The U.S. Food and Drug Administration now recommends aspirin (or aspirin-containing products) should not be given to anyone under the age of 12 who has a fever, and the UK National Health Service recommends children who are under 16 years of age should not take aspirin, unless it is on the advice of a doctor. For a small number of people, taking aspirin can result in symptoms resembling an allergic reaction, including hives, swelling, and headache. The reaction is caused by salicylate intolerance and is not a true allergy, but rather an inability to metabolize even small amounts of aspirin, resulting in an overdose.
GMOgenetically modified organismsgenetically modified
The insulin produced by bacteria, branded humulin, was approved for release by the Food and Drug Administration in 1982. In 1988 the first human antibodies were produced in plants. In 1987, a strain of Pseudomonas syringae became the first genetically modified organism to be released into the environment when a strawberry and potato field in California were sprayed with it. The first genetically modified crop, an antibiotic-resistant tobacco plant, was produced in 1982. China was the first country to commercialize transgenic plants, introducing a virus-resistant tobacco in 1992.
According to the National Academy of Sciences, Philip Needleman, who was vice president of Monsanto in 1989 and president of Searle in 1993 oversaw research into COX-2 that led to the development of the anti-inflammatory drug celecoxib (Celebrex). He became senior executive vice president and chief scientist of Pharmacia from 2000 to 2003. Celecoxib was discovered and developed by G. D. Searle & Company and was approved by the FDA on December 31, 1998. It was co-promoted by Monsanto Company (parent company of Searle) and Pfizer under the brand name Celebrex. Monsanto merged with Pharmacia, from which the Medical Research Division was acquired by Pfizer, giving Pfizer ownership of Celebrex.
COX-2 selective inhibitorCOX-2 inhibitorsCOX inhibitor
Merck's scientists incorrectly interpreted the finding as a protective effect of naproxen, telling the FDA that the difference in heart attacks "is primarily due to" this protective effect. In September 2001, the United States Food and Drug Administration (FDA) sent a warning letter to the CEO of Merck, stating, "Your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)."
biotechnology revolutionbiotechnology industry20th Century
By 1988, only five proteins from genetically engineered cells had been approved as drugs by the United States Food and Drug Administration (FDA): synthetic insulin, human growth hormone, hepatitis B vaccine, alpha-interferon, and tissue plasminogen activator (TPa), for lysis of blood clots. By the end of the 1990s, however, 125 more genetically engineered drugs would be approved. The 2007–2008 global financial crisis led to several changes in the way the biotechnology industry was financed and organized.
In the United States, the Food and Drug Administration banned the sale of cyclamate in 1969 after lab tests in rats involving a 10:1 mixture of cyclamate and saccharin (at levels comparable to humans ingesting 550 cans of diet soda per day) caused bladder cancer. This information, however, is regarded as "weak" evidence of carcinogenic activity, and cyclamate remains in common use in many parts of the world, including the European Union and Russia. Mogrosides, extracted from monk fruit and commonly called luo han guo, are recognized as safe for human consumption and are used in some commercial products in the United States.
biomedical researchmedical researcherresearch
The Food and Drug Administration was formally created in 1930 under the McNarey Mapes Amendment to oversee the regulation of Food and Drugs in the United States. In 1962 the Kefauver-Harris Amendments to the Food, Drug and Cosmetics Act made it so that before a drug was marketed in the United States the FDA must first approve that the drug was safe. The Kefauver-Harris amendments also mandated that more stringent clinical trials must be performed before a drug is brought to the market.
tobacco leavessnufftobacco leaf
In the 1990s, this prompted the Food and Drug Administration to use this strain as evidence that tobacco companies were intentionally manipulating the nicotine content of cigarettes. In 2003, in response to growth of tobacco use in developing countries, the World Health Organization successfully rallied 168 countries to sign the Framework Convention on Tobacco Control. The convention is designed to push for effective legislation and its enforcement in all countries to reduce the harmful effects of tobacco. This led to the development of tobacco cessation products. Many species of tobacco are in the genus of herbs Nicotiana.
IARCInternational Agency for Research on Cancer (IARC)Group 4
European Prospective Investigation into Cancer and Nutrition. European Organisation for Research and Treatment of Cancer (EORTC). Genotoxic. Mutagen. National Cancer Institute (US). Toxicology.
