Medical Device Safety Act of 2008

Mr. President, I am proud to join my colleagues in introducing the Medical Device Safety Act. This legislation reverses the Supreme Court's erroneous decision in Riegel v. Medtronic. There, the Court misread a statute designed to protect consumers by giving the Food and Drug Administration the authority to approve medical devices as preempting state tort claims when a medical device causes harm. Riegel prevents consumers from receiving fair compensation for injuries sustained, medical expenses incurred and lost wages, and it must be reversed.

Congressional action should be unnecessary. When Congress passed the Medical Device Amendments, or MDA, in 1976, it did so ``[t]o provide for the safety and effectiveness of medical devices intended for human use.'' In other words, Congress passed the MDA precisely to protect consumers from dangerous medical devices. Toward that end, Congress gave the FDA the authority to approve, prior to a product entering the market, certain medical devices. For over 30 years the MDA has been in effect, and over that period FDA regulation and tort liability have complemented each other in protecting consumers.

Given the MDA's purpose, and the fact it has operated successfully for 30 years, I was disheartened to find the Court twist the meaning of the statute to strip from consumers all remedies when a medical device fails. In contorted logic, the Court found that the FDA's requirements in approving a medical device preempted state laws designed to ensure that manufacturers marketed safe devices. In other words, the Court believes that a company's responsibility to its patients ends when it receives FDA approval. I strenuously disagree.

In fact, there is absolutely no evidence that Congress intended that under the MDA, consumers would lose their only avenue for receiving compensation for injuries caused by negligent or inadequately labeled devices. Not a single member or committee report articulated the view that the statute would preempt state tort law.

Nevertheless, because of the Court's decision, it is imperative that Congress act to ensure that those harmed by flawed medical devices can seek compensation. The bill introduced today addresses the Court's action by explicitly stating that actions for damages under state law are preserved. Specifically, it amends section 521 of the Federal Food, Drug, and Cosmetic Act to state that the section shall not be construed to modify or otherwise affect any action for damages or the liability

of any person under the law of any State. And, the bill applies retroactively to the date of the enactment of the MDA, consistent with Congress's intent when it passed that act over 30 years ago. Practically, that means that it applies to cases pending on the date of enactment of this legislation or claims for injuries sustained prior to enactment.

The harm from Riegel, unless Congress acts, cannot be more real. Take Riegel itself. In 1996, Charles Riegel had an angioplasty performed on his right coronary artery. During the procedure, Mr. Reigel's surgeon used Medtronic's Evergreen Balloon Catheter. The catheter burst inside Mr. Reigel's artery, causing him severe and permanent injuries and disabilities.

Under our system of law, when someone is injured, he or she can normally seek redress from the entity that caused him or her harm. Yet, because of the Court's decision, Mr. Riegel and his wife will receive no compensation for the defective design and inadequate warning.

It is not just Mr. Riegel. In 2002, Gary Despain was implanted with a defective hearing aid Soundtec manufactured. While working as a welder, he suffered damage to his right ear, apparently as a result of interference between a magnet in his hearing device and some electronic welding equipment being used in the plant. The device caused severe ringing in his ear, but the labeling for the device failed to warn of this potential risk. Mr. Despain had to have the device surgically removed and he remains unemployed and disabled as a result of the device.

Nevertheless, two weeks after the Court's Riegel decision, Mr. Despain's lawsuit against Soundtec was dismissed and Mr. Despain has no ability to seek remedies for his injuries.

The result of Riegel, therefore, is that in the event the FDA does an inadequate job of inspecting and assuring the safety of medical devices--and because tort actions are now precluded--then consumers are left at extreme risk.

While FDA approval of medical devices, moreover, is important, it cannot be the sole protection for consumers. FDA approval is simply inadequate to replace the long-standing safety incentives and consumer protections that state tort law provides.

As a senior member of the Health, Education, Labor and Pension Committee, which has oversight over FDA, I have worked hard to ensure that the FDA performs its job. No matter how effective the FDA is, however, the FDA simply cannot guarantee that no defective, dangerous and deadly medical device will reach consumers. As the former Director of the FDA's Center for Devices and Radiological Health acknowledged, the FDA's ``system of approving devices isn't perfect, and that unexpected problems [with approved devices] do arise.'' In 1993, a House report identified a ``number of cases in which the FDA [had] approved devices that proved unsafe in use.''

The fact is, the FDA conducts the approval process with minimal resources and simply does not have adequate funds to genuinely ensure that devices are safe or to properly and effectively reevaluate approvals as new information becomes available.

Further, the FDA approval process is based on partial information. A principal shortcoming is that the device's manufacturer compiles the studies and data supporting an application, and the data is often unreliable. And, the FDA does not conduct independent investigations into a device's safety. A manufacturer, moreover, is not required to submit information about development of the device, including alternative designs, manufacturing methods and labeling possibilities that the manufacturer considered, but rejected.

In 1993, an FDA committee found flaws in the design, conduct and analysis of the clinical studies used to support applications that were ``sufficiently serious to impede the agency's ability to make the necessary judgments about [device] safety and effectiveness.'' It added, ``[o]ne of the main reasons [problems arise after approval] is that the data upon which we base our safety and effectiveness decisions isn't perfect.'' Likewise, in 1996, the Inspector General of the Department of Health and Human Services reported ``serious deficiencies . . . in the clinical data submitted as part of pre-market applications.''

FDA review, moreover, is a one-time event with no reevaluation and very little FDA oversight once a device reaches doctors and patients. In fact, even the best-designed and most reliable clinical studies by their very nature cannot duplicate all aspects and hazards of everyday use. Moreover, while manufacturers are supposed to report defects and injuries, the FDA has admitted that there is ``severe underreporting'' of defects and injuries.

Given the FDA's limitations, it is crucial that an individual have a right to seek redress. When defective medical devices reach the market, whether or not approved by the FDA, patients are often injured. Those injured are often left temporarily unable to work or to enjoy normal lives, and in many cases never fully recover. State tort law provides the only relief for patients injured by defective medical devices and should not be foreclosed.

Not only does access to State court mean that a person injured can receive fair compensation, but there are other advantages. Such suits aid in exposing dangers and serve as a catalyst to address their consequences. Through discovery, litigation can help uncover previously unavailable information on adverse effects of products that might not have been caught during the regulatory system. Litigants can demand documents and information on product risks that might not have been shared with the FDA. In this way, the public as a whole is alerted to dangers in medical products.

Finally, providing the ability to sue when injured provides an important incentive to manufacturers to use the utmost care. Additionally, threat of product liability suits creates continuing incentives for product manufacturers to improve the safety of their device, even after FDA approval.

The Court fundamentally misread Congress's intent in passing the Medical Device Amendments in 1976, and Reigel represents yet another victory by big business over consumers. Those injured, however, deserve to have their day in court and are entitled to compensation when they are injured by faulty medical devices, have medical expenses to pay and lost wages, regardless of whether FDA approved a device or not. We must reverse this erroneous decision and ensure that those who have suffered serious injury at the hands of others receive justice.

Mr. President, I am pleased to join with Senators Hatch, Obama, and McCain in introducing the ADA Amendments Act of 2008. This bipartisan legislation will allow us to advance and fulfill the original promise of the Americans with Disabilities Act, which was signed into law 18 years ago this month.

I am especially grateful to the distinguished senior Senator from Utah, Senator Hatch, for his partnership and leadership in helping to craft our bill here in the Senate and to Senator Kennedy for his career-long leadership in fighting for the rights of people with disabilities. Senator Kennedy has worked from the beginning to help craft this bill.

This bill is similar to bipartisan legislation introduced in the other body by House Majority Leader Steny Hoyer and Congressman Jim Sensenbrenner. That bill passed by a 402-17 margin last month.

