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

We’re nearing the end of the year, and many people are already in open enrollment for next year’s health coverage, which means it is a great time to plan ahead for your 2010 drug expenditures. No, you can’t know every medication you are going to need, but if you are on a popular, patented maintenance drug such as Lipitor or Cozaar, you’ll be pleased to hear that their patents are expiring in 2010, opening the field for more-affordable U.S. generic versions.

In the meantime, as you do your research, you will see that many are already available as generics, manufactured outside of the U.S. There is usually a considerable cost savings.

Here are all the details of some of the highest-profile drugs that have expiring patents as of the end of 2009, or during 2010 — and how and where to get the generic versions.

ARICEPT (donepezil). Pfizer makes the acetylcholinesterase inhibitor Aricept for the treatment of Alzheimer’s disease. Aricept is scheduled to lose patent protection in the U.S. in 2010, but generic versions are already available.

COZAAR (losartan). Merck’s Cozaar is an angiotensin II receptor antagonist, used to treat hypertension. Cozaar’s patent protection in the U.S. will expire in 2010. In the meantime, generic losartan is available here.

LEVAQUIN (levofloxacin). Johnson & Johnson’s antibiotic drug Levaquin will outlive its patent protection in 2010. However, until that time, you can purchase generic levofloxacin here.

LIPITOR (atorvastatin). Pfizer has the best-selling drug in the world in Lipitor, which treats high cholesterol. In the US, the basic patent for Lipitor expires in March 2010, while the second patent covering the calcium salt of atorvastatin expires in June 2011. It is not yet clear exactly which date will see widespread availability of generic Lipitor in the U.S., but it is coming. In the meantime, generic atorvastatin is available here.

XENICAL (orlistat). Roche’s Xenical is an obesity treatment that prevents the digestive system from absorbing fats. Its patent expires in December of this year.  (Note: In some countries, including the U.S., orlistat is available over-the-counter as GlaxoSmithKline’s Alli.)

VALTREX (valacyclovir). GlaxoSmithKline’s Valtrex is a treatment for herpes simplex and herpes zoster (shingles). Valacyclovir was recently approved for generic production, and so generic versions will be on the U.S. market by the end of 2009. As of this writing, generic valacyclovir is available here.

If you’re interested in the business ramifications for the pharmaceutical companies, CNN ran a good article on the topic, and so did Chemistry World.

Enjoy using EDrugSearch.com to knowledgeably plan your medication choices for the coming year.

However, people suffering from atypical depression — characterized by hunger and sleepiness, rather than loss of appetite and insomnia — may have different needs in an antidepressant and should discuss with their doctor options such as Bupropion (familiarly known by its GlaxoSmithKline trade name, Wellbutrin), which could help where popular SSRIs might fail.

That is because SSRIs — Selective Serotonin Reuptake Inhibitors — work on the neurotransmitter Serotonin, while Wellbutrin — an NDRI — is a Norepinephrine and Dopamine Reuptake Inhibitor. This change of focus in the affected neurotransmitter may make all the difference for those individuals who suffer depression in an atypical manner.

Atypical depression differs from regular, “melancholic” depression primarily in energy and appetite. It is often characterized by “reversed vegetative symptoms” such as over-eating (regular depressives have little appetite) and/or over-sleeping (regular depression is usually characterized by sleeplessness).It is estimated that up to 40% of people suffering from depression have atypical symptoms.

Wellbutrin reportedly has a more enlivening affect than the SSRIs, so it is often considered for those who are sleeping abnormally long amounts. (For this reason, it is not advised for those suffering anxiety or agitation.) It is also one of the only antidepressants that is not associated with weight gain, and for this reason is also suitable for atypical depressives who may be overeating.

Even successful users of SSRIs have reason to consider Wellbutrin. SSRIs have widely-known sexual side effects that trouble some patients, even if the SSRI is curing their depression. This may make them turn to their physician for refinement of the prescription. Says Ray Sahelian, M.D.:

Since bupropion raises dopamine levels, it actually can enhance sexuality rather than depress libido as do many SSRIs. Bupropion has been shown to have a favorable effect on sexual dysfunction. Several reports and small, short-term trials have examined bupropion as an adjunct or substitute for other antidepressants in sexually dysfunctional patients. This means that Wellbutrin is often prescribed for sufferers of atypical depression, but it is also prescribed as an add-on for people using SSRIs who would like to try to combat the sexual side effects of SSRIs.

In other words, Wellbutrin is often prescribed as an add-on to an SSRI for the express purpose of relieving some of the SSRI’s sexual side effects (usually loss of libido or functioning).

Depression is not the only condition that Bupropion has been approved to treat. In 1997, it was approved by the FDA as a smoking cessation aid under the name Zyban. And in 2006, Wellbutrin XL was approved as a treatment for Seasonal Affective Disorder. Because both Wellbutrin (prescribed for depression) and Zyban (prescribed for smoking cessation) are essentially Bupropion, patients should not take both at the same time; they would be doubling their dose.

Caution: The most well-known side effect of Bupropion is that it lowers seizure thresholds. Doctors have worked around this with lower dosages (it is highly dose-dependent) and controlled-release formulations. Still, those with seizure disorders should avoid Bupropion. Other common side effects are nervousness/ agitation and insomnia. As with any antidepressant, people suffering from increased depressive symptoms or thoughts of suicide should contact their doctor immediately.

Some formulations of Bupropion are available as generics in the United States and Canada.

U.S. Brand Names

• Budeprion SR®
• Budeprion XL®
• Buproban™
• Wellbutrin SR®
• Wellbutrin XL®
• Wellbutrin®
• Zyban®

Canadian Brand Names

• Novo-Bupropion SR
• PMS-Bupropion SR
• RATIO-Bupropion SR
• SANDOZ-Bupropion SR
• Wellbutrin XL®
• Wellbutrin®
• Zyban®

A new study by the Fraser Institute, “Canada’s Drug Price Paradox,” compares Canadian and American prices for the 100 most commonly prescribed brand-name drugs, as well as the 100 most commonly prescribed generic drugs. The study found that while brand-name drugs are much more expensive in the United States, generic drugs cost more in Canada.

After currency adjustments, Canadian retail prices for brand-name drugs in 2007 averaged 53 percent lower than the United States — compared to 51 percent lower in 2006 and 43 percent lower in 2003.

Canadian retail prices for generic drugs, meanwhile, averaged 112 percent higher than United States prices, compared to 115 percent higher in 2006.

The Fraser Institute, which is attached to conservative political causes, blames the disparity in generic drug pricing on three Canadian government policies that “distort” prices. These policies are:

Provincial and federal drug programs direct public reimbursement of prescriptions to pharmacies instead of consumers; as such, it insulates customers from the costs and removes incentives for comparison shopping, which would pressure companies to lower prices.

Public drug programs reimburse generics at a fixed percentage of the original, brand-name drug; under such a program, there is no incentive for retailers to compete and undercut prices.

Federal prices controls on patented drugs unintentionally prevent brand-name drug companies from reducing prices on these products once a patent expires; these price controls create an artificial incentive for brand-name companies to resist competing on the basis of price with generic firms for sales of off-patent drugs.

The Fraser Institute argues that Canada’s disruption of the free market with price controls has had the unintended impact of raising prices of generic drugs. It argues that free markets allow companies like Wal-Mart to foster price competition with their $4 generic drug program, which has been matched by several other major retailers.

This is all certainly true.

But you know what? It’s also true that brand-name drugs are so expensive in the United States for the same basic reason: a lack of price competition.

Why is there a lack of price competition in the United States, the supposed home of free and unobstructed markets? Because the government has been giving drug companies monopoly protection of their drugs — which they are allowed to extend for years and years by playing games with the FDA.

Guess what? When there’s a monopoly, it ain’t a free market. You pay what you’re told to pay, and if you don’t like it, you’re out of luck.

The Fraser Institute fails to point that part of the problem out.

And really, this failing is a microcosm of what’s been wrong with U.S. policy toward the pharmaceutical industry over the past three decades. Politicians say they’re in favor of free markets, but their behavior suggests that they are actually in favor of big business, even when big business is opposed to free markets.

Coincidentally, these are the same big businesses that line politicians’ pockets and fill their campaign war chests.

We are cautiously optimistic that things will change in the current administration. But this can only happen if Americans continue to support President Obama’s agenda for change — and are not dissuaded by Big Pharma disinformation.

