Month: September 2014

(Reuters) – U.S. health specialists are ready to deploy to Dallas if a patient being evaluated for Ebola is found to be carrying the disease that has killed thousands of people in West Africa, a Dallas County official said on Tuesday.

Texas Health Presbyterian Hospital of Dallas officials said in a statement on Monday that an unnamed patient was being tested for Ebola and had been placed in “strict isolation” due to the patient’s symptoms and recent travel history.

The U.S. Centers for Disease Control and Prevention (CDC) is expected to provide initial test results on the patient later on Tuesday, hospital officials said.

Texas and Dallas County health officials are in close contact with the CDC, which would send its experts to Dallas if tests on the patient confirm Ebola, said Zach Thompson, director of the Dallas County Department of Health and Human Services.

“Everyone is preparing for the worst and hoping for the best,” he said.

The United States is sending some 3,000 soldiers to West Africa to build treatment centers and train local medics.

At least 3,091 people have died from Ebola since the West African outbreak was first identified in Guinea six months ago.

There have been no confirmed cases of Ebola being contracted in the United States but several American aid workers in West Africa have been brought back for treatment of the disease.

An American physician volunteering in Sierra Leone was admitted for treatment to an isolation unit at the U.S. National Institutes of Health medical center in Bethesda, Maryland, on Sunday.

Emory University Hospital in Atlanta admitted an American doctor infected with the virus to the same isolation unit where missionaries Nancy Writebol and Dr. Kent Brantly were treated and discharged in August.

(Reporting by Marice Richter; Writing by Jon Herskovitz; Editing by Eric Beech)

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(Reuters) – A federal judge in Oklahoma ruled on Tuesday that tax subsidies vital to the implementation of President Barack Obama’s signature healthcare law are unlawful, giving a boost to opponents of the measure known as Obamacare.

U.S. District Judge Ronald White found that the Internal Revenue Service rule that the Obama administration issued to set up tax-credit subsidies to help people afford insurance premiums under Obamacare was “an invalid implementation” of the law based on his interpretation of it.

White, who was appointed by Republican President George W. Bush, put his ruling on hold pending an appeal.

A U.S. Justice Department spokesman said the Obama administration will appeal the decision.

The issue of whether the subsidies are legal is being fought in several courts across the country and could end up being decided by the U.S. Supreme Court. The outcome of the legal challenge will determine whether the subsidies will be available in all 50 states or only in some.

The 2010 Obamacare law, officially known as the Affordable Care Act, was the most sweeping overhaul of the U.S. healthcare system in decades and was intended to increase the number of Americans with health insurance. It set up health insurance exchanges and tax-credit subsidies to help people buy insurance coverage.

Five million people could be affected, analysts have estimated, if the administration loses in court and the subsidies disappear from the federal marketplaces that have been set up in states that did not create their own exchanges.

The Oklahoma case was brought by Attorney General Scott Pruitt, a Republican, who said in a statement that Tuesday’s ruling “is a consequential victory for the rule of law.” Other cases have been brought by conservative lawyers representing individuals and business owners.

So far, two federal appeals courts have issued rulings on the issue. The 4th U.S. Circuit Court of Appeals in Richmond, Virginia backed the Obama administration in July.

On the same day, a three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of people challenging the law. That decision was thrown out on Sept. 4 when the court agreed to rehear the case. The appeals court will hear a new round of oral arguments on Dec. 17.

A federal judge in Indiana is also considering the issue in a lawsuit filed by state officials.

(Reporting by Lawrence Hurley; Editing by Will Dunham and Cynthia Osterman)

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(Reuters) – U.S. doctors and teaching hospitals received $3.5 billion from pharmaceutical companies and medical device makers in the last five months of 2013, according to the most extensive data trove on such payments ever made public.

The payments, disclosed by the Centers for Medicare and Medicaid Services (CMS) on Tuesday, include consulting and speaking fees, travel, meals, entertainment and research grants. The names of the recipients of about 40 percent of the payments reported by companies were withheld because CMS had concerns about data inconsistencies.

Some 546,000 individual providers including physicians, dentists and osteopaths and 1,360 teaching hospitals received 4.4 million separate payments from healthcare companies.

The companies were required by President Barack Obama’s 2010 healthcare reform law to disclose to CMS by March all payments of $10 or more made from August to December 2013. Even payments that physicians requested be sent to a charity were required to be reported.

