A very puzzling topic

[minimozart007]

The Q:

Why?

Your answers can't be Why not.

[Bob]

Because.

Because I said so.


What?

[Ludwig Van Rachabji]

Q. Why?

A. Well, to answer any question properly, it is important that you gather as much information as possible before coming to a conclusion. First of all, we must ask ourselves, what are our objectives?

1. To learn as much as we can beforehand.
2. To find a logical answer with facts to support it.
3. To draw a final conclusion.

So, the best place to start would be to seach it.

ttp://www.google.com/search?hl=en&q=why%3F Upon searching it, we have 239,000,000 results. So, let's try the first link.https://whyfiles.org/

So, we now see: Bye, Bye Vioxx: Drug-Testing on Trial and Tsunami Disaster! so we must assume that the answer to our question has to do with Vioxx and Tsunamis. Let's research Vioxx. https://www.vioxx.com/rofecoxib/vioxx/consumer/index.jsp

"Merck Announces Voluntary Worldwide
Withdrawal of VIOXX®
WHITEHOUSE STATION, N.J., Sept. 30, 2004—Merck & Co., Inc. today announced a voluntary worldwide withdrawal of VIOXX® (rofecoxib), its arthritis and acute pain medication. The company’s decision, which is effective immediately, is based on new, three-year data from a prospective, randomized, placebo-controlled clinical trial, the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial.

The trial, which is being stopped, was designed to evaluate the efficacy of VIOXX 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking VIOXX compared to those taking placebo. The results for the first 18 months of the APPROVe study did not show any increased risk of confirmed cardiovascular events on VIOXX, and in this respect, are similar to the results of two placebo-controlled studies described in the current U.S. labeling for VIOXX.

“We are taking this action because we believe it best serves the interests of patients,” said Raymond V. Gilmartin, chairman, president and chief executive officer of Merck. “Although we believe it would have been possible to continue to market VIOXX with labeling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take.”

APPROVe was a multi-center, randomized, placebo-controlled, double-blind study to determine the effect of 156 weeks (three years) of treatment with VIOXX on the recurrence of neoplastic polyps of the large bowel in patients with a history of colorectal adenoma. The trial enrolled 2,600 patients and compared VIOXX 25 mg to placebo. The trial began enrollment in 2000.

VIOXX was launched in the United States in 1999 and has been marketed in more than 80 countries. In some countries, the product is marketed under the trademark CEOXX. Worldwide sales of VIOXX in 2003 were $2.5 billion.

Results of the VIGOR (VIOXX Gastrointestinal Outcomes Research) study, released in March 2000, demonstrated that the risk of gastrointestinal toxicity with VIOXX was less than with naproxen, but indicated an increased risk of cardiovascular events versus naproxen. However, in other studies including Merck’s Phase III studies that were the basis of regulatory approval of the product, there was not an increased risk of cardiovascular events with VIOXX compared with placebo or VIOXX compared with other non-naproxen non-steroidal anti-inflammatory drugs (NSAIDs). Merck began long-term randomized clinical trials to provide an even more comprehensive picture of the cardiovascular safety profile of VIOXX.

“Merck has always believed that prospective, randomized, controlled clinical trials are the best way to evaluate the safety of medicines. APPROVe is precisely this type of study—and it has provided us with new data on the cardiovascular profile of VIOXX,” said Peter S. Kim, Ph.D., president of Merck Research Laboratories. “While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy. While we recognize that VIOXX benefited many patients, we believe this action is appropriate.”

Merck has informed the U.S. Food and Drug Administration and regulatory authorities in other countries of its decision. The company also is in the process of notifying health care practitioners in the United States and other countries where VIOXX is marketed. Patients who are currently taking VIOXX should contact their health care providers to discuss discontinuing use of VIOXX and possible alternative treatments. In addition, patients and health care professionals may obtain information from www.merck.com and www.vioxx.com, or may call (888) 36-VIOXX (1-888-368-4699).

