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4% Incr

Fig. 1.5. Health Care Improvements

Fig. 1.5. Health Care Improvements of existing drugs (e.g., statin drugs for cholesterol), (6) new technology (devices) (e.g., implantable defibrillators), and (7) improved surgical techniques (e.g., in stroke, carotid endaterectomy, or early aneurysm surgery) [3, 5, 7, 8].

Health care costs have risen significantly by $2,254 (102%) per person per year over the past 20 years, but major health gains have been achieved during this timeframe. Figure 1.5 suggests that improved health care has benefited several diseases, with overall disability rates decreasing over the past 20 years by about 25%. The overall number of hospital days fell 56% from 129.7 to 56.6 per 100 persons, suggesting, to some extent, better population health. Death rates for heart attacks, stroke, and breast cancer have improved 46%, 37%, and 21%, respectively. All cancer deaths have been reduced by 10% in past 12 years. Overall death rates have been reduced by 16%, and life expectancy has risen by about 4% (3.2 years). Another way to look at health gains is to document the financial benefits (in dollars gained) from disease improvement for each $1 invested in health care. Each dollar invested in therapy of breast cancer is estimated to result in a $4.50 health gain; for stroke, $1.55 gain; for diabetes melli-tus, $1.49; and for heart attacks, $1.10—besides the benefits of less trauma and family disruption. These health gains likely relate to improved diagnosis and care, better drug therapies, and better health awareness and preventative care [9].

Science is advancing at an ever increasing pace and changing the face of both the diagnosis and therapy of disease with dramatic new findings, and hence health care advances with it. The best example perhaps is cancer with the associated new benefits of extended life measured in years, but the benefits add major new costs to the health care system. In the 1950s and 1960s, a cancer diagnosis was the death sentence for patients in nearly all diseases, and the therapies were limited primarily to cell poisons, such as antimetabolites and alkylating agents with very debilitating and major life-threatening toxicities. Biology and drug research improved to a point in the 1970s and 1980s to create some new classes of life-extending drugs (e.g., tax-anes, platins, topoisomerase inhibitors, and aromatase inhibitors). Now in the 1990s and the dawn of the 21st century,

Targets:

k Oncogenes

- Lymphocyte CD-20

k Tyrosine kinase receptors k Proteosome inhibitors

- EGFR inhibitors r VEGF inhibitors / Angiogenesis r VEGF trap k Aurora kinase inhibitors k Cancer cell k Anti- sense inhibitor k Apoptosis enhancing k Ribonuclease (RNA enzyme) k Endothelin A antagonist

Company :

k Genetech (Herceptin) k Idec-Biogen (Rituxan) k Astra-Zeneca (Iressa) k Millennium (Velcade) k Imclone(Erbitux), OSI (Tarceva) r Genentech (Avastin) r Regeneron (VEGF trap)

k Dendreon (Vaccine) k Isis (Affinitak) k OSI (Exisulind) k Alfacell (Onconase)

- Abbott(Xinlay)

Fig. 1.6. Biotechnology & Cancer - New Science

Patients & Disease :

r Aging population r Advances in science (Disease biology, Genomics)

r Oncology - chronic disease r Pharmacoeconomic data demands r Medication safety focus (IOM,Businesses)

Health Care Delivery :

r Patient care from hospital to ambulatory r Guidelines for disease & treatment r Government regulations (R&D & S&M)

r Payers for drugs (Insurance & Medicare)

r Costs for health care & drugs

Fig. 1.7. Trends (2000+) & R & D Impacts biotechnology is unlocking many secrets of genetics, pro-teomics, and especially intracellular function, such that new targets and new drugs, as well as whole new categories of therapeutics, are available to support and treat the cancer patient (Fig. 1.6). The complications of cancer and its drug therapies, that is, anemia, neutropenia, and mucositis, can be controlled with protein growth factors. Monoclonal antibodies have been humanized and conjugated; they are now available to attack oncogenes or cellular nucleotide polymorphisms and carry risks of less toxicity than the cell poisons. Vaccines to treat cancer are under study. Aberrant intracellular functions are now discovered as new added mechanisms of cancer cell growth and can be mitigated through these various newly identified mechanisms, such as tyrosine kinase inhibitors, proteasome inhibitors, angiogenesis inhibitors, and ubiquitin alteration, as represented in Figure 1.6.

