Merck refuses to settle Vioxx recall lawsuits out of court

As everyone who is following the Vioxx recall story waits for the US Food & Drug Administration (FDA) to come up with its decision on marketing of Cox-2 drugs in the US, the legal process goes on. A FDA panel had recommended in February that Vioxx be allowed to resume sales in the US while Celebrex and Bextra stay on the market, though all drugs carry a black box warning. The recommendations have come under doubt because several members of the panel that made these recommendations also benefited financially from drugmakers Pfizer and Merck. (Related article: FDA should have disclosed conflicts of interest of panel members)

Analysts expect that FDA, which is virtually under control of the pharmaceutical companies, is likely to rule in favor of drug companies as it has done in the cases of Adderall, Crestor, Cylert, Ritalin, Natrecor, Avonex, Paxil, Avandamet, Elidel, Protopic, etc.

So how is Merck approaching Vioxx litigation? So far Merck has been very aggressive in its approach and is essentially hoping that if it can make it extremely hard for some of the initial plaintiffs to prove that Vioxx, and not something else, caused their heart problems, it can discourage other Vioxx victims to go to court. This is also the reason that Merck has flatly refused to settle out of court.

In a recent interview with Porus P. Cooper of The Philadelphia Inquirer, Kenneth C. Frazier, who runs Merck's legal department, also ruled out following in the footsteps of Wyeth, that set up a trust fund to compensate victims of fen-phen. It is important to note that Vioxx class action lawsuits already are estimated to be the biggest ever in the history of the United States, surpassing that for fen-phen. Vioxx liabilities are estimated to be as much as $55 billion leading many analysts to speculate that Merck will eventually be driven into bankruptcy.

The recommendations of the FDA panel may be of some help to Merck in arguing that a panel of experts did see value in Vioxx, though Vioxx attorneys are expected to argue that due to conflicts of interest that recommendation should be discarded. Any reasonable juror is unlikely to believe experts who had financial ties to the drugmakers and then were recommending that the drugs are safe. (Related article: Merck has a weak defense in Vioxx lawsuits)

Apart from hundreds of lawsuits already filed against Merck, the company faces other challenges. Its insurance providers want to abandon the company. At the same time, it faces securities related lawsuits, investigations by DOJ and SEC, and finally more lawsuits from health plans.

Recommended articles

Will you take Vioxx if it returns?

Doctors lose trust in FDA after Vioxx recall

Americans abandon Vioxx, Celebrex, and Bextra

Will you take Vioxx on its return?

Will you ever take Vioxx again? You will be surprised with what you hear. A relatively small number of people worldwide who have taken Vioxx in the past are actually ready to take it again despite the serious side effects that are now known. The pain relief that Vioxx provided to them is almost "addictive." But what about those arthritis patients who have been closely following the Vioxx recall news. But will doctors prescribe Vioxx again if its sales are allowed to resume in the US? That is a tricky question since not only do doctors have deeper understanding of risks, their decisions also tend to be more "clinical" rather than "emotional." (Related article: Doctors lose trust in FDA after Vioxx recall mess)

But a recent survey by NOP World Health has some interesting findings. New FDA Advisory Committee recommendations around COX-2 inhibitor drugs are likely to lead to prescribing gains for Bextra and Celebrex, though both physicians and patients will continue to shy away from Vioxx, even if it returns to market. The research shows that physicians, particularly general and family practitioners, anticipate increasing their Bextra prescribing, while internists, rheumatologists and orthopedic surgeons expect to boost their Celebrex prescribing. (Related article: Bextra safety)

Patients taking Celebrex or Bextra are loyal to those products and plan to continue taking them. Vioxx, however, will experience ongoing difficulties, even if Merck decides to reintroduce it. If Vioxx returns to market, most patients indicated they would be unwilling to take it-and most physicians would use it primarily as a second-line treatment, after Celebrex and Bextra. Rheumatologists are most likely to return to Vioxx, if it once again becomes available. In contrast, a third of orthopedic surgeons say they will not prescribe Vioxx, if it is reintroduced. (Related article: Americans abandon Vioxx, Celebrex, and Bextra)

"If Vioxx comes back to market, lingering concerns about cardiovascular risks may limit its potential," according to Keith Loehlein, Senior Vice President of NOP World Health's Market Assessment Practice. "To re-establish the product, Merck will have to ease fears about cardiovascular side effects. A good promotional starting point would be marketing first to rheumatologists-who are most receptive to a Vioxx return-before targeting primary care physicians or other specialists.

Physicians and Patients Remain Uncertain about COX-2s

Both physicians and patients remain cautious about COX-2s. Overall, physicians are still undecided about whether the benefits of COX-2s outweigh their drawbacks. Patients echo the concerns of many physicians. Former Vioxx users are particularly skeptical and unlikely to be swayed by the FDA's recommendations. Patients taking pain medications other than COX-2s also are highly suspicious of the category-and findings indicate that manufacturers will have to make significant efforts to change those negative perceptions. (Related article: Is Mobic a good alternative to Vioxx, Celebrex, and Bextra?)

Unsure about COX-2s, many patients are turning to their doctors for answers. Rheumatologists report that 2 out of 3 patients have inquired about the Vioxx return. Questions tend to focus on comparisons between the COX-2s and the cardiovascular risks surrounding Vioxx.

