Proposed Federal Gov’t Rule Adds Ovarian Cancer to 9/11 World Trade Center Health Program List of Covered Conditions

On June 13, 2012, the federal government will publish a proposed rule that will add ovarian cancer to the list of conditions covered by the World Trade Center Health Program. It is anticipated that the proposed rule will take several months to finalize prior to becoming effective. The WTC Health Program was established by the James Zadroga 9/11 Health and Compensation Act of 2010, which provides health benefits and financial compensation to those harmed by the attacks of September 11th and its aftermath.

The World Trade Center Health Program (WTC Health Program) was established by the James Zadroga 9/11 Health and Compensation Act of 2010, which provides health benefits and financial compensation to those harmed by the attacks of September 11th and its aftermath.

The WTC Health Program provides services to responders, workers, and volunteers who helped with rescue, recovery, and cleanup at the World Trade Center and related sites located within the defined “New York City disaster area.” It also provides services for survivors who lived, worked, or were attending school in the area. The WTC Health Program will also be serving responders to the 9/11 attacks at the Pentagon in Arlington, Virginia, and the Flight 93 crash site in Shanksville, Pennsylvania

The WTC Health Program is administered by the National Institute for Occupational Safety and Health (NIOSH). After conducting a long-term study, NIOSH stated in a recent administrative filing that it favored a major expansion of the existing $4.3 billion WTC Health Program to include eligible individuals with 50 types of cancer, covering 14 broad categories of the disease. The specifics underlying NIOSH’s administrative decision will be published on June 13, 2012 in the Federal Register as a Notice of Proposed Rulemaking, entitled World Trade Center Health Program; Addition of Certain Types of Cancer to List of WTC-Related Health Conditions. Within the proposed rule, ovarian cancer (i.e., “malignant neoplasms of the ovary”) is listed as one of the enumerated cancer types.

Pursuant to NIOSH’s proposed rule, the WTC Health Program will provide medical testing and care for specific symptoms and illnesses related to being exposed to the disaster sites. The services will be provided by clinics and hospitals that have expertise in the diagnosis and treatment of 9/11-related health conditions.

It is important to note that NIOSH’s proposed rule does not represent a final administrative determination. The Notice of Proposed Rulemaking is subject to public review and a 30-day comment period. Once public comment is received, NIOSH will consider and address those comments as appropriate before issuing a final ruling. The proposed rule may change prior to finalization, or it may not be finalized at all.

If NIOSH determines that it is appropriate to issue a final rule to cover select cancer types, and a final rule is published, additional steps would be necessary before an eligible responder or survivor could receive care and treatment under the WTC Health Program. The physician diagnosing the cancer would be responsible for reviewing the individual’s exposure history to determine whether her cancer could be related to a 9/11 exposure; the individual’s diagnosis must then be certified by NIOSH before care and treatment can begin.

Sources:

• Statement from WTC Program Administrator John Howard, M.D., The National Institute for Occupational Safety and Health, Centers for Disease Control & Prevention, U.S. Department of Health & Human Services, June 8, 2012.

• World Trade Center Health Program.

• World Trade Center Health Program; Addition of Certain Types of Cancer to List of WTC-Related Health Conditions, Federal Register Notice of Proposed Rulemaking, June 13, 2012. (Pre-publication PDF copy)

Call To Action! Protect & Expand U.S. Federal Ovarian Cancer Research Funding

Do you live in AL, CA, HI, IL, IA, KS, KY, MD, MI, MO, NH, ND, PA, TX, UT, VT, WA or WI? If so, one of your Senators sits on the U.S. Senate Defense Appropriations subcommittee that determines how much funding is given to the Department of Defense Ovarian Cancer Research Program. Ask your Senator to increase funding for this critical ovarian cancer research program. Click on the hyperlink below to obtain step-by-step instructions provided by the Ovarian Cancer National Alliance. It’s so important, and it’s so easy!

Woody Allen once said that 80% of success in life is just showing up. When it comes to U.S. federal funding of ovarian cancer research on Capitol Hill, decision are definitely made by those who show up.

Do you live in Alabama, California, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Mississippi, Missouri, New Hampshire, North Dakota, Pennsylvania, Texas, Utah, Vermont, Washington, or Wisconsin?

If so, you live in a state represented by a Senator who sits on the U.S. Senate Defense Appropriations subcommittee, the subcommittee that controls spending levels for the Department of Defense Ovarian Cancer Research Program (DoD OCRP). This critical program is the only dedicated federal budget line item that funds ovarian cancer research. Last year, funding for the program was cut. We need your Senator to support this program.

Please call your Senator’s office and request that he or she talk to the Chairman or Vice-Chair of the Defense Appropriations Subcommittee to express their support of a minimum of $30 million for the DoD OCRP in 2011.

The Ovarian Cancer National Alliance makes taking this action simple! CLICK HERE , enter your zip code, and you will receive step-by-step instructions.

If your Senator gets enough calls, he or she will believe that this is an important issue and will be more inclined to have this conversation with the Chairman or Vice Chairman. Both the Chairman and the Vice-Chair play a key role in determining how much money the DoD OCRP receives in order to carry out ovarian cancer research, so it is important that they hear from their Senate colleagues.

As seen in the chart below, ovarian cancer research funded by the U.S. federal government makes up the majority of all ovarian cancer research conducted in the U.S. We need to protect and expand this funding so we can get an early detection test and more effective treatments.

Source: Ovarian Cancer National Alliance

The more calls we make, the bigger impact we will make. Get your friends and family in your state involved in the mission to get increased U.S. federal funding for ovarian cancer research by asking them to call too!

Please place your calls by September 10th!

Source:  Call to action! Protect and expand ovarian cancer research funding! Action Alert, Ovarian Cancer National Alliance.

U.S. President Barack Obama Proclaims September 2010 As National Ovarian Cancer Awareness Month

Yesterday, U.S. President Barack Obama designated September 2010 as National Ovarian Cancer Awareness Month.  During National Ovarian Cancer Awareness Month, we honor all those lost to and living with ovarian cancer, and we renew our commitment to developing effective screening methods, improving treatments, and ultimately defeating this disease.

The White House

Office of the Press Secretary

For Immediate Release August 31, 2010

Presidential Proclamation–National Ovarian Cancer Awareness Month

While we have made great strides in the battle against ovarian cancer, this disease continues to claim more lives than any other gynecologic cancer. During National Ovarian Cancer Awareness Month, we honor all those lost to and living with ovarian cancer, and we renew our commitment to developing effective screening methods, improving treatments, and ultimately defeating this disease.

Each year, thousands of women are diagnosed with, and go on to battle valiantly against, this disease. Yet, ovarian cancer remains difficult to detect, and women are often not diagnosed until the disease has reached an advanced stage. I encourage all women — especially those with a family history of ovarian cancer or breast cancer, and those over age 55 — to protect their health by understanding risk factors and discussing possible symptoms, including abdominal pain, with their health care provider. Women and their loved ones may also visit Cancer.gov for more information about the symptoms, diagnosis, and treatment of ovarian and other cancers.

