Latest Drugwonks' Blog
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!
Remember that wild ad? The one that got your hackles up and made you ask your 8-year old to leave the room? Well, it’s gone goodbye — if the members of PhRMA follow #10 of the new voluntary DTC guidelines —and they’re (mostly) on record saying they will abide. As such, reminder ads are history. #10 guideline, the only one of the 15 with real teeth, is the first real move towards having responsible adults at pharmaceutical companies reign in their purposefully aggressive marketing brand folks. Good work Billy! A “perfect 10.”
PhRMA’s new voluntary guidelines for DTC advertising say a lot about what Big Pharma is ready to do — and that’s not much more than what they’re doing right now. That means being “in compliance.” That’s nice. But what they’re missing is that the problem is the status quo. Doing the wrong thing the right way is a very questionable strategy. Okay, maybe not the “wrong” thing, but not the best, most forward-looking thing. The real problem is that “long-term” thinking, relative to marketing, needs to shift from the end of the quarter to somewhat further down the pike. If not, it will end up being decided down another pike — Rockville Pike.
William Osler said “the young physician starts life with 20 drugs for each disease, and the old physician ends life with one drug for 20 diseases.” That’s a nice aphorism, but it has a deeper meaning. Dr. Osler recognized that while young physicians start their career on the cutting edge of medical science, they ultimately learn, through trial and error that the practice of medicine isn’t primarily about medicine, it’s about the patient.
Let me tell you about another famous physician, one who has influenced millions of people around the world, Dr. David Zorba, chief of neurosurgery at the renowned County Medical Hospital during the 1960s. You might remember him better if I remind you of his often-repeated mantra, Man, woman, birth, death, infinity. If we understand the need to make today a foundation for tomorrow, then infinity is a concept we should consider.
Dr. Zorba was mentor, father confessor, friend and teacher to Dr. Ben Casey, the star of the television series of the same name that ran from 1961 until 1966. In Ben Casey the limits of medicine, the ethics of physicians, and the role of medicine in society were thoughtfully examined. Dr. Zorba’s hospital functioned as a microcosm of the larger society it served. The professionals presented in Ben Casey were a tight group sworn to an oath of altruistic service. The majority of physicians in the employ of County General were not terribly inflated with self-importance. Their world was not so far removed from the world inhabited by those they helped. The problems that plagued the world outside the walls of County General could often be found within as well.
During their work at County General, Dr. Zorba and his colleagues came into contact with representatives from every level of society. Part of that contact was learning about and making judgments on certain societal issues and problems. Racial tension, drug addiction, the plight of immigrants, child abuse, and euthanasia were a few of the issues treated in Ben Casey. Medical malpractice wasn’t one of them.
How far we have come in just under half a century. Today, as in the time of doctors Zorba and Casey, physicians are often viewed as subjects of admiration. But, unlike those halcyon days at County General, physicians are more and more viewed with disdain as spendthrift by insurance providers, potentially liable by the tort bar, as in the pocket of big pharmaceutical companies by the media, and as heartless cogs in a malfunctioning health care system by our patients. Today, rather than making judgments about society, society is making judgments about us. We have moved from the leadership of Dr. Zorba to that of Dr. Phil.
When Thomas Edison was asked why he was so successful he responded, “Because I fail so much faster than everyone else.” Think about the millions of dollars, pounds and Euros that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process.
In partnership, regulators, industry and academia can apply modern engineering and cutting-edge scientific knowledge to medical product manufacturing. In partnership we can improve standardization and automation of clinical research. And in partnership we can develop novel and improved clinical trial designs and analytical methods for evaluation of safety and effectiveness that can reduce costs. Currently, 50% of drugs that undergo large scale Phase 3 trials turn out to be too unsafe or not effective enough for marketing. That is not a sustainable model for the 21st century.
Consider the implications if FDA could help companies to fail faster. Using the lower end of the Tufts drug development number …
* A 10% improvement in predicting failure before clinical trials could save $100 million in development costs.
* Shifting 5% of clinical failures from Phase 3 to Phase 1 reduces out of pocket costs by $15-$20 million.
* Shifting 1/4 of failures from Phase 2 to Phase 1 would reduce out of pocket costs by $12-$21 million.
FDA’s critical path activities and research must complement, not compete with, what industry and other regulatory agencies in the US and around the world and are already doing.
I believe that FDA should assume an organizational role, because FDA is at the crossroads of the translational process.
FDA is uniquely suited to take a major role in this effort because of their unique cross-industry and cross-cutting knowledge of the hurdles companies and products encounter that are causing them to fail in late stage clinical trials.
FDA has the technical expertise that can draw together stakeholders, help prioritize research that is most needed, and to partner with others to conduct this research. Obviously solutions will have to come from sources with the greatest expertise. This could entail contracting with academic organizations, private industry and other global translational research groups.
FDA’s Critical Path initiative will enable innovative growth companies to better and more efficiently attack the steep hurdles facing them, allowing them to compete more effectively against the bigger, better-funded players in the market on a more level playing field. That means a real change in the risk/benefit equation for both emerging growth companies and the public health.
Consider FDA’s critical path initiative as a revised game of Shoots and Ladders. Rather than relying on a roll of the dice, FDA can be a bridge over the shoots and a guide to the ladders.
The most important tool is collaboration. Regulators must embrace stakeholders as partners in the public health process.