According to Med Page Today, using animal studies to make certain scientific conclusions may not always be the best idea. An investigative report published in January in The BMJ looked into the general practice of using animals for scientific research. It also analyzed whether animal study results have been misrepresented. Specifically, the report analyzed the animal studies that launched clinical trials of the tuberculosis booster MVA85A.
The booster was administered to nearly 3,000 babies in South Africa. However, the booster did not make the standard vaccine, known as anti-TB Bacille Calmette-Guerin (BCG), any more effective.
Scientists who study tuberculosis extensively told The BMJ that the Oxford University researchers who led the trial picked a handful of good results from the animal studies so that they would obtain approval. However, one study that used rhesus macaque monkeys as subjects demonstrated that the booster could actually reduce the BCG vaccine’s effectiveness. The researchers brushed this study off.
In 2015, a systematic review of eight MVA85A animal studies also stated that there was not enough data to support the use of MVA85A as a BCG booster. The studies spanned the period from 2003 to 2010.
The researchers also commented on the timing of the macaque monkey study. Though the study was finalized in 2007, the results were not published until three years later in 2010. At that time, researchers were already recruiting for the South African study.
One of the co-authors of the review, Paul Garner, said that the macaque monkey study actually showed that the booster was fostering the development of tuberculosis in the subject animals. Garner is employed with the Liverpool School of Tropical Medicine.
Dr. Jonathan Kimmelman added that flaws in how animal studies are designed and published are not universally recognized. Dr. Kimmelman works for the Biomedical Ethics Unit at McGill University in Montreal. Dr. Kimmelman explained, “Many people sitting on the committees that make decisions about clinical trials often naively think that animal studies used to support clinical trials have been carefully vetted and subjected to rigorous review. I think they sometimes underappreciate just how fallible some of the animal findings used to justify the launch of clinical trials are…On the other hand, there are certainly a lot of skeptics, like myself, who are concerned about the quality of the design and reporting of animal studies.”
Dr. Kimmelman acknowledged that it is hard for many researchers to face negative or confusing animal study results when they are desperate to get a drug into a human trial. He commented, “Research programs are like supertankers. Once they are up and running they have their own momentum, and it is really, really difficult to stop them.”
The report in The BMJ included an editorial written by Dr. Merel Ritskes-Hoitinga, who works with the Radboud University Medical Center located The Netherlands. She commented that it is difficult to use animal studies to predict results in human studies. The translational success rate is usually low. In fact, one figure estimated that the non-reproducibility of some studies could be as high as 89 percent.
Dr. Ritskes-Hoitinga remarked, “Improvements in the design, registration, reporting and transparency of animal studies are urgently needed. To achieve this, we need a cultural change in which researchers are rewarded for producing valid and reproducible results that are relevant to patients, and for doing justice to the animals being used.”
She added that journals that accept animal studies for publication should make prospective registration a prerequisite for publication. Additionally, the journals “should provide their editors and reviewers with tools to help identify selective outcome reporting and HARKing (hypothesizing after results are known) in submitted manuscripts.”
Dr. Ritskes-Hoitinga also said that systematic reviews of animal trials should be more common and that they should be of excellent quality.
A neurologist from the University of Edinburgh, Malcolm Macleod, added in a separate publication that science needs “better and more systematic ways to establish when a drug is ready for clinical trials in humans—and importantly when it is not…The current scientific ecosystem sees publication in high impact journals and the award of high-value grants as ends in themselves. There is much discussion about how this might change, but until our institutions recognize that their core purpose is to produce research of value to society, they risk a slow decline in their reputation, and possibly a faster and more serious erosion of public trust in science. In these troubled times, that public trust is more important than ever.”
What happens if a drug that gained approval from the United States Food and Drug Administration is harmful?
Drug manufacturers face strict liability for injuries that are caused by their products. With strict liability, an injured victim does not have to prove that the at-fault party was actually negligent.
In drug injury cases, the injured victim must instead show:
- The victim used the product as recommended;
- The victim was injured;
- The product was defective; and
- The product’s defect caused the victim’s injuries.
Each of these elements must be established for a drug injury claim to stand. Without one of the elements, the claim will fail, and the victim will be solely responsible for the damages he has sustained.
There are three principal types of product defects that may be present in a drug. These are:
- Manufacturing defects, which occur at some point during the drug’s creation or distribution;
- Design defects, which are defects that are inherent in the structure of the drug itself; and
- Marketing defects, which could include a failure to warn about dangerous side effects or a failure to provide proper instructions with a medication.
One or all of these types of defects may be present in a single medication.
In some cases, it has been proven that a drug company provided misleading or weak clinical trial data to the FDA to obtain approval from the agency. If a drug company fails to disclose dangerous side effects or risks associated with a drug, and that drug injures consumers, the drug company may face liability.
If drug manufacturers are liable for a consumer’s injuries, that consumer may be entitled to a number of damages, including:
- Medical bills
- The cost of future care
- Lost wages
- Pain and suffering
- Emotional distress
- Loss of consortium
- If the pharmaceutical company’s behavior has been especially egregious, an additional punitive damage award could be given to the plaintiff.
Additional financial compensation may also be available, depending on the circumstances of the case.
If you believe you have been injured by a drug, you should meet with an experienced drug injury attorney as soon as possible. These attorneys can quickly get to work on your claim so that your case is as strong as possible. Without the assistance of a drug injury attorney, you may unknowingly forfeit your eligibility to seek any monetary compensation.
There are certain time deadlines in place that limit how long claimants have to seek legal recourse for their injuries. If these deadlines are missed, the court may refuse to hear the case.
Contact Parker Waichman LLP as soon as possible to discuss your claim
At Parker Waichman LLP, our personal injury attorneys are highly experienced in drug-related claims. To schedule your free consultation with our excellent legal team, call 1-800-YOURLAWYER (1-800-968-7529).
