Latest Drugwonks' Blog
Here's Sir Alan's most recent contribution:
Time for NICE to lower its cut-off price?
A leading health economist has suggested that NICE’s new year’s resolutions should include lowering the cut-off threshold for new drugs from £30,000 per quality adjusted life year gained to £20,000.
Professor Alan Maynard’s suggestion comes in the wake of the recent re-announcement of the Government’s response to the Richards Review on drug top-ups, which has suggested that for end-of-life rarer conditions such as cancer, the cut-off threshold should be raised to £70,000 / QALY.
Professor Maynard, whose OBE was announced in the New Year Honours list, also points to findings from a House of Comons Health Select Committee report that the Scottish Medicines Consortium, which reviews new technologies within six months, has reached “remarkably similar conclusions” to those on NICE, and proposes that this duplication is wasteful.
Discriminating against those not near the end of life
Maynard also argues that the £70,000 threshold for people with rarer end-of-life illnesses represents “an arbitrary equity value judgment (which) is inherently unfair for those not in the last two years of life”.
He also emphasises that NICE has much work to do in removing from use existing technologies already adopted in the NHS that are not demonstrably cost-effective. Writing on Health Policy Insight, Maynard suggests that the current recession’s inevitable effect on NHS funding “requires NICE to pay much more attention to marginal technologies already being used in the NHS, as their elimination will free resources to provide better patient care”.
Maynard also suggests that NICE should work “much harder to acquire a price setting role” – a radical proposal, given the existing barrage of negative publicity NICE has faced over its refusals to approve products for NHS use.
Hmm. If 70,000 pounds is arbitrary, then so is 20,000. And so is the judgment that the recession's inevitable effect on NHS should lead NICE to use even older and cheaper technologies and ration new ones further. Sir Alan as a hospital administrator? I'd bring my own food if I had to go inpatient at York Hospital. Come to think of it, what are the mortality rates there?
The fact is, NHS has a 3 million pound surplus attained in the same way NICE and NHS have rationed technologies. At the same time rates of chronic illness are rising and death rates from cancer are the highest in the Western world.
And here in America, comparative effectiveness is being offered as a tool to solving the innovation "problem." In reality, comparative effectiveness is just an arbitrary judgment made by government about who should get what and when.
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No, really.
Susan Dentzer (editor-in-chief of Health Affairs and an on-air analyst on health policy for the NewsHour with Jim Lehrer) has an excellent and timely Perspective piece in the January 1 edition of the New England Journal of Medicine, “Communicating Medical News — Pitfalls of Health Care Journalism.”
“Whether they realize it or not, journalists reporting on health care developments deliver public health messages that can influence the behavior of clinicians and patients. Often these messages are delivered effectively by seasoned reporters who perform thoughtfully even in the face of breaking news and tight deadlines. But all too frequently, what is conveyed about health by many other journalists is wrong or misleading.”
“Consider news reports on the findings of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, reported in March 2006. The STAR*D study was a complicated trial designed to test treatment approaches for seriously depressed patients who weren't helped by taking one antidepressant. The results showed that 50% of patients had improvement after pursuing additional treatment steps, such as switching or adding medications, taking a higher dose, undergoing cognitive therapy, or some combination of these. Arguably, for people with serious long-term depression, this was hopeful news. Yet on March 23, 2006, the Washington Post ran a story whose lead paragraph framed the study as a failure because half the patients had no improvement: ‘Antidepressants fail to cure the symptoms of major depression in half of all patients with the disease even if they receive the best possible care, according to a definitive government study released yesterday.’ Apparently, simply noting that half got better and half did not was not deemed sufficiently new or interesting.”
The full article can be found here.
It will also be a boon to China’s pharmaceutical manufacturing industry. Oh well, at least we know that quality won’t be a problem.
The new Chinese law is based on TRIPS – and is the latest example of how international organizations are wrecking havoc with the keystone of medical innovation – intellectual property rights.
It should also serve as a potent reminder that Secretary of State-Designate Hillary Clinton will indeed have an important role in healthcare reform – albeit of an international nature. And the implications for continued U.S. support of intellectual property rights could be profound.
