When the blood pressure drug Bystolic hit the market in 2008, it faced a crowded field of cheap generics.
So its maker, Forest Laboratories, launched a promotional assault on the group in the best position to determine Bystolic's success: those in control of prescription pads. It flooded the offices of health professionals with drug reps, and it hired doctors to persuade their peers to choose Bystolic — even though the drug hadn't proved more effective than competitors.
The strategy worked. In the 2012 fiscal year, sales of Bystolic reached $348 million, almost double its total from two years earlier, the company reported.
Now, data obtained and analyzed by ProPublica suggest another factor in Bystolic's rapid success: Many of the drug's top prescribers have financial ties to Forest.
At least 17 of the top 20 Bystolic prescribers in Medicare's prescription drug program in 2010 have been paid by Forest to deliver promotional talks. In 2012, they together received $284,700 for speeches and more than $20,000 in meals.
Nearly all those doctors were again among the highest prescribers in 2011, the most recent year for which Medicare data are available. Forest began disclosing its payments only last year; the company didn't specify which drugs doctors spoke about.
Dr. Bernard Lo, who was chairman of a national panel examining conflicts of interest in medicine, said he doesn't believe the findings are coincidental.
When there's no evidence a drug is better, "You have to question: Why are doctors prescribing this?" said Lo, president of the Greenwall Foundation, a New York City nonprofit that funds bioethics research. "What your evidence suggests is that there is a financial incentive for doctors who receive payments from drug companies" for pitching their products.
Until now, doctors' prescribing habits have been secret from all but pharmaceutical companies, which pay millions of dollars for such information from other firms that collect it.
ProPublica's analysis marks the first time anyone has matched payment data made public by drug companies with physician prescribing records from the Medicare drug program, which covers about 1 out of every 4 prescriptions in the U.S.
Reporters identified the drugs that were most actively promoted to doctors in 2010 and 2011 using rankings from Cegedim Strategic Data, a company that tracks marketing expenses.
The top prescribers of some of these drugs, in addition to Bystolic, also received speaking payments from the companies that made them. As a group, these heavily marketed drugs were new or had new uses, were expensive and often showed little benefit over existing medications or generics.
For example, nine of the top 10 prescribers of the Alzheimer's drug Exelon received money from Novartis, the drug's maker. Eight of the top 10 for Johnson & Johnson painkiller Nucynta were paid speakers, as were six of the top 10 for Pfizer's antidepressant Pristiq.
The same was true for seven of the 10 top prescribers of the asthma drug Advair Diskus, made by GlaxoSmithKline. One doctor made more than $100,000 from 2009 to 2012.
Many of the physicians spoke for several drug companies.
If financial relationships influence physicians to choose pricier brand-name drugs that have little benefit over generics, everyone pays the cost — particularly taxpayers, who spent $62 billion last year subsidizing Medicare Part D.
"I've never heard a doctor that said they were influenced, but obviously the companies are interested in doing it because the evidence overwhelmingly suggests that doctors are influenced," said Rita Redberg, a cardiologist at the University of California, San Francisco, and editor of the journal JAMA-Internal Medicine.
Companies are "not doing it for any reason except it improves their bottom line," she said.
A survey published in the Archives of Internal Medicine in 2010 found that physicians with industry relationships said they were more likely to prescribe a brand-name drug when a generic was available. And federal whistle-blower lawsuits against several pharmaceutical companies have alleged that payments are little more than thinly veiled kickbacks, which are illegal. Companies have paid billions of dollars to settle the cases.
Each of the top 20 prescribers of Bystolic wrote at least 530 prescriptions in Part D in 2010. ProPublica attempted to contact all those who also received money from Forest. Only a handful responded to phone calls, emails and faxed letters requesting comment.
The No. 1 prescriber of Bystolic, Los Angeles cardiologist Gary Reznik, said that if patients have blood pressure under control with another beta blocker, he doesn't switch them. But he believes Bystolic is more effective at lowering blood pressure and doesn't cause the slower heart rate and erectile dysfunction of other drugs in the class.
"If you don't have to be on a beta blocker, I would not start you on a beta blocker," said Reznik, who was paid $3,750 to give talks by Forest in 2012. "If you have to have a beta blocker, Bystolic would be my choice." Reznik prescribed the drug more than 2,500 times in 2010 and more than 2,900 in 2011, including refills dispensed, Medicare records show.
"I have never felt that there were any expectations or pressure on the part of the company that I would prescribe it more or at all," he said.
Another top prescriber, internist Mark Barats, of West Hollywood, Calif., said he uses smaller doses of Bystolic to achieve the same effects as higher doses of generic medications. "It has much less side effects, particularly much less side effects on the respiratory system," he said.
