The drug called Certriad, combines AstraZeneca’s blockbuster cholesterol pill Crestor with Abbott Laboratories TriLipix.

According to Rueters,

The manufacturers said on Tuesday they had received a so-called “complete response letter” from the U.S. Food and Drug Administration for Certriad, which combines Astra’s blockbuster cholesterol pill Crestor and Abbott’s TriLipix.

Both companies said they were evaluating the letter from the agency and would respond to the request for additional information. An AstraZeneca spokesman declined to give further details.

Combo pills are fairly common for heart drugs, and most thought that FDA approval was a given. Merck merged Zocor and Zetia to form Vytorin, and soon they plan to combine Zetia with Pfizer’s Lipitor.

Combo pills are also fairly common in diabetes drugs. For example Januvia, Avandia,and Actos are all available as combo product with generic versions Glucophage.

In typical big pharma fashion, Astra did not disclose what the FDA has a problem with, but many analysts have voiced concern that Certraid does not have enough backing to pass FDA approval after the results from a clinical study this month showed there was no real benefit from adding TriLipix to Crestor.

AstraZeneca(Atacand, Crestor), GlaxoSmithKline (Advair, Boniva) and Pfizer (Benadryl, Lipitor) have all already begun to scrap projects, while others like Sanofi-Aventis (Allegra, Plavix) are about to pick up the trend and start making cuts.

The cuts come as no surprise, as big pharma companies have been seeing there pipelines shrink since 1998, when the trend to buy out drug rights from smaller bio-tech companies began.

Despite the increased cost efficiency of buying drugs from smaller bio-techs, I am not so sure that big pharma is going to like the end result of their decision.

Stephen Foley raises some excellent questions in a recent post, saying

those calculations about the benefits of in-licensing over in-house could change rapidly if the competition for licensing deals, which has been getting more ferocious for several years, increases dramatically. It could be that they will regret swinging cuts to their R&D budgets sooner rather than later.

And there is another reason for executives to pause. There are very great political benefits from drug companies being able to trumpet the life-changing discoveries that have emerged from their research labs and their scientific trials. Yes, these are companies that have manipulated the publication of scientific data, made over-reaching claims for their drugs, and practiced price gouging of government health and insurance services, but they are also companies that lower our cholesterol, shrink tumors, keep diabetes in check and lift the burdens of depression. In the UK, there is an explicit compact with the government on this score: drug prices charged to the National Health Service are set to allow for investment in research. In the US, the good works of drug research help keep in check the demands for re-importation of drugs from lower-priced Canada, and other cost-cutting measures.

It sounds like big pharma is trying to have their cake and eat it too; outsourcing research and development to cut costs while still maintaining control over patents on drugs to protect their profits.

Cutting the cost of research and development is like cutting off your leg to lose weight. Why not cut the fat of advertisement out first. After all, aren’t doctors suppose to tell us the medicines we need?

After they get rid of the cost of research and development, what excuse will big pharma have left to overcharge consumers?

Painful conditions of the esophagus and stomach are common in our society. Stress, obesity, poor diet, and smoking can all play a part. Whether you suffer from acid reflux or ulcers, controlling acid is probably part of your game plan for comfort and health. But there are two very similar acid-controlling drugs from the same parent company on the market: Prilosec and Nexium. How does a savvy healthcare consumer evaluate which one is right or them?

The basics:
Prilosec (omeprazole) was introduced in 1989. Nexium (esomeprazole) was released in 2001. These two drugs are very similar chemically — they are both proton pump inhibitors. This means inhibit the secretion of hydrochloric acid. Yet, they are subtly different: Nexium is often described as a “reflected” or “left-hand” version of Prilosec. They are both products of the pharmaceutical company AstraZeneca, and some parties have described Nexium as a “follow-up drug” to the wildly successful Prilosec; it was introduced just as Prilosec’s patent protection was about to expire.

