Government report shows low UK medicine prices

LONDON (Reuters) - Britain, which is planning a radical overhaul of its medicine pricing system from 2014, already has some of the lowest prices in Europe, according to a government report Thursday.

The findings were seized on by pharmaceutical companies as evidence that existing voluntary price-control measures were working well and that the state-run National Health Service (NHS) was getting good value for money.

Health minister Andrew Lansley, however, sees room for improvement. From the end of 2013, he aims to switch to a new system of "value-based pricing" - a concept that has so far been only sketchily defined.

The Association of the British Pharmaceutical Industry (ABPI) is due to start detailed talks on how the system will work in late summer 2012.

Drug prices are under growing pressure across Europe as governments tackle ballooning budget deficits and firms fear the British changes might lead to direct price controls or further obstacles to launching new therapies.

The current Pharmaceutical Price Regulation Scheme (PPRS), which companies would be happy to retain, controls the prices of branded drugs by regulating profits they are allowed to make on sales to the NHS.

In its latest report to parliament, the Department of Health confirmed that the PPRS was, by and large, doing its job.

In particular, British medicine prices in 2010 were found to be lower than those in any of 10 other comparator European countries. U.S. prices were on average more than 2-1/2 times more expensive. (http://link.reuters.com/fem76s)

The picture was slightly different, however, when average exchange rates over the last five years were used. On this basis, prices were still significantly lower than in the United States and also lower than in Australia, Austria, Belgium, Germany, Ireland and Sweden, but not as cheap as in Finland, Spain and France.

Despite low prices, British drugmakers, including GlaxoSmithKline and AstraZeneca, argue that patients still struggle to access new medicines, with use of new cancer drugs 33 percent lower than in the rest of Europe.

The increasingly tough environment for drugs is a growing concern for pharmaceutical companies across Europe, some of which have started to relegate the region when it comes to developing new medicines.

Ratings agency Standard & Poor's said in a report on Wednesday that harsher conditions at home also meant Europe's big pharmaceutical firms had been faster to tap into new emerging markets than their U.S. peers.

(Reporting by Ben Hirschler)

View the original article here

Salvadoran May Be Deported From U.S. for ’80 Murders of Americans

The decision by Judge James Grim of immigration court in Orlando is the first time that federal immigration prosecutors have established that a top-ranking foreign military commander can be deported based on human rights violations under a law passed in 2004, in the aftermath of the Sept. 11 terrorist attacks, intended to bar human rights violators from coming to or living in the United States.

Judge Grim found that General Vides assisted in the killings of four American churchwomen on a rural road in El Salvador in 1980, a crime that caused shock there and in Washington and presaged the bloody violence that would engulf the Central American nation for the next decade. The immigration judge’s ruling is the first time General Vides has been held responsible for those deaths in a court of law.

Five soldiers from the Salvadoran National Guard were eventually convicted of the killings and served long prison sentences. General Vides was the commander of the National Guard at the time of the murders.

The effort by Department of Homeland Security officials to seek the deportation of General Vides, who was El Salvador’s defense minister from 1983 to 1989, is a turnabout in American foreign policy. He was a close ally of Washington throughout the war against leftist guerrillas in the 1980s, and was embraced as a reformer despite rampant rights violations by the armed forces under his command.

Judge Grim also determined that General Vides had assisted in the torture of two Salvadorans, Juan Romagoza and Daniel Alvarado, who testified against him in hearings last spring in the immigration court in Orlando.

“This is the first case where the Department of Homeland Security has taken this relatively new law and applied it to the highest military commander of their country to seek their removal,” said Carolyn Patty Blum, senior legal adviser for the Center for Justice and Accountability, a nonprofit legal group in San Francisco that represented several torture victims in the case. She called the decision “hugely significant” for future efforts to bring immigration cases for human rights abuses against the highest-level military commanders and government officials.

Many details of the judge’s decision were not available on Thursday, since in keeping with general practice in immigration courts, the ruling was not published. His main findings were described by lawyers familiar with the case.

Diego Handel, General Vides’s lawyer, said he had not had a chance to read the lengthy decision and could not comment on it.

The deportation case against General Vides was brought by prosecutors from the Human Rights Violators and War Crimes Center, a unit of Immigration and Customs Enforcement created in 2003 to focus on preventing rights violators from entering this country and deporting those already here.

General Vides contested the charges, saying he did not have any direct responsibility for, or even knowledge of, the murders and torture signaled by the government. In the hearings, witnesses, including former American diplomats, said that the general had been working to stop rights abuses by Salvadoran soldiers and to change the culture of a military known for brutality.

Judge Grim’s decision confirmed that General Vides can be deported based on the rights charges brought by the government. Federal officials and immigration lawyers cautioned that there are still several steps to go before the judge will decide whether to issue a final order for the general’s deportation. But lawyers said it would be considerably more difficult now for General Vides to avoid such an order.

A spokeswoman for Immigration and Customs Enforcement, Nicole Navas, said, “As a matter of policy, I am precluded from commenting on matters still pending before the immigration court.”

General Vides retired as defense minister in 1989, amid praise from United States officials for his performance, and came to settle in Florida as a legal permanent resident.

But the family members of the four churchwomen, as well as some Salvadorans who barely survived prolonged torture during the war, have been tenacious in seeking to hold General Vides responsible for crimes of that era.

In 2000, a Florida jury acquitted General Vides and José Guillermo García, another former Salvadoran defense minister who retired to Florida, of responsibility for the churchwomen’s murders. But in 2002, in a case brought by the Center for Justice and Accountability, another Florida jury found the two officers civilly liable for the torture of three Salvadorans and ordered them to pay $54 million. The deportation proceedings against General Vides stem from that decision.

The four churchwomen killed were Sister Dorothy Kazel of the Ursuline Order; Jean Donovan, a lay missionary; Sister Maura Clarke and Sister Ita Ford, both of the Maryknoll Order.

Sister Ita’s brother Bill Ford fought vigorously for the prosecution of General Vides. Mr. Ford died in 2008.

“Since the women were killed my father made this the single purpose of his life,” his son, Bill Ford Jr., said Thursday. Mr. Ford, who is the principal of Cristo Rey New York High School in Manhattan, said, “I’m sure he knows and is well pleased that one of the men responsible for ordering the death of the women or for the cover-up may no longer be able to live in this country to enjoy the fruits of his brutality.”

View the original article here

Mexican researchers patent heroin vaccine

MEXICO CITY (Reuters) - While Mexico grapples with relentless drug-related violence, a group of Mexican scientists is working on a vaccine that could reduce addiction to one of the world's most notorious narcotics: heroin.

Researchers at the country's National Institute of Psychiatry say they have successfully tested the vaccine on mice and are preparing to test it on humans.

The vaccine, which has been patented in the United States, works by making the body resistant to the effects of heroin, so users would no longer get a rush of pleasure when they smoke or inject it.