NSAIDNSAIDsnon-steroidal anti-inflammatory drug
On 9 July 2015, the Food and Drug Administration (FDA) toughened warnings of increased heart attack and stroke risk associated with nonsteroidal anti-inflammatory drugs (NSAID). Aspirin is an NSAID but is not affected by the new warnings. A 2005 Finnish study linked long term (over 3 months) use of NSAIDs with an increased risk of erectile dysfunction. The study was correlational only, and depended solely on self-reports (questionnaires). A 2011 publication in The Journal of Urology received widespread publicity. According to the study, men who used NSAIDs regularly were at significantly increased risk of erectile dysfunction.
non-Hodgkin's lymphomanon-Hodgkin’s lymphomanon-Hodgkin
The American Cancer Society lists Non-Hodgkin lymphoma as one of the most common cancers in the United States, accounting for about 4% of all cancers. In Canada, NHL is the fifth most common cancer in males and sixth most common cancer in females. The lifetime probability of developing a lymphoid cancer is 1 in 44 for males, and 1 in 51 for females. On average, according to data for the 2014-2016 period, around 13,900 people are diagnosed with NHL yearly. It is the sixth most common cancer in the UK, and is the eleventh most common cause of cancer death accounting for around 4,900 deaths per year.
human immunodeficiency virusHIV-positiveHIV positive
AIDS is a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. Without treatment, average survival time after infection with HIV is estimated to be 9 to 11 years, depending on the HIV subtype. In most cases, HIV is a sexually transmitted infection and occurs by contact with or transfer of blood, pre-ejaculate, semen, and vaginal fluids. Research has shown (for both same-sex and opposite-sex couples) that HIV is untransmissable through condomless sexual intercourse if the HIV-positive partner has a consistently undetectable viral load.
In the U.S., the Elixir Sulfanilamide disaster led to the establishment of the Food and Drug Administration, and the 1938 Federal Food, Drug, and Cosmetic Act required manufacturers to file new drugs with the FDA. The 1951 Humphrey-Durham Amendment required certain drugs to be sold by prescription. In 1962, a subsequent amendment required new drugs to be tested for efficacy and safety in clinical trials. Until the 1970s, drug prices were not a major concern for doctors and patients.
clinical trialsclinical studiesclinical study
After approval for human research is granted to the trial sponsor, the U.S. Food and Drug Administration (FDA) organizes and monitors the results of trials according to type: Clinical trials are conducted typically in four phases,with each phase using different numbers of subjects and having a different purpose to construct focus on identifying a specific effect. Clinical trials involving new drugs are commonly classified into five phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug development process will normally proceed through phases I-IV over many years, frequently involving a decade or longer.
laserslaser beamlaser light
Lasers are used to treat cancer by shrinking or destroying tumors or precancerous growths. They are most commonly used to treat superficial cancers that are on the surface of the body or the lining of internal organs. They are used to treat basal cell skin cancer and the very early stages of others like cervical, penile, vaginal, vulvar, and non-small cell lung cancer. Laser therapy is often combined with other treatments, such as surgery, chemotherapy, or radiation therapy. Laser-induced interstitial thermotherapy (LITT), or interstitial laser photocoagulation, uses lasers to treat some cancers using hyperthermia, which uses heat to shrink tumors by damaging or killing cancer cells.
Results regarding a possible association with liver cancer and biliary tract cancer are conflicting: workers who did not have direct occupational DDT contact showed increased risk. White men had an increased risk, but not white women or black men. Results about an association with multiple myeloma, prostate and testicular cancer, endometrial cancer and colorectal cancer have been inconclusive or generally do not support an association. A 2017 review of liver cancer studies concluded that "organochlorine pesticides, including DDT, may increase hepatocellular carcinoma risk".
If a vaccine passes all of the phases of testing, the manufacturer can then apply for licensure of the vaccine through the FDA. Before the FDA approves use in the general public, they extensively review the results to the clinical trials, safety tests, purity tests, and manufacturing methods and establish that the manufacturer itself is up to government standards in many other areas. However, safety testing of the vaccines never ends even after FDA approval. The FDA continues to monitor the manufacturing protocols, batch purity, and the manufacturing facility itself.
National Cancer Institute. In 2006, the U.S. Food and Drug Administration (FDA) approved the first preventive HPV vaccine, marketed by Merck & Co. under the trade name Gardasil. In Australia, Aboriginal women are more than five times more likely to die from cervical cancer than non-Aboriginal women, suggesting that Aboriginal women are less likely to have regular Pap tests. There are several factors that may limit indigenous women from engaging in regular cervical screening practices, including sensitivity in discussing the topic in Aboriginal communities, embarrassment, anxiety and fear about the procedure.
