The U.S. Food and Drug Administration approved the new weight loss pill Qsymia on Tuesday, adding to a very skimpy arsenal of drugs Americans can take to battle severe obesity -- and adding a last-minute name change after two years of wrangling over whether to approve the drug.
Qsymia (pronounced kew-SIM-ee-ah) pairs an old stimulant drug with an epilepsy drug to try and bring some options to the two-thirds of Americans who are overweight or obese -- and who have higher rates of heart disease, diabetes, stroke and cancer as a result.
“Obesity threatens the overall wellbeing of patients and is a major public health concern,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
It’s the second obesity drug to win FDA approval this summer. Last month, the agency OK'd Belviq, the first new weight loss drug approved in 13 years. Qsymia combines phentermine, a stimulant, with the anti-seizure drug topiramate.
The FDA took its time in reviewing Qsymia, formerly known as Qnexa, because of fears about the side-effects, which can include a fast heart rate and metabolic acidosis, a condition marked by highly acidic blood that can, in severe cases, put people into a coma and even kill them. Metabolic acidosis can also cause kidney stones and damage bones. There’s been a growing debate over whether it’s worth the risk of taking drugs that could damage the heart to battle the growing obesity epidemic.
Diet drugs have a sketchy history in the U.S. and the FDA worries about irresponsible doctors who dispense pills from their offices to just about all comers, whether they’re in the group that’s supposed to get the drug or not. The FDA approves drugs for certain uses in certain people, but once a drug is approved, a licensed doctor may prescribe it as he or she sees fit.
Vivus, the company that makes the drug, has said it’s aware of this and has said it would restrict who can prescribe Qsymia and how. The once-a-day pill will be available only through mail order so that doctors cannot dispense it from their offices. The company also plans to educate doctors about the drug's risks, which include birth defects, and to carefully watch users for any signs of heart damage.
The agency asked for a last-minute name change from Qnexa, however. "The FDA indicated concern about potential confusion regarding the name Qnexa and worked with Vivus during the final steps of the review process to identify Qsymia as an acceptable brand name," Vivus's Dr. Barbara Troupin said in a statement.
Qsymia is approved for use in obese adults, those with a body mass index of 30 or greater, and overweight adults, those with BMI of 27 or greater, who have at least one weight-related condition such as high-blood pressure, type 2 diabetes or high cholesterol.
This doesn’t calm the fears of Dr. Michael Lauer, a cardiologist at the National Institutes of Health who was on the panel of experts that advised the FDA about the drug. Lauer and one other panelist voted against approval, but 20 panelists endorsed the drug in February.
"I believe that if the public were to 'buy' (Qsymia) after FDA approval, it would run the risk of severe, even fatal, consequences from another diet lemon," Lauer writes in Tuesday's issue of the Annals of Internal Medicine.
“If we think about the history of obesity medications, we've seen plenty of lemons. Ephedra, fen-phen, phenylpropanolamine, and sibutramine had to be withdrawn from the market because of cardiovascular toxicity. Rimonabant was approved for sale in Europe, but was never approved in the United States because of severe psychiatric side effects,” he added.
Lauer is not the only opponent. Public Citizen, a consumer group, has been campaigning against the drug, too.
"As was the case for the diet drug lorcaserin (Belviq), approved last month despite concerns about heart valve damage, it was also reckless of the Food and Drug Administration to approve Qnexa. Research shows the medication increases heart rate, and four patients on the diet pill had non-fatal heart attacks during the clinical trials, while none of those on the placebo had heart attacks," Public Citizen's Dr. Sidney Wolfe said in a statement.
"It is magical and delusional thinking for anyone to believe that a drug will turn off hunger without hitting other targets where it will do harm, usually to the cardiovascular system."
Vivus hopes it will be a safer successor to the notorious and now banned “fen-phen” diet cocktail. Fen-phen combined fenfluramine and phentermine -- one of the two drugs in Qsymia -- but it damaged the heart in some cases and caused a condition in some patients called pulmonary hypertension, which causes fluid to build up in the chest, bringing a feeling of breathlessness.
Reviewers say the amount of the drug phentermine in Qsymia is safer. The two drugs together seem to lower appetite while keeping patients perky. Lauer said he would have liked to see more tests to specifically look for heart problems before the FDA approves the drug.
Doctors tested the pill in more than 4,430 overweight and obese patients. About half lost 10 percent of their weight -- enough to lower cholesterol and blood pressure, reduce the risk of diabetes and early death.
The drug, which suppresses appetite, is available to severely overweight patients with related medical problems. NBC's Tom Costello reports.
On Nov. 7, 2006, Mary Kelly went for a routine pregnancy ultrasound. Three days later, she and her unborn daughter had become pioneers.
Kelly and her daughter, Addison, now 5 years old, were the second mother and child to undergo a fetal surgery procedure where doctors removed a tumor between the heart and lungs that was causing heart failure and fetal hydrops — a condition where Addison was taking on so much fluid that she would not likely survive.
Over those three days, Kelly underwent tests and met with doctors to discuss her options. With her pregnancy only 26 weeks along, those options included monitoring the pregnancy and waiting, or inducing labor — and in both of those cases, the baby would likely die.
Courtesy: Kelly Familly
The Kelly Family today. Addison, second from left, is now 5.
Kelly and her husband opted for a third choice, fetal surgery, which gave their daughter a 50 percent chance of surviving. The surgeons planned to place the fetus back in Kelly's uterus, to allow her to develop for 10 more weeks before delivery, Kelly said.
"But that's not how it went," Kelly said.
While the surgery was successful, a few days later, Mary Kelly went into preterm labor. Addison Hope Kelly was born almost three months premature.
Although Addison faced a multitude of challenges in her young life, and did not even come home from the hospital until she was almost a year old, she will begin kindergarten this fall.
"You look at her, and you would not know she went through any of this," Mary Kelly told MyHealthNewsDaily. Addison needs ongoing observation and requires a machine to ensure she keeps breathing at night, but she has "nothing terrible, which is truly amazing," Kelly said.
Addison's survival and the challenges she has faced represent both the promise of fetal surgery, and the ways it has to go.
The tiniest patients The first ever open-fetal surgery was performed in 1981, at the University of California, San Francisco (UCSF), to correct an obstructed bladder.
Today, about 150 fetal surgeries are performed yearly at The Children's Hospital of Philadelphia (CHOP), where Kelly was treated and which has the largest volume of these surgeries in the nation, said Dr. Scott Adzick, the surgeon-in-chief.
Adzick was among the researchers who contributed to the development of fetal surgery in the 1980s. Since then, fetal surgeons have removed tumors, repaired holes in the diaphragm affecting lung development and treated conditions that threaten twin pregnancies.
"The most successful surgeries have had to do with treatment of twins that share blood through a common placenta in an uneven fashion," said Dr. Ruben Quintero, director of the Fetal Therapy Center at Jackson Memorial Hospital in Florida.
Quintero performs only minimally invasive, endoscopic surgeries, and has developed techniques for the procedures, which involve making a quarter-inch incision while a woman is typically under local anesthesia. These procedures reduce the risks of open procedures, which are more likely to bring infections, and the side effects of general anesthesia, which can include nausea, vomiting and not waking up.
Because of these risks, there is a limit to when fetal surgery should be done.
"The surgeries that are done in utero are justified only when the life of the fetus is at risk if surgery is not undertaken, or where severe damage to the fetus can occur if surgery is not undertaken," Quintero said.
He noted, however, that it can also be justified for conditions that carry serious or long-term health consequences, such as the surgeries some centers perform to treat spina bifida, a condition where the spine is left partly exposed.
"Although [spina bifida] typically is not a lethal condition, it may result in significant complications and surgeries after birth," he said.
Last year Adzick, along with colleagues at UCSF and Vanderbilt University, published a study that compared repairing myelomeningocele — the most severe form of spina bifida — while the babies were in the womb, to the traditional approach of repairing after birth.
While the results showed that mothers and children faced risks from the surgery, the trial was halted early because it overwhelmingly showed that fetal surgery produced better outcomes than repair after birth.
The future of fetal surgery Efforts under way in fetal surgery involve using less invasive or earlier treatments. One hope is that procedures done today for fetuses who are twentysome weeks old could be done sooner, with greater benefit.
Dr. Alan Flake, director of CHOP’s Center for Fetal Research, is working with stem cells from adult bone marrow to develop a treatment for the blood disorder sickle-cell anemia that could be administered 12 to 14 weeks into pregnancy. Clinical trials of the therapy should begin in a year or two.
Finally, Adzick said more work is being done for spina bifida. A tissue-engineering technique could be used to protect the spinal cord opening, essentially working as a "band-aid" early on in pregnancy, with repair being done after birth.
But that research needs more rigorous lab testing before being applied to patients.
While fetal surgery has had some dramatic successes, it is not without risks, which can include infection from the surgery, preterm birth or death for the mother or fetus.
That's why part of all lines of fetal surgery research include asking, "Can that be done with tissue engineering, can that be done in some other way that's not a fetal surgery?" said Lori Howell, executive director of CHOP's Center for Fetal Diagnosis and Treatment.
When fetal surgeries began, Howell said, other physicians were skeptical that opening up a pregnant woman to operate on the baby was necessary or advisable.
With the improvements coming in the field, the hope is that someday, many of the operations needed today won't be.
On Feb. 24, Ukrainian authorities made an alarming discovery: bones and other human tissues crammed into coolers in a grimy white minibus.
Investigators grew even more intrigued when they found, amid the body parts, envelopes stuffed with cash and autopsy results written in English.
What the security service had disrupted was not the work of a serial killer but part of an international pipeline of ingredients for medical and dental products that are routinely implanted into people around the world.
The seized documents suggested that the remains of dead Ukrainians were destined for a factory in Germany belonging to the subsidiary of a U.S. medical products company, Florida-based RTI Biologics.
RTI is one of a growing industry of companies that make profits by turning mortal remains into everything from dental implants to bladder slings to wrinkle cures.
The industry has flourished even as its practices have roused concerns about how tissues are obtained and how well grieving families and transplant patients are informed about the realities and risks of the business.
In the U.S. alone, the biggest market and the biggest supplier, an estimated two million products derived from human tissue are sold each year, a figure that has doubled over the past decade.
It is an industry that promotes treatments and products that literally allow the blind to see (through cornea transplants) and the lame to walk (by recycling tendons and ligaments for use in knee repairs). It's also an industry fueled by powerful appetites for bottom-line profits and fresh human bodies.
The business of recycling dead humans into medical implants is a little-known yet lucrative trade. The International Consortium of Investigative Journalists (ICIJ) discovered allegations of wrongdoing over the procurement of some of the raw materials used in the products. Find out more: www.icij.org/tissue.
In the Ukraine, for example, the security service believes that bodies passing through a morgue in the Nikolaev district, the gritty shipbuilding region located near the Black Sea, may have been feeding the trade, leaving behind what investigators described as potentially dozens of “human sock puppets” — corpses stripped of their reusable parts.
Industry officials argue that such alleged abuses are rare, and that the industry operates safely and responsibly.
For its part, RTI didn’t respond to repeated requests for comment or to a detailed list of questions provided a month before this publication.
In public statements the company says it “honors the gift of tissue donation by treating the tissue with respect, by finding new ways to use the tissue to help patients and by helping as many patients as possible from each donation.”
‘Our Misfortune' Despite its growth, the tissue trade has largely escaped public scrutiny. This is thanks in part to less-than-aggressive official oversight — and to popular appeal for the idea of allowing the dead to help the living survive and thrive.
An eight-month, 11-country investigation by the International Consortium of Investigative Journalists () has found, however, that the tissue industry’s good intentions sometimes are in conflict with the rush to make money from the dead.
Inadequate safeguards are in place to ensure all tissue used by the industry is obtained legally and ethically, ICIJ discovered from hundreds of interviews and thousands of pages of public documents obtained through records requests in six countries.
Despite concerns by doctors that the lightly regulated trade could allow diseased tissues to infect transplant recipients with hepatitis, HIV and other pathogens, authorities have done little to deal with the risks.
In contrast to tightly-monitored systems for tracking intact organs such as hearts and lungs, authorities in the U.S. and many other countries have no way to accurately trace where recycled skin and other tissues come from and where they go.
At the same time, critics say, the tissue-donation system can deepen the pain of grieving families, keeping them in the dark or misleading them about what will happen to the bodies of their loved ones.
