Editorial: Discussion of Data and Demeanor

Received from Steve Silverman, FDA

"In the Letter from the Editor portion of the January 30, 2009, publication, Compounding Today.com, you make the following statement: "Deaths attributed to compounding averages less than three per year according to data presented by the FDA." That is a misstatement, as I explained in my July 27, 2007, E-mail to you. You later published a correction and I hope that you will do so again based on today's erroneous repetition of this assertion.

To reiterate, the data conveyed in my presentation, which I understand is the basis for your three-deaths-per-year assertion, at best shows that anecdotal adverse events reported to FDA over a 15-year period demonstrate a rate of 2.53 deaths/year. But it continues to be the case that, because pharmacies are not required to report adverse events to FDA, there may be many additional adverse events, including deaths, of which we are unaware."

From the Editor:

First of all, it was not a misstatement but simply reported using the figures that were presented in a public forum. However, the clarification on the reliability of the data is welcomed.

Further, deaths due to compounding are few and far between. When adverse events/deaths do occur, they are often picked up by the local and then national media and broadcast over the nation. In some cases, the same deaths are re-broadcast for years to come, making the situation appear far more serious than it actually is!!!! In the past few weeks, even the FDA still refers to the deaths that occurred years ago related to the topical application of anesthetics in laser clinics; which were not the fault of the pharmacists but of the caregivers involved. However, the FDA continues to tout the deaths as if they are recent occurrences and that they are the responsibility of the compounders.

But, hypothetically, let's look at some numbers:

1. If only 10% of the deaths are reported to the FDA, that shows there may be 25.3 deaths/year, which is still a very low number compared to the actual deaths occurring in hospitals and the deaths related to FDA-approved drugs.

2. If only 1% of the deaths are reported to the FDA, that shows there may be 253 deaths/year, which is also still a low number compared to the actual deaths occurring in hospitals (98,000 IOM report) and the deaths related to FDA-approved drugs.

3. The Institute for Safe Medication Practices report (2009) states that a record number of deaths and serious injuries associated with drug therapy were reported to the FDA in the first quarter of 2008. There were 4,824 reported deaths in the first 3 months of the year, a 2.6 fold increase from the previous quarter (that's over 19,000 deaths if annualized). Source: Hospital Pharmacy 2009, 44(1): 47-56

However, this Editor is glad to post the response from the FDA and only has one request:

"FDA, please make all the corrections in the misrepresentations and incorrect statements over the years and apologize to the professions of medicine and pharmacy and especially to the public."

Thank you.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Pfizer-Wyeth Deal to Use Loans from TARP Banks
The acquisition by Pfizer of Wyeth perverts the U.S. government's Troubled Asset Relief Program (TARP), relying on loans from five banks aided by the bailout for a deal that will cut 19,500 jobs. TARP funds were meant to bolster the economy by promoting lending, not finance job cuts, where 19,500 jobs will be eliminated from the combined companies. The deal is financed by $22.5 billion in loans from banks that received at least $75 billion from the Treasury Department's rescue plan, the drugmaker said on January 26.
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a4L5MQ71e884

Physicians Must Publicly Disclose Payments and Gifts Online
Drug and medical device manufacturers will be required to publicly disclose all doctor payments and gifts exceeding $100 per year under U.S. legislation unveiled on Thursday. Companies would face penalties as high as $1 million for knowingly failing to report the payments if the bill by Iowa Republican Sen. Charles Grassley and Wisconsin Democrat Herb Kohl becomes law.

The effort is meant to shine light on the industry's lavish gifts to doctors, which range from pricey dinners to golf vacations, as well as consulting and speaking fees. Critics have said the payments may skew doctors' decision-making.

"The goal of our legislation is to lay it all out, make the information available for everyone to see, and let people make their own judgments about what the relationships mean or don't mean," Grassley said in a statement.

The information would be posted online for public viewing, the senators said.
http://news.yahoo.com/s/nm/20090122/hl_nm/us_drugs_payments;_ylt=Ai4oN18K7bEsiJNxeFjuMCgQ.3QA

The "Stimulus" or "Spending" package that Congress is considering is NOT spending OUR money? It's spending our GRANDCHILDREN'S and GREAT GRANDCHILDREN'S money! Talk about being inconsiderate and short-sighted!

Talk to your Reps
Please, please, let your elected representatives know how you feel on the issues! You know the special interests groups are on the phone daily, and it seems that the "squeaky wheel still gets the grease!" Call the local office of your elected representatives and get to know them well.