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THE REASONS WHY SO MANY "GOOD" DRUGS MAY BE GOING "BAD" (PART I)

Jun 1, 2000 Recently, there has been a dramatic rise in the number of prescription drugs taken off the market. Catastrophic side effects, including death, have shaken the public's confidence in the pharmaceutical industry as well as the Food and Drug Administration (FDA), the federal agency charged with monitoring that industry.

Over the course of the past few months, we have written a series of Newsletters on drugs such as FEN-PHEN, REZULIN and LYMErix. Unfortunately, these are but a few of the prescription drugs which have either been recently withdrawn from the market or whose safety has now been placed in question. Part II of this Newsletter will discuss a number of these additional drugs and what has now been reported about them.

In researching this Newsletter, however, we were interested in not only which drugs were under scrutiny and why, but also, the reasons for the dramatic rise in the number of drugs under fire. We hope that this additional insight will be both informative and interesting.

The good old profit motive:

Pharmaceuticals are very big business. In fact, REZULIN alone accounted for almost 500,000 prescriptions in January of 1999 and generated sales of over $1.8 billion between November, 1997 and January, 2000. Thus, it is easy to understand why getting a drug to market as quickly as possible (and then keeping it there for as long as possible) is so important to every pharmaceutical company. This is even more critical when one considers that research and development costs often run into the hundreds of millions of dollars for just one new drug.

In the new "global" economy, pharmaceutical companies also know that a successful drug will be marketed world-wide over the Internet as well as by other drug companies willing to pay for territorial distribution rights. This added marketing potential could, quite easily, multiply a drug's value many times over what it would have been if marketed here alone or slowly introduced into other countries through traditional marketing practices.

Another consideration is that the target group for any drug is limited to those people who have a specific need for it. Thus, while the automobile industry, for example, tries to sell to everyone and makes many different vehicles, models and advertising claims to accomplish that goal, a drug is, almost always, designed for a very specific market. Obviously, you do not take a drug to "keep up with the Joneses," or because it looks pretty, or because it is on sale.

Thus, the goal of every pharmaceutical company is to get their drug to market before the competition is able to market a similar drug. For about two years, REZULIN was extremely successful because it was the newest drug of its particular type on the market. AVANDIA and ACTOS, both marketed in 1999, were well behind REZULIN and hardly household names until REZULIN was withdrawn from the market. Almost overnight, SmithKline Beecham began to flood the airwaves with advertisements for AVANDIA hoping to capture as many REZULIN users as possible before Eli Lilly & Company (makers of ACTOS) also took advantage of the REZULIN debacle.

Clearly, the financial success of today's pharmaceutical companies is directly related to the speed with which they are able to get their products to market. Unfortunately, this mentality has been costly to the public in the case of many drugs that have been marketed without sufficient testing and adequate warnings. Even where a drug is potentially dangerous and may result in litigation, pharmaceutical companies have been known to market it anyway if they believe the profit from the sale of the drug will exceed the cost of the litigation and any damage awards or settlements to injured users.

Increased public awareness:

At no time in history has so much information been available to so many people from so many sources at such speed as in today's world. The media as well as numerous "watchdog" groups investigate and probe any industry or agency that has anything to do so with the public. Since AIDS, cancer, unknown viruses, and other health threats are near or at the top of the news on a daily basis, it comes as no surprise that pharmaceutical companies and the drugs they produce are under constant scrutiny as is the FDA.

Freedom of information laws (FOIL) have also made it easier for those interested, to obtain governmental records that were once off limits to private individuals or the media.

In addition, the Internet allows immediate dissemination of information to every corner of the globe in a matter of seconds. Computers also link together people with common interests who would never have met only a few years ago. Distance, language, and national borders are no longer obstacles to instant (and very detailed) communication. As a result, it has become virtually impossible for any industry, government agency, politician, or entrepreneur to hide information from the public or to control the speed or manner in which it is released.

