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Seguro Social cost-cutting switch followed by string of mysterious deaths

Change in blood pressure medicine suspected in kidney failure deaths

by Eric Jackson

On October 3, after a string of mysterious deaths from illnesses that began with diarrhea, often progressed to breathing problems and swollen throats and culminated in fatal kidney failures, Minister of Health Camilo Alleyne declared a health emergency and the Gorgas Institute began an investigation that first centered on the possiblity of a contagious disease outbreak. The victims tended to be men over 40 with histories of kidney problems, although some others outside of that demographic were affected. About two-thirds of those afflicted died. Most of those affected were from the Panama metro area, but there were cases in the Interior as well.

As the country began to panic and Costa Rica announced that it was considering a quarantine on Panama, investigators one by one eliminated various contagious diseases. Because those who fell ill did not have fever symptoms, and because neither those who lived with them nor health care personnel were afflicted, doubts arose that the problem was infectious, let alone contagious, at all. Teams from the Pan-American Health Organization and the US National Centers for Disease Control came to Panama to consult and to take blood and tissue samples back to their labs in other countries. The theory switched to some sort of toxic exposure, and the experts began looking at environmental factors.

The most common environmental factor turned out to be medications distributed or prescribed by Seguro Social, and in checking that it was noted that the histories of all the medications that patients were taking were not always well documented.

For example, Ana María Coloma de Gallardo told her story to La Estrella. On September 25, she said, she went for her usual doctor's visit. On that day, the doctor took her blood pressure and prescribed medication. Since 1999 she had been taking enalapril to control high blood pressure, plus a diuretic to control water retention. "But that day she said that [the enalpril] had now been replaced with lisinopril."

When she took her first lisinopril the following day, she said, she felt bad, and the day after that she felt really awful, with clouded vision and a generalized weakness. Her reaction wasn't bad enough to put her in the hospital, she claimed, and she got better when she stopped taking the lisinopril.

Why the switch in medication? It was a management decision by Seguro Social director René Luciani and the people working under him to cut costs by making an across the board change in high blood pressure medications for about 9,000 public health care system patients this past August.

Lisinopril, made by the Spanish pharmaceutical company Normon, costs nine-tenths of a cent per dose, a bit cheaper than enalapril, which for years had been the hypertension medication of choice in Panama's public health care system. So the order was placed through CG De Haseth & Cia SA, the Panamanian drug importer, to buy the new medicine from Spain.

So what does the manufacturer say about who probably should not take lisinopril?

"Before taking lisinopril, tell your doctor if you... are taking potassium sparing diuretics..."

"Before taking lisinopril, tell your doctor if you... have kidney disease...."

"Before taking lisinopril, tell your doctor if you... have ever had an allergic reaction that involved swelling of your lips, face, tongue, or throat or difficulty breathing...."

"Before taking lisinopril, tell your doctor if you... are taking salt substitutes [or] potassium supplements...."

"Before taking lisinopril, tell your doctor if you... have diabetes."

Among the side effects that Normon warns may occur from the use of lisinopril, there are listed:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• difficulty breathing;

• little or no urine;

• an irregular heartbeat or changes in your heartbeat;

• chest pain;

• severe dizziness or fainting; or...

• unusual fatigue or weakness;

• dry, tickling cough;

• muscle cramps;

• numbness or tingling in the hands, feet, arms, or legs; [and]

• nausea, vomiting, or diarrhea....

At the http://www.medicine.com website, after observing that "interestingly, lisinopril and other ACE inhibitors were developed from the venom of a poisonous Brazilian snake," people are warned that "first doses of lisinopril or any ACE inhibitor should be taken under observation if the patient also is taking diuretics." The website also warns that "lisinopril can impair the function of the kidneys, and every person taking this medication should have their kidney function checked."

The http://www.drugs.com website also warns about combining lisinopril with diuretics and the blood pressure medication's use by patients with kidney problems. It warns persons with "any previous occurrence involving hoarseness; swelling of face, mouth, hands, or feet; or sudden trouble in breathing" that if they use lisinopril "reaction is more likely to occur again."

On October 6 Alleyne recalled all lisinopril from Panama's hospitals and pharmacies, and various laboratories are looking at samples to see whether the Seguro Social system, which is also the source of supplies for most medications sold at private pharmacies here, got a bad batch of the drug. Normon and CG De Haseth & Cia SA say they are cooperating with the investigation and doubt that the quality of the medicines that they provided was the problem.

And although the work at the Centers for Disease Control in Atlanta and at other labs continued as this story was written and in parallel with that a Panamanian prosecutor's criminal investigation has begun, it appears that the drug manufacturer and importer are probably not to blame.

What happened was that Seguro Social, whose medicine buying program has caused repeated protests throughout this year because patients with such maladies as HIV, kidney failure and hemophilia could not get the drugs they need, made a "one prescription fits all" economic decision that ended up inappropriately giving people like Ana María Coloma de Gallardo lisinopril. She shouldn't have been put on that medication because she's also on diuretics, nor should a number of other patients with conditions specified by the manufacturer or in the medical literature.

In Panama the management posts in the public health care systems are for the most part distributed on the bases of political patronage or nepotism. This would not be the first time that multiple patients died because of a management failure, but so far the top heads have never rolled.

They didn't when supermarket baron and presidential hopeful Ricardo Martinelli headed Seguro Social and 11 kidney dialysis patients died, most likely from bad chemicals in the dialysis machines. The chemicals disappeared before investigators could examine them, those who ran the machines clammed up and that rash of deaths remains officially unsolved.

They didn't when a radiotherapy machine at the Instituto Oncologico Nacional with faulty software and no instruction manual gave at least 28 patients overdoses of x-rays, many of them fatal. Some lowly technicians were convicted of negilgent homicide, some doctors were disciplined for malpractice and nobody in management was called to account. (As one might have expected, when the hospital's director was the brother of National Police chief and the brother-in-law of the immigration director in the Moscoso administration.)

This particular string of deaths will lend itself to fingers being pointed in various directions, especially because some bad reactions to flu shots seem to have been mixed in with the lisinopril problems and because incomplete medical records will in some of these cases provide a reasonable defense against allegations of inappropriate prescriptions. But the basic problem appears to have been caused by Seguro Social management changing people's prescriptions en masse without taking care to evaluate each patient's particular circumstances.

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