According to reports, the axe is coming down all over the pharma world on research and development projects that are not yielding immediate results.

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?

According to a report from Reuters, taking ginkgo biloba, St. John’s wort and several other widely used herbal medications may impede the potency of prescription drugs, making them more or less effective.

Experts at the Journal of the American College of Cardiology found that mixing herbs and drugs also may cause serious heart rhythm problems and bleeding.

“We can see the effect of some of these herb-drug interactions — some of which can be life-threatening — on tests for blood clotting, liver enzymes and, with some medications, on electrocardiogram,” Dr. Arshad Jahangir of the Mayo Clinic in Arizona said in a telephone interview.

Many patients fail to disclose their use of herbal remedies so healthcare providers should be more probing, Jahangir said in a telephone interview.

“We need to be actively ask about alternative or complementary medicine patients may be seeking on their own to assess these potential interactions or side affects,” said Jahangir, a cardiologist.

“They don’t even consider that herbs could have a negative effect,” he said. “Their impression is that ‘natural’ is safe,”

So whether you use an ACE inhibitor like Vasotec or Monopril, alpha agonists like Zanaflex, or angiotensin II receptor blockers like Avapro or Atacand, it is a good idea to check with you doctor and make sure there won’t be an interaction with any of the additional supplements you may be taking.

Remember, whenever dealing with potential interactions between medicines and supplements, it is always better to error on the side of caution.

Better safe than sorry.

Today the Food and Drug Administration approved Ampyra, a new drug owned by Biogen Idec. to fight multiple sclerosis.

The new drug is an extended-release tablet aimed at helping to increase mobility in those battling against multiple sclerosis. The FDA said those who took the drug had better movement and faster walking speeds than those who had taken a placebo.

“For people with MS, impaired walking ability is one of the most common and concerning aspects of the disease,” said Alfred Sandrock, senior vice president of neurology research and development at Biogen Idec, in a statement. “Ampyra may be an important therapy in reducing the impact of this debilitating condition.”

The drug is set to be marketed by Acorda Therapeutics Inc. who also is responsible for marketing Zanaflex.

Despite its usefulness to help mobility is those suffering from MS, the FDA did warn that Ampyra, when given at doses greater than recommended, can cause seizures. However, the FDA did not feel that a “black box” warning on the label of the drug was necessary, which is the most serious type of warning for potential side effects.

If you have a medication you take regularly, you’re familiar with the problem of waste created by prescription pill bottles. Some people go through several bottles a month —  and many municipalities do not recycle this type of plastic. Fortunately, some ultra-creative people have thought up some clever, thrifty ways to re-use these bottles, and keep them out of our landfills, too.

The bottles have a few special characteristics that make them super-useful. For one thing, they are sized uniformly, so they’re perfect for organizational projects, where you want things to line up evenly. Even better, they’re waterproof and air-tight — qualities that you should take advantage of. You might pay a lot for little bottles like these at a place like The Container Store, so just enjoy them for free with your prescriptions instead!

Before you get started, there are two important tips to remember when re-using prescription bottles:

1. Wash and dry before re-use, so they are free of any drug residue
2. Protect your privacy: soak the bottles to remove the labels

Once you have the bottles clean and label-free, you can begin to see their real beauty and use! Here are some of the top projects, from the kitchen to the garden to the tackle box, that we found around the net:

ORGANIZATIONAL

• The bottles are perfect for holding screws, nails, tacks, and other workshop items. Glue or drill the caps to the underside of a shelf, and let your new storage units “float” underneath
• Long, skinny tubes of makeup such as mascara or lip gloss can be organized to stand up in pill bottles
• The bottles are just the right size to hold a stack of quarters for parking meters or laundromats
• Store fishing lures in the bottles to keep them from tangling with other equipment

GIFTS AND CRAFTS

• Put a few pre-threaded needles, a tiny seam ripper, and some safety pins in a bottle to form an on-the-go sewing kit
• Clean medicine bottles are a great holder for homemade spice mixes such as steak rub or herbes de provence
• Make your own humorous labels for a “funny” medicine and fill with small candies (keep this type of gift away from children to avoid confusing them)

