Day: May 16, 2018

Many women with a common and aggressive form of breast cancer that is treated with Herceptin can get by with six months of the drug instead of the usual 12, greatly reducing the risk of heart damage it sometimes can cause, a study suggests.

It’s good news, but it comes nearly two decades after the drug first went on the market and many patients have suffered that side effect.    

The study was done in the United Kingdom and funded by UK government grants. Results were released Wednesday by the American Society of Clinical Oncology and will be presented at the group’s meeting next month.

Herceptin transformed care of a dreaded disease when it was approved in 1998 for women with advanced breast cancers whose growth is aided by a faulty HER2 gene, as 15 percent to 20 percent of cases are. It was later approved for treatment of those cancers in earlier stages, too, based on studies that had tested it in patients for 12 months. That guess, that the drug should be taken for a year, became the standard of care.

But the drug can hurt the heart’s ability to pump. That often eases if treatment is stopped but the damage can be permanent and lead to heart failure.

Some studies tested shorter use, but results conflicted. The new study is the largest so far, and involved more than 4,000 women with early-stage cancers who were given usual chemotherapy plus Herceptin for either six or 12 months.   

After four years, about 90 percent of both groups were alive without signs of the disease. Only 4 percent on the shorter treatment dropped out due to heart problems versus 8 percent of those treated for a year.

“It’s great news” for patients, said the study leader, Dr. Helena Earl of the University of Cambridge in England. Earl has consulted for Herceptin’s maker, Roche. The company had no role in the study.

Compelling findings

“There’s no reason to not immediately change practice. The findings are persuasive,” said Dr. Richard Schilsky, chief medical officer for the oncology society. Most of Herceptin’s cancer-fighting benefit seems to come in the early months of use, he said.

Others said that because so few women have died or relapsed after being treated with the drug, longer followup may be needed to make sure the findings hold up before guidelines should be changed.  Doctors also want to see results published, and to study them to see if certain groups of women need longer treatment.

Herceptin is given through an IV every three weeks; a year of it costs $34,000 to $40,000 in England and about $70,000 in the U.S. In December, a copycat competitor known as a biosimilar was approved in the U.S. and already is used in some other countries.

Dr. Harold Burstein, a breast cancer expert at Dana-Farber Cancer Institute in Boston, said shorter treatment may increase access to the drug in countries where many women can’t afford it now, but that in the U.S., “my guess is that people will continue to aim for a year of treatment” because of lingering concerns that longer use is better, as a smaller, previous study suggested.

Dr. Jennifer Litton, a breast specialist at MD Anderson Cancer Center in Houston, said Herceptin was a true breakthrough, but scaling back treatment whenever possible is just as important to patients. She said the results show how important it can be to study drugs already on the market, and that drug companies alone should not be relied on to do studies like this.

 “It’s really important that we continue to have public funding for trials so we can continue to ask all of these questions for our patients,” she said.   

Herceptin’s developer, Genentech, now part of Roche, said in a statement that the new study must be viewed along with several smaller previous ones that found one year to be best. The goal of treatment “is to provide people with the best chance for a cure,” so women need to talk with their doctors about how best to reach that goal, the statement says.

Earlier this year, the American Heart Association issued its first statement on the heart effects of cancer drugs, saying women should consider carefully the risks and benefits of any therapies that may hurt hearts.

 
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Patients suffering from opioid addiction may soon be given the first non-opioid drug to help them handle withdrawal symptoms. 

The Food and Drug Administration on Wednesday approved use of the drug Lucemyra, saying it gives doctors a new option for treating the side effects of withdrawal.

“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction,” FDA Commissioner Scott Gottlieb said. “The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help.”

Those symptoms include anxiety, muscle aches, sweating, vomiting and a craving for drugs.

Opioids are synthetic painkillers generally prescribed by doctors or used in hospital emergency rooms. But they can become highly addictive, even after the original injury has healed.

Doctors usually treat addiction by substituting one opioid for another, then gradually reducing use or transitioning to other drugs.

Part of long-term plan

Lucemyra is an oral treatment and can be used for only 14 days. The FDA said Lucemyra is not a treatment for opioid addiction but can be used as part of a long-term plan to fight the problem.

Last year, President Donald Trump declared the opioid epidemic a national public health emergency. 

Despite public pronouncements on the need to cut back on opioid prescriptions and to punish drug dealers more harshly, administration critics said they have yet to see any concrete plans from the White House to battle the crisis.
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Something strange is happening with a now-banned chemical that eats away at Earth’s protective ozone layer: Scientists say there’s more of it — not less — going into the atmosphere and they don’t know where it is coming from.

