Photo by Katie Hargrave

NORWAY, IOWA (November 30, 2010) – - In response to a recall commenced by its supplier (Mincing Overseas Spice Company, Dayton, New Jersey), Frontier Natural Products Co-op, is voluntarily recalling two products manufactured with non-organic nutmeg that were sold under the Frontier brand and under the Whole Foods Market brand listed below that contain nutmeg supplied by Mincing Overseas Spice Company. The nutmeg has the potential to be contaminated with Salmonella.

“Consumption of products containing Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms) endocarditic and arthritis.”

Recalled products were sold in all 50 states and in some parts of Canada to distributors, retailers and consumers. Below is the list of products containing the nutmeg:

On the bulk package, the lot code will be found on the front label directly above the UPC code. On the bottled glass item the lot codes can be found on the bottom of the bottle.

No illnesses have been associated with these Frontier or Whole Foods Market products but proceed to the FDA web-site (www.fda.gov) for updated information.

Frontier is initiating recall notices to our accounts who received any of the above recalled products with instructions for returning or destroying the recalled products and for notifying their customers of the recall. Consumers should not consume these products.  Please contact Frontier with any questions or to inquire about replacement or reimbursement at 1-800-669-3275 . Monday through Friday from 8:00am to 5:00pm Central time.  If you have a Whole Foods item please contact your local store. Images of the products above can be seen by going to the following link: http://www.frontiercoop.com/recall/nutmeg.



A patient in a hospital bed

New requirements empower patients to designate their own visitors, including a same-sex domestic partner

The Centers for Medicare & Medicaid Services (CMS) has issued new rules for Medicare- and Medicaid-participating hospitals that protect patients’ right to choose their own visitors during a hospital stay, including a visitor who is a same-sex domestic partner.

“Basic human rights—such as your ability to choose your own support system in a time of need—must not be checked at the door of America’s hospitals,” said HHS Secretary Kathleen Sebelius.  “Today’s rules help give ‘full and equal’ rights to all of us to choose whom we want by our bedside when we are sick, and override any objection by a hospital or staffer who may disagree with us for any non-clinical reason.”

The new rules follow from an April 15, 2010 Presidential Memorandum, in which President Obama tasked HHS with developing standards for Medicare- and Medicaid-participating hospitals (including critical access hospitals) that would require them to respect the right of all patients to choose who may visit them when they are an inpatient of a hospital.  The President’s memorandum instructed HHS to develop rules that would prohibit hospitals from denying visitation privileges on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity, or disability.  It also directed that the rules take into account the need for a hospital to restrict visitation in medically appropriate circumstances.

The rules require hospitals to have written policies and procedures detailing patients’ visitation rights, as well as the circumstances under which the hospitals may restrict patient access to visitors based on reasonable clinical needs.

A key provision of the rules specifies that all visitors chosen by the patient (or his or her representative) must be able to enjoy “full and equal” visitation privileges consistent with the wishes of the patient (or his or her representative).

The rules update the Conditions of Participation (CoPs), which are the health and safety standards all Medicare- and Medicaid-participating hospitals and critical access hospitals must meet, and are applicable to all patients of those hospitals regardless of payer source.

Among other things, the rules impose new requirements on hospitals to explain to all patients their right to choose who may visit them during their inpatient stay, regardless of whether the visitor is a family member, a spouse, a domestic partner (including a same-sex domestic partner), or other type of visitor, as well as their right to withdraw such consent to visitation at any time.

“These rules put non-clinical decisions about who can visit a patient out of the hands of those who deliver care and into the hands of those who receive it,” said CMS Administrator Donald Berwick, MD, MPP.  “While we still have miles to go in making care more patient-centered, these rules make it easier for hospitals to deliver on some of the fundamental tenets of patient-centered care—care that recognizes and respects the patient as an individual with unique needs, who treated with dignity and granted the power of informed choice.”

CMS finalized the rules based on thousands of comments from patient advocates, the hospital community, and other stakeholders.  The rules will be effective 60 days after publication.  More information about the rules is available on CMS’ website at http://www.cms.gov/CFCsAndCoPs/06_Hospitals.asp and http://www.cms.gov/CFCsAndCoPs/03_CAHs.asp.

One Of The Proposed Graphic Health Warnings for Cigarette Packages and Advertisements

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires that cigarette packages and advertisements have larger and more visible graphic health warnings.