Across the Federal Government, we are working to promote awareness of ovarian cancer and advance its diagnosis and treatment. The National Cancer Institute, the Centers for Disease Control and Prevention, and the Department of Defense all play vital roles in reducing the burden of this illness through critical investments in research. Earlier this year, I was proud to sign into law the landmark Affordable Care Act (ACA), which includes provisions to help women living with ovarian cancer. The ACA eliminates annual and lifetime limits on benefits, creates a program for those who have been denied health insurance because of a pre-existing condition, and prohibits insurance companies from canceling coverage after individuals get sick. The ACA also requires that women enrolling in new insurance plans and those covered by Medicare or Medicaid receive free preventive care — including women’s health services and counseling related to certain genetic screenings that identify increased risks for ovarian cancer. In addition, the ACA prohibits new health plans from dropping coverage if an individual chooses to participate in a potentially life-saving clinical trial, or from denying coverage for routine care simply because an individual is enrolled in such a trial.

During National Ovarian Cancer Awareness Month and throughout the year, I commend all the brave women fighting this disease, their families and friends, and the health care providers, researchers, and advocates working to reduce this disease’s impact on our Nation. Together, we can improve the lives of all those affected and create a healthier future for all our citizens.

NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim September 2010 as National Ovarian Cancer Awareness Month. I call upon citizens, government agencies, organizations, health care providers, and research institutions to raise ovarian cancer awareness and continue helping Americans live longer, healthier lives.

IN WITNESS WHEREOF, I have hereunto set my hand this thirty-first day of August, in the year of our Lord two thousand ten, and of the Independence of the United States of America the two hundred and thirty-fifth.

BARACK OBAMA

Source: NATIONAL OVARIAN CANCER AWARENESS MONTH, 2010, By the President of the United States of America, A Proclamation, Office of the Press Secretary For The President of the United States of America, The White House, August 31, 2010.

“Decisions Are Made By Those Who Show Up”*

Responding to a threat of a funding reduction to the Department of Defense’s Ovarian Cancer Research Program, during the last week of October the Ovarian Cancer National Alliance urged advocates to contact their Members of Congress to appeal to the Appropriations Defense Subcommittee to increase funding for the research program. As a result of the Ovarian Cancer National Alliance’s advocacy efforts, 14 Senators and 77 Representatives showed their opposition to the funding cut by signing a Dear Colleague letter sent to the Subcommittee Tuesday, November 3, 2009. …

Advocates Work To Prevent Slash In Ovarian Cancer Research Funding

Responding to a threat of a funding reduction to the Department of Defense’s Ovarian Cancer Research Program, during the last week of October the Ovarian Cancer National Alliance (OCNA) urged advocates to contact their Members of Congress to appeal to the Appropriations Defense Subcommittee to increase funding for the research program.

Advocates lobbying on Capitol Hill for increased funds for ovarian cancer research. (Photo: Ovarian Cancer National Alliance)

As a result of OCNA’s advocacy efforts, 14 Senators and 77 Representatives showed their opposition to the funding cut by signing a Dear Colleague letter sent to the Subcommittee Tuesday, November 3, 2009.

The Dear Colleague letter, written by Senator Robert Menendez (D-NJ) and Congresswoman Rosa DeLauro (D-CT), requested that the Subcommittee allocate the $25 million set forth in the U.S. House of Representatives‘ version of the Defense bill, and not the $10 million outlined in the U.S. Senate version of the bill. The Senate funding level represented a 50 percent reduction from the $20 million appropriated in fiscal year (FY) 2009.

The date of the conference subcommittee meeting has yet to be announced.

Established in 1997, the Department of Defense’s Ovarian Cancer Research Program has received $10 million in funding annually from FY 1998 until FY 2008. However, for FY 2009, the program’s funding was doubled to $20 million. The Ovarian Cancer Research Program works to eliminate ovarian cancer by conducting innovative, multidisciplinary research on early detection, screening and treatment of ovarian cancer.

To read the full text of the letter and see if your elected officials signed, please click here.

The Ovarian Cancer Action Network periodically sends out action alerts to notify advocates of pressing issues that need constituent support. To sign up, please click here.

About the Ovarian Cancer National Alliance

OCNA is the advocacy arm of the ovarian cancer movement. OCNA works with federal policy makers, including the  U.S. President, U.S. Congress, and federal agencies like the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). OCNA commits its resources to be a voice for ovarian cancer survivors and significantly reduce the number of deaths from this deadly disease by advocating at the federal level for the following:

• Adequate and sustained funding for ovarian cancer research and awareness programs, and

• Legislation that improves quality of life and access to care for ovarian cancer patients.

Since 1997, when OCNA was founded, death rates from ovarian cancer have not significantly changed. However, OCNA has worked to increase funding for ovarian cancer research, with the goal that this funding will support breakthroughs to help detect ovarian cancer early, treat it more thoroughly, and allow women with ovarian cancer to survive, and thrive.

OCNA has worked to ensure that (i) necessary treatments are covered by Medicare, (ii) drugs and tests on the market are safe and effective, and (iii) federal policy makers are aware of the importance of the ovarian cancer community.

Join OCNA to fight for women with ovarian cancer, and policies that help support them and their families.

Source: Advocates Work To Prevent Slash In Ovarian Cancer Research Funding, News Update, Ovarian Cancer National Alliance, November 11, 2009.

*Title Quote:  Fictional U.S. President Josiah Edward Bartlet, What Kind of Day Has It Been Episode, The West Wing, created by Aaron Sorkin, originally aired May 17, 2000 [Sorkin attributes his teleplay quote to Woody Allen (“80% of success in life is just showing up”)].

FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs

The U.S. Food and Drug Administration (FDA) published two rules [on August 12, 2009] …that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options.

U.S. Food & Drug Administration

The U.S. Food and Drug Administration (FDA) published two rules [on August 12, 2009] …that seek to clarify the methods available to seriously ill

Margaret A. Hamburg, M.D., Commissioner of Food & Drugs, U.S. Food & Drug Administration

patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options.

To support the effort to help these patients, the agency also is launching a new Web site where patients and their health care professionals can learn about options for investigational drugs. In general, these options include being treated with a drug that has been approved by FDA, being given an investigational drug as part of a clinical trial, or obtaining access to an investigational drug outside of a clinical trial.

The new rule, “Expanded Access to Investigational Drugs for Treatment Use,” makes investigational drugs more widely available to patients by clarifying procedures and standards. The other rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” clarifies the specific circumstances and the types of costs for which a manufacturer can charge patients for an investigational drug when used as part of a clinical trial or when used outside the scope of a clinical trial.

“With these initiatives, patients will have the information they need to help them decide whether to seek investigational products,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand.”

Clinical trials are studies of drugs and biologics that are still in development and have not yet been approved by the FDA. Many patients enroll in clinical trials to gain access to investigational therapies and contribute to finding out how well an investigational therapy works, and how safe it is for patients. Obtaining a drug or biologic under an expanded access program may be an option for some patients who are not able to enroll in clinical trials.

The FDA has allowed expanded access to experimental drugs and biologics since the 1970s. That access has allowed tens of thousands of patients with HIV/AIDS, cancer, and other conditions to receive promising therapies when no approved alternative is available.

