From pandemic heroes to public enemy number one, the pharma industry has been labeled many things. Whether these events were serious missteps or minor misunderstandings (or something in between) is up for interpretation — but here’s what stole the headlines in 2021.
Claims that the Texas company presented misleading data for its Alzheimer's Disease candidate surfaced last August through an FDA whistleblower submission letter with “extensive details” surrounding the “accuracy and integrity of clinical and preclinical data supporting the ongoing clinical evaluation” of Cassava's simufilam. The company fired back with a Q&A-style press release refuting the allegations point by point.
Along with the whistleblower submission, two doctors also filed a public petition in August to end clinical trials of the drug, saying that they don’t buy Cassava’s data and that they have shorted the stock, believing that it will plummet once investors learn that they’ve been duped.
In Nov., news circulated that Cassava was being investigated by the Securities and Exchange Commission over the claims that the company manipulated trial data for simufilam. In a securities filing, Cassava said that it was under investigation but did not name a specific government agency. The company’s CEO denied the allegations, calling them “outlandish.”
Part of the controversy was centered around debate about whether or not the company manipulated images of western blots, which are frequently used by labs to display proteins in samples of tissue or blood.
In a Dec. 21 press release, Cassava revealed that, after examining raw data from a 2005 scientific article, including images of original, uncropped Western blots, Neuroscience journal found that there was no evidence to support claims of data manipulation in a 2005 paper authored by Cassava.
“Another science journal has cleared us of allegations,” said Remi Barbier, President & CEO. “This clearance is from an independent third party who is neutral and expert in the field. This reinforces my conviction that false and misleading allegations of scientific misconduct being made against us are simply designed to enrich those making them. People who seek to profit from false allegations may not comprehend the harm they are causing the Alzheimer’s community, or perhaps they simply don’t care. Leaving a trail of destruction in their wake in the quest for profit, with little concern for patients or their caregivers, is a twisted form of money-making and the opposite of what people with dementia deserve.”
Purdue Pharma and the Sackler family bankruptcy saga continues
A day rarely goes by without opioids making headlines in the national news. With overdoses still at staggering highs (the CDC estimates that 115 Americans die every day from opioid overdose), it has become one of the most devastating health problems in U.S. history.
At the center of the controversy has been Purdue Pharma. In a 2007 plea deal, Purdue admitted that it falsely marketed OxyContin as non-addictive. Last March, two years after declaring bankruptcy, Purdue proposed a chapter 11 plan. According to the drugmaker, the plan charted a path of more than $10 billion of value, including 100% of Purdue’s assets, to be delivered to claimants and communities across the country affected by the opioid crisis.
The plan was intended to resolve thousands of opioid lawsuits by restructuring Purdue into an entity that would steer profits to plaintiffs and require the company’s owners, the Sackler family, to contribute nearly $4.5 billion (paid out over nine years) to the settlement. It would also dissolve Purdue and transfer its operating assets to a newly formed company with the public-minded mission of addressing the opioid crisis.
Importantly, the funding of billions of dollars from the Sacklers came in exchange for the resolution of both private and public claims against the Sackler family — a point that did not sit well with many people.
On Dec. 16, the United States District Court for the Southern District of New York vacated the order confirming the chapter 11 plan of Purdue Pharma. This overturns the $4.5 billion settlement, and means that the Sackler family will not be released from legal claims over the opioid epidemic. One point of contention during the hearing was how the Sackler family members transferred $10.4 billion from the privately held Stamford, Connecticut-based company over the decade before the bankruptcy.
J&J, plagued with lawsuits, spins off a new company that promptly declares bankruptcy.
Johnson & Johnson announced in October that it would be establishing a separate subsidiary, called LTL Management, in Texas which would inherit most of the baby powder lawsuits. The legal maneuver, dubbed "Texas two-step bankruptcy" is a controversial restructuring strategy often used to help drive a settlement of personal injury claims. Under Texas law, the J&J business split in two, forming LTL Management, through a divisional merger.
LTL was then converted into a North Carolina LLC, and promptly filed for Chapter 11. North Carolina has notoriously been a friendly venue for this bankruptcy strategy, which temporarily halts litigation. Critics said the move was an attempt to hide behind bankruptcy and limit payouts.
According to a J&J press release, the move was made in order to "equitably resolve all current and future talc claims." J&J is facing tens of thousands of legal cases from people who allege its cosmetic talc caused cancer — one of which resulted in a $2.12 billion verdict against J&J.
Recently, the venue of the chapter 11 case was transferred to the District of New Jersey, where LTL will defend its decision to file for bankruptcy in a hearing scheduled for February 2022.
Emergent BioSolutions falls from grace after quality fails
Emergent has been at the center of a swirl of controversy since last March when it was revealed that contamination between AstraZeneca and J&J COVID-19 vaccines being manufactured at the company’s Bayview facility led to about 15 million J&J shots being tossed. In April, the FDA issued a Form 483 to the company for a number of serious quality observations, halting production at the plant. Subsequent reports have shown that the CDMO had been forced to discard a total of 75 million vaccine dose equivalents.
In May, executives from Emergent were grilled by members of Congress, leading to some revelations about the CDMO’s handling of COVID-19 vaccine manufacturing. In July, Emergent shareholders accused execs at the embattled CDMO of insider trading in four separate lawsuits. According to a report in The New York Times, shareholders said that executives failed to communicate its manufacturing challenges while at the same time unloading about $20 million in stocks.
And the hits kept coming for the CDMO. Most recently, Emergent announced that it had reached a “mutual agreement” with BARDA to terminate a pandemic preparedness contract the Maryland CDMO had held since 2012.
The FDA’s historic decision to approve Biogen’s Alzheimer’s treatment
It’s been a long time since an FDA approval stirred up so much controversy as the agency’s June nod for Biogen’s Alzheimer’s treatment, Aduhelm. In our March cover story, we called the Aduhelm question “one of the FDA’s biggest decisions of the decade.” However, the enormity of the backlash from the approval was unforeseen in our coverage.
For many, the decision is already being used as a case-in-point that the FDA — which was blasted for its cozy relationship with Biogen during the review process — can’t be trusted. Two FDA advisory committee members even quit following the Aduhelm approval.
Part of the debate surrounding Aduhelm was focused on the mismatched results from the drug’s two phase 3 trials — one showed a benefit, while the other did not. Although Biogen presented data suggesting that a discrepancy in dose exposure between patients in the two studies explained the diverging results, not everyone was convinced.
FDA granted the drug conditional approval, saying that Biogen would have to “conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit,” which it plans to start in March 2022.
Biogen slapped a $56,000 price tag on Aduhelm and, as expected, concerns over how patients and insurers would cover the cost have dogged the drug ever since. Despite becoming the first potentially disease-modifying drug ever approved to treat Alzheimer’s, the ongoing dispute over the demonstrated safety, efficacy and cost of the drug have hampered uptake.
Recently, Biogen announced that effective January 1, 2022, it will reduce the wholesale cost of its controversial new Alzheimer’s disease treatment, Aduhelm, in the U.S. by approximately 50% as an important Medicare decision looms.
The U.S. Centers for Medicare and Medicaid Services (CMS) have been evaluating whether the drug should be covered, analyzing published clinical studies and medical society guidelines, as well as conducting public hearings. CMS is expected to release a proposed decision about Aduhelm's coverage on Jan. 12, with a final decision expected three months later.
