The August 16th Economist had an interesting article (and commentary) about patients traveling to other countries for medical treatments, a.k.a. “medical tourism.”  The article focused on the US healthcare system, and mentioned other parts of healthcare that are being exported, (such as transcription of medical records, reading of imaging studies), and imported, (such as physicians and nurses).  But there are two aspects of this issue that the article didn’t touch upon – chronic care and pharmaceuticals:

Medical Tourism Doesn’t Work for Chronic Care
Patients are traveling from the US to other countries for expensive procedures like heart surgery and joint replacements.  While savings from this medical tourism can be significant on a per procedure basis, it may only make a small dent in overall healthcare spending – and only produce a dip in cost while not significantly changing the growth rate in health care costs.  But more importantly, such medical tourism doesn’t address the expanding problems of providing care for patients’ chronic conditions – which is a major driver of increasing healthcare costs.

Importing Medicines – Safety
Importing medicines from other countries into the US has been a controversy for more than 10 years.  The US Congress has repeatedly authorized the importation of medicines from other countries provided the Department of Health and Human Services certified their safety.  But the HHS (under both Democratic and Republican administrations) has not made such certification – and that was before the deaths earlier this year from contaminated heparin manufactured in China.

Importing Medicines – Politics
While the Obama and McCain campaigns have very different positions on health care reform, their statements on importing medicines are very similar in that both include provisions for importing medicines only if they are safe:

• “Obama will allow Americans to buy their medicines from other developed countries if the drugs are safe and prices are lower outside the U.S.”
• “John McCain will look to bring greater competition to our drug markets through safe re-importation of drugs”

Healthcare Jobs and Economic Growth
The world is clearly becoming flatter for healthcare goods and services, and this could be a worrisome trend for the US economy since healthcare products, delivery and research are significant drivers of US economic growth. After all, healthcare jobs – in both delivery and biomedical R&D – are high skilled, high wage jobs that depend upon an educated workforce and an economical comfortable society that can devote a significant portion of its income to healthcare.  If the US starts shipping more and more healthcare jobs (and money) overseas, this could result in a downward spiral as the loss of those jobs undermines the strength of the US healthcare system and the country’s economic growth.  However, it is uncertain how much the loss of that part of economy could be offset by potentially lower healthcare spending – a cost that some economists believe is inhibiting economic growth in the US and our global competitiveness

The leadership of HHS had a tele-conference on Monday to highlight the new Medicare incentives for physicians to adopt e-prescribing systems.  What the Washington Post and Kaiser Family Foundation reported about this press briefing that wasn’t in the HHS press release was that the Acting Administrator of CMS said that the per physician cost of e-prescribing systems is about $3,000 up front, and then $80-400/month for operation and maintenance.

These numbers caught my eye, because with the incentives in the Medicare bill, the break-even point for physicians is as follows:

First, let’s assume that the per month cost is $240 (the mid-point between $80 and $400), or $2,800 per year. Since the Medicare incentives for e-prescribing are a net 2% of Medicare reimbursements, that means to break-even the physician has to have $144,000/year in Medicare reimbursements – just for the operation and maintenance costs.  Additionally if the up front costs are spread over two years ($1,500/year), that raises the break-even point another $75,000, to $219,000/year.

For some clinicians, this amount of revenues from Medicare might be low, and therefore, it would make sense to get an e-prescribing system. However, if the doctor only sees a minority of Medicare patients, then the incentives could be a penalty.  Which is exactly what Congress expects the financial effects of the e-prescribing incentives to be. According to the Congressional Budget Office, “CBO estimates that the net budgetary effect of the electronic prescribing provision will be to reduce Medicare spending by $0.2 billion over the 2008-2013 period and $2.1 billion over the 2008-2018 period.”

Of course, if other insurers were to match (or exceed) Medicare’s incentive payments for having e-prescribing systems, then obviously the break-even point for physicians would come down, since the calculations wouldn’t balance solely on Medicare revenues.  However, I’m not aware that other insurers are rushing to provide financial incentives for physicians to use e-prescribing systems.

