Some explanation, if you look for it, on the Children's Tylenol recall

The recall information isn't especially easy to find, but consumers who check the Tylenol website under Children's Tylenol News will find a list of children's and infants' Tylenol liquid products that are being pulled from store shelves.

The notice begins: "You may have heard that McNeil Consumer Healthcare (the makers of Tylenol) is voluntarily recalling certain lots of Children's and Infants' Tylenol liquid products that were manufactured between April, 2008 and June, 2008 in consultation with the U.S. Food and Drug Administration (FDA)."

One of the inactive ingredients apparently didn't meet internal testing requirements. The "news" then essentially skips to the list of products.

But in wee print at the bottom of the Tylenol site's main page, consumers will find a link that says "For Healthcare Professionals."

Follow that and you'll make it to a letter that sheds some light on what you "may have heard":

The company has implemented this recall because examination of bulk raw material detected that one of the inactive ingredients did not meet internal testing requirements.Specifically, the gram-negative bacteria Burkholderia cepacia (B. cepacia) was detected. The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product. However, it was decided, as a precaution, to recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria. Please note: No bacteria has been detected in finished product and the finished product has met all specifications.

Here's US Recall News' list of 21 affected products:

Children’s Tylenol Plus Cold MS Suspension 4 oz. Grape
Children’s Tylenol Suspension 4 oz. Grape
Children’s Tylenol Suspension 4 oz. Strawberry
Children’s Tylenol Suspension 4 oz. Bubble Gum
Infants’ Tylenol Suspension 1/2 oz. Cherry
Infants’ Tylenol Grape Suspension Drops 1/4 oz.
Children’s Tylenol Dye Free Suspension 4 oz. Cherry
Children’s Tylenol Suspension 4 oz. Cherry
Children’s Tylenol Plus Cough & Runny Nose 4 oz. Cherry
Infants’ Tylenol Suspension Drops 1/2 oz. Grape
Children’s Tylenol Plus Flu 4 oz. Bubble Gum
Children’s Tylenol Plus Cold Suspension 4 oz. Grape
Children’s Tylenol Plus Cough/ST Suspension 4 oz. Cherry
Infants’ Tylenol Suspension Drops 1 oz. Grape
Infants’ Tylenol Dye Free Suspension 1 oz. Cherry
Children’s Tylenol Pediatric Suspension 1 oz. Cherry
Infants’ Tylenol Suspension Drops 1 oz. Cherry
Children’s Tylenol Plus Cold/Allergy 4 oz. Bubble Gum
Infants’ Tylenol Grape Suspension Drops H/G 1/2 oz.
Infants’ Tylenol Drops 1 oz. Grape
Children’s Tylenol Suspension 4 oz. Cherry, Hospital Govt.

-- Tami Dennis

And now a word from our internists (what they say about healthcare reform)

In a paper released today, the American College of Physicians offers up the opinion of its members -- internal medicine specialists, subspecialists and medical students -- on rising healthcare costs and what should be done about them.

"Controlling Health Care Costs While Promoting the Best Possible Health Outcomes" blames increased spending on these 10 factors:

- Advancing technology

- Demographics and declining health status

- Lack of productivity growth

- Inappropriate utilization

- Payment system distortions

- Consumer price insensitivity

- Medical errors and inefficiency

- Medical malpractice and defensive medicine

- Higher prices

- Administrative costs

Then it offers up various policy solutions. Here's the full paper.

The conclusion states: "None of our recommendations in isolation will solve all of the problems besetting our health care system. However, meaningful cost reductions can be achieved without sacrificing quality or decreasing access to health care. In fact, cost controls must be accomplished in order to expand access and to achieve health care reform."

Over at the Huffington Post, John Geyman, a professor emeritus of family medicine at the University of Washington School of Medicine, is keeping an eye on "organized medicine."

He writes today:

"Organized medicine has a poor track record in terms of reform. Although a universal system of health insurance was considered favorably for a short time by a committee of the American Medical Association (AMA) during Teddy Roosevelt's abortive attempt to establish such a program during the 1912 to 1917 period, the AMA has played a consistently reactionary role against such reform since then."

Then he notes (so you have some context for the above paper):

"Organized medicine has become so fragmented that no one group speaks for the profession. In fact, some groups have endorsed major health care reform, even to the point of single-payer national health insurance (NHI). As the second largest medical organization in the country with some 125,000 members, the American College of Physicians (ACP) has endorsed single-payer as one of two major options to reform our system.
 
