Lisa Pratta never set out to expose a pharmaceutical giant. She entered the industry because she believed in medicine – and, as the single mother of a child with special needs, understood the life-changing impact it could have.
With her natural ease around others, pharmaceutical sales seemed like the perfect fit: a job that married her people skills with a purpose she cared deeply about.
But what started as her ‘dream job’ soon became something else entirely as she began to sense the pharmaceutical industry seemed more interested in making money than helping patients.
In 2010, Pratta, now 65, started as a sales rep at Questcor Pharmaceuticals. The role was close to her home in New Jersey and paid far more than she had ever expected.
She was hired to promote a drug called Acthar, marketed for the management of multiple sclerosis (MS), a debilitating autoimmune condition affecting the brain and spinal cord that leaves people with mobility issues, memory loss and fatigue.
Initially, Pratta was proud to be selling a drug that could have profound results for people.
By 2011, however, she was leading a double life – secretly working as a whistleblower for the government to expose how the company allegedly sought to put profits over patients.
Lisa Pratta (pictured above holding a copy of her book) was a whistleblower for the government for seven years to expose the alleged illegal practices happening at Questcor
Seven years of covert efforts would eventually culminate in a lawsuit brought by the US government and a settlement of hundreds of millions of dollars.
The Daily Mail has reached out to Mallinckrodt Pharmaceuticals, which acquired Questcor in 2014, regarding the allegations made by Pratta and those detailed in this article but did not receive a response by the time of publication.
Pratta maintains she did not participate in illegal activities.
In her new book, False Claims: One Insider’s Impossible Battle Against Big Pharma Corruption, Pratta alleges that Questcor, and later Mallinckrodt, paid kickbacks to doctors in the form of dinners, gifts and vacations to incentivize them to prescribe Acthar to their MS patients.
Pratta’s book details the seven years she spent as a whistleblower for the US government
She also claimed they were allegedly committing fraud by promoting an unproven dosage regimen, and inflating the cost of the drug from $40 for a 5ml vial to $28,000.
The price has since ballooned to $48,000 – an increase of nearly 120,000 per cent from 2001 to 2025.
MS affects about one million Americans. While there is no cure, some treatments can slow progression and ease symptoms.
Questcor’s Acthar was billed as a life-changing drug that could alleviate MS symptoms, helping patients walk and talk again.
It was approved by the FDA for a two- to three-week treatment regimen, and it worked when prescribed correctly.
But Pratta claimed that Questcor and Mallinckrodt were encouraging pharma reps to instead promote a five-day dosage – a practice known as ‘off-label’ marketing.
Doctors are legally allowed to prescribe a drug for something other than what it was originally approved for, or ‘off label’, but it is illegal for pharma reps to promote or market medication for unapproved uses.
Even so, Pratta wrote that the Department of Justice (DOJ) had signaled the gift cards, the dinners and the luxury vacations were the ‘low-hanging fruit’ of evidence: ‘The systemic bribery was the easiest offense for the government to prove.’
Because of this, she said, the government’s lawsuit focused on those violations and Medicare fraud rather than on any allegations of off-label marketing.
Pratta’s undercover journey began shortly after she was approached in August 2011 by a former Questcor colleague, recently fired, who told her he planned on reporting the company to the DOJ and asked if she would go with him.
Afraid of losing her job, benefits – and even potentially custody of her son – if things went south, she hesitated. But, ultimately, Pratta was ‘disgusted’ by what was going on within the company and felt enough was enough.
‘I knew my days of keeping my mouth shut were over,’ she wrote.
The DOJ launched its investigation in January 2012 and in addition to being a mother and pharma rep, Pratta added whistleblower to her resume.
In an exclusive interview with the Daily Mail, Pratta said: ‘I looked at it [whistleblowing] as a third job, but I was so angry with what they were doing.’