Additional Points
There are additional important points about e-prescribing that need to be made.  First, e-prescribing can have additional costs for physicians’ offices in the form of training time and lost productivity, and unlike electronic medical records, e-prescribing itself is unlikely to improve the office’s billing accuracy and revenues.  Second, e-prescribing can certainly provide clinical benefits by reducing medical errors with better communications about individual prescriptions.  I wrote about these issues a couple of weeks ago (see “Challenges to Making E-Prescribing Increase Efficiency and Improve Quality”), but want to reinforce one point here: Going from paper to computer communications can also introduce new opportunities for medical errors – particularly if people rely on the computer generated information while they might question the legibility or accuracy of a hand-written prescription. That is, technology is great, but its appropriate role needs to be understood by the users, who also have to use it correctly for it to provide real value.

With two notable government actions in the last couple of weeks there has been significant movement towards increasing the use of e-prescribing.

DEA Proposed Rule
The Drug Enforcement Agency (DEA), proposed regulations on June 27th that would make it possible for controlled substances to be prescribed electronically. Interestingly, this was released right after a National Journal article on this topic.

The DEA’s proposed rule is very important, because while it is appropriate to place stronger safeguards on medicines that are likely to be abused (which is the criteria for being a DEA scheduled medicine), having controlled medicines prescribed by pen and paper while all other medicines are e-prescribed would be a logistical problem and obviate many of the potential benefits of e-prescribing.  And technologically, if banks and others can provide secure login systems and other security measures, I would think that e-prescribing systems could be similarly secure to make sure that unauthorized people aren’t electronically writing themselves prescriptions for thousands of narcotics pills using a legitimate doctor’s DEA number.  (See more about this in the e-quackery section below.)

Medicare Bill Contains Carrots and Sticks for E-Prescribing
The Medicare bill which passed Congress yesterday included a provision to increase the incentives for physicians to use e-prescribing technologies.  These incentives are a small percentage add-on to allowed Medicare charges for physicians who are e-prescribing starting in 2009, and a cut to payments for allowed Medicare charges starting in 2011 for physicians who are not e-prescribing.

Movement in a Good Direction
Together these actions move the US healthcare system towards greater e-prescribing, something that if done right, should increase efficiency (with lower administrative costs), and improve quality of care and patient safety by creating a better system for detecting and preventing adverse drug reactions from known drug allergies and drug-drug interactions.  The use of computerized prescription order systems for patients in hospitals has been shown to accomplish both of these improvements, but how e-prescribing will work in the outpatient world remains to be seen.

Challenges to Making E-Prescribing Increase Efficiency and Improve Quality
There are many challenges for e-prescribing in clinicians’ offices.  Like electronic medical records, they have to buy and install the systems, learn how to use them, and then keep them updated – since new prescriptions keep getting approved etc.  Because of these challenges, it is estimated that only about 6-7% of physicians’ offices are currently using e-prescribing systems.

Optimally e-prescribing systems should be an integrated part of the office’s electronic medical records system so that it could identify potential problems with drug allergies, or the need to alter dosages for patients with impaired kidney or liver function.  And at a minimum, a free standing e-prescribing system should be able to keep track of each patient’s prescriptions to flag drug-drug interactions, otherwise it may become nothing more than a sophisticated fax machine – which some could argue (but I wouldn’t) is a rudimentary form of e-prescribing.

While, e-prescribing systems should provide alerts about drug-drug interactions,  potential allergic reactions, and the need for dosing adjustments, systems that constantly flash up reminders for such things when they’re not relevant, leads users to ignore them altogether. I take a lesson about this hazard from my brother who works on designing aircraft information systems. Clearly pilots need to know certain things at the right time, but I doubt any pilot would fly better or more safely if they kept getting an alert about it being unsafe to land the airplane because the wheels were up – even with the plane at 30,000 feet.  OK – that may be a bit of an extreme example, but if the e-prescribing system doesn’t know anything about the patient, it may send similarly useless alerts and lead those using it to ignore all alerts – which could be worse than having no alerts at all, since it having them pop-up and be ignored could provide a false sense of security.