FDA issued a proposed rule, Required Warnings for Cigarette Packages and Advertisements, proposing to modify the required warnings that appear on cigarette packages and in cigarette advertisements.  These new required warnings would consist of nine new textual warning statements accompanied by color graphics depicting the negative health consequences of smoking.

Timeline for Final Regulations
The Tobacco Control Act requires FDA to issue final regulations requiring these color graphics by June 22, 2011.  It also specifies that the requirement for the new health warnings on cigarette packages and advertisements will take effect 15 months after issuance of this final rule.

Proposed Graphic Health Warnings for Cigarette Packages and Advertisements

WARNING:  Cigarettes are addictive.
WARNING:  Tobacco smoke can harm your children.
WARNING:  Cigarettes cause fatal lung disease.
WARNING:  Cigarettes cause cancer.
WARNING:  Cigarettes cause strokes and heart disease.
WARNING:  Smoking during pregnancy can harm your baby.
WARNING:  Smoking can kill you.
WARNING:  Tobacco smoke causes fatal lung disease in nonsmokers.
WARNING:  Quitting smoking now greatly reduces serious risks to your health.

High Resolution Image Formats

• PDF format (PDF 13 MB) The PDF contains a composite of all of the proposed images. If you do not already have Adobe Acrobat, you can download Acrobat Reader for free.
• JPEG format (6 MB) The zipped folder contains all of the compressed images. If you do not already have WinZip, you can download WinZip a file compression program.

Placement Location on Cigarette Packages
The Tobacco Control Act requires that the nine graphic health warnings appear on the upper portion of the front and rear panels of each cigarette package and comprise at least the top 50 percent of these panels.

Placement Location on Cigarette Advertisement
It also requires that they appear in each cigarette advertisement, and occupy at least 20 percent of the advertisement.  For advertisements with a surface area less than 12 square inches, the proposed rule provides a subset of proposed color graphics to accompany the nine textual warning statements.

Public Comment
FDA is seeking public comment on the proposed rule from Friday, November 12, 2010 through Tuesday, January 11, 2011. To submit an official comment during this time period:

• Go to www.regulations.gov and insert docket number FDA-2010-N-0568 into the “search” box and follow the prompts.
• Send a fax, with your comments, to 301-827-6870
• Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

All comments should be identified by Docket ID No. FDA-2010-N-0568. It is only necessary to send one set of comments.

Plastic spinal column

The U.S. Food and Drug Administration approved Xgeva (denosumab) on Thursday to help prevent skeletal-related events (SREs) in patients with cancer that has spread (metastasized) and damaged the bone. Skeletal-related events include bone fractures from cancer and bone pain requiring radiation.

Xgeva is a monoclonal antibody that targets a protein involved in cancer-related bone destruction called human RANKL. Other FDA-approved drugs for similar conditions include Zometa (zoledronic acid) and Aredia (pamidronate disodium).

Xgeva is not approved for patients with multiple myeloma or other cancers of the blood.

“Bone metastases represent a major cause of pain and suffering in patients with cancer and can affect a patient’s quality of life,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Xgeva has a different mechanism of action than currently approved drugs aimed at reducing bone complications from cancer.”

Xgeva’s safety and effectiveness were confirmed in three randomized, double-blind clinical studies in 5,723 patients comparing Xgeva with Zometa. One study involved patients with breast cancer, another in patients with prostate cancer, and a third included patients with a variety of other cancers.

The studies were designed to measure the time until occurrence of a fracture or spinal cord compression due to cancer or until radiation or surgery for control of bone pain was needed.

In patients with breast or prostate cancers, Xgeva was superior to Zometa in delaying SREs. In men with prostate cancer, the median time to an SRE was 21 months with Xgeva compared to 17 months with Zometa.

In patients with breast cancer, the median time to an SRE was 26 months with Zometa and has not yet been reached with Xgeva. In patients with other solid tumors, time to development of an SRE was similar for both Xgeva and Zometa. The most common solid tumors were non-small cell lung cancer, multiple myeloma, kidney (renal) cancer, and small cell lung cancer.

The most serious side effects experienced with Xgeva were low calcium levels in the blood (hypocalcemia), and osteonecrosis of the jaw, a severe disease resulting from reduced blood flow to areas of the jaw and exposed jaw bone, causing pain, swelling, numbness, or infection.