Those left behind, like the parents of 19-year-old Ukrainian Sergei Malish, who committed suicide in 2008, are left to cope with a grim reality.
At Sergei’s funeral, his parents discovered deep cuts on his wrists. Yet they knew he had hanged himself.
They later learned that his body parts had been recycled and shipped off as “anatomical material.”
“They make money with our misfortune,” Sergei’s father said.
Awkward silence During the transformational journey tissue undergoes — from dead human to medical device — some patients don’t even know that they are the final destination.
Doctors don’t always tell them that the products used in their breast reconstructions, penis implants and other procedures were reclaimed from the recently departed.
Nor are authorities always aware of where tissues come from or where they go.
The lack of proper tracking means that by the time problems are discovered some of the manufactured goods can’t be found. When the U.S. Centers for Disease Control and Prevention assists in the recall of products made from potentially tainted tissues, transplant doctors frequently aren’t much help.
“Oftentimes there’s an awkward silence. They say: ‘We don’t know where it went,’” said Dr. Matthew Kuehnert, the CDC’s director of blood and biologics.
“We have barcodes for our cereals" at breakfast, "but we don’t have barcodes for our human tissues," Kuehnert said. "Every patient who has tissue implanted should know. It’s so obvious. It should be a basic patient right. It is not. That’s ridiculous.”
Since 2002 the U.S. Food and Drug Administration has documented at least 1,352 infections in the U.S. that followed human tissue transplants, according to an ICIJ analysis of FDA data. These infections were linked to the deaths of 40 people, the data shows.
One of the weaknesses of the tissue-monitoring system is the secrecy and complexity that come with the cross-border exchange of body parts.
The Slovaks export cadaver parts to the Germans; the Germans export finished products to South Korea and the U.S.; the South Koreans to Mexico; the U.S. to more than 30 countries.
Distributors of manufactured products can be found in the European Union, China, Canada, Thailand, India, South Africa, Brazil, Australia and New Zealand. Some are subsidiaries of multinational medical corporations.
The international nature of the industry, critics claim, makes it easy to move products from place to place without much scrutiny.
“If I buy something from Rwanda, then put a Belgian label on it, I can import it into the U.S. When you enter into the official system, everyone is so trusting,” said Dr. Martin Zizi, professor of neurophysiology at the Free University of Brussels.
Once a product is in the European Union, it can be shipped to the U.S. with few questions asked.
“They assume you’ve done the quality check," Zizi said. "We are more careful with fruit and vegetables than with body parts.”
Piece of the action Inside the marketplace for human tissue, the opportunities for profits are immense. A single, disease-free body can spin off cash flows of $80,000 to $200,000 for the various non-profit and for-profit players involved in recovering tissues and using them to manufacture medical and dental products, according to documents and experts in the field.
It’s illegal in the U.S., as in most other countries, to buy or sell human tissue. However, it’s permissible to pay service fees that ostensibly cover the costs of finding, storing and processing human tissues.
Almost everyone gets a piece of the action.
Ground-level body wranglers in the U.S. can get as much as $10,000 for each corpse they secure through their contacts at hospitals, mortuaries and morgues. Funeral homes can act as middlemen to identify potential donors. Public hospitals can get paid for the use of tissue-recovery rooms.
And medical products multinationals like RTI? They do well, too. Last year RTI earned $11.6 million in pretax profits on revenues of $169 million.
Phillip Guyett, who ran a tissue recovery business in several U.S. states before he was convicted of falsifying death records, said executives with companies that bought tissues from him treated him to $400 meals and swanky hotel stays. They promised: “We can make you a rich man.” It got to the point, he said, that he began looking at the dead “with dollar signs attached to their parts.” Guyett never worked directly for RTI.
Smoked salmon Human skin takes on the color of smoked salmon when it is professionally removed in rectangular shapes from a cadaver. A good yield is about six square feet.
After being mashed up to remove moisture, some is destined to protect burn victims from life-threatening bacterial infections or, once further refined, for breast reconstructions after cancer.
The use of human tissue “has really revolutionized what we can do in breast reconstruction surgery,” explains Dr. Ron Israeli, a plastic surgeon in Great Neck, N.Y.
“Since we started using it in about 2005, it’s really become a standard technique.”
A significant number of recovered tissues are transformed into products whose shelf names give little clue to their actual origin.
They are used in the dental and beauty industries, for everything from plumping up lips to smoothing out wrinkles.
Cadaver bone — harvested from the dead and replaced with PVC piping for burial — is sculpted like pieces of hardwood into screws and anchors for dozens of orthopedic and dental applications.
Or the bone is ground down and mixed with chemicals to form strong surgical glues that are advertised as being better than the artificial variety.
“At the basic level what we are doing to the body, it’s a very physical — and I imagine some would say a very grotesque — thing,” said Chris Truitt, a former RTI employee in Wisconsin.
“We are pulling out arm bones. We are pulling out leg bones. We are cutting the chest open to pull the heart out to get at the valves. We are pulling veins out from the inside of skin.”
Whole tendons, scrubbed cleaned and rendered safe for transplant, are used to return injured athletes to the field of play.
There’s also a brisk trade in corneas, both within countries and internationally.
Because of the ban on selling the tissue itself, the U.S. companies that first commercialized the trade adopted the same methods as the blood collection business.
The for-profit companies set up non-profit offshoots to collect the tissue — in much the same way the Red Cross collects blood that’s later turned into products by commercial entities.
Nobody charges for the tissue itself, which under normal circumstances is freely donated by the dead (via donor registries) or by their families.
Rather, tissue banks and other organizations involved in the process receive ill-defined “reasonable payments” to compensate them for obtaining and handling the tissue.
“The common lingo is to talk about procurement from donors as ‘harvesting,’ and the subsequent transfers via the bone bank as ‘buying’ and ‘selling,’ ” wrote Klaus Høyer, from the University of Copenhagen’s Department of Public Health, who talked to industry officials, donors and recipients for an article published in the journal BioSocieties.
“These expressions were used freely in interviews; however, I did not hear this terminology used in front of patients.”
A U.S.-government funded study of the families of U.S. tissue donors, published in 2010, indicates many may not understand the role that for-profit companies play in the tissue donation system.
Seventy-three percent of families who took part in the study said it was “not acceptable for donated tissue to be bought and sold, for any purpose.”
Few protections There is an inherent risk in transplanting human tissues. Among other things, it has led to life-threatening bacterial infections, and the spread of HIV, Hepatitis C and rabies in tissue recipients, according to the CDC.
Modern blood and organ collection is bar-coded and strongly regulated — reforms prompted by high-profile disasters that had been caused by the poor screening of donors. Products made from skin and other tissues, however, have few specific laws of their own.
In the U.S., the agency that regulates the industry is the Food and Drug Administration, the same agency that’s charged with protecting the nation’s food supply, medicines and cosmetics.
The FDA, which declined repeated requests for on-record interviews, has no authority over health care facilities that implant the material. And the agency doesn’t specifically track infections.
It does keep track of registered tissue banks, and sometimes conducts an inspection. It also has the power to shut them down.
The FDA largely relies on standards that are set by an industry body, the American Association of Tissue Banks (AATB). The association refused repeated requests over four months for on-record interviews. It told ICIJ during a background interview last week that the "vast majority" of banks recovering traditional tissues such as skin and bone are accredited by the AATB. Yet an analysis of AATB accredited banks and FDA registration data shows about one third of tissue banks that recover traditional tissues such as skin and bone are accredited by the AATB.
The association says the chance of contamination in patients is low. Most products, the AATB says, undergo radiation and sterilization, rendering them safer than, say, organs that are transplanted into another human.
"Tissue is safe. It's incredibly safe," an AATB executive said.
There is little data, though, to back up the industry’s claims.
Unlike with other biologics regulated by the FDA, agency officials explain, firms that make medical products out of human tissues are required to report only the most serious adverse events they discover. That means that if problems do arise, there’s no guarantee that authorities are told.
And because doctors aren’t required to tell patients they’re getting tissue from a cadaver, many patients may not associate any later infection with the transplant.
On this point, the industry says it is able to track the products from the donors to the doctors, using their own coding systems, and that many hospitals have systems in place to track the tissues after they’re implanted.
But no centralized regional or global system assures products can be followed from donor to patient.
“Probably very few people get infected, but we really don’t know because we don’t have surveillance and we don’t have a system for detecting adverse events,” the CDC’s Kuehnert said.
The FDA recalled more than 60,000 tissue-derived products between 1994 and mid-2007.
The most famous recall came in 2005. It involved a company called Biomedical Tissue Services, which was run by a former dental surgeon, Michael Mastromarino.
Mastromarino got many of his raw materials from undertakers in New York and Pennsylvania. He paid them up to $1,000 per body, court records show.
His company stripped bodies of their bones, skin and other usable parts, then returned them to their families. The families, ignorant of what happened, buried or cremated the evidence.
One of more than 1,000 bodies that were dismembered was that of the famous BBC broadcaster and Masterpiece Theatre host Alistair Cooke.
Products made from the stolen human remains were shipped to Canada, Turkey, South Korea, Switzerland and Australia. More than 800 of those products have never been located.
It later came out in court that some of the tissue donors had died from cancer and that none had been tested for pathogens like HIV and hepatitis.
Mastromarino falsified donor forms, lying about causes of death and other details. He sold skin and other tissues to several U.S. tissue-processing firms, including RTI.
“From day one, everything was forged; everything, because we could. As long as the paperwork looked good, it was fine,” said Mastromarino, who is serving a 25-to-58-year prison sentence for conspiracy, theft and abuse of a corpse.
Global sheriff Each country has its own set of regulations for the use of products made from human tissue, often based on laws that were originally intended to deal with blood or organs.
In practice, though, because the U.S. supplies an estimated two-thirds of the world’s human-tissue-product needs, the FDA has effectively been left to act as sheriff for much of the planet.
Foreign tissue establishments that wish to export products to the U.S. are required to register with the FDA.
Yet of the 340 foreign tissue establishments registered with the FDA, only about 7 percent have an inspection record in the FDA database, an ICIJ analysis shows. The FDA has never shut one down due to concern over illicit activities.
The data also shows that about 35 percent of active registered U.S. tissue banks have no inspection record in the FDA database.
“When the FDA registers you, all you have to do is fill out a form and wait for an inspection,” said Dr. Duke Kasprisin, the medical director for seven U.S. tissue banks. “For the first year or two you can function without having anyone look at you.”
This is backed by the data, which show the typical tissue bank operates for nearly two years before its first FDA inspection.
“The problem is there is no oversight. The FDA, all they require is that you have a registration,” said Craig Allred, an attorney previously involved in litigation against the industry. “Nobody is watching what is going on.” The FDA and industry players “all point the finger at each other.”
Yet in South Korea, for example, the booming plastic surgery market uses FDA oversight as a selling point.
In downtown Seoul, the country’s capital, Tiara Plastic Surgery explains that human tissue products “are FDA-approved” and are therefore safe.
Some medical centers advertise “FDA-approved AlloDerm” — a skin graft made from donated American cadavers — for nose enhancement.
Le Do-han, the official in charge of human tissue for the South Korean FDA, said the country imports 90 percent of its human-tissue needs.
Raw tissue is shipped in from the U.S. and Germany. This tissue, once processed, is often re-exported to Mexico as manufactured goods.
Despite the complicated movements back and forth, Le Do-han acknowledges that proper tracking hasn’t been put in place.
“It is like putting tags on beef, but I don’t even know if that is possible for human tissues because there are so many coming in.”
Teaming up In its U.S. Securities and Exchange Commission filings, publicly traded RTI provides a glimpse of the company’s size and global reach.
In 2011, the company manufactured 500,000 to 600,000 implants and launched 19 new kinds of implants in sports medicine, orthopedics and other areas. Ninety percent of the company’s implants are made from human tissue, while 10 percent come from cows and pigs processed at its German facility.
RTI requires its human body parts suppliers in the U.S. and other nations to follow FDA regulations, but the company acknowledges there are no guarantees.
In 2011 securities filings, RTI said there “can be no assurances” that “our tissue suppliers will comply with such regulations intended to prevent communicable disease transmission” or “even if such compliance is achieved, that our implants have not been or will not be associated with transmission of disease.”
Like many of today’s for-profit tissue companies that were once non-profits, RTI broke away from the non-profit University of Florida Tissue Bank in 1998.