This illustrates what most people involved with healthcare reform recognize - improving the quality and efficiency of healthcare in the US requires making the systems work better since our practitioners are generally already pretty good.  But giving these good people flawed systems won’t help them, their patients (i.e. us), or our overall healthcare system.

This brings me to one last point.  How many e-prescribing systems will each clinician’s office need?  I certainly hope that every pharmacy chain/group won’t require their own version of an e-prescribing system, nor will each payer, insurer or regulator require a different electronic or paper output of the prescription information for reimbursement or quality auditing purposes.  If that becomes the case, then e-prescribing will face even greater hurdles.

Since they do good work in this area, I also want to include the eHealth Initiative’s  summary of the challenges for e-prescribing systems:

• Financial burdens – Physician practices face varying financial burdens related to e-prescribing, including covering the implementation, training and maintenance costs.
• Workflow changes and change management – Although e-prescribing efficiencies and time savings are gained in the long run, introducing e-prescribing, and electronic health records (EHRs), can be difficult, time consuming, and requires adequate planning, training, and support, particularly in the beginning.
• Continued needs for greater connectivity – The infrastructure exists for connectivity among pharmacies, physician practices, payers and pharmacy benefit managers (PBMs), but some pharmacies, payers/PBMs and mail order pharmacies are not yet connected.
• Medication history – Although e-prescribing is an improvement over relying on paper medical records and patients’ memories, the information that is available may not always be comprehensive or accurate and therefore tools to adequately reconcile medication histories from multiple sources are needed.

E-Dispensing – Bad!!  And E-Quackery – Bad Too!!!
One of the other challenges for e-prescribing may be the practical and policy interactions between physicians’ e-prescribing and internet sites that sell medicines directly to a patient without a prescription.  While e-prescribing potentially can improve efficiency and quality, e-dispensing can lead to bad fiscal and clinical outcomes from patients getting fake, adulterated or dangerous pills and potions.

Information on the worst examples of e-dispensing is in a recent report from Columbia’s National Center on Addiction and Substance Abuse (CASA).  Their recent annual report found that the number of web-sites selling controlled medicines without a prescription has decreased from the start of 2007 to the start of 2008 - from 581 to 365.  The CASA report also found, “Of those sites not requiring prescriptions, 42 percent explicitly stated that no prescription was needed, 45 percent offered an “online consultation,” and 13 percent made no mention of a prescription.”

I’m not sure if anyone knows what the total number of patients using these sites is, or the number of prescriptions they are filling, so it’s unclear if this reduction represents a real decline in the “industry,” or just its consolidation and maturation.  What CASA also found - and that I find especially worrisome - is “an emerging practice of Internet sites selling prescriptions for controlled drugs that can be filled at local pharmacies. The report also found sites selling online “medical consultations” which enable Internet users to get controlled drugs online without a proper prescription.”  I call this e-quackery, because this is physicians acting inappropriately, or non-physicians acting in the role of a physician and practicing medicine without a license by writing prescriptions.

Other notable findings from the CASA report include:

• Of the few sites that require prescriptions, half permit the prescription to be faxed, allowing significant opportunity for fraud.
• Benzodiazepines (like Xanax and Valium) continue to be the most frequently offered drugs for sale with 90 percent of sites selling them; followed by opioids (like Vicodin and OxyContin) at 57 percent of sites, and stimulants (like Ritalin and Adderall) at 27 percent of sites.
• According to DEA estimates, in 2007 eleven percent of prescriptions filled by traditional pharmacies were for controlled substances compared to 80 percent of prescriptions filled by Internet pharmacies.
• There are no controls blocking access to these sites by children and teens.

Conclusions
Just to bring things full circle – clearly e-dispensing and e-quackery are bad, so perhaps the greater use of legitimate and appropriate e-prescribing will help to clamp down on these illegal and dangerous activities.  And from a personal perspective, I can also only hope that it will reduce the ongoing flow of spam emails for on-line medicines - and the similar onslaught of spam blog comments to this blog that you never see because I delete them, but which like spam emails, just chew up time from every day.

p.s. Sorry about the long post – but this is an important and complicated topic.

