KOLAHUN

MSF's reaction

Medicine Sans Frontieres (MSF) is pretty damn happy with the ruling by an Indian court to decrease the patent protections for non-novel drugs, too:

India only began giving patents on medicines to comply with WTO rules, but it designed its law with safeguards so that patents can only be granted for real innovations. This means that companies seeking a patent for modifications to a molecule already invented, in order to extend ever further their monopolies on existing drugs, would be unsuccessful in India. It is this aspect of the law that Novartis was seeking to have removed. A ruling in favor of the company would have drastically restricted the production of affordable medicines in India that are crucial for the treatment of diseases throughout the developing world.

Developing country governments and international agencies like UNICEF and the Clinton Foundation rely heavily on importing affordable drugs from India, and 84% of the antiretrovirals that MSF prescribes to its patients worldwide come from Indian generic companies. India must be allowed to remain the 'pharmacy of the developing world.'

I believe India and Brazil produce the bulk of generic manufacturing that developing countries use (though i am still looking for actual data on this).  Especially for HIV medicines, most countries with high rates of HIV (say, greater than 10% or so), likely don't have domestic manufacturing capabilities.  The Indian court allowing companies like Cipla to continue producing these drugs allows a justifiable exception to the WTO rules.

Again, sweet.

How does one set a threshold?

We explored when a clinician should order a diagnostic test in this post about evidence-based medicine.  At its core, the principles follow this reasoning:

A)  all diagnosis in medicine are probabilities, examples:

• a college student with chest pain after failing a test - 1% of coronary artery disease
• a 57yo obese, male with history of high blood pressure with chest pain - maybe 50% further depending on the type of pain, duration, etc. 

B)  a test should significantly increase or decrease the probability, otherwise it shouldn't be ordered

C)  clinicians set a threshold probability for treating diseases, based on

• the harm of the disease (e.g spinal meningitis kills a lot more than a small skin infection)
• the benefit of the treatment (we'll explore this later)
• the harm of the treatment (every procedure or medication may result in significant adverse reactions or side effects)

D) There are caveats to even ordering a test

• If the pre-test probability already crosses the threshold, don't order the test...just treat
• If, given a certain pre-test probability, the post-test probability can't cross the threshold with a particular test even if came back positive, then don't order the test (i.e. even with a positive test, the clinician wouldn't change the treatment, therefore don't order the test).

And this all makes sense theoretically.  And evidence-based medicine continues to develop clinically useful likelihood ratios and help clinicians define pre-test probabilities. 

What I don't get however is "C" - how to set a threshold level for deciding when to treat patients.  Can anyone help?  Maybe using pulmonary embolus as an example...

Left handed words (volume 1)

Being forced to use a mouse and the keyboard simultaneously, I love words/names that can be typed using only the left hand.  Today's word:

ABSCESS

Q. Why I won't get rich quick

A.  Because I don't think like Dr. Quinlan.  He's the Ochsner Health System chief executive who believes that instead of a new, charity hospital, the LSU medical school should outsource teaching to his hospitals. 

Quinlan, chief executive of Ochsner Health System, says the state is setting itself on a course for financial disaster by spending more than a billion dollars on a new teaching hospital and betting that it will be large and modern enough to lure patients with private insurance -- patients who traditionally have shunned the state's public hospital system.

He says he approached the university shortly after Hurricane Katrina with an alternative. He offered to let LSU use his nonprofit health system, which includes five hospitals in greater New Orleans, one in Baton Rouge and one in Raceland, as the primary teaching venue for medical residents so the state would not have to build a new hospital.

"The idea that LSU needs a teaching hospital is misshapen into the idea that they have to build their own," Quinlan said. "Stop the focus on the building."

Rather than dump huge amounts of money into a new building, Quinlan says, the state should invest in research and faculty recruitment to transform LSU into one of the top five medical schools in the South over the next decade. He says the university should rely on relationships with private hospitals and continue to use existing public hospitals such as University, which opened in 1972.

Excellent.  It'll be nice to hear how Dr. Quinlan proposes that Ochsner and the other community hospitals, who historically have been averse to indigent care patients and who since Katrina have been anecdotally kicking them out of their system, deal with these patients without the safety net of Charity.  I'm further interested in how they'd train their residents to actually care for patients through evidence-based medicine without the attendings making all the decisions or pan-consulting.

Oh...and i'd finally like to know what the profit margins to the Ochsner hospitals would be in having residents (aka cheap medical labor)? 

Another one bites the dust

Another prominent New Orleans/Louisiana politician faced corruption charges today and will apparently plead guilty.  The William Jefferson bribery case continues.  David Vitter's prostitution case continues.  We've talked about this before, but Louisiana has a seemingly higher historical rate of corrupt politicians. 

I heard about this latest incident involving City Councilman Oliver Thomas last night over dinner with friends and wondered what is it about this area that lends itself to corruption.  I really have no idea.  Any thoughts?