I am also grateful that, from the outset, these bills have been conceived and crafted in a spirit of genuine bipartisanship, with members of both parties coming together to do the right thing for all Americans with disabilities.

Of course, passage of the Americans with Disabilities Act was also a bipartisan effort. As chief sponsor in the Senate, I worked very closely with Senator Bob Dole and others on both sides of the aisle. We received invaluable support from President George Herbert Walker Bush and key members of his administration, including White House Counsel Boyden Gray, Attorney General Richard Thornburgh, and Transportation Secretary Sam Skinner.

The fact is that Americans of all walks of life take enormous pride in the progress we have made since the ADA was passed 18 years ago. Nobody wants to go backward.

The Americans with Disabilities Act was one of the landmark civil rights laws of the 20th century--a long-overdue emancipation proclamation for Americans with disabilities. Thanks to that law, we have removed most physical barriers to movement and access for more than 50 million Americans with disabilities. We have required employers to provide reasonable accommodations so that people with disabilities can have equal opportunity in the workplace. And we have advanced the four goals of the ADA--equality of opportunity, full participation, independent living, and economic self-sufficiency.

The reach--the triumph--of the ADA revolution struck home to me, some time back, when I attended a Washington convention of several hundred disability rights advocates, many with significant disabilities. They arrived in Washington on trains and airplanes built to accommodate people with mobility impairments. They came to the hotel on Metro and in regular busses, all seamlessly accessible by wheelchair. They navigated city streets equipped with curb cuts and ramps. The hotel where the convention took place was equipped in countless ways to accommodate people with disabilities. There was a sign language interpreter on the dais so that people with hearing disabilities could be full participants.

For those of us who do not have disabilities, these many changes are all but invisible. But for individuals with disabilities, they are transforming and liberating. So are provisions in the ADA outlawing discrimination against qualified individuals with disabilities in the workplace, and requiring employers to provide ``reasonable accommodations.''

But despite this progress, we face a challenge. In recent years, the courts have narrowed the definition of who qualifies as an ``individual with a disability.'' As a consequence, people with conditions that common sense tells us are disabilities are being told by courts that they are not in fact disabled, and are not eligible for the protections of the law. In a ruling last year, the 11th Circuit Court even concluded that a person with an intellectual disability was not ``disabled'' under the ADA.

When I explain to people what the Supreme Court has done, they are shocked. Impairments that the Court says are not to be considered disabilities under the law include amputation, intellectual disabilities, epilepsy, diabetes, muscular dystrophy, and multiple sclerosis.

In three rulings in 1999--Sutton v. United Airlines, Murphy v. United Parcel Service, and Albertson's v. Kirkingburg--the Court held that corrective and mitigating measures must be considered in determining whether an individual has a disability under the ADA.

In Sutton, the Supreme Court held that if a person is taking corrective

measures to mitigate a physical or mental impairment, the effects of those measures must be taken into account when judging whether a person is ``disabled.'' Corrective measures could include anything from visual aids to a prosthesis. The Court went on to say that the approach adopted by the Equal Employment Opportunity Commission--that persons are to be evaluated in their hypothetical uncorrected state--was an impermissible interpretation of the ADA.

In Murphy, the Court applied the same analysis to medication used to treat hypertension, and concluded that an employee who was fired because he had hypertension was not protected under the ADA, because medication alleviated some of his symptoms.

In Kirkingburg, the Supreme Court went further and declared that mitigating measures to be included in the determination of whether someone is disabled included not only artificial aids such as devices and medications, but also subconscious measures an individual may use to compensate for his or her impairment. Kirkingburg was an individual who was blind in one eye, and the court found that he was not ``disabled'' under the ADA.

Moreover, in another Supreme Court case, Toyota v. Williams 2002, the Court held that there must be a ``demanding standard for qualifying as disabled.'' This too, has resulted in a much more restrictive requirement than Congress intended. It has had the effect of excluding countless individuals with disabilities from the protections of the law.

Together, these Supreme Court cases have created a supreme absurdity: The more successful a person is at coping with a disability, the more likely it is for a court to find that they are no longer sufficiently disabled to be protected by the ADA. And if these individuals are no longer protected under the ADA, then their requests for a reasonable accommodation at work can be denied. Or they can be fired--without recourse.

Think about it this way: Imagine that you are an individual with a disability who has a job. Due to your disability, you take some medication or maybe you use an assistive device. The use of the medication or the assistive device allows you to be qualified to do your job. It's a job that you really love. At some point, you need to request a reasonable accommodation from your employer--maybe, if you have diabetes, it is 10 minutes a day to take your insulin and check your blood levels.

Or perhaps you use a prosthesis. Your employer says no, they don't want to give you an accommodation. Eventually you get fired as a result. When you go to court, your employer argues that you aren't really a person with a disability so you aren't entitled to the protections of the ADA. Then, under these Supreme Court cases, the employer prevails by convincing the court that because of the mitigating measure--the prosthesis--you can't meet the test of being ``disabled'' under the law.

So what are you supposed to do in these cases? If you don't take the medication or use the assistive device, then you are not qualified to do the job. On the other hand, if you stop taking the medication, or stop using your prosthesis, you will be considered a person with a disability under the ADA, but you will be unable to do your job.

What would you do? This is the Catch 22 situation that, today, confronts countless people with disabilities. This is clearly not what I intended, or what Congress intended, when we passed the ADA in 1990.

It boggles the mind that any court would rule that, for instance, multiple sclerosis or muscular dystrophy, is not a disability covered by the ADA. But that is where we are today. And that is why we are introducing this bill today.

This Senate bill builds on the success of the House bill. However, it seeks to broaden the definition of disability in a way that maximizes bipartisan consensus and minimizes unintended consequences.

Our bill leaves the ADA's familiar disability definition language intact: A person with a disability is one who has a physical or mental impairment that ``substantially limits'' one or more of the major life activities of the individual. It does not substitute the term ``materially restricts'' as in the House bill. Instead, the bill takes several specific and general steps that, individually and in combination, direct courts toward a more generous meaning and application of the definition.

This bill will overturn the basis for the reasoning in the Supreme Court decisions--the Sutton trilogy and the Toyota case--that have been so problematic for so many people with very real disabilities.

This bill fixes the ``mitigating measures'' problem by clearly stating that mitigating measures--like the medication or assistive devices I talked about earlier--are not to be considered in determining whether someone is entitled to the protections of the ADA.

This bill will make it easier for people with disabilities to be covered by the ADA because it effectively expands the definition of disability to include many more major life activities, as well as a new category of major bodily functions. This latter point is important for those with immune disorders, or cancer, or kidney disease, or liver disease, because they no longer need to show what specific activity they are limited in, in order to meet the statutory definition of disability.

This bill rejects the current EEOC regulation which says that ``substantially limits'' means ``significantly restricted'' as too high a standard. We indicate Congress's expectation that the regulation be rewritten in a less stringent way, and we provide the authority to do so.

This bill revives the ``regarded as'' prong of the definition of disability, and makes it easier for those with physical or mental impairments to be able to seek relief if they have been subjected to an adverse action because of their disability.

This bill has a broad construction provision which instructs the courts and the agencies that the definition of disability is to be interpreted broadly, to the maximum extent permitted by the ADA.

Mr. President, 18 years ago, the Americans with Disabilities Act passed with overwhelming bipartisan support. Likewise, today, with the introduction of this bill, we are building a strong bicameral, bipartisan majority to support the ADA Amendments Act of 2008.

Let me say, again, that I am grateful for the bipartisan spirit with which we are approaching this legislation. We have an opportunity to come together and make an important difference for millions of Americans with disabilities.

