Opinion: New Pregnancy Drug Guidelines A Mixed Bag For Consumers



By Dr. Adam Urato
Guest Contributor

Last week the Food and Drug Administration published a final rule that will change how drug companies present information on the risks of medications during pregnancy. This is considered a very important step as there are approximately 6 million pregnancies in the U.S. every year and the average pregnant woman takes between three and five prescription drugs during the course of a pregnancy.

For decades, the public has relied on the FDA’s Letter Category system in which a Category A drug was considered safe, Category D unsafe, with B and C falling in between, and Category X meaning contraindicated in pregnancy.

This past week the FDA announced that it is scrapping that letter system and replacing it with a new system that will offer descriptions about the effects of the drug during pregnancy and lactation. A third section (the “Females and Males of Reproductive Potential” subsection) will include information about pregnancy testing, contraception and about infertility as it relates to the drug.

So what exactly does all this mean for consumers?

As a Maternal-Fetal Medicine specialist, here’s my read on the changes:

What this means is that men and women are going to have to actually go to the drug information label and read it. No longer will a pregnant woman simply be able to look up a drug and find out that it’s a Category D in pregnancy, for instance, and then avoid it.

And this is a major problem that I see with the new system: many patients and physicians do not take the time to read through the label prior to using a medication. A description-based system risks losing the benefit of warning that the current Letter System provides when the drug is simply listed as Category D or X.

Also, it seems that the drug companies themselves are going to be asked to write these pregnancy sections on the label. This strikes me as absurd. Continue reading

Viewpoint: Consider Tough Penalties To Boost Disabled Patients’ Access To Care

We already know that patients with disabilities face major obstacles when trying to access basic medical care. Now, a team of researchers are proposing some novel strategies to help fix the system, including withholding payments to health care organizations and making accreditation contingent on compliance with disability law.

The researchers, Dr. Tara Lagu and colleagues at Baystate Medical Center, Tufts University School of Medicine, and a Massachusetts not-for-profit organization, the Disability Law Center, suggest that this is the first time these types of strategies have been proposed.

“The goal of this paper was to start the conversation,” says Dr. Lagu via email.

Dr. Tara Lagu, M.D., MPH (Courtesy)

Dr. Tara Lagu, M.D., MPH (Courtesy)

Lagu’s groundbreaking earlier study on access to care for people with disabilities found that even in the current high-tech health care environment, many elements of routine medical care — like getting a patient on to an exam table — remain elusive.

The latest article, published in JAMA Internal Medicine, describes the range of barriers, including:

“…physical barriers to entering health care establishments, lack of accessible equipment, lack of a safe method for transferring the patient to an examination table, and the lack of policies that facilitate access.The barriers persist despite 2 federal laws (the Americans With Disabilities Act [ADA] of 1990 and Section 504 of the Rehabilitation Act of 1973) that explicitly state that health care settings must be accessible to patients with disabilities.

And here, Lagu offers some possible solutions:

As our study last year reported, patients with disabilities face real difficulties when they try to access health care. This suggested that our current strategy for enforcement, lawsuits, have fallen short. In part, this is because patients don’t want to bring lawsuits against doctors with whom they have an existing relationship and because lawsuits are extremely unpopular with physicians. More importantly, lawsuits have failed to initiate system-wide change: it is not clear that, in recent years, there have substantial improvements in access to care for patients with disabilities.

For these reasons, we believe that novel strategies are needed. As we considered what such strategies might look like, we considered other mechanisms of enforcement that have been successful at motivating change in health care settings, and we came to four possibilities: withholding payment, making accreditation contingent on compliance, regulation, and lawsuits at the state or national level aimed at initiating large-scale policy change. Continue reading

If Guns Threaten Health Like Smoking Or HIV, What Should Doctors Do?

The idea that guns are dangerous to your health is not new. But it is arguably as explosive as it was in 1985, when the Institute of Medicine first made the link between guns and health.

Pediatricians have established guidelines for asking parents: Do you have guns in the home, and if so, are they locked and out of reach of children?

Some physicians and gun rights groups that oppose such questions have pushed back and say they have momentum. In July, an appeals court ruled in favor of a 2011 Florida law, nicknamed Docs v. Glocks. It bans doctors from asking their patients questions about gun ownership unless the question is deemed medically necessary. Montana and Missouri have passed similar laws.

Against this backdrop, a new Massachusetts-based group, the National Medical Council on Gun Violence, says it’s time to go beyond asking patients if they have access to a gun.