"I've never seen anything that contradicts what Forest said about Bystolic," said Barats, who was paid $3,750 to speak for Forest in 2012.
Dr. Henry Yee, who was paid $5,000 by Forest, said he chooses the drug for many of the same reasons as Reznik and Barats. The cardiologist, whose office is in the Los Angeles suburb of Alhambra, said he learned about the drug from company sales reps and from reading studies. He started prescribing it "even before I started speaking for the company," he added.
Yee said he believes drug companies ask him to speak for their products because he is an influential specialist in his community. "I think it is most likely because a lot of doctors listen to me," he said.
Among the 17 top prescribers with Forest ties, speaking payments ranged from $1,250 to $85,750. Seven doctors also received at least $1,000 in Forest-paid meals.
But several prominent cardiologists say no studies have proved that the benefits cited by Bystolic's top prescribers are real. Dr. Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, said he understands why doctors would like to believe that the beta blocker has additional benefits. "Wishing it to happen isn't the same as proving it," he said.
In 2008, the U.S. Food and Drug Administration rebuked Forest for an ad claiming the drug was "novel" and superior to other products. The FDA said the claim wasn't factual.
"I don't see any purpose for Bystolic whatsoever," said Eric Topol, a cardiologist and chief academic officer of Scripps Health, a San Diego-based health system. Topol said he doesn't use the drug because it is expensive with no added benefit. "I have no idea how you could come up with a storyline for use of that drug."
Bystolic costs about $80 per month, compared with less than $10 for a generic cousin, according to Costco's pharmacy website. (Patient copays vary by drug plan.)
In an email, a Forest representative called Bystolic "an important treatment option" because it is effective and well-tolerated but didn't assert that the drug was superior.
Forest also defended its spending on physician speakers. The company "believes that patients benefit" from paid talks and other initiatives that "enable health care professionals to stay abreast of the latest treatment options available," a representative wrote.
Three years ago, Forest paid the government $313 million to settle civil and criminal allegations about its marketing of drugs, among other things. In its lawsuit, the government alleged that Forest made "cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment, and other valuable goods and services" to doctors.
Forest denied those allegations despite settling the case.
More recently, in a lawsuit unsealed in April against the drug company Novartis, the U.S. government alleged the company's "own internal analyses showed that speaker programs had a high return on investment in terms of the additional prescriptions for its drugs written by the doctors who participated in the programs, both as speakers and attendees, with the highest return arising from payments to doctors as 'honoraria' for speaking."
Novartis disputed the allegations. In 2010, the firm pleaded guilty to a misdemeanor and paid $422.5 million to settle allegations that it illegally promoted Trileptal, an antiseizure drug, and paid kickbacks for prescribing it and other drugs. Trileptal isn't frequently used in the Medicare population.
Forest, Novartis and other drugmakers said they choose speakers based on their expertise and credentials.
Pfizer "explicitly prohibits the selection of speakers based on their prescribing behavior ... any inference to the contrary is misleading," a spokesman wrote in an email. Glaxo and Johnson & Johnson also said they don't choose speakers based on prescribing.
The spending by pharmaceutical companies on speaking and consulting fluctuates based on whether they have new drugs or are marketing older ones for new uses.
To date, only 16 companies have publicly reported their payments to physicians. All companies will be required to report such payments next year under the Physician Payment Sunshine Act, a part of the broader 2010 health overhaul law.
Boehringer Ingelheim Pharmaceuticals, the maker of the blood thinner Pradaxa, began reporting its payments just last month. Pradaxa, introduced in 2010, accounted for more spending on local promotional events than any other drug in 2011, according to Cegedim Strategic Data. Of the top 20 prescribers in 2011, six received speaking fees in the first quarter of this year.
Boehringer said it doesn't pay speakers based on prescribing.
The physician prescription tallies in this story are from Medicare Part D records in 2010. Recently obtained data for 2011 show similar patterns, however. The prescription counts don't include drugs paid for by other parts of Medicare or for patients with private insurance, on Medicaid or in the Veterans Health Administration system.
Some doctors say the drug company money can undermine patients' trust.
Nissen of the Cleveland Clinic said: "I don't want the patient sitting opposite to me in the exam room to have to worry about whether I am prescribing a drug because I am being paid by the company that makes the drug."
ProPublica is an independent, nonprofit newsroom that produces investigative journalism in the public interest.
RENEE MONTAGNE, HOST:
It's MORNING EDITION from NPR News. I'm Renee Montagne.
