If we have transparency, and there is no curtain blocking our view, we would be able to trust the process of drug trials and manufacturing, and the practice of medicine in our country. But as it is today and has always been, these things are hidden from us and we are told to trust the process, trust our doctors, and trust the system with our health.
In my book, Louis Pasteur Condemns Big Pharma, I propose a solution to this transparency problem. The following is a link to my book page on my website:
Louis Pasteur Condemns Big Pharma by Stephen Heartland
The following solution can be found in my 16 Solutions section of my website:
16 Solutions for Healthcare Reform | Stephen Heartland
Solution #7: BE TRANSPARENT – CLEARLY PUBLISH ALL DRUG AND VACCINE TRIAL DATA.
Establish Drug and Vaccine Trial Transparency. All drug and vaccine trials, trial designs and methodologies, and the information obtained from them should be made public, from start to finish. In this way, the public will be informed of the true benefits and risks of these drugs and vaccines and be able to make informed decisions if and/or when they consent to their use.
The book I reviewed in my last blog, Wonder Drug, by Jennifer Vanderbes 2023, was a treasure trove of examples of why we should implement Solution #7, which is outlined above. In this blog I will delve into the ways that transparency would have prevented the world from being exposed to a drug like Thalidomide, which killed and maimed tens of thousands of babies in their wombs and/or resulted in phocomelia, which is the presence of missing or deformed arms, legs, and other body parts. This chapter in the history of medicine is a clear signal that safety measures and reforms are needed, and transparency should be established. The following link will take you to Amazon and book Wonder Drug:
Amazon.com : wonder drug the secret history of thalidomide
1> Although Thalidomide was never FDA approved, there was a widespread drug trial in the United States: “… Cincinnati based William S Merrell Company … had sent millions of ‘samples’ to more than twelve hundred doctors across the country, including two hundred obstetricians.” Wonder Drug page xiv.
The people who took this drug were not told it was not FDA approved, and that it was an experimental drug. These people were not told they were being used as guinea pigs in a vast drug trial.
2> In the trial against William S Merrell Company which followed due to all the deaths and baby deformities, many damning things were revealed.
“Trial transcripts revealed that William S Merrell Company withheld toxic animal data from the FDA. Multiple obstetricians who conducted thalidomide trials for Merrell had, in fact, witnessed birth malformations at least a year before the firm asked physicians to stop using the drug… official ‘trial’ doctors missing records of which patients had received the drug; physicians falsifying patient charts to erase any record that thalidomide had been given.” Wonder Drug. Page xvii.
If an animal study shows deformities or other problems with health, these problems should be readily identified and the information be made available to the public and/or the government regulatory agencies, and the drug trials should end at this point. But due to the lack of transparency, drug trials were allowed to proceed. The point here is that the company did not want anything to get in the way of clearing this drug through the FDA, so they could begin raking in the money. Greed and corporate profit are valued more than the health of individuals.
The doctors threw out evidence or falsified records so as to protect their businesses and reputations, and to avoid being included in a lawsuit. This type of behavior is still widespread today. They know how to protect themselves. For many of them, this is more important than their patient’s health or the truth being made known. If we had transparency in this drug trial process, then this information would have been available to the public from the onset of these drug trials, and less people would have been injured or killed.
3> “… more than half the rats given a mere five hundred to one thousand milligrams per kilogram died. In July, when Van Maanen’s division tried again, it was worse: All the experimental animals died, most within a day… Next, the research department decided to test thalidomide with a more advanced animal and gave it to a dog. Within two hours the dog was trembling and vomiting… by morning, the dog was dead… Even though all animal data was required with the FDA application, Merrell withheld the dead-rat and dead-dog results.” Wonder Drug. Page 85-86.