-- Tami Dennis

Credit: Los Angeles Times

TV health coverage: bad for your health?

Need more evidence that you should get your information about new developments in medicine from reliable news outlets such as the Los Angeles Times rather than from TV? We offer you the following:

HealthNewsReview.org, a health-journalism watchdog group that evaluates medical news coverage for accuracy, balance and completeness, announced today that it will stop grading the quality of health news stories that appear in national TV news outlets, including those that appear on the nightly news broadcasts and the morning shows of the big three commercial networks: CBS, NBC and ABC.

Why not critique the coverage of medical news seen by millions of American viewers? In part because it's lousy and, even with feedback, has shown little capacity for improvement, says professor Gary Schwitzer, publisher of HealthNewsReview and a professor at the University of Minnesota's health journalism program. In three and a half years of reviewing TV news stories reporting medical developments, Schwitzer says, his organization has graded 228 network TV health segments.

The evening newscasts have fared relatively poorly at HealthNewsReview.org: while a piece may be awarded as many as five stars for quality, health-related segments that aired on the NBC Nightly News, the CBS Evening News and ABC World News Tonight received an average of 2.7, 2.4 and 2.2 stars, respectively. The medical segments airing on the networks' morning shows scored more poorly: an average of 2.1 stars for those on NBC's Today Show, and 1.8 apiece for segments that aired on ABC's Good Morning America and NBC's Early Show.

(Full disclosure here: A search for Los Angeles Times health and medicine articles assessed by HealthNewsReview.org found that 55 articles rated in the same three-and-a-half year period averaged 3.84 out of a possible five stars.)

Schwitzer called the performance of the networks' morning news shows "embarrassing" when it comes to medical news. Celebrities, wrinkle creams, new tests and gee-whiz gadgetry abounded. Discussions of costs, risks, safety and alternatives were in much shorter supply.

The new tests and gee-whiz gadgetry that hold the attention of TV news audiences make for good drama, too, says a report by the newly minted nonprofit news agency, Kaiser Health News. But in an article on the impact of popular medical shows, media analysts and health professionals charge that medical dramas like Fox's hit series, "House," lead many patients to believe that more high-tech tests and more aggressive treatments are always better.

That belief, the article suggests, has driven up healthcare costs, often with worse or no better outcomes than they might have had with less intrusive diagnostic and treatment measures. It cites one 2006 episode as an illustration of House's penchant for costly testing: a single patient's battery of tests, including a particularly painful one, soars to about $9,200.

Emergency room physician Steven Davidson of Maimonides Hospital in New York observes in the article that between the television dramas and the omnipresence of medical news and information, patients have come to believe "that more is better." Parents who are steeped in medical dramas and coverage drag a kid to the ER with a bump on his head and demand a CT scan, he says, when a brief period of monitoring is adequate, safer and cheaper.

"Advice such as 'watchful waiting' does not make for good storylines," writes KHN staff writer Christopher Weaver.

-- Melissa Healy

Ahem. How to treat and prevent hoarseness

Millions of people experience hoarseness, especially children, the elderly and people in very vocal professions -- such as teachers. Treatment strategies for hoarseness can vary widely, but now doctors and patients can refer to the first-ever set of medical guidelines addressing the condition.

The guidelines, released today by the American Academy of Otolaryngology - Head and Neck Surgery Foundation, should help to distinguish between trivial types of hoarseness and conditions that are more serious, such as cancer. Hoarseness, also called dysphonia, is characterized by an altered vocal quality, pitch, loudness or any impairment of vocal communication.

"Most hoarseness is caused by benign or self-limiting conditions, but it may also be the presenting symptom of a more serious or progressive condition requiring prompt diagnosis and management," Dr. Seth R. Schwartz, chairman of the guidelines committee, said in a news release. "This new guideline is intended to enhance diagnosis, promote appropriate therapy, improve outcomes, and to expand counseling and education for prevention."

Some highlights of the document:

-- Laryngoscopy should be performed if hoarseness persists or the cause is uncertain.
-- Anti-reflux medications should not be prescribed for hoarseness unless there are signs or symptoms of gastroesophageal reflux disease or signs of inflammation of the larynx seen during laryngoscopy.
-- Steroids or antibiotics are not recommended.
-- Voice therapy is a well-established tool for hoarseness that can be performed at any age.
-- The risk of hoarseness may be reduced by preventive measures such as staying well-hydrated, avoiding irritants (such as tobacco smoke), voice training and amplification during heavy voice use.

