FDA oversight looks shaky with drug recalls, rising vaping deaths and injuries

Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of the prescription blood-pressure medications losartan, valsartan and irbesartan.

The actions occurred after cancer-causing chemicals known as nitrosamines — N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA, and N-Nitrosodimethylamine, or NDMA— were detected in them.

They were yanked in an abundance of caution, and doctors and public health experts have told patients to consult with their pharmacists and doctors to ensure they do not suddenly halt their use of needed treatments, especially because there are ready options.

But these incidents, involving claims of products tainted in their manufacture overseas, may raise yet more alarms for politicians, regulators, and the public about breakdowns in federal safeguards against dangerous drugs and other products under the regulation of the federal Food and Drug Administration.

Nightmarish cases involving FDA oversight also dominate the news headlines still, with the vaping-related lung-injury cases rising to more than 1,000 and the deaths to almost a score, while a federal trial over potential liability for the harms of powerful and deadly opioid painkillers grinds on and the number of Big Pharma plaintiffs dwindles due to settlements.

Tainted medications

With Zantac, the FDA did not act, surprising critics. Instead, major retailers like CVS, Walmart, and Walgreen’s leaped in and pulled the product from shelves after an online pharmacy conducting its own random quality tests raised the possibility of nitrosamine contamination. Overseas makers warned the FDA, which ordered recalls of small and select lots of the blood pressure medications sold as brands including Cozaar, Diovan, Prexxartan, and Avapro.

The cases highlight the vast and complex Big Pharma supply chains, many offshore, that end up bringing potentially risky products to the United States, the world’s biggest and richest market. To minimize production costs and maximize profits, Big Pharma has ramped up the manufacture of drugs in far-flung factories, including in India and China.

But as a Kaiser Health News Service investigation reported in January:

“Plants making drugs for U.S. consumers are supposed to be inspected every few years, according to a risk-based system. However, in the past decade more than 2,500 facilities, both foreign and domestic, have gone more than five years without an FDA drug-quality inspection, a KHN analysis found. The FDA has no drug-quality inspection records over the past decade for more than 1,200 domestic plants and nearly 400 foreign plants, excluding those that make animal drug products, according to the analysis. [Former FDA Commissioner Scott] Gottlieb said in December that he hopes to clear the backlog of uninspected drug facilities … At best, the inspections are a snapshot in time, and involve looking at processes rather than evaluating the drugs themselves, said drug-quality specialist Dinesh Thakur, who has worked for drug makers. The inspections might take place while the facility is making only one of a dozen or so drugs that it usually manufactures … Many inspections, he said, are ‘stage-managed,’ so that factories pass on the appointed day, but ‘once the inspectors leave, it’s a completely different story.’ David Gortler, a former FDA medical officer, said most drug plant inspections involve looking over paper records and trusting that they’re real, instead of randomly testing medicines. ‘Anybody can write down anything on a piece of paper,’ said Gortler, who is now a consultant at FormerFDA.com. He added that FDA inspectors aren’t reprimanded — or even told — if they’ve passed a plant that issued a recall shortly thereafter.”

Nitrosamines, including NDMA, are “an environmental contaminant that is found in water and foods, including dairy products, vegetables, and grilled meats,” the Harvard Health blog reported. “Its classification as a probable carcinogen is based on studies in animals; studies in humans are very limited. It is important to know that the NDMA in ranitidine products does not pose any immediate health risks … Although classified as a probable carcinogen, NDMA may cause cancer only after exposure to high doses over a long period of time. NDMA is one of the same impurities that was found in certain heart medications beginning last year and that resulted in the recall of many products.”

The Kaiser news service reported that drug recalls have become all too distressingly common:

“Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, comprising billions of tablets, bottles and vials that have entered the U.S. drug supply and made their way to patients’ medicine cabinets, hospital supply closets and IV drips …The recalls represent a fraction of the medicines shipped each year. But the flawed products contained everything from dangerous bacteria or tiny glass particles to mold — or too much or too little of the drug’s active ingredient. Over the same period, 65 drug-making facilities recalled nearly 300 products within 12 months of passing [FDA]inspection … Those recalls included more than 39,000 bottles of the HIV drug Atripla laced with ‘red silicone rubber particulates,’ nearly 37,000 generic Abilify tablets that were ‘super potent,’ and nearly 12,000 boxes of generic Aleve (naproxen) that were actually ibuprofen …”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damages inflicted on them and their loved ones by dangerous drugs. With their skyrocketing cost, complexity, and uncertainty, prescription medications have become confounding and even bankrupting for too many Americans. We need politicians and federal regulators to stop cozying up to Big Pharma and Big Tobacco and to protect us from the staggering harms that bad drugs and FDA-regulated products can and have caused. We need robust inspection of drug factories, domestic and international. We need rigorous testing and oversight of prescription medications and inhaled products that produce nicotine or marijuana-like highs. It, of course, would be right and helpful for members of Congress to avoid Big Pharma entanglements, notably through sketchy investing that has led to the resignation and conviction of Chris Collins,  a Republican and U.S. representative from the Buffalo, N.Y., area.

Vaping-related lung cases and deaths keep rising

As occurred in the opioid and overdose crisis, revelations are emerging about how Washington bungled its handling of e-cigarettes and vaping. The Los Angeles Times reported that Obama Administration officials appear to have caved to an industry campaign to block planned moves to crack down on flavored vaping liquids, key components that would help to boost e-cigarette use and the uptake of a nasty habit with consequences with which the nation’s only beginning to cope. The newspaper, of course, fails to follow the timeline, in which Obama officials did secure potentially important oversight on e-cigarettes — measures that Scott Gottlieb, President Trump’s FDA commissioner, delayed. The tech whizzes of Juul waltzed through the regulatory opening, leading to the terrible harms occurring now.

It’s still hard to fathom the shock now that even experts express about the lung injuries linked to vaping. Who really thinks it’s cool to vape, a practice maybe akin to sucking on emissions from a vehicle’s tailpipe, pulling toxins on to vulnerable and sensitive breathing tissues, inflicting injuries akin to chemical burns? And why are some public health officials pushing still the notion that e-cigarettes and vaping need to exist as a less harmful alternative for grownups wanting to quit burning cigarettes? Let’s see any research that shows adults taking this option — the studies suggest e-cigarette mostly occurs among younger adults, who may also engage in “dual use,” vaping and smoking. Not good. Vaping among older adults? Very little.

The sprawling, complex opioids damages case keeps shrinking

With opioids, FDA officials already have admitted they failed to protect the public from addictive and powerful prescription painkillers that have played a big role in the more than 700,000  overdose deaths between 1999 and 2017, and have become a leading killer of adults younger than 55. Opioids also opened the door to synthetic painkillers like fentanyl that pack a deadly wallop and can be quickly and easily produced in illicit fashion in labs, many of them overseas in China. The painkillers have led to increased and deadly abuse of street and illegal drugs, including heroin, methamphetamine, and cocaine. A top watchdog for the U.S. Justice Department just has excoriated the federal Drug Enforcement Agency retrospectively for allowing Big Pharma to crank out even more opioids, even as the medications terrible toll escalated.

In a federal court in Ohio, meantime, lawyers representing states, counties, cities, Indian tribes, and others continue to wrangle with Big Pharma over legal responsibilities and remedies, particularly of the financial kind, for opioids’ toll. History will tell whether the consolidation of 2,500 or so official and government claims not only reaches a “global settlement,” but also whether it provides the justice, acknowledgement of wrongdoing, and the money that claimants say they should receive for opioids’ terrible toll. The sprawling litigation always threatened to be tough to manage, especially since the governments, in turn, represent the interests of thousands or even millions of constituents. The case, however, keeps turning and twisting, particularly as Big Pharma parties settle — or struggle to — aspects of claims. And the handful of defendants remaining now may rely on a defense that argues that action or inaction by other parties — including doctors, hospitals, insurers, but most importantly agencies like the FDA and DEA share as much blame as makers might for opioids’ harms.

Now that tactic may seem rich, sufficiently so that the only way to balance out Big Pharma mendacity might be — satire? Warning: As always, HBO comedian John Oliver can be loud and a bit vulgar. But he provides yet more pungent arguments about problems in the regulation of the drug industry, with his focus on persistent problems with specialty medication makers known as compounding pharmacies. Click on the video above with care in the workplace. And with distress at its advocacy.

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