This bill also enjoys strong support out in the country. It is supported by most national disability organizations, as well as the U.S. Chamber of Commerce, the National Association of Manufacturers, the Society for Human Resource Management, and the Human Resources Policy Association.

I look forward to working with my colleagues on both sides of the aisle to pass this bill, and to advance and fulfill the original promise of the Americans with Disabilities Act.

Mr. President, I ask unanimous consent the text of the bill be printed in the Record.

Mr. President, today I rise to introduce the FDA Food Safety Modernization Act.

Yesterday, the Food and Drug Administration, which is responsible for ensuring the safety of about 80 percent of our food supply, announced that it was one step closer to pinpointing the source of the current Salmonella Saintpaul outbreak. At first we were told tomatoes were the culprit. Then tomatoes were exonerated and jalapeno

peppers in south Texas were to blame. Now FDA is saying it has discovered a strain of the bacteria in Serrano peppers from a farm in Tamaulipas, Mexico.

In the meantime, over three months have passed since the first reported case. At least 255 people have been hospitalized and two have died because of the outbreak. The tomato industry faces tens of millions of dollars in losses and a loss in consumer confidence. Some estimate that the economic impact may be as much as $100 to $500 million.

Over the last couple of years we have seen news headlines about E. coli in spinach, pet food spiked with melamine, Salmonella-tainted peanut butter, and now contaminated peppers. It's clear that these are not isolated cases but the product of a food safety system that is outdated, under-funded, and overwhelmed. Some of our most important food safety statutes date back to the early 1900s. Standards have not been updated. The budgets of the agencies that act as watchdogs over the system have eroded. We import more of our food than ever but we don't have the systems in place to make sure this food is as safe as it could be. All these shortcomings put consumers at unnecessary risk.

FDA is struggling to keep up. There are holes in its ability to protect consumers from unsafe foods. For example, the Consumer Protection Safety Commission, the EPA, and even FDA with respect to infant formula all have recall authority. But FDA is unable to pull any other contaminated food off the shelf when the company that makes it will not. FDA can suggest a recall and most of the time companies comply. But there are always bad actors and sometimes companies choose not to recall their products because they are afraid of upsetting consumer confidence or losing market share. In this case, FDA's hands are tied.

These are significant gaps in our food safety system that need to be addressed. We can and should do better.

That is why I am pleased to introduce The FDA Food Safety Modernization Act, along with Senators Gregg, Dodd, Burr, Harkin, and Alexander. This bill is a comprehensive, bipartisan effort that addresses some of the weaknesses in FDA's authorities and resources and updates food safety standards to make important improvements in our current food safety system. The bill includes a number of important preventive measures, such as increasing the frequency of FDA inspections of food facilities, especially high-risk facilities; directing FDA to set standards for fresh produce; and requiring the food industry to control hazards in the food supply chain. It also enables FDA to more effectively respond to an outbreak by giving the agency new authorities to order recalls, shut down tainted facilities, and access records to track and trace food.

The food industry is one of the most important sectors of our economy, generating more than $1 trillion annually in economic activity and employing millions of American workers. Food is also a deeply personal experience, a part of our daily lives and our traditions and culture. For far too long Congress has gone without a comprehensive review of our food safety laws. As long as we continue to do nothing, we will pay the price for an outdated and ill-equipped food safety system.

I thank Senators Gregg, Dodd, Burr, Harkin, and Alexander for joining me in crafting this bill and urge my colleagues to support.

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

Mr. President, I rise today to introduce the Student Voter Opportunity to Encourage Registration Act of 2008--the Student VOTER Act.

The success of America's experiment in democracy lies in broad participation and deep civic engagement. From the Reconstruction Amendments, to women's suffrage, to the abolition of the poll tax, and finally the ratification of the 26th amendment, we have witnessed a steady but difficult march toward a more inclusive nation.

To realize the full potential of these great strides, the Student VOTER Act provides a pathway to participation for America's youth.

The need for this bill is clear. Despite a small rise in youth voting in the current Presidential election cycle, the larger trend is unmistakable. Young voters--historically independent-minded--are far less likely to cast a ballot than older voters. In the 2004 Presidential election, only 47 percent of 18 to 24-year-old citizens voted, compared to 66 percent of citizens 25 and older. This marked the eighth straight Presidential contest in which less than half of these young Americans actually participated. In fact, the percentage of young Americans who vote today is lower than it was in the first Presidential election following the 26th amendment's ratification.

Several obstacles stand in the way of youth voting. Because so many students are first-time voters, they often are unfamiliar with how to register. In some States, first-time voters must register in person in order to cast an absentee ballot. For students who attend college outside of their home State or who do not have access to transportation, these requirements can be cumbersome, confusing, and insurmountable.

Of course, apathy contributes to the fact that young voters tend to stay home on election day. But studies show that when an effort is made to reach out to young voters, they will cast a ballot. If we fail to reach out to the youth, we may lose a generation of civically minded Americans.

Congress already tried to encourage youth voting with a provision in the Higher Education Act of 1998, which requires colleges and universities to make a ``good faith effort'' to register students to vote. Many universities fulfill that obligation. For example, even before orientation begins, Brown University in Providence provides its students with voter registration materials not only for Rhode Island but also for each student's home State.

Unfortunately, too many colleges and universities have failed to follow Brown's lead. According to a 2004 Harvard University study, only 17 percent of colleges and universities nationwide fully comply with the Higher Education Act. The health of our democracy suffers as a result.

The Student VOTER Act offers a straightforward solution: it requires colleges and universities that receive Federal funds to offer voter registration services to students. The Student VOTER Act simply amends the National Voter Registration Act of 1993, popularly known as the Motor Voter Act, to designate colleges and universities that receive Federal funds as voter registration agencies.

That designation is fitting. Our institutions of higher education are among the wealthiest in the world, and they lead the globe in producing Nobel laureates and scientific breakthroughs. But colleges and universities also have a special obligation to educate an active, informed citizenry.

The act does not impose a heavy burden on colleges and universities. We know this because the Student VOTER Act builds on the successful model of the Motor Voter Act, which brought voter registration to DMV offices across the country, adding 5 million voters--mainly independents--to the rolls in the 8 months after its passage. While some DMV offices simply mail completed registration forms to the appropriate clerk or registrar, others now use efficient, easy-to-use computer software to submit registrations electronically.

This means that the price tag of the Student VOTER Act to colleges and universities is at most a 42-cent stamp for each student. I know most of my fellow Senators would agree that this is not too high a price to pay for a lifetime of civic engagement.

In reality, costs should be even lower. Colleges and universities can provide voter registration services at student orientation or during class registration using the same technology that DMV offices already have implemented.

Like the Motor Voter Act, this bill should pass with broad bipartisan support. It is a low-cost, commonsense solution to the very real problem of low youth voter turnout. It represents a natural but modest extension of the Higher Education Act and the Motor Voter Act without changing or amending any other State or Federal voting regulations in any way.

The bill may also serve to depoliticize voter registration efforts on college campuses. Polls consistently show that young voters are less likely to identify with a political party than older voters. Polls generally show that more than 4 in 10 young voters identify as independents, with roughly 3 in 10 young voters identifying with each of the two major political parties. In a July 30, 2008 letter sent to Congress in support of this bill, the U.S. Student Association explained that under the present system, ``partisan student groups often become the main voter registrants, which can alienate undecided and independent voters. The Student VOTER Bill of 2008 seeks to institutionalize the dissemination of voting procedure and register more young people in a systematic and non-partisan capacity.''

In addition to the U.S. Student Association, this bill is supported by U.S. PIRG and the Student Association for Voter Empowerment, SAVE. In particular, I would like to recognize Matthew Segal, SAVE's founder and a Chicago native, with whom my office worked closely to prepare this bill.