Internal company files from Tutogen, a Germany medical products company, show that RTI teamed up with Tutogen as early as September 1999 to help both companies meet their growing needs for raw material by obtaining human tissue from Eastern Europe.
The companies both obtained tissue from the Czech Republic. Tutogen separately obtained tissues from Estonia, Hungary, Russia, Latvia, Ukraine, and later Slovakia, documents show.
In 2002, allegations surfaced in the Czech media that the local supplier to RTI and Tutogen was obtaining some tissues there improperly. Though there is no suggestion that Tutogen or RTI or its employees did anything improper.
In March 2003, police in Latvia investigated whether Tutogen’s local supplier had removed tissue from about 400 bodies at a state forensic medical institute without proper consent.
Wood and fabrics, replacing muscle and bone, were put into the deceased to make it look like they were untouched before burial, local media reported.
Police eventually charged three employees of the supplier, but later dismissed the charges when a court ruled that no consent from donors’ families was necessary. Again, there was no suggestion Tutogen acted improperly.
In 2005, Ukrainian police launched the first of a series of investigations into the activities of Tutogen’s suppliers in that country. The initial investigation did not lead to criminal charges.
The relationship between Tutogen and RTI, meanwhile, became even closer in late 2007, when they announced a merger between the two companies. Tutogen became a subsidiary of RTI in early 2008.
Officials at RTI declined to answer questions from ICIJ about whether it knew about police investigations of Tutogen’s suppliers.
Two ribs In 2008 Ukrainian police launched a new investigation, looking into allegations that more than 1,000 tissues a month were being illegally recovered at a forensic medical institute at Krivoy Rog and sent, via a third party, to Tutogen. Joseph Düsel, the Chief Prosecutor in Bamberg, said in 2009 that "what the company is doing is approved by the administrative authority by which it is also monitored. We do not currently see any reason to initiate investigation proceedings."
Nataliya Grishenko, the judge prosecuting the case, revealed during subsequent court proceedings that many relatives claimed they’d been tricked into signing consent forms or that their signatures had been forged.
However, the main suspect in the case — a Ukrainian doctor — died before the court could deliver a verdict. The case died with him.
Tutogen “operates under very strict regulations from German and Ukrainian authorities as well as other European and American regulatory authorities,” the company said in a statement while the case was still pending. “They have been inspected regularly by all of these authorities over their many years of operation, and Tutogen remains in good standing with all of them.”
Seventeen of Tutogen’s Ukrainian suppliers have undergone an FDA inspection. The inspections are announced, according to protocol, six to eight weeks in advance.
Only one — BioImplant in Kiev — received negative feedback. Among the findings of the 2009 inspection: not all morgues could rely on hot running water and some sanitation procedures were not followed.
FDA inspectors also identified deficiencies with RTI's Ukrainian imports when it visited the company's facilities in Florida.
RTI had English translations, but not original autopsy reports, from its Ukrainian donors, FDA inspectors found during a 2010 audit. Those were often the only medical documents the company used to determine whether the donor was healthy, inspectors noted in their report.
The company told inspectors it was illegal under Ukrainian law to copy the report. But following the inspection it began maintaining the original Russian-language document along with its English translation.
In 2010 and 2011, FDA inspectors asked RTI to change how it labeled its imports. The company was obtaining Ukrainian tissue, shipping it to Tutogen in Germany, then exporting it to the U.S. as a product of Germany.
While the company agreed to change its policies, there is some indication that it may have continued labeling some Ukrainian tissue as German.
This past February police launched a raid as officials at a regional forensic bureau in Nikolaev Oblast were loading harvested human tissues into the back of a white minibus. Police footage of the seizure shows tissue labeled "Tutogen. Made in Germany."
In this case, the security service said forensic officials had tricked relatives of the dead patients into agreeing to what they thought was a small amount of tissue harvesting by playing on their pain and grief.
Seized documents — blood tests, an autopsy report and labels written in English and obtained by ICIJ — suggested the remains were on their way to Tutogen.
Some of the tissue fragments found on the bus came from 35-year-old Oleksandr Frolov, who had died from an epileptic seizure.
“On the way to the cemetery, when we were in the hearse, one of his feet — we noticed that one of the shoes slipped off his foot, which seemed to be hanging loose,” his mother, Lubov Frolova, told ICIJ.
“When my daughter-in-law touched it, she said that his foot was empty.”
Later, the police showed her a list of what had been taken from her son’s body.
“Two ribs, two Achilles heels, two elbows, two eardrums, two teeth, and so on. I couldn’t read it till the end, as I felt sick. I couldn’t read it,” she said.
“I heard that" the tissues "were shipped to Germany to be used for the plastic surgeries and also for donation. I have nothing against donation, but it should be done according to the law.”
Kateryna Rahulina, whose 52-year-old mother, Olha Dynnyk, died in September 2011, was shown documents by investigating police. The documents purported to give her approval for tissue to be taken from her mother’s body.
“I was in shock,” Rahulina said. She never signed the papers, she said, and it was clear to her that someone had forged her approval.
The forensic bureau in Nikolaev Oblast, where the alleged incidents happened, was, until recently, one of 20 Ukrainian tissue banks registered by the FDA.
On the FDA’s website the phone number for each of the tissue banks is the same.
It is Tutogen’s phone number in Germany.
Contributors to this story: Mar Cabra, Alexenia Dimitrova and Nari Kim.
Small children may be suffering the effects of the home foreclosure crisis in a serious way, researchers reported on Monday. They found a troubling increase in the number of young children with physical abuse showing up in hospital emergency rooms.
The researchers found just under a 1 percent increase in the number of general physical abuse cases reported at 38 pediatric hospitals every year between 2000 and 2009 and a more than 3 percent rise in the number of traumatic brain injuries seen in babies.
These increased rates seemed to directly correlate with the rate of mortgage foreclosures in a community, Dr. Joanne Wood of the Children’s Hospital of Philadelphia and colleagues reported in the journal Pediatrics. There might be something uniquely stressful about losing a home that can lead to child abuse, they suggested.
“It’s well known that economic stress has been linked to an increase in child physical abuse, so we wanted to get to the bottom of the contrasting reports by formally studying hospital data on a larger scale,” Wood said in a statement.
They found that each 1 percent increase in mortgage delinquencies correlated with a 3 percent increase in the number of children 6 and under hospitalized every year for suspected physical abuse and a 5 percent increase in admissions due to traumatic brain injury from abuse.
“As the foreclosure crisis is projected to continue in the near future, these results highlight the need to better understand the stress that housing insecurity places on families and communities so that we can better support them during difficult times,” Wood said.
They said their findings need more study to confirm them, especially because they contradict other data showing child abuse rates are down overall nationwide. It might be important to pinpoint communities that are particularly affected and help those parents cope, said Dr. David Rubin, a pediatrician at Children’s Hospital of Philadelphia who worked on the study.
“It is a reminder to me that when I see families in my practice who have lost their insurance or who have changed homes, to probe a little further about the challenges they are facing. As communities, we all need to reach out a little more to identify which families may be in crisis and help guide them to appropriate resources for support," Rubin said.
There was no link between suspected child abuse cases and unemployment rates, the researchers found.
“At the local and state levels, child welfare agencies should consider additional methods of tracking child abuse data, including hospital data. These efforts will enable public agencies to better monitor child abuse and neglect and to respond effectively to the needs of children and families,” the researchers advised.
“Pediatricians and other health care providers should be aware about housing insecurity that may be affecting families in their care. Providers can help connect patients and families to appropriate social services, such as cash assistance, food stamps, medical assistance benefits, and foreclosure counseling.”
Teens who play on more than one sports team during the year are far less likely to become overweight or obese, a new study suggests.
In fact, Dartmouth College researchers concluded that the obesity rate among high schoolers could be cut by more than 26 percent if all teens signed up for multiple team sports, according to the study, published today in the journal Pediatrics.
The researchers also found that kids who bike or walk to school are less likely to become obese. If every kid in the country biked or walked to school at least four days a week, then obesity could be cut by 22 percent, they reported.
“I know that coordinating schedules can be difficult in terms of getting kids to practices and games,” said study co-author Keith Drake, a post doctoral research fellow at the Hood Center for Children and Families at the Geisel School of Medicine at Dartmouth.
“But it does look to us like getting kids involved in sports may be the best chance we have to get them physically active and to help them maintain a healthy body weight.”
Playing on a single team didn’t appear to have a strong effect. Still, Drake said: “Playing on one team is probably better than playing on none.”
Drake and his colleagues surveyed 1,718 New Hampshire and Vermont high school students and their parents for the new study. The new report is part of a seven-year review of adolescent health that started in 2002 and included five separate surveys of the kids and their parents.
In each survey, the kids were questioned about a variety of topics, including their diet, academic performance, weight, and time spend on physical activities. By the end of the study, most of the teens were in ninth or 10th grade.
Almost three-quarters of the teens reported playing on sports teams: 17 percent played on one team, 19 percent on two teams and 33 percent on three or more teams.
When the researchers accounted for factors such as weight at the beginning of the study, diet, gender and race, they found that the kids were much less likely to become overweight or obese if they played on two or more teams during the year.
Dr. William Stratbucker, a pediatric obesity specialist, isn’t surprised that kids needed to play more than one team sport to lower the risk of becoming obese. He said that teens who participate in only one sport shouldn’t consider themselves active.
“The problem is that families often assume that if they put their kid into a soccer program that that is enough,” said Stratbucker, an associate professor at Michigan State University and director of the Healthy Weight Center at the Helen DeVos Children’s Hospital in Grand Rapids, Mich. “But that’s only eight weeks a year. What about the other 44 weeks a year when they’re going about their same nutrition habits. Maybe a few weeks in the sport they’ll maintain their weight, but they will gain weight during the other weeks.”
Kids need to be doing activities all year long that will raise their heart and respiration rates, he said.
Stratbucker is particularly concerned about girls who seem to be eschewing sports more and more these days.
“There seems to be a cultural expectation of girls now,” he said. “They’re being encouraged to do things that don’t cause them to breathe hard or work up a sweat.”
Getting kids to sign up for sports may not be a panacea, Stratbucker said, “but I applaud the authors of the study for worrying about this issue and getting the discussion going,” he added.
Could you get 200 wedding guests into the bathroom if a tornado hit?
The CDC team that brought us zombie preparedness tips last year seems to have hit on one good formula for helping Americans get ready for disasters, natural or otherwise, in a blog post on preparedness, experts say. And none too soon, as half of all Americas seem clueless about what they need to do to prepare, according to a new poll.
But it weaves in some serious pointers. “Make sure all of the guests are aware of who they can call if there is an emergency,” the blog, written by Office of Public Health Preparedness and Response staffer Caitlin Shockey, advises.
“If a tornado warning rips through the area, would you know what to do? 200 guests are not going to be able to crowd into the one windowless bathroom. Ask the reception venue for their emergency plans and evacuation routes.”
The blog post got more than 50,000 hits the first week, according to the site analytics company Omniture, and generated some lively comments, many of them critical.
“Another waste of taxpayer money. It (is) not our government('s) business to be in the wedding business, get out of our lives and spend the money reducing the debt,” complained one reader who gave the name Judith Sabella.
But risk communications expert Jody Lanard said controversy can be good. “It got people who are completely uninterested and who would never read past the headline of a safety article to read all the way through, even if the only reason they read through was because they thought it was stupid,” Lanard said in a telephone interview. “CDC has seduced them into reading it all the way through so they can hone their snarky remarks.”
The key is balancing humor with serious advice, said Lanard. “I think they are brilliant for doing this,” she said. “It’s so nice to have something nice to say about CDC.”
A survey released on Friday suggests it’s none too soon. It found 53 percent of the 1,000 adults questioned did not have the recommended three-day supply of nonperishable food and water stored at home, and 55 percent thought the authorities would look after them in case of a disaster – something the Health and Human Services Department and the Department of Homeland Security have repeatedly stressed is not the case.
The survey also found 63 percent did not have a list of their current medications prepared in case of a natural disaster and 52 percent lacked copies of health insurance documents.
“About a third of people weren’t sure they could name the prescription medications that they needed with the doses. That is surprising and alarming,” said Philip Alcabes, director of the Public Health Program at Adelphi University, who led the study. He said 44 percent didn’t have a first aid kit.
“Our health officials are doing a very good job -- maybe too good a job -- of warning people about unlikely events, but not a good job of letting people know how to be prepared to take care of themselves,” Alcabes said in a telephone interview.