Many in healthcare policy land were pleased that Senator Clinton was tapped by President-Elect Obama to head the State Department because it would (in the words of more than a few) “get her out of the healthcare reform debate.”
Not so fast.
By moving into the corner office at Foggy Bottom, Mrs. Clinton will be a force majeure in global healthcare issues by dint of her ability to appoint and otherwise influence the United States delegations to the many Geneva-based organizations that address issues such as compulsory licensing (the World Trade Organization) and access to healthcare issues (the World Health Organization).
The U.S. has long been a bulwark in support of global intellectual property rights – and Mrs. Clinton should be questioned about her views on this and related issues during her upcoming Senate confirmation hearing.
By Michael Kahn
LONDON (Reuters) - Many genes linked to various cancers do not appear to raise the risk of getting cancer after all, according to an analysis of hundreds of studies published on Tuesday.
The findings highlight the need to exercise caution over the increasing number of studies associating common genetic variations with a range of diseases, said John Ioannidis of the University of Ioannina School of Medicine in Greece.
"The whole thing about genetic variations and links to diseases like cancer are very exciting, but the general public should be quite cautious about jumping to the conclusion that if they have a change in one gene or another they are doomed," Ioannidis, who led the study, said in a telephone interview.
"Genetic effects are very complex and very subtle and we need to know a lot more before we can make strong recommendations based on genetic profiles."
Ioannidis said his team had looked only at common genetic changes or polymorphisms, not at rare mutations, which in genes such as BRCA1 and BRCA2 significantly raise breast cancer risk. The rare form of these variants, for example, accounts for an estimated 5 to 10 percent of breast cancers.
Since early 2007, variations at more than 100 places on the genome have been linked to diabetes, heart disease and certain cancers.
The problem, researchers say, is that many of these genes typically interact in a complicated manner and their ultimate effects are influenced by the environment -- diet, exercise, smoking and other behavior -- in often poorly understood ways.
Ioannidis and his colleague Paolo Vineis of Imperial College London analyzed hundreds of published studies linking genetic changes to different cancers. They found that, out of 240 associations between a specific mutation and a cancer, only two genes involved in DNA repair and tied to lung cancer -- XRCC1 and ERCC2 -- turned out to be strong candidates for such a link.
"Most of the associations had weak or modest credibility," he said. That included PARP1 for breast cancer and CCND1 for head and neck tumors.
The problem is that on their own, the earlier studies fail to provide a complete picture and run the risk of drawing conclusions from too limited an amount of data, Ioannidis said.
This does not mean studies linking genes to cancer and the risk of other diseases have completely missed the mark, but rather that it takes a mountain of evidence to reach strong conclusions when it comes to the human genome, he added.
"Our study shows that it really takes a lot of research effort and many, many studies to be able to pinpoint a couple of associations," Ioannidis said.
(Reporting by Michael Kahn; editing by Maggie Fox and Tim Pearce)
Those who seek to establish a moral equivalence between Israel and it's enemies, particularly journalists, lack both conscience and context.
See here.
A study published in July showed that diabetics who take insulin plus a diabetes pill have a lower risk of developing Alzheimer's disease than diabetics who take insulin alone.
Oh and that pill? Avandia or Actos. How many people are NOT on either thanks to Nissen's cardiovascular fearmongering?
(Nearly 25 million prescriptions were written in the U.S. in 2007.)
“The issues concerning Plavix show the promise and problems with the new area of "personalized medicine," where drugs are tailored to certain people based on their genetic makeup. In Plavix’s case, the three studies pinpointed a likely genetic factor inhibiting the drug's efficacy -- but that finding has opened up more unanswered questions.”
“Unanswered questions” are a good thing – it means that we’re now being forced to think hard about how to address these new facts. Nobody said personalized medicine was going to be easy.
Three studies last week -- two in the New England Journal of Medicine and one in the Lancet -- identified a genetic abnormality in some heart patients that could interfere with their liver's ability to completely process Plavix in the bloodstream, but they differed on the number of patients affected.Two of the studies suggested the drug was less effective in about 30% of the population that has the mutated gene from one parent, while one study indicated the drug is less effective in the 5% of the population that has the gene from both parents.
