Doctors have been urged to be more cautious in offering cancer treatment to terminally-ill patients as chemotherapy can often do more harm than good, a study suggests.

Patients with incurable cancers were promised much greater access to the latest drugs which could offer them extra months or years of life by a Department of Health review last week.

Such medicines are often taken or injected as part of a “cocktail” of chemotherapy drugs.

But the National Confidential Enquiry into Patient Outcome and Death (NCEPOD) found that more than four in ten patients who received chemotherapy towards the end of life suffered potentially fatal effects from the drugs, and treatment was “inappropriate” in nearly a fifth of cases.

About 300,000 patients now receive chemotherapy in the UK each year, a 60 per cent increase compared to 2004.

But in a study of more than 600 cancer patients who died within 30 days of receiving treatment, chemotherapy probably caused or hastened death in 27 per cent of cases, the inquiry found.

In only 35 per cent of these cases was care judged to have been good by the inquiry’s advisors, with 49 per cent having room for improvement and 8 per cent receiving less than satisfactory care.

More than one fifth of patients were already severely debilitated at the time the decision to treat with chemotherapy was taken, while that many could not make an informed consent to treatment, the report said.

Mark Lansdown, surgical oncologist at Leeds General Infirmary, and a co-author of the report, said that it is usual for patients to suffer some side-effects following chemotherapy, but that very few patients die as a consequence.

“The majority of patients in this study were receiving palliative treatment where the aim is to alleviate symptoms of cancer with the minimum of side effects,” which represented a small proportion (2 per cent) of all patients receiving the treatment, he said.

“Yet 43 per cent of all patients in the study suffered significant treatment-related toxicity.”

The proportion of deaths attributed to chemotherapy “is of particular concern for the 14 per cent of patients for whom [it] was intended to cure them of their cancer,” he added.

Co-author Diana Mort, of Velindre NHS Trust, Cardiff, said that treatment can also result in life-threatening infections or patients may simply die of their cancer.

“[But] patients must be made aware of the risks and side effects of chemotherapy as well as the potential benefits. They should be given time to reflect on their decision and must always be free to change their minds.”

The Government’s national cancer director, Professor Mike Richards, said that he was “very concerned” by the report’s findings.

The National Chemotherapy Advisory Group will publish a full response to the NCEPOD report today, “to bring about a step change in the quality and safety of chemotherapy services for adult patients,” he added.

“I am asking all chemotherapy service providers to consider these reports urgently and to reassess their own services immediately against the measures we have set nationally.”

Katherine Murphy, director of the Patients Association, commented: “too many clinicians have a cavalier attitude to providing information on cancer outcomes, when they should be doing everything in their power to raise standards and give full information to their patients.”

Jane Maher, Chief Medical Officer at Macmillan Cancer Support added: “Doctors and nurses need to be much better at helping patients understand the pros and cons of such powerful treatments in the last year of life.

“Some patients may not be getting the right information and support before deciding whether to start chemotherapy and even more importantly, when enough is enough.

“Something clearly needs to be done - I welcome a prompt response by the National Chemotherapy Advisory Group.”

The Supreme Court may rule that pharmaceutical companies cannot be sued for dangerous or even deadly side effects from their drugs if those side effects arise from an FDA-approved use.

Under a legal argument known as “pre-emption,” the FDA’s approval of a drug absolves companies of any responsibility if that drug later turns out to be dangerous, even if information was concealed from the FDA during the approval process. While courts have rejected this argument for decades, the winds appear to be shifting.

In February, the Supreme Court ruled that makers of medical devices were indeed immune from state lawsuits if their devices had received FDA approval. But that decision hinged on the specific wording of the law that gives the FDA authority over medical devices, and the laws relating to drug regulation are not worded the same way.

Even so, the Bush administration has been actively urging the courts to apply the same principle to drugs. The administration argues that only the FDA is equipped to regulate drugs and decide whether a product is safe, and that judges or juries are not able to make informed decisions on those matters.