But he isn’t sure about the Bridezilla blog. “Clearly CDC is trying to take account of the relatively new way that information spreads: put something onto the blogosphere, put it in Twitter. That makes sense,” he said. “But it is hard to know whether this sort of jocular approach makes sense. Do you get information across while you are kind of joking with people, or is it so ridiculous to people that they just stop paying attention?”
The comments were running four to one in favor of the Bridezilla jokes. “These blogs are probably the absolute cheapest, most effective way to get preparedness messages out to a broad audience. This blog right here probably saved CDC a TON of $$$ compared to the alternatives,” said a reader who gave only the name Mark. “Even the haters read it despite themselves. I think it’s a great follow up to the zombie apocolypse bit.”
The CDC Office of Public Health Preparedness and Response team, led by public relations veteran Dave Daigle and his associates Catherine Jamal and Maggie Silver, won an HHSInnovates award in March for the zombie blog post. “When the campaign went viral, its messages reached millions of viewers, and personal knowledge about preparing for disasters was enormously increased – for an initial investment of only $87,” HHS said in awarding the prize.
DENVER -- A suspended Colorado dentist reused syringes and needles in his now-shuttered practice, potentially exposing thousands of patients to HIV and hepatitis infection, health officials warned on Friday.
The Colorado Department of Public Health and Environment sent letters to 8,000 patients of dentist Stephen Stein, urging them to seek tests for the diseases after learning of "unsafe injection practices" at two Denver-area clinics he owned between September 1999 and June 2011.
Investigators found that Stein reused needles and syringes in several patients' intravenous lines at his oral surgery and dental implant clinics, in violation of standard medical protocol, the department said in a statement.
"This practice has been shown to transmit infections," the statement said. It added that there had been no confirmed cases of anyone contracting the viral infections through Stein's clinics.
In the letters sent to Stein's former patients, the health department urged them to be tested for HIV, hepatitis B and hepatitis C, said Jan Stapleman, a department spokeswoman.
Stein's records were incomplete, so it is likely more people were possibly exposed than those already identified, she said.
A hot line established for Stein's patients to call was "very busy" all day on Friday, Stapleman said.
Stein's lawyer, Victoria Lovato, said her client "is cooperating with the state's investigation."
'How do I know I'm safe?' "I don't know how clean their instruments were at the time," Lillian Carillo, who was a patient of Stein's in May 2008, said according to local NBC News station KUSA. She had a tooth extracted on that day.
"I don't know what to do. I did get an injection. He did use tools on me for the extraction. How do I know I'm safe?"
She said that she was surprised about the accusations.
"When I went to this office, I remember it being over the top. I remember the equipment [was] top of the line," Carillo said.
Jeannette Monical, who sent her two daughters to Stein to get their wisdom teeth removed, said she was "going crazy inside," KUSA reported.
"I want him to pay the price. I want him to [go to] prison," she said.
Authorities said any patient who underwent any type of injection at the clinics, including sedation, might be at risk. They cautioned that if any patients of Stein tested positive for any of the viruses, there was no way to determine how they contracted the disease.
Stein's license to practice dentistry in Colorado was suspended for an unrelated matter, said Cory Everett-Lozano, spokeswoman for the state Department of Regulatory Agencies, which oversees medical licenses.
Until that probe is resolved, the reasons for Stein's current suspension are confidential, she said.
Lynn Kimbrough, a spokeswoman for the U.S. Attorney's Office in Denver, said Stein was already the target of a criminal probe for possible prescription fraud before the allegations emerged about reusing syringes. She said no criminal charges had so far been filed.
NBC News station KUSA, msnbc.staff and Reuters contributed to this report.
By DAVID SCHULTZ and CHRISTIAN TORRES, Kaiser Health News
So you think the Supreme Court upheld a law that requires most people to buy health insurance? That's only part of it. The measure's hundreds of pages touch on a variety of issues and initiatives that have, for the most part, remained under the public's radar. Here's a sampling:
Postpartum Depression (Sec. 2952) Urges the National Institute of Mental Health to conduct a multi-year study into the causes and effects of postpartum depression. It authorized $3 million in 2010 and such sums as necessary in 2011 and 2012 to provide services to women at risk of postpartum depression.
Abstinence Education (Sec. 2954) Reauthorizes funding through 2014 for states to provide abstinence-only sex education programs that teach students abstinence is "the only certain way to avoid out-of-wedlock pregnancy, sexually transmitted diseases, and other associated health problems." Federal funding for these programs expired in 2003.
Power-Driven Wheelchairs (Sec. 3136) Revises Medicare payment levels for power-driven wheelchairs and makes it so that only "complex" and "rehabilitative" wheelchairs can be purchased; all others must be rented.
Oral Health Care (Sec. 4102) Instructs the Centers for Disease Control and Prevention to embark on a five-year national public education campaign to promote oral health care measures such as "community water fluoridation and dental sealants."
Privacy Breaks for Nursing Mothers (Sec. 4207) Requires employers with 50 or more employees to provide a private location at their worksites where nursing mothers "can express breast milk." Employers must also provide employees with "a reasonable break time" to do this, though employers are not required to pay their employees during these nursing breaks.
Transparency on Drug Samples (Sec. 6004) Requires pharmaceutical manufacturers that provide doctors or hospitals with samples of their drugs to submit to the Department of Health and Human Services the names and addresses of the providers that requested the samples, as well as the amount of drugs they received.
Face-to-Face Encounters (Sec. 6407) Changes eligibility for home health services and durable medical equipment, requiring Medicare beneficiaries to have a "face-to-face" encounter with their physician or a similarly qualified individual within six months of when the health professional writes the order for such services or equipment.
Diabetes & Death Certificates (Sec. 10407) Directs the CDC and the HHS Secretary to encourage states to adopt new standards for issuing death certificates that include information about whether the deceased had diabetes.
Breast Cancer Awareness (Sec. 10413) Instructs the CDC to conduct an education campaign to raise young women's awareness regarding "the occurrence of breast cancer and the general and specific risk factors in women who may be at high risk for breast cancer based on familial, racial, ethnic, and cultural backgrounds such as Ashkenazi Jewish populations."
Assisted Suicide (Sec. 1553) Forbids the federal government or anyone receiving federal health funds from discriminating against any health care entity that won't provide an "item or service furnished for the purpose of causing … the death of any individual, such as by assisted suicide, euthanasia, or mercy killing."
Toby, a 6-year-old Boston terrier, died in May after his owners say he was sickened by chicken jerky pet treats made by Nestle Purina. The Connecticut family is among several nationwide suing the maker of the treats and stores that sold them.
By JoNel Aleccia, Senior Writer, NBC News
Dog owners in eight states who believe contaminated chicken jerky treats from China sickened or killed their pets are banding together in a class-action lawsuit against Nestle Purina, the maker of two popular brands of the canine snacks, and several mega-stores that sell them.
They are suing just as Food and Drug Administration officials have refused to release results of inspections of Chinese plants that make the jerky treats blamed for at least 1,000 illnesses and deaths in U.S. pets.
“I don’t have any new information,” FDA spokeswoman Tamara Ward said in an email to msnbc.com.
The inspections were expected to shed some light into what toxins may have caused pet problems ranging from nausea and vomiting to kidney failure. Despite repeated tests, the FDA has identified no problems with Chinese-made chicken jerky treats.
In a letter dated July 5, FDA officials denied entirely an msnbc.com public records request for results of the February inspections of treat plants, saying release would violate rules protecting trade secrets and confidential commercial information and that it could also interfere with enforcement proceedings. Msnbc.com is now NBCNews.com.
The lawsuit filed in federal court expands an April complaint by Dennis Adkins, 57, of Orland Park, Ill., who said his 9-year-old Pomeranian, Cleo, died in March after eating Waggin’ Train “Yam Good” dog treats produced by Nestle Purina Pet Care Co.
It adds six pet owners in states from coast to coast who are suing not only the treat maker, but also Wal-Mart, Target and Costco, three big retailers that sell the products.
And it seeks to join with a lawsuit filed in federal court last month by a Connecticut family who believe their two Boston terriers, Max and Toby, died after eating chicken jerky treats they didn’t realize were suspect.
“Toby was falling over and crying out in pain and we would give him another treat because we thought we were doing something nice for him because he was hurting,” said Philip Mawaka, 69, a Hartford, Conn., pastor whose wife, Elizabeth, is named as the plaintiff.
Lawyers for Nestle Purina and the three store chains said they couldn’t comment on the specifics of the suits because the litigation is pending.
“We believe the claims made in the suit to be without merit and we intend to vigorously defend ourselves,” said Keith Schopp, a spokesman for Nestle Purina and Waggin’ Train. “We can say that Waggin’ Train products continue to be safe to feed as directed.”
Three top brands of chicken jerky treats were among those most recently cited by pet owners and veterinarians in complaints of harm, FDA records obtained by msnbc.com showed. They included Waggin’ Train and Canyon Creek Ranch, brands produced by Nestle Purina, and Milo’s Kitchen Home-style Dog Treats, produced by the Del Monte Corp.
Import data compiled by the firm ImportGenius showed that Waggin' Train and Canyon Creek Ranch treats are produced and supplied by JOC Great Wall Corp. Ltd. of Nanjing, China.
The expanded lawsuit claims to represent nearly all pet owners in the U.S. who bought any dog treat product made or sold by Nestle Purina containing chicken imported from China in the past four years, court records show.
The dog owners say they’re frustrated that the makers and distributors of the treats have failed to recall the products voluntarily, despite three federal warnings since 2007 about possible safety issues and nearly 1,000 reports to the FDA of dogs sickened or killed by the products.
They also say the companies have violated implied warranties of safety and healthfulness of their products and commerce rules governing sale of sound merchandise.
"Just because they haven't found something doesn't mean it isn't there," said Barbara Pierpont, 47, of Stewartstown, Pa. Her 7-year-old rescue dog, Honey, died of kidney failure in April, three weeks after Pierpont started giving her Waggin' Train jerky tenders bought at Sam's Club, a subsidiary of Wal-Mart. The treats were the only change in Honey's diet, she said.
In addition to Pierpont, the suit includes other pet owners from California to New Jersey:
Mary Ellis of Ontario, Calif., who claims that the Waggin’ Train treats she bought in February sickened two of her dogs, Buster and Boomer, both 9, and killed Maggie, 12.
Maria Higginbotham, Gig Harbor, Wash., who contends that Chik n’ Biscuit dog treats sickened her two rat terriers, Bandit, 3, and Kali, 8.
Dwayne and Kaiya Holley of Hempstead, Long Island, N.Y., who say that Waggin' Train Yam Good treats bought from Wal-Mart led to the death from kidney failure of their 5-year-old Yorkshire terrier, Bootsie, in March.
Deborah Cowan, Perryton, Texas, who believes chicken jerky tenders caused kidney damage that sickened her 8-year-old dog, Rowdy.
Cindi Farkas, of Howell, N.J., who says her dog Chanel, 6, was diagnosed with kidney disease after eating one half of a treat each day for three weeks this spring.
Those owners are among thousands calling for the recall of the chicken jerky treats and for more vigorous FDA efforts to identify the source of the problem.
“It has been way too quiet,” said Robin Pierre, 50, of Pine Bush, N.Y., who contends that Waggin’ Train jerky treats killedher previously healthy 2-year-old pub, Bella, last fall. “They [FDA officials] are not responding to anything at this point. No emails, no phone calls. Everyday there are more and more victims added to our list.”
Many pet owners say they're reminded of the 2007 scare in which melamine-tainted pet food from China sickened and killed thousands of dogs in the U.S., leading to mass recalls and criminal indictments of Chinese and American pet food executives. The problem was not detected immediately then, either, said Bruce Newman, the Connecticut lawyer representing Mawaka. He represented dozens of pet owners whose animals were sickened then.
The FDA has tested for melamine and melamine analogs, along with other chemical and microbiological toxins, but found no evidence of harmful levels, said Ward, the FDA spokeswoman. The treat makers could recall the products voluntarily, but in the absence of an identified toxin, FDA officials say the agency can't force a recall.
The FDA remains aware of and concerned about the problem, Ward said. Officials are developing new methods for testing for compounds in the jerky treats that could cause illness. It could take months to develop and validate the tests, she said.
The agency also has formed an internal task force to study jerky treats that includes players such as Costco’s Craig Wilson, vice president of quality assurance and safety.
