Latest Drugwonks' Blog
"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.
Yes. I read Reader’s Digest.
And I’m honored to be included in their September story, “Prescription Medicines New and Old; What to consider when your doctor prescribes a new drug.”
Here’s the teaser blurb from the Digest’s website:
All things being equal, it's prudent to take older drugs whose side effects are known instead of new drugs that have less data.
"It has always been unfortunate but unavoidable that some adverse effects may not become apparent until a drug has been in wide use," says Peter J. Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner for the FDA. Sometimes it takes years and millions of users for a pattern to emerge.
When you get a prescription for a new drug, ask your doctor why the new drug is a better choice for you than something long on the market. Also ask about any known serious side effects. And read any printouts from the pharmacy before you take a new medication.
Speak up. Trust your instincts. If you experience any new physical or mental symptoms, consult your pharmacist or physician as soon as possible. Report any adverse side effects to the FDA (www.fda.gov/medwatch or 800-332-1088) and the pharmaceutical manufacturer.
I haven’t seen the complete article yet, but during my interview I spoke at length about the importance of (1) avoiding the Precautionary Principle -- the luddite tenet that preaches that we do nothing until we know everything, and (2) moving towards personalized medicine – and why molecular diagnostics is the key to providing “the four rights” -- the right medicine in the right dose at the right time to the right patient.
So it’s exciting to hear that Medco Health Solutions (the large
Medco, will help the FDA assess obstacles to the use of existing genetic tests as they relate to the prescribing of medicines, as well as new opportunities for such tests.
Medco will deliver a series of reports to the FDA under the agreement, which runs until Aug. 31, 2010. Areas of study include the safety of prescription drugs, physician participation in pharmacogenomic testing, and the usefulness of such tests in prescribing.
The first projects will likely be determined this fall and that the initial areas of study may be oncology and HIV/AIDS.
According to Reuters, "Medco seeks to lower drug spending for its clients, which include health plans and large.employers, and sees pharmacogenomics as a potential way to control costs and improve quality of care."
That’s the way to lower costs the right way. Rather than denying care, we need to focus on the four rights. That will lead to better care more swiftly and reduce adverse events.
The complete Reuters story can be found here.
In the Reuters story, Medco Chief Medical Officer Robert Epstein said, "The big-picture goal is to facilitate the uptake of appropriate pharmacogenetic testing in the marketplace. It can't really happen if you don't have good information about both the science but also the practice of medicine."
Epstein added that a more comprehensive understanding and use of genetic testing "should take trial and error out" of prescribing and "make people feel more confidence in the drugs they're being placed on because they know for them personally that drug should work.”
And that’s something that’s important not just to us healthcare policy wonks – but to the readership of Reader’s Digest. The real
It's time for America to stand up and demand that our elected representatives allow the FDA to aggressively pursue a well-funded Critical Path program. It's time for America to stand up and demand its rights-- "the four rights" -- to personalized medicine.
From this view I see the attacks on the commercialization of biomedical knowledge quite differently. Indeed, l can lump the hypocritical attack of Marcia Angell on FDA pre-emption over the regulation and labeling, the effort to eliminate DTC, CME and private sector investment in academic research, the effort to impose administrative controls on the use of new medicines, the rants of those think that attacking CMPI's funding sources is a rational response to the question of appropriate use of medicines for mental illness into one broad category:
Neo-Luddites... described in a wiki in the following manner:
Opposition to neo-Luddites consists largely of those who believe that technology is beneficial or, at worst, neutral. This opposition has sometimes been hindered by a focus on specific issues, and on occasion by a belief that the benefits of certain new technologies are obvious when in fact many people do not understand the technology in question.
