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Despite such caveats, the results presented by Ray et al. warrant serious attention. A chief strength of the results is the time-limited pattern of the risk: the azithromycin-associated increase in the rates of death from any cause and from cardiovascular causes spanned days 1 through 5, reflecting the typical 5-day duration of azithromycin administration (e.g., Zithromax Z-Pak). On days 6 through 10, an elevated risk of death from cardiovascular causes was no longer detected. This pattern is consistent with the timing of peak plasma azithromycin concentrations and the concomitant risk of QT-interval prolongation. The elevated risk was statistically significant, regardless of whether azithromycin treatment was compared with amoxicillin or with nonuse of an antibacterial drug. Furthermore, the observed excess mortality was attributable solely to cardiovascular deaths and, in particular, to sudden cardiac death; although sudden cardiac death can result from causes other than arrhythmias, an increase in deaths in this category would be the pattern expected from an arrhythmogenic, QT-interval–prolonging drug. Also, the azithromycin-associated risk was higher among patients with cardiovascular disorders, which is consistent with a drug-related arrhythmia.
One partial solution would be to impose penalties on corporate executives rather than just the company as a whole. Boston whistleblower attorney Robert M. Thomas, Jr., embraces this approach: “GSK is a recidivist. How can a company commit a $1 billion crime and no individual is held responsible?â€
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.
The acquisition of relevant data to elucidate the benefit–risk ratio in the target population requires more than merely balancing the absolute numbers of patients. Depending on the drug's profile and the target population, investigators will face a learning curve with regard to acquiring data and modulating risk for patients who might be more susceptible to adverse outcomes, such as frail patients or those taking multiple medications. In designing a strategic plan for drug development, it will be important to engage in a dialogue with regulators to ensure that the needs and requirements of older patients are considered. Investigation of population pharmacokinetics or a specific pharmacokinetic study including the very elderly should be performed and will help inform prescribing. Modeling and simulation can offer powerful tools for quantitatively evaluating differences in pharmacokinetics and pharmacodynamics, recommending dosing regimens, and identifying patients at risk. Some of the lessons learned from the experience in pediatric clinical trials can be applied to the older population; heterogeneity can, in some measure, be allowed and analyzed in clinical-trial design both before and after market authorization.
We do not believe that the results of the FDA study should cause concern regarding the overall reliability of the agency's approval process for generic drugs, including the use of extrapolation, when scientifically appropriate. Technical aspects of the Budeprion formulation may have led to the failure of extrapolation in this case. More information on this issue will be generated by the other sponsors' bioequivalence studies. The other 300-mg generic bupropion products do not use the same technology as Budeprion. The use of extrapolation for the approval of multiple strengths of generic drugs, which incorporates science-based reasoning, has been generally successful, and the FDA will continue to refine its approach to this method. The agency will also move more aggressively to perform its own studies when data are urgently needed. We wish to assure the public that drug products that are approved for generic use will continue to be held to high standards of quality, safety, and efficacy.
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.
The U.S. process for approving innovative, high-risk medical devices has been criticized for taking longer than the European approval process.1 This contention is often used to support the argument that the Food and Drug Administration (FDA) should lower its standards for approving medical devices, since a slow approval process is delaying Americans' access to innovative and lifesaving technology. But a review of the data, using appropriate end points, suggests instead that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the United States as it does in the four largest European markets (Germany, France, Italy, and Britain)2 — largely because patient access is generally delayed until reimbursement decisions are made, which often takes substantially longer in Europe than in the United States.
Inappropriate formulations and packaging may contribute to low adherence, medication errors, and safety and efficacy problems. Additional considerations for a largely elderly population will include the need for easy administration, possible dose reduction, the effects of visual and motor impairment, and the likelihood of polypharmacy. If appropriate, protocols should be designed for evaluating patients' ability to manage their own medications. Regulators should also look favorably on nondrug technologies such as information and communication technology systems for monitoring adherence or clinical signs.