I would also like to applaud the efforts of Representative Jan Schakowsky, a Democrat, and Representative Steven LaTourette, a Republican, who will introduce a companion bill today in the House of Representatives. The Student VOTER Bill of 2008 is a bipartisan effort that is an important step toward empowering our Nation's youth. I look forward to working with my Democratic and Republican colleagues in Congress to ensure its enactment into law.

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

Prescription drugs can restore health, prevent illness, and extend lives. But deciding whether to prescribe a drug, and which one, requires a careful balancing of potential benefits, risks, and costs.

Prescribing should not be determined by how heavily a drug is promoted by a pharmaceutical company. Sadly, this is largely what happens today.

Our health care system does not generate objective, easy-to-access information for doctors to guide them when it comes to prescribing options.

New drugs are constantly entering the marketplace, but there's very little objective information about what drug might be marginally safer or more effective than existing drugs.

Even the most vigilant doctors would be challenged to monitor the dozens of medical journals that could contain a helpful study comparing the safety and effectiveness of drugs.

The pharmaceutical industry has taken advantage of this information void.

It spends about $7 billion a year marketing to physicians and sends over 90,000 sales representatives, called detailers, to pitch their company's latest and most expensive drugs.

What the drug industry is doing is not education. It is promotion. And there's a big difference between the two.

The drug company sales representatives are hired more for their charisma than their scientific knowledge, and they provide doctors with information skewed to portray their company's product in the most favorable light.

The sales representatives arrive with free lunches and free drug samples. Lucrative speaking and consulting fees are possible for doctors who change their prescribing to the liking of a drug company.

The consequence of such a system is clear: an over-reliance on prescribing the latest, most expensive drugs even when existing drugs are as effective, as safe, or cost less.

The pain-reliever Vioxx provides a cautionary tale of what can happen when marketing prowess trumps evidence-based medicine.

Heavy marketing quickly made Vioxx a blockbuster drug with $3 billion a year in sales, despite a lack of evidence that it could provide any greater pain relief for most patients than Advil and despite early indications that it increased the risk of heart attacks. Many Americans needlessly paid more and placed themselves at risk because the benefits of Vioxx were oversold and the risks minimized.

Another example is the marketing of calcium-channel blockers in 1990s. Heavy marketing increased the sales of the new patent-protected calcium-channel blockers but decreased sales of other blood-pressure drugs, such as thiazide diuretics and betablockers, that were cheaper and often more effective.

A more recent example is the cholesterol drug Vytorin. The new drug has been heavily marketed since it was introduced in 2004. But a study released earlier this year did not find that Vytorin was any better at limiting plaque buildup in the arteries than Zocor, an older cholesterol drug that recently came out in a lower-priced generic form.

We have to find a better way to educate physicians about prescription drug options and fill the void of medical information that the drug industry is now taking advantage of.

Part of the solution is academic detailing, an idea first developed by Jerry Avorn, a physician at Harvard Medical School and Brigham and Women's Hospital in Boston.

Academic detailing programs use some of the marketing tools that the drug industry has used so effectively, such as office visits to physicians and easy-to-read materials, but employs them to promote appropriate prescribing, based on an objective analysis of the medical literature.

These programs--which send trained nurses and pharmacists, armed with unbiased information, to doctors' office--have been shown to generate $2 in savings for every $1 that it costs to implement them.

Pennsylvania's PACE program is the State's pharmacy assistance program for low- and moderate-income seniors, and it runs the most notable publicly funded academic detailing program.

The PACE academic detailing program has reduced costs associated with the overuse of Nexium, an acid-reflux drug for which there are similar lower-cost alternatives, and reduced the use of Cox-2 inhibitors such as Vioxx.

Today, I am joining Senator Kohl and Senators Kennedy and Casey in introducing legislation that would promote additional academic detailing programs.

The Independent Drug Education and Outreach Act would provide funds to medical schools, schools of pharmacies, and others for the development of educational materials based on what unbiased, peer- reviewed medical literature says about appropriate prescribing for a particular condition.

The bill also would provide funds to ten governmental or non-profit groups to train nurses and pharmacists and to send them to physician offices to present and discuss this information directly with physicians.

The bill includes protections against financial conflicts of interest and calls on the Agency for Health Care Research and Quality to review the accuracy of the information provided to doctors.

The Independent Drug Education and Outreach Act would begin to fix one of the glaring shortcomings of our current health care system: the lack of a systematic way of disseminating information on the relative benefits, risks, and costs of various treatment options directly to doctors.

When it comes to prescription drugs, newer isn't necessarily better. In many cases, they are not.

We can no longer afford to rely on drug company salespersons to be doctors' primary source of information about new drugs.

I urge my colleagues to support this bill.

Mr. President, today I rise with my good friend Senator Ensign to introduce the Carson City Vital Community Act of 2008.

The origins of this legislation can be found in Carson City's collaborative master planning effort, ``Envision Carson City.'' In 2004, the elected officials in Carson City started a dialogue with their citizens to determine how the city should grow and change over the next 20 years. At the end of a 2-year public process, city leaders had a clear message from their residents. The community wants to keep growth compact, maintain the integrity of the Bureau of Land Management (BLM) and Forest Service lands surrounding the town, enhance open space opportunities and maintain easy access to public lands. The Carson City Vital Community Act of 2008 was developed in close partnership with Carson City and other key stakeholders to help fulfill these goals.

Before I describe this legislation and its importance, it might be helpful for me to explain that Carson City is both a city and a county. It wasn't always this way. For over a hundred years the town of Carson City was the county seat of Ormsby County. But in 1969 the county dissolved and the government functions were consolidated into what we now simply call Carson City.

Like all but one of our counties in Nevada, Carson City is mostly Federal land. The town of Carson City is bounded on the west by Forest Service lands that stretch to the shores of Lake Tahoe and by BLM lands on the east. These open landscapes create a dramatic western backdrop for Nevada's State capital but also mean that the Federal Government is intimately involved in what would normally be local community decisions.

This legislation makes much needed adjustments to the pattern of Federal land ownership in Carson City. We have strived to make changes that will improve the ability of the Federal land management agencies to focus on their core goals. All too often, the BLM and the Forest Service are distracted from proper forest and range management by urban encroachment issues. We have a unique situation in Carson City where the community has offered to take on the responsibilities of managing the wildland-urban interface, while also offering to convey a major inholding to the Forest Service for incorporation into the Humboldt- Toiyabe National Forest. This is a major step in the right direction and hopefully will serve as a model for other communities around the west.

Our legislation also provides lands to the Washoe Tribe, strengthening the Tribe's conservation and commercial efforts in Carson City. Additionally, nearly 20,000 acres of BLM lands surrounding Carson City will be permanently withdrawn from future develop to protect local viewsheds and public access. All of these actions will move Carson City one step closer to realizing the vision that it worked hard to develop through a public process that has now spanned over four years.

Title I of this legislation aims to create a sensible land ownership pattern in Carson City, aligned with the community's vision of keeping growth compact and maintaining the integrity of the surrounding public lands. It also addresses two serious concerns facing the community: wildfires in the foothills of the Sierras and flooding along the Carson River.

Under this title, roughly 2,200 acres of Carson City land will be transferred to the Forest Service. This prime, forested land is far removed from Carson City and is surrounded by state park lands and the Humboldt-Toiyabe National Forest. Incorporating this large inholding into the Humboldt-Toiyabe will allow for improved management for wildlife habitat, watershed protection, and other important uses. It will also ensure that the land remains undeveloped and open for public access.

