phil_vardena

http://www.scoprire.biz

4 Comments

    • Dendreon's Provenge: Government Agencies Play Hide and Seek With Facts [view article]
      One last comment.

      Probably the most important point is that we know Provenge is aimed at end-stage, dying prostate cancer patients. These people do not have choices.
      If you want, please repeat with me: these people do not have choices - and are going to die anyway.

      Provenge has been voted safe! 17-0! Even the conflicted doctors voted it is safe!
      What's the downside of giving Provenge to the dying?

      The British now have hospitals where experimentation can be used on patients who request it. As I understand it, it can go beyond what's being tried in the clinic, it can go to treatment that Doctors and Patients agree to. The advantage of such a program is that anecdotal data can be gotten on different uses of drugs which if effective can result in additional trials to see if the results can be duplicated.

      The FDA is not permitting such experimental work, even for those willing to try it and also willing to sign off all legal claims against those treating them. I'm not suggesting that drugs untried in people be used experimentally first, but after they're proven safe in a Phase I and have advanced to Phase II they should be made available as long as documentation's provided on how they're to be used, and why they've been selected for the specific application.

      I strongly believe that the USA fail to equal or exceed acts like what the British are doing it won't be long before they're no longer a world leader in drug development. The FDA's been driving up the cost of US approval, while extending time to approval tremendously; this might be fine to determine a headache medicine is completely safe, but it's not fine for a drug designed to benefit the victims of terminal diseases like cancer. It's time to take Approvable out of the FDA vocabulary, especially if people are dying waiting for the drug. An approval with any number of conditions that must be met is fine, as long as it still means that people who need it can get it after the approval.       Jun 12 01:58 PM
    • Dendreon's Provenge: Government Agencies Play Hide and Seek With Facts [view article]
      Do you remember Imclone?

      Sam Waksal's daughter had sold 2.5 million dollars worth of ImClone shares on December 27, 2001, the day before the announcement and subsequent stock decline.

      The next day, there were rumors that Martha Stewart may also have sold in advance of the news, thanks to a direct tip from her friend, Sam Waksal.

      On June 9, the Wall Street Journal says that Harlan Waksal knew three days in advance that the FDA would reject the Erbitux application.

      Later, it would become clear that Alan Bennett, a lawyer for Bristol-Myers in Washington, had sent an email to Harlan Waksal and Bristol-Myers management saying that Richard Pazdur, an FDA employee, told him the Erbitux application would be rejected the following Friday, which turned out to be the case.

      On June 12, Sam Waksal was arrested by the FBI on insider trading charges.

      Martha Stewart was arrested and served prison time.

      Dr. Richard Pazdur is still at the FDA…       Jun 12 01:58 PM
    • Dendreon's Provenge: Government Agencies Play Hide and Seek With Facts [view article]
      The FDA chose not to approve Provenge, even though it was advised (on March 29, 2007) by its appointed panel of Oncologists, Urologists, and Immunologists, all experts in the fields of immunotherapy and oncology, that Provenge is unquestionably safe (100% of the experts voted yes on safety) and that there was “substantial evidence” of the drug’s effectiveness as required by FDA regulations (76% of the experts voted yes on substantial evidence of effectiveness).
      Among the NOs, Dr. Sher and Dr. Hussain.

      Provenge achieved a 200% increase in overall survival measured at 3 years… with multiple recipients alive and well over 6 years later.

      27,000 men with end-stage prostate cancer will die needlessly early (some will die needlessly period) each year the Provenge is delayed by the FDA.

      Certainly FDA has approved drugs against the recommendations of its advisory panel, but I am not aware of a decision to overrule a strong positive panel vote for a terminal illness that has no really acceptable treatment options. This decision would appear to be unprecedented, and calls for a full and open public statement of why the FDA disagrees with this panel and cannot make this drug available to terminal patients. We know of course it was not due to safety concerns. Also, if FDA found the clinical trial data submitted by Dendreon (Provenge producer company) to be insufficient, why did it even submit the data to a panel of experts for their opinions?

      Some of those doctors that voted “NO” as to the effectiveness evidence even had letters (urging the FDA NOT to approve Provenge) “leaked” to the media. They were Dr. Sher and Dr. Hussain. I let you judge on the ethics of this behaviour.

      On May 30, 2007, news was that Schering-Plough Corp. said it had agreed pay Novacea Inc. up to $440 million for rights to develop the smaller drugmaker’s prostate cancer treatment, causing Novacea shares to double.
      Both Dr. Sher and Dr. Hussain are Novacea consultants.
      Do you think Schering-Plough would have paid $60 million immediately and an additional $380 million to Novacea if Provenge was on the market?

      Why the FDA - for the first time in its history - did not approve a drug deemed safe and effective by its own panel?
      How is that Dr. Sher and Dr. Hussain - with their obvious and enormous conflicts of interest - took part in the panel?
      Who did choose Dr. Sher and Dr. Hussain?

      We already have proof that Provenge works (two phase III trials). Many people are going to die due to the delay. Who is accountable?
      Why isn’t this revolutionary and extremely safe treatment available NOW?
      I can’t imagine the motives are about monetary gains.       Jun 12 01:58 PM
    • 6 Medical Device Makers Poised for Growth [view article]
      You say that "HNSN has received FDA approval". That's true for mapping, but not true for anything else. The use of Sensei as a tool for cardiac ablation is "off label" and open to lawsuits.

      Also your statement "Among the medical community, it is believed that the Sensei system is better, as well as being cheaper" is ambiguous. "Medical community". Look, the HRS 2008 starts in a few days. 90% of core abstracts revolve around the use of Remote Magnetical Navigation devices, which means Niobe, which means Stereotaxis. Is the Sensei better? Simple math doesn't say so.

      Adverse effects with Stereotasis' Niobe represents less than 0.1% of 15,000 procedures.
      Sensei gets something north of 6%. Is the Sensei better? I wouldn't undergo a procedure with Sensei even if well paid!

      Regards,
      phil       May 12 09:43 AM
Loading...
Symbols:
Authors:
Quick Links:
Contribute an Article Become a Seeking Alpha Contributor

Transcripts

More Transcripts»

Trading Center