August 22, 2014

Shocking Secrets about Clinical Trials: 2,061 Trial-Related Deaths. Yet Only 22 Were Compensated

pin it button Shocking Secrets about Clinical Trials: 2,061 Trial Related Deaths. Yet Only 22 Were Compensated

clinical trials Shocking Secrets about Clinical Trials: 2,061 Trial Related Deaths. Yet Only 22 Were Compensated

By Dr. Mercola

Clinical research on humans is regarded as an essential component of drug research and development.

It is only after successfully being tested on people that drugs are supposed to be brought to market, but how can it be ethical to use people as guinea pigs in drug trials without fully informing them of what consequences they may face?

Typically such trials are only undertaken after there is evidence from animal experiments that the drugs are “safe and effective” …but this is far from a foolproof method by which to gauge safety.

Unfortunately, many die or are seriously injured after taking part in drug trials, and, worse still, only a fraction are ever compensated.

Thousands of People in India Died During Drug Trials

India is a popular place for drug clinical trials; the volunteer pool is huge and, for drug companies, the cost is low. In many cases, drug companies persuade the poor, illiterate, uneducated or tribal members to be their “willing” participants. But what’s the price for the trial participants who enter the testing?

Medical rights activist Anand Rai filed a Right to Information query to get data about drug-trial-related deaths and adverse events from the Drug Controller-General of India. It was revealed that more than 2,000 people in India died as a result of serious adverse events (SAEs) caused during drug trials from 2008-2011.

Only 22 cases, about 1 percent, received any compensation – which was a paltry average of about $4,800 per family. Drug companies often blame deaths that occur during trials on a person’s pre-existing medical condition. But experts say flimsy regulations that allow clinical trials to be conducted virtually anywhere “medical supervision” is present is to blame (and drug companies often pay doctors hefty sums to conduct such trials).

As The Hindu reported:1

“The reason for such a small number of cases receiving compensation is simple: Pharma companies conducting clinical trials pay compensation only in cases where it is established that the death was caused as a result of the trials and not merely during the trial.

‘But it is the companies themselves that decide whether a death was caused due to the trials or not. So there is a conflict of interest there as the companies want to pay compensation in the lowest possible number of cases,’ says Dr. Rai, who founded the Clinical Trial Victim Association of Madhya Pradesh.

‘We believe all cases of SAE-related deaths should receive compensation. We have filed a petition in the Supreme Court on the matter,’ says Dr. Rai.”

“Desperately Poor Recruits” Enroll Regardless of Potential Risks

What might drive someone to voluntarily enroll in a trial for a drug of questionable safety? Poverty, of course. India’s Drugs and Cosmetics Acts states that money cannot be used to be lured people into the trials, although a small compensation is allowed.

However, according to a Dateline NBC report, participants can actually earn up to $400 per study;2 in an area where the average worker earns 50 cents a day, and many go unemployed, this is a strong incentive. Not surprisingly, many of these volunteers will enroll in multiple studies at a time or enroll in another study before the “washout” period, designed to allow their body to become clean of the trial drug, has passed. This not only raises their health risks, it compromises study results.

And while drug companies do have some safeguards in place to prevent such occurrences, like using a thumbprint reader to enroll volunteers, one Indian insider told NBC that “if the companies need the subjects desperately, they will ignore these things.”

Further, there is little involvement from the Indian government to look into trial-related deaths or injuries, or reports of violations, such as not receiving proper consent from participants or unauthorized trials on children and mentally disabled patients. And although many of these trials are conducted by Western drug companies like Pfizer and AstraZeneca, which are seeking drug approval from the U.S. Food and Drug Administration (FDA), the FDA does not have jurisdiction to access confidential records under international law.

Gardasil Study Halted in India After 6 Children Died

In 2010, the government of India called a halt to trials of the Hu­man Papilloma Virus (HPV) vac­cine Gardasil. This came about because of a civil society-led investigation, which highlighted serious ethical violations for clinical research and informed consent rights of study participants or their legal guardians – and followed reports that six of the young participants had died, and more than 120 girls suffered severe adverse reactions, including:

  • Stomach disorders
  • Epilepsy
  • Headaches
  • Early menarche

Unfortunately, reports suggested the deaths occurred because the girls either committed suicide (by poisoning) or drowned – despite reports by parents to the contrary.3 This is, sadly, but one example of deaths occurring during drug trials.

