Merck sued by NY State over fallout from Vioxx

The number of lawsuits arising from Vioxx recall is piling up. The New York State pension fund that had invested in Merck stock has filed a securities fraud class action lawsuit in the United States District Court for the District of New Jersey claiming that the fund suffered $171 million in losses on Merck stock after the company withdrew its Vioxx arthritis drug.

While Merck continues to deny it, evidence is slowly emerging that not only did Merck used some unfair practices to get Vioxx approved by FDA, it also continued to hide problems related to Vioxx. (Related article: Vioxx approval may have been a mistake by the FDA) In fact some experts believe that Merck mounted an aggressive campaign to question the validity of data that demonstrated that Vioxx was a problem drug and was killing arthritis patients.

New York State Comptroller Alan G. Hevesi, who is seeking Lead Plaintiff status in the case, said, "The New York State Common Retirement Fund is exactly the kind of sophisticated and knowledgeable financial institution that the Congress, in the 1995 Private Securities Litigation Reform Act, intended to lead such class action suits."

The lawsuit by NY State is a welcome development for individual Vioxx victims since institutions like this have the resources to mount a strong case that can be used as evidence in other cases filed by individuals.

Related article: Shareholder lawsuits filed against Merck after Vioxx recall

Merck to mount an aggressive Vioxx recall defense

Merck has been very consistent in its PR strategy from Day One of Vioxx recall. Fortune magazine, in an article "Will Merck Survive Vioxx?" on Raymond Gilmartin (CEO of Merck), wrote, "To which Gilmartin's fundamental response is: Stay the course." That is why so far no one has ever heard from Merck that it might have made a mistake or that it is sorry for all the tens of thousands of deaths and illnesses.

Expect a similar attitude and even a more aggressive response in the courtroom. It has already hired the likes of J. Michael Gaziano, a Harvard Medical School cardiologist, who will provide expert testimony that the so-called Vioxx victims died due to other causes. Merck will try to prove in each case that the victim may have suffered heart attack due to other reasons, such as smoking, obesity, etc.

How to prepare yourself for your Vioxx lawsuit?

1. Follow the advice of your Vioxx attorney and get organized as advised. Apart from new medical tests that may be needed, it will be helpful to have all the documents related to Vioxx, if you can find them. Your doctor/hospital should have all the documents and if they give you a hard time, ask your doctor to help you out.
2. If death of a loved one is involved, the situation is going to be more difficult because it is no longer possible to conduct certain tests and not all documents may have been preserved by you and the victim's doctor/hospital. Follow the advice of your attorney.
3. Even if you are totally truthful and have actually suffered from taking Vioxx, do not expect that you will win your lawsuit. If you can not convince the court and counter every argument that will be put forth by Merck attorneys, you may not get any thing at all. It is just the way our legal system work and apart from appeals, there is little that you can do.

Recommended article: What to do if you do not have any visible side effects from Vioxx?

Vioxx approval may have been a mistake

As more details come out about how the FDA regulates the drug industry (thanks to Vioxx recall scandal), one starts to wonder if any of the drugs approved today in the United States are safe. For instance, as pointed out by Scott Hendler, "The FDA does not actually test any drugs. They only review the results of clinical trials conducted and submitted by the pharmaceutical company seeking approval for the drug." Scary; isn't it?

A very lenient process was used to approve Vioxx in 1999. The underlying data that was used to grant approval to Vioxx was not made available to the public until the end of 2000, or more than 18 months after the drug's approval. By that time there were discussions in the medical community that Vioxx had problems but the FDA did not meet to look into this until February of 2001.

In the meantime, however, Merck was happily telling the world that Vioxx was a wonderful drug that they should take for arthritis. According to Eric Topol of The New England Journal of Medicine, "Each time a study was presented or published, there was a predictable and repetitive response from Merck, which claimed that the study was flawed and that only randomized, controlled trials were suitable for determining whether there was any risk." Understandably so, these trials were never conducted by either FDA or Merck.

At the same time, Merck was also using training material for its sales and marketing staff that essentially asked them to avoid addressing the concerns about Vioxx. Many of these guides were written as those for games, e.g., "Dodge Ball Vioxx".

Recommended article: Vioxx approval process was probably faulty

Avoid gold-digger Vioxx attorneys

There is some discussion about Vioxx attorneys that are essentially gold-diggers in the lawsuits involving deaths and injuries from Vioxx. If you are a genuine victim of Vioxx and you can clearly demonstrate in a court that taking Vioxx caused harm to your health (or death of a family member), then you may be entitled to compensation from Merck. The process is not going to be easy since it is quite obvious that Merck is in no mood to either settle the cases out of court or to give in easily even if it means that the company gets destroyed in the Vioxx recall process.

But how do you watch out for Vioxx lawyers who are out there to make a fast buck at your expense and exploit your situation? Here are a few things to keep in mind when working with a Vioxx attorney:

1. If an attorney wants you to sign up on the dotted line without giving you an opportunity to ask all the questions, digest the information, and think it over, that is a red flag. There is no reason for an attorney to force you to act so quickly. These cases may take years/decades before they wind their way through the courts. Just look at what is happening to Mesothelioma victims.
2. If an attorney wants you to write a check without clearly explaining what it is for, you must be very careful. If you have to spend money to get compensation from Merck, you need to ask where the money is going and why do you have to pay to the attorney now.
3. You (and your doctor) are the best judge of adverse side effects of Vioxx on your health. If your lawyer asks you to tell lies or to show that the illness is bigger than it really is, you are probably dealing with a gold-digger. It is not a good idea to exaggerate your illness, since if you are unable to prove your case, you may not even get compensation for whatever illness that you had since you will be deemed as someone who lacks credibility.

Related articles

How to pick a Vioxx attorney?

How to hire an attorney?

Vioxx recall deaths responsibility lies with doctors too

According to some recent estimates, the total number of Americans killed by Vioxx may be as high as between 88,000 and 139,000. Of course, the responsibility for these deaths should lie with Merck and the FDA. But what about doctors who prescribed these medicines to the patients? It is indeed true that American doctors don't always do their jobs professionally for the following reasons:

• Doctors do not keep up with latest information on drugs and scientific research. No wonder then that their sources of latest information are sales people of drug companies or seminars offered by drug companies at retreats sponsored by drug companies.
• Many doctors (particularly the famous ones) write supposedly academic papers that are paid for by drug companies. The drug companies provide the funds for research and if the findings are favorable to the sponsor, the research is published in medical journals and used by the drugmaker for marketing purposes. If the result in unfavorable, as the terms of the grant provided, the research is classified as secret and is never made public.
• Some doctors work as consultants for drugmakers and then try to make favorable arguments (in academic journals or at conferences) for their client without disclosing that they are being paid to make those claims. In the case of Vioxx, an army of doctors (working as consultants to Merck) organized a campaign to support Merck's position in medical journals, as documented by EJ Topol writing in the New England Journal of Medicine. He continues, "The company sponsored countless continuing medical "education" symposiums at national meetings in an effort to debunk the concern about adverse cardiovascular effects (of Vioxx)."
• While some responsibility lies with consumers who believe direct-to-consumer advertising by drugmakers, but it is a doctor's responsibility (being the professional) to not prescribe a drug even if the patient insists if it is not in her/his best interest. What is happening is that naive consumers believe the marketing BS of drug companies and then, as the advertisements exhort them to do, they go ask their doctor about it. Rather than questioning, the doctors simply prescribe what will make their patients happy, shut up, and leave. This is exactly what happened in the case of Vioxx for which Merck spent approximately half-a-billion dollars on advertising.

Recommended article: Vioxx recall and direct to consumer advertising

Vioxx recall makes Merck a takeover target

The headlines have been there for weeks. "Will Merck survive Vioxx recall?" It seems that Merck management has now admitted that the media is right.

In a filing with the Securities & Exchange Commission (SEC), the company has hatched up a plan that protects its seniormost executives in case the company files for bankruptcy or is dissolved or is acquired by another company. Merck says, "The Board of Directors of the Company recognizes that the possibility of a Change in Control exists and that the threat or the occurrence of a Change in Control can result in significant distractions of its key executive personnel because of the uncertainties inherent in such a situation." Reading between the lines, it is pretty obvious that the company is talking about serious threats to existence of the company due to recall of Vioxx and the lawsuits that are mounting by the day.

Participants in this plan include approximately 230 members of the Company's Management Committee and other Vice President-level managers. Or in other words, no matter what happens to low-level employees, senior managers will walk away with enough money for retirement while the lawsuits make their way through the court system for years/decades. If mesothelioma cases are any indication, then Merck is definitely getting ready to prepare for the day when it wouldn't exist as we knew it in September. We should also soon expect that Merck scientists and employees will start fleeing the company before it gets uglier.

Related article: Vioxx related lawsuits filed against Merck

Vioxx recall shows FDA hijacked by drug industry

The mystery of why Food & Drug Administration (FDA) will favor the drug industry over American people is starting to solve somewhat as more research is published. (Related article: FDA sides with Merck in the Vioxx recall mess)

According to a paper published in the Journal of American Medical Association by Phil Fontanarosa, Drummond Rennie, and Catherine DeAngelis (all doctors):

• Since adoption of the 1992 Prescription Drug User Fee Act, which augmented the budget of the FDA by charging "user fees" to pharmaceutical firms, the FDA has received approximately $825 million in fees from drug and biologic manufacturers from fiscal years 1993 through 2001.
• During that time, median approval times for standard (i.e, "non-priority") drugs decreased from 27 months in 1993 to 14 months in 2001, but as an inevitable consequence of faster approvals, drug recalls following approval increased from 1.56% for 1993-1996 to 5.35% for 1997-2001.
• In addition, an investigation of 18 FDA expert advisory panels revealed that more than half of the members of these panels had direct financial interests in the drug or topic they were evaluating and for which they were making recommendations.
• In 2003, the pharmaceutical industry earmarked $4.9 million to lobby the FDA.

The authors see several major problem with the current system for ensuring the safety of medications in that drug manufacturers are largely responsible for collecting, evaluating, and reporting data from post-marketing studies of their own products. It is similar to testing your own driving skills and then asking the Registry of Motor Vehicles to issue a driving license to you.

The recent withdrawal of Vioxx (rofecoxib) has raised major concerns about the undue control of industry over postmarketing safety data. EJ Topol writing in the New England Journal of Medicine pointed out that although he and his colleagues published a clear warning about the cardiovascular toxicity of rofecoxib in 2001, the FDA never insisted on a trial to determine the extent of the problem and Merck countered with a "relentless series of publications . . . complemented by numerous papers in peer-reviewed medical literature by its employees and their consultants.

Recent reports in the media suggest that Merck was well aware of the dangers of rofecoxib as early as 2000, but made concerted efforts to conceal those findings. Yet, more than 3 years later, when the cardiovascular risks of rofecoxib were documented by FDA researchers several months before the data that ultimately led to removal of the drug from the market became publicly available, FDA officials allegedly attempted to "suppress" the conclusions of the report, according to the Washington Post and the Wall Street Journal.

Recommended article: Complete coverage of Vioxx recall

FDA sides with Merck in Vioxx recall mess

We continue to be shocked by how the Food & Drug Administration (supposedly a government agency whose sole aim should be to work for the well-being of Americans) can be literally hijacked by the very industry that it has been set up to regulate. Rita Rubin of USA TODAY is reporting that just days before The Lancet, a highly-respected medical journal, was to publish a FDA-sponsored study that raised concerns about the safety of Vioxx, an FDA official took the unusual step of calling the editor to raise questions about the finding's scientific integrity. (Related article: Vioxx recall and Washington politics)

Now do not forget that FDA, particularly since 2000, has been consistently doing its very best to help the pharmaceutical industry even if it means working against the well-being of American people. The biggest example is not lifting the ban on importing prescription drugs from Canada. Even a 6-year old would not buy the argument being offered by the current administration and the FDA that these drugs are not safe. If their argument was valid, in that case, we import literally everything else that we consume (including food) and how come no one is talking about that being unsafe.

Several Vioxx victims that have written to us are asking if they can now trust anything that the FDA does. By consistenly siding with Merck (a company that apparently continued to aggressively market Vioxx despite its lethal side effects), FDA is essentially demonstrating that its first priority is to protect the drug companies that pump millions of dollars into the political campaigns of Washington politicians rather than work for improving the life of sick and elderly Americans. Our advice is to that you should be very careful of what the FDA says/does because it is clear that its priorities are clearly dictated by the drug firms.

Recommended link: Complete coverage of Vioxx recall

How to pick a Vioxx attorney?

Several Vioxx victims have written to ask about tips on picking a Vioxx attorney. They have indicated to our Vioxx recall team that there are just too many attorneys out there interested in working with them and they are afraid that they might end up picking the wrong attorney or not get their due compensation, or even worse, fall into the hands of a crook.

Here are some things to look for when you decide to work with a Vioxx attorney?

1. Research, research, and research. Visit their websites and look around. Find out more about their team structure, how long have they been around, and how many cases of this type have they handled, etc.
2. Find out if they have an attorney in your area (within driving distance). There will be occasions that you will need to visit the attorney and you definitely don't want to be on a plane to meet an attorney.
3. If they provide a phone number on their website, give them a call to ask the questions that are not answered on their website. This will give you peace of mind before signing up.
4. Some attorneys do not have the capabilities to handle Vioxx related cases themselves. Developing the evidence to go to court and preparing a compelling case for you requires a lot of expertise and hard work. Such attorneys will partner with other firms who have more expertise in such cases. In our opinion it is not that you should not hire such an attorney, particularly if it is a good law firm otherwise and meets other criteria that you might have (for example, a local contact), but it is good to find this out up front so that you know what to expect. In fact, going through a small firm may be a better option than approaching a humongous law firm where no one will know you personally and you will be on hold for 20 minutes before you even talk to an operator.
5. Once you develop a short list of lawyers that you want to consider, do a Google search on their names and find out what others are saying about them. Stay away from a firm if you come up with a lot of negative feedback on the firm.

If you still have questions, please do not hesitate to contact the Vioxx recall team.

Vioxx recall - an example of risk management

A lot of people are horrified and appalled that Merck executives seem absolutely unfazed by the Vioxx recall controversy. From their statements and behavior, it seems it is business-as-usual for them. In fact, it has been business-as-usual for them for years since in the case of Vioxx itself, the firm knew as early as 2000 that Vioxx was killing people, but instead of doing something about it, they embarked on a $500 million direct-to-consumer advertising campaign (by the way that is a lot of money for advertising a drug) asking naive consumers to pop Vioxx and risk their lives so that Merck could continue to mint money (and they did). Merck's sales from Vioxx were approximately $2.5 billion, and even this year, despite all the mess, it will still generate about $6 billion in profits.

The reality, however, is that such behavior by drug companies (and to some extent by other companies that manufacture products or provide services that have the potential to kill, e.g. automobile companies, airlines, etc.) is standard operating procedure. This is how the system typically works:

• Every product/service has a certain level of risk attached to it and drugs are at the high end of the risk profile. So prior to launching a product (and after a product has been launched and more reliable data is available), companies continue to assess the risk profile, including estimation of number of deaths that are likely to occur. It is common to develop multiple scenarios for accidents/deaths/injuries.
• The people who do this type of analysis typically tend to be management consultants, strategy gurus, and risk management experts. Their analysis is cold and based on hard numbers without any emotion whatsoever. In their analysis, a death is only a dollar number that the firm will need to spend to resolve it.
• The analysis typically shows how many deaths will make the drug stop creating value (a complicated way to saying that the liabilities from lasuits will exceed the profits from the sale of drugs). Their recommendation is that at that point the firm should pull the drug off the market, deal with the lawsuits (for which provisions have already been made in the risk analysis), and move on as if nothing has happened. Since the pricing of the product already took into account the potential liabilities from lawsuits, over the life of the drug, it will still be highly profitable. Or in other words, it might very well be that Vioxx could still be a highly profitable drug for Merck over its life.

This is exactly what Merck is doing right now. It is simply following the action plan that was put into place many years ago as part of its Vioxx strategy. So don't expect that Merck's Gilmartin will be on national television apologizing to those who lost their loved ones or say sorry to those who are suffering even more after taking the drug or do anything different. For a drug firm, this was is all expected and planned for.

Recommended article: Vioxx drug liability for Merck

Vioxx recall process if you do not have side effects

Many of you have written to MYNIPPON asking about your options if you have taken Vioxx but have not seen any adverse side effects so far. So here is the appropriate process for those who have taken Vioxx (and have even seen good results) but are not aware of any ill effect on their health:

1. If you have not already stopped taking Vioxx, please do so immediately. Consult your doctor immediately and follow the doctor's advice.
2. Just because you have not seen any adverse side effects, it does not mean that you are OK. Only a thorough medical examination can reveal if you have already been harmed. Even if your medical examination does not reveal any actual harm, there is no guarantee that adverse side effects will not show up later.
3. Do not consult with your doctor about your legal options. Not only is a doctor incapable of providing you legal advice, s/he may even discourage you (particularly if you do not have any adverse side effects) from seeking legal remedies. Why? Doctors are afraid that it will hurt their relationships with drug companies and healthcare providers if they are engaged in lawsuits or are providing assistance to patients. So use your doctor for medical advice and keep quiet about your legal options. Consult a Vioxx lawyer instead.
4. Visit the Vioxx recall website frequently to keep up-to-date on Vioxx related developments.

