Medical Detox Programs in a stress-free environment

November 28, 2008

Replacing The Blahs With Pain: Is ‘The Onion’ Onto Something Good?

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 9:09 am

Maybe Wyeth should take a serious look at The Onion’s new tongue-in-cheek ‘Advil Release’. Who knows — maybe it could be the next blockbuster.

“New Pain-Inducing Advil Created For People Who Just Want To Feel Something — Anything”, reads the headline in the latest issue of The Onion, the popular faux-news satirical web site.

 

The goofy article announces a new line of Advil, called ‘Advil Release’, that promises to replace a dull, listless and numbing life with a refreshing burst of agonizing pain.

 

advil-release-rarticle.jpg

 

Ad for the new temporarily-life-affirming Advil.

 

Sparing nothing in its path, The Onion boldly ‘quotes’ Wyeth chairman, president and CEO Bernard Poussot as saying, “Advil Release delivers a soothing burst of pain when cold and listless Americans need it most. Just two capsules can deliver all-day relief in the form of searing, life-affirming agony; the kind of agony Advil users trust when being a pale specter of humanity adrift in a meaningless and uncaring universe is just not an option anymore.”

 

According to faux-Poussot, the new drug (presumably OTC) works “by delivering a powerful stimulant straight to the brain’s pain center, causing an intense stinging sensation all over the body. If taken regularly, the deadening futility of day-to-day life will be temporarily washed away in a flood of blessed and cleansing torment.”

 

The CEO recommends “two fast-acting, long-lasting Advil Release taken three times a day . . . for anyone who is convinced he or she will never laugh or cry again. Teenagers who see no difference between being dead or alive, nor why it makes a difference either way, may require twice the suggested dosage.”

 

As funny as this is, it is clever, I think diabolically clever, in how it captures so clearly what may be one of the defining essences of the breakdown of life in modern America — its soaring dependence on prescription drugs to just get through the day.

 

With antidepressant prescriptions somewhere in the hundreds of millions, and claims by various medical and pharma spokespeople that 16 percent or more of Americans will suffer major depression at some time in their lives — and with all the controversy surrounding antidepressants — maybe a new approach is a great idea.

 

And in fact this silly approach to depression or just the blahs is really an old one, perhaps the oldest of all — a good slap in the face and a sharp, “Oh for goodness sakes, snap out of it.”

 

At the risk of sounding callous or unfeeling, or non-pharmaceutically correct, I want to ask readers to think of the times, and there must be at least a few, when you have been faced with someone blubbering or mumbling in the depths of despair over something so trivial, so unreasonably and impossibly self-centered, so obviously an excuse just to get your attention, that you just wanted to SLAP them!

 

With new “Advil Release” you would now have the new, pharmaceutical equivalent of a face-slap that actually treats two uncomfortable conditions:

 

• It promises to snap the annoying whiner out of their specious despair into the real and enjoyable pain of everyday life, bringing blessed relief to both of you.

 

• It spares the would-be slapper from the embarrassment that must accompany the later groveling ‘slap-pology’.

 

C’mon Poussot. Think about it. Talk to your marketing people. And forget about the potential law-suits from super-sensitive sissies that don’t read the label. I think it’s a blockbuster just waiting to happen.

November 26, 2008

What’s Wrong With This Picture?

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 11:42 am

Hawthorne’s ad for a recently approved hydrocodone-acetaminophen liquid pain killer, a schedule III drug for kids as young as 2 years old, is raising more than a few eyebrows.

According to Ed Silverman’s Pharmalot blog, two months ago Hawthorn Pharmaceuticals launched Zamicet, an oral solution approved by the FDA to treat moderate to moderately severe pain for children two years and older.

Zamicet contains hydrocodone bitartrate and acetaminophen, and is therefore a Schedule III controlled substance, which means it is highly addictive.

  zamicetthumbnail.jpg

An ad accompanying the new drug on the Hawthorn web site and possibly in other media, says Silverman, appears to depict a child jumping for joy after winning a karate match, rather than a child suffering some serious pain deserving of a Schedule III drug.