"It would be a vaccine for people who are serious addicts, who have not had success with other treatments and decide to use this application to get away from drugs," the institute's director Maria Elena Medina said Thursday.

Scientists worldwide have been searching for drug addiction vaccines for several years, but none have yet been fully developed and released on the market.

One group at the U.S. National Institute on Drug Abuse has reported significant progress in a vaccine for cocaine.

However, the Mexican scientists appear to be close to making a breakthrough on a heroin vaccine and have received funds from the U.S. institute as well as the Mexican government.

During the tests, mice were given access to deposits of heroin over an extended period of time. Those given the vaccine showed a huge drop in heroin consumption, giving the institute hope that it could also work on people, Medina said.

Kim Janda, a scientist working on his own narcotics vaccines at the Scripps Research Institute in La Jolla, California, said that based on some earlier research papers he had read, the Mexican vaccine could function but with some shortcomings.

"It could be reasonably effective but maybe too general and affect too many different types of opioids as well as heroin," Janda said.

Mexico, a major drug producing and transit country for drugs smuggled into the United States, has a growing drug addiction problem. Health Secretary Jose Cordoba recently said the country now has some 450,000 hard drug addicts, particularly along the trafficking corridors of the U.S. border.

Mexican gangsters grow opium poppies in the Sierra Madre mountains and convert them into heroin known as Black Tar and Mexican Mud, which are smuggled over the Rio Grande.

Every year, the heroin trade provides billions of dollars to gangs like the Sinaloa Cartel and the Zetas. Since 2006, cartel violence has claimed the lives of over 47,000 people in Mexico.

(Additional reporting by Jorge Lebrija; Editing by Anthony Boadle)

View the original article here

World Briefing | The Americas: Argentina: Finger-Pointing Over Wreck

In Hollywood, there are untold screenwriters, actors, directors and others invisibly struggling to keep their homes.

The White House strategy of offering prizes to the public for their solutions to critical problems is working.

View the original article here

Meat Industry Spreads MRSA: Go Vegetarian Now

COMMENTARY | When I first went vegetarian seven years ago, I chose to do it for the environment. Knowing the impact of the meat industry on our planet -- the pollution of waterways, the emission of greenhouse gases, and the clear-cutting of ancient rainforest -- I could not, in good conscience, allow myself to eat meat. Concern for the planet still plays a role in my decision to avoid meat, but another factor also comes into play: concern for the health of my fellow humans. The meat industry is largely responsible for a dangerous, looming pandemic that currently claims the lives of 20,000 Americans each year. Out of concern and respect for those people, I choose not to eat meat.

According to a report by ABC's Mikaela Conley, new strains of the bacterium methicillin-resistant staphylococcus aureas, or MRSA, are continuously discovered in livestock, and these strains may be spreading to human beings. On large-scale factory farms, where animals are kept in unnaturally confined, unsanitary quarters, livestock must be fed massive amounts of antibiotics in order to prevent infection. Bacteria quickly build up resistance to these drugs, with the particularly virulent "superbug" MRSA becoming increasingly untreatable. When these bacteria jump from animal to human, severe infection and death can ensue.

My personal experience with MRSA makes the bug an especially sensitive topic. At 17, I developed a horrendously painful boil under my arm. After two minor surgeries and three mysteriously ineffective rounds of antibiotics, a culture revealed that MRSA was to blame for the infection. Even after the doctors discovered this, it took a year and a half of monthly minor surgeries, combined with regular injections of the world's strongest antibiotics, before the infection finally resolved. I was young, healthy, and blessed with access to medical care. Had I been older, immunocompromised, or uninsured, the bug could have easily claimed my life.

MRSA can and does claim new victims each day, and the numbers of casualties will grow higher as we continue to overuse antibiotics -- especially in livestock. Although the increasingly resistant MRSA strains aren't likely to jump to human victims through prepared meat, they can easily spread to the people who work on factory farms. I find this particularly disturbing, since many factory farm workers are undocumented immigrants, and almost all lack access to medical care. This means that the infections in farm workers are likely to go undiagnosed and untreated, so they can spread rapidly to the general population.

The abuse of antibiotics absolutely must stop. Overuse of these miracle drugs has led to a new era of untreatable illness, and we are mere decades away from pandemic if we don't change our ways. While antibiotics are necessary in many cases for human health, the factory farm industry is a colossal and dangerous machine that we do not need, that does no good to humans, animals, or the environment.

You do not have to be a tree-hugger or an animal lover to see the benefits of vegetarianism. Respect for human life, and a desire to halt the spread of untreatable illness, can and should be an equally valid motivation. I can't change the world or stop the spread of MRSA myself, but I'll keep declining my friends' invitations to McDonald's -- not just for myself, for cattle, or for the planet, but also to help save the lives of other human beings.

Juniper Russo is an activist, freelance writer, health advocate, and full-time mom living in Chattanooga, Tenn.

View the original article here

Profits Over People Mean Drug Shortages and Suffering

COMMENTARY | Did you know that if you are diagnosed with cancer any time in the near future, you may not get the drugs you need to stay alive? News on WebMD states that patients are suffering as drug shortages snowball. I first read about drug shortages early last year, as some of my cancer survivor blogger friends dealt with the terror of trying to stay alive without the drugs they knew would keep their disease at bay. According to Daniel J. DeNoon of WebMD, shortages have been going on since 2001 and are steadily increasing.

The WebMD article specifically mentions leukemia drugs. I provide massage therapy in a children's hospital, and many of the patients I see are fighting leukemia. Modern medicine has made enormous strides in the treatment of this childhood cancer. Some types of leukemia are largely curable with the right chemotherapy. Without it, these children will not beat their cancer and they will die. How can this be? In whose world is this acceptable?

In April last year, ABC News made a video about a shortage of cytarabine, a drug used to treat leukemia. Not having this drug means that people will die needlessly.

In June, ABC News published another video, about a Taxol shortage. I am alive today because my aggressive cancer was successfully treated in 2007 with Adriamycin, Cytoxan, Herceptin and Taxol. I was 45 years old, and my children were 7 and 9. Not having Taxol available has terrifying consequences. The speculation is that Taxol production has slowed because it is a generic drug, rendering the profit margin insignificant. A doctor on the video said, "this is not where the money is, so it does paint an unfavorable picture of the industry." Indeed.

Last week, an article was published on the Vancouver Sun about a Canadian company suspending production of numerous drugs, as it makes adjustments to bring the company into compliance with safety regulations. Why wasn't it meeting these in the first place? Profits?

Another problem is that drug companies have been under no obligation to report impending shortages to the Food and Drug Administration, so the FDA has not had the opportunity to try and prevent shortages.

