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FDA Panel Votes to Approve New Celebrex Alternate

January 02, 2008 | 10,494 views

An advisory panel to the Food and Drug Administration's (FDA) recommended approval of rofecoxib (Vioxx), the newest of the Cox-2 inhibitors, a class of pain reliever believed to be less damaging to the stomach than aspirin or similar drugs. The FDA often -- but not always -- follows the advice of such panels when it comes to approving drugs for market. However, the manufacturer, Merck & Co., cannot claim the drug is any less damaging on the gastrointestinal tract than traditional nonsteroidal anti-inflammatories (NSAIDs), such as aspirin, according to the panel.

Even so, rofecoxib may see wider use than another Cox-2 inhibitor, celecoxib (Celebrex), which was recently approved for osteoarthritis and early stage rheumatoid arthritis pain. If the FDA follows its panel's advice, rofecoxib will likely be approved for both osteoarthritis, and for the larger acute pain market as well. Panelists said the drug seemed to work as well as NSAIDs, and could be safely taken chronically for osteoarthritis at the low, 12.5 milligram (mg) daily dose. The efficacy of the drug is not a question. But there was some concern that higher doses, taken long term, might not be safe.

The FDA's reviewers said that the number of adverse events such as swelling, high blood pressure and hyperkalemia (elevated blood potassium levels) increased with rising doses of rofecoxib. The committee recommended against the drug's use for chronic pain, and said acute pain use should be limited to five days -- the longest Merck studied rofecoxib for that purpose.

Merck said rofecoxib was superior to ibuprofen in terms of gastrointestinal side effects. The drug caused fewer ulcers, bleeding and perforation, but since the company only compared its drug to the NSAID ibuprofen, the panel said it could not claim superior safety to all NSAIDs. For now, said the panel, rofecoxib should carry the same warning as NSAIDs that serious gastrointestinal problems such as ulcers or bleeds could occur at any time, without warning. Merck has the potential to take a huge chunk out of the $5 billion to $12 billion worldwide analgesic market.

COMMENT: This is an EXCELLENT article to review some basics. I would encourage you to save this article and review it at later date as I will make some predictions about this new drug which I believe will be accurate. I have not done this for awhile, so I will take the new newsletter subscribers on a tutorial of how to interpret press releases by the drug companies. The first point to consider is that the market for analgesics is about TEN BILLION dollars per year. That is one big number. That is why this is an important drug to watch. It is important to remember that anytime you are dealing with numbers that large there will inevitably be corruption, greed and negative influences that are a part of the story if drugs are involved. So ALWAYS be alert to deception. As one of my friends, Dr. Tom Stone, is found of saying "The PLANET is RULED by GREED and DECEIT!"

Don’t you find it interesting that Merck, the drug’s manufacturer can not even prove that this new drug is any less damaging than aspirin. That is supposed to be the huge advantage of this drug. It is supposed to cause less GI toxicity. It sure does not seem to be holding up for Celebrex as that drug has already killed ten people. However, the FDA in its infinite wisdom has determined to approve this drug the acute pain in addition to chronic arthritis. The major problem here will involve how much of the drug is used and for how long. The reviewers had concern that higher doses, taken long term, might not be safe. They said that the number of adverse events such as swelling, high blood pressure and hyperkalemia (elevated blood potassium levels) increased with rising doses of rofecoxib.

It is important to note that the committee recommended against the drug's use for chronic pain, and said acute pain use should be limited to five days -- the longest Merck studied rofecoxib for that purpose. Don’t you find it absolutely incredible that the longest time that this drug was studied was only five days?? This is the way they slip drugs into use. Merck is no small potatoes company as they are the second largest drug firm on the planet. They have the resources to look at new drugs and would likely submit new drugs for the broadest indication possible. I strongly suspect the drug was studied for longer periods and found to be toxic. However, this data was not submitted to the FDA panel. This is not a hard conclusion to reach when one reads the toxicities of this drug reported at only five days of use.

Don’t you find it interesting that the ONLY drug they compared it to was ibuprofen. No other comparisons were submitted to the FDA. Well, I am so relieved that this new drug is less damaging to the GI system than ibuprofen (as are most of the NSAIDS). It appears that this drug has no major advantage and may be considerably more damaging than other NSAIDs already on the market. I can see of no reason to use this drug, but many reasons to avoid it when it is introduced in the next few months. This drug will kill patients, just like the other ones that kill about 30,000 patients every year. Don’t forget that the FOURTH leading cause of death in this country is due to drugs prescribed by doctors.

To add insult to injury, it is highly likely that this drug will also reduce beneficial protaglandins and increase your risk for heart attack. Very few people seem to recognize that this has been clearly established for Celebrex in the Proceedings of the National Academy of Science as outlined in my January 24 newsletter.

The predictions I will make is that this drug will initially be approved for short term use only. This is very similar to Prilosec when it was introduced about 15 years ago. Experts would cringe when people were put on it for more than the recommended few weeks. No, it is common to see patients who have been on this drugs for years. This is unfortunate as this is one of the more toxic drugs on the market and well over 90% of the time it is unnecessary. You will undoubtedly see patients taking this drug for months and years and you will surely see toxic reactions and deaths from doing so. If you look at my very first newsletter, you will find an alternative, simple, inexpensive treatment that is highly effective.

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