Monday, October 27, 2008

NICOSAN vs. HYDROXYUREA

There has been a lot of talk about drugs that treat Sickle Cell Disease. (Not to mention cures that work for a few people but not all????) Currently, I’m not taking any drugs but I really wanted more information about the two drugs available, Nicosan and Hydroxyurea.

Here’s what I found:

The first drug I’ll discuss is the only US Food and Drug Administration (FDA) approved drug for the treatment of Sickle Cell Disease. It is Hydroxyurea, which is sold in the US under the trade name Hydrea(TM). It has also been used in the treatment of leukemia and certain other cancers.

Hydrea induces the synthesis of fetal hemoglobin, which inhibits the production of the abnormal sickle cells (what the heck does that mean?). I believe that means; this drug causes the production of healthy fetal hemoglobin without the sickle cell abnormality. In other words, it makes your body make good hemoglobin. Why do we care? Well, hemoglobin carries oxygen inside the red blood cell. One little change causes the hemoglobin to form long rods in the red cell (when it gives away oxygen). These rods change the red cell into the sickle shape…and we don’t want that.

The reports on this drug are mixed. I’ve read that not all patients respond to this treatment, and I’ve read of cases of leukemia being developed in patients…now, that’s scary.

Second, there’s Nicosan. Formally know as Niprisan, and in America it’s known as Hemoxin. This drug is not approved by the FDA. It is manufactured in Nigeria, Africa and is supposedly in clinical trials there, but none have begun in the United States. This drug is a plant base drug which means it’s made from organic plant material…that’s gotta be good, right? Some side affects reported are rash, headache, and weight gain.

XECHEM, the company that makes Nicosan in Nigeria, Africa says “Though NICOSAN/HEMOXIN does not cure Sickle Cell Disease (SCD), the medicine greatly reduce the degree of "sickling" of the affected red blood cells, which in turn eliminates or greatly reduces the devastating secondary consequences most patients succumb to, including strokes, kidney and liver failure, and extremely painful episodes known as "crises."

The problem with this drug is complicated.

It’s not FDA approved. Now, to get a drug tested and approved by the FDA takes loads of red tape (aka requirements). These red tape requirements could take a drug many, many years to get approved for use(in the US). This does not mean that a drug is not good or that it doesn’t work (look at Chinese medicines that are not FDA approved…where was the FDA in the first century anyway????)…..get it….the FDA is an American drug law/rule/red tape. But somehow, it makes me feel safer to take a drug that’s approved, and tested, with side affects known.

In addition, XECHEM (the company that produces Nicosan in Nigeria), said in a report to the SEC, “There is a lack of data to document the influence of raw materials (i.e. plant material quality, age, time of harvest, location, soil quality, preparation, handling, etc.) on the production of NICOSAN/ HEMOXIN.”
I have a problem with this lack of “data”.

Also, I’m not sure about the future of Nicosan because, according to a report to the Securities and Exchange Commission (SEC) by XECHEM, they are having severe financial troubles and may file bankruptcy.

So, in conclusion, I don’t know anything. All I know is that there are people suffering with Sickle Cell Disease, like me, and I would love to take a pill and send it far, far away.

7 comments:

  1. Anonymous7:32 AM

    Here's someone who seems to know about Nicosan.

    http://sicklecellblog.blogspot.com/

    ReplyDelete
  2. Thanks anonymous. I follow Vixen's sickle cell blog too. She uses and distributes Nicosan. I'm still concerned, however, that the FDA has not approved this drug or that it hasn't even been approved as a "natural suppliment" in the USA.

    Unregulated vitamins and herbs are sold in the USA in drug stores. My question is "Why hasn't Nicosan even been allowed to be sold as an herb?" Too many unanswered questions for me.

    ReplyDelete
  3. Anonymous11:12 AM

    http://www.mg.co.za/article/2008-07-01-nigerian-sicklecell-drug-mired-in-controversy

    This article speaks about Nicosan too.

    ReplyDelete
  4. Anonymous8:47 AM

    I have read the article about Xechem that is in this link (http://www.mg.co.za/article/2008-07-01-nigerian-sicklecell-drug-mired-in-controversy).

    At last I would like to know, if any one knows how the story ended. Did Xechem went into bankruptcy ? Nicosan is still being comercialized ? How to obtain it ?(please send e-mail to ed_giribaldi@yahoo.com.ar)

    ReplyDelete
  5. Yes, Xechem (http://www.xechem.com/) did file Chapter 11 bankruptcy in November 2008. The companies Board of Director resigned in March 2009.
    The company is being sued by investors and creditors.

    There is also Xechem International (http://www.xechemnigeria.com/index.htm) who is owned by Xechem. I assume this means trouble for them too (if they are playing by the same business rules as American).

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  6. LaMonte Forthun6:41 PM

    Xechem International filed bankruptcy in the US and Xechem Nigeria was taken into Receivership by the banks Xechem owed money to, which meant the facility shut down (that was in July, 09). I've been working with the lenders to revive the company, get Nicosan back on the market in Nigeria and then work to get FDA approval to most likely sell Nicosan as a nutraceutical in the US first, while proper trials are conducted. It's been stated that getting a herbal drug approved by the FDA will be difficult by many though, so we'll see what direction we wish to go. We have to get the banks to work with us first though and then the US Bankruptcy judge, so there are a few more hurdles to get over before anything will happen, but we are working on it...

    Feel free to ask questions if you have any.

    LaMonte Forthun
    lamontef@teamsicklecell.com

    ReplyDelete
  7. Sorry, I do not know where Nicosan is manufactured or sold. According to the companies website, WWW.XECHEM.COM (international company with manufacturing in Nigeria) they have liquidated all assets and are no longer operating or manufacturing Nicosan.

    ReplyDelete