How about avoiding high-stakes, live sports events? That's usually when I become hoarse.

-- Shari Roan

Photo credit: Irfan Khan / Los Angeles Times

JFK's Addison's probably caused by rare autoimmune disease

John F. Kennedy's Addison's disease, which came to light only after his election as president in 1960, was most likely caused by a rare autoimmune disease, according to a Navy doctor who reviewed his medical records. The disorder, called autoimmune polyendocrine syndrome type 2 or APS 2, also caused Kennedy's hypothyroidism, according to the report today in the Annals of Internal Medicine.

In today's hyperactive media environment where the smallest sneeze of a celebrity is thoroughly analyzed, it is difficult to believe that Kennedy's family and advisors were able to keep his medical history virtually a complete secret. The youngest man ever elected to the presidency at age 43, JFK was pictured as a healthy and vital young man. In reality, he suffered from a variety of problems that were kept in check only by a daily regimen of steroids and other drugs.

Addison's disease is characterized by the withering away of the adrenal glands, which produce adrenaline and other hormones. Symptoms include fatigue, dizziness, muscle weakness, weight loss, difficulties standing up, nausea, sweating and changes in mood and personality. About 20% of cases are the aftermath of tuberculosis, and the rest are autoimmune in origin.  During the 1960 campaign, Kennedy's opponents argued that he had Addison's, but his physicians released a cleverly worded statement saying that he did not have Addison's disease caused by tuberculosis, and the matter was dropped.

JFK's Addison's was initially diagnosed in the 1940s, and he suffered two severe collapses as a result, once at the end of a parade during an election campaign and once on a congressional visit to Britain. Records reveal that in 1955 he was also diagnosed with hypothyroidism -- an insufficient output of thyroid hormones. Symptoms can include many of those associated with Addison's, as well as a lack of tolerance for cold, paleness, depression and a low heart weight.

Dr. Lee R. Mandel, an endocrinologist in the U.S. Navy Medical Corps in Chesapeake, Va., was allowed to review Kennedy's medical records at the John F. Kennedy Presidential Library & Museum last year*. After synthesizing the information in the records and conducting correspondence with many of Kennedy's physicians, he concluded that both problems were the result of APS 2.

[*Correction: An earlier version said Dr. Lee R. Mandel accessed the records this year. According to the Annals of Internal Medicine report, he reviewed them in 2008.]

Mandel found that Kennedy, during his presidency, was taking a host of drugs daily: 500 milligrams of vitamin C twice daily; 10 milligrams of hydrocortisone daily; 2.5 milligrams of prednisone twice daily; 10 milligrams of methyltestosterone daily; 25 micrograms of liothyronine twice daily; 0.1 milligrams fludrocortisone daily; and diphenoxylate hydrochloride and atropine sulfate, two tablets as needed. Liothyronine is a synthetic thyroid hormone. Diphenoxylate/atropine, commonly known as Lomotil, is used to treat diarrhea. The testosterone was administered to combat the weight loss and gonadal atrophy associated with the other steroids he was given.

If Kennedy were a professional athlete, he would have been benched.

One characteristic of autoimmune diseases like APS 2 is that close relatives are often affected as well. It is well-known that JFK's younger sister, Eunice, had Addison's disease and that his son, John F. Kennedy Jr., suffered from Graves disease.

-- Thomas H. Maugh II

A collection of stories about healthcare

Being ill, or caring for a patient, is a highly personal experience. But sharing those experiences "about the way healthcare really is" could be cathartic. Perhaps it could contribute to a conversation about healthcare -- outside the Beltway and raucous town hall meetings -- that would lead to a better system.

That's the idea behind Pulse -- Voices From the Heart of Medicine. The online magazine, based at Albert Einstein College of Medicine/Montefiore Medical Center, collects personal stories from health professionals and patients and e-mails one of the stories or poems to subscribers each Friday.

Here's an excerpt from a recent essay:

As I teach first- and second-year medical students to take patient histories and to perform physical examinations, I always feel humbled and privileged -- energized by their compassion, enthusiasm and facile, curious minds.

Occasionally, I feel particularly challenged -- especially when I'm teaching a student who, though bright, is struggling to acquire some of medicine's basic skills. As we journey up the learning curve together, my responsibilities can conflict: as a teacher, I want to nurture an aspiring student physician, yet as a physician, I must ensure that patients receive appropriate care.

Now, sitting quietly in the corner of the room and watching a young medical student interview a county hospital psychiatric patient, I begin to feel this tension.

