By Dr. Adam Urato
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.
In just the past few years pharmaceutical companies have agreed to pay over $13 billion to resolve U.S. Department of Justice allegations of fraudulent marketing practices. I can think of no group that the public would trust less to warn about the risks of medications during pregnancy than the drug companies themselves. Asking Pharma to warn us about medication risks would be like asking natural gas drilling companies to warn us about the risks of fracking. The warnings regarding the use of these drugs in pregnancy should be written by completely independent parties and based on the scientific evidence.
It goes without saying that pregnant women deserve good treatment and care and their health needs should not be ignored because they are pregnant. I take care of high-risk pregnant women on a daily basis and am frequently asked whether a certain medication or medical procedure is “safe” during pregnancy. I often counsel patients and referring physicians that “safe” is a relative term: if a pregnant woman needs a medication or procedure for her health and there is no “safer” alternative for her or her fetus, then that is the way she should be cared for.
No Perfect System
There are two big problems with the current Letter Category system. First, newer drugs are often assumed to be safe and can get a “better” letter grade simply because harm hasn’t been proven yet. A good example of this is the drug Latuda (lurasidone), which is an antipsychotic medication used to treat schizophrenia and bipolar depression. It has been used in the U.S. since 2013. It is considered FDA Category B, which is relatively reassuring, and drugs.com declares it is “not expected to harm an unborn baby.”
But Latuda is an antipsychotic drug. Its exact mechanisim of action is unknown, but it likely disrupts function at dopamine and serotonin receptors. The Latuda label information warns, in adults, of the association with stroke, neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia, hyperprolactinemia, leukopenia, seizures, orthostatic hypotension, syncope, body temperature dysregulation, and several other adverse effects.
If the dopamine and serotonin systems are important for fetal development (and they are), and if this drug crosses the placenta and disrupts those systems (and is known to cause problems in adults) what about that sounds like it would be safe for fetal development? In this case the Category B is misleading.
Second, in reality the letters are often being ignored. A good example of this is in my area of research: antidepressant use in pregnancy. Most antidepressants have a Category C designation. Category C means that animal studies have shown adverse effects but that there are no adequate studies in humans. The FDA Category C designation does not mean that the medications are safe for use in pregnancy. Yet, I have been told by many patients that the only counseling they received about continuing their antidepressant during pregnancy was that “these medications are safe.” Clearly there is a disconnect between the Category C designation and the public’s understanding.
Old System Had Benefits
A major benefit of the Letter Category system, however, was that the public was given proper warning about drugs that were categorized as D or X in pregnancy. Take, for example, the drug Accutane. This medication, used to treat acne, is Category X and there is widespread knowledge that it should not be used if a patient may become pregnant. Another example is with Paxil. This antidepressant was shown to be associated with heart defects and was given a Category D classification in 2005 and we have seen a significant decrease in its use during pregnancy in the subsequent years.
How To Navigate?
The easiest approach to medication use in pregnancy is to limit it whenever possible.
Medications, for the most part, are synthetic chemical compounds that are made in chemical factories. Human development is a process that has developed over millions of years without exposure to such chemical compounds.
Fetal systems like the serotonin, dopamine, endocrinologic system and many others are critical for normal development. Many medications cross the placenta, enter into the developing baby, and interfere with those very systems. However, this does not mean that medications cannot be used in pregnancy. Patients who need medication to control lupus, diabetes, or another illness, for instance, should work with their physicians to find the most appropriate medication to use during the pregnancy and they should be given good care and support. The new labeling information may prove quite helpful in these cases.
Dr. Adam Urato is a Maternal-Fetal Medicine specialist at MetroWest Medical Center and Tufts Medical Center.
If you get health insurance at work, chances are you have some sort of wellness plan, too. But so far there’s no real evidence as to whether these plans work.
One thing we do know is that wellness is particularly popular with employers right now, as they seek ways to slow the rise of health spending. These initiatives can range from urging workers to use the stairs all the way to requiring comprehensive health screenings. The 2014 survey of employers by the Kaiser Family Foundation found that 98 percent of large employers and 73 percent of smaller employers offer at least one wellness program. (Kaiser Health News is an editorially independent program of KFF.)
