Increase in Adverse Reactions to Prescription Drugs Prompts a Few Questions

By Christine |

There was some scary news in the L.A. Times this week about the rise in the number of adverse reactions to prescription medication:

The number of serious adverse events and deaths attributed to prescription medications has nearly tripled since the Food and Drug Administration initiated a system in 1998 to make it easier to report significant side effects, researchers said Monday.

Twenty percent of drugs accounted for 87% of adverse effects, and the biggest offenders were painkillers and drugs that modify the immune system to treat arthritis, according to the report in the Archives of Internal Medicine.

A quarter of the increase could be attributed to a boost in prescriptions and an additional 15% to the introduction of new biotechnology drugs since 1998, but the rest could not be explained, said drug safety expert Thomas J. Moore of the Institute for Safe Medication Practices in Huntingdon Valley, Pa.

“The clear finding is that we are losing ground in terms of drug safety, and that ought to be of great concern,” said Moore, who led the study.

The abstract of the report published in the Archives of Internal Medicine is available online, though the full text requires a subscription. The study’s authors are affiliated with Wake Forest University School of Medicine and the Institute for Safe Medication Practices, which educates healthcare workers and consumers about safe medication practices.

The FDA and a trade group representing drug makers attribute much of the increase to more people reporting their reactions to the FDA. The L.A. Times notes, however, that studies have shown that anywhere “from as little as 3% of adverse events to a maximum of about 33% have been reported to the FDA.”

Take a look at these numbers: Between 1998 and 2005, the number of adverse reactions increased from 34,966 to 89,842, while the the number of deaths during that period increased from 5,519 to 15,105.

Women accounted for 55.5 percent of all adverse events, with elderly women accounting for a whopping one-third of all reactions, even though they only account for 12.6 percent of the population.

During that same seven-year stretch, the number of prescriptions written each year increased by 25 percent.

The story doesn’t pursue why there was a such a huge increase in prescriptions, but it does spark a few questions: Does it correspond to an an increase in the number of people who became sick? Or is it reflective of the number of new effective treatments? Or is it merely a sign of how pervasive medications have become — and how the bar has been lowered in terms of what’s considered a risk factor that needs to be treated?

For instance, a growing number of women without heart disease or diabetes are taking cholesterol-lowering statins, even though there is no clear evidence that it can reduce their future risk.

Judy Norsigian, OBOS executive director, and John Abramson, author of “Overdosed America: The Broken Promise of American Medicine,” wrote an op-ed on the subject earlier this year in which they noted the disconnect between the statin studies and the practice of prescribing the drugs:

The experts who wrote the guidelines cite seven studies that they claimed show cholesterol-lowering statins to be beneficial for such women with a 10-20 percent risk of developing heart disease in the next 10 years. But, as one of us (JA) pointed out in a recent peer-reviewed article in the respected British medical journal the Lancet, there has never been a single clinical trial showing that statin therapy is beneficial for women who don’t already have heart disease or diabetes. Not one. Even the guideline authors admit that clinical evidence to support their recommendations is “generally lacking” and that their recommendations are made by “extrapolation of data from men.”

We think this is exploitation not extrapolation.

We’d be remiss, of course, if we didn’t acknowledge how this also ties into the enormous increase in pharmaceutical advertising, both direct to consumer and to medical providers, and the commercialization of medical studies, which are now almost three times more likely to be carried out by for-profit research companies than by nonprofit medical centers.

A story published last month in the L.A. Times as part of a knock-out series on the effectiveness of pharmaceutical marketing efforts sheds more light on how drug makers are driving sales:

As marketing budgets climbed toward a 2006 high of $28 billion, sales of prescription drugs have never been higher. According to estimates published by the Kaiser Family Foundation, the number of individual prescriptions filled in the United States rose from 2.9 billion in 1999 to 3.7 billion in 2006; in 1994, Kaiser calculated that each American filled on average 7.9 prescriptions per year, including refills; by 2005, that number had risen to 12.4.

For every 10% increase in direct-to-consumer advertisements within a class of similar drugs, sales of drugs in that class (say, antidepressants or erectile dysfunction drugs) went up 1%, Kaiser found in a 2003 study. In 2000, direct-to-consumer advertising alone boosted drug sales 12%, at an additional cost of $2.6 billion to consumers and insurers.

Of more than 10,000 drugs on the U.S. pharmaceutical market, half of all marketing budgets are used to promote 50 brand-name medications, according to a 2003 study in the journal Clinical Therapy. And those 50 drugs are the ones that sell the best.

As Abramson writes in “Overdosed America”: “More care doesn’t necessarily mean better care.”

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