Recommended article: Vioxx recall leads to doubts about overall drug safety in America

Vioxx recall cases outside the United States

The whole Vioxx recall controversy has so far been focused on the United States. With hearings in Congress and the scandal over mistreatment of Dr. David Graham by the FDA, there has been a lot of press coverage in recent years. Still many experts believe that with tens of thousands of people dead, unaffected Americans have largely ignored the tragedy in a country where sanctity of life is supposedly more important. To the best of our knowledge, the church leaders who are literally ready to do anything to preserve life and the politicians who get elected on the basis of their attitude towards abortion have been quiet over the issue. Looks as if murder and death penalty do not count when sanctity of life is concerned.

In countries outside the United States, things are just starting to move with regards to Vioxx recall. There are reports that Vioxx victims in Australia and UK are planning to sue Merck. It is expected that victims in other developed nations will act soon. The problem is with poor countries like India where recordkeeping is non-existent in the healthcare sector. Most doctors do not keep a record of drugs prescribed to a patient or contact information of a patient. Patients often switch doctors and it is, therefore, almost impossible to provide them with information about Vioxx recall. The governments in these poor countries do not track deaths related to drugs. It is quite clear then that it will be impossible to come up with a good estimate of deaths caused by Vioxx.

The other challenge in many countries is the lack of legal infrastructure to sue the drugmakers. While many American law firms (some have offices in other countries or alliances with local law firms) are aggressively pursuing Vioxx victims overseas, many victims may have to rely on local Vioxx attorneys.

We have put together a helpful guide on finding a Vioxx lawyer if you live overseas, and remember that since you are not in the United States, you will need to work a little harder to get all the information that you need to understand your legal options.

Vioxx recall and direct to consumer advertising

If you are sick of television and print media full of ads for prescription drugs, you are not alone. According to Cutting Edge Information, the pharmaceutical industry's direct-to-consumer spending rose steadily by 61% from $1.1 billion in 1997 to $2.8 billion in 2002 (latest year for which data is available). The research found that DTC spending accounted for more than 13% of the industry's overall marketing spend for prescription drugs last year. Some of the most highly promoted prescription drugs have been Vioxx, Prilosec, Claritin, Paxil, Zocor, Viagra, etc.

The reason that a typical pharmaceutical firm spends more on advertising than on research and development (R&D) is that it works. The cost of drug development has continued to soar and is estimated to be approximately one billion dollars from concept stage to commercialization. What that means is that blockbuster drugs have to be advertised heavily to get the maximum return on investment (ROI), some of which goes back into R&D while the rest is given to shareholders. Investments in drug stocks have generally been very lucrative.

But tens of thousands of people who have died in the United States alone from taking Vioxx raises some serious questions about the ethics of direct-to-consumer advertising by pharmaceutical firms. At this time, US is the only country that allows this. There are reports that Merck knew as early as 2000 that there were problems with Vioxx and people were dying or having heart attacks but instead of withdrawing it, it increased its advertising budget.

If you are a consumer then you have to be extremely careful when believing what a pharmaceutical company tells you in its advertising. It is best not to discuss specific drug names with your doctor because these decisions should be left to the doctor. Little knowledge is always dangerous and when you are falling into the trap laid by the drugmaker, you are putting your life at risk, as has been clearly shown by the Vioxx case.

Recommended article: Vioxx recall leads to doubts about overall drug safety

Vioxx recall and Washington politicians

There are now reports that the House Energy and Commerce Committee is also joining efforts to investigate what went wrong and how Vioxx recall was handled by the FDA and Merck. They are following the Senate Finance Committee that has already completed some hearings on the issue.

If you look at the speed at which these politicians (mind you these are the same politicians that have received millions of dollars in contributions from pharmaceutical industry and/or Merck) have moved, you would start to believe that they are truly concerned about Americans and are responding to the avoidable deaths of tens of thousands of Americans. Not so fast!

Sources inside Washington tell the Vioxx recall blog that these hearings are essentially staged to appease the public and are typically organized with behind-the-screen collaboration with the pharmaceutical industry lobbyists (who by the way outnumber representatives of American people in Washington; latest estimate is 600 lobbyists with loads of cash at their disposal). All the way to who will be called, what questions will be asked, and who will try to act as a tough, are all decided in consultation with the drug companies. It is fairly common to circulate speeches and questions ahead of time.

It is hard to be harsh to people like Raymond Gilmartin (CEO of Merck) who have done all they could to get these politicians elected by pumping millions of dollars into the campaigns.

The Washington politics will get even uglier as the fight becomes more political, particularly because the Bush administration wants to deprive the American people of their legal right to sue companies like Merck. Many experts believe that Merck knew as early as 2000 that Vioxx was killing Americans but it started an aggressive program to hide the facts so that it could generate yearly sales of $2.5 billion. At the same time, Merck kept the politicians on its side by writing checks to every politician that mattered to their cause.

By some estimates over 55,000 Americans may have died due to a deliberate strategy by Merck. These deaths could have been avoided if greed of a pharmaceutical company was not a core component of its strategy. If Merck was not a US company in bed with the current administration in Washington it would have been described as a terrorist.

Recommended link: Complete coverage of Vioxx recall

Senator demands investigation into Vioxx recall critic

As published earlier in the Vioxx recall blog, Dr. David Graham, a highly respected expert at the Food & Drug Administration (FDA) is being harassed by senior FDA officials to discredit his testimony that the FDA bungled the handling of Vioxx recall.

Sen. Chuck Grassley has asked for an official investigation into whether the Food and Drug Administration has attempted to discredit one of its own drug safety officials who has been critical about agency actions. (Related article: Vioxx recall handling by FDA calls for reforms at FDA)

"Government whistleblowers are patriotic Americans who stick out their necks for the public good. They deserve rewards, not reprisals," Grassley said. Grassley has been conducting congressional oversight of the Food and Drug Administration.

