No hidden charges

I just read your article “Choosing an apparel service: a checklist” from July's CleanRooms magazine. I simply wanted to say how much I appreciated what you had to say. One of the things we constantly run into when bidding on cleanroom laundry service contracts is the “hidden charges” many people are paying. More than once we have talked to potential customers about laundry service and have heard the comment “you guys charge more.” This virtually always refers to the unit price for laundering a garment. It takes a great deal of time and effort to get them to look at their overall billings to discover what the actual total costs are when they revue the total amounts they are charged.

I also appreciated your comment concerning the process of tracking garments. We have spent a great deal of time and effort perfecting our garment tracking system, knowing it will provide added benefit to our customers, but again, it is sometimes difficult for customers to see that added value up front. Many times we have heard comments from customers who initially chose another laundry service that went something like, “I wish I had known how important it was to be able to keep track of each garment, I got clobbered for replacement charges and I don't know if they are right or not.”

Rich Williams, General Manager
G&K Services Cleanroom, Tempe AZ

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An evolving science

Mark A. DeSorbo's assertion (August 2001, Cuff 'em and stuff 'em, page 6) that the Food and Drug Administration (FDA) officials are conspiring with the pharmaceutical companies is not accurate. There are a number of points that I would like to make on this issue:

1. Pharmaceutical research, development and production is a very complex and evolving science. Due to its complexity, the FDA has to maintain a close but appropriate relationship with each pharmaceutical firm. I remember my involvement with FDA officials as being extremely professional.

2. The job is not done until the paperwork is complete. Many FDA violations involve poor or inadequate record keeping, whether production batch records were not completely filled out or validation documentation is insufficient. These errors usually do not infer drug efficacy or safety issues.

3. Close down a pharmaceutical process and people may die. Many critical drugs are being produced in single production sites. The FDA maintains the close relationship to guarantee a higher probability that drug production will not be interrupted. The FDA has a record of shutting down drug manufacturing facilities due to drug efficacy and/or safety concerns.

Shut downs this year have caused shortages in a number of drugs, including vaccines and clotting factor for hemophiliacs.

The FDA has done a great job evolving over the years, including the establishment of the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The passage of the Prescription Drug User Fee Act (PDUFA) by Congress provided the FDA the necessary resources to substantially reduce approval time frame for new drug applications (NDAs), which enables important therapeutic drugs to reach suffering patients sooner.

The passage of the Hatch-Waxman Act increased competition in the pharmaceutical industry and reduced drug cost to consumers by streamlining generic drug manufacturers approval cycle through the abbreviate new drug application (ANDA).

Is the FDA perfect? No. I look forward to the FDA's continued evolution to address present issues and future issues we are unaware exist.

Vincent A. Sakraida, PE, project manager
LLI Technologies Inc.
Pittsburgh, PA

Note: When I was Bayer Corp's Corporate Mechanical Engineering Manager, I was responsible for pharmaceutical capital projects.

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Statistics knowledge needed

Mark DeSorbo's viewpoint (Cuff 'em and stuff 'em, August 2001, p. 6) concerning pharmaceuticals is right on target. I have been a Quality Engineer for over 12 years and have been involved in product quality in foodstuffs, computer hard drives and printed circuit boards, and I've taken calls from folks doing the statistics on pharmaceutical test trials.

It constantly amazed me and my coworkers that the callers from pharmaceutical companies, who are required by law to perform tests to determine the rate of side effects and to use statistics to confirm the efficacy of their products, had little or no knowledge of scientific technique and statistics.

Nothing is sadder than to take a call from people doing tests and realizing that the person running the tests has less understanding of the test's hypothesis than a college freshman in his first statistics class.

My casual reading on related topics seems to imply that our medical organizations are wooed and cajoled by the pharmaceutical conglomerates in a way that resembles the lobbyists in Washington, almost ensuring that the doctors and their governing boards are heavily influenced by the funding available from these drug companies. Depending on whose opinion you trust you can find examples of drugs that have been released from what appears to be more of a marketing position rather than a medical/scientific conclusion.

The system that creates the tools (drugs) for our doctors needs to be as unbiased and conscientious as it can be, and currently it is not.

There are exceptions: I found that the plant manufacturing arterial catheters (used in angioplasty) in which I worked in Miami, FL, had a very good grasp of statistics and did excellent work on their failure analyses, but they were the exception rather than the rule.

DeSorbo raises a valid point that cuts right to the heart of it: why are the fines and other punitive actions levied by the FDA less timely and severe than those enforced by the USDA?

Marc Hayden, senior test engineer
Electroglas Inspection Products Division
Corvallis, OR