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.


Is This Bad Economy a Good Thing?

July 30, 2009

Crazy right, how could there be a silver lining in the economy cloud?  Well if you are a little older in age and this economy has forced you to rethink retiring, it may be saving your brain.

There is a promising study out of Britain that studied  medical records of 382 men whose Alzheimer’s symptoms emerged around age 75. They found that, all other factors being equal, the symptoms were delayed about seven weeks for each extra year the men worked.

It is very perplexing as to why certain people stay mentally sharp and others aren’t.  There is some thought that people posses a trait called cognitive reserve.  The reserve refers to the brains ability to cope with damage.  The more damage, the greater the chance of Alzheimer’s.   The theory is the more you expose yourself to mentally challenging activities, things like; education, work, and volunteering, the more reserve you build.  The more reserve you have the better the chance you have off fending off memory loss and dementia.

Unfortunately there is not easy answer as to how much is the right amount.

If you are looking to keep active here are some great choices:

  • Volunteer.  There are so many organizations that need your time.  This is a win win.  You help out a worthy organization and keep your brain charged up.  Get more information here…http://www.volunteermatch.org/
  • Get a pet.  Especially if you are alone.  There are a lot of studies out that show having someone to care for at home will help with fighting dementia.
  • Work part time.  There are companies out there that would love to have a reliable, nice person working for them

What does not appear to have any benefit are the brain exercise products, often sold as computer based games.  A Rhode Island company, reviewed all of the existing trials on such products and concluded in a study published in Alzheimer’s & Dementia this spring that loss of memory was not helped with these products.

Shameless plug.  There is some talk that better blood flow to the brain equates to a lower chance of getting a certain type of Alzheimer’s.  Chiropractors improve the bio mechanics in the neck area, thus improving blood flow to that region.  Is this a cure, most definitely not.  Is there a chance it could help….we’ll see.

The one thing that everyone can agree on…get and stay active.  Use it or lose it does not apply only to muscles, it appears to also do the brain a lot of good.

What are you or a loved one doing to stay active?  Please comment below.