by Lena Groeger

The fine is just the latest of more than a dozen the Red Cross has racked up in the last decade.

In 2003, a federal court, frustrated by repeated blood safety violations by the Red Cross, gave the FDA the power to fine the organization.

Forty-six million dollars in penalties later, many of the same violations — understaffing, ineffective screening of donors, failure to recall infected blood — are outlined in the recent letter the FDA sent to the executive vice president of Biomedical Services for the Red Cross.

The 32-page letter describes hundreds of violations over several months in 2010 at 16 Red Cross facilities across the country, and details how the Red Cross repeatedly failed to properly track and record information about donors and blood units.

(To see a history of Red Cross fines and many of the documents cited in this article go to ProPublica’s timeline of Red Cross fines.)

For example, the agency failed to notify health departments when donors had infectious diseases such as HIV and syphilis, failed to add new donors with infected blood to a national list of people who aren’t allowed to donate, and failed to review records of donors who had bad reactions, such as a 16-year-old who lost consciousness and fell to the floor after giving a unit of blood.

It also failed to follow written procedures, such as the case of a phlebotomist in Arizona who stuck herself with a needle before sticking a donor with the same needle to draw blood. The case went unreported for a month, because a staff member “was not aware of the need to immediately notify a Medical Director,” according to the inspection letter.

In a recent statement, the Red Cross said it was disappointed that the FDA issued the fine for “an inspection conducted so long ago” and noted that it has “already taken corrective steps to address those matters and that improvements in operations have been made.”

In an email to ProPublica, a Red Cross spokeswoman also said there is no evidence that these violations endangered any patients, adding that the blood supply is safer than it has ever been.

The spokeswoman said the agency has made significant improvements, including reducing the number of problems system-wide by at least 65 percent, and is investing in technology upgrades.

For example, the agency recently upgraded software and computer equipment at blood drives to better collect and track donor information.

The FDA’s letter laying out the fines says the Red Cross “has known of these continuing problems and has failed to take adequate steps to correct them.”

The FDA also noted that “many of the violations recounted in this letter are virtually identical to violations charged in previous [letters].” In June 2010 the FDA imposed a $16 million penalty on the Red Cross for the same type of violations.

The chronic problems raise the question of whether penalties are working at all.

The Red Cross has been making promises and failing to keep them for over a decade, according to Sidney Wolfe, who heads the health research group at the consumer watchdog organization Public Citizen.

Wolfe said he wrote to head of the FDA in 2000, urging it to hold the Red Cross in contempt of court. A federal court first put the Red Cross under government supervision in 1993 after finding blood safety lapses. A decade later, in 2003, the court empowered the FDA to impose fines.

“But fast-forward nine years ahead, and we have the same violations,” Wolfe said.

If the Red Cross disagrees with an assessment, it can ask the FDA to reevaluate the penalty, but in most cases the fine only changes by a few thousand dollars.

Most of the recent problems inspectors cited have to do with managing records and tracking blood donors. The Red Cross says it is unaware of any infections or deaths that stemmed from problems noted in the report, and that “serious problems” account for only three percent of the total problems found.

The FDA doesn’t think that’s good enough.

“FDA cannot definitively say there was never any danger to the blood supply since the violations can create conditions that could lead to potential safety consequences,” said FDA spokeswoman Patricia El-Hinnawy.

The government requires that the Red Cross (like any blood services operation) have multiple safeguards for its blood services.

That includes asking a donor questions to identify any risks, checking his or her name against a national list of people who aren’t allowed to give blood, testing for infectious diseases, keeping track of blood units so infected blood isn’t released, and investigating any deviations from standards.

Because blood transfusions always carry a degree of risk, the FDA considers every step in that process critical to minimizing problems.

“Failure of an individual safeguard does not automatically translate into the release of unsafe products,” an FDA spokeswoman told ProPublica in an email, “however, it may increase the potential for risk.”

In 2008, the Red Cross consolidated its blood work to two facilities: one in Charlotte, N.C., and the other in Philadelphia. The offices are in charge of managing, tracking and, if need be, recalling blood.

But according to the inspection letter, both offices have been chronically understaffed, and simply haven’t been able to carry out their required functions in a timely or effective manner. As of 2010, the offices had a backlog of about 18,000 donor management cases.

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Each year, about 70,000 young people in the U.S. aged 15 to 39 years are diagnosed with cancer.

In the series, a group of teens and young adults from Children’s Adolescent Young Adult Oncology Program talk about their experiences with the disease – from treatments and hair loss, to dealing with school, friends and family.

Producers of the series hope that seeing other teens and young adults with cancer talk about their experiences will help other young patients struggling with the diagnosis of cancer cope.

