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Regulators must ensure that the development and evaluation of drugs take into account global demographic changes, so that safe and effective drugs reach the patients who ultimately use them.
Renewed attention to comparative effectiveness research in the 21st century illustrates the consequences of sidelining Kefauver's initial demand for comparative data for evaluating the promotion of novel therapeutics. By 2000, pharmaceutical expenditures had become one of the fastest-growing parts of the budget of many U.S. states and third-party insurers. But the kind of knowledge required for entry into the U.S. drug market offers consumers and payers little information relevant to choosing between subtly different “me-too” drugs within the same therapeutic class — whose therapeutic effect may or may not be the same. Only in the past decade, through the action of the Reforming States Group, the Drug Effectiveness Review Project, and most recently funding of comparative effectiveness research through the American Recovery and Reinvestment Act, the Affordable Care Act, and now the Patient-Centered Outcomes Research Institute, have we begun to catch up on the vital project of comparing therapeutics so that American consumers and their physicians can make meaningful treatment decisions — the project that motivated Kefauver's original investigations a half century ago.
Within a year after gaining approval at the end of 2006, Budeprion XL 300 mg became the subject of intense media coverage describing adverse events in patients being treated for major depressive disorder who had switched to the generic drug from Wellbutrin XL. Approval of Budeprion XL 300 mg was based on the results of a bioequivalence study of Budeprion XL 150 mg and Wellbutrin XL 150 mg, which were extrapolated to the 300-mg product. Our new data provide direct comparative pharmacokinetic analyses of the 300-mg products.
The results of the FDA-sponsored study have led the agency to review its approach to other 300-mg extended-release generic bupropion products. The agency has determined that direct bioequivalence studies using the 300-mg strength of the brand-name and generic products are appropriate and feasible. Accordingly, the FDA has requested that other makers of generic extended-release bupropion hydrochloride (Anchen, Actavis, Watson, and Mylan) perform bioequivalence studies of their 300-mg products. The agency is also updating its bioequivalence guidance for these products. As new information regarding these products becomes available, the agency will take any appropriate regulatory actions and will inform the public. Patients who are taking the 300-mg strength of generic extended-release bupropion products and have questions about their medication should be encouraged to speak with their health care provider.
But questions remain about the efficacy of fines and corporate integrity agreements in deterring corporate misbehavior. The 2012 fines against Abbott Laboratories and GSK represent a modest percentage of those companies' revenue.1 Companies might well view such fines as merely a cost of doing business — a quite small percentage of their global revenue and often a manageable percentage of the revenue received from the particular product under scrutiny. If so, little has been done to change the system; the government merely recoups a portion of the financial fruit of firms' past misdeeds.
Given these data, the investigators had no reason to foresee that infants in one study group would have a higher risk of death than would those in the other group. The babies included in SUPPORT were, of course, facing substantial risks because of prematurity — the same risks as premature babies who were not enrolled in the study — but their care was never compromised for the sake of the study. The sample consent form for SUPPORT stated that each of the “possible combinations of treatments is considered by some units to represent their desired approach” (www.nih.gov/icd/od/foia/library/Records.htm). This statement describes the clinical equipoise at the time of the study, which was, in fact, the justification for conducting a clinical trial. Although the OHRP took issue with the consent form, it stated that the study design was ethical — a conclusion worth emphasizing. The increased risk of death was a significant and unexpected finding of the study; if it had been known before the study began, standard clinical care would not have encompassed the lower oxygen range, and it would have been unethical to conduct the study.
The circumstances surrounding the SUPPORT study have unquestionably created controversy in the research community, but the situation has created an opportunity for a better understanding of the scientific and ethical issues that must be addressed when designing such studies in the future. We look forward to working with the OHRP, the research community, and patient advocates to improve the effectiveness and ethical standards of research involving human participants.
It's important to provide adequate information to patients and prescribers. That's impossible if there are no good data, but sometimes data included in a drug-development dossier are not adequately reflected in the approval documents. There must be greater focus on the package insert, the regulatory document most widely referred to by the public, which must do a better job of explaining how to take the medication, whether dosage adjustments are advised for older patients, and what is known about use with concomitant medications.
Medications commonly prescribed to treat other conditions that occur frequently in patients with the condition under study should be allowed to be used during clinical trials,5 either in the pivotal phase 3 trials or — if better recruitment results would be expected — in a separate trial. Excessive “confounder cleansing” may result in the study of nonrepresentative populations.
To further illustrate this point, we compared the time to approval for five innovative, high-risk medical devices available in France, Italy, and the United States (see tableComparison of Time to Market Access for Five Innovative Devices in France, Italy, and the United States.). These case studies indicate that the average time to market access for these devices was 26.3 months in France, 30.8 months in Italy, and 15.3 months in the United States.
Even when inclusion and exclusion criteria are set adequately, clinicians and ethics review boards often act as gatekeepers in the recruitment process, creating a selection bias by allowing enrollment of only some of the eligible patients. They are particularly likely to exclude the “older old” and patients with coexisting conditions. Again, every effort should be made to gather evidence in these patients during the premarketing period of drug development. Regulatory guidance for these patients is often lacking, and more work is needed to strengthen the guidance on expectations concerning such patients when guidelines are drafted or revised.
