3 cancer scientists awarded $500K NY medical prize

ALBANY, N.Y. (AP) — Three scientists at universities in Pennsylvania, Illinois and Oregon whose research has helped transform cancer treatment will share one of the richest prizes in medicine and biomedical research.

Dr. Peter Nowell of the University of Pennsylvania, Dr. Janet Rowley of the University of Chicago and Dr. Brian Druker of Oregon Health and Science University will receive the $ 500,000 annual Albany Medical Center Prize in Medicine and Biomedical Research next month, the medical center announced Tuesday. The prize, one of the largest in medicine and science in the United States, is awarded to those who have changed the course of medical research.

Medical center officials called the trio “visionary scientists” whose work has given hope to cancer patients around the world. The researchers will officially receive the award May 17 at a ceremony at the medical center.

“These individuals exemplify the extraordinary impact that painstaking research can have on the lives of countless individuals,” said James J. Barba, president and chief executive officer of Albany Medical Center.

Nowell’s research at Penn in Philadelphia was the first to show that a genetic defect could be responsible for cancer, His work has led to numerous discoveries into the growth of cells related to cancers and other disorders.

Rowley’s discoveries of chromosome abnormalities in leukemia secured a common agreement among scientists, physicians and the general public that cancer is, in fact, a genetic disease.

Druker, an oncologist in Portland, Ore., used earlier work by Nowell and Rowley to develop a lifesaving treatment for chronic myeloid leukemia that specifically targets the leukemia cells without harming healthy cells.

The Albany Medical Center Prize was established in 2000 by the late Morris “Marty” Silverman, a New York City businessman who wanted to encourage health and biomedical research.

— please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: Jousting With Toothpicks – The Case For Challenging Corporate Journalism http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/719-jousting-with-toothpicks-the-case-for-challenging-corporate-journalism.html.

Groups sue to block Arkansas’ 12-week abortion ban

LITTLE ROCK, Ark. (AP) — A pair of advocacy groups went to federal court Tuesday claiming that Arkansas‘ legislators violated the constitutional rights of two doctors, and their potential patients, by banning nearly all abortions beginning in the 12th week of pregnancy.

The American Civil Liberties Union of Arkansas and the Center for Reproductive Rights, which filed the suit on behalf of Dr. Louis Jerry Edwards and Dr. Tom Tvedten, who provide abortions at a Little Rock clinic, say Arkansas’ ban clearly contradicts the standard of viability established by the U.S. Supreme Court‘s landmark Roe v. Wade decision.

“We are asking the court to block an attempt to essentially outlaw all abortions past 12 weeks, so early that a woman might not know the complete health and status of her pregnancy,” Rita Sklar, executive director of Arkansas’ ACLU chapter, said at a news conference.

When the Republican-led Legislature passed the law last month, it was briefly the most restrictive abortion law in the country, including a near-ban at 20 weeks that it passed a week earlier. In each case, lawmakers overrode a veto by Democratic Gov. Mike Beebe, who predicted that neither law would stand up in court and that Arkansas would waste money defending them.

North Dakota has since passed and even tighter restriction: 6 weeks.

The lawsuit contends that Edwards and Tvedten could lose their licenses if they provide abortions starting at the 12th week of pregnancy, meaning the law denies “patients their constitutionally-guaranteed right to decide to end a pre-viability pregnancy.” It names members of the State Medical Board as defendants because the board is responsible for licensing medical professionals.

Arkansas’ 12-week ban is tied to the date at which a fetal heartbeat can typically be detected by an abdominal ultrasound. The ban includes exemptions for rape, incest, the life of the mother and highly lethal fetal disorders.

The lawsuit filed Tuesday does not challenge Arkansas’ 20-week measure, as challenges to similar laws in other states are already pending. The 20-week ban is based on the disputed claim that a fetus can feel pain by the 20th week and therefore deserves protection from abortion. It includes the same exemptions as the 12-week ban, except for fetal disorders.