The conditions they treat:

1. Gastroesophageal reflux disease (GERD, commonly called acid reflux) is when the lining of the esophagus becomes inflamed from the regurgitation of stomach acid. Prilosec and Nexium can both treat GERD.
2. Duodenal ulcers: Prilosec and Nexium can both treat duodenal ulcers that are caused by a Helicobacter pylori infection, but only Prilosec can treat duodenal ulcers caused by other factors.
3. Gastric ulcers: Both drugs treat benign gastric ulcers, but Nexium is limited to treating such ulcers caused by nonsteroidal anti-inflammatory drugs. Prilosec can treat any type of gastric ulcer.

Your choices:

Prilosec is an older, more established drug, and thus has been approved to treat more conditions than Nexium has. If your condition is one that only Prilosec can treat, then your choice is crystal-clear.

However, if you are one of the millions of people whose condition is approved to be treated with either Prilosec or Nexium, then you have some research, discussion, and possibly even a trial run with the medication ahead of you. Someone suffering from acid reflux, for instance, would have a valid case to try either medication. If this is the case, discuss your particulars with your doctor for advice on which to start with.

The two drugs are so similar that many patients report choosing solely based on logistical factors such as availability and affordability. However, here are some other issues to consider in your comparison:

• Check your insurance plan: some cover both Prilosec and Nexium, while some only cover one choice.
• Prilosec has a generic version, while Nexium does not, which may affect your buying decision.
• Some people tolerate one drug better than its sibling; you may need to compare to learn what works for you.
• Prilosec can have a side effect of appetite loss, while this has not been reported with Nexium.
• Prilosec is generally recommended for shorter courses of treatment, while Nexium is often recommended for longer courses of 4-8 weeks.

These medications are very similar, but are not the same. Do not substitute. As with any drug, please consult your physician before taking.

There are six statins on the market: atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin. They differ in their ability to reduce cholesterol, and they also differ in their rates of reducing heart attacks. Their costs are also quite different — and since most people take statins for a long time, the costs add up over the years. With all of these variables, choosing the right statin for you can be complex.

All statins are capable of lowering LDL (“bad”) cholesterol and triglycerides, and raising HDL (“good”) cholesterol. The statins do differ in how effectively they can do this, and it is highly dose-dependent. Says Drug Digest:

If the needed LDL-C reduction is up to 35-36%, any of the statins should be acceptable choices for therapy. For a desired reduction of LDL-C greater than 42%, simvastatin (Zocor), atorvastatin (Lipitor), or rosuvastatin (Crestor) would be needed.

Indeed, the best-known statins are Crestor, Lipitor, and Zocor (quite probably because they have the greatest effect on cholesterol levels). The latter two are also endorsed by Consumer Reports. Taking evidence for effectiveness, safety, and cost into account, the publication rated both of these statins as “Consumer Reports Best Buy Drugs.” They recommend:

• Generic simvastatin (20mg or 40 mg) — if you need 30% or greater LDL reduction and/or have heart disease or diabetes, or if you have had a heart attack or have acute coronary syndrome and your LDL level is not highly elevated.
• Atorvastatin (Lipitor) (40mg or 80mg) — if you have had a heart attack or have acute coronary syndrome and your LDL is highly elevated; use for two years and then reconfirm need or switch to generic simvastatin.

Charts on Drug Digest have some great comparisons. For instance, they show that Lipitor (10-80 mg.) can reduce total cholesterol by 25-45%, while Zocor (5-80 mg.) can reduce the same numbers by 19-36%, and Crestor (5-40 mg.) can reduce it by 33-46%. As for lowering HDL, Lipitor can offer reduction of 5-9%, Zocor lessens HDL by 8-16%, and Crestor lowers these numbers by 8-14%. As you can see, choosing the proper statin has a lot to do with which numbers (Total Cholesterol, HDL, LDL, or triglycerides) you are trying to effect.

A final consideration is that last year there was reporting on an observational study done by Pfizer that suggested that there were certain benefits to using Lipitor over Crestor. However, one must keep in mind that Pfizer conducted the study, and they are the manufacturer of Lipitor, and they are defending this drug against Merck’s Zocor product, which is now available in a generic formula. Here is the information as presented by The Wall Street Journal:

An analysis, published in the latest Clinical Therapeutics Journal, mined a large database of health-care records and found that patients taking Lipitor had a 12% lower risk of a cardiovascular event than those on simvastatin, the generic name for Zocor. The patients on Lipitor had a 15% lower risk of having a heart attack.

