Latest Drugwonks' Blog
“That’s like a person already deeply in debt planning to buy a $50,000 car and finance it over ten years. Thanks to a dealer rebate, he pays $46,000. He has not reduced his debt by $4,000 but increased it by $46,000—plus interest.”
Read more here.
According to a new report in the Mayo Clinic Proceedings, many patients who are being treated with "off-label" drugs are unaware that the medications they have been prescribed by their doctor aren't being used in ways that would meet U.S. Food and Drug Administration approval, research shows.
Quelle surprise.
"Health care providers and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one,” says study lead author Dr. Christopher Wittich, an internal medicine physician at the Mayo Clinic in Rochester, Minn.
While this report states the obvious, the more important question is what are physicians telling their patients about the medicines they prescribe … and where is that information coming from.
Now that industry detailers are getting the cold shoulder and many inveigh against industry supported CME – wither knowledge about off label or, for that matter, on label indications?
It’s time for pharma detailers to start detailing the label – with such a detail aid being developed and approved by the FDA at launch.
The researchers also surmise that the high costs and lengthy process of obtaining FDA approval may deter drug companies from seeking approval for a new drug indication,.
How insightful.
Thomas Sowell said it best: " Prices are perhaps the most misunderstood thing in economics. Whenever prices are “too high” — whether these are prices of medicines or of gasoline or all sorts of other things — many people think the answer is for the government to force those prices down.
It so happens there is a history of price controls and their consequences in countries around the world, going back literally thousands of years. But most people who advocate price controls are as unaware of, and uninterested in, that history as I was in the law of gravity.
Prices are not just arbitrary numbers plucked out of the air or numbers dependent on whether sellers are “greedy” or not. In the competition of the marketplace, prices are signals that convey underlying realities about relative scarcities and relative costs of production.
Those underlying realities are not changed in the slightest by price controls. You might as well try to deal with someone’s fever by putting the thermometer in cold water to lower the reading.
Costs don’t go away because you refuse to pay them, any more than gravity goes away if you refuse to acknowledge it. You usually pay more in different ways, through taxes as well as prices, and by deterioration in quality when political processes replace economic process."
With that as a context, the upcoming Great Oxford Debate on drug prices seems to frame the issue in ways that go beyond the usual sophmoric level attained by policymakers and pundits...
Medicines and cost: what does GOD think?
UK NEWS | AUGUST 07, 2012
The problem with pharmaceutical policy is that it has become “over-focused to the point of obsession on issues of price and cost”, Professor Richard Sullivan, Director, Institute of Cancer Policy, will argue during the PharmaTimes Great Oxford Debate on 20 September at Oxford University, UK.
Professor Sullivan, who is also a member of the Kings Health Partners Integrated Cancer Centre, will join Eric Low, chief executive of Myeloma UK, and Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry, at the prestigious annual debating event to propose that ‘patients have the right to the best medicines, regardless of cost’.
“The argument is not that we should pay whatever a company demands for a licensed medicine irrespective of how little benefit it bestows, rather that value is a much more subtle and complex issue than price alone,” Professor Sullivan says.
However, Professor Sullivan and co will have their work cut out for them as arguing against the motion, will be the Rt Hon Stephen Dorrell, MP, Chairman of the Health Select Committee, Professor Mike Pringle, President Elect of the Royal College of General Practitioners and Laura Weir, Head of Policy & Campaigns, MS Society and Chair, Patients Involved in NICE.
Says Dorrell: “I am strongly in favour of using the NHS budget to secure the best possible outcome for patients, but not in favour of a motion that appears to give treatments based on pharmaceutical products a higher priority than other forms of treatment, nor am I in favour of implying that decisions about healthcare should never be constrained by a real life requirement to decide about priorities.”
But isn’t it society’s moral and ethical duty to ensure that as new medicines are researched and developed they find their way to patients to prolong and improve patients’ wellbeing?
What do you believe? Do patients have the right to the best medicines under the NHS Constitution? If the best medicine is the NICE approved medicine, just what are patients' rights? Are those aged over 65 being discriminated against? Or is it that the NHS simply cannot afford the best medicines?
Join the debate on 20 September at the Oxford Union. For more details and to register your attendance click here or contact Hannah Smith hannah@pharmatimes.com or phone 0208 487 9119.
What? A large government entitlement program that comes in under budget and has high participant satisfaction rates?
