First, read the Wall Street Journal article from Wednesday, before a decision was made, which included this:
Marketing Avastin to fight breast cancer is “important from a business perspective,” Dr. [Susan] Desmond-Hellmann says. But, she says, it also offers women more treatment options, her goal since her days treating cancer patients in Lexington, Ky., in the early 1990s. Few drugs were available then. Now there are more, but none are yet specifically approved as a first-line treatment for metastatic breast cancer.
Avastin is a so-called biologic drug that replicates the body’s own weapons — antibodies that block the growth of blood vessels that feed tumors. But just because Avastin mimics a natural function, that doesn’t mean it is benign. “We’re all catching up to the fact that just because they’re what the body would make, antibodies are no less powerful,” says Dr. Desmond-Hellmann. A biotech drug like Avastin causes different — but not necessarily fewer — side effects than a drug concocted from chemicals in a test tube….
The study cited by Genentech included 722 patients observed for three years. Nailing proof-of-survival benefits would require studying 2,000 to 3,000 patients for another three years, and that would unacceptably slow the pace of cancer-drug development, argues Dr. Desmond-Hellmann. “Does that 5.5 months outweigh toxicity? I think it does.”
Still, Michigan’s Dr. [Maha] Hussain wrestles with doubts. “Our job is, if we cannot make people live longer, to make them live better,” she says. “Not to lower the bar is important.”
Now, read the San Francisco Chronicle article on yesterday’s decision.
Did the FDA make the right call?
The FDA should never, and I mean NEVER, get in the way of a doctor and a dying patients attempts to get help. Was the FDA right? History shows that the FDA is as often wrong as they are right. Does the FDA have the right? No, they don’t. Short of the patient and his doctor relegating that right to the doctor, the FDA is nothing but of a slavemaster and a murderer getting in the way.
And before the chorus of whining starts complaining that the FDA serves a purpose as an impartial reviewer of new medicines, let me say “hogwash!” We do indeed need an independent, non-government reviewer that is indeed impartial and not beholden to lobbyists. The FDA is not it. It believes the drug companies’ tests instead of doing its own. And it is swayed time and again by the political powers that be, putting countless lives in danger.
This is why medical marijuana never receives an impartial review. It is why new and potentially alleviative new cancer medicines never see the light of day because they do not grease the wheels of government with millions of dollars.
And I need to do more extensive grammar checking before I submit a comment.
As I serve on our local hospital Istitutional Review Board which approves clinical trials for our hospital, I have a much less jaundiced view of the system of such trials than “Mr. Martyr” above. Hospitals, doctors, and IRBs are held to high standards for accuracy in administering and reporting the results of the trials. Adverse events are meticulously recorded and disseminated. (I ought to know as one who has to wade through such reports every other month.)
For the church these trials do present a pastoral challenge that I never heard addressed. The fact is that for most oncology trials, the use of a new drug or a new cocktail of drugs very rarely offers much more than a small chance of increased longevity. Success for these trials is incremental. One drug may increase the survival rate from 5% to 5.5% in -say- phase three metastatic cancer. Yet I have seen patients seek such trials expecting a silver bullet that will cure them. Informed consent, as required by law for clinical trials, is not aided by unrealistic expectations. Do those of us as pastors have a responsibility to help our parishioners through these issues when they arise, and do we have the information we need?
As for this particular instance, I would need much more documentation to make anything more than a guess about the propriety of the FDA’s ruling. (I’d want to see those adverse event reports.)
A very suspicious about face for the FDA to go against the advisory committee and to approve Avastin for use in breast cancer. Here is the new scenario, “Would you like to sign our new consent form? The doctor has advised you that Avastin may cause you to have a stroke, a heart attack, or a life threatening gastrointestinal perforation on top of the toxicities from the other chemotherapy drugs you will be receiving. In addition you will be expected to pay your 20% co-payment up front if you have Medicare without a supplement. We estimate your share will be $20,000 for the Avastin plus whatever the additional chemotherapy drugs will add to the cost. Please sign here and have a nice extra few weeks.”
Maybe my libertarian streak shows, but the government is so constipated in it’s regulation that it is no wonder there are people swimming the Rio Grande rather that wait 5 to 7 years for proper papers. The FDA is blocking great drugs waiting on another ten years of testing. AVBiopharm already has mollecular level drugs for a variety of cancers and infections that are extremely effective and in many cases able to cure, yet with zero side effects or problems. The military already usese them and contracts for more. This is all due to the long time testing that is repeatedly required. I think doctors and patients can be given the facts and make a valid decision. There is a need for experts to sit as a panel and evaluate the evidence, but cut it loose from the buraucrats.
The FDA’s primary purpose is as an ad regulatory agency. Oh, and they also serve as a cover for insurance companies that don’t want to pay for more and more meds because they aren’t “approved” for what we’ve been using them for over the last, oh, say 20 years in actual clinical practice?
And let’s not forget what it means when a drug is “approved”. What that means is that the drug company spent a zillion dollars on a “study” to impress the FDA that it works for whatever disease. That’s why alot of good older drugs that are off patent will never be “approved” for diseases that we are already using them for. There is no way for the drug company to recoup its costs at that point.
Since insurance companies are increasingly demanding that we doctors only use drugs for “approved” uses, it means that in the future only new, expensive medications that the pharma companies can make money on will get paid for by insurance companies. Sounds a bit fishy, doesn’t it?
Oh well, once we get Obamacare everything will be free anyway (for about 2 years or so), so no problem.
“Did the FDA make the right call?”
I don’t claim to know. But in the case of patients in danger of dying, I think that in close cases the FDA should tilt towards approval.
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“A very suspicious about face for the FDA to go against the advisory committee” —#4
The FDA has to make its own decision. And the advisory committee was split practically down the middle (with a 5-4 vote).
I almost went into medical oncology because I wanted to “hold the hand of the dying.” I am glad I didn’t. The drug Avastin increases disease free survival but not overall survival. This just means the cancer is microscopic and not detectable with conventional imaging technology. You make someone more miserable in their final 11 mos of life and they die exactly the same time and saddle the family with a huge bill to boot. This is not helpful. Of course, we all will be paying for this with higher insurance premiums. Is that special? All of us sending money to big Pharma.
[blockquote]I’m glad they’re (FDA officials) considering other things besides survival. I think that’s very important, because quality-of-life issues need to be included,” said Bailey, past president of the California division of the American Cancer Society. “This potentially gives women more options.”[/blockquote]
What is she talking about? This drug worsens quality of life.
Medical oncologists sometimes give drugs because they can cause “partial responses” which is, by definition a decrease in size by at least 50% but not disappearance. Big whoop! So I die with a smaller tumor.
Overall cancer survival without intolerable side effects is the only test that should be considered.