It’s been a while since I’ve written a health-/work-related entry, so here goes. Watch out for the weeds!
One of the most important lessons I’ve learned in my first six months here is the huge gap between theory and reality in terms of donor-funded development programs. Policies and initiatives that are dreamed up in Washington and Geneva can seem magical on paper, and then when they are implemented in the developing countries they are meant to help, magical is just about the last adjective anyone would use to describe the outcome. For me, the Affordable Medicines Facility for Malaria (AMFm) epitomizes this phenomenon. Obviously, this difference between theory and reality can be said of many things in life (A big one that Westerners like to joke about is Communism.), but I feel a very acute sense of it with the AMFm.
I have touched on the AMFm in previous entries, but I’ll give a quick overview here now. The WHO-recommended (World Health Organization), most effective drugs to treat uncomplicated malaria are called artemisinin-based combination therapies (ACTs). ACTs are highly efficacious, fast-acting and prescribed in easy-to-follow dosages. The main problem with ACTs is their prohibitively high cost. The majority of Ghanaians continue to patronize private sector pharmacies and other drug-selling shops to treat malaria, and if you were to walk into a Ghanaian pharmacy right now, brand-name ACTs are about $7-$10 a dose: quite out of reach for the average person. Even the local generic ACTs are around $3-$6. Most price-sensitive patients opt for the older, cheaper treatments – chloroquine, sulphadoxine-pyrimethamine (SP), and artemisinin monotherapy – that retail for about $.50. Now, this scenario would be perfectly fine, except that, for a variety of reasons, these alternative treatments suck. The drug resistance profiles for chloroquine and SP are unacceptably high, making them highly ineffective treatments, and continuing to consume artemisinin monotherapies greatly increases the likelihood of resistance developing, thereby completely undermining efforts to expand access to ACTs. For these reasons, the WHO has explicitly advised all countries to stop using these older drugs and to switch to ACTs. In fact, many countries have already made their dispensation illegal, as does Ghana’s new malaria drug policy (which has yet to be disseminated and rolled out); however, despite these measures, the older treatments still remain widely available.
So, in come the donors. They looked at the situation described above and decided to create a pool of money that would subsidize the price of ACTs, so that the cost to the end user would decrease enough to rival those older, less-effective treatments. The idea is that by strategically injecting funding, the natural market forces of supply and demand could be used to not only increase access to the most effective treatments but also drive out those less-desirable drugs from the market. In a nutshell, this is the AMFm, and in theory, it is hard to argue that providing the highest quality ACTs for a fraction of what they used to cost is not a great concept. Indeed, when I first heard about this initiative as a wide-eyed research analyst just a few years ago, I thought it was fantastic use of donor funds.
Before I go any further, it should also be noted that where we are now is years in the making. The AMFm concept was first conceived in the 2004 Institute of Medicine (IOM) report titled “Saving Lives, Buying Time.” From there it was shopped around for a while before landing with a consulting firm called Dahlberg & Associates. Dahlberg fleshed out the concept to really analyze what the scope of a fund like this would be and how the internal mechanisms would work. After that, it was a matter of raising the money. Understandably, it took a while to find financial backing, but the AMFm was eventually taken on by The Global Fund to Fight AIDS, TB and Malaria. (Less the ten years old, the Global Fund is a multilateral agency that pools donor health funding for the three priority diseases. Eligible countries submit project-specific applications, and the Global Fund dispenses the money directly to the local Ministry of Health, which then allocates it accordingly.) A few years ago, an early version of the AMFm was successfully piloted in Uganda and Tanzania. Backed by about $225 million, it is now being expanded to about a dozen other countries, including Ghana, with plans to expand it all over the world if this larger pilot is successful.
So there we are. Now that I’ve given adequate background, we can get into where the problems arise, causing the rift between theory and reality. For simplicity sake, I will narrow things down to the two major issues: the prequalification problem and the margins problem.
The prequalification problem refers to the fact that all ACTs being subsidized with AMFm funding have to be prequalified by the WHO. WHO prequalification is a process that started back in 2001 to provide a level of international standardization for good manufacturing practices and high product quality for multilateral procurement agencies like UNICEF. When it began, its mandate was to give the nod to the highest quality drugs against HIV, malaria and TB. Since then, the list has expanded to include antivirals for influenza and reproductive health products as well. And after a decade, WHO prequalification is now THE standard used by bilateral agencies, governments, NGOs and other bulk purchasers of drugs for the developing world.
The problem is that no local manufacturers have attained WHO prequalification.
For donors (like the US government or the Global Fund) that give money directly to developing country governments for drug procurement, it is a good quality control measure to stipulate that the products must be on the WHO prequalification list. For developing country governments, especially those with a large local pharmaceutical manufacturing sector like Ghana , it is bittersweet when donor funding cannot also benefit your local industry (but rather helps its competition). And for the local manufacturers themselves, it is an onslaught in their fight for survival.
Right now, many of the ACTs in the private sector are supplied by Ghanaian manufacturers whose products have been registered by Ghana’s regulatory agency: the Food and Drugs Board (FDB). (When the national malaria policy was changed to ACTs in 2004, the government even encouraged Ghana’s local pharmaceutical companies to increase production to meet the demand.) While the FDB is considered to be one of the best and most stringent drug regulators in Africa, that is not good enough for the donors. (And possibly rightly so. The WHO recently conducted a study of the quality of antimalarials available in the African private sector, and the results were, in a word, dismal.) But attaining WHO prequalification is a costly, time intensive process that requires the sorts of investment and sunk costs that local manufacturers cannot afford. (The manufacturers with WHO-prequalified ACTs are pharma giants like Novartis (Swiss) and Sanofi-Aventis (French), along with some emerging market behemoths from India and China like Cipla.)
So, here comes the AMFm, which says that the market will soon be flooded with the highest quality ACTs in the world, at prices so low that local companies cannot compete. And they also cannot benefit from the subsidy, because they are not prequalified. It has been hard to get a straight answer from local companies regarding what percentage of their current portfolios ACTs contribute, but it is safe to say that if the AMFm is successful, that percentage will eventually be right around zero. I have been privy to many an impashioned speech from the president of PMAG (Pharmaceutical Manufacturers of Ghana) and others denouncing the AMFm as the end of local manufacturers as we know it. While this is certainly an exaggeration, large scale job losses resulting from weakened companies may not be. To quell these complaints, the response du jour from Global Fund officials is that “resources are being made available” for those companies with a serious interest in becoming WHO prequalified. Needless to say, the prequalification process takes years, and I have not yet heard of any companies asking to access said “resources.” In summary, local manufacturers are not happy in the least, and this is the prequalification problem.
To explain the margin problem, I have to explain a little more about the specifics of the AMFm and of the private sector pharmaceutical supply chain. For simplicity sake, let’s say that the private sector supply chain looks like this:
manufacturer --> importer --> wholesaler --> dispensary --> patient
and that at each arrow (besides the first one, since it’ll just be the manufacturer’s fixed price), a 50% markup is taken as profit for that actor in the chain. As an example, let’s say that the manufacturer sells the ACT to the importer at $2/dose. The importer tacks on a mark-up of 50% to that, and sells it to the wholesaler at $3/dose, making a profit of $1/dose. The wholesaler puts a 50% mark-up on the $3, selling it at $4.50 to the dispensary (e.g. pharmacy, clinic, hospital) and making a profit of $1.50/dose. The dispensary adds 50% onto that, selling it to the patient at $6.75/dose and making a $2.25/dose profit.
