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Health Reform Evolution

By Michael D. Miller MD
May 12th, 2008

Placing health reform in an historical context shows how the debate has evolved. For example, the National Bipartisan Commission on the Future of Medicare was formed to address Medicare’s projected insolvency - at a time when the overall focus for health reform was on cost containment. However, while the Commission met and deliberated, the booming economy shifted the debate away from cost containment towards access and coverage expansion, and the Commission’s 1999 final report, proposed adding an expensive outpatient drug benefit to Medicare.

Comparing two more recent perspectives on the future of the US healthcare system also illustrates how thinking about health reform evolves.

In June, 2003, (6 months before Congress passed the Medicare Modernization Act), I gave a presentation to the Presidents of the State Medical Associations about the future of the US health care system. My conclusions were:

  1. We will continue to have a patchwork system of private and public delivery and financing
  2. Innovations – primarily genetics/individualized medicine and information technology – will change how medicine is practiced
  3. Budgetary pressures will be a prime driver of change
  4. Individual empowerment will continue to increase the role patients play in their own healthcare
  5. There will be growing emphasis on demonstrating actual clinical and economic outcomes as a prerequisite for payment or regulatory approval.
  6. There are (were) three directions the US healthcare system can go:
    A. “Consumer Opportunity”
    B. “More Medicare”
    C. “Comprehensive Care Management”

I posited that “Comprehensive Care Management” was the most likely outcome, and that integrated care management organizations that would be responsibile for the cost and quality of a patient’s entire range of healthcare services would become more prevalent and be the best way to improve the healthcare system.

I recently had the opportunity to reflect on this presentation while listening to Dr. David Blumenthal (Director of the Institute of Health Policy at Massachusetts General Hospital) give brief keynote remarks about the future of US healthcare to a group of policy interested medical residents. His top-line comments about where the US healthcare system is heading in the next several decades were:

  1. The economy is a key indicator of healthcare spending – countries with higher per capita GDP spend a higher percentage of their GDP on healthcare.
  2. Technology is changing the nature of clinical medicine as well as patient-physician interactions and relationships. In the future, these relationships will likely be more collaborative.
  3. The private insurance market will change over the coming decades, with movement away from the current employer-based model to more individual based insurance decisions.
  4. Making changes in Federal laws and programs will be very different after the 2008 election, and changes in Congress may be more important than changes at the Presidential level
  5. Globalization will affect medicine, with more international delivery of medical care.
  6. Change is going to be more of a constant feature of healthcare. Success in the future will require being ready for change, embracing change, and managing change.

First, Dr. Blumenthal’s comments where much more coherent than mine. And second, although I disagree with his views on the eventual demise of the employer based insurance system, it is valuable to see how the health reform debate has evolved because of real-world changes over the last 5 years:

  • The use of information technology by physicians in care delivery is no longer speculation
  • Genomics-based diagnostics and therapies are now realities
  • Safety and quality are much more prominent issues in the public debate
  • Budgetary issue are still important, and the pendulum is in the process of swinging from how do we pay for universal coverage to how do we contain costs as part of an overall strategy for promoting economic growth.

There will continue to be lots of debate about health reform – particularly during this election year, and in the next Congress. I don’t think we’ll see the singular focus on health reform like we had in 1991-94, but it will certainly be a big topic for the President, the Congress and the Country, and as Dr. Blumenthal noted (and I wrote last month), the economy will be a major influence on public and private health reform discussions and actions.

What do you think will happen, and when?

Posted in Economics & Financing, Health System Reform, Medicare, Politics, Private-Employer Based Health Insurance | No Comments »

Health Care Cost Containment – Reality versus Rhetoric

By Michael D. Miller MD
May 2nd, 2008

Cost Containment
Controlling Healthcare Costs
Reducing Health care Spending
Eliminating Waste, Fraud and Abuse
Creating More Value from Healthcare Spending
Increasing Cost Effectiveness for the Healthcare Dollar

These are the types of headlines and catch phrases that we are going to see over the next 6 months as the healthcare focus in the 2008 elections zeros in on spending and costs.