“The final rules balance access to promising new therapies against the need to protect patient safety and seek to ensure that expanded access does not discourage participation in clinical trials or otherwise interfere with the drug development process,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Clinical trials are the most important part of the drug development process in determining whether new drugs are safe and effective, and how to best use them.”

Source: FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs, FDA News Release, News & Events, U.S. Food & Drug Administration, 12 Aug. 09.

Additional Information:

• Access To Investigational Drugs, For Consumers, U.S. Food & Drug Administration, 08 Aug. 09.

• Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs, U.S. Food & Drug Administration, 13 Aug. 09

Senator Barbara Boxer Reintroduces Legislation to Better Diagnosis Ovarian Cancer

On March 31, 2009, U.S. Senator Barbara Boxer (D-CA) reintroduced the Ovarian Cancer Biomarker Research Act of 2009 (H.R. 1816) legislation to develop new technologies to detect and fight ovarian cancer.  The Ovarian Cancer Biomarker Research Act bill, if ultimately enacted as law, would authorize $30 million each year for four years to fund research and development of reliable screening techniques for ovarian cancer. The bill would also authorize clinical trials to verify research techniques and bring together a panel of experts to evaluate and direct the progress of the work.

Senator Barbara Boxer of the State of California

On March 31, 2009, U.S. Senator Barbara Boxer (D-CA) reintroduced the Ovarian Cancer Biomarker Research Act of 2009 (H.R. 1816) legislation to develop new technologies to detect and fight ovarian cancer.  The Ovarian Cancer Biomarker Research Act bill, if ultimately enacted as law, would authorize $30 million each year for four years to fund research and development of reliable screening techniques for ovarian cancer. The bill would also authorize clinical trials to verify research techniques and bring together a panel of experts to evaluate and direct the progress of the work.

Upon reintroduction of  H.R. 1816, Senator Boxer said, “Early detection is key to helping more women beat this dangerous disease. When ovarian cancer is diagnosed in its early stages, more than 93 percent of women go on to live longer than five years. I am proud to sponsor this bill that makes a commitment to fight ovarian cancer with every possible tool.”

Congressman Howard L. Berman (D-CA) also reintroduced the Ovarian Cancer Biomarker Research Act of 2009 on March 31st in the U.S. House of Representatives.

The complete text of H.R. 1816, the Ovarian Cancer Biomarker Research Act of 2009, is set forth below.  This is the original text of the bill as it was written by its sponsor and submitted to the U.S. House of Representatives for consideration.  For an Adobe Reader PDF copy of H.R. 1816, CLICK HERE.

This bill is in the first step in the U.S. legislative process. Introduced bills and resolutions first go to committees that deliberate, investigate, and revise them before they go to general debate. The majority of bills and resolutions never make it out of committee.  Contact your U.S. Representative and let him or her know that you support this bill.

Source: Boxer Reintroduces Legislation to Better Diagnose Ovarian Cancer, Press Release, Office of Senator Barbara Boxer, April 1, 2009.

_____________________________________________

HR 1816:  Ovarian Cancer Biomarker Research Act of 2009

111th CONGRESS

1st Session

H. R. 1816

To amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer.

IN THE HOUSE OF REPRESENTATIVES

March 31, 2009

Mr. BERMAN (for himself, Mr. HALL of Texas, Ms. BORDALLO, Ms. LEE of California, Mr. VAN HOLLEN, Mr. MCGOVERN, Mr. MCDERMOTT, Mr. BOUCHER, Mr. KING of New York, Mr. GENE GREEN of Texas, Mr. WOLF, Ms. KILROY, Mr. BURTON of Indiana, Mr. ISRAEL, Mr. HINCHEY, Mr. SESTAK, Ms. DELAURO, Ms. SHEA-PORTER, Mrs. MALONEY, Mr. MCMAHON, Ms. WASSERMAN SCHULTZ, Mrs. CAPPS, Mr. SERRANO, Mr. FARR, and Ms. EDWARDS of Maryland) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Public Health Service Act to authorize the Director of the National Cancer Institute to make grants for the discovery and validation of biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Ovarian Cancer Biomarker Research Act of 2009′.

SEC. 2. GRANTS FOR ESTABLISHMENT AND OPERATION OF RESEARCH CENTERS FOR THE STUDY OF OVARIAN CANCER BIOMARKERS.

Subpart 1 of part C of the Public Health Service Act is amended by adding at the end the following new section:

‘SEC. 417G. GRANTS FOR ESTABLISHMENT AND OPERATION OF RESEARCH CENTERS FOR THE STUDY OF OVARIAN CANCER BIOMARKERS.

‘(a) In General- The Director of the Institute, in consultation with the directors of other relevant institutes and centers of the National Institutes of Health and the Department of Defense Ovarian Cancer Research Program, shall enter into cooperative agreements with, or make grants to, public or nonprofit entities to establish and operate centers to conduct research on biomarkers for use in risk stratification for, and the early detection and screening of, ovarian cancer, including fallopian tube cancer or primary peritoneal cancer. Each center shall be known as an Ovarian Cancer Biomarker Center of Excellence, and shall focus on translational research of ovarian cancer biomarkers.

‘(b) Research Funded- Federal payments made under a cooperative agreement or grant under subsection (a) may be used for research on any of the following:

‘(1) The development and characterization of new biomarkers, and the refinement of existing biomarkers, for ovarian cancer.

‘(2) The clinical and laboratory validation of such biomarkers, including technical development, standardization of assay methods, sample preparation, reagents, reproducibility, portability, and other refinements.

‘(3) The development and implementation of clinical and epidemiological research on the utilization of biomarkers for the early detection and screening of ovarian cancer.

‘(4) The development and implementation of repositories for new tissue, urine, serum, and other biological specimens (such as ascites and pleural fluids).

‘(5) Genetics, proteomics, and pathways of ovarian cancer as they relate to the discovery and development of biomarkers.

‘(c) First Agreement or Grant- Not later than 1 year after the date of the enactment of this section, the Director of the Institute shall enter into the first cooperative agreement or make the first grant under this section.

‘(d) Availability of Banked Specimens- The Director of the Institute shall make available for research conducted under this section banked serum and tissue specimens from clinical research regarding ovarian cancer that was funded by the Department of Health and Human Services.

‘(e) Report- Not later than the end of fiscal year 2010, and annually thereafter, the Director of the Institute shall submit a report to the Congress on the cooperative agreements entered into and the grants made under this section.

‘(f) Authorization of Appropriations- For the purpose of carrying out this section, there are authorized to be appropriated $25,000,000 for each of the fiscal years 2010 through 2013, and such sums as may be necessary for each of the fiscal years 2014 through 2020. Such authorization of appropriations is in addition to any other authorization of appropriations that is available for such purpose.’.

SEC. 3. OVARIAN CANCER BIOMARKER CLINICAL TRIAL COMMITTEE.

Subpart 1 of part C of the Public Health Service Act, as amended by section 2, is further amended by adding at the end the following new section:

‘SEC. 417H. OVARIAN CANCER BIOMARKER CLINICAL TRIAL COMMITTEE.

