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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Supporters of the initiatives say these new services allow students to get good information about sex anonymously. But there are also those who oppose these initiatives, writes Hoffman.

…proponents of abstinence-based sexual education argue that these digital services presume that sexual activity among teenagers is the norm, and do not spend enough time on alternatives.

“They are only focusing on the risk-reduction model,” said Valerie Huber, executive director of the National Abstinence Education Association, which hopes to kick off its online service for teenagers next year.

Those who run digital programs say they simply want teens to have accurate information, to help them make good decisions. Even though popular culture is saturated with sex, facts and advice can be hard to find.

To learn more:

• Read Hoffman’s article Sex Education Gets Directly to Youths, via Text.

Some of the services discussed:

• ICYC – In Case You’re Curious

• Chicago’s The Sex-Ed Loop

• California’s The Hookup.

• SexEtc: www.sexetc.org

• National Abstinence Education Association: www.abstinenceassociation.org

By Dr. James Kublin

Today, December 1st, is World AIDS Day, and to mark the occasion the HIV Vaccine Trials Network, which is headquartered at Fred Hutchinson Cancer Research Center in Seattle, would like to debunk the top 10 myths about HIV vaccine research.

Myth No. 1: HIV vaccines can give people HIV.

HIV vaccines do not contain HIV and therefore a person cannot get HIV from the HIV vaccine. Some vaccines, like those for typhoid or polio, may contain a weak form of the virus they are protecting against, but this is not the case for HIV vaccines. Scientists make HIV vaccines so that they look like the real virus, but they do not contain any HIV. Think of it like a photocopy: It might look similar, but it isn’t the original. In the past 25 years more than 30,000 volunteers have taken part in HIV vaccine studies worldwide, and no one has been infected with HIV by any of the vaccines tested – because they do not contain HIV.

Myth No. 2: An HIV vaccine already exists.

There is no licensed vaccine against HIV or AIDS, but scientists are getting closer than ever before to developing an effective vaccine against HIV. In 2009, a large-scale vaccine study conducted in Thailand called RV144 showed that a vaccine combination could prevent about 32 percent of new infections. Researchers are starting to understand why this vaccine combination worked and how to improve upon it.

Researchers around the world continue to search for an HIV vaccine that is even more effective. Leading this effort is the HIV Vaccine Trials Network, the largest publicly funded group of HIV vaccine researchers in the world. The HVTN is an international effort to find a safe and effective vaccine to stop the spread of HIV. It is funded by the U. S. National Institutes of Health.

Myth No. 3: Joining an HIV-vaccine study is like being a guinea pig.

Unlike guinea pigs, people can say yes or no to participating in research. All study volunteers must go through a process called informed consent that ensures they understand all of the risks and benefits of being in a study, and those volunteers are reminded that they may leave a study at any time without losing rights or benefits. The HVTN takes great care in making sure people understand the study fully before they decide whether or not join. All HVTN research adheres to U.S. federal regulations on research, as well as the international standards for the countries in which it conducts research.

Myth No. 4: A person must be HIV positive to be in an HIV vaccine study.

Not so. While some research groups are conducting studies of vaccines that might be used in people who are already infected with HIV, the vaccines being tested by the HVTN are preventive vaccines. They must be tested on volunteers who are not infected with HIV.

Myth No. 5: Vaccine researchers want study participants to practice unsafe behaviors so they can see whether the vaccine really works.

Not true. The safety of study participants is the No. 1 priority of HIV vaccine researchers and study site staff. Trained counselors work with study participants to help them develop an individual plan on how to keep from contracting HIV. Participants also are given supplies such as condoms and lubricant as well as instructions on how to use them properly. HIV efficacy trials enroll thousands of participants over several years, and with even with the best counseling some participants will still become infected through their risky behavior. Changing human behavior is never easy; after all, many people still smoke, even though it is widely known that smoking is the major cause of lung cancer. An AIDS epidemic would not exist if prevention was as simple as counseling people to change their risky behavior.

Myth No. 6: Now that there are pills that can prevent HIV infection, an HIV vaccine is no longer necessary.

HIV-negative people who are at high risk can take antiretroviral medication daily to try to lower their chances of becoming infected if they are exposed to the virus. This type of therapy – called PrEP, short for PreExposure Prophylaxis – has been shown to be effective among those at high risk. However, it has not yet been recommended for widespread use. PrEP is unlikely to be an option for everyone because the pills are expensive and are not always covered by insurance, may cause side effects, and not everyone has access to them. Remembering to take a pill every day is also challenging for some people. The most effective way to eliminate a disease is by using an effective vaccine. It was a vaccine that eliminated small pox and has almost eliminated polio. Most likely it will be an HIV vaccine that eliminates HIV from the world. Vaccines are an effective, affordable and practical option.

Myth No. 7: An HIV vaccine is unnecessary because AIDS is easily treated and controlled, just like diabetes.