Rose Mimms, the executive director of Arkansas Right to Life, said anti-abortion groups like hers are hopeful that the new abortion restrictions being passed in conservative-leaning states will land before the U.S. Supreme Court and be considered against new discoveries regarding fetal development.

“They didn’t have that kind of information when they decided Roe v. Wade,” Mimms said, referring to the 1973 decision that legalized abortion until a fetus could viably survive outside the womb. A fetus is generally considered viable at 22 to 24 weeks.

Arkansas’ ban on abortions at 20 weeks took effect immediately when legislators overrode Beebe’s veto. The 12-week ban is scheduled to take effect 90 days after the Legislature adjourns, which could occur late this week or early next week.

Sklar said the Supreme Court has recognized that the Constitution protects a woman’s ability to make her own decision regarding abortions.

“But our state Legislature ignored the law and voted to take a woman’s decision-making ability away,” Sklar said.

A lead sponsor of the 12-week ban, Republican state Sen. Jason Rapert, said he hadn’t seen the lawsuit yet, but he said it wasn’t a surprise.

“We definitely are planning to defend it,” he said. “It’s a law duly passed by the state of Arkansas.”

___

Associated Press writer Andrew DeMillo contributed to this report.

___

Follow Jeannie Nuss at http://twitter.com/jeannienuss

— please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: Jousting With Toothpicks – The Case For Challenging Corporate Journalism http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/719-jousting-with-toothpicks-the-case-for-challenging-corporate-journalism.html.

EU: Test show no safety issues with horsemeat

BRUSSELS (AP) — More than 7,000 tests across the European Union have shown that nearly 5 percent of the food products labeled as beef contained horse meat, but there is no danger to public health, officials said Tuesday.

The tests showed that the veterinary anti-inflammatory drug phenylbutazone, or bute, was present in about .5 percent of the horse meat, the EU said in a statement. Bute is banned for human use because in rare cases it causes severe side effects, but veterinary experts say there is little risk from consuming small amounts of the drug in horse meat.

“Today’s findings have confirmed that this is a matter of food fraud and not of food safety,” European Health Commissioner Tonio Borg said in the statement. He said restoring consumer confidence was vital, and promised to propose in the coming months tougher fines for the fraudulent labeling of food.

He also pledged to develop measures “to strengthen the controls along the food chain.”

The scandal broke in mid-January, when Ireland’s food safety watchdog announced that it had discovered traces of horse DNA in burger products sold by major British and Irish supermarkets. The mislabeled products came from Irish processor Silvercrest Foods, which withdrew 10 million burgers from store shelves.

Irish officials first blamed an imported powdered beef-protein additive used to pad out cheap burgers, then frozen blocks of slaughterhouse leftovers imported from Poland — an indication of the complexity of the food-supply chain that was about to be revealed to an alarmed European public.

Subsequently, traces of horse meat turned up across Europe in frozen supermarket meals such as burgers and lasagna, as well as in in fresh beef pasta sauce, on restaurant menus, in school lunches and in hospital meals.

Millions of products were pulled from store shelves in Britain, Ireland, France, Spain, Germany, Denmark, Sweden and Norway, and supermarkets and food suppliers were told to test processed beef products for horse DNA.

The results announced Tuesday by the European Commission were drawn from 7,259 tests carried about by national authorities in the 27-country EU.

The statement said that 4,144 DNA tests on beef products for the presence of horse meat were conducted; 193 samples — 4.66 percent — tested positive. And 3,115 samples were tested for bute; 16 samples — 0.51 percent — showed traces of it.

Meanwhile, in the Netherlands on Tuesday, a meat processing plant and wholesaler suspected of mixing undeclared horse meat with beef was declared bankrupt by one judge and the owner went to another court in a bid to halt a huge recall that has crippled his business.

Dutch authorities are recalling 50,000 tons of meat sold as beef across Europe because its exact source cannot be established and it may contain horse meat. The company at the center of the accusation says that authorities are overreacting and the recall is unnecessary.

A court in the eastern Dutch city of Den Bosch declared owner Willy Selten’s plant bankrupt. He then went to a separate hearing to try to stop the recall.