‘(a) Ovarian Cancer Biomarker Research Committee Established- The Director of the Institute shall establish an Ovarian Cancer Biomarker Clinical Trial Committee (in this section referred to as the ‘Committee’) to assist the Director to design and implement one or more national clinical trials, in accordance with this section, to determine the utility of using biomarkers validated pursuant to the research conducted under section 417E for risk stratification for, and early detection and screening of, ovarian cancer.

‘(b) Membership-

‘(1) NUMBER- The Committee shall consist of 11 voting members and such number of nonvoting members as the Director of the Institute determines appropriate.

‘(2) APPOINTMENT- The members of the Committee shall be appointed by the Director of the Institute, in consultation with appropriate national medical societies, research societies, and patient advocate organizations, as follows:

‘(A) VOTING MEMBERS- The voting members of the Committee shall be appointed by the Director of the Institute as follows:

‘(i) Two patient advocates.

‘(ii) Two national experts in statistical analysis, clinical trial design, and patient recruitment.

‘(iii) Two representatives from the Gynecologic Oncology Group.

‘(iv) One representative from the Department of Defense Ovarian Cancer Research Program.

‘(v) Four ovarian cancer researchers.

‘(B) NONVOTING MEMBERS- The nonvoting members of the Committee shall include such individuals as the Director of the Institute determines to be appropriate.

‘(3) PAY- Members of the Committee shall serve without pay and those members who are full time officers or employees of the United States shall receive no additional pay by reason of their service on the Committee, except that members of the Committee shall receive travel expenses, including per diem in lieu of subsistence, in accordance with applicable provisions under chapter I of chapter 57 of title 5, United States Code.

‘(c) Chairperson- The voting members of the Committee appointed under subsection (b)(2) shall select a chairperson from among such members.

‘(d) Meetings- The Committee shall meet at the call of the chairperson or upon the request of the Director of the Institute, but at least four times each year.

‘(e) Clinical Trial Specifications- In designing and implementing the clinical trials under this section, the Director of the Institute shall provide for the following:

‘(1) PARTICIPATION IN TRIAL- To the greatest extent possible, all academic centers, community cancer centers, and individual physician investigators (as defined in subsection (f)) shall have the opportunity to participate in the trials under this section and to enroll women at risk for ovarian cancer in the trials.

‘(2) COSTS FOR ENROLLMENTS- Subject to the availability of appropriations, all the costs to the centers and offices described in paragraph (1) for enrolling women in the trials under this section shall be reimbursed by the Institute.

‘(3) NATIONAL DATA CENTER- A national data center shall be established in and supported by the Institute to conduct statistical analyses of the data derived from the trials under this section and to store such analyses and data.

‘(4) GUIDELINES FOR MEDICAL COMMUNITY- Data and statistical analyses of the clinical trials under this section shall be used to establish clinical guidelines to provide the medical community with information regarding the use of biomarkers validated pursuant to the research conducted under section 417E for risk stratification for, and early detection and screening of, ovarian cancer.

‘(f) Individual Physician Investigator Defined- For purposes of subsection (e)(1), the term ‘individual physician investigator’ means a physician–

‘(1) who is a faculty member at an academic institution or who is in a private medical practice; and

‘(2) who provides health care services to women at risk for ovarian cancer.

‘(g) Report- Not later than the end of fiscal year 2010, and annually thereafter, the Director of the Institute shall submit a report to the Congress on the activities conducted under this section.

‘(h) Authorization of Appropriations- For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for each of the fiscal years 2010 through 2013, and such sums as may be necessary for each of the fiscal years 2014 through 2020. Such authorization of appropriations is in addition to any other authorization of appropriations that is available for such purpose.’.

Senators Kennedy & Hutchison Renew War On Cancer

On March 26, 2009, Senators Edward M. Kennedy (D-Massachusetts) and Kay Bailey Hutchison (R-Texas) introduced the 21st Century Cancer Access to Life-Saving Early detection, Research and Treatment (ALERT) Act, a bill to comprehensively address the challenges our nation faces in battling cancer. This is the first sweeping cancer legislation introduced since the National Cancer Act in 1971, authored by Senator Kennedy. The 21^st Century Cancer ALERT Act is a comprehensive approach to cancer prevention and detection, research and treatment. It invests in cancer research infrastructure and improves collaboration among existing efforts. Prevention and early detection for those most at risk are emphasized through support for innovative initiatives and new technologies such as biomarkers.  The legislation addresses the need to increase enrollment in clinical research by increasing access and removing barriers to patients’ participation in clinical trials. The bill also includes a plan designed to improve care for cancer survivors. Additional provisions regarding prevention and screening initiatives will increase access to care for underserved populations and reduce the burden of disease and cost of healthcare to the nation.

Edward M. Kennedy, U.S. Senator For The Commonwealth of Massachusetts

On March 26, 2009, Senators Edward M. Kennedy (D-Massachusetts) and Kay Bailey Hutchison (R-Texas) introduced the 21st Century Cancer Access to Life-Saving Early detection, Research and Treatment (ALERT) Act, a bill to comprehensively address the challenges our nation faces in battling cancer. This is the first sweeping cancer legislation introduced since the National Cancer Act in 1971, authored by Senator Kennedy. The 21^st Century Cancer ALERT Act is a comprehensive approach to cancer prevention and detection, research and treatment. It invests in cancer research infrastructure and improves collaboration among existing efforts. Prevention and early detection for those most at risk are emphasized through support for innovative initiatives and new technologies such as biomarkers.  The legislation addresses the need to increase enrollment in clinical research by increasing access and removing barriers to patients’ participation in clinical trials. The bill also includes a plan designed to improve care for cancer survivors. Additional provisions regarding prevention and screening initiatives will increase access to care for underserved populations and reduce the burden of disease and cost of healthcare to the nation.

We provide below the full text of the following documents:

• Kennedy On The Introduction of the 21st Century ALERT Act, As Entered Into the Congressional Record, Office of Senator Edward M. Kennedy, U.S. Senator For Massachusetts, March 26, 2009.

• Kennedy Renews the War Against Cancer, Press Release, Office of Senator Edward M. Kennedy, U.S. Senator For Massachusetts, March 26, 2009.

• 21st Century Cancer ALERT Act, Senators Kennedy and Hutchinson, Section by Section Summary, Office of Senator Edward M. Kennedy, U.S. Senator For Massachusetts, March 26, 2009.

• Renewing the War on Cancer, by Edward M. Kennedy and Kay Bailey Hutchinson, Op-Ed., Houston Chronicle, March 26, 2009.

• S. 717: 21st Century Cancer ALERT (Access to Life-Saving Early detection, Research and Treatment) Act, 111th Congress,www.govtrack.us (Full text of bill as of April 13, 2009).  CLICK HERE for Adobe Reader PDF document.

_____________________________________________________

KENNEDY ON THE INTRODUCTION OF THE 21st Century ALERT Act

As Entered into the [Congressional] Record

March 26, 2009

FOR IMMEDIATE RELEASE

Thirty seven years ago, a Republican President and Democratic Congress came together in a new commitment to find a cure for cancer. At the time, a cancer diagnosis meant almost certain death. In 1971, we took action against this deadly disease and passed the National Cancer Act with broad bipartisan support, and it marked the beginning of the War on Cancer.

