What are “biologics”? They’re the next big wave in medicine — drugs made not from simple chemical formulations, but from biological components. They’re very expensive, and poised for enormous success:

By 2014, the biggest-selling meds will be biologics, according to an analysis from Evaluate Pharma. Taking the place of Pfizer’s gargantuan drug Lipitor will be Roche’s Avastin, a cancer med expected to account for $9.23 billion in 2014 sales. (Even when you factor in the recent trial disappointments.) The next five top sellers, in order, are expected to be Humira (Abbott Labs), Rituxan (Roche), Enbrel (Wyeth/Amgen), Lantus (Sanofi-Aventis), and Herceptin (also Roche).

Evaluate also predicts that half of the top 100 drugs in 2014 will be biotech meds — a huge change from last year’s level of 28 percent and 11 percent in 2000.

Because biologics are so complex, the system we all know — where patented brand names enjoy a period of exclusivity, then eventually make way to cheaper generics — doesn’t translate perfectly. Biologic “generics” are called “biosimilars,” and they are not seen as generic equivalents. They must be submitted for approvals as new drugs and do their own clinical trials, etc. 

The Eshoo-Barton amendment, named for sponsoring Representatives Anna Eshoo (D – Calif.) and Joe Barton (R – Texas), would give brand-name biologic drugmakers 12 years of market exclusivity. By comparison, President Obama favors seven years, and Rep. Henry Waxman (D –Calif.) feels that the public should have access to “generic” biologics after just five years. By contrast, says Medical News Today, “The Biotechnology Industry Organization maintains that there should be a minimum 14 years of exclusivity to account for a development process that on average takes 10 years and $1.2 billion for a product to reach market.”

5, 7, 12, or 14 years? As you can see, there is a real difference of opinion on this subject. One person who has written extensively on this is author James Love on the Huffington Post. Here he explains why this amendment is harmful:

The Eshoo/Barton amendment, which has the support of many newly pro-PhRMA democrats, will extend the period of monopolies for biologic medicines, when compared to the original Waxman text. The only question is how long. Part of the harm will be the longer period prohibiting generic suppliers from relying upon evidence that medicines are safe and provide therapeutic benefits. Much of the other harm will come from a number of technical changes in the bill that make it much easier for incumbent firms to block entry through technical issues, extended litigation, and ever-greening of protection from small medically unimportant changes in protected medicines.

This is essentially a case of innovation versus access. Drug companies want protection from the risks and costs borne in the creation and testing of new drugs; patient advocates say that Big Pharma (or Big Biotech, if you like) already make large profits and that the public deserves access to affordable biosimilars in a more timely fashion. “Entities that support longer periods of exclusivity — such as universities, biotech companies and venture capitalists — are ‘fighting to protect inventors’ rights and ensure more thorough clinical trials.’ On the other side, consumer groups, labor unions, insurers and generic drug manufacturers ‘see shorter exclusivity as the way to deliver safe, affordable and quality drugs to patients and open the marketplace to increased competition,’” explains Medical News Today.

The latest high-emotion development is blogger Jane Hamsher’s “Are You Or Someone You Know Paying $50,000 A Year For Drugs?” It paints an ugly picture of what happens to people who cannot affording life-saving biologics. A few days later, Rep. Eshoo responded to this and other online attention with a blog post on The Hill’s Congress Blog titled “Setting the record straight on our health care legislation.” If you check in with these two articles, you’ll have the latest from both side of the “biologic generics” debate.

Our mission, as always, at EDrugSearch.com is to improve the American public’s access to safe, quality medications at an affordable cost.

For more information:

• Should We Be OK With The PhRMA Deal With White House?
• US House Panel Backs Exclusivity for Biologic Drugs
• Pay or die: Deadly Pharma amendment in HCR going right under radar

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.