December 10, 2012
Drug company Novartis is betting $20 million on a cancer treatment that seems to have saved a little girl’s life, according to a report from The New York Times’ Denise Grady.
Just last spring, six-year-old leukemia victim Emma Whitehead was “near death,” having gone through chemotherapy twice without success.
But then her parents put Emma through an experimental treatment at Children’s Hospital of Philadelphia.
They infected her with a version of HIV, reprogrammed to attack cancer cells.
Emma Whitehead, with her mother, Kari. Last spring, Emma was near death from acute lymphoblastic leukemia but is now in remission after an experimental treatment at the Children’s Hospital of Philadelphia.
PHILIPSBURG, Pa. — Emma Whitehead has been bounding around the house lately, practicing somersaults and rugby-style tumbles that make her parents wince.
It is hard to believe, but last spring Emma, then 6, was near death from leukemia. She had relapsed twice after chemotherapy, and doctors had run out of options.
Desperate to save her, her parents sought an experimental treatment at the Children’s Hospital of Philadelphia, one that had never before been tried in a child, or in anyone with the type of leukemia Emma had. The experiment, in April, used a disabled form of the virus that causes AIDS to reprogram Emma’s immune system genetically to kill cancer cells.
The treatment very nearly killed her. But she emerged from it cancer-free, and about seven months later is still in complete remission. She is the first child and one of the first humans ever in whom new techniques have achieved a long-sought goal — giving a patient’s own immune system the lasting ability to fight cancer.
Emma had been ill with acute lymphoblastic leukemia since 2010, when she was 5, said her parents, Kari and Tom. She is their only child.
She is among just a dozen patients with advanced leukemia to have received the experimental treatment, which was developed at the University of Pennsylvania. Similar approaches are also being tried at other centers, including the National Cancer Institute and Memorial Sloan-Kettering Cancer Center in New York.
“Our goal is to have a cure, but we can’t say that word,” said Dr. Carl June, who leads the research team at the University of Pennsylvania. He hopes the new treatment will eventually replace bone-marrow transplantation, an even more arduous, risky and expensive procedure that is now the last hope when other treatments fail in leukemia and related diseases.
Three adults with chronic leukemia treated at the University of Pennsylvania have also had complete remissions, with no signs of disease; two of them have been well for more than two years, said Dr. David Porter. Four adults improved but did not have full remissions, and one was treated too recently to evaluate. A child improved and then relapsed. In two adults, the treatment did not work at all. The Pennsylvania researchers were presenting their results on Sunday and Monday in Atlanta at a meeting of the American Society of Hematology.
Despite the mixed results, cancer experts not involved with the research say it has tremendous promise, because even in this early phase of testing it has worked in seemingly hopeless cases. “I think this is a major breakthrough,” said Dr. Ivan Borrello, a cancer expert and associate professor of medicine at the Johns Hopkins University School of Medicine.
Dr. John Wagner, the director of pediatric blood and marrow transplantation at the University of Minnesota, called the Pennsylvania results “phenomenal” and said they were “what we’ve all been working and hoping for but not seeing to this extent.”
A major drug company, Novartis, is betting on the Pennsylvania team and has committed $20 million to building a research center on the university’s campus to bring the treatment to market.
Today, Roche declared that the European Union gave a positive recommendation for the use of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel in patients with HER2-positive metastatic or location specific recurrent breast cancer that cannot be removed with surgery. This announcement verifies a suggestion for people with this certain type of cancer who have not yet received anti-HER2 therapy or chemotherapy for their cancer.
The positive recommendation was based on overall survival and progression-free survival data from the phase III CLEOPATRA study. The most recent survival outcomes reported at the 2012 CTR-AACR San Antonio Breast Cancer Symposium revealed that the risk of death decreased by 34 percent for patients who received the Perjeta combination. Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development said:
“The CHMP positive opinion for Perjeta brings us a significant step closer to the approval of a new personalized medicine for people with this aggressive form of breast cancer. Perjeta complements Herceptin in attacking HER2-positive tumors and we believe Perjeta will transform the way people with HER2-positive metastatic breast cancer are treated.”
Perjeta is an individual medicine that focuses on the HER2 receptor, a protein found in increased quantities on the outside of cells in HER2-positive cancers. Perjeta is known to function in a way that complements Herceptin, while the two medicines focus on separate regions on the HER2 receptor.
