Parker Waichman LLP Injury Alerts
How the Public is Victimized and Put at Risk While the Pharmaceutical Industry Profits from the Over-prescribing and Mis-prescribing of DrugsJun 1, 2006
The American Medical Association (AMA) and many individual doctors are strongly advocating moratoriums on consumer advertising promoting new drugs and medical devices until the products have been shown to work and to be safe. The AMA has urged the Food and Drug Administration (FDA) to require manufacturers to wait for an unspecified period after a drug or device is approved before launching direct-to-consumer (DTC) advertising campaigns.
Doctors have complained about patients who demand inappropriate drugs after being persuaded by DTC advertisements. In addition, many experts are concerned over what they believe to be “disease mongering” by the pharmaceutical industry by either creating or overemphasizing diseases in order to drive up the demand (or perceived need) for certain drugs.
Direct-to-Consumer (DTC) advertising has become the most important form of marketing practiced by pharmaceutical companies. By employing mass media advertising directly to the general public on television and radio, in print, or on billboards, signs, or posters, drug companies are able to target different segments of the population by presenting appealing information about a specific drug or treatment.
There are two major problems that result from massive amounts of DTC advertising. The first is that consumers only get hand-picked (positive) information about a prescription drug presented in a very appealing way while more important information about serious side effects is either omitted or intentionally downplayed.
A second problem is that consumers become so taken by the advertising claims linked to happy, smiling, and otherwise carefree-looking actors that they literally demand drugs from their doctors that may not be right for their condition or illness. In order to keep patients or to avoid unnecessary conflict, doctors often appease their patients by writing prescriptions for drugs that are either unnecessary, inappropriate, far more expensive than older, safer, and more effective drugs, or for off-label uses that are questionable at best and potentially dangerous.
DTC advertising has created irrational demands for new drugs that are far more expensive than older, safer alternatives by making it appear as if the newer drugs are miracle cures, which they are not. This has created a dangerous phenomenon that has become known as overmedicating.
Overmedicating leads to consumers placing unnatural and excessive reliance on expensive prescription drugs when over-the-counter (OTC) remedies, lifestyle changes, or counseling could be equally, or even more, effective. Antidepressants and painkillers, in particular, are among the prescription drugs most often associated with overmedicating.
The bottom line is that overmedicating is a dangerous misuse of some of the most powerful prescription drugs that can lead to serious complications and even death. Overmedicating often results when a drug gains acceptance among doctors or patients for what is known as off-label uses.
Off-label prescribing occurs when a drug is used in a way for which it was not intended or as a therapy, cure, or treatment for one or more conditions for which it has not been approved. While this type of use can lead to a more expansive application of a successful drug, it can also cause a higher incidence of known side effects as well as unforeseen adverse reactions that can be quite serious or even deadly.
The off-label prescribing of drugs beyond the scope of their FDA approval has become a serious concern in recent years. Dosage levels, medical conditions, and treatment durations for which drugs were never intended or tested make the entire area of off-label use problematic at best. There is also the problem of off-label prescribing to age groups (infants, adolescents, and seniors) for which no, or insufficient, clinical data exists. At its worst, the practice can be downright deadly.
The incredibly strange thing about off-label use, however, is that doctors may prescribe drugs to treat conditions for which the Food and Drug Administration has even denied approval. Thus, while a manufacturer cannot market a drug for an unapproved off-label use, a doctor may prescribe the drug for that use.
While it is highly unlikely that DTC advertising will be significantly curtailed anytime soon, a concerted effort by doctors, the AMA, and consumer advocacy groups to increase public awareness of the dangers associated with overmedicating could encourage the public to question the claims and representations contained in advertising campaigns rather than blindly accept them.
There are many examples of how DTC advertising has led to overmedication problems. Powerful medications are being prescribed for children and adolescents even when the FDA has not approved those medications for treating any specific disorder in children or adolescents.
