FDA’s Black Box Warning On Anti-Depressants – Has It Done More Harm Than Good?

In 2004 the FDA issued a “Black Box” warning on anti-depressants indicating that these medications were associated with an increase in suicidal thinking, feelings and behaviors in young people.

Criticism

The FDA really had no choice but to issues the black box warning, as a 2004 review of 372 randomized controlled trials of anti-depressants identified a slight increase (4% as compared to 2%) in suicidal thinking and behavior among depressed adolescents and children who were prescribed anti-depressants. The increase was small but significant.

Ever since that black box warning was issued, however, there has been much criticism of the “Black Box” warning, as physicians feared it would deter patients from seeking help for depression, and would discourage doctors from prescribing necessary medication. Untreated depression is a risk factor for suicide

In response to the criticisms, in 2007 the FDA added language to the “Black Box” warning indicating that depression also increased the risk of suicide. The point of the expanded warning was to encourage physicians to weigh the benefits and risks of prescribing anti-depressants and not to withhold necessary treatment if it was indicated.

What has happened to anti-depressant prescribing rates?

We now have access to a large epidemiological study, which suggests that the primary effect of the FDA’s “Black Box” warning has been to discourage the use of anti-depressants. Even though the warning is only about adolescents and children, rates of anti-depressant use dropped in all age groups after the release of the “Black Box” warning in 2004 and continue to remain lower than expected even now.

There have been no increases in other types of treatment for depression, and there is no reason to believe that the actual rate of depression in any age group has dropped. The only logical conclusion is that since the “Black Box” warning came out, either physicians are more reluctant to prescribe anti-depressants or patients are more likely to refuse them.

Suicides?

Suicide rates across all age groups have gradually been increasing over time with no obvious sudden changes in or around 2004. However, a study of poisoning rates- using the poisoning rates as a proxy measure of the rate of suicide attempts- found a dramatic increase in rates of poisoning among both adolescents and young adults shortly after the “Black Box” warning was released in 2004.

Because all of the data about anti-depressants, suicide and depression rates are derived from observational studies, no direct causal link to the “Black Box” warning can be derived. However, the data are certainly suggestive. They seem to indicate that instead of saving lives, the warning has been harmful. Patients are not seeking treatment for depression. Doctors are not diagnosing and treating patients for depression. And patients are scared to take anti-depressants because of this black box warning.

The net effect is reduced quality of life and possibly an increase in loss of life due to suicides.

The “Black Box” warning almost certainly has made some patients believe that treatments for depression are ineffective or harmful. There are many reasons why doctors might be reluctant to prescribe anti-depressants with a “Black Box” warning on them.  A major reason is that if a depressed patient attempts suicide after being prescribed anti-depressants, the doctor is may be vulnerable to a malpractice lawsuit.

Should the FDA remove the “Black Box” warning on anti-depressants? In my opinion, the black box warning has been detrimental to the fight against depression. I’d love to hear your thoughts. 

Who is reviewing your medical records?

I have spoken to many attorneys over the years, and when I ask them who reviews their medical records, I always find myself biting my tongue as I listen to their response. It is predictable, but I still cringe.

“I review my own medical records. I have to know the details anyway, so I might as well do it myself.”

“I have been doing this for a long time and I know what to look for, so I review my own medical records.”

“My paralegal reviews my medical records. She’s awesome and does a great job.”

Again and again, over and over, I get the same replies.

Let’s face it; attorneys and paralegals (unless they are physicians) are not medical experts. If I have a legal problem or question, I don’t ask another doctor, or someone who isn’t a law professional. I don’t even ask a paralegal. I ask an attorney. Who knows more about law than someone who has been to law school and has practiced as an attorney?

I understand that attorneys have their reasons for keeping their medical record reviews and analysis in house. The bottom line is, they need to understand the details of the case and know the records.

I also sympathize with the financial benefits that are gained by keeping this process in the firm. I even think in some instances, when the case is straightforward and there aren’t a lot of records and medical data to interpret, this makes perfect sense.

In most cases, though, I feel like this is a HUGE mistake, and that many attorneys underestimate the advantage they gain (both financially and strategically) by having a medical doctor look at their case records.

The review and analysis of medical records is an art. Anybody can read a medical record and put it in the right order, or write a summary and chronological timeline. But the key to exceptional medical record reviews isn’t in the reading. The key is the interpretation of the records, and this is something that only a medical professional can do well.

A medical professional can also tell you what went wrong and who did it, identify missing information, and pick up subtle pieces of data or chart entries that serve as clues and evidence to support or discount your theory.

Now don’t get me wrong! I have the utmost respect for medical malpractice, personal injury, and other attorneys that deal with medical issues. In fact, I am sometimes amazed at how much medical knowledge a good medical malpractice attorney knows. Attorneys are some of the brightest and most capable professionals that I have ever met; however, I think it is important to remember the many benefits of having a medical doctor on your team.

1) First and foremost, having a physician review your medical records will help you win your case! Think about the opposing counsel. Do you think they have doctors looking at their medical records? In most cases they will, and therefore they will have the strategic advantage.

Do you really want to be behind the eight ball from the get go? Having a physician consultant reviewing your records can help your strategy immensely, because they will know what the opposing medical expert will be arguing. You are much more likely to win your case with the input of a medical doctor.

2) A physician consultant will be able to pick things up from medical records that nobody else can, (including a legal nurse consultant). Physicians know how to interpret lab and test results and can identify subtleties in lab trends, and they will easily identify tests that should have been done and are missing.

3) Your physician consultant has trained for many years on how to make a diagnosis. We know how to formulate a differential diagnosis and consider other issues that may be playing in to your medical case.

Nobody else, except for a physician, is qualified to do this. You could be barking up the wrong tree and not even be aware of it. Meanwhile, your opposing expert has this information already, because their physician consultant was able to identify and address the issue.

4) Hiring a physician to conduct your chart reviews may seem like an alternative that is too expensive. But in the long run, it could and probably will save you hundreds of dollars. I have seen attorneys spend countless hours reviewing their own records only to find out later that the case had no merit, or that standard of care wasn’t even breached. When I was called in to review the case it was immediately obvious that there WAS no case.

I also know that there is nobody more efficient in reviewing medical records than a physician. You will save money simply because he or she will be able to do a much more thorough job in a lot less time.

5) Physician consultants can save you countless hours. We know that attorneys need to be familiar with the records and the issues of the case. But a physician can guide you through this, making it much easier for you to know what you need to know, in a lot less time. We are quicker with the review process, can dissect the medical records for you, and then we will teach you about the medical condition and highlight important parts of the record you need to be familiar with. What takes you 10 hours to do could be done in up to half the time by a physician. Plus, you get the added benefit of their knowledge and expertise.

If these things don’t convince you that you are taking chances with anyone reviewing your charts other than a physician, I encourage you to have an open mind and try something different. If it doesn’t work for you, you have lost nothing and can always go back to your old method.

Confusion about Advance Directives Can Mean Unwanted Life or Death

An advance directive is a legal document that individuals can have prepared describing their health-care wishes in case they become incapacitated due to injury, disease or mental health issues. Advance directives are more commonly known under names such as “living wills.”

The laws allowing advance directives were originally created to address a perceived difference between the wishes of health-care providers and patients. Most health-care providers try to provide care and save lives at all costs, and many patients object vehemently to being subjected to forms of health care that seem to only briefly extend low-quality life.

Physicians confused?

However, surveys of physicians indicate a lot of confusion about advance directives. For example, many surveys report that 44% to 80% of physicians incorrectly think that the mere existence of a living will means that the patient has a Do Not Resuscitate (DNR) order in place.

Additionally, around 20% of physicians report that they would attempt resuscitation even if a DNR order was in place. This type of confusion can lead to unnecessary deaths and also to undesirable medical interventions.

A DNR order is a specific advance directive stating that if the individual is found with no pulse but not yet legally dead, resuscitation should not be attempted. Individuals with terminal illnesses are those most likely to request a DNR order as they would prefer to die with dignity instead of having the process prolonged by technology.

Many living wills and advance directives do not ask for DNRs. A healthy middle-aged person may very well have a living will stating that in the case of brain death life should not be prolonged artificially. This same person might be horrified to learn that physicians may believe the mere presence of this living will means that they should not attempt to resuscitate the patient after a car crash or heart attack causes temporary cardiac arrest. Some health-care providers mistakenly think that the presence of a DNR means to not treat a patient at all.

Too much/ too little medical care

Of complaints involving medical care conflicting with advance directives, only 20% involve patients or patient family members complaining about patients receiving unwanted interventions. The other 80% revolve around patients not receiving wanted interventions due to confusion about advance directives and what they mean. Confusion about advance directives often leads to malpractice lawsuits.

Lack of communication

One major cause of the confusion about advance directives is that attorneys and the law dictate the language used in these documents, and the physicians may not understand the legal language. Another problem is that often the legal documents are locked away and are never seen by medical personnel.

Even if the patient’s primary physician is aware of the advance directive, that does not mean that other health-care providers, such as emergency room physicians or paramedics, will automatically be aware of the document. The increased use of electronic health records may improve awareness of advanced directives.

Another legal twist is that health-care providers can legally refuse to follow the instructions provided in an advance directive under the “conscience” objection clause if they feel an advanced directive is medically inappropriate.

It is important for patients to discuss their advance directives and wishes with their health-care providers. Providing the physician with a copy of your living will and discussing with the physician what you want is one way to avoid misunderstandings. Electronic health records that will alert emergency rooms and nursing homes regarding your wishes may also help raise awareness. Better education of health-care providers about advance directives is also clearly needed.

We work at the interface of medicine and the law. If you have any questions about our services, don’t hesitate to contact us.

Still No Ebola Vaccine?

Still No Ebola Vaccine?

More than a decade ago, scientific research produced a viable Ebola vaccine candidate that worked in monkeys and was ready for testing in humans. Those tests never happened.

The economics of drug and vaccine development stopped that research from even approaching clinical trials until just recently –after the Ebola outbreak in West Africa spread to five countries in Africa and then became a global threat as travelers and health care workers brought the disease to Europe and the United States.  

While the current Ebola outbreak is the largest on record, Ebola’s history has been that of a sporadic disease. The first incidence of Ebola in Africa was in 1976, according to the World Health Organization.

 Since then, outbreaks of the disease have been sporadic and isolated, affecting patients by the hundreds. Today, however, the WHO counts more than 5,000 dead and counting from the current Ebola outbreak.

Understanding the historic rarity of Ebola is key to understanding why we have no Ebola vaccine yet, and also why a promising Ebola vaccine developed in the early 2000s is only now in the discussion for tests in humans.

Drug companies make money by producing products that can be sold to large populations. With Ebola’s historic record presenting a small potential market, there was no money to be made from an Ebola vaccine treating a small population of mostly poor, rural people.

Dr. Thomas Geisbert, one of the researchers who developed that vaccine, told The New York Times that the promising Ebola vaccine that was developed in the early 2000s was shelved and left untested in humans because large pharmaceutical companies saw only a small commercial market for the disease,

“There’s never been a big market for Ebola vaccines,” Giesbert said. “So big pharma, who are they going to sell it to?

In fact, such an effort would likely lose money. Even after the years spent researching and developing new vaccines and drugs, these potential medical products need even more time to run the gamut of clinical trials needed for Food and Drug Administration approval. Those trials take thousands of patients and can cost tens, even hundreds of millions of dollars.

If a product is approved, a pharmaceutical company could recoup those costs from product sales. But with no regular patient population for an Ebola vaccine to address, a pharmaceutical company sees no way to even break even.

The spread of Ebola in Africa and beyond has prompted a change in thinking. A newer version of the Ebola vaccine that was developed a decade ago is being tested in animals in preparation of bringing the vaccine into human testing. Pharmaceutical giant GlaxoSmithKline has already started vaccine trials in a human population group that it identified in partnership with the National Institutes of Health. Johnson & Johnson has also started work on its own Ebola vaccine.

Although the tide is turning for vaccines, economics are still a major driver for the effort. If an Ebola vaccine proves successful in clinical trials, it will finally have paying customers – the U.S. government, as well as governments of other nations looking for safeguards against an infectious disease.