Alabama Product Injury Lawyer Blog

Its been a long while since I've posted....not good. Reality is my day to day work has taken on a life of its in own. I have several significant products liability cases in their last phases before trial and been focusing all my time and energies to that endeavor. Although still in the depths of preparation for these cases, I will do what I can to bring you information of importance relating to pharmaceutical drugs, medical devices, auto problems and consumer product issues.

I also write on a day where a significant event in our countries history has occurred...the passing of the Healthcare Plan. In concept, I have always had a strong belief that health care and keeping our citizens healthy should be a main priority of our government. The insurance companies have been abusing the system...and us for so many years we have gotten use to it. Many of us just feel lucky for what our employers provide, even though today most employers require at least some employee contribution to the premium they must pay for the individual's insurance. I recall when I first started working as a young lawyer just out of law school, not only could you expect to receive rock solid medical insurance coverage from your law firm, but you would never be asked to contribute toward its cost. In the 1990s, as insurance premiums soared for employers, everything changed. More and more employers required employees to contribute to the premium and not only that, but provided less and less coverage. We would complain, be upset at our employers, but our frustration was misplaced. It is the insurance companies and their continued efforts to put more zeros in their bottom line combined with the every increasing cost of medical care that was killing the system. When i hear "opponents" to this Healthcare Plan, they spout that healthcare is not a right, it is a privilege and if you want it, go out and get a job that provides it. Not only is this such a ludicrous statement given the state of the economy and job losses, but don't forget, we are all only one step away from being on the employment line...or worse, homeless. All it takes is some catastrophic event in our lives, to set the wheels spinning.

What passed yesterday is far from perfect. Although I have been strongly in favor of a significant overhaul to the health care system, I was not convinced, with all the political favors latched on to the bill, that this is the right way to go. But as I thought more and more about it, I realized we have to start somewhere. Sure, there will be fixes and changes along the way, but something significant needed to happen to get us moving in the right direction....and yesterday it did. Wiping out the "donut hole" in medicare prescription plans, no more denial of insurance because you are "too risky", your kids can stay on your plan till they are 26 and are strongly on their way to creating their own life. Republicans refused to negotiate, to deal, to talk, even though much of this plan came from Mitt Romney's Massachusetts plan, and plans talked about in the early 90's by conservative think tanks. It was more about the politics, then what was good for Americans. Not to say many of the Democrats are without blame.....but there were doors open for negotiation, and the Republican leadership continually slammed them shut. Not to belabor the politics of it all, but take a gander at this "day after" commentary from David Frum, conservative political writer and former Bush speech writer. He concludes his commentary by saying "For the cause they purport to represent, however, the "Waterloo" threatened by GOP Sen. Jim DeMint last year regarding Obama and health care has finally arrived. Only it turns out to be our own." ....Interesting comment.

Finally, and not least important, late last week the FDA issued warnings regarding the anti-cholesterol drug Zocor (simvastatin). There is concern that those taking the highest dose (80mg) are at an increased risk for muscle injury (myopathy). Although this is a concern with regard to all statin/anti-cholesterol drugs (which became of significance several years back with the recall of the statin drug Baycol which caused myopathy and in its worse and potentially deadly form, rhabdomyolysis), people taking Zocor at the 80 mg strength have a greater risk of developing muscle injury then other patients. This also goes for drugs which include Zocor as part of the medication, such as Vytorin and Simcor. The FDA is continuing to review studies on the drug to see if more action is necessary. As a consumer, if you are taking this medication and are having muscle aches and pains, especially in the legs, you should consult your physician immediately.

So there you go. I am back. Can't make promises, because don't want to disappoint, but hopefully I will continue to post on a regular weekly basis. Let me know your thoughts and comments about anything I discussed in this post or any other issues. Until next time....be careful out there.

The Wall Street Journal reports that the FDA warned doctors earlier this week that they should tell their patients taking the anti-clotting drug Plavix not to take popular heartburn drugs like Prilosec and Nexium because they may lessen the effects of Plavix. This may be problematic since about half of the patients taking Plavix also take Nexium, Prilosec and other similar medications to prevent stomach bleeding and ulcers which are common side effects of taking Plavix. The alternatives which at this time don't appear to have any effect on the anti-clotting properties of Plavix are heartburn drugs like Zantac, Axid and Pepcid and older formulations like Mylanta or Maalox, which work differently than Nexium and Prilosec.

A previous study indicated that if you took heartburn drugs like Nexium and Prilosec with Plavix, the risk of heart attack and stroke increased by 50%. For a specific description of the FDA's position, see the FDA's press release issued on November 18th.

Yesterday the FDA issued what it refers to as an "early communication" advising Drs. and patients that it is investigating whether the weight control drug Orlistat, which is marketed over the counter as Alli, and by prescription as Xenical, may cause liver injury. Thus far, the FDA reports it has received 32 reports of serious liver injury, which include 6 reports of complete liver failure, of patients who were using Orlistat. The FDA is now reviewing data provided by the manufacturers of Orlistat of suspected cases of liver injury. In its press release, the FDA has emphasized that no definite association between liver injury and use of this drug has been determined at this time.

GlaxoSmithKline, which manufactures Alli, the OTC version of this drug, insists "there is no evidence that Alli causes liver damage". The company went on to indicate the people who are overweight or obese are predisposed to liver problems.

My only comment on this issue is the use of medication to lose weight. Time and time again you will here experts in this area say, "there is no easy fix...no magic pill" to make your weight problems go away. It all comes down to 2 things, diet and exercise. Watch what you put in your mouth, and more importantly, how much you are putting in your mouth and get out there and move! I will continue to monitor the concerns raised on this drug and will update here when further information is released. If you have any concerns or issues regarding Alli or Xenical, you are welcome to contact me to discuss them.

On Thursday, AstraZeneca, the manufacturer of Seroquel, a drug used to treat certain psychological conditions, agreed as part of court proceedings on the drug, to unseal and release certain documents to the public. Bloomberg News reports that these documents indicate AstraZeneca "buried" studies which were unfavorable about the drug. More than 15,000 people treated with Seroquel are suing the company claiming it withheld information regarding the relationship between Seroquel and diabetes from physicians and patients. There are also claims that Seroquel was promoted by AstraZeneca for uses that were not approved by the FDA. With regard to the suppression of these studies, one of AstraZeneca's management is quoted as saying in an email that "The larger issue is how we face the outside world when they begin to criticize us for suppressing data."

Bloomberg News further reports that one of the unsealed documents indicated that company officials felt one of the "buried" studies was a problem because it indicated weight gain while taking the drug. Gaining weight is known to be a factor in developing diabetes. The article goes on to discuss in detail several examples of AstraZeneca either hiding important study information from the FDA or working on how to "spin" information to avoid the negative implications. Where are the ethics? These are individuals bodies and health you are dealing with. Unfortunately, more indication that too many times its about the dollars and not about providing a safe and effective medication to the public.

At this same court proceeding, Bloomberg News also reports that lawyers for AstraZeneca indicated that it had agreed to strengthen the warning regarding Seroquel's relationship to diabetes by moving it into the warnings and precautions section of the label, indicating there is a stronger link between the drug and diabetes. The litigation regarding this drug is continuing and I expect there will be further reports regarding some of the "confidential" documents which are now being made public. I will be sure to update if there is anything of significant interest.

The FDA reported late last week that the psoriasis drug Raptiva may be linked to a rare, often fatal, brain infection known as progressive multifocal leukoencephalopathy, or PML. According to the FDA, it has received reports of 3 confirmed cases and one possible case of PML in patients being treated with Raptiva for moderate to severe plaque psoriasis. Two of these patients who were confirmed with PML have died and the the one possible PML also died. All of the patients had been taking the drug continuously for 3 years. There is no known treatment for PML.

In October of last year a black box warning (the most significant warning that can be given to a drug) was added addressing the risk of contracting certain life-threatening infections while taking Raptiva, including PML. The FDA indicates it is reviewing this latest information to determine if the risks of this drug outweigh its benefits. At the same time, the European Union's equivalent of the FDA, the European Medicines Agency (EMEA), has recommended that the drug be withdrawn from the European market. The EMEA has already determined that the risks of this drug outweigh its benefits. In Europe, the European Commission must approve the EMEA recommendations, but it typically does.

The FDA strongly recommends that doctors closely monitor their patients taking Raptiva, as well as those who have taken the drug in the past. Symptoms of the infection indicated by the FDA are weakness, blurred vision and difficulty speaking.

If you are presently taking this drug, or have in the past, you might want to consider contacting your treating physician and discussing this issue with him. I will say its curious that the EMEA immediately jumped on removing the drug from the market, while the FDA still needs to continue to look at this issue. There are other treatments on the market for psoriasis, so the delay by the FDA raises the issue again of the tail wagging the dog i.e. is Big Pharma again calling the shots.

The New York Times reports about a study published in the New England Journal of Medicine (NEJM) this week indicating that the antipsychotic drugs Zyprexa, Seroquel and Risperdal, used to treat such problems as schizophrenia, autism and dementia, double the patients risk of dying from sudden heart failure. The study indicates that the risk of death from these drugs is not high (about 3 percent in people being treated with these drugs over the past 10 years) and the risk was no different than older antipsychotic drugs. However, along with the study, an editorial was published in the NEJM suggesting doctors limit prescribing these medications, especially to children and the elderly, who are very susceptible to the problems caused by these drugs, especially weight gain issues.

These newer antipsychotics were promoted as being safer alternatives to the older antipsychoitcs, but this study, as well as earlier studies indicate these group of drugs have significant problems of their own and they are much more expensive than the older antipsychotics. Moreover, there is some indication that these drugs are no more effective than the older, cheaper alternatives. Clearly, people with pre-existing heart conditions need to address the safety of taking these medications with their physicians.

In a related issue, Eli Lilly, the manufacturer of Zyprexa, agreed to a $1.4 billion settlement on criminal and civil charges that it illegally marketed Zyprexa by promoting its use in children and the elderly to treat "disruptive" children and to use in nursing home patients to reduce "nursing time and effort" i.e. keep the old people quiet. Zyprexa has been found in a government study to be no more effective in children than older medicines but have more serious side effects such as gaining significant amounts of weight. For a discussion of the entire sorted story of Lilly's handling of this drug, see this article in the New York Times. Lilly's side of the story, i.e. we are a good corporate citizen, can be found here.

It was announced yesterday that Raptiva, a drug used to address psoriasis, has received a black box warning (the highest warning a drug can get) that taking of the drug increases the risk for certain viral and bacterial conditions. The new warning highlights increased risk for sepsis, viral meningitis, and other potential serious infections.

According to the FDA's press release regarding this label change:

Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

For further discussion of this new warning and the reasons for it, see Pharmalot's discussion of this label change.

The New York Times today is reporting about a study funded by the National Institute of Mental Health and reported in The American Journal of Psychiatry that drugs which are most often prescribed today to children suffering from schizophrenia, Zyprexa and Risperdal, are no more effective than the older, less expensive drugs used to treat this condition. More significantly, these newer drugs have been shown to be more likely to cause harmful side effects like rapid weight gain. In fact, it is reported that the children receiving Zyprexa gained so much weight that the government oversight panel monitoring safety during the study ordered that the children be taken off Zyprexa. The older drug used for comparison purposes was molindone. On average, those taking Risperdal gained about 9 pounds and those on Zyprexa gained 13 pounds. Both these groups also saw increases in cholesterol and insulin levels which are risk factors for diabetes. In contrast, those taking the older medication molindone gained less than a pound on average and had little changes in cholesterol and insulin levels. One 18 year old who was given Risperdal for several months gained 35 pounds.

The lead researcher on the study, Dr. Linmarie Sikich concluded that the guidelines for treating schizophrenia have to be changed so some of the older, more traditional medications are considered first line treatment. What is important to note is that more than 80 percent of prescriptions written for Zyprexa and Risperdal are not for schizophrenia, but for autism- related aggression, bipolar disorder or ADD issues which are not approved indications for uses of those drugs.

There are a few thoughts to take away from the results of this study. First, I have always believed that when taking medications, generally go for the one that has been on the market the longest because there has been time to really evaluate the potential adverse effects of the drug. It usually takes about 5 years or so for a drug to be on the market before the greater majority of the significant side effects can be seen. This is mainly because the amount of people involved in clinical studies used to get approval of the drug for sale is so small and selective that they can not truly evaluate problems with the drug in the general population. The other thing to be aware of is that many drugs are used "off-label" as is discussed above. In other words, doctors will prescribe the drug for conditions which have not been approved of by the FDA. You should question your doctor when he is prescribing medication about whether the condition for which he is prescribing it for is an "indicated" use or a use approved of by the FDA and addressed in the label for the drug. You shouldn't necessarily refuse to take the drug if it is being given for a "non-indicated" use, but find out from your doctor the basis upon which he relies on prescribing the medication for the condition he is seeking to treat. Yes, trust your doctor, but don't do it blindly. You need to ask questions and do your best to inform yourself about the medications he is prescribing for you and your family.

Yesterday, the FDA issued additional warnings regarding the drug Byetta, which is an injectable drug used twice a day to help patients who have type 2 diabetes. This was reported in both the New York Times and by ABC News. Back in October of last year, the FDA issued its first Information to Healthcare Professionals alerting physicians to the concern that patients taking this drug were reported to come down with acute pancreatitis, which is a very painful and potentially deadly infection of the pancreas. At that time, the FDA had received 30 reports of patients taking Byetta contracting acute pancreatitis.

Since then the FDA has received another 6 reports of acute hemorrhagic or necrotizing pancreatitis in patients taking Byetta. All of these patients had to be hospitalized and 2 died. The FDA has warned that if patients taking this drug come down with symptoms of unexplained and continuous severe stomach pain, nausea and vomiting, the use of Byetta should be stopped immediately. If you are taking this drug and do have any of these symptoms, contact your treating doctor immediately. At this time, the FDA is working with the maker of Byetta to add stronger and more prominent warnings.

Our firm assists individuals who have been injured by drugs or medical devices. If you need assistance, please feel free to contact us. I will continue to keep you up to date on further information provided regarding Byetta.

Since early February the FDA has been dealing with contaminated Heparin that was causing patients to have allergic reactions including problems breathing, nausea, vomiting, and rapid drop in blood pressure which can lead to life threatening shock. The type of Heparin at issue is typically given to dialysis patients during the dialysis procedure. At this point, the FDA is aware of approximately 131 reports of death related to being given heparin between January 07 and April 08. The significant jumps in death reports started in Nov 07 through end of February 08 when 81 of those 131 deaths occurred, prompting the FDA to call for ending the use of Heparin. As fate would have it, the problematic doses of heparin were manufactured by a company in, yup, good 'ole China.
Congress has been having hearings for several weeks now trying to get to the bottom of this problem, specifically addressing the failure of the FDA to properly and timely inspect the facilities in China who were manufacturing this product. In order to avoid this happening in the future, Congress has been trying to get the FDA to tell it how much money it needs to properly and timely inspect these foreign manufacturers and have been stonewalled by the FDA officials regarding its needs to properly undertake these inspections.

Just this past Tuesday, Jane Woodcock, director of the FDA's drug center, indicated that the FDA is now working on the hypothesis that this contamination of heparin was INTENTIONAL!!! They believe that someone(s) purposely contaminated this drug to cause people to get ill. Some are saying this is the most significant case of poisoning since the contamination of Tylenol back in 1982 when someone laced Tylenol with cyanide.

One of the Congressional investigators told Congress that this all could have been avoided if there was some oversight of this plant. Apparently, the distributor of the drug, Baxter, has purchased ingredients for heparin from the Chines plant in question between 2004 and 2008, but only visited the plant once, in September 2007. It is reported Baxter sent one person for one day to look at the plant at that time. However, 5 months later when the FDA went to the same plant after this problem came to the surface they found tons of problems. The congressional investigator, David Nelson's thoughts on this apparent 5 month "change" in the plant from fine when Baxter looked at it to horribly out of compliance when the FDA looked at: "It really is impossible for a plant to have fallen that far out of compliance in five months." So what was the Baxter official doing during that inspection...enjoying some good Chinese food????

This continues to be an interesting story as it develops. Another drug company caught with egg on its face and not spending the money to properly address safety of its products. I am in the process of evaluating several cases where patients appeared to be injured as a result of being given heparin during dialysis treatment. If you or someone you know may have been a victim of this tragic situation, you are welcome to call me to discuss.

For those of us lawyers who have been fighting Big Pharma over the last many years, the issue of drug companies "ghostwriting" studies about their drugs and then having doctors sign on to the studies to give them credence, has been one actively pursued. Last week, one of the most prestigious medical journals, Journal of the American Medical Association (JAMA) took this issue head on in addressing documents which have been uncovered during the litigation that has transpired regarding Vioxx and its manufacturer Merck. The article discussed how Merck drafted dozens of research studies regarding Vioxx and then paid prestigious doctors to put their name on the study to make it look like the study was done by "independent" doctors. Literally, with "ghostwriting", the drug companies hire marketing companies to help them write up the results of the study and to give the study the most positive spin. The drug companies then hire doctors who were not even involved in running the study and have never reviewed the detailed information regarding the results of the study, to sign off on the publication so it can be submitted to a medical journal and have some credibility.

As the New York Times reported, the JAMA article discussed one study by Merck on Vioxx which indicated Merck was still looking for a "big-name researcher" to sign on to the study. The draft of the study identified the lead author as "External author?" indicating Merck was still trying to find a doctor who would vouch for the study. The lead author of the report in JAMA, Dr. Joseph Ross indicated "It almost calls into question all legitimate research that's been conducted by the pharmaceutical industry with the academic physician."

The real problem with these type of studies that are done and drafted by the drug company and a "spin doctor" they hire, is that it is an attempt to "pollute" or manipulate the information out in the public domain on these drugs. Once these positive studies are published, the drug companies will use them to promote their product to doctors, with the doctors having no idea the information has been manipulated in such a manner as to give the most positive spin on the information developed from the study. Additionally, if there is ultimately litigation involving the drug, the lawyers for the drug companies will use all these slanted studies to show the court that there is no problem with the drug.

This information came to light just at the right time. The FDA is in the process of considering a proposal which would allow drug companies to use articles printed in medical journals to promote the use of the drug for "off-label" use or for uses not approved by the FDA. As an example, with hormone therapy which was approved to give to woman who were experiencing symptoms of "the changes" such as hot flashes, etc..., it has been found the the pharmaceutical companies making these drugs were promoting these drugs to also help woman with their heart, which was not approved by the FDA. This article that has been published in JAMA now calls into question these articles the drug companies would use to promote these off label uses since they the studies are being "ghostwritten" by some for-profit company and the drug companies then search out doctors to sign off on the studies. Several groups have now objected to this FDA proposal including the New York State's health commissioner and the Blue Cross Blue Shield Association , a trade association made up of 39 major health insurance plans.

I don't have problems with off label uses of drugs and doctors always have the ability to prescribe drugs for uses that have not been approved by the FDA. But if drug companies are allowed to use studies which they have bought and paid for to promote off label use with the doctors who are prescribing the medications, doctors may not be provided with all the necessary information needed to determine whether the potential benefits outweigh the risks of taking the drug. Experience has shown that in studies published by "ghostwriters" on behalf of drug companies, the risks are always downplayed and deemphasized, if mentioned at all, opening the door to problems on an unsuspecting doctor and his patient.

The Associated Press reported yesterday that most of the Big Pharmaceutical companies have decided to begin to disclose information regarding the members of the medical community they pay to do presentations at educational conferences. What you may not know is that virtually all the major pharmaceutical companies pay doctors throughout the country to travel to exotic locations i.e. Paris, Rome, the Virgin Islands to name a few, and to give presentations at "educational conferences" that other doctors attend. In the medical world these are known as CMEs (continuing medical education). In the past, the drug companies did not have to disclose who the doctors were they were paying to do these CME's and what perks they were being provided i.e. free trips, gifts, money and the like. The concern is that this could effect medical care because these doctors would tend to promote the drugs for the companies that provide them all these "favors."

Having friends of mine who are Drs. that have been taking part in this ritual, I have to admit that there is a part of me that's jealous. The best I've received from different groups who have requested me to give seminars on trying pharmaceutical cases or addressing legal issues like production of electronic evidence (alot of good stuff is kept on company computers as you can imagine), has been an umbrella. Now granted, it was the biggest umbrella that I have ever seen and there are days in Alabama when I am truly happy I have it. But I have yet to receive an offer for an all expense paid trip to some exotic location, as well as payment for my time, just for me to speak about an issue I know alot about. My mom always did want me to be a doctor.

I digress. Anyway, Congress has been looking out for us and are in the process of trying to pass legislation that will require drug and medical device makers to disclose anything of value given to physicians. When told this was coming, most of the major pharmaceutical companies agreed that they would proceed to begin to provide such information. Just to get an idea of how big this issue is, Eli Lilly, who voluntarily started reporting this type of information last year (thank you Eli Lilly), gave almost $19 million in one quarter of 2007 for these "grants" as they refer to them. Over a year, that could come to almost $80 million dollars....and that's just from one company!!! Knew I should have listened to my mother! (Good thing she doesn't use the internet!)

Continuing on with some other points made by the Reader's Digest Article regarding the problems with the FDA, the following issues of concern were raised:

3. Safety of New Drugs: The studies used by the drug industry to obtain approval from the FDA are so small and for such a short period of time, that the true safety of the drug cannot be determined before it is approved for marketing. As the article points out, typically, the studies used to obtain FDA approval only involve between 600-3,000 people and often only go on for a couple months. The studies also focus on specific type of people and often keep out people with any other problems other than the problem the drug is seeking to address. Therefore, once it gets on the market and used by the greater population who may have many other ailments other than the one which the drug addresses and be on many other medications at the same time which interact with the new drug, we all of a sudden see many other problems the drug can cause. As an example, this is one of the problems that arose with the drug Baycol which was ultimately withdrawn from the market. Baycol was a statin/anti-cholesterol drug, like Lipitor and Zocor, which was marketed to lower your cholesterol. People with cholesterol problems may also have a problem with their triglycerides. Historically, doctors will also prescribe a drug known as Lopid or gemfibrozil with the statin drug to also address the triglycerides. Even though this happens on a regular basis, when Bayer did its pre-marketing testing of Baycol, it never addressed Baycol's usage with Lopid. Ultimately when it obtained approval and Baycol began to be sold, it was found that people who took Baycol and Lopid together had a signficant increased risk of developing the condition of rhabdomyolisis which I discussed in one of my previous posts. Bayer never addressed using its drug Baycol with a drug which is commonly prescribed with a statin type drug, therefore no one knew how patients would react until it was on the market. The question arises, shouldn't the drug manufacturer be required to evaluate use of its drug with the types of drugs it is expected to be co-prescribed with? This is not required by the FDA and typically is never done. Moreover, many drugs are approved subject to the drug company performing additional testing. However, as the article points out, the FDA can't enforce this agreement to do further studies and 65% of the studies that have been promised in recent years have not even been started.

There have been some recent changes instituted by Congress which should help this. More money has been provided to the FDA to improve drug safety. Also, FDA can now require companies to follow the long term effects of their drugs or face fines of up to $10 million. Also, companies can no longer cherry pick the tests and studies they publish and deep six the bad ones. All clinical studies have to be published within one year of completion. But, according to the article, companies can wait 3 years to publish summaries written for the general public to understand. It is definitely a step in the right direction.

4. The article goes on to discuss other problems at the FDA such as shutting up FDA employees who have something bad to say about a drug or FDA advisory boards which provide the FDA with recommendations of what to do about a particular drug, with over half their members being paid by the drug companies in some form or fashion. The question then becomes, are you going to bite the hand the feeds you???? (Yeah, my own dog has done that, but only when I was taking a bone full of meat out of her mouth.) There have been attempts by Congress to remedy some of these problems, but we still have a long way to go till we have a properly funded and fully independent FDA who can really do the job it has been given to do....protect us from unsafe drugs and food.

Which brings this all around to that nasty issue of preemption. If the argument goes that we should leave it to the FDA to decide what drugs are safe and what are not, and what warnings should be given for these drugs, and not to our court system and individuals who cannot understand the difficult scientific and medical issues which need to be balanced when addressing the sale and marketing of a drug, the argument assumes we truly have an agency who has all the tools to make those decisions in a proper and unbiased manner. What this article points out in so many ways is that at this point at least, we do not have such an agency. Yes, things are being done to improve the process and to give the FDA more autonomy from the drug industry in making these important decisions. However, much work remains before we can all feel confident that the pill we are putting in our mouth won't do something to us that we don't know about, and that Big Pharma forgot to tell us about. Thus it is important that the right remain to the court system and the jury system to determine if the public...and the FDA....was given all the information necessary to make a decision whether the drug at issue is safe.

In some of my earlier posts I have made comments about how, when there is bad news about a drug, for some reason there is a delay in getting this "bad" information out to the public. With the recent release of the ENHANCE study indicating Vytorin really didn't do any better than the old anti-cholesterol standbys like Lipitor and Zocor, questions have been raised about why Merck, the manufacturer, delayed letting this information out for several months. In Pharmalot, one of my favorite blogs addressing information about the drug industry, this issue is addressed head on in a quote by Joel Haye, professor of pharmaceutical economics at USC, who, addressing Merck's actions with regard to disclosing the results of the ENHANCE study said:

"The longer they could keep sales up, the more tens or hundreds of millions of dollars they’d bring in. It took them two years to release the clinical trial results. That gave them huge additional dollars of revenue. In the case of Merck you really have to wonder. This isn’t their first situation along these lines. It’s really starting to hurt their reputation. They seem to get into a stonewalling mode, which is not in the best interests of the company. It needs to promote science above all else.”

When will they get the message that such gamesmanship only hurts their reputation and more importantly, potentially affects the health and welfare of the public.

Let me start off by saying that NO, I am not a regular or avid reader of Reader's Digest. Have to say, I always considered it a publication for my Mom and Dad to read. Of course, now at the ripe old age of 48, I guess I have now become my Mom and Dad and the world has come full circle. Anyway, I digress. In the April Edition of Reader's Digest, a very insightful article has been published entitled What's Ailing the FDA? In it the author discusses the overworked and underfunded FDA and how it is not able to do the job it is assigned to do, protect the public from dangerous food and drugs. A couple key points in the article bear mentioning:

1. The funding provided for this agency to do its job of regulating food, drugs, vaccines, medical devices, cell phones, dietary supplements and biotechnology is equivalent to what a county school system in Virginia is provided. The FDA's own advisory Science Board commissioned a report which led one of the members of that Board to say, "We were shocked at the appalling state of science at the FDA." The Institute of Medicine has labeled the drug branch of the FDA "dysfunctional", indicating it quiets those at the FDA who disagree, inadequately monitors drug safety and relies too much on the financial support of the drug companies, who it is given the job to regulate.

2. Pressure of the Drug Industry: Big Pharma pressures the FDA to speed up decisions on drugs so it can get the drugs to the market and make money, and to soft-pedal problems with the drugs. The article points out that Big Pharma now pays for over half of the budget of the FDA for drug review. This money comes from Big Pharma through user fees the drug companies pay the FDA to speed the drug review process. As the article suggests, it may save taxpayers money, but it calls into question the independence of the FDA when making decisions.

Moreover, there has been a big push by the drug companies for faster approval of drugs i.e. get on the market quicker so the money comes in quicker. We can all agree that getting important lifesaving drugs on the market quicker is important. Who can dispute that pushing through the approval of a drug that can cure a certain type of cancer is not important. However, when this same pressure is used to push through approval of a "life style" drug, like something to help with "restless leg syndrome" ( a condition the drug companies came up with so it could have a disease for its drug to treat), the FDA is not able to fulfill its role of really addressing the potential safety issues with these drugs. The FDA denies the overriding influence of the pharmaceutical industry in making its decisions, but the truth lies in the results. Think Vioxx, Ortho Evra, Baycol, Singulair, Chantix...and the list goes on and on. All these situations have shown that the FDA was not given complete information about a drug, or the drug company failed to disclose all the information it had. Instead the drug companies pushed like hell to get its drug to market for the almighty dollar.

Well even the mainstream media is really catching on to the problems I discussed last week about preemption. Both the New York Times and Reader's Digest have just recently printed articles taking on the issue of preemption and how the problems at the FDA make this issue one of significant importance. In the New York Times article, which appeared on the front page of Sunday's edition, it explains how the issue of preemption may significantly effect ongoing litigation involving the Ortho Evra birth control patch (the Patch). As background, the Patch was touted by its manufacturer, Johnson & Johnson (J&J), as an easy alternative to the Pill. Instead of having to take a pill every day, the Patch was applied weekly. J&J told the FDA that this patch would actually supply less estrogen to women than the Pill, but yet still provide protection from pregnancy. The amount of estrogen that goes into a woman's body is important because, as addressed in the article, it has been known for a long time that high doses of estrogen raise the risks of blood clots which can lead to heart attacks and strokes.