“FDA is working and discussing with industry and retailers how we can mutually collaborate and share data, scientific exchanges, etc,” Ward wrote in an email. “We are committed to solving the problem and Costco is one of several parties interested in determining the root cause of the illnesses.”
Costco tests the jerky treats regularly at every step of production and distribution, Wilson told msnbc.com. So far, the retailer has detected nothing that could explain the reports of illness in dogs. He said FDA officials and Costco representatives will travel later this fall to the Chinese plants that make the Costco treats.
“Our testing program is very solid,” he told msnbc.com. “We actually test these at a higher level than some human food.”
Wilson declined to comment on the lawsuit, but he said he believes government animal health experts are working hard to find the source of the problem.
“The FDA is really on this,” he said. “I applaud their efforts.”
A grieving pet owner says his 9-year-old dog was in perfect health until he fed her Waggin' Train chicken treats; the Pomeranian died 13 days later of kidney failure. He is now calling on the FDA to take another look at the product. WMAQ-TV's Michelle Relerford reports.
A study of more than 700,000 women in the U.K. found that breast-feeding was associated with lower BMIs, even decades after having weaned.
While breast-feeding is advised partly as a way to help new mothers lose weight, it may help keep their weight down even decades later, a new study from Britain suggests.
Researchers found that women who had children tended to have higher body mass indexes later in life than did women with no children; however, the researchers were able to associate every six months of breast-feeding with a 0.22 drop in BMIs among the women in their 50s and early 60s.
This translates to a 1 percent drop in BMIs for every six months of breast-feeding, the researchers said.
"We already know breast-feeding is best for babies, and this study adds to a growing body of evidence that the benefits extend to the mother as well, even 30 years after she’s given birth," said study researcher Dr. Kirsty Bobrow, a researcher at the University of Oxford.
Producing breast milk requires energy, often burning up to 500 calories per day, explained Cheryl Lovelady, a professor of nutrition and a breast-feeding expert at the University of North Carolina at Greensboro. "If you didn’t change your calorie intake at all, you’re losing a pound a week," she said.
The study was published July 10 in the International Journal of Obesity.
Weight loss and breast-feeding
Bobrow and colleagues collected data on 741,000 women who had taken part in the Million Women study, conducted in England and Scotland between 1996 and 2001. As part of that study, women had reported how many children they bore, how long they had spent breast-feeding, their BMI, and other factors known to affect weight, such as smoking or physical activity. The women's average age at the time of the study was 57.5.
Of the 741,000 women, 88 percent had at least one child, and 70 percent of those mothers reported breast-feeding for at least some time. The average duration of breast-feeding was 3.1 months per child.
Among women with the same number of children, those who had breast-fed had the lower BMIs. The researchers noted that the women with more children were more likely to have breast-fed at least one of them.
Losing weight during the post-partum period, within six months to a year after birth, is critical, because women who don't lose their "baby weight" then have an increased chance of carrying extra weight later in life, Lovelady said.
The researchers noted that childless women in the study had lower average BMIs than did mothers who breast-fed for more than 10 months.
Decreasing weight, even modestly, can improve health, the researchers said. Prospective studies have shown that a BMI increase of 1 percent is equivalent to a 1 percent increase in the risk of dying of any cause, the researchers reported.
Catherine Howard Lovazzano didn't realize she had stripped-down medical insurance until she got breast cancer at age 31. She still owes $10,000 in medical debt.
By Maggie Fox, Senior Writer, NBC News
Eight years after she was diagnosed with breast cancer at the unusually young age of 31, Catherine Lovazzano is down to her last $10,000 of debt. “I am really looking forward to paying this off, now that I have a job with great health insurance again,” says Lovazzano, now 39 and working for Chrysler in San Francisco.
Lovazzano is part of the 26 percent of U.S. women who had trouble paying medical bills in the United States in 2009-2010, according to a report released by the non-profit Commonwealth Fund on Friday. That’s double the rate of women anywhere else surveyed -- the rate's 13 percent in Australia and just 4 percent of German women report trouble paying medical bills. But Commonwealth, which advocates for health reform, says the 2010 health reform law will slash these numbers when it starts to take full effect in 2014.
Lovazzano, like many young adult Americans, took out a no-frills health insurance plan when she left a paid job to become a freelance film producer nine years ago. She called her former employer’s insurer to continue coverage after her insurance ran out under COBRA – the law that requires employers to offer coverage to employees for a few months after they leave work. The insurer, Lovazzano said, told her she was young and healthy and needed only coverage for catastrophic events. “They basically sold me junk coverage,” Lovazzano said in a telephone interview.
Catastrophe did strike, in the form of breast cancer. But Lovazzano found out she wasn’t even close to being fully covered. “When I went into surgery they said, ‘You need to write us a check for $1,000 right now’ and I said ‘I don’t have $1,000.' I knew I was in trouble.”
Lovazzano estimates she racked up $200,000 in bills and she was on the hook for about $70,000 of it. It didn’t even occur to her to declare bankruptcy, to negotiate with the hospital and her doctors, or to simply walk away from the debt. “That’s not my style,” she said. “I come from a middle-class family. I have never been part of any welfare system.”
What’s ironic, Lovazzano says, is that had she been unemployed she would have been fully covered for her care by Medi-Cal, California’s Medicaid program. Come 2014, if the health care law is not repealed as promised by Republican politicians, health insurance companies will no longer be allowed to sell stripped-down policies like the one Lovazzano got.
“Women, particularly those in their childbearing years, are uniquely at risk for being unable to afford the care they need, having trouble with medical bills, and having high out-of-pocket costs,” said Commonwealth Fund vice president Sara Collins.
The group focussed its report on women and did not look at medical debt among men because women are uniquely at risk, it says. Insurers charge women more than they charge men of the same age and health for the same policies, says Ruth Robertson, who wrote the report for Commonwealth. “We know that women use more health services than men. They also have lower incomes than men,” she told reporters. “Thirty-five million women were either uninsured or underinsured in 2009-2010 and the situation has been getting worse in the past decade.”
Commonwealth researchers compared the medical debt of U.S. women to women in 10 other countries -- Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and Britain. They also used data on thousands of U.S. women from three surveys to show that U.S. women uniquely lack insurance coverage and face high medical bills compared to women in these other countries, which all offer universal health insurance and varying levels of privately funded care.
“The analysis finds that 18.7 million U.S women went without insurance in 2010, and a further 16.7 million were underinsured; that is, they had insurance but were at risk of high out-of-pocket costs relative to their income. Uninsured rates varied across the country. They were highest in the southern and western states; in Texas 30 percent of women were uninsured in 2009–10, compared with 5 percent in Massachusetts,” the report reads.
Other findings in the report:
Twenty percent of U.S. women (18.7 million) ages 19-64 were uninsured in 2010, up from 15 percent (12.8 million) in 2000
About 39 percent of women in the U.S. spent $1,000 or more on out-of-pocket medical costs over 2009-2010, compared to 24 percent in in Switzerland, 1 percent in Sweden, and none in Britain
Twenty-six percent of women in the U.S. had medical bill problems, compared to 13 percent in Australia, 12 percent in France, and 4 percent in Germany
Last November, the same Commonwealth team reported that the number of underinsured U.S. adults rose by 80 percent between 2003 and 2010, from 16 million to 29 million. In 2009, a team at Harvard Law School, Harvard Medical School and Ohio University reported that medical bills caused 60 percent of personal bankruptcies in the United States, for men and women alike.
Lovazzano worries about her future, even with health reform. “I am branded,” she said. Currently, health insurance companies could cap her lifetime coverage or limit what they pay. “As a cancer survivor, that is always going to be a concern,” she said.
Lovazzano did get a taste of what health care looks like in one of the 10 other countries the Commonwealth Fund is always comparing the U.S. to. “I did end up going to grad school in England and they paid for all of my prescriptions through the National Health Service,” she said. “Even though I wasn’t a citizen, I was treated better than I was in my own country.”
Originally approved by the FDA to treat benign prostate problems, Propecia had a welcome side effect: hair growth. But the medication also has sexual side effects. Now, a new study says the medication may cause permanent problems. NBC's Dr. Nancy Snyderman reports.
Millions of American men use Propecia to combat baldness and grow hair. The medication, made by Merck, did $134 million dollars in sales last year. But tonight there are new questions about possible long-lasting sexual side-effects. NBC's Dr. Nancy Snyderman answers frequently-asked questions about the latest Propecia study, and the commonly-prescribed drug.
What is Propecia prescribed for?
Propecia is prescribed for male pattern baldness, a hereditary problem in which men lose hair on the crown and sides of their head. Propecia is the brand name of a drug called finasteride which is also marketed as Proscar for men with benign enlarged prostate. This occurs mostly in men over the age of 50 and is characterized by urinary problems.
What did today’s study find?
Today’s study out of George Washington University and published in the Journal of Sexual Medicine was done on younger men mostly in their thirties who were taking Propecia for hair loss. The study was small, involving only 54 participants, but they found that 96 percent of the men surveyed suffered some kind of sexual dysfunction even after stopping the drug, suggesting permanent damage. The sexual dysfunction included low libido, problems with arousal and difficulty with erections and orgasms.
How common are these side effects?
This year the FDA changed the labeling on Propecia to reflect the possibility of sexual side effects. Still, they’re not very common --clinical trials with the drug suggest sexual dysfunction in only 2 percent of men taking it. Conventional wisdom has been that most side effects were temporary, but today’s report raises questions as to whether the sexual dysfunction can be permanent.
Should I stop taking the drug?
Don’t stop taking any medication without talking it over with your physician.
How does it work?
Propecia belongs to a class of drugs called 5-alpha reductase inhibitors that blocks the conversion of testosterone to the more potent androgen dihydrotestosterone (dht). What does that mean? It alters the testosterone effects on the body. For men with an enlarged prostate it works to shrink the gland. And as an interesting side effect it causes hair growth. But this is a drug only intended for men -- there is no medical reason to ever prescribe it to women or children.
Are there any alternatives for hair loss?
There are topical treatments out there to promote hair growth without serious side effects. It’s important to weigh the risks and benefits of any cosmetic treatment. Most men who take a drug for hair growth are doing so for self-esteem and to be more attractive. But is that benefit worth the risk of possible sexual problems? This is an important decision that should be discussed with your doctor and your partner.
A shortage of properly packaged drugs could be putting patients at risk, federal health officials said on Thursday. They warned about clinics giving injections to more than one patient from vials designed for use for just one patient.
Ten patients in Arizona and Delaware were hospitalized with serious infections they got when clinic staff injected them with drugs taken from vials meant for one-time use in recent months, the Centers for Disease Control and Prevention said. Another patient was found dead at home after getting one of the injections, although it couldn’t be proven the infection killed the patient. Last April, staff at one clinic in Delaware managed to infect nine patients with bacteria from their own bodies.
The CDC said the cases illustrate a growing problem -- there have been 20 such incidents since 2007.
Staff at both clinics said they had trouble getting specially designed vials for multiple uses, the CDC said. There have been nationwide shortages of some of the drugs because of manufacturing problems. So staff diluted single-dose packages and used them in several patients, spreading infection. “Medications labeled as ‘single dose’ or ‘single use’ typically are preservative-free and should be dedicated for single-patient use to protect patients from infection risks,” the team of investigators wrote in the CDC’s weekly report on death and disease.
At one clinic in Arizona, staffers diluted a vial of contrast agent, used to help make x-rays clearer when preparing patients for injections of strong pain medications. They injected 10 patients from this one diluted vial. Three patients were infected with methicillin-resistant Staphylococcus aureus, also known as MRSA, a serious and hard-to-treat bacterial infection.
All had to be hospitalized with meningitis, blood infections or abcesses – one for 41 days. “The fourth recipient of diluted contrast from the afternoon vial was found deceased at home, six days after treatment at the clinic. The cause of death was reported as multiple-drug overdose; however, invasive MRSA infection could not be ruled out,” the health officials wrote.
In Delaware, seven patients ended up in the hospital for three to eight days after getting injections for joint pain from the same orthopedic clinic last March. “When a national drug shortage disrupted the supply of 10 mL single dose vials, office staff members began using 30 mL single dose vials of bupivacaine for multiple patients,” the investigators wrote.
CDC experts tested the patients and they all were infected with an identical strain of S. aureus – and it matched a strain found living in two of the clinic workers. The workers were colonized – meaning the bacteria lived in their noses or on their skin but didn’t make them sick.