Since then, significant progress has been made. Amazing scientific research has led to methods to prevent cancer, and treatments that give us more beneficial and humane ways to deal with the illness. The discoveries of basic research, the use of large scale clinical trials, the development of new drugs, and the special focus on prevention and early detection have led to breakthroughs unimaginable only a generation ago.

As a result, cancer today is no longer the automatic death sentence that it was when the war began. But despite the advances we have made against cancer, other changes such as aging of the population, emerging environmental issues, and unhealthy behavior, have allowed cancer to persist. The lives of vast numbers of Americans have been touched by the disease. In 2008, over 1.4 million Americans were diagnosed with some form of cancer, and more than half a million lost their lives to the disease.

The solution isn’t easy but there are steps we can and must take now, if we hope to see the diagnosis rate decline substantially and the survival rate increase in the years ahead. The immediate challenge we face is to reduce the barriers that obstruct progress in cancer research and treatment by integrating our current fragmented and piecemeal system of addressing the disease.

Last year, my colleague Senator Hutchison and I agreed that to build on what the nation has accomplished, we must launch a new and more urgent war on cancer. The 21st Century Cancer ALERT Act we are introducing today will accelerate our progress by using a better approach to fighting this relentless disease. Our goal is to break down the many barriers that impede cancer research and prevent patients from obtaining the treatment that can save their lives.

We must do more to prevent cancer, by emphasizing scientifically proven methods such as tobacco cessation, healthy eating, and exercise. Healthy families and communities that have access to nutritious foods and high quality preventive health care will be our best defense against the disease. I’m confident that swift action on national health reform will make our vision of a healthier nation a reality. Obviously, we cannot prevent all cancers, so it is also essential that the cancers that do arise be diagnosed at an initial, curable stage, with all Americans receiving the best possible care to achieve that goal.

We cannot overemphasize the value of the rigorous scientific efforts that have produced the progress we have made so far. To enhance these efforts, our bill invests in two key aspects of cancer research– infrastructure and collaboration of the researchers. We include programs that will bring resources to the types of cancer we least understand. We invest in scientists who are committed to translating basic research into clinical practice, so that new knowledge will be brought to the patients who will most benefit from it.

One of the most promising new breakthroughs is in identifying and monitoring the biomarkers that leave enough evidence in the body to alert clinicians to subtle signs that cancer may be developing. Biomarkers are the new frontier for improving the lives of cancer patients because they can lead to the earliest possible detection of cancer, and the Cancer ALERT Act will support the development of this revolutionary biomarker technology.

In addition, we give new focus to clinical trials, which have been the cornerstones of our progress in treating cancer in recent decades. Only through clinical trials are we able to discover which treatments truly work. Today, however, less than 5% of cancer patients currently are enrolled in clinical trials, because of the many barriers exist that prevent both providers and patients from participating in these trials. A primary goal of our bill is to begin removing these barriers and expanding access to clinical trials for many more patients.

Further, since many cancer survivors are now living longer lives, our health systems must be able to accommodate these men and women who are successfully fighting against this deadly disease. It’s imperative for health professionals to have the support they need to care for these survivors. To bring good lifelong care to cancer survivors, we must invest more in research to understand the later effects of cancer and how treatments affect survivors’ health and the quality of their lives.

We stand today on the threshold of unprecedented new advances in this era of extraordinary discoveries in the life sciences, especially in personalized medicine, early diagnosis of cancer at the molecular level, and astonishing new treatments based on a patient’s own DNA. To make the remarkable promise of this new era a reality, we must make sure that patients can take DNA tests, free of the fear that their genetic information will somehow be used to discriminate against them. We took a major step toward unlocking the potential of this new era by approving strong protections against genetic discrimination in health insurance and employment when the Genetic Nondiscrimination Act was signed into law last year.

In sum, we need a new model for research, prevention and treatment of cancer, and we are here today to start that debate in Congress. We must move from a magic bullet approach to a broad mosaic of care, in which survivorship is also a key part of our approach to cancer. By doing so, we can take a giant step toward reducing or even eliminating the burden of cancer in our nation and the world. It’s no longer an impossible dream, but a real possibility for the future.

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Press Contact

Anthony Coley/ Melissa Wagoner (202) 224-2633

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Kennedy Renews the War Against Cancer

March 26, 2009

FOR IMMEDIATE RELEASE

Bill will Renew America’s Commitment to Fighting Cancer and Finding Cures

WASHINGTON, DC— Senators Edward M. Kennedy and Kay Bailey Hutchison today introduced the 21st Century Cancer Access to Life-Saving Early detection, Research and Treatment (ALERT) Act, a bill to comprehensively address the challenges our nation faces in battling this disease. This is the first sweeping cancer legislation introduced since the National Cancer Act in 1971, authored by Kennedy.

The 21st Century Cancer ALERT Act will provide critical funding for promising research in early detection, and supply grants for screening and referrals for treatment. These measures will also ensure patient access to prevention and early detection, which is supplemented by increased access to clinical trials and information.

The bill places an emphasis on strengthening cancer research and the urgent need for resources to both prevent and detect cancers at an early stage. The bill strives to give scientists the tools they need to fight cancer and to understand more thoroughly how the disease works. Through fostering new treatments, increased preventative measures and funding for research, the ALERT Act begins a new chapter in how Americans will live with and fight cancer.

Senators Kennedy and Hutchison first proposed the idea for comprehensive cancer legislation last May, when the Health, Education, Labor and Pensions Committee held a hearing to discuss the need for a renewed focus on the deadly disease. Elizabeth Edwards, Lance Armstrong and Hala Moddelmog from Susan G. Komen for the Cure testified at the hearing.

Senator Kennedy, Chairman of the Health, Education, Labor, and Pensions Committee, said, “We’ve come a long way in fighting cancer since we passed the National Cancer Act thirty-eight years ago, but not far enough. Americans still live in fear that they or someone they love will be affected. Today, we’re better equipped for the fight— learning each and every day a little bit more about the disease and what we can do to fight it. Cancer is a complex disease and it requires comprehensive strategies to fight it— strategies that integrate research, prevention and treatment. This bill will renew our efforts to make progress in the battle against cancer, and to give patients and their families a renewed sense of hope.”

“Our nation declared the War on Cancer in 1971, yet, nearly 38 years later, cancer is expected to become the leading killer of Americans. We must bring renewed focus and vigor to this fight.” said Senator Hutchison. “The prescription isn’t simple, but there are steps we must take if we are going to see the cancer diagnosis rate decline, while raising the prognosis for survival among those who do have the disease. Our legislation will enact those necessary steps so we may see more progress and coordination in cancer research and treatment.”

“We know how to lengthen and improve the lives of people with cancer, but we’ve chosen as a nation to turn our backs on some of us who have the disease,” said Elizabeth Edwards. “I urge the United States Senate to embrace the ALERT Act and get it to the President’s desk as soon as possible.”

“In 2010, cancer is expected to be the leading cause of death worldwide. Every American is touched by this disease,” said Lance Armstrong, chairman and founder of the Lance Armstrong Foundation. “The 21st Century Cancer ALERT Act and its authors’ leadership in reforming our nation’s approach to the war on cancer are a very welcome step forward to every member of the LIVESTRONG movement.”