NOP World Health conducted its research after an FDA Advisory Committee issued new recommendations on February 18, 2005, about the marketing of COX-2 Inhibitors. The FDA decided that Celebrex and Bextra could remain on the market-and that Vioxx could potentially return. All three products, however, must now carry a black box warning about the increased risk of cardiovascular events. Overall, the committee agreed that, while the cardiovascular risk is a class effect, variations in that risk-based on specific drugs and dosages-necessitate a case-by-case consideration of COX-2 agents.

NOP World Health's research provides an early read on physician and patient reactions to the panel's recommendations. NOP World Health is a supplier of primary research in the global healthcare market.

Recommended articles

Non-English speakers not told of Vioxx risks

Vioxx litigation may bankrupt Merck

Merck manipulated FDA in Vioxx recall case

Natural alternatives to Vioxx, Celebrex, and Bextra

Source: NOP Health

Safe painkiller guide after Vioxx recall

Confused about which painkillers are safe to use? You are not alone. Recent controversy surrounding Cox-2 inhibitors like Vioxx, Celebrex, and Bextra and other over the counter drugs like Aleve has created so much confusion among people who need pain relief. (Related article: Pain relief medication guide)

A new American Heart Association science advisory on the use of COX-2 inhibitors and other non-steroidal anti-inflammatory drugs (NSAID) suggests this simple rule of thumb: Use the drug with the fewest known risks. This rule means that potent drugs like the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdecoxib) should be "held in reserve, generally for short-term use," said Joel S. Bennett, M.D., a hematologist and a member of the writing group that drafted the advisory. (Related article: Americans abandon Vioxx, Celebrex, and Bextra after safety concerns)

The association advisory comes in response to several reports that COX-2 inhibitors increase cardiovascular risks. Due to these risks, Vioxx was recalled in September by Merck, though in a bizarre development in February, a FDA panel filled with several Merck insiders recommended that Vioxx be allowed to resume sales in the US. Celebrex and Bextra continue to be on the market despite the risks.

Bennett, who is a professor of medicine at the University of Pennsylvania, explained that COX-2 drugs were developed with the idea of "having a good pain reliever that wouldn't upset the stomach, which sounded great." But that good idea was questioned when reports surfaced that long-term use of one of the drugs, rofecoxib (Vioxx), was associated with increased heart attacks and strokes. (Related article: Merck did not want Vioxx label changes to highlight risks)

The American Heart Association advisory recommends physicians weigh the benefits and risks before prescribing Celebrex or Bextra. Because the risks of adverse effects of COX-2 inhibitors are likely greatest in patients with - or at high risk for - cardiovascular disease, the statement suggests limiting the use of COX-2 drugs to those who have no appropriate alternatives. The lowest recommended dose should be given for the shortest duration necessary. (Related article: Louisiana Medicaid restricts Celebrex and Bextra prescriptions)

The advisory also addresses the use of other popular pain relievers such as aspirin and ibuprofen (Advil, Motrin). Consumers are warned that all over-the-counter drugs should be used in strict accordance with label directions and that if an over-the-counter NSAID is needed for more than 10 days, consult a physician. (Related article: Treatment options for Vioxx patients)

"We are recommending that patients use some common sense in selecting a medication to treat pain," Bennett said. "In terms of drug choice, one rule is always best and it holds whether you are treating cancer or treating a headache: use the safest medicine first." Medications such as aspirin and acetaminophen (Tylenol) in recommended doses and durations have minimal toxicity, which makes them good first choices, he said. "If those medicines don't work, try a stronger NSAID such as naproxen (Aleve)." Bennett noted that low-dose aspirin is recommended to reduce the risk of second heart attacks and that many people having a heart attack are given aspirin to limit heart muscle damage. (Related article: Doctors lose trust in FDA after Vioxx, Celebrex, and Bextra controversy)

Related articles

Natural alternatives to Vioxx, Celebrex, and Bextra

Non-English speakers never told of Vioxx risks

Merck manipulated FDA in Vioxx recall process

FDA did not disclose conflicts of interest in Cox-2 hearings

The advisory is published in Circulation: Journal of the American Heart Association. The advisory affirms the cautions issued by the U.S. Food and Drug Administration (FDA) in February 2005 and its co-authors are Alan Daugherty, Ph.D.; David Herrington, M.D., M.H.S.; Philip Greenland, M.D.; Harold Roberts, M.D., and Kathryn A. Taubert, Ph.D.

Vioxx class action lawsuits hearings begin

What some Vioxx attorneys are calling as the "Mother of all class action lawsuits" had a start last week in Florida. Because of the number of victims being huge (140,000 Americans alone injured, and out of that as many as 50,000 may be dead), Merck's Vioxx liabilities could be as much as $55 billion leading many analysts to speculate that Vioxx litigation could sink Merck.

Vioxx litigation is not going to be easy either for Merck or the plaintiffs. Merck has mounted a ferocious attack on Vioxx victims and has vowed to fight each lawsuit. Merck's case is quite weak though and such an aggressive public stance is merely a way to keep the company breathing its last breath till the cases wind their way through the courts. That could take years.

The number of Vioxx lawsuits is exploding and keeps growing on a daily basis. In its filings with the SEC last week, Merck had disclosed that as of January 31, 2005, approximately 850 lawsuits were filed. According to documents filed with the courts last week, that number has already jumped to 1,357. (Related article: Tough Vioxx litigation expected)

In the meantime, Merck is awaiting a final decision from the Food & Drug Administration Agency (FDA) if it will be allowed to resume sales of Vioxx in the United States. Last month in a bizarre development a panel filled with experts with financial ties to Merck recommended that Vioxx is safe to be to sold to Americans once again. The recommendation has been widely criticized due to the conflict of interest of those who voted in favor of this decision. The reason this is happening is that FDA routinely favors drug companies and this is one reason why Senator Charles Grassley has started a campaign to reform the agency. It is, however, expected that the powerful pharmaceutical lobby groups in Washington will prevail and Vioxx may be back on the market.