The U.S. Food and Drug Administration approved Perjeta in combination with Herceptin and docetaxel chemptherapy for the treatment of patients with HER2-positive mBC, who have not had any anti-HER2 therapy or chemotherapy for metastatic disease in June of 2012.
Genes are not the only drivers of colon cancer. A new study suggests cellular factors play an equally important part, and these not only drive tumor growth, but also affect how well the disease responds to chemotherapy.
Senior study author John Dick, of the Princess Margaret Cancer Centre, University Health Network, Toronto, Canada, and colleagues, write about their findings in a paper published online in Science on Thursday.
Using lab-bred mice with poor immune systems to grow human colorectal cancers, they found biological factors and cell behavior, not just genes, drove tumor growth and contributed to treatment failure and relapse.
Dick, who is also a Professor in the Department of Molecular Genetics at the University of Toronto, says in a press statement that the study represents a “a major conceptual advance in understanding tumor growth and treatment response”.
First there was Gleevec, the wonder cancer drug. Then came the sons of Gleevec. Now there is the grandson of Gleevec.
The Food and Drug Administration on Friday approved another Gleevec-like drug for the treatment of chronic myeloid leukemia, or C.M.L., adding to a crowded field vying to treat this rare cancer of white blood cells.
The new drug, Iclusig from Ariad Pharmaceuticals, works in some patients not helped by Gleevec or some of its imitators.
“The approval of Iclusig is important because it provides a treatment option to patients with C.M.L. who are not responding to other drugs,” Dr. Richard Pazdur, director of the agency’s office of cancer drugs, said in a statement.
Iclusig, known generically as ponatinib, is the first product to reach the market for Ariad, a biotechnology company in Cambridge, Mass., that was founded in 1991.
A tablet taken once a day, Iclusig (pronounced eye-CLUE-sig) will have a wholesale price of about $115,000 a year, the latest cancer drug to pierce the $100,000-a-year level. Ariad said the price was about 15 percent higher than the drug’s competitors’.
While the approval was expected, it came three months before the federal agency’s deadline of March 27, and the drug’s label allows broader use of the drug than some analysts expected. However, the label also contains a boxed warning about the side effects of blood clots and liver toxicity, something analysts did not expect.
Ariad’s shares, which have roughly doubled in the last year, sank 21 percent to $18.93 on Friday.
Chronic myeloid leukemia would seem at first glance to be an unattractive target for pharmaceutical companies. Not only is it rare — with about 5,000 new cases a year in the United States and 600 deaths — it is also one of the more effectively treated of cancers.
NEW YORK (Reuters) – The cancer cells were not behaving the way the textbooks say they should. Some of the cells in colonies that were started with colorectal tumor cells were propagating like mad; others were hardly multiplying. Some were dropping dead from chemotherapy and others were no more slowed by the drug than is a tsunami by a tissue. Yet the cells in each “clone” all had identical genomes, supposedly the all-powerful determinant of how cancer cells behave.
That finding, published online Thursday in Science, could explain why almost none of the new generation of “personalized” cancer drugs is a true cure, and suggests that drugs based on genetics alone will never achieve that holy grail.
Scientists not involved in the study praised it for correcting what Dr. Charis Eng, an oncologist and geneticist who leads the Genomic Medicine Institute at the Cleveland Clinic, called “the simple-minded” idea that tumor genomes alone explain cancer.
Calling the study “very exciting,” she said the finding underlines that a tumor’s behavior and, most important, its Achilles heel depend on something other than its DNA. Her own work, for instance, has shown that patients with identical mutations can have different cancers.
The core premise of the leading model of cancer therapy is that cells become malignant when they develop mutations that make them proliferate uncontrolled. Find a molecule that targets the “driver” mutation, and a pharmaceutical company will have a winner and patients will be cancer-free.
That’s the basis for “molecularly targeted” drugs such as Pfizer’s Xalkori for some lung cancers and Novartis’s Gleevec for chronic myeloid leukemia. When those drugs stop working, the dogma says, it is because cells have developed new cancer-causing mutations that the drugs don’t target.
Published on Thursday December 13, 2012
In a major breakthrough that will change the way cancer is studied and treated in the future, Toronto scientists have discovered a key reason why many tumours may return after chemotherapy.
In a new study, researchers at the Princess Margaret Cancer Centre have shown that some of the cells that drive tumour growth hide from common chemotherapy drugs by going “dormant” — reigniting the disease when they awaken after treatments end.
