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Uproar Over Fetal Tissue Affects ‘Under-The-Radar’ Lab

By JoNel Aleccia, The Seattle Times (TNS)

SEATTLE — As undercover videos released by anti-abortion activists roiled the nation this summer, sparking outrage directed at Planned Parenthood and re-igniting questions about the use of tissue from aborted fetuses, the Birth Defects Research Laboratory at the University of Washington quietly continued the work it has done for more than 50 years.

Since 1964, the Seattle lab has been a federally funded hub for the collection and distribution of tissues for research, obtained from miscarriages, stillbirths and abortions — including, recently, donations from a Planned Parenthood clinic in Washington state.

Few people outside of the scientific community realize that the lab exists, said Theresa Naluai-Cecchini, a research scientist at the site since 2011.

“We sort of fly under the radar,” she said.

But the tissues — fetal brain, liver, heart, kidney and other cells — long have been used at Seattle’s top science centers, as well as sites nationwide. Researchers at Fred Hutchinson Cancer Research Center, Seattle Children’s and the Allen Institute for Brain Science, among others, say the tissue has been crucial for local study of diseases and disorders as diverse as genetic heart defects, kidney malformations and macular degeneration.

In past decades, fetal cells were used to develop vaccines for diseases including polio, rubella and chickenpox, and they’re now being used in research of HIV, Alzheimer’s disease, autism, spinal cord injuries and other conditions.

“Our scientists learn so much from these fetuses,” said Stacey DiNuzzo, a spokeswoman for Seattle Children’s.

Local abortion foes say they’ve known for years about the UW lab and consistently have questioned the need to obtain the tissue.

“Obviously, we don’t object to research, but we do object to research from sources that we see as unethical,” said Dan Kennedy, chief executive at Human Life of Washington, the state affiliate of the group National Right to Life. “It is a gruesome, gruesome practice and we would urge all of those involved in it to get out of it.”

Fetal cells are prized for some research because they replicate rapidly and can adapt quickly to new uses. Federal law prohibits exchanging the tissues for profit, allowing fees to be charged only for costs such as transportation, processing and storage.

The UW lab, founded by Dr. Thomas Shepard, a pediatrician commonly regarded as the “grandfather of teratology,” or the study of birth defects, typically aims for a low profile. But controversy over covert videos released by the anti-abortion group the Center for Medical Progress, which prompted a congressional hearing last week, is having a chilling effect on the lab’s work, said Naluai-Cecchini.

In 2014, the lab collected 596 fetal samples from consenting women at two area hospitals and seven stand-alone clinics, and distributed 1,109 separate tissues to more than 60 researchers, Naluai-Cecchini said. The UW receives nearly $700,000 a year, including overhead costs, from the National Institutes of Health (NIH) to fund the lab, which has a repository of nearly 2,000 fetal samples from 370 individual donors.

Since July, when the videos surfaced purporting to show Planned Parenthood executives callously negotiating the sale of fetal parts, tissue donations have dropped dramatically, Naluai-Cecchini said.

“Most days, we have at least a single case to process,” she said. “Recently, we’ve had weeks where we’ve no tissue samples at all.”

The reason?

“I think that the women may hear that the clinics are profiting from the tissue,” she said.

The allegation had traction. Republican political leaders in several states called for investigations of Planned Parenthood’s practices. Cecile Richards, the organization’s national president, was summoned to testify before a congressional committee, where critics such as Rep. Jim Jordan, R-Ohio, called the videos “barbaric and repulsive” and accused the organization of seeking to make money from aborted babies.

Richards, however, said the videos were heavily edited to mischaracterize the organization and that Planned Parenthood facilities donate a small amount of fetal tissue nationwide and recover only processing expenses, as allowed by law.

That defense is echoed by Naluai-Cecchini, who said the UW lab charges researchers a flat fee of $200 a day to process and ship tissue. Last year the lab received a little less than $50,000 for those services.

“We don’t compensate the clinics for their tissue, and we don’t compensate the donors,” she said.