“This report reminds health-care providers of the serious consequences of multipatient use of single-dose vials that can occur even when health-care workers believe they are being careful,” the report reads. There are ways to safely use smaller vials for multiple patients, but the CDC and state health officials in Arizona and Delaware said clinic staff need special training.
How can patients protect themselves? Infection control experts say it's best to be a squeaky wheel -- always ask doctors, nurses and other clinic staff if they have washed their hands before touching you. Patients receiving injections should ask if the equipment is sterile and if it has been prepared according to procedure. And anyone who has been to a clinic or hospital recently should immediately check with a doctor if they develop a fever, rash or cough.
People who live in or travel to the Northeast or upper Midwest this summer should take precautions to avoid contracting babesiosis, a tick-born disease native to those areas, according to a new report from the Centers for Disease Control and Prevention.
In 2011, more than 1,100 cases of babesiosis from 15 states were reported to the CDC.
Ninety-seven percent of cases occurred in Connecticut, Massachusetts, Minnesota, New Jersey, New York, Rhode Island and Wisconsin. Most cases — 82 percent — occurred in the summer months (June through August). More than half of infected people were over age 60.
Babesiosis is caused by the parasite Babesia microti, which infects red blood cells. Symptoms can include fever, nausea and headache, although most people infected with the parasite feel fine, the CDC says.
In recent years, cases of babesiosis in the United States have increased, and the disease may be spreading into new regions. Last year was the first time health officials reported cases of the disease to the CDC using a standard definition of the illness. Surveillance for the disease occurred in 18 states.
To prevent babesiosis infection, people who live in or travel to regions where the disease is found should take the following precautions: avoid tick-infested areas, apply repellents, wear long pants and long-sleeved shirts when outdoors, shower soon after being outdoors, and check their entire bodies for ticks, the CDC says.
Tick bites are the most common way babesiosis is transmitted, but people can also become infected through blood transfusions, and the disease can pass from mother to child during pregnancy.
In 2011, 10 people were suspected of contracting babesiosis through blood transfusions, and one case of congenital transmission of the disease was reported.
Treatments for babesiosis are effective, and usually involve a combination of anti-malarial drugs or antibiotics, such as quinine and clindamycin, according to the New York State Department of Health. But most people do not become sick enough to require treatment, and the CDC says people who do not have symptoms should not be treated with drugs.
Because there's no way to screen the blood supply for the babesiosis parasite, people known to have had the disease should refrain from donating blood indefinitely, the CDC says.
Ongoing surveillance for the disease will allow officials to develop effective prevention and control measures to reduce the burden of babesiosis, the report says.
The report will be published July 13 in the CDC journal Morbidity and Mortality Weekly Report.
A study of nearly 200 California home cooks found that nearly a third failed to wash their hands after handling raw meat.
By JoNel Aleccia, Senior Writer, NBC News
You’d think a video camera in the kitchen might be one way to ensure food safety, but, boy, you’d be wrong.
Researchers who filmed nearly 200 California residents as they prepared salad and hamburgers at home found disturbing problems with hand-washing, cross-contamination and cooking mistakes, even in the presence of a video crew.
Less than half of the home cooks -- only 43 percent -- washed their hands before beginning food preparation, and nearly a quarter of those who did scrub spent only two seconds, literally, instead of the recommended 20 seconds.
That’s only the beginning of the revealing findings of two studies, conducted by University of California at Davis researchers, which recorded multiple violations of basic kitchen rules that could result in dangerous foodborne illnesses.
“What this tells us is that people aren’t perfect,” said Christine Bruhn, a UC Davis food safety scientist who investigates consumer food handling practices. “Sometimes, even those who know better because of habit or inattention can make an error.”
Bruhn and her colleague, Ho S. Phang, wanted to gather real-world evidence of consumers’ food safety habits instead of simply relying on self-reports. So they recruited volunteers in several Northern California counties, promising $50 and the cost of the groceries used in the experiment. They made sure to exclude people likely to have a high level of food safety skill, including doctors, nurses and microbiologists. But the ranks did include some folks who had previous food safety training, perhaps working in a restaurant or other public setting.
What they found was surprising. First, although 84 percent of people thought they could get sick from eating hamburgers, 18 percent believed they would only become ill if the burgers were prepared outside the home.
Nearly a third of the volunteers who agreed to be videotaped failed to wash their hands directly after handling ground beef and more than three-quarters performed actions that could transfer illness-causing bacteria such as E. coli O157:H7 or salmonella to other surfaces.
On average, each household in the study committed 43 cross-contamination faux pas, including nearly a third who touched lettuce or tomatoes directly after handling raw meat.
About 93 percent of the 6,576 incidents of cross-contamination involved the food preparers’ hands, the researchers found.
When it came to lettuce, less than half of the participants washed each leaf under running water with gentle rubbing, as recommended. Fifteen percent of the volunteers didn’t wash their lettuce at all, while 8 percent failed to wash the celery.
The vast majority of volunteers actually cooked their burgers correctly, with 70 percent reaching the 160 degree Fahrenheit temperature recommended by the U.S. Department of Agriculture. Still, that was largely by chance, as only 4 percent of the participants used a meat thermometer to check doneness, and only 13 percent had any idea about the correct temperature for cooked ground beef.
Four volunteers pronounced their burgers done at internal temperatures of less than 120 degrees Fahrenheit.
The studies were released last year in the Journal of Food Protection, but got little attention outside of food safety circles. Bruhn said they point to the overwhelming need for consumer education and awareness to help prevent the 9.4 million episodes of foodborne illness caused by 31 major pathogens each year, according to the Centers for Disease Control and Prevention.
People need to remember basic hygiene – soap and hot water – and to be careful to keep raw meat and vegetables separate in every way: on cutting boards, when using knives, even when touching the kitchen faucet. Produce should be washed under running water with gentle friction and then dried using a salad spinner or paper towels, not cloth.
Meat should be checked for doneness with a thermometer, not by judging the color of the cooked burger or chicken breast.
“It’s really not hard to wash your hands and do these basic precautions,” said Bruhn.
Signature Medical Spa in Tampa, Fla., in an online pitch for its “Lipo-Ex Spring Fling Fat-Off!,” described the technology as “truly the only non-invasive way to reduce fat.”
Praise also came from Sculpt Medical Spa in Chicago, which called the procedure “the most innovative, effective, and technologically advanced” non-surgical method of removing fat.
Doctors have appeared on TV news shows in Houston, Phoenix and Miami to promote LipoTron treatments.
These testimonials have translated into millions of dollars in sales for physicians, med spas, and the device’s manufacturer, RevecoMED International of Fullerton, Calif.
But there’s a problem: The LipoTron, which targets fat with radiofrequency waves, has never been cleared or approved by the U.S. Food and Drug Administration, which would make it illegal under federal law to sell or promote it for weight loss.
The FDA is aware of the activity. But an investigation by FairWarning found that the agency has not taken enforcement action — even though it has known about the situation at least since January, 2010. At that time, two whistleblowers, one a former LipoTron distributor, provided sales records and a trove of other documents to an FDA criminal investigator.
The case spotlights the booming, multi-billion-dollar business of aesthetic medicine—and the willingness of some doctors and med spas to use unapproved devices as they vie to be first with the latest technologies to smooth wrinkles, tighten skin and sculpt the body.
The FDA won’t say if it is investigating Reveco, citing a policy not to discuss investigations or acknowledge if there is one.
For his part, RevecoMED President James S. Rosen said the agency hasn’t contacted the company. He asserted that, “As of today, we are compliant with the FDA.”
Still, for observers such as Dr. Patricia K. Farris, a clinical associate professor of medicine at Tulane University and a spokesperson for the American Academy of Dermatology, the situation is baffling.
Told of the unauthorized sales, Farris responded: “It shocks me the FDA would not have cracked down on them.”
“I mean, radiofrequency is an electrical device, and you can’t just be throwing these things in the marketplace without doing the right studies to make sure that, A, the device is safe and, B, that the thing does something and has some benefit.”
Dr. Suzanne Yee, a Little Rock, Ark., plastic surgeon whom Reveco asked several years ago to take part in a LipoTron study, said she was surprised to learn that the company already was selling the device.
She noted that some medical spas have falsely stated on their websites that the LipoTron is FDA-approved. “It’s not FDA-approved,” Yee said. “I think that’s dishonest.”
There have been scattered incidents of patients receiving minor shocks and burns from LipoTron treatments, but no known reports of serious injury.
While the FDA has failed to act, the Texas Department of State Health Services issued a warning letter last September to a Fort Worth distributor for marketing the LipoTron without FDA clearance. According to an agency report, Mark Durante, managing partner of Advanced Aesthetic Concepts, told state investigators that the LipoTron had been cleared by the FDA, but later corrected himself to say paperwork had been filed but no clearance yet given.
Durante told FairWarning that, in response to the warning, his company changed some language on its website. However, a spokeswoman for the Texas agency said it recently opened a second complaint investigation of Advanced Aesthetic Concepts.
Selling for as much as $85,000, the LipoTron passes radiofrequency waves through the body to heat, and destroy, fat cells. According to Reveco, the procedure targets subcutaneous fat, which is just below the skin, as well as visceral fat surrounding the vital organs, but without harming adjacent tissues. Spas typically recommend six to eight treatments for about $400 each.
According to interviews and records, Reveco first sought a green light from the FDA in 2007. It chose the FDA’s market clearance procedure, which is less demanding than the formal approval process.
To get a new device cleared this way, the manufacturer must show it is similar in safety and effectiveness to products that are already on the market.
However, Reveco’s bid failed. The company’s initial application “wasn’t in-depth enough,” Rosen said, and the FDA repeatedly sought additional data. Finally, according to Rosen, “We said, ‘You know what, it’s not worth it.”
According to interviews and a document reviewed by FairWarning, the FDA then told Reveco that the device could not be marketed.
LipoTron sales continued, however. Rosen wouldn’t disclose how many of the devices have been sold, but the number is believed to be in the low hundreds.
In 2011, Reveco took another tack with the FDA. It classified the LipoTron as a massager used for relief of minor pain. That would make it, in FDA parlance, a Class 1 device — a category that includes such simple, low-risk items as elastic bandages and examination gloves.
The advantage for Reveco is that massagers can be sold without a green light from the FDA. They automatically are exempt from FDA review and can be put on the market once a notice is filed.
Yet doctors and med spas have been promoting the device on the Internet not for massages but for removing fat.
Rosen said that was not Reveco’s responsibility, stating that the company can’t dictate what doctors do or “police everything out on the Internet.”
Asked who would pay $85,000 for a massager, Rosen replied: “Anybody that wants to buy it.”
Physicians are free under federal law to prescribe unapproved, or “off-label,” uses of drugs or medical devices — but only if the products have been cleared or approved for another purpose, according to the FDA.
FDA spokeswoman Sarah Clark-Lynn said in an email that if a device is not legally on the market, “a physician should not have been able to obtain it, much less use it on a patient.”
Dr. Sherwood Baxt, a New Jersey plastic surgeon who advertised the procedure in a promotional video, said that when he bought the LipoTron he wasn’t troubled by its lack of FDA clearance. He explained that he had used unapproved devices before and, while he considered the agency’s green light a marketing advantage, he didn’t consider it necessary.
Besides, Baxt said, “We were told FDA approval was imminent.” It didn’t work out that way, however, and, he said, “After two years, I just stopped asking.”
He continues to use the device for skin tightening on certain patients but quit using it for fat reduction. For fat reduction, Baxt said, “It wasn’t as effective as I thought it was going to be.”
The FDA was informed of the unauthorized sales through an anonymous call. Paige Peterson, a former LipoTron distributor, and Belinda W. Worley, a marketing consultant who worked with her, told FairWarning they dialed in from a hospital phone in hopes the call could not be traced.
But they agreed to meet with criminal investigator Evan Rae a few days later at a Hilton inn in Waco, mid-way between Rae’s office in Austin and Dallas, where Peterson and Worley lived.
They found a quiet spot in the lobby bar, which was closed in the morning, and talked for a couple of hours. Peterson said she gave Rae a detailed statement, a computer flash drive and copies of records, including emails, memos and invoices. Rae taped the conversation and snapped photos of the LipoTron 3000 the women had brought along. Rae declined to be interviewed.
Peterson told FairWarning she had made 39 LipoTron sales, even though she was aware the device had not been cleared by the FDA. The evidence she gave Rae “was just as damning of me as everybody else. I have zero assurances that the FDA is not going to arrest me.”