Silverman asks: “So what might the message be? Perhaps Zamicet should be kept in a handy spot in the medicine cabinet in the event of any injury? This is subtle, no doubt. But we wonder about the targeted market.”

Judging from the more than two dozen comments on the blog — and Pharmalot readers are by-and-large a pharma-aware group of professionals — the ad is not illegal, but oversteps the bounds of ethical advertising.

To me the picture of an obviously young child — probably not more than 5 — celebrating rather than suffering, might suggest to doctors and the public that Zamicet is just the ticket for kids to play sports or go to Disneyland on while semi-stoned on hydrocodone.

I don’t know about you, but I took a hydrocodone pill after surgery a couple of years ago, and I was spaced out for most of the afternoon. Maybe I’m not typical, but one was all it took to make me decide to suffer physically rather than mentally. I simply can’t imagine how a 5-year-old sailing on hydrocodone can do much of anything, never mind whup some other kid’s butt in karate.

Hawthorn may not be illegally misleading doctors, who are supposed to know a thing or two about drugs. As for consumers, this ad is unethical in its depiction of the results of a hydrocodone buzz in a 5-year-old. And who knows, maybe there are some doctors out there who are as gullible and suggestible as the public.

My hope is that we won’t be reading soon or ever about kids (or adults) dying from downing a whole bottle of this stuff. This is definitely not something to leave unattended in a medicine cabinet or on the kitchen counter.

November 25, 2008

NPR Radio Host Received $Millions From Big Pharma

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 8:42 am

Dr. Fred Goodwin’s white-wash of antidepressants’ role in suicides leads a Congressional committee to dig up the radio host’s past as a well-paid Big Pharma promoter. And miffed that conflict of interest was not revealed, an NPR chief removes the show from its archives.

Back in May of this year, the National Public Radio (NPR) talk show ‘The Infinite Mind’, hosted by psychiatrist and Big Pharma apologist Dr. Fred Goodwin, aired a segment titled ‘Prozac Nation: Revisited’, on which he and three ‘expert’ guests took pains to point out how our worries about the well-researched connections between antidepressants and suicide have all been puffed up by ill-informed media.

What wasn’t revealed, reported Slate in May, was the fact that all four participants in the show have financial ties to Big Pharma, and the show itself has received grants from Big Pharma, including Lilly, maker of Prozac and Cymbalta.

The segment aired just two months after UK regulators concluded a four-year investigation of Glaxo’s Paxil and found the drugmaker had been aware since 1998 that its pill was associated with a higher risk of suicidal behavior in adolescents.

News breaking now, reports Ed Silverman at Pharmalot, are revelations from Sen. Chuck Grassley’s Senate Finance Committee, which has dug up some juicy facts on Goodwin’s profitable ties to Big Pharma. Since 2000, for example, Glaxo has paid Goodwin more than $1.2 million in speaking fees and over $100,000 in expenses.

Goodwin, a former director of the National Institute of Mental Health (more Big Pharma influence there) has received tens or hundreds of thousands in payments over the years from Solvay, Janssen, Pfizer, Lilly, AstraZeneca, Bristol-Myers Squibb, Elan and Novartis for plugging drugs to doctor groups. Pharmalot contains many more details we don’t have room for here.

The experts on the show last May with Goodwin, with the info that was not revealed:

• Nada Stotland, president of the American Psychiatric Association, served on the speakers’ bureaus of Glaxo and Pfizer; and APA receives millions in funding from Big Pharma.

• Peter Pitts, director of the Center for Medicine in the Public Interest which is majorly funded by Big Pharma, and senior vp for global health affairs at Manning Selvage & Lee, PR reps for Lilly, Pfizer, Glaxo and others. He was introduced only as “a former FDA official”. Pitt co-authored a Washington Times article last February titled ‘Tabloid Medicine’ that savages the media, Sen. Grassley and his committee, and anyone else who questions antidepressants’ links to violence and suicide.

