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Information Can Change Medical Practice, Patient Behaviors, and Kill Kids

By Michael D. Miller MD
April 10th, 2008

Medical information can change how clinicians treat patients, how patients care for themselves, and how healthcare payers promote or prevent the use of treatments and diagnostic tests. However, this information can act as either a broad sword or a scalpel, and produce good or bad outcomes.

A recent report from a Canadian new service about an article from the Canadian Medical Association Journal describing the outcomes from warning about the use of anti-depressants in children brings this issue down from a general concept to being very specific. This news report stated:

Two years after Health Canada warned about prescribing anti-depressants to children, the number of children and teens who died by suicide increased 25 per cent after years of steady decline, major new Canadian research shows.

And the increased suicide rate coincided with a 10-per-cent decrease in the rate of visits to doctors for the treatment of depression in children.

For the study, researchers tracked what happened in Manitoba before and after Health Canada warned in 2004 that newer antidepressants may be associated with an increased risk of “suicide-related” events in patients under 18.

They found the warning was followed by an overall 14-per-cent drop in antidepressant use among children and adolescents, fewer visits to doctors for depression, and - among eight- to 17-year-olds - increased rates of completed suicide.

More than 90 per cent of the children and teens who killed themselves were not taking antidepressants when they died.

Published Tuesday in the journal of the Canadian Medical Association Journal, the study is the first to document “such a wide range of unintended health consequences” from a major drug warning, the authors say.

Lead author Dr. Laurence Katz, a child and adolescent psychiatrist in Winnipeg, warns the increased risk of suicide could be a “random fluctuation.”

“We can’t say the warning, or the change in antidepressant use or the physician office visits caused changes in suicide rates,” says Katz.

The suicide rate among children and teens was also still relatively small, from 0.04 for every 1,000 children and adolescents before the warning, to 0.15 per 1,000 after.

But Katz worries the widely publicized drug warnings have led to more cases of untreated depression, and an impact “beyond what was intended.” The drop in doctors visits for depression suggests that some vulnerable children are getting no treatment, including psychotherapy, at all. He says his hunch is that families were afraid to go to the doctor for fear their child would be put on medication.

“But that’s not the only treatment for depression. Not going to the doctor deprives you of all forms of treatment.”

If anything, researchers expected office visits to go up after the warning was issued because physicians were urged to increase the monitoring of patients for potential adverse reactions.

Katz, an associate professor of psychiatry at the University of Manitoba, says the drug warnings and media response may have “generated a lot of fear.”

“Understandably parents who kept bringing their children, their teenagers in for troubles with depression were already struggling, and fearful (and) often appropriately cautious about whether their child or teenager should be put on a medication.”

Katz believes the findings could be applied to any Canadian jurisdiction. Other studies coming out of the U.S. are showing similar results. [Emphasis added]

The antidepressant warning involved drugs known as SSRIs, or selective serotonin re-uptake inhibitors, a class that includes Prozac, Paxil and Zoloft, as well as serotonin noradrenaline re-uptake inhibitors (SNRIs), which include Effexor. The drugs have not been approved in Canada for children, but doctors have prescribed them “off-label,” which they are legally permitted to do, to tens of thousands of toddlers, children and teens for depression, social phobia, anxiety and obsessive-compulsive disorders.

In 2003 the U.K. banned antidepressants for children. The only exception was Prozac. Studies have shown the drug is safe and effective in children.

A year later, Health Canada warned that people taking the newer-generation antidepressants may experience behaviour or emotional changes that may put them “at increased risk of self-harm or harm to others.”

Katz says he didn’t have a problem with the warnings themselves. But he says some people leaped to the assumption “that these medications lead people to kill themselves.”

[The report also notes that, “For young adults, there was no significant change in the rate of completed suicide.”]

Obviously, the outcomes found in this study are very worrisome, but it also a too dramatic example of the principle of unintended consequences.

It also reminds me of how a news story in the early 1990s about adverse reactions with the second medicine to treat AIDS.  This news report caused many AIDS patients to stop taking the medicine, and given that there was only one other medicine to treat AIDS, this certainly wasn’t a good thing for their long-term survival

Although correlations don’t prove causations, I think this study definitely underscores the importance of healthcare regulators - and their media colleagues - carefully considering how they present new health information and notices to the public - for both good findings or dire warnings. With all the proposals to empower patients to make their own decisions through consumer directed insurance plan, and to give people more health information, there should also be much more research into how people respond to health related information delivered in different forms from various sources.

