Merck Vioxx News and Press Releases

March 01, 2005 - Bangor Daily News - Before its manufacturer's pants get sued off we ought to thank the painkiller Vioxx for showing us that the process of ensuring the safety of our prescription drugs is an emperor with less clothing than a Victoria's Secret lingerie model. With any luck, however, that will change. When the lawyers are done suing, the politicians are done pontificating, and the patients are done suffering, the process for ensuring prescription drug safety will hopefully have undergone an "extreme makeover."

Until then, we are stuck with the current system of high-pressure production of mass-marketed blockbuster drugs and little post-marketing surveillance for side effects, a system in which Vioxx was a predictable disaster just waiting to happen. Here is why.

First, our pharmaceutical companies are progressively dependent for their profits on the manufacture and sales of hot drugs such as Vioxx ($2.5 billion in annual sales for Merck) and similar drugs Celebrex and Bextra (combined $4.8 billion in annual sales for Pfizer). The companies are under tremendous pressure, primarily from stockholders, to make big profits, they have fewer drugs likely to make big profits in their research and development pipelines than in the past, and drugs such as Vioxx are corporate lifesavers. Vioxx sales alone accounted for 20 percent of Merck Pharmaceutical's profits in 2003.

This reliance on a few blockbuster drugs means patient safety jockeys with corporate profits as the manufacturers' first priority in decisions about drug marketing. If Merck had highlighted a significant safety issue with Vioxx early on, the drug would have lost the main reason for its success over rivals, that being its lower risk of stomach bleeding as a side effect. Its side effects and its withdrawal from the market in September 2004 will cost Merck an estimated $14 billion in lawsuits and lost sales, and the company lost $28 billion in stock value when investors heard the bad news about Vioxx, according to a recent article in the New England Journal of Medicine (NEJM). Safety problems with a drug such as

Vioxx can shake a drug company to its financial core.

That is not to suggest when the safety issue is clear drug companies will not act appropriately. Rather, it is to suggest that unless forced to do so they may hesitate to pull a drug from the market, or broadcast side effects and thereby cause doctors to prescribe the competition. It is to suggest drug companies will struggle when having to decide between erring on the side of patient safety vs. erring on the side of prescription sales. It is to explain why, according to The Wall Street Journal and The New York Times, it is alleged that Merck may have trained its sales force to avoid directly answering questions from physicians about the increased risk of heart attack in Vioxx users.

Merck had indications of potential problems with Vioxx several years ago but vigorously resisted efforts by others to warn doctors and patients, according to articles in the The Journal and The Times. The same thing may have happened with other drugs ultimately withdrawn from the market by other manufacturers, as documented in a recent NEJM series of articles about Bayer's cholesterol-lowering drug Cervistatin. Last year the attorney general of New York had to take legal action to force another drug manufacturer to reveal information about the potential increase in suicide risk for depressed teenagers taking its antidepressant drug.

On the other end of the pipeline to the consumer is one more huge problem in the safety system; there is no formal system to look for unanticipated medication side effects once a drug is on the U.S. market. In fact, I think my dog tracks Dunkin' Munchkins coming into the house better than we track prescription drug side effects in this country. Currently, drug companies don't have to go looking for side effects; they just have to wait to hear about them. Nor does the Food and Drug Administration systematically look for side effects once a drug is on the market.

The post-marketing side effect surveillance "system" that does exist relies on doctors and patients to identify side effects and voluntarily report them to - guess who? - the manufacturer of the drug. The manufacturer is then supposed to report the side effects to the FDA, which in turn makes recommendations about the drug's marketing, use, the need for new studies of safety, or even market withdrawal, in order to ensure our safety.

That means a company is spending millions on marketing a new drug at the same time it is supposed to be looking vigilantly for unanticipated side effects, putting it in the difficult position of looking for the bad news side effect needle nobody wants to find in the middle of the new drug marketing "hypestack." Prompted by the Vioxx mess, however, the FDA has recently proposed some improvements in post-marketing surveillance for side effects.