Fewer than 20 women agreed to donate tissue last year from among more than 3,000 who had abortions at centers run by Planned Parenthood of Greater Washington and Northern Idaho, according to spokeswoman Tanya Riordan. She declined to say which of the affiliate’s nine sites participated in tissue donation, out of fear that activists would attack the facilities, endangering patients and staff. The organization’s Pullman center was the target of arson last month.

Similarly, scientists at Seattle Children’s and Fred Hutch who use or have used fetal tissue in research declined to be identified individually, saying they fear they could be the subject of harassment — or worse.

But, through representatives, the scientists emphasized that the tissue is donated by consenting patients, including many who suffer miscarriages or who must end pregnancies because the fetuses have genetic defects or other problems.

Ed Lein, a researcher with the Allen Institute for Brain Science, said tissue from the UW lab was used in the reference atlas for BrainSpan, a unique resource that details the complete set of genes involved in brain development across the human life span.

“We recognize the extraordinary value of this precious resource,” he wrote in an email. “And our approach to creating high quality public data sets allows us to put important tools in the hand of thousands of researchers around the world.”

Naluai-Cecchini said she has personally worked with parents who find comfort in the idea of donating the tissue to help scientists find treatments or cures for the conditions that claimed their children.

“The couples desire something good to come out of their loss,” she said.

NIH expects to spend about $76 million on fetal tissue research this year, part of some $280 million allocated since 2011. But that’s a small fraction of the $581 million spent on human embryonic stem-cell research, and about $1.94 billion for adult stem-cell research in the same time period.

Some scientists say the need for fetal tissue research is waning, and that other techniques, such as using induced pluripotent stem cells or stem cells harvested from umbilical cords, offer more hope without the ethical problems of abortion.

Theresa Deisher, a Seattle molecular biologist who co-filed a 2010 lawsuit to shut down NIH support for embryonic stem-cell research, said the use of fetal tissue is “unnecessary — and it’s not useful.”

“Our research is dedicated to providing alternatives so that no one will feel compelled to work with that material,” said Deisher, president of Sound Choice Pharmaceutical Institute. She said she has worked with the Center for Medical Progress, the group responsible for the Planned Parenthood videos.

Researchers at Fred Hutch, however, said that in some cases — the environment of the fetal bone marrow, for instance — the cells can’t be replaced.

“In situations where other options are available, they are used, but fetal tissues have unique properties,” spokeswoman Rhonda Curry said in a statement on behalf of the scientists.

At the UW, Naluai-Cecchini said staffers hope the controversy wanes so that they can continue to concentrate on providing basic tools for research that may save lives.

“Every sample that comes through our doors is precious and valuable,” she said. “And they go to someone who wants to do something great.”

Photo: A Seattle research institution has been involved in fetal tissue research for decades. But due to videos attacking fetal tissue donation linked to Planned Parenthood, scientists at the organization are fearful that they will be targeted for harassment. Brendan Dolan-Gavitt/Flickr

Meninigitis Survivor Urges Wider Use Of Lifesaving Vaccine

By JoNel Aleccia, The Seattle Times (TNS)

SEATTLE — Carl Buher was a 14-year-old in Mount Vernon, Washington, in 2003, when the high school freshman was hit with a sudden illness: high fever, pounding headache, disorientation and purple splotches over his face and arms.

Within a day, he’d been diagnosed with bacterial meningitis, a rare and fast-moving infection, and flown by helicopter to Seattle Children’s Hospital for lifesaving antibiotics. Within weeks, he was sent to the intensive-care unit at Harborview Medical Center in Seattle. Within months, he had lost three fingers and both legs below the knee, amputations forced by the ravages of the disease.

A dozen years later, Buher is a 26-year-old Seattle civil engineer who nimbly navigates despite his missing fingers and prosthetic legs. He’s also a vocal advocate for a vaccine that could have prevented his infection in the first place.

“When I got sick, none of us had ever heard of meningitis before,” said Buher, who testified last winter before a panel at the Centers for Disease Control and Prevention in Atlanta. “People don’t know there’s a vaccine and that they should be vaccinating their kids.”

On Wednesday, the CDC’s Advisory Committee on Immunization Practices, which sets U.S. standards, is expected to decide whether a new vaccine to prevent meningitis strain B — the type Buher contracted — should get the nod for widespread use.

The question is whether the meningitis B vaccines used to halt recent college campus outbreaks in New Jersey, California and Oregon will be included among routinely recommended shots — as vaccines that target four other types of meningitis already are.

Bacterial meningitis is an infection that attacks the linings of the brain and spinal cord. It’s spread by close contact through respiratory secretions, such as kissing or sharing drinking glasses, which puts teens and young adults particularly at risk.

“We support the most broad-scale recommendations that the committee can do,” Buher said.

An estimated 30 to 40 infections and three to four deaths each year could be prevented if the panel were to vote for routine meningitis B vaccinations, surveillance data suggest.

But insiders say concerns about the relatively small number of young people affected by meningitis B infections — 50 to 60 cases a year — as well as questions about the lasting effectiveness of the vaccine, potential problems with delivering it and overall costs — could steer the committee toward a ruling that stops short of a wide advisory.

Instead, the group could recommend a “permissive” vaccination, said Dr. Paul Offit, a vaccine expert and the chief of the division of infectious diseases at Children’s Hospital of Philadelphia. That would allow doctors to deliver it and insurance companies to pay for it, but wouldn’t place it on the list of must-have shots on which parents rely.

“That’s my sense,” Offit said. The shots — which run $130 apiece and require two or three doses — would be included in the federal Vaccines for Children program, which provides vaccines at no cost to children whose families can’t afford to pay for them.

“I think the advocates would be happy that this is a very good start,” said Offit.

But to Buher and others, including the National Meningitis Association, it’s far less than they’ve been demanding.

Lynn Bozof, president of the association, lost her 20-year-old son, Evan, to meningitis in 1998. At that time, a vaccine to prevent the infection was used to protect U.S. military recruits, but wasn’t approved in the wider population.

“There was a vaccine available, and we didn’t know about it,” the Georgia mother said. “This will be the same thing: Why didn’t someone tell me? Why didn’t I know?”
Bozof said she fears that only motivated parents with well-informed doctors will understand the benefits of the vaccine — until it’s too late.

“For the average person, it is not going to be on their radar to be looking out for that vaccine,” she said.
Linda Dahlstrom Anderson, a Seattle mother whose 7-month-old son, Phoenix, died nearly a decade ago after a meningitis B infection, said such a lack of knowledge leaves an entire community at risk.

“They’re not statistics, they’re children,” said Dahlstrom Anderson, who also has an 8-year-old son she plans to protect against the disease. “Each one represents a whole universe of people. With Phoenix, it’s hundreds of people.”

The fight for wider use caps a long and contentious effort to make a meningitis B vaccine available in the U.S.

Since 2005, vaccines have been licensed in the U.S. to protect against four strains of meningitis: A, C, W-135 and Y. Since 2011, ACIP has recommended the routine use of the shots in kids ages 11 to 18, with booster doses at 16.

But until last year, no vaccine was licensed in the U.S. to prevent infections caused by strain B, the type linked to outbreaks that caused 13 infections, including a death, at Princeton University and the University of California, Santa Barbara, in 2013 and 2014. This year, seven people have been sickened by meningitis B at the University of Oregon, including one student who died.

Now, however, there are two vaccines approved by the Food and Drug Administration that target strain B: Trumenba, made by Pfizer, and Bexsero, originally made by Novartis. The CDC’s Advisory Committee on Immunization Practices currently recommends them for people aged 10 to 25 with underlying illness and during outbreaks — but not for the broader adolescent and young adult population.

Offit and Dr. William Schaffner, a Vanderbilt University infectious-disease expert, were both part of the CDC’s work group that studied the meningitis B vaccines.
“The work group has been remarkably studious and thorough,” Schaffner said. “They’ve looked rigorously at the morbidity and the mortality of the disease.”