Recommended articles

Non-English speakers never told of Vioxx dangers by Merck

Doctors lose trust in FDA after Vioxx recall

Americans abandon Vioxx, Celebrex, and Bextra

Is Mobic a safe alternative to Cox-2 drugs like Vioxx, Celebrex, and Bextra?

Non-English speakers not told of Vioxx dangers by Merck

In a recent study completed by K.B. Forbes of Consejo de Latinos Unidos, a nonprofit organization which educates and assists Latinos and others in the areas of health care, has found that in Puerto Rico, Merck failed to adequately warn Vioxx patients and doctors about the risks of the drug since the information was available in English only. While this study was focused entirely on Puerto Rico, it is fair to assume that other speakers of other languages worldwide may not have received correct information about the risks of Vioxx. (Related article: Vioxx recall cases outside the USA)

Some of the key findings of the report are:

• As aggressive as Merck was in marketing Vioxx, Merck appears not to have adequately informed the public or medical community in Puerto Rico about the cardiovascular dangers of Vioxx, even after the FDA called on them to do so in late 2001. (Related article: Why Merck did not recall Vioxx earlier?)
• Merck appears to have failed to circulate information of the cardiovascular dangers in Spanish to the public or medical community in Puerto Rico between 2002 and 2004, time period after they had modified Vioxx warning labels (known as patient package inserts) and before the drug was pulled.
• Puerto Rico residents who used Vioxx and suffered cardiovascular problems feel they were used as “guinea pigs” and that the company should have informed them and their doctors of the associated risks. In one case, a victim knew about the dangers of using Vioxx with her kidney problems, but was never informed of the cardiovascular dangers. “The only thing I can say is that I was told that [Vioxx] would damage my kidneys. This is why I did not take them daily.” She ended up having two heart attacks.

But why did patients fail to be informed?

As Consejo de Latinos Unidos investigated the problems in Puerto Rico, they were astounded to find that literature and documents from Merck were distributed to physicians and patients in English. English is not spoken by all Puerto Ricans. "Using English-only materials was a disservice and could have been responsible for many of the deaths and injuries suffered by the individuals and families that contacted the Consejo," says K.B. Forbes. (Related article: Doctors lose trust in FDA after Vioxx recall mess)

The study concludes that, "This oversight, this possible negligence, may have also impacted other Hispanic households in the United States." The organization spoke to Vioxx victims in Puerto Rico and is suggesting a series of changes so that Vioxx-type tragedies do not happen again: (Related article: 140,000 Americans hurt after taking Vioxx)

• Merck and other leading pharmaceutical companies should institute a campaign in Spanish to educate the Puerto Rican community about the risks associated with their pharmaceutical products that is equal to the campaigns to promote their product.
• Merck and other leading pharmaceutical companies should publish all warning labels (patient package inserts) in Spanish and heavily distribute them with their representatives in Hispanic areas of the United States and in Puerto Rico.
• Merck should resolve these legal challenges by injured Vioxx patients fairly and equitably.

Related article: Vioxx lawsuits by non-US residents

Source

Consejo de Latinos Unidos

Doctors lose trust in FDA after Vioxx recall mess

While a FDA panel recently recommended that Vioxx sales be allowed to resume in the United States, and Celebrex and Bextra be allowed to stay on the market, despite serious concerns about their safety, it is not just the American people or consumer rights groups or Senator Charles Grassley that are concerned about FDA being in bed with the pharmaceutical industry. Even doctors and scientists are now seriously concerned that they may be putting their patients at risk because the FDA is not disclosing all that it knows. (Related article: Americans run away from Vioxx, Celebrex, and Bextra after safety in doubt)

Dr. Susan Okie in an article in the New England Journal of Medicine entitled "What ails the FDA?" has expressed her frustration with the way the FDA works. As anyone would expect, she discusses the story of renowned epidemiologist at the FDA, Dr. David Graham, who was pressured to change his findings about Vioxx because his superiors at the FDA did not want to make Merck unhappy. It is estimated that as many as 140,000 Americans have been injured after taking Vioxx and as many as 50,000 may have died. (Related article: FDA tries to protect Merck and Pfizer)

Dr. Jeffrey M. Drazen, in an accompanying editorial in the Journal entitled "COX-2 Inhibitors — A Lesson in Unexpected Problems," discusses that the enthusiasm that the drugmakers demonstrated for "clinical investigation to show their gastrointestinal safety was not evidenced by studies designed to show their cardiovascular safety." It is now known that most injuries from Vioxx were as a result of side effects on the heart.

Two other doctors that have been engaged in the discussion on safety of Cox-2 drugs, Bruce M. Psaty and Curt D. Furberg, have written another editorial "COX-2 Inhibitors — Lessons in Drug Safety" highlighting the importance of an integrated approach to drug safety once a study shows disturbing results. (Related article: Is Mobic a safe alternative to Vioxx, Celebrex, and Bextra?)

The FDA has become "very pro-business, anti-regulatory" and "there's been a tendency to manage all of these agencies from the top with a kind of pro-business stance," according to Dr. Okie. Since President Bush came to power, the FDA has not had proper leadership and most of the energy of the FDA was directed towards helping the drug companies, including their efforts to make it impossible for American people to import prescription drugs from Canada.