This title also makes important adjustments to the pattern of city and Federal lands on the west side of the town. Roughly 1,000 acres of Forest Service land bordering urban areas will be conveyed to Carson City as protected open space. This conveyance will let both Carson City and the Forest Service do what they do best. Carson City can more actively manage urban interface uses and the Forest Service can focus on their core responsibilities of resource protection and forest health.

Proper management of this buffer area between Carson City's neighborhoods and businesses and the broader public lands is an issue of great concern to the community. On July 14, 2004, thirty-one homes and three businesses were destroyed or damaged in the Waterfall Fire which spanned nearly 9,000 acres of public and private land. Through our legislation, the Forest Service land that currently borders neighborhoods will be conveyed to Carson City, allowing the city to take a more prominent role in managing fuel loads in this critical area.

There is a different threat on the east side of Carson Valley. The Carson River has a long history of dramatic flooding. Over the last 150 years the river has flooded over 30 times, with half of those floods causing extensive damage. Two 100-year flood events have struck just in the last decade, one of which caused over $5 million in damage. In a show of real vision and leadership, Carson City has started an aggressive campaign to acquire land along the Carson River, recognizing the value of protecting the natural function of the local floodplains.

Our legislation will enhance Carson City's efforts to acquire lands in the river corridor by conveying the 3,500-acre Silver Saddle Ranch and Prison Hill area from BLM to the city. Transferring these properties to Carson City will help create a large regional park along the Carson River, support the community's flood control efforts and address the community's call for open space. The city has been a key partner in the management of the Silver Saddle Ranch for over a decade. Along with the Friends of Silver Saddle, Carson City has taken the lead on the day-to-day management of the property, including providing law enforcement patrols and caring for facilities.

It is important to note that when this land is conveyed to the city it will come with conditions. The Federal Government will hold a conservation easement on these parcels to ensure that the scenic and natural qualities of the Silver Saddle Ranch and Prison Hill are protected in perpetuity. The details of the conservation easement, which will focus on protecting the river corridor and the important wildlife habitat associated with the property, will be worked out by BLM, Carson City and key stakeholders like Friends of Silver Saddle and The Nature Conservancy.

In addition to supporting Carson City's forward-looking plans for the Carson River and its floodplain, conveying the Silver Saddle and Prison Hill area to Carson City also makes sense from a resource management perspective. BLM's Carson City District Office manages over 5 million acres of public land in western Nevada and eastern California. Their strength is managing Nevada's wide open spaces--not urban interface. Carson City, on the other hand, has far more resources to bring to bear in managing the Silver Saddle Ranch and Prison Hill area. Carson City has over 20 employees working on parks and open space, including two park rangers. They also have contracts in place with some of Nevada's most respected natural resource experts. The BLM will also keep a light hand in the management of this property by virtue of the conservation easement.

There is one unique provision related to the Silver Saddle Ranch and Prison Hill conveyance that deserves special mention. A small section of this land was once owned by Carson City. This 62-acre property, known as the Bernhard parcel, was slated to be subdivided into 35 home sites in 2001. The BLM and Carson City both recognized that the acquisition of this land was a priority for the protection of the Carson River corridor. Carson City responded quickly and acquired the parcel for open space before it could be developed. Their purchase price in 2001 was roughly $1 million. Later, in 2006, the BLM purchased the Bernhard parcel from Carson City for fair market value, which by that time had reached $2.5 million.

Under this legislation, we transfer the Bernhard parcel back to Carson City as part of the Silver Saddle Ranch and Carson River Area. We feel it is important that Carson City pay back 25 percent of the $1.5 million profit they made on their transaction with the

BLM. Why just 25 percent? The 25 percent reflects the remaining value of the land that is being conveyed back to Carson City after the conservation easement is taken into account. In western Nevada, conservation easements restricting development typically reduce property values by anywhere from 75 percent to 90 percent. We have required Carson City to come up with 25 percent, the most generous estimate of remaining value for the Bernhard parcel. When received, these funds will be placed into an endowment account for the BLM to use for the monitoring and enforcement of the conservation easement on the Silver Saddle Ranch and Prison Hill Area.

Our legislation also conveys roughly 1,700 acres of BLM land to Carson City for recreation and public purposes and open space. These are scattered parcels of BLM land in and around Carson City that would be used for primarily for parks, but also for flood control structures, municipal infrastructure like water tanks, and to give residents room to roam. Carson City already controls roughly a third of these acres through Recreation and Public Purpose Act leases. This bill would quickly and efficiently transfer these lands to the city.

Another provision of Title I deals with 53 acres of land that Carson City acquired from BLM years ago, under the Recreation and Public Purposes Act. The city now believes the land is better suited for commercial development. Although Carson City already owns these lands, by statute, if the city uses the land for something other than public purposes, the land reverts back to the BLM. Our legislation would remove the reversionary interest on these 50 acres so that Carson City can sell the land at an appropriate time. If the City decides to sell the land, we require that it be auctioned, with proceeds returning to the Carson City special account which provides funding for federal acquisition of sensitive lands and protection of noted cultural resources.

One of the parcels where the federal interest would be released is home to the Carson City Gun Club. Once on the edge of town, the shooting range is now surrounded by commercial development and the Eagle Valley Golf Course. Although our legislation would allow Carson City to sell this land, we have asked for and received a commitment that Carson City will not sell this property until the shooting facility has been relocated to another, more appropriate location.

The first title of our legislation also transfers 50 acres of Forest Service land to the BLM. The Forest Service is also authorized to develop and implement, in partnership with Carson City, a plan for managing its land in a way that minimizes the impact of flood events on nearby residential areas.

Under Title II, 150 acres of federal lands would be made available for sale through an open and competitive process. This includes the 50 acres transferred from the Forest Service to the BLM in Title 1. All of the lands identified for sale in our legislation are isolated or seriously impacted by nearby commercial or residential development. Both agencies have concluded that these parcels should be disposed of and that this action is consistent with their respective management plans.

Similar to past Nevada land bills, this legislation directs the Secretary of Interior to reinvest the proceeds of these limited land sales back into important public projects. Ninety-five percent of the proceeds will be used to acquire environmentally sensitive lands in Carson City and to protect archaeological resources. The remaining five percent of the proceeds will go to Nevada's general education program.

This title also permanently withdraws nearly 20,000 acres of BLM lands in Carson City from land sales and mineral development. These same lands, located north and east of Carson City are already administratively withdrawn by the BLM. This bill would make the withdrawal permanent, preserving foothill views, open space and access to public lands, in line with ``Envision Carson City.''

Our bill also provides guidance that Off-Highway Vehicle (OHV) use on BLM lands in Carson City should be restricted to existing roads and trails until the BLM completes their travel management planning process. The Pine Nut Mountains east of Carson City are a favorite destination for local and visiting OHV enthusiasts. This provision will better protect this area until routes can be designated.

Finally, the second title of the bill opens a new avenue for Carson City to continue their conservation efforts along the Carson River. The Southern Nevada Public Land Management Act (SNPLMA) will be amended to authorize funds for Carson City to acquire land for parks and trails along the Carson River and to authorize conservation initiatives, also along the Carson River. In addition, we make a small change to SNPLMA which will only affect Washoe County. In the White Pine County bill of 2006 (P. L. 109-432), Washoe County was given access to SNPLMA through 2011 to acquire part of the Ballardini Ranch. The county has made good progress towards this acquisition, but may not make the 2011 deadline. We are pleased to extend the authorization to 2015.

