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Panama News Briefs

Second Seguro Social medicine recalled --- this time a tainted one --- as multiple investigations continue

Luciani claims terrorism, government withholds CDC reports, patients panic

by Eric Jackson

There are still many unanswered questions in a rash of deaths that came to public attention at the beginning of October. Now a cough syrup prepared at a Social Security Fund (CSS or Seguro Social) laboratory has been recalled after some bottles of it have been found tainted with diethylene glycol, a toxic solvent used by the instituion in certain lab tests and typically stored by Seguro Social in the same places with medicines. The sugar-free expectorant now joins the high blood pressure medication lisinopril on the list of recalled medicines and as this update was filed investigators from several Panamanian and foreign agencies were looking at other medications dispensed by the CSS as well. Meanwhile the usual long lines at Seguro Social pharmacies have dwindled to almost nothing as patients are avoiding all of the institution's medications.

Health Minister Camilo Alleyne has said that information from the US Centers for Disease Control led the investigation to the tainted cough syrup, but so far the government has withheld all actual lab reports on the situation by that institution from both the public and the nation's health care professionals. In televised statements CSS director René Luciani is characterizing the problem as "an attack on collective security" but prosecutors investigating the rash of deaths for the Public Ministry are more cautious and say that they are also looking into other theories. In addition to criminal malice these include various causes of death in the different cases and the possibility of negligence with respect to the cough syrup, on one angle because it is reported that the laboratory in question lacked proper certifications and a regular inspection process.

The cough medicine contaminant, diethylene glycol or DEG, is often used in radiator fluid. According to a CSS physician who spoke to The Panama News under condition of anonymity, DEG is found in Seguro Social's pharmacies and storage facilities because it is used in certain lab tests. The substance has a low toxicity in adults but severe effects on children. In this case, the source said, because it was used in sugar-free cough syrup it would not have been prescribed to children except possibly to those with juvenile onset diabetes. It could have been taken by many adults without causing serious symptoms but still been fatal to those with kidney or liver conditions or otherwise delicate states of health. Most of those who have died or become seriously ill are middle aged or elderly and suffering from diabetes or chronic kidney ailments. No children have been reported affected.

Many of the symptoms shown in the unexplained deaths can be found both in the warnings about side-effects of lisinopril and in the effects of DEG poisoning. One thing not in common is that DEG attacks the liver and one of the diagnostic signs of poisoning by that substance is liver lesions. So far in their public statements the Ministry of Health and Seguro Social have mentioned kidney damage but have said nothing about liver damage among the patients believed to be affected.

There are antidotes for DEG poisoning and Alleyne said that the patients in intensive care with symptoms that can be positively linked to the toxin would be treated with those. As this update was written there was no word on whether and to what extent those antidotes had been administered and how effective they might have been.

As of this writing the recall on lisinopril remained in effect. As a practical matter, six other liquid medicines that are made at the CSS laboratory that has been closed during the investigation are now unavailable and under question, although they have not been formally recalled.

The manufacturer of the lisinopril --- a generic ACE inhibitor used to control high blood pressure --- that Panama's public health care system was distributing, the Spanish firm Normon, has protested that there is nothing wrong with their product. The company's claim appears to be corroborated by the lack of a worldwide product recall in the wake of several days of investigations by the US Centers for Disease Control labs in Atlanta. However, the quality of the drug itself is not the only issue, because there are also questions about how and to whom it was administered. The side effects that the manufacturers of lisinopril  warn can be caused in certain patients include:

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

·        difficulty breathing;

·        little or no urine;

·        an irregular heartbeat or changes in the heartbeat;

·        chest pain;

·        severe dizziness or fainting;

·        unusual fatigue or weakness;

·        dry, tickling cough;

·        muscle cramps;

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

·        nausea, vomiting, or diarrhea.

Seguro Social massively switched from enalapril to lisinopril as the blood pressure medication of choice, beginning distribution of the latter to some 9,000 patients on this past August 17. At the time, this was over the protests of the professional organization of the nation's pharmacists, the Colegio Nacional de Farmaceuticos.

Colegio president Telva de Córdoba and CSS professionals who spoke with The Panama News described hellish overcrowding in Panama's public health care institutions and a lack of communication between management and both patients and health care providers that apparently led to lisinopril being given to patients whom manufacturers' warnings and the medical literature say should not be given this drug or should only get it with careful monitoring for initial reactions. Patients who are counter-indicated for lisinopril include those with kidney problems, those taking certain diuretics and those with certain sorts of allegies. The Panama News and other media have uncovered a number of cases in which people taking other medications were switched to lisinopril despite cautionary warnings applicable to their conditsion, without any of the recommended special monitoring of their first doses and without the patients being informed of potential problems.