How the AMFm works is that the Global Fund has already negotiated with the prequalified manufacturers to bring the price of ACTs down to (an average of) $1/dose. Then, whenever the manufacturer receives a purchase order from an importer under the AMFm, the manufacturer will ok the order with the Global Fund, and the Global Fund will then co-pay (an average of) $.95/dose to the manufacturer. This co-payment is the subsidy from the $225 million pot-o-money. This means that the manufacturer then sells the ACT to the importer at (an average of) $.05/dose (instead of the $2 that it was before). The Global Fund makes all importers sign an agreement saying that they will play nice when it comes to mark-ups, and the idea is that even with all the mark-ups along the way in the supply chain, the final price to consumers of co-paid ACTs will be around the Global Fund’s target price of $.50/dose.
Now, you don’t have to have an MBA to realize that some of the private sector distributors might have a problem with this. When there is only a total of $.45 to be made from manufacturer to consumer, and the profit margin that used to be $1, $1.50, or $2.25 per dose is now down to $.15 or $.20 cents per dose, some people are going to start to question the financial feasibility for all stakeholders to participate. This is the margin problem.
In Ghana, The Global Fund’s plan, with the help of Ghana's Ministry of Health (MoH) has been to hold a series of “private sector” engagement meetings, where these issues are discussed to get private sector buy-in. I have been to more than a few of these, and while they are good in theory, the politics of all the big players and the dynamics of large group meetings mean that things devolve quickly and nothing of consequence is ever achieved. The Global Fund then looks to the MoH for support, but their requests often fall on deaf ears. See, like all things the Global Fund does, it was the MoH that submitted the application. Ostensibly, that means they were the ones who wanted the AMFm to come to Ghana in the first place. However, because of all of the resistance from the manufacturers and others in the private sector, the Ministry is often less than fully supportive in public forums, deciding to play innocent and let the blame fall elsewhere. (One goal that the international development community likes to talk a lot about is “country ownership” of programs. This means that the countries themselves throw their full support behind projects and willingly take responsibility for the success or failure of programs, instead of having them feel like this is the donor’s agenda and they are just along for the ride. Let’s just say that in terms of country ownership, Ghana's MoH would be getting a failing grade right now.) This was the song and dance we were all doing for the first 5 months I was here. But, luckily, the Global Fund’s portfolio manager for West Africa is keenly perceptive and decided to make a move.
His move was to call on the Clinton Foundation to set up several one-on-one meetings with the country’s biggest importers and wholesalers to better explain the initiative and to assuage any fears they had. Since the outset, the Clinton Foundation has been supporting the AMFm implementation, and with its unwritten policy of only hiring ex-management consultants, this was the perfect time for them to step up to the plate. There is only one full time Clinton Foundation employee in Ghana, and his entire job is private sector engagement for the AMFm. He immediately created a hypothetical pricing model in Excel and called me. See, the vast majority of private sector stakeholders in Ghana, be it manufacturers, importers, wholesalers, or distributors, are pharmacists. Pharmacists who belong to PSGH. So, I was able to rope Dennis in, and we were able to set up several one-on-one meetings for when the portfolio manager was flying in from Geneva.
So, two weeks ago, the 4 of us went around meeting with these guys individually, with laptop in hand to run through the numbers. Then we would have a discussion about how feasible they thought the whole thing was. This was private sector engagement. And this was probably the most useful thing I’ve been able to do since I arrived. It was understood and agreed that with the lower per-dose profit, the private sector distributors would have to up volumes a lot: anywhere from 4 to 20 times as many, depending on which actor in the supply chain you were. The good news is that most of the people we met with thought that these higher volumes could be achieved through the increased demand. (i.e. When a good that was $6.75 is suddenly $.50, a lot more people are going to buy it.) We assured them that the $.50 figure is an ideal target set by the Global Fund, but it is certainly not set in stone. This meant that in the short term, there was a lot more flexibility on margins, but that in the longer term, with ample competition, the price should approach the target. Some also discussed the appeal of the much lower cost of capital (amount of money needed to procure the ACTs), and everyone nodded their concurrence. We were able to get through to many of them, and a few have already started the process to become registered buyers with the Global Fund. The co-paid ACTs should start arriving in August, and there should be enough buy-in from importers and other private sector distributors to give Ghana a good shot at success.
When I first learned about the AMFm as a doe-eyed research analyst in Washington fresh out of college, I thought it was a fantastic idea. On the other side of the pond, all you hear about is how this will revolutionize malaria treatment by vastly increasing access to the most effective treatments. But you don’t hear about the local manufacturers who will have to lay off workers and might be run out of business. You don’t hear about the corrupt customs officials who will undoubtedly help leak these newly-affordable antimalarials across Africa’s notoriously porous borders.
Don’t get me wrong, I still think it’s a fantastic idea, but its development and implementation could be much better. Firstly, for an initiative that is SPECIFICALLY-INTENDED for the private sector, that engagement has been atrocious. Nothing substantial is ever achieved in large conference rooms. This is nothing new. (Need I remind everyone of the C5?) Inviting a handful of stakeholders and holding a few lunch meetings so that everyone can collect their per diem, while probably necessary, is not engagement; it is lip service. I hate to think about what AMFm adoption in Ghana might be if the Global Fund's portfolio manager was less perceptive, or if the Clinton Foundation was not involved, or if I was not acquainted with that sole Foundation employee, or if Dennis cared more about profit than public health. Secondly, how about consulting those parties that will be affected by a policy WHILE the policy is being developed so that they can provide input to better shape it, instead of just informing them that it is coming and there is nothing they can do about it? A novel idea, I know. The sad thing is that this can be said for almost all development programs. The AMFm was conceived in Washington, fleshed out in Washington, and funded in Geneva over a period of years before anyone in the local private sector, whose livelihood would be directly affected, was ever consulted. This model needs to change. (I know BTE was talking about the lack of country ownership when they penned their hit, “Desperately Wanting.”) Thirdly, I have not even mentioned the sustainability aspect of this initiative, for which there is no satisfying answer. The pilot phase will go for about 2 years, after which time the numbers will be analyzed and a decision will be made to either discontinue it, or to expand it possibly to all malarial countries worldwide. In the meantime, it is a big question mark. The local manufacturers will stop manufacturing, and the importers will cut ties with long-held business relationships. All the while, there are no guarantees of anything.
The AMFm is a great initiative with enormous potential, and I really hope it enjoys wide success. If it does, then I hope this pilot phase can teach us a lot about what needs to be improved for the next phase. If nothing else, then at least it has taught me the big difference between theory and reality. And I’ve already learned that I like dealing with reality a lot more than theory. Masters – 1, PhD – 0.
* Some names have been changed (or deleted) to protect the innocent. They asked me to do it. And, no, I am not kidding.
Showing posts with label malaria. Show all posts
Showing posts with label malaria. Show all posts
Thursday, May 13, 2010
Wednesday, February 17, 2010
Theory and Reality: A Natural Experiment
Yes, another blog about malaria…deal with it. ***DISCLAIMER***This entry became longer than intended, so please know that going in. There is, however, a story involved, so hopefully it won’t seem as long as it is.