The FDA has also recently thrown its support behind pre-emption, reversing a longstanding, de-facto policy of viewing lawsuits as an extra layer of oversight to make up for the agency’s time and budget constraints. Now the agency says that lawsuits over drug side effects could lead to a confusing state-by-state regulatory patchwork that would cause hardship to drug companies and discourage patients from taking certain medications.

Drug companies are using the pre-emption argument as a legal defense in a wide variety of lawsuits, and the Supreme Court is expected to hear such a case, concerning the company Wyeth, in the fall. Before that, however, a lower federal court is expected to rule on whether pre-emption can be used to dismiss lawsuits by more than 3,000 women who claim that they were injured by using Johnson & Johnson’s OrthoEvra birth control patch according to the instructions on the label.

When Johnson & Johnson announced its plans for a birth control patch in 1996, one of the main benefits it claimed the product would provide was the ability to prevent pregnancies through lower doses of estrogen than birth control pills. High doses of estrogen are known to increase women’s risks of blood clots, heart attacks, strokes and death.

But company documents publicized as part of the lawsuits show that in 1999, the company discovered that the patch actually exposed women to significantly more estrogen than the pill, a total of 30 to 38 micrograms per day. Because only about half of the estrogen in a birth control pill actually enters the bloodstream, this means that women using the patch were getting as much estrogen each day as if they were taking a 76 microgram birth control pill.

The FDA banned birth control pills containing more than 50 micrograms of estrogen in 1988.

Rather than reporting this data to the FDA, however, the study’s author instead applied a “correction factor,” reducing the estrogen figures by 40 percent. Although the author claimed this was meant to adjust for differing rates of estrogen absorption, such a “correction” was a deviation from the study procedure previously submitted to the FDA.

In the final report submitted to the FDA, Johnson & Johnson claimed that OrthoEvra exposed women to only 20 micrograms of estrogen per day. The “correction factor” was referenced only once in the 435-page study report, buried in a complex mathematical formula.

According to internal company emails, other clinical trials conducted before approval suggested that women were experiencing side effects such as breast soreness and nausea due to high estrogen doses, but the company did not warn the FDA that the patch might be delivering more estrogen than advertised. Nor did it tell the agency about other studies, in 1999 and 2003, showing that the patch exposed women to more estrogen than the pill.

When the FDA approved the product in 2001, Johnson & Johnson marketed it as releasing less estrogen than the pill, containing 20 micrograms per day.

The label was not revised until a 2005 investigation by the FDA, following reports of deaths resulting from use of the drug. At that point, the FDA made Johnson & Johnson add a warning that the product “exposes women to higher levels of estrogen than most birth control pills.”

But the company always knew this to be the case, several lawsuits now allege, and is thus responsible for the side effects that resulted: heart attacks, strokes, and even deaths in those who used the patch as directed. Studies have since confirmed that women on the patch may have twice the blood clot risk of women taking birth control pills, and prescriptions have fallen 80 percent, from a high of 900,000 in March 2004 to only 187,000 in February 2007.

But Johnson & Johnson claims that because the FDA approved the drug, the company cannot be held responsible for its effects.

Janet Abaray, a lawyer for one of the plaintiffs, disagrees, saying the company took advantage of the agency’s shortcomings.

“Johnson & Johnson knew that FDA. does not have the funding or the manpower to police drug companies,” Abaray said.

David Vladeck of Georgetown Law School agrees that the FDA has no ability to verify that drug companies are being truthful in their reports.

“These are scientists, not cops,” he said.

Chris Seeger, another plaintiffs’ lawyer, said it would be a mistake to allow pre-emption to let the drug companies off the hook.

“Our lawsuits are the ultimate check against the mistake made by the government, or fraud made by the companies against the government, or just an underfunded bureaucracy stretched thin,” he said.

Sources for this story include: www.nytimes.com.

Barack Obama lays plans to deaden expectation after election victory (Michal Czerwonka/EPA)

Barack Obama has already started playing down expectations in his speeches - Tim Reid in Washington

Barack Obama’s senior advisers have drawn up plans to lower expectations for his presidency if he wins next week’s election, amid concerns that many of his euphoric supporters are harbouring unrealistic hopes of what he can achieve.