Things are not changing though in any way at the FDA despite the recent controversy. There is no push from the White House which is too absorbed with pushing Social Security privatization. And the FDA continues to do its part in helping the drug industry even if it comes at the expense of American lives. In recent weeks, FDA has refused to recall Adderall (that was recalled in Canada). While criticizing the misleading ads about Crestor, FDA refused to recall Crestor as well.

Recommended articles

Merck did not want to make label changes on Vioxx

Vioxx and Bextra recommendations in doubt due to conflicts of interest

Source: NEJM

Vioxx legal troubles may sink Merck

Merck's legal troubles are mounting each day and the company does not know how it will settle all those Vioxx lawsuits from victims who sustained injuries and from family members of those who lost their lives. And since Merck's insurers are more realistic about Merck's Vioxx liabilities (that are estimated to be all the way from $18 billion to $55 billion), they now want to cancel Merck's insurance. (Related article: Merck has a very weak defense in Vioxx litigation)

Since the recall of Vioxx, Merck has refused to make any provisions for its Vioxx liabilities. So far it has essentially acknowledged only that it will need to respond to lawsuits and has made provision of a tiny sum of approximately $600 million for attorney fees and legal costs. In documents filed with the Securities & Exchange Commission (SEC), Merck has reported that, "...upper level excess insurers (which provide excess insurance potentially applicable to all of the Vioxx Lawsuits) commenced an arbitration seeking, among other things, to cancel those policies and to void all of their obligations under those policies with respect to the Vioxx Lawsuits,and also to void their coverage obligations with respect to certain other types of losses covered by those policies." (Related article: Tough Vioxx litigation expected)

Merck's problems do not stop here. The insurers want to abandon the company altogether realizing that the liabilities are just too large. Merck tells SEC that, "As most of those insurers also issued lower level excess policies to Merck, it is likely that such insurers will also dispute their obligation to provide coverage under other policies."

As if lawsuits from Vioxx victims were not enough, Merck is again taking a very aggressive approach and wants to fight with its insurers also. In other words, Merck might very well be forced to abandon its drug business and focus instead on just fighting lawsuits left and right as many asbestos manufacturers had to do. No wonder then that there is widespread speculation that Merck will simply need to file for bankruptcy. In its documents submitted to the SEC, Merck says, "...it is reasonably possible that its insurance coverage will not be adequate to cover its defensive costs and any losses."

Merck also provided an update on class action lawsuits related to Vioxx as of January 31, 2005:

• Company has been served or is aware that it has been named as a defendant in approximately 850 lawsuits, which include approximately 2,425 plaintiff groups alleging personal injuries resulting from the use of Vioxx.
• A total of 14 Vioxx Securities Lawsuits were pending in various federal courts. The Company has also been named as a defendant in approximately 90 putative class actions alleging personal injuries. A total of 11 Vioxx ERISA Lawsuits are also pending. Several other categories of lawsuits has also been filed.
• Merck has also been sued in various other countries in Europe, Australia, Canada, Brazil and Israel related to Vioxx.

Source: SEC

Merck manipulated FDA in Vioxx recall case

Two out of three FDA scientists lacks confidence that the agency “adequately monitors the safety of prescription drugs once they are on the market.” And this survey was not conducted by a third party. These are the results of a survey by the US Government itself. Would you trust an agency that is not trusted by its own employees? No wonder then that Senator Chuck Grassley (mind you that he is a Republican, who are notorious for being very cozy with the drug companies that pump millions of dollars into their campaigns so that they would not allow prescription drugs to be imported from Canada or make life better for Americans in any way because that could hurt their profits) is now asking, "Is the FDA too cozy with the drug companies to ensure proper oversight?" (Related article: FDA did not disclose conflicts of interest of panel members reviewing Cox-2 drugs like Vioxx, Celebrex, and Bextra)

Since the recall of Vioxx and disclosures of dangers of such drugs as Celebrex and Bextra, Senator Grassley has come to the rescue of American people because the FDA still does not seem to be working for them. He was among the very few senators to speak out against the process used by the FDA to allow Vioxx sales to resume in the US and Celebrex/Bextra to stay on the market. All those who did not believe that the FDA was in bed with the drug industry learned that ten of the FDA panel members who voted in favor of these decisions were all recipients of money from the drug makers like Merck and Pfizer. (Related article: FDA panel recommendations in doubt due to conflicts of interest)

In a recent speech, Senator Grassley discussed the Vioxx recall mess and how the enormous help provided by world-famous FDA scientist Dr. David Graham was useful in saving lives of American people despite strong opposition from FDA and Merck officials (Related article: 140,000 Americans injured by Vioxx). In his words, "Vioxx example showed that the FDA and Merck were too close for comfort. Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck."

Here are a few other observations/charges that Senator Grassley makes:

1. When Dr. Graham found an increased risk of heart attacks and strokes in patients taking Vioxx, his immediate supervisor at the FDA dismissed it as “scientific rumor.”
2. The very same month that Dr. Graham warned the FDA of the cardiovascular risks of Vioxx, the FDA approved the use of Vioxx for children.
3. The director of FDA’s office of new drugs suggested that Dr. Graham water down his Vioxx conclusions.
4. After it was found in 2000 that heart attacks were five times higher for Vioxx patients than for patients on another drug, Merck aggressively marketed Vioxx through direct-to-consumer advertising. Merck and the FDA knew that consumers and doctors were largely unaware of the cardiovascular risks. The FDA’s overriding concern should have been the health and safety of the American people. Unfortunately for some, the FDA’s priorities were misplaced. (Related article: Merck and Pfizer fought Coke-Pepsi style marketing battle over Cox-2 drugs)
5. Merck managed to negotiate the cardiovascular risks of Vioxx right out of the “warnings” section on the drug’s label. Contrary to the FDA’s own scientist’s recommendation, the risk information went in the less prominent “precautions” section. (Related article: Merck dragged its feet on changing the Vioxx label to point out risks)
6. The Medicaid program paid more than $1 billion for Vioxx before Merck withdrew it from the market. Or in other words US taxpayers (with the help of the FDA) helped Merck market a dangerous drug and profit from it.