OUTDOORS

• Because they’re water-proof, the bottles make great waterproof matchboxes for camping. Fill them with strike-anywhere matches and glue a striking surface on inside of the lid.
• In the garden, the air-tight bottles work perfectly as seed savers.
• At Halloween, cover white outdoor holiday lights with one bottle each for an amber effect

TRAVEL AIDS

• Use the tiny bottles for a self-serving of salad dressing in your packed lunch
• The bottles are great as travel shampoo and conditioner bottles

CHARITABLE USES

• Some veterinarians will welcome your empty bottles for re-use with pet meds (varies by doctor; inquire with your vet)
• There are some community projects to collect bottles for issuing prescriptions to the homeless
• Similar programs exist for third-world nations… your empties could help with medical aid

What is your favorite use for discarded medicine bottles? We’d love to hear what you’re making!

For more ideas:

• Ways to Use Empty Prescription Medicine Bottles
• What to Do with Old Medicine Bottles
• Uses for Prescription Bottles
• 21 Ways to Recycle Empty Prescription Bottles

Healthcare reform isn’t just about the public option and paying for doctor’s visits — it’s also about equal, affordable access to life-saving medications for all Americans. That’s why many Big Pharma watchdogs are so disappointed with a recent amendment slipped into healthcare legislation that proposes extending patent protection on biologic drugs, delaying for years the public’s access to affordable follow-on versions.

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.

As the 2009/2010 influenza season progresses, there is cause for worry. Flu activity is already widespread in 46 states, according to the Center for Disease Control (CDC), and the 2009 novel H1N1 flu virus, popularly known as the “swine flu,” is on the rise. Meanwhile, the swine flu vaccine is difficult to obtain, leaving many unprotected from this new strain. Fortunately, the antiviral treatments Tamiflu and Relenza are still largely effective against the swine flu.

Why is there so much worry about pandemic flu this year? Regular flu kills 36,000 people in the US each year, but the swine flu variation has the potential to kill many more. The latest update from the CDC shows that swine flu has caused at least 95 children’s deaths since April. Why is this strain so dangerous?

• It is a new combination (made of human, swine, and avian elements) and virtually no one has natural immunity to it
• The vaccine is not yet widely available
• This strain attacks the young and healthy population in disproportionate numbers

There is some hopeful news from the CDC in terms of protecting yourself:

Almost all of the influenza viruses identified so far are 2009 H1N1 influenza A viruses. These viruses remain similar to the virus chosen for the 2009 H1N1 vaccine, and remain susceptible to the antiviral drugs oseltamivir and zanamivir with rare exception.

Influenza antiviral drugs are prescription drugs (pills, liquid, or inhaler) that decrease the ability of flu viruses to reproduce. It is advised that you begin them within two days of getting influenza. Many people ask about taking anti-viral drugs before they show symptoms, but according to the CDC, pre-exposure antiviral chemoprophylaxis should only be used in limited circumstances, and in consultation with your doctor.

The drug oseltamivir (trade name Tamiflu, from Roche) is one of two drugs that is approved for treatment of swine flu. It is taken orally, in a pill form or a suspension. Common side effects include: nausea, vomiting, diarrhea, abdominal pain, and headache. Less frequently, delirium, hallucinations, rash, hepatitis, and allergic reactions including anaphylaxis can occur. There is some concern that oseltamivir can cause the desire to self-harm, and this seems more pronounced in children. People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior. However, oseltamivir is approved by the FDA for use in children 1 year of age or older. In addition, in July 2009, the FDA issued an Emergency Use Authorization for the use of Tamiflu in pediatric patients younger than 1 year of age.

The drug zanamivir (trade name Relenza, from GlaxoSmithKline) is the other medication approved to treat swine flu. It is an inhaled powder that comes with a disk inhaler. It can cause side effects, especially in those with asthma or other chronic lung disease. Decreased respiratory function and bronchospasm have been reported with use of zanamivir. Zanamivir is generally not recommended for use in persons with underlying lung disease such as asthma and chronic obstructive pulmonary disease. Other side effects reported by less than 5% of those who have used this drug are diarrhea, nausea, sinusitis, nasal infections, bronchitis, cough, headache, and dizziness. Relenza is approved for treatment in children 7 years and older, but only those without underlying respiratory or heart disease, including asthma.