In my previous Malaria 101 posting, I spoke of how Ghana’s new “Strategic Plan for Malaria Control” calls for moving from a presumptive clinical diagnosis to a diagnosis based on laboratory testing or rapid diagnostic test (RDT). In theory, this has tremendous potential to reduce costs for patients and the overall health system; to decrease the likelihood of drug resistance emerging, thereby preserving the efficacy of artemisinin-base combination therapies (ACTs); and to improve the health outcomes for the public by treating patients for the disease that is actually ailing them. That is in theory; in practice (aka: in reality) is another story entirely. To illustrate this, I will detail a natural experiment I was lucky enough to conduct some weeks ago. But first, a little bit more explanation of the malaria diagnostic situation.
When ACTs first came on the scene 5-10 years ago, the malaria community was so happy that there was a highly efficacious, well-tolerated alternative to chloroquine and SP (the two antimalarials in wide use at the time, to which plasmodium falciparum had developed high resistance profiles in several countries), that it’s number one priority became increasing access to ACTs as quickly as possible. In this regard, many countries (including Ghana) made ACTs available over the counter, instead of needing a prescription, and the WHO recommended clinical diagnosis in high burden areas, especially for children under 5. So basically, for the last 5-10 years, if you felt feverish or sick in Ghana, you could pop into your local pharmacy or licensed chemical seller shop*, they could take a look at you, declare that in their opinion it seemed likely that you had malaria, give you a regimen of ACT, transaction completed and you were out the door: not much different than buying advil. But ACTs are not advil. Ibuprofen (advil) fights inflammation. ACTs are anti-infectives that fight living microbes that put up a fight because they don’t want to die. The other issue is price, and the main catch with ACTs is that they are significantly more expensive than chloroquine and SP. Many people can only afford these alternatives, which are actively discouraged by the government but still widely available in the private sector. Alternatively, if a person demands ACT but cannot afford a full regimen, irresponsible drug dispensers have been known to provide less-than-complete doses.
Fast forward to 2010 where several developments have caused the global malaria community and Ghana’s Ministry of Health (MoH) to rethink their treatment strategy. First, there is a growing body of evidence that malaria is being significantly over-diagnosed and, consequently, ACTs over-prescribed. In Ghana, those numbers look something like this: around 90% of patients presenting with fever at both public and private sector health facilities were diagnosed with malaria, whereas the percentage of those febrile patients that actually had malaria (confirmed through laboratory tests) was more around 50%. This is alarming not only because of the vast, unnecessary use of ACTs and other antimalarials, but also because so many sick people are not being treated for the illnesses they have. Second, the first documented cases of resistance to ACTs have been documented along the Thai-Cambodian border. This is troubling both because that is the same hotspot where chloroquine resistance first appeared in the 1950s (before spreading to the rest of the world) and because there is no new antimalarial drug in the pipeline to replace ACTs if they significantly lose efficacy. Third, there is promising evidence of reduced malaria transmission rates in some countries (including Ghana). While this is a very exciting development, it also means that the over-diagnosis that stems from equating all fevers with malaria is even more pronounced. The fourth and final development is the emergence of RDTs on the scene. RDTs for malaria are pretty awesome; they are very easy to administer (a little finger prick, a drop of buffer and voila), they are quick (results in 15 minutes), they are relatively affordable (less than $1) and they are very accurate** (sensitivity and specificity in the high 90th percentiles).
So, faced with these 4 developments, some pioneering countries have decided to change their treatment guidelines. But, as is so often the case, the difference between theory on paper and realities in practice may be massive. The MoH has not rolled this new program out yet, but a little natural experiment I was able to conduct highlights some of the practical issues it might be facing in the private sector. And the story goes like this:
I should first say that one of my number one priorities upon landing in Accra was to secure some RDTs for myself. It took me about a week, but I was eventually able to procure some from the MoH. I had to buy an entire box (30 tests), but like a good boy scout, I was prepared. I kept them under my bed at home.
One day at work, John, PSGH’s good-natured accountant and Jonas, its hard-working on-site handyman, declared that they weren’t feeling very well, and both thought (or in their own words, knew) that they had malaria. Jonas was feverish and achy all over. John, while not feverish, was also achy and had a badly sore throat with bitterness in the back of his mouth: a symptom, he said, that was unique to his bouts of malaria. Rosslyn, PSGH’s head of public health (and a pharmacist like Dennis), immediately took a slip of paper and began writing down some ACTs she recommended, so that Jonas could run out and buy them. Sensing the opportunity, I jumped in and asked if we couldn’t first use RDTs to make sure that they actually had malaria. For a split second you could hear a pin drop, but then they all decided to humor me. I offered to go home with Charles (PSGH's driver) immediately and grab them, but it was already late in the day and John and Jonas both decided that they were fine waiting until first thing in the morning. I felt bad, like I was the reason for them not being treated today, like I was the white man rationing the medication for the Africans. John, always quick with a sarcastic barb, grinned and said, “We will take the test, but I fear we are wasting them, since I have no doubt that it is malaria.” Jonas nodded his agreement. Again, I offered to go home to grab the tests, so we could do them now, but John, seeing the anxiety on my face and sensing the tension, put his arm around my shoulder and said “No worries. Tomorrow, we will see.”
Jonas, PSGH's always-smiling handman, with his typical headphones
Tomorrow came quickly, and I was sure to bring the box of RDTs to the office. Jonas was already hard at work when Dennis and I arrived, but we decided to wait for John to do the test. Waiting anxiously for John’s arrival, I opened the box to look through its contents. It was filled with lots of little, individual packages neatly arranged in a space-saving manner. The box contained: single-use sterilized lancets (miniature plastic swords), single-use alcohol swabs, single-use pipettes, the bottle of buffer and the test cards. While it was a little confusing staring at all those little packages, when John arrived, Rosslyn took over - she had actually attended a MoH training session to learn how to correctly administer it – and it was pretty logical. You wipe the tip of the index finger with the alcohol swap, do a little finger prick with the lancet, get a few drops of blood with the pipette, drop two or three into one of the little basins on the card, squeeze two drops of the buffer into the other, and wait 15 minutes for results.
We administered the tests in Rosslyn’s office, which I currently share with her. Jonas excitedly granted his finger to Rosslyn and watched the proceedings. John, on the other hand, had a decidedly all-knowing air about him, as if this was a meaningless perfunctory task which would only confirm what he had known all along. The “patients” left the room for the interim, as I snuck furtive glances at their test cards on Rosslyn’s desk. RDT results are displayed with 2 clearly-defined lines that would either appear or not on the face of the card. If the “control” line appeared, it meant that you had conducted the test correctly; if it did not, you had to do it over. If the other line appeared, a case of malaria was confirmed. Pretty simple: two lines = yes, one line = no. After a few minutes, the control lines on both of the tests appeared (good), and Rosslyn and I waited anxiously (I saw her sneaking glances, too) for the others. 15 minutes passed, 20 minutes passed, for good measure, we waited a full 30 minutes, but no second line appeared on either test.
