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Jan 1, 2005 [Also in this issue: PROZAC ALERT]

Over four years ago, in our September 2000 Newsletter, we raised serious questions about the effectiveness and reliability of the Food and Drug Administration as a government regulatory agency. Prior to that Newsletter, there had been six drugs withdrawn from the market for a variety of safety concerns within a three-year period. Moreover, at that very time, the FDA was in the midst of an embarrassing recall situation (strikingly reminiscent of the Vioxx fiasco) involving the diabetes drug Rezulin.

However, once Vioxx was pulled from the market (on September 30, 2004) in the largest drug recall in history, a growing number of experts, elected officials, and public watchdog organizations began to raise serious questions about the FDA’s drug approval process. Now that the number of drugs withdrawn from the market since 1997 has reached twelve, it has become obvious that the FDA is no longer capable of protecting the public from unsafe drugs and unscrupulous pharmaceutical companies. In fact, the very integrity of the agency is now a legitimate concern since many medical professionals believe the FDA is currently biased in favor of the pharmaceutical industry. All of this makes the average citizen wonder: “With friends like this, who needs enemies?”

We believe that it is important to take a fresh look at the FDA drug approval process as well as the necessary steps and reasons for the removal of a drug from the market. On November 18, 2004, a federal drug safety reviewer told a Congressional panel that the FDA is “virtually incapable of protecting America from unsafe drugs.” Dr. David Graham, a reviewer in the FDA’s Office of Drug Safety denounced the agency and accused them of easily surrendering to the demands of pharmaceutical companies. The FDA is under fire and many experts believe that further catastrophes are inevitable unless immediate steps are taken to change the process by which new drugs are approved.

The FDA: Past and Present

The public has always been lead to believe that the FDA is the agency that strictly supervises the approval and marketing of new prescription drugs while closely monitoring drugs already on the market for any evidence of harmful side effects, dangerous interactions, or other adverse information. Pharmaceutical companies, on the other hand, have always been in business to make money. The industry is highly competitive with several companies often racing to be the first to market with a particular type of drug for a specific disease or illness. Winning the race can mean billions of dollars in profits before other companies even get their drug approved. (This was the case with Viagra which, for years, monopolized the market as a treatment for erectile dysfunction until Levitra and Cialis were approved.)

The fierce nature of the competition has also flooded the market with multiple versions of the same class of drug (COX-2 inhibitors like Vioxx, Celebrex, Bextra, Arcoxia, and Prexige for example) or different treatments for the same condition (statins, resins, fibrates, and niacin for high cholesterol). Unfortunately, variety in the pharmaceutical field is not always a good thing as witnessed by the recent heart related problems with all COX-2 inhibitors.

In addition, the race to get new drugs approved and on the market as quickly as possible has made (pre-marketing) long-term studies a thing of the past. As a result, the public either turns out to be the test group for long-term use or is exposed to a drug for years before on-going long-term studies disclose its dangerous side effects. Pharmaceutical companies often claim that it is more important to get a new drug to the people that need it and that massive longitudinal studies would only delay the release of the drug.

The FDA abides by a simple yet essential question in its approval process: Do the benefits of a drug outweigh its risks? This idea of risk vs. benefit was first adopted about 30 years ago, but it is now the basis for new drug approval. The current law states that all new drugs need proof that they are effective, as well as safe, before they can be approved for marketing. The problem with the current approval process, however, is that even when the answer to this question turns out to be “no,” many dangerous drugs have either been approved or permitted to remain on the market for considerable lengths of time. For example, Michael Elashoff, an FDA reviewer and biostatistician, was asked to review the flu drug Relenza back in 1995. Elashoff recommended against approval due to the lack of efficacy of the drug and the agency advisory committee agreed and voted 13 to 4 against approving Relenza. Yet Relenza was ultimately approved by the FDA and Elashoff was told that he would no longer make presentations to the advisory committee. Rezulin and Vioxx were both approved and marketed for years despite the fact that strong evidence of their potentially dangerous side effects was well known while the drugs were still being tested.

For years, FDA approval has been considered “the gold standard” when it comes to approving new drugs. Yet this is becoming further and further from the truth as the FDA becomes inundated with new drug applications, pharmaceutical companies gain more control over the market, and testing standards are lowered to meet unrealistic schedules designed to “fast track” drug approvals.