The results of clinical studies with one molecule in a given class are not necessarily applicable to others in the class. Therefore, the clinical significance of the APPROVe trial, if any, for the long-term use of other drugs in this class, consisting of COX-2 specific inhibitors and NSAIDs, is unknown. The company will work with regulatory authorities in the 47 countries where ARCOXIA is approved to assess whether changes to the prescribing information for this class of drugs, including ARCOXIA, are warranted. Merck is continuing to seek approval for ARCOXIA in other countries, including the United States.

Merck will continue its extensive clinical program to collect additional longer-term data for ARCOXIA, its medication for arthritis and acute pain.

With regard to financial guidance, prior to today’s announcement, Merck remained comfortable with its 2004 earnings per share guidance of $3.11 to $3.17. The company currently expects earnings per share to be negatively affected by $0.50 to $0.60 as a result of today’s announcement. This estimate includes foregone sales, writeoffs of inventory held by Merck, customer returns of product previously sold and costs to undertake the pullback of the product. Included in this cost estimate is the expectation of foregone fourth quarter sales of VIOXX of $700 million to $750 million. In addition, Merck expects that worldwide approximately one month of inventory is held by customers and will be returned.

At this point it is uncertain which of these costs will be recorded in the third quarter and which will be recorded in the fourth quarter. Therefore, at this point, Merck is retracting the third quarter guidance it had previously provided.

Merck will report third-quarter earnings on Oct. 21. At that point, the company will provide additional information regarding the costs for product withdrawal.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.

Forward Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the cautionary statements in Item 1 of Merck’s Form 10-K for the year ended Dec. 31, 2003, and in its periodic reports on Form 10-Q and Form 8-K (if any), which the company incorporates by reference."

[Ludwig Van Rachabji]

All right, this is a good start. But still, we must find more information:






(Stock information of the company that makes Vioxx)

Also....

"Drug claims are unsubstantiated, violate federal lawThe Associated Press
Updated: 8:03 p.m. ET Jan. 12, 2005WASHINGTON - Advertisements for the arthritis drug Celebrex were misleading and unsubstantiated, overstating the pain reliever’s benefits and understating the risks, the government said Wednesday.

The Food and Drug Administration asked for an immediate halt to all ads for Celebrex, which Pfizer Inc. did last month in advance of the agency’s letter. A study in December found high doses of Celebrex were associated with an increased risk of heart attack.

The letter, sent Monday and released Wednesday, details the misleading and unsubstantiated claims in ads for Celebrex and a related drug, Bextra, that appeared on television, in print, on TV infomercials and in direct-mail brochures. The government said the claims represent serious violations of federal law.

New York-based Pfizer spent more than $70 million advertising best-selling Celebrex to U.S. consumers in the first nine months of last year. It has run minimal consumer ads promoting Bextra.

When Pfizer voluntarily pulled its ads in December, the company said it planned to keep Celebrex on the market and would continue marketing the drug to doctors.

Vioxx, a drug in the same class as Celebrex, has been found to be associated with higher rates of heart problems and stroke. Its manufacturer, Merck & Co., pulled the pain killer off the market last fall.

Ads in violation of federal law
The FDA has said it is considering warning labels for Celebrex or ordering its withdrawal from the U.S. market altogether.

Before the recent studies detailing their side effects, anti-inflammatory drugs such as Celebrex and Vioxx were heavily promoted by the pharmaceutical industry as being more effective and less irritating to the stomach than some other pain relievers.

But five ads for Celebrex and/or Bextra reviewed by the FDA were found to be misleading and in violation of federal law, the agency said. They omitted facts, including information about risks, wrongly claimed superiority and made unsubstantiated claims about the drugs’ effectiveness, the FDA said.

The FDA asked the company to detail any ads that make similar misleading claims and keep them off the air as well.

