regarding the BETASERON decision case, i have identified community, and emoloyees of Betaseron company as stakeholders. can someone help me explain comminity and employees stakes in this case ?

this is the case

The Betaseron Decision (A)' The United States Food and Drug Administration's (FDA) approval of interferon beta-lb (brand name Betaseron) made it the first multiple dierosis (MS) treatment to get FDA approval in 25 years, Betaseron was developed by Barlex Laboratories, a US wit of Schering AG, the German pharmaceutical company Berlex handled odinical development trials and marketing of Ukong while Chiron Corporation, biotechnology for based in California, manufactured it. The groundbreding approval of Betaseron repre Kented not only a great opportunity for Berkex but dilemma. Supplies were insufficient to meet initial demand and shortages were forecast for three years. With Insufficient supplies and staggering development costs, how would Berlex allocate and price the drug! such as seeing, walking, and talking The nerve fibers in the brain and spinal cord are surrounded by mye. lin, a fatty substance that protects the nerve fibers in the same way that insulation protects electrical wires, When the myelin insulation becomes damaged the ability of the central nervous system to transmit nerve impulses to and from the brain becomes impaired. With MS. there are sclerosedle scarred or hardened) areas in multiple parts of the brain and spinal cord when the immune system mistakenly attacks the myelin sheath. THE CHALLENGE OF MULTIPLE SCLEROSIS MS is a disease of the central nervous system that interferes with the brain's ability to control functions The au w papered by Ann K. Repers This was from wesoly for pose of imating dins de wreat The who Dr. Stephen Reg Rach Medical Prem Neto A Rodella Servis A Get Coate com AB y the North American Car Audio NAUwi per The Impact of MS The symptoms of MS depend to some extent on the location and size of the sderosis. Symptoms may include numbness slurred speech. blurred vision poor coordination, muscle weakness, bladder dysfunc tion, extreme fatigue, and paralysis. There is no way to know how the disease will progress for any individual because the nature of the disease can change. Some people will have relatively benigs course of MS with only one or two mild attacks nearly complete remission, and no permanent, disability. Others will have a chroni progressive course resulting save disability. A third group displays the most typical pat tern, which is periods of cacerbations when the dis case is active and periods of when symptoms receckt. yet generally leave some damage People with MS live with an exceptionally high degree of uncertainty cause the disease can change from one day to the next Dramatic downturns as well as dramatic recoveries are not uncommon instead of the customary 3. As a result, Berlex was unprepared to manufacture and distribute the treat ment. Chiron Corporation had been making the drug in small quantities for experimental use and did not have the manufacturing facilities to handle the expected explosion in demand. Chiron estimated that it would have enough of the drug for about 12.000-20.000 people by the end of the year. By the end of the second year, Chiron expected to be able to provide the drug to 40,000 patients. Depending on demand, it might take about three years to provide the drug to all patients who requested it. Chiron's expanded manufacturing represented the only option for Berlex because the process required for another company to get FDA approval to manufacture the drug would take even longer. THE PROMISE OF BETASERON Interferon beta is a naturally occurring protein that regulates the body's immune system. Betaseron is composed of interferon beta-Ib that has been geneti- cally engineered and laboratory manufactured as a recombinant product. Although other interferons (ie, alpha and gamma) had been tested, only beta interferon had been shown, through large-scale trials, to affect MS. Because it is an immunoregulatory agent, Betaseron was believed to combat the immune problems that make MS worse. However, the exact way in which it works was yet to be determined. Research In clinical studies, Betaseron was shown to reduce the frequency and severity of exacerbations in ambulatory MS patients with a relapsing-remitting form of the dis- case. It did not reverse damage nor did it completely prevent exacerbations. However, Retuscron could dra matically improve the quality of life for the person with MS. For example, people taking Bataserer wete shown to have fewer and shorter hospitaliu feron represented the first and only drugs usert on the frequency of exacerbution Administration Betaseron is administered subcutaneously (under the skin) every other day by self-injection. To derive the most benefits from the therapy, it was important that the MS patient maintain a regular schedule of the injections. Some flu-like side effects, as well as swelling and irritation around the injection, had been noted. However, these side effects tended to decrease with time on treatment. In addition, one person who received Betaseron committed suicide, while three others attempted it. Because MS often leads to depression, there was no way to know whether the administration of Betaseron was a fac tor. Last, Betaseron was not recommended for use during pregnancy THE BETASERON DILEMMA FDA approval for Betaseron allowed physicians to prescribe the drug to MS patients who were ambula tory and had a relapsing-remitting course of MS. An estimated one-third of the 300,000 people with MS in the United States fell into that category, resulting in a potential client base of 100,000. The expedited FDA approval process for Betaseron took only 1 year Pricing In addition to availability. price was a concern because successes must fund the failures that precede them. Betaseron represented years of expensive, risky research by highly trained scientists in modern research facilities. Furthermore, genetically engi- neered drugs were extremely expensive to manufac ture. In the case of Betaseron, a human interferon gene is inserted into bacteria, resulting in a genetically engineered molecule. The stringent quality controls on the procedure take time and are expensive. As a result, the price of Betaseron was expected to be about $10,000 per year for each patient. Betaseron brought great hope to people with MS and a great quandary to Be He should Berles handle the supply limitations, the distribution, and the pricing of this drug! QUESTIONS FOR DISCUSSION 1. What are the ethical issues in this situation? Which issues must Berlex consider first when determining how to distribute Betaseront 2. Given the shortage of the drug how should Berlex decide who receives it and who waits? Give a specific plan. 3. How should Berlex handle the logistics of distribution! 