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Why are generic medicines so cheap?

Unlike generic drugs, a large part of the costs incurred by original manufacturers of brand name drugs are for research and development and advertising. The expense of obtaining FDA approval alone in the U.S. is enormous. Manufacturers of generic drugs do not have to absorb or recover these costs. Consequently, significant cost savings can be passed along to you.

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1 Jul, 2008

Is this right? Viagra, yes; Chantix, no?

I went to my doctor yesterday, and he gave me a clean bill of health.

To keep me that way, he also gave me a prescription for a smoking-cessation drug called Chantix, which he said has been highly successful. I have witnessed its success myself with a co-worker.

To keep me that way, he also gave me a prescription for a smoking-cessation drug called Chantix, which he said has been highly successful. I have witnessed its success myself with a co-worker.

My insurance premiums are high, since I am 45 years old and a smoker. Imagine my astonishment when the pharmacist told me my insurance will not cover the Chantix.

It will cover me if I get lung cancer, it will cover Viagra, but it won't cover smoking-cessation medication?

The pharmacist agreed that it was ludicrous. I called my insurance company and was told that my policy does not cover those types of drugs.

Why? This madness has to end.

Linda Geisler

Stafford

http://fredericksburg.com/News/FLS/2008/062008/06302008/387533
3 Jun, 2008

Lilly drug doubles pancreatic cancer survival: study

Eli Lilly and Co's chemotherapy drug Gemzar more than doubled the overall survival for early stage pancreatic cancer patients five years after surgery to remove their tumors, according to results from a long-term study released on Saturday.

Gemzar, or gemcitabine, is the standard treatment for patients whose pancreatic cancer is too advanced for surgery. Most pancreatic cancer is diagnosed at a late stage.

Researchers at the Charite University Medical School in Berlin studied the drug in patients with early stage pancreatic cancer who had received surgery, concluding it should be the standard of care for those patients as well. Just 15 percent to 20 percent of patients with pancreatic cancer are diagnosed with the disease early enough to be eligible for surgery. The study was presented at the American Society of Clinical Oncology in Chicago. Earlier data from the study, released in 2005, found patients who received Gemzar after surgery were free of the disease longer than those who received no specific anti-cancer treatment. "Based on the earlier results of this study, this regimen is already more widely used in both Europe and the United States. These findings can reassure physicians that the drug is also extending lives," Dr. Hanno Riess, the trial's lead investigator, said in a statement.

In the study of 368 patients, the overall survival rate was 36.5 percent at three years and 21 percent at five years for the group who received Gemzar, compared with 19.5 percent at three years and 9 percent at five years for the observation group.

http://www.reuters.com/article/healthNews/idUSN3139743820080531 /
1 May, 2008

Chilean town giving free Viagra to senior citizens

SANTIAGO, Chile (AP) — A working class suburb of Chile's capital began handing out free sildenafil to senior citizens on Wednesday. Lo Prado Mayor Gonzalo Navarrete said he launched the program because "an active sexuality improves the overall quality of life."

About 1,500 residents of the working-class area are eligible to receive as many as four pills of the erectile dysfunction drug each month, the mayor said. They have to be at least 60 and be registered with the municipality's health service.

"A doctor will have to certify that they suffer from erectile dysfunction and that their condition would not put them in danger of suffering cardio-respiratory side effects," Navarrete told The Associated Press by telephone.

He said he has assured about US$10,000 (euro6,400) in financing for the program through the end of the year.

Some government insurance plans in the United States and elsewhere provide Viagra, but Lo Prado hands the 50mg pills out free, with no membership in any public or private insurance plan required.

Navarrete said some other mayors in the Santiago area, which includes 34 municipalities, have told him they plan similar programs.

Navarrete said he did not know how many pills had been distributed so far.

http://ap.google.com/article/ALeqM5gsPiYvAUO3i7krLIdN-nv09fxkvQD90CE08O0 /
1 Apr, 2008

Sildenafil wasn't a hard sell once it caught on. Erectile dysfunction pill has staying power after 10 years

Happy birthday!

You celebrated your birthday Thursday after a decade of bringing joy, happiness, peace, understanding, and a jolly good rogering to millions of people around the world.

On mountains and in planes, bedrooms, kitchens and flower shops, you've changed lives everywhere.

In addition to the straight-up benefits of helping a generation of men perform without pressure, Viagra, a.k.a.

sildenafil, has thrust its way into other areas.

Viagra has tackled jet lag (just in hamsters so far), boosted soldiers' cardiovascular performance in high-altitude

areas of Afghanistan, and extended the life of cut flowers.

It's become firmly established in the popular culture, earning the nickname Vitamin V.