Ray Duggan, 32, a former Young Bloods gang member from Providence, told physicians at the conference about the 2004 shooting that left him paralyzed, and his work now to break up gang feuds and street violence. (Martha Bebinger/WBUR)

Ray Duggan, 32, a former Young Bloods gang member from Providence, told physicians at the conference about the 2004 shooting that left him paralyzed, and his work now to break up gang feuds and street violence. (Martha Bebinger/WBUR)

“If people don’t know what to do when they get a ‘yes,’ then they’re never going to screen for it,” said Dr. Megan Ranney, an emergency room physician at Rhode Island Hospital in Providence. Ranney helped organize the first continuing medical education course on gun violence, held at the Massachusetts Medical Society this past Saturday.

Ranney says it’s time to clarify the questions doctors should ask patients at risk for domestic violence, homicide, suicide or accidental gun violence, and establish the steps doctors should take to reduce the threat.

Take this example, which Dr. Ron Gross, chief of trauma and emergency surgery at Baystate Medical Center in Springfield, presented to a panel of physicians at the conference.

“A mother with a chief complaint of anxiety shows up in the emergency room,” he said. “She has three kids: 5, 7 and 9. Among the things discussed is her husband’s loaded, unlocked handguns.” Continue reading


You’ve Heard Of The ‘Slow Food’ Movement? Now Meet ‘Slow Medicine’

(Photo: Facebook, at left: Dr. Pieter Cohen)

(Photo: Facebook, at left: Dr. Pieter Cohen)

Slow Medicine (ˈslō me-də-sən). The practice of medicine in which one is careful in interviewing (and examining) patients, careful to balance benefit and harms of diagnostic and therapeutic interventions, slow to intervene when symptoms are undifferentiated, committed to observation as an important diagnostic and therapeutic strategy and skeptical of newly introduced diagnostic tests and therapies. Although Slow Medicine might incidentally reduce costs of medical care, cost does not drive decision making but rather the drive is an effort to provide the best and safest medical care possible.

“Slow Medicine” may be about to catch on fast.

It began as thousands of emails over the years between Cambridge Health Alliance primary care doctor Pieter Cohen and Dr. Michael Hochman of Altamed Health in Los Angeles, debating and interpreting the latest medical literature. First just back-and-forths with each other, then shared more broadly with colleagues.

The focus might be their take on colon cancer screening, or spinal manipulation for sciatica, or how to treat mild high blood pressure. Their writings were opinionated but always data-driven, and clear on how that data could or should be translated into real-world medical action.

It was good stuff, by doctors and for doctors but much of it also suitable for the lay public. (CommonHealth quoted from a “Slow Medicine” message in this post on lung cancer screening for smokers.) The list of willing “Slow Medicine” email-recipients swelled; it added a Facebook page; and now, as of this weekend, it has gone national: On NPR’s Shots blog, in a post by Dr. John Henning Schumann, host of Public Radio Tulsa’s “Medical Matters,” titled “If Slow Is Good For Food, Why Not Medicine?”

It begins:

Maybe you’ve heard about the slow food movement. Maybe you’re a devotee.
The idea is that cooking, nutrition and eating should be intentional, mindful and substantive. Avoid fast food and highly processed grub. For the slow food set, the process is as important as the product.
Now I’m seeing a medical version of slow food. The concept is bubbling up in response to industrialized, hypertechnological and often unnecessary medical care that drives up costs and leaves both doctors and patients frazzled.

And about Drs. Cohen and Hochman’s brand of Slow Medicine: Continue reading

MGH Patient Monitored For Possible Ebola ‘Cleared Medically,’ Discharged

A patient who was being monitored for possible Ebola and then tested positive for malaria was “cleared medically” and discharged from Massachusetts General Hospital Friday morning, hospital officials announced in a statement.

The patient’s release and current condition are not a threat to anyone else, MGH officials said. The patient, who has not been identified, had been under the hospital’s care since Tuesday.

“As we noted previously this patient had been definitively diagnosed with malaria and is responding well to anti-malaria treatment,” hospital officials said in the statement. “The patient has had no fever or other symptoms for the past 24 hours.”

In a press conference Wednesday, Dr. David Hooper, the head of Mass General’s infection control unit, said the patient had traveled to Liberia in recent weeks, but worked in an administrative role.

Hooper said he did not have the patient’s permission to disclose where he worked while in Liberia, but said the patient “did not have direct contact with Ebola patients” and was tested “out of an abundance of caution.”