• Andrew Leuchter, a psychiatry professor at UCLA, who has received research money from drugmakers, including Lilly, Pfizer, and Novartis.

The New York Times reports this week that Bill Lichtenstein, the program’s producer, was not told about Goodwin’s financial ties to Pharma, and says that Goodwin denied receiving any funding. NPR’s vp Margaret Low Smith says the show will be removed from the satellite service, and claims it would not have aired at all if NPR had known about Goodwin’s Big Pharma apron strings.

November 24, 2008

Comedian Stephen Colbert Takes A Hilarious Whack At Big Pharma

AstraZeneca’s ‘Jupiter’ Crestor study for treating inflammation associated with cardiovascular events gets a very funny review from the Comedy Central comedian.

Comedy Central’s Stephen Colbert of ‘The Colbert Report’ reported last week that the Jupiter trial for AstraZeneca’s Crestor “is a great breakthrough in the battle to find things to prescribe to people who don’t need them.”

Saying he crushes statin drugs on his bacon-chili-cheese corn dogs, Colbert added: “True, the drug costs $100 a month, but that is a small price to pay to not have the heart attack that there’s no way of knowing that you would have had.”

And “if you are still hesitant to medicate yourself when you’re healthy, Prescott introduces VaxaCrest which eliminates your concerns about taking Crestor for no reason by dramatically increasing your cholesterol count until your heart is pumping liquid nacho cheese.”

VaxaCrest is just one of several fictitious drugs from ‘Prescott Pharmaceuticals’, all dreamed up by the show’s writers, and complete with sample bottles, realistic labels, and lists of ridiculous-sounding side effects.

For example, Colbert warns that the side effects of VaxaCrest “may include fallopian tape worms, runaway gums, and Mind of Mencia.” (Mind of Mencia is a Comedy Central show starring Latino comedian Carlos Mencia.)

During the segment on Crestor, Colbert plays a brief clip of Stanford cardiologist Mark Hlatky urging a cautious approach to the Jupiter study. Hlatky does have serious concerns about the study, but Colbert quips: “It sounds like someone hasn’t gotten enough free Crestor pens!”

On the same show, Colbert also pokes fun at women’s hormone drugs, including birth control, fertility and post-menopausal hormones, again offering another solution from ‘Prescott Pharmaceuticals’ called GynoMorph.

“Don’t forget that GynoMorph can solve a woman’s hormonal problems with — more hormones! You can take hormones when you can’t have babies. Then, when you want to have babies, you can take different hormones. Then, when your body can’t have babies anymore, you can take other hormones to make your body feel like it did when you could have babies, but didn’t — because you were taking hormones! GynoMorph is a hormone that will gradually turn you into a dude!”
 
Scientific American was so impressed by Colbert’s piece, it recommends (tongue in cheek) that he be added to the list of candidates for FDA Commissioner by the new Obama administration.

November 21, 2008

Crestor’s ‘Jupiter’ Trial Impresses Journalists

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceuticals — Rod Malcolm @ 9:57 am

Cardiologists are divided, the statistics are impressive or not depending on your viewpoint, long-term statin effects are unknown or iffy, AstraZeneca paid for the study, and researcher Ridker — and Harvard — hold a “use patent” on the crucial CRP test.

The recent Jupiter trials, that found some people with normal cholesterol levels benefit from taking the statin drug Crestor (rosuvastatin), is either a medical breakthrough, or another marketing breakthrough for AstraZeneca that impressed more news reporters than cardiologists.

It all depends on your biases and viewpoints.

For example, the Wall Street Journal article is headlined: “Jupiter Results Exert Strong Pull on Cardiologists”.

Always a doubter, I liked better a headline suggested by a commenter on the article, “Jupiter Results Exert Strong Pull on Journalists”.

If you are medically inclined, here are the actual Jupiter trial results reported in the New England Journal of Medicine.

The Jupiter trial tested 17,802 otherwise healthy men and women, average age 66, with normal cholesterol levels — half (8,901) on 20 milligrams of Crestor daily, the other on placebo. It was conducted at 1,315 sites in 26 countries.