A couple of weeks ago I wrote about how the economy has become the #1 issues of concern for the 2008 elections. Because of this, costs and spending will be the major focus for the political debate about healthcare reform. The two main traction points within these political messages and speeches will be about how healthcare spending is:

  • Draining resources from the rest of the economy
  • Increasing the public’s concern about becoming unemployed because it could mean losing their health insurance

As CNN recently pointed out, how to actually reduce spending – or at least lower the growth rate for spending – is the $2 Trillion puzzle. One of the harsh realities is that there is often very little connection between a candidate’s proposals for solving a problem and their ability to actually use those proposals to address the problem – because either the solutions won’t do much, or the politics won’t let them implement their proposals. As H.L. Menken said, “For every complex problem there is an answer that is clear, simple, and wrong.”

While each of the three remaining major candidates’ healthcare proposals has been widely discussed, it will be informative to see how they reposition themselves around reducing costs and spending. The Democratic candidates in particular have focused on increasing coverage, so how they add to or modify their positions will be particularly interesting to see.

It will also be worth watching how different advocacy groups position themselves along the continuum from increasing access to controlling spending ­– and what their proposals actually say.

For example, I noted an ad from the American Medical Association (AMA) that ran in the National Journal a couple of weeks ago, (and I presume in other policy oriented publications), that laid out 4 things they support for “controlling rising healthcare costs”:

  1. Disease prevention and wellness programs
  2. Comparative effectiveness research
  3. Eliminating excessive administrative costs
  4. Value-based decision making

These all sound good, but how effective would they be to actual control rising healthcare costs? This obviously would depend upon what time frame you’re using to measure costs, and whose costs you’re measuring. Nevertheless, Professor Stuart Altman – one of the very best health policy people I know – last fall laid out in ranked order ways to limit the growth in health spending. (See page 41 of his presentation) According to his assessment, the effectiveness of the AMA’s proposals range from “Very Limited Impact” for #1, to the better end of “Limited Impact” for #2 and #3, and possibly “Greater Impact” for #4, but I’m not really certain what the AMA means by “Value-based decision making,” because value to whom is always an important question.

Before I leave this issue (for now), I also want to point out that one of the easiest political message points in this area is to propose “reducing waste, fraud and abuse.” Since nobody is for “waste, fraud and abuse” this has great traction with voters, but it is important to remember that eliminating any part of the up to 50% of healthcare spending that is estimated to be wasted, is a lot harder than it sounds for two fundamental reasons. First, these waste calculations often don’t account for the healthcare delivery system’s need for “surge capacity.” For example, rarely do hospital emergency rooms run at truly full capacity, but they need to be staffed most of the time to do so, since emergencies aren’t planned and their treatment can’t be rescheduled for a slower time. Second, what may be considered waste in one analysis is generally someone’s salary, and is represented by an advocacy organization that will resist efforts to reduce the size of their piece of the pie.

I have a friend who thinks that the situation has gotten so bad that the political barriers to a single-payer healthcare system will be breached - since that’s the “best” way to control costs – and that’s what we’ll have in a few years. I don’t agree with his perspectives, and think we’ll have continued rationale migration towards a more efficient and coordinated system – particularly once the economy picks up again.

What are your favorite proposals for reducing healthcare spending?

Posted in Economics & Financing, Federal Healthcare Reform, Politics | No Comments »

FDA’s Resources for Evaluating and Monitoring Medicines and New Science

By Michael D. Miller MD
April 24th, 2008

For several years it has been clear that funding limitations are impairing the FDA’s ability to attract and retain qualified clinicians and scientists to review applications for new drugs and biologics, and to support their internal research and analysis concerning new drug development, manufacturing and monitoring technologies – particularly for biologic medicines. In addition, the FDA hasn’t been able to update its information technology systems to maximize staff productivity. (I suspect some people will be tempted to comment on the “productivity” of government employees, but I have found the FDA’s professional staff generally very qualified and hard working.)