The American Medical Association (AMA) and other physician groups had asked CMS to delay the release of the data by six months, saying that errors could create a false impression about the influence of industry on individual doctors.

The extent of the industry payments, which came to $23 million a day, was in line with years of research. A 2007 study found that 83 percent of physicians received gifts from drug or device companies, and 28 percent received payments for consulting or research.

BIPARTISAN SUPPORT

Both Democratic and Republican lawmakers supported the Physician Payments Sunshine provision of Obamacare, arguing that making industry payments public would increase transparency.

When patients are aware of potential financial conflicts of interest, they might question why their doctors are prescribing a drug or device from a manufacturer that pays them, for instance. And doctors will know whether experts who recommend practice guidelines were paid by companies that could benefit from them.

Of the physicians who reported receiving industry money even before the Sunshine provision, 40 percent had been involved in creating clinical practice guidelines, according to a 2009 report by the Institute of Medicine, an arm of the National Academy of Sciences.

Health insurers have raised concerns that payments from industry cause doctors to overuse expensive drugs and devices.

“These payments, while not nefarious in every case, are a perfect symbol for the misaligned incentives in our health care system,” said Brendan Buck, spokesman for America’s Health Insurance Plans. “While most health care stakeholders are working together to find ways to lower costs, drugmakers remain focused on strategies to keep them inflated.”

Some medical specialty groups have voiced concern that the data release will lead to public shaming of physicians who accept, say, all-expenses-paid trips to exotic locales.

But researchers who have studied industry payments to physicians say it is not clear whether patients care about them, let alone whether payments affect patients’ choice of doctor.

“People might not like their doctors going on these free trips, but some people might see that their doctor is accepting consulting fees from many companies and say, he must be really good,” said Genevieve Pham-Kanter, an assistant professor of health policy at Drexel University.

Medical specialty societies and others that issue guidelines have long required such payments be disclosed, but it is not clear how many, if any, verify the self-reported information.

“Bias is absolutely ubiquitous,” said orthopedic surgeon F. Todd Wetzel, an official of the North American Spine Society. “Involvement with industry can be a plus; it just has to be done correctly.”

CMS, part of the Department of Health and Human Services, made the data available at www.cms.gov/openpayments. Users cannot yet search the website by physician. Several software problems have plagued the program.

(Reporting by Sharon Begley and M.B. Pell; Editing by Michele Gershberg, Cynthia Osterman)

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By Nick Triggle
Health correspondent, BBC News

Midwives will be joining other NHS workers in England in a strike over pay next month.

The Royal College of Midwives announced 82% of its members voted in favour – the first time they have ever been balloted on industrial action.

They will join other staff, including nurses, healthcare assistants and porters, in the 13 October walk-out.

The strike will last four hours, but the RCM said midwives will still be there for women giving birth.

Instead, it will be ante-natal and post-natal appointments that will be affected by the strike which starts at 7am.

It follows last week’s announcement that the members of both Unison and Unite, which represent nearly 400,000 workers between them, had voted in favour of taking action.

These unions are also targeting non-urgent and non-emergency services. It could mean hospital outpatient appointments, community clinics and minor surgery being affected.

The walkout – the first in 32 years over pay – will be followed by a period of action short of a strike. This is likely to involve staff refusing to work unpaid overtime.

Ballot results for a host of other unions, including the GMB, are due later this week. In total, 10 balloted their members over the pay award announced earlier this year.

‘Resounding yes’

Ministers have given NHS staff a 1% increase, but not for those who get automatic progression-in-the-job rises.

These are designed to reward professional development and are given to about half of staff and are worth 3% a year on average.

But the decision by ministers went against the recommendation of the independent pay review board, which had called for an across-the-board rise.

Cathy Warwick, chief executive of the Royal College of Midwives, which has 26,000 members, said: “This is a resounding yes. It could not send a clearer signal about the level of discontent on this issue.

“The RCM will be meeting with employers to discuss our action and to ensure that mothers and babies are not put at any risk. I want to reassure women expecting a baby that midwives will continue to look after them and that they will be safe. “

As well as voting on a strike, just over 94% said they were in favour of industrial action short of a strike. Nearly half of midwives eligible voted in the ballot.

In Scotland, the recommendation was agreed to in full. Wales is doing the same as England, but has given extra money to the lowest paid.

