Latest Drugwonks' Blog
Here's a new article from today's edition of The Scotsman:
Advertising rules stifle free market for prescriptions
By Peter Pitts
IN EUROPE, it is illegal for drug companies to advertise prescription-only drugs to consumers. But the European Commission (EC) recently announced that it will allow pharmaceutical firms to disseminate "information" on their products over the airwaves, on the internet, and in print.
I think this change can't come soon enough. For too long, European bureaucrats have put cost considerations before patient care, keeping patients in the dark about alternatives that may best address their needs. Officials have, I think, paid lip service to the idea of empowering patients with more information on treatment options.
James Copping, a principal administrator of the EC, said in 2006: "We want a system where patients can be empowered to take an equal part in healthcare decisions." But thus far, no such thing has happened.
Consider the European agencies tasked with weighing the effectiveness of various treatments, such as the UK's National Institute for Clinical Excellence (Nice) or Germany's IQWiG. These agencies exist to provide unbiased medical information to government.
But because they are operated by government, I would say they have a vested interest in keeping costs down and have an incentive to conclude that newer, more expensive medicines are no more effective than older, cheaper ones.
Nice offers an instructive example. In 2001, contrary to expert findings by licensing authorities in 65 countries – including Scotland – it cited "insufficient evidence" for recommending the use of Gleevec in leukaemia patients.
In 2002, US authorities approved Gleevec for the treatment of stomach cancer and it was deemed a miracle drug. It wasn't until 21 months later that Nice authorised the use of Gleevec for English victims of the disease.
IQWiG seems similarly set on depriving German patients of vital treatments. The agency has promoted an "efficiency frontier" as its governing methodology for evaluating treatments. But such jargon is smoke and mirrors, designed to cover for the government's preference for established – and generally less expensive – treatments, and by decreeing the most cost-effective option in a treatment category, these agencies effectively determine what a doctor must prescribe, irrespective of a patient's individual characteristics.
Obviously, pharmaceutical companies have products to sell. But, by allowing them to provide Europeans with medical information, they could serve as a counterbalance to the heavy-handed pronunciations of state-run comparative-effectiveness agencies.
Indeed, a great deal of evidence demonstrates that consumers benefit when drug manufacturers participate in healthcare decision-making.
In the US, for example, a 2002 study by the Food and Drug Administration found that direct-to-consumer advertising of pharmaceuticals improved both patient-doctor discussions and compliance with physician recommendations. The study also found that 88 per cent of patients who asked about a specific drug were afflicted with the condition in question.
A 2003 study in US health policy journal Health Affairs arrived at a similar conclusion. According to the study, ad- inspired doctor visits resulted in the advertised medicine being prescribed in only about 47 per cent of cases. Put another way, patients didn't get a prescription for the medicine they came in to discuss on more than half their visits. Even with advertising, doctors exert appropriate judgment when they prescribe drugs.
On other occasions, according to the study, previously undiagnosed medical conditions get treated – a good thing.
For European bureaucrats, there is reason for concern. If consumers can get additional information on drug options thanks to direct-to-consumer efforts, there's a good chance they'll start to ask the state-run health systems why they can't access certain treatments.
As European Parliament member Jorgo Chatzimarkakis recently argued: "Citizens cannot be deprived of information by their own governments on such crucial issues as one's health."
Government-run systems have demonstrated that they're not interested in spending more money, but armed with new information, consumers may be able to make the case to their leaders that the status quo of rationed, controlled care will no longer suffice.
The researches argue that neither health care spending or private premiums would go up that much because "hospital spending on uncompensated care has been relative stable. That is partly because the public hospitals and clinics that most often care for the uninsured often don't have many privately insured patients to absorb the costs."
Translation: most uncompensated care is due to the fact that Medicare and Medicaid don't pay the full cost of medical expenditures. Uncompensated spending has been stable because Medicare and Medicaid have held reimbursement rates steady and because in many cases the state match (to pay for the care of illegals) has skyrocketed with most of the money going to urgent care and maternal health, not complex medical procedures.
