Posts tagged with "Journal of the American Medical Association"

Take a chill pill: You actually may not be allergic to penicillin

February 1, 2019

Penicillin was the original “wonder drug”—but, today, people are wondering why, for more than half a century, doctors have warned them it’s contraindicated for their care.

Discovered in 1928 and found to “miraculously” cure infections by 1942, penicillin was the first antibiotic that many Baby Boomers were prescribed as children. However, that first dose of penicillin also turned out to be the last for many youngsters—who broke out in bumps or rashes that were diagnosed as allergic reactions.

Now there is a different school of thought. In fact, according to a study posted by the Journal of the American Medical Association in January, fully 19 out of 20 people who have been told they are allergic to penicillin actually can tolerate it well.

Indeed, The New York Times reported on January 22, millions of Americans whose medical histories document their penicillin sensitivities are not actually allergic. But they are steered away from using some of the safest, most effective antibiotics—relying instead on substitutes that are often pricier, less effective, and more likely to cause complications such as antibiotic-resistant infections.

Experts in allergy and infectious disease, including the paper’s authors, are now urging patients to ask doctors to review their medical history and re-evaluate whether they truly have a penicillin allergy.

The evaluation—which may require allergy skin testing and ideally should be done while people are healthy— is especially important, The Times reports, for pregnant women, people with cancer and those in long-term care, and anyone anticipating surgery or being treated for a sexually transmitted infection.

“When you have a true infection that needs to be treated, the physician will see you have the allergy and not question it,” said  Dr. Erica S. Shenoy, an author of  the study, and an infectious diseases specialist who is s on the staff of Harvard Medical School of Massachusetts General Hospital.

The review was carried out with input from the boards of three professional medical organizations: the American Academy of Allergy, Asthma and Immunology; the Infectious Diseases Society of America; and the Society for Healthcare Epidemiology of America. All three groups endorsed the findings.

There is no question that some patients have potentially life-threatening allergic reactions to penicillin, but the label appears to have been applied far too broadly, experts say. About 10% of Americans report having a penicillin allergy, and the rate is even higher among older people and hospital patients—15% of whom have a documented penicillin allergy.

But studies that have gone back and conducted allergy skin testing on patients whose medical records list a penicillin allergy have found that the overwhelming majority test negative. A 2017 review of two dozen studies of hospitalized patients found that over all, 95 percent tested negative for penicillin-specific immunoglobulin E, or IgE, antibodies, a sign of true allergy.

 “We used to say nine out of 10 people who report a penicillin allergy are skin-test negative. Now it looks more like 19 out of 20,” Dr. David Lang, president-elect of the American Academy of Allergy, Asthma and Immunology and chairman of allergy and immunology in the respiratory institute at the Cleveland Clinic, told the Times.

What’s more, the researchers say, many people who have avoided penicillin for a decade or more after a true, severe allergic reaction will not experience that reaction again.

“Even for those with true allergy, it can wane,” said Dr. Kimberly Blumenthal, the review’s senior author, who is an allergist and an assistant professor at Harvard Medical School. “We don’t really understand this, but once you’ve proven you’re tolerant, you go back to having the same risk as someone who never had an allergy” to penicillin.

Finally, the researchers warn, don’t challenge yourself to penicillin on your own. Patients who have been told they’re allergic to penicillin should talk to their doctors, who should take a careful history and review the symptoms of the reaction.

If the past reaction to penicillin included symptoms like headache, nausea, vomiting and itching, or the diagnosis was made based on a family history of the allergy, the patient is considered low-risk and may be able to take a first dose of penicillin or a related antibiotic, such as amoxicillin, under medical observation.

