TIME tobacco

FDA Orders First-Ever Sales Halt on Four Tobacco Products

The agency is flexing its new authority under the Tobacco Control Act

For the first time ever, the Food and Drug Administration is ordering a halt in sale and distribution of four tobacco products.

The four products—Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone—are made by Jash International, and are thin, hand-rolled cigarettes that are filled with tobacco, wrapped in leaves, and tied with a string.

The FDA said Jash International failed to provide it with evidence that its products were equivalent to products already approved and on the market. Under the Family Smoking Prevention and Tobacco Control Act, the agency now has the power to forbid the sale of products that do meet these standards.

“Because the company failed to meet the requirement of the Tobacco Control Act, the FDA’s decision means that, regardless of when the products were manufactured, these four products can no longer be legally imported or sold or distributed through interstate commerce in the United States,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement.

Jash International declined to comment to Reuters.

The FDA says that any existing inventory can now be seized without further notice, and that companies that continue to sell these products will be met with legal enforcement by the FDA.

TIME public health

The Dangers of Hunting for Cancer

Why more screening is not always better

As a surgeon, I’m trained to crush cancer. For many years, every tumor I palpated and family I counseled drove me to hunt for cancer with vengeance, using every tool modern medicine has to offer. But recently, one patient reminded me that the quest to seek and destroy cancer can produce collateral damage.

The patient’s story began with a full-body CAT scan, a screening test used to detect tumors, which revealed a cyst on his pancreas. Some 3 percent of humans have these cysts and they are rarely problematic. Based on his cyst’s size and features, there was no clear answer as to what to do about it, but he was given options.

(MORE: Screening Cancer)

The patient tossed and turned every night, agonizing over stories of pancreas cancer tragedies, consumed by the dilemma of whether to risk surgery to remove the cyst or leave it alone. The conundrum strained his marriage and distracted him from his work.

Months before I met him, the patient underwent the surgery, which revealed that the cyst was of no threat to his health. The operation was supposed to cost $25,000 and eight weeks out of work. But the toll was much greater, including a debilitating surgical complication.

I thought: this is why he shouldn’t have had a CAT scan in the first place. Screening made him sick.

(MORE: What Now? 4 Takeaways From the Newest Mammogram Study)

New research is finding that some health screening efforts have gone too far. A recent study found that yearly mammograms do not prolong the lives of low-risk women between the ages of 40 and 59. Following 89,000 women for 25 years in a randomized controlled trial (the gold standard of science), the study is as methodologically impressive as they come. In fact, in research terms, the report has more scientific merit than any medical study of chemotherapy. As hard as it is for our pro-screening culture to believe, the data are clear. We are taxing far too many women not only with needless and sometimes humiliating x-rays, but also with unnecessary follow-up surgery.

The annual mammogram is not the only vintage medical recommendation under scrutiny recently. Another large study found that among low-risk adults, a daily aspirin — a recommendation hammered into me in medical school — kills as many people from bleeding as it saves from cardiac death. Doctors are also re-evaluating calls for regular prostate-specific antigen (PSA) tests and surgical colposcopies after “borderline” Pap smears because of the risks of chasing false positives and indolent disease.

The bad news is that the problem of unintentional harm is far bigger than many people suspect. The Office of the Inspector General for Health and Human Services reports that among Medicare patients alone, it contributes to 180,000 deaths annually. On a national level, unintentionally harming patients in the process of trying to improve their health now ranks as the number three cause of death in the U.S. — ironically just after cancer.

(MORE: Breast Cancer Screening Isn’t Going Away—At Least Not Yet)

In this era of rising medical prices, manifesting as higher deductibles and co-pays, cutting waste should be our top priority, especially when that waste pulls doctors away from the important work of caring for sick patients. A 2013 Institute of Medicine report concludes that Americans spend as much as one-third of our healthcare dollars on tests, medicines, procedures, and administrative burdens that do not improve health outcomes.

The patient I met also taught me about another negative outcome — one that does not show up in the national stats: emotional trauma from false alarms. The patient recounted feeling tormented by the idea that he might be harboring a “precancerous” time bomb. His distress arose not from cancer, but from medicine’s limited ability to interpret a normal variation of anatomy discovered by new technology.

The good news is that a grassroots movement within medicine is identifying unnecessary tests and procedures to educate doctors and the public about them. The American Board of Internal Medicine Foundation has been asking medical specialty associations to name the five most overdone tests and procedures within their specialty (choosingwisely.org.). The campaign has recently expanded and now includes 50 doctors associations.

Reducing over-diagnosis and over-treatment will require broadening medicine’s focus beyond hunting and killing disease to sound research and education on appropriate care. Medical training should also examine why our culture prefers CAT scans over physical exams, and pills over prevention.