Earlier this year, the Argentinean Federation of Health Professionals accused GlaxoSmithKline of misleading participants and pressuring impoverished, disadvantaged families into enrolling their children in clinical trials of the experimental Synflorix pediatric pneumonia vaccine.

Fourteen of the children participating in the experimental vaccine trial died.

The Nuremberg Code provides ethical guidelines for medical researchers to protect human test subjects in scientific experiments from injury, disability or death. The first principle of the Nuremberg Code – that doctors must obtain voluntary informed consent from the person about to be experimented on – appears to be frequently ignored, especially when it comes to clinical trials of experimental vaccines.

For example, according to Nigerian authorities, Pfizer illegally tested an unapproved drug on children with brain infections at a field hospital in 1996. Eleven of the children died and dozens were disabled before the illegal activity was exposed.

Again and again we see how major drug companies scheme to enlist people, who do not have full information about experimental vaccine or drug risks and are effectively turned into human guinea pigs in scientific experiments. In fact, this almost seems to be more the rule rather than the exception.

Outrageously, a paper published by the American Medical Association’s Virtual Mentor is concerned that current enrollment in U.S. vaccine trials is extremely low. 4 As a solution, the authors propose a federal law that would force all Americans to “opt-out” if they do not want to participate in vaccine trials or let their children be used in vaccine trials…

Drug Trials Plagued by “Ethical Dilemmas” Even in the U.S.

India in particular has seen an upsurge of clinical pharmaceutical studies, and the questionable practices employed are becoming increasingly apparent. But there are problems in other developing and developed countries as well, including in the United States.

In an essay just published in The New England Journal of Medicine, the authors point out “critical weaknesses” in the national system of ensuring drug safety that not only let dangerous drugs like Avandia, Vioxx and Celebrex hit the market, but also enroll volunteers into post-market clinical trials without disclosing the true extent of the risks.

When signing up for a post-market drug trial, patients must understand that they may be exposed to an exceptionally dangerous drug – one that is typically being tested because of suspicions that it may be causing severe side effects. But volunteers are not typically told why exactly the trial is being conducted.

The debate heated up in 2010, when the FDA restricted the use of the diabetes drug Avandia after post-market trials showed patients using it had an increased risk of heart attack and stroke – a risk the drug maker, GlaxoSmithKline, knew about but did not tell patients.

You’re Your Own Best Advocate

The take-home message here is that even if a drug or treatment is “backed by science” or in the midst of clinical trials, this in no way guarantees it is safe or effective. Likewise, if an alternative treatment has not been published in a medical journal, it does not mean it is unsafe or ineffective.

You’ve got to use all the resources available to you, including your own common sense and reason, natural medicine experts’ advice, to determine what medical treatment or approach will be best for you in any given situation. I encourage you to remain skeptical but open – including anything I’m saying, you need to realize that YOU are responsible for your and your family’s health, not me, and certainly not drug companies trying to sell their wares and convince you to take dangerous “symptom-suppressors” disguised as science-based solutions.

It is always wise to seek to better understand and treat the real problem behind your medical condition, rather than covering it up with a drug band-aid. There are hundreds of thousands of pages of free information on this site designed to help you achieve that goal, and the site search is ready to help you find information that can shed some light on your health questions.

Read the full article here: http://articles.mercola.com/sites/articles/archive/2012/09/03/clinical-trials-related-deaths.aspx


0 commentsback to post

Other articlesgo to homepage

Ebola Virus: A Major Threat to the U.S. or Overhyped?

Ebola Virus: A Major Threat to the U.S. or Overhyped?

Pin It

For the third time in the history of the US Centers for Disease Control and Prevention (CDC), the agency has raised its level of emergency alertness to “Level 1″—this time in response to the Ebola virus, following outbreaks in West Africa. On August 8, the World Health Organization (WHO) also declared the Ebola outbreak an international public health emergency.

The Ebola panic is very reminiscent of the 2005 bird flu hoax, and the 2009 H1N1 (swine flu) scare—another Level 1 “emergency” that turned out to be grossly hyped to promote the sales of unnecessary vaccines that turned out to be riddled with horrible side effects, including the devastating sleeping disorder, narcolepsy.