With billions of dollars on the line and competitors nipping at your heels, now imagine you are Merck. You are accumulating side effect reports and now must decide if the growing noise about a problem with Vioxx is enough to make you shoot a huge hole in your company's financial bottom line by reporting the side effects to the FDA and telling doctors Vioxx has a big safety problem.

The match to the gas of this combustible mix of companies financially dependent on the success of big drugs and a poor process for collecting side effect data is how prescription drugs are now marketed in the United States, and especially how they are marketed directly to the consumer.

For a drug such as Vioxx, millions of dollars in marketing to doctors and patients means that within a few years of the drug's entry into the market, millions of patients may be taking it without the benefit of systematic monitoring for side effects. The huge volume of users never used to happen so fast; a drug took much longer to hit the big time and reach millions of patients. Within a few years of it coming on the market, 20 million people were taking Vioxx. Another 30 million were taking its competitors, Celebrex and Bextra (both of which may have some of the same side effect problems as Vioxx, according to recent studies).

A weak system of side effect monitoring and an explosion in numbers of patients taking a medication means an unanticipated side effect can harm thousands before the skimpy safety system identifies the problem, the manufacturer reports it, and the FDA takes action. One FDA scientist has estimated that Vioxx caused 27,000 deaths and heart attacks before it was eventually pulled from the market.

If there is to be any consolation for the thousands harmed by Vioxx it is this; the system will be changed as a result of the Vioxx train wreck. We are likely to see changes in how drugs are marketed, how their pre-market safety record is reviewed, how their post-marketing safety is monitored, and how the FDA works.

The result should be a smaller number of American lives lost each year due to side effects of all prescription drugs, a number currently in the thousands. While that makes Vioxx a good medicine for what has ailed our prescription drug safety system, for those who took it or prescribed it Vioxx was a very bitter pill to swallow. I will never prescribe it again, no matter what Merck and the FDA say about its safety.

Upcoming columns:

Part 2 (March 15): The FDA - what it needs to change to protect us

Part 3 (March 29): The patient - what we need to change to protect ourselves

Erik Steele, D.O., a physician in Bangor, is chief medical officer of Eastern Maine Healthcare Systems and is on the staff of several hospital emergency rooms in the region.

The FDA - time for shark in the water

This is the second in a three-part series about the safety of our prescription drugs.

March 15, 2005 - Bangor Daily News - In the American land of make believe a father and son walking the beach came upon a fish flopping in the sand. "Look, Lester," said the dad, "it's the U.S. Food and Drug Administration, left here high and dry by the tide of our confidence in it receding after the Vioxx storm."

"Can we save it, Dad? Can we?" asked the boy hopefully.

"Gee, I don't know, son," said the dad, eyeing the pounding seas of prescription drug production and sales in the United States. "As an agency the FDA right now looks like a flounder and I am not sure it is going to be able to make it out there swimming with the big fish."

"Come on, Dad! Let's fix it up, you and me, right here, with my magical kit for fixing what ails us. You know, the one that made it OK there were no weapons of mass destruction in Iraq."

"OK, OK, Les. Well, if we are going to do this let's start by adding some teeth to this FDA guppy. You probably did not know this, but only during the prescription drug approval process can the FDA require the pharmaceutical companies to conduct side effect safety studies after the drug hits the market. Once a prescription drug is out on the market the FDA cannot go back and then require pharmaceutical companies to conduct studies for side effects, even if the FDA hears about some unanticipated side effects.

"Amazing, huh? And, during the approval process pharmaceutical companies often agree to do post-market safety studies and then don't follow through once the drug is on the drug is past the FDA approval hurdle and on the market. In fact, fewer than half of the post-market safety studies required by the FDA during drug approval processes have actually been done. So let's put some big teeth in this fish and give the FDA the authority to require drug companies to do new safety studies whenever the FDA sees the need, and the ability to fine companies that fail to do them."

