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Medical controversies sparking debate in 2014

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Some of 2013's biggest medical stories will likely cause ripples in 2014 and years to come.

This past year saw major shifts in policies and guidelines designed to keep Americans safe and healthy, but many of these changes were controversial and have led to more questions than answers.

Here are five areas of health and medicine you can expect to hear a lot more about in 2014. 

Will food safety efforts move forward?

In January of 2013, the Food and Drug Administration announced “sweeping” rules aimed at food safety, but 2014 may be the year when Americans and businesses actually start seeing changes. 

} The FDA action included long-overdue rules to reduce foodborne illness, the culmination of the 2011 FDA Food Safety Modernization Act that empowered the FDA to make these changes. More than 48 million Americans are hit by a foodborne illness each year. 

The rules required farmers to take precautions against contamination, such as ensuring that workers' hands are washed, irrigation water is clean, and animals stay out of fields. Food safety plans would have to be submitted to the government.

But, in December, the FDA announced those rules will be delayed to better accommodate farmers and businesses that would be affected.

FDA to roll back use of antibiotics in beef, pork and poultry
 “Because of the input we received from farmers and the concerns they expressed about the impact of these rules on their lives and livelihood, we realized that significant changes must be made, while ensuring that the proposed rules remain consistent with our food safety goals,“ the FDA’s Michael Taylor, deputy commissioner for foods, said in a Dec. 19 statement.

The agency in July announced tighter regulations for manufacturers who import their goods, but it's unclear at this time if those changes will also be delayed.

Also in December, the FDA announced plans to reduce antibiotics in meat in an effort to make Americans safer by curbing antibiotic resistance in the United States. The agency asked pharmaceutical companies to voluntarily change the labeling on these drugs so they would no longer be used for livestock production purposes.

Antibiotics are used to fatten up animals like cattle, poultry and hogs for meat consumption, but government researchers warn antibiotic-resistant germs kill 23,000 people each year.

The changes are only voluntary, but the FDA says based on its outreach, “We have every reason to believe that animal pharmaceutical companies will support us in this effort.”

Look to see whether either of these yet-to-be-enacted rules finally come into play in 2014.

Gluten questions grow

Gluten-free diets are more popular than ever, but questions persist in the medical community about who really benefits from the diet.

Experts weigh-in on “wheat-free” diets
 Cardiologist Dr. William Davis, author of "The Wheat Belly 30-Minute (or less!) Cookbook," told "CBS This Morning" in December that wheat products are inflammatory, raise blood sugar and increase appetite. He says the grain contains its own version of an addictive “opiate” that actually causes people to experience withdrawal initially once gluten gets eliminated from the diet. 

His book and others promoting wheat avoidance come at a time when “gluten-free” eating is more popular than ever. The Food and Drug Administration in August unveiled new regulations for what actually makes a food qualify as “gluten-free,” saying a product must contain less than 20 parts-per-million (ppm) of gluten to carry that label.}  

CBS News chief medical correspondent Dr. Jon LaPook explained in July that a gluten-free diet is medically helpful for people with celiac disease or what’s called non-celiac gluten sensitivity. About 1 percent of people have celiac disease, and many don’t even realize they have it.  

However, he said that a gluten-free diet likely provides no medical benefit for most other people. 

While he concedes that some people may feel better if they eliminate gluten, the discomfort and symptoms one might associate with a gluten sensitivity may in fact be caused by something else entirely -- like lactose intolerance, a bacterial infection in the intestines or irritable bowel syndrome.

"I would urge people to go to a doctor and try to really figure out what's going on," LaPook said.

Trend towards genetic-based medicine

An increasing number of studies last year looked at how an individuals’ genetic makeup could affect their risk for or progression of major diseases and mental health conditions, including addiction, autism, epilepsy, cancer, heart disease and Alzheimer’s, to name a few.

But many of the researchers behind these studies point out such individualized treatments may be years away from the medical clinic. 

Supreme Court rules human genes may not be patented
Supreme Court decision in July that ruled human genes cannot be patented may be a boon to research and greatly impact patient care and medical innovation, according to experts.

Previously, companies and researchers held patents over human genes, such was the case for Myriad Genetics Inc., which developed and sold the only test for the BRCA mutation, a genetic variant linked to increased breast cancer risk.

But the Supreme Court ruled DNA segments should not be subject to patent law, because they are part of nature. 

FDA halts sale of home genetic test kit
Later in the year, however, another government decision complicated the situation when a company offering genetic testing for disease risk found itself in the FDA’s crosshairs. Personal genetic testing company 23andMe was slammed with FDA restrictions in November. 

The agency was concerned with marketing materials that said the tests could provide genetic data on 254 diseases and conditions. The FDA had asked the company to address how false positive or negative results could cause consumers to make difficult, life-changing decisions on high-risk health issues, such as undergoing a preventive mastectomy if they test for the BRCA genetic mutation.

Following a lack of response, the FDA warned 23andMe to stop selling its health testing kits. The company complied and agreed to only sell ancestry kits, but said it hopes to work with the FDA to resolve the matter.


Continuing controversy on statins

Long-awaited cholesterol treatment guidelines were released by the American Heart Association and American College of Cardiology in November, which effectively recommended cholesterol-lowering drugs, called statins, to more Americans.

New statins guidelines put less emphasis on cholesterol
 Statins already are among the most commonly prescribed drugs in the U.S. The new guidelines called for prescribing moderate to high dose statins for four groups of Americans that studies suggest are most likely to benefit from the pills: People who have heart disease; people with an LDL, or "bad" cholesterol level of 190 mg/dL or higher; people with Type 2 diabetes who are between 40 and 75 years old; and people with an estimated 10-year risk of heart disease of 7.5 percent or higher who are between 40 and 75 years of age, as determined by a risk calculator.   

However, shortly after the guidelines’ release, two experts called the risk calculator flawed, saying it could overestimate heart disease risk by between 75 and 150 percent. 

Statins: Inside the debate over cholesterol-lowering drugs
The medical societies stood by their guidelines and the risk calculator, saying it was a good way to kick off a conversation with a doctor. The groups also emphasized the goal of the new guidelines was not to get more people put on statins, as critics had charged.

Whether the new guidelines will be accepted by doctors in the field remains unclear, and we may get a clearer picture in 2014.

Legal challenges to medical care

Several publicized legal challenges pitted families against doctors in courts, raising a host of ethical questions in the process. 

11-year-old adult lung transplant recipient goes home
 One of the biggest challenges came in July, when the family of Sarah Murnaghan, then 10 years old and dying of cystic fibrosis, captured the country’s attention by suing to get the child added to an adult waiting list for new lungs. Transplant rules required Sarah be placed on a separate list for pediatric lungs, while adult lungs were far more available.
A New York City boy Javier Acosta, who also had end-stage cystic fibrosis, also filed a lawsuit.

A judge ruled in the girl’s favor after Health and Human Services Secretary Kathleen Sebelius refused to intervene. While the judge’s ruling created ethical concerns for doctors who wondered whether a judge should be able to dictate such decisions for risky medical procedures, the Organ Procurement and Transplantation Network created a special review process for patients in similar situations to Sarah.

 Ending 2013 was the tragic story of Jahi McMath, an Oakland eighth grader who underwent a tonsillectomy on Dec. 9 at Children's Hospital Oakland, experienced complications, then was declared brain dead days later.
  
The hospital wanted to remove the girl from a ventilator, but the family challenged in court, seeking to transfer her to another facility. 

Bioethicists pointed out the hospital was under no obligation to keep the child on a ventilator.

“When someone’s declared brain-dead they are actually literally dead," Dr. David Magnus, a professor of pediatrics and director of the Stanford Center for Biomedical Ethics, told CBS San Francisco. "What’s really happening is blood has been circulating in the body. Certain biological processes with the cells and the organs are continuing, for a body that is no longer a person."

Dr. Arthur Caplan, director of the division of medical ethics at NYU Langone Medical Center in New York City, added, "They don't need permission from the family to take her off, but because the little girl died unexpectedly and so tragically, they're trying to soften the blow and let the family adjust to the reality."

The family disagrees, and is seeking the transfer to a long-term care facility in the hopes for a recovery under different doctors. A California judge gave the family a reprieve until Jan. 7 to continue to life support.

Will the next year bring more legal challenges to medical decisions?