Title III addresses the Washoe Tribe's pressing need for more land for residential and commercial development. Tribal lands adjacent to both of the colonies in Carson City, Stewart and Carson, would be expanded by this legislation. Carson Colony tribal lands would grow by over 280 acres. On this parcel, the lands located below the 5,200-foot elevation contour would be available for residential or commercial development. The lands above the 5,200-foot contour would only be available for traditional tribal uses, like ceremonial gatherings, hunting and plant collecting. Tribal lands at the Stewart Colony would grow by only 5 acres, all of which would be available for commercial and residential development.

In 2003, Senator Ensign and I passed legislation that conveyed 25 acres of Forest Service land at Skunk Harbor, on the shores of Lake Tahoe, to the Washoe Tribe. Unfortunately, the parcel was not accurately described in the legislation and consequently the land that was conveyed did not fully reflect our commitment to the Tribe. This bill includes a technical correction that will provide a long overdue fix to the Washoe Indian Tribe Trust Land Conveyance (P. L. 108-67).

Lastly, this bill directs the Forest Service to develop a cooperative agreement with the Washoe Tribe to ensure the Tribe's access across Forest Service land for their traditional ``lifeway'' walk to Lake Tahoe. For centuries the Washoe people have moved from the Pine Nut Mountains east of Carson City in the fall to Lake Tahoe in the summer. Our legislation ensures that they are able to continue this important tradition.

This bill, is built on years of public input. We believe it is a model piece of legislation and appreciate the support of our colleagues in this effort. We look forward to working with Chairman Bingaman, Ranking Member Domenici and the other distinguished members of the Energy and Natural Resources Committee to move this bill forward during the time we have remaining in this legislative session.

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

Mr. President, today there is some good news and some bad news. The bad news is that oil is at $123 a barrel and working people are paying $4 for a gallon of gas, and this coming winter residents of the Northeast could be paying over $5 for a gallon of heating oil.

But, there is some good news. Today, the CEOs of ExxonMobil, Shell, BP and ConocoPhillips are celebrating. They're feeling pretty good. And, they have good reason to feel that way.

ExxonMobil reported today that it made over $11.68 billion in profits over the 2nd quarter alone, breaking its own record for the largest quarterly profit of any American company in the history of the world.

But, ExxonMobil is not alone. Shell's 2nd quarter profit jumped by 33 percent to $11.56 billion; and BP's 2nd quarter profit jumped by 28 percent.

As a matter of fact, since George W. Bush and Dick Cheney have been in office, the five largest oil companies have made over $640 billion in profits. This includes $212 billion for ExxonMobil; $157 billion for Shell; $125 billion for BP; $80 billion for ChevronTexaco; and $66 billion for ConocoPhillips.

Believe it or not, the Big 5 oil companies made more profits during the 2nd quarter, than they did during the entire year of 2002.

Now, with the exception of my Republican friends here in Congress, there are very few people in this country who believe the oil companies give one hoot about the well-being of the American people. Our Republican friends are saying that if we just give these huge oil companies more acres offshore to drill for oil, they will certainly do the right thing, as they always have, for the American people. Let's just trust those big oil companies because they are really staying up day after day, night after night, worrying about the well-being of the American people. That is what their full-page ads in the New York Times and all their ads on television are telling us.

Well, it is good to see there are at least some people in America who believe that. I don't, but apparently my Republican colleagues do.

Let me tell you, big oil companies are so concerned about Americans paying high prices for gas and oil that this is what they are doing with their profits:

In 2005, ExxonMobil gave its CEO, Lee Raymond, a $398 million retirement package--one of the richest compensation packages in corporate history. They weren't going out looking for new land to drill on, they weren't building more refineries, and they weren't working on energy efficiency. They gave their CEO a $398 million retirement package.

In 2006, Occidental Petroleum, gave its CEO, Ray Irani, over $400 million in total compensation.

The situation is so absurd and the greed of the oil companies is so outrageous that these companies are not only giving their executives huge compensation packages during their life here on earth, but they have also created a situation, if you can believe it, where these oil companies have carved out huge corporate payments to the heirs of senior executives if they die in office. I guess this is what happens when you have more money than you know what to do with.

According to the Wall Street Journal, if the CEO of Occidental Petroleum dies in office, his family will get $115 million. The family of the CEO of Nabors Industries, another oil company, would receive $288 million. This would be funny if it were not so pathetic in the sense of the impact this type of spending has on the American people.

Not only are huge oil companies using their record-breaking profits on big compensation benefits for their CEOs, but they are also spending large sums of money buying back their own stock. In other words, when they are making these very large profits, they are not going out drilling for more oil, as our Republican friends are suggesting.

In fact, While Americans are struggling to pay for the skyrocketing price of gasoline; big oil companies are having an entirely different problem. For the past seven years, big oil companies are struggling to figure out what they are going to do with all of their windfall profits.

Let me quote from a headline taken from the front page of the Wall Street Journal way back on July 30 of 2001, ``Pumping Money: Major Oil Companies Struggle to Spend Huge Hoards of Cash.'' According to this 2001 article, ``Royal Dutch/Shell Group said it was pumping out $1.5 million in profit an hour and sitting on more than $11 billion in the bank.'' That was in 2001. Since that time Shell's profits have more than tripled.

On April 18, 2005, Fortune Magazine published an article with the Headline ``Poor Little Rich Company,'' referring to ExxonMobil. According to this article, ``ExxonMobil CEO Lee Raymond, suddenly has a new anxiety: how to spend the windfall wrought by $55 a barrel oil. By the end of April [of 2005], Exxon will have a cash hoard of more than $25 billion. . . . At a time when domestic energy production is declining and drivers are paying a record $2.15 a gallon [remember, this was in 2005], American consumers, not to mention politicians, are likely to start focusing on whether Exxon is spending enough to find oil and gas. While Exxon is returning more money to shareholders via dividends and buying back more of its stock, its spending on drilling and other development activities actually declined in 2004--even though crude prices jumped by a third.'' That was when the price of oil was $55 a barrel and gas was $2.15 a gallon. Today oil is over $123 a barrel and gas is about $4 a gallon.

What is happening today? Big oil companies are spending even more on stock buybacks and CEO compensation and less on trying to produce more oil.

For example, ConocoPhillips recently announced that it plans to give all of the $12 billion in profits it made last year back to shareholders, paying more than $3 billion in dividends and spending the rest to buy back shares of its own stock. To put this in perspective the money that ConocoPhillips is spending on stock buybacks and dividends is enough to reduce the price of gas by 9 cents a gallon throughout the entire United States.

Now, I want my Republican friends to listen closely. They have been saying over and over again that big oil desperately needs all of these windfall profits to drill for more oil.

But, guess what? According to the CEO of ConocoPhillips, James Mulva, ``We like the discipline of the share repurchase. If we find that we have more cash flow, it's not really going to be going toward capital spending.'' In other words, ConocoPhillips won't use their windfall profits to drill for more oil, or invest in renewable energy, or explore for new sources of oil discoveries no matter how much their profits rise.

Overall, since 2005, the five biggest oil companies have made $345 billion in profits and spent over $250 billion buying back stock and paying dividends to shareholders.

Last year, ExxonMobil spent 850 percent more buying back its own stock than it did on capital expenditures in the United States.

The $38 billion in windfall profits that ExxonMobil gave back to shareholders last year could have been used to reduce gas prices at the pump throughout the United States by 27 cents a gallon for the entire year.

Mr. President, let's not kid ourselves. One of the major reasons as to why Americans are getting ripped-off at the gas pump has to do with the tremendous power and influence that big oil companies have in the Congress. As a matter of fact, since 1998, the oil and gas industry has spent over $616 million on lobbying activities.

Who have they hired? Well, on April 8 of this year, The Hill reported that Chevron hired former Majority Leader Trent Lott, a Republican; former Senator John Breaux, a Democrat; their sons Chester Trent Lott, Jr. and John Breaux, Jr.; and Trent Boyles, who was Lott's Chief of Staff to lobby Congress on issues relating to trade, climate change, and energy taxes.

