WASHINGTON - Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, today released a committee report based on a two-year inquiry of the diabetes drug Avandia. The senators also asked the Food and Drug Administration to describe what steps the agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007.  In 2008, FDA officials called the clinical trial, as then-designed, "unethical and exploitative" of patients.

"There's a real problem when FDA's office that reviews drugs that are on the market is an unequal player in drug safety efforts," Grassley said.  "It doesn't make any sense to have these experts, who study drugs after they have been on the market for several years, under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision.  The Avandia case may be the most alarming example of the problem with this set-up.  Both the FDA and Congress need to take every step possible to establish independence for post-market surveillance. The Institute of Medicine has made recommendations.  It's a matter of sound science and public safety."

"Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them.  Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust," Baucus said.  "We will continue watching closely and working with the FDA to make sure patients and doctors are aware of the risks associated with Avandia and all drugs so they can make safe and informed decisions when choosing their medicines."

The committee report explores when the Avandia manufacturer, GlaxoSmithKline, became aware of heart attack risks associated with the drug, whether the company sufficiently warned patients and the FDA of the dangers, and steps the company apparently took to create doubt regarding negative findings about the drug.

The report was developed over the last two years by committee investigators who reviewed more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA, and several research institutes.  Committee investigators also conducted numerous interviews and phone calls with GlaxoSmithKline, the FDA and anonymous whistleblowers.  The report can be found at http://finance.senate.gov.

Baucus and Grassley directed the report over concerns that Avandia and other high-profile drugs such as Vioxx put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks.  In 2007, Congress enacted legislation giving the FDA some new tools to better protect patients from harm caused by drugs that are brought to market without sufficient safety oversight or consumer warnings. However, the legislation did not fix a fundamental problem at the FDA -- the imbalance between the office responsible for monitoring the safety of drugs after approval and the office that puts drugs on the market in the first place.

The FDA has overlooked or overridden safety concerns cited by its own officials, as appears to be the case with the ongoing Avandia study.  The text of the Baucus-Grassley letter to the FDA on the Avandia study follows here.  The letter with attachments is at http://finance.senate.gov.

February 18, 2010

The Honorable Margaret A. Hamburg, MD, Commissioner

U.S. Food and Drug Administration

White Oak Building 1

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Commissioner Hamburg:

As senior members of the United States Senate and Chairman and Ranking Member of the Committee on Finance (Committee), we have a duty under the Constitution to conduct oversight into the actions of executive branch agencies, including the Food and Drug Administration (FDA).  In this capacity, we must ensure that FDA properly fulfill their mission to advance the public's welfare, safeguard the nation's drug supply, and protect patients participating in clinical trials.

We recently released a report raising concerns about Avandia, a diabetes drug made by GlaxoSmithKline (GSK).  We began this inquiry after the New England Journal of Medicine published a study in May 2007 warning of the possible cardiovascular risk of Avandia.

Our report was based on a review of hundreds of thousands of pages of internal GSK documents and concluded:

The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public. Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.

In 2007, the FDA asked GSK to perform a cardiovascular safety trial, called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), to compare Avandia to other diabetes treatments such as ACTOS (piolglitazone).  According to clinicaltrials.gov, the TIDE trial is currently recruiting patients. [ATTACHMENT A]

In response to several document requests made to the FDA, we received and reviewed an analysis conducted by two FDA safety officials.  It is our understanding that this analysis, conducted in October 2008, reviewed all available studies comparing rosiglitazone (Avandia) to pioglitazone (ACTOS).  The analysis by these FDA officials raise some alarms.  For instance, they wrote:

[T]here is no evidence that rosiglitazone confers any unique health benefits over pioglitazone while there is strong evidence that rosiglitazone confers an increased risk of   [heart attacks] and heart failure compared to pioglitazone.  [ATTACHMENT B]

Even more alarming, they concluded that "any proposed head-to-head trial of rosiglitazone vs. pioglitazone would be unethical and exploitative."

