FDA Launches Center for Tobacco Products

It's gratifying to see the FDA taking it's first steps to reduce illness and death caused by tobacco products.

Cigarette smoking causes an estimated 438,000 deaths, or about 1 of every 5 deaths, each year, according to estimates from the Centers for Disease Control and Prevention. Adults who smoke cigarettes die 14 years earlier than nonsmokers. The leading cause of chronic obstructive pulmonary disease or COPD, including emphysema, is tobacco smoking. COPD is projected to be the third leading cause of death worldwide by 2020 due to an increase in smoking rates and demographic changes in many countries.

As a lung transplant recipient I have an opportunity to meet and chat with other recipients and those on waiting lists on a regular basis. COPD is one of the major reasons they require a transplant in order to live. It's easy to see from the following table how big a role smoking plays in lung transplantation.

As of 2005, the most common reasons for lung transplantation in the United States were:

• 27% chronic obstructive pulmonary disease or COPD, including emphysema;


• 16% idiopathic pulmonary fibrosis;


• 14% cystic fibrosis;


• 12% idiopathic (formerly known as "primary") pulmonary hypertension;


• 5% alpha 1-antitrypsin deficiency;


• 2% replacing previously transplanted lungs that have since failed;


• 24% other causes, including bronchiectasis and sarcoidosis.

Medscape Pulmonary Medicine

August 20, 2009 — The US Food and Drug Administration (FDA) has announced the launch of a new division, the Center for Tobacco Products, "in an historic effort to curb the hundreds of thousands of deaths caused by those products each year."

The new center will oversee the Family Smoking Prevention and Tobacco Control Act, signed into law by President Barack Obama in June 2009. The law requires that the FDA set performance standards, review premarket applications for new and modified-risk tobacco products, and establish and enforce advertising and promotion restrictions.

The Center for Tobacco Products' first director will be Lawrence Deyton, MD, MSPH, an expert on veterans' health issues, public health, and tobacco use, and a clinical professor of medicine and health policy at George Washington University School of Medicine and Health Sciences in Washington, DC.

Between 1999 and 2007, Dr. Deyton revamped the Veteran Administration's smoking and tobacco use cessation programs. Current smoking rates among veterans enrolled in the programs fell from 33% to 22% during his 9-year tenure.

"We are thrilled to announce Dr. Deyton's appointment as director of the Center for Tobacco Products and look forward to him joining the agency," said FDA Commissioner Margaret A. Hamburg, MD, according to an FDA news release announcing the center's launch. "He is the rare combination of public health expert, administrative leader, scientist, and clinician."

Cigarette smoking causes an estimated 438,000 deaths, or about 1 of every 5 deaths, each year, according to estimates from the Centers for Disease Control and Prevention. Adults who smoke cigarettes die 14 years earlier than nonsmokers.

The Center for Tobacco Products "will use the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products," the FDA said in the release.

“You Have the Power to Save Lives – Sign Your Donor Card & Tell Your Loved Ones of Your Decision”

Register to be a donor in Ontario or Download Donor Cards from Trillium Gift of Life Network. NEW for Ontario: recycleMe.org - Learn The Ins & Outs Of Organ And Tissue Donation. Register Today! For other Canadian provinces click here

In the United States, be sure to find out how to register in your state at ShareYourLife.org or Download Donor Cards from OrganDonor.Gov

In Great Britain, register at NHS Organ Donor Register

In Australia, register at Australian Organ Donor Register

Your generosity can save up to eight lives with heart, kidneys, liver, lungs, pancreas and small intestine transplants. One tissue donor can help up to 100 other people by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ transplant.

FDA Strengthens warning for CellCept

The following warning was posted by the FDA.

CellCept (mycophenolate mofetil) August 2009
Audience: Renal, cardiac, and hepatic transplantation healthcare professionals

[Posted 08/14/2009] Roche notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. The WARNINGS and ADVERSE REACTIONS sections of the CellCept Prescribing Information have been revised to reflect this new safety information.

PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of CellCept therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

See the Drug warning issued by Roche Laboratories Inc.

See CellCept Prescribing Information, revised.

“You Have the Power to Save Lives – Sign Your Donor Card & Tell Your Loved Ones of Your Decision”

Register to be a donor in Ontario or Download Donor Cards from Trillium Gift of Life Network. NEW for Ontario: recycleMe.org - Learn The Ins & Outs Of Organ And Tissue Donation. Register Today! For other Canadian provinces click here

In the United States, be sure to find out how to register in your state at ShareYourLife.org or Download Donor Cards from OrganDonor.Gov

In Great Britain, register at NHS Organ Donor Register

In Australia, register at Australian Organ Donor Register

Your generosity can save up to eight lives with heart, kidneys, liver, lungs, pancreas and small intestine transplants. One tissue donor can help up to 100 other people by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ transplant.

FDA Approves Vaccine for 2009-2010 Seasonal Influenza

Although this seasonal flu vaccine will not protect against the H1N1 virus (swine flu), receiving the seasonal vaccine is still critical for those of us who are at risk due to being immuno suppressed as well as older people, young children and people with chronic medical conditions. It's expected that a vaccine for the H1N1 virus will be available later this fall.

For Immediate Release: July 20, 2009

The U.S. Food and Drug Administration today announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States.

The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009. The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus.

Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine. No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths.

“The approval of this year’s seasonal influenza vaccine is an example of the FDA’s important responsibility to assure timely availability of vaccine to help protect the health of the American public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

The six vaccine brand names and manufacturers are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur Inc.; and FluMist, MedImmune Vaccines Inc.

Each year, experts from the FDA, WHO, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of the FDA’s Vaccine and Related Products Advisory Committee, the FDA determines the three strains that manufacturers should include in their vaccines for the U.S. population. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against the disease.

The vaccine for the 2009-2010 seasonal influenza contains:

• an A/Brisbane/59/2007 (H1N1)-like virus


• an A/Brisbane/10/2007 (H3N2)-like virus


• a B/Brisbane/60/2008-like virus

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year. More than 200,000 are hospitalized from its complications and about 36,000 people die. Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications. Vaccination of these groups is critical.

Additionally, influenza immunization of health care personnel is important in protecting them and others from influenza.

For more information:

FDA Web Page on Influenza Vaccine Safety & Availability

FDA List of Strains Included in the 2009-2010 Influenza Vaccine

U.S. Centers for Disease Control and Prevention Web Page on Seasonal Influenza Resources for Health Professionals

U.S. Centers for Disease Control and Prevention Web Page with Key Fact About Seasonal Flu Vaccine

“You Have the Power to Save Lives – Sign Your Donor Card & Tell Your Loved Ones of Your Decision”

Register to be a donor in Ontario or Download Donor Cards from Trillium Gift of Life Network. NEW for Ontario: recycleMe.org - Learn The Ins & Outs Of Organ And Tissue Donation. Register Today! For other Canadian provinces click here

In the United States, be sure to find out how to register in your state at ShareYourLife.org or Download Donor Cards from OrganDonor.Gov

In Great Britain, register at NHS Organ Donor Register

In Australia, register at Australian Organ Donor Register

Your generosity can save up to eight lives with heart, kidneys, liver, lungs, pancreas and small intestine transplants. One tissue donor can help up to 100 other people by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes.