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Africa must set up a body to monitor drugs

By Vision Reporter

Added 13th November 2007 03:00 AM

OPIYO OLOYA
PERSPECTIVE OF A UGANDAN IN CANADA

You had a niggling suspicion that had Aunt Fatuma or Uncle Kwame stayed off the medication the doctor gave last week, or tried another medication, perhaps she or he might be alive.

OPIYO OLOYA
PERSPECTIVE OF A UGANDAN IN CANADA

You had a niggling suspicion that had Aunt Fatuma or Uncle Kwame stayed off the medication the doctor gave last week, or tried another medication, perhaps she or he might be alive.

OPIYO OLOYA
PERSPECTIVE OF A UGANDAN IN CANADA

You had a niggling suspicion that had Aunt Fatuma or Uncle Kwame stayed off the medication the doctor gave last week, or tried another medication, perhaps she or he might be alive.

However, being the type of person who trusts that doctors know what they prescribe to patients (and they often do) and that medicine is supposed to heal not kill, you keep your doubt to yourself. You bury the dead and that’s that. Still, at the back of your head, the little pesky voice keeps bringing up the possibility that Aunt Fatuma or Uncle Kwame might be alive if it were not for bad medicine… That must have been the thoughts running through the minds of many North Americans last week when giant American pharmaceutical drug-maker Merck settled for $4.85b lawsuits brought against the company because its pain-killer Vioxx heightened the risk of heart attacks in certain users.

To be compensated by Merck, plaintiffs must have filed claims by last Thursday and ready to prove that they (or their loved ones) suffered a heart attack or stroke, that they received at least 30 Vioxx pills and that they received enough pills to support the claim that they were ingested within two weeks before injury.

Naturally, many must now be wondering whether that suspicious death of a relative may have something to do with bad medicine. That was the case on October 21, 1999 when a 73-year-old American woman who was part of a clinical trial of the new arthritic painkiller drug Vioxx felt short of breath. She immediately called her son to tell him that she was not feeling well, but by the time he got to her house, she was dead. It would later turn up in court documents that the woman had been taking 25 milligrams of Vioxx a day as part of a clinical trial.
Vioxx was the new wonder drug manufactured by New Jersey-based pharmaceutical company Merck.

The woman was later shown to have died from heart attack, but in a series of e-mails unveiled in court documents, senior Merck scientists tried to disguise the cause of death as “unknown”.

The pattern of denial from Merck continued for another six years as the pharmaceutical company fought mounting evidence that Vioxx, the painkilling medicine was actually killing patients.

As lawsuits started pouring in, Merck hired a legion of crack legal teams to battle each case in court, puncturing holes in the testimonies of relatives who revealed that their loved ones had suddenly died or was seriously injured after using Vioxx. Merck won many of the cases until August 2005 when a jury in Angleton, Texas, returned a verdict of $253.5m on behalf of Carol Ernst, whose husband, Robert, had died after taking Vioxx for less than a year.

Interestingly, even as Merck insisted that Vioxx was safe to use for a short period less than 18 months, it withdrew Vioxx from the market in September 2004, after a clinical trial proved that it increased the risks of heart attacks and strokes. By the beginning of this year, Merck faced personal injury lawsuits from 47,000 plaintiffs, and as many as 265 potential class action lawsuits arising from cases where Vioxx was fatal or seriously harmed the users. And, although Merck was still winning in court from New Jersey to California, the annual cost of defending the company was close to $1b.

Merck was now losing big time and it was time to own up. Therein lies the moral of the story—some drug companies will defend the profit bottom line vigorously even if lives are at stake.

The Merck case is yet another wake-up call for Africa to set up a continental drug monitoring body that approves the use of drug for the entire continent, something similar to the Federal Drug Administration (FDA) and Health Canada which approve drugs use in the USA and Canada respectively. Individually, African countries lack the infrastructure and resources needed for rigorous independent testing of new drugs before they come onto the market, thereby forcing patients to rely on the goodwill of nations that may not have the best interest of Africa at heart.

For example, early this year in April, the FDA turned down the approval of another Merck drug Arcoxia (etoricoxib) used for treating signs and symptoms associated with osteoarthritis, citing studies that showed those who took the drug appeared to have elevated risk of heart attacks. Red-flagged in the USA, Arcoxia nonetheless is currently sold in 63 countries in Europe, Latin America, the Asia-Pacific region, Middle East and parts of Africa.

In other words, what is not good enough for American citizens is okay for Aunt Fatuma and Uncle Kwame who live somewhere in the dark continent of Africa, and whose deaths don’t really matter and cannot interfere with profits for the drug maker. The question is, how many Uncle Kwame and Aunt Fatuma are out there, and who will speak on their behalf?

Opiyo.oloya@sympatico.ca

Africa must set up a body to monitor drugs

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