Nov. 22 Letters to the Editor

Stop the extra spending

The upcoming vote in the Senate on the health industry takeover will mark the biggest change in American prosperity experienced since the end of World War II.

If this passes and the government becomes responsible for health care, the entire world will look with even greater skepticism on the true value of the dollar and probably dump as much of it as fast as they can without causing a stir.

The facts:

• The U.S. is borrowing at a rate unprecedented in history just to survive.

• An anemic economy and real unemployment close to 20% and rising.

• “Cap and trade,” better known as an energy tax on the entire economy, right around the corner.

If you were a loan officer looking at the same customer daily asking you for money just to eat while concurrently he’s making plans to buy a new yacht, would you continue to loan him money? You wouldn’t because you could see he has no real plan for paying you back.

That’s exactly what we are asking of the nations that continually loan to us. We will have to offer them higher and higher rates of return until we are strangled by the interest ourselves. Not to mention their ever increasing influence on American policy. We’ll have the combined heartache of high interest rates, high unemployment and inflation.

We must stop all extra spending by the government right now and pare down immediately.

Wayne Mayo

Scappoose

No political pressure

The column you ran about the ReGen Biologics Menaflex Collage Meniscus Implant implies that political pressure was applied to the FDA (“Who can we trust if FDA puts stamp on snake oil?,” by Cathy Zimmerman, Nov. 8). The reality is that after almost two years of review by FDA in a process that is supposed to last 90 days, and a rejection based on the application of an illegal and wrong regulatory review standard, the company had no alternative but to go to their New Jersey legislators to help them gain a fair review applying the correct standard. The legislators asked for nothing other than for the FDA to investigate the matter and insure that the correct review standard was applied to ReGen’s submission. In December of 2008 the device was cleared by the FDA, following a review by an independent expert advisory panel that concluded that the device was as safe and effective as other surgical meshes.

Based on allegations by FDA review staff of management overturning staff scientific decision, a group of legislators instructed FDA to examine the procedures surrounding the review of the ReGen device. A September 2009 report by FDA examining their processes applied to the review of the device, stated, “OCC advised ….This interpretation supported ReGen’s long-standing argument that the Center was holding the CS device to the wrong review standard.” Despite this finding, FDA concluded that due its own significant departures from processes, procedures and practices a reevaluation of the clearance of the device was warranted; however, in a press conference they stated, “This device has been cleared by the FDA. And we have no basis to question the safety of this device. So it will remain on the market.”

The company is confident that FDA’s reevaluation of the Menaflex clearance will result in the determination that the extensive clinical data provided in its submissions amply supports the 510(k) clearance of the device.

Gerald E. Bisbee Jr.

Chairman and CEO, ReGen Biologics

Hackensack, N.J.

Correction: In the Nov. 8 column, Cathy Zimmerman erred when she wrote that the FDA reversed itself on the clearance of ReGen Menaflex pads. The FDA is reviewing their earlier decision to approve the pads, which are still on the market.

Health care reform

In answer to Asia Gray (Nov. 18 letter), I am a patriot too, but as I tried to read HR 3962 (which is not easy to understand), I did understand that this bill will cost the taxpayer almost $1 trillion and maybe more. This is not good for us. If it is good for us, why won’t our representatives take the same health plan as they are trying to push on us?

Another thing I did read is that, if you do not get/buy insurance, you can be fined and/or put in jail. Is this fair? I think not. Another thing I read is that, if you do not meet a certain criteria for health care, you will die, you have to be a productive person to live. I do believe that we need reform, but not at a really great cost to us, the taxpayers. I also read that you will have to pay a certain amount out of your pocket before the government picks up the rest and, if you have a very good plan, you will be taxed 45 percent to offset the ones that cannot or do not pay for insurance. Nothing will go down but everything will go up.

In response to Matt McClung (Nov. 7 letter), Fox News is not against health reform, it is against the way it is being done — too fast and at a large cost to us, the taxpayers.

Anthony Currera

Kelso