Pharmaceutical and biotechnology companies with a physical presence in New York State are currently developing more than 680 medicines and vaccines for several diseases, including many of the leading causes of disease death—heart disease, cancer, stroke, chronic obstructive pulmonary disease, diabetes and pneumonia.
New York is home to nearly 1/3 of all active clinical trials conducted in the U.S. Scientists and researchers conducted 3,877 studies in New York last year in order to develop medicines targeting cancers, rare diseases and other important conditions. Nationally, U.S. researchers conducted 15,13 active trials in 2010.
In New York, biopharmaceutical companies invested $2.1 billion in R&D in 2008. Nationally, biopharmaceutical companies invested approximately $51.0 billion in U.S. research and development in 2008, or $77,860 per direct employee.
Despite the economic downturn, pharmaceutical companies spent more than $2.1 billion on research and development in New York, and are continuing efforts to develop nearly 3,000 new medications, including drugs for cancer, heart disease and stroke, high blood pressure, diabetes, Alzheimer’s disease, HIV/AIDS and other infectious diseases.
Check back frequently for a monthly focus on a certain disease, new meds being developed for that particular disease, and notices of drug trials occurring near you.
271 New Vaccines in Biopharmaceutical Pipeline
America’s biopharmaceutical companies are currently developing 271 vaccines to prevent – and in some cases treat – a variety of conditions, including infectious diseases, various forms of cancer and neurological disorders, according to a September 2013 report.
These potential vaccines – all in human clinical trials or under review by the Food and Drug Administration (FDA) – include 137 for infectious diseases, 99 for cancer, 15 for allergies and 10 for neurological disorders. Examples include:
New Medicines To Meet Special Needs of Children
Biopharmaceutical research companies are currently testing nearly 300 new medicines to meet the unique needs of infants, children and adolescents, according to a 2012 report. The new medicines are either in clinical trials or under review by the Food and Drug Administration. Nearly 50 of the new medicines are being developed by biopharmaceutical companies in New York.
Cancer is still the leading cause of death among diseases for children but thanks to major treatment advances, 82 percent of children diagnosed in recent years will survive five years or longer, compared to 58 percent 30 years ago.
Besides cancer, other new medicines are being developed for infectious diseases, genetic disorders, neurological disorders, respiratory disorders and cardiovascular disease.
New Medicines and Vaccines for HIV/AIDS
Biopharmaceutical research companies are currently developing 88 new medicines and vaccines for the HIV infection, according to a 2011 report.
Although the rate of new infections may be declining in other countries it continues to rise in the United States. Some 110,000 people are currently infected with HIV in New York City. These cases in New York City represent about 75 percent of all HIV cases in the entire state of New York. Studies have shown that education and testing combined with early treatment is an effective strategy to combat the spread of the epidemic. New York City’s Health Commissioner Thomas Farley wants to start treating individuals diagnosed with HIV more aggressively. In early December 2011, Farley’s office released guidance that recommends patients diagnosed with HIV be offered antiretroviral drugs as soon as they are diagnosed. A copy of the Commissioner’s letter can be accessed here.
The conventional protocol has been to delay placing patients on the drug protocol until the individuals’ immune system had show signs of weakening. Indeed, the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents has been evenly divided on initiating early drug therapy or leaving it elective. Some HIV experts worry about possible side effects, patient adherence and drug resistance stemming from long term use. The cost of the drugs is also a concern for consumers.
Commissioner Farley is convinced that the benefits of early drug therapy outweigh the potential risks. Experts believe early drug therapy can allow patients to enjoy healthier lives and dramatically cut HIV transmission rates. In a country where more than 56,000 people are newly infected with HIV each year, many believe Commissioner Farley’s bold action is necessary. City health officials anticipate that the costs would be covered by private insurance or by the AIDS Drug Assistance Program. Many expect the long-term benefits of the drug therapy to far outweigh initial cost concerns.
Biotechnology Medicines in Development
According to a recent report, there are currently more than 900 new medicines and vaccines in development in New York using biotechnologies. Biotechnology medicines are developed through biological processes using living cells and organisms, rather than the traditional chemical synthesis approach.
Medicines and vaccines are being developed for a multitude of diseases including colorectal, lung, skin, breast, liver, gastric, bladder and prostate cancer, rheumatoid arthritis, lupus, lymphoma, high cholesterol, type II diabetes, colitis, Crohn’s, macular degeneration, Gaucher’s disease, HIV prevention, anthrax, hepatitis B, herpes, meningitis, gout, osteoporosis, Alzheimer’s, asthma, and psoriasis.
The Value of Medicines
Prescription medicines play a key role in maintaining health, reducing mortality, preventing emergency room visits and hospitalizations, and improving worker productivity. Research establishes that proper use of medicines yields improved health outcomes, while treatment gaps and lack of adherence to physician prescribed treatment with medicines lead to higher spending on otherwise avoidable medical care. The evidence shows that the potential cost savings on other services from appropriate use of medicines can be significant, particularly for the growing number of Americans with chronic health conditions. Policymakers, employers, health plans and other stakeholders should consider these potential savings in their efforts to promote higher quality, more affordable health care.
