Unsafe at any dose? (Part I)

Great article...In addition, clinical trials are often not representative of nation as a whole in that they don't incorporate the diversity such as age, ethnicity, gender, or comorbid conditions. Unfortunately, the expense of testing these drugs that thoroughly would translate into higher costs for us. There is a difficult balance to strike here.

I have often expressed my concerns about new drugs. I don't think the approval process covers a large enough segment of the population so I consider drugs to still be untested until they have been in general release for a few years.

Last spring, I went to a new doctor who insisted that I try the new just released drug rather than write prescriptions for the older drugs I had been taking THAT WERE WORKING FINE. Then, when I had a serious life threatening reaction to that drug all he would say was keep taking it.

During the office visit he made sure to tell me that he frequently lectured on behalf of pharmaceutical companies which explained his determination to utilize newer, less tested drugs.

There needs to be a mechanism for withdrawing drugs or publicizing problems instead of inundating consumers with ads for the latest and greatest of everything.

Even if the FDA does have, or get, the authority to have pharmas check drug safety after the drugs are out, it won't do anything about the problem of drug reps giving big gifts to doctors, and impact that has on prescribing patterns. That is a whole story of its own! (One which it sounds like I should address, separately...)

Unfortunately like any bureaucratic organization the FDA is top heavy, slow & above all inept at their supposed job! The FDA either needs to be revamped or doen away with. If revamped then a sepearte entity that deals soley & only with medications needs to be instittued. Another entity would be one that deals with surgical & therapy procedures. The food part of the FDA seems to be working just needs to be treamlined a bit.

Your note contains many errors about post-approval monitoring, and of course we in the Pharmaceutical industry do not appreciate the dishonesty comment. Regarding the former, post approval reports are the responsibility of individual Doctors who prescribe the drug. They are mandated to report adverse effects to the FDA via web-based system (known in our business as a "Dear Doctor" letter). This is the most effective avenue for doing such monitoring (in theory) since the FDA and the Pharma company are not out in the public prescribing and monitoring the health of each individual patient taking the drug...would not be possible no would it? Unfortunately you are correct in one regard, in that the Dear Doctor system does not take in as many reports as it should (i.e. not all Docs report the adverse effects that thy should, and therefore you are correct in that the system is not perfect and needs to be re-evaluated. As for drug company "involvement" in so-called cover-ups, etc, how many times must I hear this nonsense. So called advocacy groups you mention differ from us in that we use science to make decisions and the picture has to b looked at in a methodical way to ensure that an adverse effect (such as what we pick up in a clinical trial when we test) is in fact "real." We do not act on single complaints (my Mom got sick on this drug), the question is is the population in general having an increase in such an adverse event, which takes quite a bit of data to examine to confirm one way or another. We kill drugs in development for adverse effects all the time (only one in 10,000 drugs made ever makes it to market, and many fail for adverse effects noted in clinical studies). To infer that we "hide" things is bordering on comical; after all think...what would be the purpose of that...does it really make sense to you and the readers when you think about it? Forgetting the ethics even (which we do not), do you think we in the industry want to get sued, which in our society would of course be the result for a deliberate act such as you are saying we are guilty of? You never know the entire side effect profile of a new drug until it finally gets into millions of people, for we all have different sensitivities. In general, since there are few withdrawals overall, our testing does its job quite well. And always remember, there is never such a thing as a completely "safe" drug...aspirin killed over 3000 people last year due to gastrointestinal toxicity...anyone suing Bayer? There is always room for improvement, an we do out best to provide life saving drugs that keep you alive and improve quality of life, and we will always work hard to do that despite the pounding we take from all sides. And remember one thing when it comes to the unfounded comment we "hide" safety data....we take the same medication everyone else does when we get sick. Think about it.

Bill, I appreciate your comments, and I'm glad you brought these issues up. I understand your feeling put on the defensive if you work in the pharma business, as it was impossible for me, in this introductory piece, to cover all of the nuances of this very complicated business. You're right that this first part of the article gave it to pharma on the chin, as far as image. But I'm not so much saying that pharma is deliberately trying to make people sick, as that the nature of reporting on adverse effects, and more importantly, the way the FDA handles such reporting, can be improved a great deal. Saying that doesn't mean you think Merck is out to kill you. (For what it's worth, my family takes many medicines created by major pharmas, and I appreciate their benefits greatly!)

Also, you're of course right that there's no perfect testing mechanism, and that some people will get sick regardless of what precautions pharma companies take medically or administratively. (Some people will get sick on apples--maybe die, I don't know--and nobody's suggesting there's a big apple cover-up.) What I AM saying, however, is that if there's going to be an agency like the FDA, it seems clear that they have a role in better communicating the apple toxicity issue if there is one.