If the corporate fines are too small, the False Claims Act will need to be amended so that a higher percentage of the revenues derived from fraudulent activities is recouped. At the same time, federal law must insist on greater transparency for clinical trial results, so that negative safety data are not hidden from clinicians and regulators.
The other major difference observed between Budeprion XL 300 mg and Wellbutrin XL 300 mg was in the time to peak drug concentration in the blood (Tmax) (see graph). Although FDA guidance does not include Tmax as a criterion for bioequivalence of bupropion hydrochloride products, the Tmax for Budeprion XL (4 hours) is shorter than that for Wellbutrin XL (5 hours). A similar difference in Tmax values was also observed in the bioequivalence study of the 150-mg products that was originally used for extrapolation of data for Budeprion XL 300 mg. But because the comparative area-under-the-curve and Cmax values for the 150-mg products fell within FDA parameters and were supported by data on the performance of the product in vitro, Budeprion XL 300 mg was approved.
Second, an accurate comparison of time to market access requires measurement of the total time that elapses between application submission and market access. Previous studies have compared the chronologic dates of application submission and market access, but the date an application is submitted varies from country to country.
Third, patient access should be equated with the availability of reimbursement rather than with device approval, because broad patient access to a new device doesn't occur until reimbursement by a national or third-party payer is available. Previous comparisons of the U.S. and European systems have used the approval date to measure process duration, but innovative, high-risk devices don't reach a market where most patients can benefit from them immediately after gaining regulatory approval, though they may be accessible to patients who can afford to pay out of pocket. Rather, there is a second level of review through which public or private insurers decide whether and at what price they will pay for a device. Generally, public systems take longer than private insurers to make reimbursement decisions, and significantly more Europeans than Americans have public insurance. Two thirds of the U.S. population is covered by private health insurance, whereas only a fifth receives publicly funded reimbursement, primarily administered by the Centers for Medicare and Medicaid Services (CMS).
An important finding of the study was a reduced incidence of ROP in the lower oxygen-saturation range. However, contrary to what was known at the time, the study also showed a slightly but significantly increased incidence of death — 19.9% versus 16.2% (P=0.04) — among infants assigned to the lower as compared with the upper range. As a result, last year the AAP amended its guidelines, citing SUPPORT, and physicians treating very premature infants are starting to use higher saturation rates to reduce the risk of death, even with the potentially higher risk of ROP at these levels. Studies such as SUPPORT that compare two alternatives, both within current standard clinical practice, often lead to critical improvements in medical care.
Clinicians must consider the arrhythmogenic potential not only of azithromycin but also of potential alternative antibacterial drugs. An earlier study showed an association between the use of erythromycin and sudden cardiac death, augmented by concomitant use of inhibitors of the cytochrome P-450 3A isozymes that metabolize erythromycin.4 Labels for erythromycin and clarithromycin include warnings regarding QT-interval prolongation and arrhythmias. All labels for fluoroquinolone products similarly have warnings regarding QT-interval prolongation, and grepafloxacin was withdrawn from the market because of that risk. A recent observational study of elderly residents of Quebec, Canada, showed an association between outpatient fluoroquinolone use and serious arrhythmias (as defined by hospital discharge diagnoses of ventricular arrhythmia or sudden or unattended death).5 And although Ray et al. found the risk of cardiovascular death to be greater with azithromycin than with ciprofloxacin, they found the risk with levofloxacin similar to that with azithromycin. The authors interpreted this similarity as evidence that levofloxacin may be proarrhythmic; however, levofloxacin was not implicated as proarrhythmic in the Canadian study.
Chronologic age alone is inadequate for characterizing the population enrolled in a clinical trial. Frailty is a predictor of clinical outcomes,4 and the reduction of frailty has benefits for individuals and society. The EMA is exploring the possibility of reaching a consensus on an operational definition of frailty and tools for evaluating it that could be used for clinical research and to guide therapeutic decisions.
One must, of course, weigh any observed drug-associated risk against clinical benefits, so it's appropriate to consider the possibility that certain offsetting benefits of azithromycin may not have been reflected in the risk data analyzed by Ray et al. For example, other studies have suggested that macrolides have an advantage over other antibacterial agents in terms of overall survival from community-acquired pneumonia. In a recent Canadian observational study, researchers followed 2973 outpatients with community-acquired pneumonia and found significantly lower 30-day mortality among patients receiving macrolides than among those receiving fluoroquinolones (adjusted odds ratio, 0.28; 95% CI, 0.09 to 0.86).2 A recent meta-analysis of observational studies showed a statistically significant 25% difference in mortality among hospitalized patients with community-acquired pneumonia favoring macrolides over nonmacrolide antibacterials.3 Such findings, which must be considered with due regard for the limits of observational studies, do not necessarily contradict the results of Ray et al. Past the 5-day period of risk of azithromycin-associated cardiovascular death, the drug might reduce the longer-term (e.g., more-than-30-day) rate of death due to pneumonia. Pneumonia was an uncommon indication among the Tennessee Medicaid patients treated with azithromycin.
Finally, these types of fraud are hard to detect from the outside. Internal documents are often critical to these cases. Most of the time, these documents are provided by internal whistleblowers. In a recent survey, researchers identified several ways in which the whistleblower provisions of the False Claims Act could be strengthened to encourage whistleblowers to come forward and to protect them from retaliation.5 Whistleblowers should be encouraged, not punished for their testimony.
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