Last week he held a hearing about agency mismanagement of information about cardiovascular risks with Vioxx. The hearing featured testimony from Dr. David J. Graham of the Office of Drug Safety at the FDA. Graham is a 20-year FDA veteran and criticized FDA policies stating that they have left the American public "virtually defenseless" against the kind of safety problems that led to the abrupt withdrawal Vioxx.

Grassley wrote to the Department of Health & Human Services that harassment of Dr. Graham raises substantive questions about whether a number of FDA employees “used deceptive practices against [Dr. David] Graham” and whether those employees acted within the spirit and intent of all applicable laws, including, among others, laws governing whistleblowers and prohibited personnel practices.

According to the Washington Post, the alleged activities involve “managers at the FDA because of their phone numbers and other identifying information.” Grassley continues, "If these allegations indeed have merit, it appears that these activities may have been coordinated by FDA management and may have involved the misuse of government resources, including government property and time."

Recommended article: Truths about prescription drugs and pharmaceutical industry

Vioxx recall critic being harassed by FDA

The New York Times is reporting that Dr. David Graham, who exposed the mishandling of Vioxx recall by Food & Drug Administration (FDA) is likely to be fired. He has sought protection as whistleblower. Jeanne Lenzer, writing in the British Medical Journal, says that Dr. Graham has referred all inquiries to Mr. Tom Devine, legal director of the Government Accountability Project - a public interest group that helps whistleblowers in order to promote governmental and corporate accountability. (Related article: Vioxx recall hearings by the Senate produce no surprises except for statements by Dr. Graham)

The FDA has been essentially saying that Dr. Graham did not follow the established procedures in publishing his findings that contradict the position of FDA. (Related article: FDA defends its role in Vioxx recall mess)

At the same time, other anonymous calls have been made to the Government Accountability Project officials with all sorts of conflicting statements about Dr. Graham. Mr. Devine is still in the process of sorting out which calls are credible and which of the other callers need whistleblower protection.

It is becoming pretty obvious that Vioxx recall has caused a lot of turmoil at the FDA and some heads at the agency will roll in the coming weeks.

GlaxoSmithKline may launch Vioxx alternative

As we had pointed out in a previous article on Vioxx recall blog that many Merck competitors are rushing to the market with alternatives to Vioxx, we have now learned today that a major player wants to launch a new drug as an alternative to Vioxx (Related article: Alternatives to Vioxx emerging rapidly). As many readers know, Vioxx belongs to a category called Cox-2 inhibitors. Cox-2 inhibitors are mostly prescribed for arthritis pain, which affects an estimated 49 million people in the U.S., the world's largest drug market, according to the Centers for Disease Control and Prevention. Vioxx generated $2.5 billion in sales last year. Pfizer's Celebrex, a competitive product, had sales of $1.9 billion in 2003.

GlaxoSmithKline Plc, Europe's biggest drugmaker, says that its dual-acting Cox-2 inhibitor shows strong efficacy for the treatment of pain. 406381, a new dual -acting Cox-2 inhibitor, is active in pre-clinical models in both inflammatory and neuropathic pain. In Phase II studies for rheumatoid arthritis and osteoarthritis, the company says, ‘381 had better efficacy in the treatment of pain than placebo. In some pre-determined endpoints involving head-to-head comparisons, ‘381 was more effective than celecoxib, the current market leader. An initial study in neuropathic pain also suggested efficacy in this difficult-to-treat condition. In these Phase II studies, the adverse event profile was similar to celecoxib, and the overall safety evaluation supports progression to larger studies of longer duration.

The company will meet with regulatory agencies over the next few months to finalize Phase III development plans, and will then have better information on which to project a filing date for the product. GSK believes ‘381 has the potential to become a class-leading medicine for the treatment of pain.

Recommended link: Complete coverage of Vioxx recall

Vioxx recall leads to doubts about overall drug safety

In response to our discussions related to recall of Vioxx, several readers have written to ask many questions, but these can be summarized into two umbrella questions:

1. What are other prescription or even over-the-counter (OTC) drugs that I should be concerned about?
2. I am taking other drugs manufactured by Merck. Can I continue to take them?

What other drugs may be as dangerous as Vioxx?

Nobody really knows. Since the FDA is literally powerless (as itself has admitted), the drug industry operates pretty much free. To shut the mouth of Congress and the administration, the drug industry has pumped millions of dollars into the campaigns of Republican leaders all the way from the president to lowly House members who might somehow be connected to influencing policy related to drugmakers. Almost in every US government department, there are either drug industry surrogates or sympathizers in powerful position whose only role is to help the drug companies, sometimes even at the expense of American people.

So American people are basically on their own and they should be very careful what drugs they take. It is best to work with the hypothesis that the drug that you might be taking may not be 100% safe since you are never sure who is hiding the facts.

One way to find out more is to find out the chemical composition of the drug that you are taking and then research if it has been approved for use in Europe and Japan. The regulatory agencies in these two parts are more powerful and have more concern about the health of their citizens.

While we would have very much liked to say that you must trust your doctor but American doctors can not always be trusted since they are also often in bed with the drug companies. There are ways to influence a doctor's opinion and the information s/he has. Even if drug companies operate within the bounds of the law, they can taint the thinking of a doctor. So don't assume that your doctor is always working in your best interest.

Are other drugs from Merck safe?

Again, no one knows. But if one were to look at the ethics of Merck, it is logical to work with the hypothesis that Merck should not be trusted, unless proven otherwise. So if you are taking a drug manufactured by Merck, it is the right time to discuss with your doctor if there are other alternatives. Merck has clearly shown that it does not care about the life of American people. While thousands of Americans were dying, Merck was happily enjoying enormous profits and funneling funds to keep politicians happy so that they would not open their mouth in opposition to the policies of drug industry (it is important to note that no one in the administration is talking about the deaths of thousands of Americans from Vioxx).