— please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: Jousting With Toothpicks – The Case For Challenging Corporate Journalism http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/719-jousting-with-toothpicks-the-case-for-challenging-corporate-journalism.html.

Patenting genes: Justices tackle big health issue

WASHINGTON (AP) — The Supreme Court seemed worried Monday about the idea of companies patenting human genes in a case that could profoundly reshape the multibillion-dollar biomedical industry and U.S. research in the fight against diseases like breast and ovarian cancer.

Justices argued not only about snipping DNA strands but also about chewing the leaves of Amazonian jungle plants, the shaping of baseball bats and the ingredients of chocolate chip cookies as they tried to figure out whether companies can gain government protection — and profits — for their work with human genes.

The ability to claim control of genetic information found inside every American could hang on the nine justices’ decision later this summer, a ruling that could affect the intersection of science and the law for years to come.

“The issue here is a very difficult one,” Justice Samuel Alito said.

Abstract ideas, natural phenomena and laws of nature cannot be awarded patents, the legal protection that gives inventors the right to prevent others from making, using or selling a novel device, process or application. The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years, but opponents of Myriad Genetics Inc.’s patents on two genes linked to an increased risk of breast and ovarian cancer say such protection should not be given to something that can be found inside the human body.

“Finding a new use for a product of nature, if you don’t change the product of nature, is not patentable,” said lawyer Christopher Hansen, arguing against the patents. “If I find a new way of taking gold and making earrings out of it, that doesn’t entitle me to a patent on gold. If I find a new way of using lead, it doesn’t entitle me to a patent on lead.”

Several organizations, including the American Civil Liberties Union, the Association for Molecular Pathology, a number of doctors and researchers and some people at risk for hereditary breast and ovarian cancer, have challenged the patents.

But Myriad argues — and the patent office and a federal appeals court have agreed — that the company’s genes can be patented because the DNA that Myriad isolated from the body has a “markedly different chemical structure” from DNA within the body.

“What was ‘merely snipped’ out of the body here is fundamentally different in kind from what was in the body,” Myriad lawyer Gregory A. Castanias said. “The most important reason it’s different in kind is that it cannot be used in the body to detect the risk of breast and ovarian cancers.”

The company has used its patent to come up with its BRACAnalysis test, which looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer. Women with a faulty gene have a three to seven times greater risk of developing breast cancer and also a higher risk of ovarian cancer.

Myriad sells the only BRCA gene test. Opponents of its patents say the company can use its patents to keep other researchers from working with the BRCA gene to develop other tests.

In such matters, companies can have billions of dollars of investment and years of research on the line. Their advocates argue that without the ability to recoup their investment through the profits that patents bring, breakthrough scientific discoveries to combat all kinds of medical maladies wouldn’t happen. That concerned several justices.

“Why shouldn’t we worry that Myriad or companies like it will just say, ‘Well, you know, we’re not going to do this work anymore?’” Justice Elena Kagan asked.

Hansen said that a company could get recognition for its work and that money for research would always be available, a statement that Justice Anthony Kennedy said wasn’t sufficient.

“I don’t think we can decide the case on, ‘Don’t worry about investment. It’ll come,’” Kennedy said.

Justices attempted to break the argument down to an everyday level by discussing things like chocolate chip cookies, baseball bats and jungle plants.

Castanias, the Myriad lawyer, argued that the justices could think about the gene question like a baseball bat. “A baseball bat doesn’t exist until it’s isolated from a tree. But that’s still the product of human invention to decide where to begin the bat and where to end the bat,” he said.

That didn’t work for Chief Justice John Roberts.

“The baseball bat is quite different. You don’t look at a tree and say, well, I’ve cut the branch here and cut it here and all of a sudden I’ve got a baseball bat. You have to invent it, if you will,” Roberts said. “You don’t have to invent the particular segment of the strand. You just have to cut it off.”

