If you don’t know Dateline NBC‘s Chris Hansen by name or even by face, you know him by formula: hidden camera reporting that offers an inside look at people saying and doing things they would otherwise keep under wraps.
Hansen’s technique is perhaps best known for the “To Catch a Predator” programs in which he confronts would-be sex predators in person after he first poses online as a teenage or preteen youth. On Sunday, Hansen’s technique showed clinical research organizations striking deals with a fake pharmaceutical company angling to test a dangerous drug. It’s a misleading representation of CROs and an incomplete story of how the clinical research industry operates.
If you missed the broadcast, it’s available online. Hansen, posing as CEO of fictitious pharma Malum Kinetics, goes to India to find a CRO to conduct clinical trials on a compound that is chemically identical to Vioxx, the Merck (NYSE:MRK) pain drug withdrawn in 2004 due to safety risks. He finds two CROs willing to do the work: Lambda Therapeutics Research and Synchron Research Services. Synchron tells Hansen that there is no problem proceeding with a clinical trial. Lambda realizes the compound Malum wants to test is Vioxx. But even acknowledging Vioxx’s safety risks, a Lambda executive says there’s a 50/50 chance of finding success from clinical trials.
“From our perspective, we would love to take on the challenge,” he tells Hansen.
The focus on two small, obscure CROs is a little misleading, and someone unfamiliar with the industry might come away with the impression that those companies are representative of industry practices, safety be damned. The Association of Clinical Research Organizations live tweeted the broadcast and gave a cool response to the portrayal: “Lambda and Synchron are not ‘prominent’ CROs, we never heard of them.”
Outsourcing of clinical trial work is prevalent. But outsourcing in drug development is nothing new and there are legitimate explanations for why this outsourcing work has grown. Cost is just one reason pharmas and CROs look overseas. Recruiting is another. It’s harder to recruit clinical trial participants in the United States and when CROs find them, it’s hard to find enough of them. It’s a numbers game. When a CRO looks worldwide, it taps a larger pool of potential participants.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Another misrepresentation of the broadcast is the suggestion that drug testing in India replaces U.S. drug testing. A phase 3 clinical trial can test thousands of patients in a global, multicentered study. A pharmaceutical company or CRO that tests a drug in India likely also designed the trial to include tests in Europe and North America, among other global locations. Adam Chasse, vice president of Maryland clinical trials training firm RxTi, noted in a blog post following the broadcast that the U.S. Food and Drug Administration will generally ask companies to get at least 30 percent of their data from the United States.
Dateline did interview ACRO executive director Doug Peddicord, who said the conduct of Lambda and Synchron — who are not ACRO members — is not condoned by the association and the industry has too much at stake to tolerate unethical behavior. Even so, Chasse would have liked the Indian CRO’s actions balanced by perspectives from one of the CRO industry’s largest players, such as North Carolina-based CROs Quintiles or PPD, or the New Jersey-based Covance (NYSE:CVD). All of them do clinical work in India. Perhaps the large CROs deferred to ACRO to speak on their behalf. My own take on this is that while the drug development industry is a large and global business, it’s a collegial one where players know each other, their work and their track records. Any CRO that doesn’t spot Malum Kinetics as a fraud and Vioxx as a withdrawn drug is not one you want to do business with.
If there’s a takeaway from Hansen’s piece, perhaps it’s that the lure of pharmaceutical money motivates participants at all stages of drug development to get a piece of the action. That includes the New Jersey institutional review board that gave the go-ahead for fictitious Malum Kinetics to do real drug tests; the Indian CROs willing to take pharma money to test a drug already withdrawn from the market; and the Indian clinical trial participants willing to subject themselves to multiple drug tests because the compensation they receive is more than they can earn elsewhere.
The remedy might lie with the FDA. Iowa Senator Chuck Grassley, a frequent FDA critic, put the onus on the agency to wield its regulatory authority to oversee drug development at all stages, not just when a pharma company makes a drug filing. “They are the 900-pound gorilla,” Grassley told Dateline. “They need to act like a 900-pound gorilla.”
ACRO used the NBC program as an opportunity to advocate for more funding to support the FDA’s overseas oversight efforts. But more money is hard to come by in these austere times. The CRO industry recognizes that its future success rests on people’s trust that drugs and drug testing are done in a safe and ethical manner. ACRO described Synchron’s and Lambda’s conduct as the actions of the “bad actors” that can be found in any industry. Perhaps the legitimate CROs should take it upon themselves to call out those bad actors in the interest of preserving the industry integrity that they embrace. If they don’t do it themselves, one day the 900-pound gorilla will do it for them. I imagine companies will prefer the nuanced hand of industry over the heavy fists of the gorilla.