Blind acceptance and complacency on the part of the public has been replaced with a need to know as much as possible and an unwillingness to accept anything less. Thus, harmful side effects and adverse reactions are now very likely to be exposed immediately regardless of how few and how far apart (geographically) they may be. This ability to "link" most, if not all, of a drug's users together has served to hold the pharmaceutical companies and the FDA to a much higher standard of accountability. It has also acted to bring the efficacy of a drug into question much faster and with far more public impact.

Arrogance on the part of the pharmaceutical companies:

As the size of pharmaceutical companies grow, they have tended to take on the corporate demeanor of multi-national automobile manufacturers or soft drink companies where the "bottom line" is the only real consideration. Unlike defective products in other industries, however, a dangerous drug with harmful side effects may injure, or even kill, an extremely large number of people in a relatively short time and without much, or any, warning. Moreover, a dangerous drug has the added risk of causing injuries that go undetected until they are impossible to cure or treat effectively.

While pharmaceutical companies have done an immeasurable amount of good for mankind, their eagerness to place profit before safety does the public a great disservice. By not adopting realistic standards to weigh the benefit of a drug against its risk to its users has allowed many dangerous drugs to remain on the market much longer than they should have. This is precisely the attitude on the part of Parke-Davis that allowed REZULIN to remain on the market in the United States long after it should have been removed.

To Glaxo-Wel1come's credit (the company with rights to market REZULIN in Europe), its belief that there was no way to predict which REZULIN patients would be harmed and that the incidence of liver injuries and death had become unacceptably high led Glaxo to set in motion the withdrawal of REZULIN from the market in Britain in 1997. Glaxo officials concluded that based upon REZULIN related deaths and liver injuries in the United States and Japan, they could no longer support the position that the benefits of REZULIN outweighed the risks associated with its use. Unfortunately, such concern for the public at large is the exception rather than the rule.

Clearly, it is becoming more and more obvious that science just might be able to create a drug to treat or cure almost anything. The risk, however, is that some of those drugs will, undoubtedly, have side effects which will make their value questionable at best. As a result, the pharmaceutical companies must remember that, in attempting to help mankind, some of the drugs they develop may not be "what the doctor ordered" and it will be up to the companies themselves to withhold or remove the drugs from the market voluntarily and not after a gun is held to their head in the form of an FDA directive or overwhelming public avoidance of the product.

Changing perceptions:

Historically, Americans are risk takers. From the time this country was founded, risk and the "American dream" have gone hand in hand. Settlement of the colonies, the Revolutionary War, westward expansion, World Wars I and II, all demonstrate the willingness of Americans to take the most extreme risks when they believe the cause or the goal to be worth the potential sacrifice.

As we enter the twenty-first century, however, much of the risk has been taken out of everyday life. Moreover, entire generations of Americans have now grown up without the types of risks earlier generations were exposed to on a regular basis. For that reason, risk is not automatically accepted any longer. Instead, people now take risk much more seriously and weigh it against what they perceive to be acceptable under the circumstances.

For example, space flight, which was once regarded as incredibly risky in the 1950s and 1960s, became much less so in the 1970s and 1980s. When three Apollo astronauts died in a fire in 1967, the country reacted to it as a tragedy that occurred in a very dangerous occupation. When the Challenger Space Shuttle exploded in 1986, killing seven astronauts, however, people regarded it as an accident that should not have happened. The dangers associated with space flight were no longer sufficient, in and of themselves, to make the public automatically accept the disaster as part of the risk.

Today, many people engage in "extreme" sports which carry with them risks that far exceed those of any traditional sport. Participants in these "new" sports are well aware of the increased risks they are taking, yet they continue to do so because of the greater freedom, exhilaration and feeling of accomplishment these sports provide.

Another example of changing perceptions with respect to risk can be seen in the stock market. While older Americans shy away from the risk as a result of their familiarity or personal exposure to harsh economic times, younger Americans have taken to trading over the Internet as if it were nothing more than a video game.

