Make Chiangmai Mail | your Homepage | Bookmark

Chiangmai 's First English Language Newspaper

Pattaya Blatt | Pattaya Mail |

 

Copyright 2017 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Update November 2017


Home
Thailand News
World News
World Sports
Arts - Entertainment - Lifestyles
Book Review
Health & Wellbeing
Odds & Ends
Science & Nature
Technology
Update by Natrakorn Paewsoongnern
 
 
 
Health & Wellbeing
 

Update Saturday, Nov. 18 - Nov. 24, 2017

FDA moves to ax claim for heart benefits from soy foods

This file photo shows the ingredients label for soy milk at a grocery store in New York. The U.S. Food and Drug Administration announced it wants to remove a health claim about the heart benefits of soy from cartons of soy milk, tofu and other foods, saying the latest scientific evidence no longer shows a clear connection. (AP Photo/Patrick Sison, File)

Matthew Perrone

Washington (AP) - U.S. regulators want to remove a health claim about the heart benefits of soy from cartons of soy milk, tofu and other foods, saying the latest scientific evidence no longer shows a clear connection.

The announcement by the Food and Drug Administration marks the first time the agency has moved to revoke a health food claim since it began approving such statements in 1990. The claim that soy protein can reduce heart disease appears on about 200 to 300 products in the U.S., according to industry figures, including popular brands like Silk soy milk.

Calls to WhiteWave Foods Company, which markets Silk brand soy products, were not immediately returned.

The FDA first approved the language about the benefits in 1999 based on studies suggesting soy protein lowered a type of heart-damaging cholesterol in the bloodstream. But some later studies have failed to show a clear link.

One 2005 study by the U.S. government’s Agency for Healthcare Research and Quality found that soy products had little effect on bad cholesterol. The FDA began reevaluating the food claim in 2007 and said, “The totality of the evidence is inconsistent and not conclusive.”

The agency will take comments on its proposal for 75 days before moving ahead. If the language is removed, companies may still be able to use a less definitive statement about soy’s benefits by including a disclaimer or description of the mixed evidence.

Consumer advocates backed the proposal, arguing that earlier research misinterpreted soy’s effect on cholesterol.

Bonnie Liebman, a nutrition scientist at the Center for Science in the Public Interest, explained that a person might benefit by replacing red meat with soy, but the benefit would be from the reduction in red meat, not because of anything special in the soy protein.

The FDA estimates it will cost companies between $370,000 and $860,000 in upfront costs to re-label their products, according to a federal filing posted online.

An industry group for soy manufacturers disputed the FDA’s decision and pointed to 12 other countries, including Canada, that have approved health labeling claims making the link between soy protein and heart benefits. The group, Soyfoods Association of North America, said it would make its case to the FDA during the comment period.


US regulators approve 2nd gene therapy for blood cancer

Cell therapy specialists at Kite Pharma’s manufacturing facility in El Segundo, Calif., prepare blood cells from a patient to be engineered in the lab to fight cancer. (Kite Pharma via AP, File)

Linda A. Johnson

Trenton, N.J. (AP) - U.S. regulators have approved a second gene therapy for a blood cancer, a one-time, custom-made treatment for aggressive lymphoma in adults.

The Food and Drug Administration allowed sales of the treatment from Kite Pharma. It uses the same technology, called CAR-T, as the first gene therapy approved in the U.S. in August, a treatment for childhood leukemia from Novartis Pharmaceuticals.

“In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” FDA Commissioner Dr. Scott Gottlieb said in a statement.

The treatment, called Yescarta, will cost $373,000 per patient, according to drugmaker Gilead Sciences. Kite became a subsidiary of Foster City, California-based Gilead this month.

CAR-T treatment uses gene therapy techniques not to fix disease-causing genes but to turbocharge T cells, immune system soldiers that cancer can often evade. The T cells are filtered from a patient’s blood, reprogrammed to target and kill cancer cells, and then hundreds of millions of copies are grown.

Returned to the patient, all the revved-up cells can continue multiplying to fight disease for months or years. That’s why these immunotherapy treatments are called “living drugs.”

“Today’s approval of Yescarta is a very significant advance for lymphoma patients and for the cancer community as a whole,” Louis J. DeGennaro, president of the Leukemia & Lymphoma Society, said in a statement. “Immunotherapy is dramatically changing the way we approach blood cancer treatment.”

Kite’s therapy is for patients with three types of aggressive, or fast-growing, large B-cell lymphoma. The most common one accounts for about a third of the estimated 72,000 new cases of non-Hodgkin lymphoma diagnosed each year.

Yescarta, also known as axicabtagene ciloleucel, was approved for patients who have already been treated with at least two cancer drugs that either didn’t work for them or eventually stopped working.

