Early in June, Roche Pharmaceuticals announced a global recall of nelfinavir (marketed as Viracept) after discovering batches were contaminated with a carcinogen at its Swiss manufacturing plant in March.
In the announcement, Roche recalled in Europe and “some other world regions” all batches of nelfinavir and instructed patients to discontinue use of the drug and switch to other medicines.
Patients with HIV/AIDS usually take a cocktail with three drugs: two are reverse transcriptase inhibitors and one is a protease inhibitor. Using two different classes of drugs allows physicians to attack the virus at two different stages of infection. This is important because HIV, the virus that causes AIDS, is notorious for finding ways to escape the medications used against it. When doctors use only one class of drugs, the virus generally becomes resistant to it, that is, the patient gets worse despite receiving treatment. HIV has a much harder time developing resistance to medication when two classes of anti-HIV drugs are used. Nelfinavir is a protease inhibitor, the crucial other class used in the medication cocktails. If patients stop taking a protease inhibitor, the virus has a very high chance of becoming resistant to the other two drugs in the cocktail and probably would not respond as well if a protease inhibitor were to be restarted.
Recall hits Africa hardest
Nelfinavir is used as a second-line protease inhibitor in many countries because newer and more expensive protease inhibitors, such as Abbott’s Lopinavir/Ritonavir (Keletra), have been developed. However, many poorer countries still use nelfinavir as their first-line protease inhibitor.
In the developed world, this recall has not caused much of a disruption. In North America, the recall is a non-issue because nelfinavir is produced and marketed by Pfizer, a different pharmaceutical company.
Developing countries with well-developed and well-funded HIV programs such as Brazil, South Africa and Botswana have had the flexibility to adapt to the recall.
Of the estimated 45,000 patients affected by the recall around the world, the problem really has been concentrated in poorer countries with less well-developed health infrastructures. Patients and health officials in these countries are in the horrible position of having to decide to continue use of a contaminated and possibly carcinogenic drug, or stop using a life-saving drug.
Roche’s discounted median price for poor countries is 28 cents per dose. In Panama, for example, Lopinavir/Ritonavir is three times as expensive. In East Africa (Kenya, Tanzania, and Uganda), nelfinavir is covered by HIV programs where other protease inhibitors are not. Patients would have to finance their own drugs — an impossible task. More than 26,200 packets of 270 tablets have been recalled from Uganda, Kenya, Tanzania and Ethiopia.
Roche refuses to give info
According to the World Health Organization, Roche, which last year had revenues of $35 billion, has sold nelfinavir in 49 countries since 2004. According to the company, 35 countries received at least one packet of the drug with high levels of contaminant. However, Roche will not disclose which countries. It is in this, perhaps, that the fundamental problem presents itself. Countries and patients cannot simply stop using an HIV medication and switch to a new one — this is especially the case with HIV drugs that require consistent use to prevent development of drug resistance. If Roche had released more specific information about which lots and which shipments were contaminated, a much more targeted, cheaper and safer recall could have been organized. Roche, however, ignored pressure from world health authorities and did not release such “proprietary” information.
Roche gives another stark example of how profits in health care are diametrically opposed to the interest of individual patients and the public’s health. Occasional production accidents are inevitable, but because of a need to protect commercial information, Roche has created a situation where thousands have to make a choice between taking a contaminated drug and stopping a life-saving medicine. The greater risk is developing a stronger, more elusive HIV that can spread and will be harder to control with other drugs. We all lose when the institutions that develop and distribute our medications care more about their profits than our health.
Flávio Casoy works on universal health care with the American Medical Student Association.
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