Re: [N] Drug Makers: Part Two

[Guest guest]

In a message dated 10/08/2004 10:53:12 Central Standard Time,

Debbie.Borders@... writes:

Part II of this post from my nurse list.....Cary

> I do not have the link that this came from and due to the length will send

> it in two parts - this is part II.

>

> There are dozens of examples of these " me-too " drugs. There are now six

> different statins to lower cholesterol. The first, Mevacor, which was

> approved in 1987, was indeed an innovative drug. Other companies wanted to

> capitalize on this extremely lucrative market and they began creating other

> statins. Lipitor is now the biggest-selling drug in the world. But it's a

> me-too drug. There's little scientific evidence that any of them is better

> than the others in comparable doses.

>

> Q: Doesn't the Food and Drug Administration require new drugs to be safer

> and more effective than drugs already on the market?

>

> A: It should, but it doesn't. Drug makers are only required to show that a

> new medication is more effective than a placebo, or sugar pill. If a drug

> works better than a placebo and is safe, the FDA approves it, and it can

> enter the market. The result is that doctors don't know if a new drug that

> comes along is any better or worse than the drugs they're already using.

>

> A dark fear I have, in fact, is that drugs are getting progressively worse.

> There's some basis for that concern. The first drugs used to lower blood

> pressure were diuretics. Then new drugs for hypertension came along and were

> heavily marketed, and many doctors stopped using diuretics. In a study

> published in 2002, researchers compared the old drugs to the new ones, and

> guess what - the old drugs turned out to be just as good for lowering blood

> pressure and even better than the new drugs for preventing some of its

> complications.

>

> Q: Why do drug makers churn out new drugs when older ones work perfectly

> well?

>

> A: Because patents run out on older drugs and they can then be sold as

> generics at as little as 20% of the price [they sold at while still under

> patent]. Pharmaceutical manufacturers need a constant supply of new drugs

> that have patent protection so they can charge whatever they want.

>

> Q: Isn't it useful to have a variety of drugs to choose from, in case a

> patient doesn't respond to the first?

>

> A: That's an argument the pharmaceutical industry makes - that it's good to

> have six cholesterol-lowering drugs, or five selective serotonin reuptake

> inhibitors (SSRIs), the antidepressants that include Prozac, Zoloft and

> Paxil. But if that's true, then the companies should be required to test a

> new me-too drug in people who failed to respond to the first drug. And they

> don't do that. My guess is that if the first drug doesn't work, the second

> one won't work either, since me-too drugs are so similar. But no one can say

> for sure.

>

> Q: What about competition? Do me-too drugs help keep prices down?

>

> A: Probably not. When did you see a drug company advertise that its drug is

> cheaper than another drug? You don't see ads that promote Lipitor as cheaper

> than Zocor. Or Zoloft as cheaper than Paxil. I can't think of any other

> industry where price is almost never mentioned. Drug companies compete by

> implying that their new drug is better. And also by making more people think

> they need drugs.

>

> Consider psychiatric drugs. If you can define everyone who has the blues as

> having depression that needs to be treated, you've created a huge market. If

> you define everyone who is shy as having social anxiety disorder, that

> enlarges the market. There's probably not a soul alive who hasn't felt shy.

> If you listen to the pharmaceutical industry, many of the ordinary

> discontents of life are medical conditions that require drugs.

>

> You see the same thing with erectile dysfunction. Any episode of impotence,

> no matter how mild, how rare, becomes a condition, erectile dysfunction,

> that can be treated. It's no coincidence that the people in those ads tend

> to be middle aged or even younger. Pushing the disease is a big part of

> pushing the drugs. The result is that many Americans are probably on too

> many medications, with all the risks of side effects and drug interactions

> that implies.

>

> Q: If new drugs aren't necessarily better than old ones, why do doctors

> prescribe them?

>

> A: Part of the answer is marketing. New me-too drugs are heavily marketed to

> patients and doctors. Look at the ads on television. Look at the endless

> parade of drug representatives marching through doctors' offices.

> Pharmaceutical companies spend billions and billions to make us think that

> new drugs are better than old ones. They have to. If you had a drug that was

> important and unique, you wouldn't have to advertise it very much. If you

> came out with a cure for cancer, the world would beat a path to your door.

>

> So you have to ask, why are drug companies spending so much on marketing?

> The answer is that they have to convince us that their me-too drugs are

> better than the others. And that takes a heap of marketing, because there's

> usually no scientific evidence to back up the claim.

>

> Q: It's easier to imagine patients being fooled - but doctors?

>

> A: People don't realize that the pharmaceutical industry supports most of

> the continuing medical education programs in this country. These are the

> programs doctors are required to attend to update their knowledge. Drug

> makers fund the programs, so it's not surprising that they promote a

> drug-intensive style of medicine.

>

> In their offices, doctors are visited by swarms of company sales

> representatives who bring packages of free samples - about $10-billion worth

> a year - of the newest brand-name drugs. The doctors get used to prescribing

> them, the patients get used to taking them, and when the free samples run

> out, someone has to start paying for the drug.

>

> Whether these new drugs are actually better than older generic drugs never

> crosses the doctor's mind or the patient's mind. They confidently believe

> that newer is better.

>

> Q: What about clinical trials? Don't they provide evidence about how well

> drugs work?

>

> A: Research is biased in favor of the drugs and drug makers. The

> pharmaceutical industry spends a great deal to influence people in academic

> medicine and professional societies. It does a super job of making sure

> [that] nearly every important person they can find in academic medicine

> [who] is involved in any way with drugs is hired as a consultant, as a

> speaker, is placed on an advisory board - and is paid generous amounts of

> money.

>

> Conflicts of interest are rampant. When the New England Journal of Medicine

> published a study of antidepressants, we didn't have room to print all the

> authors' conflict-of-interest disclosures. We had to refer people to the

> website. I wrote an editorial for the journal, titled " Is Academic Medicine

> for Sale? " Someone wrote a letter to the editor that answered the question,

> " No. The current owner is very happy with it. " That sums up the situation

> nicely.

>

> Q: What can be done to fix the system?

>

> A: The single most important change that should be made - and it could be

> made tomorrow - is for Congress to redefine what safe and effective means,

> to insist that the FDA require manufacturers to test new drugs not just

> against placebos but against existing drugs. After all, the relevant issue

> isn't whether a new drug works better than nothing; it's whether it's better

> than older drugs already in use.

>

> That's why so many clinical trials published are of no use to doctors.

> Doctors don't want to know if this new drug is better than a sugar pill.

> They want to know if it's better than the drug they're already using. The

> FDA should require manufacturers to compare new drugs head to head, at

> equivalent doses. Only drugs that are safer, more effective, or

> significantly more convenient, should be approved.

>

> We also need to make the FDA more independent. The FDA has 18 advisory

> committees, and many of the members of those committee have financial ties

> to the drug industry. That's wrong.

>

> Finally, university medical centers and medical societies and the people who

> run them need to stop fooling themselves into thinking they can take huge

> sums of money from drug makers and still remain objective and independent.

>

> Q: Is there anything patients can do?

>

> A: Ask questions. If your doctor prescribes a medication, ask about the

> evidence that shows it is effective. Ask why your doctor is prescribing this

> particular drug. Ask if there are older, less expensive drugs that might

> work just as well. A few questions from patients might begin to make

> [doctors] think about what they're doing. Finally, ask your doctor whether

> you really need a drug at all. Maybe a lifestyle change would be better, or

> maybe the illness is mild and will go away on its own.

>