Buh-bye? Arrivederci? Sayonara? Can it be that the coronavirus pandemic puts an end to one of the disgraceful ways that Big Pharma and medical device makers push their wares on all-too malleable doctors — with big-money speaker programs?
The inspector general’s office of the giant federal Health and Human Services (HHS) agency has warned drug- and medical device-makers that these pandemic-paused marketing shams should not resume. The $2 billion that industry players have forked out for the in-person gab fests in the last three years looks sketchy at best to federal watchdogs and prosecutors, the HHS inspector general warned in a rarely issued “special fraud alert.” It reported this:
“The Office of Inspector General (OIG) and Department of Justice (DOJ) have investigated and resolved numerous fraud cases involving allegations that remuneration offered and paid in connection with speaker programs violated the anti-kickback statute. The Federal government has pursued civil and criminal cases against companies and individual [health care providers] involving speaker programs … Our enforcement experience demonstrates that some companies expend significant resources on speaker programs and that some [health care providers] receive substantial remuneration from companies. This Special Fraud Alert highlights some of the inherent fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to company-sponsored speaker programs.”
FiercePharma, a news organization that covers the industry, names some names to fill out the bullet-points of the government warning about speaker programs, honoraria paid to doctors and others in medicine, and boozy and pricey meals and galas associated with purported informing clinicians about new offerings of drugs and medical devices:
“Paid speaker programs have proven problematic for some pharma companies over the years. Novartis recently settled with the federal government in a seven-year-long legal battle for using thousands of speaker programs as a way to disguise bribes to doctors from 2002 to 2011. The Swiss drug maker agreed to pay about $600 million to the government, along with $50 million to resolve state Medicaid claims. As part of its deal with the same HHS office that just issued the fraud alert about the programs, Novartis agreed to cut back on future speaker programs. And in 2016, Salix Pharmaceuticals agreed to a $54 million civil fraud lawsuit settlement with HHS, admitting it paid doctors as speakers for programs that were mostly social events where little or no time was spent discussing drugs. Salix was bought in 2015 by Valeant, which changed its name to Bausch Health in 2018.”
The opioid abuse and drug overdose crisis — which killed at least 450,000 Americans between 1999 and 2018 and arguably was the nation’s leading health nightmare before the coronavirus pandemic — is replete with awful examples of physician speaker programs. Insys executives, several of whom were convicted on federal charges, became notorious for pushing sales personnel to use sexually suggestive pitches to doctors, including in speaker programs. Purdue Pharmaceuticals pushed the programs hard to pitch to doctors pain-management strategies focused on the company’s problematic product OxyContin.
The HHS watchdog, noting that bona fide medical education efforts aren’t at issue, said that in this day and age, the speaker programs do not make sense as the most effective way to inform doctors and other health care providers (HCPS), particularly since so many cheaper, more efficient, and clearer means exist:
“There are many other ways for HCPs to obtain information about drug and device products and disease states that do not involve remuneration to [them. They] can access the same or similar information provided in a speaker program using various online resources, the product’s package insert, third-party educational conferences, medical journals, and more. The availability of this information through means that do not involve remuneration to HCPs further suggests that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals.”
As the inspector general’s office notes, a growing body of research, sadly, shows the high susceptibility — even gullibility — of doctors to what economists call “nudges,” suggestions that come at them by various means, including speaker programs and payments, to prescribe certain drugs or use specific medical devices. The medications or devices may not be superior. But with the least push, including things as insignificant as a pizza lunch or branded swag, Big Pharma and medical device makers get doctors to prod patients to their meds or products.
This comes at a cost to patients, who might benefit as much from a cheaper, equally effective generic medication, or a medical device with less money sunk into its marketing. Hospital costs, studies have found, can increase when, for example, surgeons insist that institutions stock a veritable hardware store of devices, as doctors make claims for their benefit and not always with significant research to back themselves up.
In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles to access and afford safe, efficient, and excellent health care. This has become an ordeal due to the skyrocketing cost, complexity, and uncertainty of treatments, prescription medications, and iffy medical devices. Too many meds turn out to be dangerous drugs and too many medical devices are determined to be dangerous and defective products.
Big Pharma and medical device makers are fond of crying “poor us,” asserting that the big costs of developing drugs and hardware deprives the industry of needed profits to pursue innovations. Yeah, right. Studies have shown that Big Pharma, for example, is spending big to persuade doctors and patients that fewer drugs that aren’t much different than others are worth much higher prices, notably in cancer care. The whole health care sector has become obsessed with marketing and advertising to win market share, increase brand identification and loyalty, and to pry precious dollars out of sick patients’ hands. The hype machine adds an estimated $30 billion in wasted costs to the system that already cash-strapped Americans must pay.
The Trump Administration, by the way, is grinding out its final days with dubious and familiar executive actions aimed at reducing drug prices, including by trying to tie the costs of certain prescription drugs to what patients in other nations pay. These efforts only highlight how the folks in power for a few more weeks have failed to work with Congress (and the Republicans who have controlled key parts of it) or to follow basic legal procedures to make policies work.
We need real action on unacceptable prescription drug prices and medical device costs. The inspector general’s fraud alert may be a good move, as “special” as billed — as a stark warning to drug- and device-makers as well as doctors themselves that criminal behaviors, such as offering and taking kickbacks and bribes, is not a part of the practice of medicine. As the federal watchdog warned doctors:
“Congress enacted the anti-kickback statute, in part, to protect patients from referrals or recommendations by HCPs who may be influenced by inappropriate financial incentives. The anti-kickback statute makes it a criminal offense to knowingly and willfully solicit, receive, offer, or pay any remuneration to induce or reward, among other things, referrals for, or orders of, items or services reimbursable by a Federal health care program. When remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal health care program, the anti-kickback statute is violated. For purposes of the anti-kickback statute, the offer, payment, solicitation, or receipt of ‘remuneration’ includes the transfer of anything of value, directly or indirectly, overtly, or covertly, in cash or in kind. By its terms, the statute ascribes criminal liability to all parties to an impermissible ‘kickback’ transaction (i.e., those who solicit or receive prohibited remuneration as well as those who offer or pay the prohibited remuneration). Violation of the statute is a felony punishable by a maximum fine of $100,000, imprisonment up to 10 years, or both. Criminal conviction will also lead to mandatory exclusion from Federal health care programs, including Medicare and Medicaid. [The inspector general] may also initiate administrative proceedings to exclude persons from the Federal health care programs and impose civil money penalties for conduct prohibited by the antikickback statute.”
Here’s a hoorah to that message getting sent, with big hopes it is followed up with touch action to ensure it is received and followed.