Tag: FDA

Evidence-based medicine…the Vioxx story

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When Stefano got home from work last night, I told him about the FDA’s “avoid non toxic” warning, and he commented “that implies that everything that the FDA approves is toxic!” Eh!

Well, today I thought I would provide a sort of segue to yesterday’s tirade by discussing the Vioxx story and other related matters. Let me start off with an overview of evidence-based medicine…

 

1. The May 11 2008 Moss Report (see: http://tinyurl.com/3q8x2y) has an essay on the issue of so-called “evidence-based medicine.” This expression, Moss tells us, implies that medicine comes in two varieties – the kind that is based on a solid foundation of objective evidence, and the kind that is not. Because of the apparently stark good-versus-bad division it suggests, the phrase lends itself well to being used as a pejorative by those who are outspokenly opposed to complementary and alternative medicine (CAM). To such people, anything other than standard conventional medicine is by definition unproven, speculative, founded on dubious premises and inherently inferior.

 

Okay, so “evidence-based medicine” is generally equated only with conventional treatments. But, and I found this very interesting!, Moss informs us that this was not at all the intended meaning of the term as it was originally conceived. The Evidence-Based Medicine Working Group (EBMWG), a research collaborative of clinicians and epidemiologists from Ontario’s McMaster University, who first coined the phrase in 1992, were not attempting to draw a contrast between orthodox and unconventional medicine; far from it. They were in fact trying to change the medical profession’s entrenched tendency to cling, mainly out of habit, to procedures and treatments for which there was little if any solid evidence of effectiveness (EBMWG 1992). Aha!

 

In this utopian context, the medical experience of an individual (that of yours truly and of many blog readers and list members/friends) would not be dismissed as unproven or anecdotal…how many times have I been told that I am merely an interesting anecdote? Too many times to be counted…makes me smile, actually. On the contrary, in such a context, our results would be studied and compared to the best available external clinical evidence from systematic research. Ah, were that the case…!

 

The “British Medical Journal,” Moss continues, had experts review 2500 commonly used treatments: of these, only 13 % were found to be definitely beneficial, 23 % likely to be beneficial, 8 % equally beneficial and harmful (!), but 46 % were rated as being of unknown effectiveness.

 

Almost half these treatments were of UNKNOWN EFFECTIVENESS? A mere 13% were BENEFICIAL? And this is “evidence-based medicine”!!! EEK! Since at first I wondered if the above-mentioned “treatments” referred to conventional CANCER treatments, I went to the “BMJ Clinical Evidence” website where I found out that no, the term refers to conventional treatments in general; ones, that is, tested in clinical trials for a variety of ailments, not just cancer.

 

The final part of the Moss essay is also interesting, so if you have a snippet of time please go check it out. It has to do with plugging individual cancer patients into so-called standard protocols that are designed mainly to make things easier for our doctors. But what about us, what about the cancer patients?

 

Just a quick comment. I remember my first haematologist (a very nice, gentle man who meant well) telling me that my chemotherapy regime would be “personalized”…I believed him then. But really, what he was suggesting was a standard myeloma drug, Velcade. There is nothing personal about Velcade, whose only variable could be dosage. Back then, though, I believed him (I have not had any chemotherapy thus far, by the way).

 

So let’s define these protocols by what they really are: standard treatments. Period.

 

2. Let’s go to item number two—the Vioxx story that I mentioned yesterday. The April 16 2008 edition of the British “Guardian” has an article about Merck, the well-known multinational drug company, that had hidden death rates caused by Vioxx, also known as rofecoxib, a painkiller of its manufacture. For many years. Merck provided the FDA only with selected data on deaths in its clinical trials, and failed to include people who had a fatal heart attack soon after coming off the drug. Oh, but the story gets “better”…

 

[…] papers published in journals on the results of Vioxx trials were ghostwritten by employees or contracted medical writers, and […] leading doctors were later invited to be named as authors. Financial links were sometimes but not always declared. So, basically you (=drug company) hire a medical writer to write a favourable clinical trial report extolling your newest bestest drug and then ask a couple of doctors to put their names on the report. Nice, huh?

 

The revelations about Merck’s scandalous, indeed criminal!, conduct were published in the “Journal of the American Medical Association” in April (see: http://tinyurl.com/4z6jch and http://tinyurl.com/4pga4h). Vioxx, by the way, was pulled from the market in September of 2004, the biggest market pull in history!, after reports of deaths, heart attacks and/or strokes. Merck officials knew of the risks, apparently as early as 1997, but did nothing until a clinical trial in 2004 showed an increased risk of heart attacks and strokes. Merck knew. Did nothing…

 

This drug, like (I am sure!) many others, had no business being put on the market in the first place. Ah, but you see, it was a bestseller during the five years or so that it was on the market. Must have made Merck a bit more than a pretty penny, don’t you think? Speaking of pennies. Last November Merck settled with $ 4.85 billion the thousands of Vioxx lawsuits that involved 47,000 people. Take a look at the New York Times article on the settlement: http://tinyurl.com/4ajxrc. Appalling.