While treatment for AIDS has dramatically improved over the last 30 years, it is no substitute for prevention. Current HIV medications are very expensive, and there are also many side effects. Sometimes people develop drug resistance and have to change the regimen of pills they take. Access to these drugs for the uninsured in the U.S. and those in the developing world is also very limited.

Myth No. 8: The search for an HIV vaccine has been going on for a long time and it’s just not possible to find one that works.

The science of HIV-vaccine development is challenging, but scientific understanding continues to improve all the time. In just the past two years there have been promising results from the RV144 study in Thailand as well as exciting laboratory work, such as the discovery of new broadly neutralizing antibodies against HIV. HIV is a powerful opponent, but scientists are constantly learning from one another and using advanced technology to fight it. Science has come a long way in the 30 years since AIDS was discovered. In comparing preventive HIV vaccine work to other vaccine development, the time it has taken is not so surprising; the polio vaccine took 47 years to develop.

Myth No. 9: Vaccines cause autism and just aren’t safe.

This is not true. Numerous studies in the past decade have found this claim to be false. The British doctor who originally published the finding about vaccines and autism has since been found to have falsified his data. There is actually no link between childhood vaccination and autism. It is true that vaccines often have side effects, but those are typically temporary (like a sore arm, low fever, muscle aches and pains) and go away after a day or two. The value of protection to vaccinated individuals and to the public has made vaccines one of the top public health measures in history, second only to having a clean water supply.

Myth No. 10: People who aren’t at risk don’t need an HIV vaccine.

A person currently may not be at risk for HIV, but life situations can change along with disease risk. Such a vaccine also may be important for one’s children or other family members and friends. By being knowledgeable about preventive HIV vaccine research, a person can be part of the solution by educating friends and family about the importance of such research and debunking the myths that surround it. Even if a person is not at risk, he or she can be part of the effort to find a vaccine that will hopefully save the lives of millions of people worldwide.

To learn more or find out how to get involved in an HIV vaccine study, please visit www.hvtn.org

The film is a compilation of 15 short films about people living and thriving with HIV/AIDS.

An estimated 7,200-8,000 people are living with HIV/AIDS in King County.

Approximately 325 people are diagnosed with HIV each year.

Since 1982, more than 4,600 King County residents with HIV infection have died.

A short program will include reflections on the last 30 years of HIV and AIDS and plans for the next 30.

Seating for the event is available on a first come basis.

When:

Thursday, Dec. 1, 2011 at 7 p.m.

Where:

The Egyptian Theatre

805 East Pine St., Seattle

The CDC recommends that everyone age 13-64 who is sexually active should test for HIV at least once. Some people whose behavior puts them at risk for HIV should get an HIV test at least once a year. For testing locations in King County, call 206-296-4649 or go to www.kingcounty.gov/health/hiv.

This story was produced in collaboration with 

CDC microbiologist - Photo: James Gathany CDC

Federal funding for medical research, disease prevention and a host of public health initiatives could be sharply reduced if the congressional super committee fails to agree on a deficit-reduction package, triggering automatic cuts.

Public attention has largely focused on possible cuts to the huge entitlement programs for seniors and the poor, Medicare and Medicaid, but health advocates are raising an alarm about many other smaller programs they say need to be protected.

The bipartisan panel is charged with cutting at least $1.2 trillion over 10 years. If it can’t overcome the enormous political obstacles to a deal, automatic cuts would kick in as of 2013, half coming from defense, the other half from domestic spending.

Congress laid out this scenario – dubbed “sequestration” in legislative lingo – when it created the committee in August as part of a deal to raise the debt ceiling and avoid the first U.S. default in history.

While the committee can chop Medicaid and Medicare as part of a negotiated agreement, automatic cuts would not affect Medicaid funding; there would be a 2 percent reduction in Medicare payments to hospitals and other providers. That would make the hit to many other programs all the more severe.

“I don’t know if a lot of people have appreciated how big a hit the discretionary health programs” could take if there are automatic cuts, said Richard Deem, senior vice president of advocacy for the American Medical Association. “I think a lot of people are going to wake up to that too late.”

At stake is federal money that, among other things, helps HIV patients pay for lifesaving medication, funds biomedical research and helps prevent and respond to food borne illnesses and disease outbreaks.

Automatic reductions, for example, could translate into less staff to handle food contamination, said Georges Benjamin, executive director of the American Public Health Association. Recently, Colorado cantaloupes sickened 116 people in 25 states with listeria, killing 23, according to the Centers for Disease Control and Prevention.  “Someone has to go into stores and make sure the stuff has been taken off the shelves. I am very worried about what [automatic cutting] does to the public’s capacity to be safe.”

If the full $1.2 trillion in automatic cuts go into effect, funding for non-defense discretionary programs in 2013 would face reductions of 7.8 percent, dropping each year to 5.5 percent in 2021, according to Congressional Budget Office estimates.

Richard Kogan, a senior fellow at the Center on Budget and Policy Priorities, places the first year’s hit at over 9 percent, however.

