Clinical trial agreements can almost always be negotiated. Most part-time investigators, however, do not have the necessary legal expertise or time to interpret the agreement and conduct an effective negotiation. Proper legal representation at present requires an attorney who is expert in this very specialized field. Because sponsor negotiators often have huge backlogs of contracts in process, and over half of part-time investigators do not negotiate (or even read) the clinical trial agreement, an investigator who opens a negotiation may never emerge from the queue.

National news of interest.

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Recent rulings you need to know.

In recent years, during <i>voir dire</i>, plaintiffs in medical malpractice cases have sought to ask jurors about their attitudes regarding "tort reform" and the so-called "medical malpractice crisis." These efforts have increased as those issues have moved to the political front burner, receiving considerable media coverage. Only a few courts have considered the validity of such questions, but of those that have, plaintiffs generally have been permitted to inquire as to a potential juror's views on those issues, though some courts have limited the line of questioning.

The Pharmaceutical Research and Manufacturers of America reported on Feb. 22 that a record number of patients received free or discounted medications from America's pharmaceutical companies last year as part of an industry initiative to help low-income consumers access the medications they need. "PhRMA member companies know a medication that sits on a shelf, out of financial reach of patients, helps no one," said Billy Tauzin, president and chief executive officer of PhRMA. Under these programs, consumers received more than 22 million prescriptions with a wholesale value of $4.17 billion in 2004, up from 18 million prescriptions with a value of $3.4 billion in 2003.

In this Special Issue, we explore some of the new safeguards that are being proposed and put into place to protect consumers from the unintended side effects of using medications and medical devices. We also look at the controversy surrounding the importation of lower-cost medications from foreign sources, and at one case that highlighted the interplay between medical providers and drug manufacturers in marketing pharmaceutical products.

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The high cost of prescription medications in the United States has been troubling health care providers and their patients for years. Physicians worry that it will do no good to prescribe a medication to someone who won't be able to afford to buy it, and patients who try to save money by taking less than the prescribed dose worry that that they're putting their health in danger. Any failed medical treatment that harms a patient is fertile ground for a lawsuit against the physician, even if he or she is not the one to blame. Should medical practitioners suggest imported drugs to their patients who might otherwise not be able to afford their prescribed medications?

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In 2001, the U.S. Attorney in Boston charged TAP Pharmaceutical Products Inc. (TAP) with conspiring to provide urologists with thousands of free samples of Lupron', for which the doctors billed Medicare and their patients. In order to survive and continue selling its blockbuster product for advanced prostate cancer, TAP made a reasoned decision to pay the government $885 million to resolve both civil and criminal charges. With this resolution, Boston's talented federal prosecutors continued their remarkable success in bringing major pharmaceuticals to their knees and reaching landmark settlements.