 

And, by the way, the practice of hiring folks to write up fake clinical trial results (etc.)—ghostwriting—is apparently widespread, as we can read in this April 16 2008 New York Times article: http://tinyurl.com/5ydl2u.

 

Evidence-based medicine. I’d say this is evidence that some or most or all drug companies are about as trustworthy as little kids caught with their hands inside the cookie jar…

 

P.S. According to a long 2006 report (see link below), Merck’s top management lost no sleep whatsoever over the Vioxx disaster, and in fact would be happy to see Vioxx put back on the market (!). Oh, and the FDA apparently knew about the problems caused by this drug as early as 1999 (the proof is in a 1999 memo). Shameful. See: http://tinyurl.com/4lsv5j 

Medicine is no longer about health, it’s about market share and profits.

Big Brother

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A blog reader (thank you!) sent me some interesting info and links about warnings issued recently by the FDA (= Food and Drug Administration) to 23 companies and 2 individuals promoting various unproven cancer treatments that falsely claim to cure, treat or prevent cancer (see: http://tinyurl.com/3o89hf). I found this all so interesting and maddening at the same time that I wrote about ten pages of comments and denunciations…then did some drastic editing so I wouldn’t bore you all to tears.wink smiley What follows is what is left over from my drastic bit of chopping (so I hope it makes sense!).

 

The following link takes you to an FDA page titled “125 fake cancer cures consumers should avoid”: http://tinyurl.com/5hfj6e. I became exceedingly concerned when I saw that curcumin is listed here, too.

 

Now, I agree that, even though curcumin inhibits Notch signalling (important for the well-being of cancer stem cells) etc., it will not “cure” cancer, not by itself at any rate. As far as myeloma is concerned, we have to eradicate the myeloma stem cells to achieve a cure, and that, I am afraid, is not in the immediate future.

 

So curcumin may not be a cure, but in my particular case (I could also cite dozens of other curcumin-taking cancer patients whose results have been even better than mine!) it has kept my myeloma inactive and stable for more than two years…not to speak of how much I have benefited from more than a few unexpected side effects: cholesterol decrease, no more infections, aches or pains, etc. etc. etc.!

 

No, I was not at all pleased to find curcumin mentioned on this page in the same breath as “fake.”

 

http://tinyurl.com/67fz7n: this FDA page is titled “Beware of Online Cancer Fraud” and contains some valid suggestions, for instance how to protect ourselves from fraudulent cancer-curing online claims. Run in the opposite direction if you read sentences such as “treats all forms of cancer,” “skin cancers disappear” and so on. I too have come across some blatantly false, even absurd, cures for cancer online…and I for one would be very glad to see these types of websites disappear into the huge cyberspace rubbish bin.

 

However, scrolling down this particular FDA page to “Red flags,” I had a bone to pick with the warning against anything that claims to be “non-toxic.” Now, why should “non-toxic” be considered to be a “red flag” as a general rule if, and I repeat IF!, there are scientific studies to support such a claim for a certain substance?

 

Let’s take curcumin, for instance. Every single scientific study that I have read so far classifies curcumin as “non-toxic.” Therefore, based on the FDA red flag warning, I should avoid taking it… right? Does that make any sense? No, thought not. This business totally irritated me, and even the fact that Italy won against France last night didn’t mollify me.

 

A June 17 Bloomberg article (see http://tinyurl.com/6c24mu) provides an overview of the recent FDA activity. A few sentences in particular struck me: Regulators are concerned that patients could suffer side effects or forgo treatments that work, said Michael Levy, director of the FDA’s division of new drugs and labeling compliance. And, he continues, the FDA is very concerned that consumers will purchase these products from the Internet and use them instead of products that have been proven safe and effective. “Proven safe and effective”? Wait a sec. What the heck does that mean?

 

Hmmm, let’s see…if I got it right, according to the FDA it’s okay to take something that might harm or poison or even kill us if we fall within the small percentage of folks who have a reaction to an approved and allegedly “safe” FDA drug (shall I tell you the FDA-approved Vioxx story?), but it’s not okay to take something that has been used by folks for centuries and that has zero toxic side effects? I see…

 

In sum, I would like to state that I agree with the FDA that there are a lot of bogus online claims peddling miraculous cures for cancer. I have read some of ‘em myself. So if you come across a substance that sounds intriguing, please make sure it is backed up by scientific studies (the NCBI website can be very helpful in that sense: http://www.ncbi.nlm.nih.gov/).

 

At the same time, I am concerned that curcumin is mentioned on an FDA no-no list. I am afraid that that might scare people off, people who instead might benefit from taking curcumin. I hope that won’t happen.

 

It’s easy enough to sift through and separate the good information on Internet from the bad. If there is no scientific support for a product/substance, I don’t even take a second look at it. Period.

