Good Drugs, Bad Drugs
Friday, July 18, 2008
The global health community must strengthen its commitment to protect patients from poor-quality medicines.
The international health community has been rocked by the news that a large Indian generic drug company, Ranbaxy Inc., is currently being investigated by the U.S. Justice Department and the Food and Drug Administration (FDA) for producing substandard drugs. Ranbaxy’s suspect HIV/AIDS products may have been administered to thousands of poor Africans under a contract agreement with the President’s Emergency Plan for AIDS Relief (PEPFAR).
According to The Wall Street Journal, investigators "allege that some of the drugs were poorly made, unstable or impotent. According to court filings and lawyers close to the investigation, Ranbaxy fabricated documents to cover up the substandard products.” As the Journal reports, Ranbaxy has acknowledged “some serious allegations concerning compliance with U.S. law” but says that “except for issues that have been fully aired with the government, [it] knows of no evidence to support these allegations.”
The revelations are timely: the Senate has just passed the (previously stalled) $50 billion PEPFAR reauthorization bill, which initially said little about drug quality. According to Senator Tom Coburn (R-OK), the version of the legislation passed by the House of Representatives required that PEPFAR purchase the cheapest drugs available on the world market—without requiring any standard of safety and efficacy. “Under such a provision, African patients would have been treated worse than lab rats,” Coburn says. Thankfully, owing to the efforts of Coburn and others, the bill that was just passed and that House leaders have signaled they will approve requires that drugs purchased by PEPFAR have the approval of the FDA or another equivalent drug regulatory authority, such as the European Union’s European Medicines Agency.
Substandard HIV/AIDS drugs represent a double-threat to patients: not only do they cause a patient to forgo treatment with effective drugs, they also foster viral resistance.
Unfortunately, the United Nations-backed Global Fund, which has received over $2.5 billion from the U.S. government since 2001 (and which currently receives funding through PEPFAR), does not have such safeguards against substandard drugs; neither does the Clinton Foundation nor the Paris-based Doctors Without Borders. These groups often buy directly or provide monies for cheap Indian copy products that have not been approved by any stringent drug regulatory body. Although many of these organizations claim they test the drugs they buy, it is economically foolish to test every batch; moreover, testing randomly may not catch all potential deficiencies.
The World Health Organization (WHO) has contributed to the problem with its drug prequalification program, which “pre-qualifies” some drugs without always demanding independent, verifiable laboratory evidence of quality. In 2005, 18 separate HIV/AIDS drugs were dropped by the WHO because of the absence of such lab data. At the time, I recall joining a doctor who was visiting some HIV patients in the suburbs of Harare, Zimbabwe. The doctor had switched two patients from a generic drug back to a more expensive innovator product because he was concerned that they were not responding to the generic drug; in other words, he suspected it was of poor quality.
Substandard HIV/AIDS drugs represent a double-threat to patients: not only do they cause a patient to forgo treatment with effective drugs, they also foster viral resistance. Resistance to first-line HIV/AIDS drugs has forced patients in rich countries to buy more expensive second- and third-line therapies that may not be accessible for patients in poor countries.
Good generic drugs have one real and important benefit: they tend to be cheaper, due in part to the fact that they tend to be produced in countries with lower wage and infrastructure costs. This allows more drugs to be purchased—and, at least in the short run, it allows more patients to be treated. But if they are not subject to the same regulatory requirements or safety standards as originator drugs, the generic drugs threaten to undermine patient health. Additionally, breaking patents undermines the long-term prospects for new drug development by depriving innovators of revenue.
I visited the Ranbaxy production site at Gurgaon (outside of New Delhi) earlier this year, and it is one of the best in India. The company has a reputation for producing high-quality drugs. But if the charges of reckless behavior prove accurate, Ranbaxy will have put the lives of patients at risk. If one of India’s top drug firms has acted in this manner, what does that suggest about the country’s lesser-known producers?
Substandard drugs are an occasional byproduct of even the best production process: Western companies routinely throw away between 5 percent and 10 percent of the drugs they produce because those drugs fail to meet various standards. But in countries like India, which may lack good manufacturing practices, companies face less accountability, and it is unclear what happens to their low-quality drugs.
One hopes that Ranbaxy is cleared of any wrongdoing and that all its products are safe—not for the company’s own sake, or for the sake of its shareholders (Ranbaxy’s shares fell by 10 percent after the news was announced), but for the sake of thousands of patients whose health would be threatened if it turned out they were using substandard medicines. If any good can come from this sorry episode, it will be a stronger commitment by the global health community to promote high standards for drug quality.
Roger Bate is a resident fellow at the American Enterprise Institute.
Photograph by Getty Images.