Finally, we all must come to grips with the public’s expectation for more medicine. New research is capturing what individual patient stories, like that of my patient, have been trying to teach us: We have a quiet epidemic of unnecessary, costly, and sometime harmful medical care.

Dr. Marty Makary is a cancer surgeon at Johns Hopkins Hospital and associate professor of health policy at the Johns Hopkins Bloomberg School of Public Health.

TIME Research

What You Can Tell About Someone From Their…Earwax

Brand New Images—Getty Images

Two urine diseases can be diagnosed from the substance

New research shows that earwax varies among people of different ethnicities, suggesting that the substance holds untold secrets.

A team of scientists from Monell Chemical Senses Center in Philadelphia gathered earwax from 16 men–half were white and half were East Asian–and examined the volatile organic compounds (VOCs) they released when heated. The amount of VOCs per person varied by ethnicity, and white men had more overall.

This small finding is important to researchers who believe earwax may carry attributes specific to each individual. Wet or dry earwax is linked to a gene that is also linked to the production of underarm odor, which can convey information about one’s gender, sexual orientation, and health. Already two urine diseases can be diagnosed in earwax before blood or urine testing.

“Odors in earwax may be able to tell us what a person has eaten and where they have been,” George Preti, an organic chemist at Monell told Medical News Today.

[Medical News Today]

TIME Cancer

Tom Brokaw’s Cancer and His Hopeful Future

Harry & Jeanette Weinberg Inter-Generational Center Tour
Tom Brokaw attends the tour of the Harry & Jeanette Weinberg Inter-Generational Center in Silver Spring, Maryland. Kris Connor—Getty Images

Time 100 honoree Kathy Giusti explains how multiple myeloma patients' expected lifespan has doubled from what it was 16 years ago

My personal JFK moment came on January 12, 1996. I will never forget that day. I remember where I was, what time it was, even the weather that morning when I was diagnosed with multiple myeloma. Unlike many patients who hear about the disease for the first time I knew too well what this incurable blood cancer was all about. Partially my knowledge came from running worldwide operations for a major pharmaceutical company. The other reason was this rare cancer also ran in my family—my grandfather had myeloma. To my amazement, I was being offered the same medicines to treat my illness that patients were taking back in the late 1950’s.

My future looked grim. I was happily married with a beautiful one year old girl and suddenly I was facing an uphill battle with an uncommon and heterogeneous cancer with virtually no modern treatments available and no drugs in the pipeline. I was told to get my affairs in order—I had three years to live, if I was lucky. Despite those odds, it wasn’t in my nature to pull the covers over my head and hide. With the help of brilliant partners, donors, friends and family we started the Multiple Myeloma Research Foundation (MMRF) with the hope of one day finding a cure.

That was 16 years ago. For decades so little progress had been made in the field of multiple myeloma. So, why now, over the past 10 years has there been so much progress, and why are we so equally as hopeful for the next 10 years to come?

The answer I believe lies in the myeloma community itself, which has worked skillfully to identify the barriers to cures and develop a plan to show patients and their families that the tiniest cancer is making the greatest stride as a result of this tight knit, integrated collaboration.

Today we work with the best scientists, pharmaceutical partners, biotech companies and academic centers in the world to facilitate progress in drug development. We remain eternally grateful for the work they do and the amazing trials of these pioneering drugs they produce so quickly. In the past decade myeloma patients have seen the FDA approve six multiple myeloma treatments, and counting – an unthinkable timeline in oncology. As a result, we have witnessed the doubling of our patient’s life span.

Our hope for the future is equally exciting due to the rapid advancement of technology in terms of genomic sequencing and the ability to store, integrate and share data in an open access world where patients have become more empowered in driving toward a cure.

We’re seeing today a more robust pipeline of treatments for the many subtypes of the disease than ever before. Treating patients with the precise combinations of treatments for their subtype is the way of the future. The world has changed since I was diagnosed and patients who once felt so alone now hold the key to the cure. The more we raise awareness, the faster cures will be found. And the acceleration of finding cures won’t take decades any more thanks to these new technologies. Now patients can play a major role in not only elevating the consciousness of the disease, but by providing their tissue, sharing data and entering new trials, they are transforming outcomes for themselves and for those future patients who have yet to be diagnosed.

Kathy Giusti is Founder and CEO of the Multiple Myeloma Research Foundation (MMRF), the leading private funder of multiple myeloma research.