All had elevated blood levels of a biomarker for inflammation, determined by a high-sensitivity C-Reactive Protein (CRP) test. This test reveals a general, non-specific, inflammatory process somewhere in the body, which can sometimes underlie cardiovascular disease, but which can also mean other problems, even gum disease. For test purposes, only patients with low-level inflammation were accepted.

The Crestor group had a 50 percent reduced incidence of heart attack, stroke, bypass surgery, heart pain and cardiovascular death than those on placebos. It also reduced the number of deaths by any cause by 20 percent.

I’m no cardiologist or scientist, but I’m having problems with this study:

1. The trials were concluded early after just 1.9 of its proposed 4 years of follow-up when the “data and safety monitoring board noted a significant reduction in the primary end points of various cardiovascular events.” But among the statistics gathered, physician-reported diabetes was more frequent in the Crestor group — 270 reports of diabetes vs. 216 in the placebo group. Since it’s known that statins increase the risk of diabetes, one wonders — well, I wonder — if the trials were also ended early to minimize any more of this result.

2. Let’s not forget that AstraZeneca paid for this huge trial, and that the head of the study, cardiologist Paul Ridker of Brigham and Women’s Hospital in Boston, along with Harvard University, holds a cardiovascular “use patent” for CRP testing. And also, almost all of the clinical researchers listed as trial researchers receive significant funding from Big Pharma, including AstraZeneca.

3. In spite of the reduced cardiovascular events, the cardiology community is still divided, some saying the study is convincing and that everyone should get a CRP test and get on statins if it’s up, while others remain concerned that these results will be used to justify risky and expensive long-term medical care that includes the cost of statins, doctor visits and lab tests, all for people who otherwise are healthy.

4. There was no attempt to discover the root cause of the inflammation in any subject. This is so typically modern medicine — prescribe an expensive, risky drug rather than find and treat a cause. No wonder millions of Americans are stampeding to natural foods and natural medicine; and Big Pharma’s puppets, the FDA, continues trying to find some way to make food supplements like vitamins and minerals illegal.

5. Even if the cause of generalized inflammation remains unknown, countless doctors and patients have attested for decades that inflammation is significantly reduced by eliminating inflammatory food from the diet (the entire litany of modern fast and fried food), adding anti-inflammatory foods (fruits, vegetables, fresh fish), quitting smoking, and exercising regularly.

6. Out of the 18,000 people in the trial, 157 in the placebo group suffered myocardial infarction, stroke, or death from cardiovascular causes, compared to 83 in the rosuvastatin group. That’s a reduction, true, but at roughly $104 a month, for what could be decades of treatment with no known side-effect results for such long-term statin use, is it really worth it?

7. If only 1.76 percent of participants who didn’t take Crestor had heart attacks, compared to 0.93 percent of people who took Crestor, it just doesn’t sound all that impressive. We’re talking about point-83 of one percent. Why not say 98.3 percent of people who didn’t take Crestor remained healthy? And that’s not figuring in the 54 more Crestor people who got diabetes.

In a companion editorial on the Jupiter trials in the same issue of NEJM, cardiologist Mark Hlatky, Stanford University School of Medicine, disagreed with the way the CRP testing was implemented, and still believes that a decision for statin therapy “depends on the balance between the benefits of treatment and its long-term safety and cost.”

November 20, 2008

Big Pharma To Spend Millions Attacking Obama’s Health Care Plan

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 11:26 am

Big Pharma and Wall Street need to get a grip on reality. The time has come for the profligacy to come to an end, and for sensible business practices to take over.

The Pharmaceutical Research and Manufacturers of America (PhRMA), Big Pharma’s largest lobbying group, is readying a multimillion-dollar PR campaign to undercut the Obama administration’s expected push for price controls of prescription drugs.

According to a Washington Times report, the campaign will include television spots touting “the importance of free-market health care.”

Obama, who made health care reform a major plank in his platform, “attacked drug companies repeatedly during his election campaign,” the paper reports.

