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Old cheap drugs more effective than new expensive drugs 

Bitter medicine - there is little evidence that the huge increase in pharmaceutical spending is dramatically improving the health of Americans

 

Is US Health Really the Best in the World? 
Barbara Starfield, MD, MPH

12,000 deaths/year from unnecessary surgery, 7000 deaths/year from medication errors in hospitals, 20,000 deaths/year from other errors in hospitals, 80,000 deaths/year from nosocomial infections in hospitals, 106,000 deaths/year from nonerror, adverse effects of medications. These total to 225,000 deaths per year from iatrogenic causes. Three caveats should be noted. First, most of the data are derived from studies in hospitalized patients. Second, these estimates are for deaths only and do not include adverse effects that are associated with disability or discomfort. Third, the estimates of death due to error are lower than those in the IOM report. If the higher estimates are used, the deaths due to iatrogenic causes would range from 230,000 to 284,000. In any case, 225,000 deaths per year constitutes the third leading cause of death in the United States, after deaths from heart disease and cancer.  http://jama.ama-assn.org/issues/v284n4/full/jco00061.html

"It used to be that drug companies simply gave grants to academic medical centres for the use of their clinical researchers to do a study and that was it. It was at arm's length. The researcher did a study and he or she published the results, whatever those results would be. Now, it's very, very different. The drug companies increasingly design the studies. They keep the data. They don't even let the researchers see the data. They analyse the data. They decide whether they're going to even publish the data at the end of it. They sign contracts with researchers and with academic medical centres saying that they don't get to publish their work unless they get permission from the drug company. So, you can see that the distortion starts even before publication. It starts in determining what's going to be published and what isn't going to be published. This is no longer arm's length. It's treating the researchers and the academic medical centres as though they were hired guns or technicians or something. They just do the work. And the drug company will decide what the data show, what the conclusions are and whether it will even be published."------Dr Marcia Angell, former editor of the New England Journal of Medicine http://www.abc.net.au/lateline/s160431.htm

"By the time it was pulled from the market, the FDA had received reports of 24 deaths of children under age 6 who were given Propulsid. By then the drug had generated U.S. sales of $2.5 billion for Johnson & Johnson Co." - LA Times Read about the "new" FDA."

Did God "bless us" with doctor's as some religious people believe? And how should we pray for sick loved one's who are hospitalized or under a doctor's care?

Pray that they will find the truth and seek help outside the mainstream treatments if you really want these people to recover and live. If we are going to pray for "the doctors to have wisdom" we need to pray they will be willing to put their license on the line and treat the patient with something that really works!! Contrary to some beliefs, God did not give us doctors to heal and cure us anymore than He gave us auto mechanics to fix our cars!! They are both technicians trained to do their work, while subject to the same limitations of educational bias, profit-motive, and obsolete knowledge. The difference is that a bad mechanic may ruin your car, but an uninformed doctor can kill you - they are the 3rd leading cause of death In the US!!

What's the answer to the FDA/AMA Pharma-Cartel's tight grip around the throat of the medical industry? Give Almighty God complete control of our individual lives - then, we will begin to know the truth; the truth will set us free; and we will have His wisdom about our health, etc. It is NOT His will that our lives be cut short by disease, nor that greedy evil men be allowed to triumph.


 

STUDY: Old cheap drugs more effective than new expensive drugs 

"It is unlikely, in my opinion, that the pharmaceutical industry is going to do these kinds of studies of head-to-head comparisons on their own." - Dr Paul Whelton

Treating hypertension
'Newshour' interview, with Ray Suarez
December 18, 2002
http://www.pbs.org/newshour/bb/health/july-dec02/hypertension.html

A Journal of the American Medical Association study on the treatment of hypertension revealed that the traditional diuretics are more effective than the expensive alternatives. 

Ray Suarez discusses the study with a professor of epidemiology and medicine at Tulane University.

RAY SUAREZ: Hypertension, or high blood pressure, affects about 50 million Americans-- one in four of the population-- and can cause stroke, heart failure, and other serious health problems. For many years, water pills, or diuretics, were the most common treatment. 

But recently, several highly marketed new drugs have increased in popularity. A study in today's Journal of the American Medical Association compared the benefits of different drugs with some surprising results. 

Dr. Paul Whelton was one of the leaders of the study. He's a professor of epidemiology and medicine at Tulane University.

Hypertension, or high blood pressure, affects about 50 million Americans -- one in four of the population -- and can cause stroke, heart failure, and other serious health problems.

Dr. Whelton, what is hypertension?

DR. PAUL WHELTON, Tulane University: Hypertension is high blood pressure. And as you said, as it goes up, it increases the risk of complications-- stroke, heart failure, kidney failure, and a number of others.

RAY SUAREZ: So there is just excess fluid, pressure on your circulatory system?

DR. PAUL WHELTON: There is excess pressure on the blood vessels and eventually that leads to damage of the vessels with clotting or some sometimes with destruction of the vessels and bleeding as you will see with hemorrhagic stroke.

RAY SUAREZ: Well, if last week or last month a person in consultation with their doctor decided to start using drugs as part of their management course for hypertension, what would they have commonly done?

DR. PAUL WHELTON: Very likely in the very recent past, they would have received advice on lifestyle change, probably -- getting a good weight, being physically active; being careful with diet, and so on, but if they were to be start on a medication, many would be... they probably would have been advised to start on one of the newer agents. Calcium channel blocker agent or an ace inhibitor, two of the drugs we tested.

RAY SUAREZ: So what do you find out when looking across the range of commonly offered medications?

DR. PAUL WHELTON: "Well, we found a very interesting result. 

"All of the drugs that we tested - - and as you said, we tested the diuretic or the fluid pill against the calcium channel blocker and we also tested it against the ace inhibitor. And what we found out is that the diuretic seemed to be the best.

"All three of these drugs are known to lower blood pressure, all three are known to reduce the risk of complications.

"But none... no study had really compared all three head to head before. And we found that the diuretic certainly was as good with respect to important outcomes like heart attacks, and better with respect to preventing stroke and heart failure, very impressive results."

RAY SUAREZ: The other drugs did work, though? I mean, they weren't found to be ineffective?