Recommended article: Merck has a very weak defense in Vioxx class action lawsuits

FDA did not disclose conflicts in Vioxx, Celebrex, Bextra hearings

Health advocates have urged the Food and Drug Administration (FDA) to stop placing scientists with direct financial conflicts of interest on its advisory committees, and to limit the number of individuals with any industry ties to no more than half of any committee. In a letter to Acting FDA Commissioner Lester Crawford, the groups said that the agency failed to comply with the Federal Advisory Committee Act (FACA) when it assigned scientists with ties to manufacturers of arthritis pain drugs known as Cox-2 inhibitors to serve on a panel charged with evaluating those drugs. (Related article: FDA panel recommendations in doubt after conflicts of interest reported)

Last month, the Center for Science in the Public Interest (CSPI) found that of 32 experts serving on the FDA’s Arthritis Drug and Drug Safety Advisory Committee, 10 had received funding from Pfizer, Merck, or Novartis. Pfizer makes Celebrex and Bextra, Merck makes Vioxx, and Novartis is developing a similar drug (Prexige or lumiracoxib). At the end of the three-day meeting designed to assess the cardiovascular risk presented by these drugs, the panel voted to keep all of those drugs on the market. But according to The New York Times, the committee would have recommended that Bextra and Vioxx be withdrawn were it not for the votes of scientists with conflicts. (Related articles: Vioxx sales allowed to resume in the US and Celebrex and Bextra to stay on the market in the US)

“The FDA is the ultimate arbiter of the safety and efficacy of industry products,” states the letter signed by CSPI, the National Women’s Health Network, the Center for Medical Consumers, the U.S. Cochrane Center Consumer Coalition, and eight other health-advocacy groups. “[FDA] relies on its advisory committees for guidance. No one financially connected to the firms whose products are up for consideration should be allowed to vote on what that guidance should be.” (Related article: Americans' trust in FDA falling after Vioxx recall)

CSPI and the groups are not asking the FDA to exclude scientists with any corporate ties from serving on committees, just those currently or recently employed by companies with a direct stake in the committee’s proceedings. The groups urged the FDA to stop granting waivers that allow conflicted scientists to serve. In the case of the Cox-2 review panel, the FDA issued a blanket waiver summarily covering every scientist on the panel. None of those scientists’ financial ties to industry were disclosed prior to or during the meeting. It is interesting to mention the case of famous cardiologist Dr. Eric Topol, an early critic of Vioxx, who was widely criticized after it was disclosed that he was an advisor to a hedge fund that shorted Merck shares. As soon as these disclosures came to the knowledge of Dr. Topol, he immediately stopped working with the fund.

“The FDA has become so reliant on scientists connected with industry that it routinely grants waivers for conflicts of interest, not just in exceptional cases,” said Amy Allina, program director of the National Women’s Health Network. “FDA’s unquestioning acceptance of this degree of industry influence has had a damaging effect on the quality of advice it gets from advisory committees and also has undermined the public’s faith in the advisory process.” (Related article: FDA continues to side with Merck and Pfizer in issues involving Vioxx, Celebrex, and Bextra)

The groups are also calling for greater transparency and for greater opportunities for public participation in the federal advisory committee process. They want the FDA to post biographies of proposed committee members online 30 days before committee meetings instead of 72 hours before, and to allow the public 20 days to comment on the proposed roster. The groups say that FDA’s practices lag behind those of the Environmental Protection Agency and the National Academies. (Related article: FDA did not do its job in Vioxx recall case)

“No one would consider a jury’s verdict credible if a number of jurors had taken money from the defendant,” said Merrill Goozner, director of the Integrity in Science project at CSPI. “If the FDA wanted to restore public confidence in its decisions about the safety of food ingredients, drugs, and medical devices, it should reform the advisory committee process. I hope members of the Senate ask Acting Commissioner Crawford about these issues during his confirmation hearings next week.” (Related article: Merck and FDA haggled for months over label changes to highlight risks of Vioxx)

Other signatories to the letter include the Reproductive Health Technologies Project, Breast Cancer Action, the Annie Appleseed Project, National Consumers League, the National Autism Association, SafeMinds, the National Research Center for Women and Families, and Our Bodies, Ourselves.

Recommended article: Americans abandoning Vioxx, Celebrex, and Bextra after losing confidence in the safety of Cox-2 drugs

Useful links

Center for Science in the Public Interest

Reproductive Health Technologies

Breast Cancer Action

Annie Appleseed Project

National Consumers League

National Autism Association

SafeMinds

National Research Center for Women and Families

Our Bodies, Ourselves

Americans abandon Vioxx, Celebrex, Bextra

Nearly two-thirds of patients who were taking a COX-2 inhibitor drug prior to the Vioxx recall and Celebrex/Bextra study findings have abandoned this class of pain medication, according to a new poll by Spine-health.com that provides in-depth information and resources for patients with back pain, neck pain, and a full range of spinal disorders. (Related article: Merck did not allow Vioxx label changes to highlight risks)

The poll of 375 back pain patients who were taking Celebrex, Bextra, or Vioxx shows that only 36% are still taking some brand of COX-2 inhibitors. 42% switched to other pain medications (e.g., Aleve, Advil, Bayer, Tylenol), and 9% switched to non-drug pain relievers (e.g., herbal/dietary supplements). Surprisingly, 13% are forgoing any medication until more safety information is available. (Related article: Is Mobic a safe alternative to Vioxx, Celebrex, Bextra?)

