Angry mothers meet U.S. EPA over concerns with Roundup herbicide


Jameson Bluma, 3, holds a sign during one of many worldwide ''March Against Monsanto'' protests against Genetically Modified Organisms (GMOs) and agro-chemicals, in Los Angeles, California October 12, 2013. REUTERS/Lucy Nicholson


Jameson Bluma, 3, holds a sign during one of many worldwide ”March Against Monsanto” protests against Genetically Modified Organisms (GMOs) and agro-chemicals, in Los Angeles, California October 12, 2013.

Credit: Reuters/Lucy Nicholson


(Reuters) – A group of mothers, scientists and environmentalists met with U.S. Environmental Protection Agency regulators on Tuesday over concerns that residues of Roundup, the world’s most popular herbicide, had been found in breast milk.

The meeting near Washington D.C., followed a five-day phone call blitz of EPA offices by a group called “Moms Across America” demanding that the EPA pay attention to their demands for a recall of Roundup.

“This is a poison and it’s in our food. And now they’ve found it in breast milk,” said Zen Honeycutt, founder of Moms Across America. “Numerous studies show serious harm to mammals. We want this toxic treadmill of chemical cocktails in our food to stop.”

Roundup is an herbicide developed and sold by Monsanto Co. since the 1970s, and used in agriculture and home lawns and gardens. The chief ingredient, glyphosate, is under a standard registration review by the EPA. The agency has set a deadline of 2015 for determining if glyphosate use should continue as is, be limited or halted.

The agency expects to have a preliminary risk assessment completed late this year, Neil Anderson, chief of the risk management and implementation branch at the EPA’s pesticide re-evaluation division, told the group. He said more than 100 studies have been reviewed, many of which were provided by chemical makers, that so far have shown no reason for new restrictions on the pesticide.

Some studies that did show potential risks were not seen as valid, Anderson said. All of the information will be available for public review and comment later this year, he said.

Monsanto and other chemical makers say glyphosate has been extensively studied and has a long track record of safe and effective use.

But environmentalists, consumer groups and plant scientists from several countries have said in recent years that heavy use of glyphosate is causing problems for plants, people and animals. They say some tests have raised alarms about glyphosate levels found in urine samples and breast milk. In 2011, U.S. government scientists said they detected significant levels of glyphosate in air and water samples.

The group told the EPA Tuesday that a new U.S. study of glyphosate levels in breast milk is planned this year.

The use of glyphosate in agriculture has jumped dramatically since the mid-1990s after Monsanto started introducing crops genetically engineered to withstand direct sprays of Roundup, so farmers could more easily kill weeds without harming their crops. Glyphosate is sprayed on most of the corn and soybean crops in the United States, as well as over sugar beets, canola and other crops.

Last year, the EPA agreed to raise the permitted tolerance levels for glyphosate residue in food. The agency said at that time that toxicity data and studies it reviewed shows glyphosate is not a cancer risk and is generally safe at the approved levels.

(Reporting by Carey Gillam in Kansas City; Editing by Grant McCool)

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Allergan makes case against Valeant takeover ahead of higher bid


J. Michael Pearson, Chairman of the board and Chief Executive Officer of Valeant Pharmaceuticals International Inc., waits for the start of their annual general meeting in Laval, Quebec May 20, 2014.   REUTERS/Christinne Muschi


J. Michael Pearson, Chairman of the board and Chief Executive Officer of Valeant Pharmaceuticals International Inc., waits for the start of their annual general meeting in Laval, Quebec May 20, 2014.

Credit: Reuters/Christinne Muschi


(Reuters) – Allergan Inc (AGN.N) on Tuesday built its case with investors for rejecting a $47 billion takeover offer from Valeant Pharmaceuticals International, (VRX.TO), saying the Canadian drugmaker has overstated the possible savings from the deal.

The move comes one day before Valeant will hold a webcast in which it has said it will raise its offer for Allergan.

In slides posted to its website, the botox maker laid out its argument for rejecting Valeant’s offer and said that the research and development and tax structure savings would not materialize. Valeant and activist investor Bill Ackman made an offer to buy Allergan on April 22, which Allergan spurned.

Alvarez & Marsal and FTI Consulting, two third-party consultants, reviewed Allergan’s analysis and confirmed key components, Allergan said.