If transparency in drug trials were followed, then this terrible chapter in medicine could have been completely avoided. But as explained in the book review which I did in the prior blog, all those within the pharmaceutical companies knew there would be no prison time, no possible death penalties for killing others in the name of medicine, and the worst that would come of any proven crimes in the drug trials would be that the company would need repay back a small portion out of the company profits. And no one would go to prison. There is no real disincentive for drug trial corruption. The system needs to change.
4> “… Three rats given thalidomide turned out to be pregnant, and their litters suffered: Two had notably small litter sizes and the third birthed a stillborn. The firm, it seems, ignored this data.” Wonder Drug. Page 154.
5> “… dosing chicken with thalidomide… was shocked to see the drug caused much broader damage. His chicks lost weight and their feathers darkened. Autopsies revealed yellowed bones, scarred and blackened livers, and shrunken gonads.” Wonder Drug. Page 155.
All animal studies are supposed to be revealed to the governmental health authorities. If we had transparency in drug trials, and knew what animals were to be tested and when, then results of these trials should have been made public immediately. Transparency in drug trials would save lives. It would make those taking drugs more certain that due diligence in the drug trials was followed. Then the public would have more confidence in these drugs and the companies that produced them.
6> “… when he relayed the detailed information on the multiple disfigured babies to his superiors, no action to restrict the drug was taken.” Wonder Drug. Page 162.
Again, transparency would have saved lives. Making this information public would have saved lives and stopped more babies from dying or being permanently disfigured. But unfortunately, profits are the primary concern of drug companies. Death and injury due to their lack of disclosure is weighed against the company profits and company image. It should not be this way. People’s lives and their health should be the primary concern.
7> “… The toxicologist had been asked by her lab superiors to fudge data. Make it appear that the experiments had run longer, she had been told, and omit bad results.” Wonder Drug. Page 200.
Make these drug trials public information. Make them crystal clear with transparency. These omissions and scientific fraud have no place in science or medicine.
8> “… Fifty-six physicians in New York had dispensed thalidomide to patients, but the state health department couldn’t get straight answers from the FDA about who the doctors were, how much thalidomide they’d given out, and whether patients knew what drug they’d taken.” Wonder Drug. Page 251.
9> “… In Seattle, an obstetrician told them he had given several hundred pills to pregnant women at a charity outpatient clinic and destroyed the records…” Wonder Drug. Page 260.
Transparency in drug trials means record keeping, following up with patients, and making them understand they were trial participants with an experimental drug which had yet to pass the FDA approval. All this information should have been public, and the records should have been easy to find, but they were not. Many physicians are good at protecting themselves, their reputations, and their businesses, and if that means destroying records, then that is what they do. With transparency this would not have happened.
Conclusion: Drug Trial Transparency would save lives.
The pharmaceutical companies will not embrace transparency. For one thing, it will ruin their profit margins. If they had to keep clean and clear records of their drug trials and the experiments they were planning to do, record this data as it became available, and then report on the results of their animal studies and their human trial subjects, it would take more time and it would cost more money, but it would save lives and help to prevent fraud.
The other argument against drug trial transparency is that it would nullify the company’s ability to maintain “proprietary information” on their products. Those are code words which mean “we will not tell you anything that we do not have to.” There are too many secrets involved in drug making, and companies are literally getting away with premeditated murder in some cases.
The FDA approves these drugs quickly, and then we learn more about them as the black box warnings come into effect due to vast reported injuries and deaths related to certain drugs. Over 400 medications carry FDA black box warnings, highlighting serious or life- threatening risks that require careful monitoring and caution. Many of these drug problems were most likely revealed during their animal and/or human drug trial stages, but the companies decided to omit negative data, or to falsify data to hide this damning information so they could bring their drug to market and start cashing in.
Please remember, in the cases of drug trial scientific fraud – No one will go to prison, no one will lose their job, and if they are caught, the company will only have to pay back a small portion of their profits on the drug.
This is a system which invites widespread corruption. The system needs to change. Drug trial transparency would be helpful to prevent fraud and corruption.