Publish data on drug trials — even when it’s not flattering

Boston.com

July 26, 2010

Globe Editorial

LURKING BENEATH some of the biggest prescription drug scandals of our time is the specter of unflattering data that was known to pharmaceutical companies and could have revealed problems sooner had it been made public. Now, an international federation of drug manufacturers, whose members include the industry’s main players, has pledged to submit most clinical trial results for publication in peer-reviewed journals, whether the outcome is positive or negative.

This step should inject transparency into the now-murky process of data disclosure. But it will work only if there is a concerted effort by companies, journals, and regulators to ensure that all trials are published, and in a timely manner. Disclosure of unflattering data doesn’t just provide a fuller picture of how useful and safe a drug might be in treating a given medical condition; it also provides some guidance to researchers studying similar drugs and similar illnesses.

Until now, the industry’s track record has left much to be desired. Currently, companies seeking approval for new drugs must supply basic information about all their completed studies with ClinicalTrials.gov, a government website. But fewer than half of the studies registered there are published in journals. One-quarter to one-half of clinical trials for drugs that gained Food and Drug Administration approval remain unpublished several years later. A much higher proportion of the unpublished studies turn out to have unfavorable results for the marketed treatment.

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Posted my comment this morning:

LBotha wrote:

Fact: 18,6000 adverse reactions and 76 deaths attributed to the HPV vaccines according to the Vaccine Adverse Event Reporting System (VAERS). 278 cases of abnormal pap smears – post vaccination also reported. Numbers reflect only 1 to 10% of the population reporting.

Adverse events are life changing and debilitating for most injured women: blindness, autoimmune including, MS, BGS, Lupus, Chronic Fatigue; paralysis, seizures, brain fog, encephalopathy, ADEM. May girls have had to drop out of school – many ended up in the ER with prolonged hospitalizations – and in rehab to relearn basic skills.

The girls who died – literally dropped dead.

In the FDA’s 2008 Closing Statement on Gardasil it was noted that 73.3% of girls receiving the vaccine would develop new medical conditions. Only 1/3 of girls finish the vaccine series according to the CDC.

FDA documents also noted that if a woman is previously exposed to HPV and receives the vaccine her chances of getting cervical cancer increase by 44.6% with Gardasil and 32.5% with Cervarix.

A group of 6 women representing international countries presented research and date to the FDA in March on the potential dangers of the HPV vaccines – and our concerns fell on deaf ears.

Meanwhile the numbers of deaths and injuries continue to rise around the world…and will continue to do so since Merck is mutating their HPV vaccine into a new brand – India is developing their own vaccine – making it impossible to track adverse reactions and deaths abroad.

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.