Four Major Biopharma Scandals in 2019

The word scandalous evokes multiple emotions that range from appalled, to embarrassed, to titillated by the gossipy nature of it all. Over the past year, a few stories have emerged in the biotech and pharma industries that can be scandalous. To wrap up the year, BioSpace took a look back at a few of them.

Zolgensma Data Manipulation

Novartis received a black eye after it was revealed that there had been some data manipulation in the preclinical work that helped lead to the approval of Zolgensma, the gene therapy treatment that would be approved in May for spinal muscular atrophy. Novartis said AveXis began an internal investigation into the allegations of data manipulation in March of this year, two months ahead of the May approval of Zolgensma by the U.S. Food and Drug Administration.  In August, the FDA revealed that data manipulation was involved in the preclinical process of Zolgensma’s development conducted by Illinois-based AveXis, which Novartis acquired for $8.7 billion. The FDA said the data manipulation was “limited to only a small portion of the product testing data that was contained in the marketing application.” Novartis addressed the FDA’s concerns in a 56-page response to the claims and laid the blame on the shoulders of former AveXis scientists Brian and Allan Kaspar. Novartis said the Kaspar brothers personally manipulated or instructed others to alter some of the preclinical data that ultimately led to the approval of the $2.1 million priced SMA therapy. The Kaspar brothers were fired from AveXis in August following the revelations. In the wake of the scandal, Novartis pledged it will be more forthcoming with any concerns over data manipulation with the FDA and other regulatory agencies.

China CRISPR Scandal

While this scandal began in the later months of 2018, the fallout continued long into this year. In November 2018, Chinese scientist He Jiankui announced to the world that he had used CRISPR to alter the embryos of seven couples to make them resistant to HIV. Following the announcement, researchers across the world responded that Jiankui’s experiment was unethical and “monstrous,” particularly since it is unknown how those edits could be passed down to future generations of children. In January, the Chinese government took action against Jiankui. The government said the scientist was transferred to public security authorities and the individuals who participated in the experiment will be “severely dealt with according to the law.” As the story unfolded, not only was the work roundly condemned by the scientific community, it turns out that some of the research claims may not even be legitimate. Jiankui’s research has not been published yet, but earlier this month, the MIT Technology Review announced it had received two manuscripts from the Chinese researcher that has yet to be made public. Ahead of any publication though, it was reported that many of the claims Jiankui made are “ludicrous.” As BioSpace reported, an analysis of the documents submitted to the MIT publication found multiple problems with the claims, suggesting that the research claims do not match the data. The analysis further suggests “the babies’ parents may have been under pressure to agree to join the experiment; the supposed medical benefits are dubious at best, and the researchers moved forward with creating living human beings before they fully understood the effects of the edits they had made.”

IP Theft and the Cries of Xenophobia

The U.S. government has been closely monitoring researchers who have ties to China, either through the funding they receive or through their heritage. A 2017 report issued by the FBI noted that that intellectual-property theft by China costs the U.S. as much as $600 billion annually. The National Institutes of Health, which worked on the report with the FBI, expressed concern over three primary areas -- the diversion of intellectual property, sharing of confidential information on grant applications and failure by some researchers to disclose substantial resources from outside organizations, including foreign entities. The government of China has pushed a program called the Thousand Talents Plan in China, which provides funding for scientists willing to conduct scientific research on behalf of the government. Earlier this year the Chinese government tamped down promotion of the Thousand Talents plan as western fears mounted over concerns of intellectual property theft. The following is something of a wrap-up of a number of reports that fall under this category. Last year, two Chinese scientists pled guilty to stealing intellectual property from GlaxoSmithKline. Those trade secrets were going to be part of the foundation for setting up a company in China called Renopharma. This year, researchers at Emory University and at MD Anderson were terminated following the revelation of potential undisclosed funding ties with the government of China. Following the ouster of the scientists at the prestigious cancer center, Stephen Hahn, chief medical executive at the Texas-based cancer center (and now the new FDA Commissioner) held a town hall meeting in April to ensure employees that the firings of the scientists were not based on their ethnicity or xenophobia, as some employees suggested.

Aggressive OxyContin Marketing in China

This year saw the fall of Purdue Pharma, the business that became the poster-company for the opioid crisis in the United States due to the aggressive and manipulative marketing tactics used in the 1990s and 2000s to boost sales of the pain killer. Documents released from legal battles with the company revealed many of the tactics encouraged by the Sackler family, the first family of Purdue Pharma. It is estimated that the Sackler family has earned more than $4 billion from the sale of OxyContin. Documents from a lawsuit against the company in Massachusetts showed that former company president Richard Sackler announced at a launch party for OxyContin after its approval that his colleagues should imagine a “blizzard of prescriptions.” A 2018 report released by the U.S. Department of Justice showed the company knew about 'significant’ abuse of OxyContin in the first years after the drug's introduction in 1996 and concealed that information.” In November, it was revealed that another pharma company owned by the Sacklers, Mundipharma, is using similar marketing tactics to push sales of OxyContin in China. According to the report, Mundipharma leadership encouraged its sales team to copy the private medical records of patients without their consent, a violation of Chinese law. Also, former Mundipharma sales representatives said, that on occasion, some would don white lab coats and pretend to be doctors. These reps would enter hospitals and talk to patients about their pain and encouraged them to ask for Mundipharma medications. Paid speaking gigs were also part of Mundipharma’s playbook to “deepen relationships” between the company and prescribing doctors. Additionally, the Mundipharma marketing team made use of bogus claims about the safety of OxyContin and other opioids in the materials they provided.