In the area of science and medicine, people have lived to see the eradication of many diseases which only one or two generations ago were feared by all. Similarly, the severity of many illnesses has been substantially reduced through advances in treatment and the development of "miracle" drugs. All of this has led people to believe that medical science is no longer a risky business. Unfortunately, it still is the perception to the contrary notwithstanding.

Drugs (all of them) still have side effects and there are risks to every medical procedure. We just don't want to hear about them. In this way, we are partially responsible for the dilemma posed by rushing "promising" drugs to market before they are thoroughly tested or without adequate warnings.

Simply stated, the substantial risks Americans were once willing to take in the war against dreaded diseases are no longer acceptable. As a final example, consider the fifty-year saga of polio. When the disease crippled thousands of children, a vaccine was all that anyone wanted. When the Salk (live) vaccine was developed it was hailed as a miracle of modern science. Although

some children actually contracted polio as a result of taking the vaccine, people only thought of the thousands who had been saved. Later, when the Sabin vaccine, which does not contain live virus, was developed, it was used interchangeably with the Salk vaccine for many years.

Today, however, a major debate rages over whether the Salk vaccine should be taken off the market because of the risk some perceive exists for actually contacting polio from the vaccine, a risk NOT posed by the Sabin vaccine. Thus, depending upon the circumstances, the perception people have of a particular drug can change dramatically even if it is still a viable treatment or vaccine for a serious disease.

People's expectations:

Given the wide array of drugs and other chemical compounds developed over the past several years, it is easy to understand why the public has generally come to expect a cure for everything. Olean replaces fat in snack foods; nicotine patches ease withdrawal from cigarettes and Viagra combats “erectile dysfunction.” There are prescription drugs and over-the-counter treatments for overactive bladders, "gas," yeast infections, baldness, ear wax, acne, age spots and herpes.

This proliferation of chemical compounds, however, does present some significant problems never before encountered by the average person. The first is that of "interaction." While many substances can be taken internally or applied topically without any serious harm being done, the combination of two or more "harmless" substances may very well prove to be dangerous or even deadly. Such harmful interactions are all the more possible when one of the substances is a powerful prescription drug.

A second consideration is that today's drugs are not simple cures designed for simple ailments. The day of aspirin for headaches, Bromo Seltzer for indigestion and Calamine lotion for mosquito bites is long gone. Today, both the ailments' and the remedies are incredibly complex.

Indigestion has become “acid reflux disease” and the simple "Tums for the tummy" has been replaced by PROPULSID (cisapride) which has been linked to serious and life-threatening cardiac arrhythmias. Impotency has become “erectile dysfunction” and the current miracle drug is VIAGRA, which already has numerous problems of its own.

Even aspirin, which has always been considered a true wonder drug and one of the greatest discoveries of the 20th century, has now proven to be an extremely complicated medication. Its once limited use as a remedy for fever and headaches has been expanded to include use as a potentially life-saving heart drug. Unfortunately, aspirin too, is now under scrutiny and may not be as beneficial as once though for heart-related applications. (PROPULSID, VIAGRA and aspirin are but three of the drugs we will deal with in Part II of this article).

Obviously, the more drugs you have, the more problems you may run into when they are taken by vast numbers of people with extremely varied genetic and medical backgrounds. Science is not perfect in this area and drug reactions vary dramatically depending upon factors such as age, sex, overall physical condition, specific medical problems, genetic background, risk factors, allergies, medical history, the presence of other medications and undetermined factors. So, it may very well be unrealistic to expect perfection from anything whose performance may be influenced so drastically by so many variables. The risks inherent in prescription drugs have always been there. Today, however, the overall advances in science have made risk less acceptable regardless of the area of science under consideration. This may be unreasonable.

Consider the following example: Recently, an elected official angered by complaints that the MetroCards (for use on New York City subways) often require two or more "swipes" before they are read by the computerized turnstile, remarked: "If we can send men to the moon and back, we should be able to have this equipment work perfectly every time." Obviously, this remark is an over-simplification and indicative of the problem discussed above.

