Talk Cancer

Question:

http://www.garynull.com/Documents/warning_your_next_bottle_of_supp.htm

Response:

I think you may have answered your own question… No one dies from a common cold.  Don’t you think, therefore, that the restrictions on testing, and the ease with which clinical trials are initiated, would be different than those used for a drug to be used for cancer? Apples and oranges. J.

– Hide quoted text — Show quoted text – Did you digest that?  It has not even completed its first round of trials yet and it may be approved in as little as 6 months. Why are Cancer drugs not given this fast track? Show me where this is ever done with cancer drugs. People don’t die from colds, but thousands die every day from Cancer. It doesn’t make sense and yet you defend it, says a lot about you old boy.

Response:

I think you may have answered your own question… No one dies from a common cold.  Don’t you think, therefore, that the restrictions on testing, and the ease with which clinical trials are initiated, would be different than those used for a drug to be used for cancer? Apples and oranges. J.

Exactly, that’s why drugs that have any potential to help fight cancer should be approved much faster than any drug for the common cold, lives are at stake. Tony (tony9596-tony9899)

Response:

– Hide quoted text — Show quoted text – As usual, being factual isn’t one of your long suits.  To begin with, nowhere in the ariticle is it stated that the drug will be available to the public in six months. In fact it is specifically stated that the drug is at least a year away from FDA approval. The that’s only a small portion of your error. You complain about the lack of angiogenisis inhibitor approvals. Limiting that to Endostatin and Angiostatin for the purposes of discussion, Angiostatin is not ready yet for even early Phase I trials and Endostatin entered phase I trails only a few months ago. The drug you complain about, pleconaril, has been in trial for about five years – and MAY be approved in about a year from now. That’s a six-year effort. Yet you complain that Endostatin, which only entered trials a short while ago hasn’t been approved yet. Get real. Really Don? Read this excerpt from the article again. "An initial round of clinical trials is expected to end this spring, and a ViroPharma spokeswoman said the company hopes to apply for FDA approval to use the drug against meningitis by mid-year. An FDA application for use as a cold treatment could follow six months later." Did you digest that?  It has not even completed its first round of trials yet and it may be approved in as little as 6 months. Why are Cancer drugs not given this fast track?

This is NOT the initial set of trials for this drug, regardless of what the article says. Did you expend the tiny bit of effort it takes to do a little research? I did, and I found that formal clinical testing began with human patients years ago. It actually came to this company through an agreement with drug companies in Switzerland and France.  This drug has been previously tested (in the US) for effectiveness against various conditions. Once the phase I and II tests are conducted, it isn’t normally necessary for them to be repeated to test effectiveness for a different condition. The article says that they hope to apply for approval by mid-year (5+ months from now?) and that approval could follow six months later. That 11+ months is essentially a year from now, as I said in the original post. Now read this clip again. "Based in the suburbs of Philadelphia, the 5-year-old company has never turned a profit or seen a single dollar of revenue." 6 year effort you say? They’ve only been around for 5 Don, please learn how to read.

Yawn. Why must I do your homework for you? The company went public on Sept. 23, 1996. It was actually founded in 1994. Actually, one of their drugs, VP63843, completed phase II trials in April of 1996. So someone expended effort to do the initial testing, apply for Phase I trials & obtain approval, conduct those trials, conduct the data evaluations and summary and apply for the Phase II trials and conduct those – all prior to 4/96. As is the case with many new companies, I suspect that no Corporation was formed until it was apparent that they had a potential product. Although they weren’t founded until 1994, much work had already been done. Fact is the drug was only developed 2 years ago and may be sold to the public in 6-12 months.

Absolutely false. You didn’t do your homework again. This drug was in Human clinical testing in 1996. Show me where this is ever done with cancer drugs.

What you claim is happening isn’t done with drugs for meningitis, either. Testing on the subject drug has been long and thorough. People don’t die from colds, but thousands die every day from Cancer. It doesn’t make sense and yet you defend it, says a lot about you old boy.

You still tend to reduce discussions to a personal level, don’t you? As I said, go back and study the history of the drug and you’ll discover a number of errors in your claims.

Response:

Below is an article about a drug that may cure the common cold, it has just started Clinical Trials yet they expect it to be available to the public in 6 months.

No, if you had read it closely, they hope to gain approval for viral meningitis (far cry from the common cold) within 6 months of the trials ending.  Then they hope to have it approved for all sorts of viral infections. What happened to all the baloney that we always hear about years of testing for saftey etc etc?

I strongly suspect this is a ploy to raise funding for their research and trials.  It’s happened before.  Of course not all drug research is openly publicized–we don’t know how long the drug has been in pre-clinical testing.  Since most drugs don’t even make it out of pre-clinical trials, this is a side of pharmaceutical research we never hear about. Why can they approve a drug so quickly for something as benign as the common cold, yet they are going to make people dying of Cancer wait 10 years to get access to Angiogenisis Inhibitors?

Hardly true–it’s been only a short while since Folkman et al announced their encouraging animal results.   In fact even this announcement (and especially Gina Kolata’s NY Times article about it) was seen by many experts as premature. Whether we like it or not, the FDA does not dictate what drugs are developed, and not all drug companies search for a cure for cancer.  If a company thinks it has a drug that can get FDA approval, it will apply for it, even if it is not a cancer cure.  And, as this article clearly shows, not every biotech investor shares our research priorities. I think this is outrageous.