Posted in Clinician-Patient Relationships, Comparative Effectiveness, Delivery of Healthcare, FDA, Information & Communications, Public Health, Quality of Care & Safety | No Comments »

Toxic Dietary Supplements

By Michael D. Miller MD
April 10th, 2008

I’m usually either supportive or neutral about alternative therapies because they generally aren’t harmful, and can be beneficial. However, there seem to be more and more recalls of these products by the Food and Drug Administration (FDA) for mislabelings that are significant, although seemingly not extremely dangerous.

On the other hand, I was struck by a press release I got yesterday from the FDA about a recall for the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” The recall was because these products had more than 200 times the amount of selenium than was printed on the products’ label – and the press release noted that, “Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.”

I guess this is another instance of how too much of something that is normally good, can be, well, not so good. And with 43 adverse reactions reported to the FDA, the recall seems like a very good thing.

UPDATE: The FDA updated their warning and information on this issue this afternoon - click here to see the FDA website notice.

Posted in FDA, Nutrition, Public Health, Quality of Care & Safety | No Comments »

Canada’s Proposal for Subsequent Entry Biologics

By Michael D. Miller MD
April 1st, 2008

After writing about Follow-On Biologics in a recent posting, I saw a notice about Health Canada’s proposal for how they would approve biologic products that are similar to already approved biologics whose patents have expired. They call these products Subsequent Entry Biologics (SEBs), and the proposal is open for public comment from March 14, 2008 until April 16, 2008.

While the draft guidance is lengthy, it does strike an overall well-balanced tone:

  • “SEBs are not ‘generic biologics’”
  • Approval of an SEB does not mean it can automatically be substituted for the original biologic that it is “similar” to
  • Comparative studies will be required to generate data showing similarity to the original biologic in terms of quality, safety and efficacy

In many ways, the draft guidance is similar (no pun intended) to the process the US FDA used to approve some generic drugs prior to the 1984 Hatch-Waxman Drug Price Competition and Patent Term Restoration Act. (This was the law that created the abbreviated new drug application (ANDA) process which allowed generic drugs to only demonstrate bioequivalence, and obviated the requirement that they replicate the original drugs safety and efficacy trials.) By referencing published studies about the innovator drug as proof of safety and efficacy, these so called “Paper-NDAs” allowed generic companies to be approved much faster and more cheaply.

Health Canada’s “paper biologic licensing application” like proposal, would allow them to rely on published information about the original biologic, while also handling each SEB application individually to decide what additional studies need to be done to demonstrate quality, safety and efficacy of the SEB.

As I pointed out in my previous post, there are many levels of structural and biological complexity with biologic treatments, so Health Canada’s draft approach seems very appropriate and reasonable.

What do you think?

Posted in Economics & Financing, FDA, Patents & IP, Politics, Quality of Care & Safety, Therapeutic Substitution & Interchange | No Comments »

More on Counterfeit Medicines & Safety

By Michael D. Miller MD
March 27th, 2008

My last post contained some perspectives about fake medicines. That same day, the LA times ran an article about California’s long-delayed pedigree requirements for tracking prescription medicines. This law was prompted by the discovery of fake medicines for HIV/AIDS in 2000, and was intended to achieve what the FDA has been trying to implement for many years.

The LA Times article blames the delays in the state’s drug tracking system on the industry - from the manufacturer to the retail pharmacy. I suspect that the real challenge is not in the technical or cost aspects from the manufacturers - who certainly have lots to gain by stopping counterfeits of their products from being sold instead of the real thing, but from the wholesalers and to a lesser extent the pharmacies.

I’m assuming that wholesalers don’t knowingly sell counterfeit medicines, but under the current system, they can potentially make a lot of money doing so - particularly when buying them allows for a larger mark-up to the pharmacies than the real medicine. This is part of the economic reality of wholesalers, who in effect are arbitraging the differential costs of pharmaceuticals as a commodity by buying someone else’s excess supply and delivering it where it is needed. Now normally this would be market forces working to efficiently delivery medicines to where they were needed. However, without adequate pedigrees (i.e. paper or electronic documentation demonstrating the entire chain of custody of the medicines from the time it left the manufacturer), there is a great economic incentive for counterfeiters to push their fake medicines into this supply chain and make a huge profit.

