Procrit and Epogen Recall
Certain lots of Epogen and Procrit (Amgen Inc.) sold by Johnson & Johnson are being recalled because they may contain "extremely thin" glass flakes. About 200 lots of Epogen are included but J&J said that shouldn't disrupt the supply of the drug to patients, nor will it have a material financial impact on the company.
http://online.wsj.com/article/SB10001424052748704523604575511852897470656.html
Low Testosterone Levels and Viagra
Low testosterone levels may be the culprit for many Viagra users. Low testosterone can be a sign of various health problems. It has been stated that more than half the Viagra prescribed to men is not working and men with erectile dysfunction could be wasting their money when their real issue is low testosterone.
Testosterone levels in men generally peak in their mid-20s and then slowly decline throughout life. Testosterone replacement therapy can be prescribed and can change the lives of patients.
http://www.bbc.co.uk/news/health-11404927
Seniors Get Drugs from Online Canadian Pharmacies to Cut Costs
Prescription eye medication for a 72-year-old patient jumped from $47.13 to $113.23 in the past nine months at his neighborhood drugstore. The patient found the same medication for $21.25 online at a Canadian pharmacy.
The patient, from Dallas, is one of an estimated 68,000 Texans who order drugs from online Canadian pharmacies each year, according to the Canadian International Pharmacy Association. As U.S. costs have risen, seniors in the North Texas area on fixed incomes say the only option they have is to get prescriptions filled online from Canada. Top-selling medications for high cholesterol and arthritis, like Lipitor and Celebrex, can be found online for half the prices seen at local pharmacies.
Actually, importing drugs from Canada is illegal, but the U.S. Food and Drug Administration does not prosecute people importing a 90-day supply of prescription drugs for personal use.
In some cases, many of the drugs are not actually coming directly from Canada as they are made to appear, but are being diverted from other countries. Canadian pharmacists may not really know where they are coming from. The general manager of the Canadian International Pharmacy Association stated that drugs cost less in Canada because the Canadian government has a system that absorbs some of the costs. The drugs from Canada cost 50 to 80 percent less than they cost in the U.S.
To address the safety concerns, the association has a program for checking pharmacies. Any patient can go to Canadadrugs.com and check for pharmacies with an oval red seal of the Canadian International Pharmacy Association. The seal is a "stamp of approval" by the Association and then patients can do their own price comparison.
The National Association of Boards of Pharmacy recommends finding a pharmacy that is a Verified Internet Pharmacy Practice Site (VIPPS). Not sure if it is a VIPPS? Go to vipps.nabp.net and paste the online pharmacy's address into the verification field at the bottom of the screen. Click "verify" for an immediate answer.
Finally, a website, LegitScript.com, keeps a database of pharmacy websites that are either approved, up for review, or deemed unacceptable. Recently, LegitScript.com had 51,928 pharmacy websites in its database, of which only 341 meet its approval; 1,088 are candidates for approval; and 50,499 do not meet standards set by the National Association of Boards of Pharmacy.
http://www.dallasnews.com/sharedcontent/dws/dn/latestnews/stories/ 092810dnbuscanadadrugs.242e963.html
Ethics of Placebo Control Debated for Osteoporosis Trials
An important question today concerns withholding a therapy with proven effectiveness in preventing serious adverse outcomes in at-risk patients and can it ever be ethical?
This is a question of pressing importance for developers of new osteoporosis drugs, for whom placebo-controlled trials are the quickest and cheapest way to prove that an investigational drug reduces fracture risk.
Two Vanderbilt University researchers contend that clever study designs cannot change the fact that patients assigned to placebo would nearly always suffer more fractures than they would if they were taking an approved osteoporosis drug.
As a result, placebo-controlled studies will seem to nearly always be unethical. Can such trials be justified by regulatory preferences for placebo-controlled studies, the approval of local IRBs, or informed consent from the participants?
This is a difficult situation and there are interesting points on both sides. The Helsinki Declaration on research ethics allows for placebo controls as long as "no major harm" is expected.
http://www.medpagetoday.com/PublicHealthPolicy/Ethics/22482
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