A main concern of technological proponents is to question whether it is always worth saving those things that neo-Luddites seek to protect. The actions of the Luddites are perceived to be emotion-driven and therefore irrational. One form of this objection begins by noting their defense of traditional cultures, and then pointing out culture as a static force enslaves people to its strictures, and is counterproductive to adaptation resulting in cultural if not ethnic extinction. Further arguments would state that elements (real or imagined) of certain traditional cultures that modern societies find abhorrent, such as cannibalism and slavery. Another form is to note some problem that most people would like to minimize or eliminate - such as cancer (which many people agree can eventually be reliably treated or cured), or the sometimes crippling effects of advanced age (see Geriatrics) - and argue that the main effect of neo-Luddism would be to delay or prevent solutions to these problems.http://en.wikipedia.org/wiki/Neo-Luddism
I call the whole bundle of anti-commercialization forces Bio-Luddites because the they are a subgroup of the NL. Like the Luddites efforts of old, both the thinking and the administrative apparatus furiously being erected by today's Bio-Luddites will be swept away by a river of innovation that is spreading rapidly than any entity can control. Witness the note of exasperation in this op-ed in the Times of London about how NICE is unable to keep up with the current wave of new cancer drugs. I have highlighted the remarkable last sentence in this one section:
To judge from the genuine shock of oncologists, the decision may yet be revised - as has happened for several other drugs that NICE originally rejected. Yet even if this ruling turns out to have been misguided, NICE is going to have to make more tough choices of this nature. The reason is that the increasing success of medical research will make rationing an ever- greater challenge for the NHS.
http://www.timesonline.co.uk/tol/life_and_style/health/article4539008.ece
That's right... rationing must rise to beat back the increasing success of medical research. Anyone want to be on THAT side of the argument.
This won't happen. NICE and NHS are being besieged now by advancing innovation. What will the Bio-Luddites do when the next generation of genomic based medicines come flooding through a high-speed regulatory pipeline that is biomarker based?
It will crumble as all effort to stem innovation do. Unless we or they resort to a police state, a sort of Stalinist approach to health care where the both the intellectual freedom and the scientists who thrive in it are forced to investigate only government approved projects and private companies are reduced to merely formulating the compounds for a royalty.
But that won't happen. The Bio-Luddites are not just losing. The have lost. The equate vitriol and bullying with success. But the opposite is occuring. Innovation is on the march and market forces are and will play a key role in that victory. Just as they did when the Luddites became -- after a few decades -- a bunch of cranks meeting in dusty libraries and socialist bookstores.
In
A 1997 study in Health Policy found that whereas the average wait time for bypass surgery in
In
This is the reality in government-run health care systems, as they focus more on saving money than on saving lives. That’s why citizens experience long wait times, a lack of access to certain treatments, and substandard medical care.
Consider this new op-ed from Mark Henderson, Science Editor of The (
First consider the title: "We need cancer drug rationing."
And then some selected paragraphs:
“Rationing is never a popular exercise, and never more so than in medicine. The idea that the NHS is universal and free has become so deeply ingrained that nobody is happy when it denies treatments on grounds of expense.”
“As knowledge of the molecular and genetic mechanisms of disease increases, this situation is likely to worsen. More and more treatments will become available. Some will be personalised for a small group of patients and will thus be expensive because the market is limited. Others may extend life only for a short period and will offer poor value for money on the NICE model. Some will have to be rejected for NHS use, even though they work.”
“At present, this means in practice that most patients are refused them altogether.”
And now over to the other Times, the New York Times -- America's "newspaper of record."
In his August 11th column,
It sure hasn’t been easy for the countries that have tried.
Andrew Witty of GlaxoSmithKline has a three-part prescription for the pharmaceuticals giant
by Health News,
The Economist
IT IS a rare company boss, let alone one who has just got the top job, that can get away with likening his firm’s culture to a police state. But Andrew Witty, the new boss of GlaxoSmithKline (GSK), a British pharmaceuticals giant, somehow manages to pull it off. He invokes that analogy—tentatively, to be fair—to explain the cultural transformation he wants to see at GSK: away from today’s excessively regimented, rule-based approach towards the “utopia” of a simplified, values-based culture that trusts employees to do the right thing.
Mr Witty gets away with it in part because he is amiable. He is certainly very different from his abrasive predecessor, Jean-Pierre Garnier, who retired in May after a tumultuous term as chief executive. Mr Witty has already set the tone for a more open style of management. Whereas J.P., as his predecessor was known, often seemed arrogant, Mr Witty began his tenure with a listening tour. J.P. controversially insisted on living in Philadelphia; Mr Witty is not only based at GSK’s headquarters in London, but he even plans to move his office next to the staff canteen so he can be more accessible.
