Public skepticism

The use in animal cancer bioassays of the estimated maximum tolerated dose, MTD, is perhaps the one issue that provokes the most heated scientific debates, as well as the greatest public skepticism about the meaning of animal data. First, what is the MTD Second, why is its use problematic ... 

Additionally, despite the progress being made improving the functional value using genetic engineering approaches, it should be considered that public skepticism on transgenic crops makes rather unlikely that the developed materials could have a commercial use in the near future [3]. 

A word of caution Any publication that claims major advantages for a particular breed of suspension or propulsion should be viewed with skepticism. 

This development has taken place remarkably quickly over the past thirty years. In that period the first attempts to arrive at a proven analytical accuracy were made. Those who led the move were often considered as people with hobbies, obsessive even. Some eye-opening publications demonstrated clearly that generating analytical results could be compared with the generation of numbers in a lottery (G. Tolg), but were received skeptically by the scientific establishment. Even as recently as the late 1970 s even the most highly respected universities still had to be made aware that a result was not necessarily an accurate result. 

Still, some members of the lay public are clearly skeptical of science and scientists, as indicated by the view of the profession presented on the cover of a national magazine in Figure 6.110 Although we may be assured that scientists as a group are no more deficient in morals than, say, cartoonists, it is important to understand the basis of public perceptions and to examine the practical implications for laboratory management. Industrial products are very widely distributed and many are used intimately. There are real consequences that can arise from a serious error in manufacture or design, as illustrated by the case of L-tryptophan. 

An effective anesthetic agent must be easy to use, quickly render the patient unconscious, and not produce any toxicity. Dr. William T. G. Morton first publicly demonstrated the use of ether as an effective anesthetic agent at the Massachusetts General Hospital on 16 October 1846 before a crowd of skeptical physicians. Raymundus Lullius, a Spanish chemist, discovered ether (CH3CH2)20 in 1275. Its hypnotic effects were soon appreciated (and enjoyed by some), but for many decades ether was only used to treat the occasional medical ailment. Even with ether, the success of surgical procedures did not improve until the introduction of antiseptic procedures and infection control some 20 years later. Ether was replaced by cyclopropane in 1929, which was replace by halothane in 1956. While anesthetic agents are desirable for the patient, exposure of hospital staff is highly undesirable and an important occupational consideration. 

Pons and Fleischman had not submitted a scientific paper about their discovery at the time of their press conference, so it was very hard for other scientists to judge the claims, but as details began to leak out, there was skepticism in the nuclear physics community, even as many other scientists and the public at large were greatly enthusiastic. 

The introduction of affinity by De Donder marks the birth of the Brussels school the first publication appeared around 1922, but it took some years to make these concepts more precise.4 What was the reaction of the scientific community When we go through the proceedings of the Belgian Royal Academy, we see that De Donder s work indeed aroused much local interest. Verschaffel from Ghent and Mund from Louvain were among the people who became active in this newborn nonequilibrium chemical thermodynamics. However, one has to say that elsewhere De Donder s approach met with skepticism and even with hostility. His introduction of affinity was thought of as merely a different notation. 

Whereas many scientists shared Mulliken s initial skepticism regarding the practical role of theory in solving problems in chemistry and physics, the work of London (6) on dispersion forces in 1930 and Hbckel s 7t-electron theory in 1931 (7) continued to attract the interest of many, including a young scientist named Frank Westheimer who, drawing on the physics of internal motions as detailed by Pitzer (8), first applied the basic concepts of what is now called molecular mechanics to compute the rates of the racemization of ortho-dibromobiphenyls. The 1946 publication (9) of these results would lay the foundation for Westheimer s own systematic conformational analysis studies (10) as well as for many others, eg, Hendrickson s (11) and Allinger s (12). These scientists would utilize basic Newtonian mechanics coupled with concepts from spectroscopy (13,14) to develop nonquantum mechanical models of structures, energies, and reactivity. 

Boehmer-Christiansen, 2000 Adamenko and Kondratyev, 1999). In principle, the positions of the anthropogenic global-warming supporters and climate skeptics have not changed since the IPCC (2007) publication. 

Not-for-proht organizations, including universities and research institutes, have a natural affinity for such partnership arrangements since they avoid the natural skepticism that comes from a profit motivation. But, even for profit, companies can create a virtual partnership by communicating clearly to the FDA—in action as well as words—a willingness to put public health and safety above short-term revenue goals. 

While the FDA is under intense congressional and public pressure to shorten the approval process, however, more profound responsibilities and pressures assure that an abbreviated process does not compromise safety and quality. Therefore, there is an inverse relationship between the amount of outside referral in a 505(b)2 and the skepticism it engenders. Subjectively viewing the process, a 505(b)2 that relies entirely on published studies and Agency findings would face maximum opposition (and, without at least a BE/ BA study, no real patent projection). A 505(b)2 that represents a combination of outside published studies and/or FDA findings with applicant-conducted studies can reduce costs, shorten the research process, and stand an excellent chance in the NDA review. 

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