Big Pharma is hard to rein in. Just look at two drug cases grabbing headlines.

lotsapills-300x200Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits — in settling claims over distributors inundating the country with lethal painkillers, or with a maker’s behind-the-scenes campaign to win U.S. approval of an Alzheimer’s medication based on dubious data.

Patients are unlikely to come out ahead, or even satisfied with the outcomes of the cases involving how Johnson & Johnson (J&J), Cardinal Health, AmerisourceBergen, and McKesson handled opioids, and how Biogen and the Food and Drug Administration have dealt with Aduhelm.

A major opioids settlement

After state and local governments and Indians tribes filed thousands of lawsuits and negotiated for two years, they announced they have agreed to settle for $26 billion claims over how J&J, as well as drug distributors Cardinal, AmerisourceBergen, and McKesson moved tens of millions painkiller pills around the country.

The deal — with payments stretching across 18 years — could mean that desperately needed sums soon will start to flow to states, counties, cities, and towns across the country to help officials combat the worsening opioid abuse and drug overdose crisis. It has claimed an estimated 500,000 lives in a decade.

The crisis has only worsened during the coronavirus pandemic, with the nation recording a record 93,000 overdose deaths in 2020. That’s a 30% increase over the prior year and the steepest single-year increase on record.

Officials asserted in their suits, which the companies denied, that the four Big Pharma giants should have done more to prevent the abuse of powerful painkillers, as the New York Times reported:

“The distributors, which by law are supposed to monitor quantities of prescription drug shipments, have been accused of turning a blind eye for two decades while pharmacies across the country ordered millions of pills for their communities. Johnson & Johnson, which supplied opioid materials to other companies and made its own fentanyl patches for pain patients, is accused of downplaying the products’ addictive properties to doctors as well as patients.”

New York state separately settled its claims against the companies for $1 billion (a sum included in the $26 billion overall tally of the settlement’s value). Indian tribes are negotiating with the companies still.

The proposed agreement will be complex for the governments to finalize and carry out, both as they try to hew to the deal’s effort to shield the companies in the days ahead from more lawsuits, and for states, counties, and municipalities to sort out who gets what and how.

The aggrieved parties said they still do not consider the settlement sufficient, especially considering that some experts have estimated the opioid crisis has cost the country more than $1 trillion. It will be difficult for those who have suffered the death, addiction, and debilitation of the opioid crisis to see companies get what critics say is a limited reckoning for their roles in public health catastrophe.

The settlement could put officials under huge pressure to determine what works in communities to combat the growing abuse of opioids. Under this deal, governments cannot use money from the settlement to patch general fund budgets, as occurred when litigants reached a “global” deal in historic cases involving Big Tobacco. Instead, this opioid settlement will be targeted, the New York Times reported at funding, “addiction treatment, prevention services, and other steep expenses [for governments] from the epidemic.”

The settlement does not resolve, nor will it pay individual claims. As the New York Times reported:

“[This] agreement leaves thousands of other lawsuits against many other pharmaceutical defendants still unresolved, including manufacturers, drugstore chains, and smaller distributors. Most of those companies are working on negotiating their own deals, which could potentially bring even more money to states, cities, counties, and tribes. Purdue Pharma, the maker of OxyContin and its owners, members of the billionaire Sackler family, are negotiating a settlement of at least $4.5 billion with plaintiffs as part of a bankruptcy restructuring.”

Who was overseeing whom?

The post-mortems are just starting. But with the information already available, taxpayers may have big questions about the FDA’s oversight role of Biogen and its campaign to get approved Aduhelm, an Alzheimer’s-targeted prescription medication that could be hugely profitable for the drug maker.

Stat, a medical and science news site, already had raised questions about behind-the-scenes meetings between agency officials and Biogen in the lead-up to the drug’s recent green-lighting by the FDA.

The New York Times has dug further. And congressional committees investigating this case clearly have their work cut out for them. That’s because cozy might be too kind a description for the purported regulatory activity that occurred.

The newspaper found that company and agency officials consulted frequently, even with the blessing of supposedly independent inspectors general within the FDA. The agency, not the company, came up with the idea of accelerating approval of the drug — a controversial process with checkered results for patients.

The agency, up to the head of the division specializing in meds dealing with dementia and Alzheimer’s, dug into data from two clinical trials of Aduhelm. The company, let’s remember, initially looked at this information and talked about abandoning Aduhelm. That’s because its experts said it did not appear as if the med’s clearing of amyloid brain proteins was useful in stemming or stopping patients’ cognitive decline.

But the company reinterpreted that data, after the fact, and somehow, presto, the FDA gave a speedy approval to the drug for all Alzheimer’s patients, though it had undergone clinical trials only in individuals in early stages. The agency overruled its elite, outside, and independent experts to approve the drug. The newspaper said Aduhelm advanced, though several internal reviews by some of the highest officials in the agency were unconvinced the drug should get to market.

Agency officials also not only consulted with Biogen about its drug’s controversial data, they also used it to set up an evaluators’ framework, which they later ignored, and published in a medical journal with the information.

Responding to experts’ furor over the drug’s approval, the FDA back-tracked and said it had agreed with Biogen that the Aduhelm label would be revised, recommending the drug only for early-stage patients.

That late advisory may matter little because doctors, once a drug gets on the market with FDA approval, may rely on their professional discretion and prescribe it for non-label uses.

Critics have lambasted the FDA for raising false hopes for millions of Alzheimer’s patients and their loved ones by approving Aduhelm, which Biogen since priced at $56,000 annually — far above what specialists imagined its limited-effectives might substantiate. The drug also supposedly should be given only after doctors put patients through rigorous diagnostics to make the difficult determination that they may be in early stages of Alzheimer’s. The process is supposed to include pricey brain scans — which patients will continue to require in monitoring required as they take the drug, as Biogen has warned that Aduhelm can cause brain swelling and bleeding.

With FDA approval of Aduhelm, taxpayers suddenly also could be burdened with billions of dollars in new costs to cover the drug under Medicare and Medicaid. The agency that oversees drug coverages for those federal programs has announced that it will conduct its own extensive review before approving federal payments for Aduhelm. That drug, by the way, is more expensive because it is an infusion that can be given only in doctor’s offices, clinics, or hospitals.

Private insurers already have balked at paying for the drug over its lack of demonstrated effectiveness and cost. Respected specialists have expressed wariness about prescribing Aduhelm. And notable medical centers have gone on record as passing for now on using the drug.

Biogen has reported that its early Aduhelm sales have been more modest than expected and the company has gone on a public relations tear to promote the drug, accusing critics of spreading misinformation.

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.

The opioid crisis, which we now must tackle in the most aggressive fashion possible, took time to develop, fostered by Big Pharma, doctors, nurses, hospitals, insurers, and others in health care. The wrongdoers must be held accountable, and the tens of millions who have been injured must find care — and justice from the injuries they and their loved ones suffer.

Federal watchdogs clearly slumbered not only through the opioid nightmare, but they’ve also created a big mess with Aduhelm. Officials have not only blurred or damaged standards for FDA approval of drugs based on real criteria for their safety and effectiveness for patients, they also have undercut the agency’s crucial credibility by seeming to pander to evidence-light hopes and wishes of the desperate and the profit-making of Big Pharma.

We’ve got a lot of work to quash the opioid crisis and to ensure the FDA puts front and center beleaguered patients and not the industry it regulates.

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