Source

Here are a few of Tom’s 50 tips:

• Unplug appliances part of the time when not in use. Also unscrew lightbulbs in some places instead of just turning the light off. This especially will help with young children who are not always so good at turning lights off when they are done.
• Try to find free things to do. Watch a kids baseball game (this also reduces stress, watching them play). Go hear a free lecture at a bookstore by an author. Feed the ducks with old bread at the lake. Have a picnic. Play chess or other board games that you pick up for cheap at a local garage sale. Go to a gallery opening for an artist (oftentimes there is free wine and food there too).
• Track every expense for a month. Write down or save receipts for literally everything, even the $2 frozen yogurt that you bought last Tuesday. Sit down and review all of these expenses at the end of the month and try to figure out what you can cut out.
• Always ask for generic prescription drugs instead of the name brand when you fill your prescription.
• Compare prices online. Is there something that you found that you really want to buy? Check online first to see if you can buy it cheaper (remember to factor in shipping and tax costs).

As Wal-Mart has taken the lead in lowering prices on generic drugs among brick-and-mortar retailers, the major drug chains have been slow to respond. Walgreens came around first, and now CVS has finally responded — with a $9.99 price point on a 90-day supply of about 400 different medications starting later this month.

Despite the fact that CVS is a day late and dollar short on reducing prices on generics, its announcement got some surprisingly high-profile media coverage from the likes of the Dallas Morning News and the Los Angeles Times. Why, you might wonder? Because of an added gimmick that won’t do much for healthcare consumers — but that has obviously been good for PR.

The gimmick? To “bundle its program with medical care from its in-store clinics.”

Sounds great — till you realize what this “bundle” consists of. You pay $10 per year for a CVS Health Savings Pass, and you get the lower generic drug price and a 10 percent discount at CVS MinuteClinics.

Ten whole percent? Consider our healthcare crisis solved.

Of course, the tens of millions of Americans who are struggling to pay their prescription drug bills each month know that the problem has never been low-cost generics, but drugs that aren’t among the 400 on the lists of Wal-Mart, Target, Walgreens, Kroger or CVS. The drugs that bust family budgets aren’t on anybody’s list.

And paying a little less for a visit with a nurse in the back corner of a drugstore will do little to ease that pain.

1. Use generic medications.
2. Find a lower-cost option, such as an over-the-counter alternative.
3. Shop around.
4. Order by mail.
5. Research state discount programs.
6. Beware of freebies and commercial discount programs.

Read the full story here.

1. Start with a heart-to-heart with your doctor … Tell him or her, honestly, how much you can afford to spend on medication … In the end, you may find you just don’t need some of the drugs you’re taking.

2. Ask about generics. These are usually much, much cheaper than brand-name drugs, says Steven Findlay … The cholesterol-lowering drug Lipitor, he says, is a good example. It costs $95 to $100 a month. A generic alternative, such as Simvastatin, is about $30.

3. Check out the $4 generics many stores now offer. Those lists expand periodically, Findlay says. And more stores are offering them…

4. Don’t forget over-the-counter medicines. … Consider them especially for allergies and occasional bouts of insomnia and heartburn.

5. Don’t “ask your doctor” like all those ads tell you to… Advertised drugs are expensive, and we often don’t need them.

6. Be cautious about accepting free samples. Drug companies don’t give samples to doctors for every medication, just those that bring in the greatest profits…

7. Search the Web. You probably won’t find generics for less online, but you can save 10 to 30 percent on some brand-name medications if you buy them from reputable drugstores that sell over the Internet, Findlay says. “You will cut the brick-and-mortar — the overhead — costs,” he says. Shop around, though. Prices vary.

8. Turn to Canada. Generics are cheaper here than there. But when it comes to brand-name drugs, you can save significantly, according to Findlay, especially if you’re on two or three medications. You can find Canadian pharmacies online, too. “Don’t go to the fly-by-nights,” Findlay says. “Go to the biggies. They’re not too hard to find.” And don’t worry. Buying drugs from Canada won’t get you in trouble with the law, Findlay says, as long as you’re buying them for yourself and you have a prescription.