DR. PAUL WHELTON: Right. The other drugs are very effective. And, in fact, although we are recommending diuretics as the first step for drug treatment, and that is a very appropriate recommendation based on our results many people will require a second drug. And these two other drugs that we tested are very appropriate as second drugs.

RAY SUAREZ: Well, as you look at this as a specialist in this field, and you look back over your shoulder, how do you think it happened that a drug that is now found to be very effective and very cheap compared to the others ended up being a treatment in a minority of cases over the years?

DR. PAUL WHELTON: Well, the diuretics have always been known to be very effective. And we've done lots of trials, but naturally you are looking for new agents, and thank goodness we have many other agents. As those new ones came out, for many doctors, and for many researchers, there was the opinion and the feeling that they would be better than diuretics. In fact, of course, that is why we did the study. We wanted to know were these newer, drugs which cost a lot more, seriously better than the diuretic? I would say, you know, in the 30 years that I've been a doctor and a researcher, this question comes up every time a doctor treats a patient, and probably every time a patient asks a doctor for advice. So it's has been a question that has been around for a long time. Now we've resolved the question.

RAY SUAREZ: But we're not talking about a close call in this case, are we? I mean, these drugs cost 10 to 20 times as much as a diuretic.

DR. PAUL WHELTON: Yes, the newer drugs clearly are a lot more expensive. And it seems that for the average person, they can do as well and better with the cheaper, old friend than with the newer agent. Now, not to say there isn't a place for these newer drugs, and sometimes you are treating not only high blood pressure and worrying about its complications, but you are treating something else as well. For instance, a patient might have angina pectoris or heart pain. And in that instance, another drug, such as a calcium channel blocker, would be very appropriate because it not only lowers blood pressure and the complications of blood pressure, but also is an effective treatment of angina. So these new drugs do have a place, but I think what we are saying is for most patients the starting drug ought to be a diuretic, and if they need a second drug, that is when you add one of those other agents on top.

RAY SUAREZ: Might this be particularly good news to certain high-risk populations for hypertension, like African Americans, who also have an access and cost problem when gaining medical care at the same time?

DR. PAUL WHELTON: Yeah, I think this is good news for everyone. It's great news for African Americans. It's great news for anyone really to get the answer to the question, "Which is the best drug to start with?" It's particularly good news for the person who has to pay for their own medications. It could be the difference between getting treatment for what is a serious risk factor for cardiovascular complications or having untreated hypertension with all of the adverse consequences.

RAY SUAREZ: Now if you are one of the millions of Americans currently on a drug regimen to help manage your hypertension, should you be on the phone in the morning running down to your doctor or clinic and saying get me on diuretics or stop taking what you been taking? How do you proceed?

DR. PAUL WHELTON: Well, I think you proceed to see your doctor. And hypertension is a lifelong problem. It isn't that the consequences occur overnight, and there may be reasons that the doctor put the patient on that particular medicine other than to lower their blood pressure. So I think it's very important that people have the conversation with their health care provider. And I think in many instances, the health care provider will likely switch that person to a diuretic, or if they are starting treatment, start them on a diuretic. But it's not a good idea to change one's own medications.

RAY SUAREZ: And can this help control health care cost inflation, news like this?

DR. PAUL WHELTON: Well, I think this is important news and this is an important model for how we can test these questions. It is unlikely, in my opinion, that the pharmaceutical industry is going to do these kinds of studies of head-to-head comparisons on their own. Here is an instance where the National Heart, Lung and Blood Institute, with a lot of help from the Veterans Administration, from over 600 practitioners around the country and indeed help from the pharmaceutical industry as well, stepped up to the plate, did an important study that needed to be done, got an answer and got it at a relatively low price given the importance of the marketplace, both in terms of health and indeed the fact that we spend probably about $20 billion a year on anti-hypertensive drugs. So I think there is a message for other common treatments where we need to do these kinds of studies.

RAY SUAREZ: Dr. Whelton, thanks a lot.

DR. PAUL WHELTON: My pleasure.


Bitter Medicine

Pills, Profit and the Public Health
http://abcnews.go.com/onair/ABCNEWSSpecials/pharmaceuticals_020529_pjr_feature.html

May 29 [2002] First there was aspirin to treat pain and inflammation, then came Advil, Aleve, and 40 other similar drugs. By 1999, Celebrex and Vioxx were on the scene, and they now outsell every other prescription pain reliever on the market. Every year, $4 billion is spent on Celebrex and Vioxx alone. "There's never been a study showing that they are more effective at relieving symptoms of joint pain and inflammation than all these other medicines that have been available for many, many years and are much more affordable," said Dr. Matt Handley, a physician with Group Health Cooperative, a non-profit managed-care organization in Seattle.

On top of the $532 million spent every year on over-the-counter drugs, consumers spent $90 billion more on prescription drugs last year than the $64 billion that was spent just six years ago.

And yet, there is little evidence that the huge increase in spending is dramatically improving the health of Americans. Are consumers getting their money's worth?

$802 Million for One New Medicine

Why do prescription drugs cost so much money?

According to a Tufts University study, on average it costs $802 million to bring one new medicine to market. The high cost of drug development is the industry's justification for the high price of drugs.

"The $802 million figure is used by pharmaceutical firms, I believe, to help explain the enormous challenge involved in bringing a new product to market," said Ken Kaitin, who runs the Tufts Center for the Study of Drug Development. "These are extraordinary costs to bring individual products to market."

While it is not possible to look at a breakdown of research costs companies aren't required to make this information public their profits are public, and the drug industry is the most profitable industry in the country." Their R&D [research and development] costs could be $15 billion, $15 trillion, $15 gazillion, and it wouldn't matter if their profits are double that," said Dr. Marcia Angell, a former editor of the New England Journal of Medicine.

The drug industry claims its high profits are necessary in order to conduct expensive research and development. It spends more on research than any other industry.

The federally funded National Institutes of Health may be the drug industry's biggest benefactor. This government agency alone will spend more than $23 billion on research this year. And much of the research benefits the drug industry.

"There's no other industry in which you have so much public investment in the fundamental knowledge that enables the development of the commercial industry itself," said Dr. Bernadine Healy, who used to run the NIH. And how important is this publicly funded research to the industry? The NIH looked at the five top-selling drugs of 1995 in a report. It found that "NIH-funded research played a critical role" in discovering each one of those drugs.