When Rosslyn left her office to break the (good) news to them, their immediate response was to question the quality and validity of the test: “Are you sure this thing works?!?” “I’m sure I have it!” Rosslyn successfully parried those concerns by assuring them that the RDT is very accurate and a false negative is extremely rare. The next question, which Rosslyn so eloquently posed to me upon re-entering her office, was more troubling: “OK, now what?” In theory, the answer to the “OK, now what?” question is that the person should now go to the hospital for more tests to determine the identity of the bug that is actually ailing him/her. But I don’t have to reiterate what is wrong with theory. In reality, John had already started taking SP the day before, and Jonas did not want to wait in line at the hospital for more tests, so he did nothing and ended up feeling better in a few days. From a public health standpoint, this little 2-person experiment can provide a lot of insight into challenges facing this new diagnostic policy, especially in the private sector:
1) The public’s perception of what is and is not malaria is incorrect. This might be the consequence of too much of a good thing, where donors, government ministries, NGOs and others have put so much stress on combating malaria that the general public perceives the problem to be worse than it is. Every Ghanaian has grown up knowing and fearing malaria since birth, so when in doubt, they err on the side of malaria. It’s a common sense approach that anyone would do, but it is a real problem that is both very tough to fix and getting bigger, as malaria transmission rates go down.
2) Getting patients and practitioners to use and trust the validity of the RDTs will be a big hurdle. This was evidenced by John and Jonas’ initial reaction to their test results. In the public sector, this is not so much of an issue, but when patients have to actually pay for the RDT with their hard-earned money (instead of just finding a shop that will give them antimalarials without taking an RDT), this is a major challenge. There is also a growing body of evidence showing pharmacists and others dispensing anti-malarials anyways, even in the presence of a negative RDT result. It is not just patients who need to work on their trust issues.
3) Issue 2 in compounded by the profit motive of practitioners. As we know all too well in America, when healthcare is provided by parties with a profit motive, the incentives affecting behavior do not always align with those actions necessary for optimal individual or public health outcomes. Pharmacists in Ghana make good money dispensing anti-malarial drugs. This new policy calls for testing all possible malaria patients with an RDT, and that a good chunk of them (who they would have dispensed anti-malarial drugs to in the past) will come back negative. A negative result will mean that you can either give them something OTC (most likely with a lot smaller profit margin than an ACT) or tell them to go to a hospital for more tests (no further monies coming into your shop). How likely is it that pharmacists and other, less-trained dispensers will turn sick patients away because they need to have more tests done? How likely is it that the patient will actually go wait at the hospital for those tests, when the reason they came into the pharmacy in the first place might have been to avoid those same lines?
4) What did John and Jonas do? John chose to incorrectly self-medicate, while Jonas chose to do nothing. Leaving alone the fact that John managed to procure an antimalarial (SP) which is not supposed to be available anymore outside public hospital (and only used for pregnant women), how likely is it that patients with a negative RDT result will self-medicate, or go from shop to shop until they find one that will give an anti-malarial without conducting an RDT first? The policy is only as strong as its weakest link. And Jonas did nothing. Whether because he did not want to miss work, did not want to wait at the public hospital, could not afford a private clinic, or any other one of myriad reasons, is this outcome any better than anti-malarial over-prescription?
5) This entry is becoming much too long, so the final lesson that can be learned from my little experiment is that laboratory capacity will become even more important when this policy is rolled-out. Two RDTs = two negative results = two more patients that should then go get further testing done. The number of trained laboratory technicians capable of conducting the requisite amount of tests is already much too low in all developing countries. Microscopy takes time, culturing samples takes time, and these health workers are already spread too thinly. Some tests take days or weeks for results: days or weeks in which the patient is still sick. If we really expect patients to obediently wait it out, the MoH should couple this policy roll-out with adequate increased investments in laboratory capacity. Is that happening? All signs on the ground point to no.
So what is my part in all this? I’m trying to secure funding for PSGH to go all over the country and run training programs for all of its member pharmacists in this new policy prior to roll-out. I think that’s enough malaria talk for today. We’re really getting into the weeds on some of this stuff, and I know you’re all very excited! My next couple extries won't be malaria-related at all, so I'll give you all a break for a bit, I promise!
* In Ghana, licensed chemical sellers are able to dispense only over the counter products (including anti-malarials). They are not trained pharmacists and, so, cannot dispense prescription drugs, but they outnumber pharmacists almost 10 to 1.
** There are dozens of malaria RDTs currently marketed worldwide, all with variable quality. Thankfully, the WHO and others partners have begun conducting lot tests to determine the quality of each. The brand I procured from the MoH received very high marks for quality from the WHO lot tests.
In my previous Malaria 101 posting, I spoke of how Ghana’s new “Strategic Plan for Malaria Control” calls for moving from a presumptive clinical diagnosis to a diagnosis based on laboratory testing or rapid diagnostic test (RDT). In theory, this has tremendous potential to reduce costs for patients and the overall health system; to decrease the likelihood of drug resistance emerging, thereby preserving the efficacy of artemisinin-base combination therapies (ACTs); and to improve the health outcomes for the public by treating patients for the disease that is actually ailing them. That is in theory; in practice (aka: in reality) is another story entirely. To illustrate this, I will detail a natural experiment I was lucky enough to conduct some weeks ago. But first, a little bit more explanation of the malaria diagnostic situation.
When ACTs first came on the scene 5-10 years ago, the malaria community was so happy that there was a highly efficacious, well-tolerated alternative to chloroquine and SP (the two antimalarials in wide use at the time, to which plasmodium falciparum had developed high resistance profiles in several countries), that it’s number one priority became increasing access to ACTs as quickly as possible. In this regard, many countries (including Ghana) made ACTs available over the counter, instead of needing a prescription, and the WHO recommended clinical diagnosis in high burden areas, especially for children under 5. So basically, for the last 5-10 years, if you felt feverish or sick in Ghana, you could pop into your local pharmacy or licensed chemical seller shop*, they could take a look at you, declare that in their opinion it seemed likely that you had malaria, give you a regimen of ACT, transaction completed and you were out the door: not much different than buying advil. But ACTs are not advil. Ibuprofen (advil) fights inflammation. ACTs are anti-infectives that fight living microbes that put up a fight because they don’t want to die. The other issue is price, and the main catch with ACTs is that they are significantly more expensive than chloroquine and SP. Many people can only afford these alternatives, which are actively discouraged by the government but still widely available in the private sector. Alternatively, if a person demands ACT but cannot afford a full regimen, irresponsible drug dispensers have been known to provide less-than-complete doses.
Fast forward to 2010 where several developments have caused the global malaria community and Ghana’s Ministry of Health (MoH) to rethink their treatment strategy. First, there is a growing body of evidence that malaria is being significantly over-diagnosed and, consequently, ACTs over-prescribed. In Ghana, those numbers look something like this: around 90% of patients presenting with fever at both public and private sector health facilities were diagnosed with malaria, whereas the percentage of those febrile patients that actually had malaria (confirmed through laboratory tests) was more around 50%. This is alarming not only because of the vast, unnecessary use of ACTs and other antimalarials, but also because so many sick people are not being treated for the illnesses they have. Second, the first documented cases of resistance to ACTs have been documented along the Thai-Cambodian border. This is troubling both because that is the same hotspot where chloroquine resistance first appeared in the 1950s (before spreading to the rest of the world) and because there is no new antimalarial drug in the pipeline to replace ACTs if they significantly lose efficacy. Third, there is promising evidence of reduced malaria transmission rates in some countries (including Ghana). While this is a very exciting development, it also means that the over-diagnosis that stems from equating all fevers with malaria is even more pronounced. The fourth and final development is the emergence of RDTs on the scene. RDTs for malaria are pretty awesome; they are very easy to administer (a little finger prick, a drop of buffer and voila), they are quick (results in 15 minutes), they are relatively affordable (less than $1) and they are very accurate** (sensitivity and specificity in the high 90th percentiles).
