perihalbarah: Sutent

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Laman ini diujudkan buat anda yang mencari kaedah ubatan herba alam semulajadi untuk sakit barah, selain berkongsi pendapat dan pengalaman sesama ahli. Menyedari faktor penyebab barah selain mengelak penipuan kerana pesakit barah selalu ditipu oleh orang yang rakus mengaut untung semata-mata. Laman ini juga bertujuan menyingkap amalan buruk yang merugikan kita.

Jumaat, 1 Mac 2013

Sutent

Sutentgiven U.S. approval

Pfizersays drug will be available for use Feb. 3

The United States Food andDrug Administration (FDA) announced Jan. 26 that it has approved Sutent(sunitinib) for patients with gastrointestinal stromal tumors (GIST) and advancedkidney cancer.

It was the first time theagency has approved a new oncology product for two cancers simultaneously.

Sutent, which received apriority review and was approved in less than six months, is a tyrosine kinaseinhibitor. The once-daily, 50 mg. capsule blocks several enzymes that deprivethe tumor cells of the blood and nutrients needed to grow.

Todays approval is a majorstep forward in making breakthrough treatments available for patients with rareand difficult to treat forms of cancer, said Dr. Steven Galson, director ofFDAs Center for Drug Evaluation and Research. New targeted therapies such asSutent are helping FDA expand options for patients for whom there are limitedalternatives.

According to the AmericanCancer Society, about 6,000 new cases of GIST and 32,000 cases of advancedkidney cancer are diagnosed each year.

Sutent won approval for thetreatment of Gleevec-resistant GIST and for GIST patients unable to tolerateGleevec, the current treatment for GIST. In clinical trials, researchers did anearly analysis of data that showed Sutent delayed the time it took for tumorsor new lesions to grow. Specifically, the median time-to-tumor progression forpatients treated with Sutent was 27 weeks compared to six weeks for patients givena placebo.

Of 312 clinical trialparticipants, 207 received Sutent, while 105 were given placebos.

Typically, patients incancer trials are not given placebos because it is considered unethical to denythem effective treatments. But Sutent maker Pfizer said a third of the patientswere given placebos in this trial because no standard drug is known to workagainst such stomach tumors once they develop resistance to Gleevec.

When it became clear thatpatients taking Sutent were surviving longer than the placebo group, allpatients in the study were allowed to start taking Sutent.

FDA also granted acceleratedapproval for Sutent in the treatment of patients with advanced renal cellcarcinoma (RCC). In contrast to the approval for GIST, which was based on thedrugs ability to delay the growth of the tumors, this approval was based onSutents ability to reduce the size of the tumors in patients. An overallresponse rate ranging from 26 to 37 percent was found in patients withmetastatic kidney cancer whose tumors had progressed following cytokine-basedtherapy.

Pfizer is studying the drugfor use in treating other cancers, including colorectal, breast and lungcancer.

Pfizer says it expects theaverage cost of Sutent per six-week treatment cycle to be about $4,000, puttingthe annual cost of treatment at about $38,000. The drug is expected to beavailable to patients Feb. 3, and will come in 12.5 mg., 25 mg. and 50 mg.capsules.

Patients and physicians canvisit www.sutent.com or phone FirstRESOURCE at (877) 744-5675 for informationabout patient assistance for those who dont have drug coverage and forinformation about reimbursement issues or appeals assistance.

The FDA said in a statementthat it has a long-standing commitment of providing patients with serious andlife-threatening diseases access to safe and effective treatments, in somecases prior to FDA approval.

In the GIST clinical trial,significant clinical benefit was determined through an interim analysis ofdata, thereby allowing researchers to convert all patients in the trial totreatment.

FDA worked with Pfizer,maker of Sutent, to offer an expanded access program prior to approval, makingthe product available to patients not enrolled in a clinical trial. Currently,more than 1,700 U.S. patients are being treated with Sutent through theexpanded access program.

Expanded access programshave proven to be an effective way to get treatment to patients who need itmost, especially in cancer, said Ellen Stovall, president of the NationalCoalition of Cancer Survivorship. There needs to be a greater awareness amongpatients and doctors about both the option to participate in clinical researchas well as in these expanded access programs in order to make promising newtherapies available to as many patients as possible.

Pfizer said the mostcommonly reported side effects included diarrhea, nausea, stomatitis,dyspepsia, and vomiting. Patients also experienced, fatigue, high bloodpressure, bleeding, swelling, and altered taste. Hypothyroidism was alsoobserved.

