Wednesday, December 3, 2014

Ethics of politics in health care

The last few months, since the leave of Health Secretary Enrique Ona from the Department of Health, the health department has received several flaks from certain parties with vested interest and conflicts of interest on the matter.

I do not personally know the health secretary. However, the allegations being thrown at him, from no less than the President of the Republic of the Philippines himself has left me wondering why there is so much ire against him by no less than the person who appointed him to that position?

So far, the president has defended all his appointees, especially the favored ones. From PNP Chief Purisima who has been accused of falsifying his SALNs to Sec. Butch Abad who has been shaving the PDAF in favor of the DAP to DOTC Secretary Abaya who has been accused of running the MRT projects and bids as a family affair...strangely, it is the health secretary who has been in the news lately on controversies after controversies.

While I may not agree at certain issues with the health secretary, there are, however, public health issues that are valid decisions made on behalf of the public.

Vaccines and Public Health

Is the PCV 13 really superior to PCV 10?

There has never been a published study on a head-to-head long term study on the efficacy of preventing pneumonia, otitis media and invasive pneumococcal disease between the two vaccines.

The pneumococcal conjugate vaccine is designed to protect against the serotypes in the vaccine. For example, PCV 10 should cover against the 10 serotypes with additional cross protection against one or two other serotypes. PCV 13 should cover against 13 serotypes. Both vaccines DO NOT guarantee 100% efficacy. Improved vaccine efficacy end-points are based on the completion of all doses administered and NOT JUST ONE DOSE.

The Philippine Daily Inquirer reported that Dr. Issa Alejandria, an infectious disease specialist and epidemiologist at the UP-PGH said that PCV 13 averted more cases of pneumonia, otitis media, and invasive pneumococcal disease during a health forum in Quezon City. I am not sure whether the reporters just got confused or that the message Dr. Alejandria delivered may not have been completely accurate. But let me get that clear. There is NO WAY you can tell exactly how many cases of pneumococcal illness was averted by providing either of the vaccines. The data can only provide a mathematical approximation of "what ifs" based on the serotypes that are covered by each of the vaccine.

Clearly, there are issues that were blown out of proportion.

First. Did the World Health Organization actually file a complaint on which vaccine was to be used? NO. The utilization of which vaccine to recommend lies on each agency and each country based on local epidemiology. Both vaccines are WHO Prequalified.

Second. If you look at the vaccines being given at the health centers, or even by the Department of Health, many, are actually different from what is being given in private clinics. The DTwP or whole cell pertussis version is still being given in the community setting in spite of the fact that it is noted to be more reactogenic (higher side effects). Why? Not because it is not better. Studies now show that the wP version may actually be more effective (although more reactogenic), but a lot cheaper than the DTaP or acellular pertussis version.

As a concrete example, in selected areas where the rotavirus vaccine is being given for free, the monovalent rotavirus vaccine is the one that is being administered in spite of the fact that it covers only the G1P8 strains. Local epidemiological data from studies out of the Research Institute for Tropical Medicine have shown that the circulating strains may vary from year to year. For the Philippines, more than 70% of the circulating strains in the past three years have been G2 and G3 with less than 10% attributable to G1P8. Why was a monovalent vaccine selected over a pentavalent vaccine when the latter is also available in the Philippines? Because of cost issues.

And I can go on and on about the vaccines available in from the government compared to the ones being administered in the clinics, but this is beyond the scope of my blog.

Public health programs are designed to address a more comprehensive health coverage in spite of limited financial resources. The decision to use either the PCV 10 or 13 should be based on economics. Given the fact that there are more than 15 Million children less than 5 years old in this country, the 560,000 doses of the PCV 10 that was bought (vs. 520,000 doses if PCV 13 was purchased) was not even enough to AVERT anything. Each child will need 4 doses of the vaccine. Which means that with PCV 10, only 140,000 children would receive full immunization (or 130,000 children had PCV 13 been used). 10,000 children receiving PCV vaccine is much higher than the mathematically derived "averted" numbers.

A study published in Vaccine [Vol 30 Issue 11 on March 2, 2012, pp. 1936-1943] by CastaƱeda-Orjuela et. al. showed that using a Markov model, the authors evaluated the cost-effectiveness of three PCV vaccines - 7, 10 and 13. While PCV 13 may have increased the expectancy of LGY (life-gained years), the ICERs (Incremental cost-effectiveness ratios) of PCV 13 was above the per capita Gross Domestic Product. The study concluded that while PCV 13 would prevent more diseases and deaths with higher LGY, PCV 10 would save more cost to the healthcare system due to its higher impact in the prevention of Acute Otitis Media.

In the Philippines alone, data from the RITM on the Antimicrobial Resistance Surveillance Program in 2013 showed that of the 25 isolates for invasive pneumococcal disease, the most common were serotypes 1 and 5. The other serotypes reported were: 2, 14, 23, 18, 3, 4, 6, 19, 20, 32, 33, and 34.

PCV 10 covers against serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
PCV 13 covers against serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

Both vaccines did not cover against serotypes 20, 32, 33, and 34.

The only reported case of serotype 3 in 2013 was in an adult patient in the 20-64 years old bracket.

Which goes to the third point. The immunization program of the government covers only children and DOES NOT include adults.

As to what the president was ranting and panting in his press statements regarding this issue, smells of politics reeling its ugly head.

Cure for Dengue

I had patients that were asking me about the latest "cure" for dengue. This is the drug called ActRX TRIACT being marketed by the son of former senator Heherson Alvarez. The drug, a mixture of artemisinin-artesunate-berberin is claimed to be a breakthrough drug developed supposedly by ActRX Operational Group. Ltd. with its office out of Clark Freeport Zone, Pampanga.

As a pharmacologist, I have to put my foot down on this issue. I do not know why this clinical trial was even given a green light by the DOH. In the first place, artemisinin-artesunate are one of the most effective first line drugs in the treatment of P. falciparum malaria. Making it available for "dengue" is dangerous because the Philippines is endemic for malaria as well. Inadvertent use for every clinical symptom that smells like or looks like "dengue" can be catastrophic at the global control of malaria.

We need to remember that one has a cure (malaria), the other DOES NOT (dengue). Dengue is a self-limited disease and like many viruses, the key to addressing the problem is looking for the right vaccine. In addition, appropriate maintenance of a cleaner environment will address the outbreaks we see. Unfortunately, the present environmental and living conditions of the Filipinos will always remain a problem unless government steps in to alleviate the plight of the poorer sectors of society.

The premature approval and the marketing claims of the company that sells this is unfounded and unethical. It is but right that the clinical trials be stopped until more evidence can be shown that the use of the antimalarial drug artemisinin-artesunate has a role in the treatment of Dengue.

When someone asked me what my thoughts were of the current storm the health department is facing, I simply said that it was political.

I don't know what other baggage the administration will throw Ona's way, but please spare the public. All this political mileage is pushing the health of the public into limbo.

The worst kind of politics is to involve the continued delivery of health care to the people. What you see now is similar to PNoy approving the conduct of a badly designed clinical trial, short of calling it unethical, only because there is a pawn that can be played and that outcomes are only for the good of political alliances. Never mind the health care of the public. After all, for the longest time, the annual health budget is one of the lowest in the world. And the people do not consider health as a priority.

Noted author Laurie Garrett puts it best in perspective when she says "What public health really is is a trust. That's why I used the term 'Betrayal of Trust' as the title of my book. It's a trust between the government and the people".