“That’s where this paper lies is to begin to add more depth (and) complexity to why cancers come back, why they recur,” says renowned stem cell scientist John Dick, whose paper was released Thursday by the journal Science.
“This will stimulate a lot of activity,” says Dick, the study’s senior author.
Luba Slatkovska, head of research with Canadian Cancer Society’s Ontario division agrees, saying the discovery represents a paradigm shift for research into the disease.
“John Dick is one of those researchers who is really changing the way we think about cancer, and this is another example,” Slatkovska says.
“We think that it’s going to become one of the new hot topics … in cancer research,” she says.
Dick, also a molecular geneticist at the University of Toronto, says the newly-discovered dormant cells have precisely the same genetic mutations as those active ones that drove the original tumour to begin with.
The 74-year-old Brown is receiving a short course of conventional radiotherapy for “localized prostate cancer,” the statement said.
Brown’s “prognosis is excellent, and there are not expected to be any significant side effects,” University of California, San Francisco oncologist Eric Small said.
The radiation treatment will be completed the week of Jan. 7 — nearly four weeks from now — and Brown will continue to work a full schedule, the statement said.
Brown’s spokesman Gil Duran declined further comment.
It is the governor’s second bout with cancer. He underwent minor surgery in spring 2011 to remove a cancerous growth on his nose. He was put under local anesthetic and doctors removed basal cell carcinoma, a common, slow-growing form of skin cancer, from the right side of his nose.
The governor underwent a type of surgery known as Mohs, or micrographic surgery, in which a doctor can tell even before the wound is closed that all the cancerous cells have been removed.
Prostate cancer is the most common cancer in men. More than 241,000 new cases are expected to be diagnosed in the United States this year. More than 90 percent are early stage, and nearly all men with such diagnoses survive at least five years.
Typical radiation treatment for an early stage prostate cancer is five days a week for four to five weeks, said Dr. Ralph de Vere White, urological oncologist and director of the UC Davis comprehensive cancer center in Sacramento.
Thursday, December 13, 2012 by: David Gutierrez, staff writer
The drug works by preventing the intestine from absorbing fat. According to the conventional wisdom, orlistat itself also remains in the gut, unabsorbed.
“But orlistat is reportedly absorbed, and certainly internal organs such as the liver and kidney are exposed to this drug upon absorption,” Yan said.
“He is not a sick boy, as has been written about him,” explained Roberts to reporters. “I feel that if we go ahead with the radiotherapy we could be depriving him of his talents. When I questioned why they couldn’t target only the area where the tumor was, [the doctor] replied, ‘You have to fry the whole brain.’ I didn’t feel Neon was being treated as an individual, but that the medical advice I was getting was based on a blanket policy.”
These mostly uncritical pronouncements followed from a newly published study in Lancet, funded by a long list of contributors, including the US Army, EU-Biomed, UK Medical Research Council, and the UK division of AstraZeneca, the company that formed after the now defunct Imperial Chemical Industry, the drug’s original patent holder and manufacturer, de-merged its pharmaceutical division Zeneca Group in 1993, merging with Astra AB in 1999 to assume its present incarnation as one of the world’s most powerful pharmaceutical companies.
Most of these news stories made no mention of the fact that a major pharmaceutical industry funding source for the study would benefit directly and indirectly, perhaps in tens of millions of dollars, from its ostensibly positive findings. Mind you, AstraZeneca is a founding (and still controlling) sponsor of Breast Cancer Awareness Month, the more than a quarter-century-old push to screen millions of asymptomatic women for so-called ‘early-stage cancers’ with X-ray mammography, a campaign which was recently shown to result in the overdiagnosis and unnecessary treatment of an astounding 1.3 million American women over the past 30 years.
Therefore, it is a sad reflection on the state of journalism today that more was not said about this glaring conflict of interest. Indeed, increasingly, mainstream medical news reports have transmogrified into thinly veiled infomercials for their major advertisers.
Bill Gimson, the embattled executive director of the Texas cancer agency, announced his resignation Tuesday, and the state office that investigates public corruption and criminal activity opened an inquiry into the agency.
Gimson, the central figure in two questionable grants awarded by agency, wrote governing board members of the Cancer Prevention and Research Institute of Texas that he’s been placed in an unfortunate situation “where I can no longer be effective.”
