THE NEW FDA: GOOD MEDICINE FOR DRUG FIRMS

By Dr. Betty Martini, D.Hum.
Mission Possible International
9270 River Club Parkway
Duluth, Georgia 30097
Telephone: 770-242-2599
E-Mail: BettyM19@mindspring.com
Web Site: http://www.mpwhi.com



Posted: 11 March 2008


This is concerning the article, "The New FDA: Good Medicine For Drug Firms", which appeared in the Philadelphia Inquirer on November 22, 1981

You will find the article below.

Over the last several days, we have been adding some old articles, and again thank Lane Shore, Mission Possible Chicago for continuing his research. These articles in the beginning complete the puzzle of how aspartame, a deadly chemical poison, became marketed because of Don Rumsfeld.

I think its interesting that this is when Hepatitis B vaccine was approved which many connected with AIDS. Here is one of those articles: http://www.whale.to/b/rappoport.html Merck also makes Maxalt for headache with aspartame, having full knowledge that headache is #1 on the FDA list of 92 symptoms, and they have been written for years. Merck is who made Vioxx. Articles continue associating them with depopulation: http://www.truthnews.us/?p=899 Also knowing aspartame is an abortifacient and teratogen causing birth defects and mental retardation their only comment about this toxin in their Home Merck Manual is to use it in pregnancy. Letters have not caused them to remove this remark which could cause thousands to have miscarriages or children with birth defects.

Remember that Searle was in big trouble, the FDA wanted them indicted, and then they hired Rumsfeld to get them out of trouble. Both US Prosecutors were hired by the defense team. The FDA revoked the petition for approval which is on http://www.mpwhi.com/www.mpwhi.com, scroll down to the banners. The next day Searle sued them but the FDA wouldn't bend. Then Rumsfeld went to Washington, and was on Reagan's transition team. As per the congressional record of May, l985, Senate, and the UPI Investigation, Rumsfeld said he would call in his markers and get aspartame approved. At 3:00 AM Mary Frances Wright of the Reagan Transition Team called FDA Commissioner Jere Goyan and told him to resign. The day after Reagan took office he appointed Dr. Arthur Hull Hayes as FDA Commissioner. Knowing it would take 30 days to get Hayes to the FDA, President Reagan wrote an Executive Order making the FDA powerless to do anything about aspartame until Hayes got there. Here is the clip from Sweet Misery: A Poisoned World, http://www.soundandfury.tv with James Turner, Atty, explaining the above and we also have the letter from Dr. Goyan's wife on http://www.MPWHI.com : http://www.soundandfury.tv/pages/rumsfeld.html It should be noted that an Executive Order is a matter of public record. This one has been stricken from the records illegally.

Read this comment in the article below: " The FDA is not operating in an adversary role anymore," says Don Burggrabe, a vice president at Searle Laboratories, the Skokie, Ill., pharmaceutical giant that received FDA sanction for three major products in the last few months. " They are willing to open communication." You can thank Don Rumsfeld for this. Since then the FDA has become Big Pharma's Washington Branch office. It's easy to understand what those markers were that Rumsfeld called in from some of these older articles which will be added to web.

Dr. Betty Martini, D.Hum.
Founder, Mission Possible World Health International
9270 River Club Parkway
Duluth, Georgia 30097
770-242-2599
E-Mail: BettyM19@mindspring.com
http://www.wpwhi.com
http://www.whno.net
http://www.dorway.com

Aspartame Toxicity Center: http://www.holisticmed.com/aspartame


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THE NEW FDA: GOOD MEDICINE FOR DRUG FIRMS
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Philadelphia Inquirer, The (PA)-November 22, 1981
Author: ARTHUR HOWE

By Arthur Howe

Inquirer Staff Writer

In the last two weeks, the Food and Drug Administration has given market approval to a revolutionary vaccine to prevent hepatitis B, the most dangerous strain of the virus.

A new ulcer medication also has been sanctioned, as well as a drug to reduce high blood pressure and a compound to lessen the anxiety of five million to 10 million Americans.

In the preceding month, a new broad-spectrum antibiotic reached the market in this country. So did a calcium-blocking and nitroglycerine-based disc to control the painful heart ailment, angina. There also were two drugs to control heart flutter and a drug to combat malaria.

And, for the first time in 25 years, a new low-calorie sugar substitute, promising no " bitter aftertaste," is satisfying the nation's sweet tooth.