No pills for you

For those who may have missed it, the CDC updated its antibiotic recommendation for gonorrhea this year.  Namely, given the high level of resistance to flouroquinolones, the CDC no longer recommends this class of medicines.  The only real treatment here in the US is an intramuscular injection of ceftriaxone.  The oral treatment it recommends are a) cefixime (which isn't available here in the US) and cefpodoximine (which costs at least $100)...meaning, there are effectively no good oral medicines for gonorrhea. 

Condoms, baby...condoms!

Ah, the frustrations (sometimes)

The frustrations of working in a free clinic pale in comparison to working in a pay-for-service clinic... because, well, we don't bill.  I can't think of anything more frustrating for a clinician than wondering how to maximize compensation for services, what level to bill at, which meds fall within each insurance company's formulary, etc. 

Nonetheless, the frustrations that exist in indigent care, um...still frustrate.  When patients don't know which medicines they take ("um, the little white pill with the red stripe", "two blue pills", etc.), what medical problems they have ("the pressure", "the sugar", etc.), who their regular doctor is, etc. it gets annoying real fast. 

Infrequently do indigent care patients have a 'regular' doctor, necessitating they make frequent stops to mobile clinics, free clinics, emergency rooms.  Now, clinicians at each of these places, having never seen these patients before, may have different medications for hypertension, diabetes or asthma.  Some clinicians treat simple (i.e. viral) infections with antibiotics while others (i.e. good ones) don't.  What ends up happening is that these patients cross the threshold of medical confusion - they've been told they have various problems and need multiple medications. 

They then come to a clinic (like ours) where they want all their medications refilled.  Of course, um...we may not feel they actually have a certain disease (e.g. not everybody with a cough has asthma), or that they need antibiotics, or that the medicines they have been prescribed are appropriate for patients with poor access to lab checks (e.g. patients on ace-inhibitors need to have their kidney function routinely checked), or etc.  And of course, if the patient is already habituated to get these medicines and we don't prescribe them, then we're the assholes.

In the end, these are all pretty petty complaints (and at least we don't have to worry about billing!)...but once in a while, the frustrations do boil over...like today. 

Not everyone agrees

Dr. Reider, over at Family Medicine Notes, disagrees that free antibiotics may be helpful, given patient desire for antibiotics. 

However, while I concede that patients have been previously schooled to believe that antibiotics help with any respiratory ailment (including viral infections), there is now at least mixed success with patient education regarding antibiotic overuse.  Perhaps given further and more refined education, effectiveness can be improved.

That said, the larger issue of the cost of the antibiotics needs to be better appreciated.  Even more than with anti-hypertensive and diabetic medications, we can make the public utility argument of free/low-cost antibiotics.  If we diagnose atypical bacterial pneumonia in a patient, then dispensing low-cost or free antibiotics can theoretically improve other people's health by reducing transmission.

The first line treatment for atypical bacterial pneumonia (i.e. walking pneumonia) is azithromycin, which costs $4/full treatment at Wal-mart/Target and $0 at Publix, while costing $45 at Walgreens. 

Not the worst cancer, but still excellent news

CML is a type of adult leukemia.  Only about 5000 people in the US get it each year, and the 5 year survival reaches 90%.  In the past, a few chemotherapeutic agents could slow down the disease.  But in order to cure it, one had to undergo bone marrow transplantation, a difficult process involving finding an appropriate donor and then actually performing the procedure.

In recent years, an oral pill, Gleevec, revolutionized CML curative treatment.  Now, instead of undergoing a difficult procedure, patients with CML only have to pop a pill each day...and a high percentage achieve hematologic cure.

Which brings us to this article from the New York Times regarding Gleevec in my original home country of India.  An Indian court found that the modifications made by Novartis, the Swedish pharmaceutical manufacturer of Gleevec, don't qualify it to have further patent protection.  The likely CML patient beneficiaries of this ruling can't be more than a few thousand.   But this case has profound implications for generic manufacturers of other drugs, especially HIV/AIDS drugs. 

What we need to explore to fully understand this ruling are two independent processes:

1. What is TRIPS and how does it relate to drug manufacturing and pricing?
2. How do we actually trace the cost borne by public entities versus private entities in the development of drugs?

The answers to these questions are quite complex and over the next few days/weeks, we'll try to explore them in depth. 

Is there a Publix near you?

Too bad we here in New Orleans aren't close to a Publix Pharmacy because they're apparently giving away antibiotics (via drudgereport). 

That's just sweet.  I hope this news filters to private practicioneers and ER physicians who needlessly prescribe antibiotics that are no more effective but significantly more expensive. 

Here's the list of free antibiotics from Publix:

• amoxicillin
• cephalexin
• penicillin VK
• erythromycin
• ampicillin
• sulfamethoxazole/trimethoprim
• ciprofoxacin

I'm a little unsure of the economic pressures of the $4 Wal-mart and Target generic formularies on smaller pharmacies or medium-sized ones like Publix, but on first glance, I'd say I prefer these economies of scale.