Even the kids are doing it -- dropping E (ecstasy) and V in something called a trail mix, which is meant to heighten

arousal and make you a better dancer. It's certainly not advisable but, hey, it's worth noting.

Viagra has also infiltrated bookstores.

Take, for example, The Rise of Viagra: How the Little Blue Pill Changed Sex in America, by sociologist Meika Loe (New

York University Press, 2004), and Hard Sell: The Evolution of a Viagra Salesman, by Jamie Reidy (Andrews McMeel

Publishing, 2005).

In addition to their clever titles, both books offer some worthy information.

The former book explores the marketing of the little blue pill that established erectile dysfunction as a common

disorder.

Hard Sell, written by a former pharmaceutical sales rep for the industry giant Pfizer, documents a career spent

pushing the little blue soldier and other medications in the competitive world of prescription drug sales.

A movie based on the book is now in development.

Yes, Viagra's got staying power.

We can thank a team of chemists at a Pfizer pharmaceuticals research lab in Kent, England, for stumbling on Viagra's

unintended side-effects.

http://www.canada.com/vancouversun/news/story.html?id=571e49ad -a26e-40c9-b3a5-162e5fbbb332&k=54705&p=1/
1 Mar, 2008

Sildenafil citrate and blood-pressure-lowering drugs: results of drug interaction studies with an organic nitrate and a calcium antagonist.

Sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), is a well-tolerated and highly effective treatment for erectile dysfunction.

The mechanism of action of sildenafil depends on activation of the nitric oxide (NO)-cGMP pathway during sexual stimulation, which results in corpus cavernosal smooth muscle relaxation and penile erection. Endogenously derived NO is also involved in blood pressure regulation through its effect on basal vascular tone, which is mediated by cGMP levels. Organic nitrates and NO donors exert their therapeutic effects on blood pressure and vascular smooth muscle by the same mechanism as endogenous NO. Since both sildenafil and organic nitrates exert their pharmacologic effects via increases in cGMP concentrations, a double-blind, placebo-controlled, crossover study was undertaken to investigate the effects of sildenafil coadministered with glyceryl trinitrate on blood pressure and heart rate in healthy male subjects. The hemodynamic effects of sildenafil were also evaluated in a second placebo-controlled crossover study in men with hypertension who were taking the calcium antagonist amlodipine, which has a mechanism of action that does not involve the cGMP pathway. In the first crossover study, subjects were treated with oral sildenafil (25 mg, 3 times a day for 4 days) or placebo and then challenged on day 4 with a 40-minute, stepwise, intravenous infusion of glyceryl trinitrate (0.5 mg/mL in 5% dextrose at an initial infusion rate of 2.5 microg/min and doubling every 5 minutes to a maximum rate of 40 microg/min) 1 hour after taking sildenafil or placebo. On day 5, subjects received a sublingual glyceryl trinitrate tablet (500 microg) 1 hour after taking 25 mg of sildenafil or placebo. During sildenafil treatment, the subjects were significantly less tolerant of intravenously administered glyceryl trinitrate than during placebo treatment, based on the occurrence of a >25 mm Hg decrease in blood pressure or the incidence of symptomatic hypotension (p <0.01). When a sublingual glyceryl trinitrate tablet was administered on day 5, a 4-fold greater decrease in systolic blood pressure was observed for the subjects during the sildenafil treatment period than during the placebo treatment period. The changes in heart rate were negligible during both glyceryl trinitrate challenges. In conclusion, sildenafil potentiated the hypotensive effects of glyceryl trinitrate, an organic nitrate. Thus, sildenafil administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is contraindicated. In the second crossover study, men with hypertension, who were taking 5 or 10 mg/day of amlodipine, received a single oral dose of 100 mg sildenafil or placebo. Coadministration of sildenafil did not significantly affect the pharmacokinetics of amlodipine. In the 4 hours after dosing, differences in the mean maximum change from baseline in supine systolic and diastolic blood pressures between the sildenafil plus amlodipine and the placebo plus amlodipine treatment periods were -8 mm Hg and -7 mm Hg, respectively (p < or =0.002). The mean maximum supine heart rate increased 2.1 beats/min during sildenafil plus amlodipine treatment and decreased 1.5 beats/min during placebo plus amlodipine treatment (p <0.02). The adverse events in this study were predominantly mild or moderate and did not cause discontinuation of treatment. Adverse events considered to be related to sildenafil treatment included headache, nausea, and dyspepsia. In patients with hypertension who were taking amlodipine therapy, sildenafil produced additive, but not synergistic, reductions in blood pressure. The difference in the mean maximum change from baseline in blood pressure between sildenafil plus amlodipine and placebo plus amlodipine was comparable to the decrease in blood pressure reported for healthy men taking sildenafil alone. (ABSTRACT TRUNCATED)

http://www.ncbi.nlm.nih.gov/
1 Feb, 2008

Eli Lilly and Co on Tuesday said U.S. regulators approved once-daily use of two low-dose forms of its Cialis anti-impotence drug, offering greater convenience for men expecting frequent sexual activity.

The Indianapolis drugmaker said the once-daily formulations, in dosages of 2.5 milligrams and 5 milligrams, will allow men to attempt sexual activity any time between doses.

"In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy," Lilly said in a release. The low-dose daily formulations, already approved in parts of Europe, "may be most appropriate for men with erectile dysfunction who anticipate more frequent sexual activity (e.g. twice weekly)," Lilly said. The company said the low-dose formulations provide "a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity." The treatment, which has global annual sales of $1.2 billion, has been available in the United States since 2003 in dosages of 5 milligrams, 10 milligrams and 20 milligrams, and taken as needed. Those dosages provide effectiveness for up to 36 hours. Company spokeswoman Keri McGrath said no dosage forms of the medicine, including the newly approved lower ones, are appropriate for heart patients who take nitrates, including nitroglycerin. Members of the class of drugs to which Cialis belongs -- including Pfizer Inc's rival Viagra and GlaxoSmithKline Plc's Levitra -- can dangerously lower blood pressure when used alongside nitrates. The drugs, used by millions of men worldwide, also carry new warnings about potential risk of sudden hearing loss. Reuters Health
http://www.nlm.nih.gov/medlineplus/news/fullstory_59794.html
2 Jan, 2008

FDA Clears First Quick Test For Drug-Resistant Staph Infections Test Identifies MRSA Bacterium in Two Hours.

The U.S. Food and Drug Administration (FDA) today announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections.

Methicillin is an antibiotic that has been used successfully to treat infections from the Staphylococcus aureus bacterium. Over the years, the staph bacterium mutated and spawned MRSA, a strain of staph bacterium that is resistant to methicillin and which has a higher rate of being fatal.

The BD GeneOhm StaphSR Assay uses molecular methods to identify whether a blood sample contains genetic material from the MRSA bacterium or the more common, less dangerous staph bacterium that can still be treated with methicillin.

“The BD GeneOhm test is good news for the public health community. Rather than waiting more than two days for test results, health care personnel will be able to identify the source of a staph infection in only two hours, allowing for more effective diagnosis and treatment,” said Daniel G. Schultz, M.D., director, FDA’s Center for Devices and Radiological Health.

Staph infections occur most frequently among persons in hospitals and health care facilities (such as nursing homes and dialysis centers) who have weakened immune systems. Both types of bacteria also can infect healthy people.

Distinguishing between the two sources of infection is critical to successful treatment. The more common, less dangerous strain of staph results in infections that are generally mild and affect the skin with pimples or boils that can be swollen, painful and drain pus.

However, the MRSA staph bacterium is difficult to treat with ordinary antibiotics. It can cause potentially life-threatening conditions such as blood stream infections, surgical site infections or pneumonia.

FDA cleared the BD GeneOhm StaphSR assay based on the results of a clinical trial at five locations. The new assay identified 100 percent of the MRSA-positive specimens and more than 98 percent of the more common, less dangerous staph specimens.

In order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient’s response to treatment. Test results should not be used as the sole basis for diagnosis as they may reflect the bacteria’s presence in patients who have been successfully treated for staph infections. Also, the test will not rule out other complicating conditions or infections.

The BD GeneOhm StaphSR test is manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01768.html
14 Dec, 2007

Inhaled and oral bronchodilators do not appear to increase the risk of fracture in people with chronic lung disease, according to Danish investigators who suggest that the "severity of the underlying lung disease" may be responsible.

"Inhaled drugs are safe; therefore, the focus should be on preventing use of large doses of oral corticosteroids for prolonged periods of time," Dr. Peter Vestergaard from Aarhus University Hospital, told Reuters Health. These patients "may perhaps better be managed with the inhaled preparations in terms of bone safety," he added.

Vestergaard and colleagues investigated whether the use of any bronchodilator or other lung active drug for asthma, COPD (chronic obstructive pulmonary disease), emphysema, or other lung disease was associated with a change in the risk of fractures in nearly 250,000 patients residing in Denmark in 2000. Each patient was matched with three controls from the general population.

The risk of fracture was higher in patients with COPD, emphysema, and other chronic lung disease than in patients with asthma, they report in the journal Chest.

There was a "dose-dependent" relationship between oral steroids and an increased fracture risk, the report indicates, but no other drugs were associated with fracture risk.

There was also an increased risk of fracture associated with inhaled short-acting beta-agonists, but, the investigators say, this increased risk is likely associated with the severity of the underlying lung disease for which the drugs are administered.

"Focus needs to be maintained on the bone health of patients with lung disease," Vestergaard advised.

http://www.nlm.nih.gov/medlineplus/news/fullstory_58923.html
1 Nov, 2007

(HealthDay News) -- The new and powerful cancer drug sunitinib (Sutent), which fights stomach tumors, can also create heart problems for some patients, a new study finds.

All patients taking sunitinib, but especially those who have risks for heart disease, need careful monitoring and treatment for high blood pressure and other signs of heart problems, researchers say.

"All drugs have risks and benefits," noted lead researcher Dr. Ming Hui Chen, an assistant professor of medicine at Harvard Medical School and a cardiologist at Children's Hospital Boston. "This drug is lifesaving for people with metastatic, gastrointestinal stromal tumors," she added.

But it is important for both doctors and patients to be aware that sunitinib can have cardiac effects, Chen noted.

"The people at greatest risk are the people who have a history of coronary artery disease," Chen said. "Aggressive control of blood pressure in these patients is very important."

In a statement released Thursday, sunitinib's maker, Pfizer Inc., agreed that these heart risks do exist. However, they added that the cardiovascular events "were medically manageable in most patients and underscore the importance of having a collaborative team of healthcare professionals working together to appropriately manage patients, who have limited available options" in treating their cancer.

The new, collaborative study was supported by Children's Hospital Boston; the Dana-Farber Cancer Institute; Thomas Jefferson University; the U.S. National Heart, Lung, and Blood Institute; the Finnish Heart Foundation; and the American Heart Association.

Sunitinib is one of a family of new and powerful anti-cancer drugs called tyrosine-kinase inhibitors, which target key molecular pathways thought to encourage tumor growth. Other drugs in this family include imatinib, better known as Gleevec, and dasatinib (Sprycel).

In the study, which is published in the Dec. 15 issue of The Lancet, Chen's team looked at 75 patients with metastatic, gastrointestinal stromal tumors that had not responded to standard therapy with Gleevec. The patients had taken part in a phase I/II trial studying the efficacy of sunitinib.

The researchers looked back at the medical records of these patients, noting those who died from heart disease or had suffered heart attacks or congestive heart failure. They also looked at the effect of sunitinib on the heart's ability to pump blood and on blood pressure.

Chen's group found that eight patients given repeated cycles of sunitinib had cardiovascular events. Two had heart attacks, and six had heart failure. Of 36 patients given the approved dose of sunitinib, 10 had a 10 percent or more reduction in the ability of their heart to pump blood, and seven had a 15 percent or more reduction in heart function.

In addition, sunitinib was associated with increases in blood pressure, with a total of 35 (47 percent) of the patients developing hypertension. However, these effects were not permanent: When sunitinib treatment was stopped and patients began therapy to ease heart problems, levels of heart failure and heart functioning improved, the researchers found.

"Most of the patients who had heart problems were able to resume taking sunitinib with either a modification in their dose or initiation of heart failure medication," Chen said.

In addition, in experiments with mice and rat heart cells, Chen's team found that sunitinib triggered heart cells damage and death.

However, in their statement, Pfizer noted that, "Lower incidences of cardiovascular effects have been observed in subsequent randomized Phase 3 prospective Sutent studies in both renal cell carcinoma and gastrointestinal stromal tumor[s]." That includes a lower incidence of events such as congestive heart failure, impaired heart function, and high blood pressure that were noted in Chen's retrospective analysis, the company said.

Chen stressed that patients taking sunitinib who develop shortness of breath and fatigue and swelling of the arms or legs should be checked for heart problems. "These symptoms can be ascribed to cancer, but since this drug may have a cardiovascular effect, these may be signs of heart problems," she said.

One expert said the findings must be approached with caution.

"The findings are intriguing, but one has to be careful about generalizing them," said Dr. James Brugarolas, an assistant professor in the division of oncology at Simmons Comprehensive Cancer Center at the University of Texas Southwestern Medical Center at Dallas. "It's a small group of patients, many of whom were taking other drugs that can have cardiac effects," he said.

However, patients who have coronary artery disease who are going to be given sunitinib should be very carefully monitored for the development of heart failure, Brugarolas said. "There should be a proactive attitude on the part of the physician to manage hypertension," he added.

Brugarolas also noted that sunitinib has been shown to slow the progression of gastrointestinal stromal tumors but not to extend patients' overall survival. "These side effects may be affecting survival," he said. "If survival is compromised by adverse effects of the drug, then it may not be beneficial to patients."

SOURCE: U.S. National Library of Medicine, Desember 15, 2007.

http://www.nlm.nih.gov/medlineplus/news/fullstory_58887.html
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