"This poll illustrates the high level of concern among patients about the potential side effects of Cox-2 inhibitors," says Andrew Cole, M.D., a physiatrist in Bellevue, Washington. "And the side effects can't be ignored - studies show a significantly increased risk of heart attack and stroke, especially for those patients who are elderly or who have taken the drugs for long periods of time. Bextra also potentially carries the risk of blood clots and a serious skin reaction." And what patients may now realize is that COX-2s don't necessarily alleviate pain any better than other pain medications, including those available over the counter. (Related article: Americans lose trust in FDA after Vioxx recall)

The controversy that started after Vioxx recall and revelations that Celebrex and Bextra also have serious side effects has rattled the confidence that Americans had in the FDA. The trust tanked further after disclosures that the decision to put Vioxx back on the market and to leave Celebrex and Bextra on pharmacy shelves was actually taken by drug industry insiders chosen by the FDA. It appears that FDA no longer cares for American people's lives and health and is more committed to protecting the interests of the drug industry. (Related article: FDA panel recommendations in doubt after reports of conflict of interest of members)

COX-2's do remain a viable and perhaps preferred option for certain patients, such as those at risk for ulcers. "What medications to take is really a case-by-case decision that each patient needs to make with the guidance of his or her doctor, since so many individual factors come in to play, including the patient's medical condition, clinical situation, age, lifestyle and past experience with medications," adds Dr. Cole. (Related article: Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra)

The following principles should be considered when re-evaluating a patient's medication plan:

1. When doctors or patients have any concerns about a medication based on new medical findings or media comments, they should talk openly with one other;
2. Even if the patient's conditions improve, it may not be prudent to reduce or discontinue their medications;
3. Medications should be used in the lowest dose that is effective; and
4. Since there is no universal substitute for any particular drug, each patient requires a personal evaluation to discuss alternatives.

Changing or discontinuing a pain medication is a major decision that significantly impacts quality of life for people with chronic back pain or arthritis. This poll suggests that information about side effects made available to the public was powerful enough to cause flight from an entire class of drugs (and even from any drug), despite the potential for increased pain.

Recommended article: Merck has a weak defense in Vioxx class action lawsuits

Source: Spine Health

Americans lose trust in FDA after Vioxx recall

Consumer response to concerns about COX-2 inhibitors drugs like Celebrex, Vioxx, and Bextra was emblematic of how informed health consumers are changing pharmaceutical manufacturers' susceptibility to shifts in public opinion, consumer confidence, and corporate credibility. Despite the hype, Americans are more confident in safety of prescription drugs than in they are in the Federal Drug Administration's ability to ensure safety with use. (Related article: Dr. David Graham blasts FDA, Merck, Pfizer, and Cox-2 drugs)

The findings of an Associated Press and Ipsos Public Affairs poll suggest that consumers acknowledge the inherent risks in pharmaceutical drugs, but want the risks and benefits to be clearly communicated and effectively scrutinized by the agency approving the drugs that come to market, according to Fariba Zamaniyan, Vice President of Marketing and Business development for the Ipsos Health practice and a specialist in prescription drug purchase trends. Ipsos is a leading global survey-based market research company and conducts polling on behalf of the Associated Press. (Related article: FDA did not do its job in the Vioxx recall case and this will be a point of argument in class action lawsuits against Merck)

The trust in the FDA, supposedly an agency entrusted with the task of ensuring drug safety for Americans (and the world at large since drug regulatory authorities worldwide share information with the FDA), has tanked since it was disclosed that the FDA did nothing to prevent Merck from selling Vioxx that lead to as many as 140,000 injuries (and tens of thousands dead) in the United States alone. Apparently it was arguing with Merck over label changes for over a year without telling the American public that Merck was dragging its feet over label changes so that Americans could be aware of the drug's side effects. (Related article: Merck did not collaborate with Health Canada either)

In the meantime, FDA has continued to side with Merck and Pfizer. In a very bizarre development, a FDA panel set up to review the safety of Cox-2 drugs like Vioxx, Celebrex, Bextra, Arcoxia, and Prexige was filled with drug industry insiders (mainly Pfizer and Merck), and no surprise then, that the panel recommended that Vioxx, a drug deemed so dangerous that Merck voluntarily recalled it, be allowed to resume sales in the US and Celebrex and Bextra both be allowed to stay on the market.

Bextra, that carries a black box warning was banned by Kaiser Permanente since the HMO was not sure about its safety. Louisiana Medicaid has similarly backed off filling prescriptions for Celebrex and Bextra due to safety concerns. Drug agencies worldwide, including European Union, Australia, New Zealand, and Germany have either banned or put strong restrictions on prescriptions of Cox-2 drugs. (Related article: FDA panel recommendations in doubt due to conflicts of interest)

"Americans expect the FDA to do a better job of scrutinizing drugs before they come to market, and of communicating the risks," said Zamaniyan, "but, ultimately, pharmaceutical manufacturers will have to respond quickly and address the public's safety concerns and information demands, or risk losing consumer confidence." In her essay "Dr. Jekyll and Mr. Hyde: Pharmaceutical Companies Contend with Drug Benefit and Risk Communications," that appears in Ipsos Ideas, Zamaniyan examines the new predicament for pharmaceutical manufacturers. "With greater consumer brand awareness comes increased sensitivity to shifts in public opinion, consumer confidence, and corporate credibility."