One final caution as you navigate flu season is to beware of some unscrupulous online vendors selling fake flu drugs to capitalize on the public’s fear. The Food and Drug Administration recently issued a warning to consumers to be careful not to purchase counterfeit medications. You may rest assured that eDrugSearch.com deals only with reputable, licensed pharmaceutical suppliers in the U.S. and Canada. Our advanced search features enable members to identify pharmacies with specific licensing requirements, third-party accreditations, Better Business Bureau memberships, and more. We offer a feedback system so consumers can share their ratings of the pharmacies they deal with. Browse the ratings, and enjoy peace of mind as you choose among our consumer-tested pharmacy partners for your flu season needs.

A new blood-pressure treatment has come on the market that is of potential interest to hypertension patients whose blood pressure is not being adequately controlled with monotherapy.

Last month, the US Food and Drug Administration (FDA) approved Novartis’ Valturna (aliskiren and valsartan), which combines in a single pill valsartan, the active ingredient in Diovan — the top-selling branded high blood pressure medicine — and aliskiren, the active ingredient in Tekturna — the only approved direct renin inhibitor (DRI).

Valturna is the first and only medicine to target two key points within the renin system, an important regulator of blood pressure. It is suitable for patients whose high blood pressure has not been adequately controlled on aliskiren alone, or by an angiotensin receptor blocker, such as Diovan, alone. It could also be considered as an initial treatment for patients who are likely to need multiple drugs to achieve their blood pressure goals.

Valturna targets the renin angiotensin aldosterone system (RAAS) in two ways. The valsartan component blocks, at the receptor level, the action of angiotensin II, which causes blood vessels to tighten and narrow. The aliskiren component directly inhibits renin, an enzyme produced by the kidneys that starts a process that leads to formation of angiotensin II. This helps blood vessels relax and open.

Because Valturna combines two different types of blood pressure drug, it offers greater blood pressure reduction than either drug would alone. It also seems conceivable having both medications available in one pill would help consumers with drug costs and insurance coverage.

Cautions: Women of child-bearing age should be particularly careful with this medicine. AVOID USE IN PREGNANCY. Do not take if you are breastfeeding or if you are planning to become pregnant. If pregnancy is detected, discontinue Valturna as soon as possible. This is because drugs that act on the renin system can cause injury and death to the unborn baby. Other serious reactions to be aware of when taking Valturna are a risk of head and neck angioedema (a rapid swelling of the flesh), and hypotension (low blood pressure). If either of these are suspected, call your physican immediately. Side effects of Valturna are the same as those of its two component medications, valsartan and aliskiren. Patients may experience tiredness, sore throat, runny nose, diarrhea, upper respiratory tract infection, urinary tract infection, flu, or dizziness. Consult your doctor before taking this or any other medication.

A new paper in the scholarly journal Trends in Ecology and Evolution suggests that oral contraceptives may influence women’s choice of mates, with potentially enormous effects on their quality of life and their ultimate reproductive success.

Commonly used hormonal birth control methods such as Yasmin, Seasonale, Ortho Tri Cyclen, and Loestrin, while extremely effective at preventing unwanted pregnancy, may well have previously unsuspected effects on a woman’s choices of both long-term and short-term partners. This is of interest to the more than 100 million women around the globe who use oral contraceptives, and their sexual partners, too.

The paper, published October 9th, was authored by biologists Dr. Alexandra Alvergne and Dr. Virpi Lummaa at the University of Sheffield in England. It analyzed a large body of research that had gone before. Writes Dr. Alvergne, lead author of the study, “The use of the pill by women, by changing her mate preferences, might induce women to mate with otherwise less-preferred partners, which might have important consequences for mate choice and reproductive outcomes.”

Researchers have long known that women make different sexual choices during their most fertile phase than they do during the rest of the month. This is called “cycling mate preferences,” and quite simply, it means that most women choose more masculine and symmetrical faces when they are ovulating or close to ovulation. They are also uncharacteristically attracted to dominant males, and most likely to engage in infidelity at this time in their cycle. During the rest of their cycle — periods when the women are more likely to be infertile — they are more attracted to less masculine faces, and men who are better choices as long-term partners.