Bayer AGBayer CropScienceBayer HealthCare
Nexavar (sorafenib) is a kinase inhibitor used in the treatment of liver cancer (hepatocellular carcinoma), kidney cancer (renal cell carcinoma), and certain types of thyroid cancer. Trasylol (Aprotinin) Trasylol is a trypsin inhibitor used to control bleeding during major surgery. In a 2006 meeting called by the FDA to review the drug's safety, Bayer scientists failed to reveal the results of an ongoing large study suggesting that Trasylol may increase the risks of death and stroke. According to a FDA official who preferred to remain anonymous, the FDA learned of the study only through information provided to the FDA by a whistleblowing scientist who was involved in it.
genetically engineeredgenetically modifiedgenetic modification
The insulin produced by bacteria was approved for release by the Food and Drug Administration (FDA) in 1982. In 1983, a biotech company, Advanced Genetic Sciences (AGS) applied for U.S. government authorisation to perform field tests with the ice-minus strain of Pseudomonas syringae to protect crops from frost, but environmental groups and protestors delayed the field tests for four years with legal challenges. In 1987, the ice-minus strain of ''P. syringae'' became the first genetically modified organism (GMO) to be released into the environment when a strawberry field and a potato field in California were sprayed with it.
defoliantSuper OrangeAgent Orange Product Liability Litigation
=Soft tissue sarcoma; Non-Hodgkin lymphoma (NHL); Hodgkin disease; Chronic lymphocytic leukemia (CLL); including hairy cell leukemia and other chronic B-cell leukemias =Respiratory cancers (lung, bronchus, trachea, larynx); Prostate cancer; Multiple myeloma; Bladder cancer =Mouth, throat, and sinus cancers; Gastrointestinal cancers (esophagus, stomach, pancreas, colon, rectum); Liver, gallbladder, and bile duct cancers; Bone and joint cancers; Skin cancers; Breast cancer; Female reproductive cancers (cervical, ovarian, endometrial, uterine sarcoma); Testicular and penile cancers; Kidney cancer; Brain tumors; Cancers of endocrine glands (thyroid, thymus, etc.); Leukemia (other than CLL and hairy
acute lymphocytic leukemiaacute lymphoblastic leukaemiaALL
Acute Lymphocytic Leukemia at American Cancer Society. Childhood ALL Treatment at National Cancer Institute.
OCIFDA's Office of Criminal InvestigationsUnited States Food and Drug Administration Office of Criminal Investigations
OCI Special Agents are dedicated to protecting the health and welfare of the public by investigating criminal allegations falling within the jurisdiction of the U.S. Food and Drug Administration (FDA). OCI Special Agents are hired from a variety of federal law enforcement agencies, such as the U.S. Drug Enforcement Administration, Immigration and Customs Enforcement, the U.S. Secret Service, the U.S. Postal Inspection Service, the Federal Bureau of Investigation, and the Internal Revenue Service Criminal Investigations.
Current research directions for lung cancer treatment include immunotherapy, which encourages the body's immune system to attack the tumor cells, epigenetics, and new combinations of chemotherapy and radiotherapy, both on their own and together. Many of these new treatments work through immune checkpoint blockade, disrupting cancer's ability to evade the immune system. Ipilimumab blocks signaling through a receptor on T cells known as CTLA-4 which dampens down the immune system. It has been approved by the US Food and Drug Administration (FDA) for treatment of melanoma and is undergoing clinical trials for both NSCLC and SCLC.
bladderbladder carcinomacancer of the bladder
M1a: The cancer has spread only to lymph nodes outside of the pelvis. M1b: The cancer has spread other parts of the body. G1 – Well differentiated. G2 – Moderately differentiated. G3 – Poorly differentiated. Papillary lesions. Urothelial Papilloma. Papillary urothelial neoplasm of low malignant potential (PUNLMP). Low Grade. High Grade. Flat lesions. Urothelial proliferation of uncertain malignant potential. Reactive atypia. Atypia of unknown significance. Urothelial dysplasia. Urothelial CIS (always high grade). Primary. Secondary. Concurrent. Non-muscle invasive: transurethral resection of bladder tumor (TURBT) with or without intavesical chemotherapy or immunotherapy. Muscle invasive.