"We continue to expect full-year Celebrex revenues of at least $2 billion, an ambitious target given the ongoing pressures in the arthritis market," Pfizer told shareholders in its Second Quarter 2006 SEC filing.
Notwithstanding the fact that the FDA asked Pfizer not to run ads to promote more use of Celebrex, and that the company previously granted that request, Pfizer is right back at it. In April 2006, it began advertising Celebrex "in alignment with our new Direct-to-Consumer (DTC) advertising principles, highlighting Celebrex's unique clinical profile and benefits," Pfizer wrote in its First Quarter 2006 SEC filing.
Celebrex is a COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) used for pain relief, marketed and sold by Pfizer, Pharmacia, and GD Searle. Over the past several years, these drug makers have been hit by a massive number of lawsuits filed all over the US.
A majority of plaintiffs are represented in class actions. The procedure for filing a class action is to file suit with one or several named plaintiffs on behalf of a putative class which must consist of a group of individuals or entities that have suffered a common wrong.
Several putative class actions have been filed by consumers seeking damages from the purchases of Celebrex as a result of Pfizer's deceptive marketing scheme. In September 2005, all of the purchase claims, as well as the product liability personal injury actions, were transferred to Judge Charles R Breyer in the US District Court for the Northern District of California, by the Multi-District Litigation Panel, In Re: Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, MDL Docket No 1699, No 05-1699, (ND CA)
At the plaintiffs' request, the court allowed the filing of a Purchase Claims Master Celebrex Complaint which includes four claims for relief: (1) RICO; (2) state consumer protection laws; (3) unjust enrichment; and (4) breach of warranty.
The complaint seeks damages on behalf of a national class of all Celebrex End-Payors located in the US, including Consumers and Third-Party Payors who purchased and/or paid for Celebrex not for resale during the period from December 1, 1998 through the present.
The Prescription Access Litigation Project filed a Celebrex class action in California in February 2005, as well as a nationwide case in April 2005, which are included in the MDL proceeding.
PAL plaintiffs allege that, to increase its sales, Pfizer launched a massive deceptive advertising campaign to convince consumers that Celebrex was a premium drug that offered significant benefits over older, cheaper pain relievers. When in fact, PAL alleges, not only did Celebrex offer no safety benefits to the majority of consumers, it actually increased their risk of death from a heart attack or stroke.
According to PAL, in December 2004 and in February 2005, Pfizer disclosed two separate studies showing that Celebrex users have an increased risk of cardiovascular events and that had Pfizer revealed the risks of Celebrex, of which it was aware since 1999, consumers would not have been willing to pay the high price for Celebrex.
PAL alleges that Pfizer convinced consumers to pay a higher price than they would have paid if they had known the risks, if they would have purchased Celebrex at all. The suits seek recovery for consumers who purchased Celebrex at the inflated price made possible only by Pfizer's massive deceptive advertising campaign.
The plaintiffs specifically allege that the marketing scheme was deceptive because Pfizer (1) suppressed data showing the cardiovascular risks associated with Celebrex; (2) falsely claimed that Celebrex caused fewer gastrointestinal side effects than traditional NSAIDs; and (3) falsely claimed that Celebrex provided superior pain relief and safety over traditional NSAIDs.
The plaintiffs maintain that as a result of the marketing success, Pfizer was able to sell Celebrex "at a premium price over NSAIDs and to have it become a standard treatment option as opposed to use of less expensive NSAIDs."
According to the lawsuits, Celebrex sells for $2.53 to $6.45 per day, depending upon the dose, while NSAIDs sell for $0.21 to $0 .31 per day.
The plaintiffs allege that if Pfizer had not engaged in the wrongful marketing, advertising and promotion of Celebrex, they would have paid for other equally effective and less expensive medication.
On March 31, 2006, Pfizer filed a motion to dismiss the case. Plaintiffs opposed the motion, and a hearing and status conference was held on June 30, 2006.
In moving to dismiss the failure-to-warn claims, Pfizer argues that the claims are preempted because they conflict with the Food, Drug and Cosmetic Act ("FDCA") and the authority of the Food and Drug Administration ("FDA") to regulate warnings about prescription medicine and the promotion of such medicine.