What makes wellness plans so popular?
“It really is part of their strategy to help employees be healthy, productive, and engaged,” says Maria Ghazal, vice president and counsel at the Business Roundtable, whose members are CEOs of large firms. “And it’s really part of their strategy to be successful companies.”
And there’s another reason wellness has gotten so pervasive, said health consultant Al Lewis. It’s a big industry.
“It’s somewhere between $6 [billion] and $10 billion, which creates an awful lot of people saying ‘do more of this stuff,’” he says.
Lewis has become something of a crusader against the spread of corporate wellness programs around the nation. (He’s co-authored an e-book detailing its failings.) He says among the many problems is that a lot of wellness plans are not so innocent.
“We call them pry, poke, prod and punish programs,” he says. That refers to the ones that ask intrusive questions like how much alcohol a person consumes and whether a woman is planning on becoming pregnant. They might also require medical procedures like comprehensive blood tests. The plans urge employees to participate and then punish them if they don’t.
Under federal rules, wellness programs must in theory be voluntary. But more than a third of large companies are now using financial incentives, which include both rewards for those who participate and penalties for those who don’t, according to the Kaiser Family Foundation survey.
For example, at Penn State University last year, officials were forced to backtrack on a plan that would have required professors and other nonunion workers – and their spouses — to undergo comprehensive health screenings every year, including measurements of cholesterol, blood sugar, and body mass. Those who declined would be charged an extra $100 dollars a month for insurance. Employees rebelled, and the University didn’t implement the fees.
Ironically, says Lewis, for all the money some wellness plans spend to screen thousands of people, most companies don’t actually have that much health spending that could be saved by wellness initiatives.
“In a company with 10,000 workers,” he says, “they might have had 10 heart attacks, of which one may have been theoretically preventable with a wellness program. “This KHN story also ran on NPR. It can be republished for free (details).
That’s a big reason why most independent studies have found little or no cost savings. When there have been savings, said Aaron Carroll and Austin Frakt in the New York Times, they tend not to have come from improving workers’ health. “Wellness programs can achieve cost-savings – for employers – by shifting higher costs of care to workers,” they wrote. This is because employers can charge workers more for their insurance if they refuse the smoking cessation or weight-loss plan.
Some programs can even do harm, says Lewis. For example, false positive results from screening low-risk people end up causing workers anxiety and their health plans still more money. Lewis is quick to add that screening tests recommended by the U.S. Preventive Services Task Force are appropriate, but their guidelines “are routinely ignored by corporate wellness programs.”
But not everyone outside the wellness industry is quite so pessimistic. Harvard health economist Kate Baicker is the lead author of a 2010 study that found some potential savings.
“It could be that when all the full set of evidence comes in it will have huge returns on investment and the billions we’re spending on it are completely warranted,” Baicker says. But for now, “there are very few studies that have reliable data on both the costs and the benefits.”
Meanwhile, the federal government is divided on how to regulate this area. The Affordable Care Act embraces the wellness concept. It lets employers link up to 30 percent of premiums to participation in wellness activities – and up to 50 percent if those activities involve quitting tobacco. But the independent Equal Employment Opportunity Commission is suing several companies, including the Honeywell, with its more than 130,000 workers. It says their programs discriminate against those with disabilities.
The idea of having to follow more than one set of rules is frustrating employers.
“We want to be certain that following the Affordable Care Act is what we’re supposed to be doing, and there shouldn’t be additional requirements beyond the ACA,” said Maria Ghazal of the Business Roundtable.
The CEOs are so upset about the wellness lawsuits they’re reportedly threatening to pull their support for the health law entirely unless things are clarified – which could create one more enemy for the Affordable Care Act.
