Drug will save lives of accident victims, says study
Up to 100,000 lives could be saved every year if a known drug were given to seriously bleeding trauma patients, says a report from a global trial.
The research reported in The Lancet shows that tranexamic acid (TXA), which helps blood to clot, could lower the risk of dying by 15%.
Developing countries would benefit most from this treatment, say researchers after studying 20,000 patients.
Each year 600,000 injured patients bleed to death worldwide.
World Health Organisation figures show that nearly six million people die each year from injuries, which accounts for 10% of the world’s deaths.
Most of those injury deaths occur in developing countries, where deaths from road traffic crashes and homicide have been steadily increasing. Almost half of those deaths are caused by bleeding.
Although previous smaller trials had shown that TXA reduced bleeding in patients undergoing major surgery, this was the first trial to test its effect on injured patients with severe bleeding.
Early treatment with TXA could combat the effects of serious bleeding
These included victims of traffic accidents, shootings, stabbings or land mine injuries.
The patients were injected with 1g of TXA within a few hours of being injured, followed by another 1g in a drip over the next eight hours, or a matching placebo.
After studying the numbers of deaths in hospital within four weeks of injury, researchers found that TXA reduced the chances of death, due to massive blood loss, by one sixth.
Ian Roberts, professor of epidemiology from the London School of Hygiene and Tropical Medicine, led the CRASH-2 international trial. He said it showed a “highly significant reduction in risk of dying”.
“The large number of patients treated in very different healthcare settings around the world means we can be sure that prompt use of TXA will be of benefit to trauma patients in all kinds of facilities,” he said.
The trial also showed no evidence of complications or unwanted clotting, which doctors had feared.
Researchers estimate that TXA could prevent up to 100,000 deaths every year across the world. In countries like India and China it could save about 12,000 lives each year, they predict.
Two thousand deaths a year could be saved in the United States and more in Europe. In the UK, where about 1,800 people die from bleeding after injury each year, researchers say TXA could cut this figure by about 280.
Addressing the practicalities of making the drug available worldwide, Professor Roberts said: “TXA is one of the cheapest ways to save a life there is”.
The poverty problemTXA costs about £3 per gram; it is easily administered and does not need to be refrigerated, he says. It can also be manufactured by a number of different companies.
The authors of the trial report recommend that tranexamic acid, should be available to doctors treating trauma patients in all countries, and should be considered for inclusion on the WHO List of Essential Medicines.
Dr Etienne Krug, director of violence and injury prevention and disability at the World Health Organisation, said that doctors needed to be aware of the trial results.
“We want to avoid injuries happening in the first place but we also need to strengthen the trauma response. Death and serious injury throw families into poverty, so the problem affects hundreds of millions every year worldwide.”
The trial was jointly funded by the National Institute for Health Research, part of the Department of Health, the drug company Pfizer, the BUPA Foundation and the JP Moulton Charitable Foundation.
UK health minister Earl Howe said: “This is a great example of how important research can help the NHS save more lives and spread best practice around the world.”
Reference Link: http://news.bbc.co.uk/2/hi/health/10311371.stm
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Customs group to fight $200 bln bogus drug industry
(Reuters) – Counterfeit drugs have become a $200-billion-a-year industry and the 176-nation World Customs Organization (WCO) will sign a declaration later this month to fight the scourge, an official said on Thursday.
Fake or substandard versions of medicines are often hidden in cargoes sent on circuitous routes to mask their country of origin.
“We have more fakes than real drugs in the market,” said Christophe Zimmermann, the WCO’s anti-counterfeiting and piracy coordinator. “In 2007-2008 alone, it rose 596 percent.”
Pharmacies and back street merchants in Africa sell fake medicines at rock-bottom prices.
The World Trade Organization says fake anti-malaria drugs kill 100,000 Africans a year and the black market deprives governments of 2.5-5 percent of their revenue.
The Brussels-based WCO represents customs operations globally and has joined with former French president’s Jacques Chirac’s foundation to raise awareness at upper echelons to curtail the illicit industry.
Spurred by Chirac’s foundation, 176 national customs chiefs will sign a declaration on June 24 to ban the making and marketing of counterfeit drugs, Zimmermann told Reuters.
Fake medicines often contain the wrong or toxic ingredients and pose a growing health threat worldwide, especially in poor countries where drugs are sold to treat conditions such as malaria, tuberculosis and HIV.
“If these subjects are not dealt with and strong action not taken, they will be a source of conflict,” said Catherine Joubert, director general of the Fondation Chirac, adding that so far 30 groups had signed the declaration.
