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Big Pharma labs routinely delete toxic drugs' failed test results, then ship them to US customers


Big Pharma

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(NaturalNews) One of the problems with pharmaceuticals (as opposed to most natural remedies) is the fact that, whenever you swallow a pill or receive an injection, you are forced to place your trust in whoever manufactured the medication.

There is no way to determine beforehand whether or not the dose you are taking is safe and effective -- you can only rely on the assumption that the drug has been manufactured according to rigorous standards and thoroughly tested in regard to its efficacy and purity.

Unfortunately, although those standards and testing procedures exist, many unscrupulous drug manufacturers have been caught deleting or altering test results for batches of pharmaceuticals or their ingredients that should have been rejected, but which instead have found their way onto the shelves of U.S. hospitals and pharmacies.

This is a widespread problem, particularly regarding generic medications being imported into the U.S. by drug makers who manufacture their products in other countries, such as India and China.

A recent report published by Bloomberg News has revealed that U.S.-owned drug manufacturing facilities in India have been caught routinely deleting failed purity test results for batches of drugs which subsequently were shipped to the United States and prescribed to unsuspecting patients.

According to FDA documents obtained by Bloomberg, there were 5,301 incidences of deleted test results in one Indian lab facility alone -- a lab owned by Sun Pharmaceutical Industries Ltd.

It was reported by the FDA that, when test samples at the lab failed to pass chemical analyses for purity, the results were deleted so that other samples could be taken from the same batches which gave passing results.

This was not an isolated case. Alarmingly, the practice seems to be common among pharmaceutical labs in India, which is the second-biggest drug exporter (behind China) to the U.S.

According to Bloomberg:

A review of FDA documents by Bloomberg News found that similar actions on quality tests have happened at dozens of other companies' plants across India that make drug ingredients and pills for export to the U.S. While not as visible as the dead frogs and flies inspectors have found in other Indian labs, the pattern of data integrity breaches worries doctors in the U.S. and elsewhere. They say they fear prescribing generic drugs that may not do what they're supposed to.

Indian pharma labs manufacture mostly generic drugs or ingredients used in other drugs. The ten largest Indian drug makers rake in $15 billion per year, according to Bloomberg's calculations, and there is very little oversight of the industry.

When drugs are shipped to the U.S., there are no purity tests required as they enter the country. This means that the FDA must rely on the manufacturers to police themselves -- there are only around one dozen FDA inspectors in India, and they conduct investigations only when enough complaints are lodged about a particular drug.

India itself only has 400 staff and 1,500 additional personnel working for its Central Drugs Standard Control Organisation, while there are 600 drug manufacturing factories in the country which are registered in the U.S.

G.N. Singh, India's Drugs Controller General, has said that he is hoping to increase the total number of personnel to 10,000 or 12,000 within the next five years, but that may be an unrealistic goal.

India only began requiring manufacturer compliance last year to laboratory guidelines it introduced in 2012. Meanwhile, there's no way of knowing how many tainted drug shipments have reached the U.S. and how many of them are still being prescribed to American patients.

There is often a lag between the time an FDA inspection is made and a resulting export prohibition is implemented -- sometimes the process takes weeks or even months.

In the case of Sun Pharmaceuticals, it took the FDA four months to ban the lab's exports after the inspection in which computer files containing the deleted test results were found.

The files containing the deleted test data might never have been recovered if it weren't for the fact that the lab was using a software program that prevents test results from being erased. The software, a chromatography data system (CDS), is designed to "help labs comply with government regulations."

Luckily, in this case, someone finally paid attention -- but not until after the practice of hiding test results occurred more than 5,000 times.

It appears fairly obvious that the the laws regulating the importation of drugs into the U.S. favor those who make and sell them, and not those who take them. To rely on the foreign labs to largely police themselves and have no testing requirements at U.S. borders when the shipments arrive seems ludicrous, especially when the consequences could threaten lives.

All this points to the fact that Big Pharma cares more about profits than it does about people -- and that U.S. authorities are not doing enough to ensure that the drugs we are taking are safe.

Source:

http://www.bloomberg.com

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