But however much it may actually cost to develop a drug, which drugs are consumers getting for their money?

New drugs similar to existing drugs

A closer look reveals that much of the profits from prescription sales are not derived from breakthrough drugs, but rather from drugs that are similar to already popular medications.

When a drug company submits a drug to the Food and Drug Administration for approval, the agency tries to determine how important the drug may be. And the FDA divides all drugs into two categories: "priority" drugs which are believed to be a "significant improvement" over what already exists, and "standard" drugs which are similar to what exists.But, adding up all the drugs approved over the past six years, 80 percent of all those drugs were deemed by the FDA to be similar to what already exists. In other words, not a significant improvement.

"I think the level of innovation that we're seeing from the pharmaceutical industry is really mixed," said Nancy Chockley, who runs an institute funded by managed-care organizations. In a new report, NICHM found the percentage of new, innovative drugs coming from the pharmaceutical industry is actually decreasing.

"What we found is that over the last 12 years that there's really been a shift in the type of new drugs being approved by the FDA," said Chockley. "And we found that most of the growth was really in drugs that did not show any significant clinical improvement."

Extending the patent life

The patent system gives companies an exclusive monopoly for the length of the patent meaning they can make huge profits. That is the incentive drug companies have to continually invent new drugs. Then, when the patents on those drugs expire, other companies can copy the drug, make a generic version, and the new competition in the marketplace lowers the price. The FDA says the generic drugs are just as good as the original drugs.That's the way the patent system is supposed to work, but that is not the way it always works. The drug industry's lawyers and lobbyists have created or found so many loopholes in the laws that some generic drugs are often delayed or never get to market.

BuSpar is an anti-anxiety drug manufactured by Bristol-Myers Squibb. After the company had had a monopoly on the drug for years, the patent on BuSpar was set to expire on Nov. 21, 2000, which meant a cheaper generic version was supposed to be approved by the FDA and available to consumers the next day.

And then, just hours before its patent on BuSpar expired, Bristol-Myers Squibb got a new patent on what the drug becomes after you swallow it. And the law is written in such a way that Bristol-Myers was able to then keep the generic drug off the market, claiming that it would violate its new patent. There was no innovation involved only an innovative legal strategy.Dr. Carol Ben-Maimon, who has worked in the drug industry for 15 years and is chairwoman of the Generic Pharmaceutical Association, believes that Bristol-Myers was in this for profit and not public health. "I don't think there's any question," she said. "They didn't do anything to the product to improve it. "

Bristol-Myers was sued by the generic companies, which claimed that the last-minute patent filed with the FDA should not keep the generic drug off the market. It took four months for a court to rule in the generic companies' favor.

"During those four months, Bristol-Myers continued to have the exclusive right to sell this product on the market, no generic competition, and I believe this product is about, over a $700 million-a-year revenue product for Bristol-Myers," said Rob Funston, an attorney for a company that produced the generic version, Watson Labs. "So during those four months, they made approximately $200 million."

When asked several times to discuss its strategy to extend the patents on BuSpar and on other drugs, Bristol-Myers refused.

Less innovation

Many experts believe the industry, in general, is producing fewer innovative drugs.

"If I'm a manufacturer and I can change one molecule and get another 20 years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac, instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less-certain endeavor, which is looking for brand-new drugs," said Dr. Sharon Levine, the associate executive director and a pediatrician for the Kaiser Permanente Medical Group. She is responsible for assessing the best resources for the medical group, including helping decide which drugs are used.

But with so many drugs for each of these conditions, how are consumers supposed to know which drugs are the best? Surprisingly enough, the FDA says a new drug does not have to be any better than what already exists. "All you have to be able to prove is that the drug is better than nothing," said Levine.

The rules by which this hugely profitable industry operates do not always serve customers adequately. The Federal Trade Commission is investigating whether drug makers illegally delay generic competition. Some members of Congress are trying to close the loopholes in the law to make it easier for generic drugs to become available.

However, the drug industry has enormous influence in Washington. The pharmaceutical industry has more registered lobbyists than the number of senators and congressmen combined.

http://abcnews.go.com/sections/community/DailyNews/chat_pharmaceuticals020530.html

Moderator 

Dr. Levine, welcome and thanks for joining us. We'll begin with a question from Robert E. McLeod:

"Who is looking out for the consumer? Many, if not most physicians depend on the drug companies for education on new pharmaceuticals. Isn't that the same as asking the fox to watch the hen house? The drug representatives are looking for sales. They are trying to make more money but who is looking out for the consumer's interest?"

Dr. Sharon Levine

That's absolutely right. Physicians have a need for an independent source of credible information free from the influence of the drug industry. Drug reps' jobs are to sell and the federal government needs to sponsor the kind of research to provide physicians with that independent information.

Moderator

Edio Zampaglione, MD, writes: "The pharmaceutical industry is doing what just about every business in this country does trying to make money for itself and shareholders. If the incentive to make profits is taken away, then it will be the public who will suffer in the long run when there are no new breakthrough medications and treatments being developed."

Any comment?

Dr. Sharon Levine

The issue is balance. The need for innovative pharmaceuticals is genuine. But the incentive needs to be structured so that profit results from true innovation, not clever marketing or clever lawyers exploiting loopholes in patent laws.

Consumers today are being asked to pay an exorbitant price for the promise of innovation in the future. I think the program last night demonstrated very well that a lot of what is being sold as innovation is really just repackaging of existing drugs.

Steve Berna asks:

I was interested to know about what you think of the PPI drug class. Do you find similar evidence that the new class of PPI drugs (Nexium/Prilosec) is not significantly better than the older drugs (Tagamet)?

Dr. Sharon Levine

The PPI (Proton Pump Inhibitor) represented an innovative drug when it was introduced to the market. The issue with the PPIs is that they are being vastly over-prescribed and vastly over-utilized.

This is a drug which has genuine benefits for very specific conditions such as Peptic Ulcer Disease and GERD. What we see in the marketing and advertising is that people with heartburn are being encouraged to use the drug, when the older H2 blokers (Tagamet) would take care of the symptoms and the conditions.

