Finance Leaders Begin Investigation Into Medtronic Infuse Trials 

Washington, DC - Senate Finance Committee Chairman Max Baucus (D-Mont.) and senior Committee member Chuck Grassley (R-Iowa) asked medical device manufacturer Medtronic on Tuesday to produce documents related to its controversial bone growth product Infuse.  In a letter sent to Medtronic, the Committee raised concerns over recent media reports that indicate medical researchers in charge of Infuse clinical trials may have been aware of and failed to report evidence that the product may cause sterility in men and potentially-harmful bone growth.  The letter also notes many of these investigators had substantial financial ties to the device manufacturer.

"These reports that doctors conducting medical trials while on Medtronic's payroll may have hidden serious side effects for patients are deeply troubling," said Senate Finance Committee Chairman Baucus.  "Information is one of the most important tools patients and doctors have when making medical decisions.  Patients have a right to know the risks associated with their treatments, and medical device companies have a duty to disclose this information.  We need to do everything we can to ensure companies aren't concealing serious medical complications from patients just to increase profits."

"A patient having surgery has to rely on his doctor's knowing the risks and benefits of a medical device.  The doctor in turn has to rely on the medical literature.  If the medical literature has been written by those with financial ties to the device maker, the doctor and his patient should know that.  A lack of transparency leaves doctors and patients in the dark on something any of us would want to know before surgery.  It's alarming to learn after the fact that articles draw conflicting conclusions about a device's safety and complications.  The lack of disclosure of payments raises questions about the integrity of the conclusions reached, whether integrity was compromised or not," said senior committee member Grassley.

The full text of Baucus's and Grassley's letter to Medtronic appears below:

June 21, 2011

Via Electronic Transmission

Omar Ishrak, Ph.D.

Chairman and Chief Executive Officer

Medtronic, Inc.

710 Medtronic Parkway

Minneapolis, MN 55432

Dear Dr. Ishrak:

The United States Senate Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs.  As Chairman and a senior member of the Committee, we have a special responsibility to the more than 100 million Americans who receive health care under those programs to ensure that beneficiaries receive treatments that are safe and effective.

We are extremely troubled by press reports suggesting that doctors conducting clinical trials examining the safety and effectiveness of Infuse on behalf of Medtronic were aware that Infuse, a treatment commonly used in spinal surgery, may cause medical complications, but failed to report this in the medical literature.  This issue is compounded by the fact that some clinical investigators have substantial financial ties to Medtronic. 

• Last year, the Milwaukee Journal Sentinel reported that a Medtronic-funded study published in 2004 found that 75% of bone morphogenetic protein 2 (BMP-2) patients experienced ectopic bone growth, where potentially harmful bone growth occurs outside of the fusion area.  The authors, who had financial ties to Medtronic, "concluded that 'although not desirable,'" the ectopic bone growth "did not appear to have an ill effect on the patients." However, in a separate 2008 study conducted by physicians without financial ties to Medtronic, "neurological impairment occurred" in five patients who had the same ectopic bone formation.[1]

• According to the New York Times, a recent study "found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft."  This link to sterility was not reported in the original Medtronic-funded study.[2] In addition, the Milwaukee Sentinel Journal reports that one author of the original study, Thomas A. Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health, received "more than $23 million in various royalty payments from Medtronic since 2002."  In addition, "Zdeblick also is the editor of the journal where two of the Infuse papers that failed to mention the link [to sterility] were published."[3

We are also concerned that other severe side-effects of Infuse and similar bone-growth products developed by Medtronic may have been unreported or under-reported in clinical literature.  Reports have linked Infuse to potentially fatal swelling in the neck and throat, and radiating leg pain.  Concerns have also been expressed about a potential link to cancer.[4

Given these concerns, please provide the Committee with the following documents:

1.       All documents and communications pertaining to adverse postoperative events and/or medical complications relating to the use of recombinant human bone morphogenetic protein 2 (rhBMP-2) treatments, including but not limited to:

a.       All communications with and regarding medical journals or their representatives pertaining to adverse postoperative events and/or medical complications relating to the use of recombinant human bone morphogenetic protein 2 (rhBMP-2) treatments.

b.      All communications with and regarding clinical investigators who participated in Medtronic sponsored clinical trials pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments.

c.       All communications with and regarding the Food and Drug Administration (FDA) pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments. 

d.      All communications and records between and among Medtronic and members of FDA Advisory Boards pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments. 

e.      All communications and records between and among Medtronic and physician consultants pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments. 

2.      A detailed account of payments that Medtronic made to all Infuse clinical investigators.  Please include payments to corporate entities in which Medtronic-sponsored Infuse clinical investigators are principals. 

