Uncle Sam should be wary in partnering with Big Pharma on cancer treatments

by Patrick Malone & Associates P.C. | DC Injury Lawyers

Is Uncle Sam launching a way to speed and improve cancer treatments so they get to patients sooner—or is Big Pharma about to fleece taxpayers, yet again? The National Institutes of Health should carefully consider its just announced, five-year public-private partnership with a dozen drug makers, the “Partnership for Accelerating Cancer Therapies” or PACT.

Under this agreement, the makers each will pony up $1 million annually or a total of $55 million over the term of the accord. The NIH, in turn, will provide $160 million of its formidable research support.

The aim is to “identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments that harness the immune system to attack cancer,” the agency says.

Big Pharma participants will include: AbbVie, Amgen, Boehringer Ingelheim Pharma GmbH & Co. KG,  Bristol-Myers Squibb,  Celgene, Genentech, Gilead Sciences, GlaxoSmithKline plc, Janssen Pharmaceutical (Johnson & Johnson); Novartis, Pfizer, and the Pharmaceutical Research and Manufacturers Association.

NIH Director Francis S. Collins argues that PACT, to be overseen by the agency’s nonprofit foundation, is needed because “We have seen dramatic responses from immunotherapy, often eradicating cancer completely for some cancer patients. We need to bring that kind of success — and hope — for more people and more types of cancers, and we need to do it quickly. A systematic approach like PACT will help us to achieve success faster.”

Although this approach sounds good, the devil dances in the details. And it’s fuzzy in the materials public now what will happen with learnings and discoveries from this initiative—in legal parlance, who will control the intellectual property from this initiative?

Collins has been quoted as equating PACT to another similar accord, the Accelerating Medicines Partnership. As Stat, the online health information site describes that deal, it was a “ ‘precompetitive’ collaboration with industry groups launched three years ago that requires all parties to agree to initial data and resource-sharing without regard to future considerations of products and profit.”

Here’s a harsh translation of what that can mean: Taxpayers agree to plow a field, pay for the seed, then watch as Big Pharma harvests a bounty—and charges outrageous prices for it, to boot. Lest that sound hyperbolic consider how recent headlines about cancer immunotherapy treatments, in particular, have highlighted not only the drugs’ promise but also their sky-high costs.

Novartis is hustling Kymirah, a drug that the federal Food and Drug Administration has just approved to treat children and young adults for B-cell acute lymphoblastic leukemia, a “devastating and deadly” form of the blood cancer that has resisted standard treatment and often resulted in disheartening relapses. As promising as Kymirah may be, it carries a whopping $475,000 dosage cost. That does not include collateral expenses, like extensive hospitalization, that the 600 or so patients the drug may benefit may need to cover.

And while Novartis may see significant revenue and profit from this and other immunotherapies, the company is flatly refusing to acknowledge —notably in its pricing — that Uncle Sam contributed at least $200 million of the cost to develop the underlying, so-called Chimeric Antigen Receptor (CAR) T-Cell Therapy.

Two nonprofit groups, similarly, have assailed Astellas Pharma over its $129,000-a-year charge to Americans for the prostate cancer drug Xtandi. The patient advocate groups have urged federal officials to take a last-ditch legal step and invoke “march in” rights to force the company to acknowledge how it benefited from taxpayer-funded research and to make “fruits” of that support available to the public at reasonable cost.

Astellas, critics say, relied on three key patents to cover the drug but those protections “were granted to the University of California and were made possible by grants from the National Institutes of Health and the Department of Defense,” as the Washington Post has reported.

The drug marker has poured gas on the fiery outrage over Xtandi with its global pricing for the drug. As the Washington Post has described it:

The U.S. average wholesale price of the drug — a list price that doesn’t take into account discounts or rebates that manufacturers provide — is $88.48 per 40 milligram capsule. In Japan, that same pill costs $26.37, and in Norway it is $32.43.

“In our opinion,” the nonprofit groups have argued to federal officials, “it is unreasonable, and indeed outrageous, that prices are higher in the United States than in foreign countries, for a drug invented at UCLA using federal government grants.”

Indeed, a growing body of evidence debunks an incessant Big Pharma, “poor me” justification for unacceptably high drug prices—researchers are questioning whether makers really must pay as dearly as they claim to research and develop their products, especially when their potential revenues and profits are taken into account.

In my practice, I see not only the huge harms that patients suffer while seeking medical services but also their struggles to afford medical care—especially for exorbitantly priced medications—and the havoc that must deal with when they are exposed to dangerous drugs.

Although political leaders in Washington seem paralyzed by partisanship and other cause and unable to address soaring, unacceptable drug costs, states—to their credit—are acting. It’s an imperfect measure, of course, but California deserves credit for its new drug law. As the nonpartisan, nonprofit Kaiser Health News Service describes it, the measure “will require drug companies to give 60 days’ notice to state agencies and health insurers anytime they plan to raise the price of a drug by 16 percent or more over two years on drugs with a wholesale cost of $40 or higher. They must also explain why the increases are necessary.”

The news service quotes California Gov. Jerry Brown describing why he signed the measure and, despite furious lobbying against it by Big Pharma, allowed it to become law: “Californians have a right to know why their medical costs are out of control, especially when pharmaceutical profits are soaring. This measure is a step at bringing transparency, truth, exposure to a very important part of our lives. That is the cost of prescription drugs.”

Maryland and New York earlier had passed drug pricing measures. But the size of the California market, combined with those two, may put big, new pressure of Big Pharma to, at minimum, warn patients and publicly explain its plans to jack up product prices, analysts say.

It may be past time to ask whether astronomic drug prices, particularly for cancer treatment, have become counter-productive in their own way to patient care. Doctors and hospitals have started to refer to the financial “toxicity” of outrageously priced cancer medications. And researchers are focusing more and more on what they call drugs’ “nocebo effect.” That’s the evil twin of the “placebo effect,” the latter being the measurable beneficial outcomes that patients can experience just by receiving attention and inert therapies like saline solution or sugar bills. Patients who are prescribed exceedingly pricey drugs can experience negatives with them, a “nocebo effect” in which side-effects and other potential harms of a therapy are exaggerated and may make them feel worse rather than better.

Although we certainly want to foster innovation and everyone hopes for better ways to deal with awful diseases like cancer, we also need to recognize that private sector participants in medical services operate first and foremost in their own—not the public’s interests. They’re allowed to reap reasonable gains from their investments. But profiteering off products developed with your buck and mine isn’t acceptable.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Patrick Malone & Associates P.C. | DC Injury Lawyers | Attorney Advertising

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Patrick Malone & Associates P.C. | DC Injury Lawyers

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