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Editorial: Are these still in effect? Part 1
Periodically, it is good to review the founding documents of the United States and to view them from the aspect of those writing them. To me it seems they had an unbelievable grasp of what it takes to build a strong and prosperous nation founded upon individual responsibility and a strong work ethic; something that seems to be missing in some of our currently elected leaders.
One gets the impression that many elected officials are more interested in what they can get out of the office (salary, retirement benefits, health insurance benefits, travel, etc.) than what they can put into the office (hard work, servant attitude, doing the will of the people). Take a minute and read through the first five amendments of the Bill of Rights and reflect upon them in light of our current governmental actions. What should our responsibility be?
The Bill of Rights
Amendment I
Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the government for a redress of grievances.
Amendment II
A well regulated militia, being necessary to the security of a free state, the right of the people to keep and bear arms, shall not be infringed.
Amendment III
No soldier shall, in time of peace be quartered in any house, without the consent of the owner, nor in time of war, but in a manner to be prescribed by law.
Amendment IV
The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no warrants shall issue, but upon probable cause, supported by oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized.
Amendment V
No person shall be held to answer for a capital, or otherwise infamous crime, unless on a presentment or indictment of a grand jury, except in cases arising in the land or naval forces, or in the militia, when in actual service in time of war or public danger; nor shall any person be subject for the same offense to be twice put in jeopardy of life or limb; nor shall be compelled in any criminal case to be a witness against himself, nor be deprived of life, liberty, or property, without due process of law; nor shall private property be taken for public use, without just compensation.
Next week: Amendments VI through X
http://www.billofrightsinstitute.org/Teach/freeResources/FoundingDocuments/
Docs/TheBillofRights.asp
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
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Neohesperidin Dihydrochalcone
Uses: Sweetening agent, flavor enhancer. It is a synthetic intense sweetening agent about 1500 to 1800 times sweeter than sucrose and 20 times sweeter than saccharin. It is a flavanone that occurs naturally in Seville oranges. It is useful in masking the unpleasant bitter taste of a number of drugs, including antacids (10 to 30 ppm improves palatability), antibiotics, and vitamins.
Synonyms: Sukor
Description: It occurs as a white or yellowish-white powder with an intensely sweet taste.
Stability: It is stable for over three years when stored at room temperature. At pH 2 to 6, aqueous solutions are likely to be stable for 12 months.
Packaging and Storage: Well-closed containers in a cool dry place protected from light.
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Pfizer Pays Record Criminal Fine of $2.3 Billion Dollars
A Pfizer subsidiary has been sentenced after pleading guilty to illegally promoting the pain killer Bextra. Pharmacia and Upjohn pled guilty last month to one count of felony misbranding as part of a settlement agreement that hit New York-based Pfizer Inc. with a record-breaking $2.3 billion in fines for illegal drug promotions. They agreed to pay a criminal fine of $1.195 billion and a criminal forfeiture of $150 million.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1937571&contentType=sentryarticle&channelID=33&premium=1
$14.7M Verdict Against AstraZeneca
British AstraZeneca PLC was hit by a Kentucky jury with a $14.7 million verdict in a case that claimed the company inflated its prescription drug prices for Medicaid reimbursements. The Attorney General for Kentucky said he's pleased they were able to recover money for Kentucky's Medicaid program. The Medicaid program calculates its drug reimbursement rates based on published average wholesale prices; prosecutors claimed AstraZeneca inflated those published prices.
http://www.forbes.com/feeds/ap/2009/10/15/general-health-care-us-pharmaceutical-verdict_7008111.html
Merck Starts Revealing Payments to Doctor-Speakers
Merck & Co. disclosed that during July through September 2009, they paid doctors and nurses a total of $3.7 million to give talks to colleagues about their products and other health topics. With growing criticism of industry influence over treatment selection by doctors for their patients, the company posted a database on its Website listing speaking fees paid to 1,078 doctors, researchers, nurses, and other health professionals.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1937893&contentType=sentryarticle&channelID=33
The Food and Drug Administration Lags in Banning Researchers After Fraud
Ms. Delfina Hernandez was instrumental in carrying out one of the most audacious drug research frauds in American history; however, because federal drug regulators sent a legal notice years too late and to the wrong address, she can legally continue to conduct research.
Ms. Hernandez was a study coordinator at the Southern California Research Institute, which is a drug testing operation in Whittier, California. Federal agents raided the institute in 1997. The institute helped conduct more than 170 drug studies for nearly every major drug maker in the world and routinely falsified data and patient records while doing so. She pled guilty to fraud. Federal law required that the Food and Drug Administration (FDA) ban Ms. Hernandez from participating in further drug research and the agency had five years after her conviction in which to act. However, Congressional investigators say the agency pays so little attention to its responsibilities to ban investigators convicted of fraud and is so disorganized about carrying them out that its actions take an average of four years to complete.
As stated previously, the agency did not send a notice to Ms. Hernandez until more than four years had passed, and then it was sent to the wrong address. When the agency realized its mistake, the ban against Ms. Hernandez could not take effect because time had run out.
In a review of 18 proceedings, investigators for the Government Accountability Office found that the FDA took from 1 to 11 years to complete its process to ban researchers. This means many who were convicted of fraud remained eligible to conduct experiments for years.
http://www.nytimes.com/2009/10/22/health/policy/22fda.html?_r=1
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The FDA has released new information on medication disposal recommendations?
On October 14, the FDA posted a new Web page that includes consumer instructions and other information on the disposal of certain medications. This Web page provides information on what consumers can do with unused or expired medications and explains the FDA's rationale for specific recommendations for disposal of certain medications (i.e., an expanded list of medications to flush).
Many of the more dangerous substances, such as opioids, should be disposed of by flushing down a sink or toilet, the agency said. Included on the flush list are a number of fentanyl, morphine, and oxycodone-based drugs. The full list is available on the FDA's Website.
But the agency said most medications are not recommended for flushing and should instead be mixed with an unpalatable substance, such as coffee grounds or kitty litter, placed in a sealed plastic bag, and thrown in the trash.
The FDA also recommended the use of drug take-back programs-available through municipal trash disposal agencies in many areas-as an alternative to disposal by trash or drain.
The American Pharmacists Association (APhA) works on and partners with the SMARxT Disposal program that provides information and educational materials on proper disposal procedures including a Q&A on flushing. APhA plans to update this information in accordance with FDA's new guidelines and will provide the updated version in a future Legislative and Regulatory Update.
http://www.medpagetoday.com/ProductAlert/Prescriptions/16443Web
http://www.smarxtdisposal.net/pdf/questions.pdf
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