It affects you from the minute your mother swallows the tablet to the very end of your life.

Imagine that there may be individuals who are still alive today, who were intended to be nothing more than sustenance for the most depraved and ravenous criminals. Yes, it is true! That will say a six-decade old apology!

MEDICINE CRIME

Yes, you have read it as correct, it's "Medicine crime". Medicine crime refers to the illegal activities involving pharmaceuticals, medical devices, and other healthcare products. This can include the production, distribution, sale, or use of these products in a manner that violates the law or ethical principles. Examples of medicine crime include the manufacture and sale of counterfeit drugs, which may contain harmful substances or incorrect dosages. There have also been instances of counterfeit medical devices, such as surgical instruments or implantable devices, which pose a serious risk to patient safety.

Another type of medicine crime is the illegal diversion of prescription drugs, which involves the use of medication outside of its intended purpose or without a valid prescription. This can include the misuse of prescription opioids, which has contributed to the opioid epidemic in many countries. Medicine crime can also involve unethical conduct by healthcare professionals, such as overcharging patients for medical services or procedures, engaging in fraudulent billing practices, or accepting kickbacks from pharmaceutical companies.

The impact of medicine crime can be significant, leading to harm or even death for patients who are exposed to unsafe or ineffective products. It can also erode trust in the healthcare system and undermine the integrity of medical research. Efforts to combat medicine crime include increased regulation and enforcement, as well as public awareness campaigns to educate patients and healthcare professionals about the risks associated with counterfeit or misused medical products.

The Process of Developing and Disclosing a New Medicine: 

The process of disclosing a new medicine to the world is a long and complex one, involving several stages of research, development, and regulatory approval. Here is a general overview of the key steps involved:

• Discovery and Preclinical Testing: The first stage in developing a new medicine involves identifying a promising compound or molecule that has the potential to treat a particular disease or condition. Scientists conduct extensive preclinical testing to determine the safety and effectiveness of the compound in animals and in vitro (test-tube) studies.
• Investigational New Drug (IND) Application: Once preclinical testing is complete, the next step is to submit an IND application to the regulatory authority (such as the FDA in the United States) to request permission to begin clinical trials in humans. The IND application includes data from preclinical testing and outlines the proposed clinical trial design.
• Clinical Trials: If the IND application is approved, clinical trials can begin. Clinical trials are conducted in several phases, with each phase designed to answer specific questions about the safety and effectiveness of the medicine in humans. Phase 1 trials typically involve a small number of healthy volunteers to test the safety of the medicine, while Phase 2 and 3 trials involve larger groups of patients to test the effectiveness of the medicine.
• New Drug Application (NDA) Submission: Once clinical trials are complete, the results are compiled and submitted in an NDA to the regulatory authority for review. The NDA includes data from all preclinical and clinical studies, as well as information about the manufacturing and labeling of the medicine.
• Regulatory Review: The regulatory authority reviews the NDA to determine whether the medicine is safe and effective for use in humans. This review process can take several months to several years, depending on the complexity of the medicine and the regulatory requirements.
• Approval and Launch: If the medicine is approved, it can be launched and made available to the public. The medicine may be subject to post-marketing surveillance to monitor its safety and effectiveness in a larger population.
• Patent Protection: During the development and approval process, the pharmaceutical company may apply for a patent to protect the intellectual property of the new medicine. This patent provides the company with exclusive rights to manufacture and sell the medicine for a certain period of time, typically 20 years from the date of filing.

The Dark History of Human Trials: 

(Unethical and harmful medical experiments on human subjects)

Conducting drug tests on humans is a crucial step in the development of new medications, but it must be done ethically and with the utmost concern for the safety and well-being of the participants. However, there have been instances of drug test crimes against humans in the past, including:

A. Failing to disclose adverse effects: Participants in drug tests must be informed of any potential risks or adverse effects of the drug being tested. However, there have been instances where adverse effects were not disclosed or were downplayed. 