The offer was $153 per share at the time of the bid. Investors are looking for a price of $180 to $200 per share, according to an investor survey last week.

Allergan said Valeant’s low organic sales growth was driven by price increases, that its acquired companies experienced market share erosion and that Valeant lacked transparency in its financial reporting.

“Valeant’s business leaders will provide further clarity on our historic, current and future operating performance and address Allergan’s inaccurate assertions about our business model at our event tomorrow,” Valeant spokeswoman Laurie Little said when asked to comment on Allergan’s presentation.

Wells Fargo analyst Lawrence Biegelsen said in a research note that if Allergan rejects Valeant’s new bid, it expects Allergan to then announce new steps to increase its financial performance. That could include a strategic acquisition, a large share buyback program or cost cutting.

Allergan shares were off 1.6 percent at $164.33 while Valeant fell 3 percent to $129.54, both on the New York Stock Exchange.

(Reporting by Caroline Humer in New York; Additional reporting by Rod Nickel in Winnipeg; Editing by Bernadette Baum and Lisa Shumaker)

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Be wary of Wikipedia, say scientists








By Pippa Stephens
Health reporter, BBC News


DoctorScientists compared Wikipedia entries with peer-reviewed medical research


Wikipedia, the online encyclopaedia, contains errors in nine out of 10 of its health entries, and should be treated with caution, a study has said.

Scientists in the US compared entries about conditions such as heart disease, lung cancer, depression and diabetes with peer-reviewed medical research.

They said most articles in Wikipedia contained “many errors”.

Wikimedia UK, its British arm, said it was “crucial” that people with health concerns spoke to their GP first.


Open-access ‘concerns’

The online encyclopaedia is a charity, and has 30 million articles in 285 languages.

It can be edited by anybody, but many volunteers from the medical profession check the pages for inaccuracies, said Wikimedia UK.

The open-access nature has “raised concern” among doctors about its reliability, as it is the sixth most popular site on the internet, the US authors of the research, published in the Journal of the American Osteopathic Association, said.

Up to 70% of physicians and medical students use the tool, they say.

The 10 researchers across America looked at online articles for 10 of the “most costly” conditions in the US, including osteoarthritis, back problems and asthma.

They printed off the articles on 25 April 2012 to analyse, and discovered that 90% of the entries made statements that contradicted latest medical research.

Lead author Dr Robert Hasty, of the Wallace School of Osteopathic Medicine in North Carolina, said: “While Wikipedia is a convenient tool for conducting research, from a public health standpoint patients should not use it as a primary resource because those articles do not go through the same peer-review process as medical journals.”

Dr Hasty added the “best resource” for people worried about their health was their doctor.


Contact GP ‘first’

Stevie Benton, at Wikimedia UK, said there were a “number of initiatives” in place to help improve the articles, “especially in relation to health and medicine”.

He said the charity had a project to bring together volunteer Wikipedia editors with a medical knowledge to identify articles that need improvement, find credible sources and make entries more “accurate and more readable”.

Mr Benton said Wikipedia was also working with Cancer Research UK to review cancer-related articles by clinical researchers and writers to keep them accurate and up-to-date.

But he added: “However, it is crucial that anybody with concerns over their health contacts their GP as a first point of call. Wikipedia, like any encyclopaedia, should not take the place of a qualified medical practitioner.”

Wikipedia also expressed concern at the small sample size used in the research, as it may not be representative.

The study did not account for Wikipedia leaving out important information.

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Child sight loss 'on the increase'








Premature baby's footVery premature babies may be born with vision problems


Increasing numbers of British children are being registered as blind or partially sighted, say campaigners.

Blind Children UK says much of the rise is down to more very premature babies surviving, with one in 20 of these now likely to be born blind.

It estimates the number of babies born with sight difficulties as a result of being premature has risen 22% over the past decade to more than 1,800 a year.

It says delays in diagnosis are leaving children unnecessarily impaired.

Blind Children UK is aiming to raise awareness of the warning signs that parents should watch for.

The organisation highlights signs such as red or cloudy eyes and babies or children reacting badly to bright light, and says parents should seek medical help if they are evident.