Obama said he will hold drug and insurance companies “accountable for the prices they charge and the harm they cause.” And he has promised to give Medicare the right to negotiate with drugmakers for cheaper prices.

The PR effort, to begin airing late in November, signals what could become yet another war that the new administration will inherit from the pharma-friendly Bush administration, along with Iraq and Afghanistan.

A report from Boston Consulting Group estimates such negotiations could result in a $10 billion to $30 billion annual revenue loss to Big Pharma.

“We’re going to do an ad campaign that is designed to make people aware of the importance of preserving your free-market health care system,” Ken Johnson, senior vp at PhRMA, tells the paper, adding that PhRMA recognizes that some reforms are needed in order to keep that system vibrant, and that PhRMA would run the same ad campaign if John McCain had won the election.

The Times suggests that the PhRMA campaign indicates that the industry is leaving nothing to chance. Yet, it says, drugmakers gave more than $1.6 million to Obama’s campaign — almost triple the amount the industry gave to McCain.

“We’ve been moving the pieces on the chess board around for some time now getting ready for next year, and we’ve got a great game plan in place,” Johnson tells the Times. “We think we’ve earned a right at the table, and we’re optimistic that at the end of the day, the majority of members of Congress will recognize the importance of the pharmaceutical industry to health care.”

Big Pharma views Obama’s promises to bring down drug prices as an attack on the industry.  But a majority of Americans elected the new president because, among other things, they agree that the costs of drugs in this country are out of control — especially compared to costs for the same drugs almost everywhere else in the world.

And Americans also don’t like the fact that while it’s gouging Americans, Big Pharma logs the highest profits in the world of business and pays its top execs obscene amounts of money. The compensation for perhaps three dozen top execs of the top dozen or so corporations totals at least a billion dollars in salaries, bonuses and stock options, and lavish perks — like helicopter commutes, limos everywhere, outrageously expensive gatherings, and exotic personal getaways. And all that while tens of thousands of American pharma employees were tossed out over the past two years to “save money.”

Big Pharma and Wall Street need to get a grip on reality. The time has come for the profligacy to come to an end, and for sensible business practices to take over.

November 13, 2008

No Verdict Yet On Supreme Court Hearing Preemption Case

Filed under: Big Pharma, FDA — Rod Malcolm @ 8:05 am

Maybe the Supreme Court didn’t ‘elect’ George W. Bush after all, but if there’s a shred of decency left in the court, they should see the where that administration has led us.

On November 3, the U.S. Supreme Court began hearing testimony that could lead to a major change in American jurisprudence, and slap our country’s historical dedication to personal justice and a day in court in the face.

The Court will soon rule on what is called ‘preemption’ — the theory that federal law supersedes state law when a federal regulation has been met by a manufacturer, rendering state law null — including personal injury cases for products that cause harm.

The vehicle that carried this dangerous case to the Supreme Court is Wyeth v. Levine, an appeal from Wyeth following the firm’s loss in a Vermont state case that awarded $6.8 million to guitarist Diana Levine, who lost her right arm to amputation after an injection of Wyeth’s anti-nausea drug Phenergan, thus ending her musical career.

The Vermont jury and the state’s Supreme Court found that Wyeth failed to adequately warn the public and doctors about the drug’s dangers if it is improperly injected. Although there were warnings on the label, the case claimed these were inadequate, and the jury so found.

Wyeth appealed to the U.S. Supreme Court, arguing that it is protected from state liability law suits because the FDA already approved the label in question. But no one believes for a minute that Wyeth’s appeal is an independent action, rather it is the culmination of years of Machiavellian machinations involving Big Pharma, the FDA and the White House.

The Bush government has been trying for years to engineer preemption to protect Big Pharma, and Wyeth v. Levine is the test case. The FDA was hijacked decades ago by Big Pharma and its Washington power brokers, going back several administrations to at least the Reagan White House, if not earlier.

Rather than solving the many problems at the FDA, the Bush administration has done nothing but exacerbate them, letting the agency flounder with no leadership for eight years, understaffed, underfunded, and utterly unable to police the safety of pharmaceuticals and devices approved for the marketplace — the overarching reason we must maintain state tort law allowing us to sue when it seems indicated.

