MILWAUKEE, WI - As weight-loss warriors climb to the mountaintop of fitness and better health, they will inevitably cross a plateau or two in their journey. According to Nicholas "Dr. Nick" Yphantides, M.D., M.P.H., medical spokesperson for TOPS Club, Inc. (Take Off Pounds Sensibly), the nonprofit weight-loss support organization, "There are inevitable periods of plateau. You feel like you have changed nothing, yet the body fat no longer disappears and your weight loss seems to be stuck in neutral. The real dilemma is that the plateau can be a huge motivation killer."

The harm, he says, is that some people give up during a plateau and fall back into poor eating and exercise habits out of discouragement.

On a positive note, since it's best to lose weight slowly, steadily, and sensibly, plateaus can often be a body's balancing act. A plateau also can signal that a body has less fat left to lose.

Dr. Nick points out that real plateaus, when weight loss does in fact stall, are different from  perceived plateaus, when a person is in denial and doesn't believe they are doing anything differently, yet the weight is not coming off.

"Honesty and accuracy are such core ingredients to healthy living for TOPS members that I have to mention them, as I frequently discover what I call a 'perceived plateau' upon deeper interaction and conversations with people who are frustrated with their weight loss," he says.

One cause of a true plateau is that the body is trying to achieve equilibrium, or homeostasis. In this state, the body wants to retain the status quo and not lose weight. Weight will resist coming off, even if the number of calories consumed and level of exercise stay the same.

Dr. Nick says that the key is to mix up your routine so the body reacts to changing signals. "Some weight-loss warriors make the mistake of expecting different results with the same routine. It's easy to get discouraged, but it's more effective to get creative," he notes.

His strategies for overcoming a weight-loss plateau include :

•    Eat the same weekly amount of calories but eat less one day and more the next to make the body react differently. Also, remember to drink water to feel full and avoid problems caused by dehydration.
•    Try adding a new activity to an exercise routine. It will activate more muscles and change the way the body is used. For instance, if you typically walk daily, swim or bike instead. Add high-intensity cardio intervals to a low-intensity workout. If there's a fun, new dance class to try, this is a good time.
•    Switch the type of workout. For example, trade an aerobic session for a strength-training or muscle-toning class. This can increase lean muscle mass and jump-start the metabolic rate.
•    Spread out daily food intake to fuel metabolism over a longer period of time. Add a few mini-meals each day, going from three meals to five, without adding calories. Make sure breakfast is a solid meal, because it results in better concentration and higher energy throughout the day.

Use patience and persistence as tools in the journey to overall wellness. Weight-loss plateaus will happen along the way - but they can be overcome.

TOPS Club Inc. (Take Off Pounds Sensibly), the original, nonprofit weight-loss support and wellness education organization, was established more than 62 years ago to champion weight-loss support and success. Founded and headquartered in Milwaukee, Wisconsin, TOPS promotes successful, affordable weight management with a philosophy that combines healthy eating, regular exercise, wellness information, and support from others at weekly chapter meetings. TOPS has about 170,000 members in nearly 10,000 chapters throughout the United States and Canada.

Visitors are welcome to attend their first TOPS meeting free of charge. To find a local chapter, view www.tops.org or call (800) 932-8677.

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We would like to announce the promotion of Geoff Pearson to Business Development Manager for Ryder Transportation.

Geoff is a graduate of Illinois State University with a Bachelor of Arts Degree. Geoff will be covering the eastern Iowa market. Geoff started his career at Ryder as a Rental Manager Trainee in 2006 and most recently held the position of Rental Account Manager. Geoff has been in the Iowa market since 2007, and will be selling Ryder Transportation solutions for business to business opportunities effective May 1st.

Ryder specializes in a wide range of fleet management services, including full service truck leasing; commercial truck lease financing combined with programmed maintenance, onsite and programmed fleet maintenance, truck rental and a comprehensive network of fuel services.

For more information, contact Geoff at the Ryder location in Davenport, Iowa at 563-386-8000.