TIME Cancer

Breast Cancer Screening Isn’t Going Away—At Least Not Yet

Mammography
Brand X—Getty Images

The American Cancer Society reviewed the ongoing study years ago and concluded mammograms were still warranted

Just because a new study shows that mammography may not save lives, don’t expect the organizations that set breast cancer screening guidelines to automatically adjust their recommendations on who should get mammograms and how often.

A Canadian study published this week in the British Medical Journal tracked some 90,000 women over 25 years and found that women who underwent annual mammograms were no less likely to die from breast cancer than those who simply examined their own breasts for signs of disease. In light of this finding—along with the fact that the study included a large sample size tracked over a long period of time—it might seem logical that groups like the American Cancer Society (ACS) will alter their recommendation that all women over 40 get mammograms every year. Not so fast.

MORE: What Now? 4 Takeaways From the Newest Mammogram Study

Otis Brawley, chief medical officer for the ACS, has been outspoken about the downside of various types of cancer screening, arguing that benefits are often over-stated. But even he points out that the ACS examined the ongoing Canadian study when the group last updated its breast cancer screening guidelines seven years ago and concluded that annual mammograms for women over 40 were still warranted. (Findings from the study back then were similar to those published this week.) The ACS will take a fresh look at the research on mammography this year and may change its recommendations, but there’s no guarantee.

The U.S. Preventive Services Task Force, a government panel that exhaustively analyzes research and writes its own breast cancer screening guidelines, has concluded that annual mammograms for women in their forties reduces the relative risk of death by 15%. This means that for every 1,900 women who undergo annual mammograms, one life will be saved due to early detection. The downside of such population-based screening, which the Canadian researchers pointed out in their study, is that some women will undergo surgery, radiation and other treatments unnecessarily when non-fatal cancers or masses that look like cancer but are not are detected. Weighing this, the government panel revised their recommendations in 2009 to mammogram screenings every two years beginning at age 50.

MORE: The Screening Dilemma

But even beyond the tricky business of weighing benefits against harms, Brawley says there are aspects of the Canadian mammogram study that may undercut its findings. Although the trial used randomization, the gold standard in clinical research, women were assigned to receive or skip mammograms after they underwent breast exams. “That’s not a clean randomization,” says Brawley, “There might be some biases.”

Still, Brawley says be believed mammography has merit. “I understand peoples’ frustration,” he says, “but the truth is that medical science is not an exact science. It’s called research because you’re continuing going back to search and find the truth.”

MORE: Lessons from Angelina: The Tricky Calculus of Cancer Testing

Just as important than screening, Brawley adds, are advances in treatment, which can sometimes get lost in the public push to encourage women to get mammograms. “The talk about screening versus no screening takes away from the fact that there are thousands of women who get no treatment after they get screened and diagnosed.”

Critical improvements in treatment for breast cancer, like better chemotherapy and drugs, have saved countless lives and reduced the benefits of screening over time because cancers detected later (and without the use of mammography) are now more treatable than before. “The ultimate goal is that screening is not needed because treatment is so good,” says Brawley. “But I don’t plan on seeing that in my lifetime.”

MORE: The Mammogram Melee: How Much Screening Is Best?

TIME Cancer

Do Mammograms Save Lives? ‘Hardly,’ a New Study Finds

Samuel Ashfield / Getty Images

In fact, they may contribute to "overdiagnosis"

A study of mammograms spanning 25 years and thousands of patients has come to a startling conclusion: mammograms appear to be useless, at best.

The New York Times reports that the study, published on Tuesday in the British Medical Journal, has shaken the medical community in part because it’s one of the most thorough studies of the procedure to date.

Researchers tracked more than 89,835 Canadian women, half of whom were randomly assigned to mammogram screenings. The other half had no mammograms and performed breast exams on themselves.

Twenty-five years later, the researchers found an identical rate of breast-cancer deaths in both groups. The mammograms’ only discernible impact was to elevate the diagnosis rate by 22%, or “overdiagnose” patients who were suffering from nonlethal forms of cancer and therefore could have avoided surgeries, chemotherapy and radiation treatments.

It’s not the first study to highlight the elusive impact of mammograms, nor is it the final word in this notoriously hard-to-measure field, but the New York Times reports that the American Cancer Society will include it, along with every other study on mammography, in an official review of its guidelines this year. Whether it can nudge the advice of medical experts depends on how much weight they put on the polarizing new findings. For now, the consensus across every country’s medical guidelines, save Switzerland’s, is to keep screening.

[NYT]

TIME medicine

Nearly 20 Patients Exposed To Fatal Brain Disease

The cause might have been improper sterilization of surgical tools

Almost 20 neurological patients in North Carolina may have been exposed to an incurable and degenerative brain disease while undergoing surgery because surgical instruments were insufficiently sterilized, Reuters reports.