So, faced with these 4 developments, some pioneering countries have decided to change their treatment guidelines. But, as is so often the case, the difference between theory on paper and realities in practice may be massive. The MoH has not rolled this new program out yet, but a little natural experiment I was able to conduct highlights some of the practical issues it might be facing in the private sector. And the story goes like this:
I should first say that one of my number one priorities upon landing in Accra was to secure some RDTs for myself. It took me about a week, but I was eventually able to procure some from the MoH. I had to buy an entire box (30 tests), but like a good boy scout, I was prepared. I kept them under my bed at home.
One day at work, John, PSGH’s good-natured accountant and Jonas, its hard-working on-site handyman, declared that they weren’t feeling very well, and both thought (or in their own words, knew) that they had malaria. Jonas was feverish and achy all over. John, while not feverish, was also achy and had a badly sore throat with bitterness in the back of his mouth: a symptom, he said, that was unique to his bouts of malaria. Rosslyn, PSGH’s head of public health (and a pharmacist like Dennis), immediately took a slip of paper and began writing down some ACTs she recommended, so that Jonas could run out and buy them. Sensing the opportunity, I jumped in and asked if we couldn’t first use RDTs to make sure that they actually had malaria. For a split second you could hear a pin drop, but then they all decided to humor me. I offered to go home with Charles (PSGH's driver) immediately and grab them, but it was already late in the day and John and Jonas both decided that they were fine waiting until first thing in the morning. I felt bad, like I was the reason for them not being treated today, like I was the white man rationing the medication for the Africans. John, always quick with a sarcastic barb, grinned and said, “We will take the test, but I fear we are wasting them, since I have no doubt that it is malaria.” Jonas nodded his agreement. Again, I offered to go home to grab the tests, so we could do them now, but John, seeing the anxiety on my face and sensing the tension, put his arm around my shoulder and said “No worries. Tomorrow, we will see.”
John, PSGH's sly, slick-dressed accountant
Jonas, PSGH's always-smiling handman, with his typical headphonesTomorrow came quickly, and I was sure to bring the box of RDTs to the office. Jonas was already hard at work when Dennis and I arrived, but we decided to wait for John to do the test. Waiting anxiously for John’s arrival, I opened the box to look through its contents. It was filled with lots of little, individual packages neatly arranged in a space-saving manner. The box contained: single-use sterilized lancets (miniature plastic swords), single-use alcohol swabs, single-use pipettes, the bottle of buffer and the test cards. While it was a little confusing staring at all those little packages, when John arrived, Rosslyn took over - she had actually attended a MoH training session to learn how to correctly administer it – and it was pretty logical. You wipe the tip of the index finger with the alcohol swap, do a little finger prick with the lancet, get a few drops of blood with the pipette, drop two or three into one of the little basins on the card, squeeze two drops of the buffer into the other, and wait 15 minutes for results.
box of malaria RDTs and contents, from left: test card and pipette, buffer, alcohol swap, and sterilized lancet
We administered the tests in Rosslyn’s office, which I currently share with her. Jonas excitedly granted his finger to Rosslyn and watched the proceedings. John, on the other hand, had a decidedly all-knowing air about him, as if this was a meaningless perfunctory task which would only confirm what he had known all along. The “patients” left the room for the interim, as I snuck furtive glances at their test cards on Rosslyn’s desk. RDT results are displayed with 2 clearly-defined lines that would either appear or not on the face of the card. If the “control” line appeared, it meant that you had conducted the test correctly; if it did not, you had to do it over. If the other line appeared, a case of malaria was confirmed. Pretty simple: two lines = yes, one line = no. After a few minutes, the control lines on both of the tests appeared (good), and Rosslyn and I waited anxiously (I saw her sneaking glances, too) for the others. 15 minutes passed, 20 minutes passed, for good measure, we waited a full 30 minutes, but no second line appeared on either test.
RDT card showing negative result, on left are the two basins where the buffer and blood are dropped
When Rosslyn left her office to break the (good) news to them, their immediate response was to question the quality and validity of the test: “Are you sure this thing works?!?” “I’m sure I have it!” Rosslyn successfully parried those concerns by assuring them that the RDT is very accurate and a false negative is extremely rare. The next question, which Rosslyn so eloquently posed to me upon re-entering her office, was more troubling: “OK, now what?” In theory, the answer to the “OK, now what?” question is that the person should now go to the hospital for more tests to determine the identity of the bug that is actually ailing him/her. But I don’t have to reiterate what is wrong with theory. In reality, John had already started taking SP the day before, and Jonas did not want to wait in line at the hospital for more tests, so he did nothing and ended up feeling better in a few days. From a public health standpoint, this little 2-person experiment can provide a lot of insight into challenges facing this new diagnostic policy, especially in the private sector:
1) The public’s perception of what is and is not malaria is incorrect. This might be the consequence of too much of a good thing, where donors, government ministries, NGOs and others have put so much stress on combating malaria that the general public perceives the problem to be worse than it is. Every Ghanaian has grown up knowing and fearing malaria since birth, so when in doubt, they err on the side of malaria. It’s a common sense approach that anyone would do, but it is a real problem that is both very tough to fix and getting bigger, as malaria transmission rates go down.
2) Getting patients and practitioners to use and trust the validity of the RDTs will be a big hurdle. This was evidenced by John and Jonas’ initial reaction to their test results. In the public sector, this is not so much of an issue, but when patients have to actually pay for the RDT with their hard-earned money (instead of just finding a shop that will give them antimalarials without taking an RDT), this is a major challenge. There is also a growing body of evidence showing pharmacists and others dispensing anti-malarials anyways, even in the presence of a negative RDT result. It is not just patients who need to work on their trust issues.
3) Issue 2 in compounded by the profit motive of practitioners. As we know all too well in America, when healthcare is provided by parties with a profit motive, the incentives affecting behavior do not always align with those actions necessary for optimal individual or public health outcomes. Pharmacists in Ghana make good money dispensing anti-malarial drugs. This new policy calls for testing all possible malaria patients with an RDT, and that a good chunk of them (who they would have dispensed anti-malarial drugs to in the past) will come back negative. A negative result will mean that you can either give them something OTC (most likely with a lot smaller profit margin than an ACT) or tell them to go to a hospital for more tests (no further monies coming into your shop). How likely is it that pharmacists and other, less-trained dispensers will turn sick patients away because they need to have more tests done? How likely is it that the patient will actually go wait at the hospital for those tests, when the reason they came into the pharmacy in the first place might have been to avoid those same lines?
4) What did John and Jonas do? John chose to incorrectly self-medicate, while Jonas chose to do nothing. Leaving alone the fact that John managed to procure an antimalarial (SP) which is not supposed to be available anymore outside public hospital (and only used for pregnant women), how likely is it that patients with a negative RDT result will self-medicate, or go from shop to shop until they find one that will give an anti-malarial without conducting an RDT first? The policy is only as strong as its weakest link. And Jonas did nothing. Whether because he did not want to miss work, did not want to wait at the public hospital, could not afford a private clinic, or any other one of myriad reasons, is this outcome any better than anti-malarial over-prescription?
