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The NIH is committed to ensuring that prospective research participants — and the people who speak for and love them — are given clear, complete, and accurate information about the risks and benefits of participating in research. We are strongly committed to supporting critical research studies like SUPPORT, which inform clinical care by providing rigorous evidence for use in daily practice. This controversy has alarmed some of the parents of infants who were in the study, confused the biomedical research community, and befuddled IRBs. Several other studies seeking new insights to improve care for these vulnerable infants have been put on hold as the field tries to understand the OHRP findings.
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.
These numbers may not fully capture the reasons why a device reaches the market more quickly in one country than in another and do not reflect experiences with all innovative, high-risk devices. However, unless one uses equivalent standards in terms of the level of risk, the start and end points of the process, and the key end point of market access, accurate comparisons cannot be made.
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.
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.
To compare the United States and Europe fairly on this front, three criteria must be considered: the level of device innovation, equivalent start and end points, and patient access as defined by time to reimbursement. First, we focused on innovative, high-risk devices because in the United States such devices require the strongest evidence of clinical benefit and are the subject of most debates about the relative effectiveness of approval processes in different countries. Furthermore, previous studies have shown that lower-risk devices achieve market access in a similar amount of time in the United States and in Europe.
Kefauver initially stuck to his guns on issues of compulsory licensing and patents, but his persistence ultimately cost him control of his own bill. In June of 1962, officials from the Kennedy administration and the pharmaceutical industry presented the subcommittee with an alternate bill — with no regulatory language about patents included. Kefauver cried foul, the Kennedy administration eased off its support, and S.1552 seemed to all observers to be a dead letter. It was only by chance timing that the summer of 1962 also produced a highly visible tragedy (thalidomide), a hero (Frances Kelsey), and enough ensuing public outcry to persuade Kefauver and Kennedy to embrace the gutted bill.
On July 2, 2012, the Department of Justice announced the largest settlement ever in a case of health care fraud in the United States. GlaxoSmithKline (GSK) agreed to plead guilty to three criminal counts and settle civil charges brought under various federal statutes; the company will pay a total of $3 billion to the federal government and participating states. Since 2009, the federal government has collected more than $11 billion in such settlements under the False Claims Act.
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.
We investigated the most common ambulatory indications for azithromycin by analyzing data from a survey conducted by Encuity Research of approximately 3200 office-based physicians for the decade from 2002 through 2011. Across all age groups of patients, the two most common indications for azithromycin were chronic sinusitis and bronchitis. The tableAgents Associated with Drug-Use Mentions for Chronic Sinusitis and Bronchitis, According to U.S. Office-Based Physician Practices (January 2002–December 2011). shows the antibacterial drugs that were used most commonly in the United States for these indications. Azithromycin was the leading antibacterial drug for outpatient treatment of bronchitis during this period (even if amoxicillin is combined with amoxicillin–clavulanate). For chronic sinusitis, azithromycin ranked second after amoxicillin. Because the indications are reported by the prescribing physicians, these data don't allow us to assess the diagnostic certainty regarding the infections being treated.
Depending on patients' frailty and disability status, the desirable outcome and treatment choices might vary: different patients place different values on benefits and risks. Certain adverse events, such as dizziness leading to falls, may be of greater importance in the geriatric population. The design of a clinical trial should consider age-appropriate end points; for older people, functional outcomes may be most important, and an emphasis on such outcomes could lead to reduced costs for health care systems.
Another unintended consequence of the amendments was that the new structures of proof changed not only the behavior of the pharmaceutical industry but also the conceptual categories used by biomedical researchers around the world.5 Pharmaceutical research came to be overwhelmingly organized around the placebo-controlled, randomized, controlled trial. Although this system has greatly helped researchers gauge the efficacy of an individual drug, it has also rendered data on comparative efficacy much more difficult — and much more expensive — to find or produce.
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.
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.
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 amendments granted the FDA the power to demand proof of efficacy — in the form of “adequate and well-controlled investigations� — before approving a new drug for the U.S. market. They also led to a retrospective review of all drugs approved between 1938 and 1962 (the Drug Efficacy Study Implementation program), which by the early 1970s had categorized approximately 600 medicines as “ineffective� and forced their removal from the market. These market-making and unmaking powers were also tied to a new structure of knowledge generation: the orderly sequence of phase 1, phase 2, and phase 3 trials now seen as a natural part of any pharmaceutical life cycle.
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.
After 17 months of hearings, in which pharmaceutical executives were openly berated for profiteering and doctors were portrayed as dupes of pharmaceutical companies' marketing departments, Kefauver presented his bill, S.1552. Perhaps its least controversial components were its calls for ensuring that the FDA review claims of efficacy before drug approval, monitor pharmaceutical advertising, and ensure that all drugs had readable generic names. More radically, Kefauver proposed completely overhauling the relationship between patents and therapeutic innovation. First, he proposed a compulsory licensing provision so that all important new drugs would generate competitive markets after 3 years. Second, and more controversial still, Kefauver wanted to eliminate “me-too drugs� and “molecular modifications� by insisting that a new drug be granted a patent only if it produced a therapeutic effect “significantly greater than that of the drug before modification.�1 Proving that a drug worked, according to Kefauver, was not enough: he wanted proof that a drug worked better than its predecessors. In contemporary terms, he wanted to know its comparative effectiveness.
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.
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.

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