Well, it is not the Los Angeles Times, the Boston Globe, the Chicago Tribune or the New York Times, proper, but the editor of the Buffalo (NY) News has called the Vytorin SEAS cancer incidence findings a "tentative link" -- do go read it all, but here is the punch-line:
. . . .Meanwhile, over in the heart and cholesterol aisle, the heavily marketed drug Vytorin is under suspicion by some experts as being a big, and potentially harmful, dud. Well, half of it is.
Vytorin is a mix of two medicines, a long-proven cholesterol- fighting statin and a newer medicine called Zetia. But the Zetia part has yet to establish that it actually helpspeople avoid heart attacks, live longer, healthier lives, or to do anything else but spend a lot more money on the new drug than it did on the old one. And one study in Norway has, very tentatively, linked Zetia to cancer.
In these cases, and many others, the FDA and the public are overly reliant on the good graces of drug companies to properly vet their medications to be as sure as possible that they not only help with disease but also don’t cause any horrible problems along the way.
Such assurances require not only extensive premarket trials but also exhaustive monitoring and follow-up afterward, which is when the drugs are used by enough people over enough time to give a real indication of their benefits and risks. That’s a moral responsibility — but if corporations don’t realize that, it should also be a mandated one. . . .
Indeed -- with a HUGE H/T to PM [a fine "cameo blogger", over at Gooznews].
I don't mean to quibble too-excessively with the editor of the above-paper, but I do believe the spirit, if not the letter of the existing federal law already requires of drug firms what the editor suggests is now only a "moral" responsibility. I may come back to that
2 comments:
Consider this -- full link:
". . .Expanding safety database resources
FDA has been working to expand significantly its access to safety information, as the following examples demonstrate:
Data use agreement with the Agency for Healthcare Research and Quality (AHRQ)
FDA has entered into a data use agreement with AHRQ to use data from the Centers for Medicare & Medicaid Services (CMS) to conduct a collaborative research project to develop data structures and methodologies for identifying and analyzing adverse drug events. The study will include three projects involving the use of four drugs in the Medicare beneficiary population. In addition to studying safety issues relating to these specific drugs, the goal of this program is to gain familiarity with CMS data, in anticipation of the availability of Medicare Part D data in the near future. (Recently initiated)
FDA and Veterans Health Administration (VHA) to share information and expertise
The Veterans Health Administration (VHA) and FDA are working under a recently signed memorandum of understanding to allow sharing of certain information related to the use of drugs, vaccines, other biological products, and medical devices. The purpose of the project is to enhance knowledge and efficiency through the sharing of information and expertise between FDA and VHA regarding medical product safety, effectiveness, and patterns of use. (Recently initiated)
Active monitoring and analysis of influenza vaccine safety
FDA's Center for Biologics Evaluation and Research (CBER) and the Centers for Disease Control and Prevention (CDC) are working closely using the Vaccine Safety Datalink (VSD) as a key database for active monitoring and analysis of influenza vaccine safety. A new initiative in collaboration with the CDC and Harvard will implement and assess the pilot testing of these and other databases to assess rapidly and prospectively the safety of seasonal flu vaccines and to be prepared to track selected adverse events related to pandemic vaccines, should they be administered widely. (Recently initiated)
In addition, under the proposed PDUFA IV recommendations, we would use PDUFA funds to obtain access to additional databases and to hire the additional epidemiologists and programmers we need to use these databases. Access to types of data other than spontaneous reports would expand FDA's capability to conduct targeted postmarketing surveillance, to look at effects of classes of drugs, and to detect signals. Access to data other than spontaneous reports is essential to the transformation of the drug safety program. (PDUFA IV Proposal)
Proposing a Sentinel Network
On March 7 and 8, 2007, FDA is sponsoring a public meeting to explore opportunities for linking private sector and public sector postmarketing safety monitoring systems to create a virtual integrated, interoperable Nationwide medical product safety network. Such a Sentinel Network could integrate existing and planned private and public sector databases to enable the collection, analysis, and dissemination of safety information about medical products to healthcare professionals and patients at point of care (i.e., in the clinic where this information is needed to make informed decisions about safe and effective treatments). FDA will engage the public and private sectors in a discussion of opportunities for public and private sector collaboration on activities that could develop the data collection and risk identification and analysis components of such a potential network. . . ."
And consider this -- full link:
. . . .The goal of CDER's Post-Marketing Surveillance (PMS) system is to monitor the ongoing safety of marketed drugs. This is accomplished by reassessing drug risks based on new data learned after the drug is marketed, and recommending ways of trying to most appropriately manage that risk. This is done through a variety of activities and tools that are outlined below. This work is accomplished primarily through CDER's Division of Pharmacovigilance and Epidemiology. . . .
[Also see the links there. . .]
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