5) This entry is becoming much too long, so the final lesson that can be learned from my little experiment is that laboratory capacity will become even more important when this policy is rolled-out. Two RDTs = two negative results = two more patients that should then go get further testing done. The number of trained laboratory technicians capable of conducting the requisite amount of tests is already much too low in all developing countries. Microscopy takes time, culturing samples takes time, and these health workers are already spread too thinly. Some tests take days or weeks for results: days or weeks in which the patient is still sick. If we really expect patients to obediently wait it out, the MoH should couple this policy roll-out with adequate increased investments in laboratory capacity. Is that happening? All signs on the ground point to no.
So what is my part in all this? I’m trying to secure funding for PSGH to go all over the country and run training programs for all of its member pharmacists in this new policy prior to roll-out. I think that’s enough malaria talk for today. We’re really getting into the weeds on some of this stuff, and I know you’re all very excited! My next couple extries won't be malaria-related at all, so I'll give you all a break for a bit, I promise!
* In Ghana, licensed chemical sellers are able to dispense only over the counter products (including anti-malarials). They are not trained pharmacists and, so, cannot dispense prescription drugs, but they outnumber pharmacists almost 10 to 1.
** There are dozens of malaria RDTs currently marketed worldwide, all with variable quality. Thankfully, the WHO and others partners have begun conducting lot tests to determine the quality of each. The brand I procured from the MoH received very high marks for quality from the WHO lot tests.
Wednesday, February 3, 2010
More Than You Ever Wanted to Know About Malaria
As promised, here is another work-related blog. I have tried to keep the acronyms to a minimum but found it very difficult. The good news for me is that my work life is starting to get interesting. The bad news for all of you is that my upcoming blogs will invariably have a lot more to do with malaria (control) and a lot less to do with goats and beaches. But seriously, some of this stuff is really interesting (at least to me), and I will try my best to convey it in a way that you will also, hopefully, find it more than soporific. Now, the readership of this blog certainly has varying levels of knowledge about malaria. In an effort to get everyone on the same page, I will do a general overview of the disease and the main interventions currently in use to control it. Once that is taken care of, I can get into the interesting stuff in future entries and keep the explanations to a minimum. For those of you know all of this stuff, bear with me.
Malaria is an infectious parasitic disease endemic to most tropical and sub-tropical countries in the Americas, Asia and Africa. In humans, it is caused by 5 species of a parasite of the genus Plasmodium – falciparum, vivax, ovale, malariae and knowlesi – with falciparum by far the most deadly, as well as the predominant species in sub-Saharan Africa. The parasite is transmitted to humans via a mosquito bite, specifically the female Anopheles mosquito. Once inside humans, the parasites migrate to the liver and begin multiplying inside liver cells. After an incubation period, usually 6-15 days, these cells rupture and the parasites escape into the blood stream and infect red blood cells: killing those and infecting new ones. The most common clinical symptoms of malaria include sustained fever, shivering chills, joint and muscle pain, headache, vomiting, fatigue and dry cough. Severe malaria cases can lead to coma and death. Less common is a malarial infection of the brain, known as cerebral malaria, which can cause permanent cognitive impairments and brain damage, with children being much more vulnerable.
Annually, there are believed to be between 300-500 million cases of malaria each year, killing between 1 and 3 million people: 90% of these deaths occurring in sub-Saharan Africa and the vast majority killing children under 5. Adults die much less often from the disease, especially in endemic areas with "stable malaria" transmission, which I explained in a previous blog. (The large range of disease burden estimates is inherent in high-transmission, resource-poor countries with many constraints to adequate diagnosis. This will be discussed further in future entries, so stay tuned. I know you’re on the edge of your seat.) Malaria is the number one cause of death of children in Africa, and among adults, the lost productivity due to illness is estimated to be 1.3% of GDP. In some high-burden areas, it is estimated that malaria consumes up to ¼ of all household income.
Currently, there are 4 main interventions used to prevent and treat malaria in endemic areas. The first is using insecticide-treated bed nets (referred to as ITNs, LLINs, or other acronyms) to prevent the mosquitoes from biting humans, thereby preventing the transmission of the disease. The rationale behind this is that the Anopheles mosquito likes to bite at night. So, if people can cover their sleeping areas, this can prevent transmission. The current nets last 5 years; after that the insecticide wears off, and they become less effective. Many countries give nets out to pregnant women and children (the most vulnerable population) in the public sector hospitals and clinics for free. Prices vary greatly in the private sector, but in Ghana, you can pick one up in a pharmacy for about $7-$10. Bed nets have been shown to be an extremely cost-effective intervention, and they are now a major part of most national malaria control programs. There are also some NGOs and charities specializing in bed nets that you might have heard of across the pond, most notably Nothing But Nets, which partners with the NBA, and Malaria No More, which runs a very successful program with American Idol called "Idol Gives Back."
The second intervention is called Indoor Residual Spraying (IRS), and it involves going door to door to spray the inside walls of residences with insecticide (yes, sometimes even DDT). The rationale here is that the Anopheles mosquito, in addition to liking to bite at night, also prefers to hang out on the inside walls of homes. If we can make it so that they die every time they land on the wall, then that is one less malaria-carrying mosquito. The IRS only has a 6 month duration and can be fairly expensive, but it has still been shown to be another very cost-effective prevention intervention.
The third tried and true intervention is called Intermittent Preventative Therapy (IPT) during pregnancy. This is where pregnant women are able to take a drug during pregnancy to protect themselves and prevent mother-to-child transmission of malaria. In Ghana, the drug used is called sulfadoxine-pyrimethamine (SP, for short), and is, ideally, given 3 times at different intervals during the 9 month gestation. As children and pregnant women are the most vulnerable populations for malaria infection, this makes inherent sense and has been shown to be very effective.
The final intervention, and the one that I am most involved with in my current capacity, is increasing access to the most effective drugs available: artemisinin-based combination therapies (ACTs). Artemisinin is a drug derived from the plant Artemisia annua, or Chinese wormwood, whose antimalarial properties have been known to Chinese traditional herbalists for centuries. In the last 5-10 years, using ACTs has become the WHO (World Health Organization)-recommended treatment for uncomplicated malaria in all endemic countries due to their high efficacy and tolerability. Unacceptable levels of drug resistance have developed to all of the previous first-line antimalarial treatments, including chloroquine, SP, and artemisinin monotherapy, but using artemisinin in combination (as with ACTs) helps prevent the emergence of resistance, since 2 different drugs with 2 different mechanisms of action are attacking the parasite at once. The challenge with increasing access to ACTs is two-fold: first, over half of all malaria cases are treated in the private sector (mostly in pharmacies and community drug seller shops), and second, the natural extraction of artemisinin is costly, which means that ACTs are quite a bit more expensive than the aforementioned alternatives and out of reach for most people. A lot of this taking place in the private sector means less government control, and in resource-poor developing countries, this means that even though effective treatments are on the shelves, much less effective ones are often given (or a fraction of a regimen of ACT is given), which continues to drive drug resistance.
(Worth mentioning here is an exciting donor-funded project being piloted in 9 countries (including Ghana) called the Affordable Medicines Facility – malaria (AMFm), which will highly subsidize the purchase price of ACTs, hopefully making them as cheap as, if not cheaper than, all other alternatives for the end-user. Much more on this to come in future blogs.)