In the wake of the West Virginia coal mining disaster that killed 29 miners, the blast on a Louisiana oil rig off the Gulf of Mexico that most likely killed 11 workers and so many other work related tragedies, we are painfully reminded that we must pay more attention to the safety of American workers.  Every day folks across Iowa go to work in factories and at facilities that are quite simply, dangerous workplaces. 

As the son of an Iowa coal miner, I feel for these workers and their families, on a very personal level.  My thoughts and prayers are with the families and coworkers of those killed, injured or missing because of these awful tragedies.  One of the best ways we can honor their memory is to renew our efforts to protect workers' lives and improve safety and health in our country's coal mines and other dangerous workplaces.

This past week in Washington, I held a hearing on the very subject of what Congress needs to do to improve worker safety and create a culture of compliance at mines and other dangerous workplaces.  Our Senate hearing was held on April 27, the eve of Worker's Memorial Day - a day that is set aside to remember the thousands of brave men and women who die on the job in our country each year. 

Certainly, the history of the American workplace suggests that when we focus our efforts, we have the ability to make great strides to improve safety and health.  Since passage of the Coal Mine Health and Safety Act and Occupational Safety and Health Act four decades ago, countless lives have been saved and the number of workplace accidents has been dramatically reduced.  Yet we still have a long way to go.

In addition to putting real teeth in our safety and health laws, we have to make sure that our federal agencies have the enforcement tools they need to identify mines and non-mine workplaces with the worst safety records in the country and hold these repeat offenders accountable.  We have provisions in our laws that are supposed to target repeat offenders, but these special rules are often rendered ineffective - either weakened through mistaken interpretation, or undermined by employers who will go to great lengths to game the system.  This broken system must be fixed.

As we move forward, I plan to do everything I can in Congress to ensure that Iowa's - and our nation's - sons and daughters, moms and dads, brothers and sisters all come home safe from a hard day's work.  We should not rest until these recent work related tragedies are a chapter in the history books, and we no longer have any need to observe a day of mourning for American workers killed on the job.

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Commits to Fight for Repeal in Congress

 

WASHINGTON, DC- Iowa's First Congressional District candidate Mike LaCoste has signed the American Family Business Institute's (AFBI) "Death Tax Repeal Pledge."  By signing the pledge, LaCoste commits to vote for permanent repeal of the Federal Estate Tax, commonly referred to as the "Death Tax."

 

AFBI's President Dick Patten praised LaCoste for signing the pledge, saying "By supporting estate tax repeal, LaCoste will help save local jobs and businesses."

 

A recent study from the American Family Business Foundation, AFBI's research and education arm, found that repealing the Death Tax would increase nationwide employment by 1.5 million jobs.  In Iowa alone, repealing the Death Tax would add nearly 17,000 new jobs.

 

"LaCoste has been a strong advocate for permanently repealing this unfair double tax. He understands that the Death Tax penalizes family farmers and business owners when they die. I'm encouraged that he has committed to taking a more active role in the repeal fight," Patten added.  "With the economy in the midst of a prolonged recession, we need to be helping family businesses and farmers, not hitting them with an additional tax."

 

The estate tax is a tax on the net value of a decedent's estate, including all personal and business assets, before distribution to their heirs. Because business assets are included, the Estate Tax hits family business owners and farmers - the engines of economic growth -- particularly hard.

 

The Federal Estate Tax has expired for one year in 2010, but will return at a 55 percent rate on all assets over $1 million in 2011 unless Congress acts first.  Most political observers expect a heated legislative battle over the tax this year. 

 

The American Family Business Institute is a national, non-partisan organization of farmers and business owners who are committed to permanent repeal of the Death Tax.

 

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MOLINE, ILLINOIS - WQPT is excited to announce the winners of the 16th Annual PBS Kids Go Young Writers and Illustrators Contest, formerly known as the Reading Rainbow Young Writers and Illustrators Contest. 357 local children entered the contest and WQPT and judges from our sponsoring organizations chose the sixteen local winners (first, second, third and honorable mention) from kindergarten through third grade. The winners will be honored and awarded prizes at Deere-Wiman House on Sunday, May 16 at 3:00 pm.  First place winners will compete for prizes in the national PBS Kids Go competition. The winners will be announced in July. Last year Jayda Brunkan from Eldridge was a national first place winner for First Grade.

