Anti-phishing Act of 2005

Mr. President, the well-being of the U.S. population depends to a considerable extent on having access to high quality health care which, in turn, requires the presence of an adequate supply of health care professionals. The Congress and the President recognized this need when we passed, and President Bush signed, the Nurse Reinvestment Act in the 107th Congress. Just as with nurses, we must also insure an adequate supply of well-prepared allied health professionals. That is why, today, I am introducing the Allied Health Reinvestment Act with my good colleagues, Senator Bingaman of New Mexico and Senator Lieberman of Connecticut.

The allied health professions are many. Those recognized in the act include professionals in the areas of: dental hygiene, dietetics/ nutrition, emergency medical services, health information management, clinical laboratory sciences/medical technology, cytotechnology, occupational therapy, physical therapy, radiologic technology, nuclear medical technology, rehabilitation counseling, respiratory therapy, and speech-language pathology/audiology. This is not an exhaustive list, as the act will leave to the discretion of the Secretary of HHS additional professions deemed eligible.

Today, many allied health professions are characterized by existing workforce shortages, declining enrollments in academic institutions, or a combination of both factors. The American Hospital Association, AHA, reports vacancy rates of 18 percent among radiology technicians, 10 percent among laboratory technologists, 15.3 percent among imaging technicians, and 12.7 percent among pharmacy technicians. In addition, the AHA indicates that hospitals are having increasing difficulties recruiting these same professionals over the preceding 2-year period.

In my own State of Washington, the Washington State Hospital Association reports vacancy rates of 14.3 percent among ultrasound technologists, 11.3 percent among radiology technicians, and 10.9 percent among nuclear medicine technologists. These vacancy rates have a real effect on the hospitals in my State. When I meet with hospital officials back home, they always tell me how the lack of technicians affects patient care.

The Bureau of Labor Statistics projected that in the period 1998- 2008, the United States would need a total of 93,000 new professionals in clinical laboratory science by creating 53,000 new positions and filling the 40,000 existing vacancies. That averages 9,000 openings per year for technicians, and yet academic institutions are producing only 4,990 graduates annually. If these numbers stay constant, we will be short by 43,100 needed technicians in 2008.

According to the American Hospital Association, declining enrollment in health education programs contributes to the critical shortages of health care professionals. Similarly, data from a November 2002 study of 90 institutions by the Association of Schools of Allied Health Professions, ASAHP, shows a 3-year period of decline in enrollment in cardiovascular perfusion technology, cytotechnology, dietetics, emergency medical sciences, health administration, health information management, medical technology, occupational therapy, rehabilitation counseling, respiratory therapy, and respiratory therapy technician programs. As an indication of a worsening situation, data from the 2002-2003 academic year, alone, show that dental hygiene, physician assistant, and speech-language pathology and audiology should be added to this list.

While having an adequate number of health professionals in our country is key to ensuring access to health care for all of us, certainly one of the key populations for whom a healthy supply of health professionals is vitally important for is our senior population.

The U.S. Census Bureau reports that rapid growth of the population age 65 and over will begin in 2011 when the first of the baby boom generation reaches age 65 and will continue for many years. From 1900 to 2000, the proportion of persons 65 and over tripled, going from 4.1 percent to 12.4 percent.

The baby-boom generation's movement into middle age, a period when the incidence of heart attack and stroke increases, will produce a higher demand for therapeutic services. Medical advances now enable more patients with critical problems to survive, but in order to do so and maintain a high quality of life, these patients may need extensive therapy.

Along with the aging of the population came an increase in the number of Americans living with one, and often more than one, chronic condition. Today, it is estimated that 125 million Americans live with a chronic condition, and by 2020 as the population ages, that number will increase to an estimated 157 million, with 81 million of them having two or more chronic conditions. Twenty-five percent of individuals with chronic conditions have some type of activity limitations. Two-thirds of Medicare spending is for beneficiaries with five or more chronic conditions.

Many individuals with chronic conditions rely on family caregivers. Approximately 9 million Americans provide such services, and on the average, they spend 24 hours a week doing so. Caregivers aged 65-74 provide an average of 30.7 hours of care per week and individuals aged 75 and older provide an average of 34.5 hours per week.

Women are more likely than men to have chronic conditions, in part because they have longer life expectancies. These same women are caregivers to other chronically ill persons. In addition, 65 percent of caregivers are female, and of all caregivers, nearly 40 percent are 55 years of age and older.