The court moved on to body parts. Said Justice Sonia Sotomayor, “If you cut off a piece of the whole in the kidney or liver, you’re saying that’s not patentable, but you take a gene and snip off a piece, that is? What’s the difference between the two?”

Castanias tried again, comparing the company’s patented genes to medicine.

“It’s important to note that molecules have been patented for a very long time. That’s what drugs are. And drugs are often made by taking one molecule and another molecule, both of which are known, reacting them in a test tube,” he said. “Reactions have been around 100 years just like snipping has been, but they make something new and useful and lifesaving from that.”

Roberts still wasn’t convinced. “Well, I don’t understand how this is at all like that, because there you’re obviously combining things and getting something new. Here you’re just snipping, and you don’t have anything new, you have something that is a part of something that has existed previous to your intervention,” he said.

That was the ruling of the original judge who looked at Myriad’s patents after they were challenged by the ACLU in 2009. U.S. District Judge Robert Sweet said he invalidated the patents because DNA’s existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body or the information it encodes. But the federal appeals court reversed him in 2011, saying Myriad’s genes can be patented because the isolated DNA has a “markedly different chemical structure” from DNA within the body.

The Supreme Court threw out that decision and sent the case back to the lower courts for rehearing. That came after the high court unanimously threw out patents on a Prometheus Laboratories Inc. test that could help doctors set drug doses for autoimmune diseases like Crohn’s disease. The justices said the laws of nature are unpatentable.

But the federal circuit upheld Myriad’s patents again in August, leading to the current review.

The court will rule before the end of the summer.

The case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.

— please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: Jousting With Toothpicks – The Case For Challenging Corporate Journalism http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/719-jousting-with-toothpicks-the-case-for-challenging-corporate-journalism.html.

A new case in China adds unknowns to bird flu

BEIJING (AP) — A new case of bird flu in China‘s capital, a 4-year-old boy who displayed no symptoms, is adding to the unknowns about the latest outbreak that has caused 63 confirmed cases and 14 deaths, health officials said Monday.

The boy, who tested positive for the H7N9 virus, is considered a carrier of the strain and has been placed under observation to see if he develops symptoms, health authorities said. Medical teams found the boy in a check of people who had contact with a 7-year-old girl, who was confirmed as Beijing’s first case of H7N9 over the weekend: a neighbor of the boy bought chicken from the girl’s family.

Beijing Health Bureau deputy director Zhong Dongpo said that, as puzzling as the case is, the boy adds another data point to medical experts limited understanding of H7N9.

“This is very meaningful because it shows that the disease caused by this virus has a wide scope. It’s not only limited to critical symptoms. There can also be slight cases, and even those who don’t feel any abnormality at all. So we need to understand this disease in a rational and scientific way,” Zhong said at a news briefing.

The H7N9 strain was not previously known to infect humans before cases turned up in China this winter, and Zhong and other medical experts said no evidence exists that the virus can be passed from one person to another. Close contact with infected birds is a likely source of transmission. Making the virus hard to detect is that infected poultry display slight or no symptoms, unlike the H5N1 strain which kills birds and raged across the region in the middle of the last decade.

The appearance of cases with mild or no symptoms in humans could make tracing even more difficult, but may also mean that many people infected do not get seriously ill and recover quickly, making the virus is less deadly than it appears.

Most of the cases have occurred in eastern China. In recent days, with hospitals and health officials on alert, cases have turned up in Beijing and the populous central province of Henan. The confirmed death toll from the virus ticked up by one Monday, a 77-year-old woman in Jiangsu, while three more cases were confirmed in eastern provinces, for a total of 63, according to reports from provincial health bureaus.

— please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: Jousting With Toothpicks – The Case For Challenging Corporate Journalism http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/719-jousting-with-toothpicks-the-case-for-challenging-corporate-journalism.html.

Newtown parents back study for clues to violence

HARTFORD, Conn. (AP) — As parents, Jeremy Richman and Jennifer Hensel were plunged into grief when their only child, 6-year-old Avielle, was killed in the massacre at Sandy Hook Elementary School. As scientists, they wanted answers about what could lead a person to commit such violence.