"The contest was particularly competitive this year. There were many, many stories that we creative, poetic or funny. It was difficult for the judges to pick their favorites," said WQPT Education Outreach Director, Ana Kehoe. Children could write fact or fiction and had to provide at least five illustrations to go along with their story.

Sponsors for the contest were Butterworth Center & Deere-Wiman House, Family Museum, Figge Art Museum and WQPT, Quad Cities PBS. Winning stories will be on display May 16 - 28 at the Butterworth Center in Moline, Illinois, June 2 to 15 at the Figge Art Museum in Davenport, Iowa and June 17 to 30 at the Family Museum in Bettendorf, Iowa.

WQPT is a broadcast service of Western Illinois University - Quad Cities located in Moline, Illinois.

PBS KIDS GO YOUNG WRITERS AND ILLUSTRATORS WINNERS 2010

KINDERGARTEN

First Place

Annabella Wooten, Winola Elementary, Viola, IL

Second Place

Logan Thurman, Winola Elementary, Viola, IL

Third Place

Riley Packer, Erie Elementary, Erie, IL

Honorable Mention

Olivia Switzer, Winola Elementary, Viola, IL

 

FIRST GRADE

First Place

Kyle Skinner, Alan Shepard Elementary, Long Grove, IA

Second Place

Alexander Xiao, Rivermont Collegiate, Bettendorf, IA

Third Place

Victoria DeClercq, Home-schooled, Moline, IL

Honorable Mention

Baylor Verbrugge, Edward White Elementary, Eldridge, IA.

 

SECOND GRADE

First Place

Jayda Brunkan, Ed White Elementary, Eldridge, IA.

Second Place

Kadin Kruse, Morningstar Academy, Bettendorf, IA

Third Place

Ever Jens, McKinley Elementary, Davenport, IA.

Honorable Mention

Blake Hasson, Alwood Elementary, Alpha, IL.

 

THIRD GRADE

First Place

Eunice Yoon, Prophetstown Elementary, Prophetstown, IL.

Second Place

Courtney DeClercq, Home-schooled, Moline, IL

Third Place

Alannah Skinner, Alan Shepard Elementary, Long Grove, IA

Honorable Mention

Micah Poole, Paul Norton School, Bettendorf, IA.

 

WASHINGTON - April 28, 2010 - Senator Chuck Grassley today continued to peel back the layers of taxpayer obligations behind last week's claim and fanfare about General Motors repaying its multi-billion dollar loan from the Troubled Asset Relief Program, the $700 billion taxpayer-funded bailout.

Last week, Grassley asked the Treasury Secretary why the administration had allowed GM to use money from an escrow account at Treasury to repay this loan, allowing "an elaborate TARP money shuffle."

In a floor speech this afternoon, Grassley said the response he received today from the Treasury Department confirmed that taxpayers funded the loan repayment by way of cash that GM has because the federal government originally loaned that cash to GM, and then the federal government agreed to forgive some of GM's debt during bankruptcy in exchange for stock in the company, the value of which is uncertain.

"The bottom line is that the repayment was made on the dime of taxpayers across America, and it's misleading to say that GM repaid its TARP loans 'in full, with interest, ahead of schedule, because more customers are buying' GM cars," Grassley said.  "Taxpayers remain on the hook, thanks to the failed deal cut by the government to try to save GM from bankruptcy.  Now, GM has pulled an additional $6.6 billion out of the escrow account but has left unpaid a $2.5 billion, nine-percent loan to the union health benefit fund."

Here is the April 19, 2010, request from GM to the Treasury Department asking for the distribution to GM of the entire amount of the reserve funds. 

Grassley said the American people deserve straightforward information about what's happening with TARP and the tax dollars being used by the Treasury Department to manage what the government has taken over from the private sector.  "The situation hasn't been described in a candid way, and that's added insult to injury after more than a year of bailouts and record-level deficit spending."