To evaluate the extent of sight problems, the charity looked at data from NHS England, the Welsh Assembly, the Scottish government, the Northern Ireland Health and Social Care Trusts and the Office for National Statistics.

It found that since 2006, there had been a 9% rise in the number of children registered blind or partially sighted.

The biggest increase has been among those aged under five, according to the charity formerly known as the National Blind Children’s Society.


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Some signs of sight problems in children:

  • Red, inflamed, watery or cloudy eyes
  • Excessive rubbing or poking of the eyes
  • Puffy or swollen eyelids
  • Moving or “wobbling” eyes
  • Unusual posture when looking at something
  • Bright light causing discomfort

Source: Blind Children UK


line break


‘Affects development’

The earlier children are born the greater the risk they will have a visual impairment.

The survey of 130 parents of children with sight problems found a quarter said that they had to wait longer than a year to have their child diagnosed.

Half of those questioned said the delay they experienced in diagnosis had had a “negative” effect.

Richard Leaman, chief executive of Blind Children UK, said: “Every day a child with sight loss goes without support, it dramatically affects their development.

“As much as 80% of a sighted child’s learning takes place using vision. Without this, it’s impossible for a young boy or girl to develop fully and make sense of the world around them.

“We help children and their families tackle all the challenges of sight loss, so that they can enjoy their childhood and fully realise their potential as adults.”

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Economic slowdown tied to rise in obesity in richer nations: OECD

An overweight woman sits on a chair in Times Square in New York, May 8, 2012. . REUTERS/Lucas Jackson

An overweight woman sits on a chair in Times Square in New York, May 8, 2012. .

Credit: Reuters/Lucas Jackson


(Reuters) – The rate of obesity continues to climb across the world’s most developed countries, with certain nations and groups of people such as women and the poor hit harder by the recent economic crisis, the OECD said on Tuesday.

While rates are rising as much as 3 percent a year in countries such as Australia, France, Mexico and Switzerland, they have been fairly stable in other countries such as the Unites States, Canada, Korea and Italy, the Organization for Economic Cooperation and Development said in report.

A review of available data showed that the global recession that struck in 2008 forced many families in harder-hit nations to cut back spending on food, especially healthier but often more expensive options such as fruits and vegetables, in favor of cheaper, less healthy options, it said.

Even in nations that fared better in the economic slowdown, certain groups of people, particularly women and those who are less educated and have lower incomes, were also more likely to be obese, OECD found.

“The economic crisis is likely to have contributed to further growth in obesity,” OECD researchers wrote.

Although the overall rate of obesity has slowed among more economically developed countries over the past five years, “the obesity epidemic has not stopped spreading,” they added.

The new report, based on a review of data from 10 OECD countries, will be presented on Wednesday at the European Congress on Obesity in Bulgaria.

Most of the OECD’s 34 members are wealthy countries such as the United States and European nations, although some emerging economies such as Mexico and Turkey are also included. The group does not include China, India or other bigger developing countries.

Rising obesity rates can also add economic burden as governments grapple with the costs of chronic conditions linked to obesity such as diabetes, heart disease and even cancer.

Current efforts aimed at preventing further weight gain, including using financial incentives to boost wellness or increasing basic health exams, are improving, OECD said.

“The economic crisis may have contributed to a further growth in obesity, but most governments need to do more to stop this rising tide,” OECD health policy analyst Michele Cecchini said in a statement.

Other policy efforts, such as stricter rules for advertising unhealthy foods to children, better food labeling and “carefully designed” food and beverage taxes could have an impact, the Paris-based organization said. One bright spot in the OECD’s review: although on average one in five children in developed countries is overweight, “more countries have managed to stabilize or even slightly reduce rates of child obesity than they have of adult obesity.”

A copy of the OECD report is online at: here

(Reporting by Susan Heavey; Editing by Sofina Mirza-Reid)

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Economic slowdown tied to rise in obesity in richer nations: OECD


(Reuters) – The rate of obesity continues to climb across the world’s most developed countries, with certain nations and groups of people such as women and the poor hit harder by the recent economic crisis, the OECD said on Tuesday.

While rates are rising as much as 3 percent a year in countries such as Australia, France, Mexico and Switzerland, they have been fairly stable in other countries such as the Unites States, Canada, Korea and Italy, the Organization for Economic Cooperation and Development said in report.

