Bad News for Potent Cholesterol Drug Users, but Not Me!

Bad News for Potent Cholesterol Drug Users, but Not Me!

Two pieces of bad news for people who take "potent" anti-cholesterol statin drugs came into my email in-box today.

The first was about yesterday's New York Times OpEd piece published by a well-known cardiologist who said Americans are being "over-dosed" with statins to treat high cholesterol (see "We're overdosing on cholesterol-lowering statins says Top(ol) cardiologist").

"It is only with the more potent statins -- Zocor (now known as simvastatin), Lipitor (atorvastatin) and Crestor (rosuvastatin) -- particularly at higher doses, that the risk of diabetes shows up," said Dr. Topol. "The cause and effect was unequivocal because the multiple large trials of the more potent statins had a consistent excess of diabetes."

Coincidentally, I also received news that the FDA refused to approve Merck's experimental anti-cholesterol drug "MK-0653C" - an combination of generic Lipitor and Zetia (see "FDA Nixes Merck's New Combo Cholesterol Drug").

Merck hoped that the new drug would be better received than Vytorin, which combines a less-powerful statin produced by Merck (Mevacor - also off patent) with Zetia. Vytorin has been dead in the water since 2008, when studies showed that it worked no better than generic Mevacor alone to reduce plaques in arteries (see "Should I Stop Taking Zetia?").

I'm taking all this bad news personally since most of these drugs were recommended to me by my physicians over the past several years.

I've already documented how my GP wanted to switch me from Pravachol -- a weaker statin -- to Crestor and then she recommended I switch to Lipitor when it was about to go off-patent (see "Crestor Grapples to Compete with Lipitor: #Fail!"). Before that, my cardiologist recommended Zetia.

But I have refused to succumb to the "new is better" argument that these physicians were making. I was never impressed by Zetia and thought it was too much trouble to take two pills. Merck has been trying hard to combine Zetia with a generic statin to overcome precisely that adherence problem and to boost Rx sales of Zetia, which is not very effective on its own.

Too bad for Merck. It hasn't had much luck making a purse out of a sow's ear!

Meanwhile, my resistance to taking a stronger statin such as Crestor seems to have been the right decision for me because there is more diabetes in my immediate family than heart disease.

It seems these days that taking advice from a physician is like taking advice from a stock broker -- you can win or lose following their advice, but they win no matter what!

J&J Lowers Its Reputation Expectations

J&J Lowers Its Reputation Expectations

I recently received this simple tweet from @JNJComm (Johnson and Johnson's official corporate Twitter account):

#JNJ is pleased to rank 12th among @FortuneMagazine’s most admired companies! > cnnmon.ie/xM27z8

Hmmm... JNJ might be pleased that #12 is better than #17, which is where the company stood in last year's most "admired" list of companies.

However, when you look at JNJ's standing within the pharmaceutical industry, you see a different, ie, downward, trend as shown in the chart on the left (click on it for a larger view). A similar trend is seen in the Harris QR data.

So, I don't think JNJ should lower its expectations and be "pleased" with how it is performing against its competitors who are certain to leverage this loss of reputation to their advantage.

Reminder Ads OK in EU But Not in US. Huh?

Reminder Ads OK in EU But Not in US. Huh?

The Geneva-based International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) expanded its practice code to cover all interactions with health-care professionals, medical institutions and patient organizations, including a ban on doctors from receiving payments to attend conferences (see "Big Bad Pharma, Bribery and the New EU Industry Code").

According to the above cited source (WSJ's "Corruption Currents" blog) this was a bit like closing the barn door after the cows have left:

"This comes at a time when the association’s members are trying to drum up business in developing countries, some of which have state-run health systems. Employees of such systems, including doctors and nurses, can be considered foreign officials under the U.S. Foreign Corrupt Practices Act, a 1977 law that bars bribing foreign officials for business purposes.

"To that end, the Securities and Exchange Commission and the Justice Department are in the midst of a sweep of the industry. In April 2011, Johnson & Johnson agreed to pay $70 million to resolve violations, and The Wall Street Journal reported in November 2011 that Pfizer Inc. will pay more than $60 million when its settlement gets finalized.

"Both companies, the Journal reported, ratted on their competitors.

"Those competitors included AstraZeneca, Merck & Co., Bristol-Myers Squibb Co., GlaxoSmithKline PLC and others that have disclosed investigations for possible FCPA breaches. Eli Lilly & Co. was in advanced talks in April 2011 with the Justice Department, and the company said Feb. 24 in its annual results it’s at the same level with the SEC.

"Letters of inquiry to several of the companies, dating back more than a year, laid out several types of of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals."

Any way, I decided to download the new "IFPMA Code of Practice" to see if there was anything interesting or actually new (you can find it attached to the post here). The code is intended to cover "interactions with healthcare professionals, medical institutions and patient organizations, and the promotion of pharmaceutical products."

This section popped out at me:

5.2 Reminder Advertisements

A “reminder” advertisement is defined as a short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product. For “reminder” advertisements, “abbreviated prescribing information” referred to in Article 5.1 above may be omitted. 

The "abbreviated prescribing information" include "an approved indication or indications for use together with the dosage and method of use; and a succinct statement of the contraindications, precautions, and side-effects."

In other words, it is perfectly OK to promote drugs to healthcare professionals and patient organizations using reminder ads that do not include safety information. Note: these ads must be print ads in professional publications because no such ads would be allowed on mass media such as TV, which reaches consumer audiences. Promotions  of Rx drugs to consumers is not allowed in the EU, reminder ads included.

The U.S. pharma industry does not have a "practice code" for advertising or "marketing" to healthcare professionals, medical institutions and patient organizations. It does, however, have "Guiding Principles" for direct-to-consumer (DTC) advertising, published by PhRMA (the U.S. industry trade association) in December, 2008. Principle 13 states "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." I.e., NO REMINDER ADS!

Of course, PhRMA's principles leave open the door for running DTC PRINT ads, although I haven't seen many of these in the consumer publications I read. The exception is BOTOX, marketed by Allergan, which has NOT signed on to PhRMA's principles (see "PhRMA Intern vs. BOTOX!").

So, why does the IFPMA Code of Practice specifically carve out an allowance for "reminder ads?" Is that a technique often used in the EU to win over the hearts and minds of healthcare professionals? I don't get it.

Google Pharmacy Phish

Google Pharmacy Phish

I received an e-mail today announcing the launch of "Google Pharmacy" that promised it will "improve the Google experience for people buying pills and using pharmaceutical interfaces." It included a nifty-looking Google logo that replaced the "oo" with two pills (Viagra and Cialis):

Of course, this is a "phishing" expedition - "a way of attempting to acquire information such as usernames, passwords, and credit card details by masquerading as a trustworthy entity in an electronic communication" (wikipedia).

1. I haven't clicked on the link "Visit Google's Accredited Pharmacy" although I was tempted to do it because of my interest in Google's past misdeeds that involve collusion with "rogue" pharmacies (see "Google Settles with DOJ - Admits Aiding Illegal Online Drug Sales") and 


2. Google's failed attempts to co-opt the pharmaceutical/health sector (see "Google Health is Being Shut Down").

Actually, perhaps Google should actually launch an accredited pharmacy site where people can LEGALLY purchase Rx drugs online! That might help buff up it's tarnished promise to "do no evil."