Getting Away with Fake Data: Building of an Empire
According to the National Academy of Sciences (NAS), the scientific community should operate under an honor system rooted in truthfulness, which serves as both a moral obligation and a foundational principle guiding the research process.
An early 2000s survey done with the top-tier research institutions in the United States collected 1703 individuals with usable data, introducing 7% (119) of those in these research departments had admitted to plagiarism, 25% (425) of respondents admitted to one or more of the ten most serious types of misconduct during the last 3 years, including 1% (17) who admitted to fabrication or falsification.
According to the US Public Health Service, they define research misconduct as:
Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results
Fabrication is making up data or results and recording or reporting them
Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record
Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit
Research misconduct DOES NOT include honest error or differences of opinion
Changes were made to require all data be published in peer reviewed studies by NIH after an increase of over 50% of reported research misconduct in 2003. A survey of scientists funded by the NIH suggested that mundane 'regular’ misbehaviors present greater threats to the scientific enterprise than those caused by high-profile misconduct cases such as fraud. At least 33% of respondents said they had engaged in at least one of the top ten forms of misconduct during the previous three years. Between 15 and 20% said they had changed the design, methodology, or results of a study in response to pressure from a funding source. (Nature, June 2005).
Assessing the true extent of misconduct or fraud in scientific research, particularly in clinical trials, is challenging. Direct surveys of investigators are unlikely to yield accurate results, as those responsible for misconduct have a clear incentive to conceal their actions. This phenomenon is well-documented in studies of unethical behavior. As a result, estimates based on detected cases are likely to be underestimated, suggesting that reported instances may only represent just the tip of a more widespread issue.
The under-reporting of fraud may be even more severe in medical research than in other scientific fields because of the negative consequences such reports have on pharmaceutical companies or other sponsors associated with fraud. A survey of 1993 New Scientist readers, in which a remarkable 92% knew of or suspected scientific misconduct by colleagues. The American Association for the Advancement of Science (AAAS) in which 27% of the scientists reported having encountered some type of misconduct. In perspective, in 2012 there were estimated 535,000 scientists. Using the 27% of scientists alone from the AAAS, results in 144,450 estimated encountering misconduct.
For 40 years leading into 2013 alone, over 2,000 scientific articles were retracted, with a disproportionate number coming from the biomedical sciences. Notably, nine authors were responsible for more than 20 retractions each. The rate of retractions has surged through the years, with most cases attributed to research misconduct, particularly data fraud.
The research and treatments for AFAB (assigned female at birth) health has been compromised from the outset. Historically, women have been underrepresented in studies, and data has been falsified to include them. Despite decades of advocacy, we're only 30 years into achieving meaningful representation. The fight continues for inclusion, support, belief, honor, truth, and recognition of AFAB individuals as humans with unique needs. Recent discoveries have led to significant advancements in care, but there's still much work to be done.
The language we use when discussing endometriosis alone is crucial. Misleading terminology can perpetuate misconceptions. Treating the disease itself is distinct from managing its symptoms. However, most treatments offered to patients are symptom-focused, not disease-focused. For instance, GnRH agonists are often misrepresented as a disease treatment, when in fact, they only alleviate symptoms. Endometriosis is the underlying disease, while pain and fainting are symptoms of the inflammatory condition. Reducing inflammation may alleviate symptoms, but it doesn't address the disease's progression. These medications can be valuable management tools for improving quality of life, but exaggerated claims and inadequate discussions about potential side effects can harm and confuse patients.
Despite claims of disease treatment, there's no concrete evidence to support the idea that these medications halt or slow endometriosis growth. Reduced inflammation may masquerade as disease reduction, but it is a misconception. Notably, some top endometriosis surgeons advise against pre-surgical use of these medications, as reduced inflammation can make detection more challenging due to endometriosis' chameleon-like nature. As these medications are rebranded to appeal to desperate patients, we must hope that the increased awareness will prompt manufacturers to acknowledge their treatments' limitations and abandon deceptive marketing tactics.
Between 1992 and 1995, Dr. Friedman altered and fabricated information in permanent patient medical records and notes by changing dates, changing and adding text, and fabricating notes for clinical visits that did not occur. Dr. Friedman admitted that he had falsified and fabricated approximately 80 percent of the data in research reports published in Fertility and Sterility. Dr. Friedman was in charge of case studies for Lupron. He had published 2 studies and the 3rd hadn't been released. His own assistant went to their overseeing boss and said he had never seen any data, for ANY of the studies. By being pressured to fulfill the needs of the pharmaceutical company, juggling medical conventions, surgery time and patient office time he ended up succumbing to cheating. After being confronted by his boss about the data, he put fake medical notes into his Harvard patients records – from the past – changing things, adding things. Making patients volunteer in a study that never happened. He even made up patients that didn't exist. He then turned his fake notes into his boss. He failed to cover his tracks with an error during the fake note additions. In order to reproduce the altered notes, he used a printer that showed they originally came from a copy machine that did NOT exist at the apparent time of the study. Caught, he admitted to falsifying the data and the studies. He resigned and had his medical license suspended for 2 years.