“It’s been 38 years since our nation first declared war on cancer, and yet we are still facing a significant cancer crisis.  The Kennedy-Hutchison Cancer ALERT Act will reignite the war on cancer,” said Nancy G. Brinker, founder of Susan G. Komen for the Cure.  “We must all work together and let nothing stand in the way of discovering and delivering the cures to cancer.”

Senate action on this bill is expected this Congressional session.

A section-by-section summary of the legislation is below as well as an op-ed authored by Senators Hutchison and Kennedy that appeared this morning in the Houston Chronicle and on the Boston Globe’s website.

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21^st Century Cancer ALERT Act

Senators Kennedy and Hutchison

Section by Section Summary

The 21^st Century Cancer ALERT Act is a comprehensive approach to cancer prevention and detection, research and treatment. It invests in cancer research infrastructure and improves collaboration among existing efforts. Prevention and early detection for those most at risk are emphasized through support for innovative initiatives and new technologies such as biomarkers.  The legislation addresses the need to increase enrollment in clinical research by increasing access and removing barriers to patients’ participation in clinical trials. The bill also includes a plan designed to improve care for cancer survivors. Additional provisions regarding prevention and screening initiatives will increase access to care for underserved populations and reduce the burden of disease and cost of healthcare to the nation.

Section 1 and 2 – Findings and Declaration of Purpose

Section 3- Advancement of the National Cancer Program (NCP)

Modernize the role of the National Cancer Institute (NCI) in coordinating the NCP

• Identifies relevant federal agencies to coordinate with NCI
• Improves the annual budget estimate for the NCP by including the needs of the entire NCP and submitting the budget annually to House and Senate Budget and Appropriations Committees
• Increases participation of other federal agencies in the National Cancer Advisory Board
• Encourages early detection and translational research opportunities

Biological Resource Coordination and Advancement of Technologies for Cancer Research

• Establishes an entity within NCI to support an interconnected network of biorepositories with consistent, interoperable systems for collection, storage, annotation, and information sharing
• Facilitates research by linking cancer registries to other federal data sources including those at Centers for Medicare and Medicaid Services [CMS], Social Security Administration, and Centers for Disease Control and Prevention
• Requires hospitals and ambulatory care centers that receive federal funds to offer patients the opportunity to contribute their biospecimens and clinical data to a clinical registry

Section 4 – Comprehensive and Responsible Access to Research, Data, and Outcomes

• Calls for guidance from the Office of Human Research Protection on the use of a centralized Institutional Review Board
• Improves privacy standards in clinical research by clarifying when de-identified patient information may be disclosed
• Calls for HHS to study the advantages and disadvantages of the synchronization of the standards for research under the Common Rule and the Privacy Rule
• Clarifies the application of the Privacy Rule to external researchers

Section 5- Enhanced Focus and Reporting on Cancer Research

• Calls for NCI to report annually on plans and progress regarding research on cancers with low incidence and low survival rates
• Establishes grants program to conduct research on cancers with low incidence and low survival rates

Section 6 – Continuing Access to Care for Prevention and Early Detection

Screening and Early Detection

• Establishes a grant program to states for colorectal cancer screening and referrals for medical treatment (similar to the national breast and cervical cancer early detection program). States are given the option to cover screened persons found to have cancer under Medicaid.

Cancer Prevention

• Authorizes grants for a medical mobile van program to conduct cancer screening and prevention education activities in communities that are underserved and suffer from barriers to preventative cancer care

Access to Prevention and Early Detection for Certain Cancers

• Calls for the Secretary to include cancers with especially low survival rates in the Cancer Genome Atlas Consortium
• Calls for the Secretary to establish formal working groups for cancers with especially low survival rates in the Early Detection Research Network
• Calls for the National Institute of Biomedical Imaging and Bioengineering to ensure that the Quantum Grant program and the Image Guided Interventions program expedite the development of interventions for cancers with low survival rates

Section 7– Early Recognition and Treatment of Cancer Through the Use of Biomarkers

Promote the Discovery and Development of Biomarkers

• Establishes and coordinates federal agencies to establish a highly directed, contract based program that will support the development of innovative biomarker discovery technologies
• Calls for FDA and CMS to work together to create guidelines for clinical study designs that will enable sponsors to generate clinical data that will be adequate for review by both agencies
• Conducts a demonstration project to provide limited regional coverage for biomarker tests and establish procedures for independent research entities to conduct high quality assessments of the efficacy and cost effectiveness of biomarker tests

Section 8: National Cancer Coverage Guidelines

Ensure Patient Access to Clinical Trials

• Facilitates expanded access to clinical trials by requiring ERISA governed health plans to continue to provide coverage of routine care regardless of whether a patient enrolls in a clinical trial

Section 9: Health Professions Workforce

Ensure a Stable Workforce for the Future

• Supports retired nurse military officers to work as nurse faculty
• Directs Secretary of Health and Human Services to identify oncology workforce gaps

Section 10: Patient Navigator Program

Improve Upon Existing Patient Navigator Programs

• Ensures that patient navigators meet minimum core proficiencies
• Reauthorizes the Patient Navigator program through 2015

Section 11: Cancer Care and Coverage Under Medicaid and Medicare

Improvements in Coverage of Cancer Services

• Codifies current Medicare policy to reimburse for routine care while patients are enrolled in clinical trials
• Conducts a demonstration project to evaluate the cost, effectiveness, and potential savings to Medicare of reimbursing providers for comprehensive cancer care planning services to the Medicare population
• Directs states to offer tobacco cessation medications and counseling to pregnant women enrolled in Medicaid

Section 12: Cancer Survivorship and Complete Recovery Initiatives

Childhood Cancers

• Establishes priority areas for NIH activities related to childhood cancer survivorship
• Authorizes grants for research on the causes of health disparities in childhood cancer survivorship and to evaluate follow up care for childhood cancer survivors

Complete Recovery Care

• Defines “complete recovery care” which includes care to address secondary effects of cancer and its treatment, including late and psychosocial effects
• Coordinates complete recovery care activities across federal agencies
• Establishes a Collaborative that will develop a plan for workforce development for complete recovery care

Section 13: Activities of the Food and Drug Administration

Sense of the Senate

• Encourages the FDA to harmonize policies to facilitate the development of drugs; explore clinical trial endpoints; and, modernize the Office of Oncology Drug Products

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Renewing the War on Cancer

By Edward M. Kennedy and Kay Bailey Hutchison

Kay Bailey Hutchison, U.S. Senator For State of Texas

Cancer is a relentless disease. It doesn’t discriminate between men and women, wealthy or poor, the elderly or the young. In 2008, over 1.4 million Americans were diagnosed with some form of the disease. If it wasn’t you, it may have been a spouse or sibling, a parent or a child, a friend or a coworker. We, too, have known the challenges of cancer diagnoses for ourselves or our family members or friends. And while there are many stories of survival, this disease still takes far too many lives. More than half a million Americans lost their battle with cancer last year.

Since the War on Cancer was declared in 1971, we have amassed a wealth of knowledge about the disease. Advances in basic and clinical research have improved treatments significantly. Some of the most important progress has been made in prevention and early detection, particularly screening, including mammography and colonoscopy. Behavior modifications, such as smoking cessation, better eating habits, regular exercise, and sunscreen have been found to prevent many cancers. Continued focus must be placed on prevention, which will always be the best cure.