4. How should Berlex determine the drug's relative pricing (assume the drug costs about $12.000 per year) 5. Who, if anyone should be involved in the decision making! The Betaseron Decision (A)' The United States Food and Drug Administration's (FDA) approval of interferon beta-lb (brand name Betaseron) made it the first multiple dierosis (MS) treatment to get FDA approval in 25 years, Betaseron was developed by Barlex Laboratories, a US wit of Schering AG, the German pharmaceutical company Berlex handled odinical development trials and marketing of Ukong while Chiron Corporation, biotechnology for based in California, manufactured it. The groundbreding approval of Betaseron repre Kented not only a great opportunity for Berkex but dilemma. Supplies were insufficient to meet initial demand and shortages were forecast for three years. With Insufficient supplies and staggering development costs, how would Berlex allocate and price the drug! such as seeing, walking, and talking The nerve fibers in the brain and spinal cord are surrounded by mye. lin, a fatty substance that protects the nerve fibers in the same way that insulation protects electrical wires, When the myelin insulation becomes damaged the ability of the central nervous system to transmit nerve impulses to and from the brain becomes impaired. With MS. there are sclerosedle scarred or hardened) areas in multiple parts of the brain and spinal cord when the immune system mistakenly attacks the myelin sheath. THE CHALLENGE OF MULTIPLE SCLEROSIS MS is a disease of the central nervous system that interferes with the brain's ability to control functions The au w papered by Ann K. Repers This was from wesoly for pose of imating dins de wreat The who Dr. Stephen Reg Rach Medical Prem Neto A Rodella Servis A Get Coate com AB y the North American Car Audio NAUwi per The Impact of MS The symptoms of MS depend to some extent on the location and size of the sderosis. Symptoms may include numbness slurred speech. blurred vision poor coordination, muscle weakness, bladder dysfunc tion, extreme fatigue, and paralysis. There is no way to know how the disease will progress for any individual because the nature of the disease can change. Some people will have relatively benigs course of MS with only one or two mild attacks nearly complete remission, and no permanent, disability. Others will have a chroni progressive course resulting save disability. A third group displays the most typical pat tern, which is periods of cacerbations when the dis case is active and periods of when symptoms receckt. yet generally leave some damage People with MS live with an exceptionally high degree of uncertainty cause the disease can change from one day to the next Dramatic downturns as well as dramatic recoveries are not uncommon instead of the customary 3. As a result, Berlex was unprepared to manufacture and distribute the treat ment. Chiron Corporation had been making the drug in small quantities for experimental use and did not have the manufacturing facilities to handle the expected explosion in demand. Chiron estimated that it would have enough of the drug for about 12.000-20.000 people by the end of the year. By the end of the second year, Chiron expected to be able to provide the drug to 40,000 patients. Depending on demand, it might take about three years to provide the drug to all patients who requested it. Chiron's expanded manufacturing represented the only option for Berlex because the process required for another company to get FDA approval to manufacture the drug would take even longer. THE PROMISE OF BETASERON Interferon beta is a naturally occurring protein that regulates the body's immune system. Betaseron is composed of interferon beta-Ib that has been geneti- cally engineered and laboratory manufactured as a recombinant product. Although other interferons (ie, alpha and gamma) had been tested, only beta interferon had been shown, through large-scale trials, to affect MS. Because it is an immunoregulatory agent, Betaseron was believed to combat the immune problems that make MS worse. However, the exact way in which it works was yet to be determined. Research In clinical studies, Betaseron was shown to reduce the frequency and severity of exacerbations in ambulatory MS patients with a relapsing-remitting form of the dis- case. It did not reverse damage nor did it completely prevent exacerbations. However, Retuscron could dra matically improve the quality of life for the person with MS. For example, people taking Bataserer wete shown to have fewer and shorter hospitaliu feron represented the first and only drugs usert on the frequency of exacerbution Administration Betaseron is administered subcutaneously (under the skin) every other day by self-injection. To derive the most benefits from the therapy, it was important that the MS patient maintain a regular schedule of the injections. Some flu-like side effects, as well as swelling and irritation around the injection, had been noted. However, these side effects tended to decrease with time on treatment. In addition, one person who received Betaseron committed suicide, while three others attempted it. Because MS often leads to depression, there was no way to know whether the administration of Betaseron was a fac tor. Last, Betaseron was not recommended for use during pregnancy THE BETASERON DILEMMA FDA approval for Betaseron allowed physicians to prescribe the drug to MS patients who were ambula tory and had a relapsing-remitting course of MS. An estimated one-third of the 300,000 people with MS in the United States fell into that category, resulting in a potential client base of 100,000. The expedited FDA approval process for Betaseron took only 1 year Pricing In addition to availability. price was a concern because successes must fund the failures that precede them. Betaseron represented years of expensive, risky research by highly trained scientists in modern research facilities. Furthermore, genetically engi- neered drugs were extremely expensive to manufac ture. In the case of Betaseron, a human interferon gene is inserted into bacteria, resulting in a genetically engineered molecule. The stringent quality controls on the procedure take time and are expensive. As a result, the price of Betaseron was expected to be about $10,000 per year for each patient. Betaseron brought great hope to people with MS and a great quandary to Be He should Berles handle the supply limitations, the distribution, and the pricing of this drug! QUESTIONS FOR DISCUSSION 1. What are the ethical issues in this situation? Which issues must Berlex consider first when determining how to distribute Betaseront 2. Given the shortage of the drug how should Berlex decide who receives it and who waits? Give a specific plan. 3. How should Berlex handle the logistics of distribution! 4. How should Berlex determine the drug's relative pricing (assume the drug costs about $12.000 per year) 5. Who, if anyone should be involved in the decision making