So-called observational studies like this one that look at data after the fact aren’t as powerful as prospective clinical trials. Jack Tu, a cardiologist who specializes in outcomes research at Canada’s Institute for Clinical Evaluative Sciences, says the latest Pfizer study didn’t take into account factors that could predispose a patient to heart problems, such as smoking and cholesterol levels. “Just on this alone, you wouldn’t recommend that everyone should switch onto Lipitor,” he says.

Still, Pfizer hopes that doctors will take notice. “We’ve done two rather large observational studies and patients have a lower risk of cardiovascular events on Lipitor [compared with] simvastatin,” says Susan Shiff, Pfizer’s team leader for cardiovascular outcomes. “Doctors need to factor this into discussions with patients.”

You should definitely discuss with your physician which statin is right for you. In general, the best plan is to take the LOWEST dose of a statin that gets you to your target level for cholesterol. Overly large doses can be harmful to your liver and to your muscles. If you experience muscle aches and pains when taking a statin, contact your doctor immediately.

It’s been an absolutely horrible week. I don’t wish this on anyone. But I have to move on. I have a family to take care of…I hold no grudges or malice against anyone. Right now, I’m just trying to piece my life back together. But I don’t have any other comment at this point.

He declined to go into details about the controversial AstraZeneca newsletter article or his firing.

The good news is that consumers do have an alternative to AstraZeneca’s “big bucket of money” prices. Recently, we helped PharmaGossip put together a price comparison that shows cancer patients can save up to 65 percent by purchasing their Casodex from Canada.

PharmaGossip reports:

Thanks to Cary Byrd at eDrugSearch.com (their database encompasses PharmacyChecker-approved pharmacies as well as other pharmacies accredited by reputable organizations such as IMPAC, CIPA, MIPA and VIPPS) we can now take a look at how much of a gouging US cancer patients are getting when they have to pay for Casodex (50mg) tablets.

US price per tablet : $17.33

Canada: $6.13 per tablet (120 x 50 mg tabs = $735).

Australia: $7.63 (30 x 50 mg tabs = $228.86).

Israel: $7.70 (112 x 50 mg tabs = $862.56).

U.K.: $15.68 (28 x 50 mg tabs = $439).

So, Casodex is cheaper virtually everywhere else in the world – with the price in Canada about 65 percent less than the U.S. price cited.

Ouch!

To summarize, U.S. “big bucket” pricing: Ouch! Canadian pricing: Ahhhh!

I see it like this: there is a big bucket of money sitting in every (cancer doctor’s) office. Every time you go in, you reach your hand in the bucket and grab a handful. The more times you are in, the more money goes in your pocket. Every time you make a call, you are looking to make more money.

Poor Michael. After all, he only said what most Big Pharma execs were already thinking — that physicians are no more than stethoscope-wearing piggy banks.

Uber-whistleblower Peter Rost brought to our attention a wonderful comment on the AstraZeneca message board that sums up the issue:

Glad to see the world is finally getting a glimpse of the true motivation behind Pharma’s veneer of supposed benevolence and innovation. I was in the industry for 12 years so spare me your self righteous propaganda. We all know its about money and the power that money brings. This guy MZ actually had the kahunas to admit it. Seems to me he has already has more credibility than most of the industry. Trash him all you want but it’s the culture behind the scenes that needs to be exterminated not the employees that reflect it.

You can find a couple more takes on the subject here and here.

As well as being costly, the failures have left the group dangerously exposed, with just a few products left in its late-stage pipeline and with patents on its existing line of big-selling drugs due to expire in only a few years’ time.

This has left AstraZeneca with some tough decisions about how to bounce back. When asked how AstraZeneca will respond, Brennan said,

Our primary focus is in areas where we have existing therapies… (and) are most likely to get a hit. Right now we are much more focused on areas where we are strong, rather than in diversity

More at PharmaGossip.

Basically, AstraZeneca will use the same strategy that got them into this mess to try to get themselves out. They will advertise the same old drugs more heavily, maybe test them for a few more uses, and possibly buy out some small biotech firms.

Isn’t doing the same thing over and over again and expecting different results the definition of insanity?