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By Helen Briggs
Health editor, BBC News website

Many adults in the UK are unaware of the risk factors for heart disease, according to a new poll.

While a third of people are worried about getting dementia or cancer, only 2% are afraid of coronary heart disease, a survey by the British Heart Foundation has found.

And one in ten adults confessed to not knowing how to look after their hearts.

Coronary heart disease (CHD) is responsible for about 74,000 deaths in the UK each year.

About one in five men and one in eight women die from the condition.

Dr Mike Knapton, associate medical director at the British Heart Foundation, said: “Your heart is the most vital organ in the body, but all too often we take it for granted.

“Despite being a largely preventable condition, coronary heart disease is still the UK’s single biggest killer, causing unnecessary heartache for thousands of families.”

As well as chest pain, the main symptoms of CHD are heart attacks and heart failure.

However, not everyone has the same symptoms and some people may not have any before CHD is diagnosed.

Risk factors include smoking, high cholesterol, high blood pressure and diabetes.

Gail Sullivan, from Oxted in Surrey, lost her son Daniel to the disease.

“At his age – 43 – he shouldn’t have died the way he did and I am very passionate about trying to get this awareness across,” she said.

“I don’t want him to have died in vain. It’s devastated the whole family. We didn’t know there was anything wrong. There was no sign that he was ill whatsoever.”

She said the call informing her that Daniel had had a heart attack remained “etched in my mind”.

At the hospital she discovered he had collapsed at work with a cardiac arrest.

“They got his heart started, got him into the ambulance where he had another cardiac arrest, and then got him to the hospital and he had another cardiac arrest,” she said.

“They got his heart started again and he was on life support for a couple of weeks.

“But they told us that his brain had died, and when they took away the machines he passed away on the Friday.”

The doctors said that smoking, high blood pressure and high cholesterol had affected the health of Daniel’s heart.

“When they say the silent killer, I now know what they mean,” she said. “There were no signs of that. You wouldn’t look at him and say, ‘Oh gosh, Dan, you look really ill’. You would never have been able to tell.”

The British Heart Foundation has issued 10 tips to prevent heart disease:

• Give up smoking
• If you’re over 40, take up your free NHS health check
• Maintain a healthy weight
• Lead an active lifestyle
• Ditch the salt
• Eat your “five a day” of fruit and vegetables
• Cut down on saturated fat
• Read food labels to find out if something is healthy for you
• Don’t drink too much alcohol
• Watch food portion sizes.

The poll was conducted by YouGov and included 1,010 men and 1,089 women.

Meanwhile the World Health Organization (WHO) is calling on countries to take action on salt to cut deaths from heart disease. It wants governments to sign up to reducing global salt intake.

“If the target to reduce salt by 30% globally by 2025 is achieved, millions of lives can be saved from heart disease, stroke and related conditions,” said director Dr Oleg Chestnov.

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(Reuters) – It is too early to say whether combining Roche’s best-selling Avastin cancer drug with the company’s experimental immune-boosting medicine MPDL3280A gives a better outcome in fighting tumors.

That is the verdict of experts following a presentation of a small clinical study assessing the combination in patients with a variety of solid tumors.

Oncologists and investors alike are keen to see if Avastin’s well-known ability to stop tumors from developing new blood vessels might complement the effects of the new drug, which is designed to help the body’s immune system fight cancer cells.

The outcome is important for Roche, since Avastin counts for 13 percent of the company’s sales and new immunotherapy medicines like MPDL3280A – and similar rival products – might cannibalize this business if there is no synergy.

Data presented at the European Society of Medical Oncology annual congress in Madrid hinted at a possible effect, but was far from conclusive.

Christopher Lieu of the University of Colorado Cancer Center reported results for patients with advanced cancers treated with the drug combination, with or without chemotherapy.

Tumor shrinkage was seen in a number of cancer types, including kidney and colorectal cancers. One patient with kidney cancer given the two drugs with chemotherapy experienced a complete response, or disappearance of disease.

The overall response rate in 10 kidney cancer patients given MPDL3280A and Avastin without chemotherapy was 40 percent, but only 8 percent in 13 colorectal patients. A separate group of colorectal patients had around a 40 percent response rate when chemotherapy was added to the drug mix.