ExxonMobil has hired former Senator Don Nickles, a Republican from Oklahoma, who served in this body for 24 years, to lobby Congress on behalf of their issues.

These are just a few of the hundreds of lobbyists that big oil and gas companies have hired to influence Congress, many of them former Senators, former Congressmen, and former Congressional staffers.

That is one of the reasons why, among many other reasons, this Congress, in recent years, has decided to give some $18 billion in tax breaks to oil companies despite their record-breaking profits.

In addition, since 1990 big oil companies have made over $213 million in campaign contributions. And that is a simple fact.

Lo and behold, what we are hearing today--just coincidentally, no doubt--is that the most important thing we can do in terms of the energy crisis is to provide more land offshore for the oil companies to drill at a time when they already have some 68 million acres of leased land, which they are not drilling on today.

The American people want action, and there are some things we can do--not in 15 or 20 years but that we can do right now.

First, we need to impose a windfall profits tax on big oil companies so that they would be prohibited from gouging consumers at the gas pump.

Unfortunately, instead of taking away big oil's windfall profits and giving it back to the American people, Republicans want to provide even more tax breaks to big oil. In fact, Sen. McCain has a plan that would give ExxonMobil a $1.5 billion tax break.

Now, we have heard Republicans give three reasons as to why they are opposed to a windfall profits tax.

First, Republicans claim that the last time Congress enacted a windfall profits tax in 1981 it had the effect of increasing our dependence on foreign oil. Wrong. Mr. President, when Congress repealed the windfall profits tax in 1988, the U.S. was importing 7.4 million barrels of oil a day. Today, the U.S. is importing over 13.4 million barrels of oil a day. We are far more dependent on foreign oil today without a windfall profits tax than we were 20 years ago when we had a windfall profits tax.

Secondly, my Republican friends tell us that the windfall profits tax didn't work because Congress repealed it in 1988. That is also wrong. While I would have structured it differently, the fact of the matter is that from 1981 until 1988 when the windfall profits tax was repealed, the price of oil fell from $35 a barrel to less than $15 a barrel. In addition, gas prices at the pump fell from $1.35 a gallon to 90 cents a gallon--a drop of 45 cents a gallon. And the Federal Government collected over $80 billion in revenue.

The reason why the windfall profits tax was repealed was due to low oil and gas prices, which makes perfect sense. If oil and gas prices are low, big oil companies are not making windfall profits and there is no need for a windfall profits tax. If gas prices at the pump were only 90 cents a gallon, I would be one of the first Senators to say we don't need a windfall profits tax. But, they are not. They are over $4 a gallon.

Finally, Republicans claim that big oil companies need to keep their windfall profits so that they can increase production and build more refineries. That particular argument is laughable.

Big oil companies have been making windfall profits for over seven long years--and they are not using these profits to build more refineries and they are not using it to expand production. Instead, they are using this money to buy back their own stock, increase dividends to their shareholders,

and enrich their CEOs, as I have explained earlier.

Not only do we need to impose a windfall profits tax on these extremely powerful oil corporations, but we also have to address what I perceive is a growing understanding that Wall Street investment banks, such as Goldman Sachs, Morgan Stanley, JPMorgan Chase, and hedge fund managers are driving up the price of oil in the unregulated energy futures market. In other words, they are speculating on energy futures and driving up prices.

There are estimates that 25 to 50 percent of the cost of a barrel of oil is attributable to unregulated speculation on oil futures. We have heard from some leading energy economists, and we have heard from people in the oil industry themselves who tell us that 25 to 50 percent of the cost of a barrel of oil today is not due to supply and demand or the cost of production but is due to manipulation of markets and excessive speculation. In essence, Wall Street firms are making billions as they artificially drive up oil prices by buying, holding, and selling huge amounts of oil on dark unregulated markets.

Some of my Republican friends claim that the increase in the price of oil has nothing to do with speculation, but it is interesting to me that we have had executives of major oil companies--major oil companies--who have come before Congress and who are saying, ``Why is oil $125, $130, and $140 a barrel?'' Do you know what they say? The CEO of Royal Dutch Shell testified before Congress and said: ``The oil fundamentals are no problem. They are the same as they were when oil was selling for $60 a barrel.''

This is not some radical economist. It is not some left-winger. This is a guy who is the head of Royal Dutch Shell.

The CEO of Marathon Oil recently said: ``$100 oil isn't justified by the physical demand in the market.''

I know my Republican friends have a lot of respect for the oil industry, a great competence in them. They love them and give them huge tax breaks. So maybe they should listen to what some of these guys are saying in terms of oil speculation.

For those who believe that excessive speculation is not causing oil prices to climb higher, let me just say this. Over the past 7 years, Enron; BP; and Amaranth were caught redhanded manipulating the price of electricity; propane; and natural gas. Each time, supply and demand was to blame and each time the pundits were proven wrong. Excessive speculation; manipulation and greed were the cause. Enron employees are in jail for manipulating the electricity market in 2001; BP was forced to pay a $300 million fine for manipulating propane prices in 2004; and the Amaranth hedge fund collapsed after manipulating natural gas prices in 2006.

The Stop Excessive Speculation Act introduced by Majority Leader Reid begins to seriously address this problem. We need to pass this bill as soon as possible.

The bottom line is that it is time for the United States Senate to say no to big oil companies and greedy hedge fund managers and yes to the American people.

Mr. President, today I join my good friend and colleague, Senator Baucus, in introducing the Comparative Effectiveness Research Act of 2008. This proposal is the product of months of careful deliberations regarding the best way to expand the quality and quantity of evidence available to health consumers about the comparative clinical effectiveness of health care services and treatments. We have met with dozens of key stakeholders and thought leaders to discuss various aspects of this legislation. I am proud of the result. This legislation lays the groundwork for improving health care outcomes, enhancing patient safety, and reducing overall health care costs in the long-run.

As chairman of the Senate Budget Committee, I am acutely aware of the long-term budget challenges facing our nation. Health care spending is growing at an unsustainable rate. Although demographic changes associated with the retirement of the baby boom generation contribute to this spending growth, the most significant factor is growth in health care costs in excess of per capita GDP growth. According to Congressional Budget Office projections, by 2050, Medicare and Medicaid spending alone will consume 12 percent of our Nation's gross domestic product.

But excess growth in per capita health care costs is not just a challenge for Federal health spending and the federal budget. If we continue on the current trajectory, the private sector will also be overwhelmed by rising health care costs. In fact, total health care spending is projected to grow from about 16 percent of GDP in 2007-- which is far higher than in other industrialized countries--to more than 37 percent of GDP in 2050.

Clearly, we need to address the underlying causes of rising health care costs, not just in the Medicare and Medicaid programs, but in the overall health care system. Simply cutting Medicare and Medicaid without making other changes will do little to solve the larger problem we face. As GAO Comptroller General David Walker pointed out in testimony before the House Budget Committee, in 2005, ``[F]ederal health spending trends should not be viewed in isolation from the health care system as a whole . . . . Rather, in order to address the long-term fiscal challenge, it will be necessary to find approaches that deal with health care cost growth in the overall health care system.''

A key problem we must confront is that our health care system does not deliver care as efficiently or effectively as it should. In fact, the United States spends far more on health expenditures as a percent of GDP than any other country in the Organization for Economic Cooperation and Development. For example, the United States spent 16 percent of GDP on health expenditures in 2006, compared to 9 percent in Italy. And the disparity is even starker today. Despite this additional health care spending, health outcomes in the United States are no better than health outcomes in the other OECD countries. In fact, by some measures, they are worse.

