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?

Earlier this month, a closely-watched trial over the osteoporosis drug Fosamax ended in mistrial, to the frustration of nearly everyone involved. The trial was marked by great tension, with a deadlocked jury, reports of threats of physical violence, and a judge-ordered cooling-down period.

What could cause such intense drama? Well, this was just one of approximately 900 state and federal cases pending against Fosamax, alleging that that medication causes osteonecrosis of the jaw (the death of jawbone tissue). In large part, the tension in the Manhattan courtroom was that this trial — the first — was supposed to be an indicator of how these hundreds of similar cases might proceed. The other major factor is that it is notoriously difficult to “prove” drug-related injuries, and this difficulty was definitely shown in the frustration and tension among jury members.

Millions of women have taken Fosamax (alendronate), a Merck drug that was approved in 1995 to treat osteoporosis associated with menopause, and in 1997 to prevent osteoporosis itself. Until the recent introduction of some competing medications, it was one of the most popular drugs in the U.S. It is still prescribed millions of times per year to women suffering from bone loss.

In short, Merck’s defense on this topic is that there is no definitive evidence that Fosamax causes the death of jaw tissue, while plaintiffs and their lawyers insist that Merck overpromoted Fosamax without warning doctors about the potential for jaw injury. Obviously, no conclusions were reached.

Of course, this is of great interest to women who may have taken, or are considering taking, Fosamax. Only your doctor can decide what is the right choice for you, but we thought we would enumerate the other medications available for treating osteoporosis for those doing research on Fosamax alternatives. One very important thing to be aware of it is that Fosamax is not the only osteoporosis drug in this class (the bisphosphonates), which all have a similar mode of action. Fosamax is being talked about most in the media, but all are associated with some amount of risk of damaging the jaw.

If you do choose to take a bisphophonate, know these facts:

• A high proportion of jaw injuries occur following high-dose intravenous administration, so that is a particularly risky way to take the medication.
• As many as 60% of the cases are preceded by a dental surgical procedure involving the jaw. In short, women who are expecting major dental work should consider delaying treatment with Fosamax, Boniva, Actonel or similar drugs until after their dental surgery.

Here are the main alternatives on the market for Fosamax:

1. Actonel (risedronate) is a bisphosphonate manufactured and marketed by Procter & Gamble and Sanofi-Aventis. It belongs to the same family of drugs as Fosamax, and may be associated with the same jaw side effects.
2. Boniva (ibandronate) is also a bisphosphonate, manufactured and marketed by GlaxoSmithKline and Roche Laboratories. It is a competitor to Fosamax, and may also affect the jaw tissue.
3. Evista (raloxifene) is NOT a bisphosphonate , but rather an oral selective estrogen receptor modulator from Eli Lilly and Company that affects bones through estrogen. Evista may be an interesting alternative for women concerned about their jaw health or planning oral surgery.

Also this month, The Wall Street Journal published an article called “From the Osteoporosis Front, Updates on Potential New Drugs.” These are the up-and-comers in clinical trials and going before the FDA. The story covers the latest news about Wyeth’s Viviant, Pfizer’s Fablyn, Amgen’s denosumab, and other upcoming treatments for osteoporosis.

If you are interested in following the Fosamax case that ended in a mistrial, it is expected to be re-tried in the spring. The name of the case is “In re Fosamax Products Liability Litigation, U.S. District Court, Southern District of New York (Manhattan), No. 06-1789.”

Sanofi-Aventis SA shares had their biggest drop in three years, wiping out more than $7 billion in market value, after a U.S. panel blocked the company’s new weight-loss pill because it was linked to suicides.

Says Derek Lowe:

Everyone will have heard the news about Wednesday’s FDA Advisory Commitee vote on Accomplia / Zimulti (rimonabant). If you’d tried to convince folks a few years ago that this drug wouldn’t make it to a vote until summer of 2007, and would be unanimously rejected when it did, you’d have been looked at with pity and concern. No, this drug was going to conquer the world, and now people are talking merger-of-desperation.

By the way:

FDA approval of Zimulti was expected to boost Sanofi-aventis’ stock by five percent. The drug was expected to generate as much as $2 billion in revenues by 2010.

I have a sneaking suspicion that before the recent FDA scandals, this drug may well have been approved.

The Food and Drug Administration said … that regulators had approved generic versions of Ambien, a blockbuster sleeping pill from Sanofi-Aventis. The drug, also known as zolpidem tartrate, has been linked to potential risks like driving while asleep and allergic reactions. Like Ambien and other popular sleep drugs, the new generics will also have to carry warnings on their product labels, the agency said.

Manufacturers cleared to make generic versions include Mylan Laboratories, Teva Pharmaceutical Industries, Roxane Laboratories, Watson Laboratories, Ranbaxy Laboratories, Dr. Reddy’s Laboratories, Apotex and Synthon Pharmaceuticals. Genpharm, Mutual Pharmaceutical, Caraco Pharmaceutical Laboratories, Carlsbad Technology and Lek Pharmaceutical also won agency approval. The generic makers will sell the drug, approved to treat short-term bouts of insomnia, in 5-milligram and 10-milligram doses.

A spokeswoman for Sanofi, Emmy Tsui, said the drug maker would continue to sell Ambien as well as its extended release version, Ambien CR, which is also approved to help people stay asleep.

Forbes.com states:

The drug and the related approval process have been dogged by criticism … Last June, Sanofi-Aventis agreed to update Ketek’s labeling to reflect the possibility of severe liver damage. And last month, a European Medicines Agency panel recommended that Ketek not be given to patients with a history of such liver conditions as hepatitis or jaundice.

Sanofi-Aventis is currently under investigation by both the U.S. House and Senate for irregularities during the approval process.