From Dirty Medicine by Katherine Eban for Fortune Blogs:
[Ranbaxy] CEO Tempest had assured Kumar that the company would do the right thing. So on an evening in late 2004, several months after assigning Thakur to dig up the truth, Kumar found himself before five members of the scientific committee of the board of directors, including Tempest and the chairman of the board.
Kumar had a PowerPoint presentation of 24 slides. It made clear that Ranbaxy had lied to regulators and falsified data in every country examined in the report. “More than 200 products in more than 40 countries” have “elements of data that were fabricated to support business needs,” the PowerPoint reported. “Business needs,” the report showed, was a euphemism for ways in which Ranbaxy could minimize cost, maximize profit, and dupe regulators into approving substandard drugs.
No market or type of drug was exempt, including antiretrovirals purchased by the U.S. and WHO as part of a program to fight HIV in Africa. In Europe, for example, the company used ingredients from unapproved sources, invented shelf-life data, tested different formulations of the drug than the ones it sold, and made undocumented changes to the manufacturing process.
In entire markets — including Brazil, Kenya, Ethiopia, Uganda, Egypt, Myanmar, Thailand, Vietnam, Peru, and the Dominican Republic — the company had simply not tested the drugs and had invented all the data. Noting Ranbaxy’s agreement to manufacture brand-name drugs, a slide stated, “We have also put our partners (Bayer & Merck (MRK) in Mexico and in South Africa) at risk by using suspect data.”
Kumar proposed a drastic course: pull all compromised drugs off the market; repeat all suspect tests; inform regulators of every case of switched data; and create a process for linking the right data to the right drugs. As the PowerPoint stated, “A short-term loss of revenue is better than a long-term losing proposition for the entire business.”
Kumar completed the presentation to a silent boardroom. Only one director, a scientist, showed any surprise about the findings. The others appeared more astonished by Kumar’s declaration that if he was not given full authority to fix the problems, he would resign.
The silence told Kumar everything he needed to know.
Within two days of the board meeting, he submitted his resignation: “… given the serious nature of the issues we discussed,” he wrote, his only choice was to withdraw “gracefully but immediately.” He had been at Ranbaxy less than four months.
Katherine Eban of Fortune has written an epic investigative report on fraud, world-wide, by Ranbaxy Laboratories, manufacturer predominantly of generic medications. More:
In August, the WHO restored the company’s ARVs [Anti-retrovirals, for treating AIDS] to its prequalified list.
Thakur knew the drugs weren’t good. They had high impurities, degraded easily, and would be useless at best in hot, humid conditions. They would be taken by the world’s poorest patients in sub-Saharan Africa, who had almost no medical infrastructure and no recourse for complaints. The injustice made him livid.
Ranbaxy executives didn’t care, says Kathy Spreen, and made little effort to conceal it. In a conference call with a dozen company executives, one brushed aside her fears about the quality of the AIDS medicine Ranbaxy was supplying for Africa. “Who cares?” he said, according to Spreen. “It’s just blacks dying.”
The congressional inquiry into the FDA petered out over the years. But under the direction of David Nelson, investigators interviewed the FDA inspectors who went to Paonta Sahib and asked them a simple question: Would they feel comfortable taking Ranbaxy drugs? “Every single inspector that went to India said they would never take a Ranbaxy drug,” says Nelson, “like eight out of eight.”
They were not alone. One by one, each of the former Ranbaxy executives Fortune interviewed had determined, while still at the company, to stop taking Ranbaxy drugs.
Read the whole article: Dirty Medicine by Katherine Eban.
Are your, your family’s or your patients’ medications manufactured by Ranbaxy? See the following posts for instructions and tools to figure that out.