Peterson admitted there was no love lost between her and Reveco. She said she had paid out-of-pocket for some research costs aimed at getting FDA approval, but had not been reimbursed. And she said the company dumped her as a distributor in favor of another sales group.
But Peterson also said Reveco had misled her with repeated assurances it was taking all proper steps and FDA approval was imminent—and spread this misinformation to some anxious customers.
“I had run out of acceptable answers to give the doctors that had purchased the LipoTron,” she said. “I needed to fall on my sword and tell the truth.” Better to come clean, Peterson decided, than to wait for the FDA “to come knocking on my door.”
While declining to comment on Peterson’s statements, Rosen said she had gone over to “the dark side.”
“She’s a person that’s vindictive,” he said. “She’s doing it out of spite.”
For her part, Peterson says that after 2½ years she is surprised and frustrated by the apparent lack of action.
“Why do we have an FDA?” she asked.
“I tried to do what I thought was right, and nobody’s doing anything about it. Everybody gets to thumb their nose at the law.”
FairWarning.org is an online, nonprofit publication that seeks to provide robust, public interest journalism on issues of health, safety and corporate conduct.
For those who need another reason, beyond the ick factor, to not eat raw crawfish, here’s a frightening fact: many of these crunchy crustaceans carry the infinitely more icky lungworms – which can burrow from your digestive tract into your lungs, cheeks, or even your brain.
A new government report describes the cases of nine Missouri folks whose bodies were invaded by the parasitic little flat worms, officially known as paragonimus kellicotti, after gobbling down raw crawfish on a drunken dare.
All nine got infected with paragoniumus between 2009 and 2010. Before that, there had been just seven cases reported between 1968 and 2008, according to the new report published this week in Emerging Infectious Diseases, a Centers for Disease Control and Prevention journal. Why the upsurge? Turns out that people in the country’s interior like to cool off by rafting down rivers -- which are populated by crawfish. And someone, somewhere, got the brilliant idea to dare a friend to gobble down a live one.
“What we’ve seen is that out on rivers people like to drink and do some things we might not normally do,” says study co-author Michael A. Lane, an assistant professor of medicine in the division of infectious diseases at the Washington University School of Medicine. “We’ve seen a decent – though still relatively small – number of people eating raw crawfish on a dare after drinking beer.”
If you’re having trouble imagining someone consuming a live crawfish, just type the words “eating raw crawfish” into the search bar on YouTube and you’ll see plenty of people crunching away. Best to do this on an empty stomach.
Scientists have discovered that many of the crawfish in Missouri’s rivers are infected with lungworms. “In some rivers as few as 40 percent of the crawfish had the parasite,” Lane says. “But in others it was as high as 70 percent. So, if you pull a crawfish out of the water, you’ve got a high likelihood of getting one with the parasite.”
The parasites are about the size of a grain of rice when they’re in a crawfish, Lane says. But they can grow as big as a half an inch once they’re inside the human body.
“After you eat the crawfish, the parasite comes out and migrates across the diaphragm,” Lane explains. “They burrow through the walls of the intestine, hoping to make it to the lungs where they can complete their life cycle and mature. Once in the lungs they form nodules that mature and grow. But sometimes they get lost on the way to the lungs and they can end up in other places. One of our patients had one that had gone to the brain. Another had one that had worked its way to the cheek.”
Lane’s study only looked at people who had been seen at his medical center, but Missouri isn’t the only place with hot weather, rivers and crawfish.
“All the pieces of the parasite’s life cycle are found throughout the country,” Lane points out. “There have been animal studies that have found them in Ohio, Colorado, and other places.”
Because of that, Lane suspects there may be even more cases of people out there with paragonimus symptoms – coughing, fever, shortness of breath, high white blood cell count, fluid in and around the lungs - who are being misdiagnosed with anything from tuberculosis to pneumonia to cancer.
And the misdiagnoses may cause more damage than the worm itself. One of Lane’s patients was on the verge of getting treated for cancer because doctors assumed that had to be the problem.
“He’d had multiple procedures for draining the fluid from his lungs – which eventually caused one of his lungs to collapse,” Lane says.
Another patient had a healthy gallbladder removed when doctors couldn’t find any other explanation for his chest pain.
The good news is that there is a very effective therapy. When patients take the medication praziquantel for three days, there is a 100 percent cure rate, Lane says.
The tricky thing is for doctors to first figure out whether a patient has the parasite since there is no good blood test.
“Probably the best diagnostic test we have is to ask the patient if they ate any raw crawfish,” Lane says.
Dawn and Steve Thomas want the world to understand the chronic, crippling blushing that led their 20-year-old son Brandon to commit suicide last May.
By JoNel Aleccia, Senior Writer, NBC News
Steve and Dawn Thomas rarely saw their son Brandon blush, and if they did, it wasn’t a worry.
Brandon was blond and fair, like his twin brother, Devin, and an occasional flush of color didn’t seem concerning.
“We wouldn’t have witnessed it,” said Steve Thomas. “It wasn’t even happening here at home. I think this was his place of comfort.”
So they were stunned last fall when Brandon, a friendly, well-liked University of Washington student, confessed to his mother he’d been struggling with crippling, chronic blushing for four years.
John Brecher / msnbc.com
Steve and Dawn Thomas are speaking out about their son Brandon's death to raise awareness of the little-known disorder estimated to affect between 5 percent and 7 percent of the population.
And they were devastated on May 29, when Brandon jumped from the 11th floor balcony of his Seattle dormitory, leaving behind a five-page note blaming his suicide on despair caused by the little-known disorder.
“When Brandon finally let us in to his secret life of torment, we were obviously way behind,” his mother said.
Six weeks later, the Thomases are speaking out about Brandon’s death to honor his last wish. In the letter, the young man who hid the problem from his friends, his family -- even his twin -- wanted the world to know that there’s nothing trivial about turning red.
“One of the reasons he took his life is that if he took this drastic measure, it would raise awareness,” Dawn Thomas said. “He wanted his death to have an impact.”
Courtesy Thomas family
Twins Brandon, left, and Devin Thomas were close, but Brandon hid his condition even from his brother.
To that end, Dawn, 45, Steve, 47, and Devin, 20, are seated on a couch in the family’s manicured lakeside home in Renton, Wash., just outside Seattle, stoically facing a reporter’s notebook and a video camera. Dawn, who works at nearby Microsoft, and Steve, a firefighter, wanted to set the record straight.
“I’ve had people come up to me, even at his service, and say ‘I know, I blush, too, when I’m in public,’” said Dawn Thomas. “That is not what this is about.”
Instead, they say that Brandon was fighting a daily battle with what experts describe as pathological blushing, facial reddening that goes far beyond the typical flush most people feel at committing a social faux pas or speaking in front of a group.
An estimated 5 percent to 7 percent of the population may suffer from chronic blushing, an uncontrollable reaction triggered by an overactive nervous system and compounded by the fallout of social shame. That’s according to Dr. Enrique Jadresic, a Chilean psychiatrist and the world’s foremost expert on the disorder, who also suffered from it himself.
There are ways to treat chronic blushing, including hypnosis, therapy, anti-anxiety drugs and, for some, a controversial surgery that snips or clamps the nerve in the torso that controls flushing. But like Brandon, many so-called blushers suffer silently, ashamed to admit to the condition that colors work, romance and other crucial parts of life.
Courtesy Thomas family
Brandon Thomas confessed to his mother last fall that he'd been struggling with chronic blushing for more than four years.
'No, mom, you need to just go look it up' When Brandon called his mother in tears last fall, she knew only that it was serious -- and that he must have been desperately in need of help.
“I was sitting there trying to make sure I chose my words carefully: ‘OK, Brandon, you know we all blush,’” Dawn Thomas recalled. “And he said, ‘Mom, no, you need to just go look it up.’”
Online, she discovered what Brandon had found: blogs, anecdotal reports and a few scientific studies that described people for whom routine blushing had become unbearable.
“The biggest thing for him and the biggest thing for all the people who suffer with chronic blushing is the shame,” she said. “People do think of it as trivial because we all blush. And what’s the problem?”
At first, the problem isn’t even the blushing itself, Jadresic said in emails to msnbc.com. Around puberty, some people with a heightened sympathetic nervous system, the network that controls involuntary actions like sweating and blushing, seem to start to blush more, but without the social cues such as embarrassment that typically trigger a blush.
Blushing occurs when the tiny blood vessels of face, called capillaries, widen, allowing more blood to flow through them, causing the skin to redden. The widening occurs in response to signals sent from the brain through the nerves. It's an involuntary action often sparked by strong emotions, such as embarrassment or anger, but also can be caused by spicy foods and alcohol. In chronic blushers, though, there may be no obvious trigger.
That was the case with Brandon, who started blushing around age 15. Without warning, he'd flush bright red from his neck to his ears.
“He would be laughing with people and someone would point out, ‘Oh, look how red Brandon’s getting,’” said Dawn Thomas, recounting what Brandon had told her. “And he’d be thinking, ‘I am?' Because he didn’t realize he was turning red.”
The color was noticeable, said Troy Colyer, 20, who had been friends with Brandon since middle school and attended the University of Washington with him. But Brandon was such a funny, energetic guy, well-liked by everyone, that it didn't draw too much attention.
"He used to blush, but we didn't think much of it," recalled Colyer, who organized a vigil after Brandon's death attended by at least 100 people. "People thought it was cute and funny."
'He was the last person in the world you'd think would do this.' Some friends may have joked about the blushing, but it was never mean-spirited; no one ridiculed Brandon, Colyer said. He and others were stunned to learn that Brandon was suffering.
"He was the last person in the world you'd think would do this," Colyer said.
What no one knew, Brandon's mother said, was that when anyone pointed out the blushing, Brandon became embarrassed. And then he started dreading the blushing he couldn’t control, leading to what experts call “erythrophobia,” or fear of blushing.
“Since it’s visible and uncontrollable and frequent, you are always on the alert. You dread blushing or the possibility of it happening,” Jadresic explained.
Doctors, psychiatrists and others have long debated the source of chronic blushing. For years, professionals thought it was a psychological issue.
“The view was that the main problem was in the blusher’s mind, in the way the blusher thought about the blush,” Jadresic said.
More recent research has suggested that it actually is based in biology, Jadresic said.
“Clearly, we do not all blush the same, to the same extent and severity,” he noted.
When people blush more frequently and intensely than normal, it can trigger severe psychological and social reactions, Jadresic said. Sixty percent of blushers in one study and 90 percent in another study met the diagnostic criteria for social anxiety disorder, or SAD, he added.
Courtesy Thomas family
When Brandon and Devin were young, the family enjoyed hiking, camping and traveling to places such as Hawaii.
'I am tired of blushing.' Regardless of the cause, chronic blushing can cripple a sufferer’s life. In his last letter to his parents, Brandon tried to explain how the disorder dominated him.
“I blush several times a day. It doesn’t have to be when I am embarrassed either,” he wrote.
He would blush in class, on the phone, while driving in his car, late at night when he recalled blushing during the day. He would take the stairs instead of the elevator from the 11th floor in order to avoid meeting someone he knew entering the elevator on the way down, which he knew would trigger a blush.
All of this agony was kept secret, Brandon's friends and family say. The business major who hoped to be a firefighter like his dad was outgoing and loved sports, especially basketball and soccer. He and his brother had a longstanding rivalry about the Huskies vs. the Cougars, the mascots of the state's warring college teams. When Devin left for school at Western Washington University in Bellingham, a couple hours north of Seattle, the brothers were in frequent contact. "We texted a lot," said Devin.
With friends, Brandon was something of a peacemaker, his friend Troy Colyer recalled.
"He was the glue that kept everyone together," he said.
Outwardly, there was no sign of the young man whose last letter reported that he cried himself to sleep nearly every night.
“I am tired of blushing,” Brandon wrote. “It is exhausting to wake up every day and have to find little ways to avoid blushing situations.”
Desperate efforts Once they knew about the problem, Brandon’s family tried desperately to get him help. In April, they took him to doctors, found a counselor, got prescriptions for low doses of anti-anxiety drugs and beta-blockers, which have been successfully used to treat blushing. They discussed the possibility of endoscopic thoracic sympathectomy, or ETS, the controversial surgery sometimes used to treat both excessive sweating, or hyperhidrosis, and pathological blushing.
Jadresic, who had the surgery himself, believes that it can be an effective cure. He led a study of more than 300 patients published last year that compared surgery, drug treatments and no treatment. Among those treated with ETS, 90 percent reported being either “quite satisfied” or “very satisfied” with the results.
