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Side effect general doesn'tS affect FDA approval

On the state of the drug industry, it is worse than you can image, see http://healthfully.org/rc/id1.htmlt and http://healthfully.org/rc/id9.html for confirmation. The cause is the corporate takeover of government which became blatant under Reagan for the Republicans and under Clinton (1992) for the Democrats.   

Studies for approval are short term and thus won’t uncover most common causes of death (cancer and heart attack being the big ones). The “request” for follow up study when made is a bureaucratic mockery that is not meaningfully enforced, and in most cases ignored by PhARMA.

 Does the FDA consider dire side effects as a reason for withholding approval?



Harming Tuberculosis Patients Instead of Helping Them?

Worst Pills Best Pills Newsletter article February, 2013 

Multiple drug-resistant tuberculosis (MDR TB) is estimated to kill about 150,000 people worldwide each year. In the U.S. and some other developed countries, prescribing a variety of antibiotics, instead of ones to which patients may be resistant, has greatly reduced the number of cases of MDR TB. Researchers have long searched for a new drug to more successfully treat this serious, life-threatening disease. One drug developed by Johnson & Johnson, bedaquiline (SIRTURO), seemed to have some promise in that relative to other drugs used to help patients with MDR TB, it appeared to more rapidly result in patients’ sputum no longer containing the tuberculosis (TB) bacteria (also known as sputum conversion).

In a clinical trial, patients with MDR TB who were already using other possibly beneficial TB drugs were randomized into two groups. One group kept taking the previous drugs and, in addition, was given a placebo. The other group kept using their previous drugs but was given bedaquiline instead of a placebo.

At the end of 24 weeks, 79 percent of the group getting bedaquiline had converted to negative sputum compared to 58 percent of the group getting a placebo. So far, so good. In the absence of some downside to the drug, the so-called surrogate marker, or biological measure used to indicate the effect of treatment — in this case, sputum conversion — could result in actually curing the patients’ disease, an important clinical outcome.

Unfortunately, a significant downside did exist. When the results were analyzed three years after the start of the study, there were 10 deaths in the group of 79 patients randomized to get bedaquiline, compared with two in the group of 81 getting the placebo. This increased death rate was highly statistically significant.

In their enthusiasm to approve a drug for MDR TB, the FDA and its advisory committee seem to have overlooked the significance of the increased deaths and, over Public Citizen’s objections, the drug was approved at the end of 2012.

Tragically, the FDA thought it could simply remedy this serious regulatory error of approving the drug by including the following text in the Patient Medication Guide that will be distributed to those getting the drug: “In one clinical trial, more deaths were seen in people who were treated with SIRTURO compared to people who did not receive SIRTURO.”

We urgently need to be able to expect more than this from the FDA.



There is some controversy over the approval for the drug, as the FDA's ruling was based on a surrogate outcome (sputum cultures) as opposed to patient deaths. In the clinical trials used for approval, the patients taking bedaquiline were more likely to die, even though they had resolution of TB based on sputum cultures.[10]

Adverse effects [edit]

The most common side effects of bedaquiline in studies were nausea, joint and chest pain, and headache. The drug also has a black-box warningfor arrhythmias, as it may induce long QT syndrome by blocking the hERG channel.[11]


Problem with approving a drug based on surrogate marker.

Approval of a Tuberculosis Drug Based on a Paradoxical Surrogate Measure


JAMA. 2013;309(13):1349-1350. doi:10.1001/jama.2013.623.

Jerry Avorn, MD

Recent years have revealed several problems with drugs evaluated on the basis of surrogate measure alone.  Rosigliazone (Avandai) was approved based on its ability to reduce hemoglobin A1 levels in patients with diabetes.  However, 8 yeas later the drug was found to significantly increase the risk of myocardial infraction; it is now hardly ever used.  Ezetimibe (Vyytorin, Zetia) was approved because it lowered low density lipoprotein cholesterol levels through a novel mechanism; however, 10 yeas after approval the drug has not yet been convincingly shown to reduce the risk of cardiac events.  [Entails that patients have not received an effective treatment.]  … However for bedqauiline, the agency agreed that enrollment in that confirmatory trial [as required by law] would not have to start until late 2013 or 2014 with study results not required until 2022 [about the time it is likely to go off patent.]

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Those who have a financial interest in the outcome manipulate the results, Major study finds that all 37 journal articles positive effects over stated; the average was 32%.