The most tragic aspect of this, in my view, is to see our own FDA, charged with safeguarding public health, now behind the effort to bring about preemption — something it cannot possibly support and maintain public safety.

But driven by the new rules and regulations slipped in by the Bush administration and its political cronies in the pharmaceutical industry, the FDA now is the figurehead for a move that benefits no one but Big Pharma and the money train that follows it.

If the unspeakable happens and the Supreme Court finds in favor of Wyeth, more than half a century of accepted law will be overturned that holds manufacturers accountable for damages caused by their products — regardless of federally approved labels or any other federal approvals.

Now that the puppet FDA is attempting to take away their rights to a day in court, Americans need to be wakened up and encouraged to act, to persuade Congress and the Supreme Court that a manufacturer must be held accountable for damages caused by FDA-approved medications or medical devices.

If there’s a shred of decency left in the court, they must not find for preemption.

It’s not too late to Sign The Petition.

For more background  and more links, see my earlier blogs on preemption:

Preemption: What it is and what it means to America

Preemption and the FDA: Placing our trust in a failed system

Lies and misdirection from Big Pharma about preemption

November 10, 2008

Big Pharma’s Blackmail Threat Won’t Affect Democratic Health Care Plans

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 9:01 am

Pharma’s threats to relocate outside the U.S. if Washington policies negatively affect profits sound extreme. Whether it would actually happen, or whether such threats will carry any weight at the new Democratic White House, no one knows — yet.

According to the Wall Street Journal, the president and CEO of the Pharmaceutical Research and Manufacturers of America, Billy Tauzin, likes to remind politicians that the industry employs more than 500,000 people and spends nearly $60 billion a year on research and development.

“There are things Congress could do to drive it out of the country,” Tauzin is reported as saying.

This naked threat to Congress, implying that Big Pharma could pull up stakes in the U.S. and head off to Europe, Asia or the third world is, apparently, Tauzin’s way of telling Congress to keep its regulatory hands off the status quo, primarily Big Pharma’s deeply-rooted tentacles in the FDA and its connections to Washington’s corporate power brokers.

President-elect Barack Obama and the newly enlarged Democratic majority have made it clear they plan to overhaul health insurance and reduce health care costs, which will certainly impact Big Pharma as well as the insurance industry.

Industry analysts mostly agree that the Obama health care plans would in some ways be good for Big Pharma — if more people are insured, more people can afford to buy prescription and over-the-counter drugs. And it would also be good in some ways for the insurance industry, which could soon see millions of new clients signing up.

But any good health plan that addresses health care costs will have to include more government negotiating power over Medicare and Medicaid drug costs, which has some, but not all, pharma and insurance interests concerned about reduced income from negotiated drug prices.

As it stands now, insurance companies make more commission money per insured than it would cost the government to completely take over health care insurance — in other words, nationalize the industry. And Big Pharma’s practice of promoting expensive branded drugs through Medicare and Medicaid has fallen into trouble several times recently, as cheaper generics are proving to be just as effective, often with fewer dangerous side effects.

At this point, no one knows in what ways business will have to change to adapt to a new Democratic health care regime.

But as I see it, Tauzin’s blackmail threat is hollow — lacking any real-world support from Big Pharma CEOs and shareholders.

And it’s a tawdry, sleazy, and arrogant back-handed slap in the face, not just at Congress, but at the hundreds of thousands of American employees, apparently expendable chattel who are not worth consideration.

November 7, 2008

Glaxo Axing 1000 US Sales Reps By Year’s End

Joining the pharma ‘streamlining’ trend, GlaxoSmithKline will cut 1,800 sales jobs, but reassignment to vaccine sales will mean a net loss of about 1000 jobs.

British drugmaker GlaxoSmithKline PLC is following a Big Pharma trend to cut staff and trim operations. GSK will start with the elimination of 1,000 U.S. sales jobs, and consolidation of U.S headquarter operations from two locations to one.