Grassley has conducted oversight of the Treasury Department's management of TARP and gone to bat for the Special Inspector General for TARP when the administration has put up barriers to the Inspector General determining where the money has gone.  The Iowa senator has criticized the lack of transparency with how TARP funds have been used and, last fall, he cosponsored legislation to end the program.

The Special Inspector General for TARP was created at the urging of Grassley and Senator Max Baucus of Montana, and when the Treasury Department changed the focus of the program less than a month after it began, Grassley worked with Senator Claire McCaskill of Missouri to retool the Inspector General's authority and empower the office to adequately scrutinize TARP spending and management.

Here is the text of Grassley's remarks today.

Floor Statement of U.S. Senator Chuck Grassley

GM and TARP

Wednesday, April 28, 2010

Mr. President.  Last Thursday, I wrote Secretary Geithner asking why the Treasury Department allowed General Motors to use TARP money from a Treasury escrow account to repay its multi-billion dollar TARP taxpayer loan.  This afternoon, I received a response from Treasury.  I'd like to say a few words about the reply and the questions that remain unanswered.  Last week, Treasury and GM announced with press releases and nationwide TV commercials that GM had repaid its TARP loans "in full, with interest, ahead of schedule, because more customers are buying [GM vehicles]."

However, the hype does not match the reality.  Taxpayers have not been repaid in full?far from it.  Many billions of TARP dollars remain invested by Treasury in GM, and much of it will never be repaid.  The Congressional Budget Office estimates that taxpayers will lose around $30 billion on GM.  In addition, the payment that occurred last week did not come from revenue GM earned by selling cars, despite what was claimed.  Instead, Treasury allowed GM to use funds in a separate escrow account to pay its TARP debt.  The Treasury Department's response to me today makes a point of saying that GM "owns" the money in the escrow account, as if that somehow justifies all the hoopla about GM's so-called "repayment."

Well, let's look at how GM came to "own" those escrow funds in the first place.  The escrow funds were part of the TARP money Treasury paid for GM stock coming out of the bankruptcy.  The money was supposed to be used by GM for expenses, as Treasury concedes.  Treasury had the power to approve or disapprove GM's use of the money to repay the TARP taxpayer loan.  Treasury approved, and GM pretended it was paying the loan back from revenue because business had improved.  Business may have improved, but that's not how they paid the loan.  Taking TARP money out of one account to pay back TARP loans in another account is not at all the same as paying off a loan with earnings, as GM's TV commercials imply they have done.  That is why I called it "an elaborate TARP money shuffle" and nothing in Treasury's reply today changes that.

The public would know nothing about the TARP escrow money being the source of the supposed repayment from simply watching GM's TV commercials or reading Treasury's press release.  Treasury's letter today says all these details are public knowledge and nothing new.  Well, that may be technically correct, but it wasn't clearly communicated that way to the average citizen.  Most Americans don't pore through SEC filings and Special Inspector General's reports.

The GM commercial also did not mention that GM could have used the TARP escrow funds to repay a $2.5 billion, nine-percent loan it received from its union health plan as part of the bankruptcy process.  The union loan runs until 2017.  The TARP loan was at seven percent and ran until 2015.  What sort of money manager would advise you to pay off a lower interest loan before a higher interest loan?  GM and Treasury have still not explained that, and I have asked the TARP watchdog, Special Inspector Neil Barofsky, to get to the bottom of it.  And to make matters worse, Treasury has admitted that it let GM take an additional $6.6 billion of TARP dollars out of the escrow fund last week with no strings attached.  That money, too, could have been used to repay the high interest union loan.

There are reports that GM also applied to the Department of Energy for a $10 billion, five-percent loan to retool its plants to meet fuel economy standards.  GM seems to be using government money to pay back government money, and then asking for more government money at a lower interest rate.  It sounds like a plan to refinance GM's government debt with more taxpayer money--not pay it back.