Fortunately, last year President Obama signed into law legislation mandating that drug companies alert the FDA of impending shortages, so a solution can be found before lifesaving drugs become unavailable. Slowly, public awareness is growing and people are putting pressure on our lawmakers to address this problem proactively before it gets worse. Unfortunately, this does not address the needs of patients who are doing without right now.

As I approach the five-year anniversary of my diagnosis, I shudder to think what would happen to me if my cancer recurred and there was no Herceptin or Tykerb for me. I would probably die. This is the reality for many of today's cancer patients.

I hope no one you love is diagnosed with a life-threatening illness until the drug companies get their priorities straight.

Elizabeth Danu is a survivor of inflammatory breast cancer, celebrating five years on Feb. 22. She maintains a cancer resource blog at the Liberation of Persephone.

View the original article here

Health Highlights: Feb. 23, 2012

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Teen Drivers' Marijuana Use Causes Concern

Teens who drive while high on marijuana appear to be a growing problem.

Pot smoking is up among teens and use of the drug among high school students is higher than it has been in three decades, finds new survey data compiled by Students Against Destructive Decisions (SADD) and the insurance industry, the Washington Post reported.

Survey results also show that 19 percent of teens said they'd driven a vehicle while stoned, and more than one-third said marijuana causes no distractions to their driving, according to the information released Wednesday.

"What keeps me up at night is that this data reflects a dangerous trend toward the acceptance of marijuana and other substances compared to our study of teens conducted just two years ago," Stephen Wallace, senior adviser for policy, research and education at SADD, told the Post.

Last week, the Governors Highway Safety Association said that teen highway deaths increased in the first half of 2011, reversing an eight-year downward trend.

----

Male Y Chromosome Won't Vanish: Study

Men's Y chromosome may not wither away to nothing after all, according to a new study.

The male Y and female X chromosomes once had about 800 genes in common but the Y now carries just 19 of its ancestral genes, along with its male-determining gene, and is just a fraction of its original size, The New York Times reported.

This has led some scientists to wonder if the Y chromosome will eventually vanish and make human males a thing of the past.

But a new study suggests that the Y chromosome's gene-shedding is finished and it will shrink no more, The Times reported.

The study was published Wednesday in the journal Nature.

-----

State Can't Force Pharmacies to Sell Emergency Contraceptives: Judge

Washington state cannot force pharmacies to sell Plan B or other emergency contraceptives, a federal judge ruled Wednesday.

State regulations require pharmacies to stock and dispense drugs for which there is a demand. The regulations were implemented in 2007 after reports that some women in the state were denied access to Plan B, the Associated Press reported.

A pharmacy and two pharmacists filed a lawsuit that said the rules infringed on their religious freedom. U.S. District Judge Ronald Leighton agreed with them.

The judge ruled that the intent of the state regulations was not to promote timely access to medicine, but to override religious objections by pharmacists who believe that emergency contraceptives have an effect that's similar to abortion, the AP reported.

-----

U.S. Releases Draft Strategy to Fight Alzheimer's Disease

Finding effective ways to treat Alzheimer's disease by 2025 is the main goal of the Obama administration's draft of a national strategy to fight the disease.

That could be a huge challenge. Current treatments only temporarily ease symptoms of Alzheimer's and efforts to develop better medications have been slow, the Associated Press reported.

The draft also recommends improved training and support for caregivers of loved ones with Alzheimer's, campaigns to raise awareness about the early warning signs of the disease, increased education for doctors and other health care providers, and improved early detection of Alzheimer's.

The draft was released Wednesday and is open for public comment through March. The final strategy will be released this year, the AP reported.

More than 5 million Americans have Alzheimer's or similar dementias and that number is expected to reach as many as 16 million by 2050.

-----

View the original article here

U.S. panel backs Forest Labs drug for smoker's cough

SILVER SPRING, Maryland (Reuters) - An experimental inhaled lung treatment from Forest Laboratories Inc and Almirall SA won the support of a U.S. advisory panel on Thursday, a boost toward eventually gaining approval for the drug to treat smoker's cough.

A panel of outside expert advisers to the Food and Drug Administration voted 12-2 to recommend approval of the twice-daily drug, known generically as aclidinium bromide.

The drug treats chronic obstructive pulmonary disease (COPD), commonly called smoker's cough as it is often caused by cigarette smoking. It is the fourth-leading killer of Americans from disease.

Panelists said the lung helped patients breathe, but called for the company to do post-approval studies to test safety because some patients died from heart problems during clinical trials.

"I think the efficacy is modest, but with COPD treatments, the efficacy tends to be modest," said panel member Dr. William Calhoun, professor at the University of Texas Medical Branch.

"It seems to me that the critical question here is the safety issue."

The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by April 23.

Shares of Forest, which has a licensing agreement with Almirall to market the drug in the United States, closed up 1.2 percent at $32.21 on the New York Stock Exchange.

Forest is counting on new treatments such as aclidinium to help prop up profits after its blockbuster antidepressant Lexapro is expected to lose U.S. patent protection this year.

Up to 24 million people in the United States, and more than 100 million worldwide, suffer from COPD, which gets worse with age and can persist even if patients stop smoking.

Wall Street expects global sales of COPD treatments to exceed $5 billion in 2014.

COMPETING FOR SMOKERS

FDA staff reviewers earlier this week raised concerns about potential heart problems linked to drugs in the same class.

In the clinical trials for Forest and Almirall's lung drug, four patients taking the drug died from cardiac arrest and one from heart failure, out of a total of about 1,500 people who took the 400 microgram dose of the inhaled powder.

FDA staff said clinical trials may not have been big enough to show whether the problems came from the drug, or because patients with the disease may also have heart problems.

If approved, Forest's drug, which the company plans to sell under the name Tudorza Pressair, would compete with Boehringer Ingelheim and Pfizer Inc's Spiriva, which is also an inhaled drug that opens airways.

Other treatments for chronic lung disease are inhaled steroids such as AstraZeneca Plc's Symbicor and GlaxoSmithKline Plc's Advair.

Forest gained U.S. approval last year for Daliresp, a tablet that treats exacerbations caused by chronic lung disease.

"Today shows our commitment to the COPD community with a second product to treat a very common disease," said Dr. Marco Taglietti, senior vice president for research and development at Forest Laboratories.

"Certainly we're very pleased the committee has agreed the product is effective and has adequate safety to be approved."

(Reporting by Anna Yukhananov; editing by Gary Hill and Andre Grenon)

View the original article here

US health experts give nod to new obesity drug

More Americans died in 2007 of hepatitis C infection, which causes incurable liver disease, than from the virus that causes AIDS, US health authorities said this week.

View the original article here

Amalia de Fortabat, 90, Dies; Noted for Art and Scandal

Her family announced her death.

Mrs. Fortabat was married to another man when the cement mogul Alfredo Fortabat, 27 years her senior and also married, asked her to dance. As he recounted the story to biographers, he had followed her to Paris from Argentina to ask that question. She said yes. He told her he loved her. They traveled through France, Italy and the Aegean. He asked her to marry him. She said yes again.