Denosumab was originally approved under another trade name, Prolia, in June 2010. Prolia is indicated to treat postmenopausal women with osteoporosis who are at high risk for bone fractures. Xgeva is administered using a higher dose and with more frequent dosing than Prolia. Denosumab has a different safety profile in patients with osteoporosis than in patients with cancer and bone metastases.

Xgeva is marketed by Thousand Oaks, Calif.-based Amgen.

For more information:

FDA: Office of Oncology Drug Products

Mauri Gorgonzola cheese

• Mauri Gorgonzola cheese with sell-by dates of 01/13/11 and 01/14/11 is being recalled because of a positive test for E. coli O157:H7. DPI Specialty Foods of Tualatin, Ore., cut, packaged and distributed the cheese to Costco Wholesale Corporation (Costco) stores in Colorado.
• Consumers who have any of this cheese should not eat it. They should return the cheese to the place of purchase or dispose of it in a closed plastic bag and place in a sealed trash can to prevent people or animals, including wild animals, from eating it.
• Most people infected with E. coli O157:H7 develop diarrhea and abdominal cramps, but some illnesses may last longer and can be more severe. While most people recover within a week, some may develop a severe infection. Rarely, as symptoms of diarrhea improve, a type of kidney failure called hemolytic uremic syndrome (HUS) can occur; this can happen at any age but is most common in children under 5 years old and in older adults. People with HUS should be hospitalized immediately, as their kidneys may stop working and they may be at risk for other serious health problems.
• The bacterial strain from this cheese is different from the strain linked to those illnesses reported in the recent E. coli O157:H7 outbreak in Southwestern states. Investigations are ongoing to determine if any illnesses are associated with eating this recalled cheese.
• The FDA is investigating how this cheese became contaminated.

St. Joseph Medical Center in Maryland

BALTIMORE – St. Joseph Medical Center (SJMC) in Towson, Md., has agreed to pay the United States $22 million to settle allegations under the False Claims Act that it paid unlawful remuneration under the Anti-Kickback Act and violated the Stark Law when it entered into a series of professional services contracts with the Pikesville, Md., based cardiology group, MidAtlantic Cardiovascular Associates (MACVA), the Justice Department announced.

The allegations resolved in the settlement include the payment of kickbacks to MidAtlantic under the guise of professional services agreements, in return for MACVA’s referrals to the medical center of lucrative cardiovascular procedures, including cardiac surgery and interventional cardiology procedures, over the period from Jan. 1, 1996, to Jan. 1, 2006. The settlement agreement resolves issues relating to 11 professional services agreements between MidAtlantic and St. Joseph under which MACVA received payments above fair market value, for services not rendered or that were not commercially reasonable and were entered into for the purpose of inducing referrals by MACVA to SJMC.

Under the settlement the hospital also agrees to settle allegations that it received from federal health benefit programs between Jan. 1, 2008, and May 12, 2009, for medically unnecessary stents performed by Mark Midei, M.D., a one time partner in MACVA who was later employed by SJMC.

The settlement was announced by Tony West, Assistant Attorney General of the Justice Department’s Civil Division; Rod Rosenstein, U.S. Attorney for the District of Maryland; Nicholas DiGiulio, Special Agent in Charge, Office of Inspector General of the Department of Health and Human Services, Office of Investigations; Roger Craig, Special Agent in Charge of the Defense Criminal Investigative Service – Mid-Atlantic Field Office; and Jill Maroney, Special Agent in Charge of the Office of Personnel Management – Office of Inspector General.

“Kickbacks for medical services undermine the integrity of our health care system,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. “When hospitals put their own financial interests ahead of the best interests of patients, we will take action.”

The settlement resolves a lawsuit brought by whistleblowers, Stephen D. Lincoln, M.D.; Peter Horneffer, M.D.; and Garth McDonald, M.D., cardiac surgeons who practiced together as members of Cardiac Surgery Associates in Baltimore. The lawsuit, which was filed in the District of Maryland in June 2010, alleges that SJMC violated the Anti-Kickback Act, Stark Law and the False Claims Act by paying various forms of illegal remuneration to MACVA to induce referrals of patients insured by federal health care programs for cardiac procedures.

