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New Drugs, Evidence and the Choices You Make

Posted Mar 11th, 2009 by Trisha Torrey

A few years ago, a wonderful new drug came on the market which put smiles on the faces of cardiologists everywhere.  Called Vytorin, it was a drug developed to help control two kinds of cholesterol problems, both the cholesterol build up in our arteries that develops when we eat foods with bad fats, and the cholesterol problems some people inherit from their ancestors. 

 

Cardiologists were happy with this new drug because they often prescribed two different prescription drugs, one for each form of cholesterol, to many of their patients who had problems with both.  If those patients took Vytorin, it would mean they needed to take only one drug, and that would improve compliance rates.  Compliance refers to how disciplined patients are – do they faithfully take the right medicines in the right doses at the right times each day?  Improved compliance would mean decreased numbers of heart attacks and strokes.

 

Vytorin didn’t need approval from the FDA.  That’s because the two drugs that had been combined to create it had each received approval already.  Vytorin was able to jump right from development to the marketplace – and onto the prescription pads of cardiologists everywhere.

 

Almost immediately, millions of prescriptions were written for Vytorin. And millions, or billions of dollars went directly to the bottom line of the manufacturers. Vytorin was very expensive, much more expensive than the total price of the two drugs it was comprised of.  But the manufacturer and cardiologists insisted it was worth the price. And for a few years, it was highly profitable for the manufacturer.

 

Then researchers decided to actually test those improved outcomes to determine just how well it protected patients.  Thousands of Vytorin-taking patients were followed over the span of several years.  The expected outcome was that the numbers of people who suffered heart attacks or strokes would decline, and decline significantly.

 

The results were supposed to be made public by 2006, but were delayed. Cardiologists started to become suspicious. Finally, almost two years late, the results were revealed and what they said surprised everyone:  Vytorin users suffered the same rate of heart attacks and strokes as the general population. No improvement. None.

 

Granted, there weren’t negative effects. No patients had gotten sicker from the drug.  There was no increase in strokes or heart attacks. 

 

The bottom line was that Vytorin is a safe drug – but very expensive.  It would be like comparing a peanut butter sandwich to a lobster dinner.  Afterwards your stomach is full, but you’ve paid a fortune just to fill your stomach.  At least the lobster dinner was delicious. Vytorin yielded no extra benefit except to the pharmaceutical companies who profited by it.

 

The Vytorin results followed on the heels of other drugs that had been prescribed for patients, but were later found to be harmful, and were pulled off the market. Vioxx was one such drug.

 

You may have heard of Vioxx.  Vioxx actually went through the FDA approval process and received its approval in 1999.  Hundreds of thousands of patients found great pain relief by taking Vioxx, until it was discovered that some people who took it died.  It turned out that Vioxx did not work well for patients with heart disease.  AND it turned out that Merck, the manufacturer, knew about the problems with Vioxx but withheld negative study results when it applied for FDA approval.  Since then, it has been taken off the market, lawsuits have been filed and won, and even those who benefitted from taking Vioxx must now look for other solutions for their pain.

 

Many other drugs have been pulled off the market for one reason or another.  Rezulin, Baycol, Fen-Phen, Redux and others are no longer available because they were discovered to be dangerous.  The problem is, they were put on the market for a period of time, patients took them, and patients suffered from them before they were taken off the market.

 

We wonder why those drugs were put on the market if they were worthless or dangerous… and the simple answer is…. Because they could still be money-makers.  Yes, the FDA is supposed to protect us, but for many reasons, those protections don’t work the way they should. 

Knowing it’s possible a drug can be prescribed that may harm us, or simply won’t be helpful yet may be very expensive, means we need to be that much more cautious when we are given a prescription for a new drug.

 

To be clear, I’m not talking about a drug that has known side effects or contra-indications. Your doctor should be aware of those, and they will be documented in the drug’s literature. But there may be problems your doctor is not aware of because the manufacturer has not made them available to professionals or the public.  That happens most frequently for a drug that has just become available for patient use.

So how can we patients protect ourselves from dangerous drugs or unneeded expense?

 

If your doctor prescribes a drug that’s new to you, ask her how long it has been available on the market. If the drug is generic, or has a generic version, then it will already have a well-documented track record. You won’t need to worry about its safety or expense, although you could still have a problem with side effects or contraindications yourself. 


If the drug is too new to have a generic version, then make sure it has at least a two or three year history to draw from. If not, ask if there is a drug in the same class with more of a history, one that has been around longer and has a more substantial track record.

 

If no older drug is available, and the newly prescribed drug is newer than two or three years, then ask your doctor to help you weigh the pros and cons, knowing that it’s possible neither of you will know about all the possible negative outcomes.  Ask her what sorts of problems you might encounter, and ask what kinds of problems you should report to her if you experience them. You can also do an Internet search to see if anyone has raised questions about its safety or effectiveness. Check with the FDA’s Medwatch website.

Then, be extra vigilant about problems you may experience with the drug yourself. Report all side effects to your doctor the moment you experience them so the doctor can tell you if you need to stop taking it, or whatever other instruction he might give you. If your doctor seems surprised by a side effect, then ask if it should be reported to the FDA.  Your doctor should be watching for unusual side effects, but doctors don’t always report them the way they should.  You, too, can report to the FDA if you experience a problem using the same FDA MedWatch website mentioned above.

 

New, lifesaving drugs are developed and approved constantly, and perhaps if they are considered lifesaving, you will be willing to use them even if they are brand new.

 

But smart patients know they don’t care to be the guinea pigs for drugs that have not been tested to the extent they should be.  There’s no sense in us paying the ultimate price through either our health, our lives OR our wallets.

 

About the author

Trisha Torrey is Every Patient's Advocate. She is a newspaper columnist, radio talk show host, national speaker, and the guide to patient empowerment at About.com.

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