GM had to ask permission from Treasury to use the taxpayers' stock investment to pay off the taxpayers' loan. Treasury's response to my letter says that "Treasury retained approval rights over GMs use of funds from the escrow account in order to protect the taxpayer."  Well, why didn't they protect the taxpayer then?  Why would Treasury allow GM to use its equity investment to pay off the loan when it means giving up the legal right to a seven percent rate of return for the taxpayers in exchange for essentially nothing?  Since the taxpayer has an equity stake in the company, it's true that future growth of GM could theoretically make taxpayers whole, but taxpayers already had that equity interest before this latest transaction and didn't get any more equity as a result of the transaction.

Another key question is why would GM orchestrate a major media campaign to make the public think this all represents some big accomplishment by GM when the truth is that the taxpayers are still on the hook for billions that we may never recover?  Using the taxpayers' stock investment in GM to reduce its debt to the taxpayers is not the same as repaying that debt from money actually earned by selling cars.  Treasury's reply today does not explain why it approved this transaction.  Maybe it's a step in the right direction, maybe not.  But, instead of misleading the American people, we should be clear and up front about what happened here.

Highlights need to focus on visa security and protecting American workers

WASHINGTON - During an oversight hearing of the Department of Homeland Security, Chuck Grassley this week told Secretary Janet Napolitano that during his town hall meetings in March and April, Iowans were upset that federal immigration laws weren't being enforced.

Grassley also brought to Napolitano's attention legislation that he has introduced that would treat visa revocations similar to visa denials, because the right of that person to be in the United States is no longer valid.  Already, if an individual is denied a visa by the consular officer, there's no judicial review of that decision.  The Grassley bill would apply the same standard for individuals on U.S. soil who should not have been granted a visa, limiting their rights to judicial review of such a decision.

"The Christmas Day bomber highlighted the need to review U.S. visa policies, especially how agencies handle visa revocations when alarming information is provided to authorities," Grassley said.  "The Secretary has the authority to revoke a visa to any individual who is a threat to the country, however if a foreign national is already on U.S. soil, there's concern about that person accessing the U.S. court system and challenging the revocation."

During his questioning of Napolitano, Grassley also continued to highlight abuses within the H-1B and L Visa programs.  He pointed out that some of the problems previously highlighted by congressional oversight of the H-1B Visa program have led applicants to use the L Visa program.  The L Visa program has no wage protections, no annual numerical limits, fewer obligations on employers, and fewer protections for American workers.

Grassley is the author of H-1B and L Visa reform legislation which would increase enforcement, modify wage requirements, and ensure protection for visa holders and American workers.  The bill would not eliminate the program or change the numerical cap of visas available to petitioning employers.

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Davenport, IA, April 28th, 2010: Garlic Mustard is an invasive, noxious plant that threatens our native woodlands, natural areas and wildlife habitat. Help us control it in our community by participating in the Challenge between the Quad Cities and Johnson County.

    All volunteers are invited to a hot dog roast at Black Hawk State Park after the event.

    Date: Saturday, May 8th, 2010

    Time: 9:00am-Noon

    Location: Sunderbruch Park, 4675 Telegraph Rd. Davenport, IA

 

WASHINGTON - April 28, 2010 - Senator  Chuck Grassley is working to make sure changes made to the federal False Claims Act are recognized and incorporated by the 14 states that passed state False Claims Act in response to a federal incentive aimed at reducing Medicaid fraud.

In a letter sent today, Grassley asked the Inspector General for the Department of Health and Human Services and the Attorney General to review existing state False Claims Acts for compliance with recent changes to the federal False Claims Act and to issue appropriate guidance for any state interested in the federal incentive, which allows states to increase their shares of Medicaid recoveries by 10 percent by allowing whistleblower lawsuits.  In addition to the 14 states which have qualified for this incentive, six states applied for it but did not meet the requirements.

"Updated information will help states fine tune existing state laws and state-level proposals, in order to be eligible for the federal incentive and beef up fraud-fighting efforts," Grassley said.  "This kind of effort at the state and federal level is more important than ever as Medicaid programs are expanded and face new burdens and growing fiscal challenges.  Every dollar lost to fraud is one less dollar for those who depend on the program and harms the sustainability of the Medicaid program."