Drs. Lincoln, Hornefer and McDonald brought their suit under the qui tam or whistleblower provisions of the False Claims Act, which permit private citizens with knowledge of false claims against the government to bring a lawsuit on behalf of the United States and to share in any recovery. Under the civil settlement announced today, the relators will receive a portion of the federal share of the recovery.

“Kickbacks give doctors an incentive to pursue unnecessary treatments that are costly and sometimes even dangerous to patients,” said U.S. Attorney Rosenstein. “Medical care providers are prohibited from giving or receiving kickbacks because of the risk that they will put their own financial interests ahead of their patients’ interests.”

Saint Joseph’s also signed a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services, Office of Inspector General (HHS-OIG). It requires SJMC to engage in activities that will help ensure accurate billing and appropriate relationships with referral sources. The CIA also addresses patient care issues by requiring the hospital to: appoint physician executives to oversee medical staff quality-of-care matters; hire a Peer Review Consultant to evaluate SJMC’s peer review practices; and engage an Independent Review Organization to perform a Cardiac Catheterization Procedures Review, evaluating and analyzing the medical necessity and appropriateness of interventional procedures performed at SJMC. The hospital is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for major noncompliance with this CIA and subject to stipulated penalties for less significant noncompliance.

“Payoffs to influence health care decision-making too often result in inappropriate, unnecessary and harmful medical practices,” said Daniel R. Levinson, Inspector General of the Federal Department of Health and Human Services. “OIG is committed to protecting patients from needless medical procedures, such as the insertion of unnecessary cardiac stents — as is alleged in this case.”

The settlement announced today was the result of an investigation by the U.S. Attorney’s Office for the District of Maryland and the Commercial Litigation Branch of the Justice Department’s Civil Division with assistance from the U.S. Department of Health and Human Services, Office of Inspector General; the Department of Defense Office of the Inspector General, Defense Criminal Investigative Service; and the Office of Personnel Management, Office of Inspector General. The case was handled by Maryland Assistant U.S. Attorney Jamie M. Bennett.

Photo by Kathie Lapcevic

FDA, state of Maryland, and Baugher Enterprise warn consumers to avoid Baugher’s Apple Cider
Cider may be related to outbreak of  E. coli infections

Fast Facts

• Baugher’s Apple Cider in half gallon and gallon containers, offered for sale in Maryland and Pennsylvania, is preliminarily linked with an outbreak of E. coli O157:H7 infections.

• Consumers who have any of this cider should not drink it and should dispose of the cider in a manner that prevents people or animals, including wild animals, from consuming it.

• Most people infected with E. coli O157:H7 develop diarrhea and abdominal cramps, but some illnesses may last longer and can be more severe. While most people recover within a week, some may develop a severe infection. Rarely, as symptoms of diarrhea improve, a type of kidney failure called hemolytic uremic syndrome (HUS) can occur; this can happen at any age, but is most common in children under 5 years old and in older adults. People with HUS should be hospitalized immediately, as their kidneys may stop working and they may be at risk for other serious health problems.

• As of Thursday, Nov. 4, 2010, 7 persons infected with the outbreak strain of E. coli O157:H7 have been reported from Maryland since October 22. There have been 3 reported hospitalizations, 1 possible case of HUS and no deaths.

What is the Problem?
The U.S. Food and Drug Administration and the Maryland Department of Health and Mental Hygiene (DHMH) join Baugher Enterprise in warning consumers to not consume Baugher’s Apple Cider, as this cider may be associated with an outbreak of E. coli O157:H7 infections. The cider was available for sale in Maryland and Pennsylvania.

What are the Symptoms of Illness/Injury?
Most people infected with E. coli O157:H7 develop diarrhea and abdominal cramps, but some illnesses may last longer and can be more severe. While most people recover within a week, some may develop a severe infection. Rarely, as symptoms of diarrhea improve, a type of kidney failure called hemolytic uremic syndrome (HUS) can occur; this can happen at any age but is most common in children under 5 years old and in older adults. People with HUS should be hospitalized immediately, as their kidneys may stop working and they may be at risk for other serious health problems.

What Do Consumers Need To Do?
Do not drink Baugher’s Apple Cider. Consumers should dispose of the cider in a manner that prevents people or animals, including wild animals, from consuming it.