Physicians report that their training does not adequately prepare them to care for this type of patient by providing education and offering effective nutritional guidance. Those aspects of care can be provided by allied health professionals, but many of them need better preparation to treat and coordinate care for patients with chronic conditions. While much emphasis is placed on curative forms of care, additional efforts must be devoted to slowing the progression of disease and its effects.

One example of the effectiveness of allied health interventions may be illustrated by a study funded by the National Institute on Aging, the National Center for Medical Rehabilitation Research, and the Agency for Health Care Policy and Research--since renamed the Agency for Healthcare Research and Quality. The investigation showed that significant benefits resulted from a 9-month occupational therapy intervention intended to reduce health-related declines urban, multiethnic, independent-living older adults. The majority of study participants, 73 percent, lived alone and 26 percent reported at least one disability. Important health-related benefits attributable to the intervention continued over a 6-month interval in the absence of further treatment.

The bill my colleagues and I introduce today, like the Nurse Reinvestment Act in the 107th Congress, is intended to provide incentives for individuals to seek and complete high quality allied health education and training. Furthermore, the bill will provide additional funding to ensure that such education and training can be provided to allied health students so that the U.S. healthcare industry with have a supply of allied health professionals needed to support the Nation's health care system in this decade and beyond.

The bill offers allied health education, practice, and retention grants. Education grants will be used to expand the enrollment in allied health education programs, especially by underrepresented racial and ethnic minority students, and provide educational opportunities through new technologies and methods, including distance-learning. Practice grants are intended to establish or expand allied health practice arrangements in noninstitutional settings to demonstrate methods that will improve access to primary health care in rural areas and other medically underserved communities. Retention grants are intended to promote career advancement for allied health personnel.

Grants will also be made available to health care facilities to enable them to

carry out demonstrations of models and best practices in allied health for the purpose of developing innovative strategies or approaches for retention of allied health professionals. These grants will be awarded to a variety of geographic regions, and to a range of different types and sizes of facilities, including facilities located in rural, urban, and suburban areas.

Furthermore, this bill will give the Secretary of HHS, acting through the Administrator of HRSA, the authority to enter into an agreement with any institution that offers an eligible allied health education program to establish and operate a faculty loan fund to increase the number of qualified allied health faculty. Loans may be granted to faculty who are pursuing a full-time course of study or, at the discretion of the Secretary, a part-time course of study in an advanced degree program.

I am especially proud of the provisions of this legislation regarding the National Health Service Corps program, the brain child of Senator Warren Magnuson of Washington. The NHSC program, of course, encourages students in the health professions such as doctors and dentists to serve in underserved areas throughout our nation in return for loan repayment assistance. And, like the NHSC program, this Allied Health Reinvestment Act will establish a scholarship program that provides scholarships to individuals seeking allied health education in exchange for service by those individuals in rural and other medically underserved areas with allied health personnel shortages.

There are a number of organizations supporting this bill, and I thank them for that support. Among them, the list includes, but is not limited to:

Washington State Hospital Association

Health Work Force Institute (Seattle, WA)

American Association for Respiratory Care

American Association of Community Colleges

American Clinical Laboratory Association

American Dental Hygienists' Association

American Dietetic Association

American Health Information Management Association

American Hospital Association

American Physical Therapy Association

American Society for Clinical Laboratory Science

American Society for Clinical Pathology

American Society of Radiologic Technologists

Association of Academic Health Centers

College of Health Deans

Midwest Regional Deans Group

Myositis Association

National Association of EMS Educators

National Cancer Registrars Association

National Network of Health Career Programs in Two-Year

Colleges

Northeast Regional Deans Group

In addition to these organizations, I would also like to express my appreciation to the Association of Schools of Allied Health Professions, ASAHP, for its support of the legislation as well as its ongoing efforts to address the need for allied health professionals and allied health faculty.

ASAHP, founded in 1967, has a membership that includes 108 institutions of higher learning throughout the United States, as well as several hundred individual members. ASAHP publishes a quarterly journal and also conducts an annual survey of member institutions. This annual survey, called the ``Institutional Profile Survey,'' is used for, among other purposes, collecting student application and enrollment data. These data substantiate that there is a pressing need to address existing allied health workforce shortages, which have been further exacerbated by declines in enrollment that have occurred for 4 straight years.