The group has noted that all meningitis infections in the U.S. are at historic lows, with about 550 cases in 2013, down from a peak of about 3,800 cases in the late 1990s. Although individual illnesses and outbreaks are rare, they’re devastating to the communities — and the families — they strike.

The infections are caused by Neisseria meningitidis bacteria. When the bacteria infect the lining of the brain and spinal cord, it’s called meningitis. When the infection remains in the blood, it’s called meningococcemia. About 10 percent of people infected with the bacteria die, and an additional 20 percent are left disfigured, disabled or deaf, the CDC notes.

“For me, vaccination is not theoretical. It’s intensely personal,” Dahlstrom Anderson said. “When I think about vaccination, it comes down to that one little, sweet face.”

Neither Offit nor Schaffner could say for sure how the panel will vote, or even whether the scheduled vote was certain to occur. The group could decide to postpone a decision.

(c)2015 The Seattle Times. Distributed by Tribune Content Agency, LLC.

Photo: Meningitis B survivor Carl Buher battled a life-threatening infection in 2003, which resulted in the loss of three fingers and his legs below the knee. He recently testified in favor of widespread use of new vaccines to prevent the infection. (Sy Bean/Seattle Times/TNS)

Patch To Treat Peanut Allergies To Get Expedited FDA Review

By Jonel Aleccia, The Seattle Times (TNS)

SEATTLE — A medical skin patch tested by Seattle-area doctors and families to treat dangerous peanut allergies in children will receive accelerated regulatory review, officials said Thursday.

The Viaskin Peanut patch made by the French biotech firm DBV Technologies was granted a breakthrough therapy designation by the federal Food and Drug Administration.

That status is granted to expedite development and review of drugs or biological products that demonstrate substantial improvement over other therapies in treating serious or life-threatening diseases or conditions. Further study is pending before the FDA’s final review.

In the case of the Viaskin patch, it’s the first breakthrough designation aimed at a drug to treat food allergies, which affect about 15 million people in the U.S., company officials said.

The new status was based on the results of a recent Phase IIb multicenter clinical trial that showed that the immunotherapy patch boosted the amount of peanut protein it took to elicit an allergic reaction by at least tenfold, particularly in children younger than 12.

Dr. James Tilles, a physician partner at Northwest Asthma & Allergy Center in Seattle, oversaw the study in 11 area participants. He works with the Seattle Food Allergy Consortium, or SeaFAC, which works to bring allergy-related clinical trials to the area.

“To me, the significance is that the FDA is encouraged that there may be an approved treatment for peanut allergy in the near future and they don’t want to have logistical hurdles get in the way,” Tilles said.

The latest trial tested the safety and effectiveness of the adhesive patches infused with doses of 50 micrograms, 100 micrograms or 250 micrograms of peanut protein. The patches work by administering small amounts of peanut protein in the outer layers of the skin, activating an immune response, but without releasing antigens into the bloodstream, where they can trigger allergic shock.

It’s a new kind of treatment that potentially poses fewer challenges and dangers than allergy shots or oral immunotherapy, which are now available.

The 250-microgram patch was the most effective, the study found, with more than half the children ages six to eleven responding to the medication.

DBV Technologies is preparing to launch a Phase III clinical trial in children, the last step before the product will be submitted to the FDA for review.

If all goes well, the peanut patch could be commercially available by 2018, Tilles said.

Photo: U.S. Department Of Agriculture via Flickr

‘Superbug’ Outbreak Sparks Changes At Hospitals

By Jonel Aleccia, The Seattle Times (TNS)

SEATTLE — An outbreak of drug-resistant “superbug” infections may have sent officials at Virginia Mason Medical Center scrambling for solutions, but hospitals across Seattle — and beyond — say they’re stepping up surveillance and safety practices, too.