Still, the surgery is controversial. Some patients have reported serious side effects, including unusual sweating or weakness, sometimes without controlling the blushing.
“Health professionals should ensure that surgery is used only as a last resort,” said Jadresic.
Brandon wanted the surgery, but reluctantly agreed to try drugs and therapy first, his parents said. During an anxious meeting in Seattle, a doctor told Brandon the surgery had only a 50 percent chance of success. In response, the family planned to see a new doctor in New York this summer, one who was more familiar with the operation. If that didn't work, they planned to visit an expert in Ireland who claims to cure chronic blushing.
Before they could take those steps, however, Brandon was gone.
“He was so hopeless by the time [he told us],” his mother said. “He believed in his mind that he was never going to have a successful career, and that he would never have a successful relationship because of this.”
Now they’re speaking out about chronic blushing, hoping to create a website that gathers information about the condition all in one place, providing links to Jadresic’s book, which may have provided hope to Brandon if he’d seen it earlier. The website is still under construction. People who want to know more -- or to contact Brandon's parents -- can send an email to email@example.com.
With more information, maybe Brandon could have held on long enough to get help, his parents said. As it is, they'll never know exactly why Brandon couldn't wait, or what specific event might have spurred his final action.
“That’s the hard part,” Steve Thomas said. “There are just so many unanswered questions.”
Drugs used to control the AIDS virus can also be used to protect uninfected people, researchers concluded on Tuesday in a “last-word” review of the data.
Their report, released in the Cochrane Library, bolsters calls for policies backing distribution of the drugs to people most at risk from the virus -- including gay and bisexual men, drug users, and women in some African-American communities as well as across the developing world.
The findings also underscore the debate over how best to use scarce resources to fight the pandemic of human immunodeficiency virus or HIV, which infects 33 million people globally, including more than a million in the United States. It has killed 25 million people. There is no cure and no vaccine.
But studies are showing hope on several fronts.
“We think we are at the beginning of the end of the AIDS epidemic,” Dr. Diane Havlir, an AIDS specialist at the University of California, San Francisco, and one of the organizers of a giant, international AIDS conference being held in Washington, D.C. later this month, told reporters on Tuesday. “Over the past three years, there has been a series of breakthroughs in interventions that can dramatically curb the rate of infections with HIV.”
Work on a vaccine is promising, it’s been shown clearly that circumcising men protects them from infection, and it’s also obvious that treating infected people not only keeps them alive and healthy, but it helps prevent them from infecting others. Work is also progressing on a microbicide -- a gel that women could use to protect themselves from infected husbands and partners. And now research is also showing that giving people a once-a-day dose of the pills used to treat HIV can keep them from becoming infected in the first place.
The studies on this last approach, called pre-exposure prophylaxis or PrEP, have been mixed. So Charles Okwundu of Stellenbosch University in South Africa and colleagues studied the studies.
They looked at experiments involving more than 9,800 people around the world at high risk of becoming infected with HIV, including gay or bisexual men and sex workers. The drug tenofovir alone -- sold under the brand name Truvada by Gilead Sciences -- cut the risk of HIV infection by nearly two-thirds, while trials using Truvada with a second drug called emtricitabine, brand name Emtriva, cut the risk by 49 percent, they reported in the Cochrane Library, a journal that seeks to find the “last word” on studies.
It’s not clear why using two drugs seemed to be less effective than using just one, but the trials were done very differently and using different groups of people.
"Our findings suggest that antiretroviral drugs can reduce the risk of HIV infection for people in high risk groups," Okwundu said in a statement. "However, in the search for highly reliable HIV prevention strategies, it is important to determine how pre-exposure prophylaxis can best be combined with existing programs, as no strategy is likely to be 100 percent effective."
Okwundu’s team noted controversy over using PrEP.
“One concern is the long-term side effects of antiretroviral drugs used over many years by uninfected individuals,” they noted.
These include possible kidney damage and bone loss. In addition, if people don’t take the drugs consistently, they could develop what is known as resistant virus -- infections that defy the use of drugs. This can hurt the patients themselves, and they can also pass this resistant and hard-to-treat virus to others.
“There also are concerns that PrEP will lead to an increase in high-risk behavior,” Okwundu’s team adds. “If PrEP is not completely effective, even a partial reduction in use of safer sex could lead to an increased rate of HIV transmission.”
And the drugs are expensive -- Truvada costs more than $1,000 a month in the United States, although Gilead allows for much cheaper generic versions to be made and distributed in the developing world.
Despite the concerns, in May a panel of Food and Drug Administration advisers recommended that the FDA approve the pills for this use. Already, doctors can and often do prescribe the pills as they like, but FDA approval would clear the way for U.S. insurance companies to pay for it and for the company to promote the drug for this use.
Melissa Harris-Perry sat down with former House Speaker Nancy Pelosi on Friday to discuss - among many issues - the congresswoman's work in combating the HIV crisis. Christopher MacDonald Dennis, dean of multicultural life at Macalester College, joins Harris-Perry to talk about what HIV and AIDS looks like in America today.
Only one in 10 middle-aged women thinks hormone replacement therapy is a good thing, but doctors who treat them think it could help many women – if only they’d get up the nerve to ask.
A survey released this week by the Endocrine Society shows 90 percent of doctors would be happy to talk to their patients about menopause, and 73 percent think hormone replacement therapy can be a good thing. But 71 percent of them say they are prescribing hormone replacement therapy (HRT) less often than they were 10 years ago. The reason: a landmark study called the Women’s Health Initiative that showed HRT raises the risk of heart attacks, stroke and breast cancer.
The study, released 10 years ago this week, caused women to drop HRT wholesale -- even though it might help some of them. Women say they are still doubtful about it and the Endocrine Society says a separate survey it commissioned in April confirms this.
“Nearly every physician participating in the survey said menopausal symptoms have a negative impact on quality of life,” Dr. William Young, president of The Endocrine Society, said in a statement. “It’s important for a woman to know what hormonal and non-hormonal treatment options may be best for them to provide symptom relief,” Young added.
The group, which educates doctors specializing in hormonal conditions from obesity to menopause, asked pollsters Lake Research Partners to survey 424 internal medicine, family practice and OB/GYN specialist doctors. In April the group surveyed 810 women aged 45 to 60.
The doctors who were surveyed said they believe women are uncomfortable: 88 percent of the doctors said patients are unwilling to even consider HRT because of the risks, and 57 percent of OB/GYNs said their patients were confused. And just 11 percent of the women surveyed said they had a favorable view of HRT.
The Endocrine Society, North American Menopause Society and the American Society for Reproductive Medicine issued a joint statement on Monday outlining the risks and benefits of HRT. “Hormone therapy is an acceptable option for the relatively young (up to age 59 or within 10 years of menopause) and healthy women who are bothered by moderate to severe menopausal symptoms,” it says. “Individualization is key in the decision to use hormone therapy. Consideration should be given to the woman's quality of life priorities as well as her personal risk factors such as age, time since menopause, and her risk of blood clots, heart disease, stroke, and breast cancer.
As patients in the U.S. struggle with ongoing shortages of critical prescription drugs, federal lawmakers are investigating so-called “fake pharmacies” that they say are trying to turn a profit by buying and reselling scarce medications.
When cancer patient Jay Cuetara, 50, of San Francisco arrived for a scheduled chemotherapy treatment last August, his infusion nurse told him one of his prescriptions, an injectable form of the drug fluorouracil, was out of stock.
“When my nurse told me that the drug wasn’t available, that I wouldn’t be able to do my chemo that day, I was literally shocked,” says Cuetara, who has stage IV rectal cancer. “How could this be happening in the United States of America?”
Cuetara’s experience is not uncommon. The number of drugs in shortage reached a record 267 in 2011, up from 211 the year before, according to the University of Utah Drug Information Service, which tracks the problem. Some of the drugs in shortage treat cancer and other life-threatening diseases.
At the same time Cuetara learned his chemo drug was out of stock, congressional investigators say, records show that a company called LTC Pharmacy, licensed as a pharmacy in Durham, N.C., was buying the same drug – fluorouracil – supposedly to fill its own patients’ prescriptions.
But when North Carolina regulators inspected LTC Pharmacy, they found what appeared to be just a shipping and receiving office – with no records, no dispensing equipment, no patients. Not even a pharmacist on duty.
Congressional investigators claim "fake pharmacies" are popping up around the country that purchase drugs in short supply, and then turn around and sell them at higher prices. NBC's senior investigative correspondent Lisa Myers reports.
“They had not dispensed any medications for a prescription,” said Bob Braswell, one of the inspectors who visited the company.
Suspicious, the inspectors opened an investigation and obtained prescription drug sales records, invoices and purchase orders, which they later shared with congressional investigators. The records showed that LTC Pharmacy was buying drugs – including some chemotherapy drugs in shortage – and then, sometimes on the same day, reselling them to a wholesale drug company called International Pharmaceuticals. That wholesale company, it turned out, was located at the same address as LTC Pharmacy, and was registered to the same individual.
The records showed that International Pharmaceuticals was then reselling the drugs to other companies, at higher prices.
According to Braswell, the records showed that approximately 26 percent of the drugs they were buying were in short supply.
Although the company was selling some drugs to health-care providers such as hospitals, Braswell told NBC News that it was reselling approximately two-thirds of the drugs it bought to other wholesale distributors.
Congressional investigators told NBC News and Reuters that all inspections and records showed that, although the company had applied for and received appropriate licenses, and although the wholesale part of the business was legitimate, the pharmacy was in fact a “fake.”
Rep. Elijah Cummings, D-Md., says the investigation he launched in October shows that so-called “gray-market” drug suppliers – sometimes operating as fake pharmacies – are reselling scarce medications at higher prices, while some hospitals and patients scramble for supplies. And making drug shortages worse.
“This is about greed,” Cummings, ranking member of the House Oversight and Government Reform Committee, told NBC News. “This is simply about greed, people wanting to make a quick buck at the expense of sick American people.”
Braswell’s supervisor, Dan Regan, director of the Food and Drug Protection Division of the North Carolina Department of Agriculture, told NBC News his office denied renewal of the International Pharmaceuticals’ wholesale license, effectively shutting it down in North Carolina. (It denied the renewal because of a rule violation. While International Pharmaceuticals had a wholesale license, LTC Pharmacy was reselling drugs without one.)
“We took it seriously enough to deny renewal of the license, Regan said. “That's about as significant as we can react.”
When NBC News reporters visited the building where LTC Pharmacy and International Pharmaceuticals had operated earlier this year – after the renewal of the license was rejected -- no one was there. A “for lease” sign stretched across one window. The interior space, glimpsed through blinds, appeared empty.
Documents filed with the State of North Carolina list Jessica Hoppe of Florida as president of both companies. A lawyer for Hoppe told NBC News that she is a smart businesswoman who is “helping, not hurting” the drug shortage problem by enabling medical facilities to get medications to their patients more quickly.
This spring, however, Hoppe acknowledged that she and her partners “decided to close” International Pharmaceuticals and that the company had “ceased operations” as of the end of last year. Her statements came in a letter to the State of Texas’ licensing office, requesting that it cancel its wholesale drug distributor license for International Pharmaceuticals. Congressional investigators released the letter, dated in March, a few weeks ago.
Congressional investigators say LTC Pharmacy is not an isolated case. They say they’ve found what appear to be fake pharmacies around the country, buying up medicines in short supply and then selling them at a profit.
“It’s definitely making the shortages worse," Cummings said.
Recently, two Senate committees – the Committee on Commerce, Science, and Transportation and the Committee on Health, Education, Labor, and Pensions – joined in Cummings’ investigation and are also making active inquiries.
In late May, Cummings introduced a bill H.R. 5853, the “Gray Market Drug Reform and Transparency Act of 2012,” to address the issues his investigation revealed. The bill “includes several provisions to address weaknesses in the drug supply chain, deter price gouging and improve drug safety and efficacy,” according to a statement from the House Committee on Oversight and Government Reform.
Meanwhile, the shortages of critical drugs continue. Cancer patient Jay Cuetara told NBC News this week that he is now experiencing new shortages of the drugs prescribed to treat his cancer. The same chemotherapy drug that was out of stock last summer, fluourouracil, is again unavailable, he said. And now another cancer-treating drug his doctor had prescribed, Leukovorin, is unavailable too.