In the survey conducted during the period September-November 2004 for the 2004-2005 class starting in fall 2004, the results from 90 academic institutions indicate that in 16 of the 20 professions studied, available classroom seats were not filled. For example, only 33 percent of enrollment capacity was reached for health information management programs in these schools. Given the emphasis on increasing the use of information technology in health care such as conversion to electronic patient records, that figure is disturbingly low.

Similarly, the survey shows that enrollment levels were low in the following professions: rehabilitation counseling, 44 percent, emergency medical sciences, 66 percent, cytotechnology, 69 percent, and medical technology, 77 percent. Severe workforce shortages already exist in the two laboratory professions and emergency medical personnel will play a key role as first responders in dealing with any bioterrorism incident that might occur.

Using data from the Institutional Profile Survey, as well as the General Accounting Office, U.S. Census Bureau, and other sources, ASAHP has compiled what I believe to be a compelling rationale in its support for the Allied Health Reinvestment Act that Senators Bingaman, Lieberman, and I introduce today. I ask unanimous consent that the text of this Rationale for an Allied Health Reinvestment Act from the Association of Schools of Allied Health Professions be printed in the Record.

I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I rise today to introduce the Fair Access to Clinical Trials, FACT, Act. I want to begin by thanking Senator Grassley, Senator Johnson, and Senator Wyden for joining me in introducing this legislation. Our bill will create an electronic databanks for clinical trials of drugs, biological products, and medical devices. Such a databank will ensure that physicians, researchers, the general public, and patients seeking to enroll in clinical trials have access to basic information about those trials. It will require manufacturers and other researchers to reveal the results of clinical trials so that clinically important information will be available to all Americans, and physicians will have all the necessary information to make appropriate treatment decisions for their patients.

Events of the past year have made it clear that such a databank is needed. First, serious questions were raised about the effectiveness and safety of antidepressants when used in children and youth. It has now become clear that the existing data indicates that these drugs may very well put children at risk. However, because the data from antidepressant clinical trials was not publicly available, it took years for this risk to be realized. In the meantime, millions of children have been prescribed antidepressants by well-meaning physicians. While these drugs undoubtedly helped many of these children, they also led to greater suffering for others. Recently, it has been suggested that the risk of antidepressants might even extend beyond children.

The news is similarly disturbing for a popular class of painkillers known as Cox-2 inhibitors. These medicines, taken by millions of Americans, have been associated with an increased risk of cardiovascular adverse events, such as heart attack and stroke. It has been suggested that one of these medicines, which has since been pulled from the market, may be responsible for tens of thousands of deaths.

Unfortunately, antidepressants and Cox-2 inhibitors are just two examples of a story that has become all too common. It has been suggested that negative data might actually have been suppressed; and if this is discovered to be the case, those responsible should be dealt with harshly. However, because of what is known as ``publication bias,'' the information available to the public and physicians can be misleading even without nefarious motives. The simple fact is that a study with a positive result is far more likely to be published, and thus publicly available, than a study with a negative result. Physicians and patients hear the good news, but rarely the bad news. In the end, the imbalance of available information hurts patients.

Our bill would correct the imbalance of information, and prevent manufacturers from suppressing negative data. It would do so by creating a two-part databank, consisting of an expansion of clinicaltrials.gov--an existing registry that is operated by the National Library of Medicine, NLM--and a new database for clinical trial results.

Under the FACT Act, the registry would continue to operate as a resource for patients seeking to enroll in clinical trials for drugs and biological products intended to treat serious or life-threatening conditions--and for the first time, it would also include medical device trials. The new results database would include all trials, except for preliminary safety trials, and would require the submission of results data.

Our legislation would enforce the requirement to submit information to the databank in two ways. First, by requiring registration as a condition of Institutional Review Board, IRB, approval, no trial could begin without submitting preliminary information to the registry and database. This information would include the purpose of the trial, the estimated date of trial completion, as well as all of the information necessary to help patients to enroll in the trial.

Once the trial is completed, the researcher or manufacturer would be required to submit the results to the database. If they refuse to do so, they would be subject to monetary penalties or, in the case of federally funded research, a restriction on future funding. It is my belief that these enforcement mechanisms will ensure broad compliance. However, in the rare case where a manufacturer does not comply, this legislation also gives the Food and Drug Administration, FDA, the authority to publicize the required information.