“It is so important for these teens and young adults with cancer to know that there is a peer out there that understands what they are going through and that support is available,”  Dr. Rebecca Johnson, medical director of the Adolescent and Young Adult Oncology Program at Seattle Children’s Hospital.

The discussion group was facilitated by Teen Talking Circles, a nonprofit organization that offers teens “a safe place to tell their truth,” and trains adults to start Teen Talking Circles in their communities.

• To view the complete series go to:  ”Good Times and Bald Times” or click on individual episodes listed below.

• To learn more visit the website of the Children’s Adolescent Young Adult Oncology Program.

To learn more about the challenges facing teens and young adults with cancer read our series from the NCI Cancer Bulletin.

Series Episodes:

• Good Times and Bald Times – Meet the Circle
• Good Times and Bald Times – Family, Friends & Cancer
• Good Times and Bald Times – How Did it Feel?
• Good Times and Bald Times – Treatment and Medication
• Good Times and Bald Times – Eggs
• Good Times and Bald Times – Fertility Preservation
• Good Times and Bald Times – Food, Appetite & Cancer
• Good Times and Bald Times – Feeding Tubes
• Good Times and Bald Times – Losing Your Hair
• Good Times and Bald Times – PICC Lines, Hickman Lines & Ports, Oh My!
• Good Times and Bald Times – Dealing with School
• Good Times and Bald Times – What If

When the Food and Drug Administration allowed silicone gel-filled breast implants back on the market in November 2006, the agency required the manufacturers to conduct follow-up studies to learn more about the long-term performance and safety of the devices.

Today, FDA released a report that includes preliminary safety data from these studies, as well as other safety information from recent scientific publications and adverse events reported to FDA.

FDA approved silicone gel-filled breast implants for increasing breast size (augmentation) in women age 22 or older and for reconstruction (after breast cancer surgery or other medical issues) in all women. They are also approved for revision surgeries, which correct or improve the result of an original augmentation or reconstruction surgery.

Almost five years later, FDA’s report continues to support the safety and effectiveness of these implants when used as intended, but states that women should fully understand the risks before considering getting them.

• Breast implants are not lifetime devices. The longer a woman has them, the more likely she is to have complications and need to have the implants removed or replaced. Women with breast implants will need to monitor their breasts for the rest of their lives.

• The most frequently observed complications and adverse outcomes are tightening of the area around the implant (capsular contracture), additional surgeries, and implant removal. Other complications include a tear or hole in the outer shell (implant rupture), wrinkling, uneven appearance (asymmetry), scarring, pain, and infection.

• Studies to date do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, no study has been large enough or long enough to completely rule out these and other rare complications.

FDA is working with the two manufacturers who make silicone gel-filled breast implants, Allergan and Mentor, to address the challenges in collecting follow-up data on the women who have received these implants.

“It is important that women with breast implants who experience any symptoms see their health care providers,” says Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “Women who have enrolled in clinical studies should continue to participate so that we can better understand the long-term performance of these implants and identify any potential problems.”

FDA also provided other information today on both silicone gel-filled and saline-filled breast implants:

• A redesigned website on breast implants at www.fda.gov/breastimplants

• A booklet, “Breast Implants: Local Complications and Adverse Outcomes”, which highlights the most common problems that occur with breast implants and things to consider before having breast implant surgery.

• A handout with questions to ask your surgeon before getting breast implants

• Two videos (one for women and one for health care providers) on a small but increased risk of a rare type of cancer called anaplastic large cell lymphoma (ALCL) in women with breast implants

FDA recommends that women with silicone gel-filled breast implants do the following:

• Follow up. Continue to routinely follow up with your health care provider. Get routine MRIs to detect a rupture that you may not be aware of (silent rupture).  FDA recommends that women with silicone gel-filled breast implants get screenings for silent ruptures three years after they get implants and every two years after that.

• Be aware. Breast implants are not lifetime devices. The longer you have breast implants, the more likely you are to have complications. One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 1 in 2 will require removal within 10 years of implantation.

• Pay attention to changes. Notify your health care provider if you develop any unusual signs or symptoms. Report any serious side effects to the breast implant manufacturer and MedWatch, FDA’s safety information and adverse event reporting program. Report online at www.fda.gov/MedWatch or by calling 800-332-1088.

• Stay in touch. If you’re enrolled in a manufacturer-sponsored study, continue to participate. These studies are the best way to collect information about the long-term rates of complications.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

June 22, 2011

E. coli -- Photo: Janice Haney Carr/CDC

The U.S. Centers for Disease Control and Prevention (CDC) is investigating three suspected cases of E. coli infections linked to the outbreak in Europe.

All had recently travelled to Hamburg, Germany, the agency reports.