Skin discoloration possiblydue to the drug color (yellow) occurred in approximately a third of patients.Other possible dermatologic effects may include dryness, thickness or crackingof skin, blister or rash on the palms of the hands and soles of the feet.

Pfizer, which acquiredSutent in 2003 through its purchase of Pharmacia Corp., has said it intends tobecome a major player in the oncology arena. It is now far better known fordrugs such as Viagra and cholesterol fighter Lipitor.

Miracle Cancer Drug Extends Life With $48,720 Cost (Update1)

ByKen Wells and Shannon Pettypiece - March 5, 2010 17:41 EST

March 5 (Bloomberg) -- GeorgeDemetri had witnessed countless near-death experiences in his career as acancer doctor. This time, the life of a drug was on the line. It was calledSU11248, and PfizerInc. had just acquired the company developing it. Tumors were shrinking intwo thirds of the digestive tract cancer patients in the clinical trial Demetrihad been running since February 2002. One dying mans malignancy had stoppedgrowing so suddenly after five doses that it was a miracle, the oncologistsaid. Interesting parlor trick youve got there, but this isnt a market, hesaid Pfizer executives responded when they learned of the results. The trialspatients had a type of cancer accounting for less than 1 percent of new U.S.cases diagnosed every year. We are probably going to shut this down, he saidthey warned. Still, a Pfizer official agreed to accompany him to a December2003 meeting with U.S. Food and Drug Administration regulators, who wereencouraged by the data and sanctioned a second, larger trial. Credit to Pfizerfor realizing it had a winner, Demetri said. Company spokesman ChrisLoder declined to comment on the doctors recollection of events.

In January 2006, Sutentbecame the first treatment simultaneously approved for two cancers:gastrointestinal stromal tumors, or GIST, and renal cell carcinoma. A pill thatalmost landed on the scrap heap of medicine has, according to New York-basedPfizer, since generated $2.6 billion in sales.

Its Not Sustainable

Sutent is part of anexplosion of treatments that attack cancer at the molecular level, holding thepromise of turning intractable malignancies into chronic diseases like diabetesor HIV. Targeted therapies are already extending life -- and adding to the costof end-of-life care, which in the case of Sutent could be on the order of$48,720 a year.

The story of the drug, whichtook 15 years to get from theory to therapy, shows why such medicines, whichhave limited periods of effectiveness, are so expensive that some governmentsresist paying for them. On the advice of the British National Institute for Health and Clinical Excellence,the U.K. National Health Service refused for three years to buy Sutent for itspatients. The price, the institute decided in 2006, was simply too high for theamount of time it bought.

We are all worried thatits not sustainable, said Demetri, 53, director of the Ludwig Center at theHarvard University-affiliated Dana-Farber Cancer Institute in Boston, in an interview.Ultimately, our country may say, OK, we can have these expensive cancer drugsor we can have vaccines for our kids -- what do you want?

Just 29 Days

For those who can afford apill with a retail price of about $200, or whose insurer will cover it,Sutent is a life extender. The metastatic cancer of GIST patients on Sutent washeld in check for about 21 weeks longer than that of patients who began aclinical trial on a placebo, according to Pfizer.

While about a third of those with GIST who switch to Sutent get no benefit, thedrug has been a lifeline for thousands, Demetri said, often buying enough timefor a new medicine to roll out of the targeted therapy pipeline.

Terence Foley, a musicianand teacher living in Philadelphia, was one for whom it offered no benefit. Acombination of GenentechInc.s Avastin and Bayer AGsNexavar helped keep his kidney cancer at bay for 17 months, but he died 29 daysafter his first dose of Sutent.

A Grandsons Birthday

I didnt see it coming,said Keith Flaherty, 39, a protg of Demetris who was Foleys oncologist atthe time of his death in December 2007 at age 67. Why didnt Sutent extend hislife? Perhaps, Flaherty said, his patients tumor was made up of preponderanceof cells that were Sutent-resistant.

Susan Farmer was a different case.

Sutent worked for theretired Rhode Island public television executive, who has fought metastaticGIST for seven years with what doctors call daisy chaining. When her malignancyno longer responds to a treatment, she switches to another, moving from onetargeted therapy to the next to the next. She took Sutent, the second in herchain, for 18 months.

I am alive because of thesedrugs, said Farmer, 67. She credits Novartis AGsGleevec, the first, for allowing her to see her second grandson born in 2005.Sutent kept her well for his fifth birthday.

