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All FDA drug approvals not created equal

January 22, 2014 8:21 am | by Karen N. Peart, Yale Univ. | News | Comments

Many patients and physicians assume that the safety and effectiveness of newly approved drugs is well understood by the U.S. Food and Drug Administration (FDA). But a new study by researchers at Yale School of Medicine shows that the clinical trials used by the FDA to approve new drugs between 2005 and 2012 vary widely in their thoroughness.

Merck blood thinner gets "yes" vote from FDA panel

January 15, 2014 5:10 pm | by MATTHEW PERRONE - AP Health Writer - Associated Press | News | Comments

A panel of federal experts has recommended approval for an experimental blood thinner from Merck despite serious side effects including internal bleeding. The Food and Drug Administration's panel of cardiology experts voted 10-1 Wednesday in favor of approving the pill vorapaxar to help prevent blood clots in patients with a history of heart attacks.

Costs for complications from cancer surgical care extremely high

January 6, 2014 11:14 am | News | Comments

Although complications from surgical care for cancer patients may seem infrequent, the costs associated with such outcomes are extremely high, according to researchers from Rice Univ.’s Baker Institute for Public Policy and the Univ. of Texas MD Anderson Cancer Center.

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Study finds Medicaid expansion drove up ER visits

January 2, 2014 2:34 pm | by JONATHAN J. COOPER - Associated Press - Associated Press | News | Comments

A new study has found that people enrolled recently in Medicaid went to the emergency room 40 percent more frequently than others, often seeking help for conditions that could be treated less expensively in a doctor's office or an urgent care clinic. 

UNOS to oversee hand, face transplants like organs

December 27, 2013 10:39 am | by Lauran Neergaard, AP Medical Writer | News | Comments

The government is preparing to regulate the new field of hand and face transplants like it does standard organ transplants, giving more Americans who are disabled or disfigured by injury, illness or combat a chance at this radical kind of reconstruction. The United Network for Organ Sharing, or UNOS, will develop the new policies over the next few months.

U.S. ranks near bottom among industrialized nations in efficiency of health care spending

December 13, 2013 9:05 am | News | Comments

A new study by researchers at the Univ. of California, Los Angeles and McGill Univ. reveals that the U.S. health care system ranks 22nd out of 27 high-income nations when analyzed for its efficiency of turning dollars spent into extending lives. The study illuminates stark differences in countries' efficiency of spending on health care, and the U.S.'s inferior ranking reflects a high price paid and a low return on investment.

Updated healthcare.gov gets mixed reviews

December 3, 2013 6:38 pm | by KELLI KENNEDY - Associated Press - Associated Press | News | Comments

Counselors helping people use the federal government's online health exchange are giving mixed reviews to the updated site, with some zipping through the application process while others are facing the same old sputters and even crashes. The Obama administration had promised a vastly improved shopping experience on healthcare.gov by the end of November, and this is the first week for users to test the updated site.

FDA extends review of Biogen hemophilia B drug

December 2, 2013 9:19 am | by The Associated Press | News | Comments

Biogen Idec said Monday the U.S. Food and Drug Administration (FDA) extended its review of Alprolix, a drug designed to treat hemophilia B. Biogen Idec said the FDA extended its review by three months. The move came after the agency asked Biogen for more information about validation of part of the Alprolix manufacturing process.

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FDA tells 23andMe to halt sales of genetic test

November 26, 2013 11:57 am | by Matthew Perrone, AP Health Writer | News | Comments

The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits. In a warning letter posted online Monday, FDA regulators say that the Silicon Valley company has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of email exchanges."

FDA panel backs drug for early-stage breast cancer

September 12, 2013 2:52 pm | by The Associated Press | News | Comments

Government cancer experts say a drug from Roche has shown effectiveness as a new option to treat breast cancer before tumor-removing surgery. The U.S. Food and Drug Administration panel voted 13-0, with one abstention, that the benefits of Perjeta as an initial treatment for breast cancer outweigh its risks.

FDA approves Celgene drug for pancreatic cancer

September 6, 2013 7:07 pm | by The Associated Press | News | Comments

Federal regulators have approved Celgene Inc.'s drug Abraxane to treat late-stage pancreatic cancer. In experimental trials, the drug extended the lives of patients by a little less than two months more than those treated with the current standard drug.

Study suggests robotic surgery complications are underreported

September 4, 2013 7:44 am | News | Comments

Despite widespread adoption by hospitals of surgical robot technology over the past decade, a “slapdash” system of reporting complications paints an unclear picture of its safety, according to Johns Hopkins researchers. When an adverse event or device malfunction occurs, hospitals are required to report these incidents. But this doesn’t always happen, the researchers say.

First estimate of total viruses in mammals

September 3, 2013 4:30 pm | News | Comments

Scientists estimate that there is a minimum of 320,000 viruses in mammals awaiting discovery. Collecting evidence of these viruses, or even a majority of them, they say, could provide information critical to early detection and mitigation of disease outbreaks in humans. This undertaking would cost approximately $6.3 billion, or $1.4 billion if limited to 85% of total viral diversity.