Some cancer doctors said the results suggested MPDL3280A and Avastin might have a role in kidney cancer but this was more uncertain for colorectal cancer, where chemotherapy alone can produce a response rate of 40 percent or more.

“There may be synergies but we can’t draw any firm conclusions from the data so far,” said Eric Van Cutsem of the University of Leuven, who was not involved in the research. “We don’t know if it is due to the chemotherapy or due to the other drugs.”

MPDL3280A is part of a closely watched class of drugs known as anti-PD-L1 drugs, which work by blocking a tumor’s ability to evade the immune system’s defenses.

(Editing by Aidan Martindale)

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The death toll from the Ebola outbreak in West Africa has passed 3,000, the World Health Organization (WHO) says.

The latest figures indicate that more than 6,500 people are believed to have been infected in the region.

Liberia is the worst affected country, having recorded around 1,830 deaths linked to the latest outbreak.

The outbreak is the world’s most deadly – US President Barack Obama has called it a “threat to global security”.

Some studies have warned that the numbers of infected could rise to more than 20,000 by early November.

The report said two new areas, in Guinea and Liberia, have recorded their first confirmed cases of Ebola in the last seven days.

It also highlights the risk of infection for health workers trying to stem the outbreak.

It says 375 workers are known to have been infected, and that 211 have so far died from the virus.

The deaths and sickness have made it even more difficult for the already weak healthcare systems in the affected countries to cope with the outbreak.

There is a severe shortage of hospital beds, especially in Liberia.

The US is sending some 3,000 troops to help Liberia tackle the disease, and set up emergency medical facilities.

Ebola virus disease (EVD)

• Symptoms include high fever, bleeding and central nervous system damage
• Spread by body fluids, such as blood and saliva
• Fatality rate can reach 90% – but current outbreak has mortality rate of about 70%
• Incubation period is two to 21 days
• There is no proven vaccine or cure
• Supportive care such as rehydrating patients who have diarrhoea and vomiting can help recovery
• Fruit bats, a delicacy for some West Africans, are considered to be virus’s natural host

Ebola virus: Busting the myths

Sierra Leone last weekend enforced a three-day curfew in an attempt to quell the outbreak in the country.

During the curfew more than a million households were surveyed and 130 new cases discovered, the authorities say.

On Wednesday, Sierra Leone extended the quarantine area to three new districts, meaning more than a third of the country’s six million people cannot move freely.

Some 600 people have died in Sierra Leone and a similar number in Guinea, where the outbreak was first confirmed in March.

Nigeria and Senegal, two other West Africa countries that have also been affected by the outbreak, have not recorded any new cases or deaths in the last few weeks, the latest WHO report says.

At the United Nations General Assembly in New York on Thursday, US President Obama called for more urgent action in the response to the outbreak.

“There is still a significant gap between where we are and where we need to be,” he said.

A new BBC Ebola programme with the latest news about the outbreak is broadcast at 19.50 GMT each weekday on the BBC World Service.

Have you been affected by the Ebola outbreak? You can send us your experiences by emailing haveyoursay@bbc.co.uk

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(Reuters) – Liberia’s chief medical officer, who is also a deputy health minister, has put herself in quarantine as a precaution against Ebola after one of her assistants died from the disease, the government said on Saturday.

Bernice Dahn is the latest senior West African medical official to be directly affected by an outbreak of Ebola, which has killed over 3,000 people as it spreads across most of Guinea, Liberia and Sierra Leone.

“She has placed herself under self observation due to the fact that her special assistant contracted the virus,” Isaac Jackson, Liberia’s deputy information minister, told Reuters.

Jackson said that the government praised Dahn’s decision to come forward to be monitored after potentially coming into contact with the disease.

“If everyone were to do what Dr. Dahn has done, Liberia would be free of Ebola,” he said.

The latest figures from the World Health Organization show that the death toll from the worst outbreak of Ebola on record has killed at least 3,091 people, out of 6,574 probable, suspected and confirmed cases.

Liberia has recorded 1,830 deaths, around three times as many as Guinea or Sierra Leone, the two other most affected countries. Nigeria and Senegal have had confirmed cases of Ebola but appear to have prevented it from spreading.

Although relatively common in Central Africa, the hemorrhagic fever has taken West Africa by surprise, spreading into heavily populated areas and across borders before authorities were able to coordinate their response.

Already weak national health care systems have been over-run by the disease, which has infected 375 health care workers in the region, killing 211 of them.