Example, in the case of the anti-inflammatory drug Vioxx, it was later discovered that the drug had serious cardiovascular risks that were not disclosed to participants, resulting in significant harm and ultimately leading to the drug being withdrawn from the market.

B. Using vulnerable populations: Certain populations, such as prisoners, the elderly, and individuals with mental or cognitive disabilities, are considered vulnerable and require extra protection in drug tests. However, there have been instances where drug tests were conducted on vulnerable populations without their fully informed consent or adequate protection. 

Example, in the case of the Willowbrook State School, mentally disabled children were deliberately infected with hepatitis in order to study the disease, resulting in significant harm and controversy.

C. Lack of oversight and regulation: Drug tests must be conducted under strict oversight and regulation to ensure the safety of participants. However, there have been cases where tests were conducted without proper oversight or regulation, resulting in harm to participants. 

Example, in the case of Jesse Gelsinger, a participant in a gene therapy trial, there were serious lapses in oversight and regulation that led to his death.

D. Conflict of interest: Researchers may have financial or other conflicts of interest that could compromise the integrity of the research or put participants at risk. 

Example, if a researcher has financial ties to the drug being tested, they may be more likely to downplay the risks or exaggerate the benefits of the drug. In some cases, conflicts of interest have led to serious harm to participants, as in the case of the clinical trial of TGN1412, a drug intended to treat autoimmune disorders, which resulted in severe adverse effects for all six participants.

An Overview of Acts and Regulations Governing Clinical Trials: 

(Understanding the legal framework for medical research)

Clinical trials are conducted in accordance with ethical and regulatory standards to ensure that the rights and welfare of study participants are protected, and that the results obtained are scientifically valid and reliable. The following are some of the key acts and regulations that govern clinical trials:

A. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): The ICH is a global organization that brings together regulatory authorities and the pharmaceutical industry to develop harmonized guidelines on the design, conduct, and reporting of clinical trials. The ICH guidelines provide a framework for the conduct of clinical trials that is consistent across different countries and regulatory authorities. The ICH guidelines cover various aspects of clinical trials, including study design, data management, statistical analysis, and reporting of results.

B. Good Clinical Practice (GCP): GCP is a set of ethical and scientific quality standards that must be followed in the design, conduct, recording, and reporting of clinical trials. GCP guidelines provide a framework for ensuring that clinical trials are conducted in a way that protects the rights, safety, and well-being of study participants. GCP guidelines cover various aspects of clinical trials, including the selection and monitoring of study participants, the conduct of clinical investigations, the recording and handling of data, and the reporting of results.

C. Declaration of Helsinki: The Declaration of Helsinki is a set of ethical principles for medical research involving human subjects. It outlines the ethical responsibilities of physicians, researchers, and sponsors involved in clinical research and provides guidance on the protection of human subjects in clinical trials. The Declaration of Helsinki covers various aspects of clinical trials, including informed consent, the selection and monitoring of study participants, the conduct of clinical investigations, and the reporting of results.

D. Food and Drug Administration (FDA): The FDA is a regulatory agency that oversees the safety and efficacy of drugs and medical devices in the United States. The FDA provides guidance and regulations for the conduct of clinical trials, and reviews the results of clinical trials to determine whether a new medicine can be approved for use in humans. The FDA covers various aspects of clinical trials, including study design, selection and monitoring of study participants, data management, statistical analysis, and reporting of results.

E. Institutional Review Boards (IRBs): IRBs are independent committees that review and approve clinical trial protocols to ensure that they are ethical and comply with regulatory requirements. IRBs are typically made up of a diverse group of professionals, including scientists, clinicians, ethicists, and community representatives. IRBs review various aspects of clinical trials, including the selection and monitoring of study participants, the conduct of clinical investigations, the recording and handling of data, and the reporting of results.

The Historic Sixty Year Old Incident 

- A Retrospective look at the event that shaped our World

Thalidomide was a sedative medication that was marketed in the late 1950s and early 1960s as a treatment for morning sickness in pregnant women. The drug was developed by the German drug company Chemie Grünenthal and was initially believed to be safe and effective. These clinical trials were designed to test the safety and efficacy of the drug for the treatment of various medical conditions, including morning sickness in pregnant women.

