Welcome to our first theme issue of ShortCuts. This week, we decided to focus on the tribulations of the pharmaceutical industry, which recently seems to be plagued by new FDA advisories and NY Times exposés.
The first bad news for pharmaceutical companies occurred on May 2nd when the FDA expanded its black box warning on antidepressant medications, stating that the drugs may have the potential to increase suicidal symptoms in young adults between the ages of 18 and 24. The warning, previously targeting adolescents and children, now targets all people younger than 25. This black box warning, approved by a vote of 6 to 2, may confuse both patients and physicians and has the potential to deter the prescribing of antidepressants in this age group. Moreover, the risks of untreated depression clearly outweigh the potential risks of antidepressants. The warning should merely remind physicians to closely monitor these patients and alert their patients to the possibility of the drugs causing an increase in suicidal symptoms in the early weeks of treatment.
NEJM Perspective
FDA Proposal
Next came an advisory issued by the FDA outlining new safety information for erythropoiesis stimulating agents (ESAs) such as darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). The advisory stems from new studies that show an increase in death, blood clots, stroke, and heart attacks in patients with chronic kidney disease who were given higher than recommended doses of ESAs, as well as studies showing more rapid tumor growth in patients with head and neck cancer who were given higher doses. The warning advises physicians to dose ESAs with the goal of achieving the lowest hemoglobin level needed to avoid blood transfusions.
FDA advisory
Adding fuel to the fire, a NY Times report revealed that both Amgen and Johnson & Johnson, makers of Aranesp/Epogen and Procrit respectively, are paying millions of dollars annually to physicians as an incentive for prescribing these drugs. Because these drugs are injectable, they are exempt from federal laws barring drug companies from paying physicians to prescribe drugs. Instead, after buying the drugs, physicians receive rebates from the drug companies while also receiving reimbursements from Medicare or private insurers, enabling physicians to substantially profit from prescribing the drugs.
NY Times link
Later in the week, Purdue Pharma, the maker of the painkiller Oxycontin, agreed to pay $600 million in fines and payments after pleading guilty to criminal charges that it had made false statements regarding the drug’s abuse potential as part of a deceptive marketing campaign.
NY Times link
Meanwhile, in Washington this week, the Senate passed a bill by a vote of 93 to 1 that would give the FDA more policing power and require the agency to focus on the entire life cycle of a drug, rather than just deciding whether a drug should be approved. The bill calls for the establishment of a surveillance system to track adverse effects of prescription drugs, as well as a public database of the results of clinical trials. Under the bill, the government could order pharmaceutical companies to conduct more clinical trials even after a drug is already on the market. However, the bill failed to legalize the import of prescription drugs from abroad. It also further increases the FDA’s reliance on user fees from pharmaceutical companies to finance its drug review processes. This user-fee system has fostered a heavily criticized dependence of the FDA on the industry which it oversees. The House is expected to begin hearings on the bill this month, with a full vote on the bill expected in July.
NY Times link
-Cara Litvin, MD, Associate Editor Clinical Correlations
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