While we have sent men to the moon and back, ten astronauts have died in the space program. Apollo XIII (as in the movie by the same name) experienced a catastrophic failure on the way to the moon. Only luck and good old human ingenuity prevented three additional deaths. Numerous space missions have been postponed or cancelled because of equipment malfunctions and failures. So, even the space program is prone to the kind of equipment problems experienced in the subway system. Clearly, the millions of MetroCard swipes that work perfectly are what should be analogized to sending men to the moon and back. The MetroCard swipes that do not work are really no different than a blown 0-ring on the Space Shuttle.

It is this unrealistic view of science as being infallible that gets us into trouble. You simply cannot use the example of one scientific triumph, no matter how spectacular, to support the conclusion that every scientific creation must perform flawlessly under all circumstances. Even more dangerous is citing a scientific success in one field as the reason why a much more problematic undertaking in a completely unrelated field should also succeed. MetroCards are not spaceships and prescription drugs are not video games or some other scientific creation that works well most of the time.

While it may not be unrealistic to expect a fully tested and properly labeled (as to warnings) drug to be safe, it should come as no surprise that inadequately tested drugs that are rushed to market with insufficient warnings often prove to be dangerous and unmarketable. Had they been adequately tested, they probably would not have made it to market in the first place.

Thus, our expectations should remain high with respect to drugs that are marketed after adequate testing and with proper warnings. We should not have unrealistic expectations for a drug simply based upon; (1) its manufacturer's claims, (2) misplaced belief that science is infallible, and (3) the desire to eradicate one more of life's ills with a different colored pill.

The "risk" versus "benefit" equation:

In order to understand this concept, consider the following:

Currently, every person with AIDS will die from one or more complications of the disease. Although current drug therapies may delay the inevitable, the sad fact remains that AIDS is a death sentence. Now, imagine a treatment is developed in the form of a pill which has a 99% cure rate. The only side effect is that, for some unknown reason, 1% of the people taking the drug die from it and not from AIDS. That's 1 out of 100, 10 out of 1000, 100 out of 10,000 and 1000 out of 100,000. So, if world-wide, 2,000,000 people suffering from AIDS take the drug, 1, 880, 000 will have their lives saved (without the slightest side effect) while 20,000 will unquestionably die from the drug itself.

Given the above scenario, is there any real doubt that the drug would be considered one of the greatest scientific achievements of all time? Moreover, it is safe to say that the 1% death rate (which is extremely high for a drug of any kind and which would probably prevent the successful marketing or even the approval of any prescription drug) would be ignored by the FDA and every person with AIDS. In other words, approval would be guaranteed. Clearly, where the benefit is so great as to make even a serious risk seem inconsequential, a drug's success is assured.

Now, consider the following: An AIDS vaccine is developed which is 100% effective. The only side effect is that the vaccine kills 1% of the people inoculated with it. Obviously, the risk/benefit consideration is now much different. Even though, if given to everyone, the vaccine would: (1) prevent any new cases of AIDS from occurring; and (2) eventually eradicate the disease, there are numerous reasons why the drug would not be used by everyone and why approval would be hotly debated.

First, an adult who has no foreseeable risk of exposure to AIDS (the HIV virus) might not want to risk dying from the vaccine. Second, parents would not want to risk their children's lives long before the risk of AIDS was even a factor to consider. Third, the risk of death to a healthy person is far more ominous than it is to a dying one. That's why prisoners already sentenced to death or extremely long sentences at hard labor were willing to volunteer for a high-risk military operation in the movie "The Dirty Dozen." You probably could not have come up with 12 volunteers for a suicide mission if you looked for them at Harvard Medical School.

Thus, in this scenario, approval might be much more difficult to obtain especially on an expedited basis. At the very least, the risk would be weighed much more heavily than in the case of an outright cure for those already suffering from AIDS.

