Rhetorical fireworks exploded at a meeting of the FDA Antiviral Drugs Advisory Committee Dec. 12 near Washington, D.C. Its stated purpose was to discuss post-marketing clinical study of the drugs PEG-Intron ( interferon ) and Rebetol ( ribavirin ) made by Schering Plough to treat hepatitis C. An unstated purpose was to let the community air grievances against the way the company is marketing the drugs.
A particularly contentious issue is the access registration program initiated by Schering. Many contend it requires the patient to reveal personal medical information the company has no need to know.
"This program was purposefully designed to skirt those laws [ of patient confidentiality ] by making the patient contact the company and its representatives directly," charged Brian Klein during public testimony at the meeting. "I believe it was designed to assure the company quick and free access to patient confidential information in order to ensure itself that it does not manufacture too much product."
Grant Gailey, a Nevada man infected with hepatitis C, was halfway through his 48-week regimen of PEG-Intron when his pharmacist told Gailey that he could not refill the prescription unless he had a patient registration number issued by Schering. Gailey called the registration number but balked at giving them information such as his weight, physician, insurance carrier, and home phone number. He contacted the Nevada Board of Pharmacy.
General counsel Louis Ling told the Las Vegas Sun that he was outraged by Schering's demands for private information. "The board is investigating all possible avenues of recourse, including legal action." Its powers over Schering are limited, but it does control a license for McKesson, the company that Schering has contracted to gather patient information.
Denial of the prescription refill "is an incredibly nasty ploy," said Richard Klein ( no relation to Brian ) , the FDA official who coordinates special health issues surrounding HIV and hepatitis C. But the FDA general counsel feels the agency does not have legal authority to restrain Schering from implementing a registry program.
"In our view, Schering has pushed the envelope of ethical marketing in a lot of areas," said advisory committee member Sharilyn Stanley, MD, associate commissioner of the Texas Department of Health. She was among those urging the FDA to look at marketing issues.
Brian Klein, cofounder of the Hepatitis C Action & Advocacy Coalition, called upon the FDA to establish a policy that in the future will require companies to gain agency approval before registration programs are implemented.
SCHERING'S PERSPECTIVE
Company representatives limited their comments to scientific issues at the meeting and did not discuss marketing issues. Later, in a telephone interview, Schering spokesman Robert Consalvo explained the registration program "was created to allow us to track the actual amount of product being used, to assure it will be available over the full course of the 48-week therapy." Interruption of treatment might lead to the emergence of drug-resistant virus.
Schering sees "an artificial market" right now because of the backlog of patients who have been waiting for the drug, and "yet another wave of hepatitis awareness" that may come from media coverage. Once this bulge goes through the system and it stabilizes, the risk of not being able to meet patient demand will subside. He suggested that they might do away with the registry at that point.
Consalvo justified the information they request. Simply counting the number of patients wouldn't work because PEG-Intron is prescribed by body weight, with four different dosages. The company also fears double counting of patients if they go to different pharmacies. That could lead to unnecessarily putting patients on a waiting list if they cannot guarantee enough drug for the entire course of treatment.
He said the company would call patients only if two conditions occurred: if the supply of drug became tight, bringing the possibility of rationing, and if the patient had not renewed the prescription within the last 60 days, suggesting no further need for the drug.
Patients can elect to not give their telephone number and still get a registration number, said Consalvo, though they run the risk of being discontinued from the program without warning if they do not continue to renew the prescription.
The PEG-Intron / Rebetol combination costs about $25,000 for the one-year regimen of therapy. Interferon is sometimes used in treating cancer. Because the product is not widely used and is expensive, it is not sitting on most pharmacy shelves but at a limited number of regional distribution centers.
RESISTANCE
Laurence "Bopper" Deyton, MD, is sensitive to the company's "need to have an understanding of what the need is going to be, so that they can assure delivery of the drug to people who need it." But the director of the Veterans Administration ( VA ) programs for HIV and hepatitis C feels that Schering was going too far in its quest for private medical information.
"It is illegal for us to release medical information to a non-VA source," says Deyton. "Fortunately in the VA, I had a law that I was able to turn to and say, either you are going to sell us the drug in a way that we are not going to violate the law, or we are not going to buy it. And since we are the largest single purchaser of the drug, they are doing it our way." The VA will provide Schering with gross numbers of patients but will completely protect individual patients.
Other large users find that they have similar power. Fred Maue, MD, Chief of Clinical Services for the Pennsylvania Department of Corrections, says, "We are going to assign arbitrary [ identification ] numbers to our inmates," and pass aggregated data on to Schering.
In the state where Schering is headquartered, the New Jersey Board of Pharmacy began an inquiry into those marketing practices at their Dec. 12 meeting. Board spokesperson Beth Rosenberg said they were concerned about privacy issues and expected a response from Schering before their January meeting.
Schering has initiated lawsuits against two companies that intend to manufacture a generic version of ribavirin when the patent expires. Ribavirin can be used with a variety of brands of interferon to treat hepatitis C. A generic version would cost significantly less.
