Interesting poll at Forbes

What's Your Take On Drug Advertising To Consumers?
12.20.04, 8:00 AM ET

The U.S. Food and Drug Administration is considering further regulatory measures, including withdrawal from the market, of Pfizer's arthritis treatment Celebrex. The recent FDA attention is in response to a study by the National Cancer Institute showing that high doses of Celebrex--a Cox-2 inhibitor similar to Merck's recalled drug Vioxx--were associated with an increased risk of heart attack and stroke (see: "Pfizer's Heart Attack").

Yesterday, New York-based Pfizer (nyse: PFE - news - people ) announced it would immediately halt TV, radio, newspaper and magazine ad campaigns promoting Celebrex to U.S. consumers. The drugmaker spent more than $70 million on such advertising in the first nine months of 2004. Pfizer will continue to market Celebrex, which has annual sales of $3 billion, to doctors.

Do you think that it's appropriate to advertise prescription drugs to consumers?

Vote Here

As someone who worked for several years in physician practice management, I can tell you in all honesty that this is one of the WORST things to happen in YEARS.

Although we all know it's best for patient care when patients are informed and able to fully participate in making decisions concerning their care, nothing is more a waste of time than having to convince a patient that the medication they saw on TV or in their favorite magazine is NOT right for them. After all, they're supposed to, "...ask your doctor...".

The only thing more irritating to someone in the "field" is trying to convince people that, in MANY cases, they would not need a particular medication whatsoever IF they would lose weight, make important lifestyle changes, etc.

I think it is terrible too. They don't really inform you what the stupid drug is supposed to do, you're supposed to figure it out from someone wind surfing through a field of wheat or belly flopping a dive.

The drug companies need to take their enormous advertising budgets and invest them in R&D or lower the damn prices on the drugs!

Nothing worse than asking your doc about a drug and finding out its for menstrual cramps. You ladies who've asked about Cialis know what I'm talking about.

I agree. Commercial, informercials and the like can not by any stretch of the imagination be considered "information". Disinformation is more like it. As such they should not be aimed at consumers. And I guess the comparaison will sting a little, but just like commercials should not be aimed at children. Children do not have the capacity to evaluate the information directed at them. IN the same way, your average consumer does not have the required knowledge to separate fact from fiction when it comes to drug ads. As we well know, ads are not designed to inform but they are designed to push you into buying certain products, and they are often very clever at it as well. This is definitively not something you want when the product is potentially dangerous drugs.

Sometimes I feel the days of snake-oil salesmen are not over They just got more sophisticated at it.

No. Too many people already have the idea that "all I need is a pill to make things better" and the pharmaceutical companies play that up to the max while not fully disclosing what a drug is for and the potential harm it may do.

I'm totally against it for the same reasons others have stated. There shouldn't be a distinction between the controlled substances, IMHO - if you can't advertise morphine, you shouldn't be able to advertise ritalin.

Slightly off topic, but addresses the issue of advertising: I was involved in a discussion recently of the Listerine ad campaign where they say their product is 'clinically proven' to be as effective against gingivitis as flossing. The fine print says, "floss regularly." To paraphrase what this person said: "I don't floss because Listerine is just as good. Science proved it. The graphic on the ad even shows the mouthwash getting under the gums, so I'm not worried." Uh... hello... Pfizer cherry-picked a couple of studies that they funded, and all that can be concluded from those results is that Listerine was as effective at preventing gingivitis as flossing. It says nothing about cavities, peridontitis, halitosis and long term dental health. Yet this person concluded that there was no reason to floss anymore.

Technically, Pfizer isn't lying in their ad, but they obviously want you to draw the erroneous conclusion that this person drew. When this kind of misleading misinformation gets out about prescription drugs, it's even worse.

But I can hardly wait to see what happen when they start selling statins otc:

http://www.thincs.org/Malcolm.birthdefects.htm

June 17, 2004


We Are Sleep-Walking Into What Could Become A Major Medical Disaster Because Statin Drugs Will Soon Be Sold Over-The-Counter



By Dr. Malcolm Kendrick
(email - malcolm~llp.org.uk)

Holoprosencephaly (defective septum separating lateral cerebral ventricles, with cerebral dysfunction), atrial septal defect, aortic hypoplasia, death at one month of age.