In the last ten years, over 300 new medicines have been approved by the FDA. These medicines are helping patients live longer, healthier lives. They are transforming many cancers into treatable conditions, reducing the impact of cardiovascular disease, offering new options for patients with hard-to-treat diseases like Alzheimer’s and Parkinson’s, and fighting even the rarest conditions.
Increasing Life Expectancy
Since 1950 life expectancy for men and women in the US has increased by nearly a decade. In 1950, men could expect to live to 66 years and women 71 years.[i] By 2007, life expectancy was up to 75 years for men and 80 years for women.[ii] Life expectancy is continuing to rise.
A 2008 study by Harvard University researchers found that between 1984 and 2005 disability in the elderly population fell by 20 percent.[iii] For cardiovascular disease, researchers reported that medicines and other treatments increased the chances an elderly patient would survive a cardiovascular event without becoming disabled by 50 percent.
Life expectancy is increasing for cancer patients because of medicines. Since 1980 life expectancy for cancer patients has increased by 3 years and 83 percent of those gains are directly attributable to new treatments, including medicines.[iv] Another study found that medicines specifically account for 50-60 percent of increases in survival rates since 1975.[v]
Cancer death rates are down. Advances in treatment have helped speed the pace of improvements in cancer death rates between 1990 and 2006; cancer death rates fell an average of 1.6 percent per year between 2001 and 2006, compared with a drop of just 0.3 percent in 1990-1993.[vi]
Five-year cancer survival rate is rising. The chances that a cancer patient will live at least 5 years increased from 50 percent in 1975 to 68 percent in 2002.[vii] Between 1975 and 2002, 5-year survival went up 20 percent for women with breast cancer, 48 percent for men with prostate cancer, 35 percent for colon and rectum cancer, and 35 percent for lung and bronchus cancer.[viii]
Deaths from heart disease and stroke fell 29% between 1999 and 2006.[ix] According to the Centers for Disease Control and Prevention, new medicines contribute to improving trends in cardiovascular disease, as well as better control of risk factors, early detection, better treatment and expanded uses for existing drugs.[x]
Heart failure and heart attack death rate fell by nearly half 1999-2005. Death rates for heart attack patients in hospitals decreased from 8.4 percent in 1999 to 4.6 percent in 2005. The researchers point to the increased use of blood thinners, cholesterol drugs, and angioplasties as a direct cause of lowered rates of death and heart failure.[xi]
Blood pressure medicines save lives and prevent hospitalizations, but even more could be saved if all patients received recommended care. Use of antihypertensive medicines prevented 86,000 premature deaths from cardiovascular disease in 2001 and 833,000 hospitalizations for heart attack and stroke in 2002.[xii]
Life with HIV/AIDS has changed dramatically; death rates are down. Patients diagnosed with AIDS in 1990 could expect to live only 26 months and the only treatment available had to be taken every four hours and had significant side effects. Since the approval of anti-retroviral treatments (ART) in 1995, the AIDS death rate has dropped by over 75 percent.[xiii] If diagnosed today, earlier use of medicines is recommended before the CD4 cell count drops to a dangerous level. Furthermore, medicines have become easier to use with the invention of once-daily, one-dose pill combination tablets.
Diabetes patients are living longer than diabetic patients diagnosed only a decade or two ago.”[xiv] In recent years eight new classes of diabetes medicines have been approved, giving patients and providers powerful new tools to treat the condition so that they can stay out of the hospital.
Diabetes patients treated with medicines are less likely to develop other health problems. Diabetes patients who are treated with diabetes medicines are 31 percent less likely to develop lipid disorders and 13 percent less likely to develop high blood pressure than untreated patients.[xv]
Clinical remission is now possible for patients with severe rheumatoid arthritis.[xvi] Studies have shown that that patients treated with combination therapy consisting of both a new and older medicine had a 50 percent chance of complete clinical remission after 52 weeks of treatment, compared with 28 percent taking only the older medicine.
Osteoporosis medicines greatly reduce the risk of fractures when taken consistently. Patients who are over 80 percent adherent to their osteoporosis medicines have a 25 percent lower rate of fractures compared with those who are less adherent. [xvii] Those who are the least adherent have a 40 percent increased risk.
Medicines are life saving and enhancing for patients only if they are used exactly as prescribed. Yet research shows that medicines commonly are not used as directed. Nonadherence to medicines is a major health care cost and quality problem, with numerous studies showing high rates of nonadherence directly related to poor clinical outcomes, high health care costs and lost productivity. The cost of nonadherence has been estimated at $100 billion to $300 billion annually, including costs from avoidable hospitalizations, nursing home admissions and premature deaths.[xviii]
Adherence to therapy is especially important for management of chronic diseases, such as diabetes, heart diseases and cancer. Chronic disease affects nearly one in two Americans and treating chronically ill patients accounts for $3 out of every $4 spent on medical care.[xix]
Patients who are adherent spend more on medicines but less on medical care. According to a recent Health Affairs study in 2011 [xx], adherent patients spend more on prescription medicines than nonadherent patients, but their additional drug spending was more than offset by substantial reductions in spending on other medical care. Patients with chronic conditions who took their medicines as prescribed achieved total health care savings ranging from $1,200 to $7,800 per patient per year and every additional dollar spent on medicines generated between $3 and $10 dollars in savings on medical care.
