This time, it’s not your fault. (E951) Part 1

(This is part 1 of a 2 part series on the aspartame.  we will not discuss, in details, the problems it has caused or medical issues.  Instead, we discuss the disturbing process that was used to get the substance approved for public consumption)

PART I-

I did it for years, and many people do it and have done it for years as well.  It’s not really our fault.  We struggle with fat, so we look for different ways to ‘cut calories’ and lose the weight.  You can’t really beat zero calories! I’ve told people they were ‘crazy’ when I was told it ‘wasn’t good’ for me.  Well, beez in peez- you know I love me a good conspiracy!

I was duped.

So, we are here today to talk about good ol’ aspartame. The name sounds evil, so let’s just call it artificial sweetener.  Before you shrug it off as another ‘food rant’ post and say ‘I don’t use the stuff’…you may be shocked to find out how many products contain it.  You may not add it to your food, but chances are it has been placed in it…especially products intended for children. I can assure you that anything with the words ‘fat’ or ’sugar’ free on the package, it contains some type of artificial sweetener.  It is also contained in many other items, such as vitamins and children marketed snacks.  I should point out, it has been accused of creating learning disabilities in kids.  If you have children, you know the first 5 years is HUGE in brain development.

The key is to look on the label for the words:

‘Contains a source of phenylalanine’.  I won’t get into the scientific part of this one,  but phenylalanine has been proven (not theory) to cause problems in people with a ‘rare’ genetic disease.  They say about 1 in 10,000 births is affected.  So, yeah…’we put the label there so these ‘weirdos’ won’t get hurt.

Riiiight….

Or you may say, ‘I’ve used it for years…never had a problem”.  And, you may be right.  But for thousands of others that have experienced problems, they ‘may be right’ as well.    Being my loyal readers that you are *cough-ya right-cough* I figure it’s my duty to bring you some interesting facts you may not know.  Get yourself some coffee, or maybe a protein shake- and let’s get started:

It started in the mid 60’s when it was discovered by GD Searle Co.  GD Searle was later sold off to Monsanto Co, then NutrSweet.  Monsanto is kinda like that guy who just ’seems to be around trouble’  all the time. Or they can be seen as ‘modern day food heroes’ I guess.  Regardless to which side you take, you could be right..  Anyhow.  They (searle) were working on an ulcer medication, when they stumbled upon this sweet miracle.  They spent years on research.  According to the FDA and GD Searle, it was researched from 1967-1975.  Personally, I think it was researched for so long before it was sent to the FDA because there were so many problems being found….but it was a HUGE payoff if thye could get it to fly.  You can’t being to fathom the amount of money that was set to be made with an approval. Things didn’t get started off on the right foot for the good ol boys at Searle, but they were persistent!

1974- Aspartame was approved for limited use as an additive only in dry foods.  Later, Searle studies were found to be flawed.  Some tests and results were flawed to the point of ‘criminal misconduct’.  A ‘task force’ was formed by the FDA to investigate the test, studies, and other findings provided by GD Searle and their staff.

Some of the highlights included; lab rats that died DURING the study, and did not have autopsies performed to determine the cause.  Discarded. Tumors were removed and discarded without being documented.  Food was often given with ‘big clumps’ of the aspartame in it, but only in certain areas.  This made it easy for lab rats to ‘eat around’ the substance and avoid it.  Other cases included lab rats that were given antibiotics, and not documented as such.  Basically, there were holes in the story and plenty of patch work cover ups attempted.

Remember, the FDA did form an investigation…this is NOT theory.  At one time, I guess they did actually care about integrity and consumer safety.

1974-1975- FDA puts a hold on any further approvals until ‘further studies’ are done.  At this point, they were not very happy with the studies they looked into.  They “uncovered serious deficiencies in Searles operations and practices”. They also recommended Searle should face a Grand Jury and “identify more particularly the nature of the violations, and to identify all those responsible.” The task force formed by the FDA was pissed!

Wow.  That’s some serious fighting words!

1975- Searle agrees to stop marketing aspartame until further research can be done.  Over the next few years, aspartame is not sold at all.  Battles go back and forth.
1976- The FDA forms a new task force, headed by veteran inspector Jerome Bressler, to further investigate  Searle’s aspartame studies uncovered by the original task force. The findings eventually go on to be put into a document known as the Bressler Report.
January 1977- FDA chief counsel Richard Merrill formally requests the US Attorney’s office to begin grand jury proceedings to investigate whether indictments should be filed against Searle for knowingly misrepresenting findings and ‘concealing material facts and making false statements’ in aspartame safety tests. This is the first time in the FDA’s history that it requests a criminal investigation of a manufacturer.

