Can We Trust the FDA?

October 13, 2009

fda-logoThe Food and Drug Administration (FDA) is a federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products.  Health related products includes but are not limited to medicine, cosmetics, supplements, and even certain veterinary products.  Their mission is to be responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe.

In a nutshell, we trust them to have our back when new products hit the market.

There have always been whispers that the FDA was ignoring the risks of artificial sweeteners, that they had been bought off by the companies that produced and used them.  MSG was another one that people have forever said the FDA is looking the other way despite mounting evidence that it may not be all that great for you.

Most of these claims were written off to conspiracy theorists with nothing better to do…..until now.

The FDA recently came out and admitted that 2 senators and 2 representatives from New Jersey placed undo influence on the FDA to approve a knee operation patch made by the company ReGen Biologics, which happens to be located in New Jersey.  The well wishing senators claim that the money that was donated to their coffers, around $26,000, had nothing to do with the pressure they put on the FDA, they were merely looking out for a constituent company.

Here is how it went down.  The agency’s scientists for years unanimously ruled that this device was unsafe due to a high failure rate, forcing the patient to have another surgery.  A clinical trial of the device failed to show that it worked any better than routine surgery.  That should have been the end of it, however, the agency managers overruled the scientists and approved the device for use.

The FDA’s report said that its Office of Legislation began receiving calls from members of Congress in December 2007 complaining about its review of the device, and the office’s director “described the pressure from the Hill as the most extreme he had seen.”

With all this pressure from the Congress the FDA caved and approved a device that does not appear to work.  The San Antonio Spurs, of the NBA, orthopedic physician Dr. David R. Schmidt said he was involved in the original clinical trial of ReGen’s Menaflex device and concluded that patients did not benefit. He said he was surprised that the FDA approved it.

In January, the Government Accountability Office concluded that it was long past time that the agency demanded that manufacturers prove that all complex devices are safe and effective before being approved for sale.

What should we make of this?  Do we need more oversight?  Do we really want politicians placing calls to the FDA to approve things that shouldn’t get approved?

Hopefully in the future these agencies can stay above the fray of campaign finance and rule on things as they see fit.


Doctors Getting Paid To Market Drugs

October 5, 2009
Drug Marketing

Drug Marketing

A while back I wrote a post on a drug company, Eli Lilly, using ghost writers to write favorable articles and having doctor’s sign their names to them as if they had written them.  You can read that here.  At best it is a murky situation.

Recently, Eli Lilly was back in the news here in Boston, when the Boston Globe reported that at least 60 area doctors received more than a half million dollars in speakers fees.

A very common practice in the drug industry is to hire physicians as speakers , provide them with the literature on the drug they are marketing, and turn them loose speaking on behalf of the company that hired them.

Imagine the difference in credibility between a drug salesman and a renowned doctor.  When that doctor, whom may be at the top of their field, speaks people will listen.  The drug companies know this and have very smartly used the doctor’s credibility to help them push drugs through these talks.  The question I have is this:  Hasn’t that doctor become nothing more that a glorified drug salesman?  Is their credibility now under fire?  I think it has to be and I am not alone in those thoughts.

Mass General researcher, Eric Campbell found out that 16% of all US doctors and 25% of hospital department heads belong to one speaking bureau or another.  Mr Campbell is quoted as saying, “Academics who want to be drug salesmen should go be drug salesman. But don’t do it under the shroud of academia.’’

Everyone from politicians to other physicians are voicing concern that these company paid doctors cannot give unbiased information, whether that may be downplaying the side effects of a drug or not talking about the generic equivalent which would cost less.

What do these doctor’s whom are paid this money say?  They claim they vet all information and would only present material that they believe in, even if the company is the one providing the material.  They also claim these talks are great ways to educate other doctors about new drugs.  Although one doctor did admit he was doing the talks in order to cover his children’s college tuition.

The public is starting to wake up to this and put pressure on these companies to disclose their financial relationship with doctors.  To their credit Eli Lilly released a list of all their paid speakers.  Good for them, it is nice to see that the much asked for transparency is starting to become reality.

Because of this debate and other problems – pharmaceutical firms have paid millions in fines for illegally marketing medications – companies are under political pressure to disclose their financial relationships with doctors. Lilly is one of the first companies to publicly release a list of paid consultants and speakers.

In January the FDA reported they were fining Eli Lilly 1.4 billion dollars for illegally marketing a drug.  That is a lot of money until you realize that Eli Lilly did 20.38 billion in sales in 2008.

