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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?

 

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Are you one of millions of people battling some type of hair loss? More than half of males experience some degree of male pattern baldness by age 50, but even women and children can experience unwanted hair loss. There are more options than ever before to treat hair loss — such as herbal treatments, scalp massage, lasers, and surgery — but one of the most popular options is the safe and effective pharmaceuticals on the market.

There are two main medications approved by the FDA for treatment of hair loss — and they’re very different. For starters, Rogaine is a topical solution applied to the scalp, while Propecia is an orally administered pill. One medication is better than the other at treating a receding hairline. Men can use either medication, or even both, but women are restricted to just one. Because of these distinctions, it is important to choose the right hair-loss medication for you.

Let’s take a closer look at each one.

Rogaine (minoxidil) was first on the scene. Its ability to fight hair loss was discovered accidentally. The drug, a vasodilator, was originally used exclusively to treat high blood pressure, when some patients began reporting that it re-grew hair as a side effect. It was approved by the FDA in 1988 to treat male pattern baldness. Rogaine, by Pfizer, is primarily effective at stopping hair loss, but in some patients, it can increase protein blocks, which can promote new hair growth. It is said to be effective both on the hairline and vertex of scalp. Rogaine can be used by both men and women, in a 2% or 5% solution.

Propecia (finasteride), made by Merck, is an orally administered medication approved by the FDA in 1997 to treat hair loss. Unlike Rogaine, which is a vasodilator, Propecia acts on hair loss through hormonal means. (Because of this, Propecia should NOT be used by women or children; it could be very dangerous.) Propecia is an anti-androgen, which decreases the conversion of testosterone to dihydrotestosterone (DHT), a chemical responsible for balding. With DHT inhibited, existing hair is better maintained, and the body can put more energy into thinning follicles so that they become thicker. Propecia has high effectiveness with early to moderate hair loss, and works best on the crown of the head, but not as well with a receding hairline.

Neither Rogaine nor Propecia is a quick fix for hair loss. They both need to be taken for long periods. It can take anywhere from 6 to 24 months to see initial results, and patients may need to take their chosen medication indefinitely keep treating the condition.

Knowing all this, which factors should guide your choice between Rogaine and Propecia?

  • Your gender: if you are male, you can be prescribed either (or both), but if you are a woman, you can only use Rogaine.
  • Your goals: Rogaine is slightly more useful for retaining existing hair, while Propecia is said to be more effective at promoting new hair growth.
  • Your area of hair loss: Propecia has good results mainly on the crown, while Rogaine has documented success on the hairline and the crown.
  • Medical interactions: Consult your physician to determine which drug is a better fit for your personal health conditions and other medications.
  • Side effects: With Propecia, you may experience decreased libido or gynecomastia. Rogaine may trigger allergic effects, chest pain, dizziness, or irregular heartbeat.
  • Ease of use: Some people feel that a daily pill is simpler than a twice-daily application to the scalp, but others prefer to pick their medication based on its mode of action.

Whichever method you select, be patient, and remember to keep feeling good about yourself, your hair, and your overall health. As with any drug, please consult your physician before you begin any medication.

A diagnosis of high cholesterol can be intimidating, but there is a lot you can do to control this condition. In addition to modifying your diet and upping your exercise, the addition of a HMG-CoA Reductase Inhibitor — a class of drugs commonly called “statins” — can safely and effectively lower your cholesterol. (HMG-CoA Reductase helps our liver produce cholesterol; when the chemical is inhibited, the amount of cholesterol is correspondingly reduced.) For people with heart disease, statins can lower the risk of a cardiac event and subsequent death. If you and your doctor have determined that you need a statin, how can you pick the right statin for your needs?

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.

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Buy Your Phizer Pfelon Tee Today!

Buy Your Phizer Pfelon Tee Today!

Pfizer, the world’s largest drug maker, will pay a record $2.3bn (£1.4bn) civil and criminal penalty over unlawful prescription drug promotions, the US Justice Department announced today.

The department said the $2.3bn settlement included a $1.2bn criminal fine, the largest criminal fine in US history. The agreement also included a criminal forfeiture of $105m.

Hat Tip to our friend Jack at PharmaGossip :)

 

It’s no secret that Americans pay far more for prescription drugs than consumers in any other country in the developed world. Most European countries impose price controls on Big Pharma that keep their prescription drug prices to less than two-thirds of what Americans pay.

Obviously, Big Pharma doesn’t want that happening here — which may help to explain why Pfizer has funded a new Rand Corporation study saying that lowering drug prices through price controls would have horrific consequences for Americans.

How horrific? It would actually reduce the length of your life!

As Reuters reports:

Imposing European-style price controls on prescription drugs in the United States would result in modest cost savings that would be more than offset by shortened life spans as the pace of drug innovation slows, U.S. researchers said on Tuesday. They said lowering insurance co-payments would be a better way of attacking the problem of rising prescription drug prices in the United States, which pays more per capita for pharmaceuticals than any other nation.

“We found policies that regulate the prices of drugs could result in modest savings for consumers, in the best cases on the order of $5,000 to $10,000 per person over a lifetime,” said Darius Lakdawalla of the nonprofit Rand Corporation, who worked on two studies appearing in a special report on drug pricing in the journal Health Affairs.

“But in many other cases, those policies resulted in very substantial losses to consumers in the form of reduced life expectancy and those would be worth tens of thousands of dollars”…

They said introducing price regulations into a largely unregulated market like the United States would result in less investment in developing life-saving drugs, which in the long run would reduce the life expectancy of Americans.

I found it interesting that Pfizer’s funding of this little project was not mentioned until the 11th paragraph of the story.

