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Lots of letters in today's edition of the New York Times on NICE and the issue of cost-based vs. patient-centric care. To see them all, click here.
Here's my contribution:
To the Editor:
The National Institute for Health and Clinical Excellence in Britain is set to lift its ban on several kidney cancer drugs. The move will give patients access to lifesaving medicines that had previously been deemed “too costly” to cover under public health insurance.
This reversal is effectively an acknowledgment that the agency hasn’t worked as intended. By denying patients access to cutting-edge treatments simply because of cost, it has heartlessly put lives at risk.
Peter Pitts
New York, Dec. 3, 2008
The writer is president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration.
Here's my contribution:
To the Editor:
The National Institute for Health and Clinical Excellence in Britain is set to lift its ban on several kidney cancer drugs. The move will give patients access to lifesaving medicines that had previously been deemed “too costly” to cover under public health insurance.
This reversal is effectively an acknowledgment that the agency hasn’t worked as intended. By denying patients access to cutting-edge treatments simply because of cost, it has heartlessly put lives at risk.
Peter Pitts
New York, Dec. 3, 2008
The writer is president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration.
Barbara Stanwyck (the actress) said of egotism that it's a case of mistaken nonentity. The same can be said the rampant speculation and self-promotion regarding who is going to be the next FDA commissioner. Lots of people weighing in who don't know the full story or the full weight of the job. Lots of second guessing. Only one or two people who are willing to stand and accept the responsbility and stand by decisions regardless of what is said to attract the crowd or generate a headline.
That's why Janet Woodcock's statement regarding Vytorin and Avandia are so courageous and on point: "People have convicted them without a trial." But she has taken similar stands on drugs that others though should have been approved, but have not, because of lack of compelling benefit data, and on demanding that FDA have more hires, that staff actually get paid on time, that the new FDA building have a cafeteria(!).
Drugwonks has made it clear who it thinks should NOT be FDA commissioner. But with regard to who should FDA Commissioner, it should be someone who can emulate and admire Janet Woodcock's dedication to science-based overhaul of the agency.
That's why Janet Woodcock's statement regarding Vytorin and Avandia are so courageous and on point: "People have convicted them without a trial." But she has taken similar stands on drugs that others though should have been approved, but have not, because of lack of compelling benefit data, and on demanding that FDA have more hires, that staff actually get paid on time, that the new FDA building have a cafeteria(!).
Drugwonks has made it clear who it thinks should NOT be FDA commissioner. But with regard to who should FDA Commissioner, it should be someone who can emulate and admire Janet Woodcock's dedication to science-based overhaul of the agency.
According to the Wall Street Journal, HHS Secretary-Presumptive Tom Daschle wants Americans to host “holiday-season house parties to brainstorm over how best to overhaul the U.S. health-care system,” He’ll make the suggestion as part of his case for health reform in a speech to be delivered in Denver today.
(PS/ Why hasn't Daschle's nomination been made official yet?)
Congressman Bart Stupak does not have the courage of his convictions.
Here’s what he wrote to President-Elect Obama:
"I would encourage you not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA … Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for."
He’s a bully – and a coward since he didn’t back up any of his accusations with even a scintilla of evidence – and didn’t name any names, yet he’s calling for a "complete change in the FDA's leadership."
Here’s some news for Mr. Stupak – there are precisely zero political appointees (“Schedule C” employees) in any of the FDA’s five centers (drugs, biologics, food, medical devices, and veterinary medicine). None. And all five center directors are career public health officials. And Mr. Stupak – the 11,000 career staff at the FDA know precisely who they work for – the American public.
It is an absolute abomination that Congressman Stupak should cast such squalid aspersions on the men and women of the FDA who work long hours under tremendous pressure with little recognition at government pay to help protect and advance the public health.
Is the Honorable Mr. Stupak accusing career FDA staffers of taking bribes? If so, let him say so. If not, let him apologize.
Just as the FDA dips its toes into the world of social media with via a new partnership with WebMD (details here), some pharmaceutical and medical device companies are stepping into something else -- abuse of social media.
Here's the dénouement -- social media must play by the same regulatory rules as, well, pre-social media.
After all, if the medium is the message – and the message is regulated – than the same rules apply. Specifically FDA rules, guidances – and draft guidances. This is not rocket science and pharmaceutical and medical device companies should know this without having to be told.
Alas, that does not seem to be the case with some.