The romance was the talk of Buenos Aires. Soon, two divorces ensued, at a time when that was not easily done in heavily Roman Catholic Argentina. They were married in Uruguay in 1947 and reaffirmed their vows in ceremonies four more times.

Mr. Fortabat died of a stroke in 1976 at the age of 81, leaving Mrs. Fortabat with a cement conglomerate, more than a million acres of ranchland, 170,000 head of cattle, three airplanes, a helicopter, a yacht and real estate around the world, including a 14-room duplex in the Pierre hotel in Manhattan.

After a period of mourning, Mrs. Fortabat went to work managing the company, Loma Negra, Argentina’s biggest supplier of cement and concrete. She became known as the “Dama del Cemento” — the cement lady. She won government contracts from the military dictatorship of the 1970s to build dams, roads and stadiums while tripling the company’s assets. Before long it had captured three-quarters of the nation’s cement business.

“I went to work as if I understood everything,” she said. “And, finally, I understood very well.”

She amassed a fortune estimated at $1.8 billion, though America Economia, a Latin American business magazine, now lists it as $902 million. Still, it made her the third-richest person in Argentina and the richest woman there at her death.

As a businesswoman, she diversified into fields like banks, a newspaper, a radio station and an 1,800-mile railroad. As a volunteer public servant, she was appointed Argentina’s roving ambassador-at-large and president of the National Arts Foundation. As a philanthropist, she gave many millions to various causes, including the arts, the veterans of Argentina’s war with England over the Falkland Islands and refugees from the war in Kosovo in 1999. As a socialite in Argentina, New York and Europe, she was often photographed with friends like David Rockefeller and Henry Kissinger.

As a patron of the arts, Mrs. Fortabat paid $6.4 million in 1980 for J. M. W. Turner’s painting “Juliet and Her Nurse,” at the time a record price for a painting sold at auction. In 2008, she built Museo Fortabat, a modernist museum in Buenos Aires designed by Rafael Viñoly to house her large and much admired art collection. It includes a portrait Andy Warhol did of her in the style of his Marilyn Monroe prints.

Maria Amalia Lacroze de los Reyes Oribe was born in Buenos Aires on Aug. 15, 1921. Her grandfather had established the city’s first streetcar line, and an ancestor was the first president of Uruguay. Known as Amalita, she moved to Paris when she was a year old. Her first language was French, and her second was English. When she was 14, she said, a fortuneteller revealed her future: “You’ll marry a maharaja.”

In 1942 she married a lawyer, Hernan Saenz Valiente Lafuente. They had a daughter, Maria Inez de Lafuente, who survives her, along with three grandchildren.

Amalita was at the theater with Mr. Lafuente, her fiancé at the time, when she met Mr. Fortabat in 1941. He invited them to sail on his yacht, the Tigre Fortabat, but said he could not bear to go to their wedding. Five years later he followed the couple to Paris to ask Mr. Lafuente’s wife to dance.

In recent years, Mrs. Fortabat had respiratory problems and repeated hip replacements. In 2002, she sold some paintings, including a Degas for $16.5 million. She sold the cement company to a Brazilian buyer for $1.025 billion in 2005. Last year, she sold the duplex at the Pierre for $19.5 million.

For all the uproar that her divorce and marriage caused in the 1940s, Mrs. Fortabat was scandalized herself in 1997 during a literary contest that her Fortabat Foundation was sponsoring. A jury had decided to give the prize to “The Anatomist” (1998), a novel by Federico Andahazi that tells of a scientist who studies clitorises, first by examining corpses, then prostitutes. Mrs. Fortabat did not approve.

She bought a newspaper ad saying the subject matter did not “contribute to the exaltation of the highest values of the human spirit.” In the end, she agreed to give Mr. Andahazi the $15,000 award that went with the prize but not the prize itself.

Mr. Andahazi, who is also from Argentina, said he had chuckled at first but then felt something else, telling The New York Times, “Being pitted against the most powerful woman in Argentina sent a shudder down my spine.”

View the original article here

Baby Boomers at Risk of Hidden Hepatitis C

Due to a number of risk factors, including intravenous drug use and limited testing of the blood supply before 1992, those born from 1946 to 1964 -- baby boomers -- are at the highest risk for having the hepatitis C virus, as reported by CBSNews.com.

Health officials such as those at Montefiore Medical Center were already expressing concern about the health risks associated with the illness that is labeled a "silent epidemic" for baby boomers, even before recent study revealed the mortality rate for hepatitis C in that age group.

Hepatitis C Study Results

The Centers for Disease Control and Prevention funded a study, reported Tuesday in the Annals of Internal Medicine, titled "The Increasing Burden of Mortality From Viral Hepatitis" in the U.S. from 1999 through 2007.

The study researchers concluded that deaths from HCV outnumbered those from HIV by 2007. Even more pertinent for baby boomers are the deaths from HCV were disproportionately high in their age group.

Those numbers might have been higher, but because the physician signing the death certificates were often not the person's primary caregiver, HCV might have been under-reported as a contributing cause of death.

Plans to Address Undiagnosed Hepatitis C

A second study published Tuesday, also in the Annals of Internal Medicine, addresses the cost-effectiveness of a one-time antibody blood test to determine if people born from 1945 to 1965 have the hepatitis C virus present in their bodies. This study, also funded by the CDC and the Division of Viral Hepatitis, concluded it would be cost-effective to perform such blood screening through a person's visit to their primary health care giver.

Importance of Diagnosing Hepatitis C

Milan Kinkhabwala of the Montefiore Einstein Center for Transplantation explains, "The blood test is essential to detecting Hepatitis C because now there are ways to treat the condition, and even reverse damage to the liver."

But people can't receive treatment until they know they have an illness, and HCV can be present in the body for a long period of time before symptoms occur, as the CDC's director of hepatitis division, John Ward, said to Bloomberg. The blood test would reveal the hidden virus and allow health care providers to treat HCV before more liver damage, such a liver cancer, can occur.

Risk Factors for Hepatitis C

There are a number of factors that, if present, indicate your risk of having hepatitis C is greater than people who have no risk factors. The Mayo Clinic lists some of these factors as having HIV; having used illegal, injectable drugs; a health care worker exposed to infected blood; received a blood transfusion or organ transplant prior to 1992; or received clotting factor concentrates before 1987.

Smack dab in the middle of the baby boomer generation, L.L. Woodard is a proud resident of "The Red Man" state. With what he hopes is an everyman's view of life's concerns both in his state and throughout the nation, Woodard presents facts and opinions based on common-sense solutions.

