KOLAHUN

GORT,

KLAATU

BARADA

NIKTO

The Ministry of Information

“more power to the misinformed”

 

Do Protocols Make Dumber Clinicians?

There's a lot of push-back from clinicians arguing that patients are individuals and can't be pegged into uniform clinical protocols.  This argument necessarily invokes the straw-man in the guise of the 'physicians don't have control anymore' lament.  I readily counter with the refrain that common things occur commonly and that most patients do fall within the parameters of protocols.  Most patients with DKA need insulin, fluids and potassium.  Most patients with community acquired pneumonia improve with empirically chosen antibiotics.  

But the more important part of the rebuttal is that for the exceptional patients who don't conform, the clinician still has the choice to change treatment.  As of yet, there's no one arguing that when justified, a clinician still doesn't have final decision making authority.  Not insurance companies.  Not the government.  And not the egg-head proponents of protocolized medicine.  

More defensively against protocols is the argument that they make trainees stupider.  It's perplexing why this should be so.  Currently, it's probably the case that trainees have too many models to study - each attending teaches a different method.  Consolidating these should simplify the majority of cases, allow trainees to understand the basics and, as there are always exceptions, enable them to treat these non-conforming clinical quandaries.  

This just published JAMA retrospective study on how well Critical Care fellows fared on their Board exams gives some initial evidence that, in fact, protocols don't make them dumber.  The study divided up the fellows based on how many protocols were in place in their institution and then compared how they performed in relevant sections of the boards.  What they found was that there was no difference in clinical knowledge between programs with a high number of protocols and those with a low number of protocols.  

Results Ninety of 129 programs (70%) responded to the survey. Seventy-seven programs (86%) had protocols for ventilation liberation, 66 (73%) for sedation management, and 54 (60%) for lung-protective ventilation at the time of the survey. Eighty-eight (98%) of these programs had trainees who completed the ABIM Critical Care Medicine Certification Examination, totaling 553 examinees. Of these 88 programs, 27 (31%) had 0 protocols, 19 (22%) had 1 protocol, 24 (27%) had 2 protocols, and 18 (20%) had 3 protocols for at least 3 years. Forty-two programs (48%) were classified as high intensity and 46 (52%) as low intensity, with 304 trainees (55%) and 249 trainees (45%), respectively. In bivariable analysis, no difference in mean scores was observed in high-intensity (497; 95% CI, 486-507) vs low-intensity programs (497; 95% CI, 485-509). Mean difference was 0 (95% CI, –16 to 16), with a positive value indicating a higher score in the high-intensity group. In multivariable analyses, no association of training was observed in a high-intensity program with mechanical ventilation score (adjusted mean difference, −5.36; 95% CI, –20.7 to 10.0).

Conclusion Among first-time ABIM Critical Care Medicine Certification Examination examinees, training in a high-intensity ventilator protocol environment compared with a low-intensity environment was not associated with worse performance on examination questions about mechanical ventilation management.

 

 

Gleevec, India, Patents and the Fate of Affordable Medications

An important editorial by Dr. Druker - one of the key investigators of Gleevec [imatinib] - and how a legal case in India may affect the affordability of generic medications across the world.  The argument in India centers around how much modification a pharmaceutical needs to make in order to be granted a full new patent on the modification.  

The Indian law states should have the following characteristic (paraphrased from an MSF editorial):  "a new form of a known medicine can only be patented if it is not obvious and shows significantly improved therapeutic efficacy over existing medicines"  Novartis, Gleevec's manufacturer, contends that smaller changes are material and should be granted full patent privileges.  

I agree with Dr. Druker on this:

However, the price at which imatinib has been offered for sale by Novartis around the world has caused me considerable discomfort. Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible.

Public institutions around the world have continuously played a critical role in the research that leads to vital new medicines reaching the market. Without access medical research becomes a luxury good. Most of my colleagues would be very uncomfortable if we felt that this would be the result of our decades ofeffort.

 

Water-world - India and Bangladesh

According to this Al-Jazeera article, a recent signing between India and Bangladesh resolved many land-border issues:

India and Bangladesh have signed a raft of agreements during a visit to Dhaka by Manmohan Singh, India's prime minister, including one to resolve long-running border disputes.The South Asian neighbours concluded a land boundary agreement on Tuesday to demarcate their 4,000km shared border and sort out 162 "enclaves" - small pockets of one country's territory surrounded by the other."Both of our countries have now demarcated the entire land boundary and have resolved the status of enclaves," Singh said at a ceremony with his Bangladeshi counterpart, Sheikh Hasina, in Dhaka.

But what may be the key graf in this story isn't the above headline but rather the unresolved disputes left over water access between the two countries.  The 1996 Ganges water sharing treaty - already in peril due to political and economic tensions - is possibly being tested by the changes in climate change leading to a conflict between asymmetric partners:

A review of current literature on the Ganges reveals that the issue of majo r concern is the quantity of water available to the mega-city of Kolkata and to southwestern Bangladesh, both of which rely on the Ganges water for short- and long-term needs. However, there is evidence that theunderlying causes of water quantity problems are of po

litical and economic nature, both in the conditions that had lead to the construction and implementation of the Farakka Barrage itself, as well as those precluding a fair and workable long-term water sharing agreement. Politically and militarily, India is by far the stronger of the two nations, and wishes to not only maintain its dominance but also enhance it; these factors are reinforced by India's advantageous terms of trade, economic growth, and position as the upper riparian state. Any future effort to resolve the ongoing dispute between India and Bangladesh must address these underlying variables to be successful in the long run.