Dec 292011
 

Artificial hips have made a dramatic improvement in the life of patients with fractures or severe arthritis of hips. The standard surgery consists of putting a metal hip ball inside a polymer (plastic) socket. About ten years back medical device and drug companies came out with new and improved versions. These artificial hips consist of metal ball inside a metallic socket. The new devices were quickly approved without adequate long term studies.

The New York Times reported today that the new joints are failing in a large number of patients. The results are devastating for the patients. Replacement of an artificial joint is not easy. The new prosthesis has no bones to hold on to. Often the patient is left without working hip joints. There are thousands of lawsuits pending. There are an estimated 500,000 patients with these implants in USA alone. The worldwide impact of this disaster is anyone’s guess.

We as a society have to come to term with the fact that new drugs and devices are often not beneficial and in a several cases worse than the old ones. The FDA does not compare new drugs to old ones. The FDA is satisfied if the new drug is better than placebo. When it comes to artificial joints, we do not know what criteria were used by the FDA to approve this metal on metal joints. Whatever criteria were used they did not involve any long term safety and efficacy studies.

To read the New York Time article click on the link below.

http://www.nytimes.com/2011/12/28/business/the-high-cost-of-failing-artificial-hips.html

 Posted by at 3:40 pm
Dec 222011
 

After PFIMR filed a lawsuit to force the FDA to make a decision on its petition, the FDA took prompt action on the petition. The FDA denied the petition.

Now PFIMR filed an amended complaint asking the court to determine if the petition was wrongfully denied. It all depends upon the question of fact whether Bronchial Thermal Cautery, also called Bronchial Thermoplasty, is “safe and effective.”

Congress authorized the FDA to evaluate new drugs and devices only if they are safe and effective. There is no analysis or definition of “safe and effective” in the law passed by Congress. How safe is safe? How effective is effective?

The court is the place to decide this important question. Then again it will apply only to the drug or device in litigation. This process may have to be repeated for other questionable drugs approved by the FDA.

To read the amended complaint click below.

Complaint-Amended

 

 Posted by at 11:02 am
Dec 202011
 

Finally the US government has done something right . It convicted Merck of a misdemeanor. Merck paid a fine of $321 million and pleaded guilty. Merck also paid $629 million for the civil settlement and agreed to a corporate integrity plan for five years. Now if we could only get all of the drug companies to agree to a similar plan in regards to their clinical research.

As you probably know by now, among other things, Merck conducted a clinical study on Vioxx. After the study was over Merck went looking for an author, someone with academic qualifications and prestige. They found someone willing to put his name on the article in return for money. The article was published in the Annals of Internal Medicine. We do not know how often this happens  but when I look at the CVs of some of the professors, I find that some of them have authored over 200 articles. There is a good possibility that drug companies wrote a lot of these articles. I cannot imagine a busy professor having the time to author 200+ articles in a few years, in addition to seeing patients, teaching students, and conducting research.

Now when I read an article in NEJM or any other prestigious journal, it does not carry the same weight with me. Who knows who actually wrote it?

Read the letter from Merck admitting to committing a crime:

merck0001

 Posted by at 8:17 pm
Dec 202011
 

After sixteen months the FDA finally rejected our citizen's petition against the Alair(r) Bronchial Thermoplasty System.  The FDA did say that since the very sickest patients were excluded from the clinical trial  the device should be used with caution in patients who have severe asthma as indicated by:

1. FEV1 under 65% of predicted.

2. Use of oral corticosteroids over 10 mg a day.

3. Any of the following in the past one year:

a. Four or more lower respiratory infections.

b. Three or more hospital admissions for respiratory symptoms.

c. Four or more oral corticosteroids pulses for asthma exacerbations.

Read the FDA response by clicking on the following link

FDA_Final_Reply_Petition

 

 Posted by at 8:09 pm