View the original article here

FDA: New suppliers to ease 2 cancer drug shortages

TRENTON, N.J. (AP) — Federal regulators said Tuesday that they've approved new suppliers for two crucial cancer drugs, easing critical shortages — at least for the time being — that have left patients and parents frightened about missing life-saving treatments.

The news brings a light at the end of the tunnel for some patients, but not for thousands of others, given that there are currently 283 separate drugs in short supply or totally unavailable in this country.

On Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement drug for Doxil, a drug for ovarian and other cancers that hasn't been available for new patients for months.

The agency also has approved another supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL and for high-dose treatment of bone cancer. The version with preservatives can be toxic or cause paralysis in children and other patients getting the drug either via injections into spinal cord fluid or at very high doses.

The FDA also has approved the release of a batch manufactured by Ben Venue Laboratories Inc., shortly before it closed several factories at its complex in Bedford, Ohio, due to serious quality problems. That closing is what turned the on-again, off-again methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that patients would begin missing treatments as soon as the end of this month.

"We have made real progress ... We believe that (suppliers) will be able to meet the demands of patients in the U.S. market" for the two drugs indefinitely, FDA Dr. Commissioner Margaret A. Hamburg told The Associated Press in an exclusive interview. "It's a huge relief for us."

The FDA increasingly has been able to prevent drug shortages, mainly due to a sixfold increase in manufacturers voluntarily notifying the FDA when they anticipate shortages, Hamburg said.

Thanks to such notice, the agency prevented 195 drug shortages in 2011, mostly late in the year after President Obama issued an executive order giving FDA additional powers to address the shortages. Between that order on Oct. 31 and this week, the agency has prevented a total of 114 drug shortages.

Hamburg said that when FDA's much-expanded drug shortages team is notified about impending shortages and contacts other manufacturers, those companies have been "very responsive" as FDA worked with them on finding ways to boost production.

In the latest case, the FDA said it has temporarily allowed importation of an alternative to Doxil called Lipodox, made by Sun Pharma Global FZE. The Indian drugmaker is already known to the agency, and its factory and the production line for Lipodox have been inspected.

The FDA also has given approval to APP Pharmaceuticals LLC to begin making a preservative-free version of methotrexate in addition to its current drug that includes preservatives. The company had made a preservative-free version years ago, but needed to update paperwork and meet other requirements, which the FDA expedited. It's expected to start shipping the medication by the middle of March.

Another maker, Hospira Inc., expected today to start shipping about 31,000 vials of preservative-free methotrexate, more than enough to meet a month's demand, to hundreds of hospitals and treatment centers.

Still, hundreds of other drugs remain in short supply, including many other cancer medicines.

"I don't think we can ever close the book on drug shortages," Hamburg said. "I think we will always have to be vigilant."

Drug shortages have increased dramatically in the U.S. over the past six years, particularly for generic injected drugs. They are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers. At least 15 deaths since 2010 have been blamed on the shortages, which have set a record high in each of the last five years.

So far this year, 27 new shortages have been reported, and about 215 that began in 2010 or 2011 remain unresolved, according to Erin R. Fox, manager of the University of Utah Drug Information Service, which tracks shortages.

"At this time last year, we were on a pace of about one new shortage per day. Thanks to FDA's hard work, that pace is cut in half for this first part of 2012, when we have counted 27 new shortages" in nearly two months, Fox said.

The shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories.

In addition, consolidation among generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs, has led to decreased capacity. That means when one manufacturer suddenly stops production, the small number of others making a drug can't quickly pick up slack.

The inability to get crucial medicines has disrupted not only carefully timed chemotherapy regimens, but surgery and care for patients with infections, pain and other serious conditions.

Meanwhile, some unscrupulous smaller distributors, dubbed "gray marketers," have been exacerbating shortages by charging hospitals many times the normal price for drugs that can't be acquired through normal suppliers. Several bills in Congress are pending that would establish penalties for drugmakers that don't give notice of impending shortages, or by setting penalties for price gouging on prescription drugs.

Of late, the cancer drug shortages have attracted the most attention, partly because missing multiple treatments can sharply reduce the chances of curing the disease. In the case of methotrexate, its use as part of the treatment for acute lymphoblastic lymphoma results in nearly 90 percent of children being cured, so parents and doctors were particularly upset at the prospect of it not being available.

___

Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma

View the original article here

Argentina Train Crash Kills Dozens and Injures 600

The train, which runs from the ring of urban areas that surround greater Buenos Aires, crashed at about 8:30 a.m. at its final stop at the Once Station, not far from downtown Buenos Aires.

The train was carrying more than 800 passengers and traveling at an estimated 16 miles per hour when it entered the station, slamming into the barrier of the platform, destroying the engine.

“It is a very serious accident,” Juan Pablo Schiavi, the national secretary of transportation, said in his initial assessment of the crash during a televised press conference outside the Once Station. Mr. Schiavi said brake failure was the suspected cause.

“The train hit the bumper,” Mr. Schiavi said, “causing one car to crumple into another.”

He said one car pierced into another by nearly 20 feet.

The injured were taken to hospitals in the vicinity, Dr. Alberto Crescenti, head of the state emergency medical system, said on Argentine television on Wednesday. He said around midday that about 30 people were trapped in the wreckage.

Passengers told the local news media that the train, which is operated by the private company Trenes de Buenos Aires, was traveling faster than normal and had struggled to slow down when braking at stations ahead of Once Station.

Trenes de Buenos Aires said in a statement that the reasons for the crash had not been determined, though the company acknowledged that the train “wasn’t able to stop.”

Video footage of the crash taken by people at the scene showed people walking along the platform, with screams audible. People were pulling others out of the wreckage.

“I saw a lot of people bleeding and some who were trapped,” said one survivor, a 23-year-old woman, quoted by the newspaper Clarín.

Last September, a commuter train on the same line crashed into a passenger bus and hit a second train at the Flores Station, killing 11 and injuring more than 200. The bus had crossed the tracks when the barrier was down. In February 2011, four people were killed in a collision of two trains.

The newspaper La Nación said the accident was the third-deadliest in Argentina’s history, surpassed only by a 1972 collision that killed 142 people and a 1978 accident involving trains and other vehicles that left 55 dead.

Charles Newbery reported from Pinamar, Argentina, and Simon Romero from Rio de Janeiro.

View the original article here

FDA panel backs previously rejected obesity pill

SILVER SPRING, Md. (AP) — A previously rejected weight loss pill won an overwhelming endorsement from public health advisers Wednesday, raising hopes that the drug from Vivus Inc. could become the first new anti-obesity medication to reach the U.S. market in more than a decade.

The Food and Drug Administration has rejected three weight loss pills in the last two years, including Vivus' pill Qnexa, due to safety concerns. Experts agree new weight loss drugs are needed to treat an estimated 75 million obese adults in the U.S., but the string of rejections has raised questions of whether any pharmaceutical treatment is safe enough to win approval.

