Actemra: Can This Arthritis Drug Hurt You?

Clay Hodges — Tue, 27 Feb 2018 16:36:45 GMT

You go to the doctor to get help, not to be hurt. And you take medicine to be healed, not to be harmed. However, some prescription drugs, like Actemra, may do the latter – hurt you instead of help you.

If you or a loved one have rheumatoid arthritis, you may have been prescribed or heard of Actemra. Rheumatoid arthritis (RA) is an autoimmune disorder that causes the joints to swell and become painful. Actemra, also known as tocilizumab, is a prescription drug that is injected weekly or infused monthly to aid patients with their symptoms and slow the progression of RA.

Recently, Actemra has also been prescribed to “help” those with giant cell arteritis. Giant cell arteritis (GCA) is a blood vessel disease that causes the vessels, primarily those in the scalp and head, to swell and become inflamed.

Actemra is believed to work by blocking the protein that causes inflammation. However, the prescription medication is doing a lot more than blocking the protein that plays a part in RA and GCA: it is causing serious side effects.

Drug maker Genentech lists side effects as serious infections, stomach tears, changes in blood test results, increased risk of cancer, Hepatitis B infection, serious allergic reactions, nervous system problems, upper respiratory tract infections, headache, increased blood pressure, and injection site reactions.

All these side effects, and others that Genentech does not disclose, have generated over 13,500 adverse event reports regarding Actemra – this means that there have been over 13,500 occurrences of negative side effects reported to the FDA. Worse, over 1,100 people have died while taking Actemra.

While these numbers and these side effects are scary, they are not new. Before Actemra was released to the general public in 2010, five clinical trials were performed. During these clinical trials, over 70% of patients experienced negative side effects. Nine of these patients actually died during the clinical testing; other negative side effects were stroke, pancreatitis, lung disease, stomach tears, and heart attack.

So, if this drug is potentially bad for you, why is it still on the market? Unfortunately, Actemra received FDA-approval and Genentech was allowed to list only a few of its side effects on the prescription label, in exchange for continuing to test for negative side effects, specifically cardiac issues in patients. Additionally, the studies that reported the adverse events and the death toll are not able to definitively say whether Actemra was the actual or sole cause of death. By limiting what information it shares with patients and doctors, Genentech markets the drug as help for those with RA, GCA, and other arthritic issues, not as the potential harm it may be to patients.

People with rheumatoid arthritis are not receiving all the information they deserve. The maker of Actemra is telling us what it wants patients to hear and withholding important, potentially life-threatening information from the public. By not knowing what all the side effects of Actemra may be, patients are at risk to experience these undisclosed side effects such as stroke, pancreatitis, lung disease, stomach tears, and heart attack.

Not knowing all the potential risks and side effects associated with any prescription drug can be dangerous. Before taking any prescription medicine, including Actemra, be sure to talk to your doctor. If you or a loved one have already been harmed by Actemra, talk to me.

This post was produced through review of online new sources, clinical trial studies, and the FDA website.

Tarceva Whistleblower Lawsuit Costs Genentech $67 Million Settlement

Clay Hodges — Fri, 08 Jul 2016 15:00:12 GMT

You see ads for them all the time. Supplements, creams and pills that will help you lose weight, clear up your skin, improve your sex life or maybe do all of these things at the same time. Whether they’re in late night cable TV infomercials or spam email, you might think this kind of medical scam is perpetrated by small time operators making a fast buck. But scams can also be done by multi-billion dollar pharmaceutical companies (but in much more sophisticated ways), sometimes with potentially deadly results.

California based Genentech and its marketing partner OSI Pharmaceuticals will pay $67 million to settle claims that they misled doctors into prescribing a drug to lung cancer patients that the defendants knew would not work. Due to this highly corporate hucksterism some of these patients may have precious time robbed from them, dying earlier than they would have if they had taken more effective drugs. These allegations are in the settled lawsuit filed by a former Genentech employee. Federal prosecutors joined the lawsuit, reports the Los Angeles Times.

more Company Accused of Taking Advantage of Dying Patients

How defendants marketed the drug Tarceva was the focus of the lawsuit. Lung cancer is often a fatal disease. If not diagnosed and treated quickly enough the disease can spread and be more difficult to treat.

Providing lung cancer patients ineffective treatment essentially doesn’t slow the clock down for patients like an effective treatment might. Instead of slowing the disease down and giving a cancer patient more time, the disease marches forward.

The legal action claims that from 2006 to 2011 Genentech and the company’s marketing partner OSI Pharmaceuticals promoted Tarceva as an initial treatment for all patients with non-small-cell lung cancer. This despite the fact studies had shown it only worked for those who had never smoked or had a gene mutation known as EGFR.

Genentech Sales Rep Brings Whistleblower Action

In 2011 Brian Shields, a former Tarceva sales representative and product manager, filed the whistleblower lawsuit claiming violations of the False Claims Act. This federal law allows individuals to file lawsuits as a stand-in for the federal government in claims that a defendant defrauded the federal government. In cases such as these the allegations would be that the defendant sold the government (through Medicare, Medicaid, VA hospitals) a pharmaceutical under false pretenses, claiming it would work while knowing it would not.

The companies claim they’re settling the case to avoid costly litigation and they stand by their promotional communications and practices.

Money, Meals, Bad Advice, and False Hopes

The lawsuit claims,

The defendants published promotional materials that discouraged doctors from testing patients for EGFR.
The companies promoted Tarceva by paying doctors illegal kickbacks disguised as fees for making speeches or serving on Genentech’s advisory boards.
Sales representatives were “instructed to spend lavishly” on physicians and given “an unlimited budget to wine and dine.”
Defendants organized lunches or dinners for lung cancer patients featuring “patient ambassadors” who were paid to talk about how Tarceva could be used in ways never approved by federal regulators.

The Takeaway

Cancer treatment is serious business. And serious business. Medicine has come a long way over the past few decades. More effective drugs are one reason why more cancer patients are being cured and for those who are not cured they’re living longer. Those drugs are made and sold by pharmaceutical companies. But with an estimated 1.7 million new cancer diagnoses this year there’s no reason for companies to stoop to fraud to generate sales. There will be about 224,390 new cases of lung cancer this year, according to the American Cancer Society, and most of them will be non-small cell lung cancer.

There will be plenty of customers for cancer drugs and lots of money spent on them (with an estimated $100 billion spent on cancer drugs in 2014, according to NBC News). It is tragic to steal money with ineffective drugs, especially when time is also stolen from cancer patients.

As always, be careful and beware.

genentech - Hodges Law, PLLC

Actemra: Can This Arthritis Drug Hurt You?

Tarceva Whistleblower Lawsuit Costs Genentech $67 Million Settlement