In September, the FDA sent a letter to Shire Pharmaceuticals, asking it to pull a YouTube video for Adderall XR that the agency said overstated the hyperactivity drug's effectiveness and omitted risk information. The company said it didn't intend to post the video on the site and, upon learning of the posting in May 2007, promptly removed it.
The newest culprits in this space are YouTube videos for medical devices sold by Abbott Labs, Medtronic and Stryker. The Prescription Project (with whom we share almost no common ground) points out that these videos violate federal rules because they don't contain required warnings and disclosures. And they’re right.
Stryker said it wouldn't comment because the issue was before the FDA. Medtronic said it is committed to adhering to FDA guidelines for direct-to-consumer advertising. The company said the video in question had been taken down. An Abbott spokesman said the company posted a link to safety and risk information next to its YouTube video, but will from now on embed safety and risk information in such videos.
Social media is the wave of the present and presents powerful new ways to both market to and educate the public. Mistakes such as these are not acceptable and will only lead to more Congressional fist pounding. The good news is that they are easy to avoid. Just follow the rules. Social media – indeed all media – must be used responsibly, in compliance, and for the benefit of the public health.
In his discussion of how NICE covers or doesn't cover cancer drugs Gardiner Harris asserts that I "..likened Dr. Rawlins (the head of NIC) and his institute to terrorists and said their decisions were morally indefensible."
Not true. I said that the NICE decisionmaking approach -- which takes years -- held patients hostage to a QALY measurment that only took into account what NICE thought was valuable to the NHS, not to the patients themselves. And I said that decision because of its perspective and delay was and will be morally indefensible. I stand by that view and stand by the people who lives are cut short and ruined by NICE.
Innovation is not the problem with health care. Innovation is the solution. Cancer care is a small part of the cost of health care and is often the most effective in terms of reducing expenses and extending life. The question is if we had applied the NICE knife 30 years ago, how many of us, our parents, our siblings, our children would be far worse off (yes -- even dead) because of the absence of products not developed or unavailable due to the cumulative impact of cost trumping care?
Not true. I said that the NICE decisionmaking approach -- which takes years -- held patients hostage to a QALY measurment that only took into account what NICE thought was valuable to the NHS, not to the patients themselves. And I said that decision because of its perspective and delay was and will be morally indefensible. I stand by that view and stand by the people who lives are cut short and ruined by NICE.
Innovation is not the problem with health care. Innovation is the solution. Cancer care is a small part of the cost of health care and is often the most effective in terms of reducing expenses and extending life. The question is if we had applied the NICE knife 30 years ago, how many of us, our parents, our siblings, our children would be far worse off (yes -- even dead) because of the absence of products not developed or unavailable due to the cumulative impact of cost trumping care?
Do we want British-style comparative effectiveness? Is NICE the answer?
The most recent installment of the New York Times series, “The Evidence Gap,” explores NICE and the proposition of balancing cost-based government concerns with patient-centric care.
And ground zero is kidney cancer. According to the Times’ story:
"When Bruce Hardy’s kidney cancer spread to his lung, his doctor recommended an expensive new pill from Pfizer. But Mr. Hardy is British, and the British health authorities refused to buy the medicine. His wife has been distraught."
“Everybody should be allowed to have as much life as they can,” Joy Hardy said in the couple’s modest home outside London. "It’s hard to know that there is something out there that could help but they’re saying you can’t have it because of cost. What price is life?”
Surprisingly the Times’ reporting is a bit old – considering that earlier this week NICE said that their ban on drugs that can give kidney cancer patients many months of extra life is to be lifted. According to the Guardian, “"The move follows British Health Secretary Alan Johnson's decision this month to overhaul the way new medicines are assessed for terminally ill patients. Denying cancer patients access to drugs that are widely available abroad has become a major political issue."
Caveat Baucus.
For more on NICE and the issue of cancer drug denial, see here.
To see how other nations (in this case, Mexico) are developing their own comparative effectiveness protocols, see here.
And consider the words of Professor Atanacio Valencia, of the Mexican Institudo Nacional de Salud Publica who cautioned. “A good economic analysis is not a faultless crystal ball. Don’t make the remedy worse than the disease.”
The most recent installment of the New York Times series, “The Evidence Gap,” explores NICE and the proposition of balancing cost-based government concerns with patient-centric care.
And ground zero is kidney cancer. According to the Times’ story:
"When Bruce Hardy’s kidney cancer spread to his lung, his doctor recommended an expensive new pill from Pfizer. But Mr. Hardy is British, and the British health authorities refused to buy the medicine. His wife has been distraught."
