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    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.
    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.
    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.
    However, a well-circulated grievance pointed to one unanticipated consequence of the amendments: the new burden of proof appeared to make the process of drug development both more expensive and much longer, leading to increasing drug prices and a “drug lag” in which innovative compounds reached markets in Europe long before they reached the U.S. market. Industry agitation surrounding the “drug lag” finally led to modification of the drug patenting system in the Drug Price Competition and Patent Term Restoration Act of 1984 — through further extension of drug patents. Indirectly, then, Kefauver's amendments ultimately affected both pharmaceutical pricing and patenting — in a manner diametrically opposed to the one he intended.
    The long delay between the approval of Budeprion XL 300 mg in late 2006 and the appearance of the bioequivalence results reported here, during which the product remained listed by the FDA as a generic substitute for Wellbutrin XL 300 mg, is problematic. Because of the risk of seizure associated with high doses of bupropion, the agency initially took a conservative approach to trial design. Today, the FDA has greater understanding of the risk of seizure with bupropion. At the time of the sponsor's 2007 study, some critics considered its design to be flawed. The results of the recent study by the FDA show that a design entailing the enrollment of a more accessible trial population might well have brought the bioequivalence data to light sooner. In retrospect, the conservative approach did not provide the right conclusions regarding therapeutic equivalence in a timely manner.
    The federal Office for Human Research Protections (OHRP), which is charged with providing leadership in the protection of the rights, welfare, and well-being of persons involved in research conducted or supported by the U.S. Department of Health and Human Services (DHHS), asserted in March 2013, on the basis of its own examination of the evidence, that the SUPPORT researchers failed to provide prospective parents sufficient information about the risks posed by the study. After a detailed review of the protocol, the relevant consent documents, and the research literature, we respectfully disagree with the conclusions of the OHRP, which we believe resulted from a fundamental difference in interpretations of how the regulations should apply to the state of scientific understanding when the SUPPORT study commenced. Moreover, there is a larger issue here: how risks should be conveyed in the informed-consent process when research is comparing interventions that are all considered to be the standard of care.
    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.
    The study by Ray et al. has limitations that are intrinsic to observational, nonrandomized clinical studies. In particular, nonrandomized studies cannot exclude the possibility that patients receiving a drug under evaluation differ from control patients in some important but undetected way, causing bias in the results. Such confounding may bias comparisons not only between patients receiving antibacterial drugs and those receiving no antibacterials but also between patients receiving different antibacterials. Although Ray et al. used appropriate analytic methods to address potential confounding, we cannot know for certain whether these methods were fully successful. Replication of the authors' results, through analysis of a distinct data set, would provide more confidence in the finding of increased cardiovascular mortality among patients receiving azithromycin.
    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.
    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).
    A new study by Svanström and colleagues (pages 1704–1712), using Danish national health care data, found no difference between azithromycin and penicillin V in the 5-day risk of cardiovascular death (relative risk, 0.93; 95% confidence interval , 0.56 to 1.55). However, the upper bound of the 95% confidence interval does not exclude an increased risk of as much as 55%. As Svanström et al. point out, the population they studied differed from that studied by Ray et al. with respect to the baseline risk of death and cardiovascular risk factors. Overall, the Danish patients had better cardiovascular health than the Tennessee Medicaid patients. In a subgroup analysis of patients with a history of cardiovascular disease, the risk ratio for azithromycin versus penicillin V was greater than 1, though the difference was not statistically significant (relative risk, 1.35; 95% CI, 0.69 to 2.64). Svanström et al. conclude that their results do not conflict with those of Ray et al. Rather, the effect on cardiovascular mortality may be limited to patients with cardiovascular disease.
    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.
    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.
    For both private and public systems in the United States, the pathway to patient access to a device starts with the submission of an application to the FDA. The FDA reviews innovative, high-risk devices for safety and effectiveness (clinical benefit) under the premarket approval (PMA) process, and information on the duration of reviews is publicly available. In fiscal year 2011, the FDA approved 40 applications for PMA. The average review time was 13.1 months, with 8.4 months attributed to FDA review time, and 4.7 months to the time the agency waits for the sponsor to address deficiencies in the application (“sponsor time”).3 CMS provides reimbursement for the majority of devices when they earn FDA approval. For a limited number of devices each year, however, CMS conducts a national coverage determination in response to external requests for validation or for devices that have limited or conflicting evidence of clinical benefit. This process averaged 8.6 months over the past 5 fiscal years.4 Although it is difficult to obtain data on how long private insurers take to make coverage decisions, anecdotal information from private insurers suggests that decisions are made within a few weeks to a few months after FDA approval, depending on the amount and quality of evidence of clinical benefit.
    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.
    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.
    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?”
    After the approval of Budeprion XL, the Tmax disparity between Budeprion XL 150 mg and Wellbutrin XL 150 mg remained a source of concern. This concern, along with the reports that began surfacing after initial marketing of Budeprion XL 300 mg, prompted the FDA to recommend, in November 2007, that the sponsor conduct a clinical comparison with the 300-mg product. The FDA believed that the most appropriate population for this study would be patients who had reported a lack of efficacy or unwanted side effects after switching from Wellbutrin XL 300 mg to Budeprion XL 300 mg; the protocol therefore stipulated the enrollment of such patients. By early 2008, the sponsor had begun preparing to conduct the recommended study. Unfortunately, the study was terminated because of an inability to enroll a sufficient number of patients who met the entry criteria.
    In 2011, approximately 40.3 million people in the United States (roughly one eighth of the population) received an outpatient prescription for the macrolide azithromycin, according to IMS Health. During that year, we at the Food and Drug Administration (FDA) reviewed the labels of azithromycin and other approved macrolide antibacterials in view of cardiovascular risks that had become evident from published studies and reports emerging through postmarketing surveillance. On the basis of its review, the FDA approved revisions to azithromycin product labels regarding risks of QT-interval prolongation and the associated ventricular arrhythmia torsades de pointes. The revised labels advise against using azithromycin in patients with known risk factors such as QT-interval prolongation, hypokalemia, hypomagnesemia, bradycardia, or use of certain antiarrhythmic agents, including class IA (e.g., quinidine and procainamide) and class III (e.g., dofetilide, amiodarone, and sotalol) — drugs that can prolong the QT interval. In March 2013, the FDA announced that azithromycin labels had been further revised to reflect the results of a clinical study showing that azithromycin can prolong the corrected QT interval.
    By the time Kefauver began his investigation into the pharmaceutical industry in the late 1950s, the escalating expense of lifesaving prescription drugs was illustrating that the free-market approach to medical innovation had costs as well as benefits. From the development of insulin in the 1920s, through the “wonder drug” revolutions of sulfa drugs, steroids, antibiotics, tranquilizers, antipsychotics, and cardiovascular drugs in the ensuing decades, the American pharmaceutical industry had come to play a dominant role in the public understanding of medical science, the economics of patient care, and the rising politics of consumerism. For Kefauver, the “captivity” of the prescription-drug consumer in the face of price gouging and dubious claims of efficacy under-scored the need for the state to ensure that innovative industries worked to the benefit of the average American.

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