The sudden financial crisis and the prospect of a deep and painful recession have increased the urgency inside the Obama team to bring people down to earth, after a campaign in which his soaring rhetoric and promises of “hope” and “change” are now confronted with the reality of a stricken economy.

One senior adviser told The Times that the first few weeks of the transition, immediately after the election, were critical, “so there’s not a vast mood swing from exhilaration and euphoria to despair”.

The aide said that Mr Obama himself was the first to realise that expectations risked being inflated.

In an interview with a Colorado radio station, Mr Obama appeared to be engaged already in expectation lowering. Asked about his goals for the first hundred days, he said he would need more time to tackle such big and costly issues as health care reform, global warming and Iraq. “The first hundred days is going to be important, but it’s probably going to be the first thousand days that makes the difference,” he said. He has also been reminding crowds in recent days how “hard” it will be to achieve his goals, and that it will take time.

“I won’t stand here and pretend that any of this will be easy – especially now,” Mr Obama told a rally in Sarasota, Florida, yesterday, citing “the cost of this economic crisis, and the cost of the war in Iraq”. Mr Obama’s transition team is headed by John Podesta, a Washington veteran and a former chief-of-staff to Bill Clinton. He has spent months overseeing a virtual Democratic government-in-exile to plan a smooth transition should Mr Obama emerge victorious next week. The plans are so far advanced that an Obama Cabinet has been largely decided upon, with the expectation that most of his senior appointments could be announced shortly after election day.

Yet Mr Obama and his aides are under no illusions about the size of the challenges the Democrat will inherit if he enters the Oval Office. Tom Daschle, the party’s former leader in the US Senate and a strong contender for the post of White House chief-of-staff in an Obama administration, said last month that the winner next week would have only a 50 per cent chance of winning a second term in 2012.

Not only will the next president take office with the country sliding into a potentially long recession — and mired in debt — but the challenges abroad are immense. There is an unfinished war in Iraq, a worsening situation in Afghanistan and an unstable and nuclear-armed Pakistan to contend with. Iran appears intent on acquiring the bomb and there remains the ever-present threat from al-Qaeda and Islamic extremists.

If he wins, Mr Obama will inherit a Democratic-controlled Congress, and might even have the benefit of a 60-seat filibuster-proof “supermajority” in the Senate. Such a scenario would allow him to push through legislation largely unfettered by Republican opposition. Yet it also means that should the country still be mired in recession in three years’ time, voters — who have short memories — will probably blame him and the Democrats on Capitol Hill. Those stakes have led Mr Obama to conclude that while expectations need to be tempered, big things need to be achieved very early in his first term, when he will still have the political capital to achieve some of his most ambitious legislative goals.

Having promised “real” change, the pressure will be on him to deliver. In the Colorado interview, Mr Obama added: “The next president has got to come quickly out of the box.”

The early priorities being lined up if he takes power are a mixture of symbolism and substance. He plans to make a major address in a big Muslim country early in his first term. Having pledged on the campaign trail to close Guantanamo Bay, he is also determined to make early moves to rid America of the controversial prison. Yet what to do with the remaining inmates looms as an intractable problem, as many of their home governments refuse to allow them to return.

Mr Obama’s first legislative goals will be to follow through on his pledge to cut taxes for the middle class and raise them for the wealthiest Americans, and to push through a hugely expensive Bill to provide near-universal health insurance.

The last of the Seven Ancient Wonders gets a twenty-first century facelift, but pleasing everyone proves to be a difficult task

The site of the 5,000-year-old Giza Pyramids is now up to speed with the twenty-first century, complete with cameras, lasers and control rooms. Last month, part of a multi-phase plan to renovate the site of the only remaining Wonder of the Ancient World was completed, a modern makeover cooked up by the Supreme Council of Antiquities (SCA) to make the Giza Plateau more tourist-friendly.

The first phase, costing roughly LE 60 million, includes an 18-kilometer-long steel fence equipped with 199 closed circuit TV cameras, infrared motion sensors and elaborate control rooms placed alongside the fence. In addition to the reinforced boundaries, the plan dedicated one of three entrances, the one near the Mena House Oberoi Resort, as the primary security entrance, kitted out with x-ray machines and metal detectors.