Of course, the pedigree system needs to be sophisticated enough that it too can’t be forged - otherwise it is worthless. This is why retail pharmacies may be balking at the cost of implementing a system where they aren’t going to benefit, and don’t believe they are part of the problem. In general, pharmacies, don’t have great incentive for selling fake medicines - they would get paid the same dispensing and product fees whether the product was real of fake. The only case where pharmacies would increase their profits is if they were to be able to buy the fake medicines for less, but this would probably only occur for large chain pharmacies where they are essentially acting as their own wholesalers and wouldn’t be the case for the independent pharmacies - the few that are left.

Because pharmaceutical companies have incentive to track shipments of their medicines and make sure they aren’t stolen, some are starting to use RFID technology. This is surely a big investment that is worth the cost. Implementing a secure pedigree tracking system might be more costly, but would certainly be a worthwhile expense to ensure the safety and quality of medical care.

In general health policy people in the US don’t like to talk about counterfeit medicines because it raises the potential that people won’t trust their medical systems or their medicines. That attitude would be OK if there was nothing to be done about it, but since there is a solution, I think it should be talked about. The other challenge to pushing for drug tracking systems is that as health reform initiatives go, it’s not as “sexy” as electronic medical records, checklists, “evidence based medicine” or eliminating fraud and abuse and using the savings to expand insurance coverage to the uninsured. But it is a doable improvement. The challenge is figuring out how to pay for it, and convincing all the stakeholders effected to work together to make it happen.

Posted in Access to Healthcare, Delivery of Healthcare, Economics & Financing, FDA, Information & Communications, Public Health, Quality of Care & Safety | No Comments »

Safety, Costs and Quality of Medicines

By Michael D. Miller MD
March 25th, 2008

I’ve been trying to figure out how to write something meaningful about the many reports over the last several months about the safety, costs and quality of medicines. I finally concluded that rather than a too lengthy blog post, a series of snapshots would create a good description of the situation - sort of like a slide show rather than a feature film:

Safety of Generic Drugs: A recent LA Times article discussed patients who had adverse reactions when switched from a brand name to a generic medicine. This article includes physicians’ experiences with several types of generic medicines, e.g. for epilepsy, depression, high blood pressure, irregular heart rhythms, and to prevent rejection of organ transplants. Aside from epilepsy, these are different types of medicines from “narrow-therapeutic-index” (or NTI) medicines which have a small dosage range which produces the desired clinical effects before causing known side-effects. Also, the current safety concerns are not related to what happened in the early 1990s, when some generic companies where caught submitting false safety data — they used the brand name medicine for the bioequivalency testing required by the FDA instead of actually testing their generic versions. (Yes, people went to jail.)

Safety of Medicines Imported into the US: Medicines imported from other countries have raised safety concerns because of lack of quality oversight and the murkiness of the chain of custody. These concerns have recently been highlighted by the contamination problems of herparin from a factory in China, and reminds me of how the head of the Chinese State Food and Drug Administration was convicted last summer of taking bribes in exchange for approving generic drugs that hadn’t had the required testing. (They sentenced him to death, and actually hanged him shortly after he was convicted.)

Fake Medicines: Whether produced in the US or someplace else, there is a growing market in fake medicines. The economic incentives are huge, and unlike illegal recreational drugs, the risk of your customer to violently come after you for selling substandard products is very low. There have been cases of fake medicines made here in the US, and the World Health Organization estimates that up to 30% of medicines in some parts of the world are fake.

Fake antibiotics are of particular concern: Fake antimalarial medicines sometimes contain tylenol or asprin which lowers the malarial fever without actually treating the infection - so people think they are getting better while they continue to spread the infection. And subpar medicines that only contain a fraction of the antibiotic promote the spread of resistant strains of bacteria. So fake or substandard antibiotics may actually be worse than no pills at all.

Even the New York Times editorial board recognized the global dangers of fake medicines in a December 12, 2006 editorial.