So it's an issue of over-prescribing and over-utilizing an expensive PPI for many people for whom an established, effective and less expensive H2 blocker would do.

Moderator

A number of people in our audience say last night's broadcast was off the mark regarding the benefits of Celebrex and Vioxx compared to the older, over-the-counter anti-inflammatory drugs.

Amanda Herman writes: "After watching the program, I found it interesting that about 15 minutes was taken up by bashing Celebrex and not Vioxx. Why was it not expressed that these new drugs are significantly safer, especially in the GI tract? Seventeen thousand people die every year from a GI bleed. Drug companies are producing SAFER drugs for the public to use."

And from Peggy: "I disagree with the doctor who spoke about Ibuprofen and Aleve giving the same relief effects for osteo arthritis. Having suffered for over two years with tremendous hip pain, hand pain, and using up to 2400 mg of ibuprofen and then four Aleve a day, I bless the day my doctor suggested Vioxx. I feel like a new person."

Can you comment?

Dr. Sharon Levine

Celebrex and Vioxx have a demonstrated modest benefit for patients who are at high risk for a GI bleed. At most, that represents 4-5 percent of the population, and it's only a modest benefit. Neither drug eliminates the risk of a GI bleed completely.

What we see is that 55 percent of all the prescriptions for NSAIDS in this country today are for Celebrex and Vioxx. So a huge number of people are paying a very expensive premium for protection against a risk they don't have.

For Peggy: the research does not look at individual results it looks at large numbers of people in order to demonstrate that on a statistical basis, these drugs have a high likelihood of being more effective for pain reduction and inflammation reduction. Both of these drugs, Celebrex and Vioxx, failed that test time and again.But that doesn't mean that in an individual situation, it may not be the best medication for a specific patient. And for Peggy, it may make sense if it's the only anti-inflammatory that gives her relief.

My point in the broadcast was that for most people, it doesn't do a better job, and there's tons of research that supports that.

Gerry Grasso says:

What disturbed me most in the broadcast last night was the fact that no one, not even the medical community, seems to have the objective data needed to evaluate the value of prescription drugs. Where does a wary buyer go for information?

Dr. Sharon Levine

There are a number of people who are beginning to take seriously the need for good, independent pharmaco-economic research that answers the value question. It's difficult work to do because many times the true value of a drug takes a decade or so to emerge.

But it's absolutely essential that it be done, and that consumers begin to ask the value question of their doctors and of their pharmacists, and that is: Am I getting a dollar's worth of health value for every dollar I spend on these very expensive drugs. Is there an equally effective generic drug that will treat my condition?

There really isn't a particularly good source of consumer information comparing the cost and benefits of similar drugs that do the same thing.

The best thing most patients can do today is ask their doctors to help them determine what the most cost-effective drug is for their situation and encourage their physicians to begin to ask the same questions of the pharmaceutical industry, representatives in the federal government and the FDA. This is an issue that requires national action.

One good source of information for physicians is the Medical Letter. JAMA and the British Medical Journal, particularly in the last several years, have published good articles looking at the relative efficacy and value of prescription drugs.

J. Coghlan asks:

Is it possible and probable to enact legislation that would effectively close the loop holes that allow drug companies to re-patent 20-year-old drugs with only minor alterations and would this press the big drug companies to come up with more radically beneficial drugs at a faster rate than at present?

Dr. Sharon Levine

I think so. I think the case has been made many times that the way you structure incentives determines what you get.

It's much cheaper to pay lawyers to preserve patents and much faster than it is to develop innovative new drugs.

Some of these issues around the patent extension are addressed in a bill that is pending in Congress the McCain-Schumer bill. That would be a good start.f67wes says:

No one mentioned the culpability of the insurance companies in the cost inflation. Since insurance companies won't pay for over-the-counter drugs, the doctor feels compelled to prescribe 'something' so that the patient doesn't have to pay for his/her medications. Often the patient liability is as much or more than the cost of the over-the-counter drug, but he/she doesn't know it.

Dr. Sharon Levine

Consumers are led to believe that if a prescription is covered by their insurance company, it is less costly to them than an over-the-counter drug.

The reality is that oftentimes the cost of the over-the-counter drug is less than the drug co-pay the consumer is paying.

When a physician prescribes and a consumer uses a very expensive drug, when an inexpensive or generic over-the-counter drug would work, the consumer is paying for the drug. They're just paying for it in the form of a rapidly-increasing monthly premium for their health insurance.

Moderator

Finally, from Judith Passmore: "So how do we convince the general public, especially those who pay for their own prescriptions, that newer (and more expensive) is not necessarily markedly better?"

Dr. Sharon Levine

Judith has raised the million-dollar question. I think the first step is for people to ask the question: How do I distinguish "new" from "improved?"

Clarinex is Claritin in a new package. In fact, when you swallow Claritin, your body makes Clarinex. When Claritin loses its patent protection later this year, why would you pay a premium for Clarinex?

When you dissolve Prilosec, you get Nexium in another metabolite. When Prilosec loses its patent protection, why would you pay a premium for Nexium?

In both cases, the manufacturer is trying to convince consumers that "Nex" drugs are improved just because they're new.

As consumers and as physicians, our biggest challenge to the pharmaceutical industry must be: Convince me that this is not just new, but really better.

Your viewers have raised all the right questions and all the right issues. When physicians and consumers together begin to ask the hard questions, hopefully we'll get some better answers from industry.

Moderator

Our thanks to Dr. Sharon Levine and all those who joined the live chat.

Moderated by ABCNEWS.com's Saira Stewart

_______________________________________________

 

XI - Big Pharmaceuticals, Big Money
By Wanda Hamilton - Publication date: August 24, 2001

"The top 10 drug companies are reported to have profits averaging about 30 percent of  revenues-a stunning margin. Over the past few years, the pharmaceutical industry as a  whole has been by far the most profitable industry in the United States." Angell M, "The Pharmaceutical Industry-To Whom Is It Accountable?" New England Journal of  Medicine, June 22, 2000.

