2011: A Year of Important Pharmacological Advances for Patients
December 21, 2011
http://www.innovation.org/index.cfm/NewsCenter/Newsletters?NID=193
New advances in biopharmaceuticals came as welcome good news for U.S. patients. In recent years, despite increasing investments in R&D, fewer medicines have recieved approval, reminding us just how difficult drug discovery is. But in 2011 there were more new medicines approved than in recent years and these approvals represented important advances in many areas.
The Food and Drug Administration reported in November that in fiscal year 2011 (10/1/10–9/30/11) there were 35 new medicines approved,[i] among the highest in the last decade. According to the FDA report, "few years have seen as many important advances for patients." The final tally of medicines approved in calendar year 2011 waits to be seen but it is clear that 2011 has been a great year for advancing the fight on many disease fronts. Below is information on some of the treatments highlighted in the FDA report.
Cancer: With improvements in early detection and a steady stream of new and enhanced treatments cancer can be more effectively managed and even beaten. Two new personalized medicines for lung cancer and melanoma now provide effective options for patients with tumors expressing certain genetic markers.[ii] The personalized melanoma treatment and another new melanoma medicine became the first new approvals for the disease in 13 years. Read about continued efforts to improve cancer treatment and the 887 medicines currently in development.
Rare Diseases: An estimated 25-30 million Americans suffer from rare or "orphan" diseases, which are often among the most devastating to patients and complex for researchers.[iii] However, advances in science have allowed us to hone in on the causes of many rare diseases and translate those findings into new treatments. Between January 1st and December 7th 2011, eleven new medicines to treat rare diseases were made available to patients for diseases such as the genetic defect congenital Factor XIII deficiency, several cancers, and scorpion poisoning.[iv] A record 460 new medicines are in clinical trials or awaiting FDA review.[v] Read more about the ongoing commitment to improve treatment for rare diseases.
Lupus: Lupus is a serious and potentially fatal autoimmune disease that attacks healthy organs and tissues of the body. For the approximately 300,000 to 1.5 million lupus sufferers in the U.S. the last approved drug came in 1955. This year a newly approved medicine ended that drought with a new approach to treating lupus. Read more about medicines in development for autoimmune diseases.
Hepatitis C: Hepatitis C is a chronic viral disease that affects the liver and can lead liver cancer and liver failure. It affects approximately 3 million people in the United States. Two new medicines approved this year are the first in a new class and offer a greater chance of cure for some patients compared with existing therapies. For more information on medicines in development for infectious diseases, click here.
This is only a partial list of the many advances approved in 2011, for a more complete listing visit www.FDA.org.
Looking ahead to 2012, biomedical research continues to draw us in new directions and helps us to better understand the cause and progression of disease. Coupled with innovative approaches at the bench and in the clinic, we can better prevent, detect, and treat disease to save and improve lives.
References
[i]US Food and Drug Administration, FY2011 Innovative Drug Approvals, (November 2011) http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm
[ii]US Food and Drug Administration, FY2011 Innovative Drug Approvals, (November 2011) http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm
[iii]PhRMA, Orphan Drugs in Development for Rare Diseases (February 2011) http://www.phrma.org/sites/default/files/878/rarediseases2011.pdf
[iv]US Food and Drug Administration, CDER New Drug Review: 2011 Update (December 2011) http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM282984.pdf
[v]PhRMA, Orphan Drugs in Development for Rare Diseases (February 2011) http://www.phrma.org/sites/default/files/878/rarediseases2011.pdf
The IMF’s first Financial Sector Assessment Program (FSAP) review of China was carried out jointly with the World Bank. China is one of 25 systemically important countries that have agreed to mandatory assessments at least once every five years. The FSAPs are part of the IMF’s activities in financial surveillance and the monitoring of the international monetary system.
“China’s banks and financial sector are healthy, but there are vulnerabilities that should be addressed by the authorities,” says Jonathan Fiechter, deputy director of the IMF’s Monetary and Capital Markets Department and the head of the IMF team that conducted the FSAP. “While the existing structure fosters high savings and high levels of liquidity, it also creates the risk of capital misallocation and the formation of bubbles, especially in real estate. The cost of such distortions will only rise over time, so the sooner these distortions are addressed the better.”
Risks
According to the FSAP report, China’s financial sector is confronting several near-term risks: deterioration in loan quality due to rapid credit expansion; growing disintermediation by shadow banks and off-balance sheet exposures; a downturn in real estate prices; and the uncertainties of the global economic scenario. Medium-term vulnerabilities are also building and could impair the needed reorientation of the financial system to support the country’s future growth. Moving along this path will pose additional risks, so priority must be given to establishing the institutional and operational preconditions that are crucial for a wide-ranging financial reform agenda.
The main areas of reform should include:
- Steps to broaden financial markets and services, and developing diversified modalities of financial intermediation that would foster healthy competition among banks;
- A reorientation of the role of government away from using the banking system to carry out broad government policy goals and to allow lending decisions to be based on commercial goals;
- Expansion of the use of market-based monetary policy instruments, using interest rates as the main instrument to govern credit expansion, rather than administrative measures;
- An upgrading of the financial infrastructure and legal frameworks, including strengthening the payments and settlement systems, as well as consumer protection and expansion of financial literacy.
Stress Tests
Stress tests conducted jointly by the Fund and Chinese authorities of the country’s largest 17 commercial banks indicate that most of them appear to be resilient to isolated shocks, which include: a sharp deterioration in asset quality (including a correction in the real estate markets), shifts in the yield curve, and changes in the exchange rate. If several of these risks were to occur at the same time, however, the banking system could be severely impacted, the report warns.
About the FSAP
The Financial Sector Assessment Program, established in 1999, is an in-depth analysis of a country’s financial sector. The IMF conducts mandatory FSAPs for the 25 jurisdictions with systemically important financial sectors, and any member countries that request it. Assessments in developing and emerging market countries are conducted jointly with the World Bank. FSAPs include two components: a financial stability assessment, which is the responsibility of the Fund; and, in developing and emerging market countries, a financial development assessment, conducted by the World Bank.
To assess the stability of the financial sector, IMF teams examine the soundness of the banking and other financial sectors; rate the quality of bank, insurance, and capital market supervision against accepted international standards; and evaluate the ability of supervisors, policymakers, and financial safety nets to respond effectively to a systemic crisis. While FSAPs do not evaluate the health of individual financial institutions and cannot predict or prevent financial crises, they identify the main vulnerabilities that could trigger one.
In September 2010, the IMF made financial stability assessments under the FSAP a mandatory part of IMF surveillance every five years for jurisdictions deemed systemically important based on the size of the financial sector and their global interconnectedness. The countries affected by this decision are: Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hong Kong SAR, Italy, Japan, India, Ireland, Luxembourg, Mexico, the Netherlands, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, the United Kingdom, and the United States.
For more information on FSAPs, see Press Release No. 10/357