On August 16, 2006, the Court ruled that claims that Pfizer failed to warn about the cardiovascular risks were preempted by the FDA's authority to determine prescription drug labels, and that those claims were dismissed but with permission for plaintiffs to amend the complaint.
In opposing the motion, the plaintiffs argued that because the FDA's preemption statement appears in a preamble to a Final Rule, and is not itself a regulation or even an interpretative rule, the Court should ignore the FDA's view.
The plaintiffs asserted that Congress had not delegated authority to the FDA to opine on the preemptive effect of its regulations. However, the court ruled that Congress has delegated the responsibility for administering the FDCA to the FDA, and that such responsibility implies the authority and expertise to determine which state laws conflict with its regulations.
The plaintiffs asked the court to consider the inconsistency of the FDA's position when determining what weight to give the current preemption view and highlighted the FDA's statements in 1998, that its labeling regulations establish minimum standards, and that in 2000, when the FDA published the proposed drug labeling rule to which the preemption preamble is now attached, that the FDA determined that the proposed labeling rule does not preempt state law.
The following year, the plaintiffs argued, only after a change in administrations, did the FDA begin for the first time to submit amicus briefs arguing in favor of preemption.
The court noted the drastic change but said it made no difference. "While the FDA's current view of the preemptive effect of its labeling regulations is a 180-degree reversal of its prior position," the Court stated, "the Supreme Court has recognized that an agency's view of the preemptive effect of its regulations may change over time as the agency gains more experience with the interrelationship between its regulations and state laws."
"Moreover," the judge continued, "the Supreme Court has never held that a court may not give weight to an agency's view of the preemptive effect of its own regulations simply because that agency's view changed contemporaneously with a change in administration."
The plaintiffs also unsuccessfully argued that the FDA's failure to comply with Executive Order 13132, regarding consultation with local officials about a possible conflict with state law should be considered.
The court disregarded plaintiffs' allegation that Pfizer withheld material cardiovascular risk data from the FDA, saying it "does not change the preemption analysis." The law is well established that a claim premised on a drug manufacturer's failure to provide data to the FDA is preempted, the court wrote citing a US Supreme Court case.
"Plaintiffs' state law failure-to-warn-claims," the judge said, "conflict with the FDA's determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the FDCA."
In its conclusion, that court stated that, "Plaintiffs' claims that Pfizer's promotion of Celebrex was unlawful because it failed to warn of the drug's cardiovascular risks are preempted because they conflict with the FDA's determination of what warnings are substantiated by the scientific evidence."
"Accordingly," the court ruled, "the failure-to-warn of cardiovascular risk claims are dismissed with leave to amend."
A point not mentioned that indicates the court's faith in the FDA's ability, or inclination, to protect the public against dangerous drugs promoted by profit driven drug makers is misplaced, is the fact that it took the FDA two years to negotiate a label change to warn consumers about Vioxx during which time, the FDA's own career scientist, Dr David Graham, said tens of thousands of people were needlessly injured or killed.
Legal experts say its difficult to gauge how the California decision will effect other Celebrex cases because different judges in different states can mean different results.
According to attorney, Ted Parr, of the Washington DC firm, Ury & Moskow, "State court judges are likely to reach conclusions regarding preemption that are inconsistent, both with the federal court and with each other to some extent."
"Some cases will be dismissed, and others will not," he states.
For instance, he points to the Pennsylvania Paxil case, Colacicco v Apotex, Inc, where the court dismissed the entire lawsuit, since, under Pennsylvania state law, failure-to-warn is the only cause of action available.
On the other hand, in another Pennsylvania case, Mingus v Wyeth, Mr Parr states, "the plaintiff withdrew her failure-to-warn claim and agreed to proceed only on claims for negligence and strict product liability based on design defect under Ohio law; in that case, the court denied the defendant's preemption motion."
"We really do not know yet," he advises, "how extensive the preemption problem will be nationwide."
"Two federal courts in the 8th Circuit have rejected preemption motions," he points out.
The fact that studies might come out, like has happened in Vioxx litigation, that show Pfizer knew about the heart risks might not even make a difference, according to Mr Parr.
"The defendants will no doubt argue that the FDA's enforcement mechanisms are exclusive," he explains. "Therefore, even if it were shown that Pfizer engaged in outright willful fraud," he said, "the plaintiffs' claims could still be dismissed."
