Faculty Bibliography

The official who canceled the government trial, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said it was becoming clearer that more fundamental research and animal testing would be needed before an H.I.V. vaccine was ever marketed

Though our food is by far the safest it's ever been, food-borne bacteria is still an issue. There are 76 million cases of food poisoning in the United States every year, and 5,000 deaths. But produce is only a small part of the problem. Unfortunately, organic marketers have put up roadblocks against safeguarding produce from the occasional contaminant, despite the fact that no amount of washing is completely effective, and even among non-organic growers, culprit bacteria can be introduced at many points in the field-to-market process. Current technology that might be helpful-including methods for irradiating food and using gene-splicing techniques to neutralize toxins and introduce therapeutic proteins into plant cells-are decried by vocal consumers, despite the fact that there's no evidence to suggest that these techniques aren't safe. As far as McDonald's goes, they probably won't be missed. Tomatoes have never had a major presence there. Remember the old jingle for the Big Mac? 'Two all-beef patties, special sauce, lettuce, cheese, pickles, onions on a sesame seed bun.' No tomatoes, but plenty of calories-540 in fact, 260 of which are from fat. Overall, a Big Mac has 29 grams of fat-45 percent of the suggested daily ; value, and that's before adding a side of fries. A tomato could hardly make that meal good for you

PURPOSE: The regulatory background surrounding biosimilars (biopharmaceuticals that are considered similar in composition to an innovator product, but not necessarily clinically interchangeable); equivalence, interchangeability, and unique considerations associated with biopharmaceuticals; the biopharmaceutical protein production process; scientific facts for use in the policy discussion about biosimilars; the European Union system for biosimilars; and the current status of biosimilars legislation in the United States are described. SUMMARY: An abbreviated regulatory pathway for the approval of biosimilars, and a process for safely demonstrating the therapeutic interchangeability of these proteins, has the potential to provide meaningful cost savings. This economic advantage to patients can translate into important public health benefits. But to date, no formal regulatory process exists in the United States for bringing these drugs to market. In addition, the current tools for fully characterizing biopharmaceuticals are not--in certain cases--well developed, especially for proteins that have complex structures or are heavily glycosylated. In addition, using 'similar' but not completely 'identical' proteins interchangeably raises concerns about potentiating immunogenicity. The bottom line is that demonstrating therapeutic equivalence and interchangeability for biosimilars is not a straightforward matter--it cannot be based on the same criteria as for conventional small-molecule drugs. The science, while obtainable, is more complex. For example, it is assumed that showing that a biosimilar protein can be safely used interchangeably with an innovator protein would require, at the least, some limited clinical data and interchangeability studies. Notwithstanding the more complex scientific and clinical issues particular to protein products, most believe that a process for enabling the approval of safe and effective biosimilar proteins is not only possible, but an important public health goal. The European Union system for biosimilars may provide a model for anticipating and resolving the scientific and policy issues related to biosimilars in the U.S. However, biosimilars legislation is unlikely to be passed before the 2008 presidential election. CONCLUSION: The legal and regulatory status of biosimilars remains to be resolved in the United States as policymakers address the scientific and policy issues surrounding product manufacturing, patent terms, and clinical use

[Michael E. DeBakey]'s pioneering surgical procedures in bypassing blocked arteries in the neck, legs and heart have been performed on millions of patients around the world. By the time he stopped a regular surgical schedule, when he was in his 80s, he had performed more than 60,000 operations

Secret Life of the American Teenager [Television Program] -- The show is misleading about pregnancy tests -- home urine tests are just as effective as the urine tests available in the doctor's office, with a greater than 95% accuracy rate when used properly after a missed menstrual period. False positives on home pregnancy tests are generally not caused by strange diseases, as Amy's friends suggest, but rather by hormone-containing medications such as fertility treatments, which very few high school students are taking

The trust he earned helped shape recent history when, in a consultation in Russia, he determined that President Boris N. Yeltsin, who had fallen ill during a re-election campaign in 1996, could undergo coronary bypass surgery.

An early invention, the roller pump, devised while he was in medical school in the 1930s, became the central component of the heart-lung machine, which takes over the functions of the heart and lungs during surgery by supplying oxygenated blood to the brain