“The last eight months have been extremely difficult for those at CPRIT,” Gimson wrote in a letter to the board, known as the oversight committee. “During this time they have not been able to do their jobs due to wasted efforts expended in low value activities that do nothing to advance cures for cancer.”
The difficult times included revelations, extensively detailed in the Houston Chronicle, about a $20 million grant that the cancer agency rushed through the approval process and gave to the University of Texas M.D. Anderson Cancer Center in March despite red flags raised by staffers.
Then, two weeks ago, the Associated Press and the Dallas Morning News broke stories about an $11 million grant the agency awarded to a start-up biotech company in Dallas, Peloton Therapeutics, in 2010 without proper review.
Gregg Cox, director of the Travis County District Attorney’s special prosecution division, said the office’s public integrity unit decided last week to investigate the agency. In a Dec. 7 letter to Gimson and cancer agency lawyer Kristen Doyle, Assistant District Attorney Rob Drummond wrote that “we will be in touch in the near future with a subpoena or other legal demand for documents and/or electronic material.”
At a cancer agency meeting last week, an agency compliance officer said emails about the Peloton proposal and process could not be located.
The public integrity unit investigation is the latest of a number of investigations at the agency, a $3 billion assault on cancer that Texans overwhelmingly approved in 2007.
The state auditor has been looking into possible irregularities at the agency since summer and on Monday the Texas Attorney General’s Office said it would launch an inquiry into the Peloton grant.
In a statement Tuesday night, cancer agency Oversight Committee Chairman Jimmy Mansour and Vice-Chairman Dr. Joseph Bailes said the board “will immediately begin the process of transitioning to new leadership of the organization.” The statement noted that the resignation is subject to the approval of the Oversight Committee,” scheduled to meet next on Jan. 17.
Fri Dec 7, 2012 11:13am EST
(Reuters) – GlaxoSmithKline signed a collaboration agreement with the MD Anderson Cancer Center in Houston to develop new drugs that promote a patient’s immune system to attack cancer based on discoveries by Anderson researchers.
Anderson, one of the world’s premier cancer research and treatment centers, announced the agreement on Friday. Under terms of the deal, it will receive an undisclosed upfront payment and research funding from Glaxo and could earn $335 million plus royalties if the collaboration leads to approved medicines.
The British drugmaker will get exclusive worldwide rights to develop and sell antibodies that activate OX40, a protein on the surface of T cells – a type of white blood cell that is an important component of the body’s immune system. The antibodies were discovered by Dr. Yong-Jun Liu and colleagues when he was professor and chair of MD Anderson’s Department of Immunology.
“This agreement is … a testament to the vision shared by GSK and MD Anderson that successful clinical development of oncology drugs requires seamless integration of drug development expertise and deep biological knowledge,” Dr Giulio Draetta, director of Anderson’s Institute for Applied Cancer Science, said in a statement.
So-called immunotherapies, which help the body’s immune system to more efficiently attack cancer, are seen as an important new frontier is the fight against the disease in its many forms. Several companies are developing promising cancer immunotherapies.
Any drugs that come out of the Glaxo-Anderson collaboration would be several years away as more preclinical testing is needed before the OX40 approach will be tested in human subjects, MD Anderson said.
Keep in mind that these quotes are coming from a mainstream doctor who is inside the system and who believes in the system. That makes Makary’s statements all the more shocking.
“…1 in 4 hospital patients are harmed by a mistake.”
“A cardiologist in Wisconsin was fired for pointing out that EKGs were misread more than 25% of the time.”
“We [doctors] are also evaluated by the number of ‘value units’ at the end of each fiscal quarter. Our management will sit down with us and say your work units are down or up and in order for you to receive a large bonus you need to increase the number of operations you do…”
“There is New England Journal of Medicine-level data that suggests that almost half of [health] care is not compliant with evidence.” [In other words, almost 50% of all health care in America isn’t even based on published mainstream studies…and, I should add, there is conclusive evidence that half of these studies are untrustworthy in the first place. Therefore, to say that conventional doctors are winging it is a vast understatement. JR]
“…up to 30% of health care in unnecessary…”
“I saw cases where a patient was not told about a minimally invasive way of doing a particular surgery because of physician preference or training, and the doctor would just hope the that he [the patient] wouldn’t find out.”
“Medical mistakes are fifth-or-sixth-most common cause of death in the United States, depending on the measure.”