I agree with this statement (though not for the same reason.)  IMHO it’s a fund-raising scheme, pure and simple.  Biotech is big these days–very high risk, but also very high payoff.  And everyone gets the cold–several times a year for some of us. But calm down, Tony.  This drug’s not approved yet–it’s still at least a year before they can expect approval and even then it won’t be for the common cold first, it’ll be for viral meningitis.   Think of it this way:  they’re aiming for the common cold  and other relatively benign infectious diseases.  They will have to prove the benefit of the drug will outweigh the risk of the disease itself before the FDA will approve it. ViroPharma shares rally after rash of press

[snip] The title of the article sort of says it all, doesn’t it? T.

Response:

Below is an article about a drug that may cure the common cold, it has just started Clinical Trials yet they expect it to be available to the public in 6 months. What happened to all the baloney that we always hear about years of testing for saftey etc etc? Why can they approve a drug so quickly for something as benign as the common cold, yet they are going to make people dying of Cancer wait 10 years to get access to Angiogenisis Inhibitors? I think this is outrageous.

As usual, being factual isn’t one of your long suits.  To begin with, nowhere in the ariticle is it stated that the drug will be available to the public in six months. In fact it is specifically stated that the drug is at least a year away from FDA approval. The that’s only a small portion of your error. You complain about the lack of angiogenisis inhibitor approvals. Limiting that to Endostatin and Angiostatin for the purposes of discussion, Angiostatin is not ready yet for even early Phase I trials and Endostatin entered phase I trails only a few months ago. The drug you complain about, pleconaril, has been in trial for about five years – and MAY be approved in about a year from now. That’s a six-year effort. Yet you complain that Endostatin, which only entered trials a short while ago hasn’t been approved yet. Get real.

Response:

- Hide quoted text — Show quoted text – As usual, being factual isn’t one of your long suits.  To begin with, nowhere in the ariticle is it stated that the drug will be available to the public in six months. In fact it is specifically stated that the drug is at least a year away from FDA approval. The that’s only a small portion of your error. You complain about the lack of angiogenisis inhibitor approvals. Limiting that to Endostatin and Angiostatin for the purposes of discussion, Angiostatin is not ready yet for even early Phase I trials and Endostatin entered phase I trails only a few months ago. The drug you complain about, pleconaril, has been in trial for about five years – and MAY be approved in about a year from now. That’s a six-year effort. Yet you complain that Endostatin, which only entered trials a short while ago hasn’t been approved yet. Get real.

Really Don? Read this excerpt from the article again. "An initial round of clinical trials is expected to end this spring, and a ViroPharma spokeswoman said the company hopes to apply for FDA approval to use the drug against meningitis by mid-year. An FDA application for use as a cold treatment could follow six months later." Did you digest that?  It has not even completed its first round of trials yet and it may be approved in as little as 6 months. Why are Cancer drugs not given this fast track? Now read this clip again. "Based in the suburbs of Philadelphia, the 5-year-old company has never turned a profit or seen a single dollar of revenue." 6 year effort you say? They’ve only been around for 5 Don, please learn how to read. Fact is the drug was only developed 2 years ago and may be sold to the public in 6-12 months. Show me where this is ever done with cancer drugs. People don’t die from colds, but thousands die every day from Cancer. It doesn’t make sense and yet you defend it, says a lot about you old boy. Tony (tony9596-tony9899)

Response:

Below is an article about a drug that may cure the common cold, it has just started Clinical Trials yet they expect it to be available to the public in 6 months. What happened to all the baloney that we always hear about years of testing for saftey etc etc? Why can they approve a drug so quickly for something as benign as the common cold, yet they are going to make people dying of Cancer wait 10 years to get access to Angiogenisis Inhibitors? I think this is outrageous. ViroPharma shares rally after rash of press EXTON, Pa., Jan 18 (Reuters) – Shares in ViroPharma Inc.<VPHM.O soared on Tuesday amid feverish speculation on Wall Street that the tiny bio-tech company will some day have a cure for the common cold, analysts said. Based in the suburbs of Philadelphia, the 5-year-old company has never turned a profit or seen a single dollar of revenue. And its most advanced drug is at least a year away from gaining Food and Drug Administration approval for sale in the United States. But last Friday, NBC Nightly News inaugurated what became a global round of press coverage focusing on the tremendous market potential for ViroPharma’s experimental drug, pleconaril, which could be effective against nearly 170 viral infections, including bad colds and viral meningitis. An initial round of clinical trials is expected to end this spring, and a ViroPharma spokeswoman said the company hopes to apply for FDA approval to use the drug against meningitis by mid-year. An FDA application for use as a cold treatment could follow six months later. The drug has been known about for months, and none of the weekend’s media coverage involved new information from the company. But by the time the Nasdaq market opened on Tuesday after a long holiday weekend, retail investors, inspired by visions of a new Holy Grail for the medical industry, were lining up as buyers. ViroPharma’s stock briefly doubled in market value as shares soared to an intraday high of $85 before falling back to a close of $58.25 a share, for a gain of 39 percent or $16.25. The company was one of the most actively traded issues on the Nasdaq, where more than 8.7 million of its shares changed hands. "If they indeed do well in the clinical trials, then this will be an exciting concept for investors," said Mehta Partners analyst Sushant Kumar. Like Internet shares before them, bio-tech stocks as a group have been driven up in value recently by investors eager to get in on a potentially explosive new marketplace. "In just the past four to five weeks, huge gains have been made. Look at some of the genomics companies and there are 300 to 400 percent runups," Kumar noted. 19:06 01-18-00

Response: