Taking Away Your Pills

Taking Away Your Pills

Examining the Varied Blueprint for Pharmaceutical Recall and Withdrawl

16 June 2007

Product recalls are an accepted phenomenon of American commerce. Companies routinely issue public alerts to make consumers aware of defects in manufactured goods that become known through marketing surveillance. They remedy the problem by either replacing the faulty part, or if a fix is not possible, withdrawing the product entirely from the marketplace. The expectation is that the manufacturer is proactively looking out for the safety of its consumers. This process can be more complicated in the pharmaceutical industry because of the time and expense of developing and testing drugs , the difficulty in isolating a direct link to the problem from the drug in question, and - in high profile cases - lapses in ethical judgment regarding the safety of patients, clouded by the magnitude of lost potential revenue. In addition, with branded prescription pharmaceuticals, there is pressure by stakeholders to maximize the revenue of a given drug during its window of exclusivity granted by the Food and Drug Administration (FDA) before the compound is opened up to generic competition . These variables can result in a significant range of inconsistency regarding the urgency of action taken by companies in addressing products recalled or withdrawn for very similar reasons.

This paper will investigate the varied actions surrounding pharmaceutical product recall by looking at three different cases - Tylenol, Baycol and Vioxx. It will discuss the factors that weighed into the decision-making and steps taken by the manufacturers, elucidate how information was collected and disseminated, measure the swiftness of each response and examine the consequences that arose from each deliberation, both to the company and to the public. The threat or safety determination for these drugs will be considered - with the information available to them at the time - as will the action and judgment of the companies involved, to demonstrate that while there is a "blueprint" for healthcare compliance and adverse event reporting within the medical affairs departments and sales organizations of pill manufacturers, it is not necessarily standardized to the industry or always adhered to with patient safety being the primary goal.

Is it Really a Problem?

According to the Pharmaceutical Research and Manufacturers Association (PhRMA), less than three percent of medicines have been taken off of the market over the last thirty years because of safety concerns . Jeff Trewhitt, current PhRMA spokesperson said, "it should be reassuring...(but) companies that don't move quickly enough...risk receiving expensive product liability lawsuits. Both PhRMA's use of raw statistics without adequate context, as well as its position here that the chief danger of a sluggishly-executed recall is the potential for consumer litigation, underscore widespread public perception that drug recalls are not executed to the standard expected of American consumers with patient safety being the chief concern . First, minimizing this point by citing ratio of medicines on the market to those that have been pulled is ambiguous at best. There is a significant difference in the enormity of concern for the population when a multi-billion dollar drug like the anti-inflammatory Vioxx (rofecoxib), taken by tens of millions of people with chronic diseases, is suddenly pulled from the market, versus when an obscure fluroquinolone antibiotic like Tequin (gatifloxacin), used temporarily and only by a few thousand patients, is removed , . Each counts against the pool of medicines on the market equally in terms of number of compounds, however the impact on patients is largely disproportionate in the favor of Vioxx. Taking into consideration the fact that some drug-related side effects can often only be discovered upon FDA approval through post-marketing surveillance, where the numbers of patients increase exponentially over the comparatively limited populations studied during clinical trials, the reality of some drugs being recalled is inevitable, even with the highest level of investigator scrutiny. However, both before and after the point at which this link is determined, there is a financial element that has the potential to affect the course of action taken by the manufacturer. The drug companies that understand and embrace the gravity of the impact of their actions on the consumer health and public opinion have historically faired better than those who have minimized or deflected the concerns in putting revenues ahead of consumer safety.

What is at Stake?

Pharmaceutical companies undertake the costs of drug research and development with the expectation that revenues from sales will finance not only these costs for drug creation, but also the expenses for the drugs of the future. When this cycle is disrupted prematurely (prior to FDA approval, or subsequently, in the case of a recall, patent expiry), the company stands to lose in a number of ways; if one accepts PhRMA's stated costs to developing a drug, this loss to the company pipeline is upwards of a billion dollars already invested, fruitlessly. Though independent researchers have disputed these figures , the impact on shareholder stock value is inescapable, especially with the high profile and public nature of clinical trials and drug company pipelines. So there is high pressure, billions of dollars and countless jobs at stake for an exploratory compound and eventual branded drug to succeed in the marketplace.

The Father of Drug Recalls: Tylenol

The most famous and widespread drug recall in American history was the result of deliberate tampering. In September 1982, several unusual deaths in and around Chicago, IL were all traced to cyanide-laced Tylenol capsules. Authorities alerted the drug's manufacturer, Johnson & Johnson (J&J) immediately, and as news of the murders spread nationally, hospitals around the country found themselves flooded with patients concerning Tylenol and suspicions of poisoning . Some hospitals immediately banned all forms of Tylenol products . With lives already lost and its reputation at stake at the hands of an unknown killer, J&J immediately issued a nationwide warning to all doctors, distributors and the public. It then recalled every bottle of Tylenol - approximately 31 million bottles, at the cost of $125 million and immediately halted all advertising relating to the product . The month following the recall, another bottle was found contaminated in one of the batches removed from a drug store in Chicago, demonstrating