Alabama Product Injury Lawyer Blog

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!)

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Posted In: Drugs , Pharmaceutical Companies

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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.

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Posted In: Drugs , Pharmaceutical Companies , Preemption

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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.

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Posted In: Drugs , Pharmaceutical Companies , Preemption

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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.

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Posted In: Drugs , Pharmaceutical Companies , Preemption

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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.

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Posted In: Drugs , Pharmaceutical Companies

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