The new boss can also joke about police states because his loyalty to GSK is unquestioned. Having spent nearly his entire professional career at the firm, he is the ultimate insider. By contrast, two years ago Pfizer, GSK’s American rival, picked Jeffrey Kindler, a lawyer with little pharmaceuticals experience, as its new boss. Perhaps needing to build up credibility and knowledge of his firm, Mr Kindler took his time crafting a turnaround plan. Mr Witty, however, has already announced big changes at GSK. Driving this strategic revamp is his desire to “derisk” the firm to provide reliable growth with less volatility.
His plan has three components. First, he wants to end the obsession with blockbusters, which he likens to “finding a needle in a haystack right when you need it”. The industry’s reliance on risky blockbusters, he reckons, makes it vulnerable to “sudden torpedoes” in the form of lawsuits from generics firms, or regulatory crackdowns like the one that recently hit Avandia, GSK’s big diabetes drug. Instead he wants researchers to look for many more potential drugs, both small and large, that can make up a more reliable pipeline. This, he reckons, will make GSK’s drug-discovery efforts more akin to a nimble fleet of destroyers, rather than two or three vulnerable battleships.
Second, Mr Witty wants the firm to expand its businesses beyond prescription-drug sales in the rich world, so that its revenue streams are more diversified. To this end, he has announced a big push into emerging markets, which many drugs giants had hitherto seen as mere charity cases. He is also taking the firm into the branded-generics business through a deal with Aspen of South Africa, which should help smooth out GSK’s earnings volatility.
Third, and most controversially, Mr Witty has been sitting down with his biggest customers to ask them what future products they are willing to pay for. This might seem like common sense in any other industry, but it has been heresy in the drugs trade. In the past Big Pharma innovated as it saw fit, and big payers (such as Britain’s National Health Service, or America’s “pharmacy-benefit managers” and insurers), then coughed up for its pricey pills. But now health services and insurers are refusing to reimburse fully for drugs that are deemed to provide poor value for money. Britain has even set up an official agency, the National Institute for Health and Clinical Excellence (NICE), to do explicit cost-benefit analyses of this sort.
Here's the rest of the story.
With Lebron out of town, perhaps the Congressman thought he could grab some media cowbell. But all he’s done is show his, well, cavalier attitude towards healthcare reform in general and the facts in particular.
And adding to the lunacy, his “Medicare Drugs For Seniors Act” (HR 6800) would also impose limits on the prices which drugmakers would be allowed to charge for their products if the R&D which led to the drugs’ discovery had been financed “by taxpayers’ dollars.”
According to Mr. Kucinich, “Medicare beneficiaries want their prescription drugs without having to navigate complicated maze of choices and stealth loopholes.”
Really? Perhaps he’s missed the fact that seniors are very pleased with the Part D benefit – with very high satisfaction rates – and even higher usage. The Wall Street Journal Online/Harris Interactive survey of U.S. adults age 65 or older, shows 87% of those enrolled in a Medicare drug benefit plan are satisfied with their plan. Sorry Dennis.
Here’s another example of Mr. Kucinich embracing The Big Lie:
“The privatized drug plan has been given a chance and, as predicted, it has failed. There is no reason for us to keep throwing money at a bad idea when we know we can save taxpayers billions of dollars and give seniors the medication they need.”
Really?
According Kerry Weems, acting administrator at the U.S. Centers for Medicare and Medicaid Services (CMS), "Overall, costs for beneficiaries and taxpayers are considerably lower than originally projections, enrollment continues to rise and customer satisfaction remains very high.” Sorry Dennis.
The projected cost for Medicare part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.
Why? Marketplace competition. Sorry Dennis.
And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled. Sorry Dennis.
And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage. Sorry Dennis.
Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda (sorry Dennis!) but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.
Sorry Dennis. Sorry Part D is working so well.