Let me also say that any time you are collecting large amounts of data and making it public, protecting patient privacy and confidentiality must be paramount. Our legislation would in no way threaten that privacy. The simple fact is that under this bill, no individually identifiable information would be available to the public.

I believe that the establishment of a clinical trials databank is absolutely necessary for the health and well-being of the American public. But I would also like to highlight two other benefits that such a databank will have. First, it has the potential to reduce health care costs. Studies have shown that publication bias also leads to a bias toward new and more expensive treatment options. A databank could help make it clear that, in some cases, less expensive treatments are just as effective for patients.

In addition, a databank will ensure that the sacrifice made by patients who enroll in clinical trials is not squandered. Many patients would be less willing to participate in trials if they understood that the data are unlikely to be made public if the results of the trial are negative. We owe it to patients to make sure that their participation in a trial will benefit other individuals suffering from the same illness or condition.

The problems associated with publication bias have recently drawn more attention from the medical community, and there is broad consensus that a clinical trials registry is one of the best ways to address the issue. Accordingly, the American Medical Association, AMA, has recommended the creation of such a databank, and the major medical journals have established a policy that they will only publish the results of trials that were registered in a public database before the trial began. Our legislation meets all of the minimum criteria for a trial registry set out by the International Committee of Medical Journal Editors.

To its credit, the pharmaceutical industry has also acknowledged the problem, and has created a database to which manufacturers can voluntarily submit clinical trials data. I applaud this step. However, if our objective is to provide the public with a complete and consistent supply of information, a voluntary database is unlikely to achieve that goal. Some companies will provide information, but others may decide not to participate. We need a clinical trials framework that is not just fair to all companies, but provides patients with peace of mind that they will receive complete information about the medicines they rely on.

The American drug industry is an extraordinary success story. As a result of the innovations that this industry has spawned, millions of lives have been improved and saved in our country and around the globe. Because of the importance of these medicines to our health and well- being, I have consistently supported sound public policies to help the industry to succeed. This legislation aims to build upon the successes of this industry, and help ensure that the positive changes to our health care system that prescription drugs have brought are not undermined by controversies such as the ones now surrounding antidepressants and Cox-2 inhibitors, which are at least in part based on a lack of public information. This bill will help ensure that well- informed patients will use new and innovative medicines.

I look forward to working with industry, physicians, the medical journals, patient groups, and my colleagues--including the Chairman and the Ranking Member of the Health, Education, Labor, and Pensions Committee, Senator Enzi and Senator Kennedy--to move this legislation forward. This bill has already been endorsed by the National Organization for Rare Disorders, Consumers Union, the Elizabeth Glaser Pediatric AIDS Foundation, the American Academy of Child and Adolescent Psychiatry, the American Psychiatric Association, the New England Journal of Medicine, and the National Women's Health Network. I thank these organizations for lending their expertise as we crafted this legislation.

The creation of a clinical trials databank is a critical step toward ensuring the safety of drugs, biological products, and devices in this country--but it should not be the end of our efforts. I believe that other steps are necessary to fully restore patient confidence in the safety of the medicines they rely on. I have already announced my intention to introduce another piece of legislation that will create an Office of Patient Protection within the FDA, which will be responsible for ensuring the safety of prescription drugs once they are on the market. I look forward to introducing this bill in the coming weeks.

Clinical trials are critical to protecting the safety and health of the American public, and for this reason, trial results must not be treated as information that can be hidden from scrutiny. Recent events have made it clear that a clinical trials databank is needed. Patients and physicians agree that such a databank is in the interest of the public health. I urge my colleagues to support this legislation, and I am hopeful that it will become law as soon as possible.

I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I rise to reintroduce comprehensive legislation aimed at addressing the issue of economic and financial illiteracy on college campuses. I am referring to the worrisome problems of skyrocketing debt levels, low rates of saving, and the proliferation of unchecked predatory practices by unscrupulous financial institutions among young adults who hold our country's future in their hands. Entitled the College LIFE or College Literacy In Finance and Economics Act, this bill has the support of Senators Sarbanes and Corzine. I thank my colleagues from Maryland and New Jersey for joining me as original cosponsors of this measure. I also thank Senator Enzi, the Chairman of the Health, Education, Labor, and Pensions Committee, for working with me on financial literacy as it affects all constituencies, including college students.