No infections tied to contaminated medical scopes have been detected at Swedish Medical Center, but Dr. John Pauk, the hospital’s medical director of infection control, is taking no chances.

Last month, Swedish started performing daily cultures on the specialized endoscopes used for the procedure identified in the Virginia Mason outbreak, plus at least seven other similar outbreaks nationwide.

“Luckily, so far, we haven’t seen anything,” said Pauk. “But I don’t think any hospital system could fairly say there isn’t a potential problem with their scopes.”

They’re testing for multidrug-resistant bacteria that could stick to the devices, even after recommended cleaning, and spread from one patient to another, potentially causing dangerous infections, Pauk said. The Virginia Mason outbreak infected 32 people, including 11 who died, though it’s not clear whether the superbug played a role.

Officials at Harborview Medical Center, the University of Washington Medical Center, Providence Everett and the Veterans Affairs Puget Sound Health Care System say they’ve also recently begun testing the scopes.

“It’s kind of been on people’s radar screens, but the scope of the problem was not totally understood,” Pauk said.

Then came recent reports of the superbug in Seattle, Los Angeles and Hartford, Conn., in addition to previous outbreaks in Pennsylvania, Illinois and Florida. Those have echoed reports dating to the early 1980s of potential cross-contamination spread by the scopes.

The trouble, critics say, is the design of the devices, known as duodenoscopes, used for ERCP, or endoscopic retrograde cholangiopancreatography, a procedure that snakes a scope down the throat and into the gut to diagnose and treat problems with the pancreatic and biliary ducts. A channel on the end of the scope that is used to hold and move tools has intricate crevices that can trap bacteria.

The scope is different from those used to perform colonoscopies, hospital officials emphasize.

The Food and Drug Administration (FDA) warned last month that transmission of infections may occur even after meticulous cleaning of devices. In the U.S., the scopes are made by three manufacturers: Olympus America, Pentax Medical and Fujinon, though Olympus has the largest market share. But the agency has not called for a recall or redesign of the devices.

Swedish performs about 1,000 ERCP procedures a year, placing it second in local volume only to Virginia Mason, which logs about 1,800 procedures annually. UW Medical Center performs about 500 ERCPs each year, Providence Everett performs about 250 and Harborview about 200. VA Puget Sound performed 89 procedures in Seattle in 2014.

Nationwide, more than 500,000 people undergo ERCPs each year. The procedure can be lifesaving, which has made FDA officials reluctant to pull devices from the market, they said.

Pauk said Swedish officials took their cue from Virginia Mason, which launched a test-and-hold policy that quarantines the ERCP scopes until they’re free of dangerous bacteria. It’s a method recommended in a pending protocol being developed by the Centers for Disease Control and Prevention and in new guidelines just published by the ECRI Institute, a respected patient safety advocacy agency.

The most worrisome bug is CRE, or carbapenem-resistant Enterobacteriaceae, a family of germs resistant to nearly all top-gun antibiotics available to treat them. They can cause infections with a mortality rate as high as 50 percent.

“The reality is, as we look at this, more and more hospitals are going to encounter this bug,” said Chris Lavanchy, engineering director in the health devices group at ECRI Institute.

But Virginia Mason’s outbreak was caused by different kinds of multidrug-resistant bacteria, including hyper-AmpC-producing E. coli. And an outbreak at Hartford Hospital in Connecticut was caused by a strain of ESBL, or extended-spectrum beta-lactamase, E. coli.

From a patient’s standpoint, the new surveillance in Seattle and elsewhere is good news, said Lawrence Muscarella, a patient safety expert who has been tracking infections tied to dirty endoscopes for years.

Before they agree to ERCP procedures, patients should ask several specific questions, he said.

“You can ask: Did you have any CRE or related superbug infections within the last two years? Were any linked to endoscopes? What are you doing to ensure my safety?” Muscarella said, adding:

“Before, patients never knew what questions to ask, so hospitals never had to answer.”

(c)2015 The Seattle Times, Distributed by Tribune Content Agency, LLC

Image via NIAID