Drug Warning Labels Should Include FDA Ties to Big Pharma


They're just dropping like Chinese imports -- prescription drugs that turn out to be deadly after FDA approval.

Not just Vioxx -- recently found to cause kidney problems on top of the heart attacks for which it was pulled -- but its seven deadly sisters named by the FDA's Dr. David Graham before Congress in 2004: Crestor, Meridia, Serevent, Lotronex, Arava, Accutane and Bextra.

After a post-Vioxx damage control campaign -- "FDA has confidence in the safety and efficacy of Crestor" read AstraZeneca ads which the FDA pulled -- it wasn't that confident. The cholesterol drug Crestor was found in the heart journal Circulation to be eight times more likely to cause rhabdomyolysis, kidney failure or spillage of protein in the urine than other cholesterol drugs.

Thirty users of Meridia, Abbott Laboratories' weight-loss drug, died of cardiovascular problems from 1997 to 2003 and 224 other experienced nonfatal strokes, heart attacks and other cardiovascular ailments according to FDA reports.

And Accutane manufacturer Hoffman-La Roche Inc. goes to trial this October in Madison County, Illinois -- where the first Vioxx trial occurred -- to defend charges that its acne drug caused Jason Peipert's inflammatory bowel disease, which ruined the young soccer star's career.

Then there's Sanofi-Aventis' notorious antibiotic Ketek -- blamed in the death of four and liver injury or failure of 37 since 2004 -- whose primary clinical trials doctor, Anne Kirkman Campbell, is in federal prison in Lexington, KY for forging data for money. (Test subjects included her entire staff and members of her family.)

Another doctor upon whose clinical data Ketek was approved conducted trials while his medical license was on probation and was arrested for cocaine and gun possession soon after.

And consider the atypical anti-psychotics whose marketing was also "atypical," with 29 percent of AstraZeneca's Seroquel sales coming from off-label Alzheimer use, even though studies say it worsens the condition. Or Eli Lilly settling 29,000 lawsuits from inadequate warnings about Zyprexa's diabetes, weight gain and pancreas infection side effects.

Finally there's GlaxoSmithKline's Avandia, prescribed for 1 million Americans for type 2 diabetes and now known to increase the risk of heart attack by 43 percent and cardiovascular death by 64 percent.

Avandia is more expensive and dangerous than older drugs and NOT more effective, said Dr. Graham to a joint panel of experts convened to consider the drug in July -- a charge he could also level against the other suspect drugs and Big Pharma itself.

But instead of pulling the purloined drugs, the FDA just adds warnings and subtracts uses.

Ketek is no longer recommended for sinus infections; just community acquired pneumonia.

Meridia is only recommended for people who have to lose 30 pounds or more who don't have poorly controlled hypertension, a history of heart disease, stroke or severe liver or kidney disease.

And Accutane users are clearly warned about suicidal behavior, birth defects and inflammatory bowel disease risks to the drug on the label.

Because pulling the drugs not only affects sales, company image and stock price, it feeds lawsuits. ("The drug was so unsafe they PULLED IT FROM THE MARKET.")

Besides, thanks to fast-tracking and six-month approvals, no one knows if a drug is dangerous anyway until a critical mass of human guinea pigs takes/tests it. Only about 3,000 people are tested in clinical trials that are conducted premarket, and what if the drug harms one in every 3,001? Do you really think lethal tests on beagles and other mammals keep you safe? Talk about dying in vain.

But finally, pulling a drug after approval just casts light on the approval process itself, which is teeming with conflicts of interest. Ninety-two percent of FDA advisory meetings in the last decade included a member with financial ties to drug companies, according to USA Today -- the FDA calls them sponsors -- and federal law against using experts with financial conflicts of interest was waived 800 times.

Too bad THAT can't be on the warning label.

Serial number: 513 The Fatalism: tarsal line by the mites Total Kelading Name: Tarsonemoidea Fatalism: tarsal mite Branch Line Kelading Name: Tarsonemidae Species Name: Multi-lateral tarsal Fresh line mite The Latin species name: Polyphagotarsonemus fishes (Banks) Domestic distribution: Beijing, Tianjin, Shanghai, Hunan, Hubei, Jiangxi, Zhejiang, Jiangsu, Anhui, Sichuan, Guizhou, Yunnan, Guangdong, Guangxi, Hainan, Hebei, Henan, Shandong, Fujian and Taiwan Foreign distribution: Other States Morphological characteristics: female mite-mite body length 200-250 um, um wide 100-150. Oval back Lung abdominal between. Pale yellow or orange-yellow, translucent, a sheen. The jaw of small, nearly circular; Emphasis of the limb. Before and after the half-foot of a hyphen between separated. Before the foot of the former full-back hair two pairs; At the foot of a phony anterolateral valve for one pair of false-end of the expansion valve. The second half of the five individual sections, sections of a horizontal line between separated from the first quarter there, the hair of one pair of shoulders; Section II has one pair of back hair; Sections III and IV have been healed, no hyphen is separated from the hair and lumbar cage with the one pair of wool; Section V 1 on the tail hair right. Four pairs of abdominal Mask Festival, the epidermis sudden, before there are two pairs of feet abdominal hair, the second half of a 5-6 right abdominal hair. Have a full end of a stout claws; Foot 11, IH claw end of degradation, but the film developed claws pad; IV Foot slender, underdevelopment, the end of a whip - thorn-like hair and the hair of the Asia-1. Spindle-mite-long 160-180 um, um wide 80-90, opal to pale yellow. Cross section of the group back to play, before full-back hair 3 right. The second half of the first, two merger; The third, also with four, two pairs of back hair, section V of tail hair. Among non-claw feet, but claw pad; W developed foot, the medial-section shares outstanding like distance, and the Festival of shares into sections of plastic sections, slender, curved inward, proximal Department hispida a whip, claws degradation of the buttons. Oval Eggs, milk-white, translucent, long trail 100-110 urn, short track 70-80 um, table eggs are vertical with a small number of firms white warts sudden, every trip 6-8. You if You Mite Mite near the Oval, milky white or light green, of Diamond, the latter half of the festival was, at the end of the cone on the 2 1 hispida right. If mite-long oval of about 150 um. Biological characteristics: more fresh tarsal side of the main hazards mite leaves, followed by Soft Ukraine tablets, fruit. Victims of leaves in the rough brown spots, along the leaf edge of the leaf curl, leaf qualitative hard brittle hair, mesophyll thickening, shoots shrinking fish toxin disease was serious brown leaf, not the victims of the new plant leaves, shoots out not seriously affect tea production. Victims often fruit cracking, the value of goods declined. According to the determination of tea shoots suffer heavier losses of 63.2%, crude Cha 51.9% weight loss, small weight losses of Caijing 81%. As of the middle of the victims in Sichuan and Yunnan leaf species, the loss of moisture were 3.35% and 1.72%, flooding a loss of 16.38% and 10.22%, 21.08% loss of tannin and 10.6%, tea polyphenols decreased 9 .7%, significantly affect the yield and quality of the tea. Besides fresh multi-lateral line tobacco whitefly predator mites can therefore Genus Omnivorous mites. This mite-leaf or in the words of wrinkles habitat, and harm reproduction. This mite-harm young plants, the distribution of the tip is: at the top of the second leaf mite of the total number of mites for 88.9%, while the first - and third of the total respectively 4.2% and 6.9%. It indoor distribution: When the death rate of 37.5-42%, gathered for distribution; This is a large number of uniform distribution. Propagation approach to gender-based reproductive, their descendants a male and female of two individuals; Estrogen, male ratio: about 2-4:1 in indoor and outdoor about 10:1. Middle-camp also parthenogenesis, received all-mite future generations, but parthenogenesis egg hatchability only 40.2%. Adults are more lively, especially male mites, more agile operation; It often carry mites crawling if estrogen, estrogen once if mites emerged as adults, which mate immediately. Mating was a chevron, mating for about a minute. - Mite can be repeated mating, the female mite to a mate based. Copulation 1-2 days after spawning. Each of the first female mite eggs on the average of two to four tablets, the total amount of spawning 23.7-245.7 tablets. Spawning period as long as 15 days a regulation. Female mites life 4-74 days. Estrogen overwintering mites can survive six months. Close mite migration initiative is crawling on its rapid, passive and long-distance migration was mainly on seedlings, wind, water, Farm Implements, people, animals and insects carry. L can occur in a 30 and 25. In warm areas or in the greenhouse can outlast growth, development and reproduction, while in the field with estrogen in the leaf curl mite, bud scales, crack and petiole mosquito wax shell and clover on the winter. According to a survey such as this mite in the winter except at the wrong angle and 72.4% of the crust, in the old petiole 12.6% in the trunk of tea 10.8%, in other places, at 4.2%. March-April next spring between the hibernate.n

C. Humidity on the hatching eggs and young, if mites greater impact on the growth and development, relative humidity less than 80%, egg hatchability very low or even zero, David, if the mite growth was inhibited; But if the base of eggs for dry, the cold can play a role in alleviating and reducing egg hatchability impact. Adults right humidity is not strictly required, but wetter or rainstorm can mites in sharp decline. Fresh line of multi-lateral mites in a regular session of the two peaks, usually in June through August, and then not only is more appropriate for the temperature, but with good food conditions (summer and autumn long-wang) close. Moreover, in custody tea, tea and autumn tea Young did not adopt the net generally suffer heavier tea, anti-mite varieties of the poor also suffer heavy. Control methods: 1. Outside a quarantine is to prevent or control the risk of the spread-mite proliferation and the spread of effective measures. If the material is checked seedlings, cuttings and scion found harmful pest mites in various states there can be 40% Omethoate 1000 fold, 75% s Ngong 1000-2000 fold benefit, or 25% more insecticidal 0 3 H agent 600-1000. L - 0.5 Baume mixture of lime sulfur, insecticidal rate can be up to 90% can also kill eggs rate above 80%. If an alternate for the application (including the planting), we can eliminate the basic pest mites.n

C, for the temperature, there will be undoubtedly very good results. 2. Use of cultivation and management measures and the election plant cultivation and management of anti-mite measures properly, can control the pest mites in the economic threshold below. Planting, weeding row, timely irrigation and fertilization is commonly used and effective cultivation and management measures. Tea-picking and timely autumn tea picking clean, there is more control of the Andean tender tip of the fan s side mites and mite more fresh tarsal-effective measures, we can at least substantially reduce population density tea, which is known to tea farmers one of the measures. Election planted thick hairy leaves of tea varieties, pest mites can stop feeding. , Sichuan Province, Yunnan Province than in the middle of the tea leaf tea by the side of many varieties of fresh tarsal mite against heavy. Eriophyes year in the winter buds have not yet shifted to the hazards, can be used artificial Acquisition Gall ball, concentrate on. 3. Protection of predators (1) natural enemy insects: According to incomplete statistics, there are known Fresh mite more than 100 species of insects, including important are: 1 Fresh mites floating LIKE: My name has been recorded in fresh mites floating worms are about 10 species of insects, they distributed widely, and the water mites. The most common example of the deep water mites floating point adult insects, larvae can predatory mites in various mites individual states. L head larvae of predatory mites can be a lifetime of the individual 136-830 head, and their adult, the average food intake for the first 20.8-21.8.


Additional information :

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