Two days after releasing this analysis, one of these same safety officers reviewed the protocol for the TIDE trial. This safety officer wrote that because of cardiovascular concerns with Avandia "the safety of the study itself cannot be assured, and is not acceptable." [Attachment C]

After reading these documents, we would like to know what steps the FDA has taken to protect patients in the TIDE trial, and why this trial is allowed to continue.  We would also like to know if the Office for Human Research Protection (OHRP) was notified about the safety concerns of the TIDE trial identified by the FDA.  Further, we were alarmed to learn that the warnings from these safety officers do not appear to be addressed in the consent form that was handed out to patients that were enrolled in the study.  [Attachment D]

We look forward to hearing from you by no later than March 4, 2010.


Max Baucus, Chairman

Chuck Grassley, Ranking Member

WASHINGTON, February 19, 2010 ? Agriculture Secretary Tom Vilsack today announced the funding of 47 projects designed to protect public health by improving water quality and public sanitation services in 19 states. The projects, funded through the American Recovery and Reinvestment Act, are expected to provide construction jobs and create infrastructure needed to support community growth.

"These investments in water and wastewater infrastructure will deliver safe drinking water and protect the quality of our environment," Vilsack said. "A safe, reliable water supply is vital to economic growth and development. Through these projects, we are helping to achieve the Obama Administration's economic recovery goals to rebuild and revitalize the nation's infrastructure."

For example, the state of Kansas will build eight projects including one in the city of Muscotah. The community has been selected to receive a loan of $240,000 and a grant of $506,000 to construct a new 65,000-gallon elevated water storage tank and install new water lines. Muscotah water system improvements will reduce waterline breakages, meet the state water pressure requirements, and provide community residents with safe, dependable drinking water supplies.

The Fort Smith Water and Sewer District in Montana has been selected to receive a $1,368,000 loan and $2,322,000 grant to construct a new well and well house, connect two systems to a main line, install new fire hydrants and water meters, and construct a 100,000-gallon water storage tank. These system improvements will boost community water pressure.

The loan and grant funding announced today totals $128.1 million. To date, USDA has announced $2.2 billion in Recovery Act funds for water and environmental projects. The Recovery Act was signed into law by President Obama one year ago.

The funding announced today is being administered by USDA Rural Development's Water and Environmental Program which provides loans and grants to ensure that the necessary investments are made in water and wastewater infrastructure to deliver safe drinking water and protect the environment in rural areas.

Funding of individual recipients is contingent upon their meeting the terms of the loan or grant agreement. Below is a list of award recipients in the Midwest:


  • Village of Marissa: $1,380,000 loan; $815,000 grant; water system improvements

  • FMC Water Company: $700,000 loan; water system improvements


  • Mexico Community Regional Sewer District: $1,506,000 loan; $4,449,000 grant; wastewater system improvements

  • Town of Osgood: $2,370,000 loan; $778,000 grant; water system improvements


  • Southern Iowa Rural Water Association (SIRWA): $538,000 loan; $1,256,000 grant; wastewater system improvements

  • Southern Iowa Rural Water Association (SIRWA): $181,000 loan; $402,000 grant; wastewater system improvements


  • City of Burlingame: $890,000 loan; wastewater system improvements

  • City of Muscotah: $240,000 loan; $506,000 grant; water system improvements

  • City of Olpe: $355,000 loan; $570,000 grant; water system improvements

  • Osage County Rural Water District No. 6: $395,000 loan; water system improvements

  • City of Parker: $390,400 loan; wastewater system improvements

  • City of Smolan: $598,000 loan; wastewater system improvements

  • City of Weir: $237,000 loan; storm drain system improvements

  • City of Woodston: $342,000 loan; $484,000 grant; water system improvements


  • City of Maple Lake: $1,314,000 loan; $604,000 grant; wastewater and water system improvements


  • Vernon County Public Water Supply District #7: $272,000 loan; $68,050 grant; water system improvements

South Dakota

  • City of Sisseton: $616,000 loan; water system improvements


  • Village of Clyman: $2,317,000 loan; $1,727,000 grant; construction of a new Wastewater Treatment Facility (WWTF)

  • Village of Winneconne: $3,659,000 loan; $916,000 grant; wastewater treatment plant improvements