A review of available data showed that the global recession that struck in 2008 forced many families in harder-hit nations to cut back spending on food, especially healthier but often more expensive options such as fruits and vegetables, in favor of cheaper, less healthy options, it said.

Even in nations that fared better in the economic slowdown, certain groups of people, particularly women and those who are less educated and have lower incomes, were also more likely to be obese, OECD found.

“The economic crisis is likely to have contributed to further growth in obesity,” OECD researchers wrote.

Although the overall rate of obesity has slowed among more economically developed countries over the past five years, “the obesity epidemic has not stopped spreading,” they added.

The new report, based on a review of data from 10 OECD countries, will be presented on Wednesday at the European Congress on Obesity in Bulgaria.

Most of the OECD’s 34 members are wealthy countries such as the United States and European nations, although some emerging economies such as Mexico and Turkey are also included. The group does not include China, India or other bigger developing countries.

Rising obesity rates can also add economic burden as governments grapple with the costs of chronic conditions linked to obesity such as diabetes, heart disease and even cancer.

Current efforts aimed at preventing further weight gain, including using financial incentives to boost wellness or increasing basic health exams, are improving, OECD said.

“The economic crisis may have contributed to a further growth in obesity, but most governments need to do more to stop this rising tide,” OECD health policy analyst Michele Cecchini said in a statement.

Other policy efforts, such as stricter rules for advertising unhealthy foods to children, better food labeling and “carefully designed” food and beverage taxes could have an impact, the Paris-based organization said. One bright spot in the OECD’s review: although on average one in five children in developed countries is overweight, “more countries have managed to stabilize or even slightly reduce rates of child obesity than they have of adult obesity.”

A copy of the OECD report is online at: here

(Reporting by Susan Heavey; Editing by Sofina Mirza-Reid)

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A bitter pill as China crackdowns squeeze pharma margins

The logo of Shanghai Roche Pharmaceutical Co. Ltd. is seen outside their headquarters in Shanghai May 22, 2014.  REUTERS/Aly Song


(Reuters) – A crackdown on corruption and pricing in China’s fast-growing pharmaceutical market has squeezed profits and margins, raising a red flag to global Big Pharma that the days of easy growth in the country may be over.

A Reuters’ analysis of more than 60 listed Chinese healthcare firms shows average profit margins declined to around 10 percent last year from 15 percent in 2012. Average net profits fell 2.1 percent, down from close to 20 percent growth in previous years.

China has been a magnet for the big global pharmaceutical companies and other healthcare firms as growth slows in Europe and the United States. It is the largest emerging drugs market and is set to be the global number two overall within three years, according to consultancy IMS Health.

While global drugmakers withhold their China profit figures, the analysis suggests profit growth is harder to come by – a concern as many global firms look to China as a future growth driver.

“Most companies, local and foreign, have enjoyed an easy growth phase for 5-6 years as money was thrown at the healthcare system to improve access,” said Alexander Ng, Hong Kong-based associate principal at McKinsey & Co. “Now China is more into cost containment mode… and the squeeze on pricing and margins is a lot more apparent.”

Over the past year, China has cracked down on high prices and corruption in the healthcare sector. Authorities probed drugmakers over pricing in July, while a high-profile investigation into British drugmaker GlaxoSmithKline Plc led to executives at the company being charged with bribery earlier this month.

Industry and legal sources said the investigations into the sector are likely to grow more intense, meaning downward pressure on profits is likely to remain.

SALES DRAG

The climate of investigation has stymied sales growth, with some doctors saying they are worried to meet pharmaceutical reps, fearing being caught in the glare of China’s watchdogs.

In 2013, Chinese authorities visited global drugmakers including Novartis AG, AstraZeneca Plc, Sanofi SA, Eli Lilly & Co and Bayer AG as part of a broad investigation into the sector.

GSK, which saw its China revenues plunge 61 percent in the third quarter last year, has since overhauled its management structure in China, stopped payments to healthcare professionals and changed its incentive systems for drug reps.

“Of course there will be an impact on sales. The pattern of selling through bribing definitely won’t work anymore,” said a Shanghai-based sales executive at another global drugmaker, speaking on condition of anonymity.