Though heightened awareness and prevention should be emphasized, alone they don’t translate into adequate progress for those with cancer. Since 1971, the cancer mortality rate has decreased by only 6 percent. In the same period, by contrast, mortality rates have dramatically declined for heart disease (by 56 percent) and stroke (by 66 percent). Today, cancer is the second leading cause of death in the United States, exceeded only by heart disease. If the current trend continues, the National Cancer Institute predicts that one in every two men and one in every three women will be diagnosed with cancer in their lifetimes, and that cancer will become the leading killer of Americans.

The solution isn’t easy, but there are steps we should take now if we hope to see the diagnosis rate decline substantially and the survival rate increase.  To do so, we must identify and remove the numerous barriers that obstruct our progress in cancer research and treatment.

First, it is essential that cancer be diagnosed at an initial, curable stage. One of the most promising breakthroughs is the monitoring of biomarkers, which leave evidence within the body that alerts clinicians to hidden activity indicating that cancer may be developing. Identification of such biomarkers can lead to the earliest possible detection of cancer in patients.

Second, even if we significantly improve early detection, lack of health insurance and other impediments to care will preclude many Americans from undergoing routine screening. With early screening, the disease may be detected at a treatable stage and dramatically increase the rate of survival. Greater outreach is clearly needed to make screening more available to all, and especially to underserved populations.

Third, we must adopt a more coordinated approach to cancer research. Establishing an interconnected network of biorepositories with broadly accessible sources of tissue collection and storage will enable investigators to share information and samples much more effectively. Integrated research will help accelerate the progress of lifesaving research. The search for cures should also be a cooperative goal. The current culture of isolated career research must yield to more cooperative arrangements to expedite breakthroughs. Our national policy should encourage all stakeholders in the War on Cancer to become allies and work in concert toward cures.

Fourth, as our nation’s best and brightest researchers seek new ways to eradicate cancer, we must improve treatment for those who have it today. Raising awareness of clinical trials would result in more patients and their doctors knowing what promising trials are available. Doing so will expand treatment options for patients, and enable researchers to develop better methods for prevention, diagnosis, and therapy.  Today, less than five percent of the 10 million adults with cancer in the United States participate in clinical trials. Disincentives by the health insurance market, preventing patients from enrolling in clinical trials, must be eliminated.

Finally, as our knowledge of cancer advances and patients live longer, we need a process that will improve patient survivorship through comprehensive care planning services. There is great value in equipping patients with a treatment plan and summary of their care when they first enter remission, in order to achieve continuity of therapy and preventing costly, duplicative, or unnecessary services.

We have introduced bipartisan legislation to bring about these necessary changes, and we hope to see the bill enacted in the coming weeks and months. These policy initiatives cannot be fully implemented without broad support and sufficient resources, and we are committed to leading this effort to completion.

It’s time to reinvigorate the War on Cancer, and more effective coordination of policy and science is indispensible for rapid progress.

Libby’s H*O*P*E*(tm) Adds New Cancer Video Archive Courtesy of Vodpod.com

Yesterday, Libby’s H*O*P*E* added a new cancer video archive to the weblog courtesy of Vodpod.com.  Currently, the archive contains approximately 90 videos that address many general cancer and ovarian cancer issues, as well as the personal voices of those affected by cancer. The new video archive is located on the homepage right sidebar.  All you have to do is “click and play.”

Yesterday, Libby’s H*O*P*E* added a new cancer video archive to the weblog courtesy of Vodpod.com.  Currently, the archive contains approximately 90 videos that address many general cancer and ovarian cancer issues, as well as the personal voices of those affected by cancer. The new video archive is located on the homepage right sidebar.  All you have to do is “click and play.”  The video arrangement is set to “random order” so that new videos appear on the homepage sidebar each time you visit Libby’s H*O*P*E*.

If you are aware of a general cancer/ovarian cancer video that is educational, heartfelt, inspirational, humorous, poignant, or is simply dedicated to the one you love, please provide us with the URL address of the video.  The URL video address can be sent to us by email (click on the “contact” button located at the top of the homepage), or by comment (post a comment under this post).  Upon receipt of the video URL address, we will add the referenced video to the new archive.  We appreciate your participation in adding to our video archive and hope you find the archive helpful.

2008 Genetic Information Nondiscrimination Act Signed Into Law By President Bush

“For Immediate Release
Office of the Press Secretary
May 21, 2008

President Bush Signs H.R. 493, the Genetic Information Nondiscrimination Act of 2008

Oval Office

2:05 P.M. EDT

THE PRESIDENT: I want to thank the members of Congress who’ve joined us as I sign the Genetic Information Nondiscrimination Act, a piece of legislation which prohibits health insurers and employers from discriminating on the basis of genetic information. In other words, it protects our citizens from having genetic information misused, and this bill does so without undermining the basic premise of the insurance industry.I also want to pay homage today to — and not only to members of the Congress who are behind me, but also to Senator Ted Kennedy, who has worked for over a decade to get this piece of legislation to a President’s desk. All of us are so pleased that Senator Kennedy has gone home, and our thoughts and prayers are with him and his family.

Now it’s my honor to sign the Genetic Information Nondiscrimination Act.

(The Act was signed.)

Thank you. (Applause.)

END 2:06 P.M. EDT”

[Quoted Source: “President Bush Signs H.R. 493, the Genetic Information Nondiscrimination Act of 2008,” White House Press Release, May 21, 2008.]

Comment: The enactment of the Genetic Information Nondiscrimination Act (GINA) of 2008 is momentous. Yesterday marks the start of the genetic medicine era – an era made possible by the Federal privacy protection extended to each individual under GINA. For additional GINA background, see Federal Enactment of the 2008 Genetic Information Nondiscrimination Act (GINA) As Law Appears Imminent, by Paul Cacciatore, H*O*P*E*™ Weblog posting dated April 30, 2008.

Federal Enactment of the 2008 Genetic Information Nondiscrimination Act (GINA) As Law Appears Imminent

“Although nearly 40 states have had individual forms of the legislation in place, with the federal passage of GINA, the message would be unambiguous: the misuse of genetic information resulting in discrimination in employment or health insurance is against the law in all U.S. states.”

“After installing compromises and ‘minor’ changes, including a ‘firewall’ separating the potential liabilities insurers and employers could face, the US Senate last week unanimously passed the Genetic Information Nondiscrimination Act [‘GINA’].

The bill, which seeks to protect individuals’ genetic information from being misused by insurers and employers, now moves to the House, where it is also expected to pass, and then to the White House, where President Bush is expected to sign it into law.

According to American Society of Human Genetics Executive VP Joann Boughman, the Senate version of the bill adopts language appearing in the House bill (HR 493) designed to ‘limit, but not completely prevent,’ employees from suing their employer for being denied insurance based on genetic information obtained by a payor.

