Poor FDA communication harms patients, taxpayers, other agencies

fdanulogo-300x126Critics are slamming the federal Food and Drug Administration for dropping the ball in informing the U.S. officials who run the Medicare, Medicaid, and veterans’ health programs about crucial regulatory decisions, leading the federal government apparently to pay hundreds of millions of dollars for patients to get a defective heart device and potentially to pay billions of dollars for a prescription medication targeted at Alzheimer’s but with questionable evidence of its effectiveness.

FDA officials insist that they acted in patients’ best interests when they posted on an agency website, along with thousands of other public communications, a warning letter issued to the maker of the HeartWare Ventricular Assist Device, or HVAD. That missive told the device maker HeartWare — and later its acquiring company Medtronic — that the FDA found serious problems with the HVAD tied to patient injuries and deaths.

The FDA eventually would amass “thousands of reports of suspicious deaths and injuries and more than a dozen high-risk safety alerts from the manufacturer,” ProPublica, the Pulitzer Prize-winning investigative new site found. “One horrifying device failure after another” led HVAD’s maker to halt the manufacture of the supposed life-sustaining heart pump. The firm has agreed to a long-term plan to deal with the calamity of patients who now cannot have the defective device removed.

But during the years in which HVAD problems mounted and the FDA knew of them, the agency failed to flag the Centers for Medicare and Medicaid Services (CMS) or the Department of Veterans Affairs. Both those agencies, ProPublica found in a follow-up to its investigation of the HVAD mess, paid hundreds of millions in taxpayer dollars for patients to keep having risky, complicated procedures to implant the defective device.

VA officials said their agency never received information from the FDA about the HVAD nightmare, noting that warning letters typically are issued to device makers, not federal agencies. CMS declined to discuss with ProPublica whether it got notice from its sister agency and why it kept paying for HVAD devices and procedures, sending reporters back to the FDA and saying that was the federal agency with oversight of medical devices.

Dr. Rita Redberg, a cardiologist at the University of California San Francisco who researches medical device safety and regulation, told ProPublica of the FDA’s bungled handling of the HVAD menace:

 “It’s clearly a breakdown of communication. It’s not just the money, obviously. It’s people’s lives.”

Will Medicare agency balk at covering FDA-approved drug?

CMS, by the way, quickly may join the VA in giving the FDA a figurative punch in the nose over the regulatory agency’s approval of the prescription drug Aduhelm, made by Biogen and targeted at patients with Alzheimer’s.

CMS announced to tens of millions of seniors that it was taking the fiscal protective step of imposing one of the largest annual increases in Medicare costs in recent times due to the potential expense of doctors widely prescribing Aduhelm and with other prescription drugs hiking prices.

Once the FDA approved Aduhelm — over the objections of its own, independent experts and leading lights in the field — CMS typically would be obligated to pay for doctors prescribing the drug. Biogen, however, rode roughshod over independent experts’ estimates of what Aduhelm would cost annually, setting its price at $56,000.

That amount covers only the drug, not the administration of Aduhelm. It is a monthly infusion that patients can take only in doctors’ offices, clinics, or hospitals. Further, because the drug has detected, serious side effects, patients taking Aduhelm have been told to get regular, pricey brain scans. Those tests are supposed to warn doctors if patients are experiencing brain swelling or bleeding due to Aduhelm.

CMS is conducting its own, independent review of the drug to determine the level of coverage seniors might be eligible for under the federal health plan.

The VA, quickly after Aduhelm was approved and amid critics’ denunciations of too cozy relationships between regulators and the drug’s maker, said it would not grant blanket approval of the drug for use in one of the nation’s largest health system serving onetime military personnel and their families. Veterans undergo an individual review of requests for the drug, instead.

That rebuke of the FDA approval of Aduhelm — which showed minor cognitive benefits, at best, for patients in clinical trials — was echoed by nationally known Alzheimer’s specialists, insurers, and academic medical centers, with reporters finding that few of the major institutions of high repute are treating patients with the drug.

Biogen, according to media reports, has taken a major financial hit due to its banking on Aduhelm’s potential big profits. Instead of tens of millions of dollars in revenue, the drug has generated what for Big Pharma is a paltry few hundreds of thousands of dollars. Biogen has halved its cost for the drug, while also announcing major staff layoffs and retrenchment plans.

With Biogen’s price cut of its controversial drug, Xavier Becerra, the chief of the giant Health and Human Services agency that includes CMS, has ordered a reexamination of the Medicare premium rate hike related to Aduhelm. This could be good news for seniors.

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 and by risky and defective products, notably of the medical kind. It is unacceptable that one federal agency knows of problems or challenges with a drug or medical device and, through bureaucratic evasion or silence, allows precious taxpayer money to be spent on such goods or services.

It is a remarkable, sad, and wasteful day when multiple federal agencies — which should be working hand in hand to safeguard and advance the interests of the American people — are reviewing and weighing in on prescription medications and medical devices. That long has been the valued, respected responsibility of the FDA, an agency whose administrators ought to be embarrassed that other public officials feel their hand so forced that they must intrude on the agency’s purview.

President Biden and Becerra must work with Dr. Robert Califf, the nominee to head the FDA, and get a listing agency right again. We need a strong, independent, credible FDA to keep in check the wealthy, powerful, and profit-hungry Big Pharma and medical device industry. We have much work to do to ensure that the power-that-be in the nation’s capital provide the health safeguards on which we spend billions for in funding a working federal bureaucracy.

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