The problem we are working to address with the College LIFE Act is simple. Our college students are many of America's best and the brightest and will go on to become leaders--in business, education, politics, the military, the community--any area you can name. I find it wonderful that many young people are fulfilling their dreams of higher education in numbers that I did not imagine when I was in college. In fact, as reported by the Census Bureau, college enrollment was estimated at 15.9 million for the current school year, compared to 5.7 million in 1965 when the Higher Education Act was enacted. However, I am gravely concerned, both as a member of this body and particularly as a grandparent and great-grandparent, that our young people are entering college without proper direction or good skills for money management or economic decisionmaking.

As we work on increasing access to higher education, we must give students access to tools needed to make sound economic and financial decisions once they are on campus; however, the lack of personal finance and economics standards or implementation of existing standards in elementary and secondary education in a number of States results in many students arriving at college with little understanding of economic concepts like supply and demand or benefits versus costs, or personal finance concepts such as household money management or the importance of maintaining good credit history. Without this basic understanding, college students are not effectively evaluating credit alternatives, managing their debt, and preparing for long-term financial goals, such as saving for a home or retirement.

Imagine life from the point of view of a college student. A young adult leaves his home and travels many miles--thousands of miles in the case of Hawaii students attending mainland colleges--to the campus that holds his hopes and dreams. Perhaps he is not being mindful of how much money he needs for textbooks, school supplies, or student fees. He visits the campus bookstore and walks out with a bag that includes a preapproved credit card application, which he immediately completes and sends. Months later, he has joined other credit card-holding college students who, on average, have credit card balances above $3,000. Sophomore year rolls around and, instead of conferring with his parents about the details of his renewal FAFSA for student financial aid or master promissory note, he is saddled with another $20,000 loan. According to the Census Bureau, average college tuition, room, and board have increased to $29,119 for a four-year private institution and to $9,953 for a four-year public institution. The same scenario repeats itself in junior and senior year. Finally, after completing all coursework, he graduates, finds an entry-level job, and realizes that, after servicing his debt, he has little left to spend on basics such as food, transportation, and rent, much less career clothing or a new briefcase. His lack of knowledge about how to properly use credit has led him to anxiety-causing financial missteps. With appropriate financial and economic literacy, he may have known what debt load to anticipate and made wiser financing and spending decisions while in school.

Instead, she may be on the road to true financial trouble. A U.S. Public Interest Research Group and Consumer Federation of America analysis of Federal Reserve data indicates that the average household with debt carries approximately $10,000 to $12,000 in total revolving debt and has nine credit cards. From January through September of 2004, approximately 1.2 million consumers filed for bankruptcy, keeping pace with last year's record level, which is almost half of the number of college diplomas expected to be conferred this year at 2.5 million. Furthermore, the Federal Reserve Board reports that Americans currently pay more than 13 percent of after-tax income to service their debts. We must ensure that our youth make the right decisions to follow a better financial path. This is especially in light of a report cited by Dan Iannicola, Jr., Deputy Assistant Secretary of the Treasury for Financial Education, at a House hearing last Congress, noting that youths spent more than $172 billion in a recent year, and figures from MarketResearch.com noting that typical 8- to 14-year-olds spend--from allowances, jobs, and gifts--nearly $1,300 a year or $25 a week.

The College LIFE Act represents a comprehensive approach to assist upcoming generations of Americans. It proposes four new grant programs that provide resources to encourage experimentation with delivery systems--innovative methods used in or out of the classroom to increase college students'

financial literacy. Another grant would allow higher education institutions to share best practices about or create personal finance courses where none exist. A third grant would assist efforts that are looking at the best ways to integrate personal finance and economic education into basic educational subjects, which is especially important as schools are facing challenges under the No Child Left Behind Act and are tempted to focus on subjects being tested for Adequate Yearly Progress. The final grant would train teachers and high school counselors toward increasing financial and economic literacy in grades K-12 so that our college students are prepared when they arrive at college campuses.