The New York Times article goes on to explain how a study was done for J&J on the Patch and it found in 1999 that in fact the Patch released significantly more estrogen into the body than the Pill, Moreover, the amount of estrogen being put into the body by the patch was at a dangerous level and beyond the level of estrogen which the FDA had determined 11 years earlier, could not be sold in the Pill. The interesting fact was that the author of this J&J study, who has since retired from J&J, applied what has come to be known as a "correction factor" to this study such that he played with the numbers and showed that the Patch released alot less estrogen into the body than the study actually showed, Apparently when this study was provided to the FDA so it could evaluate the Patch, it only mentioned this "correction factor" ONCE in 435 pages of the report, and that mention was only when discussing a complicated math formula. J&J did what they could to obscure the fact that this "correction factor" was applied to the results so that the levels of estrogen being released into the body looked OK, when in fact they were at dangerous levels.

Ultimately the FDA relied on this study to make its decisions regarding approval of the drug and the warning to place on the drug. J&J had two other studies, one in 1999 and one in 2003 which both showed that the Patch released more estrogen than the Pill, but guess what???? J&J delayed giving this information to the FDA.

J&J has now filed a motion with the Court requesting it find preemption and that the lawsuits regarding this drug not be permitted to continue. The argument goes that the FDA is in the best position to decide issues regarding whether the warnings are good and since the FDA approved the warnings regarding the Patch, a court cannot now say the FDA was wrong. Problem with this argument is that the FDA's decision is only as good as the information provided to it by the manufacturer when it makes these decisions. The FDA does not do its own testing on these drugs. It relies on the manufacturers to be forthright and provide it with all the information it has learned about the drug.....good AND bad. It appears J&J hid this problematic information from the FDA when it made its decisions about permitting the marketing of the Patch and the warnings that should go with the Patch.

This is one of the main reasons for the problematic nature of preemption, especially in the context of the FDA. The drug manufacturers argue that the FDA should have the last word about warnings on a drug. But this assumes the FDA is provided ALL the necessary information to make the right decisions, and clearly in the case of the Patch, that was not the case.

As mentioned at the beginning of this post, Reader's Digest published an article recently addressing the problems with the FDA which also relates to this issue of preemption. Stay tuned for part II of this post where I will address this article and how it points out problems at the FDA which impact on this argument of preemption.

As a fitting follow-up to my previous post in which I questioned whether the highly touted ending of a study on the anti-cholesterol drug Crestor because the results were too good was due to the fact that the people who were the "guinea pigs" (sorry, but that's what they are) were too perfect to show a problem, the Washington Post reported on a study issued by Chronic Disease Prevention & Control Research Center at Baylor College of Medicine which indicates that testing on new drugs has excluded alot of important potential patient populations such as women, older people and minorities. Daniel Goldberg, the chief policy advisor for the report is quoted as saying "We've got a big problem, and it is extremely urgent that we fix it. Because we're trying to figure out how to streamline health care and make people healthy, of course. And the fact that we have under-representation in clinical trials undermines both of these goals and undermines the quality of the evidence we come up with."

This echoes the point I made in my previous post. These drugs, in the clinical trials the drug companies do to see if the drug works, must be tested on the type of population that it is expected will use the drug. Otherwise, in the clinical trials we will not see the REAL benefit of the drug and potentially what adverse reactions there might be when used in the population that will actually use the drug in the real world. As an example, if you are developing a drug to reduce cholesterol, you need to test it on people who have significant cholesterol issues. Additionally, you know that such drugs are more likely than not going to be used in the elderly and senior population, so you have to include seniors in your testing of the drug to see how they react. Unfortunately what you find when you read the details of many (not all) studies done by drug companies on drugs they are evaluating is that they try and pick the "perfect" patient with no significant medical issues other than maybe the one particular one which they are trying to address.

I understand that you need to exclude certain individuals because they may have a condition which may confuse your results i.e. you won't know if its the drug that's helping the individual or the other condition they may have, but there must be some consideration given to testing these drugs on the type of patient who will really be taking the drug once it gets out to the general population. In fact, part of the reason, in my view, that so many new drugs are running into problems once they get on the market is because of the failure to really evaluate the drug in the patient population which will actually be using the drug.

On a personal note, one thing I have learned after spending time learning about the pharmaceutical world and how it works is that I try not to take a drug the doctor prescribes for me unless its been on the market for at least 5-7 years. That way there has been time for the drug to be used in the "real" population and all the potential problems and issues addressed.

Now this is something you don't often see. A study on a drug, in this case Crestor, an anti-cholesterol drug, is ended early because the results were just too good. What is even more interesting is that this same drug had a hard time getting approved for marketing by the FDA several years back because it appeared to have a high incidence of rhabdomyolosis (rhabdo). Rhabdo, as its come to be known, is a condition where the muscle tissue breaks down and releases a substance known as myoglobin into your bloodstream and ultimately it can clog up your kidneys and lead to kidney failure. I became very familiar with this condition back in 2001 when I became involved in representing many consumers who took the anti-cholesterol drug Baycol and developed this condition. Baycol was ultimately taken off the market and Bayer, the drug manufacturer, settled thousands of claims of consumers who took this drug and developed rhabdo. Now it is known that these types of anti-cholesterol drugs, which would include Lipitor and Zocor, known as statins, can cause this condition, but Baycol caused it at a statisically higher rate than the other similar type drugs like Lipitor and Zocor. It was, as it is referred to, "an outlayer" in these class of drugs.