The drug they are getting fined over….in 2006 did 4.7 billion in sales.

Now let me ask you this, if I told you I would let you market a drug to 4.7 billion in sales, but if you get caught you would have to pay a fine of 1.4 billion would you take that deal?  Darn right you would.

Paying doctors to market drugs needs a complete overhaul.  We need to be demanding complete transparency.  Good for Eli Lilly to be the first one to do it, let’s hope it keeps going.


E Cigarettes, Are They Safe?

July 23, 2009

Have you ever heard of an E Cigarette?  I mean I know I am hardly cutting edge of cool but these are news to me.

I was walking through the Burlington Mall the other day when I noticed a kiosk that was selling E Cigarettes.  Having never seen these before I went home and looked them up.  It turns out they are an electronic smoking device or an electronic cigarette which is also known as E-Cigarette.  This E Cigarette is non flammable and through technology claims it can provide the smoker a real smoking experience without the fire, flame, tobacco, tar, carbon monoxide, or ash that you would see in real cigarettes.

So at first I thought, wow, a real looking cigarette without all the bad stuff.  Then I kept reading.

The smoker will still get nicotine.  They are very upfront about that.  Apparently the device turns nicotine into a vapor so you can inhale it.  One must remember, however, that nicotine is highly addictive.

What I don’t like about this product is they make the nicotine packet come in different flavors including bubblegum, chocolate, apple and cherry.  While they claim that they are not marketing this to children, this rubs me the wrong way.  Can you just see an adult ordering bubble gum flavored nicotine?

The CEO of one of these companies claims that they are instructing vendors to follow all state laws when they sell them, yet when I went online and attempted to purchase these devices, I was never asked for my age.

Just recently, the FDA weighed in and as you may have surmised they are not too warm on this idea either.  The FDA analyzed the ingredients in a small sample of cartridges from two brands of electronic cigarettes marketed by U.S. companies: NJOY, of Scottsdale, Ariz., and Florida-based Smoking Everywhere.

In one sample, analyses detected diethylene glycol, an antifreeze component. In several other samples, analysts found carcinogens.  What bothered the FDA was the lack of quality control in these packets and they feel that there could be a safety issue due to this lack of control.

Bottom line if one of your children comes home with this E Cigarette, please do not be fooled into thinking that are not getting nicotine with them, they most assuredly are.


DHA or Omega 3 Fatty Acids and Alzheimer’s

July 13, 2009

The most complete study to date done on Omega 3 Fatty Acids (DHA) and the hope that it would slow Alzheimer’s has shown there is little help to be gained by taking the popular supplement.

In this study a group of people were given a placebo, with another group getting  a two gram dose of fatty acid every day. After 18 months the results showed no difference in the two groups.

If you are getting older in age and are worried about getting Alzheimer’s there is some evidence that a drink or two a day might help you fend off this terrible disease.  Experts at Wake Forest University School of Medicine in North Carolina examined and interviewed 3,069 people aged 75 or older.  What they found was the light drinkers were 40% less likely to get Alzheimer’s when compared to the people who did not imbibe at all.

The study did point out that drinking more than that wiped out all benefits, so please don’t order that keg of Chablis just yet.

There is also a promising study out that states DHA may help people who are just starting to get a little forgetful, let’s call it pre-Alzheimer’s.  If you are starting to get forgetful, taking these supplements may improve your memory.  One of the researchers noted it would be like having the memory of someone 3 years younger.

The key distinction here is if the person already has Alzheimer’s.


Percocet and Vicadin could get banned

July 2, 2009

Yesterday I wrote about more stringent warnings about acetaminophen (ACM). You can read that here.

Now a govt. agency is recommending that Percocet and Vicadin be banned due to the problems associated with ACM. The way that Percocet and Vicadin work is they combine a narcotic with ACM to fight pain.

ACM is combined with different narcotics in at least seven other prescription drugs have a combination with ACM and these will all be banned if the FDA listens to the advice of the experts. Vicodin itself is prescribed more than 100 million times a year in the US.

When the panel members were asked what the consumer could do to help themselves, most agreed that the there needs to be better education about the risks of these popular meds.

Dr. Jan Engle, a panel member and head of the Department of Pharmacy Practice at the University of Illinois in Chicago, encourages people to keep track of what they are taking. ““If you keep track of what you’re taking, none of this is an issue for you.”

