[Also posted on Postscript]

The guilty plea and $1.5 billion settlement by Abbott to resolve their illegal off-label promotion of Depakote revealed a saga of extensive industry abuses and influence peddling that put millions of vulnerable seniors at risk. Abbott’s extensive promotion of the unapproved uses of the anti-convulsant drug Depakote to treat both seniors with dementia and to treat children is shocking. But it is even more alarming that this not the first major drugmaker to plead guilty to illegal marketing tactics that have targeted this exceptionally vulnerable population of seniors.

Many may recall that Eli Lilly was caught illegally promoting the unapproved, or “off-label” use of the antipsychotic drug Zyprexa to treat seniors with dementia, despite their internal studies showing that the risk of death from this drug increased in elderly patients.

Marketing these drugs to nursing homes for use on patients who ‘act up’ or are unruly has been a lucrative strategy for drugmakers. In response, we applaud the Department of Justice and the State Attorneys-General for their increasingly aggressive litigation to penalize these dangerous and unconscionable marketing practices.

But unfortunately for the millions of seniors who may be given Depakote or Zyprexa today or in the near future, the record-breaking $1.4 and $1.5 billion settlements respectively may not translate into improved care, unless further action is taken.

We urge Medicare and Medicaid officials at the federal and state level to move quickly to develop and implement safeguards, such as prior approvals or mandatory second opinions, that could be put in place to protect these vulnerable seniors from any unwarranted or inappropriate use of the drug Depakote to treat their dementia.

Looking forward, it’s time that all off-label settlements by the DOJ or the states include a requirement that the drugmaker pay to correct the misinformation that off-label marketing creates – i.e. that a drug is safer or more effective than it really is. Using lawsuits to fund corrective educational campaigns has a long history, both in public and private sector litigation. (See description here.)

To help stop the inappropriate and potentially harmful overuse of Depakote, Zyprexa, or Risperdal from continuing, doctors should be retrained to undo the misinformation campaigns by Abbott, Eli Lilly, and Johnson and Johnson. Several states, including Pennsylvania and New York have implemented “academic detailing” programs that send independent medical experts, usually nurse practitioners and pharmacists, to provide doctors with the truth about how effective drugs are from an objective, evidence-based perspective. Many state programs specifically address mental health drugs such as Zyprexa and Depakote. Indeed, one of the first of these education programs designed by Dr. Jerry Avorn, who spearheaded the concept in the 1990’s, recommended that a little tender loving care by nursing home staff could reduce the inappropriate use of sedatives, common at that time. A similar conclusion was reached by some nursing homes profiled in an  inspiring Boston Globe article addressing the overuse of Depakote.

– Wells Wilkinson,
Director, Prescription Access Litigation
Staff Attorney, Community Catalyst

Consumer Reports recently published a list of drugs that have heightened risks for older adults, due to the fact that as kidneys age, they lose some ability to process drugs. Consumer Reports compiled a “list of medications that are best avoided by those 65 and older, as well as a list of alternative medications.” See below:

Medicines Older Adults May Want to Avoid

Adverse drug reactions that result in emergency room visits affect older Americans nearly twice as often as young people. One reason is that as the body ages, the kidneys’ ability to process medications declines. As a result, some drugs stick around longer in the body, and others can build up to unhealthy levels if multiple doses per day are required.

At the same time, millions of older Americans take five or more medications a day, which multiplies the risk of experiencing an adverse drug event.

Consumer Reports Health has published new information to help guide people in their drug selections. A list of medications that are best avoided by those 65 and older, as well as a list of alternative medications, is included.

For example, antihistamines Chlor-Trimeton (chlorpheniramine) and Benadryl (diphenhydramine) can cause confusion, sedation and the inability to fully empty the bladder (urine retention) in people over 65. Generic cetirizine (Zyrtec), fexofenadine (Allegra) and loratadine (Claritin) are generally safer bets.

Another example is pain relievers. Aleve and Naprosyn (naproxen), Daypro (oxaprozin) and Feldene (piroxicam) can cause gastrointestinal bleeding and kidney damage. Demerol (meperidine) can cause confusion and falls. Better and safer choices include Tylenol (acetaminophen), Advil (ibuprofen), Zostrix (capsaicin cream) and for severe pain, morphine.

Click here for a complete list of drugs to avoid for older individuals.

Find more information at Consumer Report’s Best Buy Drugs about comparative effectiveness
and comparative cost for many of these medicines.

The Government Accountability Office released a report today, finding that “in several key areas, FDA rules for drug approval fail to guarantee the safety and effectiveness of drugs for seniors.” Among the problems identified:

• Inclusion of seniors in clinical trials. GAO found that drug manufacturers “generally included elderly persons and reported safety and effectiveness data for elderly persons in clinical trials.” However, in a number of cases, selected drug trials excluded participants on the basis of age, restricting the participation of seniors.
• Inadequate FDA guidance. FDA has failed to clarify important requirements in the drug evaluation process for seniors, resulting in potential information gaps. For example, FDA does not require that medical officers determine whether a sufficient number of seniors participated in drug trials.
• Failure to document safety and effectiveness. According to GAO, one-third of new drug reviews failed to include documentation of FDA medical officers’ review of drug safety and effectiveness data for seniors.

Of these, excluding or failing to recruit adequate numbers of seniors for drug trials is the most troubling. Since the clinical trials are the only data that the FDA has to determine whether a drug is safe and effective for the population that will be using it after approval, it is vitally important that the clinical trial participants be a microcosm of the much larger patient population that is likely to use the drug once it’s approved.

We know that some side effects don’t show up in clinical trials, either because of the smaller number of people taking the drug or because some side effects only surface after patients have used the drug for longer periods. The FDA at times requires drug makers to conduct “post-marketing studies” after the drug has been approved — studies designed to ferret out the drug’s true risks and side effects once the “real world” data from millions of uses are available. Yet last year, the Office of the Inspector General issued a report documenting the incredibly shoddy job the FDA does at following up and making sure that drug companies actually do these studies.

The FDA’s failure to ensure that post-marketing studies are conducted makes it all the more important that clinical trials conducted to get the drug approved accurately reflect the patient population that is likely to take the drug once it’s approved. This is doubly important for seniors, who take more drugs, are likelier to suffer side effects, and far likelier to have other, complicating conditions.