The couple believes it’s unlikely there ever will be a full answer explaining why a man gunned down 26 people inside the Newtown, Conn., school last year. But they feel more research into brain health — and how a propensity for violence is manifested — could help prevent future tragedies.

“When we started reaching out to scientists to talk about the underpinnings of violence and how this particular factor played a role in what happened to us, there is some, but no real, research going on this field,” Hensel said.

On Monday, they announced a scientific advisory board for the Avielle Foundation, which was established with the goal of reducing violence. While some other victims’ families have immersed themselves in the push for tighter gun restrictions, Avielle Richman‘s parents see the foundation named for their curly-haired daughter as their response to a tragedy that has launched advocacy work on many fronts, including school safety and mental illness.

The Dec. 14 massacre was carried out by 20-year-old Adam Lanza, who killed 20 first-graders and six educators inside the school with a military-style semi-automatic rifle before committing suicide. The isolated, socially awkward Lanza played first-person shooter video games in a weapon-filled house where he lived with his mother, according to search warrants released last month, but authorities have not described a possible motive or released details of any medical condition that might shed light on his actions.

Avielle, a girl who loved horses, Harry Potter and the color red, had moved to Connecticut with her family about two years before the shooting. Her father kept a blog called “Avielle’s Adventures,” telling friends about a trip to a Thanksgiving Day parade, her 6th birthday at a horse stable, a road trip to Iowa.

Jeremy Richman is a researcher at the pharmaceutical company Boehringer Ingelheim. Hensel, his wife, is a medical writer with her own company. The foundation is a way for them to harness their training and skills — and to channel their grief.

“I think the best way to help from a tragedy such as this is by action where your strengths lie,” Hensel said. “This is our motivation now. We will never stop being parents to Avielle.”

The Avielle foundation, funded through donations and grants, aims to raise $ 5 million this year and begin reviewing its first grant applications later this year.

One member of the foundation’s advisory board, Terrie E. Moffitt, said science on the origins of violence has been neglected by federal agencies that provide research grants.

“Families of individuals with autism, ADHD, learning problems or schizophrenia demand that funding agencies support research into these disorders,” said Moffitt, a neuroscience professor at Duke University and at the Institute of Psychiatry, King’s College London. “Families of violent individuals don’t.”

The other members of the board announced Monday are R. John Krystal, chair of the psychiatry department at the Yale University School of Medicine, and James Blair, chief of the unit on affective cognitive neuroscience at the National Institute of Mental Health.

The Avielle Foundation says it hopes to remove stigmas for people seeking mental health aid, develop the concept of a “brain health check-up,” and identify behavioral and biochemical diagnostics for detection of people at risk of violent behaviors.

— please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: Jousting With Toothpicks – The Case For Challenging Corporate Journalism http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/719-jousting-with-toothpicks-the-case-for-challenging-corporate-journalism.html.

Court: Can human genes be patented?

WASHINGTON (AP) — DNA may be the building block of life, but can something taken from it also be the building block of a multimillion-dollar medical monopoly?

The Supreme Court grapples Monday with the question of whether human genes can be patented. Its ultimate answer could reshape U.S. medical research, the fight against diseases like breast and ovarian cancer and the multi-billion dollar medical and biotechnology business.

“The intellectual framework that comes out of the decision could have a significant impact on other patents — for antibiotics, vaccines, hormones, stem cells and diagnostics on infectious microbes that are found in nature,” Robert Cook-Deegan, director for genome ethics, law & policy at Duke University, said in a statement.

“This could affect agricultural biotechnology, environmental biotechnology, green-tech, the use of organisms to produce alternative fuels and other applications,” he said.

The nine justices’ decision will also have a profound effect on American business, with billions of dollars of investment and years of research on the line. The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years.

And Myriad Genetics alone has $ 500 million invested in the patents being argued over in this case. Without the ability to recoup that investment, breakthrough scientific discoveries needed to combat all kind of medical maladies wouldn’t happen, the company says.