3.       For each individual and organization identified in question number 2 above, please provide the following information for each payment in table format:  

a. Date of payment

b. Payment description (CME, royalty, honorarium, research support, etc.)

c. Amount of payment

d. Year end or year-to-date payment total

In cooperating with the Committee's review, no documents, records, data, or other information related to these matters, either directly or indirectly, shall be destroyed, modified, removed, or otherwise made inaccessible to the Committee.

We look forward to hearing from you by no later than July 11, 2011. All documents responsive to this request should be sent electronically, on a disc, in searchable PDF format to [staff] and [staff].

If you have any questions, please do not hesitate to contact [staff] with Senator Baucus at (202) 224-4515 or [staff] with Senator Grassley at (202) 224-6522.

Sincerely,

 

Charles E. Grassley                       Max Baucus

Senator                                                Chairman

¹ "Complications rise along with off-label use of BMP-2," Journal Sentinel, August 28, 2010.

2 "New Study Links Spine Product From Medtronic to Risk of Sterility in Men," New York Times, May 25, 2011. 

3 "Researchers get royalties, papers omit sterility link," Journal Sentinel, May 25, 2011.

4 "Complications rise along with off-label use of BMP-2," supra note 1.

   

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Many parents wonder if their child is ready for kindergarten at age five. School readiness is complex. It is more than chronological age or the ability to recite numbers, letters, and colors. Here are some questions to think about as you decide if your child is school-ready.

Is your child socially ready?
For instance, does she trust other adults and children? Can she play ina group?

Is your child emotionally ready?
Does she have some degree of independence and self-direction? Does she have self-control; is she able to wait when there is a delay? Is she reasonably confident and willing to try new things?

Does your child have the language skills she'll need?
Can she understand directions? Is she able to express her needs to adults and other children? Can she express her thoughts in sentences?

Is your child physically ready?
Can she dress, eat, and toilet herself? Can she run and jump? Does she have a sense of space and balance? Can she manipulate small objects? Can she copy simple line drawings and hold a pencil properly?

Is your child intellectually ready? Is she able to focus and concentrate on an activity for 10 to15 minutes? Does she understand that letters stand for something; that printed words are spoken language expressed in writing? Can she remember simple routines? Is she able to stick with and solve simple problems?

Children see everything and are influenced by what they see. For example, they notice how parentsspend their time, what they read, what TV programs they watch. One of the best things a parent cando is read to children. It prepares them for school in several ways. Reading to a child for as little as ten minutes a day:
§ Helps develop security and independence (through the close body contact/sitting on mom or dad's lap).
§ Helps the child practice using language and learning concepts.
§ Helps to develop an interest in the world and its people, and most importantly.
§ Helps to develop the belief that learning can be fun.

Contact:Kathleen Olson, Extension Educator, Family Relations, University of Minnesota Extension, phone: 651-380-9339, email: kaolson@umn.edu

AMES, Iowa -- Stephen Ronstrom, Sacred Heart Hospital CEO, wanted the healthiest foods available served at the Eau Claire, Wis., hospital. So, in 2008 he gave his hospitality service director the go-ahead to begin buying local food for the institution's kitchen. The directive stemmed from Ronstrom's belief that healthy, fresh, nutritious foods are part of the healing cycle of the patient. He was tired of sending the hospital's money around the country and beyond to truck in food that could be grown and raised better by people in the hospital's own community.

Rick Beckler, Sacred Heart Hospitality Services Director, admits it took a bit of fumbling around to figure out how to work with local producers to get the quantities of product needed by the hospital on an ongoing basis. "I knew I couldn't just show up at the farmers' market and buy 1,500 pounds of ground beef," Beckler said. The other thing he knew was 10 percent of the hospital's food budge twas committed to purchasing local food products. He used that to publicly challenge growers and producers to address this compelling community need and opportunity. As a result of that public challenge a new business, the Producers & Buyers Co-op, rose to meet the need.

Forming the cooperative
In communities across the country, people are working together through cooperatives to get the things they need. From telecommunication, electric and farmer cooperatives in rural areas to housing, organic food and childcare cooperatives in metropolitan areas - cooperatives bring people together to improve their quality of life and financial well-being.

Madeline Schultz, Iowa State University Extension cooperatives specialist, says there are a set of principles that define cooperatives. "Cooperatives have three basic principles that they adhere to - member benefits, member ownership and member control," she said. "When we think about cooperatives, we think about businesses organized for the people that are going to use those products or services."