Among those cited in the letter:

“Guitar” TV ad: This is a “reminder ad,” which is supposed to call attention to the name of a drug without giving any details — including what it is meant to treat or what the risks are. In this case, the ad showed a woman playing guitar, focusing on her hands and fingers while a voice says, “With Celebrex, I play the long version.” The FDA said this suggested the woman had better movement and flexibility and was therefore able to play the longer version of the song where she previously could not — making a claim about Celebrex’s benefits without explaining any side effects.
“Arthritis tips” TV ad: The ad opens with, “Celebrex presents, arthritis tips,” and goes on to give facts about the disease. Celebrex is mentioned again at the end of the ad, which clearly suggests that the drug is the arthritis treatment, the FDA said. It said the ad suggests that Celebrex is effective in treating problems such as “crippling disability” when it will simply relieve the signs and symptoms, not modify the disease itself. Overall, the agency said, the ad “greatly overstates the proven benefits of Celebrex.”
An infomercial called “On the Road to Joint Pain Relief”: The 27-minute show includes testimonials and statements from health care providers promising dramatic effects and complete pain-free relief. It repeatedly mentions Pfizer and points consumers to the company for more information, yet the ad omits information about the drug’s safety and risks.
Pfizer spokeswoman Mariann Caprino said the company had received the letter but had no other comment.

Sales of Celebrex and Bextra had been expected to total more than $4 billion worldwide in 2004, nearly 10 percent of Pfizer’s revenue." https://www.msnbc.msn.com/id/6819177/

And.....

Vioxx 25 mg - 30 Tablets

Drug Uses
Vioxx is indicated for relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, for the treatment of primary dysmenorrhea.
How Taken
Vioxx comes as a tablet and liquid to take by mouth. It is usually taken once a day. Follow the directions on the prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Vioxx exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Vioxx tablets may be taken with or without food.

Warnings/Precautions
Before taking Vioxx, tell your doctor if you smoke; drink alcohol; have ever had an ulcer or bleeding in your stomach; have liver disease; have kidney disease; have asthma; have congestive heart failure; have fluid retention; have heart disease; have high blood pressure; have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin). You may not be able to take Vioxx, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above. Vioxx is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Vioxx should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take Vioxx without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Vioxx passes into breast milk. Do not take Vioxx without first talking to your doctor if you are breast-feeding. If you are over the age of 65 years, you may be more likely to experience side effects from Vioxx. You may require a lower dosage or special monitoring during treatment.

Missed Dose
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Possible Side Effects
Although side effects from Vioxx are not common, they can occur. Tell your doctor if any of these symptoms are severe or do not go away: upset stomach, dizziness, heartburn, vomiting, and constipation. If you experience any of the following symptoms, call your doctor immediately: bloody vomit, bloody diarrhea or black, tarry stools swelling of the face, hands, feet, ankles, or lower legs, unexplained weight gain, fatigue, unusual tiredness, yellowing of the skin or eyes, right upper abdominal pain, flu-like symptoms, skin rash, itching.

Storage
Store at 25?C (77?F), excursions permitted to 15-30?C (59-86?F).

Overdose
Seek emergency medical attention. Symptoms of a Vioxx overdose are not known

More Information
Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; blood in your vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of your skin or eyes, flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

https://vioxx.rxpills.biz/


Now we have plenty of information on Vioxx. On to Tsunamis - https://www.geophys.washington.edu/tsunami/intro.html





https://www.geophys.washington.edu/tsunami/general/physics/physics.html


In order to answer your question, it is imperative that you read all of the information. Now we must ask ourselves, what is the connection between Vioxx and Tsunamis? Well.....

https://search.msn.com/pass/results.aspx?srch=105&FORM=MSN8A&q=vioxx+tsunamis


I, for one, never thought I'd find the answer.

I hope I have helped you.

[pianobabe56]

Impressive 

[lenny]

what?

[Hamfast]

www.selete.co.jp/Data/200401/0401a01.pdf

[richard w]

Before I commit my evening (weekend?) to reading Ludwig Van Rachabji's posts please can I have a review and synopsis.



 


Richard

[calidris]

You guys just have waaaaaaay too much time on your hands! 

[puma]

You guys just have waaaaaaay too much time on your hands!

LOL