Recommended articles: Making sense of FDA panel's recommendations on Vioxx, Celebrex, and Bextra

FDA refuses to recall Crestor

FDA must recall Adderall till sufficient risk analysis is completed


Source: Ipsos

Natural alternatives to Vioxx, Celebrex, Bextra

In the aftermath of the Vioxx recall and recently reported concerns with Celebrex and Bextra, more consumers are searching for natural approaches to joint health, according to Carol Simontacchi, MS, CCN, and author of the newly released book "Natural Alternatives to Vioxx, Celebrex, and other Anti-Inflammatory Prescription Drugs." Simontacchi provides information on chronic inflammation, which has recently been linked to a wide range of diseases, including Alzheimer’s, arthritis, cardiovascular disease, depression and even schizophrenia. (Related article: Merck did not Vioxx label changes to highlight risks of the drug)

In a separate study released recently, nearly two-thirds of patients who were taking a COX-2 inhibitor drugs prior to the Vioxx recall and Celebrex/Bextra study findings have abandoned this class of pain medication. Since their pain has not gone away and they are looking for other alternatives for pain relief (Related article: Pain relief medication guide), they are evaluating natural alternatives. It is important to point out that Cox-2 drugs like Vioxx, Celebrex, Bextra, Arcoxia, Prexige, Mobic, etc. all are lifestyle drugs. (Related article: Is Mobic a safe alternative?) They do nothing to treat the underlying diseases like arthritis; they merely provide temporary pain relief. Other studies have pointed out that over-the-counter pain relief drugs like Aleve and ibuprofen do an equally good job for most patients.

Simontacchi explores the myriad of influences that contribute to chronic inflammation, including diet, lifestyle and the frantic pace of modern life. Simontacchi addresses safety concerns surrounding pharmaceutical drugs for inflammation, particularly the increased likelihood of heart disease, and offers natural alternatives that have been proven effective for managing pain and swelling.

Simontacchi’s book also addresses specific natural supplements that work to diminish inflammation. From bromelain, a proteolytic enzyme and cat’s claw, a traditional South American herb, to the well-known glucosamine and SierraSil, a new mineral supplement, Simontacchi details the science and safety of these widely available natural remedies.

Natural Alternatives to Vioxx, Celebrex, and other Anti-Inflammatory Prescription Drugs is extremely timely in light of the controversy surrounding COX-2 inhibitors, the risks of increased heart disease, and a recent FDA Advisory Committee recommendation to allow Vioxx to return to the market.

Recommended article: Vioxx and Bextra decisions in doubt due to conflict of interest of FDA panel members

Is Mobic a safe alternative to Vioxx, Celebrex, Bextra?

Since the recall of Vioxx (Related article: Vioxx sales may resume in the US), and doubts raised about safety of Celebrex and Bextra, arthritis patients have turned to alternatives like Mobic (meloxicam). No surprise then that Mobic sales in the US jumped 85% in 2004 from 2003. In the fourth quarter of 2004 (during which most of the shift to Mobic happened after Vioxx was recalled in September 2004), sales jumped as much as 175%. (Related article: FDA panel recommendations on Vioxx and Bextra questioned after conflicts of interest reported)

While consumers somehow feel that Mobic is not a Cox-2 inhibitor drugs like Vioxx, Celebrex, and Bextra, the reality is that this is the case only in the United States. In some countries like Australia and New Zealand, meloxicam (sold under brand names like Mobic, Movalis, etc.) is treated as a Cox-2 drug. The US FDA, that tends to be friendlier to drug companies rather than American people, has put Mobic in the same NSAID category as ibuprofen, naproxen (Aleve), etc. (Related articles: Australia limits/bans use of most Cox-2 drugs and New Zealand restricts Cox-2 prescriptions)

During the FDA panel hearings in February, almost all members agreed that Cox-2 drugs have a class effect. Or in other words, all drugs that use the Cox-2 mechanism to provide pain relief have varying degrees of side effects on the heart. Dr. David Graham, a highly respected expert at the FDA, has conducted a study on side effects of Mobic and called the drug a "bad actor." The data is still preliminary and is highly disputed by the drug manufacturer and the agency itself. "We found an increased risk," Dr. Graham said at the FDA panel hearings. "It's one study. It's the only study." (Related article: Dr. David Graham blasts Cox-2 drugs)

The FDA, an agency not known for keeping track of drugs on its own after they have been approved, does not provide any information on the side effects of Mobic on the heart. But FDA does say that "even short-term treatment is not without risk." It goes on to say that a doctor will need to decide if Mobic is right for you if you have heart failure.

Public Citizen, a consumer watchdog group, that focuses on drugs and has asked for recall of all Cox-2 drugs including Vioxx, Celebrex, and Bextra, also lists Mobic as a "Do Not Use" drug because it is no more effective than related drugs, has not been shown to have a lower rate of ulcers than related drugs, and has been shown to cause heart disease.