These challenges are also compounded by the difficulties of adequately diagnosing malaria, where the vast majority of diagnoses (especially in the private sector) are presumptive and symptomatic (euphemistically called clinical diagnosis) rather than confirmed with laboratory tests. This practice is actually recommended by WHO in most high-burden countries, especially for children under 5. However, as the main symptom of malaria is fever, it has becoming common practice to equate all fevers with malaria and treat accordingly. And, not surprisingly, more and more studies have concluded that there is vast over-diagnosis of malaria and over-prescription of antimalarials happening. Combined with this growing evidence base of over-diagnosis, studies showing decreasing transmission rates in some countries (thanks to the interventions above), as well as the development of accurate rapid diagnostic tests (RDTs), have made it feasible to take action in some countries. And Ghana is one of those countries. The 2009 Strategic Plan from Ghana’s National Malaria Control Program (NMCP) calls for moving from clinical diagnosis to laboratory or RDT-confirmed diagnosis. While this is an exciting paradigm shift, indeed, it is one thing to have it on paper, and another thing entirely to roll it out in practice (especially in the private sector).
So there you have it: Malaria 101 brought to you by Scott(y). Don’t say I never gave you anything. As you can see, there are several cost-effective proven interventions in the arsenal, which makes malaria control a very dynamic field to be in. However, challenges remain, especially in relation to leveraging the full potential of the private sector (“leveraging” is business speak for “using to the fullest”), which is why working with pharmacists is an exciting place to be. There will be much more on malaria to come, and you have been adequately warned, so try to contain your enthusiasm. And, to answer your question: no, there is not a vaccine (yet). The farthest one along in the pipeline is British pharmaceutical giant GlaxoSmithKline’s (GSK) RTS,S candidate. It is in phase III clinical trials, but it is at least 3 years away and will most likely only be partially effective (30-60%).
I know that I used the word gestation is this post, so I hope it wasn't too much like a science lesson. And I apologize about the lack of pictures. I’m tired of acronyms, aren’t you?
Malaria is an infectious parasitic disease endemic to most tropical and sub-tropical countries in the Americas, Asia and Africa. In humans, it is caused by 5 species of a parasite of the genus Plasmodium – falciparum, vivax, ovale, malariae and knowlesi – with falciparum by far the most deadly, as well as the predominant species in sub-Saharan Africa. The parasite is transmitted to humans via a mosquito bite, specifically the female Anopheles mosquito. Once inside humans, the parasites migrate to the liver and begin multiplying inside liver cells. After an incubation period, usually 6-15 days, these cells rupture and the parasites escape into the blood stream and infect red blood cells: killing those and infecting new ones. The most common clinical symptoms of malaria include sustained fever, shivering chills, joint and muscle pain, headache, vomiting, fatigue and dry cough. Severe malaria cases can lead to coma and death. Less common is a malarial infection of the brain, known as cerebral malaria, which can cause permanent cognitive impairments and brain damage, with children being much more vulnerable.
Annually, there are believed to be between 300-500 million cases of malaria each year, killing between 1 and 3 million people: 90% of these deaths occurring in sub-Saharan Africa and the vast majority killing children under 5. Adults die much less often from the disease, especially in endemic areas with "stable malaria" transmission, which I explained in a previous blog. (The large range of disease burden estimates is inherent in high-transmission, resource-poor countries with many constraints to adequate diagnosis. This will be discussed further in future entries, so stay tuned. I know you’re on the edge of your seat.) Malaria is the number one cause of death of children in Africa, and among adults, the lost productivity due to illness is estimated to be 1.3% of GDP. In some high-burden areas, it is estimated that malaria consumes up to ¼ of all household income.
Currently, there are 4 main interventions used to prevent and treat malaria in endemic areas. The first is using insecticide-treated bed nets (referred to as ITNs, LLINs, or other acronyms) to prevent the mosquitoes from biting humans, thereby preventing the transmission of the disease. The rationale behind this is that the Anopheles mosquito likes to bite at night. So, if people can cover their sleeping areas, this can prevent transmission. The current nets last 5 years; after that the insecticide wears off, and they become less effective. Many countries give nets out to pregnant women and children (the most vulnerable population) in the public sector hospitals and clinics for free. Prices vary greatly in the private sector, but in Ghana, you can pick one up in a pharmacy for about $7-$10. Bed nets have been shown to be an extremely cost-effective intervention, and they are now a major part of most national malaria control programs. There are also some NGOs and charities specializing in bed nets that you might have heard of across the pond, most notably Nothing But Nets, which partners with the NBA, and Malaria No More, which runs a very successful program with American Idol called "Idol Gives Back."
The second intervention is called Indoor Residual Spraying (IRS), and it involves going door to door to spray the inside walls of residences with insecticide (yes, sometimes even DDT). The rationale here is that the Anopheles mosquito, in addition to liking to bite at night, also prefers to hang out on the inside walls of homes. If we can make it so that they die every time they land on the wall, then that is one less malaria-carrying mosquito. The IRS only has a 6 month duration and can be fairly expensive, but it has still been shown to be another very cost-effective prevention intervention.
The third tried and true intervention is called Intermittent Preventative Therapy (IPT) during pregnancy. This is where pregnant women are able to take a drug during pregnancy to protect themselves and prevent mother-to-child transmission of malaria. In Ghana, the drug used is called sulfadoxine-pyrimethamine (SP, for short), and is, ideally, given 3 times at different intervals during the 9 month gestation. As children and pregnant women are the most vulnerable populations for malaria infection, this makes inherent sense and has been shown to be very effective.
The final intervention, and the one that I am most involved with in my current capacity, is increasing access to the most effective drugs available: artemisinin-based combination therapies (ACTs). Artemisinin is a drug derived from the plant Artemisia annua, or Chinese wormwood, whose antimalarial properties have been known to Chinese traditional herbalists for centuries. In the last 5-10 years, using ACTs has become the WHO (World Health Organization)-recommended treatment for uncomplicated malaria in all endemic countries due to their high efficacy and tolerability. Unacceptable levels of drug resistance have developed to all of the previous first-line antimalarial treatments, including chloroquine, SP, and artemisinin monotherapy, but using artemisinin in combination (as with ACTs) helps prevent the emergence of resistance, since 2 different drugs with 2 different mechanisms of action are attacking the parasite at once. The challenge with increasing access to ACTs is two-fold: first, over half of all malaria cases are treated in the private sector (mostly in pharmacies and community drug seller shops), and second, the natural extraction of artemisinin is costly, which means that ACTs are quite a bit more expensive than the aforementioned alternatives and out of reach for most people. A lot of this taking place in the private sector means less government control, and in resource-poor developing countries, this means that even though effective treatments are on the shelves, much less effective ones are often given (or a fraction of a regimen of ACT is given), which continues to drive drug resistance.
(Worth mentioning here is an exciting donor-funded project being piloted in 9 countries (including Ghana) called the Affordable Medicines Facility – malaria (AMFm), which will highly subsidize the purchase price of ACTs, hopefully making them as cheap as, if not cheaper than, all other alternatives for the end-user. Much more on this to come in future blogs.)
