To paraphrase Calvin Coolidge, “The business of America is business.” Even, we would add, when it should be about medical care.
According to a recent news report, “[T]he drugs most aggressively promoted to doctors typically aren’t cures or even big medical breakthroughs. … they are newer drugs that manufacturers hope will gain a foothold, sometimes after failing to meet Wall Street’s early expectations.”
So said a report earlier this month published by the New York Times and ProPublica.org (NYT/ProPublica). Using Open Payments, the federal government’s new database of drug and medical device manufacturers’ payments to medical providers, the reporters found a disturbing, if unsurprising, pattern of dual self-interest that’s all about sales, not the advancement of medical care.
“In almost all cases,” the story said, “older, cheaper products are available to treat the same conditions [as the drugs being promoted]. Companies typically try to differentiate the new drugs by asserting they are easier to use; carry fewer side effects; work faster than competitors; or have medical advantages.”
Assertion is not science. It’s marketing.
This is such a perennial story in the prescription drug world that longtime drug industry scourge Sidney Wolfe MD developed a "seven-year rule": Patients should avoid drugs until they've been on the market for at least seven years. Otherwise you the patient are really participating in an experiment to see if the drug is truly safe. The only rare exception for the seven-year rule is a new drug that is a genuine breakthrough, which rarely happens.
As an example, the reporters offered the blood thinner Coumadin. For many decades, it was the only drug available for millions of patients at risk for life-threatening blood clots. Today, “a furious battle is underway among the makers of three newer competitors for the prescription pads of doctors across the country.”
They are Pradaxa, Xarelto and Eliquis, and their manufacturers entice (some people might say “bribe”) physicians to prescribe them in part by subsidizing meals, promotional speeches, consulting jobs and educational opportunities. In the last five months of 2013, these companies spent more than $19 million on doctors and teaching hospitals.
It’s not about announcing new, cutting-edge treatments, as Dr. Joseph Ross told the reporters. It’s about selling a product to whomever will buy it. “They [the drugs] may have some unique niche in the market, but they are fairly redundant with other therapies that are already available,” said Ross, a professor of medicine and public health at Yale University School of Medicine. “Many of these, you could call me-too drugs.”
The three drug makers claim that their drugs are at least as effective as Coumadin for certain conditions. They claim that patients needn’t undergo regular blood tests as they do with Coumadin, and that patients needn’t limit their diet as much. (People who take Coumadin, or its generic version, warfarin, shouldn’t eat grapefruit or cranberries and they must limit their consumption of green, leafy vegetables.)
But as we’ve blogged, thousands of patients on Pradaxa, which was the first of the three to be approved by the FDA, have been harmed by uncontrolled bleeding, and its manufacturer, Boehringer Ingelheim, has been fined for covering up adverse outcomes in its research for the drug. There are similar concerns about Xarelto and Eliquis.
We recently blogged about the diabetes drug Victoza, which also came under scrutiny in the NYT/ProPublica story. Made by Novo Nordisk, Victoza was responsible for the most payments to doctors, by dollar amount — more than $9 million in the last five months of 2013, despite its questionable benefit/harm balance. Its packaging carries a “black box” warning, which is the most severe alarm about potentially harmful side effects, including an increased risk of thyroid cancer and pancreatitis.
Dr. Todd Hobbs, chief medical officer of Novo Nordisk in North America, told the reporters that the $9 million reflected Victoza’s newness and the need to address such safety concerns. We wonder why that money wasn’t spent on making the drug safer in the first place.
Eliquis ranked No. 2 on the doctor spend-o-meter, at nearly $8 million. Its corporate talking heads (Bristol-Myers Squibb and Pfizer) said such spending helps ensure that providers understand its appropriate use, and how important it is “to have a speaker program that adequately provides robust education to these physicians.”
In what other profession are you paid to learn how to use a tool that is your responsibility to understand?
The No. 3 drug in the doctor payment club was Brilinta, yet another blood thinner. It competes with Plavix, whose generic version is clopidogrel. Brilinta’s manufacturer, AstraZeneca, tabbed it for special promotion attention, noting that doctors are “indispensable partners in our efforts to bring new medicines to patients.”
We get that. We don’t get why being an indespensible advancement in science isn’t more important than being a huckster.
Of the top 20 most promoted drugs on the list, 14 were approved by the FDA since 2010. Some treat similar conditions, including diabetes, schizophrenia and chronic obstructive pulmonary disease, so, as one pharmaceutical company consultant told the NYT/ProPublica, “They’re fighting over the same doctors, I guarantee you.”
A troubling number of highly promoted, doctor-palm-greasing meds have caused harm. Samsca, which treats low sodium levels in the blood, can cause involuntary movements and seizures, side effects that emerged after it was approved by the feds. The manufacturers of some drugs, including Copaxone, Latuda, Xarelto, Daliresp and Humira, have been called out by the FDA for sleazy promotions.
Subsys, which we discussed recently, was approved to treat cancer pain. Its market is tiny (cancer patients who have developed a tolerance to opioids), but it still ranked No. 23 in spending on doctors, and it’s often used for off-label, or unapproved, uses, as you might expect with a drug whose consumer base is so limited.
It’s not only drugs, but medical devices that have hefty doctor promotional budgets. Among the heftiest is Intuitive Surgical’s da Vinci surgical robot system, which has been fraught with problems and lawsuits we’ve tracked. Da Vinci is promoted as less invasive for many procedures, but it’s crazy-expensive, and has caused serious complications and some deaths.
But in the last five months of 2013, Intuitive shelled out almost $13 million for physicians to promote the robot. About half of that amount, Intuitive said, was “pass through” spending: Surgeons or hospitals paid the company for services, and the company, in turn, paid doctors to provide them.
According to Open Payments, one doctor who was paid about $75,000 in the last five months of 2013 gave promotional talks about several of the most heavily marketed anticoagulants and blood thinners, particularly Brilinta.
He’s an emergency room doctor who said he offers a different perspective from the cardiologists and internists who usually prescribe those drugs because he treats complications of blood clots in the emergency room.
He told NYT/ProPublica that he reviews clinical studies before deciding to speak for a drug, and that he no longer speaks on behalf of Pradaxa. But he does get paid to speak for Xarelto, a drug he has taken himself for a deep vein thrombosis.
Well, at least he uses the product he hawks.
But, sadly, “Largely absent from the top of the [promoted drugs] list were drugs that cure disease,” the reporters found, “such as a new class of hepatitis C treatments, or those that significantly extend life, particularly for cancer patients. If a drug is either the first to treat a disease or is much better than existing drugs, said Dr. Sidney Wolfe, the founder and now senior adviser to Public Citizen’s Health Research Group, ‘they “sell themselves” on the merits of their unique benefits.’”
You can see how much money drug and device companies spend on interactions with doctors, (excluding research and royalties) with ProPublica’s Open Payments Explorer tool here.