A. Testing on Pregnant Women

One of the most egregious ethical lapses in the clinical trials of Thalidomide was the testing of the drug on pregnant women. The drug was initially marketed as a treatment for morning sickness in pregnant women, despite the fact that it had not been tested for safety in pregnant women or animals. This led to a significant number of infants being born with severe birth defects, including limb deformities.

The testing on pregnant women was unethical because it exposed the women and their unborn children to unnecessary risks. Pregnant women are a vulnerable population, and it is essential to protect them and their unborn children from harm. Informed consent is also essential when testing drugs on pregnant women, and in the case of Thalidomide, there were serious lapses in informed consent procedures.

B. Testing on Healthy Volunteers

In addition to testing on pregnant women, Thalidomide was also tested on healthy volunteers. Some of these volunteers were not informed of the risks or potential harm of the drug, and this led to a significant number of individuals suffering from adverse effects of the drug.

Testing on healthy volunteers is a common practice in clinical trials, but it must be done ethically and with proper informed consent procedures in place. The testing of Thalidomide on healthy volunteers without proper informed consent was a serious ethical lapse, as it exposed individuals to unnecessary risks without their knowledge or consent.

C. Ethical Lapses in the Clinical Trials

The ethical lapses in the clinical trials of Thalidomide were numerous and significant. The clinical trials were not properly designed or monitored, and many participants were not adequately informed of the risks or potential harm of the drug. This led to a significant number of infants being born with severe birth defects.

The unethical conduct of the clinical trials of Thalidomide has had lasting implications for the medical research community. It highlights the importance of ethical conduct in clinical trials and the need for rigorous testing and monitoring of new drugs. It has also led to significant changes in the regulatory frameworks governing clinical trials and the approval of new drugs, with a greater emphasis on safety and risk management.

D. Deaths caused by Thalidomide

The exact number of deaths caused by Thalidomide is difficult to determine, as the drug was prescribed to pregnant women around the world and the full extent of its harm may never be known. However, it is estimated that between 10,000 and 20,000 children were born with Thalidomide-related disabilities, and many of these individuals have experienced significant health complications and challenges throughout their lives.

While the number of deaths directly attributable to Thalidomide is unclear, the drug has been linked to an increased risk of mortality among individuals with severe disabilities, particularly those with respiratory problems. Additionally, many Thalidomide survivors have died prematurely as a result of complications related to their disabilities, such as heart failure or infections.

E. Consequences of the Thalidomide Disaster

The Thalidomide disaster had far-reaching consequences, both for the victims and for the regulation of drug testing. It led to significant changes in drug testing regulations, particularly in the United States, where the Food and Drug Administration (FDA) was given greater authority to regulate drug testing and require more rigorous safety testing before a drug can be approved for sale. The Thalidomide disaster also resulted in significant compensation for the victims and their families, as well as increased awareness of the importance of ethical conduct in medical research.

F. Penalty to the company

In 1970, the company reached a settlement with the German government, in which the company agreed to pay 100 million Deutsche Marks (equivalent to around $26 million at the time) to compensate the victims of Thalidomide in Germany. The company also agreed to set up a trust fund to provide ongoing financial support to the victims.

In other countries, compensation for Thalidomide victims varied. In the United Kingdom, the Thalidomide Trust was established in 1973 to provide support and compensation to victims, and in 2010, the British government announced a one-time payment of £20 million to Thalidomide victims. In Australia, a class-action lawsuit was filed against Chemie Grünenthal in 1991, and in 2012, the company agreed to a settlement of A$89 million (equivalent to around $92 million at the time) to compensate Australian Thalidomide victims.

In addition to financial compensation, Chemie Grünenthal also faced significant legal consequences. In 1968, a German court found the company guilty of negligence in the marketing of Thalidomide and imposed a fine of 10,000 Deutsche Marks (equivalent to around $2,600 at the time). However, the company was not found guilty of any criminal wrongdoing, and no individual executives or employees were prosecuted for their role in the Thalidomide disaster.