According to Larry Lesko, director of the FDA's office of clinical pharmacology, "What I think we're struggling with is what is the label going to say in light of all the ambiguous data out there."
That’s a key point to remember – that “personalized” labeling is not a black-and-white proposition. And it’s the FDA’s job to review all of the information (much of it vague and contradictory) and then make the best choice on behalf of the public health. Larry Lesko’s honesty acknowledges some tough truths about drug regulation – like the nascent nature of the agency’s understanding of pharmacogenomics relative to “safe use” and the dearth of 21st regulatory tools to explore it.
These new studies mean "life just got very confused and much more complex" for cardiologists and patients, said Dr. James Calvin, director of cardiology at Rush University Medical Center in Chicago. He added, "We have to start to become very, very aware of how big an issue this is."
Indeed, not “safety” per se, but “safe use.”
According to Dr. Lesko, the agency is considering amending the Plavix label to recommend that patients get a genetic test to screen them for the gene mutation. This is similar in concept to the FDA’s change to the Warfarin label – but with one big difference ... at present there aren't any alternatives to Plavix approved for use in the United States. "Once you know the answer, what do you do?" said Douglas Weaver, president of the American College of Cardiology.
Good question – and one that the FDA should acknowledge and take into consideration as it reviews the various safety profiles of new medicines that could fill this gap.
Dr. Paul Gurbel, who authored one of the first studies showing that many heart patients don't process Plavix effectively, said, "Clearly I think just the blind administration of these drugs is rapidly coming to an end."
Dr. Grubel’s comment is a clarion call that the era of “trial-and-error” medicine is over. One size does not fit all. Not for anti-clotting drugs, not for cancer medications, not for statins.
The Journal article opines that, “The new Plavix studies may give a boost to personalized medicine as a cost-saving measure under President-elect Barack Obama. As an Illinois senator, he introduced a bill in Congress encouraging genomic research and personalized medicine that would "target the delivery of health care." Insurance companies might be able to limit prescriptions for Plavix based on patients' genetic makeup, as they do now with some cancer drugs.”
First of all, news articles shouldn't opine. Secondly, personalized medicine is not about denying care. It’s about providing the right care. The four rights (right medicine at the right time to the right patient in the right dose). And as far as “cost-savings” are concerned, not providing Plavix to some subset of patients (and particularly one as potentially large as 30%) doesn’t mean these patients don’t need treatment – it means they need alternate treatment, newer therapy, therapy that may cost more than Plavix does today – and considerably more once it goes off-patent.
And as far as former Senator Obama’s “Genomics and Personalized Medicine Act,” goes – I look forward to hearing about its passage during his first State of the Union address.
One of Lord Darzi's recommendations is that NICE work faster so that the fine and timely work of the MHRA (the FDA’s sister agency in the United Kingdom) isn’t wasted.
According to NICE Chairman Sir Michael Rawlings, "Our ambition is to make sure guidance is available within three to six months.” He said this could be achieved by increasing the number of advisory committees and starting the evaluation process a year before a drug company expects to obtain a license. (Not a bad idea for similar action by CMS right here at home.)
That’s good news. What’s better news is that Sir Michael seems to be almost, kind of, sort of ready to reconsider NICE’s inflexible devotion to the Holy QALY.
According to the NICE chairman, "People attach a special importance to extending the lives of [those with] mortal illnesses, even for a few months, and we appreciate these extra weeks and months can be very special.”
Further, "We are proposing to provide our advisory bodies with supplementary advice ... which will have the effect of extending the threshold range of what we would normally regard as cost-effective."
Good golly! Miss QALY?
However, "We are not proposing to extend this to all conditions. Frankly, it would cost the NHS hundreds of millions of pounds."
Well, heaven forbid that the NHS should provide the best care when adequate care is available. That’s cost-based versus patient-centric care. That’s NICE.
In other words, when Sir Michael’s political masters feel the heat – NICE sees the light. This is a case (one not unknown in American politics) of the squeaky wheel getting the oil. And now that British citizens with “mortal illnesses” will finally be treated like human beings, it’s only a matter of time until every other segment of the British population figures out that where their best chances for best treatment lies – in public activism.
Is this any way to run an airline?
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.
