted to the FDA for review a new consumer-friendly and consumer-tested print brief summary. I hope they share their concepts more broadly, because if it works, there are broader public health communications lessons to be learned. And it’s about time because, as folks within FDA are fond of saying, the current brief summary is like the Holy Roman Empire. It is neither brief nor a summary. And it most certainly is not a useful public health tool. If Pfizer can help change this, more power to them — and to all of us.
And when it comes to disease awareness, the world’s biggest pharmaceutical company is stepping up to the plate and putting their money where their mouth is. In 2006, Pfizer will invest on par with what it spends on a branded advertising to create more disease awareness with advertisements that do not mention a product; address crucial public health issues such as health literacy, compliance and improving the patient/physician relationship through additional non-product advertising; and continue a dedicated advertising campaign to promote their “Pfizer Helpful Answers” program that helps people who need help affording the medications they need.
These announcements are more than programs inoculating Pfizer against the anti-DTC desperados. It’s about saving lives and saving our health care system big bucks. Improving disease awareness, treating people appropriately and promoting compliance with medical treatments helps eliminate the costs associated with under-diagnosis, under-treatment and untreated conditions, which often lead to more surgeries and expensive hospital care. Understandable and accessible information, in the form of direct-to-consumer advertising (disease awareness as well as branded messages) also helps with other costly factors, such as low health literacy (which costs our health care system approximately $58 billion annually) and noncompliance (estimated at more than $100 billion a year in increased emergency room visits, hospital and nursing home admissions, and lost productivity).
Kudos Karen.
The debate over FDA’s new Drug Watch plan is a bellweather for how the FDA views both the pharmaceutical companies it regulates and the public it must keep informed. PhRMA’s position is that “Plans by U.S. regulators to release preliminary information about potential drug side effects could lead to unnecessary confusion and irrational fears about medicines.” And, according to Reuters, “PhRMA also voiced concern that the FDA may not provide companies with adequate notice of new information for the Web site or a chance for input.” These are all rational concerns. Where’s Aristotle when you need him? Where is the moderation? Does the public deserve to know about potential risks earlier? Of course. But what does that mean? It should not mean scaring people with the results of early, often ambiguous studies. Unfortunately, the media and some politicians jump on these FDA postings to bash drugs that are, overwhelmingly, safe. Precipitous postings only magnify the media’s thirst for “the next Vioxx,” and magnify the unintended consequences of non-compliance. And unintended consequences are not in the best interest of the public health. But this does not mean that swifter release of appropriate science isn’t a crucial goal. It most certainly is and on this both sides agree. The proper answer, the “how to,” is somewhere in the middle — but seeking that out through dialogue and debate is exceedingly hard in today’s highly-charged political environment. It’s time for politics to take a back seat to science and the public health. It’s time to abandon the Precautionary Principle for the Aristotelean Mean.
Remember when Wrong-Way Rod Blagojevich said he was going to buy flu vaccine from non-FDA approved sources? Well, now it seems that he doesn’t want to pay for the roughly 700,000 doses because of a provision that allows termination for “unforeseeable circumstances beyond its reasonable control, including governmental regulation.” Last time I looked, the FDA told the Governor NOT to buy the vaccine in the first place BECAUSE IT WAS ILLEGAL.
But that’s never stopped Wrong-Way Rod before. Somehow I don’t think the “savings” earned from his embarrassing drug importation schemes are going to cover the cost of this latest fiasco.
Well, at least the White Sox are winning.
A welcome breath of sanity from from the leader of the Utah State Senate …
Preferred drug lists come with problems
Last week, the Utah Legislature’s Executive Appropriations Committee
declined to institute a Preferred Drug List policy that would require
Medicaid recipients to use drugs on a discount list or go through a prior authorization process. A few reporters and editors were quick to broadcast their assumption that this decision was driven by political contributions. That assumption is wrong. In 2001, the state of Maine implemented a PDL policy — one of the first in the nation. Six months ago, it issued a report which scrutinized Maine’s system and found what it characterized as “disturbing trends.” According to the report Emergency room visits have increased; Hospital admissions and patient referrals to specialists have increased;Many patients experience a worsening of their medical conditions as they jump through the hoops to get medications not on the PDL; Many patients are forced to go to the doctor multiple times to get the right medicine; Medical staff time and attention is diverted from patient care to handle “voluminous paperwork” and increased calls from patients; Doctors are cutting off or limiting the number of Medicaid patients they accept due to the increased administrative burden; and Quality of care has decreased and patients have suffered painful consequences. They reported, “while (a PDL) is an important cost containment tool, aspects of its implementation have adverse consequences directly affecting the health care of thousands.” Other PDL states are also experiencing serious problems. I found these concerns to be compelling. As a taxpayer and legislator, I would like nothing more than to save money in our Medicaid program. The bottom line for me, however, is that I am unwilling to conduct medical experiments on our most vulnerable residents. Some have asked why we don’t just approve a limited program to see how it would work. The answer is simple. We imagine that we might well save a significant amount of money in the short term, as have Maine and the other PDL states. Short-term savings, however, are only part of the equation. Let’s look at the dynamics that would be set in motion. A limited program is
likely to generate quick positive numbers while the long term impact and human cost would remain unquantifiable for several years.
Stories of frustration and tragedy would have a difficult time competing with clear financial data that would build political momentum in favor of PDLs, to the injury of a population that is already striving to overcome immense challenges. In other words, this train has no brakes. I do not want it to start rolling down the mountain when we know there are people on the tracks below.
Maine is currently investigating the administrative problems caused by its PDL program. At some point in the future, Maine plans to try to quantify the human damage caused by the program to determine if the money it saved was worth the cost. At this point, I am unwilling to plunge Utah into a similar experiment.Perhaps we can revisit the issue when the bugs are worked out of the PDL system. Seven legislators on Utah’s Executive Appropriations Committee voted for a
Utah PDL; nine voted against it. Each was lobbied fiercely from all sides of the issue. Each has their own reasons for the judgment call they had to make. They are all good legislators. They did their job.
You will find your representatives to be far more informed, far more
sincere, and more compassionate than the two-dimensional caricatures
portrayed by recent media accounts.
John L. Valentine is president of the Utah State Senate.
The one thing I got out of Gardiner Harris’ story in Saturday’s NY Times is that the current drug label isn’t a terrific public health tool. Just like its crainial cousin, the “brief summary,” it’s written more for liability protection than for physician/patient utility. And that’s a shame — especially now that the FDA is adding so many more warnings to already crowded spaces. While approprite language is crucial to responsible use, more and more black boxes won’t make the label any more used today than it was before the Grassley Inquisition. In fact, it might even lead to a hideous unintended consequence of “label fatigue,” where a black box is no longer viewed as an extraordinary thing. What a shame to cry wolf and only end up with Sid Wolfe.
Today’s words of wisdom from Nobel Prize-winning drug researcher and United States Senator Charles Grassley, “The F.D.A. should not be slowing things down or speeding them up depending on how the wind blows.” That certainly carries a lot of weight from a man who wears a weathervane on top if his head and, during Commissioner Crawford’s confirmation vote, needed to be reminded that the FDA doesn’t have the authority to mandate label changes. The answer, my friend, is not bloviating in the wind. Rather than commenting on the prevailing winds (which certainly seems a classic case of projection) perhaps Mr. Grassley should work to increase the FDA’s budget.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