The FDA regularly discourages and even warns against such uses of drugs, specifically antipsychotics, heart medications, and antidepressants. It is extremely dangerous for a child to take a medication that is only approved for adults or is only approved to treat one specific condition.
A study by Medco Health Solutions, a managed-care company, found an 85% increase in the use of sleeping pills among children and young adults between 2002 and 2004. According to the study, about 15% of the adolescents who took sleeping pills were also taking drugs to treat attention deficit (ADD) and hyperactivity disorder (ADHD). Since those drugs can cause insomnia, the sleeping pills may actually be little more than an attempt to counteract that side effect.
In 2004, the FDA announced that some antidepressants were linked to an increased risk of suicide in adolescent patients. While medical professionals recommend that adolescents who have been diagnosed with depression be treated with a combination of psychotherapy and medication, researchers discovered that between 1995 and 2002, antidepressants became the most popular type of treatment for depression in adolescents. Alarmingly, while Prozac is the only antidepressant that has been approved for use in children, the study found doctors were prescribing a number of other powerful mood-altering drugs to their young patients.
Natrecor, or nesiritide, manufactured by Scios, was approved by the FDA in 2001 to treat congestive heart failure or acute decompensating heart failure in which patients experience shortness of breath when the heart fails to adequately pump blood to other organs in the body. The drug works by mimicking a hormone-like molecule that dilates vessels to prevent blood from gathering in the heart and lungs thereby allowing the patient to breathe. As many as 600,000 patients have been treated with the drug since its approval. Natrecor was, and still is, supposed to be used for the sole purpose of treating hospitalized patients with the aforementioned heart conditions.
Despite this express limitation on its approved use; Natrecor has become an increasingly popular option in outpatient clinics nationwide where it is used for far longer periods than it was originally approved for. Some outpatient clinics even administer Natrecor twice weekly for up to 12 weeks. This type of use is considered to be extremely dangerous as no study has been conducted to confirm whether long-term use is either safe or effective. This “off-label” use of Natrecor has lead to the discovery of severe side-effects and a subsequent push from medical experts and consumer advocates for the manufacturer to conduct further large-scale, longitudinal studies of the drug.
Unapproved use of atypical anti-psychotic drugs such as Abilify, Zyprexa, Seroquel, Risperdal, Clozaril, Geodon, and Symvyax can lead to severe health risks in elderly patients. While these drugs are approved to treat mental illnesses such as schizophrenia and depressive episodes associated with bipolar disorder, they are not approved for treating dementia in elderly patients. Nonetheless, doctors have been prescribing them extensively for this “off-label” use.
For many people, prescriptions drugs are necessary and beneficial and can even prolong or save lives. For others, however, prescription drugs are unnecessary, inappropriate, or even dangerous. For example, a recent comprehensive review of studies of off-label and over-prescribing in older patients found that 21.3% of patients 65 years or older, who were not residents in nursing facilities, were using at least one drug that was inappropriately prescribed.
Off-label and over-prescribing wastes tens of billions of dollars annually and often places an unnecessary financial burden on less affluent Americans and those without prescription drug coverage.
But perhaps the most serious situation is the amount of people who are hurt or killed by prescription drugs each year. As reported in Adverse Drug Reactions, more than 1.5 million people are hospitalized and more than 100,000 die each year from largely preventable adverse reactions from drugs that should not have been prescribed in the first place.
Public Citizen points out what it describes as the “seven all-too-often-deadly sins of prescribing.” These include
- The “disease” for which a drug is prescribed is actually an adverse reaction to another drug, masquerading as a disease but unfortunately not recognized by doctor and patient as such. Instead of lowering the dose of the offending drug or replacing it with a safer alternative, the physician adds a second drug to the regimen to “treat” the adverse drug reaction caused by the first drug.
- A drug is used to treat a problem that, although in some cases susceptible to a pharmaceutical solution, should first be treated with commonsense lifestyle changes rather than automatically reaching for the prescription pad.
- The medical problem is both self-limited and completely unresponsive to treatments such as antibiotics or does not merit treatment with certain drugs. This is seen most clearly with viral infections such as colds and bronchitis in otherwise healthy children or adults.
- A drug is the preferred treatment for the medical problem, but instead of the safest, most effective—and often least expensive—treatment, the physician prescribes a dangerous or much less preferable alternative.
- Two drugs interact. Each on its own may be safe and effective, but together they can cause serious injury or death.
- Two or more drugs in the same therapeutic category are used, the additional one(s) not adding to the effectiveness of the first but clearly increasing the risk to the patient.
- The right drug is prescribed, but the dose is dangerously high. This problem is seen most often in older adults, who cannot metabolize or excrete drugs as rapidly as younger people, and in small people, who are usually prescribed the same dose as that prescribed to people weighing two to three times as much as they do.
Researchers at the University of Toronto and at Harvard have now documented and described what they call the prescribing cascade.
The problem begins when an adverse drug reaction is misinterpreted as a new medical condition. Another drug is then prescribed, and the patient is placed at risk of developing additional adverse effects relating to this potentially unnecessary treatment.
Two recent studies have documented the costly and dangerous considerable over-prescribing of antibiotics for viral conditions that do not respond to these drugs. Some 44% of children under 18 were given antibiotics for treatment of a cold and 75% for treatment of bronchitis. Similarly, 51% of people 18 or older were treated with antibiotics for colds and 66% for bronchitis.
Despite the lack of evidence of any benefit for most people from these treatments, more than 23 million prescriptions a year were written for colds, bronchitis, and upper respiratory infections.
When doctors prescribe additional drugs to treat side effects caused by prior medications, the result is often what has been dubbed “Drug-Induced Diseases,” which include drug-induced Parkinsonism, depression, sexual dysfunction, insomnia, psychoses, constipation, and many other problems.
Also, drug interactions can cause health problems that are worse than the original condition. When serious drug interactions are not detected or unknown, they can cause serious injury or death. In addition to drug interactions, sometimes two drugs from the same “category” of medications are prescribed thereby producing a potentially dangerous cumulative effect by far exceeding the recommended dosage.
There are also many conditions that do not need to be treated with prescription drugs. Some medical problems can be remedied with lifestyle changes and some psychological problems can be treated with therapy as opposed to antidepressants. Yet many people go the route of prescription drugs because they are marketed as a quick fix, a miracle cure. Also, the cheapest and safest treatments are often not what people request or what doctors end up prescribing.
The pharmaceutical industry sells about $216 billion worth of drugs in the United States alone. Upwards of $21 billion a year is spent to promote drugs using DTC advertising and other promotional tricks. Studies have shown that a large amount of the information in these ads is false or misleading and violated FDA laws and regulations concerning advertising.
Many factors in addition to rampant DTC advertising also lead to massive over-prescribing or mis-prescribing of drugs. These include premature approval of drugs by the FDA or approvals that do not reflect limitations or restrictions that should be imposed, or that later must be imposed, on a drug’s use, drug companies targeting physicians with all types of incentives to generate prescriptions, biased or misleading clinical trials used to influence medical journals or doctors, and pharmacists who engage in unethical practices that contribute to off-label, misuse and over-prescribing of drugs.
The public’s willingness to accept unrealistic advertising, misinformation, or abbreviated data is also a factor relied upon by the drug industry to stimulate sales and drive demand up. In this regard, the consumer is his own worst enemy and the drug companies take full advantage of that fact.
As always, if you believe you or a loved one has been injured by any prescription or over-the-counter (OTC) medication, please do not hesitate to contact Parker & Waichman at www.yourlawyer.com for a free consultation. Our firm is currently engaged in, or investigating the possibility of, litigation involving several prescription and OTC drugs. We invite you to review the extensive materials provided on our award winning Web site with respect to any particular drug or medical device profiled there.