Aqueductal stenosis with hydrocephalus, concurrent limb deficiency

Cerivothoracic-to-lumbar neural-tube defect, myelocele, duplication of spinal cord, cerbellar hernation with hydrocephalus; apparent agenesis of palate

Spina bifida, right-arm abnormality Left leg: femur 16% shorter than right side; foot: aplasia of metatarsals and phalanges 3,4 and 5; additional VACTERL (vertebral, anal, cardiac, tracheal, esophageal, renal and limb defects): left renal dysplasia, reversed laterality of aorta, disorganized lumbosacral vertebra, single umbilical artery;

additional findings: clitoral hypertrophy, vaginal and uterine agenesis.

It always amazes me that some things seem to strike terror into the hearts of mankind whilst other, much more dangerous things, are accepted with a shrug of the shoulders. As my son has taken to saying ‘Yeh, whatever.’

Around the world, for example, car crashes wipe out thousands of people each and every day, yet few people worry about getting into a car. On the other hand, one plane comes down; killing a couple of hundred, and it hits the front page of the newspapers around the world. And we are all nervous about getting into planes – especially the landing bit.

The things that frighten us, it seems, bear absolutely no relationship to the level of risk that they represent.

Looking at a medical example of irrational fear, the world still reels in terror at the word “thalidomide.” However, it turns out that this drug provides huge benefits in the treatment of myeloma – who would ever have thought? Yet, it is almost impossible to prescribe thalidomide to many who need it, due to extremely strict controls on its use. Which is completely mad, because it only has one major side effect, which is to cause birth abnormalities in pregnant women. So, why is it so difficult to prescribe it to a seventy-year-old man? Because it is thalidomide, and thalidomide is scary.

On the other hand, in the UK we are going to allow statins to be made available over the counter and - hey, guess what? If you are a woman, and you get pregnant whilst on statins there is a massive risk of severe, horrible birth defects. Worse defects than were ever caused by thalidomide. At least thalidomide didn’t affect the brain, causing ‘defective septum separating lateral cerebral ventricles’, or ‘duplication of the spinal cord.’ Duplication of the spinal cord!

We are sleep-walking into what could be a major medical
disaster. Most people, and most doctors, are unaware – or don’t seem to care – that statins should never ever be taken by a women of child-bearing age. The risk, it would seem, is greater than that posed by thalidomide, and no-one seems to be the least bit bothered. ‘Yeh, whatever.’

Yet, when statins go OTC it is absolutely certain that women of childbearing age will take them, knowing nothing of this risk. It is equally certain that a number of these women will become pregnant, and many of these pregnancies will result in horribly deformed children.

How can this possibly be allowed to happen? I can only suppose that it is because everyone believes statins to be utterly safe and cuddly. ‘Statins, why they can’t do any harm. They are safer than aspirin aren’t they?’

Left arm: aplasia of radius and thumb, shortened ulna; additional VACTERL (vertebral, anal, cardiac, tracheal, esophageal, renal and limb defects): left arthrogryposis, thoracic scoliosis, fusion of ribs on left, butterfly vertebra in thoracic and lumbar region, esophageal stricture, anal atresia, renal dysplasia; additional findings: hemihypertrophy of entire left side, craniofacial anomalies (including asymmetric ears, ptosis of eyelids, high arched palate), torticollis.

I am quite certain that many of you won’t know what some of these defects actually are; neither do I. Arthrogryposis….. isn’t that the fabled winged beast in Harry Potter? But these defects shouldn’t exactly come as a surprise.

Cholesterol is essential for the development of neural tissue, so we should expect to find that if the mother is taking a drug that inhibits cholesterol synthesis at a time when the fetus is developing – horrible developmental abnormalities will occur. Such as failure of the brain to develop in the right way, or duplication of the spinal cord.

For more complete details of the birth defects caused by statins consider reading the New England Journal of Medicine, April 8, 2004: pages 1579 – 1582. It’s a letter by Robin J Edison and Maximilian Muenke.

"Yet, when statins go OTC it is absolutely certain that women of childbearing age will take them, knowing nothing of this risk. It is equally certain that a number of these women will become pregnant, and many of these pregnancies will result in horribly deformed children."

George, I agree 100%....however, they're also taking about prescribing statins for children, teens and young adults. Now....what are they going to do about making sure they don't get pregnant?