Now, health officials warn that an Ebola outbreak in the US is just “one airline passenger away.” While theoretically plausible, panic should be tempered by the fact that the American medical system is far better equipped to contain a non-airborne virus like Ebola, compared to West Africa. According to Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, it would be “extraordinarily unlikely that it will be an outbreak at all because of the way we take care of people, how we have the capability of isolating them, how we understand what one needs to do to protect the health care providers and the kinds of health care facilities we have.”

The fact is, the CDC is trumping up the fear factor, while simultaneously downplaying its own role in potentially creating a devastating outbreak through its own negligence. Mere weeks ago, the CDC was found to have accidentally released two dangerous pathogens: anthrax and H5N1 avian influenza. Dr. Thomas R. Frieden, head of the CDC, recently issued a report that admits to sloppy work ethics at the lab. If you ask me, we should probably be more afraid of what the CDC does with the Ebola virus than anything.

ALS Ice Bucket Challenge: Do You Know What You Are Supporting?

ALS Ice Bucket Challenge: Do You Know What You Are Supporting?

Pin It

The ALS Ice Bucket Challenge to raise money for the ALS Association is sweeping the nation, and going viral in social media. However, do you know what you are supporting if you contribute funds to the ALS Association? Many people may be surprised to learn that only 27% of the Associations’ funds are spent on research, with over 50% of its expenditures supporting salaries.

Also, if you are pro-life, did you know that the ALS Association supports drug research utilizing stem cells from 8-week old aborted fetuses?

Will India be First Country to Revoke Marketing Licenses for HPV Vaccines?

Will India be First Country to Revoke Marketing Licenses for HPV Vaccines?

Pin It

A petition currently before the Supreme Court of India alleges that the Drugs Controller of India issued licenses for Gardasil and Cervarix without adequate research on safety as directed by the Parliamentary Standing Committee on Health and Family Welfare.

Petition number 558/2012, filed by Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao, seeks to resolve this and several other issues by asking the Supreme Court of India to rescind the licenses for marketing and administration of HPV vaccines, make provisions to identify and treat any girls left with chronic health problems and/or autoimmune disorders after their participation in HPV vaccine trials, blacklist the Program for Appropriate Technology in Health (PATH), and allow no other foreign agencies to have a field presence in India.

Will India be the first country in the world to revoke the marketing licenses for Gardasil and Cervarix? Will the Supreme Court of India move to protect the health and welfare of their young citizens, or the interests of the HPV vaccine manufacturers? Will PATH and similar agencies be banned from operating in India?
Will the victims of adverse reactions to HPV vaccines be located and treated? We can only hope these questions will be answered when the final hearing will take place.

CDC Whistleblower: CDC Covered Up MMR Vaccine Link to Autism in African American Boys

CDC Whistleblower: CDC Covered Up MMR Vaccine Link to Autism in African American Boys

Pin It

A top research scientist working for the Centers for Disease Control and Prevention (CDC) played a key role in helping Dr. Brian Hooker of the Focus Autism Foundation uncover data manipulation by the CDC that obscured a higher incidence of autism in African-American boys.

“We’ve missed ten years of research because the CDC is so paralyzed right now by anything related to autism. They’re not doing what they should be doing because they’re afraid to look for things that might be associated.” The whistleblower alleges criminal wrongdoing of his supervisors, and he expressed deep regret about his role in helping the CDC hide data.

The Cancer Industry is Too Prosperous to Allow a Cure

The Cancer Industry is Too Prosperous to Allow a Cure

Pin It

We have lost the war on cancer. At the beginning of the last century, one person in twenty would get cancer. In the 1940s it was one out of every sixteen people. In the 1970s it was one person out of ten. Today one person out of three gets cancer in the course of their life.

The cancer industry is probably the most prosperous business in the United States. In 2014, there will be an estimated 1,665,540 new cancer cases diagnosed and 585,720 cancer deaths in the US. $6 billion of tax-payer funds are cycled through various federal agencies for cancer research, such as the National Cancer Institute (NCI). The NCI states that the medical costs of cancer care are $125 billion, with a projected 39 percent increase to $173 billion by 2020.

The simple fact is that the cancer industry employs too many people and produces too much income to allow a cure to be found. All of the current research on cancer drugs is based on the premise that the cancer market will grow, not shrink.

John Thomas explains to us why the current cancer industry prospers while treating cancer, but cannot afford to cure it.

read more


Get the news right in your inbox!