Professionalism/Shiv Chopra and Livestock

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Shiv Chopra was a Canadian veterinary scientist who was employed by the Veterinary Drugs Directorate (VDD), a subdivision of Health Canada. In the 1990s, Chopra was bribed and pressured by Monsanto to approve certain controversial livestock hormones without proof of human safety. When his objections were ignored at Health Canada, he went to the media to protect Canada's public health. His actions led to his termination, but provided valuable exposure to Health Canada’s unethical behavior.

Background[edit]

Shiv Chopra[edit]

Shivdarshan L. Chopra was an Indian-born veterinary scientist whose career centered around public service. He received his Ph.D. in microbiology from McGill University and subsequently worked in England for a short period of time. He began his work as a veterinary scientist at Health Canada in 1969, where he worked for 35 years before his termination. After his termination, he wrote an autobiography about his work there, Corrupt to the Core: Memoirs of a Health Canada Whistleblower in 2009. Chopra passed away in January of 2018.

Health Canada[edit]

Health Canada is a governmental department in Canada responsible for national health. Its U.S. corollary is the Department of Health and Human Services. Health Canada is responsible for similar duties to the U.S. National Institute of Health (NIH) and Food and Drug Agency (FDA). Health Canada's major branches include Public Health Agency of Canada, Canadian Institutes of Health Research, Health Products and Food Branch, and the Veterinary Drugs Directorate.

Monsanto[edit]

Monsanto was a former Fortune 500 agrochemical company that existed until 2018, when it was acquired by Bayer. Monsanto primarily focused on genetically engineered crops, insecticides, herbicides, and growth hormones for livestock. Its most famous products include Roundup, an herbicide; DDT, an insecticide; Agent Orange, an herbicide used by the United States military in the Vietnam war; and recombinant bovine growth hormone (rBGH), a hormone designed to stimulate milk production in cows. rBGH is also known as recombinant bovine somatotropin (rBST).

During World War II, many soldiers were low on calcium and milk was an excellent source of calcium. However, this increased demand led to a post-World War II milk surplus. Farmers successfully lobbied to make milk an essential part in the American diet. Monsanto use Genentech's discovery of the BGH gene in the 1970s and recombinant DNA technology to make rBGH. Monsanto was the first of four large pharmaceutical companies to receive approval for an rBGH product in the United States in 1994. The increased demand for milk in the U.S. had ripple effects in Canada. Canada created a system in which farmers were tasked with meeting monthly quotas for milk production. rBGH thus allowed farmers to increase efficiency in their cows’ milk production and could more easily meet their quotas.

Whistleblowing[edit]

In the late 1990s, Monsanto was trying to expand its commercial success of rBST from the U.S. into Canada, as it had already received approval from the U.S. FDA. rbST was one of four hormones it sought to get approved in Canada. The other three were Carbadox, to increase growth in pigs, Baytril, to increase growth in cows and chickens, and Tylosin, to kill bacteria in chickens [1]. To hasten this process, Monsanto began pressuring Health Canada to approve the drugs without proof of human safety. In 1999, Tylosin was banned in the European Union due to its food poisoning incidence and induced antibiotic resistance in humans. Chopra, then a senior scientist, was tasked with reviewing the Monsanto hormone file. Chopra’s colleagues on the case included Margaret Haydon, Gerard Lambert, and Cris Bassaude. Monsanto attempted to bribe Chopra and his colleagues between $1-2 million to approve their hormones.

Chopra and colleagues were hesitant to approve the hormones because they were concerned the drug residue would remain in the meat and environment after consumption. This would have repercussions on human bodies and the surrounding ecosystems. After meeting this resistance, more drastic steps were taken. All files that contained scientific data by Monsanto were mysteriously stolen from one of the scientist’s cabinets and relocated to one Health Canada senior executive’s office. [2] If Chopra and colleagues wanted to access the data, they needed permission.

