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Editorial: If it ain't broke, don't fix it!

Part of the government talks about lowering drug prices but another part of the government works to increase them. Two examples are as follows:

1. The requirement that selected pre-1938 drugs be submitted to the FDA for approval can result in a single manufacturer for the product and the company being able to charge almost whatever they want to for the product, as follows:
   • Quinine sulfate capsules increased from $15 per 100 to $55.
   • Colchicine tablets (Colcryst) increased from $25 per 100 to $550.

   Note: These prices are from the 2006 Redbook and current Internet pricing.

   The impact of the recent decision on cough/cold medications and their costs after approval is potentially staggering!

2. Approval of a "generic" version of a formerly FDA-approved drug product resulting in a single manufacturer for the product and the companying charging outrageous prices for their product as follows:

   • Hydroxyprogesterone caproate injection (Makena) increased from $15 (compounded, current) and $3 (generic in 2006) to $1500 per dose.

   Note: The Makena price is from media releases.

Both of these examples make it look like not everyone is on the same page. The pre-1938 drugs have been marketed for (2011 - 1938 = 73) at least 73 years and have been used by "millions and millions" of patients. Allowing a company a monopoly of limited distribution, and exorbitant pricing doesn't seem to enhance quality patient care.

It seems that the FDA has more than they can do to monitor the already-approved drug products that are coming from overseas (see story below) where a significant lack of oversight is occurring that can result in significant patient harm. The Agency has announced it must "reinvent" itself to handle the impact of foreign manufacture of approved drug products. One step would be to eliminate activities with marginal consequences and move those personnel to the major problem of monitoring foreign drug manufacturers.

It would be good if the government agencies at least considered the axiom, "If it ain't broke, don't fix it!"


Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief

Compounding Opportunity? Quinidine Shortage
The slow disappearance of quinidine from the pharmacies of countries around the world is causing concern among physicians treating patients with rare arrhythmias. Quinidine is the most effective treatment for patients suffering from unique ventricular arrhythmias, such as short-QT syndrome and Brugada syndrome and some arrhythmias associated with organic heart disease. This may be an opportunity for compounding pharmacies to be of service.
http://www.theheart.org/article/1197113.do

FDA Taking over Three Tylenol Plants Following Drug Recalls
The FDA and the Justice Department have taken action against McNeil PPC and two of its executives for failing to comply with federally mandated manufacturing practices. McNeil (a division of Johnson & Johnson) agreed to put its plants under FDA supervision via an agreement, known as a "consent decree." The agreement requires McNeil to adhere to a strict timetable to bring those facilities into compliance.

If the decree is violated, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law, up to a total of $10 million annually.
http://money.cnn.com/2011/03/10/news/companies/johnson_mcneil_fda_action/

Drug Prices Rise Despite Calls for Cuts
Even as government and private health plans push to restrain spending on medicines, the prices of brand name prescriptions are climbing rapidly, reaching the steepest rate of the decade last year. A report of the list prices of the 130 top-selling drugs by sales shows the 2010 rate of almost 7% topped 2008's average increase of 6.8%, the previous high.
http://online.wsj.com/article/SB10001424052748704629104576190621185676798.html

Pfizer Moving Antibacterials Operations to Shanghai
Pfizer plans to move its antibacterials research unit in Groton, Connecticut to Shanghai, China. Industry analysts said Pfizer's action will be the first wholesale move of a major U.S. pharmaceutical research unit to China. Until now, U.S. firms have relied on China mostly for support functions rather than high-level discovery work. This acknowledges the lower labor costs and high intellect in China. Some analysts feel that the Pfizer move could be a way to skirt the strict regulatory guidelines of the FDA, even though unsure whether Chinese standards are more lax than in the U.S. and raise the question of whether clinical trials conducted in China would be accepted by the FDA.
http://pharmalive.com/news/index.cfm?articleID=768211&categoryid=9&newsletter=1

$4 Lipitor "Coupons" Could Increase Health Costs for All!
A war over Lipitor could contribute to higher healthcare premiums--even for those who don't use the drug. Late last year, Pfizer launched a coupon card allowing insured patients to purchase a month's supply of Lipitor for as little as $4. The card paid up to $50 of the co-payment of the price, but the patient's insurance company was left paying the rest, which could be four times the total cost of a generic alternative. The insurance plans may have to pay more money because of the program and potentially higher premiums could result. These coupons and co-pay cards promoted by manufactures are an attempt to get consumers to use expensive brands while sticking payers with the extra cost.
http://blogs.forbes.com/matthewherper/2011/03/16/how-bargain-lipitor-could-raise-health-costs/

Texas Changes Drug Used For Executions
Texas has been forced to change one of the drugs it uses for execution of condemned inmates because of a shortage of sodium thiopental. They plan to substitute pentobarbital for sodium thiopental in the three-drug cocktail that's used to execute inmates. A number of states have been forced to find substitutes due to the shortage of sodium thiopental. A Texas prison agency spokesperson says this alternative drug has been used for executions in Oklahoma and has survived court challenges there.
http://www.kwtx.com/news/headlines/Texas_Forced_To_Change_Drug
_Used_For_Executions_118085119.html?ref=119

FDA: Another Tainted Drug Crisis Seems Inevitable
The FDA states that as more drugs sold in the U.S. are manufactured overseas, it cannot guarantee their safety. 40% of drugs consumed in the U.S. are imported, while 80% of the ingredients used in U.S. drugs come from other countries.

The Agency says it must reinvent itself to operate more effectively globally, or another public health crisis like Heparin seems inevitable. The difficulty in monitoring imports is also leading to more counterfeit and adulterated products entering the U.S.
http://www.pharmalot.com/2011/03/fda-official-another-tainted-drug-is-inevitable/

Medical Abbreviations: 32,000 Conveniences at the Expense of Communication and Safety
15th ed.
Davis NM
Neil M Davis Associates
2011; 424 pages; Paperback ; $28.95

32,000 current acronyms, symbols, abbreviations, slang, and their possible meanings are presented in an alphabetical listing. This is a great collection that is very useful. In addition to the print copy, purchasers also obtain the Internet version that can be accessed from a computer or from WiFi-enabled devices and added as a home-page icon or bookmarked. The Internet version is updated with 20 new entries per week.

It also contains 3,400 cross-referenced drug band and trade names. This is a great reference tool that will come in handy many times throughout the year.

�our world was changed a week ago with the earthquake and tsunami in Japan? It will impact us all in some way or another for years to come!

Fact or Opinion?
As has been mentioned in this newsletter before, one has to carefully critique the news that we receive every day from a multitude of sources. It seems to be getting more difficult to separate fact from opinion!