Massive recall of packaged vegetables gets even bigger as more stores pull products



Massive recall of packaged vegetables gets even bigger as more stores pull products

OCTOBER 23, 2017 9:30 AM

New Ovarian Cancer Drug Wins Speedy FDA Approval


DEC 19 2016, 7:21 PM ET

New Ovarian Cancer Drug Wins Speedy FDA Approval

U.S. health officials have approved a new option for some women battling ovarian cancer: a drug that targets a genetic mutation seen in a subset of hard-to-treat tumors.

The Food and Drug Administration cleared the drug, Rubraca, from Clovis Oncology Inc. for women in advanced stages of the disease who have already tried at least two chemotherapy drugs.

The Clovis medication targets a mutation found in 15 to 20 percent of patients with ovarian cancer. Women with the variation, known as BRCA, face much higher risks of breast cancer and ovarian cancer compared with other women.

The FDA also approved a companion test that screens for the mutation.

About 1 percent of women will be diagnosed with ovarian cancer in their lifetime, according to the National Cancer Institute. This year an estimated 14,240 women will die from the disease in the U.S. Currently, standard treatment includes surgery to try and remove tumors or chemotherapy.

Related: This Formula Might Catch Ovarian Cancer Sooner

The FDA cleared the new drug under its accelerated approval pathway, reserved for medicines with promising results that must be confirmed by additional research. If the drug’s benefits do not pan out, the FDA has the option of removing it from the market.

The agency said it cleared Rubraca based on studies of more than 100 women in which 54 percent of patients saw complete or partial shrinkage of their tumors. Typically that benefit lasted about nine months, the agency said in an online posting.

Rubraca will carry a warning label about serious risks, including bone marrow problems and a form of blood cancer called acute myeloid leukemia. Common side effects of the drug include nausea, fatigue, vomiting and low levels of red blood cells.

Related: Ovarian Cancer Gets Shortchanged, Report Finds

Rubraca is part of an emerging class of drugs that blocks an enzyme that helps cells — including those affected by cancer — repair themselves. Blocking this mechanism is thought to slow tumor growth. Biotech drugmaker Tesaro Inc. is expecting an FDA decision on a similar drug next year.

“This approval gives Clovis the chance to build a market in this space before the approval of Tesaro’s niraparib,” Stifel analyst Thomas Shrader said in a note to investors. He has a “Buy” rating on Clovis.

Shares of the Boulder, Colorado-based company rose $3.28, or 8.8 percent, to $40.48 in trading Monday. Shares of competitor Tesaro fell $4.19, or 3.2 percent, to $127.24.

Study: States with medical marijuana have lower prescription drug use—Plus Fewer Drug Overdoses And Deaths


Study: States with medical marijuana have lower prescription drug use—This Causes Fewer Drug Overdoses And Fewer Drug Related Deaths As It Is Impossible To Overdose (Die) From Marijuana Usage!

Prescription drug prices are up, making policy experts increasingly anxious. But relief could come from a surprising source. Just ask Cheech and Chong.

New research found that states that legalized medical marijuana — which is sometimes recommended for symptoms like chronic pain, anxiety or depression — saw declines in the number of Medicare prescriptions for drugs used to treat those conditions and a dip in spending by Medicare Part D, which covers the cost on prescription medications.

The study, which appears in Health Affairs, examined data from Medicare Part D from 2010 to 2013. It is the first study to examine whether legalization changes doctors’ clinical practice and whether it could curb public health costs.

The findings add context to the debate as more lawmakers express interest in medical marijuana. Ohio and Pennsylvania have this year passed laws allowing the drug for therapeutic purposes, making the practice legal in 25 states, plus Washington D.C. The question could also come to a vote in Florida and Missouri this November. A federal agency is considering reclassifying it under national drug policy to make medical marijuana more readily available.

Medical marijuana saved Medicare about $165 million in 2013, the researchers concluded. They estimated that, if the policy were nationalized, Medicare Part D spending would have declined in the same year by about $470 million. That’s about half a percent of the program’s total expenditures.