The E. coli strain — Escherichia coli O104:H4 (STEC O104:H4) –produces a toxin that can cause severe, bloody diarrhea and kidney failure, a condition called hemolytic uremic syndrome, or HUS.

The outbreak was centered in Germany, which as for May 31, has seen 470 patients with HUS with nine deaths, the CDC said.

“Any person with recent travel to Germany with signs or symptoms of STEC infection or HUS, should seek medical care and let the medical provider know about the outbreak of STEC infections in Germany and the importance of being tested,” the CDC warns.

To learn more read the CDC update below:

CDC Statement on Outbreak of STEC O104:H4 infections in Germany

CDC is following a large outbreak of Shiga toxin-producing E. coli O104, or STEC O104, infections currently going on in Germany.

As of May 31, 2011, the Robert Koch Institute (RKI), Germany’s disease control and prevention agency, has confirmed six deaths and 373 patients with hemolytic uremic syndrome, or (HUS) (kidney failure), a life-threatening complication of E. coli infections.

To date, no confirmed cases of STEC O104 infections have been reported in U.S. travelers to Europe. Two cases of HUS in the United States have been reported in persons with recent travel to Hamburg, Germany.

CDC is working with state health departments to learn more about these two cases and to identify others. CDC has been in contact with the German public health authorities at RKI. We have alerted state health departments in the United States of the ongoing outbreak.

We have also requested that they report to CDC any cases in which people have either HUS or Shiga toxin-positive diarrheal illness, with illness onset during or after travel to Germany since April 1, 2011.

The strain of STEC causing illness, STEC O104:H4, is very rare. CDC is not aware of any cases of STEC O104:H4 infection ever being reported in United States.

Any person with recent travel to Germany with signs or symptoms of STEC infection or HUS, should seek medical care and let the medical provider know about the outbreak of STEC infections in Germany and the importance of being tested.

Symptoms of STEC infection include severe stomach cramps, diarrhea, which is often bloody, and vomiting. If there is fever, it usually is not very high.

Most people get better within 5–7 days, but some patients go on to develop HUS—usually about a week after the diarrhea starts. Symptoms of HUS include decreased frequency of urination, feeling very tired, and losing pink color to skin and membranes due to anemia.

CDC is not aware that a specific food has been confirmed as the source of the infections. Travelers to Germany should be aware that the German public health authorities have recommended against eating raw lettuce, tomatoes or cucumbers, particularly in the northern states of Germany (Hamburg, Bremen, Lower Saxony, Schleswig Holstein).

We have no information that any of these suspected foods have been shipped from Europe to the United States at this time. The US Department of Defense has been notified of this outbreak because of the presence of U.S. military bases in Germany. We are not aware of any cases among U.S. military personnel.

Here are answers to frequently asked questions:

Would this be the largest E. coli outbreak ever in the world?

We are still learning more about the overall size of this outbreak. The number of HUS cases involved indicates that the outbreak is very large.

Tell us about this rare strain and are we testing for it here?

A very rare strain of Shiga toxin-producing E. coli, or STEC has been reported from some patients in the outbreak. This strain, E. coli O104:H4 has never been seen in the United States, and CDC is only aware of few reports of this strain from other countries.

Although it is rare, the United States’ public health surveillance systems are designed to be able to identify this, and other rare STEC strains, in ill people. However, the ability to detect STEC infections through surveillance depends on proper diagnostic testing of patients presenting with symptoms suggestive of STEC.

In 2009, CDC published recommendations for the diagnosis of STEC infections by clinical laboratories. The illness that it causes is similar to that caused by E. coli O157:H7 which is also a Shiga toxin-producing E. coli and the one most commonly identified in the United States.

Could people travel from Germany and spread it here?

STEC infections can be spread from person to person. The best defense is careful, thorough hand washing. Persons returning from Germany who have diarrhea should be sure to wash hands well with soap and warm water after using the bathroom, and should not prepare food for others while they are ill.

People who are in contact with ill people who recently visited Germany should also follow basic hygiene practices carefully, including washing their hands thoroughly before eating or drinking and after caring for an ill person.

Why so many sick people?

It is too early to know why this is such a large outbreak. The large size may have to do with contamination of a popular food item. However, to our knowledge a specific food vehicle has yet to be confirmed. It is also possible that the unusual strain is particularly likely to cause HUS.

May 9, 2011 - 7 p.m. – Wilde Rover

In the past century, we’ve seen outbreaks of new viruses such as HIV, SARS and several flu strains, but what about the viruses that came before them? These ancient, extinct viruses (“paleoviruses”) affect modern humans, too. Join Dr. Harmit Malik from the Fred Hutchinson Cancer Research Center to learn how these prehistoric germs have not only shaped our immune system, but also contributed to the repertoire of human genes.

Wilde Rover is located in downtown Kirkland at 111 Central Way.