NO CONTRACEPTIVE is 100% effective except total abstinence....and we all know how well that would go over! So....what happens when these women unintentionally get pregnant? They missed a dose of the pill, or their diaphragm is getting a bit old.....or that damned condom broke or fell off! It happens all the time!

Also....ok, say you are on statins....and get married, decide to start a family? If you come off the statins, which I'm now hearing should be withdrawn gradually, is there any rebound? How long after stopping statins are you now "safe" to get pregnant?

Man this stuff scares the daylights out of me! But I think OTC use is only part of the issue. Too many docs are handing this stuff out with little thought to the side effects.

Worse than that, is that the system is so badly broken that given the “standard of care” rule, if a doctor prescribes a statin to some one with a total cholesterol of 201 he is 100% covered, if it harms the patient he is covered, if the patient has a heart attack he is covered, on-the-other-hand, if he fails to prescribe it he damn well better be ready to explain himself in court if anything bad happens to that patient.

Prescription drugs should be advertised but there also should exist legislation to ensure honesty and integrity in advertising.

Fifteen years ago I had a quadruple by-pass and for the following 5 years was at death's door until I ventured into the field of pharmaceuticals. There I discovered the reason why I might be feeling so horrible; it was from the pills prescribed for me. Further reading lead me to try other drugs on my own volition and I found that I was able to abandon the 'medics' prescription pills and for the past 10 years I have been in remarkably good health. More interestingly, there was and are substances available that would have resolved my arterial blockages without surgery which is another secret hidden from the public.

Today, pharmacology has become a hobby of mine much to my doctor's dismay. Probably all the information required on drugs can be obtained from the Internet. There are many civilised countries that sell drugs OTC without a medical prescription yet there never seems to be any problem relating to this freedom.

Statistically, there are more deaths through accident in hospitals in Westernised countries than there are on public highways so if you want to increase your chances of living longer, guess what to do?

The pertinent questions are, why should any of us feel compelled to depend on 'medics' and why is the freedom to purchase what we desire denied us. We're not imbeciles as the medical profession likes to belive. Any apparent foolishness from the public is due solely to the forced dependency on State institutions.

A relative of mine, at the age of 50, had his bi-annual medical and was passed fit. Within 24 hours he was dead from cardiac arrest. The MD continues today to practice his quackery and probably without guilt.

Many others could manage their own health problems quite adequately and competently as I do today.

http://www.nybooks.com/articles/17244?email

The most startling fact about 2002 is that the combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion).[12] In 2003 profits of the Fortune 500 drug companies dropped to 14.3 percent of sales, still well above the median for all industries of 4.6 percent for that year. When I say this is a profitable industry, I mean really profitable. It is difficult to conceive of how awash in money big pharma is.



[12] Public Citizen Congress Watch, "Drug Industry Profits: Hefty Pharmaceutical Company Margins Dwarf Other Industries," June 2003 (www.citizen .org/documents/Pharma_Report.pdf). The data are drawn mainly from the Fortune 500 list in Fortune, April 7, 2003, and drug company annual reports.

Advertising presecription drugs to consumers should be a criminal offense. Beyond the marketing of one drug or another, it reinforces the idea that all conditions are diseases that need to be controlled by drugs and that one needs drugs to stay healthy. These are lies perpetrated by the pharmaceutical industry to boost its profits.

People on this bulletin board are aware, as most are not, that 80% of the disorders for which we take prescription drugs are caused directly or indirectly by insulin resistance and hyperinsulinemia. If people controlled insulin levels through diet, then we could avoid most prescription drugs and lessen dependence on them considerably. Of course, this information will never reach the general public because the drug companies and their paid lackeys such as the American Heart Association and the American Diabetes Association stand in the way.

The drug companies have a sweet deal. When you treat an IR related disorder with a drug, it alters your body chemistry to require other drugs and allows the underlying insulin resistance to go untreated and to cause other disorders which will require drugs. The truth is that the drug companies have no better moral standing than the dope peddler in the schoolyard.

What's happening in California re stem cell research is an interesting development. Research and development will be carried on by a quasi governmental-academic board funded by a bond issue. Once a drug or a therapy is developed, it will be licensed to a drug company for manufacture and distribution only. The patent will be owned by the people of California and profits will be used to pay back the debt on the bond. This is how it should be done. The drug companies are fond of saying that their high prices are justified by the costs of development, so let's take development away from them. Prescription prices will tumble and me-too drugs will disappear.

