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Food and Drug Administration (FDA) spokesperson Linda Grassie wrote in an e-mail that the FDA is currently reviewing the IRS report. Grassie said that the differing conclusions between the Harvard Risk Assessment and the IRS report are “striking...
Starting this week, the FDA will try to make sense of it all: the studies, published and unpublished; expert testimony from both sides; and the personal stories of ordinary people like Mark Taylor, 19, wounded in the Columbine school shootings by Eric Harris, 18, who was taking the antidepressant Luvox at the time...
...British, on the other hand, actually banned the use of Paxil (under the drug's British trade name, Seroxat) for kids last June, and went on to ban the others in the following six months. Why the difference, when British authorities were looking at the same data as the FDA? One reason is that most studies on effectiveness aren't really definitive. They don't prove one way or the other whether the drugs work significantly better than placebos--and the Brits went with the more conservative interpretation. That, argues Dr. Graham Emslie, co-chair of the American panel...
Finally, say critics, the British medical authorities looked at the evidence in an unsophisticated way. Many of the unpublished studies they reviewed came from the drug companies themselves, and at least some of those had been carried out for a very specific purpose. Under FDA rules, any company that tests its medications on young people at the FDA's request wins an extra six months' worth of patent protection, whether or not the results are positive. Since these studies were done for financial gain and weren't reviewed by independent scientists, they probably shouldn't be given full weight. Making...
...mandated by the state and protocols for handling people in a medical environment exist, but for the most part, professional standards are lacking in the industry. For example, a medi-spa's skin-care products, which generate lots of profit, are not regulated by the Food and Drug Administration (FDA). About 75% of Denese's $3 million business, for example, comes from the sale of creams and lotions she developed and tested with chemists. For Avis, about 40% of the medi-spa's revenue is from cosmetic-product sales. "The FDA has little control over the claims made for products...