When a hole in the ozone formed over Antarctica, countries around the world in 1987 agreed to phase out several types of ozone-depleting chemicals called chlorofluorocarbons (CFCs). Production was banned, emissions fell and the hole slowly shrank.

But starting in 2013, emissions of the second most common kind started rising, according to a study in Wednesday’s journal Nature . The chemical, called CFC11, was used for making foam, degreasing stains and for refrigeration.

“It’s the most surprising and unexpected observation I’ve made in my 27 years” of measurements, said study lead author Stephen Montzka, a research chemist at the National Oceanic and Atmospheric Administration.

“Emissions today are about the same as it was nearly 20 years ago,” he said.

Countries have reported close to zero emissions of the chemical since 2006 but the study found about 14,300 tons (13,000 metric tons) a year has been released since 2013. Some seeps out of foam and buildings and machines, but scientists say what they’re seeing is much more than that.

Measurements from a dozen monitors around the world suggest the emissions are coming from somewhere around China, Mongolia and the Koreas, according to the study. The chemical can be a byproduct in other chemical manufacturing, but it is supposed to be captured and recycled.

Either someone’s making the banned compound or it’s sloppy byproducts that haven’t been reported as required, Montzka said.

An outside expert, Ross Salawitch, an atmospheric scientist at the University of Maryland, is less diplomatic. He calls it “rogue production,” adding that if it continues “the recovery of the ozone layer would be threatened.”

High in the atmosphere, ozone shields Earth from ultraviolet rays that cause skin cancer, crop damage and other problems.

Nature removes 2 percent of the CFC11 out of the air each year, so concentrations of the chemical in the atmosphere are still falling, but at a slower rate because of the new emissions, Montzka said. The chemical stays in the air for about 50 years.
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The first batch of 4,000 experimental Ebola vaccines to combat an outbreak suspected of killing 23 people arrived in Congo’s capital Kinshasa on Wednesday.

The Health Ministry said vaccinations would start at the weekend, the first time the vaccine would come into use since it was developed two years ago.

The vaccine, developed by Merck and sent from Europe by the World Health Organization, is still not licensed but proved effective during limited trials in West Africa in the biggest ever outbreak of Ebola, which killed 11,300 people in Guinea, Liberia and Sierra Leone from 2014-2016.

Health officials hope they can use it to contain the latest outbreak in northwest Democratic Republic of Congo.

8,000 doses needed

Peter Salama, WHO’s deputy director-general for emergency preparedness and response, said the current number of cases stood at 42, with 23 deaths attributed to the outbreak.

“Our current estimate is we need to vaccinate around 8,000 people, so we are sending 8,000 doses in two lots,” he told Reuters in Geneva.

“Over the next few days we will be reassessing the projected numbers of cases that we might have and then if we need to bring in more vaccine we will do so in a very short notice.”

Health workers have recorded confirmed, probable and suspected cases of Ebola in three health zones of Congo’s Equateur province, and have identified 432 people who may have had contact with the disease.

WHO spokesman Tarik Jasarevic said the supplies sent to Congo included more than 300 body bags for safe burials in affected communities. The vaccine will be reserved for people suspected of coming into contact with the disease, as well as health workers.

“In our experience, for each confirmed case of Ebola there are about 100-150 contacts and contacts of contacts eligible for vaccination,” Jasarevic said. “So it means this first shipment would be probably enough for around 25-26 rings — each around one confirmed case.”

Storage temperature 

The vaccine is complicated to use, requiring storage at a temperature between -60 and -80 degrees Celsius.

“It is extremely difficult to do that as you can imagine in a country with very poor infrastructures,” Salama said.

“The other issue is, we are now tracing more than 4,000 contacts of patients and they have spread out all over the region of northwest Congo, so they have to be followed up and the only way to reach them is motorcycles.”

The outbreak was first spotted in the Bikoro zone, which has 31 of the cases and 274 contacts. There have also been eight cases and 115 contacts in Iboko health zone.

The WHO is worried about the disease reaching the city of Mbandaka with a population of about 1 million people, which would make the outbreak far harder to tackle. Two brothers in Mbandaka who recently stayed in Bikoro for funerals are probable cases, with samples awaiting laboratory confirmation.

The WHO report said 1,500 sets of personal protective equipment and an emergency sanitary kit sufficient for 10,000 people for three months were being put in place.
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