The scientists decided to address the situation by testifying before the Canadian Senate Standing Committee of the bribery. Chopra said, “We have been pressured and coerced to pass drugs of questionable safety, including rBST.”[2] Four years later, in 2002, the scientists still did not concede in approving the “questionable” drugs. They were reprimanded, suspended without pay, and demoted thereafter. On May 31st, 2002, they filed a complaint to the federal Public Service Integrity Office (PSIO)[1]. This office was born out of the Federal Accountability Act, an act specifically designed to protect whistleblowers, among other aims. The office decided to only investigate claims regarding Tylosin. Chopra filed a lawsuit, and in Chopra v. Canada (Attorney General), it was concluded that the PSIO failed to fully investigate the claims properly.[3] This represented a huge victory for the whistleblowers. In the court decision, it was decided that “the issue that all these veterinary pharmaceuticals had in common was that the VDD failed to follow the relevant human safety requirements of the Food and Drugs Act and Regulations. The manner in which the approval process for the veterinary drugs in question was being conducted could entail criminal sanctions being brought against everyone involved.”

Chopra chose to take more serious measures after still feeling pressure to approve the drugs and after their punishments by Health Canada for not doing so. In July of 2002, his team went on record to CTV News, a Canadian TV network, to publicize their views and report on the situation. Before even going to CTV news, the scientists had written to “every health minister in the last five years and have voiced their concerns internally at Health Canada.”[4] Regarding the reprimand, CTV news said, “[Chopra’s] concerns were dismissed and he was advised in a letter that his opinions weren’t supported by Health Canada.” In the letter, Health Canada wrote, “Failure to address this behaviour, as would be evidence by another such episode, will result in more severe disciplinary action.“ CTV reported, “they say they know that their jobs could be at stake, but they believe public safety is more important. They said they were also told not to discuss their views outside the government.” In his interview with CTV, Chopra reported, “We’re being told to approve things even without receiving data from the company. But we’re often told that the U.S. has approved it so we should approve it and we shouldn’t even ask questions.” This has serious implications regarding the integrity of Health Canada. The department is not affiliated with the United States and should therefore be responsible for its own due diligence regarding approvals or denials. Regarding Monsanto’s motives, CTV said, “For the companies to make back what they’ve invested in research and development their drug needs to be approved. These scientists say that’s what leads to pharmaceutical pressures.” As of 2014, it has been reported that to take a drug from conception to market takes between 10-15 years and more than $1.3 billion.[5][6] Health Canada denied everything from the CTV report.

Two years later, on July 14, 2004, all four scientists were fired from Health Canada. CBC News reported that they were “terminated because of their outspokenness vis-a-vis the approval process for new drugs.”[7] According to the Canadian Press, “Chopra said he and the others are in financial distress because they've lost their jobs and the government is deliberately delaying an appeal hearing hoping to ‘starve them out.’”[1]

Broader Implications[edit]

rBST[edit]

Recombinant bovine growth hormone, commonly known as rBGH or rBST, is an injection developed by pharmaceutical companies to increase milk production in cows. In 1987 Monsanto released their rBST injection to Health Canada and FDA for approval. While Canada has never approved it, the U.S. FDA approved the drug in 1993. [8] In a statement on the drug’s approval, the FDA claimed as evidence a summary of a Monsanto 90-day rat study that indicated that milk from rBST treated cows was not significantly different[9]. However, the FDA didn’t release the actual report, and stated that milk from rBST cows should be labeled as such. This labeling requirement clashed with a law that said they could only mandate labeling of products that are materially different[10]. These contradictory statements prompted a 1994 Congressional task force to investigate the FDA's position on rBST. The force concluded the FDA’s position was supported, but they could not require labeling. The FDA therefore suggested that milk be labeled as genetically modified, but include the classic disclaimer, “No significant difference has been shown between milk from rBST-treated and non-rBST treated cows.”[11] In 2008, the topic of genetically modified foods (GMF) resurfaced over an Ohio law prohibiting the labeling of milk from rBST treated cows. The 6th Circuit Court determined the law was unconstitutional under the 1st Amendment. They also stated in their decision that the milk was materially different, citing increased levels of the hormone IGF-1 and increased somatic cell counts in the milk[12]. They also found a period of milk with lower nutritional quality during each lactation. This overruled the FDA's claim that the milk was materially different, prompting them to release a report in 2009, clarifying their position. They still contended that the milk was materially different, but had no proven adverse effects on human health. The United States handling of rBST is troubling. Monsanto has a lot of power over the FDA. One tool Monsanto has used to pressure the FDA is to offer FDA officials higher paying jobs. The also have lobbied at federal and state levels to convince the public that GMF are the same as regular food. While rBST may not have had devastating effects, it should have been scientifically proven not to have adverse effects before approval. The FDA and Health Canada need to be more open with information surrounding GMF, and GMF labeling should be constitutionally corrected.

U.S. Influence on Canadian Drug Approval[edit]

Another troubling habit from Shiv Chopra's whistleblowing is Health Canada's reliance on the United States to follow the FDA's approval. Agencies risk legitimacy claims when they base their work off of other people’s summaries. Summaries can often focus on the reasons why the decision was made, and therefore fail to account for concerns. In addition, health agencies should be working as a democratic check on drug companies. Unbiasedly funded studies should be the basis for approval. If health agencies rely on one another for decisions, they can lack the due diligence necessary to make an informed decision. If one agency approves the drug, it has a cascading effect on the others. This system is more susceptible to corruption because pharmaceutical companies sometimes only have to convince one agency to approve their drug. One of the reasons GMF remains a discussion is because countries have differing views and the public is uninformed. While health agencies often follow this democratic view, it is important to see the value this model provides and adhere to it. Francis Oldham Kelsey Francis Oldham Kelsey kept the FDA from approving thalidomide based on European approval. Her claimed was justified when thalidomide was linked to severe birth defects. Shiv Chopra kept Health Canada from approving rBST based on FDA approval. Agencies need to see the value in developing their own conclusions to prevent the next health crisis.

Conclusion[edit]

The integrity of the whistleblowers revealed multiple issues rooted in Health Canada, and their process of approving drugs. Monsanto attempted to bribe Health Canada to approve the rBST. When Shiv Chopra and his colleagues, Margaret Haydon, Gerard Lambert, and Cris Bassaude were offered this bribe, they decided to take action. They did not believe that they could approve the drug since they were unaware of the effects it could have on humans. They therefore placed the public's safety above their own careers. rBST increased milk production of cows rapidly to meet the demands of milk production that had been rising since WW2. Monsanto, Health Canada, and farmers all believed that rBST was the solution to this increased demand. However, after the attempted bribe, the whistleblowers were skeptical of the motives behind implementing rBST. After the whistleblowers refused to approve the drug they were disciplined. They were fired from their jobs, and ridiculed by the media. The case was never overturned and the whistleblowers used the incident to raise awareness surrounding Health Canada's corruption. Shiv Chopra wrote the book, Corrupt to the Core, which emphasizes the underlying issues in his field. The case reveals that scientists and government disagreed on what was best for the public interest. The government is responsible for protecting the public interest; however, at times, it fails.

References[edit]

  1. a b c Dennis Bueckert. (2005). Health Canada whistle-blowers win round against public service integrity office. Canadian Press Newswire.
  2. a b James Baxter. (1998, October 23). Monsanto Accused of Attempt to Bribe Health Canada for rBGH (Posilac) Approval. The Ottawa Citizen, p. A1.
  3. Chopra v. Canada (Attorney General). , T-624-03 (Federal Court April 29, 2005).
  4. HEALTH CANADA WORKERS FEEL PRESSURED TO OK DRUGS. (2002, July 4). CTV News.
  5. Morgan, S., Grootendorst, P., Lexchin, J., Cunningham, C., & Greyson, D. (2011). The cost of drug development: A systematic review. Health Policy, 100(1), 4–17. https://doi.org/10.1016/j.healthpol.2010.12.002
  6. DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20–33. https://doi.org/10.1016/j.jhealeco.2016.01.012
  7. SCIENTISTS TO FIGHT GOVERNMENT FIRING. (2004, July 15). CBC News.
  8. Bijman, J. (1996), "Recombinant Bovine Somatotropin in Europe and the USA." Biotechnology and Development Monitor, No. 27, p. 2-5.
  9. FDA(1993) Food and Drug Administration. Report on the Food and Drug Administration's Review of the Safety of Recombinant Bovine Somatotropin. https://www.fda.gov/animal-veterinary/product-safety-information/report-food-and-drug-administrations-review-safety-recombinant-bovine-somatotropin(
  10. National Academy of Sciences (2010) Front-of-Package Nutrition Rating Systems and Symbols. https://www.ncbi.nlm.nih.gov/books/NBK209859/
  11. Moulton, Libby (2008, October 28) Labeling Milk from Cows Not Treated with rBST. http://stlr.org/2010/10/28/labeling-milk-from-cows-not-treated-with-rbst-legal-in-all-50-states-as-of-september-29th-2010/
  12. Ohio State University (2012) rBST labeling regulations. https://farmoffice.osu.edu/blog-tags/rbst-labeling-regulations