Health advocates fear deep cuts will harm the public by reducing services and investment in several areas, including:

• Public health. The Centers for Disease Control and Prevention is particularly vulnerable because it was hit hard in the last round of budget cuts, according to Benjamin. In fiscal year 2011, federal funding for the CDC declined by $740 million. “They’ve already cut deeply into the bone at CDC,” he said.

The agency plays an important role in detecting and responding to emergencies such as tornadoes, hurricanes, food-borne illnesses, and infectious disease outbreaks. It also helps fund state and local public health departments and labs, which Benjamin said is extremely important as states struggle with massive budget deficits.

The CDC also subsidizes the cost of vaccines for uninsured and underinsured children. The prices of standard childhood vaccines are rising, Benjamin said. “The more vaccines we require kids to have, the less money we have to pay for it. If we discovered tomorrow a marvelous new vaccine, we probably wouldn’t have the resources to put that into place.”

• Medical research. U.S. investment in biomedical research is beginning to lag behind some other nations, namely China and India, at a time when robust funding could help with job creation, NIH Director Francis Collins said at a May hearing of the Senate Appropriations subcommittee on Labor, Health and Human Services and Education.

Collins said at the hearing that the BGI genome center in Shenzhen, China, “is capable of sequencing more than 10,000 human genomes a year. The capacity of that one Chinese institution now surpasses the combined capacity of all genome sequencing centers in the United States.”

“This critical area of scientific innovation stimulated by the U.S.-led Human Genome Project is now being developed more aggressively in China than it is here — a sobering story indeed and one that I hope would inspire our nation to redouble its efforts on the research front.”

Congress in recent years has given NIH small increases that haven’t kept pace with medical inflation, advocates claim. Funding actually declined in 2006. Lawmakers are still negotiating funding levels for fiscal year 2012, which began Oct. 1. House appropriators are considering a small increase in NIH funding, while their Senate counterparts are contemplating a small reduction.

Reductions in NIH funding “will lessen the chance of research breakthroughs in cancer. It will interrupt clinical trials at the National Cancer Institute,” said Dick Woodruff, vice president of federal relations and strategic alliances at the American Cancer Society’s Cancer Action Network.

• HIV/AIDS. About 500,000 HIV-infected people currently get help with expensive care and lifesaving medication through the Ryan White HIV/AIDS Program. Ronald Johnson, vice president of policy and advocacy at AIDS United, says that automatic cuts would be devastating.

Ryan White help is a last resort for many people who are low-income, uninsured or underinsured. On average, a year’s worth of medication costs about $15,000 to $20,000, and total care for an infected person can run about $100,000, according to Johnson.

He also fears cuts to federal funding that help states provide free or subsidized HIV testing. The Centers for Disease Control and Prevention sent $800 million to states in fiscal year 2011.

While the programs’ cost may be significant, they have decreased the spread of AIDS, said Johnson. “If a person gets on treatment early and adheres to it, that person on the whole is less infectious, so the chance of transmission is reduced significantly.”

• Disease prevention. Prevention funding in the health law is already under fire, by both Democrats and Republicans. Republicans have pushed to repeal the funding and President Barack Obama said recently that he would support decreasing it by $3.5 billion over 10 years.

The prevention fund has provided money for programs aimed at reducing obesity and tobacco use, among other public health priorities.

Reductions are short-sighted, said Jeffrey Levi, executive director of Trust for America’s Health. “The irony here is that there is so much focus on health care costs, yet there is significant evidence that the kind of prevention programs that the [health law] is supporting can have a positive impact on health care utilization and costs,” he said.

While the House and Senate appropriations committees would decide the initial 2013 funding levels for each agency and program, across-the-board cuts in sequestration would occur on top of the initial funding decisions and apply equally to all non-exempt, non-defense programs within an agency, Kogan said.

Many lobbyists, representing all sectors of the mammoth health care system, say they doubt that the committee of 12 lawmakers will be able to reach consensus on issues that have stumped Congress for decades, including overhauling the tax code and reining in fast-growing entitlement spending.

The committee’s deadline for action is Nov. 23, after which Congress would have until Dec. 23 to approve any deal.

The committee’s task is made even harder by a divided Congress, ongoing battles about federal health program funding for fiscal year 2012, and a presidential campaign season that is already in full swing. Whatever Congress cuts this year could be restored in whole or part in the future.

Benjamin says lawmakers should look for acceptable savings in the big spending Medicaid and Medicare programs. If they don’t, “There will be all kinds of unanticipated and unintended consequences” from automatic cuts, he said. “The tradeoff will be having to cut something that you really don’t want to cut.”

Marilyn Werber Serafini is the Kaiser Family Foundation’s Robin Toner Distinguished Fellow based at Kaiser Health News.  The fellowship honors the late Robin Toner, The New York Times’ long-time health and politics reporter whose work  often framed the public debate on health issues. KHN is an editorially independent program of the foundation.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.