  • City of Mauston: $782,000 loan; $208,000 grant; water system improvements

  • City of Mauston: $694,000 loan; $204,000 grant; wastewater system improvements

  • Country Estates Sanitary District: $1,456,000 loan; $3,120,000 grant; wastewater system improvements

President Obama signed The American Recovery and Reinvestment Act of 2009 into law on Feb. 17, 2009. It is designed to jumpstart the nation's economy, create or save millions of jobs, and put a down payment on addressing long-neglected challenges so our country can thrive in the 21st century. The Act includes measures to modernize our nation's infrastructure, enhance energy independence, expand educational opportunities, preserve and improve affordable health care, provide tax relief, and protect those in greatest need.

More information about USDA's Recovery Act efforts is available at www.usda.gov/recovery. More information about the Federal government's efforts on the Recovery Act is available at www.recovery.gov.

# # #

State board votes 6-0 in favor of reclassifying marijuana for medical use and establishing a legislative task force to implement the change

CONTACT: Mike Meno, MPP assistant director of communications ............... 202-905-2030

DES MOINES, IOWA ? Today, the Iowa Board of Pharmacy voted 6-0 to recommend to state lawmakers that marijuana be reclassified as a Schedule II drug and that a state task force be established to study how a medical marijuana law could be implemented in Iowa. Marijuana is currently classified on the federal level as a Schedule I drug, alongside much more harmful substances such as heroin and LSD, as having no proven medical use and a high potential for abuse. Schedule II drugs have accepted medical uses for treatment.

The recommendation comes after the board held four hearings last year to receive public input on the issue. Dozens of doctors, patients, researchers, and advocates testified before the board, and nearly all comments were supportive of medical marijuana. The Iowa House and Senate are each considering bills that would protect from arrest chronically ill patients who use marijuana to alleviate their conditions, though the bills missed the funnel deadline and will not be enacted this year.

"This vote sends a clear message to Iowa lawmakers that they should, as soon as possible, pass legislation that would give chronically ill patients who could benefit from medical marijuana safe and legal access to their medicine," said Noah Mamber, a legislative analyst for the Marijuana Policy Project, who testified during the Board's hearings last year. "The recognition of marijuana as medicine in Iowa is a huge step. But for patients' lives to improve, the legislature must also provide protections from arrest, as 14 other states have already done."

"This is a great step forward for seriously ill Iowans who can benefit from medical marijuana," said state Sen. Tom Courtney (D-Burlington). "Several years ago, my wife passed away from cancer. Marinol pills gave her some relief, but it would have been so much better if she had had legal access to marijuana."

A Des Moines Register poll released yesterday found that 64% of Iowans support patients' use of medical marijuana with a doctor's recommendation. Fourteen other states, including most recently New Jersey and Michigan, have passed medical marijuana laws, and nearly a dozen others, including Illinois, Minnesota, and Wisconsin, are considering such legislation. In Iowa, the legislature is considering S.F. 293, sponsored by Sen. Joe Bolkcom, and H.F. 2179, sponsored by Rep. Mary Mascher.

With more than 29,000 members and 124,000 e-mail subscribers nationwide, the Marijuana Policy Project is the largest marijuana policy reform organization in the United States. MPP believes that the best way to minimize the harm associated with marijuana is to regulate marijuana in a manner similar to alcohol. For more information, please visit www.mpp.org.


WASHINGTON --- Senator Chuck Grassley is asking the Food and Drug Administration for an update on the implementation of new guidelines for medical device makers on when they need to file new information with the agency and seek clearance for the marketing and use of modified devices under the 510(k) system, the agency's less stringent process for reviewing most medical devices.

Grassley said that his inquiry today follows up on questions he asked more than a year ago, after a ring used in heart-valve repair was being implanted in patients even though the device hadn't been cleared for this purpose by the FDA.  The FDA subsequently told Grassley that its current policy was inadequate and that an update was underway.  Grassley also asked a number of questions today about the FDA's requirements for manufacturers to report changes made to FDA-approved devices.