DAVID GREENE, HOST:
And I'm David Greene. Good morning. We're digging deeper into the relationship between drugmakers and the doctors who prescribe their drugs. Bystolic is a popular high blood pressure medication. It's made by Forest Laboratories. ProPublica, the nonprofit investigative news organization, examined new data and found that frequent prescribers of this drug often have financial ties to the drug's maker. We sat down with ProPublica reporter Charles Ornstein. He explained why this is significant.
CHARLES ORNSTEIN: What's new here is that we obtained information from Medicare. Medicare pays for about one out of every four prescriptions in the country. And so we took this data and linked it up with the payment data that we received to look for any connections that may exist there.
GREENE: OK. What connections did you find?
ORNSTEIN: We found that with a number of really highly marketed drugs, drugs like Bystolic, that many of the top prescribers of those drugs within the Medicare program also receive money for speaking from the companies that made those drugs.
GREENE: And this is something, though, that we believe might have been going on for a long time. I mean, pharmaceutical companies have always been accused of...
ORNSTEIN: That's right. Pharmaceutical companies have had access to this data. They've paid millions of dollars for it every year. So they know what they spend on doctors for speaking and consulting. And then they track very, very closely their return on investment. We've seen these pop up in dribs and drabs in these whistleblower lawsuits where they make mention to the analyses that these companies do, the return on investment analyses, and where they track it super closely. But as a public we have not known the drugs that doctors prescribe, nor have we known sort of the contours of how these relationships affect prescribing.
GREENE: OK. So you looked closely at this one drug, Bystolic, for high blood pressure, and you found that doctors who are getting money from the company that makes it are some of the biggest prescribers of the drug over generic alternatives. What has been the response from the people involved - the company and these physicians?
ORNSTEIN: So it's 17 of the 20 top prescribing doctors are speakers for the maker, Forest. These doctors say they think of this drug as better. This drug has fewer side effects than other, these are called beta blockers. So it has fewer side effects than other beta blockers and they think that it just works well for their patients. But as we talked to experts across the country, what they said to us was that they did not think that there was any evidence to show that this drug was any better than the existing beta blockers, but it certainly was a lot more expensive.
GREENE: What about the company, Forest Labs? What do they - how have they responded to this?
ORNSTEIN: They responded to us that this is an important treatment option, that it had undergone studies and had performed well. But they didn't reiterate the point that it was superior; they just called it an important treatment option. I think what you find with a lot of pharmaceutical companies is they're sort of boxed in by what the FDA allows them to say so the phrase "important treatment option" is one that you hear a lot by companies to promote their drugs.
GREENE: So you're getting some corporate-speak here, but corporate-speak that they have to do.
GREENE: You mentioned money. These doctors are prescribing this drug Bystolic over the generic alternatives. That's probably costing the government a lot more money since, you know, generics are usually cheaper.
ORNSTEIN: Right. So one prescription for Bystolic is about $80 a month. By comparison, a prescription for a generic is less than $10 a month. So that's a difference of about $70 per prescription. If you multiply that by a million prescriptions you're at $70 million. And the federal government is paying a big chunk of that in terms of the subsidies it's providing in Medicare Part D, which is the name of the drug plan. So that's just one drug. If you add in a whole bunch of drugs, you can see how this starts adding up to real money.
GREENE: Could there be cases are prescribing something more often than they should that might not be as effective in terms of treating? I mean, where you can actually dealing with someone's health here.
ORNSTEIN: When you look at the diabetes drug Avandia, which is a drug that a couple of years ago was restricted because of risks that came to light, GlaxoSmithKline, which is the maker of Avandia, was spending a lot of money on physicians to speak on its behalf. And so the question that we weren't able to answer because our data is more recent is, you know, was there a connection back then?
But I think that as new risks of drugs come out we'll now have the information to look back and see are the top prescribers of those drugs also people who have financial relationships with the company. And then we'll be able to put the pieces together and do the analysis.
GREENE: So what you're saying is that as we get more of these numbers, I mean, a lot more investigation to do. There could be times where someone might be prescribed a drug from a doctor who's getting money from a company and actually a different drug might be better for them.
ORNSTEIN: Well, we can't turn the page backward. Beginning next year, every drug company and every medical device company is going to have to begin reporting the payments that they make to doctors across the country. That's going to be a totally new universe. Right now we're talking only about 15 drug companies that we know about.
You also can't take back this information that we're getting from Medicare. So when you put this together, you're going to learn a lot more about how these relationships affect physicians and their prescribing.
GREENE: Charles, thanks so much. Thanks for bringing this report to us.
ORNSTEIN: Thanks for having me.
GREENE: He's a reporter for ProPublica, the nonprofit investigative news organization. Transcript provided by NPR, Copyright NPR.