Zantac warnings offered early hint of big problems with Big Pharma practices

zantac-300x169Big Pharma’s slavish devotion to maximizing profits and “enhancing shareholder value” has led industry executives to shove the manufacture of their products to far-flung shores. The dubious consequences of these moves have become clear not only with common, over-the-counter medications but also — with potentially tragic results — with drugs needed in the war on the Covid-19 pandemic.

Even before the world was terrorized by the coronavirus outbreak in China, safety advocates warned about serious “supply chain” issues in drug making, with one small lab sounding alarms about Zantac, a widely used over-the-counter heartburn pill.

Valisure, a commercial pharmacy that sought to distinguish itself by testing and assuring consumers of the quality of the drugs it sold, provided the federal Food and Drug Administration its lab tests and analyses as evidence that Zantac (aka ranitidine) was contaminated with, what the New York Times has described as, “a type of nitrosamine called N-nitrosodimethylamine, or NDMA, which is believed to be carcinogenic in humans and is found in a variety of products, including cured meats.”

The FDA and the drug’s U.S. maker Sanofi initially downplayed the claim and sought to minimize Valisure’s findings. But the federal regulator slowly changed its view, leading Sanofi to order a recall, telling consumers and vendors to stop using supplies and destroy them.

The FDA has gone a step further now, as the New York Times reported:

“The agency also recommended that consumers who use over-the-counter forms of the drug, also known as ranitidine, stop taking it and that they should dispose of any tablets or liquid that they have. People who take prescription forms of the drug should speak with their doctors about other options before stopping treatment. Most manufacturers withdrew their products from the market several months ago, after an outside pharmacy raised the alarm about the drug last year. Large pharmacy chains, including Walgreens, Rite Aid and CVS, had also removed all of the products from their shelves.”

This next-level action is worth more than casual noting, especially going back to November and the Washington Post’s reporting then on Zantac and Valisure:

“For Valisure’s scientists, finding NDMA in ranitidine was a particularly dramatic example of the kind of discovery they make routinely. Valisure checks the chemical makeup of drugs before it ships them to consumers, and it rejects more than 10% of the batches because its tests detect contaminants, medicine that didn’t dissolve properly or pills that contain the wrong dose, among other issues. Since late 2018, Valisure has reported more than 50 problems directly to drug companies. Occasionally — as in the case of Zantac — their scientists find a problem so urgent they play the role of watchdog. ‘I had a fairly dim view of drug quality in the United States going into this, but we’ve discovered tons of problems I never even thought of — and they’re all over the place,’ said Adam ¬Clark-Joseph, one of Valisure’s founders.”

The newspaper article goes on, noting this and quoting experts including Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research:

“Much of the concern over the quality and safety of the drug supply has been propelled by a massive movement of drug production to foreign factories in recent years, ‘driven by the pharmaceutical industry’s desire for cost savings and less stringent environmental regulations,’ Woodcock said in testimony submitted to Congress in October. The FDA rigorously evaluates drugs for effectiveness and safety before approval, including visits by inspectors, who review records to ensure compliance with requirements — including that companies test batches of medicine before distributing them [experts said. But] a 2016 Government Accountability Office report found that almost a third of 3,000 foreign drug establishments licensed by the FDA may not have been inspected, although the FDA said it has now caught up on the backlog.”

With the coronavirus ripping through China, and with India on a sudden, nationwide lockdown, the FDA announced that it has suspended its already much-criticized overseas inspections of drug- and medical device-making sites.

The Trump Administration also has found itself needing to negotiate hard with China and India to ensure that vital supplies of drugs and medical products, including desperately needed personal protective equipment like masks, gowns, and gloves for medical personnel, keep flowing. The talks with Beijing have been especially freighted due to Trump’s tariff battles with the Chinese and his insistence until recently in calling Covid-19 the “China virus” or referring to the Wuhan sickness.

