FDA Rewards Johnson & Johnson’s Lies with Cancer Drug Approval

Earlier this month, the FDA granted accelerated approval to Johnson & Johnson’s new bladder cancer drug, even as the company deals with the fallout from asbestos-containing talc and surgical mesh.

The drug, Balversa, was approved based on a small study of just 87 patients and will cost up to $5,670 per week.

This is fortunate timing for Johnson & Johnson – and their investors – and presents an opportunity for billions in new revenue. But as the company faces thousands of lawsuits from customers who have been injured or killed by their products, it’s easy to wonder if Johnson & Johnson and their friends at the FDA are more interested in profit than cancer patients.

Let’s take a look at the darker side of Johnson & Johnson, the people who have been hurt by their lies, and the truth behind their new cancer treatment.

Johnson & Johnson Puts Profits Over Safety | A History of Deceit

Talc and Cancer

A few months ago, we covered a story about how Johnson & Johnson knew that their products contained asbestos and lied about it. Popular products like Johnson’s Baby Powder and Shower to Shower were causing mesothelioma and ovarian cancer in consumers, but company executives hid the information.

As people continued to die, court documents revealed that the company knew that there was asbestos in their talc for decades but never made an effort to disclose it to the public.

They were even successful in a campaign to influence regulators who planned to evaluate asbestos in talc products. Reports submitted to the FDA intentionally omitted results showing that their products cause cancer.

In the past several months, the company has paid billions of dollars in damages and settlements, while fiercely defending the lie that their talc products are safe.

But this isn’t the only instance of Johnson & Johnson continuing to turn a profit while their customers suffer injury or death…

Fraud, Bribes, and Risperdal

This “health and wellness” company owns a pharmaceutical subsidiary called Janssen Pharmaceutica, who makes a vast number of drugs under the Johnson & Johnson umbrella. Back in 2004, the U.S. Department of Justice began investigating claims that their schizophrenia drug Risperdal was being illegally marketed. They’ve since lost billions in court cases determining that they knowingly lied to patients, putting them in harm’s way.

Whistleblowers within the company also exposed that Johnson & Johnson and Janssen paid tens of millions of dollars to bribe pharmacists at Omnicare, the nation’s biggest supplier of drugs to elderly care facilities. The drug has also been the subject of lawsuits alleging that the company intentionally withheld information about serious side effects, resulting in hundreds of millions in additional penalties and settlements.

In one of the company’s biggest single losses, an Arkansas Circuit Court Judge ordered them to pay a fine of over $1,200,000,000.00 for lying to consumers and defrauding Medicaid. Dustin McDaniels, the Arkansas Attorney General at the time, approved of the steep fines:

These two companies put profits before people, and they are rightfully being held responsible for their actions.”

And the lies and fraud came from the very top. The Department of Justice found that the president and head of sales for Janssen, Alex Gorsky, was “actively involved” in the deception. Gorsky is now the Chairman and CEO for Johnson & Johnson.

Surgical Mesh Becomes Commercial Mess

In case you needed more evidence that Johnson & Johnson is an evil corporate entity who will do anything for money, consider what’s been happening with their surgical mesh. About a week ago, the FDA prohibited all sales of surgical mesh – an extremely rare exercise of power for the regulatory body.

This decision stems from years of ongoing legal battles about the safety of surgical mesh used to repair pelvic organ prolapse. According to the New York Times:

Litigation over pelvic mesh, also called transvaginal mesh, ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars. Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, are paying nearly $8 billion to resolve the claims of more than 100,000 women.”

And while Johnson & Johnson and others voluntarily stopped selling the product just before the FDA’s ban, the damage has already been done. As of last year, the FDA had learned of over 10,000 serious complications and almost 80 fatalities from the product. Pelvic mesh is an industry worth hundreds of millions of dollars in the U.S. alone.

It’s All About the Money

A Wolf in Sheep’s Clothing

So, we know that Johnson & Johnson has a history of lies and deception, and that they will literally let people die to protect their profits. But before we go any further, it’s important that you understand exactly what this company really is.

You know Johnson & Johnson. You trust them. You, your children, and your children’s children have grown up with them. They own some of the most recognizable brands in health and wellness. You don’t ask for an adhesive bandage, you ask for a Band-Aid. No one says acetaminophen, they ask for Tylenol. In fact, it’s likely that every person reading this has Johnson & Johnson products in their home right now.