The company that developed Sutent, Sugen Inc., gotits start in Redwood City, California, in 1991. Cancer treatment at the timehad been largely unchanged for decades. Doctors bombed tumors with a toxicchemical mix and hoped for the best. They rarely got it, and patients sufferedchemotherapy side effects including hair loss and debilitating nausea.

A Kinases Race

The idea propelling Sugenhad been postulated 20 years earlier by Harvard Medical Schools JudahFolkman, who became director of vascular biology at Childrens HospitalBoston. His theory was that malignant solid tumors depended on a geneticcorruption of angiogenesis, the blood-vessel building process. Shut downangiogenesis, his thinking went, and the tumors would starve for lack of blood.

By 1989, scientists had identified a protein -- known as a kinase -- as theprimary driver of angiogenesis: vascular endothelial growth factor, or VEGF.The discovery set off a race to isolate others and develop inhibitors.

One of Sugens founders, AxelUllrich of Germanys Max Planck Institute of Biochemistry, had cloned humaninsulin as a researcher for South San Francisco-based Genentech. Ullrich, now66, also helped discover the gene HER2, thought to be responsible for runawaycell replication in some cancers.

Gen for Genetics

His partner was JosephSchlessinger, then head of the New York University Medical School pharmacologydepartment and now director of Yale Universitys department of pharmacology.Schlessinger, 64, did research at Rhone-Poulenc Rorer Inc. before it becamepart of Sanofi-AventisSA, and worked on the technology that led to ImClone Systems Inc.s coloncancer treatment Erbitux and other drugs.

The company was named afterthem: S for Schlessinger and U for Ullrich, followed by gen, for genetics.

Sugens first chiefexecutive officer was StephenEvans- Freke. He had raised more than $600 million for Thousand Oaks, California-basedAmgen Inc., and other biopharmaceutical startups, according to the Web siteof Celtic PharmaManagement LP, a Hamilton, Bermuda-based private-equity firm where Evans-Freke is a managing general partner. Evans-Freke pulled together $2.5 millionin venture capital for Sugen, which raised $20 million when it went public in 1994.

$100 Million a Year

The hunt for kinaseinhibitors was slow and expensive, Ullrich said in an interview. For one thing,all the kinases had to be identified, which Sugen did by building a kinome,mapping the 500 or so that inhabit the body.

Another challenge was thatkinases exist at the core of cellular biology, sharing space with adenosine triphosphate, or ATP, the very engine ofintracellular energy.

The worry was that you couldntdrug these kinases without shutting down every energy-generating process in thebody, Demetri said. Youd kill people faster than the disease would.

A solution required designing drug molecules so precise they could slip intothe pockets of specific kinases without interfering with ATP. Sugen scientistsbombarded cancer-driving proteins with synthesized chemical compounds to figureout which of them showed promise as kinase inhibitors.

By 1998, Sugen was burning through about $100 million a year, and running outof money for the clinical trials that are fundamental to bringing a drug tomarket, according to PeterHirth, who was president at the time.

Betting on VEGF

Pharmacia & UpjohnInc., based in Bridgewater, New Jersey, stepped in with the cash in 1999,buying Sugen for $650 million.

Genentech, acquired lastyear by RocheHolding AG, had shown that targeted therapy could be a commercial successafter FDA approval in 1998 of the metastatic breast cancer drug Herceptin. Itattacks the HER2 gene, the one Ullrich helped find, and was the first kinaseinhibitor on the market.

In May 2001, Novartis, based in Basel, Switzerland, secured FDA approval forGleevec, which worked by knocking out the main molecular driver in chronicmyeloid leukemia. Genentech was by then in trials with what it would callAvastin -- used today against five cancers -- and early results indicated itwould prove that VEGF inhibitors could thwart angiogenesis.

Sugens bet was on targetingVEGF, and of the 50,000 compounds scientists threw at it in the lab, exactlythree seemed promising, according to Ullrich and Hirth.

A Dirty Inhibitor

One of the three --christened SU5416 because it was the 5,416th substance tried out -- was givenin 2001 to 350 colorectal cancer patients. So few responded that the trialfailed statistically, according to Ullrich.

The scientists concludedSU5416 wasnt soluble enough to slip with adequate dosage into its moleculartarget. They turned to SU11248, the 11,248th of the compounds tested, andtweaked it. The adjustments made it less specific, and SU11248 went afterVEGF and also as many as 200 other kinases, Ullrich said.

Because protein kinasesregulate many normal cell signaling functions, not just those driving cancer,the drug might block healthy activities, too, Ullrich said.

Nobody was sure they wanteda dirty kinase inhibitor like SU11248, Ullrich said.

Then Sugen tested it in a 2002 basket trial, so named because people with avariety of cancers took part. SU11248 was sent to oncologists worldwide, and inwhat Ullrich called a lucky accident a Paris doctor gave it to three kidneycancer patients. Two had outstanding responses, he said.

The Lipitor Company

The basket trial occurredbefore Pfizer closed its $58 billion acquisition of Pharmacia in April 2003.Pfizer, which disbanded Sugen as a unit, decided to finance trials focusing onrenal patients. Demetri was wrapping up his clinical evaluation of SU11248s abilityto target kinases driving GIST for patients who had run out of treatmentoptions.

After Pfizer learned abouthis patients spectacular results, Demetri said he was quizzed on hisestimate that the market for the drug would be only a few thousand patients.

A few thousand? Look, werethe Lipitor company, were looking for a few million, he said Pfizerexecutives told him. Lipitor, Pfizers cholesterol pill, is the worlds topselling drug with more than $11.4

billion in 2009 revenue.

At the December 2003meeting, FDA officials wouldnt accelerate the SU11248 approval process,because standard scans didnt show tumors were shrinking definitively enough,Demetri said. Pfizer agreed to fund placebo trials.

A Vampire Cancer

The drug would be given totwo-thirds of a group and sugar pills to the rest -- rare in oncology wherelives are on the line. The FDA agreed that sugar-pill patients whose tumorsgrew would be given the real drug. The trial started in January 2004.

Within a year, every placebopatient had been switched because of staggeringly statistically positiveresults, Demetri said. Tumor growth in those taking SU11248 halted for 27 weekscompared with six weeks for those on sugar pills, according to FDA data.

For Farmer, the trialssuccess meant more life.

Farmer, who served two termsas Rhode Island secretary of state, was diagnosed with GIST in October 2001 after an abdominal tumor burst andhemorrhaged. A surgeon removed the growth -- it was about the size of a shotput, she recalled -- but by January 2003 the malignancy had spread to herliver.

Invincible to mosttreatments, GIST was known as a kind of vampire cancer whose cells have ananti-death pathway turned on, Demetri said. They dont know how to die, whichis why chemotherapy doesnt work.

Heart Flutters

Doctors began building Farmersdaisy chain with Gleevec, which shrank her liver tumors within a month of herfirst dose in February 2003. Side effects included puffy eyes, muscle cramps,diarrhea and chemo brain, she said. I thought I was getting Alzheimers.

A scan in April 2008 showedtwo of the largest growths were active once more. Gleevecs effectiveness hadrun out.

So Farmer started on Sutent.This time, her teeth became so sensitive she couldnt brush. Eating sugar hurtthem. She couldnt catch her breath.

I got heart flutters, shesaid. I got headaches. It hurt to talk. One day I just sat there with mySutent in my hand saying I cant possibly have one more of these things. It maygive me one more day of life, but it felt like death. I made the decision I wasjust going to stop and not take it.

She changed her mind after a scan showed the tumors shrinking once more.

Every Customers Premium

Her dose was reduced, andthe side effects abated. The cancer didnt grow again until last October, whenSutent was replaced with Novartiss Tasigna, developed as a Gleevec backup andapproved in November 2007.

Should Tasigna fail, twotreatments in clinical trials seem promising, Farmers doctors have told her.She said she would be willing to keep the daisy chain going.

For people who have privatehealth insurance like Farmers or who qualify for Medicare, the tax-fundedprogram for Americans over 65, Sutent isnt a personal financial issue.

UnitedHealth GroupInc., the worlds largest health insurance provider, pays for every cancertreatment for the use for which the FDA approved it, and UnitedHealthscompetitors do the same, said Lee Newcomer, senior vice president of oncologyat the Minnetonka, Minnesota-based company.

Pfizer knows very well I cant refuse to cover this drug, Newcomer said in aninterview.

Rationing by Pricing

The cost of reimbursing forSutent and other targeted therapies is factored into every customers premium,which results in a kind of rationing that is putting life-extending treatmentsbeyond the reach of more and more Americans, he said.

Everyones premium goes upbecause we layer that across everyone we insure, he said. All the recenthealth policy talk is that in the U.S. we dont ration, but that isnt a truestatement. We just keep pricing more and more people out of the ability toafford health insurance. We have chosen to ration by just pricing some peopleout.

