A cardiologist from Cleveland, Ohio, has come forward to question the effectiveness of drugs made by Ranbaxy, the India-based pharmaceuticals company that pleaded guilty in May 2013 to seven felonies in a case brought by the U.S Department of Justice.
Citing several cases of health issues faced by patients of his who used Ranbaxy drugs, Harry Lever of the Cleveland Clinic said that those whose symptoms were either worsening or not improving with these drugs saw significant improvement after he switched them to drugs made by other manufacturers.
Speaking at a seminar organised by the American Enterprise Institute here Dr. Lever said that drugs made by Ranbaxy, which agreed to pay $500 million in fines for having sub-standard manufacturing processes and making false statements made to the Food and Drug Administration, came to his attention after the U.S. regulator found repeated violations of current Good Manufacturing Practices at multiple Ranbaxy facilities in India.
In one case, Dr. Lever noted, a patient with heart trouble, who was taking an 80mg dose of the Ranbaxy drug Furosemide, was suffering from shortness of breath even after the dose was doubled. Then Dr. Lever switched the patient to a drug made by another manufacturer and he lost 15 pounds of fluid in one week – a desirable result for this condition.
Commenting on the efficacy of Furosemide this case, Dr. Lever said, “Is it that their batch-to-batch consistency is a problem? Maybe some companies are more consistent at making consistent drugs, but some companies like Ranbaxy aren’t. They still put [in] the active ingredient but for some reason it’s not consistent.”
Speaking to The Hindu Ranbaxy USA spokesperson Charles Caprariello said that deducing the causes of certain health conditions and how they respond to medications was a complex matter, and sometimes the differences even came down to patients not taking the drugs per doctors’ advice.
He similarly outlined the case of a patient using Ranbaxy’s formulation of cholesterol-reducing drug atorvastatin, for which the company in 2012 announced a massive recall after glass particles were found in the tablets, where the cholesterol level was about 100 points above normal.
Dr. Lever said, “All I did was kept the dose the same, called the pharmacy and said ‘Give him the name brand drug, instead’. We checked within a month and [his cholesterol] was back to normal.” The comments mark one of the first few cases of physicians stepping forward to question the quality of drugs made by Ranbaxy.
Although Dr. Lever admitted that for heart failure patients the condition was relatively “multifactorial” and it could be harder to isolate the causes, in the cited cases other factors apart from the drug manufacturer were held constant, he noted
Responding to comments by former senior Ranbaxy officials Kathy Spreen and Dinesh Thakur, who disclosed details about forged drug testing data to CBS news channel last month, Ranbaxy said that there was “no evidence that patients were adversely harmed as a result of the manufacturing issues at these facilities.”
However Mr. Thakur, who is a whistleblower in the FDA case against Ranbaxy, said at the AEI event that Dr. Lever’s account was a testament that the quality-control process for new generic drug applications was not working as intended, and “we have no mechanism to follow that up and see exactly what is happening in the market when people are switched from the brand to the generic.”
Further, Mr. Thakur noted, this was exacerbated in the case of generics because “There are two different standards of drug manufacturing, one for drugs made in India and shipped to countries such as Ghana or Latin America, or consumed in India, and a second standard for drugs sold in places such as the U.S.”