Aug 282011

Recently, the Department of Justice (DOJ) and Google settled a dispute. The details were sealed by mutual agreement. What we know is that Google paid a $500M fine for allowing Canadian Pharmacy ads to appear on Google search result pages.

This is a big victory for drug companies and a big loss for patients with low incomes. With all the corruption and crime going on in the USA, why did the DOJ spent so much time investigating a business practice that was not harming anyone? The answer is that it was harming the big drug companies.

The drug companies probably contacted their friends in Washington and got the DOJ involved. When the drug companies crack their whip the US government responds quickly. When you or I try to get the US government to do something, well you know what happens. When I moved my office two years ago and asked Medicare to change my address it took over ten months. My Medicare correspondence file on this address change was over two inches thick. How many thousands of trees would be cut to make paper if half of the doctors in the USA changed their addresses?

The Minnesota state government actively encouraged its employees to buy drugs from Canadian Pharmacies. The state government even sent inspectors to Canadian pharmacies and certified some of them as good pharmacies. Recommending Canadian pharmacies cannot be that big of a crime.

August 30, 2011: Today I saw a patient of asthma. Her insurance deductible is $5000 a year, so basically she has no insurance for treatment of her asthma. I prescribed a cortisone inhaler, the cheapest one (for equivalent cortisone dose), I think is Pulmicort Flexhaler. It comes in a bottle of 120 puffs, each puff contains 180 mcgm. One bottle costs over $160.

So I called a Canadian Pharmacy to get price over there. The price for 200 mcgm per puff, 200 puffs canister was $98. So the price in Canada is one third of the price in the USA. I advised the patient to get her asthma inhaler from Canada.

Is DOJ going to come after me and fine me for doing something illegal?

I think the DOJ should investigate why drug companies charge American patients two to five times more than they charge Canadian patients for the same drug, made by the same company in the same facility.


 Posted by at 6:43 am
Aug 092011

The FDA approved a theophylline-like drug for COPD without any clinical studies comparing the drug to theophylline. Roflumilast is another phosphodieasterase inhibitor like theophylline. It is supposed to be specific for PDE-type 4, which is supposed to be beneficial although there is no such clinical evidence to support this claim.

The clinical literature on roflumilast falls into two distinct categories. One category is the literature sponsored by the drug company. Most of the literature on this subject belongs to this group. The second category is literature not sponsored by the drug company. There are only a handful of editorials in this category.

The drug company sponsored literature talks of the statistically significant improvement in FEV1 and the rate of exacerbations in COPD patients. The articles seldom mention the fact that it is another theophylline. Just like theophylline it increases FEV1. No one has studied the effect of low dose theophylline on the rate of exacerbations so we cannot say if this is a generic effect or something specific to PDE-4 inhibitors.  Half of the clinical studies mentioned in the FDA Summary Review show NO BENEFIT of roflumilast on the rate of exacerbations. The other half are at best equivocal. If you dice and slice the data you can show statistically significant benefit on the rate of exacerbations in some sub-groups. But if you pool all the data together, there is no clinical benefit. Just like theophylline, nausea and diarrhea are the main side effects. There was an increased incidence of depression and suicides in the treated group. However this is seldom mentioned in any of the sponsored literature.

The independent literature is sparse and is united in its assessment that roflumilast has not been shown to have any clinical benefits. The editorials ask for more studies before it is accepted as standard treatment in COPD.

The clinical trials sponsored by the drug company compare this drug to a placebo. Most clinical trials prohibit the trial patients from using inhaled steroids, LABA, and/or Spiriva. In the real world roflumilast will almost always be used in patients taking inhaled steroids with LABA and/or Spiriva. Therefore the trials are not useful to practicing physicians or their patients. They do not show what benefit, if any, roflumilast will have when used in clinical practice.

Roflumilast may be a useful drug. At this point we do not know. A clinical trial comparing roflumilast with a placebo on one the hand and theophylline on the other hand is essential to demarcate the role of roflumilast. These trials must also allow the patients to continue their standard medical treatment with inhaled steroids, LABA and/or Spiriva.




 Posted by at 1:23 pm
Aug 072011

The FDA has been appointed gatekeeper by the US Congress and is required to approve only those drugs that are safe and effective. But how is safety and effectiveness determined? This question brings into focus the concept of a strong gatekeeper versus a weak gatekeeper.

A weak gatekeeper would allow all drugs that are somewhat effective and reasonably safe. The marketplace of free enterprise would then discard those drugs that are not very effective and keep those that are really effective. In a free marketplace, doctors would evaluate the newly released drug and would compare it to existing drugs on the market. Then, doctors and patients together would decide the fate of the new drug.

A strong gatekeeper would only allow those drugs that are clinically significantly effective and reasonably safe. The drugs, preferably, would be more effective and/or safer than the existing drugs on the market or there would be a clear indication that the drug is just as effective as others on the market. Then doctors and patients would not need to evaluate each newly released drug.

For the concept of the weak gatekeeper to work there has to be “free and open market” in society. Unfortunately the market in the medical field is anything but “free and open.” There is a tremendous distortion of the market by drug companies. When a new drug is released, the company goes into marketing frenzy.

Hundreds of thousands of drug representatives call on doctors all across the country giving free samples to try with patients. They sing the praises of the new drug, claiming that is safe and effective because it has FDA approval. Doctors are feasted at fancy restaurants where “local leading physicians” convince them of the new drug's effectiveness.

There is hardly any mention of existing drugs, especially if they are old and out of patent. There is almost never any clinical study comparing the new drug with the existing drug. The drug company salesman, in this case the “local leading physician,” always touts the latest drug company sponsored clinical study comparing the new drug with a placebo. They note some chemical difference between the molecule of the new drug as compared to the old drug, claiming some benefit. There is almost never any clinical study that would show this benefit. The family doctors come back from the lecture/dinner ready to try the new drug. The next day the drug representative dutifully shows up at their offices to inquire how they enjoyed the dinner and to drop off free samples. Hundreds of thousands of patients are given samples and prescriptions for the new drug.

Doctors are too busy to conduct any systematic study comparing the old to the new. Academic centers do not have money to conduct any clinical studies. They all depend on drug company money to conduct research. The drug companies have no reason to sponsor clinical studies comparing their new FDA-approved drug to old out of patent drugs.

 Posted by at 7:31 am