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The FDA/Mass Murder

Better version here courtesy of youtube's column of related videos:



I'm about seven minutes in, but I'll have to save this for later. Looks interesting.
 
Great movie. I had a Burzynski thread on the DS board. Glad to see another one here now that the movie is free online.
 
Its really unbelievable what the government and FDA get away with. Imagine if all the money that has been spent over the years had poured into his research. At the end of the movie they show the FDA purposely sabotaging the trials of his patented drug.
 
i love that part of the hype is that "THIS WILL ALLOW A SINGLE PERSON TO EARN ALL THE MONEYS RATHER THAN HUGE CORPORATIONS!!!1"
 
Being a pharmacy student, I'm amazed by the undying faith in the FDA which I've witnessed among my instructors.
 
Does the video discuss any of these points?

- His CV is posted online, or at least it was last year when someone asked my opinion of him. While he was granted licensure in TX in 1973, he conveniently omits the fact that he had it suspended and also fails to mention that it’s not currently active.

- His for profit company has created it's own IRB just to oversee his company's research. The IRB chair just also happens to be a director and co-investigator of the for profit company. Can we say, conflict of interest? What are the chances that the IRB ever denies a protocol or requests changes be made to the protocol? It sounds more of a rubber stamp IRB to me.

Whether he likes it or not 21CFR50 (human subject protection), 21CFR56 (IRBs) and GCP/ICH guidelines were developed over a long period of time to ensure patient safety. His drugs may or may not work, but unless he goes through the process (including proving statistical significance vs. anecdotal accounts) then he is no better than the tonic sellers of the 1800s.
 
ddeacs98 said:
Does the video discuss any of these points?

- His CV is posted online, or at least it was last year when someone asked my opinion of him. While he was granted licensure in TX in 1973, he conveniently omits the fact that he had it suspended and also fails to mention that it’s not currently active.

- His for profit company has created it's own IRB just to oversee his company's research. The IRB chair just also happens to be a director and co-investigator of the for profit company. Can we say, conflict of interest? What are the chances that the IRB ever denies a protocol or requests changes be made to the protocol? It sounds more of a rubber stamp IRB to me.

Whether he likes it or not 21CFR50 (human subject protection), 21CFR56 (IRBs) and GCP/ICH guidelines were developed over a long period of time to ensure patient safety. His drugs may or may not work, but unless he goes through the process (including proving statistical significance vs. anecdotal accounts) then he is no better than the tonic sellers of the 1800s.
Click to expand...

They won't run any tests with his guidance and only run test on their version and at much lower doces to make the drug appear ineffective. He can't go through the correct process because the FDA will not let him and no board will give him the chance to prove the safety and effectiveness of his drug.
 
no one would give him the chance? the world doesn't work that way. if he was for serious, why not go to Georgia or Thailand or N Korea and ignore all the shit from the US gov?
 
I don't mean to pick a fight, but this "research" center needs to be carefully looked at. Besides the previous things I noted, here is a description from an email sent by them to someone who was interested in being one of their patients last year. Like I said, I was asked my opinion about this place, and I gave my honest opinion. I realize that people who have a diagnosis of metastatic or terminal cancer will want to try any treatment available; however, I think it's foolish to assume that there is some vast conspiracy in play that wants to crush a cancer cure. There's no way in hell I would be making cash payments to them for possible treatments in the hopes that this center thinks that I am a viable candidate. By the way, I doubt there will ever be a single "magic" drug that cures all cancers because all of them are different and respond to different treatments.

Requirements To Become Dr. Burzynski’s Patient
1) Pathology report confirming patient has cancer
2) History of the disease progress & previous treatments – medical file, which we can help to get.
3) Patient must be able to travel
4) We recommend patient have a companion with him or her to stay in Houston 2 to 3 weeks.
5) Patient must be able to pay
$500.00 – To be sent prior to appointment date with:
• Medical Records File
• Patient Information Forms
• Release of Medical Records Authorization Form
• HIPPA Forms
$1,000.00 – Consultation
$4,000.00 – After Consultation for Blood Testing
$10,000.00 – Deposit to start basic treatment.

After Dr. Burzynski receives the results of genetic lab testing he will establish a treatment plan, and additional deposits for prescribed medications will be required. Sometimes the cost for these medications can be high, because the FDA has just recently approved some of these medications. We will not know the exact cost for treatment until these medications are prescribed. (Estimated deposit for medications: $5,000.00 - $15,000.00).

When you are discharged to go home, the monthly deposit for basic treatment ranges between $4,500 to $6,000 plus medication. The treatment regimen can last between 4 and 12 months on average for the majority of patients.

We employ experienced insurance personnel who will file medical claims with your health insurance company for all medical services, supplies and medications received at the clinic. While each patient is required to make initial deposits to initiate treatment, many private insurance companies will reimburse for the clinic’s services, medications and supplies. Patients who have HMO’s, Medicare or Medicaid will be considered self-pay, as our clinic is not a participating provider for these organizations.