“Everybody should be allowed to have as much life as they can,” Joy Hardy said in the couple’s modest home outside London. "It’s hard to know that there is something out there that could help but they’re saying you can’t have it because of cost. What price is life?”
Surprisingly the Times’ reporting is a bit old – considering that earlier this week NICE said that their ban on drugs that can give kidney cancer patients many months of extra life is to be lifted. According to the Guardian, “"The move follows British Health Secretary Alan Johnson's decision this month to overhaul the way new medicines are assessed for terminally ill patients. Denying cancer patients access to drugs that are widely available abroad has become a major political issue."
Caveat Baucus.
For more on NICE and the issue of cancer drug denial, see here.
To see how other nations (in this case, Mexico) are developing their own comparative effectiveness protocols, see here.
And consider the words of Professor Atanacio Valencia, of the Mexican Institudo Nacional de Salud Publica who cautioned. “A good economic analysis is not a faultless crystal ball. Don’t make the remedy worse than the disease.”
Nirit Weiss, MD (a neurosurgeon with a Master of Business Administration and a specialization in healthcare economics) has written a blistering appraisal of heavily reported and oft cited July 2008 Commonwealth Fund report, “Why Not the Best?”
After reading her analysis, perhaps a better title would have been “Why Not the Best Use of Statistics?”
In addition to entirely discrediting the report’s methodologies, the article (in a series of very disturbing sidebars) shows that the mainstream media was either lazy or complicit (or both) in reporting the story.
Weiss’ full exposé can be found here.
Weiss writes:
“On July 17, 2008, the Commonwealth Fund commission published its second Scorecard report, Why Not the Best?: Results from the national scorecard on U.S. Health System Performance, 2008. Its findings that U.S. health care performance had not improved since 2006 and that access to health care significantly declined were again reported widely in the media and in a way that gave wide credence to the Scorecard’s conclusions (see sidebar). As the New York Times noted, The findings are likely to provide supporting evidence for the political notion that the nation’s health care system needs to be fixed.”
However, the 2008 Scorecard must be interpreted with caution. In attempting to diagnose the ills of America’s healthcare system, the Scorecard suffers from serious flaws that challenge the validity of its conclusions – flaws that were, essentially, ignored by the authors of the study and completely missed by the media coverage. These flaws fall into three categories:
1. The methodology by which the data were collected and the studies were designed to address specific questions.
2. Arbitrary definitions and metrics used to define the concept of “quality” in health care.
3. Sweeping, broad conclusions that are unsubstantiated by the findings of the study.
1. Flawed methodology
The 2008 Scorecard is based upon multiple disparate studies, using various methodologies, non-uniform definitions of “benchmark,” and arbitrary assumptions as to what “logical policy goals” are, and what “adequately insured” actually means. The Scorecard attempts to draw meaningful conclusions based on a summation of individual studies with varying sample sizes, varying performance comparisons, and varying data collection techniques.
In peer-reviewed, scientific literature, it is invalid to lump together the results of multiple studies, using multiple methodologies, in the same charts, graphs, and conclusions, without assigning relative weight to the results of the studies. Adding even more to the confusion, many of the reported data are not directly referenced to published studies, so it is impossible to trace and evaluate the sources of the information. A substantial number of the individual analyses were merely described as “conducted by the authors,” limiting the reader’s ability to evaluate the quality and validity of the studies.
Perhaps more troubling are those data which can be traced back to their source studies, and turn out to be based on patient self-reporting. For example, in its section on “quality,” the Scorecard quantified mistakes made in health care delivery according to patient interpretation and self-reporting! Patients were asked how often they felt mistakes were made in their medical care, such as errors in laboratory testing, or medication errors.
2. Arbitrary metrics used to define “quality”
The entire premise of the Scorecard, is that “quality” in the U.S. Healthcare System can be quantified by assessing mean scores with respect to 37 “indicators” across five “dimensions” of health system performance. The 37 “indicators” across five “dimensions” are modeled after those used in studies of industry, and focus on health care delivery systems performance, which is indeed one component of value and return-on-investment. But it is not the largest determinant of what most Americans would define as “quality.” Assessing the quality of delivery of goods by studying uniformity, for example, is appropriate when evaluating the transformation of undifferentiated inputs into uniform outputs, each machined to be identical to the other.
In other words, the conclusions of the study are dependent on the authors’ assumption that all patients with a given diagnosis, say diabetes, are otherwise identical, and should have no difference in outcomes. This input/output calculation disregards the fact that all inputs, such as patients with diabetes, have other comorbidities, and cannot be expected to have the same outcome or outputs.