"My questions are aimed at establishing greater transparency and accountability for doctors and their patients," Grassley said.  "People have a right to know exactly what the FDA has approved, or not, in making decisions about their health care.  For this to happen, the FDA's policies need to be effective in establishing an accurate public record about the FDA-approval status of any particular product."

The text of the letter sent today from Grassley to the FDA Commissioner follows here.


February 16, 2010

The Honorable Margaret A. Hamburg


U.S. Food and Drug Administration

10903 New Hampshire Ave.

Silver Spring, MD 20993

Dear Commissioner Hamburg:

The United States Senate Committee on Finance (Committee) has jurisdiction over, among other things, the Medicare and Medicaid programs.  As Ranking Member of the Committee, I have a responsibility to the more than 100 million Americans who receive health care coverage under these programs to oversee their proper administration and ensure that taxpayer dollars are appropriately spent on safe and effective drugs and devices.

I appreciate your response of September 30, 2009, to my questions regarding the Food and Drug Administration's (FDA or Agency) guidance to manufacturers on when a modification to a device requires the filing of a new 510(k).  Over a year ago, I wrote to the FDA regarding serious allegations that an annuloplasty ring used in heart valve repair was being implanted in patients even though the device was allegedly not cleared for marketing by the FDA.  The FDA concluded that the company had made the wrong decision when it marketed the product without first seeking clearance from the Agency.  That device, the Myxo dETlogix Annuloplasty Ring (dETlogix ring), has since been cleared by the FDA, but as I stated in my letter to the FDA last April, the fact remains that for more than two years, patients at Northwestern Memorial Hospital were being implanted with the device before a 510(k) was submitted to the Agency.

I also wrote to Northwestern Memorial Healthcare and Northwestern University in September regarding the same allegations and asked them whether or not they obtain assurances or confirmation from a device manufacturer that a device is FDA-approved before it is used in their facilities. Attached are their responses for your consideration.  Northwestern Memorial Healthcare stated in its response that Edwards Lifesciences assured Dr. McCarthy that it was taking the steps necessary for FDA approval.  It also stated that, "the health care provider relies on the manufacturer to provide timely and accurate information regarding the regulatory status of the device."  However, in this case, the manufacturer followed FDA's guidance and made the wrong decision regarding its device.

In your September response, you stated that FDA believes its current policy on when a modification to a device requires a new 510(k) submission is not sufficiently clear and is revising the guidance document.  I agree that the guidance document needs to be revised so that we can prevent similar events from occurring in the future.  However, it has been more than four months since I received your response and the new guidance has yet to be released.  Accordingly, I would appreciate you advising me immediately on the status of FDA's revisions to the Agency's guidance entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device."

In addition, it is my understanding that device manufacturers registered with the FDA must also list the devices that they make with the Agency.  According to FDA's website, registration information must be submitted each year between October 1 and December 31 even if no changes have occurred, and at that time listing information should be reviewed as well.  The website also states that a manufacturer can access the FDA Unified Registration and Listing System at any time to update changes to their registration and listing information as the changes occur.  Examples provided by the FDA include a change to a previously listed device or the introduction of another device into commercial distribution.  In light of the statements made on FDA's website please respond to the following questions:

1)         Would a manufacturer be required to update its device listings even if it changed only the name of an existing device?

2)         Would the manufacturer also be required to update its listings if it made a modification to a device that did not require submission of a new 510(k) but marketed that device under a different name?

3)         If the answer to either question is no, please explain why not.  Please also explain how patients and their doctors would obtain information about the status of a device other than from the manufacturer itself.

4)         FDA concluded that Edwards Lifesciences' dETlogix ring did require a new 510(k).  However, even if a new 510(k) had not been required, was the company required to list that device with the FDA?

Thank you for your attention to this important matter.  I would appreciate a response to the requests set forth in this letter by no later than March 2, 2010.


Chuck Grassley

United States Senator

Ranking Member of the Committee on Finance

MILWAUKEE, WI - Just in time for National Sleep Awareness Week, March 8-14, TOPS Club, Inc. (Take Off Pounds Sensibly), the nonprofit weight-loss support organization, explains the connection between obesity and sleep habits. According to TOPS, studies show a link between too few hours of sleep and increased body weight in both adults and children.

