The criminal conviction of Dr. Krishnarao V. Rednam started with a billing and dosing fraud involving three drugs.
Five years ago, eye doctors had few choices for treating macular degeneration, a leading cause of blindness in older adults. The more serious wet form of macular degeneration occurs when blood vessels leak into the retina, damaging central vision.
Macugen, a drug approved to inject into the eye, had shown some effectiveness in slowing the progression of vision loss by limiting the blood vessels' growth. But doctors were more excited by another drug in the pipeline, Lucentis, that in early tests had shown evidence of improving patients' vision.
Lucentis was still being tested and was not yet on the market. However, Genentech, the drug company that makes Lucentis, sold a similar drug that had been FDA approved — Avastin. Avastin is designed to slow the growth of blood vessels in tumors and was approved for treating certain cancers. A few physicians decided to experiment with smaller doses of Avastin injected into the eye.
By the summer of 2005, Avastin was increasingly prescribed to treat macular degeneration. It still is not FDA-approved for that use, although doctors commonly and legally use drugs for different indications, called off-label prescribing.
"We felt that the benefits of using Avastin far outweighed the risks at that point," said Dr. Manju Subramanian, an eye surgeon at Boston University.
A compelling reason to switch to Avastin was the price difference. Macugen cost more than $800 per dose. Avastin was $45.
Rednam, who practiced at the St. Louis Eye Clinic in Kirkwood, injected Avastin more than 250 times into patients' eyes, while billing their insurance for the more expensive Macugen. He pocketed the difference.
Patients had given consent to receive Macugen and were not told they got Avastin instead.
When Lucentis gained FDA approval in 2006, many ophthalmologists started using it because the newer drug had gone through a more rigorous testing process for safety and effectiveness for use in the eye. At the time, there had been no published research directly comparing Avastin with Lucentis for treatment of macular degeneration.
Last month, Subramanian published results from the first head-to-head study of the drugs, which in a small patient sample proved equally effective. Larger research studies are ongoing.
Lucentis, which is packaged in single vials for use in one eye, costs more than $1,600 a dose.
Rednam admitted to the Missouri healing arts board that he split the single vials among three patients while billing each for the full dose.
A spokesman for Genentech said the single-use vials of Lucentis did not provide enough medication for more than one eye in one patient. Subramanian confirmed the same.
"They only give you just enough to do one injection, there's not enough for two injections," she said.
State regulators do not know whether Rednam's patients suffered any ill effects from his actions.