GIve people a full blue plate entitlement and watch both government expenditures rise and uncompensated care increase as well. In every state where a single payer plan has been enacted uncompensated care continues to go up. The best example is the Oregon Health plan which ensures the uninsured by rationing access to cutting edge treatments and raising taxes. The trend of uncompensated care since 1994 in that state is below.
Statewide Uncompensated Care by Year: | |||||||
Year | Charity Care | % Change from Prev. Year | Bad Debt | % Change from Prev. Year | Total Uncomp. Care | % Change from Prev. Year | |
1994 | 74,653,735 |
| 90,272,616 |
| 164,926,351 |
| |
1995 | 55,645,120 | -25.5% | 90,262,052 | 0.0% | 145,907,172 | -11.5% | |
1996 | 53,036,784 | -4.7% | 80,387,137 | -10.9% | 133,423,921 | -8.6% | |
1997 | 55,123,781 | 3.9% | 83,974,361 | 4.5% | 139,098,142 | 4.3% | |
1998 | 58,291,332 | 5.7% | 96,289,876 | 14.7% | 154,581,208 | 11.1% | |
1999 | 53,994,527 | -7.4% | 102,732,393 | 6.7% | 156,726,920 | 1.4% | |
2000 | 64,916,584 | 20.2% | 128,914,104 | 25.5% | 193,830,688 | 23.7% | |
2001 | 77,772,655 | 19.8% | 138,822,832 | 7.7% | 216,595,487 | 11.7% | |
| 2002 | 107,854,204 | 38.7% | 164,629,911 | 18.6% | 272,484,115 | 25.8% |
2003 | 183,626,444 | 70.3% | 221,580,947 | 34.6% | 405,207,391 | 48.7% | |
2004 | 268,333,010 | 46.1% | 269,741,864 | 21.7% | 538,074,874 | 32.8% | |
2005 | 374,330,244 | 39.5% | 301,574,208 | 11.8% | 675,904,452 | 25.6% | |
2006 | 445,884,426 | 19.1% | 305,343,908 | 1.3% | 751,228,334 | 11.1% | |
2007 | 524,707,945 | 17.7% | 351,866,447 | 15.2% | 876,574,392 | 16.7% | |
 | |||||||
The same thing happened in Tennessee when Tenncare was enacted. The idea that a single payer system will eliminate uncompensated care is bogus unless the single payer doubles what it pays providers, hospitals, etc. Just the opposite takes place in a single payer system. What will reduce uncompensated care -- apart from rationing which will drive up costs elsewhere -- are changes to the financial and technological structure of healthcare that reward saving and investment in personal health and staying healthy. Indeed, as the percent of people in consumer directed plans increases and includes the uninsured, the amount of out of pocket spending has remained stable and as a RAND study last year shows, the consumer directed plans are associated with reduced hospital and physician visits and increased access to prescriptions. This does not always "control" costs but does appear to improve quality by encouraging more management of costly chronic illnesses,
http://content.healthaffairs.org/cgi/content/full/hlthaff.27.5.w399/DC1
At least that seems to be the position of some state Medicaid plans.
Case in point, pregabalin (Lyrica) and Iowa (coincidentally, the state represented in the United States Senate by Charles Grassley).
Iowa Medicaid requires preauthorization for pregabalin -- which is FDA-approved for (among other indications) fibromyalgia. In Iowa a patient with a diagnosis of fibromyalgia must first fail on at least two of the State's "preferred" agents -- trycyclic anti-depressants, topical lidocaine, or gabapentin. None of these three agents are approved by the FDA for the treatment of fibromyalgia.
But they are less expensive than the on-patent, on-indication product. So what we've got here is step-therapy based on off-label usage. Not unheard of, certainly , but it does start sending some interesting policy messages about the appropriateness of off-label use in various circumstances. (And it's more than a little bizarre when you consider that Pfizer, the manufacturer of pregabalin, had to pay a $430 million fine for off-label promotion of gabapentin.)
The actions of the Hawkeye State Department of Human Services are even more peculiar considering that Senator Grassley (R, IA) asked the U.S. Government Accounting Office (GAO) to investigate off-label prescribing -- and not because he thought it was a valuable tool for patient care.