At a public meeting Wednesday, an FDA panel of outside physicians voted 20-2 in favor of the weight loss drug from Vivus, setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.

Nearly all the panelists backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.

"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.

The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected by mid-April.

In a key question, the physicians said Vivus could conduct the cardiovascular safety study after FDA approval. A requirement to conduct the study ahead of market approval would cost the company millions of dollars and take at least three more years.

"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."

Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA rejected Qnexa in October 2010, citing numerous side effects including elevated heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.

Vivus President Peter Tam said the overwhelming panel vote Wednesday indicates doctors recognize the urgent need for effective weight loss drugs.

"Right now there aren't any good treatments out there besides dieting and bariatric surgery — clearly there's a huge gap," Tam said.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.

Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anti-seizure and anti-migraine drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

Along with heart safety, panelists raised concerns about potential birth defects in women who become pregnant while taking Qnexa: topiramate is known to more than double the risk of birth defects.

There were 34 pregnancies among 3,386 women enrolled in Vivus' studies of Qnexa, despite precautions to make sure women used contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa.

If approved, FDA scientists said they would require Vivus to train prescribers to educate patients on the pregnancy risks of Qnexa. The drug would only be available from 10 mail-order pharmacies.

Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.

Fen-phen is just one example in the decadeslong history of failed weight loss drugs, which have continued to pile up in recent years.

Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke. The drug won approval in 1997 in the wake of the recall of fenfluramine but never achieved widespread use due to modest weight loss and safety concerns. Only 100,000 prescriptions were written in the U.S. during Meridia's last full-year on the market.

Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is sold over the counter as alli by GlaxoSmithKline. The drug is not widely used because of modest weight loss results and unpleasant side effects, including gas and diarrhea.

View the original article here

Judge says Wash. can't make pharmacies sell Plan B

A new drug to treat advanced skin cancer, or metastatic melanoma, has been shown to nearly double average survival time in a study of more than 130 patients, researchers said Wednesday.

View the original article here

Johnson & Johnson CEO Bill Weldon retires in April

TRENTON, New Jersey (AP) — Johnson & Johnson's longtime CEO Bill Weldon is stepping down as the health care giant's top executive after an embarrassing string of recalls of everything from Tylenol to Benadryl that has cost the company hundreds of millions of dollars and consumers' trust.

The maker of Band-Aids and biotech drugs said Tuesday that Alex Gorsky, vice chairman and head of the company's largest business by revenue, will become CEO on April 26, the day of its annual shareholder's meeting. Weldon, who as CEO since 2002 helped the company grow through acquisitions and licensing deals, will remain chairman of the board for now.

The change at the top comes as the company struggles to regain its footing after more than two dozen product recalls since September 2009, for reasons from bacterial contamination to liquid medicines that may contain tiny glass or metal. While there haven't been reports of patients harmed by the recalled products, the sheer volume is likely unrivaled in the industry.

Congress has been probing J&J's handling of the recalls, including a "stealth recall" in 2008 in which the company paid a third party to quietly buy up packages of faulty medication from stores. Federal regulators have had three of J&J's factories under increased scrutiny for nearly two years, and one is being completely rebuilt.

J&J also faces lawsuits over the recalls, including one in which a family alleges its toddler died shortly after ingesting a "super dose" of Tylenol.

The recalls have hurt the company's financial performance. Under Weldon's tenure, J&J's revenue slightly more than doubled to $65 billion last year. But lost sales from all the recalled products not on store shelves have cost the company more than $1 billion. J&J shares plunged from nearly $72 in early 2009 to $48 after the recalls began and have been stuck in the mid-60s for about a year.

Weldon has repeatedly assured investors and consumers that he had the problems under control, only to have another recall pop up. Last April, for instance, he charmed shareholders with a pledge that brighter days were coming. But as recently as last week, J&J announced that it would recall about a half a million bottles of infant Tylenol because of complaints about bottle tops meant to make doses easier collapsing in some cases.

As the company worked to resolve the problems, several executives below Weldon departed suddenly. One was Colleen Goggins, the former head of the consumer health business, where many of the recalls originated.

A handful of analysts had been calling for Weldon's ouster, saying J&J had abandoned its highly touted corporate credo, displayed prominently at headquarters, that stresses responsibility to patients, doctors and nurses. Others said they thought the succession planning had long been in the works.

"While I am sure the board was not happy with the recalls that have plagued (J & J), I am not convinced Mr. Weldon was pushed out due to the latest recall," wrote Edward Jones analyst Linda Bannister.

The departure of Weldon, who has spent his entire 41-year career at J&J working his way up to chief executive, is being described by the company as normal succession planning. Weldon had repeatedly said he had no plans to leave unless asked to do so by the board of directors, which has long been loyal to him. But late Tuesday, Weldon, 63, said in a statement: "I look forward to the transition of leadership."

"The way I read it is, he wouldn't have left on his own if he didn't think the company was on its way to recovery," said Miller Tabak & Co. analyst and fund manager Les Funtleyder.

Gorsky and Sherri S. McCoy, who heads both the pharmaceutical and consumer businesses, had been considered the most likely successors to Weldon after both were named company vice chairmen in January 2011. McCoy will become vice chairman of the executive committee and report to Gorsky once he becomes CEO.

Gorsky leads the company's medical devices and diagnostics unit, which J&J claims is the largest business of its kind in the world. But besides that, he oversees 140 manufacturing facilities around the world. He's also in charge of both government affairs and policy, and the company's venture capital subsidiary, called the Johnson and Johnson Development Corp.

"I'm honored that the board has placed such confidence in me, and I am also aware of the serious responsibilities that come with this office," Gorsky, 51, said.

Pharmaceutical manufacturing expert Girish Malhotra said he considered the management shake-up at J&J an overdue firing of Weldon. But Malhotra wrote that the heads of manufacturing and accounting should also be fired, and the board dismissed.

"How a global icon of care and quality could not control its practices is just beyond imagination," he wrote. "I am not sure Mr. Alex Gorsky would be able to clean the house quickly to restore confidence in the company. Time will tell."

View the original article here

Pig-to-Human 'Superbug' May Be Due to Animal Antibiotics

TUESDAY, Feb. 21 (HealthDay News) -- Researchers who traced the evolution of a potentially deadly antibiotic-resistant bacteria strain that can jump from livestock to humans say their findings highlight the dangers of widespread antibiotic use in animal food production.

The international team of scientists studied methicillin-resistant Staphylococcus aureus CC398, also known as pig MRSA or livestock-associated MRSA, which most often infects people with direct exposure to swine or other livestock.

It's likely that MRSA CC398 originated as an antibiotic-susceptible strain in humans before it jumped to livestock, they said. Once in livestock, MRSA CC398 became a so-called superbug, resistant to two important antibiotics, tetracycline and methicillin, used to treat staph infections.