To decide what to charge fortargeted drugs, some companies use as a benchmark kidney dialysis -- for whichMedicare pays a per-patient average of $71,000 a year -- because it is anotherheroic but effective way of keeping people alive, said TimByers, associate dean of public health practice at the Denver- basedColorado School of Public Health.

The general estimate of thecost of Sutent for the average kidney cancer patient is $50,000 a year,according to UnitedHealth.

Most Liberal Nation

Pfizer wont disclose whatwas spent bringing Sutent to market or the profit it makes off the drug, Loder,the spokesman, said. The company charges wholesalers an average of less than$5,100 for a month at the highest dosage, he said. Pfizer rose 15 cents, orless than 1 percent, to close at $17.48 today in New York Stock Exchange compositetrading.

U.S. regulators dont takepricing into consideration when evaluating whether a therapy should be sold tothe public.

The U.S. is by far the mostliberal nation in letting the market decide the fate of these drugs, saidFlaherty, director of developmental therapeutics at Massachusetts GeneralHospital Cancer Center in Boston, affiliated with Harvard Medical School.

In the U.K., where thetax-funded NationalHealth Service covers all residents, the calculus is different. This drugwas way outside of what we considered cost effective, said PeterLittlejohns, the clinical and public- health director for Britains healthinstitute, in an interview about the 2006 decision again Sutent. The averagelife expectancy was in terms of months, not years, and there will be some whohave no benefit from it.

Daisy Chaining Momentum

The institute reversed itsruling on Sutent last year, persuaded by pressure from oncologists and patientadvocacy groups, a campaign by Pfizer and the companys promise to provide thefirst round of prescriptions to National Health Plan patients at no cost.

At the same time, the U.K.rejected two other targeted therapies covered by Medicare and U.S. insurers:Nexavar for liver cancer and Avastin for advanced bowel cancer. Nexavar wasestimated to cost 65,900 pounds ($102,000) for every quality adjusted year oflife, while for Avastin it was 74,999 pounds, according to institute reports.

The drugmakers areappealing.

The success of targetedtherapy relies on a steady stream of approvals of new drugs and on insurersbeing willing to pay for them. Patients need alternatives because tumor cellsthat survive one drugs attack can regroup and grow, and only a new medicinecan work on them.

More Expensive Treatments

With daisy chaining themomentum is undeniable, according to Flaherty. In metastatic kidney cancer, forinstance, Sutent and five other drugs made available in the last four yearsmoved the average survival rate from 14 months to a range of 36 to 48 months, Flahertysaid.

Improving cancer survivalrates are a real success story that sometime get lost in the noise over ourhealth-care system, said Douglas Blayney, president of the Alexandria,Virginia-based American Society of Clinical Oncology, the largest U.S.organization of cancer doctors. Targeted drugs are driving that survival in amajor way.

The FDA has approved 25targeted agents since 1998, the agencys Web site shows. With hundreds indevelopment, 40 more could be on the market by 2015, according to a 2008 reportby the Boston-based TuftsCenter for the Study of Drug Development, which is affiliated with TuftsUniversity.

The Deep End

As pharmaceutical companies continue to produce these and other more advanced,and more expensive treatments, U.S. cancer-fighting costs will rise fasterthan overall medical spending, according to the National Cancer Institute in Bethesda, Maryland. Cancertreatment spending rose 75 percent in the decade ending in 2004, to $72.1billion, according to a 2007 NCI report, the latest data available.

Medicare already devotes about a quarter of its budget -- now $450 billion --to care in the last year of life, according to the policy journal Health Affairs. As baby boomers age and fall underthe U.S. tax-funded program, theyre ushering in a new era of spending.

People 65 and older have 10times the cancer rate and 16 times the cancer mortality rate of those younger, NCI datashow. Cancer is the No. 2 killer behind heart disease, responsible for onein four non-accidental deaths, according to the Centers forDisease Control and Prevention in Atlanta.

That number might fall as researchers invent better diagnostics that letdoctors more quickly identify a cancers genetic driver and make smarter drugsthat cleanly knock out cancer drivers, according to Flaherty.

If we can get one moredrug, can we push the tumor so far into hibernation that, while not curing it,were managing it as a chronic disease? he said. We think thats possible.

To contact the reporters onthis story: KenWells in New York at kwells8@bloomberg.net;ShannonPettypiece in New York at spettypiece@bloomberg.net

To contact the editorsresponsible for this story: Robert Blau in Washington at rblau1@bloomberg.net; Reg Gale in NewYork at Rgale5@bloomberg.net

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