So here's where we stand: Off-label use of on-patent medications is bad, but off-label use for generics is good. Translation: off-label use is good when it saves the payer money.
Is cost-based trial-and-error medicine really the path we want to take in the era of personalized medicine?
What about science?
What about relying on the professional judgment of the physician?
What about what's best for the patient?
It's a Q&A. Here's a sample:
DIA: Do you think that the general public -- the average "patient on the street" -- would recognize the concept of patient-centered care?
JB: "I think that if they experience it, they can tell the difference, but at the moment we're setting up barriers to patient-centered care.
To find out what that means, have a look at the compete interview here. It begins on page 18.
"We adopted a societal perspective, discounted costs and benefits by 3% annually, and expressed benefits as quality-adjusted life-years (QALYs) gained. After eliminating strategies that were more costly and less effective or less costly and less cost-effective than an alternative strategy, incremental cost-effectiveness ratios were calculated as the additional cost divided by the additional health benefit associated with one strategy as compared with the next-less-costly strategy. Although there is no consensus on a cutoff point for good value for resources, we interpreted our results in terms of a commonly cited threshold of $50,000 per QALY gained, as well as an upper-bound threshold of $100,000 per QALY gained."
Hmm, and what does that cover...
"The routine vaccination of 12-year-old girls, in the context of current screening and assuming lifelong vaccine-induced immunity, had an incremental cost-effectiveness ratio of $43,600 per QALY gained, as compared with screening alone (Table 2). The addition of a 5-year catch-up program for girls between the ages of 13 and 18 years cost $97,300 per QALY, and extension to 21 years of age cost $120,400 per QALY. The extension of the catch-up program to 26 years of age cost $152,700 per QALY, as compared with the catch-up program to 21 years of age."
The extra $52 K is really society saying, we have decided after $100K we will roll the dice and see if we have to pay for all the costs relateded to screening, treatting, etc. cevical cancer. It does not even address what a 26 year old woman might think a catch up shot is worth....
Oh, and the additional benefits. like avoiding screening and the worry or other illnesses were never counted either.
"when the potential benefits associated with preventing noncervical HPV-16–related and HPV-18–related cancers and HPV-6–related and HPV-11–related juvenile-onset recurrent respiratory papillomatosis were included, cost-effectiveness ratios were reduced"
So of course the NEJM runs an editorial claiming the vaccine is not cost effective, it's press department hypes that and not the guts of the study and the rest of the media takes the lead and will ikely cite (via misrepresentation) the study as proof that many new products are not worth their cost. .
Still believe cost-effectiveness will certainily be a patient-centered and objective process taking into account all stakeholder concerns.
http://content.nejm.org/cgi/content/full/359/8/821
Here's what he has to say:
Peter Pitts’ depiction of the almost ten year old “cost-effectiveness” wars in
"This is in addition to Merck's efforts to make the vaccine mandatory for young U.S. girls, with many wondering if the rise in cervical cancer vaccines are due to increased awareness or to Merck's aggressive, award winning and highly controversial marketing schemes. "
First of all, is the above an actual sentence written by a journalist whose first language is English or was it translated from the original Vulcan?
Second, given the increasing reliance on other blogs with a bias as a primary source instead of real background, it is obvious that FiercePharma believes that arsenic causes diabetes, all marketing is a ploy and vaccines are dangerous.
Third, the argumentation of the piece is consistent with tendency of bio-Luddites to use their belief than medical innovations are just an excuse to rape the public as evidence instead of a fearful emotional response.
Note the lack of clear deductive or inductive reasoning balanced with a complete lack of empirical information. For instance there is a problem with increased used through marketing but not public awareness....is there a difference? Or are those responding to Merck marketing brainwashed and the those that received it from on high enlightened? Does evidence of adverse events mean the vaccine should NOT be marketed. What is the marketing was less aggressive? And what about the trend towards not covering by insurance companies? Obviously sales are lagging so what good is awareness is the so-called health maintenance organizations won't pay for prevention? They cover chicken pox vaccines but not cervical cancer?