"In every year since 1982, the drug industry has been the most profitable in the United  States, according to Fortune magazine's rankings. During this time, the drug industry's  returns on revenue (profit as a percent of sales) have averaged about three times the average for all other industries represented in the Fortune 500." Public Citizen Report,  "Rx R&D Myths: The Case Against the Drug Industry's R&D 'Scare Card," July 23, 2001.

"Put together, the market capitalization of the four largest [pharmaceutical] companies is  more than the economy of India." David Earnshaw, formerly director of European  government affairs for SmithKline Beecham, now leader of Oxfam's campaign on access  to medicines. Quoted in Roger Dobson, "Drug Company lobbyist joins Oxfam's cheap  drugs campaign," BMJ, 322, April 28, 2001, p. 1011.

The international illegal drug cartel no doubt makes a lot of money, but the risks are very  high and include death by multiple gunshot wounds. The big pharmaceutical companies,  on the other hand, make even more money, and the worst risks they face are such things  as lawsuits. Furthermore, instead of trying to put them out of business, the U.S.  government uses tax dollars to help them develop highly profitable new products.

Just how much money is involved in legal drug sales? According to IMS Health's Drug  Monitor Report, pharmaceutical sales in major world markets were $179 billion for the  fiscal year ending March 1998. Of that, U.S. sales accounted for $68.7 billion. By March 2000, IMS America reported that in the U.S. alone prescription drug sales had climbed  to an astonishing $145 billion, and those monitoring U.S. prescription drug sales expect  this trend to continue
at least for the next nine years. Since 1993, nationwide spending for prescription drugs has increased at an average annual rate of 12%, while all other types of  health spending increased at an average annual rate of only 5%. The cost of drugs is now  outpacing the cost of physician care in the U.S. and Canada.

"Historically, hospitals have constituted the greatest of Canada's total health expenditures,  followed by the combined cost of all physicians' services, with drug expenditures in third  place. In 1997 drug spending vaulted into second place, at 14.5% of the total $79 billion  spent on public and private health costs. (Spending on physicians' services represented 14.2% of expenditures; hospitals 32.5%). By 2000, drugs were 15.5% of total  expenditure." Candis McLean, "The Real Drug Pushers," Report Newsmagazine.

The enormous growth in drug sales isn't due to a growth in revolutionary new drugs.  According to a new report by Public Citizen, only about 22 percent of new drugs brought  to market in the last 20 years were truly innovative drugs representing important  therapeutic improvements over existing drugs (Public Citizen report, "Rx R&D Myths:  The Case Against The Drug Industry's R&D 'Scare Card,'" July 23, 2001). According to  many experts, the single biggest factor in
the increase in drug sales can be summed up in  one word: Marketing.

Breakthroughs Down, Marketing Up

"Last year, the Food and Drug Administration approved just 27 wholly new drugs, down  from 53 in 1996." Gardiner Harris, "Pitch to Switch," Wall St. Journal, May 21, 2001,  p.1A.
 
"Overall, the industry's marketing and administration expenses are generally more than  twice those of research and development. At Pfizer, for instance, marketing and  administration make up 39% of expenses, compared with 17% for R&D.. A Pfizer  spokesman says the company 'is very optimistic about the future' and relies not only on launching new medicines but increasing the sales of old ones. While that can be done by  testing new uses to old drugs and combining them with other drugs, the best means is  boosting marketing budgets." Gardiner Harris, "Drug Firms, Stymied in the Lab, Become  Marketing Machines," Wall St. Journal, July 6, 2000, p. A1.

"If one company epitomizes the modern drugs industry it is Pfizer. Just a decade ago, it  was regarded as an industry also-ran. But the US company has powered its way up the  global ranking list to its unassailable position thanks mainly to its marketing prowess..  While some of Pfizer's research has been excellent, its success stems largely from its  ability to turn drugs-often ones licensed in from its competitors-into multi-billion dollar  products." David Pilling,
"Pharmaceuticals 2001/Sales & Marketing: Relentless rise in role  of reps and big launches," Financial Times, April 26, 2001.

While they have not run completely dry, the pharmaceutical industry's labs simply aren't  producing many important new medicines. As one industry spokesman put it, all the  low-hanging fruit has already been picked. Because the big companies' own labs aren't  coming through,
they are increasingly relying on licensing new drugs from universities,  government or smaller companies that hold the patents
for them.

Sometimes these licensing agreements are very complex. For example, Advanced  Therapeutic Products (ATP) patented the technology forming the basis of both the  Nicorette and Nicotrol nicotine inhalers. Pharmacia acquired the production rights for the  inhaler from ATP for a percentage of product payments. Pharmacia, in turn,  manufactured the Nicorette inhaler for SmithKline Beecham and the Nicotrol inhaler for  Johnson & Johnson subsidiary McNeil, and these two companies market the inhalers  under their own trademarks.

Many, if not most, of the biggest-selling drugs are actually developed through government  grants to universities or individual researchers.

"According to NIH [National Institutes of Health], taxpayer-funded scientists conducted
55 percent of the research projects that led to the discovery and development of the top  five selling drugs in 1995." "Rx R&D Myths: The Case Against the Drug Industry's R&D  'Scare Card,'" Public Citizen report, July 23, 2001.

Though it has not yet been clinically tested for FDA approval, the new orally ingestible  nicotine for smoking cessation drugs was developed by two Duke University researchers  with funding by the U.S. Department of Veterans Affairs. The researchers have already  sold production rights to a small pharmaceutical company. This company in turn will no  doubt sell ingestible nicotine formulations to one or more of the big pharmaceutical  companies, which will fund the  clinical trials, get FDA approval, and then market the new  cessation drugs under their own trademarks.

Thus, the taxpayers, not the big pharmaceutical companies, actually pay for much of the  basic research for new drugs entering the market. 

"In 1999, the National Institutes of Health (NIH) provided $17.8 billion for research, and  the major proportion was expended for basic research; the top 10 pharmaceutical  companies spent $22.7 billion, primarily on clinical research." DeAngelis CD, "Conflict of  Interest and the Public Trust," JAMA 284(17), Nov 1, 2000. 

"45 of the 50 top-selling drugs from 1992-1997 received government funding for some  phase of development, according to an investigation by The Boston Globe. In all,  taxpayers spent at least $175 million helping to develop these 50 drugs." "Rx R&D  Myths," Public Citizen report, July 23, 2001.