As to drug discovery financed by “taxpayer dollars,” based on the case histories of 35 widely prescribed drugs, researchers from the Manhattan Institute and Tufts University determined that almost all of the medicines they analyzed would not have been developed without private sector research. And in 28 cases they found that private sector research led to improvements in a drug's clinical performance or to a better way to manufacture the drug. Discovery is cool. And so is development. One without the other leads nowhere. Sorry Dennis.
Dollar for dollar, the pharmaceutical industry outspends the government in drug development. In 2007, the collective membership of PhRMA spent $44.5 billion on research and development of prescription drugs, while the industry overall spent $58.8 billion. The same year, the National Institutes of Health allocated $28.6 billion in grants, some of which went to developing new drugs. Both are important and collegiality is the way things get done. Sorry Dennis.
As for drug importation, here we go again:
(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.
And the important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.”
(3) The state experience has been dismal and politically embarrassing. Remember the high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. They don’t call him “Wrong Way” Rod Blagojevich for nothing.
And what of Minnesota and Governor Tim Pawlenty’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
And remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield is now out of the drugs from Canada business.
(4) National Security concerns. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.
These are important facts to keep repeating and repeating in the appropriate context. Because there are those who chose to manipulate the facts to tell their own version of the truth for their own selfish political purposes.
Sorry Dennis indeed.
If you’re not a regular reader of the Federal register, you might have missed the August 6th notice that the FDA is moving forward with plans to evaluate “distractions” in consumer ads. The experimental study will analyze everything from the placement of text to competition between audio and visual elements, and the use of “major statements.” FDA has opened the proposal for comments until September 5th.
According to the FR, "Data from this study will provide useful information for FDA as it considers whether it is appropriate to develop guidance to help improve how broadcast ads present a prescription drug's risks and benefits."
The FDA will create ads for a fictitious brand to treat high blood pressure to control for participants' prior experience and attitudes. Participants in the study would be men and women age 40 years and older. Everyone will be presented a series of ads—each with different tone, neutrality, and presentation of risk information.
As the terrific Crystal Rice (aka “FDA spokesperson”) told Pharmaceutical Executive Magazine, "We chose high blood pressure as the condition because it is chronic and under-treated, and there are few DTC ads currently running.”
And here’s what I had to say:
"Just like no two people respond the same way to a medication—everyone doesn't respond the same way to advertisements," said Peter Pitts, president of the Center for Medicine in the Public Interest. "The most important thing that DTC advertising does is drive people to their doctor's office to talk about a condition. Whether they glean three, six, or 12 contraindications from a commercial because a child is or is not running through a field of daisies is interesting, but not important."
The complete Pharmaceutical Executive story can be found here.
Okay, I overstated. It is important. Mea culpa. Fair balance and adequate provision serves a useful purpose. (Really!) But, when we consider the social science that’s been done surrounding, for example, the Brief Summary, that “purpose” requires closer examination.
Consider the peer-reviewed study that appeared in Drug Information Journal (Vol. 41, pp 111-127). It found that, when it came to print DTC, “As the number of side effects listed (4, 8, or 12) increased, more consumers recalled no side effects correctly (37%, 45%,, and 53% respectively).” The complete paper can be found here.
(Full disclosure: I am one of the authors of this paper.)
So let’s say, for matter of discussion, that we could devise a method whereby every viewer of every DTC television commercial fully understood everything detailed (you should excuse the expression) in the fair balance/adequate provision.
Is that a good thing or a bad thing?
Well, since better understanding of risk/benefit is, um, better – it should fall into the “good” category, right?
But what if this enhanced understanding results in decreased visits to physicians? Is that a good thing? (According to FDA research, about 6% or all doctors’ appointments are scheduled because a consumer saw a DTC commercial.) What about the undiagnosed conditions uncovered during these appointments. (According to FDA research, in 6% of those DTC-generated office visits, a previously undiagnosed condition was discovered.)
Will the new FDA study capture data that speaks to the increased or decreased likelihood of visiting a physician based on more or less complete recall of risk information?
That’s important context -- particularly since the results of this new study are likely to be highly (shall we say) "media worthy."
Hopefully, the research protocol for this study will be discussed at a future meeting of the agency’s Risk Communications Advisory Committee.
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.