The Centers for Disease Control and Prevention released some interesting data yesterday.  They reported that in 2007 an estimated 23.6 million people (7.8% of the total US population) have diabetes.  Of these people, only 17.9 million know they have diabetes, while 5.7 million have not been diagnosed.  The good news is that the percentage of people with diabetes who don’t know it has decreased from 30 to 25% The bad news is that the number of Americans with diabetes is increasing.

Number  of People in the US (in Millions) with Diagnosed Diabetes: 1980- 2005

(from http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm)

How Bad Is a Little Sugar?
As the CDC’s Fact Sheet states, “Overall, the risk for death among people with diabetes is about twice that of people without diabetes of similar age.” Diabetes causes high blood pressure, heart disease and stroke, and is the leading cause of blindness and kidney failure in adults.  Diabetes – because it affects the small blood vessels – also predisposed people to infections, and can lead to amputations from lack of adequate blood flow.  It also increases the risk of pregnancy complications, and leads to nervous system impairments.

How Many People Have Diabetes Where I live?
The CDC doesn’t have county level data for 2007 yet, but the map below shows the percentage of people with diabetes in counties across the country.  [Note – People in Colorado do have diabetes, but in Colorado the country with the highest incidence of diabetes falls just below the threshold for the second color in the map.]

(from http://apps.nccd.cdc.gov/DDT_STRS2/NationalDiabetesPrevalenceEstimates.aspx)

What to Do About Diabetes?*
There are lots of good resources of information for patients about diabetes (see below), but without getting into too many specifics, people should talk to their doctors about three different types of things:

1. Testing: Get tested – both for diabetes as well as pre-diabetes, a condition which indicates impaired metabolism of sugar and a higher risk of developing diabetes.
2. Treatment: Get treated if you have diabetes.  Get treated for the diabetes itself and for other conditions that increase the risk of developing the complications of diabetes, such as high blood pressure and high cholesterol.  And be sure to take your medicines as instructed by your physician, and test your blood sugar as they recommend.  If you don’t understand how to take your medicines or have any questions about them, just ask your doctor or pharmacist.  Quality healthcare professionals would rather answer your questions and prevent problems from developing, than have to help you resolve any problems you develop from taking medicines incorrectly.
3. Personal Choices - Eat Right and Exercise: Whether you have diabetes or are at risk for developing diabetes diet is crucial, and exercise and weight loss can help improve diabetes and lowers the risk of developing diabetes and its complications.

Resources About Diabetes
American Association of Diabetes Educators - www.diabeteseducator.org
American Diabetes Association - www.diabetes.org
Centers for Disease Control and Prevention - www.cdc.gov/diabetes
National Diabetes Information Clearinghous - http://diabetes.niddk.nih.gov/ and http://diabetes.niddk.nih.gov/dm/pubs/stroke/#connection

*DISCLAIMER – THIS INFORMATION IS NOT SPECIFIC MEDICAL GUIDANCE, IT IS NOT INTENDED TO DIRECT TREATMENT OR PREVENTION FOR INDIVIDUALS,  AND SHOULD NOT BE SUBSTITUTED FOR ADVICE FROM PHYSICIANS AND OTHER HEALTHCARE PROFESSIONALS INCLUDING NUTRITIONISTS, AND DIABETES EDUCATORS.

The FDA announced today that they have sent letters to 25 companies to stop selling fake cancer cures. That is, things that the companies claim cure cancer, but have never been tested, or approved by the FDA. The FDA has a web-site with more information about this, and a sub-page that lists 125 Fake Cancer Cures.

I know the FDA gets lots of flack for not doing enough - and not doing it fast enough - I applaud the FDA for taking this action, and encourage them to do more because I have found the advertisement and selling of these non-medicines troubling for a long time.