We can and must find ways to deliver health care more efficiently, reduce ineffective or unnecessary care, and get better health outcomes without harming patients.

One solution is to generate better information about the relative effectiveness of alternative health strategies--and encourage patients and providers to use that information to make better choices about their health. Many newer, more expensive health care services and treatments are absorbed quickly into routine medical care--yet there is little evidence that these services and treatments are any more clinically effective than existing treatments and services.

The Federal Government currently funds some comparative effectiveness research through the Agency for Healthcare Research and Quality. The Effective Health Care Program has been a successful initiative, and we commend AHRQ for its work, but comparative effectiveness research is not the primary focus of any federal agency--nor is this federal funding occurring on a large-scale. The Congressional Budget Office, CBO, the Medicare Payment Advisory Commission, MedPAC, and the Institute of Medicine, IOM, have all discussed the positive impact of creating a new entity charged solely with conducting research on the comparative effectiveness of health interventions, including pharmaceuticals, medical devices, medical procedures, diagnostic tools, medical services and other therapies.

In its June 2007 report to Congress, MedPAC issued a unanimous recommendation that ``Congress should charge an independent entity to sponsor credible research on comparative effectiveness of health care services and disseminate this information to patients, providers, and public and private payers.''

And the Congressional Budget Office agrees. In a recent report, entitled, ``Research on the Comparative Effectiveness of Medical Treatments: Issues and Options for an Expanded Federal

Role,'' CBO Director Peter Orszag wrote that, ``generating better information about the costs and benefits of different treatment options--through research on the comparative effectiveness of those options--could help reduce health care spending without adversely affecting health overall.''

The IOM also supports getting better information into the hands of patients and providers. As part of its report, ``Learning What Works Best: The Nation's Need for Evidence on Comparative Effectiveness in Health Care,'' the Institute concluded that, ``[a] substantially increased capacity to conduct and evaluate research

on clinical effectiveness of interventions brings many potential

opportunities for improvement across a wide spectrum of healthcare

needs.''

This bill that Senator Baucus and I are introducing today represents an important step in expanding comparative effectiveness research. The bill would significantly expand the conduct of comparative clinical effectiveness research to get better information into the hands of patients and providers in the hopes of improving health outcomes and reducing unnecessary or ineffective care.

The purpose of this bill is to provide health care providers and patients with objective and credible evidence about which health care treatments, services, and items are most clinically effective for particular patient populations. The research conducted under our bill would evaluate and compare the clinical effectiveness of two or more health care interventions, treatment protocols, procedures, medical devices, diagnostic tools, pharmaceuticals, and other processes or items used in the treatment or diagnosis of patients. Access to better evidence about what works best will help patients and health care providers make better-informed decisions about how best to treat particular diseases and conditions. Our hope is that the evidence generated by this research could lead to savings in the overall health care system over the long-term by allowing providers to avoid treatments that may be clinically ineffective, while at the same time improving health care outcomes.

Specifically, our bill creates a private, nonprofit corporation, known as the Health Care Comparative Effectiveness Research Institute, which would be responsible for organizing and implementing a national comparative effectiveness research agenda. In conducting the research, the Institute would contract with the Agency for Healthcare Research and Quality, the National Institutes of Health and other appropriate public and private entities and could use a variety of research methods, including clinical trials, observational studies and systematic reviews of existing evidence.

Many thought leaders on this issue, such as the Medicare Payment Advisory Committee, had concerns that a large entity within the Federal Government would be vulnerable to political interference that could hamper the Institute's credibility, and, therefore, limit the usefulness of its research. As a result, we chose a model outside of the Federal Government, but subject to government oversight.

In order to ensure that the information developed is credible and unbiased, our bill establishes a 21-Member Board of Governors to oversee the Institute's activities. Permanent board members would include the Secretary of Health and Human Services and the Directors of the Agency for Healthcare Research and Quality and the National Institutes of Health, NIH. The remaining 18 board members would be appointed by the Comptroller General of the United States and would include a balanced mix of patients, physicians, drug, device, and technology manufacturers, public and private payers, academic researchers, philanthropic organizations and quality improvement entities.

To ensure further credibility, the Institute is also required to appoint advisory panels of patients, clinicians, and other stakeholders that would assist in the development and carrying out of the research agenda; establish a methodology committee that would help create standards by which all research commissioned by the Institute must be conducted; create a peer review process through which all research findings must be assessed; and develop protocols to help translate and disseminate the evidence in the most effective, user-friendly way.

Moreover, Senator Baucus and I want to ensure that the operations of the Institute are transparent. Therefore, we built in a strong role for public comment prior to all key decisions made by the Institute. For example, the bill requires public comment periods prior to the approval of the overall research agenda and the individual study designs. In addition, the bill calls for periodic public forums to seek input, requires that all proceedings of the Institute be made public and available through annual reports, and requires that any conflicts of interest be made public and that board members recuse themselves from matters in which they have a financial or personal interest.

Because all health care users will benefit from this research, our legislation funds the Institute with contributions from both public and private payers. These contributions will include mandatory general revenues from the Federal Government, amounts from the Medicare Trust Funds equal to $1 per beneficiary annually, and amounts from a $1 fee per-covered life assessed annually on insured and self-insured health plans. Funding will ramp up over a series of years. By the fifth year, we expect the Institute's total annual funding to exceed $300 million per year and continue to grow thereafter.

The concept of an all-payer approach for comparative effectiveness research has been embraced by a number of health care experts. For example, on the subject of comparative effectiveness information in its June 2008 report, MedPAC stated: ``The Commission supports funding from federal and private sources as the research findings will benefit all users--patients, providers, private health plans, and federal health programs. The Commission also supports a dedicated funding mechanism to help ensure the entity's independence and stability. Dedicated broadly based financing would reduce the likelihood of outside influence and would best ensure the entity's stability . . .''

To ensure accountability for these funds and to the Institute's mission, our bill requires an annual financial audit of the Institute. In addition, the bill requires GAO to report to Congress every five years on the processes developed by the Institute and its overall effectiveness, including how the research findings are used by health care consumers and what impact the research is having on the health economy. Finally, the bill requires a review after eight years of the adequacy of the Institute's funding, which will include a review of the appropriateness and adequacy of each funding source.

Let me take a moment to address some of the criticisms that might be levied against this proposal. Some may say this Institute will impede access to care and will deny coverage for high-cost health care services. That is not the case. Our proposal explicitly prohibits the Institute from making coverage decisions or setting practice guidelines. It will be up to specialty societies and patient groups to use the research findings as they see fit. Moreover, to the extent that high-cost health care services or new technologies are studied by the Institute and found to be clinically ineffective compared to other services and technologies, such evidence will be made public to consumers and providers so that they can make the best possible health care decisions. Other critics may claim that this proposal will result in one-size-fits-all approach to comparative clinical effectiveness research. We recognize that different health care treatments may have different levels of effectiveness for different subpopulations. That is why our bill requires that the Institute's research be designed, as appropriate, to take into account the potential differences in the effectiveness of health care services as used with various subpopulations, such as women, racial and ethnic minorities, different age groups, and individuals with different comorbidities.

This bill is a balanced, carefully crafted proposal that has taken into consideration the recommendations of a broad range of stakeholders and thought-leaders. We welcome further discussion and suggested improvements. But we refuse to allow this proposal to get bogged down in political

maneuvering or scare tactics. Our nation needs to ramp up comparative effectiveness research immediately to improve health outcomes and reduce ineffective and inefficient care.

Senator Baucus and I will work jointly to push for the expeditious enactment of this bill. I urge all of my colleagues to join our effort and cosponsor the Comparative Effectiveness Research Act of 2008. There is no time to waste.