9. Look into Prescription Assistance Programs. Pharmaceutical companies typically offer them to provide free or low-cost drugs to people who lack prescription drug coverage … But you must meet certain income guidelines, and the application process can be time-consuming…

10. Consider pill-splitting. Sometimes a pill that’s double the dose isn’t double the price. So you can split it in half and save money. Be careful, though … always check with your doctor first.

Did you know, for example, that when large corporations buy one another, they often have to pay millions — or even billions — of dollars for something accountants call “intangible assets”? One of these assets — called “goodwill” — can be thought of as the value of the brand. It reflects the profits a company makes over and above what you’d expect from the tangible assets alone, simply because of its reputation.

Big pharmaceutical companies want you to buy into the value of brands when purchasing prescription medications — so you’ll pay more for them. That’s one of the reasons they spend so much on advertising.

The problem for Big Pharma, however, is that once a brand-name drug’s patent runs out, the value of the brand name (logically at least) is nil.

What would the value of Coca-Cola’s brand be if everyone were allowed to make soft drinks using Coke’s formula? How about if KFC had to share Colonel Sanders’ secret recipe? It would diminish quite a bit, wouldn’t it?

In the pharmaceutical business, once a drug’s patent runs out, the FDA (or equivalent regulatory bodies in Canada and elsewhere) basically allows the secret recipe for the drug to be given to other qualified drug makers, who create generic versions of the drug. Because the generic drug makers don’t spend billions of dollars on marketing, research and development, they can charge significantly less for the drug than the original drug manufacturer.

At that point, it just doesn’t make sense to buy the brand name version of the drug. It’s like paying for the designer label on your shirt rather than the shirt itself. And is ANYONE really impressed by the fact that you use brand-name drugs? (I didn’t think so.)

Two informative news reports over the past few days, one from KING5 in Seattle/Tacoma (looking at over-the-counter meds) and another from a pharmacist writing for an Ohio newspaper (focusing on prescription drugs), look into the difference between brand and generic drugs and come to the same conclusion: the only difference is the price.

This is obviously why large pharmaceutical companies are now lobbying state legislatures to make it more difficult to substitute generic drugs for brand drugs when your doctor writes the name of the brand drug on your prescription. From Delmarva Now:

Pharmacists are usually authorized to automatically substitute generics for brand-name drugs — unless specifically instructed not to do so. Major drugmakers are fighting back by lobbying state legislatures to make it more difficult to make substitutions, seeking to require direct communication between doctor and pharmacist before making each switch. Maryland’s General Assembly considered two such bills during the 2008 legislative session and will likely see similar proposals in 2009.

While doctors may have legitimate reasons to prefer a brand-name drug, they also have the option to make that specification on a prescription. There is no need for a phone call to a busy doctor every time a prescription is filled.

This lobbying is an attempt to protect pharmaceutical profits by making it more difficult to purchase generic drugs. Since many insurance plans will not pay for a brand-name drug once the generic is available, this could end up costing patients a lot more –or forcing them to forego a medication altogether.

So don’t be fearful of generic drugs — and fight for your right to buy them if you need to. They’re not inferior to brand-name drugs; they just cost less.

Brazil’s president is to decide whether his country will honor Merck & Co’s AIDS drug patent, after the health ministry rejected the company’s price-cut. “We consider the offer insufficient and we told the manufacturer,” Brazil’s health minister, Jose Temporao, told Reuters on Thursday. “The decision (on whether to break the patent) is now being analyzed by the president.”

The government said last week it was considering importing generic versions of the drug, Efavirenz, for Brazil’s lauded AIDS treatment program if it decides not to honor the patent. It has not mentioned any plans to make the drug locally. Brazil has threatened to break patents before, but has hammered out deals in the end. Under World Trade Organization rules, a country can sidestep patents by issuing a “compulsory license,” which allows production and imports of generic drugs for public health and national emergencies. Brazil declared the drug “in the public interest” and too expensive to buy.

Brazil wanted Merck to cut the price of Efavirenz to $0.65 per pill — the same price paid by Thailand — from $1.57 per pill paid by Brazil, the ministry said. A source close to the negotiations said the New Jersey-based drugmaker has since come back with an offer of $1.10 a patient per day, but Brazil rebuffed that bid. The source said the talks were at an impasse.

Can you imagine the U.S. government standing up to drug companies in this way? Unfortunately, it would never happen.