Cancers are serious diseases by anyones definition, and real medical science is making great strides in developing better treatments and cures, and in overall improving the lives of people living with cancer - both through traditional drugs and biologics, as well as with complementary therapies. But those profiting from selling fake medicines are selling false hope.

I would like the FDA go after more of these people who are profiting from selling fake medicines marketed as cures for other diseases and conditions - particularly ones that may be for symptoms of serious conditions. For example, every time I see the plastic-faced grinning guy on TV hawking a non-FDA approved “natural male enhancement” product, I wonder about all the men who may still be too embarrassed to talk to their physician about their erectile dysfunction problem - which unknown to them is being caused by a serious medical problem, like cancer. And of course for men who are buying this stuff who don’t have ED, then it would be nice if they could talk to their physician about therapy to address the route causes of their feelings of sexual inadequacy.

But of course, the FDA currently has insufficient resources to cover all of it’s multiple priorities - which is why Congress and the Administration are discussing how to provide more funding. Until that happens, I hope the FDA continues being vigilant and stops as many of these purveyors of false hope as they can - at least so these people don’t get the idea that because the FDA’s resources are stretched a bit thin, that the FDA won’t bother them.

The Medicare Payment Advisory Commission released its annual report to Congress on Friday. In chapter 2 of its report, MedPAC makes two significant proposals for improving the financial incentives for primary care providers.

Great Incentives for Primary Care Practitioners Not Just Primary Care Services
First, it recommends changing Medicare’s reimbursement system for “evaluation and management” (E&M) services. While last year Medicare increased payments for E&M services, they couldn’t differentiate between types of physicians providing these E&M services, i.e. the Medicare system doesn’t distinguish between a family physician and a cardiologist if they are providing the same type and level of intensity of service.

Therefore, MedPAC recommends that a subset of primary care related E&M services, (e.g. office visits, home visits, long-term care patient visits), provided by clinicians who meet a minimum percentage threshold of a clinician’s total Medicare billing, (and thus would be identified as being “primary-care-focused practitioners”), should receive higher Medicare payments. (MedPAC choose to identify primary care clinicians based upon a percentage of primary care services - rather than specialty designation - because it would be administratively simpler and ensure that the incentives would be directed towards clinicians actually providing primary care services.)

The specific recommendation from the MedPAC report is:

The Congress should establish a budget-neutral payment adjustment for primary care services billed under the physician fee schedule and furnished by primary-care-focused practitioners. Primary-care-focused practitioners are those whose specialty designation is defined as primary care and/or those whose pattern of claims meets a minimum threshold of furnishing primary care services. The Secretary would use rulemaking to establish criteria for determining a primary-care-focused practitioner.

This is a sea-changing proposal in that it seeks to differentiate how Medicare Part B reimburses primary care providers versus subspecialists – and thus makes Medicare Part B payments more granular than was done when the RBRVS system was first installed in the early 1990s. (Back then, the fight was between so-called cognitive and procedural services.) This refinement will enable Medicare in the future to use its payment system as a more managerial tool for shaping the healthcare delivery system to increase the supply and access of primary care practitioners. The need for such changes is evident by the shrinking number of medical school graduates going into primary care:

However, because the proposal is intended to be budget-neutral it explicitly pits the financial interests of primary care practitioners against subspecialists, which means that the subspecialists will not eagerly welcome these changes to Medicare since they would be getting a smaller piece of a same-sized pie. (Note – MedPAC’s analysis shows that using the a cut-off of 65% of primary care services for clinicians to receive a 10% increase in payments for these services, would increase reimbursements for these services by a total of 6.2%, and would require a reduction for all other services of 0.9% to achieve budget neutrality.)

Build a Medical Home
MedPAC’s second proposal to promote more primary care is to increase the number of Medicare beneficiaries with medical homes.