The Reuters’ analysis showed combined revenue growth in the sector fell to 17.9 percent last year, from 22.6 percent in 2012 and more than 28.8 percent in 2011.

PRICING PRESSURE

Price cuts are also putting a strain on profits and margins as China’s leaders look to cut a healthcare bill that is set to hit $1 trillion by 2020, according to McKinsey & Co. Combined profit growth dropped to around 5.2 percent last year from 23.9 percent in 2011, according to the Reuters’ analysis.

While authorities have made some moves to step back on price caps, Chinese healthcare procurement still puts the main emphasis on cost, creating an incentive for firms to push prices lower to beat rivals to contracts.

“The industry is in a very competitive stage, where firms want to take market share to stay in the game, but at the same time can’t deal with the low prices,” said Yu Mingde, president of the Chinese Pharmaceutical Enterprises Association, an organization supervised by China’s cabinet.

The crackdown on pricing has pushed some Chinese firms out of business and forced global drugmakers to rethink their China strategy, industry sources and analysts said, putting greater emphasis on high-tech drugs which command greater pricing power.

International drugmakers have long banked on being able to charge a steep premium in emerging markets for branded generic drugs that have gone off patent in their home market.

Generics specialist Actavis Plc pulled out of China this year, saying the market was too risky and not a business-friendly environment.

“When you have 5,000 competitors you have to be special, and being a foreign company is no longer enough,” said Guillaume Demarne, Shanghai-based business development manager at healthcare research body Institut Pasteur.

M&A DRIVER

Rising competition in the market will also likely spur a round of consolidation as firms look to strengthen in terms of scale or technology to stay ahead of rivals, analysts said.

Bayer said in February it would buy Chinese traditional medicine maker Dihon Pharmaceutical, while Shanghai Fosun Pharmaceutical Group Co Ltd said last month it plans to take U.S.-listed Chindex International Inc private in a $461 million deal with equity firm TPG.

“The level of industrial concentration will rapidly increase by way of acquisitions and reorganizations,” Fosun Pharmaceutical said in a statement with its annual earnings.

M&A activity this year has so far outstripped 2013, said Phil Leung, China healthcare head and Asia Pacific M&A head for consultancy Bain & Co, noting that local and global firms were looking at acquisitions, joint ventures and other tie-ups.

Drugmakers with advantages of scale, low-cost production or unique, in-demand products should hold their own, he said, while others would struggle to survive.

“In this environment, the strong will get stronger and the stragglers will be more exposed.”

(Additional reporting by Li Hui in BEIJING and SHANGHAI newsroom; Editing by Ian Geoghegan)

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Duchenne drug 'nears approval' in EU








PillsA new drug could be used to treat children in the UK with Duchenne in 2015


A drug to treat a particular form of Duchenne muscular dystrophy has been given the green light by the European Medicines Agency and could be available in the UK in six months.

Translarna is only relevant to patients with a ‘nonsense mutation’, who make up 10-15% of those affected by Duchenne.

The EMA decided not to pass the drug in January, but they have since re-examined the evidence.

A campaign group said the drug must reach the right children without delay.

There are currently no approved therapies available for this life-threatening condition.

The patients who will benefit the most are those aged five years and over who are still able to walk, the EMA said.

Duchenne muscular dystrophy is a genetic disease that gradually causes weakness and loss of muscle function.

Patients with the condition lack normal dystrophin, a protein found in muscles, which helps to protect muscles from injury.

In patients with the disease, the muscles become damaged and eventually stop working.

There are 2,400 children in the UK living with muscular dystrophy, but only those whose condition is caused by a particular ‘nonsense mutation’ – namely 200 children – are suitable to use Translarna.


Urgency in UK

The drug, ataluren, will be known by the brand name of Translarna in the EU. It was developed by PTC Therapeutics.

The next step will see the European Commission rubberstamp the EMA’s scientific ‘green light’ within the next three months and authorise the drug to be marketed in the European Union.

At that point, individual member states, including the UK, must decide how it will be funded.

The Muscular Dystrophy Campaign is calling for urgent meetings with National Institute of Health of Clinical Excellence (NICE) and NHS England to discuss how Translarna can be cleared for approval and use in the UK.