MGH officials also noted in the statement that screening the patient for Ebola afforded them the “opportunity to see firsthand the benefits of the extensive preparations that have been under way through the hospital for the past several months.”

Officials praised their response and said preparations included carefully following Centers for Disease Control and Prevention protocols for treating possible Ebola cases.


My Father, Your Mother/Child/Cousin? Medical Mistakes Affect Millions Nationwide

Betsy Lehman, a former Boston Globe health columnist, died as a result of a massive chemotherapy overdose. (Courtesy of the Lehman family)

Betsy Lehman, a Boston Globe health columnist, died 20 years ago as a result of a massive chemotherapy overdose given in error. (Courtesy of the Lehman family)

By Richard Knox

Some years back, my 78-year-old father suddenly collapsed with kidney and liver failure. He had no prior kidney or liver disease. Several doctors told us what happened.

The catastrophe was caused by his use of a medication called Pyridium for several months. It was prescribed to relieve bladder pain caused by radiotherapy treatments for Dad’s prostate cancer, which was localized and thought to be curable.

Albert L. Knox, late father of journalist Richard Knox, relaxing in New Hampshire in the mid-1980s. (Courtesy of Richard Knox)

Albert L. Knox, late father of journalist Richard Knox, relaxing in New Hampshire in the mid-1980s. (Courtesy of Richard Knox)

The package insert for Pyridium warns it shouldn’t be taken for longer than two days and elderly patients taking it should be monitored carefully for signs of liver and kidney failure. In Dad’s case, the prescription was renewed three times over a two-month period by two different doctors — who did not order any kidney or liver function tests.

It was a clearly avoidable error. “This has been an eye-opener to me,” one of his doctors told me during a conversation in the intensive care unit where Dad lay dying.

That was in 1989. Five years later, Boston Globe health columnist Betsy Lehman died of a chemotherapy overdose at Dana-Farber Cancer Institute — a medical error I documented extensively for the Globe. That tragedy, perhaps the nation’s iconic medical mistake, is credited with launching a national movement to prevent medical errors.

I’d like to think these kinds of preventable mistakes are a thing of the past. But new data from the Harvard School of Public Health, released this week, shows that’s not the case. The Harvard survey indicates that one in every four Massachusetts adults has experienced a medical mistake in the past five years, or is close to someone who has. Half of these have caused serious harm. That translates to hundreds of thousands of medical injuries in a state that prides itself on having the very best medical care.

“We do a staggering amount of harm every day.”
– Dr. Ashish Jha, Harvard

But there was also more promising medical-error news this week. Federal health officials reported a recent 17 percent reduction in “hospital-acquired conditions” such as infections, falls, trauma and bedsores. That’s 1.3 million fewer injuries and 50,000 fewer deaths since 2010, says Health and Human Services Secretary Sylvia Burwell.

Hospitals Are Killing Tens of Thousands Fewer People” was how the Washington Post billed it – a headline that managed to sound both cheerful and not-so-reassuring.

These are big numbers, on both sides of the ledger. So what’s the upshot? Do they mean American patients are safer than they were when Betsy Lehman died? Or at greater peril?

One thing’s clear: Whatever the exact numbers, they reflect a big problem that profoundly affects millions of American families.

Something like 1,000 Americans die of medical errors every day, according to one credible recent estimate. “We do a staggering amount of harm every day,” Dr. Ashish Jha of the Harvard School of Public Health testified last July at a U.S. Senate subcommittee hearing. John James of Patient Safety America, an advocacy group, recently estimated that 440,000 Americans die every year from such tragic mistakes. Nonfatal errors are 10 to 20 times more common, James says, which would mean something like 8 to 10 million medical mistakes a year.

That makes medical errors the nation’s third-leading cause of death, after heart disease and cancer, Vermont Sen. Bernie Sanders noted at last summer’s hearing.

“When you talk to people, it seems everyone has a story — everyone, whether it’s themselves, a family member, a friend,” says Barbara Fain, director of the Betsy Lehman Center for Patient Safety and Medical Error Reduction, a Massachusetts state agency whose name memorializes my Globe colleague.

Twenty years after her death, many are now asking if that movement has worked. The new federal numbers signal substantial progress toward safer care. But the new Harvard study — and a number of other recent studies — suggest that Americans are just as likely to suffer from medical errors as they were when Al Knox and Betsy Lehman died.

Which picture is right? Continue reading

New Pro-Circumcision Guidelines: Cutting Comments, Adolescent Choice

Preparing for a circumcision

Preparing for a circumcision (Cheskel Dovid/Wikimedia Commons)

Just days after the U.S. Centers for Disease Control and Prevention issued draft recommendations on male circumcision asserting that the health benefits outweigh the risks, more than 300 comments (and counting) have been posted on the agency’s website.