The bill also proposes a pilot program for five higher education institutions to encourage students to take a personal finance course and participate in preventive annual credit counseling, working in conjunction with State or local public, private, and nonprofit entities selected by the local education agency or the school, and measuring the effectiveness of efforts in any behavioral changes that may result. It promotes greater collaboration with and support from Federal agencies in the form of the Financial Literacy and Education Commission. Finally, the measure emphasizes the importance of personal finance and economic education and counseling by authorizing these activities as allowable uses in existing Higher Education Act programs, such as TRIO, GEAR UP, and Title III and Title V Serving Institutions.

Furthermore, I intend the reach of this bill to be beyond the traditional college student. Our returning college students are a vital part of society--many who are already community leaders and breadwinners for their families who have already gained valuable work experience that they may use as they learn a new field or continue their undergraduate study in the pursuit of a graduate or doctoral degree. In addition, older adults who are entering higher education for the first time can also be lauded for their enterprising spirit in wanting to better their lives by earning an associates or bachelors degree. I anticipate that the assistance provided through the College LIFE Act will work to provided needed help to many of these students as well.

I am looking forward to continuing to work with my colleagues to have the College LIFE Act passed or included in the upcoming Higher Education Act reauthorization. I encourage my colleagues' support for this bill.

Mr. President, earlier today, Senate Bill 470 was introduced. I am pleased to sponsor the Fair Access to Clinical Trials Act of 2005, with Senator Dodd. I am co-sponsoring this legislation as part of a sustained effort to restore public confidence in the Federal Government's food and drug safety agency. Enactment of this bill will be a meaningful step toward greater transparency and accountability in clinical trials and the scientific process.

The Food and Drug Administration earned its prized reputation through decades of good work on behalf of the American people. The FDA's drug approval process has long been considered the ``Good Housekeeping Seal of Approval.'' However, the Vioxx disaster and its aftermath have shaken the public's confidence. American consumers demand and deserve assurances that the medicines in their cabinets are safe. The health and safety of the public must be the FDA's first and only concern. Unfortunately, reforms at the FDA are necessary to place that mission front and center once again.

I began my oversight of the FDA last year in response to concerns about the reluctance of the FDA to provide information to the public about the increased suicidal risks for young people taking anti- depressants. Last November, I chaired a groundbreaking hearing on drug safety, the FDA and Vioxx. That hearing and other critical drug safety concerns of the past year highlighted the need for reforms and more stringent oversight of the FDA.

Sometimes congressional scrutiny of agency mismanagement can lead to necessary reforms. Sometimes an agency will act on its own to enhance its credibility. I have been pressing for reforms--both administrative and legislative--to bring about greater responsiveness and transparency at the FDA. The risks and benefits of prescription drugs should be readily available to patients and doctors seeking to make informed decisions.

The FACT Act will expand www.clinicaltrials.gov to create a publicly accessible national data bank of clinical trial information comprised of a clinical trial registry and a clinical trial results database. The legislation will foster transparency and accountability in health- related intervention research and development and ensure that the scientific community and the general public have access to basic information about clinical trials. Importantly, the FACT Act will maintain clinicaltrials.gov as a registry for patients and physicians seeking information about ongoing clinical trials for serious or life- threatening diseases and conditions. The legislation will also prevent companies from withholding clinically important information about their products.

The FACT Act will maintain a clinical trial registry accessible to patients and health care practitioners seeking information related to ongoing clinical trials for serious or life-threatening diseases and conditions; establish a clinical trials results database of all publicly and privately funded clinical trial results regardless of outcome that is accessible to the scientific community, health care practitioners, and members of the public; require the Food and Drug Administration (FDA) to make internal drug approval and safety reviews publicly available; build on the successful model of www.clinicaltrials.gov, which was established in 1997. The web site will continue to be run by the National Library of Medicine at the National Institutes of Health, with assistance from the FDA; apply to clinical trials for drugs, biologics, and medical devices. All trials must be registered in the database in order to obtain approval from a U.S. Institutional Review Board; require that foreign trials that are submitted to the FDA or used in advertising to U.S. physicians be registered in the database at the time of submission; require that researchers promptly disclose the objectives, eligibility criteria, sources of funding, and anticipated timeline of clinical trials. The bill's standards will meet all of the minimum criteria for a trial registry set out by the International Committee of Medical Journal Editors on September 8, 2004; mandate that the results of clinical trials be available to doctors and patients. Recognizing that the peer review process is the best safeguard for scientific accuracy, the bill provides time for researchers to publish their results. The disclosure of important trial results satisfies the recommendation of the American Medical Association; establish strong enforcement mechanisms. The bill will provide for civil monetary penalties of up to $10,000 per day for sponsors who refuse to comply. Monetary penalties will be earmarked for studies that compare clinical therapies; provide authority to audit the completeness and accuracy of the information in the registry; and ensure that the Food and Drug Administration has the authority to correct false or misleading statements about the results of clinical trials.