I'm not in the business, and Bill B took most of my thoughts away, ha ha. I bet it is tough to be in a business that produces things wanted and needed, but can also kill. I'm thinking that law suits and research is why the cost is so high, but with advertising next in line. I was personally bummed when Bextra was pulled (like Vioxx) because it helped me. No alternative except that which bothers my stomach because of acid reflux is forthcoming. I have to do without.
As mentioned, a drug is not a normal thing for the body and thus can never be 100% safe for everybody. There are risks.
The FDA does have a website and alert system you can sign up to if you want to be informed of re-calls etc. I get emails all the time on things being pulled off market shelves we eat everyday. You would, or may, be surprised how much is pulled and for why. Products and food that can kill you, make you deathly ill, and by far more often then any drugs.
What I am surprised with frankly with the drugs is the Pharmacies. I have used two different prescriptions over the years that I heard were bad on the news first, and not once got a call or anything from the pharmacist. I would think they should have to tell their customers right away, and also have the fastest means of doing so right there in their computer. Both times this has happened to me, and with two different pharmacies, they said nothing until I went for a re-fill or asked first. Couldn't they call or something? They take my money easy enough, or will call to help get a prescription filled with no problem....
Anyway, thanks for the article.

I think with the new laws tht are supposed to be going into effect for doctors not being allowed to take the extravagant perks that they do from the pharma salespeople, we might see some improvement in the reckless script writing that is going on now.

I read with interest all of the pieces written here, and I'd like to add my two cents to the debate

Why is it that the pharmaceutical companies feel it so necessary to continuously lobby Congress? I could not believe it when I heard this industry succeeded in getting a law passed that, in short, states only "...a drug can CURE disease and illness.…" Does this mean that all of my Mom's home remedies, (and we all know our moms' home remedies worked just fine), didn't really "cure" me when I was home with a cold or fever? Of course they did! It's the human body that is the miracle. Given what it needs to remain healthy, it will heal itself; it doesn't take drugs or anything synthetic. To the contrary, as we see almost daily, drugs often add to the problems humans experience.

Cleanse your body (as those of us who are of European ethnicity have been taught to do...) then feed your body proper, GOOD nutrition. Don't rely on the nutritionally bankrupt foods you find at most grocery stores. Grow your own food, if possible, without adding chemical fertilizers, growth hormones, steroids, insecticides, herbicides, etc. If this isn't possible, check out the organic section of your grocery store. We'll never be able to avoid all of the pollutants we are bombarded with on a daily basis, from the air we breathe to the food we eat, but we certainly can limit what we physically put into our bodies. This is why cleansing should be part of EVERYONE'S health routine...even those who believe they are physically fit need to cleanse the impurities from their bodies, albeit not as often, perhaps only twice a year. Cleansing is NOT a new fad…ancient Egyptians, Greeks, and Romans did it. Most cultures throughout the world still do it in some way or fashion.

While there is a time and a place for prescribed and over-the-counter drugs, such as a traumatic accident, or an ailment presiding in a body that has been abused for too long, one does not need to rely on his or her doctor to solve every little problem one is experiencing by asking doctors for prescriptions. Doctors shouldn't even be put in the position of having to offer them unless the case is extreme and truly out of control, or the individual needs assistance on a temporary basis. What the doctors should do is tell their patients to look at their nutritional intake. Many common ailments can subside with cleansing and proper nutrition. Of course, considering the fact doctors only study nutrition for a few days, but spend months studying pharmaceutical drugs, don't be surprised if yours doesn't know how to explain cleansing and proper nutrition to you. I researched this topic for weeks before I took the first step. It took me months to find the right nutritional line.

As I said, cleanse your body, give it proper nutrition, and watch what happens. I've been cleansing and giving my body what it needs since May 2006. I know the difference it has made in my life...everything from helping me to release weight to sleeping more soundly (and naturally without the use of ANY drug) to increased energy to lessening discomfort I felt due to injuries I received in a car accident several years ago. Drugs only masked the symptoms...cleansing and superior all-natural nutritional products gave me back my life.

Folks, I personally believe there is a time and a place for drugs; there is a time and a place for surgery. But before relying on these two things, start taking responsibility for your own health - become your doctor's partner. See him for check-ups. Let him or her be the person who monitors your state of health, and when necessary, take further action. But use cleansing and good nutrition first. Not only will you be happier, but you'll give your "partner" more time to see other patients who truly need him, or better yet, give him more time to spend doing the things he likes to do...like spending time with his loved ones or going on a well-deserved vacation!

Thank you for allowing me to share my views with you.

Great advice, Bernie! I think you are so right!

I appreciate the fair and balanced discussion and comments and for understanding (AZ and John and others) that we in the business can be a little defensive these days! I agree completely too that there is always room for improvement, and we must always be open (even us!) to ideas to help in any way. It is our obligation too. As for Bernie, we have lobbyists because we are constantly under attack and need to keep Congress and others aware of the issues and challenges that we face. Admittedly, we are a very misunderstood industry, and a lot of that is our fault. It might surprise you that I see nothing wrong in any way with your philosophy that "cleaning up one's act" is a valid and fine approach. I am often disturbed, however, that many feel that as part of such an approach that many of the natural supplements they take are free of toxic liabilities. To anyone who takes them please be careful and do not make this mistake; mother nature makes some of the most toxic substances known to my science. Please remember the basic premise of the science of toxicology: Nothing is "safe," all things are poisons...it just depends on the dose you take .

Nice discussion all! Be well!