The federal incentive for states to adopt whistleblower provisions as part of state laws on false claims was established by legislation Grassley got passed as part of the Deficit Reduction Act of 2005.  Additionally, in 1986, Grassley was the principal Senate sponsor of whistleblower amendments that updated the federal False Claims Act.  To date, those provisions have helped to recover $22 billion for the federal Treasury that otherwise would be lost to fraud.

Grassley said updated guidance is needed because of changes made to the federal False Claims Act during the last year.  In May 2009, the President signed the Fraud Enforcement Recovery Act, sponsored by Grassley and Senators Patrick Leahy and Ted Kaufman, which made major changes to strengthen the federal False Claims Act by removing liability loopholes and addressing statutory confusion.  Additional related, though less extensive changes, were made as part of the Patient Protection and Affordable Care Act enacted in March 2010, based upon legislation originally sponsored by Grassley and Senators Dick Durbin and Patrick Leahy.

"The federal False Claims Act has become the federal government's most effective tool against health care fraud, and a major factor in its success is the way that it empowers whistleblowers who know about wrongdoing.  They are the watchdogs that taxpayers and beneficiaries need working on their behalf, and the more states that recognize the value of whistleblowers in fighting fraud, the better," Grassley said.

Grassley is Ranking Member of the Finance Committee, with jurisdiction over Medicaid and Medicare, and a senior member of the Judiciary Committee, with jurisdiction over the False Claims Act.

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WASHINGTON - Wednesday, April 28, 2010 - Senator Chuck Grassley today testified before a House Subcommittee hearing chaired by Representative Rosa DeLauro regarding drug safety and the work of the Food and Drug Administration.

Grassley has been conducting active oversight of the FDA since 2004, when a dissenting opinion from an FDA scientist about suicide risks for teenagers with anti-depressants was suppressed by the agency.  Grassley has called the FDA's relationship with the drug industry "too cozy" and sought greater independence and transparency from the agency.

Grassley described the need for a legislative reform, which he has twice introduced, to empower the office that monitors post-market drug safety at the FDA.  "There's a lack of equality between the FDA office that decides whether to approve a drug, or not, and the FDA office that monitors a drug's safety once a drug is on the market and being sold to patients, when much more information is available than can ever be achieved from pre-market samples."  Grassley says the result is that the FDA physicians and scientists committed to post-market monitoring of drugs have sometimes been suppressed and even ignored.

Here is the full text of the prepared testimony Grassley gave this morning.

Statement of Senator Chuck Grassley

U.S. House Committee on Appropriations Agriculture Subcommittee

Wednesday, April 28, 2010

Avandia and Drug Safety

Chairwoman DeLauro, Ranking Member Kingston, and distinguished colleagues, thank you for inviting me to speak today at this hearing on drug safety.

Far too often, we read press reports about partisan warfare and a "do nothing" Congress.

So I am glad to see both the Senate and the House, Democrats and Republicans coming together to work to protect the American supply of pharmaceuticals.

As the Ranking Member of the Senate Committee on Finance, I have made it my job to look into various aspects of the health care industry.

I do this to protect the public's health and to guard their pocket book.

As part of this duty, I have taken a keen interest in the Food and Drug Administration and the pharmaceutical and device industries.

Back in May of 2007, Senator Baucus and I opened up an inquiry into Avandia, a drug sold by GlaxoSmithKline to control glucose levels in diabetics.

We started this inquiry because the New England Journal of Medicine published a study which found that Avandia may cause heart attacks.

Obviously, this was bad news, because one of the things diabetics are most at risk for is a heart attack.

The Finance Committee staff spent over two years combing through hundreds of thousands of pages of documents.  Let me tell you a little of what they found:

Back in 1999 when Avandia first came on the market, executives at GSK intimidated a physician at the University of North Carolina.

The physician was worried that Avandia might cause heart attacks.

To suppress his comments, top officials at GSK called his superiors and had him sign a form that he would no longer criticize the drug.

Senator Baucus and I released a report on this finding, and I would like to enter that document into the record at this time.

The 2007 study that first caught the Committee's attention was submitted to the New England Journal of Medicine by Dr. Steve Nissen, a professor and cardiologist at the Cleveland Clinic.