This resistance is likely caused by the widespread use of antibiotics in livestock to prevent infection and promote growth, said the authors of the study published online Feb. 21 in the journal mBio.

The findings reveal evolution in action, according to Paul Keim, one of the study authors and a professor and director of the Center for Microbial Genetics and Genomics at Northern Arizona University. He is also director of the pathogenic genomics division at the Translational Genomics Research Institute (TGen) in Phoenix.

"The most powerful force in evolution is selection. And in this case, humans have supplied a strong force through the excessive use of antibiotic drugs in farm animal production. It is that inappropriate use of antibiotics that is now coming back to haunt us," Keim said in a university news release.

This strain of MRSA was discovered less than a decade ago but appears to be spreading quickly, according to study lead author Lance Price, a university faculty member and director of the Center for Food Microbiology and Environmental Health at TGen.

"Our findings underscore the potential public health risks of widespread antibiotic use in food animal production," Price said in the news release. "Staph thrives in crowded and unsanitary conditions. Add antibiotics to that environment and you're going to create a public health problem."

More information

The U.S. Centers for Disease Control and Prevention has more about antibiotic resistance.

View the original article here

Hugo Chávez Says His Cancer May Have Returned

The announcement comes at the start of what could be Mr. Chávez’s most challenging re-election campaign since he first took office in 1999, and it seemed bound to unsettle the political landscape. Although he previously said that he had beaten cancer, questions about Mr. Chávez’s health have continued, including whether he would be able to campaign or stay in office if he were re-elected.

“I am in good physical condition to face this battle,” Mr. Chávez said on Tuesday, appearing to tear up as he spoke of not wanting his supporters to suffer on hearing the news of his setback. He spoke in a live television broadcast while touring a truck factory in his native state of Barinas, in western Venezuela.

During his remarks, the socialist president did not mention the political campaign or the election, which is scheduled for October, but he sounded a warning to critics who might take pleasure at his misfortune.

“Let no one be alarmed, and, I would say, let no one be happy, because independent of my personal destiny, this revolution, as Bolívar said one day, has gotten its start, and nothing and no one can stop it,” he said.

He denied reports and rumors that his cancer had spread to his liver or other parts of his body, or that he was dying.

“On the contrary, and it is good news,” he said. “I do not have metastasis anywhere.”

Mr. Chávez, 57, was given a diagnosis of cancer last June and underwent two operations in Cuba, followed by chemotherapy. His illness forced him to be absent from the country for long periods and tamped down his fiery presence, leading many to wonder whether he would be able to hold off the opposition during its electoral challenge.

Luis Vicente León, a political analyst, said that Mr. Chávez had built his political strategy around convincing the public that he had recovered from cancer. If he is able to keep campaigning, Mr. León said, he will in one sense be at a disadvantage against the opposition candidate, Henrique Capriles Radonski, 39, whose youth and energy will be accentuated in comparison with a weakened Mr. Chávez.

The president has never said exactly what kind of cancer he had, and his illness and treatment have been shrouded in mystery, which has fueled more doubts about his health. Those rumors spiked in recent days, as opponents of Mr. Chávez speculated on Twitter that he had been rushed to Cuba for an emergency operation. While the government made no official statement before Mr. Chávez’s appearance, the information minister, Andrés Izarra, called the rumors a “dirty war” in a Twitter post. Mr. Chávez said that he was responding to those rumors by making his announcement a day earlier than planned.

He said that he flew to Cuba over the weekend for a regular medical exam and that doctors had found a lesion about two centimeters in diameter in the same place that the tumor was found last year. He has said in the past only that his operation was in the pelvic region. Mr. Chávez said that the new operation should take place in the next few days and that doctors would perform tests to determine whether the lesion was malignant. He said Tuesday night that the procedure would take place in Cuba.

View the original article here

FDA Moves to Head Off Shortages of 2 Cancer Drugs

TUESDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday what it called a series of steps to ensure the continued availability of vital cancer drugs that have been in dangerously short supply.

One of the drugs, methotrexate, is used in combination with other drugs to combat -- and in many cases cure -- acute lymphoblastic leukemia (ALL), the most common type of cancer in children. It typically strikes kids aged 2 to 5.

And another drug, Lipodox, will be temporarily imported from a pharmaceutical company in India to ease a shortage of the chemotherapy drug Doxil (doxorubicin), which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma. Lipodox is similar in chemical makeup to Doxil; there are no generic versions of Doxil.

"Through the collaborative work of [the] FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need," FDA Commissioner Dr. Margaret A. Hamburg said in a news release.

The FDA also said it was issuing guidelines to the drug industry that spell out detailed requirements for "both mandatory and voluntary notifications" to the agency of potential problems that could result in a drug shortage or supply disruption.

Methotrexate is a cornerstone in the treatment of children with acute lymphoblastic leukemia. In high doses, the generic drug has been successful in curing patients and beneficial in preventing recurrence. Without the drug, a patient's chance for a cure is reduced while the risk of recurrence rises, oncologists said.

Some cancer doctors had warned last week that supplies of methotrexate could be exhausted within two weeks.

To offset the shortage of methotrexate, the FDA said Tuesday that it has worked with several drug manufacturers to help maintain supplies to meet all patient needs. Preservative-free methotrexate is needed for the intrathecal (injection into the fluid surrounding the brain and spinal cord) treatment of children with ALL, the agency said.

The FDA said the steps taken with methotrexate included approving a preservative-free version of the generic drug manufactured by APP Pharmaceuticals, of Schaumburg, Ill. Those supplies should become available in March and continue indefinitely, the agency said.

Second, Illinois-based Hospira Inc., which already manufactures methotrexate, has sped up additional supplies, producing 31,000 new vials of the drug -- enough for more than one month's supply. Those additional vials are being shipped Tuesday to hundreds of U.S. hospitals and treatment centers, the FDA said.

The FDA also noted that it continues to work with other manufacturers of methotrexate that have also stepped up production. Those manufacturers include Mylan Inc., of Canonsburg, Pa., and Sandoz US Inc., of Princeton, N.J.

At a midday news conference Tuesday, one of the speakers was Sara Stuckey, mother of 6-year-old Nate Stuckey, who has been on methotrexate since he was diagnosed with ALL in 2009.

"It is hard enough to hear your child has cancer, but to hear that the treatment that is successfully working is suddenly not available is devastating," she said. "My husband and I pray the recommended drugs to fight his cancer will be available when it's time for Nate's next treatment. And we hope that in the future no more families have to go through the stress of wondering whether proven, lifesaving treatments will be out of reach when they need it the most."

Speaking at the news conference, Hamburg said: "There are too many families like the Stuckeys who worry they won't have the medication they need for their next treatment and are understandably anxious about switching to a medication that may have more side effects or may be less effective. Clearly this is not acceptable."