Getting the WCO’s 176 members on board will lend legitimacy to proposals to revamp obsolete legislation and improve coordination between enforcement agencies, Zimmermann said.
Western Europeans spend an estimated 10.5 billion euros ($14.3 billion) a year on illicitly sourced medicines, according to a Pfizer-sponsored survey published in February.
In a sign Europe is taking the issue seriously too, justice ministers on the Council of Europe are set to ratify a convention on counterfeit medicines in Istanbul this November.
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Free drugs may help more get chlamydia treatment
(Reuters Health) – Vouchers for free medication might help the sexual partners of people being treated for chlamydia get treatment too, a new study says.
Treating partners is important, the researchers note, because patients who have been treated can get chlamydia again from a partner who has the infection. Going to a clinic and seeing a doctor is still the best option for those partners.
But the study’s authors say the vouchers are an option for people who might avoid clinics and never get treated to get the drugs they need without a prescription.
“Partners may not feel they have an STI (sexually transmitted infection),” Dr. Sharon Cameron, the lead author of the study and a gynecologist at the Dean Terrace Center in Edinburgh, Scotland told Reuters Health. Or, “they might be embarrassed to go to a clinic.” This system “gives individuals another option of where they would want to go be treated.”
Chlamydia is one of the most common STIs. In the U.S., around 1 percent of the population gets chlamydia every year. Young people age 15 to 24 are most at risk.
In the study, doctors gave out almost 600 vouchers to people diagnosed with chlamydia, most of them women. The vouchers allowed the sexual partners of those patients to go to a pharmacy and get a free dose of antibiotics used to treat the STI, which might otherwise cost around $20 if they didn’t have insurance. If they preferred, the partners could go to a clinic to be tested and treated there.
Forty percent of the vouchers were redeemed at a pharmacy, most within a few days. Four percent of partners chose to get treatment at one of the clinics tracked by the authors instead. The researchers don’t know whether the rest of the partners were treated by their primary care doctors or not at all.
Cameron said that these results are at least as good as what previous studies have shown for getting treatment to partners of people with chlamydia.
The voucher system is one way of getting medication in the hands of infected people quickly. Some states in the U.S. allow clinics to hand out extra antibiotics for patients to give to their sexual partners. But this isn’t allowed in the UK.
One worry is that giving people antibiotics without a doctor’s consult, either directly or through vouchers, could increase resistance to these drugs. The more antibiotics are used – and especially the more they are used for not enough time or at the wrong dose – the more likely that the infection will be able to fight off the drugs and become resistant to them. Resistant infections are more dangerous and costly to treat.
But Peter Carr, manager of the STD and HIV section at the Minnesota Department of Health, said the effect on resistance would not be significant. Resistance hasn’t been an issue for chlamydia like it has been for gonorrhea, and “the effect on overall antibiotic use would be small,” he told Reuters Health. “It would be a really tiny portion of the total antibiotics prescribed.”
Then there are the ethical issues of giving people treatment when a doctor hasn’t told them the drug’s side effects or their other options. An American Medical Association (AMA) report on the ethics of giving patients medication for their sexual partners said that the technique could be used as a back-up for times when doctors don’t think their patient’s partners will see a doctor.
“There are ethical trade-offs in what we do,” Dr. Mark Levine, the former chair of the AMA Council on Ethical and Judicial Affairs who was not involved in the study, told Reuters Health. “This is a means of getting treatment to more people than would be getting it using … the traditional doctor-patient relationship that requires an in-person visit.”
“The bottom line is if the partner’s not going to get anyway, it’s a way to make sure the partner does get treated,” said Carr, who was also not involved in the study. “We think it’s a valuable tool, and we need all the tools we can get for managing sexually transmitted infections in patients and their partners.”
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Drug fights tumors in advanced lung cancer
(Reuters) – A drug being developed by Pfizer Inc shrank lung cancer tumors in more than half of treated patients, and nearly all showed some benefit, U.S. researchers said on Saturday.
The experimental drug crizotinib is designed to target a specific genetic mutation most commonly found in nonsmokers with non-small cell lung cancer.
“Many of these patients had received three or more prior treatments, and we would expect only about 10 percent to respond. That is why we are so excited about the results,” said Dr. Yung-Jue Bang, the study’s lead investigator, who presented the data at the American Society of Clinical Oncology meeting in Chicago.
The results from the small study were so impressive that the company said it planned to seek U.S. regulatory approval in the first half of next year.