Finally, consider the other extreme. A drug is developed that cures snoring. It's 100% effective and has no side effects except for one, the drug causes total paralysis to .01% of the people who use it. That's 1 in 10,000, 10 in 100,000 and 100 in 1,000,000. While snoring has ruined many marriages and even puts people at risk of serious consequences due to related sleep disorders, the chance of becoming a quadriplegic, is probably a bit much to risk in the search for a good night's sleep. It's safe to say that this drug, as successful as it might be, would never reach the shelves. The risk would be just too great when compared to the benefit achieved.

The problem with all of this is that the risk/benefit concept is much like "beauty" in that it is all in the "eye of the beholder." Thus, a few dozen lives, a group of people waiting for liver transplants and a bunch of people with severe liver problems seemed insubstantial to Parke-Davis, the manufacturer of REZULIN, and failed to convince company officials that the risk, from the very beginning, far outweighed the benefit of the drug. (Next month we will examine the drug DIFULCAN which poses risks such as death, liver failure, kidney failure, possible birth defects and many, many others. DIFULCAN is being heavily advertised as an attractive alternative to far less dangerous creams and ointments for the treatment of female yeast infections. We will let you decide if the potential benefit to this particular target group justifies the possible risks they face or if it is just another example of the dramatically different value system used by pharmaceutical companies for making their marketing decisions.)

Another risk/benefit consideration is: what are the alternative uses, if any, for the drug. In some cases extremely risky drugs with horrendous track records have shown promise when used by an entirely different target group for a completely different purpose. In those cases, the risk has gone from grossly unacceptable to quite tolerable while the benefit has gene from marginal to promising. An example of such a drug is THALIDOMIDE.

In 1956, THALIDOMIDE was marketed in Europe as an influenza remedy and mild sedative. It was widely prescribed to pregnant women for morning sickness. By the late 1950's, the drug was approved for sale in the United States with very little additional testing. By 1962, it was confirmed that THALIDOMIDE caused catastrophic birth defects when taken by pregnant women. Graphic photos of grotesquely deformed "Thalidomide babies” were slashed across the front pages of tabloids like The National Inquirer. A shocked America stared in horror at these little "victims" of science and, as a result, THALIDOMIDE was demonized. Although the drug remained on the market with substantially enhanced warnings, its reputation was so tarnished; it was driven into the shadows for well over three decades.

Today, while still carrying some of the strongest warnings of any pharmaceutical product in history, THALIDOMIDE has risen from the ashes and has found an entirely new market. Now, the drug is used to treat severe mouth sores or extreme weight loss and weakness in AIDS patients, as well as ENL (erythema nodosum leprosum) a painful skin problem caused by leprosy (Hansen's disease). It is also being used by bone marrow transplant patients.

Clearly, in the case of THALIDOMIDE, the enormous risk to unborn fetuses when used as a sedative was never justified by the relatively small benefit it was designed to give pregnant women with very minor medical conditions. Today, however, the drug is targeted for use by people with extremely serious (life-threatening) illnesses. Moreover, the drug is used to treat much more serious conditions than it was originally meant to treat in 1956. Most importantly, however, THALIDOMIDE poses less extreme risks to its "new" target market than it does to pregnant women who are now specifically excluded from that market.

Finally, the risk/benefit model must consider other available drugs or treatments already in use. If a drug is the only available treatment for a serious illness, the tolerable risk will be significantly higher than it is for a drug which is only one of several acceptable treatment options. Obviously, as the number of available treatments increases (especially if those options are already proven to be safe and effective), the acceptable risk level for any new drug will drop substantially.

Thus, when it is properly considered, without undue influence from profit motive or behind the scenes in-fighting at the FDA, the risk/benefit model provides an excellent gauge of when to approve (or disapprove) a drug and when to remove it from the market. An analysis of the evaluation of some recent problem drugs, however, demonstrates the willingness of both the pharmaceutical companies and the FDA to engage in a risk/benefit analysis which is both illogical and unjustified. (See for example, our recent article on REZULIN).

Conflicting information:

Although he finds the future to be scientifically advanced in the movie, "Sleeper," Woody Allen soon learns that the greasy, fried junk food he was told to avoid in the 20th Century was really good for you and that the so-called health foods of our era "will kill you."