Recommended link: Complete coverage of Vioxx recall

Alternatives to Vioxx emerging rapidly

It is no surprise that Merck's competitors will try to capture the market share that Merck has now lost, probably forever, if Merck survives as a drug company. Advil was among the first drugs positioned as an alternative to Vioxx. In recent days, more drugs are being offered.

Our advice to readers is to consult your doctor prior to doing anything.

Mosaic Nutraceuticals announced that it will launch its proprietary osteoarthritis formula called Joint-2-Life for retail and international distribution December 14. Distributors, retailers and physicians interested in this product can contact the company prior to this date to arrange pre-orders and obtain more information.

President of Mosaic Nutraceuticals, Charlie Townsend, said, "The initial response we have gotten from Joint-2-Life has been incredible. We have already arranged international distribution and have plans to take the osteoarthritis marketplace by storm. Joint-2-Life is the real deal and we feel it will be considered the natural osteoarthritis cure within the coming year."

Joint-2-Life combines glucosamine with a revolutionary patented ingredient called celadrin. By combining celadrin with glucosamine the typical results experienced by taking glucosamine alone is greatly magnified. The Joint-2-Life combination of celadrin and glucosamine provides rapid joint cushioning, alleviates inflammation quickly, and accelerates the re-building/building of damaged cartilage, helping restore the entire joint area. Joint-2-Life is available without a prescription and is very cost-effective.

Another drugmaker, PBM Pharmaceuticals, Inc., developer of innovative prescription formulations, now offers the only prescription medication with omega-3 fatty acids. The only Rx product of its kind, Animi-3(TM) is already being widely prescribed by physicians as supplement therapy in rheumatoid arthritis (RA), cardiovascular disease, and depression.
"We are pleased to offer the only prescription product containing omega- 3's to aid physicians in their efforts with inflammatory related diseases," said PBM Executive Vice President Jack Schramm.

Recommended link: Complete list of articles on Vioxx recall

Vioxx recall handling calls for reforms at FDA

University of Washington researchers, in a review article published in the Dec. 1 edition of the Journal of the American Medical Association, argue that an independent group, perhaps appointed by Congress, should be charged with determining when a medication should be withdrawn from the market. Dr. Bruce Psaty, professor of medicine and epidemiology, and colleagues say that when interpreting reports of suspected adverse drug reactions, pharmaceutical companies may have too high a threshold for taking actions in a timely fashion that protect the health and safety of patients. (Related article: FDA's political approach in handling Vioxx recall may have hurt Americans)

Some patients suffered adverse outcomes after taking cerivastatin, sold under the brand name Baycol, alone or in combination with another drug for the purpose of reducing blood cholesterol levels. Those adverse outcomes included rhabdomyolysis, a potentially deadly breakdown of muscle tissue that dumps toxins into the bloodstream. Psaty and his co-authors, Dr. Noel Weiss, professor in the UW School of Public Health and Community Medicine and member of the Fred Hutchinson Cancer Research Center, Dr. Curt Furberg at Wake Forest University Baptist Medical Center and Dr. Wayne Ray at Vanderbilt University, examined documents regarding cerivastatin research after they were recruited to serve as expert witnesses in a series of litigations brought by patients or their families. The JAMA article was written independently of any litigation.

“Some of the cerivastatin studies conducted by Bayer, which showed frequent adverse drug reactions, were not published by the company, but became public during a trial in Texas,” Psaty said.

“In effect,” noted Furberg, professor of public health sciences at Wake Forest, “what happens is that some companies may treat scientific data as if it is a marketing problem.”

Ray, professor of preventive medicine and director of the division of pharmacoepidemiology at Vanderbilt, added, “The cerivastatin affair, and more recently, the similar failure to promptly restrict rofecoxib (Vioxx) use when major doubts were raised about its safety, demonstrate that the drug regulatory system in the U.S. is not doing a good job of protecting patients' health and needs a major overhaul.”

Psaty added that the failure to publish the results of all scientific studies makes it impossible for patients and physicians to make truly informed decisions about the risks and benefits of a therapy.

“In the case of cerivastatin, the drug became available by prescription in early 1998,” Psaty said. “By May of that year, there was certainly evidence that there was a problem when it was co-prescribed with gemfibrozil. The company did analyses that suggested that even the use of cerivastatin alone was associated with a high risk of rhabdomolysis, yet the drug stayed on the market for three years.”

Psaty went on, “The question is, who should decide when a drug is removed from the market? The company has perhaps an impossible conflict of interest in interpreting adverse event reports. Leaving these decisions to pharmaceutical companies may subject the public to the adverse effects of medications, if decisions are made too slowly.”

As of Sept. 2004, Bayer AG had agreed to settle 2,861 cerivastatin lawsuits out of court. Litigation continues in other cases related to cerivastatin and rhabdomyolysis or myopathy.

Psaty testified regarding similar post-market adverse outcomes of the recently withdrawn pain medication Vioxx before a U.S. Senate committee Thursday in Washington, D.C. He and his colleagues testified that the manufacturer of Vioxx and the Food and Drug Administration should have been more attentive to problems that were noted in Vioxx studies as far back as the 1990s. (Related article: Vioxx recall hearings by the Senate Finance Committee produce no surprises)

Recommended link: Vioxx recall news, updates, & advice

More Vioxx related lawsuits filed against Merck

It seems that Merck will spend years dealing with lawsuits arising out of Vioxx recall. Apart from Americans who have suffered strokes and other side effects, there are shareholders that have suffered tremendous losses due to poor Vioxx strategy followed by Merck.

Scott + Scott, LLC has now filed a class action lawsuit on behalf of participants and beneficiaries of the Merck & Co., Inc. Savings and Security Plan and the Employee Stock Purchase and Security Plan. ERISA clients include both union and non-union workers as well as current and former employees.