Total abstinence wasn't all that effective a contraceptive for the Virgin Mary, as I understand it.

http://www.healthcentral.com/news/N...t.cfm?id=518293

Cholesterol Drugs Tied to Birth Defects

U.S. government study finds an unusually high number of abnormalities in babies of women who took statins during first trimester of pregnancy.

By Serena Gordon
HealthDay Reporter

WEDNESDAY, April 7 (HealthDayNews) -- If you're pregnant or thinking about getting pregnant, there's one more group of medications to add to the long list of drugs you shouldn't take because they can harm your baby: the cholesterol-lowering medications called statins.
Researchers from the U.S. National Institutes of Health found that statin use during the first trimester of pregnancy is associated with severe central nervous system defects and limb deformities.
Their findings, published in a research letter in the April 8 issue of the New England Journal of Medicine, showed that 20 of 52 babies exposed to statins in the womb were born with malformations.

"We can't tell whether the defects were caused by the use of statin medications, but other birth defect studies suggest that these are the kinds of problems that occur if the embryo does not get enough cholesterol in early pregnancy to develop normally," said one of the study's authors, Dr. Maximilian Muenke, a senior investigator and chief of the medical genetics branch at the National Human Genome Research Institute in Bethesda, Md.
Statins are commonly used medications that help lower blood cholesterol levels. Muenke said most people who use these medications are older than 45, but that 1 to 3 percent of the prescriptions for these medications are for women in their childbearing years.
These medications are already considered contraindicated in pregnancy, and the Food and Drug Administration requires that all statin prescriptions carry a warning about taking them during pregnancy, Muenke added.
"FDA took this action because it was recognized that fetal cholesterol synthesis was essential for development, and because animals given statins during pregnancy had offspring with a variety of birth defects," he said.
The real problem, according to Dr. Nancy Green, medical director for the March of Dimes, is that about half of all pregnancies are unplanned, so exposure to drugs can happen inadvertently before a woman even knows she's pregnant.
"Statins are very good for general health. But there's a lot we don't know about their safety in pregnancy because there is no national system for monitoring the safety of drugs during pregnancy," Green noted.
"This report is worrisome," she added.
Muenke and NIH colleague Dr. Robin Edison reviewed the 52 reports to the FDA of statin exposure in the first trimester of pregnancy that occurred from 1987 through 2001.
Of the 20 babies born with malformations, five had severe central nervous system defects, and five had malformed limbs. One baby had both, according to Muenke. There were also two cases of a very rare birth defect called holoprosencephaly, which occurs when the brain fails to divide properly.
"These are such very rare birth defects that one would not expect to find the number we found in a population this small," Muenke said.
He added that it's hard to know if there are more birth defects found in women who take statins, because the FDA reporting system is voluntary and many women don't report early-pregnancy statin exposure.
Green said the study highlights the need for a more comprehensive reporting system for medication use during pregnancy. With such a system, health-care providers could know if a medication was safe for use during pregnancy or not.
"For most drugs, we can't say for sure if they're safe. That often leads to under-treatment," Green said.
"Our study supports the need for [warning labels on statins], and it points to the need for larger, controlled studies to better define the risks of using statins in pregnant women," Muenke added.
"In the meantime, if a woman becomes unexpectedly pregnant while taking statins, she should immediately consult with her physician," he said.

http://content.nejm.org/cgi/content/extract/350/15/1579

Central Nervous System and Limb Anomalies in Case Reports of First-Trimester Statin Exposure

To the Editor: The cholesterol-lowering statin drugs are contraindicated in pregnancy1; therefore, few data exist regarding their safety in human gestation. We reviewed 178 cases of first-trimester statin exposure reported to the Food and Drug Administration (FDA) from 1987 through 2001 for patterns suggesting possible drug-related effects on embryogenesis. After the exclusion of cases involving first-trimester elective or spontaneous abortions (46 and 42 cases, respectively), pregnancy loss due to maternal illness (15), fetal genetic disorders (3), transient neonatal disorders (5), or loss to follow-up (15), 52 cases were considered evaluable (Table 1)

Out of 178 pregnancies, does it seem odd to anyone else that only 52 resulted in birth? Never mind that only 32 of them did NOT have sever defects?