Medical homes are the latest name for initiatives to give patients a single clinical practice or practitioner to ensure that their care is coordinated with the goal of improving the quality of care, and controlling costs by avoiding unnecessary complications and unnecessary testing. Medical homes are particularly important for people with chronic conditions for ensuring appropriate compliance with recommended treatments, disease monitoring and preventive testing. As the MedPAC report states, “Unlike the current fee-for-service (FFS) payment system, which emphasizes treatment for acute conditions and face-to-face care, medical home programs encourage practitioners to coordinate their patients’ care between visits and among providers. In improving care continuity and coordination, medical homes can enhance the role of primary care practice … [and] … increase our health system’s quality and efficiency.”

Medical homes are not new concept, as care coordination has been discussed since the original concept for HMOs several decades ago. Recently they have been promoted by primary care associations, and Medicare will start a medical home demonstration project in January 2009. MedPAC’s proposal builds off of the planned pilot, and would provide additional monthly payments to medical home practices providing the care coordination services. (Signing up with a medical home would be voluntary for Medicare beneficiaries and they would not have to pay any additional co-payments or premiums.)

MedPAC’s specific medical home proposal, which goes beyond the planned pilot project, is:

The Congress should initiate a medical home pilot project in Medicare. Eligible medical homes must meet stringent criteria, including at least the following capabilities:

• furnish primary care (including coordinating appropriate preventive, maintenance, and acute health services) [and medication management]
• conduct care management
• use health information technology for active clinical decision support
• have a formal quality improvement program
• maintain 24-hour patient communication and rapid access
• keep up-to-date records of beneficiaries’ advance directives, and
• ‘maintain a written understanding with each beneficiary designating the provider as a medical home.

Medicare should provide medical homes with timely data on patient utilization. The pilot should require a physician pay-for-performance program. The pilot must have clear and explicit thresholds for determining whether it can be expanded into the full Medicare program or should be discontinued.

MedPAC recommends an enhanced pilot project - rather than a national initiative -because there are administrative and technical factors that still need to be worked out, including, how to structure monthly payments to medical homes, and how to provide medical homes information about services provided to their patients by other providers so they can do care coordinating. The good news proposals for specialist physicians in MedPAC’s is that the pilot is not being proposed as budget neutral, but would cost between $250-750 million over 5 years.

Conclusions
Most experts think these proposals will be effective in improving the healthcare delivery system in the US, and I agree – provided that they are structured and implemented so they actually change the actions of physicians and patients. To be successful they need to change physicians’ practice patterns to focus more on primary care and care coordination, and to change patients’ behaviors so they use their primary care clinicians for more of this care management. In addition, as is reflected in the charts above, these proposals face the logistical challenge of finding enough primary care clinicians to provide these services. These changes will take time - it takes years to alter patient-physician relationships, shift how physicians practice or increase the supply of primary care clinicians – but this is not a reason for further procrastination.

p.s. I’m writing this from the road, so my editing and grammar may be somewhat deficient – my apologies.

The FDA announced yesterday that both the FDA and the European Medicines Association (EMEA) will accept seven biomarker tests for early kidney damage. These animal based tests were developed by a public-private collaborative and will be a voluntary part of the regulatory applications for new drugs. However, it is believed that companies will benefit by doing these test because they will both be able to detect toxicity problems earlier in a drugs development, and enable the approval of more powerful drugs, “because health care professionals could closely monitor patients and halt the drug if early signs of renal toxicity appear.”

“The development of these and other biomarkers can result in important tools for better understanding the safety profile of new drugs,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “We hope these biomarkers will lead to human tests that detect drug-induced kidney injury in people earlier than is now possible, and help health care professionals better manage potential kidney damage from drugs.”

This advanced use of biomarkers represents a quantum leap in our understanding of molecular toxicities and organ damage - these tests detect cellular damage in a matter of hours rather than the actual kidney dysfunction which had occurred over several days by the time the traditional tests of blood urea nitrogen (BUN) and creatinine have become elevated.