The Producers & Buyers Co-op in Eau Claire has become a business that produces, processes and delivers nutritious local produce for institutional use, illustrating those principles. With assistance from River Country Resource and Development (RC&D) and Margaret Bau, Wisconsin-USDA Rural Development cooperative development specialist, the Producers & Buyers Co-op was formed using a multi-stakeholder approach with a membership that includes the producers, buyers, processors and local transportation. "This co-op is interesting from so many different perspectives," said Bau. "For example, buyer-members are not mere customers. Buyer-members serve on the board, work on committees concerning product standards, work through fair pricing, and sweat through details of initial product runs."
Through co-op membership, the Producers & Buyers Co-op buyers are part of the learning process about the seasonality of food, the constraints of not having enough processing facilities, crop failures, etc. "If a hospital likes the idea of obtaining locally grown food but isn't willing to put in this extra effort or pay more for high quality food, then local food isn't for them," said Bau. "Cooperatives are all about being in an ongoing relationship with the other co-op members. It is a relationship of equals."

The community benefits
As of September 2010, the Producers & Buyers Co-op had facilitated the purchase and transportation of more than $177,000 of locally grown product from more than 18 producer-members and four processor-members to three buyer-members.

There is growing interest in cooperatives especially among young adults, according to Iowa State's Schultz. "Cooperatives are self-affirming - you see a need and you address that need through the business," she said. "People can make a contribution to their community by becoming involved in cooperatives several ways. They can start a business, become a member or serve on the board of directors."
Folks around Eau Claire recognize the value of the Producers & Buyers Co-op. Member Darrell Lorch of Lorcrest Farms Inc., in Blair, Wis., says having a stable market price allows him to do more long range planning with his farm operation. Sacred Heart's Beckler reports an outpouring of warm compliments on the hospital's food from patients, Meals on Wheels patrons and employees. "We have learned a great deal about our community through the co-op," said Beckler. "The civic engagement has been good on many levels. We are eating healthier and supporting a healthier local economy."

Producers and processors that sign up for the Producers & Buyers Co-op promise to employ growing practices and animal husbandry that's good for the land, good for the animals and good for the people who eat the food. The buyers, in turn agree to pay a price that reflects the cost of producing food that lives up to those standards plus a small profit. Buyers also agree to be flexible if certain products or quantities aren't available when they want them, filling the gaps through other suppliers.

Educational materials about cooperatives online
Schultz said that anyone interested in starting a cooperative, needing to know more about cooperative board of director responsibilities, or wanting to learn about the opportunities associated with cooperatives can easily access information at www.eXtension.org/cooperatives. eXtension is an educational partnership of 76 land-grant universities collaborating with industry experts and the USDA. Information on specific topics is developed by teams of educators from across the country, called communities of practice (CoP).

"Cooperatives is one of about 50 communities of practice publishing on the eXtension website," said Schultz who serves as chair for the CoP. "eXtension is an exciting place for us to be developing and delivering Web-based content on cooperatives because there are so many other topics of interest there."

Schultz said it is the goal of the cooperatives CoP leadership team to bring the best information forward. "Many universities andorganizations have some information about cooperatives available online, but it's often difficult to find," she said. "The leadership team has gathered the best of the best available information and is creating new content where they see unmet needs. We are hoping by using the eXtension platform more people will be able to access this collection of resources."Some cooperative experts believe economically challenging times foster the growth and interest in cooperatives, in part because start-up capital comes from member-investors and because of the civil engagement that is intrinsic to cooperatives. That interest is finding fresh support through models like the Producers & Buyers Co-op in Eau Claire, Wis., and the resources available at eXtension.

Youth and adults can increase their understanding of the cooperative business model; become more engaged as cooperative business members, employees, board directors and managers; and achieve greater economic and social improvements in their communities from the information available at eXtension.

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AMES, Iowa - Farmers, researchers and native plant aficionados are invited to a one-day workshop exploring how to enhance the ecosystem services provided by beneficial insects. Iowa State University's Departments of Entomology and Natural Resource Ecology and Management, with support from the Leopold Center for Sustainable Agriculture, will host the workshop on Aug. 4.

Beneficial insects provide services like pollination and the suppression of pests. Farmers and gardeners can encourage these insects by creating a refuge that supplies them a source of pollenand nectar. At the workshop, participants will learn how to identify helpful insects and the native plants that attract them. Experts will discuss how to create resilient landscapes that provide multiple services, and federal and state programs that help support this form of conservation.

Participants will have a chance to examine insect specimens and visit the Field Extension Education Laboratory (FEEL), where researchers are testing the ability of native plants to attract helpful species, like bees and lady beetles.

Speakers include Iowa State's Lisa Schulte and Mary Harris, natural resource ecology and management, Kelly Seman and Matt O'Neal, entomology, Meghann Jarchow, agronomy and Practical Farmers of Iowa representative, Sarah Carlson.

The workshop will take place at FEEL, five miles west of Ames. Register by July 15 at www.aep.iastate.edu/ent. Reduced hotel rates are available for out-of-town visitors through the ISU Memorial Union. Lunch will be provided.

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