Corporations have a responsibility to their customers and the public to be ethical, honest, and forthright.
But that obligation is heightened to a degree for pharmaceutical firms, especially the ones whose customers are dealing with serious illness or acute, chronic pain.
Insys Therapeutics deals with both types of patients.
The Arizona-based drug company got approval five years ago from the U.S. Food and Drug Administration (FDA) to sell Subsys, an under-the-tongue spray for cancer patients dealing with chronic pain.
Subsys contains fentanyl, the highly addictive synthetic opioid that is 100 times more powerful that morphine and 50 times more powerful than heroin, according to the National Institute on Drug Abuse.
Fentanyl has been in the news for the past few years.
It’s been the cause of many deaths by those who mix it with street heroin.
An accidental overdose of fentanyl was the cause of rock star Prince’s death.
Despite the dangers and all the controversy surrounding this drug, Insys thought it had a winner on its hands with its sublingual version.
But apparently not as many cancer patients were using the drug as the company had hoped.
So, executives concocted an elaborate scheme in which they created “fake” cancer patients to improve sales, according to a Senate investigation whose findings were released last week.
The report from the Senate Committee on Homeland Security and Governmental Affairs was released just days after Arizona Attorney General Mark Brnovich filed a consumer fraud lawsuit against Insys and three doctors over a “marketing scheme” to increase sales of the drug.
Brnovich called the action part of a fight against “the unethical and greedy behavior in the pharmaceutical industry that is fueling the opioid crisis in our state.”
Senator doesn’t mince words
Sen. Claire McCaskill (D-Missouri), who is steering the Insys investigation, said last week in a press conference that the company aggressively pressured its employees and many in the medical industry to increase the use of the drug.
And, she noted, it was done during a national opioid epidemic that is taking the lives of tens of thousands of people in the United States a year.
“It’s hard to imagine anything more despicable,” said McCaskill.
The senator said Insys executives misled insurance companies, provided kickbacks to doctors who went along with the scam, and falsified medical records, all just to make money.
According to the Senate report, insurance companies would only pay for the drug for a patient who “had an active cancer diagnosis, was being treated by an opioid (and, thus, was opioid tolerant) and was being prescribed Subsys to treat breakthrough pain that the other opioid could not eliminate.”
Federal prosecutors in Boston announced in December that six former Insys executives and managers, including former Chief Executive Officer Michael Babich, had been indicted.
Prosecutors said Babich and others led the conspiracy to bribe medical practitioners to unnecessarily prescribe Subsys to non-cancer patients, for which the drug is not designed, through payments disguised as marketing events and speaker fees.
Reuters reported in July that while Insys ostensibly designed the speaker program to educate healthcare professionals about Subsys, its primary purpose was to reward healthcare providers who prescribed the drug.
Prosecutors said the medical providers earned thousands of dollars in kickbacks through the speaker events, which were usually just a gathering of friends and co-workers at high-end restaurants.
In July, two former Insys sales representatives, including the wife of the company’s former chief executive officer, pleaded guilty to engaging in schemes to pay kickbacks to medical practitioners to prescribe the drug.
Pharma’s image damaged
Pharmaceutical companies in the United States are closely monitored by the federal government and intensely scrutinized in their clinical trials and marketing practices.
However, when a drug company does something as egregious as Insys is accused of, the industry’s image is damaged.
The image wasn’t helped last year by Martin Shkreli, the former chief executive officer of Turing Pharmaceuticals who raised the price of a medication for AIDS patients from $13.50 to $750.
Last month, Shkreli was convicted of two counts of fraud and one count of conspiracy for misleading investors in hedge funds he ran. He’s now doing time at a federal jail in Brooklyn.
The details of the Insys story are another public relations headache for the industry.
A recent national survey by Kantar Media, a healthcare industry research firm, showed that only 22 percent of consumers who were surveyed trust the drug companies that advertise the medications they take.
Kantar’s 2017 MARS Consumer Health Study also showed that only 28 percent believe pharmaceutical ads make them more knowledgeable.
Only 44 percent agreed that prescription drugs are a more effective treatment than over-the-counter drugs.
Patients respond to scandals
Meanwhile, the response to the Insys scandal among cancer patients has been one of outrage.
In interviews with Healthline, a half-dozen cancer patients and cancer patient advocates had harsh words for Insys as well as stern advice for the industry at large.
“When you violate the trust of someone in the cancer community, it’s almost impossible to gain it back,” said Dan Duffy, a stage 3 testicular cancer survivor, author, and advocate for cancer patients.
“Insys violated the trust a company needs to have on so many levels that it defies comprehension,” Duffy added. “I’ve never been someone to call for the public shaming or firing of anyone, because I know just how important it is to have the ability to take care of yourself, as well as your family if you have one. But whoever thought this was a good idea needs to find a new line of work. Stat.”
Duffy said what Insys has allegedly done is especially appalling because it involved faking cancer for financial gain.
“I can’t say that I haven’t thought, ‘There’s a special place in hell for this person,’” he said.
Linnea Olson, a stage 4 lung cancer patient, artist, blogger, cancer activist, and mother of three, told Healthline that the relationship between cancer patients and pharmaceutical companies is complicated.
“It is a relationship fraught with tension, as they are profit-driven, which is a different onus than patients, oncologists, researchers, and advocacy organizations,” said Olson, who is currently enrolled in her third clinical trial.
Olson said cancer patients sometimes don’t trust drug companies because “we don't feel they necessarily have our best interests at heart. There is a lot of talk about patients as partners right now, and I regard most of it as rhetoric. You can’t be a true partner in a relationship if you are not an equal.”
Olson added that the one thing patients trust drug companies to do is deliver a product that is safe and appropriate.
“When we hear of a fraudulent situation such as this one — pretending that people had cancer in order to get prior approval for a powerful pain killer — it erodes that very slim sliver of trust and enhances our perception that they are in it for the money and only the money,” she said.
Casey Quinlan, a breast cancer survivor, cancer patient advocate, healthcare policy wonk, and comedy writer, is dedicated to creating a healthcare system that serves people, not profits.
She told Healthline that the issue of trust is central to cancer patients who are in treatment.
“Trust in the clinicians making the diagnosis, trust in the treatment plan proposed, trust in the science and statistical modeling that predicts outcome,” she said.
“Good science can save lives. Fakery ruins them,” she added. “To earn back trust, pharma will have to do some very public penance. I suggest they start with full transparency on all trials, and also clean house of all sales-driven decision making.”
It’s hard to imagine how Insys will survive as a company at this point.
But its product can and does help some people with cancer, so there could be efforts in the future to save the product, if not the company.
Insys isn’t speaking to individual media outlets.
But in a statement released earlier this month, the company said it disagreed with “certain characterizations” in McCaskill’s report but agreed the “opioid epidemic must be addressed.”
In the Senate report, Insys Chief Executive Officer Saeed Motahari said the company is working to prevent the “mistakes and unacceptable actions” of the past by establishing protocols that hold employees to ethical standards.
“Insys has completely transformed its employee base over the last several years,” said Motahari, one of many new leaders at the company, which has seen more than 90 percent of its sales staff exit since 2014.
Motahari also said in the statement that the company’s former employees’ “mistakes and unacceptable actions” were not indicative of the company’s current employees.
“Over the past several years, Insys has actively taken the appropriate steps to place ethical standards of conduct and patient interests at the heart of our business decisions,” Motahari said.