Previously Fiercepharma claimed a article relying upon memos redacted and provided by tort lawyers that was published in the Archives of Interna Medicine (or was it annals? Who cares, right?) alleging the Advantage study Merck conducted was primarily for marketing "proves" that it was so because it was run in a "peer reviewed journal." It is my humble opinion that the Advantage study was designed to assauge fears, but that is just my opinion and publishing it here or even in JAMA using documents from a biased source does not make it fact.
I am supposed to be on vacation.
Leading the ISPOR hit parade is "German Recommendations on Health Economic Evaluation: Third and Updated Version of the Hanover Consensus."
Consider these tidbits:
"All benefit parameters that are relevant for the study situation in question should be incorporated in the assessment. It may be that data from various sources must be taken into account, which can be acomplished with the help of models. Possible essential data sources include medical meta-analyses, randomized clinical studies, as well as epidemiological observational data on the disease or long-term impacts of the disease. Additional relevant sources are cohort studies, data from health-care services research, data on current therapy standards, and possibly also expert opinions wherever other evidence is not available." (p.540)
And:
"The comparative quantification of the effectiveness of treatment alternatives requires studies that have a scientific design comparable to the designs in randomized, controlled studies. As a prerequisite for economic considerations in a specific case, clinical studies evaluating medical efficacy are indispensible. Nevertheless, as mentioned before, clinical studies often cannot serve as the sole basis of information for a health economic assessment. A realistic estimate of the costs can be limited under study conditions, if the use of some health-care services only arises from the study plan." (pp.541-542)
In the same blockbuster (block that metaphor!) issue, Peter L. Kolominsky-Rabas ((IQWiG) and J. Jamie Caro (Department of Medicine and Epidemiology and Biostatistics, McGill University) offer a sort of minority report in the form of an editorial.
In speaking about the updated Hanover Consensus, Kolominsky-Rabas and Caro write that:
"It is a remarkable achievement to being together most of the health economics community in Germany. To reach consensus in such a large group, however, much must be left unspecified and the exercise tends to be a search for the lowest common denominator." (p. 545)
And, they conclude:
"Little seems to have been changed from the previous HCG version published almost a decade ago. Meeting the worthy goals of the HCG -- to provide standards and yet promote methodological progress and scientific innovation in health economics -- requires more than a compilation of disparate current approaches. Actual recommendations must be concrete, tailored to the German context, coherent, and carefully justified, if they are to be helpful to German decision-makers." (p.546)
Ouch.
Does it seem counter-intuitive that “universal” care results in restricted access and poor outcomes? Not when you consider the facts.
A recent report published in The Lancet was the first international analysis of cancer survival that provides comparable data across countries. Across all cancers studied, survival in the
The researchers attributed the variation in survival to “differences in access to diagnostic and treatment services.”
Similarly,
Is the conventional wisdom that medicines for the very ill are healthcare budget busters? Not when you consider the facts.
A recent study published in Health Affairs found that for the severely ill, commercially-insured population, the costs of medical services account for more than 75% of health plan costs. Hospitalization costs accounted for half of this amount. In contrast, medications accounted for just over 20% of health spending for this group, whose annual costs are more than nine times higher than the overall plan population. The authors concluded that medication costs “do not seem to be the driver of health care costs for these members.”
Among the 2.5% of members with the highest spending, specialty medicines (defined in this study as "biologic-derived agents that target specific immune processes and proteins”) were used by 45% and accounted for 32% of spending on medicines and just 6.6% of total plan spending.
Pharma is not the enemy – disease is the enemy.
(But that’s not a convenient political sound-bite.)
Let’s not forget the wise words of Aldous Huxley, “Facts do not cease to exist because they are ignored.”
“If I were designing a system from scratch, I would probably go ahead with a single-payer system.”
Coming on the heels of last week's announcement by Great Britain's National Health Service (NHS) that, “Patients cannot rely on the NHS to save their lives if the cost of doing so is too great," that's quite a statement.
Perhaps Senator Obama is planning on naming the Grim Reaper as his Veep selection.
"Designing from scratch?" Back to the drawing board, Senator.
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.