The bill exempts employers from liabilities if the employer ‘inadvertently’ garners genetic information through a company-sponsored wellness program, or must request such information in order to monitor biological effects of toxic substances in the workplace. The bill’s language also specifies that ‘an employer, employment agency, labor organization, or joint labor-management committee shall not be considered to be in violation … [for the] use, acquisition, or disclosure of medical information that is not genetic information about a manifested disease, disorder, or pathological condition of an employee or member, including a manifested disease, disorder, or pathological condition that has or may have a genetic basis.’

Industry observers have long said that the lack of legal protections for people’s genetic information deters them from participating in clinical trials for gene-based therapies and tests, which in turn hampers advances in the genetics field.

In an NIH-funded study of families newly -diagnosed with a hereditary cancer syndrome named hereditary non-polyposis colorectal cancer, researchers found that participants consistently asked how their involvement in the study would impact their and their families’ insurance. During the study, ‘it was clear that there was an overwhelming concern, and in some cases, a palpable anxiety about the impact of genetic testing on health insurance,’ Donald Hadley, an associate investigator and a genetic counselor with the National Human Genome Research Institute, said in a 2004 testimony to the HHS Secretary’s Advisory Committee on Genetics, Health, and Society.

‘These concerns dominate our informed consent process and recur session after session with an intensity that opened our eyes to the level of concern that the public feels about genetic discrimination,’ Hadley said in his testimony.

With the expected passage of GINA, academic genetic researchers, diagnostics firms, and pharmacogenomics companies can better assure clinical trial participants that their genetic data will not be used to make insurance or employment decisions, and that they have recourse under the law if their genetic information is abused in such a manner.

GINA is expected to go back to the House of Representatives where it will be aligned with the Senate version of the bill and voted on again. Because GINA has already passed in the House twice with ‘considerable support,’ it is not expected to encounter any problems when the lower chamber votes on it, which can happen as early as this week.

Once it clears the House, GINA is expected to be signed into law ‘in short order,’ Kurt Bardella, press secretary for GINA sponsor Sen. Snowe, told Pharmacogenomics Reporter sister publication GenomeWeb Daily News last week.

In a recent address to the National Institutes of Health, President George Bush said he is willing to sign the bill into law if it passes Congress.

GINA’s Long Haul

Since last summer, after GINA cleared the House the first time by a vote of 420 to 3, the bill has had many detractors. The bill’s main opponent was Senator Coburn, who placed a hold on GINA, citing concern that the bill could potentially increase lawsuits against employers.

Mainly, Coburn wanted the bill to include a ‘firewall’ that would prohibit employees from being able to sue their employers if an insurer denied coverage based on genetic information.

Then in March, in a surprising move, the House passed GINA by a vote of 264 – 148 as part of the Paul Wellstone Mental Health and Addiction Equity Act of 2007 (H.R. 1424), which would require health insurers to cover mental health and substance abuse-related disorders under group health plans.

Attaching GINA to that bill appeared to invite more detractors to the expanded legislation. When the Wellstone bill passed in the House, 11 senators, including Coburn, sent a letter to Democratic leaders in Congress raising concerns about GINA’s ability to ‘maintain current law distinctions between employee benefit disputes … and disputes about civil rights in the employment context.’

Some of GINA’s other detractors, including the US Chamber of Commerce, the National Association of Manufacturers, and the National Retail Federation, shared the Senators’ concerns. These groups, which formed the Genetic Information Non-Discrimination in Employment Coalition, remained optimistic that the group may be appeased with ‘minor technical fixes’ to GINA, according to Michael Eastman, executive director of labor policy at the US Chamber of Commerce.

With GINA’s passage in the Senate, it seems those ‘minor fixes’ are now in place.

Senator Coburn’s office did not return requests for comment on GINA’s passage prior to deadline.

Employer Exemptions

Although the bill would make it unlawful for an employer to obtain genetic information from an employee or a family member in order to make employment decisions, the employer is not held liable for a number of scenarios.

For example, an employer would not be breaking the law if he “inadvertently requests or requires family medical history of the employee or family member of the employee” through a employee-provided wellness program; if the employee provides prior, knowing, voluntary, and written authorization; if the employee and the doctor receive individually identifiable information concerning the results of such services; and if the employer receives genetic information regarding these services in ‘aggregate terms that do not disclose the identity of specific employees.’

The employer is also exempt if genetic information is requested to comply with medical leave laws; if an employer purchases documents that are commercially and publicly available that include family medical history; or where the information involved is to be used for genetic monitoring of the biological effects of toxic substances in the workplace. In the last instance, the employer is required to provide written notice of the genetic monitoring on an employee.

Genetic Alliance President Sharon Terry described the compromise as a product of a “great conversation” between all parties involved and the engagement of the genetics community. She also suggested that the sudden advancement in consumer genetic testing businesses over the past year, and greater discussion in the media about the uses and ethics of such tests, could have helped push the bipartisan effort to pass GINA.

Grassroots Instruction

Expecting GINA to be signed into law, its supporters are now focused on educating physicians and patients regarding their rights.

‘Our challenge now is to make sure that doctors and patients are aware of these new protections so that fear of discrimination never again stands in the way of a decision to take a genetic test that could save a life,’ Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University.

The pending passage of the bill also was lauded by the Personalized Medicine Coalition, a collection of industry, academic, payor, and other partners. The PMC lauded two of its members, IBM and Eli Lilly, for adding genetic nondiscrimination to their employment policies in advance of GINA’s passage.

‘GINA closes important gaps in the current patchwork of federal and state protections against the misuse of genetic information,’ the PMC said in a statement. ‘Current federal statutes for protecting medical information, including the Health Insurance Portability and Accountability Act, do not prohibit insurers from requiring genetic testing or from denying coverage based on genetic information; and while the Americans with Disabilities Act protects individuals with symptomatic genetic disabilities, it is not clear if it explicitly covers discrimination based on unexpressed genetic susceptibility to disease.’

In the ASHG‘s view, the promulgation of a national genetic anti-discrimination law will help clear up the confusing patchwork of state laws that have emerged.

‘Although nearly 40 states have had individual forms of the legislation in place, with the federal passage of GINA the message would be unambiguous: the misuse of genetic information resulting in discrimination in employment or health insurance is against the law in all US states,’ the ASHG said in a statement.”

[Quoted Source: “Senate Unanimously Passes GINA, Though With‘Compromises’; Now Faces Sympathetic House,” by Turna Ray, Pharmacogenomics Reporter, April 30, 2008.]

Comment: For additional GINA and genetic discrimination information, please refer to the following: (i) “Genetic Information Nondiscrimination Act: 2007-2008,” National Human Genome Research Institute, National Institutes of Health, April 24, 2008; (ii) “Senate Gives GINA Critical Boost Toward Becoming Law,” National Human Genome Research Institute, National Institutes of Health, April 24, 2008; (iii) “Genetic Discrimination” Overview, National Human Genome Research Institute, National Institutes of Health, April 28, 2008; and (iv) “State Genetic Privacy Laws,” National Conference of State Legislatures, January 2008.

Updates:

• “Genetic Anti-Discrimination Bill Clears Congress,” Genetic Discrimination, National Human Genome Research Institute, May 1, 2008. It is expected that President George W. Bush will sign GINA, thereby enacting GINA as federal law.
• President Bush Signed GINA on May 21, 2008, thereby enacting GINA as Federal law.