Drug Company Tactics:

In light of the recent revelations about the harmfulness of the prescription drug rofecoxib (Vioxx) and other painkillers, drug companies have come under increased scrutiny.

Fact: Between 1997 and 2001, drug companies tripled the amount of money they spent on direct-to-consumer advertising for prescription drugs -- the ads now seen so frequently on television and in newspapers. The number of retail prescriptions rose from 2.4 billion in 1997 to 3.1 billion in 2001. Those prescriptions carry a total yearly price tag of at least $200 billion, with the cost rising about 12% per year, approximately six times the rate of inflation.

But doesn't the increased use of medications signal better health for Americans? Not necessarily. To learn more about the claims made by drug companies, Bottom Line/Health spoke to Marcia Angell, MD, former editor-in-chief of the prestigious New England Journal of Medicine.

Claim: The increased costs of drugs reflect large investments in research and development (R&D).

Fact: Drug companies spend more than twice as much on "marketing and administration" as they do on R&D -- 31% of sales, compared with 14% in 2003.

Drug industry sources say the R and D cost per drug is $800 million, on average. An independent analysis by the nonprofit consumer advocacy organization Public Citizen shows that the real cost is probably $100 million or less.

Actually, the big drug companies don't develop most of the novel medications. These drugs, such as the cancer medications paclitaxel (Taxol) and imatinib (Gleevec), mostly are the result of taxpayer-funded research at academic institutions or the National Institutes of Health (NIH) or research at small biotechnology companies.

Claim: New drugs are constantly being brought to market.

Fact: Of the 487 drugs approved by the FDA from 1998 through 2003, only 32% contained new active ingredients and fewer than half of those (14% of the total) were classified by the FDA as improvements over older drugs.

Most "new" drugs are chemical variations of older drugs already on the market -- so-called "me-too" drugs. Companies try to grab a piece of a profitable market by producing a medication similar to a top-selling drug.

Example: Mevacor, approved in 1987, was the first cholesterol-lowering statin in the marketplace. Now, there are five more, all variants of the original -- Lipitor, Zocor, Pravachol, Lescol and Crestor. Even though Lipitor and Zocor are the top-selling statins, no head-to-head studies have been conducted comparing their effectiveness with lovastatin (the cheaper generic form of Mevacor) when taken at equivalent doses.

Claim: Scientific studies on drugs are reliable.

Fact: Drug companies have always sponsored almost all research on their drugs, but now they control how the research is done and if it will be published. Much of this research is seriously flawed, presenting results that cause both doctors and consumers to believe that drugs are a lot better than they are and have fewer side effects than they do. What's more, only favorable results are published. Unfavorable results rarely see the light of day.

Claim: Doctors' prescribing habits aren't unduly influenced by drug companies.

Fact: In 2001 the drug industry employed approximately 88,000 sales representatives to visit doctors in their offices and hospitals to promote their products -- roughly one representative for every six practicing physicians.

In 2001, drug companies paid more than 60% of the costs for continuing medical education for doctors. Meetings of professional societies, such as the American College of Cardiology and the American College of Physicians, now are largely sponsored by drug companies.

Knowing this, do you think the prescribing habits of America's doctors are based only on objective evaluations of their patients?

Ignore drug ads. An ad is meant to sell something, not educate or inform. Drug ads are no different. There's a good reason that direct-to-consumer drug ads are illegal in every other developed country (except New Zealand).

Be skeptical about new drugs. When it comes to drugs, newer doesn't necessarily mean better. There are exceptions, but you should make sure your doctor is relying on scientific evidence, not just a sales pitch from a drug company.

Watch out for "me-too" drugs. If a drug is being advertised on TV, It's probably a me-too drug. The drug company is trying to convince doctors and patients -- usually in the absence of any scientific evidence -- that the "new" drug is better. Double whammy: The new drug usually costs more.

Always ask for an equivalent generic or over-the-counter (OTC) drug. Doctors tend to prescribe what the drug company reps who haunt their offices are pushing. There may be a cheaper alternative that's just as effective. Ask about it.

Beware free samples. Drug reps give doctors free samples of expensive drugs. When the sample runs out, both doctor and patient are in the habit of using that particular drug. If you accept a free sample, be sure there is a compelling medical reason to take that drug.

Don't be easily convinced that you have a new disease. Do you really need to take the me-too antidepressant paroxetine (Paxil) for "social anxiety disorder", when you thought you were just shy?

Give your doctor permission not to prescribe. Many doctors assume correctly, in many cases that a patient won' feel satisfied unless he/she leaves the office with a prescription. Tell your MD: "If I don't need a prescription drug, don't prescribe one."

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