Oct 252011

Lilly finally withdrew Xigris from the market, a drug that should never have been approved. The company sponsored study showed that Xigris was slightly better than a placebo. The FDA advisory committee was split on its approval but went ahead and gave the okay anyway.

After a few years independent studies showed that mortality was higher in the patients who took Xigris compared to the ones who received a placebo. The FDA reviewed the studies and again sided with Lilly. The FDA said that the label contained a warning that the drug might cause increased mortality. The FDA asked Lilly to conduct another study. Meanwhile the drug stayed on the market and Lilly kept making millions. The annual sale of Xigris was over $100 million.

After ten years of worldwide use, we now find that the drug was useless to start with. In the meantime, Lilly made $100 million a year in sales for ten years. Is Lilly going to refund that money?

 Posted by at 8:19 pm
Oct 222011

Drug companies pay doctors for speaking engagements and expert opinions. They bring lunches to doctors' offices and provide dinners (with a promotional speaker of course) to gain access. The question is "how much money do they spend"?  The Propublica organization has tallied all the available data and has come up with a figure of $760 million during the past two years. Only some drug companies provided data but these companies have 40% of the US market. So if we extrapolate the figures to all drug companies, we come up with a figure of 1.2 billion dollars. That is a large number, no matter how you look at it. Since there are about 800,000 doctors in the US, that comes to about $1500 per doctor.

You can go their web site www.propublica.org and see if your name is there. I checked my name and it is not there 🙂 but some of my colleagues show up. One is listed as having received lunches and dinners worth $653 during the past two years.

Several years ago, I was visiting a friend's office. I was telling him how drug company samples, pens, and post-it notes -- all displaying the company logo -- influence our prescribing habits. My friend is a very intelligent and conscientious doctor. He said that such things do not influence him, that he totally ignores them. Just then his nurse brought in a prescription refill for Darvocet. I pointed to the Darvocet post-it note on his desk and said, “You know that Darvocet [patented] is just a combination of Darvon [patent expired] and Tylenol and there is no medical reason to use Darvocet and yet you are prescribing it. " He was so embarrassed and admitted that Darvocet had no place in a good medical practice.

 Posted by at 7:06 pm
Oct 192011

PFIMR filed a petition with the FDA on October 16, 2011 asking the FDA to revoke its approval of roflumilast for the treatment of COPD. The FDA website lists several of the documents related to the approval process. There are excellent summaries of the clinical trials conducted. The FDA staff doctors, who wrote these summaries, voted against giving approval to roflumilast. They noted that this medicine has a lot of serious side effects and the benefits are marginal at best. Dr. Anthony G. Durmowicz, M.D. of the FDA wrote, “The overall rate of moderate or severe exacerbations was reduced by 0.24 per patient year with a reduction of 0.21 for moderate (use of corticosteroids) and 0.03 for severe (hospitalization) exacerbations. Thus for an individual COPD patient treated with roflumilast, it would potentially take five years of therapy to get the benefit of not having to receive one 10-14 day course of corticosteroids..”

The side effects of roflumilast are common and sometimes very serious. The incidence of intractable diarrhea, acute pancreatitis, suicides, and cancers was higher in the roflumilast group as compared to the placebo group. There was a statistically significant increase in the incidence of prostate, lung, and colo-rectal cancers in the roflumilast group.

The advisory committee convened by the FDA, voted 10 to 5, against giving approval to roflumilast. Advisory committee members pointed out that inhaled steroids are universally used in severe COPD and there was no data to suggest that the addition of roflumilast improved outcome in these patients. The committee members suggested that roflumilast should be tried in patients already taking inhaled steroids before they could decide if roflumilast was safe and effective.

The FDA went ahead and approved roflumilast without any further testing or comments. This is not good news for the patients of COPD. Now the drug company will go ahead with a marketing campaign to get as many of the patients on roflumilast as possible, even though scientific research shows that risk/benefit ratio is not in favor of roflumilast.

Please click here to see the petition filed with the FDA.


Roflumilast Petition




 Posted by at 6:24 am
Oct 082011

The latest recommendation from the US Public Health Task Force on Prostate Cancer Screening is very disturbing. The task force recommends that we abandon PSA testing as a general screening tool. If we agree with that, it would imply that the prostate cancer cases detected solely by PSA screening in the past were overdiagnosed and were overtreated. Dr. Welch at Dartmouth Medical School has estimated that the number of such cases is slightly over one million patients in the years 1987 to 2005.

Since mortality from radical prostatectomy is 0.5%, if half of the patients had surgery and the other half radiation, about 25,000 patients died from overtreatment. About 20% of patients have other serious side effects like erectile dysfunction, urinary incontinence or radiation proctatitis. So there are 200,000 men who have had degradation of their lives from unnecessary treatment.

How do we prevent such a disaster in future? First, we need to examine the history of PSA testing. We must look at how and when it was introduced, at what the clinical studies showed, and at those who should have raised a red flag. The role of the FDA in approving PSA testing as a screening test for prostate cancer should not be overlooked. It was a critical mistake that costed our society a lot of misery.

We at PFIMR, Inc. hope to do our bit to help prevent such tragedies in the future. We have started by analyzing the clinical literature on Bronchial Thermal Cautery (also called  Bronchial Thermoplasty, a misnomer since there is no repair or remodeling involved). We found this surgery to be no better than a placebo but with potentially many side effects that have not been thoroughly investigated. Therefore we have petitioned the FDA to revoke the authorization given to the device  that is used for this surgery. Without this device this surgery cannot be performed.

We have filed a lawsuit to force the FDA to act on the petition. The FDA has been sitting on the petition for over one year and two months.

 Posted by at 8:29 pm
Oct 082011

A petition was filed in July 2010 asking the FDA to revoke its approval of the Alair® device used in bronchial thermal cautery (thermoplasty).  As of October 6, 2011, the FDA had not made a definitive determination on the petition. So PFIMR has filed a lawsuit in an attempt to compel the FDA to make a final determination.

Federal law allows any US citizen to petition the FDA and the FDA must accept or reject the petition within six months. However the FDA was given an “escape clause.” If a petition requires further data or review or if the FDA is bogged down in other work, it could issue an interim response and give a final response later on. Unfortunately the FDA has taken this to mean that all petitions from the public can be given a “boilerplate reply” saying just that and then the FDA sits on the petition for years. Somehow this does not happen when the petition is filed by a drug company. I have several letters from the FDA where a definitive response was given to the "citizen's" petitioner within six months -- but these were all responses to drug companies and their attorneys.

I am sure the FDA has some way to explain the discrepancy between how they respond to petitions from the public and petitions from drug companies. However this does not seem fair to me. Anyway the District Court in the Central Division of California has the petition now and hopefully the judge will ask the FDA to respond in a timely fashion. The whole process should not take more than six months.

Update: The district court dismissed the petition on the ground that PIMR did not suffer any injury and therefore it has no standing to sue.

Update: The Appellate Court of 9th Circuit has taken up the case and is holding a hearing on February 13th in Pasadena. The Circuit Court will decide if PIMR has standing to sue. If they rule in favor of PIMR, the case will go back to the district court for trial.

Click on documents:




 Posted by at 5:40 pm