3. Unsubstantiated conclusions
The authors of the Scorecard present their results in raw form, and then apply these results to reach broad conclusions, which are several steps removed from the data actually being presented; indeed, the data presented often does not directly support or relate to some of the Scorecard’s conclusions. Because there are so many such examples, it is reasonable to summarize them. In general, the authors conclude that universal health insurance in the U.S. would improve quality at substantial cost-savings, that increased primary care and preventative care always improves outcomes at reduced cost, and that “preventable” hospitalizations and outcomes are preventable entirely by policy changes in health care delivery, in the absence of a drastic culture shift in this country. These conclusions may have some validity, but they are not directly supported by the data presented.
Given the potentially far-reaching implications of publications such as the 2008 Scorecard on policy-making and financing of healthcare, the authors and sponsors of these studies must be held to the same high standards as are physicians and scientists when reporting results of their investigations. This responsibility must be shared by the media, who control the dissemination of information, and must present the results of such studies in as objective and informative a manner as their audience deserves.
As Trevor Butterworth comments in a sidebar:
“Both the Washington Post (“U.S. Health Care Still Ill, Survey Finds”) and Forbes (same headline) ran an article by Healthday News, which simply reported the Scorecard's conclusions and cited Karen Davis, the Commonwealth Fund's president, and Cathy Schoen, the Commonwealth Fund's senior vice president for research and evaluation, to explain the significance:
“‘The United States also lags behind other countries in health-care results, Schoen said. ‘Even where the U.S. average improved, other countries have improved much more rapidly,’ she said. ‘As a result, we are falling further behind the leaders.’”
No other expert opinion was offered in either article, but Post readers were invited to visit the Commonwealth Fund's website “To learn more about health care in the United States.”
A half-truth, as my grandmother used to say, is a whole lie.
After reading her analysis, perhaps a better title would have been “Why Not the Best Use of Statistics?”
In addition to entirely discrediting the report’s methodologies, the article (in a series of very disturbing sidebars) shows that the mainstream media was either lazy or complicit (or both) in reporting the story.
Weiss’ full exposé can be found here.
Weiss writes:
“On July 17, 2008, the Commonwealth Fund commission published its second Scorecard report, Why Not the Best?: Results from the national scorecard on U.S. Health System Performance, 2008. Its findings that U.S. health care performance had not improved since 2006 and that access to health care significantly declined were again reported widely in the media and in a way that gave wide credence to the Scorecard’s conclusions (see sidebar). As the New York Times noted, The findings are likely to provide supporting evidence for the political notion that the nation’s health care system needs to be fixed.”
However, the 2008 Scorecard must be interpreted with caution. In attempting to diagnose the ills of America’s healthcare system, the Scorecard suffers from serious flaws that challenge the validity of its conclusions – flaws that were, essentially, ignored by the authors of the study and completely missed by the media coverage. These flaws fall into three categories:
1. The methodology by which the data were collected and the studies were designed to address specific questions.
2. Arbitrary definitions and metrics used to define the concept of “quality” in health care.
3. Sweeping, broad conclusions that are unsubstantiated by the findings of the study.
1. Flawed methodology
The 2008 Scorecard is based upon multiple disparate studies, using various methodologies, non-uniform definitions of “benchmark,” and arbitrary assumptions as to what “logical policy goals” are, and what “adequately insured” actually means. The Scorecard attempts to draw meaningful conclusions based on a summation of individual studies with varying sample sizes, varying performance comparisons, and varying data collection techniques.
In peer-reviewed, scientific literature, it is invalid to lump together the results of multiple studies, using multiple methodologies, in the same charts, graphs, and conclusions, without assigning relative weight to the results of the studies. Adding even more to the confusion, many of the reported data are not directly referenced to published studies, so it is impossible to trace and evaluate the sources of the information. A substantial number of the individual analyses were merely described as “conducted by the authors,” limiting the reader’s ability to evaluate the quality and validity of the studies.
Perhaps more troubling are those data which can be traced back to their source studies, and turn out to be based on patient self-reporting. For example, in its section on “quality,” the Scorecard quantified mistakes made in health care delivery according to patient interpretation and self-reporting! Patients were asked how often they felt mistakes were made in their medical care, such as errors in laboratory testing, or medication errors.