In addition to licensing new drugs to market, the big drug companies are also focusing on  developing "me too" drugs (products almost identical to drugs already on the market),  finding new medical applications for existing drugs, and marketing "new" formulations of older drugs. But all of these require little investment in basic research. In fact, they are  more akin to new marketing tools than anything else, despite the clinical testing that must  be conducted
for FDA approval.

"Consider the welter of very similar drugs to lower cholesterol levels. Developing  genuinely innovative drugs is difficult and chancy. It is easier to make 'me-too' drugs or  minor variants of
established products. To be profitable, the variation need only be sufficient to secure a new patent, and the rest is marketing." Angell M, "The  Pharmaceutical Industry-To Whom Is It Accountable?" New England Journal of  Medicine, June 22, 2000.

Johnson & Johnson's Nicotrol patch is essentially the same as SmithKline's Nicoderm  patch and neither was developed by the companies marketing them. Glaxo Wellcome's  Zyban for smoking cessation is exactly the same thing as Glaxo Wellcome's older drug Wellbutrin for depression. GlaxoSmithKline's see-through patch is the same old wine in a  new bottle as is the company's "new" orange-flavored Nicorette gum.

Direct-to-Consumer Marketing

Since 1997, when the FDA relaxed television and radio advertising restrictions for  prescription drugs, the big pharmaceutical companies have increasingly turned to  direct-to-consumer (DTC) marketing to increase their profits.

"Last year pharmaceutical companies spent $1.8 bn on 'direct to consumer' advertising,  mostly on television. Advertising expenditure in 1999 rose by 38.5% from the 1.3 bn  spent in 1998, and was 33 times the amount spent on media advertisements in 1991."  Fred Charatan, "Prescription drug sales boosted by advertising," BMJ, 321, Sept. 30, 2000, p. 783.

And it appears to be working. As the big drug companies have poured more and more  money into DTC television ads, drug spending has risen enormously, and the bulk of the  rise was accounted for by increased sales of the most heavily advertised prescription  drugs.

"Doctors wrote 34.2% more prescriptions in 1999 than in 1998 for the 25 drugs  promoted direct to consumers that contributed most to overall drug spending. Doctors  wrote only 5.1% more prescriptions for all other prescription drugs." Charatan, BMJ,  Sept. 30, 2000, p. 783.

However, some physicians and industry watchdog organizations are becoming  increasingly alarmed by the influence of the drug companies' direct-to-consumer  advertising tactics. They point out that not only do all drugs-especially prescription  drugs-have negative side effects, but that such continual bombardment by drug ads  "normalizes" taking drugs.

"It's insidious; companies want you to think there's something wrong with you. It's saying  in effect, 'If you've got a problem, the way to deal with it is through pills.' It's also  'medicalizing' a problem which may not be a problem you need to deal with, like male  pattern baldness or shyness. Once you have a drug, it becomes a medical problem." Dr.  Joel Lexchin, a Toronto physician and member of Medical Reform Group. Quoted in  Candis McLean, "The real drug pushers," Report Newsmagazine, Mar 19, 2001.

In addition to increasing numbers of these highly profitable "lifestyle" drugs, the  pharmaceutical industry has capitalized on the current medical focus on prevention by  turning out more and more medications designed to prevent disease, such as drugs to  lower cholesterol and blood pressure levels and a host of new vaccines. While some of  these drugs undoubtedly do help prevent disease for some people, they are sometimes  prescribed when there is not a clear
and compelling need for them (or when  industry-friendly quasi-government panels lower the bar for what is deemed high blood pressure or high cholesterol).

Even such toxic and costly pharmaceuticals as chemotherapy drugs are sometimes used  without sufficient justification, despite their serious side-effects.

"Many patients with cancer receive chemotherapy at the end of life, even if their kind of  cancer is known to be unresponsive to the drugs, according to a study reported at the  recent annual meeting of the American Society of Clinical Oncologists held in San  Francisco." Gottlieb S, "Chemotherapy may be overused at the end of life," BMJ, 322,  May 26, 2001, p. 1267. Dr. Ezekiel Emanuel, lead author of the study, also noted that  chemotherapy is very expensive, $38,308 for treatment of a patient in the final year of life  as compared to $27,567 for a patient not in the final year of life.

While treating cancers known to be unresponsive to chemotherapy with these drugs may  do nothing to help suffering patients, it certainly benefits the pharmaceutical companies  providing the drugs.

The fact is that all drugs, not just chemotherapy drugs, have potentially serious side  effects, and no drug should be prescribed unless it is truly necessary to the health and  well-being of a patient. Not even if the patient insists on having it because he or she has  seen an upbeat television ad and is convinced that the advertised wonder drug will cure all  of life's pains and anxieties.

Side-effects and Medication Errors

"[P]rescription drugs.account for more deaths each year than all murders, auto  accidents and airplane crashes combined. It is estimated that 100,000 people die every  year from the adverse effects of prescription drugs, and 1 million are injured so severely  they require hospitalization." Thomas Moore, "Prescription drug risks are too high," The  Miami Herald, April 12, 1998, p. 6L.

"It has been estimated that fatalities directly attributable to adverse drug reactions are the  fourth to sixth leading cause of death in US hospitals, exceeding deaths caused by  pneumonia and diabetes. The economic burden resulting from drug-related morbidity and mortality is equally significant and has been conservatively estimated at $US30 billion  dollars annually, and could exceed $US130 billion in a worst-case scenario." White TJ,  Araakelian A, Rho JP, "Counting the costs of drug-related adverse events,"  Pharmacoeconomics, 15(5): 445-58, May 1999.

"David Lawrence, CEO of Kaiser Permanente, the nation's oldest HMO, calls  medication errors 'the number one public health risk in the United States, ahead of  tobacco, alcohol, [illegal] drugs, or guns." Ted Sandoval, "Cutting Medication Errors  Requires Proactive Steps," Web MD, Medcast, June 20, 2000.