Later this month I will also introduce legislation to establish an independent office of drug safety in the Food and Drug Administration. Today's legislation is an important step toward reforming the FDA. I urge my colleagues to join me in this effort by cosponsoring this important legislation.

Mr. President, today I am introducing a bill, the Anti- Phishing Act of 2005, which targets a serious threat to the security of the Internet.

Phishing is a rapidly growing class of identity theft scams on the Internet that is causing both short-term losses and long-term economic damage. In the short-term, these scams defraud individuals and financial institutions. Estimated losses from phishing attacks are now in the billions of dollars, and those losses are growing. The short- term losses, however, are just a chapter in a larger story. In the long-term, phishing undermines the public's trust in the Internet. By making consumers uncertain about the integrity of the Internet's complex addressing system, phishing threatens to make us all less likely to use the Internet for secure transactions. If you can't trust where you are on the web, you are less likely to use it for commerce and communications.

Those well versed in popular culture may guess that phishing was named after the phenomenally popular Vermont band, Phish. But phishing over the Internet was in fact named from the sport of fishing, as an analogy for its technique of luring Internet prey with convincing email bait. The ``F'' is replaced by a ``P-H'' in keeping with a computer hacker tradition.

Phishing attacks usually start with emails that are, in Internet jargon, ``spoofed.'' That is, they are made to appear to be coming from some trusted financial institution or commercial entity. The spoofed email usually asks the victim to go to a website to confirm or renew private account information. These emails offer a link that appears to take the victim to the website of the trusted institution. In fact the link takes the victim to a phony website that is visually identical to that of the trusted institution, but is in fact run by the criminal. When the victim takes the bait and sends their account information, the criminal uses it--sometimes within minutes--to transfer the victim's funds or to make purchases. Phishers are the new con artists of cyberspace.

Phishing is on the rise. The Anti-Phishing Working Group reports that the number of new phishing messages climbed at a monthly rate of 38 percent in the last six months of 2004. The number of new phishing websites has climbed 24 percent per month since last August. And phishing attacks are increasingly sophisticated. Early phishing attacks were by novices, but there is now evidence that some attacks are backed by organized crime. Some of the attacks these days also include spyware, a type of software that is secretly installed on the victim's computer to surreptitiously capture account information when the victim visits legitimate websites.

In addition, the Internet faces the threat of ``pharming.'' This insidious crime does not rely on email bait. Rather, it attacks web browsers and the Internet's addressing system. The effect is that even individuals who type a desired Internet destination into their web browser may be redirected to a phony web site, with the same disastrous result as clicking on the phony link in a phishing attack.

Some phishers and pharmers can be prosecuted under wire fraud or identity theft statutes, but often these prosecutions take place only after someone has been defrauded. For most of these criminals, that leaves plenty of time to cover their tracks. It has been reported that the average phishing website is active on the Internet for less than six days. Moreover, the mere threat of these attacks undermines everyone's confidence in the Internet. When people cannot trust that websites are what they appear to be, they will not use the Internet for their secure transactions. Traditional wire fraud and identity theft statutes are not sufficient to respond to phishing and pharming.

The Anti-Phishing Act of 2005 protects the integrity of the Internet in two ways. First, it criminalizes the bait. It makes it illegal to knowingly send out spoofed email that links to sham websites with the intention of committing a crime. Second, it criminalizes the sham websites that are the true scene of both types of crime.

There are, of course, important First Amendment concerns to be protected. The Anti-Phishing Act protects parodies and political speech from being prosecuted as Phishing. We have worked closely with various public interest organizations to ensure that the Anti-Phishing Act does not impinge on the important democratic role that the Internet plays.

To many Americans, phishing and pharming are new words. They are certainly a new form of an old crime. They are also very serious, and we need to act aggressively to keep them from eroding the public's trust in online commerce and communication. I look forward to working with others in the Senate in addressing this growing threat to the Internet with effective and responsible action.