HIV gene therapy tests broadening

Cell Genesys Inc. in Foster City, CA, has begun a second Phase II trial of AIDS gene therapy aimed at a different patient population. Already studying the effects of gene therapy on patients failing antiviral drug therapy, the company is focusing its new enrollments on patients who have been treated successfully with drugs and have undetectable HIV levels in their blood.

But based on science presented at the 12th World AIDS Conference (see Drug Utilization Review, September 1998, p. 161), reservoirs of HIV-infected cells are remaining in patients with even undetectable viral loads in their blood. These patients are responding well to, and remaining stable on, drug therapy, but it’s been unable to completely wipe the virus from their systems.

10 patients enrolled in test

Believing this patient population may be more likely to respond to cell gene therapy than those failing drug therapy, the company has enrolled 10 patients for gene therapy. It involves removing CD4 and CD8 T-cells from the patient, genetically modifying them to seek and destroy HIV-infected cells, expanding their numbers, and then returning them to the patient. These patients will be compared with patients being infused with unmodified cells.

From its original trials of failing patients, the company reported to the 38th Interscience Con fer ence on Antimicrobial Agents and Chemotherapy this fall that decreasing levels of HIV were found in gastrointestinal lymphoid tissues, thought to be a primary reservoir for HIV-infected cells. Overall, a 0.5 or better log decrease in viral load was found in 10% of the study group, while CD4 counts increased in the majority of patients.

For more information, contact Cell Genesys at (650) 425-4542.

Certification numbers increase, board says

This fall’s round of certification testing by the Board of Pharmaceutical Specialties (BPS) in Washington, DC, attracted 675 applicants, a record number of pharmacists seeking to enhance their skills, according to the board.

The largest areas of interest were pharmacotherapy, with 323 applicants, followed by the board’s newest option, oncology pharmacy, with 218. Oncology pharmacy as a certification test was added in 1996. Among the other certifications sought were 51 for psychiatric pharmacy, 44 for nuclear pharmacy, and 39 for nutrition support.

Along with new certification testing, the board reports that 192 pharmacists also applied for recertification this fall, 114 in pharmacotherapy, 64 in nuclear pharmacy, and 14 in nutrition support. All told, BPS says it has certified 2,500 pharmacists since 1978.

For additional information, contact BPS at 2215 Constitution Ave., Washington, D.C. 20037. Tele phone: (202) 429-7591.

Drug makers begin to settle price-fixing suit

Four of eight pharmaceutical companies have offered to settle a class action lawsuit brought by community pharmacists in 1993 that accused drug makers of price fixing by offering managed care organizations better discounts than those offered to chain drug stores. The suit alleged the discounts were not allowing community pharmacists to compete and therefore were forcing them out of business. So far, Hoechst Marion Roussel has agreed to pay $149 million, Pharmacia & Upjohn $102.5 million, Abbot Labs $57 million, and Rhone-Poulenc Rorer $34 million as a settlement offer being negotiated among attorneys. Still to come is whether Forest Labs, Johnson & Johnson, Novartis, and Searle will join a settlement or go to court. Several wholesalers also are named as dependents in the suit, which alleges collusion between them and the drug makers.

Pharmacist collaboration ImPACTs new study

The American Pharmaceutical Association (AphA) in Washington, DC, is reporting good results from Project ImPACT (Improve Persistence and Compliance with Therapy), a hyperlipidemia effort stressing collaborative practice between physicians, pharmacists, and patients.

After the first 14 months of the study, begun in 1996, APhA reports 84% medication compliance overall, while 44% of patients have maintained national cholesterol level goals. The study involves 29 participating pharmacies nationwide, divided into clinic, home care, HMO, chain, and independent settings, with each pharmacy enrolling 30 patients who have been newly diagnosed with dyslipidemia or are poorly controlled.

Ongoing pharmacist input involves testing, mon itoring, and counseling patients in one on-site visit. Patients visit the pharmacist regularly for a finger stick, results analysis, and appropriate counseling. APhA notes that pharmacists can help lower lipid levels directly and decrease incidents of heart attack. It also reports that managed care organizations have begun contracting with some of the study’s sites as partof its plan’s benefits.

For details, contact APhA at (202) 429-7537.

Pharmacists left out of HCFA reimbursement

Despite lobbying efforts from national pharmacy organizations, it’s likely that pharmacists will not be included in a payment plan by the Health Care Financing Administration (HCFA) that reimburses other caregivers for training Medicare recipients to self-manage diabetes care.

HCFA began the new benefit this summer and listed physicians, nurse practitioners, physician assistants, clinical nurse specialists, nurse-midwives, clinical psychologists, and clinical social workers meeting National Diabetes Advisory Board standards as health care practitioners eligible to receive payments. Industry groups have proposed the pharmacists certified as diabetes educators or carrying 16 or more hours of continuing education in the subject should be included.

HCFA says eligibility for the program could expand to include pharmacists, but no expansion can be made until 1999 under its guidelines.

For more details, call AphA at (800) 237-2742.