Oral contraceptives work by mimicking pregnancy and stifling ovulation, which flattens out the hormonal cycles usually experienced by a fertile woman. Why is this a concern? Says the paper:

New evidence suggests that the pill, by eliminating oestrus, changes the natural cycling preferences in women for markers of both genetic quality and compatibility in mates as well as natural cycling attractiveness to men. As compared with normally cycling women, pill users show no or weaker preferences for facial and vocal masculinity. For instance, the preferred face shape is more masculine during the high conception-probability phase of the menstrual cycle in non-pill users, but pill users do not show similar preference.

The possibility is that a woman could make a choice influenced by birth control that is perhaps not in her best reproductive interests. Even worse, with our cultural customs of lifelong mating and marriage, a woman could change her contraceptive practices and find that she is not attracted to her mate in the same fashion as she was when she was under the influence of prescribed hormones. Either of these outcomes could be devastating to a paired couple.

Oral contraceptives are still regarded as one of most effective forms of birth control available to women (they trail the intra-uterine device by a fraction of a percentage point, but the IUD is appropriate for fewer patients, and is rarely prescribed for women who have not already gone through childbirth). Birth control pills are affordable, simple to obtain, and work extremely well. However, this paper has given us all something to think about: the possibility that altering the hormonal cycles of the human female en masse could have significant reproductive effects for individual women, and the entire species, too.

More research is forthcoming in this arena, and the results are sure to be fascinating.

Millions of people suffer from severe, debilitating acne that does not respond to over-the-counter treatments such as acne washes and benzoyl peroxide, and even resists prescription antibiotics. Ongoing severe acne can cause physical effects such as pain, infection, and scarring, and social and emotional effects such as shame and low self-esteem. According to the Acne Resource Center:

Of the 85% of teenagers (between the ages of 12 and 24) that suffer from acne, 25% will have permanent scars ranging from severe to light. The American Dermatologist Association finds that:

• 20% of all adults have active acne
• 60 million Americans have active acne
• 20 million Americans have acne badly enough to cause scars.

Acne affects people regardless of age, gender or race. While thoroughly treatable, of those who suffer from acne:

• 11% will see a physician
• 20% will go to a skin care center
• 30% will use an over-the-counter medication from a drug store or pharmacy
• 40+% will do nothing

The concept of 40% of sufferers doing nothing is tragic. Since 1982, we have had access to a prescription drug that treats serious cases of cystic or nodular acne. That was the year isotretinoin, under the trade name Accutane, was approved by the FDA for the treatment of severe acne. Its exact mechanism is not known, but it is thought to limit the production of sebum. Most patients see significant improvement, or remission, after a 15-to-20-week course of treatment with isotretinoin.

The drug was controversial from the start, as it is known to cause teratogenic birth defects. All physicians and patients involved with this treatment must abide by a strict pregnancy risk-management program. Isotretinoin has some other serious side effects, too. Mild side effects involve skin dryness and eye dryness, rashes, headaches, hair thinning, and backaches. More serious side effects include inflammatory bowel disease, alopecia, catacracts, blood glucose problems, and more. Because of these side effects, it is only recommended to treat the most severe cases of disfiguring acne, and patients must pay close attention to side effects.

Availability of the drug has changed this year, resulting in some confusion in consumers. Earlier this year, in July 2009, Swiss drugmaker Roche announced that it was discontinuing its sales of Accutane and moving to delist with the FDA. This was not done for safety and efficacy reasons (although Roche has had to defend itself in many lawsuits), but rather because generics of Accutane (isotretinoin) have been available since 2002 and now dominate the market. Accutane itself had only held on to a 4-5% share of market, and it did not make business sense Roche to keep selling it.

Accutane is still available in many countries outside of the United States. Within the United States, its generic form, isotretinoin, is available, and this drug is also marketed as under several different names within the United States: Claravis, Amnesteem, Sotret are a few of the best-known.

Accutane being retired in the U.S. has caused a great deal of confusion among consumers. Posts on many popular acne-related message boards reveal people trying to compare side effects and benefits of several different brand names that are all essentially isotretinoin. To clarify: there is no difference between Accutane, Sotret, Claravis, or generic isotretinoin except for their makers and packaging.

If your doctor has prescribed a cream instead of a pill, topical isotretinoin is marketed under the trade name Isotrex.

If you are one of the millions suffering from acne, know that you do have options, and your condition can improve.