"What brought you into the hospital?" the student queries nervously.

Small and reserved, she's quite a contrast to her patient -- a burly, imposing middle-aged man, his body splattered with tattoos of birds of prey and firearms. He folds his arms tightly across his chest, and a large cross sparkles on his neck chain.

"It's when I tried to commit suicide on the bridge," he responds agitatedly.

There is a long, awkward pause. . .

Readers can link to the Pulse website to post comments, read archived issues and learn how to submit their own stories. Participation is free.

"I'd like readers to come to think about Pulse as their own, a place where they can speak from personal experience and from the heart. A place where generous listening leads to understanding and the inspiration to advocate for change," said Dr. Paul Gross, editor in chief.

Perhaps members of Congress should spend some time with Pulse while they ponder healthcare reform.

-- Shari Roan

Photo credit: Pulse -- Voices From the Heart of Medicine

Too much radiation from medical testing?

Americans may be receiving too much radiation from medical tests whose value has not been proven, researchers reported today in the New England Journal of Medicine. More than two-thirds of Americans underwent at least one such imaging procedure in the three years covered by the study, reported Dr. Reza Fazel of the Emory University School of Medicine and colleagues. The two biggest contributors to the radiation exposure are CT scans, which use a series of X-rays to produce a three-dimensional image of the body, and heart perfusion scanning to measure blood flow through the arteries leading to the heart. In that test, radioactive technetium-99m is injected into blood vessels and its progress through the heart monitored with external radiation detectors.

Radiation is known to cause cancer, typically years after exposure. By some estimates, medical testing radiation contributes 2% of all cancer cases, but experts fear that it may be higher in the future as more and more patients are exposed to these relatively new procedures. They are also concerned because increasing numbers of tests are being performed on younger people, which allows more time for tumors to develop, and on women, who normally live longer than men.

Some studies have suggested that the growing number of CT scans being performed results at least in part from ownership of the machines by physicians, who view them as a new profit source and prescribe unnecessary tests. There is also a growing incidence of whole-body CT scans in which physicians check for any signs of potential disease in healthy individuals. Such scans were not included in the report because they are not covered by insurance.

The researchers studied medical records of 952,420 adutls between the ages of 18 and 64 who were insured by United Healthcare plans in Arizona, Dallas, Orlando, South Florida and Wisconsin. Between 2005 and 2007, 655,613 of them underwent at least one procedure that exposed them to radiation. The mean dose of radiation was 2.6 milliSieverts (mSv), a relatively low dose. A dose of 3 to 20 mSv is considered moderate, from 21 to 50 MSv is considered high and a dose over 50mSv is considered very high. Federal regulations put the maximum annual safe dose at 50 mSv.

Cardiac stress testing was the procedure that exposed patients to the highest radiation levels, an average of 15.6 mSv, and accounted for 22% of all radiation exposure. CT scans of the abdomen, which typically produce about 8 mSv, accounted for more than 18% of exposure. A mammogram -- a single X-ray -- produces about 0.4 mSv.

If the findings are extrapolated to the entire population, more than 4 million Americans are receiving a dose greater than 20 mSv each year, the authors said. "It is important to note that we are talking about radiation doses that are incurred in one year," said Dr. Brahmajee Naliamothu of the University of Michigan, senior author of the study. "Cumulative doses over a lifetime may be much higher."

About 79% of women in the study had at least one exposure to radiation, compared with 58% of men. Mammograms accounted for only a small part of the difference, Fazel said.

Dr. Michael Lauer, director of the division of prevention and population sciences at the National Heart, Lung and Blood Institute, said in an editorial in the same journal that clinical trials of the efficacy of such testing should be conducted before their use is expanded further. Despite the wide use of nuclear perfusion for cardiac imaging, he noted, there is no evidence that it increases survival.

-- Thomas H. Maugh II

Photo credit: Lawrence K. Ho / Los Angeles Times

FDA studying reports of liver failure with weight loss drug orlistat

The Food and Drug Administration announced today that regulators are assessing at least 32 reports of liver problems between 1999 and 2008 in patients taking the weight-loss drug orlistat, sold as a prescription drug Xenical and more recently, as an over-the-counter medication called Alli.

Of the 32 reports of liver problems the FDA has in hand, 27 patients were hospitalized and six suffered liver failure. In an "early communication" of a drug safety review, the FDA said it will also review additional data on "suspected cases of liver injury" submitted by drug firms that make and market orlistat in its branded and generic forms. Orlistat was originally marketed, and still is, by Roche Pharmaceuticals as Xenical, a prescription drug. The medication, which blocks the absorption of fat through the digestive tract, gained approval as an over-the-counter drug in 2007, and is marketed as Alli by GlaxoSmithKline. Orlistat has been approved for use in 100 countries.

