Dec 072013
 

Finally there is flicker of light among the dark clouds. Just to go over the background, the FDA approved a new surgical device, a heat cautery called Alair(R) thermoplasty system, for surgery of severe asthmatic patients. On behalf of a non-profit, PIMR, I filed a lawsuit to get the FDA to revoke the approval given to the device.

The District Court dismissed my petition on the grounds that the PIMR did not suffer any injury from the FDA's actions, therefore PIMR did not have standing to sue. I appealed to the 9th Circuit Court of Appeal.

The Appellate Court has scheduled oral arguments on February 13, 2014 in Pasadena Courthouse. This is very unusual. Their web site clearly says that oral arguments are seldom granted, and to get oral argument you have to request it in your opening brief. Neither PIMR nor FDA asked for oral arguments. So the court ordered oral arguments on its own initiative.

I see it as a very encouraging sign. They are taking my appeal seriously But then it is a long war against the FDA, to stop them from approving unsafe drugs and devices. So far I have lost all of the battles 

Let us hope the lightning is the dark cloud is not a sign that my hopes are just as short lived !

 Posted by at 9:44 am
Nov 092013
 

New York Post reported on November 4, 2013 about a new promising drug for Hepatitis C. However it cautioned:

“Researchers and patients have been disappointed before, when the first two direct-acting antiviral pills, telaprevir and boceprevir, reached the market in 2011. The drugs, which inhibited the virus’s protease enzyme, still required interferon and ribavirin, but they raised the cure rate to about 70 percent.

There was a huge rush to treatment. But doctors now say that side effects were worse than expected, in part because the sickest patients had been excluded from the clinical trials of the drugs.

“A lot of that didn’t come to light until after the drugs were approved,” said Dr. Brian R. Edlin, an associate professor of public health and medicine at Weill Cornell Medical College. “Then it turns out they were just horrible.”

 

It is interesting to know how much money the drugs made for the companies while causing a lot of pain and suffering to the patients. Vertex, maker of telaprevir (Incivek) made $1.6 Billions in 2012 and Merck maker of boceprevir (Victrelis) made $502 Millions in 2012.

 Posted by at 2:23 pm
Jun 132013
 

The American Association of Clinical Endocrinologists published revised guidelines for treatment of diabetes on May 1, 2013. The guidelines degrade the use of glipizide and insulin. They promote the use of expensive new medications, giving them parity with metformin. This is in spite of the fact that there are few independent studies that compare new drugs to metformin or glipizide.

The members of the committee should indicate the bias they have in favor of new drugs. At least each member should reveal how much money they received from the sponsors of the new drugs.

The influence of drug companies is enormous. They fund most of the research in the academic centers. The professors cannot survive without this funding. They would lose their coveted post of professorship if they do not get funds from drug companies.  The professors in turn recommend the new drugs to the practicing physicians. The new guidelines by AACE is an example of such pervasive power of the drug companies.

 Posted by at 12:06 pm
Apr 022013
 

A new study in April 2, 2013 issue of the journal Annals of Internal Medicine shows that 17% of patients taking statins discontinued the medicine because of side effects. This is almost twice the number of people stopping statins in the clinical trials. The study emphasized that almost half of these people could go back on statins, a different one or a lower dose of the same one, without recurrence of side effect.

The point I noticed was that in practice the number of side effects of drugs is far more than in clinical trials. We saw that about the ACE inhibitors. The incidence of cough was reported to be 0.7% in the FDA approved label for Zestril in 1993. Later on studies of patients in clinical practice showed that the incidence of cough was 10%!

 Posted by at 7:40 am
Nov 082012
 

 

FDA approved two drugs that lower high triglycerides, Lovaza® and Vascepa®. Both of these drugs contain fish oils and have been shown to lower high triglyceride levels, just like the OTC fish oil capsules. However there is no evidence that using fish oils help the patients.

Acute pancreatitis is a complication of high triglycerides. There was no reduction in acute pancreatitis in clinical studies using these two drugs.

Fish oils have been extensively studied in prevention of coronary artery disease. Studies in primary prevention as well as secondary prevention have failed to show any benefit.

Even if you believe that there might be some benefit, OTC fish oils deliver the same stuff for about $3.00 a month. The cost of these two drugs would be twenty to thirty times higher.

Medical Letter  54:1401 October 15, 2012

 Posted by at 1:42 pm