Sheik Umar Khan, the doctor leading the fight against Ebola in Sierra Leone, contracted the disease himself and died in July.

Foreign governments and international organizations are dispatching funds, supplies and personnel to the region amid warnings that the disease could claims tens or hundreds of thousands of lives before it is halted.

(Reporting by James Giahyue; Writing by David Lewis; editing by Jason Neely)

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(Reuters) – Early results for a closely watched cancer drug combination from AstraZeneca that boosts the immune system show the cocktail is promising, though limited patient numbers mean the data is far from conclusive.

The British drugmaker, which fended off a $118 billion takeover bid from Pfizer in May in part by talking up its cancer drug prospects, has high hopes for the combination of two experimental drugs known as MEDI4736 and tremelimumab.

The company is still exploring a range of doses, so testing of the drugs in lung cancer is taking time to yield results and data on only two dozen patients was reported at the European Society for Medical Oncology (ESMO) congress on Saturday.

Chief Executive Pascal Soriot had said earlier this month that the ESMO numbers would be limited.

Still, researcher Scott Antonia of the Moffitt Cancer Center in Florida said the early signals were encouraging, both for safety and efficacy. “It looks very, very promising,” he said.

AstraZeneca expects to have more definitive results later this year and also plans to start a pivotal clinical trial with the combination either late this year or at the start of 2015.

Immunotherapy treatment is the hottest area of cancer research – widely tipped to become a market worth tens of billions of dollars in annual sales – and combinations are viewed by many oncologists as the best way to use the new drugs.

Safety, however, is an issue, especially after results from another small study with a similar Bristol-Myers Squibb cocktail showed about half of patients experienced serious side effects, with three treatment-related deaths.

In the case of AstraZeneca’s combination, six out of 24 advanced lung cancer patients had adverse events rated as serious, or grade 3/4, and three had events that led to discontinuation of treatment. There was one treatment-related death.

So far, 18 of the patients have been assessed for efficacy and five of these, or 28 percent, had tumor shrinkage, according to research presented at the meeting in Madrid.

Although direct comparisons are difficult, Antonia said this was much better than the efficacy benefit seen with the Bristol-Myers combination in lung cancer.

“In terms of what you would hope to see at this point, we are very much on track,” Edward Bradley, head of oncology at AstraZeneca’s biotech unit MedImmune, told Reuters. “It’s early days but we’re pleased with where we are and I think it’s a very manageable tolerability profile.”

$6.5 BILLION FORECAST

AstraZeneca already presented data on a handful of patients at the American Society of Clinical Oncology earlier this year. The new results build on that by providing more safety data and showing some evidence of clinical activity in sick patients who have failed to respond to other drugs.

MEDI4736 is part of a class of drugs known as anti-PD-L1 therapies, which work by blocking a tumor’s ability to evade the immune system’s defenses. Tremelimumab is a so-called anti-CTLA4 drug that unlocks a different brake on the immune system.

The two-pronged approach is designed to expose cancer cells as fully as possible to the killing power of the body’s own immune system. But boosting the immune system can cause damaging side effects, including colitis, a serious inflammation of the colon, as well as liver and thyroid problems.

Immunotherapy drugs are seen as AstraZeneca’s most important pipeline assets and the company has predicted that MEDI4736 could generate annual sales of $6.5 billion, including its use in combinations.

AstraZeneca is vying with rivals Bristol-Myers Squibb, Merck & Co and Roche in the immunotherapy race.

It is viewed by analysts as being behind these leaders but the company has a long history in cancer treatment and believes it is in a good position to develop a wide range of drug cocktails.

Because such immunotherapy does not work for all patients, some companies have looked to focus on people whose tumors test positive for a likely response. However, most of the patients assessed in the AstraZeneca study were actually PD-L1 negative.

“This supports our strategy to explore this combination more broadly, particularly in the PD-L1 negative population,” Bradley said.

Currently, immunotherapy is most advanced as a treatment for melanoma but research is advancing rapidly into other tumor types, with non-small cell lung cancer – a major killer – the biggest commercial opportunity.

As a result, doctors and investors alike are following the AstraZeneca drug combination very closely, particularly after the earlier disappointment with Bristol-Myers’ combination using nivolumab and its already approved drug Yervoy.

(Editing by Pravin Char and David Holmes)

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