The complaint alleges that defendants Merck & Co., Inc. and other Plan fiduciaries breached their fiduciary duties under ERISA (the Employee Retirement Income Security Act) by, among other things: (1) failing to properly manage the Plans' assets by imprudently investing a significant amount of the Plans' assets in Merck stock; (2) failing to provide complete and accurate information to participants and beneficiaries; (3) failing to monitor those Defendants who were charged with managing the Plans and their assets; and (4) failing to avoid conflicts of interest with respect to the Plans.

Merck withdrew Vioxx from the market Sept. 30 because the drug significantly increased the risk of heart attacks and strokes in patients taking it longer than 18 months. After the drug had been withdrawn, the Wall Street Journal reported that internal company emails and memos showed that Merck was aware of the problems with Vioxx as early as March 2000, over 4 years before the drug was withdrawn. Also, earlier this week, the SEC and the Department of Justice announced that they were investigating whether Merck misled investors and federal regulators about the safety of Vioxx. Since Vioxx was withdrawn from the market, Merck's stock price has dropped over 40% and is currently trading at an 8 1/2 year low.

Recommended article: Merck response on Vioxx recall

Vioxx approval process was probably faulty

AIDS Healthcare Foundation (AHF), the largest AIDS organization in the United States which operates free AIDS treatment clinics in the US, Africa, Central America and India, has highlighted the current "FDA fiasco" involving the FDA's initial approval and subsequent recall of Merck's troubled arthritis drug, Vioxx. In their opinion Merck and other drug companies have hijacked a 'fast track' drug approval process initially developed by the FDA to bring life-saving AIDS drugs to market more quickly in order to seek huge profits on other, now troubled drugs.

"In its never-ending quest for huge profits, the pharmaceutical industry has driven a Mack truck through the 'fast track' drug approval process exception that the FDA first instituted for the very first AIDS drugs," said Michael Weinstein, AIDS Healthcare Foundation president. "At a time when thousands of Americans were dying from AIDS and there were virtually no AIDS drug treatments available to the public, AIDS activists chained themselves to the FDA's headquarters, an act of civil disobedience that served as a catalyst for the FDA to streamline the approval process for such life-saving AIDS drugs. However, from Vioxx to Viagra, it appears that drug companies have now hijacked the fast track approval process for profit over people, as the safety crisis over Vioxx clearly demonstrates."

Recommended link: Complete coverage of Vioxx recall

Vioxx recall strategy aggressively defended by Merck

It is obvious that the public relations and strategy experts for Merck are asking the company leadership to mount an aggressive campaign to defend its strategy. Apart from statements made to the media, Merck has also inserted full-page ads in several leading newspapers discussing and defending its strategy related to Vioxx recall.

In a prepared testimony by Raymond V. Gilmartin, President, Chairman and Chief Executive Officer of Merck and Co., Inc. before the United States Senate Committee on Finance last week, nothing new was said. Here are the key points made:

• The Food and Drug Administration approved Vioxx only after Merck had extensively studied the medicine.
• Merck continued to extensively study Vioxx after it was approved for marketing to gain more clinical information about the medicine.
• Merck has promptly disclosed the results of numerous Merck-sponsored studies to the FDA, physicians, the scientific community and the media and participated in a balanced, scientific discussion of its risks and benefits.
• Until data from the APPROVe clinical trial became available in September, the combined data from randomized controlled clinical trials showed no difference in confirmed cardiovascular event rates between Vioxx and placebo and Vioxx and NSAIDs other than naproxen.
• While epidemiological studies have an important role to play, given their inherent limitations, when both epidemiological studies and randomized controlled clinical studies are available, the randomized controlled clinical trials are the most persuasive evidence.
• As soon as the data from the APPROVe study became available, Merck acted quickly to withdraw the medicine from the market.

Recommended article: Vioxx recall hearings at Senate produce no surprises

Vioxx recall leads so shareholder lawsuits against Merck

While millions of Americans are more concerned about the impact of taking Vioxx on their health and have to deal with this really important issue right now, there are many other Americans who have been seriously hurt by the strategy pursued by Merck: the shareholders of Merck.

Since the company did not fully disclose what was going on with Vioxx until it recalled the drug, shareholders were kept in the dark. No wonder the stock has been in a free fall and there is speculation that the company could become a takeover target or file for bankruptcy if the cases related to mesothelioma provide some guidance.

So the shareholders are now going to court. Lockridge Grindal Nauen commenced a class action lawsuit in the United States District Court for the Eastern District of Pennsylvania on behalf of all persons or entities who purchased or otherwise acquired Merck & Co., Inc. securities, including common stock, between October 30, 2003 and September 29, 2004, inclusive, and who suffered damages.

The Complaint alleges that Merck failed to disclose material information during the Class Period concerning the safety of its arthritis drug Vioxx, and that a growing body of evidence demonstrated that patients who used the drug for more than 18 months were exposed to an increased risk of heart attack.

Key questions related to Vioxx recall

U.S. Senator Max Baucus has developed a list of key questions raised by recall of Vioxx by Merck. These relate not only to what Merck and FDA should have done to prevent over 25,000 American deaths but also to the basic structure of how the United States approves drugs and monitors their performance over time

• When did Merck know about the potential dangers of Vioxx?
• And should the company have acted sooner to withdraw the drug?
• Why didn’t the FDA detect the risks associated with Vioxx during the initial approval process, or even in the 5 years since approval?
• Does the FDA have sufficient resources, authority and independence to ensure that the drugs it approves are safe?
• And should we be doing more to monitor drug safety after a drug has been approved?

Experts believe that while faster drug approval may be in the interest of American people but it should not allow a company to play with American lives. That is where the role of FDA is crucial. Baucus adds, "I am concerned that what happened with Vioxx may have been due, in part, to insufficient emphasis on complete, rigorous, and expansive clinical trials. Clinical trials focused on drug safety should not stop when the FDA approves a drug. We need to continue testing drugs to thoroughly evaluate the potential risks, not just the benefits."