Here are just a few of their brands:

• Band-Aid
• Motrin
• Tylenol
• Benadryl
• Listerine
• Aveeno
• Acuvue
• Clean & Clear
• Neutrogena
• Rogaine
• Lubriderm
• Imodium
• Bengay
• Pepcid
• Rolaids
• Splenda
• Mylanta

And while these brands are in many ways the face of the company, they’re actually a small fraction of its identity. In fact, consumer products make up less than 10% of Johnson & Johnson’s annual profit. The other 91% comes from medical devices and prescription drugs.

Since going public in 1944, Johnson & Johnson has become one of the largest corporations in America, with its stock forming a component of the Dow Jones. But as the company has faced one defeat after another, its value has suffered. Before a jury uncovered the truth about their talc products causing cancer, the company was worth about $393 billion. After the verdict was read and the articles written, they had lost nearly $53 billion of that valuation, or 13.5% of their total market capitalization.

Since December, the stock price as made a slow return, but faces continual setbacks with each new verdict and settlement. It seems convenient, then, that the FDA would expedite approval for a new cancer drug just when this company needs a win the most.

Money, Cancer, and More Money

Here’s the press release from Janssen and Johnson & Johnson:

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that BALVERSA™ (erdafitinib) received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. BALVERSA is the first FGFR kinase inhibitor approved by the FDA.”

The drug is still in an experimental phase and comes with plenty of known side effects already. It is also only for patients whose cancer has progressed during or after chemotherapy, which means their immune systems will be weakened. Nevertheless, the new drug will come with a hefty price tag and can generate over $1 billion for Johnson & Johnson each year.

Since news of the approval, the company’s value has increased by $14.5 billion. This is no small number and a major win for executives, investors, and anyone else who profits from Johnson & Johnson’s success. That might explain why the FDA so quickly granted approval for an experimental drug to a company with a history of fraud, deceit, and bribery. A company which is currently facing countless lawsuits from people who have been injured or killed because of its lies. A company run by a man who has been directly involved in these scandals and continued to grow richer.

The FDA’s Financial Ties to Big Pharma

At risk of sounding like a broken record, I will say this again: The FDA is a corrupt agency that is paid by the pharmaceutical industry. It is a virtual revolving door for those protecting corporate interests. We’ve talked about how executives from Monsanto were able to literally conduct their own research through the FDA regarding GMOs, or how Merck was able to use its influence to bury information proving the MMR vaccine to be dangerous.

Johnson & Johnson is no different.

And it’s hard to blame them; nearly every pharmaceutical company exercises influence over regulators at the FDA. You see, when a new therapy is up for FDA approval, advisory committees are formed to review the new drug and vote on whether or not it should be approved. The FDA always follows these recommendations.

But a look into the financials of these committee members paints a more sinister picture. Physicians who sit on these advisory boards nearly always end up taking money from the companies relying on their votes. These bribes are not well-masked, showing up as consulting fees, travel compensation, or research grants.

According to sciencemag.org, “An analysis of pharma payments to 107 physicians who advised FDA on 28 drugs approved from 2008 to 2014 found that a majority later got money for travel or consulting, or received research subsidies from the makers of the drugs on which they voted or from competing firms.”

Doctors expect gifts from Big Pharma the way waiters expect tips from their guests. It’s not required, but it’s expected. And it makes a significant difference in their income.

And while physicians with financial ties to pharmaceutical companies are generally not permitted to serve on the committees, analysis shows that the majority receive gifts after voting in the companies’ favor. Johnson & Johnson has given millions to these committee members in return for favorable votes, and Balversa will likely be no different.

After approving Xarelto, a prescription blood thinner manufactured by Johnson & Johnson, several FDA advisors received gifts from the pharmaceutical industry. In all, Johnson & Johnson paid almost $200,000 to advisors who approved the drug.

To advisors approving the antipsychotic Adasuve, Johnson & Johnson paid over $500,000.

Robert Harrington, who voted to approve a new blood pressure medication, received $426,289 from the pharmaceutical industry after his vote. Johnson & Johnson contributed $252,480.

Until we fix the system, companies like Johnson & Johnson will continue to lie. They’ll continue to profit. And people will continue to die. It is imperative that we get money out of the equation when it comes to corporate entities and their regulatory bodies. As long as the FDA can be bought, our food and medicine will continue to be unsafe. There is just too much money for these corporate giants to go down without a fight.

Johnson & Johnson will tell you that their new drug is a miracle for patients with bladder cancer. The only miracle here is that the company’s executives aren’t in prison.