"Our society is an insomniac, underslept society, perhaps because of economic stress, chaotic lifestyles, or sedentary time spent with modern media, such as the Internet or cable TV," says Nicholas "Dr. Nick" Yphantides, M.D., M.P.H., medical spokesperson for TOPS. "Sleep is an afterthought to many of us."

Dr. Nick points out that insomnia often leads to late-night eating binges, which are proven to be disruptive to the digestive cycle and result in weight gain. "Falling asleep with a full stomach means you are less likely to eat breakfast, which is an essential part of maintaining a healthy lifestyle," he says. "Every study of successful long-term weight loss shows that the eating plan includes a healthy breakfast."

While it's not easy to break old habits, Dr. Nick notes that the more resistant people are to saying "lights out" the more they have to deal with the consequences the next day. For example, when fatigue sets in from late-night activity, there is less desire to engage in exercise the next day, an essential element of weight control.

Lack of sleep also affects the way the body processes and store food and alters hormones which affect the appetite. "Physiologically, when a body is not rested, it kicks into survival mode," he says. "Stress hormones are generated, resulting in less production of appetite-suppressing leptin. Instead, more ghrelin, which stimulates appetite, is generated." In addition, Dr. Nick notes, there is a suspected association with insulin, which has an impact on food going into storage in the body.

The importance of sleep cannot be overestimated. More than just resulting in fatigue and affecting daily activities, lack of sleep can impact the immune system, memory recall, hypertension, and other serious problems.

"I don't believe everyone needs seven hours or another specific number, but I do believe in adequate sleep. It fits into the larger category of being responsive to what the body needs," Dr. Nick says. "Part of the evidence of the restorative nature of sleep points out that when we are ill, we need more of it, and not less or the same."

To improve your success for a restful night, consider the following:

  • Aim to exercise at least twenty to thirty minutes each day and no later than three hours before bedtime.
  • When tired enough to seek coffee and energy drinks, take a short, half-hour nap instead.
  • Go to bed and get up at about the same time every day, even on weekends.
  • Keep bedrooms cool, dark, quiet, and comfortable.  Consider a sound machine or small fan for white noise and an eye mask to block out light.
  • Follow a relaxing bedtime routine, such as reading a book, engaging in light stretching, or taking a bath.

TOPS Club Inc. (Take Off Pounds Sensibly), the original, nonprofit weight-loss education and support organization, was established more than 62 years ago to champion weight-loss support and success. Founded and headquartered in Milwaukee, Wis., TOPS promotes successful weight management with a philosophy that combines healthy eating, regular exercise, wellness education, 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, and several chapters in Europe.

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.


WASHINGTON --- Senator Chuck Grassley has asked the Food and Drug Administration about progress made to improve foreign drug inspection, following commitments made by the agency when Baxter International temporarily suspended production of its blood thinner heparin in 2008 because of adverse reactions.

"My letter today follows up on oversight I did at that time because requirements the FDA already had in place then were not met by the FDA, and the drug company itself didn't have a system to check the quality of upstream providers of the drug components.  In fact, pharmaceutical companies aren't required to have those checks in place," Grassley said.  "I will continue asking the FDA for information and working to hold the federal agency accountable in its work to protect the safety of the drugs in our medicine cabinets."

Since 2007, Grassley also has twice filed legislation to dramatically beef up the FDA's foreign inspection operation, including enhanced enforcement for quality and safety violations.  The legislation, which Grassley had introduced with the late Senator Kennedy, hasn't been passed by Congress.  China is one of the largest exporters of pharmaceutical products to the United States.  Following questions raised by Grassley and others in 2007 and 2008 about the inadequate foreign inspections, the FDA has opened an office in China to facilitate inspections.

Below is the text of the letter Grassley sent today to the FDA Commissioner.