He also raises questions about the broad implications of the medical malpractice reform bill currently being considered by the Congress. As it is American people are totally helpless when it comes to being used by drug companies. With denial of a legal remedy to Americans, the Congress will give a boost to the efforts of drug companies to abuse the system. He expressed his concern by saying, "Liability restrictions in this bill apply not just to doctors and hospitals. They also include pharmaceutical and medical product manufacturers, such as Merck. And the legislation creates new protections for products approved by the FDA, like Vioxx."

Recommended article: FDA's political approach in handling recall of Vioxx

Vioxx recall handling by FDA raises concern about drug approval process

AIDS Healthcare Foundation (AHF), the largest AIDS organization in the United States which operates free AIDS treatment clinics in the US, Africa, Central America and India, noted that the current "FDA fiasco" involving the agency's initial approval and subsequent recall of Merck's troubled arthritis drug, Vioxx, raises serious questions about the FDA's ongoing parallel role in the approval of generic AIDS drugs for widespread use in Africa and the developing world. At present, the President's Emergency Plan for AIDS Relief (PEPFAR) which pays for, or provides AIDS drug treatments for patients in developing world countries stipulates that if cheaper generic drugs are to be used, they must be approved for 'bio-equivalency' to their branded drug counterpart by the FDA.

"This latest FDA fiasco underscores the need for a better method for drug approval to ensure the health and welfare of all patients-be they in Alabama or Africa, India or Indiana," said Michael Weinstein, AIDS Healthcare Foundation president. "Drug industry spin usually slants heavily toward the notion that 'branded equals safe,' yet this Vioxx recall and the removal of Rezulin from the market in 1997, remind us that any drug could have problems. Just as there are some dangerous branded drugs, there are also some excellent generics drugs. The issue is really one of developing a competent and respected testing and approval process that the public can truly trust."

The drug safety issue rose in Washington in testimony before a United States Senate Committee by Dr. David Graham, the FDA official who first blew the whistle on the approval and subsequent recall of Merck's Vioxx. The arthritis drug has been implicated in as many as 160,000 heart attacks and strokes in patients and has been removed from the marketplace. According to the Guardian newspaper, "Dr. Graham (also) identified GlaxoSmithKline's asthma drug, Serevent, AstraZeneca's cholesterol fighter Crestor, Pfizer's arthritis treatment Bextra, Roche's acne treatment Accutane and Abbott Laboratories weight-loss drug Meridia, as carrying possible risks."

In a similar arena, the World Health Organization last week de-listed several generic AIDS drugs manufactured by the Indian drug company, Ranbaxy from its list of WHO-approved 'essential medicines' over concerns for the drugs' bio-equivalency tests. At present, no problems have been found with the use of any of these cheaper generic medications; however, many drug industry lobbyists and officials who oppose the use of such cheaper generic HIV/AIDS drugs quickly capitalized on the WHO de-listing. Ranbaxy is expected to resubmit the required bio-equivalency testing data to WHO by January.

"After Vioxx and the flu vaccine debacle, why should we trust the FDA?" continued AHF's Weinstein. "Tens of thousands have died because of FDA malpractice, whereas not one single person has been shown to be harmed by AIDS generics. The assumption that expensive branded drugs are safer is a myth that is supported if not outright cultivated by the pharmaceutical industry and its cronies. Millions of people in developing areas are dying while U.S. regulators and politicians fuss over the fine points of the safety and efficacy of generic drugs, when Vioxx clearly shows the problem is more about the approval process itself. AHF currently has 13 treatment centers operating in poor countries worldwide; all told, these clinics provide life-saving generic HIV treatment to thousands and we have had no serious safety or efficacy problems to date. It's high time we fix the drug approval process for all drugs, both branded and generic, for use here and in the developing world."

Related article: Vioxx recall hearings at Capitol Hill produce no surprises as FDA defends its handling of the issue

FDA's political approach in Vioxx controversy hurts Americans

It is now becoming increasingly apparent that the American victims of Vioxx are pretty much on their own and they can not only expect the FDA and the administration to shield Merck due to the close ties between Merck and almost everyone who matters in the current administration. (Related article: Vioxx related deaths higher than Iraq War and 9/11 but Americans do not seem to be outraged)

Dr. Bryan A. Liang, professor and executive director of California Western School of Law’s Institute of Health Law Studies, says that with more resources and less politics, the FDA would be more resilient—and better positioned to help protect Americans. “The FDA is not supposed to be a political organization,” he says. “They are taking a health-policy issue that reveals a weakness in the system and turning it into a political issue.” He maintains that the FDA did try to do the right thing in approving Vioxx in the first place. “But preliminary studies often don’t have enough info to make conclusions about side effects,” he says. (Related article: FDA defends its role in handling of Vioxx recall)

Merck is reported to have known for about four years that there were problems with Vioxx. It is also becoming obvious that FDA did not do it job in the meantime. During this time, however, Merck was raising money for reelection of President Bush and other Republicans. CEO Gilmartin contributed thousands of dollars to reelection campaigns. (Related article: Merck response on Vioxx recall)

“The FDA's primary mission is to protect the public health. The front-line people at the FDA--the scientists, the researchers, and others--are committed to that mission. But when politics gets involved, we have a problem. The fact that Vioxx, and the warnings about the cardiovascular problems with the drug, were late coming to the consciousness of policymakers and significantly delayed action was a symptom that there is a tremendous gap in the regulatory methodology for drug safety at the FDA. Remember, it was Merck--not the FDA--that acted to withdraw the drug voluntarily from the market. So the FDA, Congress, and the President have an obligation to look to the drug safety system to determine how this can be avoided so that another ‘Vioxx’ doesn't occur.