Dr. Steven Osborne, executive director of the FDA's drug safety oversight board, called the issues surrounding orlistat's safety "complex" and stressed that "no definite association between liver injury and orlistat has been established at this time." He noted that 30 of the 32 reports of liver damage already received by the FDA come from outside the United States. The most common symptoms reported to the FDA by patients taking orlistat were jaundice -- yellowing of the skin or eyes -- stomach pain and weakness.

The FDA says that patients taking orlistat under prescription or in its over-the-counter form should continue to use the product as directed. But those who experience symptoms that could point to liver injury, including jaundice, fatigue or brown urine, should consult a healthcare professional. Abdominal pain, nausea, vomiting, light-colored stools, itching or loss of appetite also may be symptoms of liver damage. Physicians, as well as consumers taking orlistat and experiencing such symptoms, can make an online report to the FDA's Medwatch Adverse Events Reporting system, or call (800) FDA-1088.

-- Melissa Healy

Diabetes drug Avandia comes under new criticism

The diabetes drug rosiglitazone, already under fire because it has been found to increase the risk of heart attacks, can also produce liver failure and death in some patients, researchers from the activist group Public Citizen said this week.

They wrote in the journal Pharmacoepidemiology and Drug Safety that a review of adverse events reported to the Food and Drug Administration found 11 deaths due to liver toxicity between 1997 and 2006 associated with the drug, which is sold under the brand name Avandia. The group had petitioned the FDA in October to ban the drug because of the heart risks, and they renewed their call for action.

"Because of low reporting rates to the [FDA] database, the 11 cases likely represent a small fraction of the patients who developed liver failure because of the drug," said Dr. James Floyd of Public Citizen. He estimated that 1 in every 44,000 patients who take the drug develops liver failure.

Previous studies have shown that Avandia increases the risk of heart attack by about 40%, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by the accumulation of fluids in the eye, according to Public Citizen. Reports of the drug's risk have sharply reduced prescriptions for it: They dropped from a peak of about 13.2 million in 2006 to 3.1 million in 2008. That means that 8,500 prescriptions for the drug are still filled every day.

The group also found 10 deaths from liver failure associated with the related drug pioglitazone, sold under the brand name Actos. That drug has not been linked to heart attacks, but is associated with an increased risk of heart failure, Floyd said. Public Citizen estimated 1 case of liver failure for every 52,000 patients taking it.

The manufacturers of both drugs contend that no scientific study has linked them to liver toxicity. Public Citizen, however, recommends that patients should stick to older and safer -- and, not incidentally, cheaper -- medications like metformin (Glucophage) and glipizide (Glucotrol).

-- Thomas H. Maugh II

Tylenol and the liver

The Food and Drug Administration's advisory panel has recommended that the agency reduce the maximum recommended dosage of acetaminophen, an over-the-counter pain killer more commonly known as Tylenol. The drug's potential risk of liver damage is the issue.

Here's the Associated Press story.

And, for a fuller explainer, here's this from MedicineNet: "How is acetaminophen processed (metabolized) in the body?"

"The liver is the primary site in the body where acetaminophen is metabolized. In the liver, acetaminophen first undergoes sulphation (binding to a sulphate molecule) and glucuronidation (binding to a glucuronide molecule) before being eliminated from the body by the liver. The parent compound, acetaminophen, and its sulphate and glucuronide compounds (metabolites) are themselves actually not harmful. An excessive amount of acetaminophen in the liver, however, can overwhelm (saturate) the sulphation and glucuronidation pathways. When this happens, the acetaminophen is processed through another pathway, the cytochrome P-450 system. From acetaminophen, the P-450 system forms an intermediate metabolite referred to as NAPQI, which turns out to be a toxic compound. Ordinarily, however, this toxic metabolite is rendered harmless (detoxified) by another pathway, the glutathione system."

If that's more than you want to know, there's always this from the FDA: "Acetaminophen and liver injury: Q & A for consumers."

It begins: "Acetaminophen is the generic name of a drug found in many common brand name OTC products such as Tylenol, as well as prescription products such as Vicodin and Percocet."

Most people, of course, don't take the more tightly controlled Vicodin and Percocet like candy -- as they sometimes do Tylenol.

-- Tami Dennis