When you visit the Library of Congress you are likely to hear or read about the loss of collections to fires, first in 1814 during the War of 1812 and then later, on Christmas Eve 1851. Unfortunately, a number of other countries have also suffered losses of parliamentary or national library buildings and important materials due to fires that have either started accidentally or as a deliberate act. In 1849, for example, the Canadian Library of Parliament in Montreal lost all but 200 of its 12,000 books to fire. Many more documents were also lost in the fire, and last year archeologists uncovered the charred remains of seven books from the site of the pre-Confederation parliament.
The British House of Commons Library and its materials at the Houses of Parliament in London also burned in a fire in 1834. Nearly all the House of Commons records were destroyed “in one of the greatest archival disasters the United Kingdom has ever known.”
The Canadian Library of Parliament, now in Ottawa, was again threatened by a fire that engulfed large parts of the Parliament buildings in 1916. This time the collection was saved “because of the foresight of librarian Alpheus Todd in insisting on iron fire doors and clerk “Connie” MacCormac’s quick thinking in ordering them to be slammed shut before evacuating the building.”
A similar situation to that later event had also occurred in New Zealand. This week, on December 11, it is the anniversary of a devastating fire that destroyed New Zealand’s wooden Parliament buildings in 1907. However, the General Assembly Library (now the Parliamentary Library) and its collection were saved. It was the only building in the complex that survived, and it remains standing today. According to the New Zealand History website,
Staff and volunteers moved more than 15,000 volumes from the building’s ground floor as a precaution against the flames breaking through. The morning light revealed the scale of the devastation to the crowds and parliamentarians who had come to watch: the old wooden buildings were completely destroyed, but New Zealand’s de facto national library – with its 80,000 volumes and many other treasures – had been saved by its brick walls and metal fire door.
People also worked through the night to save other items from the buildings. According to one report, “refreshments were provided at the hotel opposite.”
I visited the Parliamentary Library in 2011 and returned with pictures for an In Custodia Legis blog post. The building has been restored and refurbished, although the process was interrupted by three fires in 1992. You can see 360 degree panoramic images of parts of the Parliamentary Library building as it looks today on the New Zealand History website (scroll down to the “Interactive” section).
And I’m sure you’ll be glad to know that the Library of Congress has comprehensive plans, procedures, and equipment in place to protect collections from fire and other potential disasters, and provides information on emergency preparedness and response to help other institutions as well.
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 accredidation 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.
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.
As far as we know, this is the first time that these sorts of strategies have been proposed for the purpose of improving access-so while we believe there will be “traction” on this issue in the future, the goal of this paper was to start the conversation. In the upcoming months, we hope to approach CMS, MassHealth, and the Joint Commission to discuss how some of these strategies might be employed to improve access to care in the future.
Here are more details from the Baystate news release:
“… many of the problems with access to care faced by patients with disabilities are related to the way that health care is financed and delivered in the United States. Because big payers such as Medicare and Medicaid are not directly associated with agencies charged with ensuring that these patients have access, such as the U.S. Department of Justice, one of the major mechanisms for changing practice and improving access—withholding payment—is not used to motivate physicians to provide access to care. Instead, enforcement has primarily been in the form of lawsuits, which have proven to be ineffective at catalyzing system-wide change.
Now Dr. Lagu and colleagues are recommending policy changes intended to improve access. For example, they recommend that Medicare and Medicaid approach this problem in the same way that they monitor fraud among providers, so if a doctor or facility fails to provide access, participation in Medicare and Medicaid would be automatically terminated. The authors recommend a similar tactic for accreditation: hospitals that fail to provide access for patients with disabilities would be at risk of losing their accreditation. They also recommend that medical equipment should adhere to accessibility standards in order to be sold in the U.S. The similar example is that of child safety seats for automobiles: Because unsafe seats cannot be purchased in the U.S., nearly all safety seats in use are safe.
“By proposing these policy changes, we hope to start a conversation about how far we should go to ensure that patients with disabilities have access to care,” said Dr. Lagu. “Doctors and healthcare facilities that are failing to provide appropriate care to the disabled are technically in violation of federal law, but lawsuits are burdensome to all parties and relatively rare, which can make it feel like enforcement is intermittent and random. These changes would make it very clear that the default expectation is to provide access to care for all patients.”