As we head into the 21st Century, we need not look far to find that; once again, "many a true thing is said in jest." In the past several years, eggs have gone from very good to very bad to not so bad to acceptable. Butter has gone from very good to very bad to actually much better than traditional margarine which was once touted as an absolute must substitute for butter. All alcohol was considered bad until red wine was found to be good for you when taken in moderation. Nuts? Very bad. But now, walnuts, pecans and even the much maligned macadamia nut, good! And, what about oat bran's journey from cholesterol fighter to “has been” in just a few short years?

Consider the range of diets which are, or have been, considered healthy by their respective medical or nutritional advocates, at one time or another. High protein high fat low carbohydrate, low fat low protein high carbohydrate, high fiber, cabbage soup, vegetarian, vegan, rice, "Calories Don't Count," low calorie, grapefruit, pineapple, liquid protein, Slimfast, Jenny Craig, Weight Watchers, Deal-A-Meal, and so on.

If the scientific and medical communities are prone to such vacillation and disagreement on what appears to be relatively simple issues, one must assume that the problem is much more pronounced when dealing with complex chemical compounds and their effect on the human body.

Clearly, when one factors in economic and political considerations, professional reputations, egos and the like, the probability of having conflicting opinions increases while the likelihood of resolving those conflicts quickly, and with the consumer in mind, decreases. In the case of REZULIN, many people died or suffered severe liver damage unnecessarily while the FDA hierarchy quibbled among themselves, with their own staff doctors and with numerous outside experts. Of course, while this occurred, Parke-Davis made over $1.8 billion.

So, in a nation where bureaucratic red-tape has been raised to an art form, once a prescription drug makes it to market, a significant conflict as to its safety often serves to prolong, rather than shorten, its stay there.

The FDA as its own worst enemy:

Although the FDA is one of the most powerful federal agencies, it often succumbs to some of the most petty of human frailties. In the case of REZULIN alone, the FDA was guilty of `internal personality and territorial disputes, extremely questionable conduct by its officials, poor public relations, evidence of a possible cover-up, the issuance of threats against its own staff doctors, the blind acceptance of the pharmaceutical company's data, and the failure to conduct a full and proper investigation.

These unfortunate circumstances figured prominently in the repeated failure of the warnings to be adequate and up-to-date, and the inordinate delay in removing REZULIN from the market. Sadly, this example of "fiddling while Rome burned" cost many lives as well as severe liver damage to hundreds, if not thousands, of other people. In recent years, many medical and scientific experts as well as public interest groups have called for an overhaul of the FDA. The REZULIN debacle has only served to revive those demands.

CONCLUSION:

For years, many have complained that it takes far too long for drugs to be approved for use in the United States. Advocates of that position cite to a number of drugs which have been approved and marketed successfully in other countries without any significant problems. As we hope you have seen, however, the consequences of approving a drug too quickly can be far worse than taking too long to do it. The complex nature of today's drugs and the conditions they are designed to treat make "fast-track" approvals problematic to say the least. When drug interactions and potential short and long-term side effects are factored in, an approval that is done in haste may lack sufficient warnings and turn out to be little more than a ticking time bomb whose benefit is far outweighed by the risks it exposes its users to. To be sure, in some situations the fault may very well be with the pharmaceutical companies which have enormous financial interest in gaining quick approval of a new drug. As we have demonstrated, however, many other factors which have little or nothing to do with the drug companies usually play some role in such situations.

In fact, as pointed out above, problems within the FDA and unrealistic expectations and perceptions on the part of the public often have a negative impact on the approval process. Thus, it is only when the pharmaceutical companies, the FDA and the public work together, with the common goal of developing and marketing safe and effective drugs, that the ultimate users of those drugs are adequately protected and best served. In the field of prescription drug development, "haste, “most certainly, "makes waste." To believe otherwise would be to ignore the reality of why so many apparently good drugs go bad.
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