Surprise: The feedback overall reflects anger over mounting institutional support for what some call a “barbaric, outdated practice.” (The public comment period on the agency’s proposed recommendations ends on Jan. 16.)

Here are a few random comments:

When I was a little girl and discovered my little brothers had been cut, I was horrified for them and grateful I wasn’t born a boy.

The only benefit of infant circumcision is the fatter wallet of the circumciser. Wake up people! Condoms prevent sexually transmitted diseases, not circumcision. Males deserve the same protection from genital cuttings that females do. Shame on the CDC for condoning such a barbaric, outdated practice that nearly every other industrialized nation has refused to adopt!

Routine infant circumcision is morally wrong because it is non-essential cosmetic surgery performed on the body of a human being not yet old enough to give informed consent….

Your agenda clearly shows your primary purposes is for health insurance to pay for male genital mutilation. Please don’t continue to make the U.S. the continued laughing stock of the international medical community.

You get the picture.

The CDC stopped short of actually telling parents they must circumcise their baby boys; instead the agency offered guidelines — including a new recommendation that un-circumcised adolescent boys discuss the risks and benefits with their doctors — and laid out the latest research. Male circumcision, according to an AP report, can:

•Cut a man’s risk of getting HIV from an infected female partner by 50 to 60 percent.

•Reduce their risk of genital herpes and certain strains of human papillomavirus by 30 percent or more.

•Lower the risk of urinary tract infections during infancy, and cancer of the penis in adulthood.

Studies have not shown that circumcision will reduce an HIV-infected man’s chances of spreading the AIDS virus to women. And research has not found circumcision to be a help in stopping spread of HIV during gay sex.

The guidelines say circumcision is safer for newborns and infants than for older males, noting the complication rate rises from 0.5 percent in newborns to 9 percent in children ages 1 to 9, according to the CDC. Minor bleeding and pain are the most common problems, experts say.

CDC officials are recommending doctors tell parents of baby boys of the benefits and risks of circumcision…

These are the first federal guidelines on circumcision, a brief medical procedure that involves cutting away the foreskin around the tip of the penis. Germs can grow underneath the foreskin, and CDC officials say the procedure can lower a male’s risk of sexually-transmitted diseases, penile cancer and even urinary tract infections.

I asked circumcision expert Marvin Wang, co-director of the newborn nurseries at Massachusetts General Hospital (and someone who has performed thousands of circumcisions), about the new CDC draft recommendation, and he offered this thoughtful analysis:

First a little history:

For decades, the American Academy of Pediatrics (AAP) (which produces the majority of research-based policy for U.S. pediatric care) has led a relatively neutral stance on male neonatal circumcision, as the literature has shown that there is a relatively small health benefit by performing circumcision (there is huge debate on how one interprets the numbers on this, but overall, that conclusion is true). However, a game changer that tilted the balance towards claiming health benefits came in 2005-2007, when three separate World Health Organization clinical trials were performed in Africa demonstrating that circumcision among adult men in Sub-Saharan African settings reduced the acquisition of HIV by 50%.

With that, the AAP changed its recommendations in 2012 to reflect these studies. Their statement basically said that, yes, we know that there are health benefits now – enough to encourage parents to strongly consider circumcision for the newborn. However, the decision still lays with the parents, balanced by their beliefs (which may be influenced by religious, social or familial reasons). There are other tenets to the statement, but let’s just focus on this one topic, as this is most relevant to the recent CDC statement.

In light of the infectious disease issues involved, the medical community had been told that the CDC would make their recommendations regarding circumcision at about the same time as the AAP’s release. So, with this week’s statement, you are basically seeing a reaffirmation of the 2012 AAP statement. We don’t really see anything new. The health benefits touted in the CDC report have all been discussed before in the literature.

The only potentially new issue here is a topic that the 2012 AAP statement neglected: The idea of encouraging un-circumcised adolescents to discuss the option with their physician. Continue reading

Boston Survey: Most Parents Say Sure, I’d Like To Know My Newborn’s Genes

(Wikimedia Commons)

(Wikimedia Commons)

For years, futurists have foreseen an era when all newborn American babies would be sent home with a supply of self-knowledge: a readout of their full set of genes, with all it may imply about heightened chances for disease or health.

So how would you feel about that, as a new parent? Eager to absorb any possible indicator of your child’s potential future? Or wary that genes are not destiny, and you may spend a lifetime fearing something that never comes to pass?

If you answer, “I’d want to know about my baby’s genetic makeup,” your sentiments are in line with the majority of parents surveyed in the first poll of new parents about genomic screening, just out in the journal Genetics In Medicine. Researchers from Brigham and Women’s Hospital and Boston Children’s Hospital led the study. From the press release:

“Several other studies have measured parents’ interest in newborn genomic screening, but none focused on new parents in the first 48 hours,” said Robert C. Green, MD, MPH, a geneticist and researcher at BWH and Harvard Medical School and senior author of the study. “Since this is when genomic testing would be of the greatest value, it is especially important to study parents’ attitudes immediately post-partum.”

The researchers surveyed 514 parents at the well baby nursery at BWH within 48 hours of their child’s birth. After receiving a brief orientation to the genome and its impacts on human health, including information about what the genome is, what genes are and how they can affect both health and medical care, 82.7 percent of parents reported being somewhat (36 percent), very, (28 percent) or extremely (18 percent) interested in newborn genomic testing. Results were similar regardless of parents’ age, gender, race, ethnicity, level of education, family history of genetic disease, or whether or not the infant was a first-born child. Parents who had experienced concerns about the health of their newborn, however, were less likely to be interested in genomic testing. Continue reading

Sweet Dreams: Study Finds Later Nights, Less Sleep Linked To Negativity

(eltpics via compfight)

(eltpics via compfight)

Sleep is the new Prozac. Or, put another way, sleep is emerging as one of the most potent weapons you can use to stave off depression, anxiety and a whole host of other physical and mental ills.

Here’s the latest pro-sleep research by psychologists at Binghamton University in New York. Their new paper, “Duration and Timing of Sleep are Associated with Repetitive Negative Thinking” is just published in the journal Cognitive Therapy and Research.

From the news release:

When you go to bed, and how long you sleep at a time, might actually make it difficult for you to stop worrying. So say Jacob Nota and Meredith Coles of Binghamton University in the U.S., who found that people who sleep for shorter periods of time and go to bed very late at night are often overwhelmed with more negative thoughts than those who keep more regular sleeping hours…

Previous studies have linked sleep problems with such repetitive negative thoughts, especially in cases where someone does not get enough shuteye. Nota and Coles set out to replicate these studies, and to further see if there’s any link between having such repetitive thoughts and the actual time when someone goes to bed.

They asked 100 young adults at Binghamton University to complete a battery of questionnaires and two computerized tasks. In the process, it was measured how much the students worry, ruminate or obsess about something – three measures by which repetitive negative thinking is gauged. Continue reading

Study: New Way To Hold Back Herpes, Keep Virus Latent

Fluorescent staining shows areas of the cornea affected by herpes virus that infected a man's eyes. (Photo: Wikipedia)

Fluorescent staining shows areas of the cornea affected by herpes virus that infected a man’s eyes. (Source: Wikipedia)

Chances are, you’ve got herpes, I’ve got herpes, we’ve all got herpes.

Studies find that by age 60, virtually all adults carry herpes simplex virus 1 — best known for seeping cold sores but also potentially blinding when it hits the eyes. Herpes simplex virus 2, the sexually transmitted disease, infects more than a quarter of people by their forties, the CDC says.

While anti-viral medications can help, there is no cure for herpes viruses. Their wily ways of going latent between recurrences, hiding out in viral reservoirs in our bodies, make them supremely hard to eradicate.

So it’s welcome news that a study just out in the journal Science Translational Medicine describes a whole new strategy for beating down herpes viruses and keeping them down — at least in mice, rabbits and guinea pigs.

Far fewer of the mice died or had virus spreading throughout their bodies.

It’s a tactic that researchers say may also hold promise for attacking HIV, another virus whose habit of hiding out makes it hard to kill, and the herpes zoster virus that causes excruciating shingles.

The new method hinges on epigenetics — specifically, protein “packages” that determine how genes are turned off and on.

For a herpes virus to go from a latent state to an active state, it needs to unpackage or unbundle its genes so they can be “turned on” and begin to replicate and spread. But, the researchers found, if they block an enzyme called LSD1, those genes tend to stay bundled up and inactive.

It’s as if the viral DNA encoding the genes needed to reactivate the virus naturally carries a “Don’t open me!” sign on it, says the paper’s senior author, Dr. Thomas M. Kristie. The LSD1 enzyme can remove that sign. But block the enzyme and the “Don’t open me!” sign stays up. Continue reading