That is an admittedly small proportion of the multi-billion dollar program. But the figure is nothing to sneeze at, said W. David Bradford, a professor of public policy at the University of Georgia and one of the study’s authors.

“We wouldn’t say that saving money is the reason to adopt this. But it should be part of the discussion,” he added. “We think it’s pretty good indirect evidence that people are using this as medication.”

The researchers found that in states with medical marijuana laws on the books, the number of drug prescriptions dropped for treating anxiety, depression, nausea, pain, psychosis, seizures, sleep disorders and spasticity. Those are all conditions for which marijuana is sometimes recommended. Prescriptions for other drugs treating other conditions, meanwhile, did not decline.

The study’s authors are separately investigating the impact medical marijuana could have on prescriptions covered by Medicaid, the federal-state health insurance program for low-income people. Though this research is still being finalized, they found a greater drop in prescription drug payments there, Bradford said.

If the trend bears out, it could have meaningful public health ramifications. As doctors and public health experts grapple with the consequences of excessive prescription painkiller use, medical marijuana could provide an alternate path. Experts say abuse of prescription painkillers — known as opioids — is in part driven by high prescribing. In states that legalized medical uses of marijuana, painkiller prescriptions dropped — on average, the study found, by about 1,800 daily doses filled each year per doctor. That tracks with other research on the subject.

Questions exist, though, about the possible health harms or issues that could result from regular use.

It’s unlike other drugs, such as opioids, in which overdoses are fatal, said Deepak D’Souza, a professor of psychiatry at Yale School of Medicine, who has researched the drug.

“That doesn’t happen with marijuana,” he added. “But there are whole other side effects and safety issues we need to be aware of.”

“A lot of people also worry that marijuana is a drug that can be abused,” agreed Bradford. “Just because it’s not as dangerous as some other dangerous things, it doesn’t mean you want to necessarily promote it. There’s a lot of unanswered questions.”

Meanwhile, it is difficult to predict how many people will opt for this choice instead of meds like antidepressants or opioids.

Because the federal government labels marijuana as a Schedule I drug, doctors can’t technically prescribe it. In states that have legalized medical marijuana, they can only write patients a note sending them to a dispensary. Insurance plans don’t cover it, so patients using marijuana pay out-of-pocket. Prices vary based on geography, but a patient’s recommended regimen can be as much as $400 per month. The federal Drug Enforcement Agency is considering changing that classification — a decision is expected sometime this summer. If the DEA made marijuana a Schedule II drug, that would put it in the company of drugs such as morphine and oxycodone, making it easier for doctors to prescribe and more likely that insurance would cover it.

To some, the idea that medical marijuana triggers costs savings is hollow. Instead, they say it is cost shifting. “Even if Medicare may be saving money, medical marijuana doesn’t come for free,” D’Souza said. “I have some trouble with the idea that this is a source of savings.”

Still, Bradford maintains that if the industry expanded and medical marijuana became a regular part of patient care nationally, the cost curve would bend because marijuana is cheaper than other drugs.

Lester Grinspoon, an associate professor emeritus of psychiatry at Harvard Medical School, who has written two books on the subject, echoed that possibility. Unlike with many drugs, he argued, “There’s a limit to how high a price cannabis can be sold at as a medicine.” He is not associated with the study.

And, in the midst of the debate about its economics, medical marijuana still sometimes triggers questions within the practice of medicine.

“As physicians, we are used to prescribing a dose. We don’t have good information about what is a good dose for the treatment for, say pain,” D’Souza said. “Do you say, ‘Take two hits and call me in the morning?’ I have no idea.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Invest In YourSelf First!!

Only We Can Change our Life, No one Else Do it For Us

cracked rear viewer

Fresh takes on retro pop culture

The New Pork Grimes

Satirical, Weird, Funny News and Opinion.

Marta Felipe

Semeando Amor...

My Fantasy World

-- Jalpa Makwana

%d bloggers like this: