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More than 40 percent of Americans are now taking at least one prescription drug and one-in-six takes at least three, according to a government reported released in December 2004. Those rates were up from 39 percent and 12 percent between 1988 and 1994, according to the Centers for Disease Control and Prevention. The report said prescription drug use was increasing among people of all ages, and use increases with age. The report found that nearly a fourth (24.1 percent) of people under age 18 were taking at least one prescription medication. The rate rose to 34.7 percent between age 18 and 44, and for those ages 45 to 64, it was 62.1 percent.
"Americans are taking medicines that lower cholesterol and reduce the threat of heart disease, that help lift people out of debilitating depressions, and that keep diabetes in check," said Health and Human Services Secretary Tommy G. Thompson. The report also shows that $216 billion was spent on prescription drugs last year, for 3.4 billion prescriptions - the equivalent of a dozen prescription for every man, woman and child in the United States.
Drugs help save and improve the quality
of many peoples lives. However, in recent years, many drugs
have been linked to serious health problems that clearly outweigh
their potential benefits. According to the Journal of the
American Association, adverse drug reactions resulting from
correctly administered Federal Food and Drug Administration
(FDA)-approved prescription drugs are responsible for over
100,000 deaths per year in the United States making it the
fourth leading cause of death in the United States.
There are also typically over 2.2
million annual occurrences of non-fatal, but serious, reactions,
and millions of complications and disabilities related to
the unexpected effects of drugs and a variety of products.
Many drugs turn ineffective or even
deadly when combined. Harmful drug interaction has become
a serious problem as many older Americans are taking more
and more drugs simultaneously. A quarter of adult Americans
and 40% of those 65 or older take more than five medicines
a week. Since many of these drugs are new, doctors are only
beginning to understand how these drugs interact with other
drugs.
For example many seniors who take Vioxx or Celebrex to ease
their arthritis pain, also take aspirin daily to prevent a
heart attack. Unfortunately patients and many doctors do not
realize that even low doses of aspirin can neutralize the
gentleness of Celebrex and Vioxx and cause stomach upset and
bleeding. Vitamins, popular dietary supplements, and herbal
remedies can also produce harmful reactions or cancel the
benefits of certain drugs. Patients should inform their doctors
about all medications, supplements, vitamins, and herbal remedies
they are taking.
One major factor contributing the
large number of injuries and fatalities caused by fen phen and other prescription
drugs is pharmaceutical companies’ increasing desire
to raise corporate profits at the expense of safety. In recent
years, pharmaceutical companies have aggressively marketed
their products to pharmacies, doctors, health care providers,
and the public at large, and in some instances, have downplayed
the risk of their products by failing to put stricter warnings
on their labels. Additionally, pharmaceutical companies have
pressured the Federal Food and Drug Administration to allow
many new drugs “Fast Track” status in order to
reduce the amount of time involved with the drug approval
process. The abbreviated “fast track” approval
process means that many drugs are entering the market place
with inadequate clinical trials, increasing the risk of serious
side effects and health problems.
According to a report by the Los Angeles
Times, published in December 2003, some of the National Institutes
of Health's (NIH) top scientists are collecting paychecks
and stock options from biomedical firms. Such deals are often
kept secret, raising serious ethical issues. The report suggests
that private consulting fees may tempt government scientists
to pursue less-deserving research and to "put a spin
on their interpretation" of study results. Such consulting
fees create a serious conflict of interest and may possibly
bias NIH scientists in favor of certain drugs and products.
Such bias could lead to serious public health risks.
February 2005 Update: The Los Angeles Times reported that the all staff scientists at the National Institutes of Health (NIH) will be banned from accepting any consulting fees or other income from drug companies, and the employees must also divest industry stock holdings. For the last decade, NIH scientists have quietly been allowed to consult for biomedical companies. Hundreds of NIH scientists took millions of dollars in fees and stock from the pharmaceutical industry. Most of the payments were hidden from public view, raising questions about the scientists' impartiality in overseeing clinical trials and in making recommendations to doctors for treating patients. Some NIH scientists worked for drug companies that benefited directly from their recommendations to doctors. Other scientists appeared at public forums and commented upon or endorsed treatments or drugs without divulging that they were on the payroll of companies making the products they were endoresing. All NIH scientists will be prohibited from accepting consulting fees, speaking fees and any other form of income from all biomedical companies, professional societies and other outside entities. Additionally, NIH scientists must sell or otherwise dispose of any stock or stock options they hold in individual pharmaceutical or biotechnology firms.
Although drug manufacturers are prohibited from marketing or promoting drugs for any use beyond what is listed on the drug label, doctors are allowed to prescribe an FDA-approved drug for any reason they see fit. Off-label prescription drugs are extremely common and account for up to 40% of all prescriptions written each year. According to a 1997 survey by the American Cancer Society, as much as 60% of cancer doctors use drugs for unapproved uses.
Supporters of off-label prescription drug use assert the practice is safe and that off-label use has resulted in many medical innovations that doctors may not have otherwise discovered. The American Medical Association vocally supports doctors' rights to prescribe drugs for any reasons they feel are helpful.
However, some critics charge that the practice essentially gives doctors the power to turn patients into human guinea pigs and that using drugs for conditions never evaluated by the FDA creates a serious risk to patients. For example, only a few years ago, doctors regularly prescribed a combination of two FDA approved drugs - fenfluramine and phentermine - for unapproved weight-loss treatment. The popular drug combination, commonly known as fen-phen, later was charged with causing heart valve damage and primary pulmonary hypertension.
Recent events have suggested that some off-label prescriptions are the product of fraudulent marketing schemes that put patients at serious risk. There is growing concern that some drug companies are finding ways to abuse the systems and promote their products for unapproved uses even when their is little good science to support their claims.
One accepted way in which pharmaceutical companies bypass federal prohibitions on promotion and marketing for off-label uses, is by publishing papers in medical journals citing newly discovered benefits. However, sometimes such papers and underlying research are compromised by the fact that the research is conducted or funded by the drug companies themselves, creating a possible conflict of interest. Moreover, although the FDA prohibits drug makers from distributing unsolicited research materials directly to doctors, the companies often find ways around the rules.
Such practices have prompted the government to investigate the promotional practices of several pharmaceutical manufacturers, including Pfizer, Schering-Plough Corp. and Wyeth.
In May 2004, pharmaceutical giant Pfizer agreed to plead guilty and pay a $430 million fine to settle federal criminal charges that the drug company promoted its epilepsy drug Neurontin for many off label uses for which it had no scientific support. The government's complaint alleged that Pfizer's promotion of neurontin amounted to "an illegal promotion scheme" that put patients "at risk." It is estimated that 90% of Neurontin's $2.7 billion in sales last year were from off label uses of the drug.
Moreover, according to a June 2004 Los Angeles Times article, officials of Schering-Plough acknowledged that the company is under investigation by the U.S. Justice Department for off-label marketing of a cancer medication. Furthermore, Wyeth has stated that the federal government has subpoenaed records involving Wyeth's promotion of its antidepressant, Effexor.
In the wake of the Vioxx recall and mounting concerns over drug safety, the FDA has started reviewing the possibility of building a new adverse event reporting system (AERS).
The adverse event reporting system is used by consumers, doctors, health professionals and researchers to notify the FDA of FDA regulated drug and product side effects and serious adverse events. The FDA may use such information to determine whether a warning, advisory, recall or other action is warranted. The current AERS receives approximately 350,000 reports annually, and critics contend the system is fraught with opportunities for human error because there is so much information flooding the system.
March 2005 - FDA Asks Congress For Authority to Dictate Label Changes
FDA representatives asked Congress for the authority to
order label changes for drugs to end the type of haggling with pharmaceutical companies that could result in dangerous delays in warning patients about potential drug problems. The case of Vioxx demonstrated the dangers waiting too long to report serious side effects - reports and studies revealing cardiovascular problems such as heart attack and stroke were known early - but strong warnings failed to appear on the label until much later. FDA deputy director of new drugs explained that the FDA
had to "negotiate with the company how the specific language should be worded" resulting in a delay in getting warnings on the Vioxx label. In addition to the FDA's request to mandate label warnings, Congress is alsoconsidering legislation to tighten rules on how the government keeps track of the safety of drugs after the FDA approves them. The Bush administration announced in February that it would set up an independent Drug Safety Oversight Board to monitor FDA-approved medicines once they're on the market and update physicians and patients with emerging information on risks and benefits. Additionally,
recent warnings about several drugs that have been on the market for years prompted the Bush administration to announce a new policy to publicize warnings before differences between the FDA and drug makers are worked out.
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