GSK currently has about 8,500 U.S. sales reps. The plan is to cut 1,800 sales reps, but add 800 to its vaccine sales force, leaving a net of about 7,500 reps. The company employs 22,500 people in the U.S., and 100,000 worldwide,

The firm’s dual U.S. headquarters, in Philadelphia, PA, and Research Triangle Park, N.C., will be consolidated at the N.C. facilities. GSK spokeswoman Mary Anne Rhyne said the change will eliminate confusion and is largely symbolic, and includes no plans to reduce Philadelphia staff.

“The goal is to build a business that’s more streamlined, that’s more customer focused, that meets the challenge of the current marketplace and is better prepared to manage the future portfolio of medicines,” Rhyne said.

The company announcement also says there will be an unspecified number of other jobs lost among sales management and sales support staff. Workers losing jobs are being told this week, and will be gone by the end of the year.

So far this year, job cuts –  some of them surprisingly heavy — have been announced by Bristol-Myers Squibb, Wyeth, Pfizer, Merck, Schering-Plough and others.

David Heupel, pharmaceuticals portfolio manager at Thrivent Large Cap Growth Fund, told the Associated Press that GSK’s move continues an industry-wide trend to reduce expenses in sales and marketing, supply purchases, manufacturing and even R&D. He said that ‘right-sizing’ is healthy for the industry.

“You’re going to see plenty more of this as these businesses mature over the next several years,” Heupel said, referring to patent expirations, pricing pressures, and other factors affecting revenue.

GSK’s outlook wasn’t helped recently when the American Diabetes Association and its European counterpart removed Avandia from their recommended treatments last month. And last week, consumer watchdog group Public Citizen urged the Feds to ban Avandia because of its links to heart and liver damage.

Another factor in Big Pharma’s downsizing may be indications that an Obama administration will push for regulated lower drug prices, including negotiating Medicare prices. These and other considerations about Obama’s intentions regarding health care led Big Pharma, traditionally a strong Republican supporter, to contribute unusually heavily to the Democratic campaign — about equal to the McCain coffers.

It appears that as the polls continued to rise in favor of the Democratic candidate, Big Pharma wanted to make sure it had a favorable hand in the Obama pocket when the new president takes office.

November 6, 2008

Bad News For Merck Just Keeps On Coming

Filed under: Big Pharma, Merck, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 9:51 am

The massive job losses at Merck are fairly typical in the industry, but for Merck, the bad news keeps piling up. Now the Dept. of Justice is investigating Merck and Schering-Plough’s marketing of Vytorin, while state attorneys also ganging up.

Merck’s recent announcement of a further 12 percent workforce cut — nearly 7,000 more job losses on top of the 10,400 jobs slashed earlier — follows news that the U.S. Department of Justice has launched an investigation of whether the Merck and partner Schering-Plough’s promotion of Vytorin resulted in false claims to federal health care programs.

At the same time, a group of 35 state attorneys general are ganging up with their own investigation to determine if the partners violated state consumer protection laws in their marketing of Vytorin.

If the feds find false claims, federal health programs can file suit to recover expenditures on the drug. The states’ investigations could follow with similar suits.

According to news reports, Merck has been served with or become aware of about 140 civil class-action lawsuits alleging consumer fraud claims over the two cholesterol drugs, Vytorin and Zetia, marketed by the Merck-Schering joint venture. Some lawsuits allege personal injuries or seek medical monitoring for people who used the drugs.

The two drugs were blockbusters raked in a combined $5.2 billion in 2007, but bad news about the drugs has cut 2008 revenue by about 15 percent since last fall, helping contribute to new rounds of layoffs at both Merck and Schering-Plough.

Under pressure from congressional investigators early this year, the companies released results of a long-delayed study showing that Vytorin was no better at reducing plaque buildup than generic Zocor, a Vytorin component, which costs a third as much.

The release of the study sparked congressional committee investigations into whether the companies deliberately delayed releasing the study’s results to boost sales of Vytorin and Zetia. Both companies have denied the charge.

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