It is not uncommon for a pharmaceutical company to create a drug with side effects far out-weighing the potential benefits. After a number of patients get hurt, the company gets sued and is forced to pay damages (while still pocketing a large sum of money) and to remove the product from the market. Some cases do more damage than the others.
The arthritis, anti-inflammatory drug Vioxx by Merck was one of the cases that shook the medical field, raising a lot of questions about drug safety, exposing drug makers’ lies, and highlighting the FDA’s failure to protect consumers.
Before Vioxx got pulled from the market in 2004, it wreaked havoc on the health of many and killed an estimated 38,000 people.
Some sources say that the numbers are much higher and up to 140,000 people experienced heart attacks, and as many as 44% of them died.
And now, 14 years later, a different company is trying to bring this risky drug back on the market. While some support this move, others are concerned that history may repeat itself.
Vioxx’s Bad History: A Case of Heart Attacks and Merck’s Lies
Vioxx was approved by the FDA in May 1999 after Merck presented nine studies with 5,400 subjects to showcase its medical usage a year prior. From first glance the drug seemed promising to this community with fewer side effects than its competitor drugs (though gastrointestinal bleeding sometimes still happened).
What the health panel discussing the drug did not foresee is that this pharmaceutical came with another side effect, and this one killed patients. It was soon evident that Vioxx may cause serious heart problems leading to deaths. This was first discovered in November 1999, just six months after the drug’s approval.
What happened next was years of Merck purposefully trying to buy more time. They promised to study cardiovascular problems concerning the drug, but the results were not submitted until a year after. The submitted information only discussing about 17 out of 20 cases of heart attacks that they said they had available. Moreover, Merck failed to disclose other adverse cardiovascular events that they knew about.
The New England Journal of Medicine stated that the “inaccuracies and deletions” in the papers Merck submitted “call into question the integrity of the data.”
Merck finally removed Vioxx from the market after numerous independent studies came out between 2002 and 2004 outlining the cardiovascular issues. Yet, the drug was removed too late. Between 1999 and 2004, about 20 million people have were prescribed this pharmaceutical.
During these years, it caused an estimated 88,000 heart attacks and 38,000 deaths. Research shows that people who have taken the drug remain having risks of heart problems long after they stop taking it.
“A heart attack in exchange for an ulcer is poor treatment,” said Dr. Wayne Ray, who was working with lawyer to sue Merck.
Merck later faced 13,000 lawsuits and paid $3.85 billion in damages, yet the pharmaceutical company never admitted fault.
The drug caused so much damage that its successor Arcoxia was rejected from the market by an almost unanimous vote, 20-1 against the drug’s approval.
“What you’re talking about is a potential public health disaster. We could have a replay of what we had with rofecoxib (Vioxx),” said FDA scientist Dr. David Graham.
Remembering Vioxx as such a disaster, why risk getting it re-approved?
Why Bring Vioxx Back?
If past history is any indication, Vioxx is a highly risky drug in any shape or form to say the least. Besides heart issues, it has been associated with:
- abdominal pain
- back pain
- digestion issues
- flu-like symptoms
- high blood pressure
- sinus infection
- swelling of lower extremities
- upper respiratory infection
- urinary tract infection
Despite all of these risks, a startup company called Tremeau Pharmaceuticals is working on bringing Vioxx back. Their reasoning is that it may be beneficial for patients of hemophilia, a bleeding disorder that cause severe pain and has few treatment options.
However, here is what Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, had to say about Vioxx and similar drugs and their risky potential uses:
“It is time to shut the door on further additions to this dangerous class of…drugs. The idea that there may be certain patients, however unidentifiable they are, who might benefit from this drug is just not good enough as a basis for its approval. In addition, further trials on these…drugs are unethical and should be stopped.”
While patients not seeing other options may choose to rely on this risky drug, another issue with Vioxx’s re-approval is that doctors may then prescribe it for off-label uses, even if the company itself will not be legally able to advertise it for these uses.
Off-label prescription is common in the medical field, and with these drug in particular, it is no wonder that many are concerned for patients’ safety.
Vioxx Sales Representative’s Brutal Opinion of the Drug
In 2009, a Merck representative blew the whistle about the drug and the system:
“Selling drugs is a lie. … I sold Vioxx for Merck before it got taken off the market for killing people. I knew damn well it was dangerous; I went around telling them to write it,” said Corinne Kaplan, a former Vioxx sales rep said.
Kaplan who also appeared on a reality show Survivor did not censor her feelings toward the drug:
“I’m doing a job. For me, in that case, Merck told me to go out and sell the drug even though I had hesitation about it. It’s not for me to say. … Don’t listen to me. Read your journals. Why are you listening to your rep? Just because I’m pretty? You think I know more about the drug? No.” [This quote was edited to remove profanity.]
If drug representatives know it is dangerous, what hope is there for the drug to not kill more people if it is approved again?
Many patents, doctors, and researchers conclude that the hope is minuscule.