While the modernizing of the most ancient site in the world — one that was previously an uncontrolled sandbox of pandemonium — has tourists and international media impressed, it has left local peddlers and bazaar sellers locked out and worried about their livelihood.

According to Sabri Abd El Eziz, assistant to SCA Secretary General Zahi Hawass, the plan was put in motion about seven years ago. After finishing site management for all the areas in Upper Egypt — including Abu Simbel, Luxor, Philae and Kom Ombo — the SCA’s plan for 2008-2009 was to focus on the pyramids. “There are roughly 6,000 to 10,000 visitors daily at the Pyramids and though we accommodate them easily, there was a need for a [facelift],” says Abd El Eziz.

A principal reason for the developments was that the SCA, although part of the Ministry of Culture, needs to find ways to be self-sufficient. “The SCA doesn’t take money from the government; we depend on entrance fees and exhibitions both locally and abroad, as well as royalties,” says Abd El Eziz. With the previously lax control over the Pyramids area, income from entrance fees was approximately LE 300,000 daily. “After the fence and the setting-up of a proper entrance, income is now around LE 800,000 [] and that’s money that we use for maintaining museums and restoring antiquities.”

The SCA is home-base to nearly 400 archaeologists in Egypt and supports beginners in the field as well, even building a school of excavation for hands-on training for fresh graduates in the field.

Phase Two will soon kick off, thanks to a 15 million (LE 116 million) loan from the Spanish government. During this phase, the entrance from the Fayoum road will become the main one, due to its vast area for parking. According to Abd El Eziz, hundreds of buses bring tourists to the site every day, sometimes “convoys of 50 buses from Alexandria and Port Said at the same time.” Once there, electric carts will take the tourists along the roads on the plateau to the Pyramids. “The second phase will include roads inside the plateau [for] better transportation,” adds Abd El Eziz.

A large visitor center will also be set up at the Fayoum entrance, equipped with cafeterias, decent bathrooms and a bazaar area inside. Phase Two will reinforce even stricter rules for local vendors of trinkets, postcards and animal rides who want to enter the site.

The Pyramid facelift stemmed from the authorities’ need for basic security and control. “It’s the only way to protect the Giza Plateau from urban development and [from trespassers]. The fence is up and control rooms are operational with golf carts on standby for a quick response should the guards see anything on the cameras. We also had to make a concrete fence next to the houses near Selman village,” says Abd El Eziz, adding that “If you see the control room with the cameras, you’ll feel protected.”
A hard sell

For the locals at Selman village, an area that hosts roughly 5,000 peddlers, stable owners, and salesmen, that protection feels one-sided. Forty-year-old Ibrahim Mahmoud says his work has suffered since the added security. “They have a list of those who can enter the site, and the list has names of people, some of whom aren’t licensed and yet still get in,” he claims. “You can be registered with the state but if you’re not on the list you don’t get in. And the state security and the Giza security know all about the list.”

Mahmoud has been selling horse rides to tourists for the past 35 years and says his two-horse business can’t compete with larger stables that have the connections to get around the new regulations.

Mahmoud claims the fence has hindered his business, as previously with horses “we used to just ride up through the desert.” While he praises the new system’s better organization and control, he claims it has stunted his livelihood. “I’m married and I have a family I need to provide for, plus I don’t have any other line of work. I’ve been licensed for 20 years and this is all I know how to do.”

Summer is usually high season for the Selman villagers, but Mahmoud says he hasn’t had much work since the start of Ramadan. “Before the fence and this new system, there was more work, but what’s unfair is that it’s all about connections now. Even if you don’t have a license you can get in if you know the right people or have the money to bribe the entrance guards,” he says. “I don’t know what to do, my kids need clothing.”

Mahmoud asserts that the majority of the inhabitants at the village have come to realize that working legitimately may not be the way to survive. Facing a diminished volume of work due to the new developments, peddlers are further inclined to cheat the system. He says that though the state has a fixed price of LE 30 an hour for horse rides at the Pyramids, he and others manage to set higher prices with tourists, providing the tourist police a cut of the profits.