February 16, 2010

The Honorable Margaret A. Hamburg


U.S. Food and Drug Administration

10903 New Hampshire Ave.
Silver Spring, MD 20993

Dear Commissioner Hamburg:

As Ranking Member of the United States Senate Committee on Finance (Committee), I have a special responsibility to the more than 100 million Americans who receive health care coverage under those programs to ensure that taxpayer and beneficiary dollars are appropriately spent on safe and effective drugs and devices.

In 2007 and 2008, I wrote a series of letters to the Food and Drug Administration (FDA/Agency) inquiring about the Agency's oversight of foreign-made drugs and active pharmaceutical ingredients (API).  I appreciate FDA's responses to my letters and look forward to the Agency's continued cooperation.

Almost two years ago, in February 2008, Baxter International (Baxter) had announced that it had temporarily suspended production of its blood thinner heparin because of increased reports of serious adverse events, in particular allergic reactions, associated with the use of its drug.  The company recalled its heparin sodium injection single-dose vials, the remainder of its multiple-dose vials, and the heparin flush products from the market.  Prior to the recall of its products, Baxter manufactured about 50 percent of the heparin used in the United States.  Thus, there were serious concerns about whether or not this country would have enough heparin to meet patient needs.

After several months of investigation, the FDA and the Centers for Disease Control and Prevention concluded that the adverse events were caused by heparin contaminated with oversulfated chondroitin sulfate.  According to the FDA, this contaminant was found in heparin API produced by Baxter's API supplier in China, Changzhou Scientific Protein Laboratories (SPL), as well as more than 10 other Chinese facilities in the heparin supply chain.  In addition, the Agency revealed that due to human error, the FDA had failed to conduct a pre-approval inspection of Changzhou SPL in accordance with its pre-approval inspections program to ensure compliance with current good manufacturing practices (CGMP).

Despite its own audits and inspections of the API supplier, Baxter did not discover that its heparin API supply was contaminated because the company did not have mechanisms in place to ensure that the upstream providers, such as the crude heparin processors and slaughterhouses, were providing quality product to Changzhou SPL.  Baxter and other heparin manufacturers, however, are not required to have such mechanisms in place.  FDA has stated that API and drug manufacturers "frequently audit suppliers of critical materials" but the audits are not a requirement of the CGMP regulations for finished pharmaceuticals.  Nonetheless, there was one heparin manufacturer, APP Pharmaceuticals, which had a traceable distribution system that did allow it to trace crude heparin from the API supplier to the workshops and pig farms.  That company was able to increase its heparin production capacity and take over as the major supplier for the U.S. market after Baxter's product recalls.

Investigation of the contamination of the U.S. heparin supply in 2008 highlighted the need to improve FDA's protection of the safety of products made in this country and abroad.  In fact, the FDA acknowledged at a press conference on April 21, 2008 that the heparin problem "illustrated the need for [the FDA] to focus on enhanced regulation and scrutiny of the whole supply chain for drugs, including all sources of materials, including the natural sources."  In the Agency's response to me, dated June 5, 2009, the FDA also stated that "Aside from a traceable distribution system, it is imperative that both the API and drug product manufacturer establish and implement procedures and controls to secure and assure the integrity of the supply and distribution chain."

In response to the heparin contamination, the FDA announced a number of efforts it was implementing to prevent similar incidents from occurring in the future, including the establishment of an FDA presence abroad by opening field offices in China, India and Latin America, as well as the pursuit of international agreements to augment its foreign inspection program.  The FDA also stated that the FDA and international regulators had agreed to hold an inspection summit in 2009 to apply the lessons learned from the heparin contamination.  In addition, the FDA stated in its letter to me that it is collaborating with several pharmaceutical associations "to establish more robust systems and procedures to qualify suppliers of pharmaceutical ingredients and assure the identity and purity of batches of incoming ingredients."

I am writing today to follow up on the status of FDA's initiatives to improve its foreign drug inspection program, in particular any efforts to prevent tainted final dosage forms and API from entering this country.  I would also appreciate a response to the following requests:

· A reporting of FDA's plans to ensure the safety and quality of drug products that are imported into this country, including efforts to improve surveillance, technology and testing capabilities, to harmonize regulatory standards and procedures, and to enhance the Agency's regulation of the whole supply chain of drugs.

