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Most Online Pharmacies Illegal According to NABP
Over 96% of online pharmacies operate illegally, according to data presented by NABP at a June briefing in the Senate Visitor Center at the U.S. Capitol in Washington, DC.
The NABP Internet Drug Outlet Identification Program had reviewed 8,207 online pharmacy websites, and of these websites, they identified 7,890 sites as acting in conflict with pharmacy laws and practice standards.
An FDA spokesperson said “These are not pharmacists.
These people who are selling the drugs over the Internet from these sites don’t know anything about pharmacy.
They just want to make a buck.
They don’t care about the patient that is going to be receiving these products.”
www.pharmacist.com/AM/Template.cfm?ContentID=26316
Ethics Left Behind as Drug Trials Soar in Developing Countries
By 2008, the number of clinical trials conducted in developing countries had tripled.
However, the legal and ethical framework to make them fair is often not in place, the 7th World Conference of Science Journalists, in Qatar, heard recently.
For PHARMA, the attractions are the lower costs and the availability of “treatment-naive” patients, who are much less likely to have been previously exposed to drugs or trials.
Incentives for the developing countries include the promise of advanced medical science and access to the latest medications.
Problems include a less stringent ethical review, anticipated under-reporting of side effects, and the lower risk of litigation, all of which make carrying out research in the developing world less demanding.
www.guardian.co.uk/global-development/2011/jul/04/ethics-left-behind-drug-trials
FDA Warns Cadila and Bans on Dr. Reddy’s Mexico Plant
A Dr. Reddy’s plant in Mexico is now under an import ban until manufacturing issues there are resolved, and Cadila Healthcare got a new warning from the FDA based on an inspection at its new injectables facility in Gujarat, India.
These actions are just the latest in a series of warnings and bans involving Indian drugmakers with the longest-running problem with Ranbaxy Laboratories’ import ban, which has kept at least 30 products out of the U.S. since 2009.
www.nasdaq.com/../us-fda-slaps-import-ban-on-products-from-drreddys-mexico
www.fiercepharma.com/story/fda-warns-cadila-slaps-ban-dr-reddys/..
Three Harvard Psychiatrists Punished Over Undisclosed Industry Pay
Three faculty members of Harvard Medical School and Massachusetts General Hospital (MGH) have been disciplined in a long-running conflict-of-interest case that became a prime exhibit in the debate over the federal Physician Payments Sunshine Act of 2010.
The three physicians were accused of accepting more than $4.2 million from drug companies for psychiatric research and other activities between 2000-2007 without reporting the income to Harvard, MGH, or the federal government.
Industry payments to the three made headlines in 2008 when Sen. Charles E. Grassley (R-IA) accused them of understating, or failing to report at all, millions of dollars in support.
Grassley detailed many discrepancies between what various drug companies said they paid the doctors and what the doctors reported to Harvard and the MGH.
NIH has been less cooperative.
In 2008, Grassley had charged that the Harvard psychiatrists may have violated federal guidelines on disclosure of industry support while accepting federal grants.
At that time, NIH spokesman John Burklow stated that “if there have been violations of NIH policy—and if research integrity has been compromised—we will take all the appropriate action within our power to hold those responsible accountable.
This would be completely unacceptable behavior, and NIH will not tolerate it.”
However, as of this week, another NIH spokesperson said they could not say whether the agency had ever mounted an investigation on the matter or whether one has been concluded.
To obtain that information, a Freedom of Information Act inquiry must be made.
www.npr.org/../2011/07/02/../harvard-punishes-3-psychiatrists
Drug Shortages Having Impact on Pharmacies, Doctors
Pharmacy shelves across the country are missing vital pharmaceuticals, including medications for chemotherapy and surgery because there aren’t a lot of alternatives, especially in children.
The ASHP estimates that there may be as many as 300 drugs listed as in short supply by the end of 2011.
Due to industry consolidation, there are fewer manufacturers to pick up the slack if one company’s production is disrupted; some drugs are discontinued if they are not profitable to make, and others get hung up in the regulatory process.
Alternatives are usually available, but doctors say it complicates how they treat their patients.
Meanwhile, pharmacists at Children’s National Medical Center are finding ways to reduce waste; since most vials contain some overfill from the manufacturer, they are looking at alternate ways to re-package the excess so there’s no waste, and they can preserve every drop until supplies are plentiful again.
www.myfoxdc.com/dpp/health/drug-shortages-having-impact-on-pharmacies-doctors
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