As for whether all Celebrex plaintiffs will be permitted to amend their complaints, the answer is once again a mixed bag. "Some plaintiffs may have an opportunity to amend their claims;" Mr Parr states, "others will not, depending upon the interpretation of preemption and decision of the court and differences in state laws."
In moving for a dismissal of the GI claims, Pfizer argued that the plaintiffs' theory of liability, that Pfizer falsely claimed that Celebrex had fewer GI complications than other NSAIDs, and was more effective, was preempted because it stands as an obstacle to the accomplishment of the objectives of the FDCA.
Pfizer maintained that the FDA requires companies to submit all advertising to the
FDA's Division of Drug Marketing, Advertising, and Communications, and that the
DDMAC reviews the ads for compliance, and has the authority to require a company to stop running a particular ad or to run a corrective promotion.
According to Pfizer, the FDA has "necessarily determined" that the unobjected to ads are accurate and strike a fair balance between the benefits and risks of Celebrex; therefore, any claim that such ads were deceptive conflicts with the FDA's determination and are impliedly preempted.
The court acknowledged that Pfizer has submitted its challenged ads to DDMAC and, with a few exceptions, the DDMAC did not object to the ads.
However, the judge stated, "there is nothing in the record from which the Court could conclude that the FDA has actually reviewed all of the submitted advertisements, let alone conclude that the FDA's review means that it has definitively determined that the advertisement was not misleading."
The court pointed out that the FDA's silence is significant here because when "the FDA believes that its regulations preempt state law it says so."
"The FDA has been silent with respect to the preemption of lawsuits challenging false claims in prescription drug advertisements," the court wrote. "This silence suggests that the FDA does not intend its review of promotional materials to preempt false advertising claims."
The plaintiffs' claims are premised on the assertion that the ads imply that Celebrex is superior to other NSAIDs because it has fewer GI symptoms, a claim which the FDA expressly determined would be false and misleading.
Pfizer argues that particular ads identified in the complaint are consistent with the FDA-required label and therefore any claims based on those ads are preempted.
Pfizer is actually arguing, the judge said, that certain ads were not misleading as a matter of law, that the ads do not imply GI superiority or greater efficacy than other NSAIDs.
The court said it declined to make such a determination on the limited record and briefing currently before the Court.
Pfizer also argued that the FDA should initially decide whether the ads are misleading because plaintiffs' claims fall within the "primary jurisdiction" of the FDA.
The court determined that the false advertising claims do not implicate the primary jurisdiction doctrine. "The issue is not whether Celebrex has fewer GI complications than other over-counter NSAIDs;" the court stated, "the FDA has already determined that it does not."
"The issue," it explained, "is whether contrary to the FDA's findings, Pfizer nonetheless falsely claimed that Celebrex was superior."
Courts and juries frequently decide similar false advertising claims, the court noted.
In its conclusion, the court stated that, "Pfizer has not established that the FDA has determined that all of Pfizer's promotional material strikes a "fair balance" and are not false and misleading."
"Accordingly," the court ruled, "Pfizer's motion to dismiss the false advertising claims on conflict preemption grounds is denied."
There is certainly ample evidence to present to a jury to back up the claims that the Celebrex makers engaged in false advertising and over-promotion of Celebrex, within the walls of the various FDA offices alone.
First off, Pfizer's claim that Celebrex ads were preapproved by the FDA is dead in the water. On December 1, 2005, Tom Abrams, director of the DDMAC, said in an interview for Pharmaceutical Executive that although FDA regulations require companies to submit advertising material at the time of first use, his office receives an average of 53,000 promotional items a year and his staff of 35 cannot handle that volume of screening.
"DDMAC has limited resources and we use our limited resources as effectively as we can to do our job," he said.
In fact, Mr Abrams says the biggest misconception is that the FDA approves all ads before they are released, and most ads are launched without the agency reviewing them. In fact he states, "Often, we're seeing it at the same time as the American public."
According to Mr Abrams, when the FDA determines that an ad violates regulations, the agency sends the company either a notice of violation letter or a warning letter. Notice letters are issued for the least serious offenses and warning letters are issued for serious or repetitive violations and request that the company stop the promotion, and disseminate corrective messages.
FDA records show that Celebrex received seven citations for false or misleading promotions between 1997 and 2005. In 1997, before Celebrex even obtained FDA approval, the FDA accused Celebrex maker at the time, GD Searle, of touting the drug on the internet as "a breakthrough in arthritis therapy,'' and suggesting that it caused no gastrointestinal bleeding.
The claim of no gastrointestinal risks was not approved for the label when the FDA approved Celebrex and yet, Searle, Pharmacia and Pfizer, have each been cited for stating or implying in promotional materials that Celebrex worked better than other pain relief drugs because it posed no gastrointestinal risks.
In fact, when the FDA approved Celebrex it specifically warned that any promotional activities "that make or imply comparative claims about the frequency of clinically serious GI events compared to NSAIDs or specific NSAIDs will be considered false and/or misleading . . ."
Furthermore, the FDA required the Celebrex label to include the warning that "serious gastrointestinal toxicity can occur at any time, with or without warning symptoms, in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs)."
In 2005, the FDA required the Celebrex label to include a boxed warning stating: "NASIDs, including CELEBREX, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal."
Claims that portray Celebrex as a superior pain reliever are also false and misleading because the FDA has stated that, "none of the comparative studies with naproxen, ibuprofen, and diclofenac to-date has been designed to demonstrate superiority or a specified degree of similarity in a rigorous way."
One Celebrex TV ad found to be false and misleading promoted the drug for use in treating osteoarthritis or rheumatoid arthritis, and shows a woman playing a guitar with a voice-over saying, "With Celebrex, I will play the long version." The FDA sent Pfizer a "warning" letter on this ad stating:
"While the Guitar TV ad suggests a direct benefit to this patient's wrist/hand/finger joints related to movement and flexibility, it fails to state the actual approved indication (e.g., relief of signs and symptoms of osteoarthritis)."
The FDA also pointed out that this ad failed to include any risk information about Celebrex, thus omitting the major side effects and contraindications, and said the omission of this information implies that there are no risks, which overstates the drug's safety.
The FDA determined that another TV ad was misleading and warranted a warning letter that began with the announcement: "Celebrex presents, arthritis tips."
The ad features a woman dressed as doctor stating: "Arthritis is the most wide-spread crippling disability in the United States today. Arthritis is the predominant cause of activity limitations and is a major determinate of nursing home institutionalization for the elderly."
"One out of every 7 people and 1 in every 3 families is affected by arthritis," the ad states. "If you feel any pain or discomfort in your joints, contact your local doc."
The commercial concludes by saying: "These arthritis tips have been brought to you by Celebrex."
The FDA said that this ad is product-specific, and misleading because it omits important information about the drug's safety and effectiveness and makes unsubstantiated claims. The FDA said the ad promotes Celebrex by name at the beginning and end and that using the term arthritis tips clearly suggests that the drug is an arthritis treatment.
The totality of this presentation, the FDA letter advised, suggests that Celebrex is an effective treatment for preventing or modifying the progression of arthritis, such that crippling disability and nursing home institutionalization may be avoided, when in fact, Celebrex is indicated only for relief of the signs and symptoms of OA and RA and is not indicated for disease modification (i.e., altering the course of the progression of arthritis).
"Moreover," the FDA said, "we are not aware of substantial evidence or substantial clinical experience demonstrating that treatment with Celebrex will prevent crippling effects or disability due to arthritis or prevent nursing home institutionalization of elderly patients with arthritis."
"Therefore," the letter warned, "your Arthritis Tips TV ad greatly overstates the proven benefits of Celebrex."
The FDA also noted that the ad fails to disclose any risk information and omits the major side effects and contraindications, including warnings and precautions, which implies that there are no risks to the patient who takes Celebrex, thus overstating its safety.
In the same letter the FDA warmed that a Celebrex print advertisement also made unsubstantiated claims with respect to less expensive alternative drugs. The print ad features the headline "Strength They Can Stay With" and shows a chart comparing Celebrex, Ibuprofen and Naproxen, titled "6-Month Patient Persistency Rate."
Over the chart is the statement, "In a study of approximately 1 million patients, persistency rates of different OA/RA treatments were assessed at 6 months." The line below the Celebrex logo says, "Proven strength that lasts."