· If FDA conducted its own assessment of how the Agency handled the heparin contamination, a copy of any report or memorandum generated from that assessment, including any recommendations and lessons learned.

· A status report on FDA's review of reports of adverse events occurring after heparin administration and the number of deaths and adverse events that have been determined to be epidemiologically associated with use of the contaminated product.  During the April 21, 2008 FDA press conference, the Agency stated that there were 81 deaths linked to the allergic reactions that may have been caused by contaminated heparin.  A month earlier, on March 5, 2008, the Agency stated that it had received 785 reports of adverse events.  FDA's webpage on adverse event reports and heparin, last updated July 1, 2009, shows that between January 1, 2007 through May 31, 2008 there were 146 reported deaths that included one or more allergic symptoms that is associated with use of the contaminated heparin.  The webpage, however, does not identify the total number of other adverse events reported to the FDA.

Thank you for your assistance on this important matter.  I would appreciate a response to the requests set forth in this letter by no later than March 2, 2010.


Chuck Grassley

United States Senator

Ranking Member of the Committee on Finance

MADISON, Wis. - While cancer prevention in the future may never be as simple as sipping green tea or eating watermelon, a researcher at the University of Wisconsin Carbone Cancer Center (UWCCC) says that more specific study of nutrients and vitamins for cancer prevention is the next big frontier in cancer research.

"In our research on green tea and a nutrient in broccoli, we've discovered that both appear to have some beneficial effects on certain tissues, and that they are safe. But we're still studying whether either or both actually prevent cancer," says Dr. Howard Bailey, professor of medicine at the UW School of Medicine and Public Health. Bailey, also a practicing oncologist, is one of the main investigators for a multi-center National Cancer Institute study of soy products, green tea, vitamin D and a compound associated with certain fruits and vegetables.

Very few nutrients have been proven to have cancer-prevention characteristics, but a handful of drugs have shown promising results in clinical trials or have been proven to prevent certain cancers. Tamoxifen, originally developed to treat breast cancer, and raloxifene, first used to prevent osteoporosis, can reduce the risk of breast cancer for high-risk women. Another FDA-approved cancer-prevention drug is the HPV vaccine for cervical cancer.

While research on drugs for chemoprevention has made progress, Bailey says the study of nutrients lags behind. He says there are several theories about why there's so much to learn about potential disease-prevention characteristics of nutrients.

"Because we've been exposed to nutrients and vitamins for ages, any potential health advantage to consuming them is likely to be modest. Early on, we thought we could increase the effect by increasing the dose or amount of nutrient or vitamin taken. However, the old adage about 'too much of a good thing' may apply."

Bailey says he and other researchers will try to determine the level of nutrients or vitamins needed to be effective in prevention of specific cancers. He is currently researching the effective dosage of nutrients and vitamins like green tea and vitamin D for specific diseases, including bladder and prostate cancers.

He also plans to explore the idea that a one-time, large dose of vitamin D is safe and has prostate cancer-prevention properties. For more information on clinical trials at the UWCCC, go to www.uwhealth.org/cancertrials


WASHINGTON, D.C. - Senator Tom Harkin (D-IA) today announced that a total $1,236,175 will be coming to Iowa for public wellness efforts aimed at reducing obesity rates, decreasing smoking and promoting healthy living through increased physical activity and better nutrition.  The grants are being provided through the U.S. Department of Health and Human Services and were funded in the American Recovery and Reinvestment Act of 2009.  Harkin worked to secure these funds through his role as a senior member of the Appropriations Committee, which wrote the Recovery Act.

"To improve our state's physical and financial health, reduce incidents of chronic disease and reign in rising health care costs, we must take steps to keep people well and out of the hospital in the first place," said Harkin.  "Today's funding shows that the Recovery Act continues to help Iowans on all fronts -- today making investments that encourage better health choices and help prevent the chronic diseases related to obesity and smoking."

Specifically, the funds will be used as follows:

$600,256 is being awarded for health policy and environmental change. Under direction of the Center for Disease Control and Prevention, Iowa will receive funding to promote state-wide policy and environmental changes that support good nutrition, physical activity, obesity control and reduce tobacco use.

