Ovarian cancer is brutal. It’s rarely detected in the early stages, which is why it’s known as the silent killer. I recently lost someone very near to me to ovarian cancer, and I can tell you, any new treatment would have been a God send. Little did I know that the FDA is keeping an effective ovarian cancer drug from American women. If this drug was available in 2006 maybe things would have been different.
As the debate about health-care reform has heated up, there’s been a lot of talk about creating expert panels that give bureaucrats control over what treatments we can receive. Truth be told, these panels already exist. Earlier this month, the Food and Drug Administration (FDA) bureaucracy made a decision that will deny women a viable option for fighting ovarian cancer.
Ovarian cancer is a rare disease and is therefore not usually targeted by drug companies. The pharmaceutical industry tends to focus on cancers that strike a large number of people. Finding treatments for such cancers gives drug companies their best chance to earn enough profit to pay for the enormous cost of developing a new drug.
Thus it was remarkable that the Centocor Company even developed its chemotherapy agent Yondelis. The culmination of the company’s efforts was an appearance July 15 before the FDA Oncology Drug Advisory Committee (ODAC), a panel of cancer experts that assists the FDA. But on the day of the meeting the FDA turned its back on 25 years of regulatory precedent and rejected a new cancer drug that by all known standards had passed muster for approval.
Centocor had all of its ducks in a row. For example, in 2006 approval standards for ovarian cancer drugs changed. So Centocor modified its process to meet the new standards. The FDA told the company that Yondelis would have to show a six-week improvement over the most effective therapy now being used to slow the progress of ovarian cancer. When its efficacy results came back, Yondelis showed a six-week improvement. …
I’m assuming nobody involved in rejecting this drug ever watched a loved one die of ovarian cancer.
I’m sorry for your loss, LC. I lost two women in my family to this cancer, as well. The FDA is an evil organization for many reasons. This is just one of them. Some very effective drugs which have been used in other countries, are denied to us here in the US. That’s a fact.
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The FDA?
Hey wait! I thought “Big Pharm” has the market all corrupted so they can make the big bucks.
The sad fact is there are actually a lot of agendas out there.
Saving people’s lives isn’t always at the top of the list.
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Too true, Sam Adams. Apparently, however, saving erections is a priority since Viagra is not only approved but covered under health insurance. No offense, but I think my ovaries trump your, erm, uh, y’know….
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Claims are easy to make but harder prove. Some proof would be appreciated in support of your claims about Yondelis.
My wife is in a clinical trial for a PARP inhibitor to treat ovarian cancer. She has battled the disease for over 5 years and has been in and out of chemo 3 times. Simultaneous to joining the PARP inhibitor trial she was offered a spot in a trial testing Yondelis so I did EXTENSIVE research about the potential benefits of it. In short, its a bust. It harms more women than it benefits and the few benefits are minimal. But hey, don’t let the facts stand in the way of demonizing people trying desperately to make like and death decisions about the public’s health.
http://www.fiercebiotech.com/story/fda-rejects-yondelis-doxil-combo-ovarian-cancer/2009-09-10?utm_medium=rss&utm_source=rss&cmp-id=OTC-RSS-FB0
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“WASHINGTON (Dow Jones)–A Food and Drug Administration panel on Wednesday rejected Yondelis, a proposed cancer drug for women with relapsed ovarian cancer, and said another current ovarian cancer treatment shouldn’t be used for advanced breast cancer patients due to concerns about side effects.
The panel of outside medical experts was asked to review Yondelis, which would be marketed by a unit of Johnson & Johnson (JNJ), as well as a proposal to expand the use of the company’s ovarian cancer drug Doxil to breast cancer patients.
The panel voted 14 to 1 against a question that asked whether adding Yondelis to Doxil represented a favorable risk-benefit analysis in patients with relapsed ovarian cancer, or cancer that returns after previous treatment. The FDA usually follows its panels’ advice when deciding whether to approve products.”
The rejection was issued by an INDEPENDENT panal of cancer experts and the vote of the 13-1 in favor of rejecting the drug. In the face of that rejection, who here still thinks the FDA should approve Yondelis????????
http://apps.komen.org/forums/tm.aspx?high=&m=286942&mpage=1#286942
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http://www.medicalnewstoday.com/articles/121619.php
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The rejection was issued by an INDEPENDENT panal of cancer experts and the vote of the 13-1 in favor of rejecting the drug. In the face of that rejection, who here still thinks the FDA should approve Yondelis????????
This analysis is naive. No panel is independent; removed; a purely scientific robotron. Worse yet, it assumes that a panel – any panel – is best to make this decision rather than a dieing patient. We should dismantle the FDA. It has killed more than it has saved.
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No panel is independent? Got any specifics to back up the claim that this advisory panel was not independent?
As for who the FDA has killed, is this more mere bluster or do you have any FACTS to share?
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BTW, your article cite INTERIM results from over a year ago. The decision was based upon FINAL results reported in July of 2009. Yondelis is a bust and will not be approved in Europe either.
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The drug is already being used in Europe. Also Russia and South Korea. What the hell is your problem, anyway? Do you work for the FDA?
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“Progression-free survival was increased by 6 weeks — from 5.8 months for doxorubicin alone to 7.3 months for trabectedin plus doxorubicin (hazard ratio [HR], 0.79).
But the FDA pointed out that the combination showed more toxicities than doxorubicin alone (see table below), and questioned whether the 6-week increase in proprogression-free survival at a cost of additional toxicity was “sufficient benefit for approval.”
Toxicities Reported in the 2 Groups
Adverse Event Trabectedin Plus Doxorubicin Doxorubicin Alone
Grade 3–4 Neutropenia 63% 22%
Grade 3–4 Thrombocytopenia 18% 3%
Febrile Neutropenia 8% 2%
Raised Liver Enzyme Levels 31% 1%
Cardiac Adverse Events 10% 3%
“An interim analysis, conducted after 300 deaths (46% of trial participants), showed little difference between the 2 groups, with median survival of 20.5 months for trabectedin plus doxorubicin and 19.4 months for doxorubicin alone (HR, 0.85).
http://cancerology.blogspot.com/2009/07/yondelis-not-approved-for-ovarian.html
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The FDA has been compromised by Master Criminals.
“The FDA’s cancer director, Richard Pazdur, heavily influences the choice of ODAC members each year.”
http://online.wsj.com/article/SB10001424052970204488304574424804155293702.html
And here is documented evidence that, 2 years ago, Richard Pazdur sabotaged another cancer drug:
http://www.deepcapture.com/?s=richard+pazdur&x=49&y=14
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Yondelis is being used in Europe for Sarcoma’s and NOT ovarian cancer and it is being used here for Sarcoma’s too. The issue is the use of Yondelis in combination with Doxil for the treatment of recurrent ovarian cancer. Try to keep up.
Yondelis has never cured anyone of cancer so even if your loved one had received it her life would have been extended 6 weeks on average. Thats not an opinion; that is a fact borne out by the data.
My problem is ignorance and your claims are brimming with it. An independent advisory board voted 14-1 against using the drug for ovarian cancer and the “Tin Foil Hat” brigade screams conspiracy. You conflate unrelated facts to propagate misinformation either out of ignorance or willful disregard of the truth.
I do not work for the FDA. My wife has ovarian cancer and I want a cure as much or more than anyone. That said, two years ago my father went into hospice. Two nights later, my father died but I couldn’t be with him because I was with my wife in a hospital emergency room seeking emergency treatment for the side effect of her chemo drug. You act as if the toxicities and side effects don’t deserve consideration and blame the government for what is clearly a very insular and uneducated conclusion.
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I stand corrected. The EMEA just approved Yondelis earlier today for ovarian cancer treatment in Europe.
Who here among the Tin Foil Hat brigade trusts the EMEA over the FDA?
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Who has the FDA killed?
When a drug kills a patient, that person is identifiable, and family and friends may learn the cause of the death. In contrast, the patient who would have lived, had new drugs been available, is identifiable only in a statistical sense. Family and friends will never know whether their loved one could have survived had the FDA not delayed the introduction of a new drug. In some cases the drug that could have saved the patient’s life is never created, because the costs of the FDA’s testing procedures make the necessary research and development appear unprofitable… — economist Alex Tabarrok
That said, there are some very educated guesses on lives lost to this agency:
In 2003, enough studies had been published on the 1962 Kefauver-Harris Amendments to estimate the true cost of these FDA regulations. Prior to the passage of these Amendments, the FDA primarily regulated only drug safety. The Amendments gave the FDA authority over drug manufacturing, advertising, animal studies, and the design of clinical trials.
The result was predictable: the time it took to take a drug from the laboratory to the market went from 4½ years to 14½ years. The death toll from losing half of our innovations from 1962 to 2003 is somewhere between 4 and 16 million people depending upon the assumptions used. Adding the 4.7 million deaths due to an extra 10 years of development time suggests that as many as one out of three people who died of disease since 1962 may have done so needlessly.
–Mary J. Ruwart, Ph.D; 19 years as a research scientist, Upjohn Company
See also, scholarly work by economist Robert Higgs. Google Dan Klein, Sam Petsman and Russ Roberts (all economists) on the subject as well. A good fact filled overview can also be found here
Lastly, I’ll quote John Stossel:
“Some years ago, the FDA held a press conference to announce its long-awaited approval of a new beta-blocker, and predicted it would save 14,000 American lives per year. Why didn’t anybody stand up at the time and say, “Excuse me, doesn’t that mean you killed 14,000 people last year by not approving it?”
Yes – it does.
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You act as if the toxicities and side effects don’t deserve consideration and blame the government for what is clearly a very insular and uneducated conclusion.
The question isn’t whether toxicities and side effects deserve consideration – they do. The question is who gets to make the decision to take the risk in a life or death situation. You and I or the FDA.
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I see where you are coming from. We don’t live in a perfect world and FDA is not omniscient so it must therefore be dismantled and stripped of its regulatory authority.
You are so lucid. The hell with safety and oversight. Lets just let dying patients self-medicate. And while we are at it, lets deregulate food manufacturing standards, airline safety standards and all securities trading rules too because they don’t work 100% of the time either. I guess you would allow big pharma to decide which of its drugs is safe for your mom to take?
Grow up.
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Have you heard of off label uses of chemo drugs? Did you know Medicare covers the costs of many off label uses?
Obviously you don’t or else you wouldn’t be making the claim that the FDA prevents you from getting treatment with a drug your doctor thinks will help you.
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You ask for facts. I give them. You resort to ad hominem. You set up straw men. This is the point where I begin to lose interest.
Did you even read through the facts you asked for? It’s fine if you didn’t find them convincing, but don’t pretend they didn’t at least attempt to answer the questions you raise – including the flailing absurdities you sputtered in the last two posts.
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Uncommonnonsense – you come to my site and insult me. Then you insult my readers. What’s your purpose here? To convince us the FDA is wonderful and benevolent and you are far superior to all of us? Why don’t you go tend to your wife. My best to her. To you I say find somewhere else to sling your insults.
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Another example of FDA independence
http://www.nytimes.com/2009/09/25/health/policy/25knee.html
F.D.A. Reveals It Fell to a Push by Lawmakers
By GARDINER HARRIS and DAVID M. HALBFINGER
Published: September 24, 2009
WASHINGTON — The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting……..
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What people can’t seem to imagine is what it would be like if the FDA had some competition. People who favor the FDA monopoly don’t really understand that it is basically a monopoly:
http://www.jewishworldreview.com/0605/stossel060805.php3
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