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NEW YORK - A liquid morphine painkiller given by family caregivers to dying patients can remain on the market, federal regulators have decided after hearing protests over their decision to remove it. The Food and Drug Administration had announced last week that it was ordering manufacturers to stop making 14 medications including the liquid morphine. All were developed so long ago they had never received FDA approval.
But on Thursday, the FDA's Dr. Douglas Throckmorton told The Associated Press the morphine liquid will remain on the market until it's replaced by an approved version or some equivalent therapy.
The reversal was welcomed by experts in hospice care and pain relief. One doctors group had told the FDA that last week's order would "cause extreme suffering for many patients who are nearing the end of life."
The order has not changed for the other painkillers, at least for now, said Throckmorton, deputy director of the agency's Center for Drug Evaluation and Research.
The agency said last week that the unapproved drugs might be unsafe, ineffective or poor quality. The order gave manufacturers 60 days to stop making those products.
The liquid morphine is highly concentrated. Other approved forms of liquid morphine are more dilute, and Throckmorton said the FDA had thought the other forms could take the place of the concentrated form.
But reaction from hospice experts and others "helped us understand" that some patients need the unapproved version, Throckmorton said.
In interviews, experts said they didn't have firm numbers on how many patients use the concentrated liquid. But Dr. Diane Meier, director of the Center to Advance Palliative Care at the Mount Sinai School of Medicine in New York, estimated that it may be at least 2 million Americans a year.
She called Thursday's decision "fabulous.... It's incredibly refreshing and makes me hopeful about our government."
The high morphine concentration is crucial, she and others said. It allows caregivers to rapidly relieve pain by placing just a few drops in the mouth of a person who has trouble swallowing, perhaps because of confusion, lethargy or other conditions.
The more dilute morphine requires much more liquid, which could make an impaired person choke or sputter, or refuse to take the medication, experts say.
Caregivers can administer the concentrated solution at home, where morphine shots often aren't a good option. Without the concentrated liquid, families could end up calling 911 to rush their loved ones to an emergency room for morphine shots, which would be expensive and against patient wishes, said Dr. Porter Storey, executive vice president of the American Academy of Hospice and Palliative Medicine.
Storey called the FDA reversal "a really important step in the right direction," showing "an amazing level of responsiveness we're not used to seeing in our government officials."
But Storey said he was still concerned about the other painkillers ordered off the market, products containing morphine, hydromorphone or oxycodone.
While approved medications with those ingredients remain on the market, Storey noted that opiate painkillers are in short supply. So rather than removing the unapproved versions all at once, exacerbating the problem, he suggested the FDA proceed more slowly.
In a letter to the FDA earlier this week, Storey's organization said the painkillers covered by last week's order "have been used safely and effectively for decades."
Throckmorton said the FDA is open to getting additional information about the other painkillers, and would discuss them with experts in hospice and palliative care.
But Storey said that in a later phone call with physicians and pharmacists, the FDA said that the order against the other painkillers would stand.

Further shortfalls in painkiller supply could spell trouble for chronic pain patients such as 62-year-old Ora Chaikin in New York City, said her physician, Dr. R. Sean Morrison at Mount Sinai.

Chaikin takes an unapproved version of the drug Dilaudid � hydromorphone � when her joint pain flares, which is typically on most days. She said she needs that medication "just to be able to walk, to be able to do daily activities (like) putting a coat on."

Although approved versions of the drug are available, the FDA order makes Morrison worry about their supply.

"It's already hard to get them," he said.

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On the Net:

FDA statement on original order: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01983.html

FDA background information: http://www.fda.gov/cder/drug/unapproved_drugs/narcoticsQA.htm

FDA web page on unapproved drugs: http://www.fda.gov/cder/drug/unapproved_drugs/default.htm

Fight fat with fat? The newest obesity theory suggests we may one day be able to do just that. Just like good and bad cholesterol, there apparently are good and bad types of body fat. Scientists until recently believed this good fat, which spurs the body to burn calories to generate body heat, played an important role in keeping infants warm but by adulthood was mostly gone or inactive.
Now three studies � from researchers in Boston, Finland and the Netherlands � show that some good fat remains in adults, affecting metabolism and potentially offering a target to help people shed pounds.
Dr. Francesco Celi, an endocrinology and metabolism researcher at the National Institute of Diabetes and Digestive and Kidney Diseases, said the studies show this fat burns large amounts of energy.
"So it could be used as a target" for a pill that would somehow rev up the fat, he said.
Dr. Louis Aronne, former president of the Obesity Society and a weight control expert at Weill Cornell Medical Center in New York, said the findings are the most conclusive evidence so far of the role of such fat in regulating body temperature and weight.
"I don't want to use the word 'exercise-in-a-pill,' but it's doing something (that's) getting rid of calories," he said, adding that any obesity treatment developed around the fat could be a potential treatment for diabetes as well.
The studies were published in Thursday's New England Journal of Medicine.
The good fat is actually brownish, while the more predominant bad fat is white or yellow. Brown fat is stored mostly around the neck and under the collarbone. White fat tends to concentrate around the waistline, where it stores excess energy and releases chemicals that control metabolism and the use of insulin.
All three research groups documented the presence and activity of the brown fat by examining tissue samples from some patients and using high-tech imaging that indicated how much sugar, and therefore calories, the fat burned.
One group from Joslin Diabetes Center, Harvard Medical School and three hospitals in Boston looked at scans done on nearly 2,000 patients to diagnose various health problems. The other two groups scanned small numbers of patients, first at room temperature and then after a couple hours in mild cold, about 60 degrees.
Here's what the scientists learned about brown fat:
• Lean people had far more than overweight and obese people, especially among older folks.
• It burns far more calories and generates more body heat when people are in a cooler environment.
• Women were more likely to have it than men, and their deposits were larger and more active.
Finding a successful treatment for obesity would be a Holy Grail for scientists. Most obese and overweight people are unable to shed pounds and keep them off with dieting and exercise.
And despite plenty of effort, pharmaceutical companies have been unable to develop a medicine that helps people safely lose and keep off a significant amount of weight. Any drug that could do that would be a guaranteed blockbuster.
Aronne said the findings likely would renew interest in the area of brown fat among drugmakers; at least one briefly studied a treatment in lab animals several years ago.
So how could researchers use these basic findings about good fat to eventually come up with a weight-loss medication?

One possibility would be a pill to stimulate a specific protein to release more energy from the fat cells in the form of heat rather than storing it for future energy needs, Aronne and Celi said.

Finding a way to increase the amount of brown fat in a person would be another strategy. Researchers at Dana-Farber Cancer Institute in Boston have been injecting certain genes into mice to try to produce brown fat cells instead of white ones.

Celi said researchers also could try to make a pill that stimulates nerve endings inside brown fat to make it burn more calories.

Or overweight people could simply try turning down the thermostat to see if it makes them burn more energy and lose weight � a strategy that Celi and researchers are testing in a small study that could produce results by the end of the year.

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On the Net:

New England Journal: http://www.nejm.org

Obesity Society: http://www.obesity.org