At that point, patients are generally out of options and only have about a 10 percent chance of even temporary remission of their cancer, said Dr. Frederick Locke, director of research for the Immune Cell Therapy Program at Moffitt Cancer Center in Tampa, Florida. Locke helped run patient tests of Yescarta.

“This is really an exciting advance for patients without hope,” Locke said.

Yescarta is not a benign treatment, though: Three people died after getting the treatment, which can cause serious side effects. The FDA is requiring Kite to do a long-term safety study and train hospitals to quickly spot and handle those reactions.

In the key test, Yescarta was given to 101 patients. About 72 percent saw their cancer shrink and about half showed no sign of disease eight months later.

While it is billed as a one-time treatment, because the patients’ cancer is so far advanced, it returns in some. The therapy is still working in most study participants, so the average duration of its effects isn’t known yet.

A different type of gene therapy is waiting in the wings at the FDA. Spark Therapeutics’ treatment for a rare form of blindness could be approved within months. It aims to improve vision by replacing a defective gene needed to process light.

Other gene therapies for blood cancers are being tested and scientists think they may work for solid tumors within several years.


Update Saturday, Nov. 11 - Nov. 17, 2017

Ultra-personal therapy: Gene tumor boards guide cancer care

Cancer patient Alison Cairnes poses for a portrait at the University of California San Diego in San Diego, Calif. (AP Photo/Gregory Bull)

Marilynn Marchione

San Diego (AP) - Doctors were just guessing a decade ago when they gave Alison Cairnes’ husband a new drug they hoped would shrink his lung tumors. Now she takes it, but the choice was no guesswork. Sophisticated gene tests suggested it would fight her gastric cancer, and they were right.

Cancer patients increasingly are having their care guided by gene tumor boards, a new version of the hospital panels that traditionally decided whether surgery, radiation or chemotherapy would be best. These experts study the patient’s cancer genes and match treatments to mutations that seem to drive the disease.

“We dissect the patient’s tumor with what I call the molecular microscope,” said Dr. Razelle Kurzrock, who started a board at the University of California, San Diego, where Cairnes is treated.

It’s the kind of care many experts say we should aim for - precision medicine, the right drug for the right person at the right time, guided by genes. There are success stories, but also some failures and many questions:

Will gene-guided care improve survival? Does it save money or cost more? What kind of gene testing is best, and who should get it?

“I think every patient needs it,” especially if cancer is advanced, said Kurzrock, who consults for some gene-medicine companies. “Most people don’t agree with me - yet. In five years, it may be malpractice not to do genomics.”

Few people get precision medicine today, said Dr. Eric Topol, head of the Scripps Translational Science Institute. “The only thing that’s gone mainstream are the words.”

How it works now

If you have a cancer that might be susceptible to a gene-targeting drug, you may be tested for mutations in that gene, such as HER2 for breast cancer. Some breast or prostate cancer patients also might get a multi-gene test to gauge how aggressive treatment should be.

Then most patients get usual guideline-based treatments. If there’s no clear choice, or if the disease has spread or comes back, doctors may suggest tumor profiling - comprehensive tests to see what mutations dominate.

That’s traditionally been done from a tissue sample, but newer tests that detect tumor DNA in blood - liquid biopsies - are making profiling more common. The tests cost about $6,000 and many insurers consider them experimental and won’t pay.

Gene tumor boards analyze what the results suggest about treatment. They focus on oddball cases like a breast cancer mutation in a colon cancer patient, or cancers that have widely spread and are genetically complex. The only options may be experimental drugs or “off-label” treatments - medicines approved for different situations.

But as tumor profiling grows, it’s revealing how genetically diverse many tumors are, and that oddball cases are not so rare, said Dr. John Marshall. He heads the virtual tumor board at Georgetown Lombardi Comprehensive Cancer Center that also serves cancer centers in Pennsylvania, North Carolina, Michigan and Tennessee.

“There is a little bit of faith” that testing will show the right treatment, but it’s not a sure thing, said Dr. Lee Schwartzberg, who heads one participating center, the West Cancer Center in Memphis.

Dr. Len Lichtenfeld, the American Cancer Society’s deputy chief medical officer, is optimistic yet wary. Drugs that target BRAF mutations work well for skin cancers called melanomas, but less well for lung or colon cancers.

“Just because a mutation occurs it doesn’t mean that drug is going to work in that cancer,” he said.

Lucky cases

When it does, results can be dramatic. Cairnes’ cancer was between her stomach and esophagus, and had spread to her liver, lungs and lymph nodes. Tissue testing found 10 abnormal genes, but on the liquid biopsy only EGFR popped out as a good target.

Two drugs aim at that gene but aren’t approved for her type of cancer. A tumor board advised trying both - Erbitux and Tarceva, the drug her husband also had taken. Within two weeks, she quit using pain medicines. After two months, her liver tumor had shrunk roughly by half. There are signs that cancer may remain, but it is under control. She feels well enough to travel and to take care of her granddaughter.