Avastin: a tale of appalling approval

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I love the idea of starving a tumour to death by cutting off its blood supply. That is what anti-angiogenic drugs are supposed to do. But first, what exactly is angiogenesis? I have mentioned this process here and there but don’t think I really have dealt with it in much depth. So yesterday and then today, after getting home from work, I looked it up.

From a previous post we know that tumours cannot grow beyond a certain size (the size of a sesame seed, I read!) because of a lack of oxygen and nutrients. But, unfortunately for us, tumours are very adaptable, so instead of kicking the bucket they start secreting a horde of growth factors (e.g., the infamous VEGF, or vascular endothelial growth factor) which induce angiogenesis, or blood vessel growth. The tumour is thus able to receive a constant supply of nutrients and can grow inside of us like a nasty weed. Without the process of angiogenesis, tumours wouldn’t be able to grow or spread.

In 2004, an anti-angiogenic drug called bevacizumab (trade name: Avastin) was approved by the FDA “for use in combination with standard chemotherapy in the treatment of metastatic colon cancer and most forms of metastatic non-small cell lung cancer. In 2008, it was approved by the FDA for use in breast cancer, against the advice of its advisory panel.” (source: Wikipedia) Say WHAT??? Against the advice of its own advisory panel???
 
How could something so bizarre happen? I went to read the February 22 2008 New York Times article (http://tinyurl.com/yu3xx5) dealing with this subject (notice that it’s printed in the “Business” section of the paper…this will make sense as you read on…). An excerpt: “FDA approval for late-stage cancer treatments is usually contingent upon data showing a drug extended, or improved the quality of, patients’ lives. Avastin showed neither in a study, according to Genentech’s application.” NEITHER? Ehhhh?
 
Genentech, the pharmaceutical company that produces Avastin, showed that this drug “slowed tumor growth, without actually increasing life expectancy.” Contrary to what we read in this particular New York Times article, however, the FDA decision has a lot of breast cancer advocates and organizations very worried. And with good reason. Take a look at this February 16 2008 Science Daily article: http://tinyurl.com/2a33u7 Fatal seizures? Brain swelling? If you aren’t convinced yet, read this NY Times August 24 2007 article: http://tinyurl.com/yvuozf The news is sobering indeed. I wouldn’t go anywhere near Avastin.
 
Why am I suddenly interested in this drug? Well, I became concerned after reading a few Science Daily articles about it. It is also being discussed by myeloma patients right now. So today I checked to see if there were any clinical trials, and yes, there are currently seven trials testing bevacizumab on myeloma patients (relapsed and refractory…), mostly in combination with other drugs (bortezomib and so on). And there are 96 breast cancer and Avastin clinical trials. 96? Oh yes, I admit to being concerned, not for myself but for all the patients who are in clinical trials testing drugs with unknown side effects in the long run. And the short-term side effects are scary enough, as we have learned from the Science Daily articles.
 
A recent Ralph Moss report focused on the Avastin issue: http://tinyurl.com/2edftu An excerpt (but please go read the full report, it’s excellent on many MANY levels): “On Friday, Feb. 22, 2008, top administrators of the Food and Drug Administration (FDA) approved the drug Avastin for the treatment of advanced breast cancer. Avastin, which has already been approved for colon and lung cancer, is controversial because it has never been shown to extend overall survival (OS) in breast cancer patients. It has been shown to improve disease-free survival (DFS) by as much as 5.5 months, but disease-free survival is not by any means the same thing as overall survival. A patient receiving Avastin may have a 5.5 month improvement in disease-free survival yet still die at approximately the same time as someone who did not receive the drug.”

Need I mention that Genentech’s stock, which had been declining, according to a February 23 2008 New York Times article (http://tinyurl.com/26zts4), after the FDA approval…all of a sudden rose more than 8 percent? Money, profit, and more money…but who CARES about the patients??? Certainly not the CEOs whose pockets are being lined with blood money.

Ralph Moss ends his report attacking the FDA’s double standards: on the one hand, this agency is always ready to squash any promising CAM (complementary and alternative medicine) treatments, on the other, it gives a “free pass” to a big pharma company “for a drug that has yet to be proven to do anything significant for breast cancer patients.”
 
In Moss’ words, the “FDA has once again significantly lowered its standards for drug approval. If it proposed doing so across the board, including taking a more even-handed approach to CAM treatment, that would be the basis for an interesting discussion. But what FDA is doing is permitting a lower standard for the expensive products of Big Pharma, while remaining wary of all non-toxic or non-patentable agents. So, whatever happened to the level playing field that a former director of the National Institutes of Health (NIH) promised the CAM movement back in 1992? Gone with the wind.”
 
But wait, it isn’t all doom and gloom out there. Curcumin inhibits angiogenesis. No kidding. There are 85 studies in PubMed dealing with this topic. Not one. Eighty-five. I have read a few of them, myself. Oh, and so does resveratrol. But this is material for at least another post. I will leave it at that…for now.
 
Concluding thought: do we really need to strangle a tumour with drugs that are toxic, potentially fatal (some women have already died from Avastin) and outrageously expensive?