“Countless companies and investors have risked billions of dollars to research and develop scientific advances under the promise of strong patent protection,” said Peter D. Meldrum, the president and CEO of Myriad Genetics, in a statement.

But their opponents argue that allowing companies like Myriad to patent human genes or parts of human genes will slow down or cripple lifesaving medical research like in the battle against breast cancer.

“What that means is that no other researcher or doctor can develop an additional test, therapy or conduct research on these genes,” said Karuna Jagger, executive director of Breast Cancer Action.

The Supreme Court has already said that abstract ideas, natural phenomena and laws of nature cannot be given a patent, which gives an inventor the right to prevent others from making, using or selling a novel device, process or application.

Myriad’s case involves patents on two genes linked to increased risk of breast and ovarian cancer. Myriad’s BRACAnalysis test looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer.

Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer. Men can also carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer. The mutations are most common in people of eastern European Jewish descent.

Myriad sells the only BRCA gene test.

The American Civil Liberties Union challenged Myriad’s patents, arguing that genes couldn’t be patented, and in March 2010 a New York district court agreed. But the U.S. Court of Appeals for the Federal Circuit has now twice ruled that genes can be patented. In Myriad’s case, it’s because the isolated DNA has a “markedly different chemical structure” from DNA within the body.

Mark C. Capone, president of Myriad Genetics Laboratories, Inc., a subsidiary of Myriad, said some of the concerns over what they have patented are overblown and some simply incorrect.

“Myriad cannot, should not and has not patented genes as they exist in the human body on DNA,” Capone said in an interview. “This case is truly about isolated DNA molecules which are synthetic chemicals created by the human ingenuity of man that have very important clinical utilities, which is why this was eligible for a patent.”

But the ACLU is arguing that isolating the DNA molecules doesn’t stop them from being DNA molecules, which they say aren’t patentable.

“Under this theory, Hans Dehmelt, who won the Nobel Prize for being the first to isolate a single electron from an atom, could have patented the electron itself,” said Christopher A. Hansen, the ACLU’s lawyer in court papers. “A kidney removed from the body (or gold extracted from a stream) would be patentable subject matter.”

The Obama administration seems to agree. Artificially created DNA can be patented, but “isolated but otherwise unmodified genomic DNA is not patent-eligible,” Solicitor General Donald Verrilli said in court papers.

That was the ruling of the original judge who looked at Myriad’s patents after they were challenged by the ACLU in 2009. U.S. District Judge Robert Sweet said he invalidated the patents because DNA’s existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body or the information it encodes. But the federal appeals court reversed him in 2011, saying Myriad’s genes can be patented because the isolated DNA has a “markedly different chemical structure” from DNA within the body.

The Supreme Court threw out that decision and sent the case back to the lower courts for rehearing. This came after the high court unanimously threw out patents on a Prometheus Laboratories, Inc., test that could help doctors set drug doses for autoimmune diseases like Crohn’s disease, saying the laws of nature are unpatentable.

But the federal circuit upheld Myriad’s patents again in August, leading to the current review. The court will rule before the end of the summer.

“The key issue now for the court will therefore be whether the scientist working in the lab to isolate a particular gene innovated in a way that allows for that isolated gene to be patented,” said Bruce Wexler, a lawyer with the law firm Paul Hastings, who advises pharmaceutical and biotech companies on patent issues.

The case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.

— please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: Jousting With Toothpicks – The Case For Challenging Corporate Journalism http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/719-jousting-with-toothpicks-the-case-for-challenging-corporate-journalism.html.

Report finds lax oversight of specialty pharmacies

WASHINGTON (AP) — Congressional investigators say pharmacy boards in nearly all 50 states lack the information and expertise to oversee specialty pharmacies like the one that triggered a deadly meningitis outbreak last year.

A report released Monday by House Democrats shows that most states do not track or routinely inspect compounding pharmacies. Staffers surveyed officials in 50 states about their oversight of pharmacies and then compiled the responses.

The findings come as lawmakers debate how to prevent another outbreak like that caused by the New England Compounding Center, a Massachusetts compounding pharmacy. Contaminated injections distributed by the company last year have killed more than 50 people and sickened hundreds more.

Compounding pharmacies, which mix customized medications based on doctors’ prescriptions, have traditionally been overseen by state pharmacy boards. But the growth of larger compounding pharmacies like the NECC, which mass-produced and distributed thousands of vials of drugs across the U.S., has prompted calls for more federal oversight.

The report from Democrats on the House Energy and Commerce Committee argues that state regulators are not adequately policing the space, and that the Food and Drug Administration should be given direct authority over the pharmacies.

“In states from coast to coast, compounding pharmacies are going untracked, unregulated, and under-inspected, exposing patients everywhere to tainted drugs, disease and death,” said Rep. Ed Markey, D-Mass, in a statement. Markey represents the congressional district where NECC is located.

Of the 49 states that responded to the inquiry, only officials from Missouri and Mississippi could provide the exact number of compounding pharmacies in their state. Missouri and Mississippi were also the only two states that require permits or licenses for pharmacies that perform compounding.

None of the states indicated that they track whether pharmacies sell compounded drugs across state lines or in large quantities. That kind of mass production was a key issue in the case of NECC, which shipped more than 17,600 doses of its pain injection to 23 states.

Investigators found that many states do not keep any inspection records of compounding pharmacies. Twenty-two states, or 44 percent, said they do not keep histories of problems like contamination, cleanliness and drug potency. Other states said they use a combination of inspection reports, complaints and “staff recollections,” to track problematic pharmacies.

On average, most pharmacy boards have five inspectors responsible for visiting all the pharmacies in the state. Budgets vary greatly from state to state, with Nevada providing $ 3,000 in funding for each pharmacy in the state and Indiana providing with less than $ 200 per pharmacy. Only 19 states train inspectors to recognize problems with sterile compounding, which is considered the riskiest type of compounding because it requires highly sanitary conditions and complicated production techniques.

“This report clearly indicates what we’ve known for quite some time — that there is no clear, functioning, or uniform process for all 50 states to manage and oversee compounding pharmacies,” said Rep. John Dingell, D-Mich., in a statement. Dingell’s office helped conduct the survey.

The findings will likely come into play on Tuesday, when a House investigative committee holds its second hearing on the meningitis outbreak. Republicans on that committee have argued that the FDA could have shut down the NECC using its existing powers. Lobbyists for the compounding industry generally share that view, and have fought proposals to give the federal government more authority over compounding for decades.

Last week House Democrats released dozens of documents from the International Academy of Compounding Pharmacists, the industry’s leading trade group. The documents include internal memos to members suggesting how they deal with FDA inspectors, in particular: “when a pharmacist should NOT provide certain information to the FDA,” and “when pharmacists should draw the line and discontinue the visit and call their attorney.”

Democrats on the House Energy & Commerce Committee suggested the CEO of the trade group should testify at Tuesday’s hearing. However, Democratic staffers said late last week they had not received a response on that request from Republicans, who control the chamber.

FDA Commissioner Margaret Hamburg is schedule to testify.

— please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: Jousting With Toothpicks – The Case For Challenging Corporate Journalism http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/719-jousting-with-toothpicks-the-case-for-challenging-corporate-journalism.html.

Death toll from bird flu in China rises to 13

BEIJING (AP) — Two more people have died in China from a new strain of bird flu, raising the death toll from the virus to 13, state media reported Sunday.

The official Xinhua News Agency said the two deaths were reported in Shanghai and that three new cases were also confirmed in the financial hub. A total of 11 new cases were reported Sunday — including two in a central province that previously had been unaffected. In all, 60 cases of the virus, known as H7N9, have been reported in China.

The two cases reported Sunday in central Henan province, which is next to Beijing, followed an announcement Saturday that a 7-year-old girl had become the first person in the capital to be infected with the virus. All previous reported cases were in Shanghai and other eastern areas of China.

A World Health Organization official said Sunday that it wasn’t surprising that the virus had spread to Beijing.