At a Rezulin Litigation Conference held in Washington D.C., on June 14-15, 2000, Christopher Tisi, Esq., of the law firm of Ashcraft & Gerel submitted an analysis of this very issue. (Rezulin was withdrawn as a result of liver toxicity.) Mr. Tisi asserted the following statements in his analysis:

    * The FDA does not “test” proposed new drugs. It relies almost exclusively on safety and efficacy data provided by the drug’s sponsor.
    * The FDA is increasingly understaffed. A single Medical Officer is primarily responsible for each NDA (New Drug Application). That reviewer may be responsible for many new drugs at the same time. (A typical NDA is enormous and may contain hundreds of thousands of pages.)
    * Since there is no limit to how much information a company can submit to the FDA, a sponsor has ample opportunity to bury or hide data, present data in a biased or misleading fashion, or simply omit negative information (see Prozac update below).
    * FDA resources have been further stretched in the past ten years by increased pressure from Congress and the industry to approve drugs at an accelerated rate.
    * Although the FDA claims that the removal of over 10 (now 12) drugs from the market since 1996 indicates that the system “works,” the facts are to the contrary.

In the case of Rezulin, the drug was quickly approved by the FDA despite many unanswered questions about safety and efficacy. Also, despite several indications of liver problems and the withdrawal of Rezulin in Britain, the FDA repeatedly dismissed and ignored warnings of the scientists entrusted with the responsibility of approving new drugs. This very same problem failing persists today as witnessed by the Vioxx debacle. Clearly, nothing will change until either a new approval mechanism is put in place or a new agency with greater accountability and resources is formed.

Despite the complex nature of today’s drugs, the FDA is processing new drug applications at a record pace. From 1993 to 1999 the FDA approved 232 drugs known as “new molecular entities.” This term is used to describe a new drug which does not already exist in prescription or over-the-counter form. During the previous seven years, the FDA only approved 163 new molecular entities. Dr. Solomon Sobel, director of the FDA’s metabolic endocrine drugs division throughout the 1990s, said that there was extreme pressure to meet deadlines and complete reviews. “The basic message,” he said, “is to approve.”

Another major problem with respect to monitoring the prescription drug business is the way that everyone plays the “blame game.” FDA officials claim they can only do so much to protect the consumer and that physicians must play a greater role in the proper administration and monitoring of drugs. Many experts see direct to consumer (DTC) advertising as a real problem because it targets patients who have no medical or pharmacological training. Doctors complain that patients now demand prescriptions for drugs based upon claims made in DTC advertisements. Finally, patients themselves are blamed for many drug-related problems since a number of studies have found a considerable number of people do not follow the instructions they were given as to dosage, timing, dangerous interactions, medical monitoring, or duration of treatment.

It is important to know and accept the fact that all drugs have the potential to cause side effects or allergic reactions. It is also true that the list of side effects that accompany any drug will never be totally complete as there are always cases of people having unpredicted and unprecedented reactions to new drugs as well as drugs which have been on the market for years. Many dangerous interactions between two or more drugs, between a drug and another substance like food or alcohol, or between a drug and something as common as sunlight are not discovered until after a drug is on the market.

Public Citizen, a public watchdog organization we have written about many times (, has drafted a guideline for consumers called the Seven-Year Rule which states that you should wait at least seven years from the date of release to take any new drug unless it is one of those rare “breakthrough” drugs that offers you a documented therapeutic advantage over older proven drugs. This “rule” is based on three major factors: inadequate testing, the probability that a dangerous drug will be withdrawn within seven years, and the addition of adverse reaction warnings to new drugs within their first seven years on the market.

In April of 2002, the Journal of the American Medical Association (JAMA) published a study led by Dr. Karen Lasser of Cambridge Hospital and Harvard Medical School which concluded that one in five new drugs has unrecognized adverse drug reactions (ADRs) that do not show up until after the drug has been approved. The study analyzed 548 drugs approved from 1975 through 1999 and discovered that 56 of them were later given a serious side-effect warning or even taken off the market completely.

Dr. Sidney Wolfe of Public Citizen who worked on the study said: “Most troublesome drugs do not represent any advance in treatment and are at best no better than older, safer drugs already on the market.” The study specifically focused on black box warnings, which highlight the most serious side effects that were added to the drug’s label after its release. If one of the more life-threatening side effects is not detected prior to release, it can cause major problems and create a serious hazard for the general public once the drug is on the market. In addition, if a serious ADR is discovered, all drugs in that class should be reviewed as they may pose the same previously undetected risks. This is certainly the case with the entire class of COX-2 inhibitors including Vioxx, Celebrex, Bextra, Arcoxia, and Prexige.

The Withdrawal Process

When the FDA believes a drug is no longer safe to use, it will ask the manufacturer to withdraw the drug voluntarily. Usually, the company agrees and the drug is immediately pulled. Sometimes, as in the case of Vioxx, a drug is voluntarily withdrawn when the manufacturer determines it can no longer be safely marketed. Today, most withdrawals can be traced directly to either inadequate pre-application testing, inadequate disclosure in the application process, or inadequate FDA scrutiny of existing data and expert opinions.

Although known side effects cause more injuries and deaths than unknown side effects, it can be is quite unnerving to experience a reaction you were not warned about. Sometimes, an unknown side effect can be even more serious than the existing ones. Limited studies (both in duration and in group size) are more likely to “miss” a particular side effect or potential risk than studies conducted on large test groups over an extended period of time.

Robert Temple, M.D., director of the FDA’s office of medical policy claims that test groups cannot be made larger and research studies cannot be dragged out since the public requires “reasonably rapid” access to needed drugs. Unfortunately, once a drug is placed on the market, millions of people will be exposed to it for extended periods of time. Thus, short-term studies involving limited test groups offer little assurance that all serious side effects, allergies, dangerous interactions, and long-term problems have been discovered prior to marketing. It is for this very reason that Public Citizen’s “seven-year rule” makes sense. Regrettably, during that seven year period, the public itself is acting as the test group. It can only be hoped that manufacturers and the FDA make every effort to update and strengthen warnings as often as necessary once a drug is on the market and that a drug will be pulled as soon as it becomes too problematic to remain on the market.

Direct-to-Consumer Advertising (DTC)

While the FDA must shoulder a large share of the blame for allowing dangerous drugs to reach market, pharmaceutical companies are far from blameless. Drug advertising aimed at patients instead of medical professionals has tripled to a staggering $2.7 billion a year since 1997 when the FDA loosened its drug-promotion rules. Instead of doctors recommending new medications when their use is indicated and appropriate, patients are taking matters into their own hands by demanding drugs based upon nothing more than what they see and read about them in DTC advertisements. Often, a patient will simply shop around until he or she finds a doctor who will prescribe a particular drug. Many doctors have been placed in the difficult position of choosing between prescribing drugs and losing patients.

The FDA is responsible for making sure that all drugs ads are fair and accurate. Yet most DTC advertising is problematic since warnings and side effects are often relegated to small print or rapidly spoken disclaimers at the end of the commercial. An even greater problem is posed by the use of celebrity spokespersons (athletes, actors, and even retired politicians) and famous rock-and-roll songs turned into jingles. Many ads are also misleading and run for long periods of time before they are ordered stopped by the FDA.

The issue of direct-to-consumer advertising was at the forefront of the recent Vioxx case. Critics argued that patients who might have been better off taking ibuprofen or acetaminophen were turned on to Vioxx through an aggressive television and print advertising campaign. Between January 2003 and June 2004 alone, Merck & Co. spent almost $123.9 million dollars in DTC advertising to persuade the public that Vioxx offered safe and effective treatment for acute and chronic pain associated with osteoarthritis, primary dysmenorrhea (moderate to severe menstrual pain), and other problems. Attractive actors and celebrities, like Olympic figure skating champion Dorothy Hammil, pitched the drug in carefully orchestrated commercials set to The Rascals’ 1968 hit “Beautiful Morning”.

On September 17, 2001, the FDA issued an 8-page WARNING LETTER to Merck concerning its false and misleading promotional campaign. The FDA found:

“You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).”

The FDA demanded that Merck discontinue promoting Vioxx to doctors for unofficial uses and found after a review of several of Merck's promotional conference calls and sales pitches that the promotions by Merck “are false, lacking in fair balance, or otherwise misleading in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.” The FDA also required Merck to send letters about the deception to the medical community.

The letter dealt with so many improper and deceptive practices that it is difficult to imagine Merck, a leader in the field of prescription pharmaceuticals, had not formulated a plan to intentionally deceive the public, prescribing physicians, and the FDA itself as to the dangers posed by Vioxx. The FDA found:

    * False advertising in misrepresenting the safety profile for Vioxx;
    * Minimization of the potentially serious cardiovascular findings found in a prior study;
    * Failure to disclose the fact that Merck’s explanation for the cardiovascular incident discrepancy in a prior study was only “hypothetical” and not “demonstrated by substantial evidence;”
    * Failure to disclose that another explanation for the increased cardiovascular incident rate in the Vioxx group was that Vioxx “may have pro-thrombotic properties;”
    * Improper minimization of the Vioxx/Coumadin (warfarin) drug interaction;
    * The omission of “important risk information;”
    * Unsubstantiated superiority claims against other NSAIDs;
    * Promotion of Vioxx for unapproved uses;
    * Promotion of an unapproved dosing regimen; and
    * Misrepresenting Vioxx’s safety profile by “minimizing the potentially serious risk of significant bleeding that can result from using Vioxx and warfarin concomitantly.”

The FDA concluded that Merck’s “minimizing these potential risks and misrepresenting the safety profile for Vioxx raise significant public health and safety concerns. Your misrepresentation of the safety profile for Vioxx is particularly troublesome because we have previously, in an untitled letter, objected to promotional materials for Vioxx that also misrepresented Vioxx’s safety profile.”

Direct-to-consumer advertising was also brought up by Senator John Edwards during the vice-presidential debate as a severe problem in the medical field.

While stricter rules and regulations are needed, the FDA is currently looking at a proposal which would allow drug manufacturers to simplify magazine and newspaper ads which are currently required to include a list of detailed information about risks and benefits. Removing such information is clearly a step in the wrong direction.

Reporting Risks

More than 250,000 side effects linked to prescription drugs are reported each year. Yet these reports are only filed voluntarily by doctors and other health care professionals. It is estimated that the current records of adverse drug reactions (ADRs) only account for 1% to 10% of all such cases. The country’s existing system for tracking drug side effects is called MedWatch. MedWatch, however, is not an accurate representation of existing ADRs as the drug manufacturers are the ones who collect and evaluate most of the information on side effects from their own products and then report it to the FDA.

Reporting ADRs should no longer be voluntary. All healthcare providers including physicians, pharmacists, nurses, dentists, and others should look upon adverse event reporting as part of their professional responsibility. The few reports that are actually filed do not provide enough data to determine whether the problem resulted from medicines or from the original illnesses. A complete report of an ADR should include the following information:

    * Product name (and information such as model and serial numbers in the case of medical devices);
    * Demographic data;
    * Succinct clinical description of adverse event, including confirmatory/relevant test/laboratory results;
    * Temporal information including date of event onset and start/stop dates for use of medical product;
    * Dose/frequency of use;
    * Biopsy/autopsy results;
    * Outcome;

There is an absolute need for post-marketing supervision as there will always be new risks to be detected. Part of this supervision would be to report ADRs in the proper way so that the information does not go unnoticed and can be used to prevent future harmful situations from occurring.

A “New” Solution

The editors of the Journal of the American Medical Association (JAMA) recently made an extremely valid point about the position of the FDA. They argued that it was “unreasonable to expect that the same agency that approves drugs to also be committed to actively seek evidence to prove itself wrong.” They suggested the creation of an independent drug safety board to monitor the safety of drugs and medical devices following FDA approval, as it is no longer the “gold standard” it once was.

There are currently five other drugs on the market that have the potential of becoming the next Vioxx if a new system is not instituted rapidly and efficiently. Accutane (acne medication linked to suicides and birth defects), Crestor (cholesterol-lowering drug known to cause kidney failure), Bextra (COX-2 inhibitor linked to increased risk of heart attack), Meridia (weight-loss pill that can cause substantial increase in blood pressure), and Serevent (asthma medication linked to an increased risk of asthma related deaths) are now all under serious scrutiny because of the serious risks they pose. These drugs all represent cases where the risks outweigh the benefits and, thus, fail to comply with one of the key standards for approval by the FDA.

Celebrex, the COX-2 inhibitor distributed by Pfizer, is another drug living on borrowed time. It would appear that Vioxx has only set the stage for what may be a long line of withdrawals involving numerous other drugs.

In a perfect world, the scenario surrounding the development and marketing of a new prescription drug would include the following:

    * A true need for the drug.
    * A well-planned and adequately funded research and development program with active FDA participation in the process.
    * Accurate and honest document of every step of development and testing by qualified experts in an NDA (New Drug Application).
    * Submission to the FDA with proof that the drug is effective and safe and that its benefits outweigh its risks.
    * A full and fair review of the NDA and all supplemental materials and safety updates by the FDA with supervisory personnel conducting additional reviews.
    * Have well controlled studies demonstrated the drug to be effective for its intended use?
    * Is the product safe under the proposed conditions of use?
    * If approved, the drug will be “on the market” as soon as the manufacturer is able to implement production and distribution.
    * The manufacturer and the FDA continue to monitor and evaluate all reported adverse events associated with the drug as well as the results of any additional long-term studies. If necessary, label information and product information is modified or supplemented. Warnings may be added, modified, or strengthened. In the most extreme situations, the drug is removed from the market.

Unfortunately we do not live in a perfect world. The history of the pharmaceutical industry and its interaction with the FDA is replete with well-publicized instances of fabricating and falsifying data, concealing negative information and adverse event reports, ethical violations, conflicts of interest, undue influence, favoritism, misleading advertising and other forms of conduct designed to improperly influence FDA decision making.

It is not too late to change the system. Although a great deal of damage has been done by dangerous drugs in the past, the public can be saved from further harm in the future if Congress takes decisive action now. The FDA is clearly unable to protect the public to the degree it once did. This is not the time for bureaucratic red tape and caving in to the powerful pharmaceutical lobby. Every citizen should contact their elected representatives and demand action. It is clearly a matter of life and death.


On December 31, 2004, The British Medical Journal (BMJ) reported (in an article dated January 1, 2005) that an anonymous source had provided “missing documents” from clinical trials of the antidepressant Prozac which appear to suggest a link between the drug and suicidal behavior. The documents were then sent to “health regulators in the United States.” The documents suggest that in the 1980s, officials at Eli Lilly & Company were aware that fluoxetine (Prozac) had “troubling side effects.” (

Dr. Richard Kapit, the original FDA reviewer for fluoxetine told the BMJ: “If we have good evidence that we were misled and data were withheld then I would change my mind [about the safety of fluoxetine]. I do agree now that these stimulatory side effects, especially in regards to suicidal ideation and homicidal ideation, are worse than I thought at the time I reviewed the drug.”

In the face of this highly incriminating information from documents that had been “missing” for more than 10 years, Lilly declined to be interviewed. Its image, however, could be seriously tarnished. The discovery of these documents also raises serious questions concerning the status of any existing or discontinued litigation against Lilly involving Prozac. Proof that Lilly knowingly withheld or destroyed evidence would certainly provide injured plaintiffs with an ample opportunity to continue or even reopen their cases.

On January 5, Lilly claimed that it had given the “missing” documents to federal regulators years ago (N.Y. Times/A.P. 1/5/2005). After examining some of the documents, Congressman Maurice Hinchey (D. NY), a member of the Appropriations Committee, which oversees a number of agencies including the FDA, stated that they “clearly show a link between Prozac and actions of violence perpetrated by people taking the drug against themselves and against others.” Mr. Hinchey also stated that the “documents we have show that the company was instructing its employees to hide this information. We’re seeing evidence here that it was a conscious act on the part of the company.”

Parker & Waichman prides itself on the fact that it has always been a leader in protecting the public in the area of pharmaceutical litigation. In fact, we brought the first case in the United States alleging Prozac caused suicides and were appointed to the Plaintiffs’ Steering Committee for Prozac litigation. If you or a loved one has suffered an injury associated with the use of Prozac, or any other prescription drug, please contact Parker & Waichman for a free case evaluation or visit our award winning website at for further information.
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