$635,919 is being awarded for tobacco cessation. Iowa will receive the funding to expand Quitline Iowa (1-800-QUIT-NOW), and promote its use through expanded media campaigns.  Quitline Iowa provides free support and coaching to all Iowans who wish to quit smoking.

(IOWA)? February is American Heart Month, drawing attention to heart disease, America's No. 1 killer, and the strides being taken through research and education to raise awareness of risk factors and to decrease death rates.  Appropriately kicked off on National Wear Red Day (Feb. 5, 2010), the American Heart Association and its Go Red For Women movement urge everyone to support the fight against heart disease in women by wearing red that day.

On National Wear Red Day, Friday, Feb. 5, 2010, thousands of people, employees at more than 10,000 companies, national and local news anchors and talk-show hosts across the country will wear red to support the cause.  Men and women across the state of Iowa are also encouraged to show their support by wearing red on Feb. 5.  The red dress and the color red symbolize one's support in the fight against heart disease.

Go Red For Women is the American Heart Association's promise to save women's lives.  Too many women die each year because they are unaware that heart disease is their No. 1 killer.  One in three women dies of this largely preventable disease - that's almost one woman every minute.  This year, Go Red is asking women to bring a voice to this silent killer: SPEAK UP TO SAVE LIVES.


* Cardiovascular disease kills approximately 450,000 women each year, about one every minute.

* More women die of cardiovascular disease than the next five causes of death combined, including all forms of cancer.

* Ninety percent of women have one or more risk factors for developing heart disease.

* Heart disease is largely preventable. In fact, 80 percent of cardiac events in women may be prevented if women make the right choices for their hearts, involving diet, exercise and abstinence from smoking.

Only 1 in 5 women believe that heart disease is her greatest health threat and that's why the communities in Iowa are trying to educate women by "Going Red" on Friday, Feb. 5, 2010.

Research shows that women who "Go Red" are more likely to make healthy choices. For example:

* More than one-third have lost weight.

* Nearly 55 percent have increased their exercise.

* Six out of ten have changed their diets.

* More than 40 percent have checked their cholesterol levels.

* One third have talked with their doctors about developing heart health plans.

Women and men interested in "going red" on Friday, Feb. 5th and joining the Go Red For Women movement should visit www.GoRedForWomen.org.

February has been celebrated as American Heart Month since 1963 to urge Americans to join the battle against heart disease.  A presidential proclamation pays tribute to the researchers, physicians, other public health education professionals as well as volunteers for their tireless efforts in preventing, treating, and researching heart disease. The observation also recognizes the critical importance of developing tools that will increase survival rates from heart attacks and cardiac arrest.  President George W. Bush entered his proclamation on Feb. 1, 2002, and the message continues to ring true today.

For more information about American Heart Month or National Wear Red Day please contact Ciara O'Brien Murray, communications director at (913) 652-1966 or Ciara.Murray@heart.org.


DAVENPORT, Iowa - Jan. 29, 2010 - For the third straight year, Genesis Health System has been recognized by SDI as a one of the nation's Top 100 health systems for integrating services to improve quality and operate efficiently.

Genesis moved up from No. 93 in 2009 to No. 71.

"This ranking is recognition of the hard work and dedication of the staff, physicians, volunteers and leadership of Genesis Health System,'' said Doug Cropper, President and CEO, Genesis Health System. "This ranking also is recognition of the quality of care and financial stability of Genesis that allows us to continue to provide that quality care

The 2010 edition of the rankings from SDI identifies the top 100 Integrated Health Networks (IHNs) from a universe of 593 local and regional health networks in the United States that meet critical success factors.

The ratings are based on SDI's IHN Rating System, which evaluates each network's ability to operate as a unified organization in eight categories: integration, integrated technology, contractual capabilities, outpatient utilization, financial stability, services and access, hospital utilization, and physician participation.

SDI is a Pennsylvania-based healthcare analytics organization that provides innovative services that help the healthcare industry solve a wide range of business challenges.