G. Families concern

Families affected by the Thalidomide tragedy have expressed deep anger, grief, and frustration at the harm caused to their loved ones. Many have spoken out about the devastating impact that Thalidomide has had on their lives, including the physical and emotional toll of caring for a child with a disability.

Some families have also criticized the response of Grunenthal, the company responsible for producing Thalidomide, as insufficient and insensitive. Many feel that the compensation provided by the company did not adequately account for the lifelong care and support needed by individuals with Thalidomide-related disabilities, and that the company did not do enough to acknowledge and address the harm caused.

Despite the legal and financial consequences faced by Grunenthal, families affected by Thalidomide continue to advocate for greater accountability and transparency in drug testing practices, as well as increased support for individuals and families affected by drug testing crimes.

How Thalidomide affects Cellular Processes in fetal development

Thalidomide is known to cause phocomelia by interfering with the process of angiogenesis, which is crucial for the development of limbs during fetal development. Angiogenesis is a tightly regulated process that involves the formation of new blood vessels from existing ones. Thalidomide is believed to inhibit the growth of new blood vessels, particularly in the developing limbs, leading to reduced blood flow to the area.

The reduced blood flow can cause a variety of problems in the developing limb, including reduced cell growth and differentiation, decreased nutrient supply, and reduced oxygen levels. These factors can contribute to the underdevelopment or complete absence of limbs that is characteristic of phocomelia. The exact mechanism by which thalidomide inhibits angiogenesis is not fully understood, but it is believed to involve the drug's interaction with certain molecular targets, including the protein cereblon and several cytokines.

In addition to its effects on angiogenesis, thalidomide has been shown to interfere with other cellular processes involved in fetal development, including the regulation of gene expression and the proliferation and differentiation of cells. Thalidomide has been shown to affect a variety of signaling pathways involved in these processes, including the Wnt, Hedgehog, and BMP signaling pathways.

Hence, the effect of these cellular and molecular changes is to disrupt the normal process of limb development during fetal development, leading to the characteristic birth defects associated with thalidomide use. While the exact mechanisms by which thalidomide causes these effects are still the subject of ongoing research, it is clear that thalidomide has the potential to cause significant harm during fetal development and underscores the importance of rigorous testing and regulation of new drugs to ensure their safety and effectiveness.

1960's traces in 2023

Experts are discussing the thalidomide's effects and mechanism 60 years after its withdrawal: Neil Vargesson, a professor of developmental biology at the University of Aberdeen, spoke at an online event titled "Thalidomide 60 Years On: History, Withdrawal, Renaissance and Mechanisms," marking the 60th anniversary of thalidomide's withdrawal. He explained that survivors of thalidomide had a range of issues beyond shortened limbs or phocomelia, including damage to internal organs, reproductive organs, and the cardiovascular system. He noted that thalidomide had led to changes in drug testing and the emergence of toxicology as a field. Vargesson also mentioned that while thalidomide was highly restricted, it was used to treat leprosy and had been examined for use against COVID-19 and swine flu in 2009 due to its anti-inflammatory properties. And also said that a new generation of thalidomide survivors had emerged in Brazil due to thalidomide being used to treat leprosy without adequate precautions.

The situation continues to persist without any further precautions. It is unclear why the effects of this awful condition are still being felt 60 years later, and despite knowledge of its side effects, people continue to use it. Some speculate that it could even be a form of biowarfare.

The apology

In December 2021, Dr. Michael Wirtz, chief executive of Grünenthal and son of the company founder met the press and announced the apology publicly to the world as, 

"We cannot change what happened . . . the Contergan tragedy is part of our company history and we regret deeply the far-reaching consequences".

Will the apology bring all back?

One of the members affected by the disease replied that,

Some of our members are very keen that we have an apology to not only us, but for the parents of thalidomiders