Still, with Big Pharma and medical device makers having offshored so much of their work, the United States finds itself in a less than optimal position regarding crucial supplies. Indeed, as the New York Times reported:

“Across the country, as hospitals confront a harrowing surge in coronavirus cases, they are also beginning to report shortages of critical medications — especially those desperately needed to ease the disease’s assault on patients’ respiratory systems. The most commonly reported shortages include drugs that are used to keep patients’ airways open, antibiotics, antivirals and sedatives. They are all part of a standard cocktail of medications that help patients on mechanical ventilators, control secondary lung infections, reduce fevers, manage pain and resuscitate those who go into cardiac arrest. Demand for these drugs significantly increased in March as the pandemic took hold in the United States. Orders for antibiotics like azithromycin and antiviral medicines like ribavirin nearly tripled. Medicines used for sedation and pain management, including fentanyl, midazolam and propofol, increased by 100%, 70% and 60% respectively. Demand for albuterol, a common asthma inhaler medication, has also risen significantly, given its importance in easing the breathing of patients with severe infection.”

The newspaper also quoted Stephen Schondelmeyer, a University of Minnesota College of Pharmacy professor and co-leader of the Resilient Drug Supply Project, which aims to provide a detailed map of the supply chain for important drugs used in the United States:

“Out of 21 antibiotics that would be critical for treating secondary infections in Covid-19 patients, 18 antibiotics have greater than 80% of their supply coming out of either China, India or Italy — all places that have had production disruptions.”

This is not good. 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. For some time now, Big Pharma and medical device makers have cried “Poor us,” and lobbied Congress and the White House to loosen federal oversight of their products, purportedly to speed innovative therapies to patients who would benefit from them.

But no matter how expedited the process has become, with stretching of the use of randomized clinical trials and allowing prescription medications into markets based on dubious reasoning (that they, for example, shrink tumors — without considering if that contributes to patients’ well-being or survival), drug- and device-makers have pushed for fewer and fewer checks and safeguards, even while sending manufacturing overseas.

Will voters remember that one reason that front-line medical personnel lack protective gowns while treating Covid-19 patients can be traced not only to a big makers’ decision to manufacture the products in China — and that lax inspections and improper sterilizing forced a recall of 9 million pieces of this now desperately needed gear just before the pandemic struck?

If anything, Big Pharma is getting an unhelpful boost by, among other things, unfounded claims for the use of various drugs in the treatment of Covid-19, with assertions about exigent circumstances and the need for “why not?” dire care. Medical experts have tried to maintain hard-fought boundaries for treating the desperately ill.

Still, to see the industry’s willingness to shove hard at reasonable oversight, just look at the Op-Ed Pages of the Wall Street Journalism, unbridled capitalism’s favorite chat corner. There, a pair of free-market advocates, citing the pandemic, argued that the nation’s drug standards are too tough — that once prescription drugs are deemed safe, that’s enough. They do not need to show, too, that they are effective.

The more drugs the merrier, maybe they can find usefulness somehow at some time, right? Is this a familiar refrain, painfully so, as in cancer care, a situation described recently by a science writer for Scientific American online:

“Pharmaceutical companies keep bringing new drugs to market. But one study found that 72 new anticancer drugs approved by the FDA between 2004 and 2014 prolonged survival for an average of 2.1 months. A 2017 report concluded that ‘most cancer drug approvals have not been shown to, or do not, improve clinically relevant end points,’ including survival and quality of life. The authors worried that ‘the FDA may be approving many costly, toxic drugs that do not improve overall survival.’ Costs of cancer treatments have vastly outpaced inflation, and new drugs are estimated to cost on average more than $100,000/year. Patients end up bearing a significant proportion of costs. More than 40% of people diagnosed with cancer lose their life savings within 2 years, according to one estimate.”

Here’s hoping that all who read this blog stay safe at home, that they stay healthy, and we all see Covid-19’s worst ebb soon. When the world returns to greater normalcy, we have much work to do to ensure that America’s supplies of drugs and medical devices stay as safe, secure, and reliable as possible, and that we never find ourselves at the mercy of shaky supply chains, sketchy makers, and industry profit-making ahead of patients’ well-being.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information