The FDA said these claims imply that Celebrex is more effective (i.e., stronger) than ibuprofen and naproxen for treatment of osteoarthritis or rheumatoid arthritis and that patients "stay with" or are more compliant with Celebrex therapy than with the other products. "We are not aware of substantial evidence or substantial clinical experience to support these claims," the FDA wrote.
The cited retrospective retail pharmacy database analyses by NDC Health, the FDA advised, do not contain any data or information demonstrating that patients found Celebrex to be more effective than the other products, or that patients will be more "persistent" or compliant with Celebrex therapy.
Moreover, the agency said, the information did not note the indication for which the drug was prescribed, so the suggestion that these rates reflect specifically OA/RA patients is misleading.
In addition, the FDA said, the analyses do not account for factors that affect persistence or compliance such as cost insurance coverage, side effects, dosage regimen, and ease of use.
"Therefore," the agency wrote, "the analyses do not constitute substantial evidence or substantial clinical experience demonstrating that OA/RA patients are more compliant with Celebrex or stay on Celebrex longer because it is more effective than other products for the treatment of OA or RA."
Experts say these overly aggressive promotional campaigns are causing great harm to consumers. Former FDA commissioner, David Kessler, told the San Francisco Chronicle, February 27, 2005, that the rapid adoption of new drugs -- fueled by heavy promotional campaigns -- is an inherent threat to the public.
"The way it used to be, if a drug got approval, its use would increase gradually over time,'' said Mr Kessler, who is dean of the UCSF School of Medicine. Thus, when unexpected side effects surfaced, he said, relatively few people had been exposed to the risk.
In recent years, though, he said, new medicines explode into widespread use before they build up a safety track record. Mr Kessler is credited with preventing the widespread use of drug TV commercials when he was commissioner.
"Many more people are going to be exposed," he warned in the Chronicle. "That's the nightmare.''
Patients who suffer from chronic pain, like Sandy Lambrecht, say Pfizer and other drug companies take advantage of their suffering. "Excruciating relentless pain is indeed a strong motivator," she states.
"That's why so many of us finally give in and take drugs that may indeed harm us even further," she explains, "we are that desperate."
Sandy says chronic pain sufferers keep up with the news about pain drugs like Celebrex but when the doctor says take it or go without, they take it. "We are not stupid," she states, "we know that we are being coerced into taking drugs pushed by these unconscionable criminals."
Her medicine cabinet still has half-empty bottles of Vioxx, Celebrex and Bextra. Last month she found out that she has heart problems, but has no way of knowing if its related to one of those drug or all 3. "And it's not likely I'll ever find out," she says.
"We pay a price that is rarely considered in law suits," Sandy notes, "and we never get recognition - let alone any compensation - for simply being in such tragic situations."
Sandy contends that the few dollars still being spent on the disabled should not be used to boost drug companies profits. "I've long known that the real criminals are not the few people who take advantage of social programs," she states, "its the greedy corporations whose legions of unscrupulous lawyers and salesmen exploit the most vulnerable of our society."
Critics agree that consumers have been ripped off when it comes to Cox-2 inhibitors. "Though billed as super aspirins," says Merrill Goozner, author of, The $800 Million Dollar Pill, "the Cox-2 inhibitors provided no more pain relief than over-the-counter aspirin, ibuprofen, or prescription naproxen, which were the most popular NSAIDs on the market."
"This inconvenient fact," he says, "was overlooked by the new drugs' marketers." In the spring of 2002, then Pfizer CEO, Henry McKinnell, awarded PhRMA's highest research award to the four scientists who developed Celebrex stating:
"Thanks to their pioneering work, millions of people throughout the world who were once crippled with arthritis can now work, walk, garden, and do all the little things that make life worthwhile,"
Mr McKinnell said all this, even though, as Mr Goozner points out, "they were no more able to perform those tasks than if they had popped a couple of over-the-counter ibuprofen."
Pfizer has been one of the foremost proponents of the position that many FDA rules limiting drug advertising violate the company's First Amendment right to free speech. That argument has made headway in a number of court cases, former deputy commissioner, Mary Pendergast, acknowledged to the San Francisco Chronicle on February 7, 2005.
However, according to Ms Pendergast, the FDA could still win a case for promotional limits by producing enough evidence to show public health could be at risk.
"You don't have a First Amendment right to lie, to say false and misleading things,'' she points out.