“We just give the officer LE 5 or 10 and tell them we’re charging the fixed rate,” Mahmoud alleges. “When I do that, he praises me in front of the tourist and tells them I’m the right man for the job; otherwise he’ll scare them off and tell them I’ll rob them or something.”

In September, just a few weeks after the Ministry of Culture announced the new security and control measures, Egypt Today visited the Plateau’s Sphinx entrance. Two guards slouched in wooden chairs, drinking tea and yelling at a nearby vendor for approaching tourists.

This vendor, 20-year-old Ahmed Sabri Saeed, alleges that to cope with the new measures, he has to resort to bribery to get in.

“With horses and camels we’d go up as we wished; no entrances or anything. Now, with the fence I have to leave my ID card with the guard and in order to get it back at the end of the day, I pay him LE 5.” Saeed sells souvenirs but will sometimes go seven to eight days without work since his name isn’t on the list as an authorized vendor. He says he jumps the fence with a bag of postcards and the antique trinkets.

While he’s doing that, his eight-year-old apprentice Moussa handles three camels. New to the work, he’s also quickly learning that honest pay for him isn’t as honest as he would like. “The government won’t let us work in anything so we have to pay [bribes],” the boy alleges. “We pay the security official LE 10 so that we can charge a client LE 100 for two hours, even though it should only be LE 60,” he says, adding that money clears the path, even at the gates to get around the frisking by the guards.

Saber Mahmoud has owned a bazaar store for 19 years and says he’s had trouble getting onto the Plateau since July. “I used to go up and sell merchandise, but now it’s not as easy as before,” he says. “They give us a number to get in, but it really depends on the mood of the entrance guard. I don’t have a license; most of us sellers don’t have licenses because we never needed them. Before the fence we’d just walk in.”
The other side of the fence

Though government officials do not offer a solution to the alleged onsite corruption, the new regulations, says Abd El Eziz, make visiting the Pyramids much more pleasant.

“It was just too chaotic and haphazard [before]. Chariots, camels and horses [were] all over the place. There wasn’t much trouble with complaints [to tourist police] but the need for more organization was obvious.” Abd El Eziz adds that once the second phase is complete, most of the peddlers will have to relocate to a designated bazaar area by the Fayoum entrance and pay a monthly rent.

He says that most of the peddlers are licensed and registered with the Ministry of Tourism; those who aren’t will not be allowed into the site. Those registered will pay rent for kiosks rather than just roam freely in the desert.

Abd El Eziz is sympathetic with the locals: “They need to make a living so we can’t cut them off, but if we provide them with an area in which they can operate, they can pay rent. It’s all about organization. I’ve sat with these people a couple of times, and I agree that we have to protect their livelihood. We’re not going to prohibit them from entering the Plateau because it’s their well-being and their children’s well-being, and they’ve been working there for years.

“At first it will be hard for [the peddlers] to get accustomed, but we needed to intervene. They’ll grow to like it later,” Abd El Eziz says, adding that tourists feel safer when there’s visible enforcement and organization.

“I, myself, don’t enjoy my time when I go. Surrounded by horses, camels and chariots, I can’t see behind me and I look ahead to see the Pyramids and they’re blocked. The horses just run around in an unorganized fashion, stumbling over tombs and important sites. This isn’t right. The Giza Plateau needs a facelift and these people need a dedicated site to provide their services.” et

The Bill and Melinda Gates Foundation awarded 100,000 dollars each on Wednesday to scientists in 22 countries including funding for a Japanese proposal to turn mosquitos into “flying syringes” delivering vaccines.

The charitable foundation created by the founder of software giant Microsoft said in a statement that the grants were designed to “explore bold and largely unproven ways to improve global health.”

The grants were awarded for research into preventing or curing infectious diseases such as HIV/AIDS and tuberculosis and limiting the emergence of drug resistance.

http://www.pyrabang.com/view.php?ref=surfingtheapocalypse&post_id=4577