That would be Medicare Part D. User satisfaction rates push 90 percent and the program’s cost is below budget, with an anticipated price tag of nearly $120 billion less than originally estimated over the next decade.
And here’s another gold to add to the Part D Olympic medal count – according to HHS, Medicare beneficiaries will pay almost the same premium for prescription drugs next year as they did this year.
Part D is the Michael Phelps of healthcare reform – providing victories today and a policy roadmap towards real healthcare evolution.
Premiums for drug plans that accompany basic Medicare coverage for the elderly and disabled will be an average of $30 in 2013, the department said today in a statement. The estimate is based on bids from private insurers who offer the plans to Medicare patients.
Smart partnership between government and the free market worksSATURDAY, AUGUST 4, 2012
Why I've Always Written So Much With Such Intensity And why I won't stop now.
By Barry Rubin
Nothing is stranger than having a normal life and then within a few hours knowing that it might end at almost any moment. That’s what happened to me when I was just diagnosed with what is called inoperable lung cancer. I am still waiting final results of the tests and the choice of therapies.
I have no desire to make this my focus but it’s been suggested that I write something about it that might be of broader interest.
First, for those of us whose understanding of cancer is based on past information, it is very important to understand that a lot has changed. That diagnosis twenty or thirty years ago would have given a person only a few months to live. Today, with many of the new therapies invented, one has a fighting chance. Still, it is tough to have your life expectancy lowered from around twenty years to a minimum of two within moments.
People always asked me why I wrote so much and so intensively. I never told them one of the real reasons: I always expected my life would be limited. My grandfathers died, respectively, at 42 and 44, both of things that could have been cured today. My father died of a heart attack at 62, and his life probably could have been extended many years today by all the new tests and drugs available. But I felt that once I passed that birthday, less than a year ago, I might be living on borrowed time.
They say that when you are fighting cancer that becomes a full-time job in itself. Supported by my truly wonderful family, I’m working on it. Right away one starts paring things down: unsubscribing to lots of things; knowing that I will never again have time for hobbies. The decision to start reading a book is like a major life choice.
And I know I won’t be going canoeing down the Jordan River with an old friend in August. In fact, having passed out briefly about a half-dozen times—though we think we’ve solved that problem—I’ll probably never drive again nor, after cancelling two trips, travel internationally. In fact, the way things are going at the moment, I might never eat solid food again.
The best thing to do is to accept everything calmly—bargaining, hysteria, rage, won’t do any good--and then decide that one is going to fight with the object of beating the disease. Unlike much of political life, this is not caused by malevolent forces.
This is not, however, the only transformative event I’ve had this week. I don’t want this to come out wrong but I have been touched and encouraged by an outpouring of emails from friends, acquaintances, and readers about how much they appreciated my work. Up until now, I’ve really thought that my articles have gone into a void.
As you know, we live in an era where many ideas, much truth, and certainly the kind of things that I think are largely barred from the most prestigious (although daily less so) media and institutions. We are either ignored or vilified. Now, though, the counter-audience has grown so long and people are so hungry for accuracy and cutting through the nonsense that our ranks have grown into the millions. When someone tells you that you’ve helped them, informed them, encouraged them, or even changed their lives it is an immeasurable feeling.
And while I wouldn’t go so far as to say that the cost has been worth receiving these messages, it is closer than one might ever believe.
There are some constructs I’ve come up with that I find comforting. Briefly:
Every living thing that has ever existed has died, at least in terms of being on this earth. If they could do it I can do it.
I feel like I have been captured by an enemy force (you all can insert specific names) and they want to execute me. I hope to escape or to be rescued by my friends.
Even if I didn’t have this disease, I could leave life on any day due to many causes without warning.
For 2000 years my ancestors dreamed of returning to their homeland and reestablishing their sovereignty. I have had the privilege of living that dream. How amazing is that?
We have to judge ourselves by whether we’ve lived up to our ideals and done our best. Not by the accumulation of power, wealth or fame; not for failing to achieve the impossible.
A famous Jewish story about that is the tale of Rabbi Zosia who said that he did not expect God to berate him for not having been Moses—who he wasn’t—but for not having been Zosia.
To me, that means we must do the best to be ourselves while trying to make ourselves as good as possible. I’ve really tried to do that. I don’t have big regrets, nor bitterness, nor would I have done things very differently.
And I’ve discovered the brave community of those who are supporting and encouraging each other in the battle against this disease.