"Cool, Dad, but I figure a big mouth with big teeth is not enough. If the FDA cannot see side effects very well there is not a lot of point to having the teeth to clamp down on pharmaceutical companies whose drugs are causing them. Right? So despite the fact that the number of prescriptions written in the United States has almost doubled to 3.7 billion in the last ten years, and 40 percent of Americans take at least one prescription drug, the FDA itself does not even really monitor us for drug side effects.

"It requires the drug companies to do that - can you believe it? That's like you letting me make sure I take out the trash, which would be way cool, now that I think about it. The FDA has got to have big eyes, Dad, so let's make the FDA do the side effect monitoring, and have the FDA analyze side effect patterns to see if there are problems, instead of the drug companies, don't you think?"

"What a concept, Lester! I wonder why the FDA commissioner and the U.S. Congress did not think of that? But if you don't want an agency that is just big eyes over big teeth, then you need to give it some muscle and power, and that means money. Currently, almost 80 percent of the FDA budget is spent on the drug approval process. Despite more of us taking medicines and prescription drug side effects hospitalizing 1.6 million Americans each year, the money to monitor drug safety after drugs go on the market has been cut significantly at the FDA. So the FDA needs more money - think of that as more muscle - to monitor prescription drug safety after drugs are approved.

We should add a 10-cent-per-prescription tax to the sale of medications in the United States. Now, Americans hate new taxes like a snowball hates hell, but that little tax would raise about $370 million for the FDA to beef itself up and better protect us. With that additional money the FDA could systematically hunt for side effects (currently most go unreported), conduct drug safety studies, make sure doctors know about new side effects when those are discovered, better monitor misleading drug advertisements, and a lot more."

"That's a boss idea, Dad. With big eyes to look for side effects, big teeth to put the bite on when it needs to, and muscle to play with the big boys, this baby will be a fish and a half.

But there's still a problem - this fish stinks a lot, I mean, like my favorite socks after a day in my boots."

"Well, kiddo, of course it does. That's because this FDA fish has gotten a little gamey. Did you know that about half of the drug experts the FDA uses to help it study drug safety and effectiveness have financial ties to the pharmaceutical companies? In the recent Vioxx mess, the FDA convened a special panel to review the safety of Vioxx and similar drugs, and 10 of the 32 panel members had some kind of financial tie to the companies that make these drugs. And guess what, those experts with the ties almost all voted to keep the drugs on the market. Even Vioxx!"

"Oh, P-U, Dad," exclaimed Lester, holding his nose. "That stinks worse then my socks even if I wear them two days in a row. I guess if the FDA is to smell less fishy, it has to stop relying on experts with ties to the pharmaceutical companies, huh?"

"That does seem kind of obvious to anyone with a nose, doesn't it, son? The FDA will have to pay for that kind of help, but that is why a better FDA needs more money for our safety."

"Dad, now I'm kinda bored of rehabilitating federal agencies. Can we put the new FDA back in the water and then go home?"

"You bet, ace. By the way, did you notice that with big teeth, forward-looking eyes, plus lots of muscle and power, that former FDA flounder now looks a lot like a big, tough shark? But I guess if you are going to swim with pharmaceutical companies - some of the most powerful companies in America - and protect the 100 million-plus Americans taking prescription drugs, you probably need to be a shark, and not a flounder."

"Ah, Dad ..."

"Yes, Les?

"Duhhhh!"

Next column (March 29): How to be your own FDA and protect yourself from prescription drug side effects.

Erik Steele, D.O., a physician in Bangor, is chief medical officer of Eastern Maine Healthcare Systems and is on the staff of several hospital emergency rooms in the region.

Protect yourself: Be your own FDA

This is the last of a three-part series on the safety of prescription drugs in America. At the time of regulatory approval for most drugs, a number of issues remain unknown: the occurrence of rare but serious adverse drug events (side effects), drug interactions, late events during treatment or after discontinuation of treatment, effects in pregnancy, or differential effects on subgroups that may be defined by age, sex, or race."