1977- You know these things work, they’re slow…months drag on with no action.  Money goes back and forth and  there are plenty of ‘closed door’ meetings.  Needless to say, Searle was a bit paranoid about these new allegations.  But this year it heats up!  Searle gets strategic and brings on good ol’ Donald Rumsfeld to the company. He becomes chairman of the organization, and then goes to work trying to ‘mend things up’.

Note: August 1977- The Bressler Report, compiled by FDA investigators and headed by Jerome Bressler, is released. The report finds that 98 of the 196 animals died during one of Searle’s studies and weren’t autopsied until later dates, in some cases over one year after death. Many other errors and inconsistencies are noted.

Still no indictments yet, but US attorney, Samuel Skinner, has been put in charge of the case formed in part by the FDA. He’s been working diligently on the case!

Then….around July 1977, after meeting with Searle appointed lawyers, he quits.  He soon joins Sidley & Austin, a law firm in Chicago.  And, (yup, you guessed it!) the same lawyers representing Searle on the case.  Yes, you read that correctly.  The lawyer working for the FDA to investigate the case…jumped ship, and is now working for the law firm that represents GD Searle. (the accused)

I guess Sammy boy was having meetings about his new salary, not the charges they planned on filing.

The FDA task force still wanted to pursue the case, as did the Justice Department.  Of course, we need someone to take the empty spot, so another US attorney, William Conlon takes over. He ‘reviews’ the case again, and basically just ’sits’ on it.  Despite the advice to follow up and pursue the investigation, he decides to use his power to do nothing and the file is dropped and not pursued any more than Skinner had taken it.

1979-  William Conlon joins Sidley & Austin. HA!!  Bet you didn’t see that one coming!

So, no case, and Bill and Sam are chillin in Chicago…getting pizaid to keep their mouth shut!

June 1979- The FDA continues to get heat about the product.  Many research scientists, and other independent studies are advising the FDA to keep the product off the shelves.  They decide to gather the opinions of 2 separate panels of three experts.  It was called a Public board of inquiries.  PBOI, to rule out any problems with aspartame.  3 are to come from within the FDA staff, and 3 are from outside sources.  After data is reviewed, BOTH panels agree the product should not be marketed until further studies can be performed.  It is important to point out, these 3 inside the FDA were just for the data review.  They obviously weren’t involved in the payoff.  They just did the scientific stuff…  The FDA board had already deemed aspartame to be ’safe’ for the general population the first time around, based on flawed studies by Searle.  The PBOI study concluded late September, 1980.

The FDA did seek the services of these ‘outside sources’ and they did find some disturbing things, so… At this point, it looks like it may be lights out for the new miracle calorie cutting sugar introduced by Searle. Then, like a fat kid taking his ball home half way thru the game…he ruined it.

They needed action, fast.  Then Reagan was elected, and as it is usually common for many government jobs to be shuffled up when a new president comes in…the FDA was no exception, and there were some changes made.  After years of downtime, it was a good time to get things heated up again.  If you can’t beat em, don’t join em…fire em, then put someone in their spot!

January 1981- Reagan is sworn into office.  Good ol’ Rummy is part of this transition team, and he hand picks the new FDA commissioner.  One day after Reagan is sworn into office, Searle files for FDA approval on aspartame, again.

Rummy basically said, fu** science…I got political pull, bitches!

1981-  Dr. Arthur Hull Hayes is appointed under the Reagan administration to Commissioner of the FDA.

March 1981- a review panel is formed by the FDA to review and rule on the earlier findings by the FDA’s PBOI…that said aspartame should NOT be marketed yet.  Hayes picked 5 people for this panel.

May 1981- The panel was instructed to review the brain tumor issue found in the lab rats. The original ruling was 3-2, in favor of keeping aspartame off the market.  Hulls appoints one more member to the panel and it becomes deadlocked, 3-3.

July 1981- Against the advice of his own appointed scientists, he shocks everyone- Hayes approves aspartame for the limited use of ‘dry goods’.

It was just a matter of time now.  The public would soon be consuming aspartame on a daily basis.

Time to get this party started, it’s ON!

—To be continued—

Related posts:

1. This time, it’s not your fault. (E951) Part 2
2. 4 Real Movies You Must Watch
3. Fast Food Bites, Vol. IV: Supplements
4. Fast Food Bites, Vol. II