“These results are quite dramatic, and represent an important improvement over what we would see with standard chemotherapy for patients with metastatic disease,” added Bang, professor in the Department of Internal Medicine at Seoul National University College of Medicine in South Korea.
Crizotinib, a pill taken twice a day, works by blocking a genetic mutation that occurs when two genes fuse together to form a gene called EML4-ALK, which causes cancer.
All of the 82 treated patients in the study had the gene mutation and were either nonsmokers or had long given up smoking. Most had already undergone multiple rounds of chemotherapy.
Fifty-seven percent of the treated patients had their tumors shrink at least 30 percent, which was considered a partial response. But 87 percent experienced at least some tumor shrinkage or stable disease after eight weeks, and at least one patient’s tumor disappeared altogether.
Three or four others had no measurable tumor, but could not be characterized as a complete response because of some residual abnormality, such as scarring, Pfizer said.
‘DRAMATIC BENEFIT’
“Patients whose tumors have this mutation … can expect a dramatic benefit. This is what we as oncologists have always wanted to give our patients,” Dr. Mark Kris, a lung cancer researcher at New York’s Memorial Sloan-Kettering, told reporters at the ASCO meeting.
Many patients also had fewer tumor-related symptoms, such as severe shortness of breath, coughing and severe pain.
“We have seen a number of patients whose symptoms begin to improve within days or weeks of starting therapy,” said Mace Rothenberg, Pfizer oncology’s senior vice president for clinical development and medical affairs, said in a telephone interview.
The most common side effects were nausea and vomiting and were considered to be relatively mild.
On average, the treatment benefits lasted about six months — another encouraging sign since most patients with advanced lung cancer typically live just three or four months.
There was no available data to say whether the drug extended survival.
Although the study was small, the results were so strong that Pfizer has started testing the drug in a late-stage study.
Pfizer has partnered with Abbott Molecular, a unit of Abbott Laboratories, to develop a diagnostic test that looks for the ALK gene mutation.
“We would only administer it to patients who have that mutation, and not to those without it,” Kris said. “That is helpful.”
The company estimates there are about 7,500 to 10,000 patients in the United States with the gene mutation.
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Roche's Avastin helps ovarian cancer: study
(Reuters) – Long-term use of Swiss drugmaker Roche Holding AG’s Avastin, in combination with chemotherapy, helped women with advanced ovarian cancer live longer without their cancer getting worse, according to results from a new study.
The trial, funded by the National Cancer Institute, found that women who received Avastin and chemotherapy, followed by “maintenance” use of Avastin, had a 39 percent improvement in the likelihood of living without the cancer worsening, compared with chemotherapy alone.
Women who continued treatment with Avastin lived for an average of 14.1 months without cancer growth, compared with 10.3 months for women on chemo alone.
Patients who did not stay on Avastin did not do significantly better in the trial — which enrolled 1,837 patients — than those treated only with chemotherapy.
Avastin, which starves tumors of blood supply, is already a key weapon in the fight against colon, lung, breast and other types of cancers, but it has stumbled at key hurdles this year, failing in late-stage stomach and prostate cancer studies.
Roche is in discussions with the U.S. Food and Drug Administration regarding the ovarian cancer data, said Sandra Horning, global head of clinical oncology development at the company’s Genentech unit.
Avastin is the first targeted therapy to show a benefit in ovarian cancer, one of the most deadly types of the disease.
“We do need to learn more about what is the effect of using this agent on overall survival,” said Dr. Robert Burger, director of the women’s cancer center at Fox Chase Cancer Center in Philadelphia, Pennsylvania.
Women treated with Avastin had higher rates of side effects, including high blood pressure, bleeding, and gastrointestinal problems, than patients getting chemotherapy alone.
Some 230,000 women worldwide are diagnosed with ovarian cancer each year and nearly 70 percent of women with advanced disease die within five years, according to Roche.
The company, which announced in February that the ovarian cancer trial had succeeded, has estimated that use of Avastin in ovarian cancer could add another 1 billion Swiss francs ($865 million) to sales.
The world’s largest maker of cancer drugs is looking to expand the reach of Avastin, which had sales of 6.2 billion francs in 2009 and could become the world’s top selling drug by 2014 with sales of some $9 billion a year.
Initial treatment with Avastin for colorectal cancer costs about $48,000, with annual costs capped at $56,000 by Roche.
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Eisai's breast cancer drug extends lives: study
(Reuters) – An experimental breast cancer drug made from sea sponges added months to the lives of breast cancer patients whose cancer had come back despite several rounds of chemotherapy, doctors reported Sunday.
Eisai’s eribulin added an average of two and a half months to the lives of patients dying of breast cancer, which is a big improvement in such seriously ill cancer patients, the international team of researchers said.
The results of the Phase III trial, presented to a meeting of the American Society of Clinical Oncology in Chicago, have been anticipated after Eisai was given priority review June 1 for U.S. Food and Drug Administration approval of the drug.
“This is potentially practice changing,” ASCO president Dr. Douglas Blayney said in a telephone interview.
Dr. Christopher Twelves of St. James Hospital in Leeds in Britain and an international team studied 762 breast cancer patients with different types of tumor.
All had cancer that had spread and been through at least two rounds of chemotherapy. Two-thirds got two doses of eribulin while getting standard treatment, usually with one other chemotherapy drug but occasionally with just supportive care to treat pain and other symptoms.
The other third got either a third round of chemotherapy or supportive care. “Once this treatment fails, the patient often died,” Blayney said.
The patients given eribulin did considerably better, the researchers told the meeting. The eribulin patients lived a median of 13 months, compared to just under 11 months for patients who did not get eribulin.
LONGER LIVES
Most cancer trials look for what is called progression-free survival, meaning the doctors are looking to see if the tumors start growing back, or sometimes just response rate, to see if the tumors shrink at all.
This one looked to see how long the patients actually lived.
“This study is the first to compare overall survival with this new chemotherapeutic agent to real-life choices in heavily pretreated patients with metastatic breast cancer,” Twelves and colleagues said in their written presentation.
The drug works on the same principle, but with a slightly different mechanism, as older cancer drugs called taxanes and is infused intravenously.
Other experts said eribulin could be one of the last new chemotherapy drugs, which typically target fast-growing cells that include tumors but also healthy cells.
“This is the era of targeted therapy. It’s not an era of chemotherapy,” said Dr. Eric Winer of Harvard’s Dana-Farber Cancer Institute in Boston, who was not involved in the study.
“I don’t know that there are going to be many more chemotherapy agents approved for women with breast cancer. That said, this may be one of the last, and potentially provide women with an additional option and maybe an option to be used in combination with targeted therapies in the future.”
Three other studies presented to the meeting showed eribulin was effective and tolerated in a different group of patients with breast cancer, as well as colon cancer and urinary cancer patients.
Eisai has filed in Japan, the United States and Europe for approval of eribulin. The company hopes it will become a blockbuster, with global earnings of $1 billion a year.
“I think there is a reasonable chance that this drug will actually get approved,” Winer said. “There aren’t many drugs that show a survival advantage in this setting.”
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Drug hope for sepsis uncovered
Septic shock is a serious inflammatory response to an infection
Scientists have uncovered a potential new treatment for blood poisoning.
Experiments by a team in Glasgow show that blocking a molecule, previously found to be activated during septic shock, cuts the risk of death in mice.
It is hoped the finding, published in Science , could lead to a wider range of drugs for the condition which affects 20 million people worldwide every year.
As many as 50% of people with septic shock die, figures show.
In England and Wales there are an estimated 31,000 cases a year of severe sepsis, which is a catastrophic immune system reaction to infection leading to organ failure.
Patients need to be admitted to intensive care so their organs can be supported while the infection is treated.
“The incidence of sepsis is on the increase and clinical treatments are still inadequate, so a medical breakthrough of this kind is timely and will hopefully lead to a way to treat this killer condition” – Professor Alirio Melendez Study leader
In the latest study researchers built on previous work showing that an enzyme called SphK1 is triggered during the inflammation that occurs in septic shock.
They showed that immune cells from patients with severe sepsis produced abnormally high levels of the enzyme and that blocking it from reduced the inflammatory signals sent out by the cells.
Protection
Using drugs which block the enzyme, they showed that treatment cut the risk of death in mice with the condition.
The treated mice were also protected from multi-organ failure, and were much better at clearing the bacterial infection than untreated mice.
Study leader Professor Alirio Melendez, from the University of Glasgow, said drugs which block the enzyme may become useful treatments.
“The incidence of sepsis is on the increase and clinical treatments are still inadequate so a medical breakthrough of this kind is timely and will hopefully lead to a way to treat this killer condition.”
John Heyworth, president of the College of Emergency Medicine, said the results were very interesting but one of the key factors in improving survival in people with sepsis was getting an early diagnosis.
He said people end up in hospital because they are very unwell but there may not be an obvious source of infection.
“It’s important to identify sepsis early and treat it aggressively.
“There is a window when you can make a big difference – it is a time-critical condition.”
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Peregrine drug shows promise against breast cancer
(Reuters) – A small, mid-stage trial of an experimental breast cancer drug developed by Peregrine Pharmaceuticals Inc showed that 74 percent of patients responded to the treatment, according to the company.
The Phase 2 trial enrolled 46 patients with advanced breast cancer who were treated with a combination of the drug, called bavituximab, and chemotherapy drugs paclitaxel and carboplatin.
The trial found that, after a treatment period of about six months, 34 patients achieved an “objective tumor response,” meaning their tumors shrank at least 30 percent. Four patients, or 9 percent, had their tumors completely disappear.
Patients survived a median of 6.9 months without their cancer worsening and overall survival will eventually be reported, Peregrine said.
By comparison, an older trial showed that treating advanced breast cancer patients with the chemo drugs alone resulted in a response rate of 62 percent and median progression-free survival of 4.8 months.
Side effects were in line with those typically seen with chemo drugs, said Marvin Garovoy, head of clinical science at Peregrine.
Bavituximab is an antibody designed to reactivate the immune system to fight tumors and tumor blood vessels.
Peregrine, which will present the bavituximab data at a meeting of the American Society of Clinical Oncology next month, said it is planning future Phase 2 trials.
Garovoy said the company plans to launch by the middle of this year a controlled study of the drug in lung cancer patients.
(Reporting by Deena Beasley; editing by Carol Bishopric)
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Sanofi prostate cancer drug shows 28 percent survival
(Reuters) – Sanofi-Aventis’ cabazitaxel candidate prostate cancer drug combined with prednisone reduced the risk of death by 28 percent compared with another treatment, the outcome of a final-stage trial showed.
The French drugmaker said on Thursday that the combination of the treatments led to an improved median overall survival of 15.1 months against 12.7 months in patients who took a chemotherapy of mitoxantrone with prednisone/prednisolone.
The primary endpoint of the so-called Tropic trial was overall survival.
Cabazitaxel won priority review from the U.S. Food and Drug Administration (FDA), meaning the health regulator will take about six months instead of the usual 10 months to assess if a drug is efficient and safe to be marketed.
The FDA’s review should happen in the third quarter, Sanofi said.
Filing for approval in the EU has been completed.
Some 4.9 percent of patients using cabazitaxel died from side-effects. Sanofi said this was mainly due to neutropenia, a blood disorder people can get from chemotherapy treatment, and its complications.
This compared with 1.9 percent using mitoxantrone.
“The development of cabazitaxel is one of many investigational compounds we hope to present to the cancer community in the months and years to come,” Debasish Roychowdhury, Sanofi’s oncology senior vice president, said.
The clinical trial results will be presented at the 2010 American Society of Clinical Oncology (ASCO) on June 6.
(Reporting by Caroline Jacobs; Editing by David Cowell)
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Sea sponge-derived drug treats several cancers
(Reuters) – An experimental new breast cancer drug made from sea sponges helped in a range of cancers, from breast cancer to sarcoma, researchers report.
Three studies show the drug, Eisai’s eribulin, was effective and tolerated in patients with breast cancer, colon cancer and urinary cancer, according to brief data released on Thursday by the American Society of Clinical Oncology. Sarcomas are cancers that grow from muscle or bone.
A fourth study of patients with advanced breast cancer will be detailed in a “late-breaker” session at ASCO’s annual meeting in June.
The drug is not yet approved, but Eisai has filed with relevant agencies in Japan, the United States and Europe.
The drug works on the same principle, but with a slightly different mechanism as older cancer drugs such as the taxanes and is infused intravenously.
Only a few details are available in the abstracts of the research published ahead of the meeting.
Researchers at Aichi Cancer Center in Nagoya, Japan and several other Japanese sites tested eribulin in 81 breast cancer patients whose cancer had come back despite several rounds of chemotherapy.
They said 21 percent of the patients had some response to the drug and side-effects were common — 95 percent had low blood counts. Nonetheless they said the drug was effective and tolerable.
Researchers at the European Organization for Research and Treatment of Cancer tested eribulin in several types of advanced soft tissue sarcoma and found varying responses but said it deserved further study.
Up to 45 percent of the patients with one type of sarcoma saw three months before their tumors began growing again — a significant result in advanced cancer.
And a team led by the California Cancer Consortium at the University of Southern California and elsewhere will report details of a mid-stage study of 40 patients with advanced urological cancer. They said 38 percent of the group had a response to eribulin.
An international team will report more details at the meeting itself in their trial of patients with breast cancer.
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