On Tuesday, the Energy and Commerce Committee in the US House of Representatives held a hearing about the FDA’s ability to adequately oversee foreign production of medicines being sold in the US. This was part of the ongoing dialogue that was heightened by the contaminated heparin from China.  (The Government Accountability Office also released their study about foreign drug inspections on Tuesday.)

What I found interesting about reports from the hearing was its predictable political theatrical aspects: Chairman Dingell excoriating the FDA Commissioner for not admitting that the FDA needs more resources, and Commissioner von Eschenbach responded that he had asked for more funds to increase foreign inspections. But he also adhered to the Administration’s rhetoric that reforms are needed in addition to some extra funding. As the NY Times reports him saying, “the solution needs to be much more comprehensive than simply inspecting a facility.”

While this hearing focused on foreign inspections – which are clearly a concern – I believe the FDA also needs to step up their monitoring of medicines once they are already here in the US. While counterfeit medicines don’t appear to be a major problem in the US (at least yet), the continuing news reports of problems with generic medicines are worrisome – including a Wall Street Journal report that including the information that one patient’s generic pills had no markings, which is a violation of FDA regulations.

The FDA’s budget, staffing and technology challenges, together with the growing domestic and international quality and safety problems with various medicines raises concerns about how well prepared the FDA is to review and monitor biosimilar medicines and genomic based diagnostics.

I believe that Congressman Dingell is right, and that Commissioner von Eschenbach needs to be a stronger advocate for increased funding for the FDA, even if it means tearing up the Administration’s script he’s told to stick with. This Administration has only another 9 months of shelf life, so he doesn’t need to worry about being fired for speaking off-script – unless he is planning on running for office and wants to remain the good graces of the Republican Party. And if this is the case, then he is violating his duty as FDA Commissioner to fulfill the agency’s mission:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

I’ll get off my soapbox now, and check to see if the soap that came in it was made in China.

Posted in FDA, Politics, Quality of Care & Safety | No Comments »

1 of 100 Adults Gets Free Government Health Care

By Michael D. Miller MD
April 21st, 2008

A recent report from the Pew Foundation indicated that 1 out of 100 adults in the US get free government health care with no premiums, deductibles or co-payments. The reason this report didn’t get more media attention was because the 1% of Americans getting free government health care are behind bars – as in prison or jail.

The Pew report indicates that for the first time, more than 1 in 100 adults in America are in prison or jail. That’s over 2.3 million in state or federal prisons or local jails, and the numbers and percentages have been growing. (See the Department of Justice chart below)

Rise in Prison Population in the US

This data is an interesting launching point into other aspects of our current health care system’s problems:

First, health care costs for people behind bars represent about 10% of the costs of incarceration. (In 2004 this was about $3.7 billion.) And as the Pew report notes, “Under the 1976 U.S. Supreme Court ruling Estelle v. Gamble, states are compelled to provide a constitutionally adequate level of medical care, or care that generally meets a “community standard.” (I assume that Federal prisons are required to meet a similar standard.)

This was the basis for Harris Wofford’s 1991 successful campaign message, (in a special election for the US Senate), that Americans in jail have a guaranteed right to health care, but nobody else does. He was quoted in the New York Times in 1994 as saying about health insurance: “The wealthy have it. The poor have it. If you go to jail, you have it. Only the middle class doesn’t have it, and I don’t think that makes much sense.” (It will be interesting to see how the health care issues of costs and access play out in this year’s elections.)

Second, upon leaving prison (or jail) these individuals are not automatically enrolled in any type of health insurance. Given that they are likely making a difficult transition back into unincarcerated society, health insurance paperwork is probably not their highest priority. A study done by the American Public Health Association of parolees in Los Angles County described these challenges:

Many of the parolees’ illnesses go undiagnosed and untreated by prison physicians. To exacerbate the problem, California’s prison-based health care system does not prepare parolees to use public and private health clinics in the counties where they will reside. There is no coordination between counties and prisons in planning for the continued care of inmates after they are released.

