Tag Archives: fda

What Do The Labels Tell You?

26 Nov

Just taking a look at a couple of labels on toothpaste and an “organic” milk carton as examples, what can you find out?

The active ingredient in toothpaste is monofluorophosphate that aids in the prevention of cavities. If you swallow more than that used for brushing, “get medical help or contact a Poison Control Center right away.” It is up to the consumer to weigh the risk and benefits of using toothpaste. Of note in the Wikipedia link is the fact that cavities are formed from the acid that plaque generates. And the production of plaque is fueled by the consumption of carbohydrates and sugar. Not that you would want to, or need to trash your toothpaste, but you might want to consider the impact of carbohydrates and sugar on your teeth.

In the case of the organic milk carton, what can be seen?

Certified Organic is produced without any artificial growth hormones, but what about that asterisk? rbST is an artificial growth hormone. The FDA has determined that “no significant difference has been shown”, between the milk produced using cows that have been treated with rbST and those that have not been treated with rbST.

Again, it is up to the consumer to determine if this is of any impact to their health. What is interesting in this statement on this milk carton is simply the fact that no mention is made to if the milk came from cows treated with rbST. The statement does provide the following insights :

  1. The consumer is now aware that there is an artificial growth hormone that apparently supersedes the definition of “Certified Organic”.
  2. Until “A significant difference between milk derived from rbST supplemented and non-brST supplemented cows” can be shown to the FDA, this approval will remain in effect.

Per FDA guidelines, milk produced from cows not treated with rbST can state on the label: “from cows not treated by rbST”, but this must also contain the statement: “no significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows.”

Therefore, we can conclude that the organic milk in this package has been produced with cows treated with rbST, or it would otherwise state “from cows not treated by rbST”. The regulation of such things is performed on a state by state basis, and Ohio has no legislated oversight, therefore the producer would have no way of verifying non-rbST treated cows anyway.

In Canada, Europe and Japan, the use of rbST is prohibited in the dairy industry, so there is no need to such labeling requirements.

Ref: TED Case study #399

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Investigation of Cancer Research Organizations – 1953

20 Jul

During the 1950’s, the Hoxsey Cancer Clinic in Dallas was the world’s largest cancer clinic in the world with branches in 17 states. It did not achieve this feat overnight. It had been treating patients at a rate of 300/ day in Iowa in the 1920’s.

During the 1930’3 the state of Texas was trying to convict Harry Hoxsey of practicing medicine without a license. The prosecutions in Texas ended when the Assistant Attorney General, Al Templeton found that his brother Mike, was cured of his terminal cancer by sneaking to The Hoxsey Clinic for treatment. Al then became Harry’s attorney, later to become a district judge.

In 1949, after the AMA had been blasting away at Dr. Rife for his cures for cancer, they took up the battle against Harry Hoxsey and lost.

Judge W. L. Thorton ruled: “I am of the firm opinion and belief that Hoxsey has cured these people of cancer. Hoxsey has been done a great injustice and . . . articles and utterances by defendant Morris Fishbein (AMA) were false, slanderous, and libelous.”

From the Congressional record of 1953 (Fitzgerald Report, August 3, 1953) :

  • Patients who received no treatment fared better than those who received surgery, radium, or X-Ray
  • The American Medical Association (AMA), and the American Cancer Society, state “radium, X-Ray therapy, and surgery are the only recognized treatments for cancer.”
  • Senator Elmer Thomas was petitioning the Surgeon General to investigate The Hoxsey Cancer Clinic. The Clinic supplied 62 case histories in 1945 and 77 case histories in 1950. Not only did the Surgeon General avoid an investigation, The Council of National Cancer Institute refused to investigate, in favor of hindering, suppressing, and restricting The Hoxsey Cancer Clinic.
  • My investigation to date should convince this committee that a conspiracy does exist to stop the free flow and use of drugs in interstate commerce which allegedly has solid therapeutic value.
  • Public and private funds have been thrown around like confetti at a country fair to close up and destroy clinics, hospitals, and scientific research laboratories which do not conform to the viewpoint of medical associations
  • “Behind and over all this is the weirdest conglomeration of corrupt motives, intrigue, selfishness, jealousy, obstruction, and conspiracy that I have ever seen.”

Realize that during these days in the 1950’s, you could buy rat poison and arsenic with no problem, but a $.25 tube of penicillin required a doctor’s prescription.

When Healing Becomes a Crime: The Amazing Story of the Hoxsey Cancer Clinics and the Return of Alternative Therapies

After the State of Texas failed to bring down Harry Hoxsey, and the AMA failed to bring down Harry Hoxsey, the FDA closed and padlocked all 17 Hoxsey Clinics in 1960.

July 20, 2013: Where are we today in (our search) finding the cure for cancer?

Trial Results Not Published – Dr. Burzynsky

15 Jul

For the first time in history, a private individual was granted the ability to enter the federal drug approval process for a proprietary cancer therapy. The entire process is being funded without any financial support from the American Government, the Pharmaceutical Industry or The Cancer Establishment.

On November 26, 2012 (6:13:08 am), the results of the phase III study on antineoplastons was released to The Lancet for publication, showing over 8 – 16 years survival using antineoplastons to treat a rare brain cancer.

On November 26, 2012 (8:22:57 am) the study was rejected by The Lancet from publication. ” … we have now had time to consider your manuscript… We have decided not to publish it because we believe the message would be better elsewhere.” It appears to have only taken a little over two hours to “consider” publishing.

Earlier, on November 19, 2012: The Texas Medical Board dismissed its motion to revoke Dr. Burzynsky’s medical license after four years of trying.

January 7, 2013: The FDA physically enters Dr. Burzynsky’s Clinic, and demands that all information pertaining to antineoplastons be removed from their website , and that no new patients be provided treatment on American soil (temporary hold). The FDA remained on site for 45 days reviewing data collected over 25 years, finding no evidence of either safety or efficacy violations with Antineoplastons.

The relationship between the FDA and Dr. Burzynsky has a rich legal history which began in 1983 when the “FDA takes Dr. Burzynski to court in a civil action to stop him from manufacturing and using antineoplastons. ” The FDA has since convened 4 grand juries without a grand jury indictment.

While in Japan, a study testing for the “safety” of antineoplastons (1995), which is a Phase I type of test was positive, yet in December of 2012, the Kurume Medical University announced :

“We can’t go any further with these clinical trials allowing antineoplastons to gain market approval exclusively for the Japanese people due to the United States FDA and the power they have over the world market. The FDA would retaliate against any Japanese pharmaceutical company who would try to get antineoplastons approved in Japan by no longer approving their other drugs for market in the USA” – Hideaki Tsuda, MD

Phase II Results (March 2003)

One would think that if there was progress in the treatment of such serious cancers, the FDA would be expanding research in that area. They apparently do not agree with Dr. Burzynsky.

They Used to Call It Price Fixing

19 Jun

It used to be that companies could not collude to fix prices and avoid competition.

In 2008, DeBeers settled a lawsuit about price fixing diamonds.

In 2010, DRAM makers settled a price fixing litigation with 33 states.

Even this month, Chocolate manufacturers in Canada were being sued for price fixing chocolate in that country.

Canada’s Competition Bureau said in a statement that Hershey Canada was expected to plead guilty later this month “for its role in the conspiracy to fix the price of chocolate confectionery products in Canada.”

This week the Supreme Court ruled that profit sharing between drug companies that hold patents and generic manufacturers can be legally challenged.

“Today’s ruling is a victory for millions of Americans who depend on generic drugs to treat illness and pain,” New York Attorney General Eric Schneiderman said. “Pay-for-delay drug settlements should receive serious scrutiny because they are frequently anti-competitive, unlawful, and harmful to health-care consumers across the country.”

In the Federal Trade Commission vs. Activis lawsuit, Solvay Pharmaceutical had negotiated an agreement to pay three generic manufacturers between $31M and $42M to withhold a generic version (and patent challenges) of the AndroGel product from the market until 2015. AndroGel is topical testosterone applied in gel form.

The FTC has fought such “pay-for-delay” settlements for a decade as their number has grown, from just three in 2005 to 40 last year. They were joined in this case by a coalition of 36 states that argued the deals should be subject to challenge.

It is suggested that generic manufacturers have to legally challenge a drug patent before they can bring a generic version to market. The “pay for delay” agreements are apparently put in place to avoid the litigation costs. An explanation of the duration, and types of drug patents can be found here.

Either way, the Supreme Court ruling should open the door for generic drugs to make their way to market earlier.