It said families in the UK could have access to the drug by spring 2015.

Robert Meadowcroft, chief executive of the campaign, said: “This decision by the EMA is fantastic news.

“Most of those diagnosed with Duchenne muscular dystrophy, usually before the age of five, will use a powered wheelchair before they are 12, will not have the muscle strength to pick up a glass of water by the age of 20 and will not live to see their 30th birthday.

“This step forward for Translarna offers much needed hope.”

He added that extending the numbers of patients taking Translarna would help to accelerate the development of the drug.

Clinical trials are still ongoing on the drug and the results will have to be sent to the EMA.

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Qiagen wins U.S. approval for test to accompany Amgen cancer drug


(Reuters) – U.S. health regulators on Friday approved Qiagen NV’s gene-testing kit to identify those colorectal cancer patients most likely to benefit from Amgen Inc’s drug, Vectibix, Qiagen said.

In addition, the Food and Drug Administration expanded the approval of Vectibix to allow its use as a first-line, or initial, treatment for colon cancer in combination with the widely used FOLFOX chemotherapy regimen, Amgen said.

The expanded Vectibix approval is for patients who have a non-mutated, or wild type, KRAS gene after clinical trials demonstrated that those patients were most likely to be helped by the drug.

The FDA approval for the genetic test marks the third U.S. approval for a Qiagen companion diagnostic for use in combination with a specific drug, a key growth market for the German company.

Both approvals could pave the way for increased use of Vectibix, which has been largely a disappointment for Amgen. It means the drug can be used earlier in the disease and would be accompanied by a standarushdized diagnostic to help doctors pinpoint patients that would best respond to the medicine.

Amgen had $389 million in sales from Vectibix last year, $126 million of which came from U.S. sales.

Close to 40 percent of colorectal cancer patients have tumors with mutated forms of the KRAS gene, which make them poor candidates for Vectibix. The rest have the non-mutated, or wild, forms and stand a better chance of benefiting from the drug, which was approved in the United States in 2006.

(Reporting by Ludwig Burger in Frankfurt and Bill Berkrot in New York. Editing by Andre Grenon)

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OncoBriefs: Myeloma Tx, Penis Shrinkage, Rx OKs

Oncology/Hematology

Published: May 24, 2014

Continuous therapy topped fixed-duration treatment for newly diagnosed multiple myeloma in a retrospective review that will be reported during the American Society of Clinical Oncology meeting, which begins May 30 in Chicago.

Other oncology-related news in this edition of OncoBriefs includes a possible therapy to minimize penile shrinkage after radical prostatectomy and regulatory approvals for drugs used to treat a type of leukemia and colorectal cancer.

Continuous Therapy Gets the Nod for Newly Diagnosed Multiple Myeloma

Although continuous therapy prolongs remission duration in multiple myeloma, drug resistance at relapse might adversely affect overall survival. To examine the issue, investigators in Italy and Israel retrospectively analyzed data from two phase III trials that compared continuous versus fixed-duration therapy. The results will be reported by Antonio Palumbo, MD, of the University of Torino in Italy.

Both trials involved patients with newly diagnosed multiple myeloma. One trial evaluated induction therapy with lenalidomide (Revlimid), followed by consolidation, and lenalidomide maintenance (continuous) versus induction and consolidation without maintenance (fixed duration). The second trial compared bortezomib (Velcade)-based induction and maintenance therapy versus bortezomib-based induction alone.

The analysis had three primary outcomes: first progression-free survival (PFS1), defined as the time from start of therapy to first relapse; PFS2, defined as the time from treatment initiation to second relapse; and overall survival.

A pooled analysis of data from both clinical trials comprised 452 patients randomized to continuous therapy and 461 to fixed-duration therapy. Median follow-up was 52 months.

Continuous therapy was associated with significant improvement in all three outcomes:

  • Median PFS1 – 35 versus 24 months (HR 0.58, P<0.0001)
  • Median PFS2 – 63 versus 47 months (HR 0.69, P=0.0001)
  • Median Overall Survival – Not reached versus 70 months (HR 0.70, P=0.0019)

“Prolongation of PFS2 suggests that the clinical benefit observed during first remission is not canceled by a shorter second remission,” the investigators concluded. “PFS2 should be included in all continuous therapy versus fixed-duration therapy studies to evaluate the risk of tumor resistance induced by continuous therapy.”