Follow-On Biologics: There has been a lot of interest in new versions of biologic treatments. These have many names: generic biologics, biogenerics, biosimilars, and follow-on biologics. One of the great confusions with this issue is that drugs and biologics are different categories of treatments. Because of their different chemical natures they are covered by different parts of US law, and until recently they were regulated by separate divisions of the Food and Drug Administration.

While drugs and biologics are both made up of atoms, drugs are much simpler, generally much more stable, and produced by chemical reactions starting from raw chemical ingredients or from a natural compound purified from a plant or animal source. Biologics on the other hand are much larger compounds (often proteins), and are generally made by living cell cultures (or in some cases whole animals), with the active drug is purified from that source.

The different structural complexities of drugs and biologics is because small molecular drugs are based upon a limited number of configurations of their atoms - usually 1, or 2, or sometimes 4 variations that are either mirror images of each other, or forms that exist in a predictable equilibrium. Biologics on the other hand have 2 or 3 more levels of structural complexity beyond that found in small molecules. (See here for a description of the primary, secondary, tertiary and quaternary structures of proteins.) Printing is a good an analogy to the structure of drugs and biologic, with a drug being like a sentence, where the series of letter and punctuation defines it. Conversely, a biologic is a like a book, where the construction of the paragraphs and chapters are its secondary and tertiary structures, and the footnotes, references, bibliography and appendices are the quaternary structures. Obviously it is easy to copy a sentence to look like the original, but replicating a book, with the same pagination and structure is much more complicated.

As a semi-avid baker, another analogy I like for the difference between drugs and biologics is a comparison between baking powder and eggs. Baking powder is a combination of chemicals designed to produce a chemical reaction to yield the right chemical/baking effect when used in the right amount. It is generally stable, and lasts for a long time when not exposed to air. Eggs on the other hand, can easily spoil (particularly if the shell is cracked), and have two major parts - the yolk and the white. The whites are mostly protein, and yield very different results depending upon how they are used. For example, adding raw egg whites to cake batter produces a very different result than if they are heated first and then added. (Think about the difference between an angle food cake and a quiche.) Egg yolks are mostly fat are are nicely separated from the whites. Mixed with the whites they cook up one way, and separately are used in pudding, custards, etc.

Adverse Drug Events and Medical Errors in Hospitals: There have been many studies about medical errors in hospitals and how many of those relate to adverse drugs events because the patient received the wrong medicine or the wrong amount of the medicine. These studies clearly point out the value of electronic medical records which avoid handwriting mistakes, and can automatically check for drug-drug interactions. Another important organizational feature of hospital care is the integrated medical team that includes experienced pharmacists and nurses. Such teams ensure rapid and accurate communications about treatment issues among the clinicians writing the prescription and those dispensing it or delivering/administering it to the patient.

Conclusions: Medicines are extremely potent, they can be very complex, and they are central to one of the mantras of clinically and cost effective care: “The right treatment, to the right patient, at the right time.” Electronic medical records and electronic prescribing systems certainly can help achieve that goal, while substituting non-identical medications, or enabling the distribution or use of substandard of fake medicines undermines movement towards that goal.

Posted in Delivery of Healthcare, FDA, Politics, Public Health, Quality of Care & Safety, Therapeutic Substitution & Interchange | 1 Comment »

Trans Fat Shocker

By Michael D. Miller MD
March 21st, 2008

A couple of days a week I work out of shared office space in Cambridge, MA that is part of a multi-floor incubator/start-up facility. One of the benefits in the office is the food stocked in the kitchens - including lots of healthy things, like fresh fruits, nuts, dried fruit, bagels, etc….. Now not all the food is purely healthy…. They have sodas and M&Ms, etc. But today I did a double-take, when I saw that the Drakes Apple FruitPies had 8 grams of Trans Fats per serving.

For those of you not familiar with Trans Fats, they are chemically created by taking naturally occurring oils and heating them in the presence of a metal catalyst (like nickel or platinum) to add extra hydrogens to the oil. This process creates “partially hydrogenated oils” which are solid at room temperature and easier to bake with etc. Chemically modifying the oils also causes the naturally occurring double bonds within the oil’s carbon backbone to rearrange so that the hydrogens on the same side of the carbon chain (see A bel0w), get flipped around so that the hydrogens are on opposite sides (See B below)

Cis Fat Molecular Structure Trans Fat Molecular Structure

A: Cis - Fat  . . . . . .B: Trans-Fat

So why does this matter. Numerous studies have shown that Trans Fats increase blood levels of triglycerides and lower good cholesterol (HDL) — both of which increase risks for cardiovascular disease and death. The biochemical reasons for this are not clear, but it seems to me that Trans Fats are acting like a metabolic poison.

The process that keeps so-called foods that contain Trans Fats from spoiling, is the same that messes up human physiology: In Trans Fat “foods,” microorganisms that normally cause food to spoil can’t digest the trans fats, so the food doesn’t spoil. In the human body, our natural molecular processes for breaking down fats can’t easily “eat” Trans Fats either - so it literally gums up the works. An analogy might be if you put your shoes on the wrong feet and tried to run. You could move, but it would be awkward, inefficient, and sooner or later something connected to your feet would start complaining and eventually break. It’s not that the shoes doen’t look like shoes, but they don’t fit the feet so things don’t work right. Trans fats look like oils (just like the oil in your car looks like oil), but trans fats are not the shape of oils your body’s cells are expecting, so problems arise when they have to deal with them.

Now if you don’t like this situation, (and crave those snack cakes), don’t blame your body’s cells - they didn’t ask for the Trans Fats - you’re the one who decided to eat them - your cells are doing their best to figure out what to do with them. But unfortunately they aren’t equipped to easy break them down - they’d rather have real food, not Trans Fats.

Posted in Nutrition, Public Health, Quality of Care & Safety | No Comments »

Culture of Healthcare Organizations

By Michael D. Miller MD
March 17th, 2008

Culture change is one of the core messages of a book I’m working on, so I was interested to see an article about “cultural transformation” in Modern Healthcare by John Mitchell, CEO of Harbor Community Hospital in WA.  He notes that there is frequently a disconnect between a hospital leader’s stated goal of wanting to create a great culture and their actions: Retaining a central command and control structure does not empower people, and forcing solutions onto hospital staff who feel uninspired to excel will not produce sustainable improvements. Rather cultural changes leading to improved quality and reduced costs requires the leader to inspire the staff to perform while also empowering them to achieve shared goals.

He lays out four components for creating cultural transformation, and my interpretation of those components are:

  1. Get help - A leader can’t do something this fundamental alone
  2. Be ready to change - Create internal teams that fosters champions and an inclusive process
  3. Budget - Culture change is an investment in the core competencies of the organization
  4. Hold everyone accountable - Voluntary compliance without accountability will not produce changes

John Mitchell reports that changes in his hospital have turned a $1M/month deficit into a $1M/month profit, and greatly improved their quality scores, employee and patient satisfaction levels, and on-site reviews by JCAHO and others.

One difference between John Mitchell’s observations and my prescriptions are their scope: He focuses on hospitals, and my work encompasses all types of healthcare organizations and stakeholder groups.  Specifically, Part Four of my book looks at how to use social and economic forces to solve cultural problems by fostering champions, creating inclusive process and targeting economic incentives. The goal of these actions is to create healthcare cultures within organizations and systems so that the behaviors and actions of individuals and organizations are directed toward outcomes related to system-wide value as opposed to only benefiting the individual or the single organization.  Creating such a culture - along with making synergistic structural changes - can produce healthcare systems that provides higher quality care at lower costs, and are prepared to efficiently continue to improve and adopt value-producing innovations.

While John Mitchell talks about his success in turning around the economics for his hospital, I am always curious to learn more details:  Did they improve their finances by reducing costs? Improving efficiency? Increasing revenue with better/more accurate billing, or from increasing patient volumes? And what have been the effects on the region’s healtcare system? Are other hospitals in the area losing patients to Harbor Community Hospital, and are they now running deficits?

It reminds me of the story about the person who says that because of a hospital’s poor reputation they, “wouldn’t be caught dead in that hospital.” While a reputation like that certainly doesn’t help increase the hospital’s revenues, if the hospital actually has sub-par quality and only fixes their reputation and not their underlying problems, their finances could improve while overall healthcare costs would go up, and quality of care might actually go down.

Any thoughts or insights into culture problems or changes at healthcare organizations and how it relates to improving quality or reducing costs?

