Big Pharma, battling over sky-high prices, called out on big fib on R&D costs

While Big Pharma wages an expensive behind-the-scenes battle to prevent federal lawmakers from cracking down on soaring prescription drug prices, industry officials have sought to take advantage of a sudden, positive shift in public perceptions about their industry due to the great outcomes of the coronavirus vaccines.

Drug makers are hitting hard their argument that the high prices for their products, including vaccines and top-selling treatments for cancer and other serious conditions, can be attributed to factors like the huge expense of scientific research and development of breakthrough therapies.

Members of Congress had terse, evidence-based responses to the contention: It’s bull feathers, countered Rep. Katie Porter (D-Calif.), as she and other members of the House Committee on Oversight and Reform confronted Richard Gonzalez, CEO of drug maker AbbVie, in a hearing.

cakatieporter-150x150Porter and other lawmakers told him that they and their staff had reviewed “more than 170,000 pages of internal documents spanning 18 years and published a staff report that concluded AbbVie hiked prices in the U.S. while having to reduce prices in other countries” for two blockbuster products: the anti-inflammatory drug Humira and cancer drug Imbruvica, according to The Hill news organization. It quoted Porter telling Gonzalez about Imbruvica:

“You haven’t made the drug any better even as you doubled the cost. You’re feeding us lies that we must pay astronomical prices to get innovative products.”

The Wall Street Journal reported that oversight committee Democrats found in their scrutiny of AbbVie that the company “has raised Humira’s price 27 times since it launched in 2003, with a year’s supply now costing $77,586 before insurance and rebates.”

Gonzalez defended his company, its prices, and argued that Americans who need prescription drugs get them and with reasonable prices, including with manufacturer rebate programs. As the Wall Street Journal reported:

“Gonzalez said lowering drug prices alone wouldn’t increase access to prescription drugs for patients, including some Medicare patients. He said AbbVie provides medications to some patients who can’t afford them at no cost or through copay assistance. ‘Overall, most Americans have access to affordable medicines,’ he said. ‘As we tackle the issues of drug pricing and access, it’s important that we focus on what’s working and what needs to change to make sure that patients get the medicines they need.’”

Porter, of course, has become a politician who has mastered guerilla theater. And she again pulled out her trusty whiteboard to assail Big Pharma and slash at its arguments — especially about R&D costs versus profit making — in easily comprehended fashion (see video).

Still, Big Pharma has ramped up its 2021 spending on lobbying in the nation’s capital, forking over $92 million between January and March of this year to get its way with federal lawmakers and regulators. That cash outlay puts the industry on pace for a second year of record influence spending. Lawmakers are split over proposals that aim to rein in ever-rising prescription drug costs. And the Biden Administration — while its officials talk up ideas in this area — may have so much on its legislative agenda already that only time will tell if drug makers skate for a while longer on prices.

A rare drug reconsideration fizzles 

The industry, it is worth noting, recently skidded past a rare regulatory reconsideration of some of its costly cancer medications. The drugs under review by outside experts were granted an accelerated approval, with firms and pro-industry advocates arguing they should be allowed on the market based on promise shown with clinical trials and so-called surrogate endpoints.

This often means the drugs show early promise in shrinking tumors or seeming to slow a cancer’s spread. It does not mean the medications improve or extend patients’ lives. But the federal Food and Drug Administration, under pressure from GOP lawmakers and in the name of innovation, has allowed many more of these drugs on to the market or to be used with conditions they were not originally approved for — with the promise they would be reconsidered as to their effectiveness, particularly because many of the drugs carry sky-high costs.

The FDA, in April, conducted a rare review of a half dozen cancer drugs, leaving unchanged their current status for most of the medications scrutinized.

That was an unacceptable outcome, Dr. Vinay Prasad commented on social media. Prasad —  a hematologist-oncologist and associate professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco — and his colleagues have researched extensively cancer drugs and their skyrocketing costs and limited benefits to improving or increasing patient lives.

Prasad has criticized regulators for confusing doctors and wrecking the finances of patients and families by approving expensive cancer drugs based on weak research.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by dangerous drugs.

While select drug companies deserve praise for their roles in the coronavirus vaccination effort, let’s not forget that taxpayers poured billions of dollars into direct and indirect support for this increasingly successful campaign. It was dogged and individual researchers — not the industry — that toiled for decades to develop novel vaccines, often building on government-funded study.

Big Pharma as white-hat heroes? Hardly. The pandemic has left us all with a worsened nightmare from the industry — a surging opioid abuse and drug overdose crisis, which already has claimed hundreds of thousands of lives in recent times.

Further, as patients return to more normal medical treatment, too many of them will face bankrupting costs for prescription medications, as drug makers exploit patents and other intellectual property protections to maximize their profits.

We have lots of work to do to ensure that this country stays a leader in having innovative and effective prescription drugs, giving enterprises that make them a fair but not a ghastly and customer-crushing profit.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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