I also found it interesting that there is no mention of the fact that in most European countries with prescription drug price controls, life spans are longer than in the United States.

Way to keep your eye on the ball, Reuters.

A final point to ponder: Rand says its study is objective. It just happens to put the burden of healthcare price reform on Big Insurance rather than Big Pharma, by saying the solution is to find a way to lower drug co-pays.

Do you think if the study had been funded by Humana or some other big insurance provider, Rand’s report might say something different?

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The National Center on Addiction and Substance Abuse at Columbia University (CASA), last week issued a fascinating survey of teens. Two results stood out to me:

1. Teens (aged 12 to 17) indicated, for the first time, that it is easier to acquire “prescription drugs such as OxyContin, Percocet, Vicodin or Ritalin, without a prescription” than it is to buy beer.

2. While Internet pharmacies have been widely blamed for the increase in prescription drug abuse, few of the teens surveyed say that the drug abusers acquire their drugs from online pharmacies.

That’s right. Here’s what CASA’s press release says:

When teens who know prescription drug abusers were asked where those kids get their drugs:

  • 31 percent said from friends or classmates;
  • 34 percent said from home, parents or the medicine cabinet;
  • 16 percent said other;
  • Nine percent said from a drug dealer

You may recall that just last month, CASA issued a study warning that 85 percent of online pharmacies do not require a prescription. Clearly, the organization is strongly opposed (as we are) to rogue Internet pharmacies.

But I think it’s telling here that — even with all the negative media attention that Internet pharmacies are receiving — these kids didn’t say, “We buy our OxyContin online.” They said they’re sneaking pills from their parents’ medicine cabinets — or their friends’ parents’ medicine cabinets.

This says to me that we need to look beyond the easy scapegoat of Internet pharmacies in getting to the root of the problem of teen prescription drug abuse.

Could it be that the billions of dollars drug companies have spent to advertise, promote and sell their drugs have resulted in a flood of pills on the market?

Could it be that we’re taught by wall-to-wall direct-to-consumer advertising today that there’s “a pill for every ill”?

In this environment, isn’t it reasonable for teens to seek out the much-hyped prescription drugs they keep hearing about?

Let me give you one example. Viagra is a very popular drug among young men, including even teens, who are not impotent but believe that Viagra will improve their sexual performance. Do you think — for even a minute — that Viagra abuse would be as severe if Pfizer had not spent millions of dollars shouting “Viva Viagra” from every rooftop in America?

If you do, you’re kidding yourself. And if you think the problem of teen prescription drug abuse will be solved by focusing on Internet pharmacies rather than the larger issues at work, you’re also kidding yourself.

 

For about a year and half now, Dr. Robert Jarvik, inventor of the artificial heart, has been a paid endorser for the cholesterol-lowering drug Lipitor. Pfizer keeps using Jarvik despite his being branded a “fop” who goes over like a lead balloon by the all-powerful John Mack. He’s also been called “Gollum-y” by Dr. Michael Eades. And NBC has questioned whether his medical credentials are all they’re hyped up to be.

But there’s something else that bugs us about Jarvik’s commercials: the audio track. Is it just me, or does it sound like Jarvik’s lines have been dubbed over later rather than recorded along with the video? It’s creepy.

 

Sermo, the online physician community, announced it will be collaborating with Pfizer to

Discover, with physicians, how best to transform the way medical information is exchanged in the fast-moving social media environment

Create an open and transparent discussion with physicians through the innovative channel offered by online exchange

Engage with the FDA to define guidelines for the use of social media in communications with healthcare professionals

Work with physicians to develop a productive exchange between pharmaceutical professionals and the Sermo community

After I heard of Pfizer’s involvement with Sermo, I was thinking the same thing as everybody else: “Did anyone ask the doctors about this?”

According to John Mack , Sermo did — kind of:

[Sermo founder Daniel] Palestrant said that over 50% of Sermo members consistently said that Sermo should invite pharma companies to be clients. He based this partly at least on a poll of Sermo members conducted between May 19, 2007 and June 2, 2007 that showed 54% favored pharma clients, 18% were against it, and 28% were not sure.

The problem is, there were only 89 responses — a self-selected group of less than 0.3% of all Sermo members! Hardly a scientific poll as many of my Pharma BlogosphereTM colleagues would say. In fact, most of the poll data that I saw in Palestrant’s slides had fewer than 100 responses.

I am going to agree with Mack on this one. With a community of over 35,000 physicians, a more substantial poll than just 89 responses is a must.

 

Pfizer CEO Jeff Kindler has finally thrown out the Exubera baby with the bong water, saying, “We made an important decision regarding Exubera, a product for which we initially had high expectations. Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted.”

A video at PharmaGossip sums it up:

 

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Lord knows there are tons of Star Wars fans out there who would give their collector lightsabers and Darth Vader helmets to have a close encounter with a Wookiee — but it turns out all you need is a fungal infection and a prescription for Pfizer’s Vfend.

From CNBC:

At a scientific conference in Chicago this week, a researcher presented the results of a study showing that 12% of the people who take Vfend start seeing things. Like Chewy. Yep, the scientist told doctors at the Interscience Conference on Antimicrobial Agents and Chemotherapy meeting that one patient claims to have had visions of Wookiees after taking Vfend.

So here’s Les’ hilarious take on all this: “Included in the reported visions was at least one sighting of a Wookiee (presumably Chewbacca). We make the following observations: what is wrong with seeing Wookiees? We are making no changes to our 2007 $700 million sales forecast for Vfend, and continue to believe that sales for the drug can grow at a 10% clip over the next few years. We do not see future FDA action in terms of a black-box Wookiee warning or an FDA Wookiee panel.”

May the Pforce be with Pfizer.

 
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