The switch "was very abrupt," Mrs. Córdoba said. She said that her organization urges pharmacists to take time with patients to know about any special conditions or other medications that might indicate against the use of a particular prescribed drug. But in the public health care system, where a pharmacist will typically be looking after the medications of 1,500 people at once, this can be difficult. At Seguro Social, she said, "the volume of patients is enormous --- the pharmacists work there like it was a maquiladora. It's even worse in the Interior, where there are many few professionals for the number patients served."

Our physician source also talked about heavy work loads for doctors, but said that a sudden switch from enalapril to lisinopril was not as much a concern as the constant medicine shortages at Seguro Social pharmacies. That, the doctor said, routinely leads to patients getting their prescriptions changed from what the physician ordered to what's available on a given day, occasionally with bad results.

A complicating factor is the state of Panamanian medical records. Within the CSS there is no computerized patient database that keeps track of the medications that various doctors within the institution may prescribed and  a person may be going to one Seguro Social facility to be medicated for one condition and a different facility to be treated for another, with the professionals in each locale being unaware of what each other are prescribing. Add to that the availability of many medications over the counter without prescriptions, the private health care system that exists alongside the public one --- often treating the same patients for different complaints --- and the popularity of herbal medicines, and the result is a high risk of problems arising from the incompatible mixing of different drugs. "The principle that everybody has to recognize is that medicine is not innocuous," the doctor said. "Things that are strong enough to help you can also hurt you if they are used in the wrong way, so patients need to make sure that physicians get complete medical records." Doctors, on the other hand, need to be "less complacent" about possible side effects and counter-indications of the substances they prescribe.

Chaotic to nonexistent medical records have apparently hampered the investigation of the current crisis. As far as the records show and investigators have been told, there is no single medication in common among the at least 21 suspect deaths and 29 other illnesses thought to be related. However, that doesn't rule out a common cause. It just means that it's not found among the available data.

Both the pharmacists and physicians say that they are eager to cooperate in the investigation and warn of grave damage to the reputations of Panama's public health care institutions and patients' eroded trust in the professionals whom they consult. Both groups complain about the management at Seguro Social, which they say by acts of commission and omission in effect make medical decisions that are not always in the patients' best interests and for what they say is its mis handling of this particular crisis.

"Our authorities have handled this very irresponsibly," our physician source told us. Speaking 10 days after the Ministry of Health declared an emergency, it was pointed out, "we still have no report on the first cases."

Later that day the Colegio Nacional de Farmaceuticos issued a statement complaining that "so far we have no complete and precise information that allows us to exercise professional judgment to safeguard the health... of the Panamanian people." After an emergency meeting, the pharmacists resolved to "demand of the health authorities all of the truthful and pertinent information," and called for independent evaluations of all of the medications about which questions have been raised.

Full transparency and independent investigations are also increasingly demanded outside of health care circles. Former President Guillermo Endara, noting that the problems appear to be with medications dispensed by Seguro Social and Health Ministry facilities, has called for Alleyne and Luciani to step down during the investigation because otherwise there is a conflict of interest that has individuals running investigations that may implicate themselves. President Torrijos has begged off on all questions about the crisis, saying that he's not a doctor and thus can't have an opinion, but Vice President Samuel Lewis Navarro blasted Endara for supposedly playing politics with people's health. Both Endara and the labor/left FRENADESO coalition --- the latter which includes many CSS employees --- allege that the government has understated the severity fo the crisis by ignoring and discounting apparently related cases that had been happening for weeks before the October 2 declaration of a health emergency.

Luciani, for his part, is alleging criminal malice and in effect pointing the finger at one or more CSS employees. But so far his televised claim of an "attack on collective security" is not being repeated by people from the Public Ministry, who are conducting separate criminal investigations to determine whether intentional foul play or serious negligence may be behind any of the deaths. Part of the criminal investigation, however, has been the interrogation of everyone who works at the lab where the tainted cough syrup was found.

The negligence allegations have been given some impetus by the facts that the medications made at the CSS lab were not tested and certified as safe and effective; that the facility had not been formally inspected since 2002; and that the drug production was endangered by the lab's proximity to other industrial facilities that could contaminate products. Samuel Rivera, who served as purchasing director for the CSS during the Moscoso administration, noted to several media that there had been a recommendation to move the lab three years ago. Luciani, however, told La Prensa that the cough syrup that had been recalled was properly inspected but somehow the DEG went unnoticed.

Both the pharmacists and doctors with whom The Panama News spoke, and most of the organizations of Panama's health care professionals, are taking a "wait and see" attitude about the cause or causes of the various deaths and illnesses. "We can't discount a criminal hand," the CSS doctor told this reporter, adding that "it could be an interaction" among two or more drugs as well. Mrs. Córdoba said that the Colegio Nacional de Farmaceuticos is investing a lot of its money and efforts to assist the investigation, and also to put such trustworthy information that it obtains at the disposal of the Panamanian people.

Editor's note: for a previous report on this situation, click here.