[i] U.S. Department of Health and Human Services, CDC, National Center for Health Statistics, Health United States, (Hyattsville, MD), http://www.cdc.gov/nchs/data/hus/hus09.pdf, 2010.
[ii] U.S. Department of Health and Human Services, CDC, National Center for Health Statistics, National Vital Statistics Reports, Vol. 58, No. 19, May 2010,(Hyattsville, MD), http://www.cdc.gov/nchs/data/nvsr/nvsr58/nvsr58_19.pdf.
[iii] D.M. Cutler, M.B. Landrum, K.A. Stewart, “Intensive Medical Care and Cardiovascular Disease Disability Reductions,” in David Cutler and David Wise, eds., Health at Older Ages: The Causes and Consequences of Declining Disability Among the Elderly, (Chicago:University ofChicago Press, 2008), p. 191-222.
[iv] E. Sun, et al., “The Determinants of Recent Gains in Cancer Survival: An Analysis of the Surveillance, Epidemiology, and End Results (SEER) Database,” Journal of Clinical Oncology, May 2008 Suppl (Abstract 6616).
[v] F. Lichtenberg, “The Expanding Pharmaceutical Arsenal in the War on Cancer,” NBER Working Paper 10328, February, 2004.
[vi] B.K. Edwards, et al. “Annual Report to the Nation on the Status of Cancer, 1975-2006, Featuring Colorectal Cancer Trends and Impact of Interventions (Risk Factors, Screening and Treatment) to Reduce Future Rates,” Cancer, 1 (February 2010): 544-573.
[vii] National Cancer Institute, Surveillance Epidemiology and End Results, http://seer.cancer.gov/faststats/index.php, accessed 27 May 2010.
[viii] National Cancer Institute, Surveillance Epidemiology and End Results, http://seer.cancer.gov/faststats/index.php, accessed 23 July 2010.
[ix] D. Lloyd-Jones, et al., “Heart Disease and Stroke Statistics 2010 Update: A Report from the American Heart Association,” Circulation, published online 17 December 2009.
[x] Centers for Disease Control and Prevention, “National Center for Health Statistics.Health,United States, 2006 With Chartbook on Trends in the Health of Americans.” http://www.cdc.gov/nchs/hus.htm>
[xi] K. Fox, et al., “Decline in rates of Death and Heart Failure in Acute Coronary Syndromes, 1999-2006,” Journal of the American Medical Association, 297 (2 May 2007): 17, 1892-1900.
[xii] D.M. Cutler, G. Long, E.R. Berndt, et al., “The Value of Antihypertensive Drugs: A Perspective on Medical Innovation”, Health Affairs, 26(2007): 97-110.
[xiii] Center for Disease Control and Prevention, National Center for Health Statistics, Health, United States, 2009 with Special Feature on Medical Technology, Table 38, (Hyattsville, MD: 2010) http://www.cdc.gov/nchs/data/hus/hus09.pdf.
[xiv] J.B. Brown, G.A. Nichols, and A. Perry, “The Burden of Treatment Failure in Type 2 Diabetes,” Diabetes Care, 27 (July 2004): 7, 1535-1540.
[xv] PharMetrics, Examination of Treatment Patterns and Effects of Medication-Taking Behaviors Among Patients with Diabetes, (Watertown,MA: PharMetrics, 2004) (research supported by PhRMA).
[xvi] P. Emery, et. al., “Comparison of Methotrexate Monotherapy with a Combination of Methotrexate and Etanercept in Active, Early, Moderate to Severe Rheumatoid Arthritis (COMET): A Randomized, Double-Blind, Parallel Treatment Trial,” The Lancet, 372 (August 2008): 9636, 375-382.
[xvii] J.J. Caro, et al. “The Impact of Compliance with Osteoporosis Therapy on Fracture Rates in Actual Practice,” Osteoporosis International, 15 (2004): 12, 1003-1008.
[xviii] L. Osterberg and T. Blaschke. “Adherence to Medication,” New England Journal of Medicine, August 2005 and M.R. DeMatteo, “Variation in Patients’ Adherence to Medical Recommendations: A Quantitative Review of 50 Years of Research,” Medical Care, March 2004.
[xix]US Centers for Disease Control and Prevention, “Chronic Disease Overview,” available at www.cdc.gov/nccdphp/overview.htm, accessed November 14, 2008.
[xx] M.C. Roebuck et al. “Medical Adherence Leads to Lower Health Care Use And Costs Despite Increased Drug Spending.” Health Affairs, January 2011.