These challenges are also compounded by the difficulties of adequately diagnosing malaria, where the vast majority of diagnoses (especially in the private sector) are presumptive and symptomatic (euphemistically called clinical diagnosis) rather than confirmed with laboratory tests. This practice is actually recommended by WHO in most high-burden countries, especially for children under 5. However, as the main symptom of malaria is fever, it has becoming common practice to equate all fevers with malaria and treat accordingly. And, not surprisingly, more and more studies have concluded that there is vast over-diagnosis of malaria and over-prescription of antimalarials happening. Combined with this growing evidence base of over-diagnosis, studies showing decreasing transmission rates in some countries (thanks to the interventions above), as well as the development of accurate rapid diagnostic tests (RDTs), have made it feasible to take action in some countries. And Ghana is one of those countries. The 2009 Strategic Plan from Ghana’s National Malaria Control Program (NMCP) calls for moving from clinical diagnosis to laboratory or RDT-confirmed diagnosis. While this is an exciting paradigm shift, indeed, it is one thing to have it on paper, and another thing entirely to roll it out in practice (especially in the private sector).
So there you have it: Malaria 101 brought to you by Scott(y). Don’t say I never gave you anything. As you can see, there are several cost-effective proven interventions in the arsenal, which makes malaria control a very dynamic field to be in. However, challenges remain, especially in relation to leveraging the full potential of the private sector (“leveraging” is business speak for “using to the fullest”), which is why working with pharmacists is an exciting place to be. There will be much more on malaria to come, and you have been adequately warned, so try to contain your enthusiasm. And, to answer your question: no, there is not a vaccine (yet). The farthest one along in the pipeline is British pharmaceutical giant GlaxoSmithKline’s (GSK) RTS,S candidate. It is in phase III clinical trials, but it is at least 3 years away and will most likely only be partially effective (30-60%).
I know that I used the word gestation is this post, so I hope it wasn't too much like a science lesson. And I apologize about the lack of pictures. I’m tired of acronyms, aren’t you?
Thursday, November 19, 2009
Why It’s a Good Thing That Dennis Had Malaria Last Week*
*Disclaimer: This blog takes a very simplistic stance on the very complex topic of malaria endemicity. I would like to personally apologize to any public health professionals who may be reading this. Also, with a sample size of 1, a more appropriate title would be: “Why It Could Be Seen As a Good Thing That Dennis Had Malaria Last Week.” But that title isn’t as catchy.
It can be the very definition of growing pains. And something that can be tricky to explain to those who don’t deal with it every day; so let me have a go at it:
In areas of high malaria transmission, individuals are bitten by infected (vector) mosquitoes on a constant basis. This is an enormous problem for children and pregnant women, but by adulthood, an acquired immunity is developed whereby the malaria parasite (usually Plasmodium falciparum) is always in the bloodstream, and each additional exposure to the vector (aka: mosquito bite) rarely results in an episode of clinical malaria. This scenario is euphemistically termed “stable malaria”.
In areas of lower transmission, individuals are bitten by infected mosquitoes less often, and the amount of malaria parasite in the blood stream fluxuates. This is a somewhat better situation for children and pregnant women; however, immunity is not acquired in adulthood, at least not as consistently, and each new vector exposure leads to an episode of clinical malaria more often. This scenario is called “unstable malaria”.
Now, it may seem like both scenarios have their pros and cons, and one is not necessarily better than the other, but lower transmission is certainly better than higher. (Think of which one is better for the women and children, sort of like a Titanic/life boats situation…They are more important and get saved first.) And the end goal of all malaria programs is eradication: the elusive E word. In order for that to happen, areas of high malaria transmission will have to become areas of lower transmission before they can become malaria-free areas. Alas, for my friend Dennis, these growing pains can be literal pains indeed. (Though he seems to be smiling now.)
A somewhat related “growing pains” type of situation worth mentioning is one from the field of HIV/AIDS that my old CGD colleague, Mead Over, an expert in AIDS economics, deals with on a daily basis. It has to do with the difference between incidence and prevalence, and the fact that, counterintuitively, higher HIV prevalence rates can undoubtedly be a good thing. Incidence refers to the amount of people newly diagnosed with a disease over a certain period of time; a lower number here is almost always better**. Prevalence, on the other hand, refers to the number of people currently living with the disease. And for HIV/AIDS, the main goal right now is increased access to ART (antiretroviral therapy). Thanks to the great advancements in these HIV drugs, people are now able to live much longer lives with the disease. And higher prevalence rates – more people living with the disease – means more people not dying from it. Seems straightforward enough, but it still causes headaches for Mead and other AIDS experts dealing with policymakers doling out the money.
**Higher incidence rates can also be a somewhat good thing if great strides have been made in the number of people being tested for a disease. Obviously, it is not a good thing that more people have the disease, but it is better that the higher burden is now known by public health professionals. This happened recently when the HIV/TB co-infection rate jumped from 1-in-8 to 1-in-4 almost overnight.
It can be the very definition of growing pains. And something that can be tricky to explain to those who don’t deal with it every day; so let me have a go at it:
In areas of high malaria transmission, individuals are bitten by infected (vector) mosquitoes on a constant basis. This is an enormous problem for children and pregnant women, but by adulthood, an acquired immunity is developed whereby the malaria parasite (usually Plasmodium falciparum) is always in the bloodstream, and each additional exposure to the vector (aka: mosquito bite) rarely results in an episode of clinical malaria. This scenario is euphemistically termed “stable malaria”.
In areas of lower transmission, individuals are bitten by infected mosquitoes less often, and the amount of malaria parasite in the blood stream fluxuates. This is a somewhat better situation for children and pregnant women; however, immunity is not acquired in adulthood, at least not as consistently, and each new vector exposure leads to an episode of clinical malaria more often. This scenario is called “unstable malaria”.
Now, it may seem like both scenarios have their pros and cons, and one is not necessarily better than the other, but lower transmission is certainly better than higher. (Think of which one is better for the women and children, sort of like a Titanic/life boats situation…They are more important and get saved first.) And the end goal of all malaria programs is eradication: the elusive E word. In order for that to happen, areas of high malaria transmission will have to become areas of lower transmission before they can become malaria-free areas. Alas, for my friend Dennis, these growing pains can be literal pains indeed. (Though he seems to be smiling now.)
A somewhat related “growing pains” type of situation worth mentioning is one from the field of HIV/AIDS that my old CGD colleague, Mead Over, an expert in AIDS economics, deals with on a daily basis. It has to do with the difference between incidence and prevalence, and the fact that, counterintuitively, higher HIV prevalence rates can undoubtedly be a good thing. Incidence refers to the amount of people newly diagnosed with a disease over a certain period of time; a lower number here is almost always better**. Prevalence, on the other hand, refers to the number of people currently living with the disease. And for HIV/AIDS, the main goal right now is increased access to ART (antiretroviral therapy). Thanks to the great advancements in these HIV drugs, people are now able to live much longer lives with the disease. And higher prevalence rates – more people living with the disease – means more people not dying from it. Seems straightforward enough, but it still causes headaches for Mead and other AIDS experts dealing with policymakers doling out the money.
**Higher incidence rates can also be a somewhat good thing if great strides have been made in the number of people being tested for a disease. Obviously, it is not a good thing that more people have the disease, but it is better that the higher burden is now known by public health professionals. This happened recently when the HIV/TB co-infection rate jumped from 1-in-8 to 1-in-4 almost overnight.
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