Surgeons at the Novant Health Forsyth Medical Center in Winston-Salem operated on 18 patients using surgical equipment that had not been sufficiently sterilized after they were used on a patient who tested positive for Creutzfeldt-Jakob Disease (CJD), the hospital said in a statement.

CJD kills 90 percent of patients within one year and causes failing memory, blindness, and coma, according to the National Institute of Neurological Disorders and Stroke.

About 200 cases of Creutzfeldt-Jakob disease are recorded annually in the United States, according to the National Institutes of Health. Just last year, at least 15 patients in Connecticut, Massachusetts and New Hampshire may have been exposed to the disease in similar cases tied to unsanitary surgical instruments, health officials said.

[Reuters]

TIME Sexual Health

FDA Hiccup Means You’ll Have to Keep Waiting for Female Viagra

Agency has asked maker Sprout Pharmaceuticals for more studies on libido drug for women

The Food and Drug Administration says it needs more evidence before it approves a new drug that promises to boost female sex drive.

The agency told Sprout Pharmaceuticals that it needs to complete three additional human studies on their drug flibanserin, an experimental daily pill used to treat female sexual dysfunction, most specifically Hypoactive Sexual Desire Disorder (HSDD). The disorder causes women to experience a lack of sexual desire. If the drug receives approval, it will be the first on the market to treat women’s libidos.

The agency wants more information on how the drug interacts with other medications, whether it impairs driving, and whether it causes sleepiness. About 10 percent of women taking the drug have reported extra sleepiness. Once the company submits the evidence, the FDA can consider it for approval.

Since erectile dysfunction drug Viagra became a hit over a decade ago, the pharmaceutical industry has been searching for a similar drug that would stimulate dormant sexual appetites in women. Flibanserin is thought to interact with neurotransmitters in the brain that influence sexual desire. The drug has been rejected in the past for lack of evidence, but Sprout Pharmaceuticals wants the FDA to give their drug another look.

Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals says they are pleased with the new FDA guidance. “In the absence of an approved solution, women with HSDD today are faced with the dilemma of trying unapproved products which could pose a safety risk or living with a condition that has important impact on their lives,” says Whitehead.

TIME medicine

What’s Happening With Bob Costas’ Eye and How You Can Avoid It

Bob Costas with Matt Lauer Today" show.
Bob Costas with Matt Lauer Today" show. Peter Kramer—NBC

After a battling and ultimately losing to what appears to be a rapidly-spreading eye infection, the NBC broadcaster is ceding his nightly Olympics hosting duties to fellow anchor Matt Lauer for the first time since 1988

Bob Costas put forth an Olympian effort, but his red, swollen eyes have gotten the best of him. For the first time since 1988, the veteran sports anchor will cede his his nightly Olympics hosting duties to Matt Lauer while his mysterious infection clears.

It’s not clear how Costas’ eyes got so inflamed – but pink eye, or conjunctivitis, is the most common infection among U.S. children and adults. It’s caused by both bacteria like staph and strep, and viruses like the cold virus (which means it is highly contagious). It can also be caused by allergies or chemicals. Pink eye causes red, inflamed, and swollen conjunctiva, or the membranes that cover the white parts of the eyes. Infections are common wherever people are in close contact: day care centers, classrooms, college dorms and work places. Worried about your risk? Here’s what you need to know.

How do I avoid getting eye infections?

There’s no way to foolproof yourself, especially if you have an allergic reaction to something you touch or something that you are exposed to in the air.

But the best way to protect against the bacteria and viruses that trigger infections is to wash your hands and not share things like washcloths, pillows, sheets or eyewear.

If someone near you is already infected, make sure you avoid touching anything that has been near their eyes. It’s also a good idea to disinfect common areas such as bathroom and kitchen surfaces.

How do I know if my eyes are infected?

Infections can cause a runny discharge that can dry to form a crusty layer, making it hard to open your eyes in the morning. You may also feel some pain and itchiness in your eyes. Use a disposable paper towel and warm water to clear away any residue, or, if you use a towel, wash it thoroughly afterward.

Costas appeared on air Thursday with one swollen pink eye, but as of Monday evening, this is how he looked:

How long do infections last?

Viral infections can cause redness and itching for up to a week, while other reactions, particularly those caused by allergic responses to chemicals or smoke, can last as long as three weeks or more.

What’s the best treatment?

For viral infections, there is no real treatment other than artificial tear drops, which can help to relieve itchiness and pain. Doctors may prescribe antibiotics for bacterial infections, which can clear up pink eye in several days. See your doctor to determine which treatment is appropriate for your case.

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