Anyone who experienced signs of E. coli O157:H7 infection should contact his or her health care provider immediately. Health care providers should report any suspected infection to state or local public health authorities right away.

Where is it Distributed?
Baugher Enterprise reports that the cider is distributed throughout Maryland and in the Gettysburg area of Pennsylvania.

What is Being Done to Protect Consumers?
The FDA, DHMH and Baugher Enterprise are working together on the investigation.  Initial public notification was made by DHMH on Nov. 4, 2010.  FDA and the DHMH will continue to update the public with more information as soon as it is available. The FDA, in conjunction with the DHMH, has initiated an investigation at the Baugher Enterprise production facility.

In addition, Baugher Enterprise has voluntarily recalled the cider from its distributors.

Photo by Adrian Clark

The U.S. Food and Drug Administration today announced a partnership agreement with the University of Rochester to form the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative.
The initiative is aligned with the FDA’s recently launched Initiative for the Advancement of Regulatory Science, and is designed to streamline the discovery and development process for new pain-reducing (analgesic) drug products.
This multi-year, multi-phased initiative will address major gaps in scientific information that can slow down analgesic clinical trials and analgesic drug development. Key objectives include:

• Establishing a scientific and administrative infrastructure to support a series of projects;
• Establishing relationships with key expert stakeholders, industry, professional organizations, academia and government agencies;
• Coordinating scientific workshops with key experts in the field of anesthesia and analgesia;
• Conducting in-depth and wide-ranging data analyses of analgesic clinical trial data to determine the effects of specific research designs and analysis methods.

Study results, best practices, and outcomes of the ACTION Initiative will be available at http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm166082.htm as they are developed.

• Piperacillin/Tazobactam (TZPvv) and Escherichia coli results
• Piperacillin/Tazobactam (TZPvv) and Klebsiella pneumoniae with resistant results

bioMérieux also provided instructions to implement suppression rules to prevent inappropriate reporting of results. Customers can continue to use the VITEK^® 2 cards following the guidelines above.

An internal investigation by bioMérieux confirmed user reports that VITEK^® 2 antimicrobial susceptibility testing may incorrectly report E. coli and K. pneumoniae susceptible isolates as resistant to Piperacillin/Tazobactam (TZPv). This same investigation also found that E. coli isolates resistant to Piperacillin/Tazobactam (TZPv) may be incorrectly identified as susceptible

Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam when infected with a resistant E. coli isolate. There have been no reports to date of treatment failures associated with either falsely-resistant or falsely-susceptible E. coli results for Piperacillin/Tazobactam (TZPv), or for falsely-resistant K. pneumoniae results.

Attached below is a list of VITEK^® 2 cards that are affected by this product correction. Of these affected cards, all lot numbers currently in distribution, as well as future distribution are affected until further notice. In addition, all new VITEK^® 2 cards created that contain TZPv are affected by this product correction.

bioMérieux has notified the U.S. Food and Drug Administration (FDA) and is working closely with the agency regarding this urgent product correction. Laboratories with questions should contact bioMérieux, Inc. at 1-800-682-2666, option 3, 24 hours a day; physicians should contact their clinical diagnostics laboratory for additional information if necessary. Consumers with questions should contact their physician.

Adverse reactions or quality problems experienced with the use of the cards should be reported to bioMérieux by contacting Customer Service at 1-800-682-2666, option 3. Customers may also report adverse reactions or quality problems through FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm⁹; by regular mail using the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/medwatch/getforms.htm¹⁰; or by fax at 1-800-FDA-0178.

Photo by Melissa Wiese

October 27, 2010 –  Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product (“methotrexate”) to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of these two dosage presentations.

Due to particle size, there is the potential to develop adverse reactions in areas where the particles lodge. While it is unlikely, parenteral injection of drug from the affected lots could lead to serious adverse events, resulting in disability and death. Additionally, neurologic damage could result from intrathecal administration. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. Intra-arterial administration could result in damage to blood vessels in the distal extremities or organs. To date, Sandoz has not received any adverse event reports or product complaints attributable to particles from any lot of methotrexate, including the lots where flakes have been found.

Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. The affected products are only the 50mg/2mL and 250mg/10mL presentations of methotrexate. The product lot numbers, label type and expiration dates are listed  on the Sandoz US website at http://www.us.sandoz.com.