Latest Drugwonks' Blog
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).
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.
I’m sorry, did somebody say that counterfeit drugs are a “red herring” of the global pharmaceutical industry? The only comment I can make is, WHO’s on first.
LONDON - Worldwide, the WHO believes counterfeits make up between 5 and 8 percent of the $550 billion of medicines sold each year. But WHO spokeswoman Daniela Bagozzi said this was based on incomplete information and the actual amount could be higher.
“It represents a huge number of people who are suffering and in some case dying,” she said. “A lot of deaths could be avoided if the drugs being taken were not substandard counterfeits.”
Here’s a thoughtful article from a doctor who’s having a hard time “donating” staff time to helping patients navigate the often difficult paperwork problems of patient assistance programs. He’s trying to do the right thing. How can we help? URL for this article:
Do we now have to start referring to “Big Generics?” As reported today,Teva agreed to buy Ivax in a $7.4 billion cash-and-stock deal that will restore the Israeli company’s No. 1 position in the market for generic medicines. Used to be that those little ‘ol generic companies were the poor country cousins of the “real” pharmaceutical companies. But it seems as though the sides are evening up and, with a big assist from Uncle Sam, “Big G” is ready to make its move to prime time. Will this move presage a more aggressive legal posture by the purveyors of off-patent in general and towards biologics in particular? Don’t bet against it. G-Wiz!