FDA Tries Bizarre and Sloppy Whitewash of Heart Drug that Causes Cancer

The FDA produces an absurd pseudo-study that claims to show no cancer link to common blood pressure drugs, but actually shows strong FDA link to Big Pharma.

by Heidi Stevenson

4 June 2011

In the wake of a damning study showing that commonly-prescribed heart drugs called angiotensin receptor blockers (ARBs—blood pressure lowering drugs) increase rates of cancer, the first response of mainstream cardiologists was to attack the study and authors in utterly absurd and bizarre ways. (Documented here.) The study's quality was quite good, so it left leading heart doctors nothing legitimate to complain about.

You might expect, or at least hope, that the FDA would step in and issue a warning about ARBs. That, though, assumes that the FDA is there for patients, and such an assumption is sadly mistaken. The FDA demonstrated where its real loyalties lie by wading in with its own pseudo-study.

FDA's Pseudo-Study

The FDA carefully designed its study to avoid finding cancer. It didn't do a patient-level analysis, which follows patients long enough to find cancer. Instead, they examined clinical trials, most of which performed short-term analyses. Worse, they mixed in trials that had low patient compliance rates for taking the ARB drugs and trials of low-dosages rates.

If the FDA had wanted to find the truth of ARB cancer risk, it would have examined the records of patients over a long term. They would have noted the individual rates of dosing and patient compliance and correlated them with cancer rates. They did none of that. Instead, the FDA carefully set up its study to assure the outcome that Big Pharma wanted to see, as substantiated by the FDA's own quote:

The analysis included all drug sponsor-identified randomized clinical trials that met pre-specified criteria.

In other words, the FDA examined only studies paid for by Big Pharma! So, not only did they carefully choose studies that were almost certain not to demonstrate a connection between ARBs and cancer, but they also made a point of using only studies by the companies that profit from the sale of ARBs.

The study was a meta-analysis of 31 randomized clinical trials. They were not concerned with trials that compared ARBs with placebos. They only included those that compare ARBs with other drugs. Therefore, their comparison, at best, has nothing to do with cancer rates among people who choose not to take their drugs, but instead treat themselves naturally!

They inspected 31 studies that included a total of 84,461 patients who took ARBs and 71,355 who took other drugs, for a total number of 155,816 patients. The FDA brags that this is far more than Ilke Sipahe's study that included 62,000 patients—but, of course, at no point do they mention that Sipahe's study wasn't slanted like theirs.

Dr. Sipahi, Author of the Study that the FDA Is So Desperate to Disclaim

Ilke Sipahe, author of the study that the FDA is trying to contradict, contacted me after the article I published about the absurd comments made by leading cardiologists who wanted his study censored. (Docs Want Censorship of Study Showing Cancer Risk from Heart Drug) He was pleased with the article, saying that it was well done. He contacted me about the FDA's study, saying that it is:

...incomplete due to the fact that agency only conducted a trial-level examination rather than a patient-level analysis

[and that it]

does not enable the investigation of the cumulative exposure-risk relationship.

Then, Dr. Sipahe mildly stated that the FDA's study is, "Surprising," because the agency has the ability to obtain patient records. Even more notably, he points out the FDA's hypocrisy for refusing not to do a patient-level analysis, when they had previously attacked his study by writing, "The [Sipahi] analysis is not based on patient-level data. Knowledge of the specific timing and nature of events in individual patients would aid in interpretation of the findings." Yet, as Dr. Sipahi stated to me:

Now they avoid doing a patient level analysis themselves! And at theheart.org FDA says "We decided against a patient-level meta-analysis because we were not convinced that such an analysis would provide any better information".

But, the Absurdity Is Even Worse!

The FDA clearly has no limits of hypocrisy in support of its Big Pharma masters.

Frankly, nothing could be more condemning of ARBs than the FDA's pseudo-study. It clearly shows that the FDA—along with the manufacturers—know precisely what the ARB cancer risk is. Otherwise, they would not have so carefully designed the study to avoid finding the truth about the ARB-cancer connection. In summary, the FDA's pseudo-study's failings include:

• Failure to compare with placebo, that is, comparison only with other heart drugs.
• Failure to examine long-term studies of ARBs.
• Failure to do a patient-level study, that is, failure to follow histories of patients who take ARBs, in spite of having access to the records.
• Use only of studies that were financed by the companies that benefit from sales of ARBs.

Could the FDA's intentions and allegiance be any clearer?

In a bit of humor, though, the FDA's study overshot its mark. They actually claimed that there was less cancer risk in patients who take ARBs! Their results purport to show that there is a 1% lower cancer risk in those who take the drugs. It's a wonder that they aren't trying to push ARBs as the ultimate anti-cancer treatment. Or is that the next step?

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