Most parolees do not have medical insurance or stable sources of medical services. Eligible parolees may sign up for various programs but few do, often because they are unable to complete required application forms, do not possess appropriate personal identification documents, and/or have no permanent address. If parolees do succeed in applying for public health insurance programs, they often experience long delays while their enrollments are finalized.

Third, these individuals have more health care needs than average. As the APHA report found, parolees in LA County had:

  • 4 times higher rate of active tuberculosis
  • 9-10 times higher rate of hepatitis C
  • 5 times higher rate of AIDS
  • 1.5 -5 times higher rate of mental illness

Fourth, about 25% of children get health insurance through Medicaid or the State Children’s Health Insurance Program (~34 million), about another 24 million adults have insurance through Medicaid, about 3 million Americans get health care from the Veterans Affairs (VA) health system, and over 8 million have health insurance benefits through the Federal Employees Health Benefits Program.

Together this all paints a picture where multiple government health systems lack coordination. One of the most likely pairs for coordination would be the government run Department of Defense and Veterans Administration health programs, but they have had significant coordination problems that they continue to work on today. Conversely, one of the best examples of coordination may be in the private sector, where people can transition from one private insurer to another if they maintain insurance coverage. However, this ability is not an innate result of the market, but was a provision in the Health Insurance Portability and Accountability Act (HIPAA) of 1996, and illustrates the managed-market reality of the US health care system.

Some would argue that this all just means we should have a single-payer health care system. However, while that may look good in theory, the challenges of getting from our current system to a single payer program are beyond huge. And even if that is our ultimate goal, getting better coordination between programs would make lots of sense – as would making it easier (or routine) for people being released from behind bars to get health insurance. After all, we do this for people leaving their jobs by enabling them to continue their employee coverage (this was in the 1986 COBRA law), and then transition to another private insurance plan under HIPAA. So we should be able to do something similar for people being released from jail, shouldn’t we?

What do you think?

Posted in Access to Healthcare, Delivery of Healthcare, Economics & Financing, Medicaid, Politics, Private-Employer Based Health Insurance | No Comments »

A Perfect Stormy Mess for Health Reform

By Michael D. Miller MD
April 15th, 2008

A year ago the hype in healthcare was about state-based reform initiatives. Massachusetts was implementing its law, and several other states - including California - were considering their own proposals for increasing insurance coverage as a first step towards universal coverage and cost containment.

How things have changed in a year. Not only has California’s initiative crumbled under the expected costs to employers, but the economic downturn has undercut states’ healthcare expansion ideas, and may force them to cut back Medicaid enrollment and/or services. This week’s National Journal has an article titled “State’s Rapidly Shifting Gears,” that discusses these and other issues, including how a few years ago states cut their Medicaid payments to providers, so that on average Medicaid pays physicians 69% of Medicare levels, and how pending Federal Medicaid rules and proposals would reduce funding for State Medicaid programs making it difficult for states to reverse these payment reductions.

The importance of our current economic uncertainty for health reform initiatives is tremendous. Consider the following facts:

  • Massachusetts’ Medicaid waiver is up for renewal this summer. If this isn’t successfully negotiated and renewed, it could mean the collapse of the state’s insurance expansion program - which is already running well over budget because of underestimates of the number of uninsured who would enroll.
  • As the economy falters, not only do more people end up out of work, but they also end up uninsured - with about 40% of them enrolling in Medicaid or SCHIP.
  • Medicaid costs represent about 20-24% of state budgets, and 49 states have requirements for balanced budgets.
  • National Journal’s poll of political insiders (April 12th issue) showed that 83% of Democrats and 79% of Republicans believe that the economy is much more important issue national security for the 2008 presidential election. AND, these percentages are WAAAAY up from November 2007, when they were only 35% (D) and 34% (R), and national security were deemed more important at 56%(D) and 59%(R).
  • The Kaiser Family Foundation’s analysis of public opinion polls found a similar dramatic rise in voters’ interest in the economy as an issue for the 2008 campaign:

Health Care Polling and the 2008 Elections

The key factors that I believe will determine the fate of health reform intiatives over the next several years are:

  • How deep the economic downturn goes
  • How long it lasts
  • What actions the states and the Federal government take to preserve or dismantle the healthcare delivery, financing and public health systems
  • When the economy rebounds, how well prepared the states and the Federal government are to pursue health reform initiatives, and what resources are available for these initiatives

The economic drain imposed by the ongoing conflicts in Iraq and Afghanistan, and the inflationary ripple rising energy costs are sending through the world economy are also factors that may very well undermine anyones ability to expand coverage, while at the same time, increasing incentives and efforts to control healthcare costs.

As Homer Simpson might paraphrase James Carville from the 1992 Presidential campaign, “It’s the Stupid Economy.”

Posted in Access to Healthcare, Delivery of Healthcare, Economics & Financing, Federal Healthcare Reform, Health System Reform, Medicaid, Politics, State-Level Healthcare Reform | 4 Comments »

More on the Supply of Primary Care Clinicians

By Michael D. Miller MD
April 9th, 2008

Yesterday, when I wrote about “Ensuring Enough Primary Care Clinicians,” I didn’t realize that public radio station WBUR would be doing a story this week on the same topic. (The WBUR story can be heard/read on their web-site.)

Nor did I know that this was an agenda item for today’s Medicare Payment Advisory Commission (MedPAC) meeting. While the one-page MedPAC briefing summary doesn’t include their draft recommendations, Modern Healthcare reports that they are recommending budget-neutral adjustments to Medicare’s fee schedule to increase payments to physicians who provide primary-care services – including office and home visits, and visits to patients in non-acute facilities. (Presumably they are recommending Congress enact these payment changes to start in 2009.)

According to Modern Healthcare:

HHS would establish criteria to determine which physicians would be eligible to receive the adjustment. Specialty physicians could stand to lose financially under this proposal, however, and some specialty societies are hoping that Congress will pursue other avenues to improve primary-care payments. In rewarding some physicians under a budget-neutral proposal, “You also have to be careful about who you hurt,” said MedPAC Commissioner Karen Borman, a surgeon who voted against the recommendation.

[Disclosure note: Many years ago I worked with MedPAC’s Executive Director Mark Miller at the White House Office of Management and Budget, but we are not related.]

I don’t see Congress doing anything significant with this problem this year, but with a new Presidential Administration, it certainly could be a very hot issue in 2009 and beyond. Any other perspectives on when or how this should be addressed?

Posted in Access to Healthcare, Delivery of Healthcare, Economics & Financing, Medicare, Politics | No Comments »

Ensuring Enough Primary Care Clinicians

By Michael D. Miller MD
April 8th, 2008

Like many complicated problems in the US healthcare system, setting a goal can be easy, but achieving it can be hard. In recent years there has been a number of proposals for increasing the use of primary care clinicians to help patients with chronic diseases (like diabetes) manage their care and avoid long-term complications - and to presumably lower long-term healthcare spending. For example, the “Patient Centered Medical Home” proposal supported by a dozen organizations, (including companies and family practice and pediatrics associations), doesn’t specifically use the term “primary care,” but it gets to the same result - heightened relationships and communications between patients and a particular clinician or clinic. This .

Increasing the use of primary care clinicians is a great concept, but as has been seen in Massachusetts, increasing relationships between primary care clinicians and patients often runs into a wall when you improve insurance coverage. A recent New York Times article reported on what people here in Massachusetts have been talking about for some time: Before the start of the Massachusetts insurance expansion program there were parts of the state where it was hard to find primary care doctors taking new patients. Now that the program has expanded insurance coverage to about 340,000 more people, it has gotten really hard - particularly in Western Massachusetts. (A friend of mine moved to the most Western part of the state last summer, and almost had to go 90 minutes to Hartford, CT to find a primary care doctor.)