- Editorial in the Journal of the American Medical Association, Dec. 1, 2004

March 29, 2005 - Bangor Daily News - The scandal over the pain killer Vioxx has told us the Food and Drug Administration (FDA) is going to protect us from prescription drug side effects as though the FDA is run by Major League Baseball. It has also told us that we as patients must ultimately protect ourselves from the pills we take. Here are some suggestions for how to do that.

. When adding a new medicine to your other pills, make sure your doctor or pharmacist runs your whole list of medications through a computerized drug interaction analysis program. Doctors who thinks they are smart enough to know all of these drug interactions off the top of their heads are standing behind the green curtain with the Wizard of Oz;

. Know what medicines you are taking, unless you are Barry Bonds and need plausible deniability. That sounds obvious but many patients don't know, or don't remember and don't keep a list. If you answer the question ""What medicines are you taking?" with "You know, Doc, that little green one," (or a call to your lawyer), wake up and smell the risk of disaster;

. Don't seek a pill for every problem. Forty percent of Americans now takes a prescription drug, and many could find safer, cheaper answers than pills for their problems in physical therapy, weight loss, biofeedback, exercise, counseling, hard work and more;

. Remember that every medication out there that can kill you, one way or another. The only medication that is absolutely safe is the one you are not taking;

. If you walk out of the doctor's office with a new medicine and don't know what side effects to watch for, you need a pill to stop you from acting like a moron. If your doctor forgets to give you the information, ask for it. The doctor-patient team must make sure the patient knows what side effects to watch for, because the patient is the side effect cop on the beat;

. If you have a need to reject authority do it somewhere other than in your medication regimen, and take your medications the way you are supposed to, at the right time of day, with or without food or certain foods, as directed, etc. The failure to take medications appropriately often reduces their effectiveness, causing your doctor to prescribe higher doses with higher side effect risks. Inhalers, for example, if not shaken before use and "puffed" with proper technique, can lose more than two-thirds of their effectiveness. Pharmacists can often help with these issues of appropriate medication use;

. In general and if possible, avoid taking the latest and greatest drug being advertised on TV. The less time a drug has been on the market the less we probably know about its side effects. If you have a choice, let others be the mass market guinea pigs. Ask your doctor about older medications, which have been around a while and whose safety profile are more well known. And if a cute yellow bee that sounds like the actor Antonio Banderas can convince you to try a new allergy drug you should take something to clear your brain of congested thinking, my darling;

. When you see a drug advertised on TV your manure meter should flip into the red zone, not because the information is all poor but because TV advertising is about selling you a drug, not about making you a smarter consumer;

. If you have other health problems (particularly liver or kidney disease), or if you take several other medications, you are at particularly high risk of drug side effects and need to protect yourself from them like a pit bull protects the mailbox. A few weeks after starting new medications, such patients should consider having follow-up appointments to make sure they can continue to use the medication safely;

. Keep a prescription medication notebook. In it list your medications, dosages, important side effects you should be aware of, when you should take your pills, what foods to avoid when you take certain medications (for example, grapefruit juice decreases the effectiveness of several medicines if you take your pills soon after drinking it), what medicines you should avoid taking with other the medicines you are taking, etc. Too many of us know more about our stock portfolios than our pill portfolios;

. Don't suddenly stop a prescription medication without talking to your doctor, lest a seizure, heart attack, or some other side effect of sudden withdrawal interrupt your new-found pharmaceutical freedom. Many prescription drugs should be tapered off slowly;

. Americans need to approach their medications the way they would approach a busy intersection, an intersection where the FDA crossing guard is a little sleepy and high-powered drugs driven by Madison Avenue marketing are barreling down at us. We need to have our eyes wide open, be a little paranoid, be scanning for trouble, and remember that a false step could get us pharmaceutically flattened or epitaphed. We are, in the final analysis, responsible for our own prescription drug safety because only we are in harm's way.

And, oh yeah, don't take any medicines from a juiced-up guy named Jose Canseco.

Erik Steele, D.O., a physician in Bangor, is chief medical officer of Eastern Maine Healthcare Systems and is on the staff of several hospital emergency rooms in the region.

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