Pratta was a divorced single mother afraid to lose her job if the company caught her investigating it for the government
Pratta alleged that the kickbacks started at ground level with the medical assistants or nurses, who were pharma reps’ first point of contact. She said the reps would give gift cards – sometimes worth up to $5,000 – for popular retail stores in exchange for the office staff flagging patients who might be eligible for Acthar.
From there, Pratta said pharma reps would offer doctors financial incentives to prescribe the drug.
‘That’s the fraud and kickbacks with the doctor,’ she said. ‘It’s so horrific. Not once do reps talk about making your patients feel better.
‘It’s not about you getting better… It’s about raising the stock prices. It’s about quotas.
‘Does it ever talk about people getting better? No.’
In addition to the alleged kickbacks, the DOJ lawsuit against Mallinckrodt and Questcor alleged that the companies acted illegally regarding what is known as the Medicare ‘Donut Hole’ – a gap in insurance coverage where patients are responsible for more of their medical costs.
During such a time, people might struggle to pay for their medication. To cover this gap, charities will elicit donations and use those funds to provide financial aid.
But it is illegal for pharmaceutical companies to be involved in filling in the ‘donut hole’ by way of directly subsidizing patients.
According to a press release issued by the US Attorney’s Office of the Eastern District of Pennsylvania in March 2022, Mallinckrodt allegedly paid these illegal subsidies through three funds that Mallinckrodt established through a foundation in order to induce Medicare-reimbursed purchases of Acthar at its ever-increasing price.
‘Mallinckrodt used the subsidies,’ the statement said, ‘to counteract doctor and patient concerns about the drug’s high cost and to market the drug as ‘free.”
Pratta’s years as a government informant were spent taking detailed notes, and creating digital copies of files and emails as well as trying not to get fired or caught.
That moment eventually came, though, in 2017. Pratta was told the company was reducing its workforce, and she was let go.
The investigation, however, continued.
Her book’s title is a nod to the False Claims Act, a federal law that makes people and companies liable if they defraud governmental programs. It allows whistleblowers to sue entities that are doing so and receive a portion of the recovered funds.
In an exclusive interview with the Daily Mail, Lisa Pratta showed off a 5ml vial of Acthar, which is now being sold for $48,000
Finally, in March 2019, the DOJ served Mallinckrodt with a 100-page lawsuit citing details gained through Pratta’s undercover work.
The complaint alleged that between 2009 and 2013, a dozen Questcor sales representatives marketing Acthar provided illegal compensation to healthcare providers ‘in the form of lavish meals and entertainment expenses’.
A DOJ press release issued in September 2019 stated: ‘The company paid this remuneration, the government alleges, with the intent to induce Acthar Medicare referrals from those health care providers, resulting in a violation of the Anti-Kickback Statute and the submission of false claims to Medicare.’
The company agreed to settle the claims but admitted no wrongdoing.
‘Under the settlement, Mallinckrodt has agreed to pay the expected $15.4 million relating to these legacy Questcor activities,’ the company said in a September 2019 press release. ‘Importantly, the settlement agreement contains no admission of wrongdoing.’
The company paid an additional $260 million to settle claims of illegal kickbacks and Medicare underpayments. In its press release announcing the settlement in March 2022, the DOJ noted that the claims were ‘allegations only and there has been no determination of liability’.
Pratta told the Daily Mail: ‘With regards to the settlement of $234 million – since Mallinckrodt went bankrupt, the government combined two whistleblower cases to make it easy.
‘Our case settled for a combined amount of $15 million in 2019, which was only 10 per cent of the case before bankruptcy, and around $26 million in 2022 for a combined amount of around $41 million.’
Despite the size of the payouts, Pratta was disappointed that the government didn’t manage to hold those in power personally accountable.
‘My motto was: I’m going to bring them down,’ she said. ‘I’m going to bring them to their knees and they won’t even know it was me.’
False Claims: One Insider’s Impossible Battle Against Big Pharma Corruption (William Morrow), by Lisa Pratta, is available now.
This article was originally published by a www.dailymail.co.uk . Read the Original article here. .