All drugs have negative side effects, even aspirin. However, prescription drugs have far  more potentially dangerous side effects than do over-the-counter medications. Most  people who take these drugs according to their physicians' directions do not experience serious side effects, but some do. Some people have severe allergic reactions, some  suffer heart attacks or seizures, and some experience organ damage because of the  prescription drugs they take. One of the
most common serious drug problems is liver  damage because most medicines taken by mouth are ultimately processed through the  liver.

In addition to the negative side effects induced by individual drugs, some drugs interact  negatively with certain foods or with other drugs.

Another factor involved in the large number of people killed or made ill by prescription  drugs are medication errors, and the primary reason for medication errors can be traced  to the sheer number of prescription drugs on the market.

"There are currently more than 17,000 trade and generic names for drugs in the United  States, according to the Institute for Safe Medication Practices in Huntingdon Valley, Pa.  The organization also estimates that the number of drugs on the U.S. market has grown 500% in the last decade." Braus P, "Want to avoid drug errors? New software can help,"  American College of Physicians-American Society of Internal Medicine Observer, April 2001.

The vast majority of these drugs are not important, breakthrough medications, but  "me-too" drugs, generic versions of name-brand drugs, new variations of older drugs, and  old drugs with new names for new medical applications. But with so many medications  and so many names for the same medications, it is not surprising that there are medication  errors, including negative drug interactions.

"With so many people on so many pills, small wonder that part of the increase in  healthcare costs is illness caused by drug interactions. A Queen's University study of  seniors' medication released in January, for example, found that in 96% of cases studied,  doctors' knowledge of their patients' medication use was inaccurate. On average, the  patients had a daily dose of seven medications." Candis McLean, "The real drug  pushers," Report Newsmagazine, March 19, 2001.

Given so many potential hazards-from prescription errors to life-threatening side effects-it  is clear that pharmaceutical products can kill as well as cure. Nevertheless, most people  navely
continue to believe that FDA approval means a drug has been thoroughly tested  and is safe for them to use.

Clinical Tests

"Baycol is the 12th prescription drug to have been taken off the U.S. market because of  dangerous side effects since 1997. Some critics said many of those bans happened  because the FDA, under political pressure, had sped up drug approvals during the 1990s.  Baycol was not a 'fast-track' drug: The agency spent 11 months reviewing it before approving it in 1997." "Bayer Pharmaceutical's Cholesterol-Lowering Drug Baycol  Linked to Deaths, Pulled Off Market," AP, Aug. 8, 2001. One of the statin drugs, Baycol  destroyed muscle tissue and was
linked to 31 deaths in the U.S. and 9 abroad.

"Rezulin [a diabetes drug] was taken out of pharmacies and off the market. But by then it  was linked to 63 deaths from liver failure." "FDA: Guardian Or Rubber Stamp?" CBS  Evening News, July 12, 2001.

Critics of the FDA point out the agency's close ties to the big drug companies as one of  the problems in the drug approval process. A USA Today report found that more than  half the advisors to the FDA have "financial relationships" with drug companies that have  an interest
in FDA decisions (De Angelis C, "Conflict of Interest and the Public Trust,"  JAMA, Nov 1, 2000). But even if panel members involved in approving a drug are  scrupulously honest, they still depend on data from that company's clinical trials to  approve the drug as safe and efficacious, and the data can be misleading.

Pharmaceutical companies are well aware of how to manipulate clinical trials and the  resulting data to show their products in the most favorable light.

"Efforts by drug companies to suppress, spin, and obfuscate findings that do not suit their  commercial purposes were first revealed to their full, lethal extent during the thalidomide  tragedy. Although government drug regulation schemes around the world are now in  place,
the insidious tactics of big pharma have changed little." "The Tightening Grip of Big  Pharmaceutical Companies," Editorial, The  Lancet, April 14, 2001.

For example, a clinical trial might over-select young, healthy subjects when the drug being  tested is intended for use primarily on older patients.

"Rochon et al. found that only 2.1 percent of subjects in trials of nonsteroidal  anti-inflammatory drugs were 65 years of age or older, even though these drugs are more  commonly used and have a higher incidence of side effects in the elderly." Bodenheimer  T, "Uneasy Alliance-Clinical Investigators and the Pharmaceutical Industry," New England Journal of Medicine, 342(20), May 18, 2000.

After FDA approval, it was discovered that Glaxo Wellcome's flu medication Zanamivir  could be dangerous for patients with underlying respiratory diseases such as asthma or  other chronic pulmonary illness. After some deaths were reported, the FDA issued a  warning and required labeling changes for the drug.

Or in comparison trials, the drug being tested might show that it is more efficacious than  the drug it is being compared with simply because higher dosages of the new drug were  administered. And, since the data from the trials are generally housed and often analyzed  by the drug companies themselves, unfavorable results can be suppressed or long-term  data showing negative effects might not be presented.

The highly advertised (and expensive) anti-inflammatory drug Celebrex was hailed by an  article in the Journal of the American Medical Association as vastly superior to existing (and far less expensive) anti-inflammatory drugs such as aspirin and Ibuprofen (Motrin  and Advil) because it eliminated the problem of gastric bleeding associated with these  drugs. However, researchers at the Therapeutics Initiative in Canada discovered that the  study's authors had cut the trial data off at six months. The longer-term results showed  that Celebrex was also associated with gastric bleeding, but that it just took longer for  these side effects to manifest themselves. The FDA had concluded that there were no  major differences between Celebrex and the existing medications, but the published study  in JAMA left out the longer-term data.

"Perhaps even more importantly, the [Therapeutics Initiative] report suggests significant  safety concerns. 'Any benefit in serious gastrointestinal side effects appear to be cancelled  by increased cardiovascular events, including heart attacks, clotting, hypertension and  heart failure,' Dr. Wright [director of TI] declares. Celebrex may be 'trading off a  decreased chance of stomach ache and ulcer for potentially serious cardiovascular  problems.'" Candis McLean, "The real drug pushers," Report Newsmagazine, March 19,
2001.

Celebrex is now being clinically tested for lung cancer prevention and has already been  approved by the FDA for use in preventing colon cancer in patients who are at  particularly high risk for the disease ("Celebrex Under Study for Lung Cancer  Prevention," ScienceDaily Magazine, Aug. 8, 2001).

