Celgene Voice Recognition Helps Manage Medical RisksBy Deborah Gage | Posted 2005-12-06 Email Print
The drug maker's best-seller has some nasty side effects. A voice recognition system helps patients, doctors and pharmacists manage the risk.
Just a few tablets of thalidomide taken in early pregnancy causes babies to be born with webbed limbs or no limbs at all. Back in the 1950s, women took thalidomide, which was developed by a German company called Chemie Grunenthal, for morning sickness. It was not until 1961 that a German pediatrician made the connection between the seemingly innocuous drug and the deformed babies. The drug was taken off the market, but not before 10,000 severe birth defects in 46 countries were traced by health authorities back to the drug's use.
Since then, thalidomide has been found effective in combating other illnesses, including cancer and erythema nodosum leprosum (ENL), an inflammation that accompanies leprosy. In 1998, the Food and Drug Administration approved thalidomide for treatment of ENL. And while the drug hasn't been approved for cancer treatment, more than 90% of thalidomide prescriptions now go to cancer patients. Since 1998, about 130,000 people have taken the drug.
Thanks in part to a voice recognition system developed by Celgene, the Summit, N.J.-based biopharmaceutical company that licensed and commercialized thalidomide, there have been no reported birth defects caused by the drug, which Celgene sells as Thalomid. The system, called S.T.E.P.S.System for Thalidomide Education and Prescribing Safetywas developed by Celgene in-house for $20 million and approved by the FDA.
S.T.E.P.S. is a network of Oracle database, fax, image storage, telecommunications and Interactive Voice Response (IVR) servers that keeps records on all who handle Thalomidincluding doctors and pharmacists as well as patients. Before any prescription can be filled, all three parties must fax in a registration form. The doctor assists the patient in completing the form, which identifies the patient's risk category (e.g., female, childbearing age).
At several points during the process of getting or refilling a prescription, patients, pharmacists and doctors must call the IVR system and answer a series of questions about how they are using or dispensing the drug. If there are problems or wrong answers, the IVR transfers the call to a Celgene representative. S.T.E.P.S. also tracks the whereabouts of Thalomid packages by attaching authorization numbers to each prescription.
But not everyone is thrilled with the results.
Health-care workers who use S.T.E.P.S. say it's the most restrictive system they've encountered in their medical careersso restrictive that it is sometimes inconvenient to use. For example, Katy Welch, a registered nurse at the University of Arkansas' Myeloma Institute, finds it frustrating that patients must be reprocessed through S.T.E.P.S. if they can't fill their prescriptions within Celgene's deadline, which is seven days.
And some critics, including Richard Blumenthal, attorney general of Connecticut, say the system should be adapted to track new potential risks, such as blood clots, that have recently been associated with the drug when used as a cancer treatment.
Thalomid can be an effective cancer drug for the same reason that it harms developing fetuses: It inhibits the growth of new blood vessels that feed tumors. But a potentially lethal side effect is blood clots, especially when patients are taking Thalomid along with other chemotherapy.
Twelve patients out of 190 died of blood clots while taking Thalomid for renal cell cancer, according to the Research on Adverse Drug Events and Reports project, which published a paper on drug side effects in May in The Journal of the American Medical Association. The group, funded by the National Cancer Institute and other organizations, figured that between 1 in 3 and 1 in 5 patients were developing blood clots in these clinical trials.
"Cancer drugs are the most toxic, and cancer patients have the worst prognosis," says Dr. Charles Bennett, a professor of medicine at Northwestern University in Evanston, Ill., who works with the project. "It's not surprising that off-label use in cancer may be more adventurous."
In May, Blumenthal petitioned the FDA to require Celgene to change S.T.E.P.S. so it would also track blood clots. Blumenthal wants Celgene, relying on clinical data from the research project, to create a seventh category of patient in addition to the six who are divided by age, sex and fertilitypatients who use Thalomid concurrently with other chemotherapy. He also wants Celgene to add questions to S.T.E.P.S.' voice response system so the program is collecting information on risk factors for blood clots. And he wants all blood clots reported to Celgene and the FDA.
So far, Celgene says it has no plans to change S.T.E.P.S.
Celgene's executive director of information technology, Steve Lerner, says the company already has a system to track all of its drugs' side effects, including blood clots, and that the sole purpose of S.T.E.P.S. is to prevent birth defects caused by thalidomide. He says no one at Celgene has asked him to change the system to track blood clots, although "if the FDA asks [Celgene] to do something, we'll do it."
In a letter to Blumenthal on Oct. 31, the FDA said it is still studying the petition and has not reached a decision.
Meanwhile, S.T.E.P.S. will be part of a new system that the FDA hopes will stop birth defects caused by another drugAccutane, known generically as isotretinoin, a medication produced by several manufacturers that is used to treat severe acne. The FDA believes isotretinoin has caused at least 160 birth defects since 1982, in addition to untold miscarriages. After several voluntary registries run by the drug manufacturers failed to stop pregnancies, Celgene in 2004 licensed its patents for S.T.E.P.S. to four manufacturers, which are building a system due in 2006 to control the distribution of Accutane.
But the March of Dimes says it will be far harder to control access to Accutane than to thalidomide. Millions of women of childbearing age use the anti-acne drug, according to Dr. Nancy S. Green, the March of Dimes' medical director, compared to the 130,000 patients who have taken Thalomid. Also, Accutane goes by many other names, making the task of tracking the drug more complex.
"There's no guarantee that this system will work on such a widely distributed drug," Green says.