Recommended article: Vioxx recall makes health agencies worldwide more careful

Merck has a weak defense in Vioxx lawsuits

During recent hearings on Capitol Hill, the FDA officials who have testified have contradicted each other. In other words, FDA is in a mess and no one has any clue what they should say and how should they work to ensure safe drugs for Americans. No wonder then that as many as 140,000 Americans got injured and tens of thousands of Americans are dead because Merck had so much influence on FDA that it stopped it from putting any warnings on Vioxx labels. (Related link: FDA panel recommendations on Vioxx and Bextra questioned due to conflicts of interest of members)

But the cozy relationship between the two is now quite shaky. In order to save themselves, expect both Merck and FDA to accuse each other. Merck is likely to argue that FDA approved Vioxx (even though world-famous FDA expert Dr David Graham thinks that Vioxx should have never been approved), and thus, Merck did nothing wrong by marketing an approved drug. FDA is expected to say that Merck did not provide it with enough data and it lacks the powers to do anything once the drug has been approved. (Related article: FDA defends its actions in Vioxx recall case)

This fight between Merck and FDA is going to weaken Merck's case and Vioxx attorneys will use it to paint the picture of FDA as an agency that is subservient to its masters in the drug industry who pay the salaries of FDA staff through user fees. They will also argue that Merck simply exploited the weak FDA to focus on profits and ignore the number of Americans who were dying and suffering from heart attacks and strokes. Such an argument is going to melt the heart of any jury in the United States. No wonder Wall Street analysts expect that Vioxx liabilities could be as high as $55 billion. (Related article: FDA tries to protect Merck and Pfizer)

During recent months as more disclosures of the mess at the agency have been made, FDA is no longer perceived by many Americans as an agency that does its job. Particularly the revelation about picking panel members to review Cox-2 drugs blew a big hole in its credibility. Once it was pointed out that the panel was staffed with drug industry insiders who happily took money from Merck and Pfizer over the years and then tried to help the drug firms by recommending that Vioxx be allowed to resume sales in the US and Celebrex and Bextra continue to stay on the market. Many are calling for panel recommendations to be ignored because of serious conflicts of interest. Senators are arguing that they will feel very uncomfortable if Vioxx were to return on the market. Jury members are not likely to believe either Merck or FDA any more and are more likely to favor the family members of dead Americans and Vioxx victims who have suffered heart attacks and strokes. (Related article: Merck also did not cooperate with Canadian drug authorities)

Will Vioxx litigation bankrupt Merck? According to Jim Jubak, an analyst, it all depends on what the jury awards in damages to family members of dead Americans. If the damages are a few billion dollars, the company will survive, but will become weaker. But if the estimate of tens of billions of dollars in damages turn out to be true, as Merck itself has admitted, it will simply go out of business. (Related article: Vioxx recall hurts Merck financially)

Will Vioxx victims get justice in what many are calling as the "Mother of all class action lawsuits"? According to Jubak, who is predicting that Merck will lose the cases in courts, says, "Product-liability cases often don't have very much to do with justice and evidence. They often hinge on which side can make an emotional argument that is convincing but doesn't overwhelm the jury with endless detail. Before Merck's "victory" at the FDA in mid-February, I thought the odds were that Merck would be able to limit the damages it faced from these suits. It seemed these cases would quickly sink into a morass of scientific detail about which study showed what and when, about the mathematics of risk/benefit calculations and about the difficulties of figuring out the potential effects on real patients from studies that use extremely high dosages. But the events at the FDA in the last month make it more likely that the plaintiffs will be able to make the kind of emotional argument that wins cases like these by sticking to the hot-button issue of a company using its money to overwhelm the safeguards that are supposed to protect the drug supply. I still don't know if justice -- whatever that may turn out to be -- will be served. I do know that as an investor, I'm less interested in justice than in which party will win. And the odds, thanks to the FDA over the last month, have tilted against Merck."

Recommended article: Vioxx litigation update

Merck did not want Vioxx label changes

So finally FDA is starting to take some responsibility for 140,000 injuries (as many as 55,000 Americans dead) in the United States due to its failure to point out the risks of Vioxx to doctors and patients. In a presentation before a Senate committee, FDA officials admitted that they found it extremely difficult to work with Merck, the maker of Vioxx, when they wanted to make changes in the label. (Related article: Merck does not cooperate with Health Canada either)

As has been disclosed before, Merck did everything possible to hide the adverse side effects of Vioxx for years, and as far as changes in the label is concerned, in negotiations with the FDA, it simply dragged the process so that Vioxx could be on the market as long as possible. (Related article: Why Merck did not recall Vioxx earlier?)

It is very unfortunate that Merck and FDA did not consider informing patients and doctors a priority and continued to go back and forth on label language. All this while, Americans continued to die or suffered from heart attacks, strokes, and other serious side effects. The question that needs to be asked is if Merck was not cooperating with the FDA, why did the FDA not do something about it early on? Why did it wait for disaster to happen? Why did FDA not approach the lawmakers for the powers that it needed? Why did it not issue an advisory? Was it because FDA has been hijacked by the drug industry? Or because pharma industry lobbyists control what the FDA does? Or FDA simply too busy helping drug companies by making sure that Americans could not import prescription drugs from Canada?

These disclosures by the FDA can be a major problem for Merck which is now facing as many as 800 lawsuits from Vioxx victims. Merck was very combative in its approach at the FDA panel hearings in February. Dr. Peter S. Kim, who represented Merck at the hearings, said, "We made the decision to voluntarily withdraw VIOXX from the market in September (2004) based on the clinical data available at that time." (Related article: Merck wants to sell Vioxx again)

Many investigations by newspapers have shown that in reality Merck may have known Vioxx risks for years. Casey Stavropoulos, a Merck spokeswoman, is quoted in the New York Times as saying, "We worked diligently with F.D.A. to do all requested analyses and develop labeling that provid