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FDA Says It May Tighten Standards for Generic Drugs
The FDA has announced that it may tighten standards for how closely generic drugs resemble brand-name equivalents. Reports from patients and employees of generic-drug makers have told the FDA that some of the medicines don't work as well as the original, brand name product. The FDA is considering tightening the limits so there is less variability.
This subject is gaining visibility as more prescriptions are filled with lower-cost copies of medicines as insurers try to cut costs and name-brand drugs lose patent protection. Brand-name drugs have a market advantage for an average of 12.8 years before facing generic competition. After their first year, generics can capture nearly 60 percent of market share.
There is no timetable as to when the agency would come to any conclusions about generic standards of equivalence. Generally, drugs like digoxin, lithium, phenytoin, and warfarin come to mind for review.
Another suggestion was that generic drugmakers try to make their products look more like the original versions.
http://www.bloomberg.com/news/2010-10-20/fda-says-it-may-tighten-standards-for-generic-drugs-update2-.html
17,000 U.S. Doctors and Others Paid by Drug Companies, Report Finds
According to a recent report, more than 380 of the 17,000 doctors, nurses, pharmacists, and other professionals took in more than $100,000 in 2009 and 2010. The report said far more doctors are likely to have taken such payments.
The payments are not illegal and usually not even considered improper, but the report showed doctors were sometimes urged to recommend "off-label" prescriptions of drugs. The report used information from AstraZeneca, Cephalon, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Merck, and Pfizer.
The report also stated that more than 70 other pharmaceutical companies have not disclosed payments made to doctors.
The amount of money involved is significant, and the report's account of the background of some of the physicians is disturbing. A review of state medical board disciplinary records found more than 250 of the doctors paid to speak had been sanctioned for activities such as inappropriately prescribing drugs or having sex with patients. Forty others had been warned by the FDA for research misconduct, had lost hospital privileges, or were convicted of crimes.
http://www.reuters.com/article/idUSTRE69I3PO20101019
Caffeinated Alcohol Drinks Getting Closer Look by FDA
Joose, Four Loko, and other caffeinated alcoholic beverages provide a ready-to-drink version of what its originators observed young drinkers doing when they combine energy drinks with alcohol. Mixing caffeine and alcohol has been around a long time and it's nothing new or novel. However, some doctors and behavioral scientists say caffeinated alcoholic beverages turn drinkers into wide-awake drunks who are more dangerous to themselves and those around them. "I think the science is clear that consumption of alcohol with caffeine leads to risky behaviors," said Bruce Goldberger, director of toxicology at the University of Florida College of Medicine.
Dr. Goldberger and a colleague published a study on alcoholic energy drinks this spring in Addictive Behaviors, a scientific journal. They found that college-age adults who had consumed energy drinks mixed with alcohol left bars later and were more likely to leave intoxicated than those who drank just alcohol. They also were more inclined to think they were capable of driving than those who consumed just alcohol. Dr. Goldberger calls caffeinated alcoholic beverages "a new, emerging drug problem."
The FDA has approved caffeine as an additive for soft drinks but has never made a similar ruling with alcohol. The FDA is currently looking into the situation. Regarding their response to complaints, the agency says it will evaluate what the producers have to say as quickly as possible but "a decision regarding the use of caffeine in alcoholic beverages could take some time."
http://www.post-gazette.com/pg/10292/1096384-28.stm
Breast Cancer Seen as Riskier with HRT
In a recently published study, women who took hormones and developed breast cancer were more likely to have cancerous lymph nodes, a sign of more advanced disease, and were more likely to die from the disease than were breast cancer patients who had never taken hormones.
The new information results from the continuing follow-ups with 12,788 women who were in the Women's Health Initiative (WHI) Study. The study was halted in 2002 because researchers found that the hormones were causing small but significant increases in the risk of breast cancer, heart disease, strokes, and blood clots in the lungs. Six million American women had been taking the hormones, but the number quickly fell by about half.
http://www.nytimes.com/2010/10/20/health/20hormone.html?_r=2&ref=health
(Editors Note: As compounding pharmacists know, the estrogen used by the patients in the study was Premarin (conjugated equine estrogens). It was NOT estradiol, estriol, estrone, or other estrogen "bioidentical hormone" APIs used by compounders. Premarin is not a "bioidentical" hormone. Also, a "progestin," medroxyprogesterone acetate 0.25 mg, was used, NOT progesterone as some media outlets have reported. Medroxyprogesterone is not a "bioidentical hormone." The study only involved commercially manufactured Premarin and Prempro and NOT bioidentical hormones. Also, although "twice as many died" sounds alarming, the actual statistics are 2.6 deaths for every 10,000 women vs. 1.3 deaths for every 10,000 who were taking placebos.
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