If the past reaction included hives, a rash, swelling, or shortness of breath, patients should have penicillin skin test, followed by a second test that places the reagent under the skin if the first test is negative. If both tests are negative, the patient is unlikely to be allergic to penicillin, and an oral dose may be given under observation to confirm

Research contact:  @nytimes

As spending on consumer drug advertising skyrockets, experts advise ‘healthy skepticism’

January 24, 2019

If you spend any time watching television, you are bound to see “real people” who appear to be healthy and happy bicycling down the road, hugging a grandchild, walking on the beach, or working in the garden. They mention the consonant-heavy name of a pharmaceutical drug you could use. “Ask your doctor, “an announcer suggests, after spouting the product’s benefits—and speed-talking her way through a scary list of side effects.

And it’s not just one ad; it’s several per prime-time show: A recently televised sporting event, for example, featured one ad for a drug to help you fall asleep, followed by another to keep you awake, according to an editorial in JAMA  that was written by Howard Bauchner, M.D., and Phil B. Fontanarosa, M.D., (who are, respectively, the editor and executive editor of the Journal of the American Medical Association).

Indeed, according to a Dartmouth College study, over a 20-year period, from 1997 through 2016, drug marketing increased dramatically—from $17.7 billion to $29.9 billion; while regulation did not.

“Because the goal of medical marketing is to shape our perceptions of the benefits and harms of drugs, treatments, and even of diseases, themselves, it can have a very significant impact on healthcare and can even hamper efforts to control unsustainable healthcare spending,” says Dartmouth Institute Professor for Health Policy and Clinical Practice Steven Woloshin, MD, who co-authored the paper with his wife and longtime research partner, the late Professor Lisa Schwartz, MD. (Dr. Schwartz passed away in November 2018).

In their review of spending, Schwartz and Woloshin found that the most rapid increase was in direct-to-consumer (DTC) advertising, which increased from $2.1 billion (11.9% of total spending) in 1997 to $9.6 billion (32% of total spending) in 2016. 

Over the same time period, the total amount consumers spent out-of-pocket on their prescription medication also skyrocketed to $328.6 billion from $116.5 billion (after industry rebates and discounts), the study found.

Why the explosion in drug ads over the past 20 years? The study notes that in 1997 the Food and Drug Administration began allowing drugs ads to mention side effects with voice-overs, instead of scrolling through a visual list on the screen, which takes more time. Shorter ads can allow for more ads, says Dr. Woloshin.

Another possible explanation is that at the same time that drug companies are spending more on drug ads directed at consumers, they’re also spending more marketing the new drugs to physicians, says Adriane Fugh-Berman, M.D., an associate professor in the department of Family Medicine at Georgetown University who has studied drug advertising. That can increase “irrational prescribing and overuse of medication,” Dr. Fugh-Berman recently told Consumer Reports.

Perhaps the most important reason for the increase: “The ads work,” Woloshin says. “They increase patient requests and prescriptions for advertised drugs, even when there are lower-cost alternatives.”

Indeed, Consumer Reports notes, numerous studies suggest that drug ads increase healthcare costs by promoting higher-cost medications when lower-cost, older ones might work as well.

In recent years, the consumer-oriented news outlet reports, many TV drug ads have focused on expensive drugs used to treat relatively uncommon, and hard to treat, conditions, such as rheumatoid arthritis, psoriasis, rare cancers, and seizures, according to figures from Kantar Media for the year ending in October 2018.

What’s an inundated consumer to do? The magazine warns, those sorts of pricey meds may not be covered by your insurance, especially if you get insurance through your employer. A 2017 survey of employers by the Pharmacy Benefits Management Institute found that when it came to high-cost medications, most of the insurers required a person to try other medications first, required a person to obtain approval from the insurer for expensive medications before filling a prescription, or limited the amount of the drug a person could obtain. Fully 75% of employer plans simply did not cover certain drugs, including high-cost drugs, according to the survey.

There are alternatives, Consumer Reports advises: For complicated medical conditions, which may necessitate higher-cost medications, work with your physician and insurance plan to find covered treatments. Also check NeedyMeds for the drug you’re being prescribed to see what Patient Assistance Programs, manufacturer coupons, or other discounts might be available.

Research contact: steven.woloshin@dartmouth.edu