The options for increasing the number of primary care clinicians have both logistical and cultural challenges: Training more physicians takes many years, and as the Wall Street Journal on-line reported, until a few years ago, it had been 30 years since a new medical school granting the MD degree had opened in the US. (Several new osteopathic medical schools have opened.) Another option is retraining specialized physicians to practice primary care. This not only takes time for the retraining, but almost invariably, the potential income from practicing primary care will be less than practicing in a specialty area - which is why physicians aren’t lining up to go back into primary care.

The cultural barriers to increasing the supply of primary care clinicians involve biases that vary in different parts of the country towards osteopathic physicians (ODs DOs) and foreign born physicians, as well as against physician assistants (PAs), and nurse practitioners (NPs). Too many patients - and particularly around places like Boston - want to see an MD that trained at an Ivy league medical school and hospital. (Having graduated from an Ivy league medical school, I can tell you that’s a credential which alone is certainly not a perfect measure of a clinician’s quality.)

Another interesting proposal has been raised in the United Kingdom, where according to the Financial Times, the UK’s National Health Services wants to start having pharmacists provide some primary care services - “pharmacists prescribing drugs and administering tests for minor ailments will free up time for family doctors.”

Of course what this all comes down to is money. The UK pharmacists welcome the proposal, as long as it is backed up with funding to pay them for their increased work. And with the battle over Medicare payments to physicians looming with the 0.5% increase in the Sustainable Growth Rate set to expire at the end of June, (and then revert to the default formula’s 10.1% reduction), it would be nice if Congress (or Medicare itself) could weigh into this policy problem and adjust how they pay clinicians to increase incentives for primary care services. However, my understanding is that Medicare still pays according to the type of service (e.g. intermediate office visit), without regard to the type of physician (e.g. primary care or specialist).

So my conclusion is that while money seems to be a driving force behind the primary care clinician shortage, there needs to be some more good thinking about how to redirect money to increase the supply and availability of primary care, as well as how to use other forms of influence to address some of the cultural and logistics problems keeping the functional supply of primary care clinicians smaller than it could be.

Any ideas? Criticisms? Rants? Raves?

Posted in Access to Healthcare, Clinician-Patient Relationships, Delivery of Healthcare, Economics & Financing, Health System Reform, Politics | 3 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 »

Ben Franklin’s Virtues and the Pennsylvania Primary

By Michael D. Miller MD
April 1st, 2008

While reading a Ben Franklin biography (”The First American,” by H. W. Brands), I was struck by a list of 13 virtues he wrote while in his mid-20s to guide his life:

1. Temperance. Eat not to dullness. Drink not to elevation.
2. Silence. Speak not but what may benefit others or yourself. Avoid trifling conversation.
3. Order. Let all your things have their places. Let each part of your business have its time.
4. Resolution. Resolve to perform what you ought. Perform without fail what you resolve.
5. Frugality. Make no expense but to do good to others or yourself: i.e., Waste nothing.
6. Industry. Lose no time. Be always employ’d in something useful. Cut off all unnecessary actions.
7. Sincerity. Use no hurtful deceit. Think innocently and justly; and, if you speak, speak accordingly.
8. Justice. Wrong none, by doing injuries or omitting the benefits that are your duty.
9. Moderation. Avoid extremes. Forbear resenting injuries so much as you think they deserve.
10. Cleanliness. Tolerate no uncleanness in body, clothes or habitation.
11. Tranquillity. Be not disturbed at trifles, or at accidents common or unavoidable.
12. Chastity. Rarely use venery but for health or offspring; never to dullness, weakness, or the injury of your own or another’s peace or reputation.
13. Humility. Imitate Jesus and Socrates.

The thesis of the book is that Franklin was the first person to fully embody what it meant to be an American - as opposed to a Colonist. So, reading this list, and constantly hearing perspectives about the upcoming Democratic Presidential Primary in Pennsylvania, led me to wonder - since Franklin spent most of his adult life in Philadelphia - “who would Ben Franklin support?” My tally came out at 6-4 with 3 ties.

What do you think?

Posted in HealthPolCom Blog, Nutrition, Politics | 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 »

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