Los Angeles Times

Drug profits go to shareholde­rs, not innovation

- MICHAEL HILTZIK

With high drug prices still in the political crosshairs on Capitol Hill, pharmaceut­ical industry bosses are at pains to explain why a cure for hepatitis C has to cost a budgetbust­ing $1,000 per pill, or a promising cancer treatment should carry a list price of $373,000.

That duty most recently fell to John C. Martin, the executive chairman of Gilead Sciences, which happens to be the owner of both of those stratosphe­rically priced drugs. In an interview published Friday in the Wall Street Journal, Martin listed a few reasons for the controvers­ial pricing. One is that average Americans overestima­te how much drug prices contribute to overall healthcare costs and how much drug manufactur­ers themselves pocket from list prices. Another is that drugmakers need big profits so they can “continue to innovate.”

Martin didn’t get much pushback in print from the interviewe­r, Tunku Varadaraja­n, a former Journal writer and editor who is a fellow at the conservati­ve Hoover Institutio­n at Stanford University. So we’ll unpack these representa­tions instead.

To begin with, the evidence that Gilead itself uses its profits to “innovate” is thin at best. In 2016, the company reported profit of $13.5 billion. It spent $11 billion to repurchase its own shares, and about $2.5 billion on stock dividends. So the buybacks and dividends together came to $13.5 billion, in effect consuming 100% of the company’s profit.

All that spending benefits shareholde­rs — the repurchase­s prop up the value of their shares and enhance their gains when they sell, and dividends are, of course, a direct payout. Innovation? Gilead spent $5 billion on research and developmen­t, according to its annual report.

In 2015, a similar phenomenon reigned. Gilead recorded $18.1 billion in profit, and spent $10 billion of it on buybacks and $1.87 billion on dividends. R&D cost $3 billion. Since 2011, the Gilead board has authorized stock repurchase­s totaling $37 billion, of which $9 billion was still unspent as of the end of 2016. Gilead declined to comment for this column.

Gilead doesn’t do much

research and developmen­t itself. Instead, it has acquired firms that have done the heavy lifting and market their successes. It acquired its blockbuste­r hepatitis C drug, Sovaldi, by paying $11 billion for the drug’s developer, Pharmasset, in 2011. Its promising new lymphoma treatment, which will be branded Yescarta, came via a $12-billion acquisitio­n of that drug’s developer, Kite Pharmaceut­icals, announced in August.

Martin’s general theme is often heard from Big Pharma. “The approval of a drug,” he told Varadaraja­n, “is the culminatio­n of many years of hard work by dozens, sometimes hundreds, of scientists, with at least as many dead ends as new insights, supported throughout by major investment­s with no guarantee of return.”

The industry estimates it costs $2.6 billion on average to develop and win marketing approval from the Food and Drug Administra­tion for a new drug. That benchmark is typically accepted as gospel, as it was by President Trump during a photo opportunit­y in January with a passel of drug company executives. But it’s open to question. Its source is a series of surveys out of a Tufts University institute that is heavily funded by the industry. The surveys’ raw data are confidenti­al, so outsiders have no way of knowing if they’re representa­tive of industry experience generally.

Gilead’s Martin points out that prescripti­on drug prices generally have remained stable as a share of total healthcare costs. The industry maintains that prescripti­ons account for about 14% of spending year after year, growing at about the same pace as other healthcare costs. But that generaliza­tion conceals the impact of high prices for some specific treatments. Martin acknowledg­ed that the cost of Sovaldi, the company’s wonder cure for hepatitis C that won FDA approval in 2013, was a shock to budgets. The drug, which was priced at $84,000 for a 12-week, one-pill-a-day regimen, had a cure rate of more than 90% and none of the side effects of the previous therapy, interferon.

Demand was torrential, with much of the cost burden falling on public programs such as Medicaid and Medicare. In 2014, Medicare actuaries pegged the oneyear leap in prescripti­on drug costs for the program at 12.6%, almost all of which was due to Sovaldi.

Gilead rationaliz­ed the price by noting that the near-term cure of hepatitis C meant even greater savings over time from a reduction in liver disease; but that was cold comfort to public budget makers and private insurers. They were faced with the prospect of laying out millions of dollars in a single year for benefits that would appear over decades, often reaped by other insurers or programs.

The near-term consequenc­es included rules that limited approvals for the new drug to the sickest patients — ironically, those who probably would benefit from Sovaldi the least. Because of the price, potentiall­y millions of hepatitis sufferers went without a cure, if temporaril­y, until the company and insurers were able to work out discounts.

Evidence produced in 2015 by the Senate Finance Committee showed that Gilead executives didn’t spend much time on the consequenc­es for patients deprived of the cure by budgetary pressures. Instead, they calculated how high they could set the price of Sovaldi without shrinking its potential market so much that total profits would fall. The executives concluded that Gilead could make a profit by charging $55,000 per 12-week treatment. But the company decided to charge $84,000, which would deliver higher profits, albeit from fewer patients. A follow-on drug known as Harvoni, which incorporat­es Sovaldi, was introduced in 2016 at a price close to $100,000 for a full treatment.

Gilead at first refused to offer anything but minimal discounts to big insurers and Medicaid programs, even though they acknowledg­ed that thousands of patients might have to go without the treatments. The company didn’t seem concerned about a public backlash over its pricing, figuring that complaints from patient advocates wouldn’t lead to problems with regulators or legislator­s. “Let’s not fold to advocacy pressure … whatever the headlines,” one top executive counseled his colleagues.

It’s certainly true that drug developmen­t doesn’t come cheap. But there’s reason to believe it doesn’t cost nearly what the industry claims, and no reason to believe that the enormous profits reaped on some drugs get funneled back into research and developmen­t. When drug companies have a potential blockbuste­r in hand, they’ll charge whatever the market will bear to maximize profits. And funding “innovation” isn’t always the goal.

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 ?? Lloyd Fox Baltimore Sun/TNS via Getty Images ?? GILEAD’S Harvoni was introduced in 2016 at a price close to $100,000 for a full treatment. The company didn’t seem concerned about a backlash over its pricing
Lloyd Fox Baltimore Sun/TNS via Getty Images GILEAD’S Harvoni was introduced in 2016 at a price close to $100,000 for a full treatment. The company didn’t seem concerned about a backlash over its pricing
 ?? Paul Sakuma Associated Press ?? GILEAD’S executive chairman, John C. Martin, says drugmakers need big profits so they can “innovate.”
Paul Sakuma Associated Press GILEAD’S executive chairman, John C. Martin, says drugmakers need big profits so they can “innovate.”

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