Editorial: INFARMA 2009

This editorial is being written while sitting in a compounding pharmacy session at the INFARMA 2009 meeting in Barcelona. This meeting, similar to the APhA, is held every other year and covers all different practices of pharmacy, including community, hospital, compounding, homeopathy, nutritional, etc. There is a day scheduled with sessions on compounding pharmacy; my session will be on "Trends in Pharmaceutical Compounding and the Future." Approximately 2,000 participants are at this meeting, arranged by the pharmacy associations of Spain and the Barcelona University College of Pharmacy.

The meeting includes about 50,000 square meters of exhibits covering most of five floors of the congress meeting center. Exhibitors include everything from pharmaceutical, nutritional, homeopathic, cosmetic, robotic dispensing systems, durable medical equipment, compounding companies, publishers, etc.

The specifics of the meeting are interesting. Even though the language of Catalonia (where Barcelona is located) is Catalan, since this is a sanctioned European meeting, the official language of the meeting is Spanish. Fortunately, there are interpreters for English-Spanish translation. The meeting hours run from about 10 AM until 7 PM. Dinners start at about 9 PM and last until about midnight. Dinner last evening was held at the Picasso Museum that is housed in a palace building in the Medieval (Gothic) section of Barcelona.

Spanish pharmacists throughout Spain should feel good about the quality programming in their profession. In a few weeks, I will have the opportunity of attending the specialty compounding pharmacy meeting here in Spain. Having attended this meeting for several years, it is a great opportunity to spend a few days immersed in compounding pharmacy as it is practiced in Spain, share time with friends, and to enjoy more of the culture and hospitality of Spain.



Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Pain Physician-Scientist Fabricated Study Data
According to the hospital where he worked, Dr. Scott Reuben, a prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex.

Baystate Medical Center, Springfield, Massachusetts, reported that their former chief of acute pain, Scott S. Reuben, had faked data used in the studies; the studies were published in several anesthesiology journals between 1996 and 2008. The anesthesiologist allegedly faked data in 21 studies on the use of various painkillers, including Vioxx.

Some of the studies reported favorable results from the use of painkillers, including Pfizer's Bextra and Merck & Co.'s Vioxx -- both since withdrawn -- as well as Pfizer's Celebrex and Lyrica. Dr. Reuben's research work also claimed positive findings for Wyeth's antidepressant Effexor XR as a pain killer. He also wrote to the FDA urging the agency not to restrict the use of many of the painkillers he studied, citing his own data on their safety and effectiveness. Dr. Reuben had been a paid speaker on behalf of Pfizer's medicines, and it paid for some of his research.

Last month, the journal Anesthesia & Analgesia retracted 10 of Dr. Reuben's studies and posted a list of the 11 published in other journals on its web site. The journal Anesthesiology said it has retracted three of Dr. Reuben's articles.

An FDA spokeswoman said late Tuesday she wasn't aware of the matter.

Editors Note: It is unknown how many statements have been placed in pharmacy texts related to pharmacotherapeutic recommendations based on Dr. Reuben's work. Also, it appears the FDA may need to strengthen the basis on which they admit research studies that are used in approving new drugs and in basing all decisions related to drugs. A question naturally comes to mind, "Are there no charges (criminal?) that can be levied against a "scientist" that abuses the position for financial or personal gain?"
http://online.wsj.com/article/SB123672510903888207.html?mod=googlenews_wsj

FDA Warns Genzyme on Plant Conditions
FDA investigators found "significant objectionable conditions" during an inspection of a Genzyme Corp. plant where expensive biotechnology drugs are made. This is according to a copy of an agency warning letter dated February 27. There were a number of deficiencies in the manufacturing process at the Boston plant, which produces some of the company's best-selling products, including drugs such as Myozyme, Cerezyme, and Fabrazyme.
http://online.wsj.com/article/SB123669797974884201.html?mod=googlenews_wsj

It's Not Nice to Fool (with) Mother Nature!

Even though the story on "global warming" is still out, politicians have jumped on the bandwagon requiring the expenditure of billions of your dollars to correct something that has not been proven to occur, according to many scientists. Even people in Europe are now being told to expect significant expenditures out of their pockets on these new activities.

Why is it that:

• Scientists cannot agree one way or the other on global warming?
• We don't really see any concrete, agreed-upon and up-to-date "facts"?
• Some now say the polar icecap is growing, not shrinking, according to satellite photos?
• The Pacific ocean (the largest touching the U.S. on the west coast) is cooling now?
• The Atlantic ocean (the smallest touching the U.S. on the east coast) is warming?
• Personnel on the Weather Channel say global warming is not occurring!
• Some scientists state this is regular cyclical activity over the long run.
• A scientist at the global warming conference this week stated that he was wrong years ago and the increase in temperature by the end of the century will NOT be 2�C but 10�C!
• If he is wrong about that, could he be wrong about it even occurring?
• Why is it that many scientists that initially supported global warming now do not think it is occurring?

Does it seem to you that politicians, grant recipients, and "green-related industries" are the ones that are winning in this situation? Just follow the money! Isn't it best that we know that something is or is not happening before placing billions of hard-earned tax dollars thrown at something that may nor may no be real!

Personally, whether it is real or not, many of the initiatives can be good, e.g., natural gas cars, wind farms, clean coal, etc., but private industry can handle this and make a profit without the government spending billions on who knows what!

The Responsiblity of Skepticism
Just because the government, politicians, bureaucrats, etc. state something in their speeches doesn't mean that it is true. It is still our responsibility to check it out. Just think of the ridiculous things that have been stated by politicians in recent months! Makes you wonder who they think they are trying to fool and/or convince!