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October 10, 2017

Every Friday morning in the glorious, high desert town of Santa Fe, New Mexico, a 77-year-old retired nurse is being treated at a community cancer center for metastatic breast cancer. Stricken with a form of the disease in 1984 that had migrated to her lymph nodes, she underwent a unilateral mastectomy, radiation, chemotherapy and anti-hormonal therapy. She was lucky–and a beneficiary of late-20th century surgery, medicine and drug development–living another 30 years cancer-free. At the end of her diverse nursing career in hospitals and private medical practices in northern New Jersey, she was running clinical trials of drugs for HIV/AIDS patients.

When she developed back and hip pain three years ago, she first wrote it off as the wear-and-tear from decades of lifting patients out of beds. But when the pain couldn’t be resolved with medicine, PET and CT scans revealed that her dormant breast cancer had reappeared in her pelvis and vertebrae, with some metastases to her liver.

But three more decades of drug development and advances in radiation therapy have bought her even more time. In fact, every single drug she has been given since her 2014 recurrence was not available in 1984: letrozole (Femara), palbociclib (Ibrance), capecitabine (Xeloda), paclitaxel (Taxol) and gemcitabine (Gemzar). Two other biologic treatments have also been essential: filgrastim (Neupogen) is a white blood cell growth factor that allows her bone marrow to recover faster from chemotherapy drugs and denosumab (Xgeva) prevents fractures due to an imbalance in bone signaling in response to the cancer cells.

I mention these medical case details for two reasons. First, the patient is my mom. Second, the two biologic treatments (Neupogen and Xgeva) she’s received during her treatment are manufactured by Amgen in their plant in Puerto Rico. Since Hurricane Irma grazed the US island commonwealth and Hurricane Maria scored a direct hit, patients like my mom have been concerned, not only for the people of Puerto Rico but also for the continued availability of drugs they need for their continued survival.

Headquartered in Thousand Oaks, California, Amgen operates a 2,000-person biopharmaceutical manufacturing plant in Juncos, Puerto Rico. Juncos a town of 40,000 residents in eastern central Puerto Rico that also counts Medtronic and Becton Dickinson as employers. Juncos is only about 17 miles inland from Yabucoa Harbor, the site where Hurricane Maria made landfall on September 20. According to a Washington Post article four days later, thousands of homes in Juncos were damaged and the mountains around the city were denuded of vegetation.

Within two days, Amgen was already assisting staff and their families with pay continuity assurances and disaster relief funds in the form of grants up to $5,000 to cover expenses for shelter, transportation, medical expenses and clothing, a pledge of $3 million to the surrounding community for immediate relief and another $2 million for rebuilding efforts. While critical manufacturing areas did not sustain substantial damage, the facility was running on diesel-powered electric generators fueled by deliveries from existing contracts. Those diesel generators are capable of supplying power to the entire facility at full production. Some of that fuel was also shared with the community for the local hospital, dialysis center and a grocery store.

By the end of the following week, Amgen reported that several hundred of their employees were making it into work and keeping the plant running. “We have been heartened by the response from so many of our dedicated staff members. Despite the hardships they are facing with damage to their homes and lack of power and water on the island, their commitment to the Amgen Operations motto of ‘every patient, every time’ is admirable,” wrote Kristen Davis, director of Amgen’s global media relations.

Over this past weekend, Amgen released more details on the current state of operations. Some local water service has returned that has been augmented by Amgen’s own on-site wells and storage tanks. The plant has some satellite and microwave telecommunications capacity and has already sent their first drug shipments since the hurricane. About 40% of their staff–800 employees–are already back full-time and they expect to reinitiate bulk drug production, formulation, filling and packaging within the next several weeks.

As the company announced the Monday after the hurricane, they do not expect any shortages of products made in Puerto Rico, in part because their continuity plan allowed for production lines at other sites to be FDA-licensed to produce some pharmaceuticals normally made in Juncos. Amgen was the only company to release to me a full list of the products made at their Puerto Rico plant:

-Aranesp (darbepoetin alfa)

-Enbrel (etanercept)

EPOGEN (erythropoetin)

Neulasta (pegfilgrastim)

-NEUPOGEN (filgrastim)

-Vectibix (panitumumab)

-Repatha (evolucomab)

-Prolia (60 mg denosumab for osteoporosis)

-XGEVA (120 mg denosumab for fracture prevention with bone metastases)

-Sensipar/Mimpara (cinacalcet)

-Nplate (romiplostim)

-Corlanor (ivabradine)

According to the American Society of Health-Systems Pharmacists, Amgen has a particularly good drug supply record and was the only pharmaceutical company to have no U.S. drug shortages between 2011 and 2015. Amgen is one of five companies with Puerto Rico plants who are working closely with the FDA to prevent any drug shortages. The FDA currently has a watchlist of over 40 medicines they have deemed as high-priority to maintain supplies, such as cancer drugs and immunosuppressants for transplant patients.

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