Finally, I find myself identifying with a poem by a Turkish writer named Ilhami Bekir that goes like this:
“Neither vineyards, nor gardens
Do I ask.
Nor horses, nor sheep.
Don't take my soul away,
O God!
I am curious.
I must see how this game ends!”
The game, of course, doesn’t end and I don’t expect to live to see utopia realized. But it would be nice to live long enough to see America and the world pass out from this current dreadful era, to see some restoration of sanity and reality, some kind of victory for goodness, some kind of restoration of intellectual standards, and a higher level of justice.
Some friends tell me they think we’ve turned the corner and that there’s real hope of beating the terrible forces that have messed up our societies and insulted our intelligence and tried to sully our reputations.
That’s something worth living for and fighting for. I hope to do it with you people as long as possible.
Just who are these “academic detailers” anyway? And what are their qualifications?
(For more on this topic see this article from the May 2012 edition of Drug Information Journal.)
Well, here’s an actual job description as created by Total Therapeutics Management, the company AHRQ is paying $11,680,060 to recruit, train, and field what we should more appropriately call “government detailers.”
Patient Centered Outcomes Consultant
Our Part-Time Patient Centered Outcomes Consultant positions provide a distinctive opportunity for pharmacists looking for the perfect balance between professional challenge and work/life without practicing in a traditional healthcare workplace. This part-time position provides flexibility and is perfect for self-motivated individuals who thrive in a fast paced environment with an emphasis on personal accountability. Your success will be determined by the number and quality of the details you achieve, not only the amount of time you log.
Essential Job Duties and Responsibilities:
* Schedule and conduct 250 details annually to targeted healthcare providers
* Develop relationships to facilitate ongoing success of academic detailing program
* Document meeting & communication feedback in relationship management software
* Complete accurate and timely administrative reports and required documentation requests.
Minimum Qualifications:
* Pharmacy, degree with current, active license.
* Five years clinical experience.
* Therapeutic competency.
* Personal computer skills including advanced knowledge of word processing, database management, and reporting is required.
* Excellent scientific presentation and public speaking skills.
* Ability to plan, prioritize and execute multiple responsibilities.
* Ability to travel 60%-70% day travel; some overnight possible
* Clean and valid driver's license.
* Dedicated home office with internet and phone connectivity.
250 details annually? Sounds more like academic retailing. Are former pharmaceutical company representatives welcome to apply?
According to a new IMS report (funded by the Generic Pharmaceutical Association) use of generic medicines has reduced U.S. health care spending by more than $1 trillion over the past decade.
The report notes that using inexpensive generic versions of pricier brand-name prescription drugs now saves the country about $1 billion every other day. Drugs for heart conditions and central nervous system disorders such as depression and convulsions account for 57 percent of the annual savings.
What’s missing in the report is a big “thank you” to the innovator companies who, through their scientific ingenuity, perseverance, and financial investment made the generics industry both possible and profitable.
Just sayin'.
Silent gratitude isn’t much use to anyone.
-- Gertrude Stein
According to DSHEA, dietary supplements are foods. And now a food (or in this case, a fruit juice) is behaving like a dietary supplement -- making false health claims.
Makers of POM Wonderful (a pomegranate juice drink) have been warned by both the FDA and the FTC to stop making unsubstantiated claims about the drink's health benefits.
Among the claims made by the company is that POM is "40% as effective as Viagra" because it improves blood flow and promotes healthy blood vessels. The firm also claim POM is "proven to fight cardiovascular, prostate and erectile health" and that "clinical studies prove that POM Juice prevents, reduces the risk of, and treats, erectile dysfunction."
A randomized, placebo-controlled, double-blind, crossover pilot study examined the efficacy of pomegranate juice versus placebo in improving erections in 61 male subjects. The study did not achieve overall statistical significance, but the authors (from the Keck School of Medicine, University of Southern California,) conclude that additional studies with more patients and longer treatment periods may in fact reach statistical significance.
And then again -- it may not.
The Federal Trade Commission has filed a lawsuit against the makers of POM Wonderful. This comes six months after the FDA told POM to stop misleading consumers with claims of “super health powers.”
http://abcnews.go.com/Health/Wellness/whooping-cough-vaccine-effective-early-form-study-finds/story?id=16898211#.UBmQU8j3v5h
Jonca Bull returns to the agency after stints at Novartis and Genentech to become director of the Office of Minority Health.
Great choice.
Good luck, Jonca.
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.