“I’m very, very grateful to have a targeted therapy,” Cairnes said.

“I cannot expect a better outcome than what we’re seeing right now,” said her doctor, Shumei Kato.

What studies show

But is gene-guided treatment better than usual care? French doctors did the first big test, with disappointing results. About 200 patients with advanced cancer were given whatever their doctors thought best or off-label drugs based on tumor profiling. Survival was similar - about two months.

Another French study, reported in June, was slightly more encouraging on survival but exposed another problem: No drugs exist for many gene flaws. Tests found treatable mutations in half of the 2,000 participants and only 143 got what a tumor board suggested.

Some doctors worry that tumor boards’ recommending off-label treatments diverts patients from research that would benefit all cancer patients. For example, the American Society of Clinical Oncology’s TAPUR study tests off-label drugs and shares results with their makers and federal regulators.

Letting patients choose

Ann Meffert, who lives on a dairy farm in Waunakee, Wisconsin, endured multiple standard treatments that didn’t defeat her bile duct cancer.

“She was going to be referred to hospice; there was not much we could do,” said Dr. Nataliya Uboha, who took the case to a tumor board at the University of Wisconsin-Madison. The panel gave several options, including off-label treatment, and Meffert chose a study that matches patients to gene-targeting therapies and started on an experimental one last October.

“Two weeks in, I started feeling better,” she said, and when she saw test results, “I couldn’t believe the difference.”

Many lung spots disappeared and the liver tumor shrank 75 percent. She is not cured, though, and doctors are thinking about next steps. And that could involve a fresh look at her tumor genes.


Update Saturday, Nov. 4 - Nov. 10, 2017

FDA approves better vaccine against painful shingles virus

On Friday, Oct. 20, 2017, the Food and Drug Administration approved the Shingrix vaccine to prevent painful shingles in people aged 50 or older. (GlaxoSmithKline via AP)

Linda A. Johnson

U.S. regulators have approved a new, more effective vaccine to prevent painful shingles, which is caused by the chickenpox virus.

Drugmaker GlaxoSmithKline said the Food and Drug Administration approved it late Friday. It will be the second shingles vaccine in the U.S. market. Merck launched the first one in 2006.

Studies paid for by Glaxo found it prevents shingles in about 90 percent of people. Merck’s is about 50 percent effective.

Both versions are for adults 50 and older. The U.S. Centers for Disease Control and Prevention, though, recommends vaccination for those 60 or older, partly because it loses effectiveness over time.

Anyone who’s had chickenpox - nearly everyone over 40 - harbors the varicella-zoster virus that causes the disease. The virus can resurface decades later, triggering painful sores on one side of the body. About 10 to 20 percent of those who get shingles also develop debilitating nerve pain that can last for months, even years.

About one-third of people who have had chickenpox get shingles. That’s about 1 million Americans a year. But once someone has recovered from shingles, it rarely reoccurs.

Chickenpox was a very common childhood illness until a Merck vaccine was introduced two decades ago; it’s now part of routine childhood shots.

GlaxoSmithKline PLC said the price of its shingles vaccine, called Shingrix, will be $280 for the required two shots. Merck & Co.’s one-shot Zostavax costs $223. Most insurance plans cover it.

The two vaccines are made differently. Glaxo’s is genetically engineered and includes an ingredient that boosts effectiveness. In addition to preventing shingles, it also reduces the risk of nerve pain by nearly 90 percent. Glaxo studies also show it retains about 90 percent of its effectiveness for four years, and follow-up studies indicate it lasts years longer, according to Dr. Leonard Friedland, Glaxo’s vaccines director for North America.

Merck’s vaccine uses a live but weakened virus, so it can’t be used by people with compromised immune systems. It reduces risk of shingles by half and risk of nerve pain by 67 percent, according to the CDC. One study found it doesn’t prevent shingles after eight years.

More research is being done. Glaxo is testing its vaccine against Merck’s. Meanwhile, Merck has been testing a different vaccine on cancer patients and people with compromised immune systems. (AP)
 


DAILY UPDATEE

|

Back to Main Page

HEADLINES [click on headline to view story]

FDA moves to ax claim for heart benefits from soy foods

US regulators approve 2nd gene therapy for blood cancer


Ultra-personal therapy: Gene tumor boards guide cancer care


FDA approves better vaccine against painful shingles virus


 



Chiangmai Mail Publishing Co. Ltd.
189/22 Moo 5, T. Sansai Noi, A. Sansai, Chiang Mai 50210
THAILAND
Tel. 053 852 557, Fax. 053 014 195
Editor: 087 184 8508
E-mail: [email protected]
www.chiangmai-mail.com
Administration: [email protected]
Website & Newsletter Advertising: [email protected]

Copyright © 2004 Chiangmai Mail. All rights reserved.
This material may not be published, broadcast, rewritten, or redistributed.