I hope I answered all of your questions. If you have any other questions or would like to schedule a consultation, please call and I will be happy to assist you. I wish you the best in whatever therapy you decide to pursue.

Sincerely,

Mark Louvan
Patient Coordinator
Burzynski Clinic
9432 Katy Freeway, Ste. 200
Houston, TX 77055
P: 713-335-5609
F: 713-335-5609
louvan@burzynskiclinic.com
mark.burzynski@yahoo.com
www.cancermed.com
 
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That is expensive but some of the stuff currently issued by doctors can cost up too $100,000 and some of those drugs have been around since the 80s.
 
As ITC mentioned, the center does not need to conduct research in the US. They can go to other countries. If they don't want to follow ICH/GCP then they can go to places other than the US, Japan, EC (and they would probably stay out of Australia, Norway, Iceland and Liechtenstein). However, they are insistent that these drug cocktails work and that they will only do them at their research site (in TX). If they were really confident that this was the magic cure, then they wouldn't care how much it would cost to conduct trials because the end profit would be billions.
 
The end profit wouldn't be billions if the FDA is dead set on keeping it off the shelves at all cost.
 
They could provide results from studies conducted in South America, South Africa, Israel, Eastern Europe, or China. Yet, they don't. The FDA doesn't control influence in these countries.

Also....they can get approval in other countries without having FDA approval. Has that happened? No.
 
ddeacs98 said:
They could provide results from studies conducted in South America, South Africa, Israel, Eastern Europe, or China. Yet, they don't. The FDA doesn't control influence in these countries.

Also....they can get approval in other countries without having FDA approval. Has that happened? No.
Click to expand...

Yes, one man should just build multiple million dollar research facilities all around the world when he already has an established and well working one in Texas. That makes sense.
 
Again, should you go with anecdotal stories or go with statistical significance?

For anyone else that deals with oncology patients on a daily basis, I'd love to hear your opinions.

For those of you hoping for a holy grail, best of luck and I hope whatever treatment you choose or recommend to your family or friends works out well.
 
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Did you watch the video? It's just the principle of the fact that the FDA is doing everything they can to hinder his research when his patented drug has shown more promise than anything they have ever put on the table.
 
Since I did my own research into the matter, I don't need to watch Burzynski's movie. Of course he's going to portray himself as the good guy and the FDA as evil.

He developed antineoplastons in the '70s and '80s, which means the patent protection is no longer there and anyone can develop them. However, only a handful seem to be conducting clinical trials with them. You can see by going here http://clinicaltrials.gov/ct2/results?term=Burzynski that all of the trials conducted are Phase II trials. Basically, Phase I will determine dosing and safety profile. Phase II will include more subjects and expand on the safety profile while starting to look at efficacy as a secondary endpoint. The FDA won't approve/reject a drug until an NDA is submitted after a Phase III study.

If Burzynski really believed that his antineoplastons work, then his stubborn refusal to conform to the clinical trial process is costing thousands, millions of people their lives. Again, his secretive approach to practicing medicine (and really he shouldn't be practicing since his license is not active) raises way too many red flags. If it works, then conduct multi-center trials and let the statistical analysis speak for itself.
 
You really need to watch the movie. In your own research, you are hearing from those who have tried to prosecute, harass, discredit, and steal from Dr Burzyinski. I would be more interested in your posts after you have heard both sides. There is specific segment about how they used clinical trials to discredit (and simultaneously steal) from him by changing the protocol w/o his permission. The movies cites letters written from both sides regarding this, so it is not just a "he said/she said" situation.

As ITC noted, Dr Burzynski's only fault is that he is an outsider of the established medical corporate establishment - who, like all other industries, have their hooks in the federal agencies designed to oversee them.
 
Please show me where what I have said has come from the opinion of others out there whose primary objective is to discredit him and his research. What I have said has all been based on fact:

- CV that he posted online was reviewed and highlighted the misrepresentations
- A review of list of medically licensed people in TX showed that his license was suspended and is currently not active
- The IRB that they use and the person who is the IRB chair clearly shows a conflict of interest
- Upfront costs and refusal to deal with HMOs (taken from their own email) is not the traditional model of healthcare costs and payment
- No trials have been past Phase II
- Patent protection for antineoplastons that are being studied is over which means others can develop protocols, but very few are
- Has the ability to conduct research outside of the US, but doesn’t
- Has yet to provide statistical results for specific indications; rather personal testimonials are given.

Again, all of the above has been based on information obtained by going to either his sites, clinicaltrials.gov, or a patent history of the molecules, as well as referencing CFR and ICH/GCP guidelines. So, no, I didn't do the google search for: Burzynski Scam.

I know that I use acronyms (CFR, GCP/ICH, NDA, etc) but it's easier than explaining them and really making a long post. For anyone who is more interested, PM me and I'll explain them. I'll be happy to discuss clinical trials (and no, I don't work for a pharma company or employed by the FDA, but I do have a lot of insight into clinical trials).
 
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