In summary, what are the health care trends in the 20th century and the birth of the 21st century that have and will impact research and development of drugs and biologicals? We are observing changes in the patient pool, science, health care delivery, and its finances. Ten factors impacting R&D are listed in Figure 1.7 and discussed here [4, 10-14]. (1) The aging population creates a rapidly growing pool of older patients who also are living much longer, especially over the next 30 years as the baby boomers reach 60 years plus of age. Also, these people will retire and seek more active lifestyles and demand a better quality of life than previous generations. The older patient has multiple diseases and often more advanced disease. Prescription drug use in the elderly (65 years old and over) is 84% vs. 35% for 18-44 years old and 62% for 45-64 years old. The larger number of older and more complex patients creates an opportunity for research and new products for the industry.

(2) Sciences of molecular biology, genomics, proteomics, and pharmacogenomics, along with medicinal chemistry, are discovering new disease mechanisms and possibilities for drug intervention. More drug use is occurring in the population in general, especially multidrug use (three or more drugs; e.g., 12% of population in 1988-1994 vs. 17% in 1999-2000). Medical visits with prescriptions for five or more drugs rose from 4.1% in 1995-1996 to 6.7% of population in 2001-2002. Categories for increases in drug use were broad (e.g., drugs for pain, depression, hyperlipidemia, hypertension, asthma, allergies, and diabetes). (3) Oncology therapy has advanced with more and more patients living for years instead of months, because of novel therapies that are more effective and less toxic, along with more supportive protective products. (4) The health care providers and payers want new data for drugs regarding their overall impact on health, quality-of-life, and delivery of care, in addition to safety and efficacy. Pharmacoeconomic studies now need to done routinely by pharmaceutical companies before the health care systems will accept new drugs. (5) Medication safety causing morbidity, lost work, and mortality continues to be a major health issue, especially for adverse events and their prediction, prevention, and management. The Institute of Medicine (IOM) in 1999 raised the public awareness along with business groups, such as the Leapfrog group. The cost of adverse events and medical errors includes an estimated 40,000 to 100,000 deaths per year and a cost of $29 million for health care costs and lost productivity. Adverse drug events have increased, for example, to being responsible for 4.8 emergency room visits per 1,000 persons by 1999-2000, doubling from 1992 to 1993. More safe drugs are needed.

Health care delivery changes also significantly impact R&D for drugs and biological products. (1) The site of care of patients is moving from hospitals to outpatient environments, which changes the types of drugs needed to care for patients. Of course, oral agents are the preferred choice in an ambulatory or home setting, but as many more patients with more serious diseases are treated more often at home, injectible drugs are being used much more frequently. Many examples now exist for such injectible drugs being used for chronic conditions and at home (e.g., Aranesp® and Procrit® for anemia of cancer, beta-interferons [Avonex® and Rebif®] for multiple sclerosis, and Remicade® and Enbrel® for rheumatoid arthritis). (2) and (3) Guidelines for the diagnosis and treatment of diseases in most organ systems are now commonplace. Many groups create such guidelines; for example, government (National Institutes of Health, and Agency for Health Care Research); societies (American Heart Association, American Society of Clinical Oncology); institutions (National Cancer Center Network; and individual university hospitals). A company must keep abreast of all these sources of health care decisions, which can change therapy and drug choices while they are studying a new drug based on prior guidelines in place. (4) Payers' role in health care has grown and changed how health care is delivered and financed. Insurance companies, for example, employ a variety of mechanisms; they use prescription benefits managers to track drug use and even change a physician's drug choices, require health maintenance organizations to deliver care instead of private physicians and offer drug choices at reduced costs, demand more novel products with overall health cost data, and have referral systems and negotiated rates for physician services. Medicare now pays for oral drugs for chronic disease in the elderly population, extending access to drugs but then influencing health delivery and drug choices. (5) The rising cost for health care and especially the cost of drugs at double digit rates can become an impediment to R&D investment, if perceived by the public and government as excessive and not of sufficient value. Companies are and must look at the financial return on R&D investment for new drugs, such that, for example, antibiotics are being developed less often, related to their short-term use and restrictions in use for new, even advanced, drugs. As noted earlier, requirements for pharmacoeconomic research have grown substantially in the past 10-15 years to meet the demands for such data by health systems and to establish the overall value of a new drug.

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