As bad as some of the manipulations of clinical trials and study data and published clinical  reports are, none approach the sheer immorality of some of the drug companies' clinical  trials conducted in developing countries. Test subjects in developed countries today are  legally protected against abuse, but protective laws in some poorer countries are more lax  and are not as rigidly enforced.

"An investigation into corporate drug experiments in Africa, Asia, Eastern Europe and  Latin America reveals a booming, poorly regulated system in which experiments involving  risky drugs proceed with little independent oversight, and impoverished, poorly educated  patients are sometimes tested without understanding that they are guinea pigs. These  foreign trials speed new drugs to the marketplace-where they are often sold mainly to  patients in wealthy countries." Joe Stephens, "Testing drugs: Overseas trials lack  oversight: Companies target patients in poor nations," The Miami Herald, Jan 7, 2001, p.
1L.

"'We're colonizing a region for clinical trials' declared Juan Pablo Guzman, who has  worked on clinical trials in Latin America for Searle and Pharmacia, at June's annual  meeting of the Drug Information Association in San Diego. 'We have to believe there is  gold at the end of the journey.'" "Latin America is fertile ground for experiments," The  Miami Herald, Jan 7, 2001, p. 3L.

In one such instance, researchers for Pfizer clinically tested what the company believed to  be a promising new antibiotic on Nigerian children who had fallen victim to the country's  meningitis epidemic. Among the 200 test subjects, 11 died and others suffered meningitis-related symptoms such as seizures, blindness, deafness, and lameness. The  drug being tested, orally-administered Trovan, had never been approved or tested for use  with children, and chemically similar drugs had caused joint damage in animal  experiments. According to an article in the Miami Herald, Pfizer's own internal report  showed children did die shortly after taking oral Trovan.

"The experiment's final report concluded that Trovan and the comparison drug were  equally safe and effective." Joe Stephens, "Testing drugs: Overseas trials lack oversight,"  The Miami Herald, Jan. 7, 2001.

But of course many of the sick and dying in these countries will never be able to afford  treatment with the successful drugs once they are approved as safe and efficacious by the  FDA.

Maintaining the High Cost of Medicines

Increasingly the big multinational drug companies are coming under fire for doing  everything in their power to maintain the high costs of their products, even when those  costs mean that essential drugs will not be available to the poor (or even to some of our  own elderly who have limited incomes).

"Using big money, creative court challenges and a regulatory system prone to delays, the  nation's leading manufacturers of brand-name drugs are fighting harder than ever to keep  cheaper generic imitations off the market.. Generic drug makers have at times enriched  themselves by keeping their products off the market, deliberately, in exchange for  payments from patented drug companies." Greg Fields, "Brand-name drug makers'  tactics slow generics," The Miami Herald, Aug. 17, 2000, p. A1.

By far, the greatest public outcry over the high cost of drugs came as a result of the AIDS  epidemic in Africa. AIDS drugs, such as those manufactured by GlaxoSmithKline, are  extremely expensive, far too expensive for them to be used in developing countries where  the disease is truly at epidemic proportions.

"These drugs aren't expensive because of the cost to develop and manufacture them (many were actually invented at public universities using grants from taxpayers). Rather  they're expensive because some of the pharmaceutical giants that market them demand  huge profits, estimated by Brazil's health minister, Jose Sera, at up to 10 times cost, or 1,000 percent." Tom Fiedler, "AIDS fight boils down to dollars vs lives," Miami Herald  editorial, June 24, 2001, p. 5L.

Smaller drug companies in such countries as India and others in sub-Saharan Africa  sought to manufacture affordable versions of the AIDS drugs for use in their own and  other poor countries, but the big multinationals sued the smaller companies, alleging they  were pirating patented drugs.

GlaxoSmithKline ultimately bowed somewhat to public pressure and lowered the cost of  its antimalarial and newer HIV and AIDS drugs to developing countries. However, as  critics pointed out, even with the lowered prices of the AIDS drugs, they will still be too  expensive for the huge majority of Africans.

At the same time, the burden of medication expense for many of our own elderly citizens,  who often take multiple medications, means that they are either doing without essential  drugs or are lowering their use of the medications by deliberately skipping doses (which in  some cases could be more dangerous than not taking the drugs at all). Medicare does not  cover prescription drugs except those administered in hospital. According to Public  Citizen, the big drug companies are charging these seniors twice as much on average as  the companies charge their most favored customers such as HMOs and the Departments of Veterans Affairs and Defense. Public Citizen claims that the mark-up for Medicare  outpatients for Merck's high cholesterol drug Zocor is 144%. The organization says that  the mark-up for Pharmacia's diabetes medication Micronase is a whopping 363%, and  that Abbot Laboratories' hormone treatment Synthroid is even worse at an incredible 1,446%.

The current political solution to this problem of medication cost to seniors is to have the  taxpayers assume the burden for it, but since the taxpayers have already paid for the  basic research to develop many of these drugs and have even paid for some of the clinical trials, that seems asking a bit much of the taxpayers. Perhaps a better solution would be  to put pressure on Big Drugs to come up with a reasonable plan to lower the cost of  necessary medications for seniors-or at least give them the same price breaks they give  their "favored" customers.

There is no question the pharmaceutical industry provides important and necessary  products to improve the health of Americans and save the lives of those who have  infectious and parasitic diseases. However, the big drug companies' marketing and testing  abuses and their almost unbridled influence on public policy (and government agencies)  are major problems in this country and in the world. It could be that their control of the  practice of medicine and of public
health policy is even more dangerous to the health of  society in the long run than some of their drugs are to the health of individual consumers.

Suggested Supplemental Reading Online

"The real drug pushers," by Candis McLean, Report Newsmagazine, March
19, 2001.  http://193.78.190.200/10a/the%20real%20drug%20pushers.htm

"Rx R&D Myths: The Case Against The Drug Industry's R&D 'Scare Card,'"
Public  Citizen report, July 23, 2001.
http://www.citizen.org/congress/drugs/R&Dscarecard.htm

"The Drug-Induced Lung Diseases," Pneumotox Online.
http://www.pneumotox.com

http://www.forces.org/evidence/pharma/bigpharma.htm

http://www.forces.org/evidence/pharma/bigpharma.htm