This brings us around to Crestor. As mentioned, when Crestor was going through the approval process, which was during the time Baycol and its problems with rhabdo were front page news, there were concerns raised that it too had a high rate of rhabdo. However, the drug was ultimately approved by the FDA and Astra Zeneca has been highly touting and marketing the drug ever since. Clearly, this is great news for Astra Zeneca, especially considering the concerns now being raised with other anti-cholesterol drugs Zetia and Vytorin. But honestly, I am just waiting for the other shoe to drop. I expect in this study they also looked at adverse events. When the information is ultimately published on this study, I will be interested to see what, if any information is disclosed about adverse events reported in the study.

One other interesting tidbit. It is reported byAstra Zeneca that the study participants, of which there are over 15,000, had no existing evidence of cardiovascular disease and the end point (what they were looking at in these patients given Crestor vs. a placebo) was if the drug would reduce major cardiovascular events. Well, you picked people to be in the study who had no prior history of heart problems, so how do you know your drug helped them vs. the fact that they were individuals with no evidence of heart disease to start with. Now the participants did have elevated C reactive protein which is an indication of inflammation and associated (not cause) with a higher risk of cardiovascular events. We will now see Astra Zeneca telling everybody Crestor protects people from heart attacks based on this study, when in fact they give it to a population at a lower risk for heart attacks and in fact that may be the reason why there was such a reduced incidence of cardiovascular events. Such is the way of big pharma and its manipulation of data. This will be an interesting drug to continue to follow.

The FDA was very busy yesterday. I already mentioned about the investigation into the potential link between Singulair and suicide. Now there has been a concern raised regarding a potential risk of cancer from a topical medication used to treat ulcers on feet and legs. The drug, Regranex, is used by diabetics to address ulcers on their feet and legs. For diabetics, such ulcers are serious because if not properly cared for, they could ultimately result in amputation. However, apparently there are several studies using a health insurance database which indicate that for those who were given 3 or more prescriptions of this medication, the deaths from cancer were higher than those who were had less than 3. No particular type of cancer has been identified at this time. The FDA, along with Johnson and Johnson are going to work together to see if there is an actual link.

Look, all medications have risks. All medications have potential adverse reactions. The issue has always been whether the benefits of the drug outweigh the risks. Clearly, assuming this drug does work, the benefit i.e. saving a diabetic from losing a limb, is significant. But depending how significant the potential is to develop cancer if you use that drug, the benefit may clearly be outweighed by the risk. Again, I am happy to see the FDA being very proactive in getting the word out there. Although it appears the first study which indicated this relationship with cancer was completed in 2001.....Yes, 7 years ago. Now the FDA does indicate it is looking at additional data through June 2003 and it does take sometime to gather and evaluate data, but again, that data is almost 5 years old. When you are dealing with the potential of a drug causing cancer, you'd think the FDA and more importantly, the manufacturer of the drug would move a little quicker.

Today the FDA published an "early communication" regarding the drug Singulair which is used to treat asthma and allergies. According to the FDA, there is indication that taking of this drug might lead to suicidal thinking and behavior, otherwise known as "suicidality". Here is a drug meant for asthma and allergies and it is causing people to think about killing themselves?!? This is out of control.

I have handled several cases over the last many years involving children and adolescents who have been prescribed anti-depressants such as Paxil and Prozac and killed themselves. I have to tell you, there is no more difficult case to deal with on a personal level than a client who's young innocent child has decided to take their own life. The usual defense raised by the phamaceutical companies is that it was the disease i.e. depression, not the drug which lead the child to kill him or herself. In the cases I handled I was able to successfully show to the pharmaceutical companies that these children were never diagnosed clinically depressed, but instead were prescribed the medication by the family physician because the child was "going through a rough patch" i.e. adolescents. The doctors were lead to believe by the pharmaceutical companies that these anti-depressants were "safe" and promoted the drugs to be used to help those who are feeling "down in the dumps". This was despite the fact the drug was approved by the FDA to be prescribed for diagnosed depression. Thus, I was able to show that there was nothing else which could have caused the child to take the desperate act of suicide but the drug itself.

With Singulair, a drug prescribed for allergies and asthma, Merck, the manufacturer cannot claim the disease called the patient to take his own life. Should be interesting to see how Merck explains this one. Clearly, a patient taking a drug for allergies isn't expecting to feel suicidal. One thing I would say is it appears the FDA is trying to get information out there to the public on safety concerns alot quicker. I have to commend them for that. According to the FDA's website, Merck changed the adverse events on the package insert (what you generally get from the pharmacy when you pick up your prescription) on this drug in October 2007 to include suicidality concerns. They are working with Merck to figure out how to publicize this to the public and to doctors. It has been almost 6 months since they changed the package insert on this drug and they are still trying to figure out how to publicize this to doctors????? Something as significant as potential for suicide ??? Things that make you go "Hmmmm????"