Michael O’Leary, head of WHO’s office in China, said it’s not the case that everyone confirmed to be infected with H7N9 was “clustered in one small area with the same source of exposure.”

“So we’ve been expecting new cases to occur. … Furthermore, we still expect that there will be other cases,” he said.

Four new cases were reported Sunday in eastern Zhejiang province and two more in Jiangsu.

Health officials believe the virus, which was first spotted in humans last month, is spreading through direct contact with infected fowl.

O’Leary said “the good news” was that there was still no evidence that humans had passed on the virus to other humans.

“As far as we know, all the cases are individually infected in a sporadic and not connected way,” he said, adding that the source of infection was still being investigated.

The girl from Beijing, whose parents are in the live poultry trade, was admitted to a hospital Thursday with symptoms of fever, sore throat, coughing and headache, the Beijing Health Bureau said.

O’Leary said early treatment can be effective, as demonstrated by the girl, who was in stable condition.

In the only other reported cases outside of eastern China, health officials in Henan province said tests on two men Thursday had later revealed they had the virus.

They said a 34-year-old restaurant chef who had displayed flu symptoms for about a week was in critical condition in a hospital, while a 65-year-old farmer who was in frequent contact with poultry was in stable condition after receiving treatment.

They said 19 people who had been in close contact with the two men did not show any flu symptoms.

China has been more open in its response to the new virus than it was a decade ago with an outbreak of SARS, when authorities were highly criticized for not releasing information.

— please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: Jousting With Toothpicks – The Case For Challenging Corporate Journalism http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/719-jousting-with-toothpicks-the-case-for-challenging-corporate-journalism.html.

WHO official: Beijing bird flu case not surprising

BEIJING (AP) — A World Health Organization official said Sunday that it wasn’t surprising that a new strain of bird flu had spread to China‘s capital after sickening dozens of people in the eastern part of the country.

Up until Saturday, when Beijing officials reported the capital’s first case of H7N9, all cases had been in Shanghai and other areas of eastern China. On Sunday, officials announced the first two cases in central Henan province, which is next to Beijing.

It’s not the case that everyone confirmed to be infected with H7N9 was “clustered in one small area with the same source of exposure,” said Michael O’Leary, head of WHO’s office in China. “So we’ve been expecting new cases to occur. … Furthermore, we still expect that there will be other cases.”

A 7-year-old girl was Beijing’s first confirmed case of H7N9. Four more cases were reported Sunday in eastern Zhejiang province and two more in Jiangsu, bringing to 57 the number of people sickened from the virus. Eleven of the victims have died.

Health officials believe the virus, which was first spotted in humans last month, is spreading through direct contact with infected fowl.

O’Leary said “the good news” was that there was still no evidence that humans had passed on the virus to other humans.

“As far as we know, all the cases are individually infected in a sporadic and not connected way,” he said, adding that the source of infection was still being investigated.

The girl, whose parents are in the live poultry trade, was admitted to a hospital Thursday with symptoms of fever, sore throat, coughing and headache, the Beijing Health Bureau said.

O’Leary said early treatment can be effective, as demonstrated by the girl, who was in stable condition.

In the only other reported cases outside of eastern China, health officials in Henan province said tests on two men Thursday had later revealed they had the virus.

They said a 34-year-old restaurant chef who had displayed flu symptoms for about a week was in critical condition in a hospital, while a 65-year-old farmer who was in frequent contact with poultry was in stable condition after receiving treatment.

They said 19 people who had been in close contact with the two men did not show any flu symptoms.

China has been more open in its response to the new virus than it was a decade ago with an outbreak of SARS, when authorities were highly criticized for not releasing information.

— please read the FAQ at fivefilters.org/content-only/faq.php#publishers. Five Filters recommends: Jousting With Toothpicks – The Case For Challenging Corporate Journalism http://www.medialens.org/index.php/alerts/alert-archive/alerts-2013/719-jousting-with-toothpicks-the-case-for-challenging-corporate-journalism.html.