"We are making progress," Hamburg added. "There were 195 drug shortages prevented in 2011 and 114 drug shortages prevented since October 2011 when we made the call for early notification" of potential shortages.

As for the ovarian cancer drug Lipodox, the FDA said it will allow the temporary importation of the drug made by Sun Pharma Global FZE. The agency said in its news release that "temporary importation of unapproved foreign drugs is considered only in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs."

The shortages of methotrexate and Doxil are just the latest in a series of drug shortages that have existed for several years.

In 2011, prescription drug shortages in the United States hit an all-time high. Last fall, some 200 drug shortages had been reported, compared to 178 in all of 2010, the FDA reported.

Many of the scarce drugs are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as cancer. Some are only given in hospitals and are "absolutely critical," Valerie Jensen, associate director of the FDA's drug shortage program, said during a news conference last September.

More than half (54 percent) of shortages in 2010 were due to quality issues, such as drug impurities. Some were caused by delays or manufacturing capacity problems, while 11 percent were caused by discontinuation of a drug and 5 percent resulted from raw material shortages, Jensen said.

Jensen also said the shortages tend to occur in drugs that aren't "economically attractive." This could mean that only one company produces the drug, making it harder to find alternatives if the supply dries up.

A lot of the problems are tied to generic drugs, health experts explained, because few manufacturers make them and profit margins aren't as high as for brand-name drugs still under patent protection.

On Oct. 31, 2011, President Barack Obama signed an executive order designed to help ease the drug shortages. The order directed the FDA to "take action" to prevent and reduce worsening prescription drug shortages.

In response to Tuesday's announcement, Dr. Armand Keating, president of the American Society of Hematology (ASH), said in a statement: "ASH is encouraged by the steps FDA is taking to alleviate drug shortages that have significantly affected so many patients with hematololgic malignancies under our members' care. The measures announced today are consistent with the Society's recommendations to FDA, Congress and the Obama Administration to expand the agency's authority to prevent drug shortages by requiring manufacturers to provide early notification of impending shortages and importing drugs in critical supply."

"While ASH applauds the specific actions announced today," Keating added, "we also realize that these measures represent only a portion of a solution to a much larger problem. In addition to these steps, additional measures -- such as developing a national drug registry and providing economic incentives to manufacturers to produce a steady supply of generics -- must be implemented to permanently prevent shortages. Until a complete solution is in place, treatment will be delayed and care will be rationed for critically ill patients."

More information

For more on drug shortages, visit the U.S. Food and Drug Administration.

View the original article here

FDA: New suppliers to ease 2 cancer drug shortages

TRENTON, N.J. (AP) — Federal regulators said Tuesday that they've approved new suppliers for two crucial cancer drugs, easing critical shortages — at least for the time being — that have left patients and parents frightened about missing life-saving treatments.

The news brings a light at the end of the tunnel for some patients, but not for thousands of others, given that there are currently 283 separate drugs in short supply or totally unavailable in this country.

On Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement drug for Doxil, a drug for ovarian and other cancers that hasn't been available for new patients for months.

The agency also has approved another supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL and for high-dose treatment of bone cancer. The version with preservatives can be toxic or cause paralysis in children and other patients getting the drug either via injections into spinal cord fluid or at very high doses.

The FDA also has approved the release of a batch manufactured by Ben Venue Laboratories Inc., shortly before it closed several factories at its complex in Bedford, Ohio, due to serious quality problems. That closing is what turned the on-again, off-again methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that patients would begin missing treatments as soon as the end of this month.

"We have made real progress ... We believe that (suppliers) will be able to meet the demands of patients in the U.S. market" for the two drugs indefinitely, FDA Dr. Commissioner Margaret A. Hamburg told The Associated Press in an exclusive interview. "It's a huge relief for us."

The FDA increasingly has been able to prevent drug shortages, mainly due to a sixfold increase in manufacturers voluntarily notifying the FDA when they anticipate shortages, Hamburg said.

Thanks to such notice, the agency prevented 195 drug shortages in 2011, mostly late in the year after President Obama issued an executive order giving FDA additional powers to address the shortages. Between that order on Oct. 31 and this week, the agency has prevented a total of 114 drug shortages.

Hamburg said that when FDA's much-expanded drug shortages team is notified about impending shortages and contacts other manufacturers, those companies have been "very responsive" as FDA worked with them on finding ways to boost production.

In the latest case, the FDA said it has temporarily allowed importation of an alternative to Doxil called Lipodox, made by Sun Pharma Global FZE. The Indian drugmaker is already known to the agency, and its factory and the production line for Lipodox have been inspected.

The FDA also has given approval to APP Pharmaceuticals LLC to begin making a preservative-free version of methotrexate in addition to its current drug that includes preservatives. The company had made a preservative-free version years ago, but needed to update paperwork and meet other requirements, which the FDA expedited. It's expected to start shipping the medication by the middle of March.

Another maker, Hospira Inc., expected today to start shipping about 31,000 vials of preservative-free methotrexate, more than enough to meet a month's demand, to hundreds of hospitals and treatment centers.

Still, hundreds of other drugs remain in short supply, including many other cancer medicines.

"I don't think we can ever close the book on drug shortages," Hamburg said. "I think we will always have to be vigilant."

Drug shortages have increased dramatically in the U.S. over the past six years, particularly for generic injected drugs. They are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers. At least 15 deaths since 2010 have been blamed on the shortages, which have set a record high in each of the last five years.

So far this year, 27 new shortages have been reported, and about 215 that began in 2010 or 2011 remain unresolved, according to Erin R. Fox, manager of the University of Utah Drug Information Service, which tracks shortages.

"At this time last year, we were on a pace of about one new shortage per day. Thanks to FDA's hard work, that pace is cut in half for this first part of 2012, when we have counted 27 new shortages" in nearly two months, Fox said.

The shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories.

In addition, consolidation among generic drug manufacturers, as well as manufacturers deciding to end production of marginally profitable drugs, has led to decreased capacity. That means when one manufacturer suddenly stops production, the small number of others making a drug can't quickly pick up slack.

The inability to get crucial medicines has disrupted not only carefully timed chemotherapy regimens, but surgery and care for patients with infections, pain and other serious conditions.

Meanwhile, some unscrupulous smaller distributors, dubbed "gray marketers," have been exacerbating shortages by charging hospitals many times the normal price for drugs that can't be acquired through normal suppliers. Several bills in Congress are pending that would establish penalties for drugmakers that don't give notice of impending shortages, or by setting penalties for price gouging on prescription drugs.

Of late, the cancer drug shortages have attracted the most attention, partly because missing multiple treatments can sharply reduce the chances of curing the disease. In the case of methotrexate, its use as part of the treatment for acute lymphoblastic lymphoma results in nearly 90 percent of children being cured, so parents and doctors were particularly upset at the prospect of it not being available.

___

Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma

View the original article here