Is that Drug Really Necessary?

A recent Boston Globe article described a large settlement a family won against Johnson & Johnson, the maker of Children’s Motrin. There’s an old adage, “All I know is what I read in the newspaper” and that is the case here. While it may sound like a windfall for the family, there was more to the story than just suing for—and winning—millions of dollars, and there is no happy ending nor winner.

According to the article, when a little girl was seven years old her parents gave her Children’s Motrin for a fever. She apparently received three doses over 24 hours, but the article did not go into further detail. All we know is that shortly after taking the Motrin she started to experience symptoms the paper called a “severe reaction” that doctors diagnosed as toxic epidermal necrolysis (TENS).

Toxic epidermal necrolysis is a rare, potentially deadly skin condition. Usually the cause is drug-related reaction, but there are other causes and often the cause isn’t found.

The girl suffered a lot from her TENS—she lost most of her skin, developed permanent lung and liver damage and blindness. She had multiple complications, surgeries, hospitalizations and other issues. She needs special care and will never be able to get a driver’s license. Now 16, she is doing well in school and has plans to attend college.

The family sued Johnson & Johnson and won a $63 million settlement. It’s not final as it needs to be approved by the judge and the manufacturer will undoubtedly appeal. It will probably be years before the case is finalized.

This is a case where no one really wins. The girl’s life is altered forever. She will continue to suffer as long as she lives. The money she receives—$50 million—is an enormous sum, but it will never make her completely healthy. Her parents, now divorced, each received $6.5 million. If properly managed, neither will ever have financial concerns. But they will always have guilt because they gave her the medicine.

Similarly, the manufacturer loses. Insurance will probably cover the money, but, if the verdicts holds up, it may affect their sales, insurance costs and reputation.

Lastly, society loses. A case like this reinforces the “jackpot” mentality that permeates our society. Parents may shy away from a generally safe treatment because of out-of-proportion fears of dangers it may pose to their children.

This case raises a number of questions. One is how far should a drug company go with its warnings? TENS is a very rare condition, but should every drug contain a list of every possible reaction? Currently the common reactions are listed. Since any drug may cause any reaction in any one person, there’s no reliable way to list all the potential reactions. The warnings list, often referred to as the package insert, of prescription drugs is quite detailed and can be scary.

Second, do the warnings make much difference to most people? Rarely does anyone read the entire package insert. If everyone did, many fewer drugs would be taken.

Would a parent not give a febrile child a product because of the warnings? I suspect most parents think that if a drug is sold without a prescription, is labeled as being for children and is used by so many kids for so long then it must be safe. And generally they are right. The over-the-counter medicines are very safe. But in rare cases that doctors, manufacturers, and parents can’t foretell, medicines can be harmful.

Rich Sagall MDAnother question, rarely addressed, is if the medicine is really necessary. Again, I don’t know the details of this situation. However, many doctors now recommend against treating a fever unless it’s making the child very uncomfortable. The easiest way to prevent an adverse drug reaction is to not take the drug at all, so parents need to seriously consider if their child’s ailment warrants taking medicine.

You could say there’s a risk-to-benefit ratio for just about anything we do. Most of the time we don’t consciously think

about it and carefully weigh the pros and cons of what we do. When making health-related decisions for you or your

children it is important to consider the risk-to-benefit ratio. It could make the difference between health and sickness, or even life and death.

Rich Sagall, MD, is the president and co-founder of NeedyMeds. He practiced family and occupational medicine for 25 years. In addition to his role at NeedyMeds, he is the editor and publisher of Pediatrics for Parents, a children’s health newsletter.

Gender-Specific Medicine: Part 2

This week we continue to look at gender medicine- how diseases may manifest themselves differently, and how medications may affect differently- depending on whether you are male or female.

An editorial in Nature in 2010 urged us to “put Gender on the Agenda,” as increasingly we are seeing from research results that there are distinct gender-based differences in disease incidence and activity, and treatment methods, especially medication. Cancer, for example, is the second leading cause of death among women and men, (Anderson, R.N., Deaths: Leading Causes for 2000. National Vital Statistics Reports. 2002, National Center for Health Statistics: Hyattsville, MD), however mortality rates and the disease course differ according to gender.gender

In looking at cancer, we see that in general, more women are screened but more men are diagnosed, and that “The gender differential in cancer incidence rates is comparable to ethnic and racial disparity in magnitude, and yet, most studies fail to look for it.” That is beginning to change with recent studies and clinical trials seeking to reduce disparities by including more women.

If we look at lung cancer specifically, Lynne Eldridge, M.D. comments: “There are differences between the way men and women develop lung cancer as well as their response to treatment. These differences are helpful to note, especially when women look at statistics regarding lung cancer survival. Statistics usually lump men and women together, but for women, the chances of survival are higher at all stages of the disease. We are just beginning to learn how genetic and hormonal influences play a role in the development of lung cancer and what might explain these differences. How do men and women differ in the development of, and response to, lung cancer?”

What accounts for these differences? Hormones? The environment? Genetics? Differences in how we react to medications? All of these can be factors, and many are being explored through gender-based studies.  This new research is fascinating and we promise to bring you updates!

Gender-Specific Medicine

“Women are from Venus, Men are from Mars.” “Women think differently than men.”

These viewpoints appear to be widespread and popular, fueling spirited and on-going debate in the media and the arts, but what about healthcare and medicine?

Most medical research over the years has focused on white men as subjects, and results were then extrapolated to include everyone else. From an ethical perspective, there were some humanistic reasons for this, e.g., protecting women and children from experimental research that may not have benefited them. In many cases, however, research focused on those in positions 4.10.13genderof power. This situation is slowly but surely changing, and we are now witnessing the rise of Gender Medicine.

A very interesting article in Clinical Chemistry and Laboratory Medicine, entitled “Gender Medicine: A Task for the Third Millennium,” defines gender-specific medicine as the study of how diseases differ between men and women in terms of prevention, clinical signs, therapeutic approach, prognosis, and psychological and social impact. They focus on five major fields of medicine: cardiovascular disease, pharmacology, oncology, liver diseases and osteoporosis.

For example heart disease has mostly been studied in men, but we do know that cardiovascular diseases are the top causes of mortality and disability in women. Further, research results reveal that risk factors, clinical manifestations and the influence of medications all can differ depending on whether you are male or female. The authors purport that “sex-related differences in pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body) are also emerging. This is important information given that efficacy and side effects of prescribed medications may differ according to gender. It is also important information to be considered in the development of new drugs.

In our next post, we will examine further the issue of gender differences in medicine. We would love to hear your thoughts on this topic!

The Lowdown on Specialty Drugs II: Biosimilars and How to Get Your Insurance Company to Cover the Costs

Biosimilars are defined as “similar versions of an existing biological medicine by a different manufacturer.” Biosimilars may be used to treat difficult-to-manage conditions including rheumatoid arthritis, multiple sclerosis, chronic pain, HIV and cancer, among other conditions. Because they are more complex and more difficult to manufacture than other pharmaceuticals, rigid compliance to regulations and quality control are crucial to avoid contamination and drug shortages. Their complexity also means that they are more expensive for the patient.

A recent article by NBC News suggests that “the number of patients who could benefit from these more sophisticated therapies will only continue to grow, in some cases by 15% annually.” But how will we afford them?

medicineChanges are afoot in many health insurance plans, and some new rules state that any cost-savings must be weighed against severe health consequences, particularly where obtaining prior approval (an often lengthy process) or “step therapy” where a number of cheaper drugs are tried before moving on to more expensive ones. Seth Ginsberg, of the New York-based Global Healthy Living Foundation, says: “Insurance plans should not come between the patient and the doctor who is right there with them, deciding what the best course of treatment is.”

As well, the Affordable Care Act will provide some relief in 2014 when insurers will be required to restrict out-of-pocket costs, including for prescription drugs.

 

What can you do in the meantime? Kathleen Kingsbury of Reuters has these suggestions:

  • Contact the drug manufacturer directly and inquire about their Patient Assistance Program for your medication. They may be able to help you maneuver the insurance approval process.
  • Ask your doctor’s practice administrator for help. Health plans often require prior authorizations and the paperwork can be daunting. Be polite and persistent.
  • Make sure your health history, including prescribed medications, is well-documented. Ask your physician or nurse practitioner to assist you in pulling together your health record.
  • Ask your doctor for assistance and advice regarding authorizations.
  • Ask your employer for help if you have a health insurance plan through your workplace.
  • Appeal if you are denied.
  • Pay attention to deadlines.
  • Keep detailed records of all correspondence.

 

What has your experience been with obtaining biologics? What advice do you have? Please share with us!

 

The Lowdown on Specialty Drugs

Healthcare costs continue to be a concern, despite efforts underway to reduce them through healthcare reform initiatives.  One area, in particular, is worrying patients and physicians alike: specialty drugs or biologics. An article in Workforce Management reports that specialty drugs “make up about 17% of employers’ total drug costs, even though just 1% of the workforce takes them.”  Reuters reports that “approximately 57 million Americans rely on specialty drugs,” with the average prescription costing $1,766.00 in 2011.

03.27.13“Specialty drugs are high-cost drugs used to treat complex or rare conditions, such as multiple sclerosis, rheumatoid arthritis, hepatitis C and hemophilia. The drugs are often self-injected or administered in a physician’s office or through home health services,” according to Wellmark. Specialty pharmacies specialize in the delivery and clinical management of specialty drugs.  It is reported that the average cost per specialty medication is $2,000.00 per month, 10 times greater than that for nonspecialty medications, according to the 2012 Specialty Drug Benefit Report by the Pharmacy Benefit Management Institute, a research organization in Scottsdale, Arizona.

Why do specialty drugs cost so much? Workforce Management reports that “overall pharmacy spending is relatively low because of the number of drugs available in generic form, but specialty medications are derived from living organisms and have no substitute, unlike most drugs which are made chemically.”  The complexity involved in manufacturing biologics stems from the fact that these medicines are derived from living cells grown in vitro in a highly controlled environment. The risks for contamination, counterfeiting and drug shortages is higher as well.

But there are new developments that may make it easier and more affordable for patients to obtain their specialty drugs. In our next post, we will discuss the advent of “biosimilars,” and include tips on getting your insurance company to cover the costs of your biologic medications.