2. Arbitrary metrics used to define “quality”
The entire premise of the Scorecard, is that “quality” in the U.S. Healthcare System can be quantified by assessing mean scores with respect to 37 “indicators” across five “dimensions” of health system performance. The 37 “indicators” across five “dimensions” are modeled after those used in studies of industry, and focus on health care delivery systems performance, which is indeed one component of value and return-on-investment. But it is not the largest determinant of what most Americans would define as “quality.” Assessing the quality of delivery of goods by studying uniformity, for example, is appropriate when evaluating the transformation of undifferentiated inputs into uniform outputs, each machined to be identical to the other.
In other words, the conclusions of the study are dependent on the authors’ assumption that all patients with a given diagnosis, say diabetes, are otherwise identical, and should have no difference in outcomes. This input/output calculation disregards the fact that all inputs, such as patients with diabetes, have other comorbidities, and cannot be expected to have the same outcome or outputs.
3. Unsubstantiated conclusions
The authors of the Scorecard present their results in raw form, and then apply these results to reach broad conclusions, which are several steps removed from the data actually being presented; indeed, the data presented often does not directly support or relate to some of the Scorecard’s conclusions. Because there are so many such examples, it is reasonable to summarize them. In general, the authors conclude that universal health insurance in the U.S. would improve quality at substantial cost-savings, that increased primary care and preventative care always improves outcomes at reduced cost, and that “preventable” hospitalizations and outcomes are preventable entirely by policy changes in health care delivery, in the absence of a drastic culture shift in this country. These conclusions may have some validity, but they are not directly supported by the data presented.
Given the potentially far-reaching implications of publications such as the 2008 Scorecard on policy-making and financing of healthcare, the authors and sponsors of these studies must be held to the same high standards as are physicians and scientists when reporting results of their investigations. This responsibility must be shared by the media, who control the dissemination of information, and must present the results of such studies in as objective and informative a manner as their audience deserves.
As Trevor Butterworth comments in a sidebar:
“Both the Washington Post (“U.S. Health Care Still Ill, Survey Finds”) and Forbes (same headline) ran an article by Healthday News, which simply reported the Scorecard's conclusions and cited Karen Davis, the Commonwealth Fund's president, and Cathy Schoen, the Commonwealth Fund's senior vice president for research and evaluation, to explain the significance:
“‘The United States also lags behind other countries in health-care results, Schoen said. ‘Even where the U.S. average improved, other countries have improved much more rapidly,’ she said. ‘As a result, we are falling further behind the leaders.’”
No other expert opinion was offered in either article, but Post readers were invited to visit the Commonwealth Fund's website “To learn more about health care in the United States.”
A half-truth, as my grandmother used to say, is a whole lie.
Our friend Peter Huber (senior fellow, Manhattan Institute) has a provocative article in the current issue of City Journal, “Curing Diversity.”
Huber discusses, among other things, the current inflection point of innovation vs. cost and how we got to where we are.
Some of his comments to whet your appetite”
“Pharmacology has found better ways to tame smaller shards of hostile life while dodging friendly molecular bystanders. And in scrambling to do all that, it has revealed that we aren't all the same deep down, neither in sickness nor in health.”
But …
“The Fourteenth Amendment doesn't guarantee equal protection at the pharmacy … So the stage is set for a long battle between radically new medical science and a senescent, unscientific vision of how diseases are cured and what the "health-care system" ought somehow to deliver.”
Huber is the first policy wonk (as far as I know) to compare a restrictive formulary to a cheese wheel:
“Charles de Gaulle once wondered how anyone could govern a nation that had 246 different kinds of cheese. Designer medicine could probably stock that many varieties on just the cholesterol shelf of its fromagerie. The simplest fix: fewer cheeses.”
There's a punchline in there somewhere.
Huber discusses, among other things, the current inflection point of innovation vs. cost and how we got to where we are.
Some of his comments to whet your appetite”
“Pharmacology has found better ways to tame smaller shards of hostile life while dodging friendly molecular bystanders. And in scrambling to do all that, it has revealed that we aren't all the same deep down, neither in sickness nor in health.”
But …
“The Fourteenth Amendment doesn't guarantee equal protection at the pharmacy … So the stage is set for a long battle between radically new medical science and a senescent, unscientific vision of how diseases are cured and what the "health-care system" ought somehow to deliver.”
Huber is the first policy wonk (as far as I know) to compare a restrictive formulary to a cheese wheel:
“Charles de Gaulle once wondered how anyone could govern a nation that had 246 different kinds of cheese. Designer medicine could probably stock that many varieties on just the cholesterol shelf of its fromagerie. The simplest fix: fewer cheeses.”
There's a punchline in there somewhere.
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.