The development of these types of biomarkers was also predictable. Over 10 years ago - with prompting by senior industry scientists - I had several discussions with Congressional and NIH staff about the potential value of government support for validating these types of biomarkers. It was important that the government take the lead in developing these tests since all companies would benefit once the biomarkers were validated, and thus the research was beyond the scope of any single company. This reality led to the formation of the public-private coalition to conduct the research to validate specific biomarkers. However, the formation of this consortium is somewhat remarkable because of the structural/cultural barriers between the industry and the regulatory and scientific agencies, and the extreme public scrutiny and criticism of any collaboration between the pharmaceutical industry and its regulatory agencies – no matter how valuable the public benefits.

The development of the kidney related tests is not an isolated advancement. The non-profit organization managing this initiative is working on similar tests for cardiovascular diseases, cancers, and other diseases. Patients and clinicians certainly hope that similar tests are developed quickly for these conditions, and that they will improve the speed and quality of developing and approving new and better medicines.

Accelerating these advancements will depend on how Congress funds the FDA to increase its scientific capabilities and modernize its information technology, as well as how much attention the next President gives to the FDA’s activities - which he should since they touch every American and affect ~25% of the US economy.

Are people who participate in clinical trials patients or subjects? This may seem like a minor rhetorical difference, but I believe it has tremendous implications for health and biomedical research policy. Let me explain why -

Clinical trials are experiments to discover new knowledge. Their intent is to see if a new way of treating a specific disease or condition is better than, the same as, or worse than, another option – either a placebo or an established treatment. Therefore, when people agree to participate in a clinical trial they are participating in this experiment, and their fundamental goal for participating should be to help future patients by expanding biomedical and/or clinical knowledge. As part of their participation, they may receive some benefit – IF the experimental therapy does prove to be beneficial. Therefore, they are not patients; they are subjects within the clinical trial.

I often see phrases like “clinical trial patients” or “patients in clinical trials,” and I understand what they are talking about, since for many patients with serious conditions that lack good treatment options, clinical trials offer some hope. However, I think that the term muddles the distinction, and can lead to conflicting responsibilities for the clinician-investigators conducting the trials and the patient’s primary physicians. This is one reason that I believe that patients who elect to participate in clinical trials should maintain a relationship with their primary care physician during the clinical trial – even if the researcher in charge of the clinical trial is responsible for all their clinical care. This also means that the clinical investigator and the primary care physicians for the subjects in the clinical trial need to have regular communications - both before and during the person’s participation in the clinical trial.

When the person’s primary care physician is also the clinical investigator in the clinical trial, these lines are easily blurred, and this can lead to problems – something that all clinician-investigators struggle with. This is why clinical trials have protocols that are pre-approved by at least one Institutional Review Board (IRB) that is charged with protecting the rights and welfare of subjects in the clinical trial. (IRBs are also involved with monitoring the clinical trials and modifying the protocols as needed during the course of the trial.)

I was reminded about this issue by an article in the May 1^st issue of American Family Physician that discusses when and how it is OK to use a placebo in clinical practice, i.e. for patients rather than clinical trial subjects. The article lays out a bright line for physicians - “do not lie” - as well as referencing an older article* that lists five conditions that should be met before giving a placebo to a patient:

1. There is a well-established, durable physician-patient relationship
2. There is a concrete diagnosis that does not mandate or support the use of other “active” interventions
3. The patient specifically requests that the physician provide some form of intervention
4. The use of such agents is a consideration of last resort
5. The use of such agents does not substitute for, or interfere with, diagnostic and therapeutic diligence

The distinction here is between using a placebo clinically, and using it in a clinical trial. For someone to become a subject in a clinical trial, they need to first give their informed consent so they are aware of the risks involved with their participation. Having a physician give such informed consent in clinical practice when using a placebo might actually undermine the placebo effect, and thus remove any benefit the patient might receive from the placebo. The AFP article specifically counsels that if a patient asks about a recommended treatment that is a placebo, that an appropriate response from their physicians should be something like - this may not directly affect your condition, “but it may turn on other mechanisms that might be important for your health and make you feel better.”

Any additional thoughts on this issue?

* Bok, S., “The ethics of giving placebos,” Sci. Am. 1974; 231 (5): 17-23

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.

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)

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?