However, GSK got a copy of the manuscript before it was published.  One of the experts who was peer-reviewing the study for the New England Journal of Medicine leaked it to GSK.

This allowed GSK to launch a PR campaign to undermine legitimate concerns that Avandia might cause heart attacks.

Then, last February, Senator Baucus and I published a Committee Staff Report on Avandia.  This report is about 15 pages long, and contains another 300 pages of attached internal documents, charts, and emails.

With this report, we wanted to let the people of America know what the company knew, and when they knew it.

I would now like to tell you some of what we found:

Shortly after GSK got a copy of Dr. Nissen's study, they had their own statistician dissect it.

GSK's statistician found the study to be scientifically sound.

However, GSK immediately drafted talking points to undermine Dr. Nissen's study.

At times, these talking points run counter to legitimate concerns of Avandia's safety that are raised in emails by GSK's own scientists.

In an internal email, GSK's head of research discussed "take home messages" of the research on Avandia.  If you look through the report that the Finance Committee released, you'll find this email on page 163.

In that email, GSK's head of research pointed out that Avandia has an increased risk of cardiovascular death.

Let me emphasize this?cardiovascular death.  Not heart attacks.  Not heart failure.  Death.

Well, the American public never knew about this risk until the Committee released the Avandia report.  And you still can't find any mention of "cardiovascular death" in the warning section of Avandia's label.

There are other findings in this report, but I would also like to discuss some internal FDA documents that we came across during our inquiry.

When concerns were first raised about the safety of Avandia, the FDA responded by requiring GSK to do a safety study.

Well, some drug safety experts inside FDA looked at that study that GSK was doing with patients and wrote that it was "unethical."

Here's the troubling thing about the study: the patients that enrolled in that safety study never learned that FDA's own safety experts thought that the trial was unethical.

At least, they didn't know this until the Finance Committee made that internal FDA document public in February.

This is not the first time questions have been raised about whether or not a study sanctioned by the FDA was ethical.

In 2006, I inquired about FDA's decision to allow a study on a blood substitute, PolyHeme, to proceed without adequate prior informed consent from the potential study participants.

I raised questions about FDA's decision, especially in light of the fact that another office within HHS, the Office for Human Research Protections, disagreed with the FDA.

In particular, I was concerned that during this study, when subjects arrived at the hospital after being treated with the blood substitute and real blood became available, the real blood was withheld from the patients as part of the study protocol.

To end, I would like to highlight what I feel we can all learn from the FDA's handling of Avandia. Because I think that we all want to move forward and make this agency better.

The Avandia case is another example of why I twice introduced legislation to establish an independent office of drug safety at the FDA.

The Center for Postmarket Drug Evaluation and Research would tackle the lack of equality between the Office of New Drugs (OND), which decides whether to approve a drug, and the Office of Surveillance and Epidemiology (OSE).

OSE is the office that monitors a drug's safety once it's on the market and being sold to patients.

The imbalance between OND and OSE was apparent in the Vioxx controversy about six years ago, and we can see it today in the incidents involving Avandia.

Individuals in the office responsible for post-market surveillance should be allowed to provide an independent opinion based on the best available evidence.

FDA employees dedicated to post-market surveillance should be able to express their opinions in writing and independently without fear of retaliation, reprimand, or reprisal.

Instead, the FDA physicians and scientists committed to post-market monitoring of drugs have sometimes been suppressed.  In the case of Avandia, it appears that they have been ignored.

Before I conclude my remarks, I would like to call to your attention another matter related to drug safety.

As you may have seen in press reports over the last two years, FDA has been taking action against some unapproved drugs.

The problem is?FDA does not have a complete and accurate list of all of the products sold on the US market, including unapproved drugs, so the agency can't take appropriate enforcement actions.

I hope that we can work together to ensure that FDA has the resources and tools to ensure that the drugs in our medicine cabinets are safe and effective and approved for use by the FDA.

This concludes my testimony, and I once again thank you for this invitation.

I look forward to working with you as you continue your oversight of our country's pharmaceuticals which remain vital to public health. I appreciate your leadership in this area.

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