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Onyx, Bayer expect new Nexavar decision by Dec. 25

August 27, 2013 11:17 am | by The Associated Press | News | Comments

Onyx Pharmaceuticals and Bayer said Tuesday that regulators will conduct a faster review of their pill Nexavar as a treatment for thyroid cancer. The U.S. Food and Drug Administration (FDA) is reviewing Nexavar as a treatment for locally advanced or metastatic thyroid cancer that doesn't respond to treatment with radioactive iodine. The companies said the FDA expects to complete its review by Dec. 25. to.

Dropout rates for oncology Phase I trials remain under 10%

August 26, 2013 8:12 am | by The Associated Press | News | Comments

The overall dropout rate for oncology Phase I trials is very low at only 8%, a study by Cutting Edge Information found. However dropout rates tend to rise as the number of required visits increases. The study discovered that the average number of patients enrolled for these trials across all therapeutic areas is 47.2.

Feds, family reach deal on use of DNA information

August 9, 2013 8:13 am | by Malcolm Ritter, AP Science Writer | News | Comments

Some 60 years ago, a doctor in Baltimore removed cancer cells from a poor black patient named Henrietta Lacks without her knowledge or consent. Those cells eventually helped lead to a multitude of medical treatments and lay the groundwork for the multibillion-dollar biotech industry. Now, for the first time, the Lacks family has been given a say over at least some research involving her cells.

When writing antibiotic prescriptions, doctors favor strongest drugs

August 1, 2013 1:55 pm | News | Comments

A study at the Univ. of Utah finds that more than 60% of antibiotic prescriptions are for types that kill multiple kinds of bacteria. Unfortunately, in more than 25% of cases such prescriptions are useless because the infection stems from a virus, which cannot be treated with antibiotics. This overuse of antibiotics has a number of downsides.

FDA proposes rules for safer imported foods

July 26, 2013 5:14 pm | by MARY CLARE JALONICK - Associated Press - Associated Press | News | Comments

Chances are that about 15% of the food you eat—more if your diet includes lots of fruits, vegetables and cheese—comes from abroad, and the government is taking steps now to make it safer. New rules proposed Friday by the U.S. Food and Drug Administration would make U.S. food importers responsible for ensuring that their foreign suppliers are handling and processing food safely.

Activists warn trade pact will keep out generics

July 3, 2013 4:42 am | by EILEEN NG - Associated Press - Associated Press | News | Comments

A free trade pact being negotiated by the U.S. and 11 Asia-Pacific nations will impose aggressive intellectual property rules that will restrict access to affordable medicines in developing nations, health activists warned Wednesday. The 12 countries will start an 18th round of talks in Malaysia on July 15 and hope to complete negotiations by October.

U.S. health care: Does more spending yield better health?

May 23, 2013 8:20 am | News | Comments

Health care spending is much higher for older Americans than for younger adults and children, on average, and analysts have said that increasing spending leads to longer life expectancy. But new research from the University of Michigan indicates that aging populations could view things differently.

Huge drug cost disparities seen in health overhaul

May 13, 2013 3:11 am | by RICARDO ALONSO-ZALDIVAR - Associated Press - Associated Press | News | Comments

Cancer patients could face high costs for medications under President Barack Obama's health care law, industry analysts and advocates warn. Where you live could make a huge difference in what you'll pay. To try to keep premiums low, some states are allowing insurers to charge patients a hefty share of the cost for expensive medications used to treat cancer, multiple sclerosis, rheumatoid arthritis, and other life-altering chronic diseases.

Nanomaterial toxicity study sets stage for policies to address health risks

May 6, 2013 7:41 am | News | Comments

For the first time, researchers from institutions around the country have conducted an identical series of toxicology tests evaluating lung-related health impacts associated with widely used engineered nanomaterials (ENMs). The study provides comparable health risk data from multiple laboratories, which should help regulators develop policies to protect workers and consumers who come into contact with ENMs.

FDA finds safety issues at specialty pharmacies

April 12, 2013 11:29 am | by The Associated Press | News | Comments

The Food and Drug Administration says it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs. The agency said its inspectors targeted 31 compounding pharmacies that produce sterile drugs, which must be prepared under highly sanitary conditions.

New world strategy aims to eradicate polio by 2018

April 2, 2013 5:44 pm | by LAURAN NEERGAARD - AP Medical Writer - Associated Press | News | Comments

A new global plan aims to end most cases of polio by late next year, and essentially eradicate the paralyzing disease by 2018 — if authorities can raise the $5.5 billion needed to do the work, health officials said Tuesday. Part of the challenge will be increasing security for vaccine workers who have come under attack in two of the hardest-hit countries. And the plan calls for changing how much of the world protects against polio, phasing out the long-used oral vaccine in favor of a pricier but safer shot version.

Obama proposes $100M for brain mapping project

April 2, 2013 12:35 pm | by Nedra Pickler, Associated Press | News | Comments

President Barack Obama on Tuesday asked Congress to spend $100 million next year on a new project to map the human brain in hopes of eventually finding cures for disorders like Alzheimer's, epilepsy and traumatic injuries. The BRAIN Initiative, he said, could create jobs and eventually lead to answers to ailments including Parkinson's and autism and help reverse the effect of a stroke.

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