Editorial: Cowboy Ethics Revisited: What Has Happened to Our Culture?

As previously mentioned in this column, I enjoy reading westerns and watching western movies. Growing up in the Midwest with ranchers, cowboys, cattle, open spaces, etc., one grows to appreciate this country. In addition, there has been a "Code of the West" that has been a part of our ethics and culture that we may want to revisit in light of current political, business, and social changes. The Code of the West is as follows:

1. Live each day with courage.
2. Take pride in your work.
3. Always finish what you start.
4. Do what has to be done.
5. Be tough, but fair.
6. When you make a promise, keep it.
7. Ride for the brand.
8. Talk less and say more.
9. Remember that some things aren't for sale.
10. Know where to draw the line.

The above are from a book entitled Cowboy Ethics-What Wall Street Can Learn from the Code of the West. It seems we can't believe anything our political leaders say any more. We seem to expect them to lie and to sell out. We tend to just believe what we want to hear and let other things ride. There is little consistency in their statements and their actions. If we allow continued actions such as these, we will have no idea what or who we are voting for when we go into the voting box! Maybe it's time that our elected leadership revisited Cowboy Ethics and we hold our leadership to the statements they make! If they can't be honest and truthful and not "sell out," they need to be removed-regardless of which "party" they are in!


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

FDA Impersonators Threaten Public Safety
The U.S. Food and Drug Administration (FDA) issued a warning on December 29, 2009 about criminals posing as FDA special agents and other law-enforcement personnel as part of an international extortion scam. The impersonators target individuals who have previously purchased drugs over the Internet or through telepharmacies. These impersonators tell the victim that purchasing drugs online or by phone is illegal and that they must pay a fine of $100 to $250,000 via wire transfer (usually to the Dominican Republic). Individuals refusing to pay the fake fine are threatened with physical harm, arrest, or property searches. The impersonators have also used the victims' credit cards for fraudulent purchases.

The public should know that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. Individuals receiving calls from potential agency impersonators can report the information by phone to the FDA Office of Criminal Investigations Metro Washington Field Office at 800.521.5783.
http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=650318

Novartis Looks to Buy Out Alcon for $38.5 Billion
Novartis AG plans to take over Alcon Inc. by paying $38.5 billion for the 77 percent stake it does not already own in a deal that would make it one of the biggest players in the global market for eye-care products. The Swiss pharmaceutical company will purchase Nestle SA's 52 percent stake for $28 billion, or $180 per share, before carrying out a merger with Alcon that would give it control of the remaining 23 percent held by minority shareholders. If successful, the takeover will cost about $50 billion, making it the biggest in Swiss corporate history. Alcon employs some 15,000 people worldwide and specializes in surgical equipment and devices, contacts lens solutions and other consumer eye-care products.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1951498&contentType=sentryarticle&channelID=33

Indian Drug Makers and U.S. Marketing Approvals
Twenty five Indian generic drug makers received slightly over 200 approvals from the U.S. FDA in 2009; this is 6 more than in 2008. This increase is despite the decreased growth of drug sales in the U.S. with tighter regulations and aggressive competition. Dr Reddy's Laboratories got the highest number (32) of tentative and final approvals in 2009, according to the latest data on the FDA website.

Many Indian companies have learned that it is difficult to survive in the U.S. market with only a few products and are expanding their offerings. Established players like Ranbaxy or Reddy's are now concentrating on niche and specialized products, rather than trying to sell all products going off-patent.
http://www.business-standard.com/india/news/indian-drug-makers-maintain-paceus-marketing-approvals/381595/

FDA Approved 26 New Drugs in 2009 Compared with 25 in 2008
Federal regulators approved 26 new medicines in 2009 compared with 25 in 2008, though several key drugs that were expected to be approved were not. The U.S. FDA approved 26 first-of-a-kind medicines in 2009, more than in any of the prior four years.

Drug companies pay user fees to the FDA annually to help speed drug-approval reviews. In 2008, FDA officials reported that they missed more than 32 deadlines for approving drugs and stated the goal for 2009 was to meet 90% of the deadlines.
http://online.wsj.com/article/BT-CO-20100105-712823.html?mod=dist_smartbrief

Stay Young & Sexy with Bio-Identical Hormone Replacement-The Science Explained
Wright JV, Lenard L
Petaluma, CA: Smart Publications; 2010; $19.95

This edition is revised, expanded, and updated with over 500 references. Eye-catching chapter titles make it easy to navigate and get right to the current topic of interest. Great photos and graphics make it eye-appealing and interesting. Current and popular information, not only from the clinical literature but from the political and business world, make it entertaining, informative, and easy-to-read. The book contains a Foreword by Suzanne Somers, broad discussions of bioidentical hormone replacement for women and even a chapter for men, a chapter on compounded bioidentical hormones, and on the politics of bioidentical hormones. This book will be read by many of your patients, so it would be a good idea to pick up a copy and be able to respond to your patients' questions.

�that the legal and policy issues of unapproved drugs are to be discussed during a January 22, 2010 audioconference? A panel will provide an overview of the applicable legal requirements regarding new drug approvals, the issues that drive the FDA's and CMS' efforts related to unapproved drugs, and the factors that may influence the FDA's exercise of discretion. The audioconference will include discussion of the legal and policy issues, as well as practical guidance on effective compliance and reimbursement considerations.

Take Care with the Web

If you have a website, please be careful and accurate with what is published on the site. Patients depend upon the accuracy of your information. Regulatory agencies are always scanning these for evidence of wrongdoing. Websites can be a great tool for good business practices, but they can also be a real problem if incorrectly used.