Posted in Delivery of Healthcare, Economics & Financing, Health System Reform, Quality of Care & Safety | No Comments »

Vaccines and Autism - More Mess

By Michael D. Miller MD
March 11th, 2008

There has been a lot reported in the news about the recent payment from the Federal Vaccine Injury Compensation Program for Hannah Poling, a girl who developed autism after being vaccinated. (See New York Times article and a Wall Street Journal blog report about this case.)

Amidst all the debate and news reporting there have been several connected and interesting facts:

  • The Federal program that is making the payment to the Poling family doesn’t concede that the payment is in any way an admission of a link between vaccines and autism.
  • Since most vaccines no longer contain the mercury containing preservative thimerosal, and yet the rate of new cases of autism hasn’t declined, it would seem that whatever arguments there were for a link between thimerosal and autism should have been settled.
  • Hannah Poling’s father is a neurologist in training, and reported that his daughter was eventually diagnosed with a disorder of the mitochondria - the power producing parts of the cellular factory. (It is theorized that this defect inhibits the ability of cells to respond to stress, and that a fever - including those that can be caused by a vaccination - could lead to the neurodegenerative problems seen in autism….. at least in some cases.)
  • In a Wall Street Journal on-line report a few days before the Poling’s settlement was disclosed, Senator John McCain is quoted as saying while campaigning in Texas that “there’s strong evidence that indicates that [autism’s rising rate in children has] got to do with a preservative in vaccines.” (Hopefully Senator McCain’s political reasons for making this statement do not reflect his substantive position or understanding of the issue.)

Thus, it seems that the cause of rising autism rates are still not understood, but the public is still looking for a scapegoat to blame. It would not surprise me to see a report out soon linking autism to the recent AP report about minute traces of pharmaceuticals in drinking water. But in this case, who would patient’s families drag into court? The municipal water companies? The people who flushed the pharmaceuticals that ended up in the aquifer? The biopharma companies that didn’t make their medicines completely biodegradable?

Do you have any other perspectives or thoughts on the evolving autism situation?

Posted in Delivery of Healthcare, Innovation, Politics, Public Health, Quality of Care & Safety | No Comments »

More On Evidence Based Medicine

By Michael D. Miller MD
March 6th, 2008

In a previous post I was somewhat critical of evidence-based medicine (EBM) when it is used to make payment decisions. One of the points I was trying to make is that EBM is not a passing fad. The staying power of EBM was recently reinforced by two recent developments.

First, the Medicare Payment Advisory Commission’s (MedPAC) March 2008 Report to Congress cites their own 2005 report recommending EBM as a touchstone for comparing physicians’ practices as one way to improve quality of care and value for the Medicare program:

In the March 2005 Report to the Congress, the Commission recommended that CMS measure physicians’ resource use over time and share the results with physicians (MedPAC 2005). Physicians would then be able to assess their practice styles, evaluate whether they tend to use more resources than their peers or what evidence-based research (when available) recommends, and revise their practice styles as appropriate.(13) Moreover, when physicians are able to use this information in tandem with information on their quality of care, they will have a foundation for improving the value of care beneficiaries receive.

Private insurers increasingly measure resource use to contain costs and improve quality (MedPAC 2004b).(14) Evidence on measuring the effectiveness of resource use in containing private sector costs is mixed and varies depending on how the results are used. Providing feedback on use patterns to physicians alone has been shown to have a statistically significant, but small, downward effect on resource use (Balas et al. 1996, Schoenbaum and Murray 1992), but, when paired with additional incentives, the effect on physician behavior can be considerably larger (Eisenberg 2002).

This report also notes that dialysis care is one area most ready to make use of EBM for payment purposes:

The dialysis sector is ready for pay for performance: Evidence-based measures are available, providers can improve on these measures, data are available to risk-adjust the measures, and systems are available to collect the information. CMS already collects some clinical information—dialysis adequacy and anemia status—on providers’ claims. CMS is developing additional data infrastructure that will permit the agency to collect information about quality of care from all facilities.

Any nephrologists our their have any thoughts about this?

 

The second new development related to EBM is the launch of “the updated, expanded, and searchable Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry website.” According to an email from the Peter Neumann, the Director of the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, (Peter - get a shorter title), this registry “provides public access to a comprehensive online database of cost-effectiveness ratios from the published medical literature.” And has the “mission is to identify society’s best opportunities for targeting resources to save lives and improve health and to help standardize cost-effectiveness methodology.”