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 process started in 2006, when the EMA provided an opinion on the adequacy of guidance on the elderly regarding medicinal products. In 2011, the agency's Committee for Human Medicinal Products adopted the EMA geriatric medicines strategy,1 marking its commitment to improving our understanding of how best to evaluate the benefit–risk ratio for a medication in older patients.
In France, a centralized body makes reimbursement decisions after assessing the safety and effectiveness of individual devices. Reimbursement decisions in Italy are devolved to the various regions, and Britain and Germany conduct broader assessments of device types or procedures, rather than of individual devices. Typically, innovative devices not covered under an existing diagnosis-related group (DRG) require review under the lengthier Health Technology Assessment process, which assesses safety, clinical benefit, and cost-effectiveness. Government-provided information on time to reimbursement varies by country. Estimated time frames are an average of 71.3 months in Germany, a range of 36.0 to 48.0 months in France, a range of 16.4 to 26.3 months in Italy, and an estimated 18 months in Britain.
Going forward, the NIH strongly and unequivocally supports the importance of the role of the OHRP in the oversight of human subjects research. But the community will benefit from an explicit description of the process the OHRP follows for investigating complaints. For example, when questions are raised about reasonably foreseeable risks and the state of the science relevant to a particular clinical trial, appropriate independent experts might need to be consulted. Finally, we are pleased to see the DHHS plans to ensure that investigators and IRBs will have a fair and transparent process for appealing OHRP findings and compliance actions, in those situations in which reasonable people disagree about the actions taken.
In a letter dated March 7, 2013, the OHRP asserted that the study's consent form failed to convey that “the level of oxygen being provided to some infants, compared to the level they would have received had they not participated, could increase the risk of brain injury or death.â€3 That finding was influenced by research conducted in the 1950s, but in our view, it failed to assign proper weight to studies conducted in premature infants in the 2000s, which used more sophisticated oxygen-monitoring and oxygen-measurement devices, similar to those used in SUPPORT.4 The more recent studies showed no increased risk of death or neurodevelopmental impairment at saturation levels as low as 70%.5
Although we expect the age distribution of patients to be representative in studies presented for marketing authorization, postmarketing studies might also be required to consolidate knowledge regarding higher-risk subpopulations. Regulators should make better use of pharmacovigilance tools to strengthen the planning of the postauthorization phase and reduce preventable harm.
Given continuing questions about the efficacy of the 300-mg product, the FDA decided to conduct, under its own auspices, the bioequivalence study described here. Because the results indicated that Budeprion XL 300 mg cannot be considered therapeutically equivalent to Wellbutrin XL 300 mg, the FDA requested that the sponsors of Budeprion XL (Impax Laboratories and Teva Pharmaceuticals) voluntarily withdraw the 300-mg version from the market, which they agreed to do.
The Food and Drug Administration (FDA) has completed a head-to-head bioequivalence study of single doses of the generic drug Budeprion XL 300 mg (extended-release bupropion hydrochloride, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals) and the brand-name drug Wellbutrin XL 300 mg (Biovail). The agency has concluded that Budeprion XL 300 mg cannot be considered therapeutically equivalent to the brand-name product. We at the FDA are therefore changing our bioequivalence recommendations for extended-release bupropion products and have asked other manufacturers of 300-mg extended-release bupropion products to conduct additional bioequivalence studies.
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.
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.
The use of data extrapolation for the approval of Budeprion XL 300 mg should be considered in historical context. When applications for generic versions of Wellbutrin XL 300 mg began to come under FDA review in 2005, more than 11 million prescriptions for the brand-name product were being written each year. Programs to develop generic bupropion products, and the requisite bioequivalence studies, were important for addressing the widespread need for the treatment of major depressive disorder. At the same time, the FDA and sponsors recognized that bupropion conferred a dose-related risk of seizures, which the agency believed warranted a conservative approach to bioequivalence testing of bupropion in healthy volunteers. Bioequivalence studies that used only the lower strength (150 mg) reflected this conservative approach.
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.
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