"All of a sudden, there seems to be a lot going on" at the FDA, said Joseph Riccardo, an analyst at Bear Sterns & Co., the New York investment house.

Since the mid-1960s the drug industry has viewed the FDA, which is based in Rockville, Md., as a haven of bureaucratic torpor, an impediment to new drugs and innovation.

In 1979, the General Accounting Office (GAO), the investigative arm of Congress, accused the agency of creating a de facto embargo on a number of medications that have proven highly effective in the treatment of cardiovascular disease, kidney infections, skin problems and cancer. A "drug lag," the GAO labeled it.

In recent months, however, industry executives and analysts say they are perceiving subtle but meaningful changes at the FDA. Under the Reagan administration, the FDA has becoming a sympathetic " friend" of industry, they say.

"The FDA is not operating in an adversary role anymore," says Don Burggrabe, a vice president at Searle Laboratories, the Skokie, Ill., pharmaceutical giant that received FDA sanction for three major products in the last few months. " They are willing to open communication."

Said a spokesman for the Washington-based Pharmaceutical Manufacturing Association: " The FDA is giving us definitely more cooperation. A number of our companies are very encouraged by what they see."

However, FDA spokesmen insist that nothing significant has changed at the agency.

"It's coincidence that . . . all these drugs were approved all of a sudden. It's serendipity. It was expected all along," said Christopher Smith, an FDA spokesman.

Still, industry officials nod approvingly at the policies being implemented by the FDA's new commissioner, Arthur Hull Hayes Jr., a former Hershey, Pa., clinical pharmacologist, who took office in the spring. "He's got a great instinct as to what is needed," said Bob Benezra, an analyst with the Boston investment house of Alex Brown & Sons. " He's developing a well-oiled, lubricated system."

In testimony before a House subcommittee on science and technology early last month, Hayes said: " We have taken a number of steps to cut down unnecessary delays in approval time . . . We have instituted a series of procedural changes to allow us to identify important new drugs promptly and to manage them through the investigational and pre-marketing phases to assure that they do not languish from insufficient attention."

On Sept. 9, Hayes announced that he had formed a 21-member task force to evaluate the complex drug- approval process and recommend changes.

Already the task force has recommended that so-called orphan drugs like isoprinosine - used to treat a rare form of encephalitis that affects a few hundred Americans each year - be made available to patients before they receive official FDA sanction, provided there is no evidence that they are harmful.

The most significant drug to enter the market in recent years is Heptavax-B, the vaccine produced by Merck Sharp & Dohme of West Point, Pa., to prevent hepatitis B. FDA market approval was granted last week after almost 20 years of research and preparation.

Hepatitis affects about 500 million people throughout the world, including some 200 million carriers of the virus. In the United States, an estimated 10 million people - a great many of them health workers, male homosexuals and drug addicts - run a high risk of contracting hepatitis.

In tests concluded in September 1980, researchers determined that the new vaccine reduced hepatitis by 92 percent among members of a group of 1,083 male homosexuals who were sexually active with more than one partner.

Because of the complexities of producing the vaccine (from the blood of hepatitis victims) and the FDA's history of taking 1 1/2 years or more to grant approval to a new drug, Merck had predicted that the vaccine would not be available until sometime in 1982.

Benezra, of Alex Brown, believes that Hayes gave the vaccine " fast- track" attention. "There was tremendous pressure to get the drug out," he said.

"Fast-track" attention also appears to have been given to Merck's cardiovascular agent, Blocadren, industry analysts say.

Studies completed in the spring showed that not only does Blocadren relieve high blood pressure, but it substantially reduces - by up to 40 percent - the chance of a second heart attack among heart patients.

As recently as October, Merck chairman John J. Horan projected that the drug would not become available until sometime next year. Yet this week the company said it received FDA notice that approval would be coming " in a matter of days."

Another Merck product given close FDA attention is Ivermectin, an injectible drug used in the treatment of cattle scabies, mites, worms, lice, ticks and grubs - all of which cost U.S. cattlemen millions of dollars annually. The drug, which functions by attacking the nervous system of parasites, also is believed to be effective on household pets.

Merck is projecting 1982 market approval, but some analysts are more optimistic.

Said Bear Sterns' Riccardo: " Maybe it could come sooner." Other promising drugs approved by the FDA in recent months include:

Edition: SB
Section: BUSINESS
Page: F01
Record Number: 8102200146
1981 The Philadelphia Inquirer