While I think that Dr. Engle is correct, you must take it one step further. You must examine what is causing you the pain you are feeling. If it is something obvious, say golf, you must stop. Taking a Percocet or Vicadin in order to play golf is only covering up the pain signals. Continuously covering these signals of pain is only going to lead to further problems down the road.

In the past I used to think that patients would only hurt themselves worse by taking a bunch of meds to keep doing what they want to do. Now I am afraid that taking these meds may actually really hurt someone, and to me that is unacceptable.


Acetaminophen is Getting a Closer Look

June 30, 2009

Acetaminophen (ACM) is the most popular over the counter drug for pain relief in the United States. There was an estimated twenty nine billion units sold in 2005. Twenty nine BILLION! Whoa, that is a lot.

The FDA recently released a report urging stronger warnings and stricter dose limits for drugs, like Tylenol® that contain ACM. The concern here is the apparent liver failure that people are experiencing after taking drugs with ACM in it. Research has shown that hundreds of people are experiencing liver failure and approximately 100 die each year from overdose whether intentional or unintentional.

One of the major problems is that people don’t realize how many products contain ACM. There are currently over 200 products that you may not even think about. Products like….Robituson®, Alka Seltzer Plus® and Sudafed®.

When the max recommended amount is 4,000 milligrams, one can see how it is not too hard to exceed that when one isn’t feeling well.

Now onto the rant portion of the blog.

I am not licensed to dispense drugs, I cannot legally give you advice, etc. What I am about to share is my opinion and should no way be construed as advice from an MD.

In my humble opinion most of this stuff is crap. It is bad for you, it covers up symptoms and does damage to vital organs. Do I understand there are situations where you need to take it…of course.

However, there is a large portion of the population that are taking these drugs for the completely wrong reason. If you need to take 4 Tylenol® before tennis and 4 Tylenol® after tennis just so you can play….STOP PLAYING.

Let’s assume that it is your neck that is bugging you. If you take the 4 Tylenol&reg before and after, you can swing the racket pain free. If you don’t you can’t. Now we know the pills aren’t fixing the problem, they are just covering it up.

One question then, “What is causing the pain?”

Shouldn’t we look into that?

“Oh, Doc I don’t have the time”….”It will go away”……”I think it is genetic, my mom used to get this when she played tennis”

Look you may not have the time now, but I can assure you, if you keep covering this problem up, you will have time in the future……your body will make sure you get it fixed.  I have seen this too many times.  What starts out as a small problem, can very easily escalate into a major problem if you keep patching it up.

End rant.

The experts say these drugs are safe if taken as they are intended and I don’t doubt them. When you sell 29 million units and only a small number of people get real sick from them, the problem is small. What I am more worried about is the prevailing attitude that we can just patch stuff up and it will go away.

Sometimes it will, sometimes it won’t, do you want to gamble with your liver, kidneys, etc?


Doctors Ghost Writing Articles. Is That Unethical?

June 13, 2009

The practice of hiring someone to write an article and you put your name on it as if you wrote it is called ghost writing.

Recently the large drug company Eli Lilly (EL), inventor of Prozac amongst other things, has come under fire for using ghost writers to market a drug.   According to unsealed company files they hired scientists to write these articles for publication and then asked doctors to put their name on them, passing them off as their own.

Sleazy, maybe a little….unethical, I don’t know, it is a tough one.

EL is getting accused of hiring scientists to write favorable articles.  If that bears out to be true, then yes that is extremely unethical.  Now if they hired non biased scientists and asked them to write articles on the up and up then the situation gets a little murkier.

Here in Boston we have had a bunch of journalists get fired over not citing sources when reporting something.  They passed the info off as theirs when it clearly wasn’t.  It is called plagiarism.  Now we appear to have the same thing going on with drug marketing.

As a total aside, is anyone else horrified at how much of this marketing goes on?  Aren’t our doctors supposed to be the experts at this?  Could you imagine being an MD and having people show-up with ads from some magazine that promises them better…….  and they have to explain to them why this drug may or may not be good for them.  Way to bog the system down.

What is the solution?  Transparency in all medical marketing and advertising.  If a ghost writer wrote an article, don’t let a Doctor pass off that he or she wrote the article.  Why not have it stated clearly that Doctor X reviewed the article but didn’t write it.

This of course brings up one other question.  If Doctor X endorses an article for a drug that turns out to harm people should Dr. X be held liable?

For that I vote yes.