He got new job with Johnson and Johnson within just 60 days of his suspension being up – reviewing clinical trials for hormonal birth control, lecturing doctors, and writing package insert labels. He then became the face for a birth control patch, and within 8 months he became director of women's health at Ortho Mcneil, J&Js subsidiary. The patch later became under scrutiny, called Evra. It caused massive strokes and failed to work like they claimed. The company ignored facts, ignoring the 60% correction levels in estrogen via their own findings, and then hid behind Dr. Andrew Friendman. He was eventually repositioned, all the while still being a part of Johnson & Johnson, a baby company.
He is currently responsible for providing strategic leadership and oversight of pharmaceutical product labeling development, execution and compliance for all Janssen products with J&J. He also serves as a medical consultant for Harvard Medical School Risk Management Foundation. It's also been found he has had a name change and now goes by Andy Friedman, according to his LinkedIn profile, with over 30 endorsements from other professionals. They range from gynecologists, chief medical officers, pediatric drug doctors, to global biopharma leaders.
“I think it’s not at all surprising that a drug company would hire somebody who is very comfortable with hiding the effects of a very dangerous drug.”
Dr. Andrew/Andy Friedman has been tried multiple times for leading multiple patients into paths of harm and neglect, and being an all around con artist. Yet he is still behind the current harm and neglect passed off as treatments for endometriosis, with the false data still stimulating the care received to this day.
In 1985 Lupron became the 1st approved GnRH agonist for palliative treatment of prostate cancer. It slowly started being introduced to women with certain symptoms, and as Dr. Andrew/Andy traveled and hyped it up in the 90s, it changed to being "widely" prescribed for most symptoms. GnRH drugs are supposed to be a 2nd line drug therapy option – but took over as main line recommendations by gynecologists for symptom relief and even guessing games to get a suspected diagnosis on charts. Patients are often found on the drug far longer than FDA approval, risking more harm. They also are not properly informed on the drug in general – not told it is a chemotherapy drug, a chemical castration shutting off hormones overnight drug, into mental distress onto heat flashes, basically bringing otherwise healthy individuals into irreversible menopause.
Abbvie is the owner of Lupron. A subsidiary of Abbott since 2013. With recent manufacturing issues and lawsuits, they have since dropped down to relying on their next GnRH agonist, but instead of an Injection it's a pill called Orlissa. Many manufacturers have since made hormone receptor, Leuprolide Acetate, into generic versions of the brand Lupron such as Eligard, Synaril (nafarelin acetate) or Zoladex (goserelin acetate). Where the pill versions like Orlissa have Elagolix, Mcfembree, Myovant.
What's the biggest problem with ALL of these medications? They stemmed from that falsified data mentioned in the beginning, with blatant disregard to unfolding negative reactions to the medications in patients after the fact. Multiple names and manufacturers changing one thing or two in labeling and such to get FDA approval. Creating battles of the manufacturers, suing each other to prevent a cheaper drug option from being available to the patients, the consumers, the ones living in agony most days. While being lied to about a drug while robbed legally, in any hope of relief – and if it doesn't work either an increase of dosage, a new prescription, or a "you're not trying hard enough, you must not want to get better"
Who says these things? Who is behind the push of these irreversible chemical castrations?
Let's break it down.
Med schools who teach gynecologists and those in women's health — who are funded by research avenues and top paying handouts or bribe like situations. Then gynecologists go into the field and seep what they learned into conferences to those around them including general society.
But who is behind med schools and the guidelines of treatment and care of endometriosis in America? The American College of Obstetricians and Gynecologists (ACOG).
Who had a generous payout from Abbvie to set up the website with ACOG specific guidelines, stressing GnRH agonists as treatment for endometriosis and incorrect information surrounding the disease in general? ACOG.
Who also refuses to budge from old outdated, debunked, and falsified data and studies? ACOG.
It's puzzling why, despite overwhelming evidence of harm outweighing benefits, these treatments remain deeply ingrained. A closer look reveals that acknowledging the flaws in current care would require a seismic shift in the medical establishment. This would entail a substantial financial loss for those invested in the status quo. It's unlikely that they would willingly relinquish their financial interests to prioritize patient well-being and prevent harm.
As we examine the relationships between pharmaceutical companies and research institutions, it becomes clear where their priorities lie. Patients are reduced to mere dollar signs. Healthcare providers are incentivized to churn out quick “treatments”, lining their pockets with profit, moreover, the proven gold-standard treatment like excision surgery, which is championed by leading endometriosis experts.
The Endometriosis Community is spearheading a movement for transformative change in treatment protocols and medicine. Decades of flawed data have led to ineffective treatments and devastating side effects. Patients have witnessed the truth, and now it's time for revolution. Building on 30 years of advocacy, it’s time to take control from those who prioritize profits over people. We demand treatments grounded in truth, transparency, and patient-centered care. A historic convergence is underway, as founders of global endometriosis charities join forces with endometriosis activists worldwide, igniting one of the most significant health rights revolutions of our time.