PDE5 Inhibitor Reduces Penis Shrinkage after Prostatectomy

Early, continuous treatment with tadalafil (Cialis) after bilateral nerve-sparing radical prostatectomy led to a significant reduction in loss of penile length, a common after-effect of the surgery.

After 9 months of randomized therapy, men treated with daily tadalafil had a mean reduction in stretched penile length of 2.2 mm from baseline compared with a loss of 6.3 mm among men allocated to placebo (P=0.032). Men randomized to tadalafil on an as-needed basis fared worse than the placebo group, losing an average of 7.9 mm in stretched penile length from baseline.

Loss of stretched penile length was a secondary endpoint of the trial, Gerald Brock, MD, of the University of Western Ontario in London, said at the American Urological Association meeting in Orlando. Previously reported results showed significant improvement in erectile function and ability to engage in intercourse among men randomized to daily tadalafil.

The data showed a significant association between preservation of stretched penile length, scores on the erectile function component of the International Index of Erectile Function, and overall sexual satisfaction, he added.

The trial design included a 6-week washout period after randomized therapy, followed by a 3-month trial of open-label daily tadalafil. By the end of open-label therapy, men originally randomized to tadalafil as needed had erectile functions scores that did not differ significantly from those of men who took tadalafil daily during the randomized phase of the study, said Brock.

Oncology Drugs Win Approvals in US, Europe

The FDA has approved panitumumab (Vectibix) plus FOLFOX chemotherapy as first-line therapy for wild-type KRAS metastatic colorectal cancer, according to a statement from Amgen, which markets the targeted agent.

The approval was based primarily on results of two randomized phase III clinical trials demonstrating improved survival in patients who received first-line treatment with panitumumab, a monoclonal antibody against epidermal growth factor receptor. In one trial patients without mutations in KRAS exon 2 had significant improvement in PFS (9.6 versus 8.0 months) and in overall survival (23.8 versus 19.4 months) with FOLFOX plus panitumumab versus FOLFOX alone.

The second trial demonstrated noninferiority for panitumumab versus cetuximab (Erbitux) for treatment of wild-type KRAS metastatic colorectal cancer that had not responded to chemotherapy.

In news on the other side of the Atlantic Ocean, the European Union Committee for Medicinal Products for Human Use (CMPH) approved obinutuzumab (Gazyva) in combination with chlorambucil for previously untreated chronic lymphoid leukemia in patients with comorbidities that make them unsuitable for treatment with fludarabine.

Supporting data for the approval applications came from a phase III trial that showed an 86% reduction in the hazard for PFS among patients treated with anti-CD20 monoclonal antibody obinutuzumab and chlorambucil versus chlorambucil alone. Patients also lived longer with the addition of the monoclonal antibody to the chemotherapeutic agent. The combination also reduced the PFS hazard by 61% compared with patients who received rituximab (Rituxan) and chlorambucil.

The CMPH is analogous to an FDA advisory committee, and the final decision rests with the European Commission, according to Roche, which manufactures obinutuzumab (known as Gazyvaro in Europe).

Palumbo disclosed relevant relationships with Amgen, Bristol-Myers Squibb, Celgene, Janssen, Millennium, and Onyx.

Brock disclosed relevant relationships with Pfizer, Astellas, Eli Lilly, Bayer, Johnson & Johnson, Coloplast, American Medical Systems, and GlaxoSmithKline


Working from Houston, home to one of the world’s largest medical complexes, Charles Bankhead has more than 20 years of experience as a medical writer and editor. His career began as a science and medical writer at an academic medical center. He later spent almost a decade as a writer and editor for Medical World News, one of the leading medical trade magazines of its era. His byline has appeared in medical publications that have included Cardio, Cosmetic Surgery Times, Dermatology Times, Diagnostic Imaging, Family Practice, Journal of the National Cancer Institute, Medscape, Oncology News International, Oncology Times, Ophthalmology Times, Patient Care, Renal and Urology News, The Medical Post, Urology Times, and the International Medical News Group newspapers. He has a BA in journalism and MA in mass communications, both from Texas Tech University.

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