What distinguishes the CEA registry from the proposal to create a Center for EBM that MedPAC made in February, is that the registry is a resource for understanding the “evidence” part of EBM without any direct ties to using this information for changing payments. A colleague recently agreed with my off-line assessment that one of the challenges is that EBM - and its cousin pay-4-performance - are almost always directed at clinical areas where there is believed to be costly overuse or misuse. Very rarely are these same potentially quality improving tools directed towards clinical situations where there is documented underuse - situations where quality could be improved, long-term cost savings achieved, but there also might be short-term cost increases. This is one of my touchstone secrets for evaluating the intentions of “quality improving” initiatives - do they target any practices where there is documented underuse?

And one other interesting observation about the CEA registry. It classifies its information into 4 categories depending upon the conclusion of the research:

  1. Increases Costs/Improves Health
  2. Increases Costs/Worsens Health
  3. Decreases Costs/Worsens Health
  4. Decreases Costs/Improves Health

Doing a quick assessment of the registry revealed an interesting landscape: There are about 27 more sources for #2 than there are for #3. (Types #1 and #4 are midway between, with 8 and 10 times as many pieces of information as #3.)

There could be several possible reasons for this lopsided distribution: There really could be a LOT more clinical practices that waste money and worsen health. Or this could be the area that healthcare payers will pay for research to be conducted. Or researchers know that these types of findings will bring more research funding from payers.

I believe that the second of these scenarios is the most likely since payers are primarily concerned about reducing care that increases costs and worsens health. However, I also believe that these ratios don’t reflect the full picture of clinical care, and that there are many clinical practices that if used more would improve health - whether they increase or decrease costs….. of course that calculation often depends upon what time-frame and scope of society is considered, which leads back to the old question “costs to whom?”

What do you think?

Posted in Access to Healthcare, Comparative Effectiveness, Delivery of Healthcare, Economics & Financing, Medicare, Quality of Care & Safety | 1 Comment »

UK NHS Restricting Access to Uncovered Treatments

By Michael D. Miller MD
February 22nd, 2008

A very interesting article in yesterday’s New York Times discusses how the National Health Service (NHS) in England is clamping down on patients using both their own money and the NHS services to get treatments for the same condition at the same time. The article primarily discusses the case of a woman with breast cancer where the NHS wouldn’t pay for Avastin, and told her if she paid for it herself, she would have to pay for all her medical treatments for breast cancer.

The article also discusses the complexity and apparent confusion within the medical community and the NHS about how this policy is supposed to be implemented. But it doesn’t delve into how this policy would undermine patient-physician communications, quality of care, and the integrity of the medical record. What would happen if a patient knowing that paying on their own for treatments not covered by the NHS could cause the NHS to deny them coverage for this condition. Would they then not tell their physician about this “other” treatment they were receiving? Certainly this could affect the quality of their care and possibly lead to drug-drug interactions. And then if the physician found out about it, how would this undermine their trust in what else the patient told them? And what if the patient decided it was important to tell their physician that they were getting this other treatment, but asked that it not be recorded in their medical record? Could the physician be liable if something happened because of this - possibly because of treatments ordered by another clinician who didn’t know about the “other” treatment not included in the medical record?

This situation reminds me a little of 10+ years ago when patients were reluctant to talk to their clinicians about the complementary treatments - such as acupuncture or herbals - they were be taking. Now it it encouraged for physicians to ask, and patients to tell ,their clinicians about these non-prescription treatments because of the known (and possibly unknown) interactions that can occur with prescription treatments.

It all just makes my head shake and shoulders shudder. But at least I don’t have to wonder why the NHS is adopting this policy - it’s all about money. I guess that they have decided that if a patient can afford to pay for something expensive that the NHS hasn’t approved for them, then they can afford to pay for all of their care for that illness.

And now for the irony. Towards the end of the New York Times article it notes that “…Mrs. Hirst was told early this month that her cancer had spread and that her condition had deteriorated so much that she could have the Avastin after all — paid for by the health service. In other words, a system that forbade her to buy the medicine earlier was now saying that she was so sick she could have it at public expense.”

Any thoughts?

Posted in Access to Healthcare, Clinician-Patient Relationships, Delivery of Healthcare, Politics, Quality of Care & Safety | 4 Comments »

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