“…The desire and reflex of docs to offer something to patients, even when there’s not much more else they can offer. There’s a strong financial incentive. Doctor groups pay for new equipment that they purchase on borrowed money.” [In other words, ‘we have this expensive equipment, we have to use it to pay for it.’ JR]
Since Dr. Makary works at Johns Hopkins, he is no doubt familiar with a landmark review done by the late Dr. Barbara Starfield, who also worked at Hopkins for many years.
On July 26, 2000, the Journal of the American Medical Association published Starfield’s review, “Is US health really the best in the world?” Starfield revealed the following facts:
In the US, the annual death rate, as a direct result of medical treatment, is 225,000 people. Of those, 106,000 are killed by FDA-approved pharmaceutical drugs. The other 119,000 are killed by medical mistreatment in hospitals. This makes medically caused death the third leading cause of mortality in America.
In 2009, I interviewed Dr. Starfield.
She assured me that, since the publication of her review in 2000, no federal agency had contacted her to ask for help in fixing this unconscionable horror, and no agency had undertaken a significant program to reverse the third leading cause of death in the US.
Aside from the medically caused death rate, there is medical maiming. In 2001, the LA Times published a shocking article by Linda Marsa.
Thearticle revealed that, in addition to the deaths, 2.1 million more people were admitted to US hospitals every year, as a result of severe reactions to pharmaceutical drugs. And, every year, there were 36 million adverse drug reactions in America.
Nap mats, changing pads and crib mattress pads may be comfortable places for infants to rest, but some contain dangerous levels of a known carcinogen, a local watchdog group has found.
The Center for Environmental Health in Oakland said Thursday it is taking legal action against major national retailers, including Toys R Us, Target and Walmart, to force them to stop selling foam products that contain levels of chlorinated Tris that exceed those permitted by California law.
Chlorinated Tris was banned in 1977 from children’s pajamas and has been linked with gene mutations and hormone disruption. Last year, California added it to its list of carcinogens, meaning that products with a certain level of the chemical must carry a warning label.
But a growing number of studies, including the Center for Environmental Health’s, show that chlorinated Tris and other flame retardants used to meet a unique state law haven’t disappeared from store shelves.
Your breath may hold clues to a lot more than what you ate for lunch.
In the small study of less than 80 participants published in the British Journal of Surgery, researchers from the the University Aldo Moro of Bari in Italy found a profile of breath-based chemicals that are linked to colorectal cancer. The scientists collected exhaled breath from 37 patients with colorectal cancer and 41 healthy control participants, and evaluated them for volatile organic compounds (VOCs) that could be red flags for cancer. According to the researchers, cancer tissues operate differently compared to non-cancerous cells and may release a distinct chemical signature.
Indeed, the researchers identified 15 of 58 specific compounds in VOC that correlated with colorectal cancer, and were able to distinguish with over 75% accuracy which patients had cancer and which were healthy. Among the cancer patients, the team correctly identified 19 as having colorectal tumors.
Ethan A. Huff
December 12, 2012
Once again, the penny pinching bureaucrats running Great Britain’s National Health Service, notable for a euthanasia program that kills 130,000 people a year, may be responsible for creating yet another unhealthy environment for British subjects.
In this case, British dentists have been warned against using a cheap, hand-held x-ray machine on their patients because they pose a significant health risk.
According to the BBC, the imported machines, known as the Tianjie Dental Falcon, expose “users and patients to 10 times the normal level of radiation, increasing their risks of cancer and organ damage.”
Doctors and dentists in such chronically underfunded, government-run health care systems are always looking for ways to curb costs. In this case, it seems as though one cost-cutting measure has been hurting the very patients they were caring for. But other bureaucrats from the Medicines and Healthcare Regulatory Agency are now asking NHS, as well as private dentists, to get rid of the devices.
Entire skull irradiated
In assessing the damage so far, officials have had to admit they don’t know how many patients have been exposed to the additional risk. So far, 13 of the Chinese-made devices have been seized at a distribution center. Most were sold on Internet sites including eBay, the BBC said. At least one dental surgery office was found to be using the dangerous device.
Officials discovered the devices were emitting excessive radiation during emergency testing of the product by the Health Protection Agency, as well as scientists at King’s College Hospital in London. There, officials found that the devices contained insufficient lead shielding inside of them to protect both dentists and patients from excessive radiation exposure.
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