Merck Pays a Pittance for Mass Deaths

 (Maybe the biggest corporate/political lie out there is that pharmaceutical companies are these hard working scientists toiling to find a cure for every ailment known to man. People believe pharma is here for us, to make us better when we get sick.  They are sanctioned drug dealers who can get away with anything they want because they have billions of dollars to throw at any problem that could arise, any politicians who can be bought for the right price, and any pusillanimous, pretend regulatory agency like the impotent FDA, manned by future employees of big pharma once they leave "public service." 

The biggest joke is on sick people who desperately need something to feel better, to heal, and they have no choice (it seems to them) but to put all their faith in big pharma's latest, newest drug trial. When people stopped taking the anti-psychotic Orap (Pimozide) due to its horrible side effects, its makers had it reclassified as an anti-depressant so that they could milk it for more profits. The side effects of it range from akathisia (inability to sit still or stay in one place), tardive dyskinesia (repetitive, uncontrollable body movements) , and,possibly, neuroleptic malignant syndrome to death. They prescribe it to people with delusions, too. 

The drug companies exist to make huge mountains of profits. There's no money in curing any disease because diseases are huge money makers, especially cancer. A drug company, hospital and insurance company can milk hundreds of thousands of dollars out of one cancer patient. Oh, and these guys are very generous donors to political campaigns...no one can offer as much money to a campaign except for the banks.

And finally my point: so is it any wonder at all to any reasonably thinking human being that Merck would actually be punished? No one goes to jail, no one loses their job--even though there were numerous deaths--maybe conspiracy to commit murder, or voluntary manslaughter. And we keep taking each and every new pill they shit down the pike... and that fine amounts to nothing t=for a company that routinely clears billions of dollars per year net profit.

"This one will work! Oh,no! Maybe this one? Ahhhhh nooo, well something's gotta work! how about this one? Ooooohhhh..." And it's obvious that they only make things worse. --jef)

The VIOXX Settlement

by FRED GARDNER

Q: Who killed more Americans —al Qaeda crashing airplanes into the World Trade Center, or Merck pushing Vioxx?
A: Merck, by a factor of 18.

One of the most downplayed stories of our time ended with a whimper this week.  “Merck has agreed to pay $950 million and has pleaded guilty to a criminal charge over the marketing and sales of the painkiller Vioxx,” the New York Times reported Nov. 23 (in the business section, where important medical news is usually found).  The pharmaceutical giant copped to a misdemeanor: urging MDs to prescribe Vioxx for Rheumatoid Arthritis prior to 2002, when the Food & Drug Administration approved its use for that disorder.

The FDA had initially approved Vioxx (after a hasty “priority review”) in May, 1999 to treat osteoarthritis, acute pain, and menstrual cramps.  By September 30, 2004, when Merck announced its “voluntary recall,” some 25 million Americans had been prescribed the widely hyped drug. Evidence that using Vioxx doubled a patient’s risk of suffering a heart attack or stroke —based on a review of 1.4 million patients’ records— was about to be published in Lancet by David Graham, MD, an FDA investigator.  The FDA director’s office, devoted valet of Big PhRMA, had contacted the Lancet in a futile effort to stop publication of their own scientist’s findings.

Graham’s data indicate that 140,000 Americans suffered Vioxx-induced heart attacks and strokes; 55,000 died, and many more were permanently disabled. The Merck executives’ real crime was conspiracy to commit murder.

Some 3,000 Americans died in the attack on the World Trade Center. The murders perpetrated by Merck executives were not as dramatic, obviously, but were every bit as intentional. An early clinical trial had alerted them to the fact that Vioxx caused coronary damage. Their response was to exclude from future trials anyone with a history of heart trouble!

Once Vioxx was approved, Merck spent more than $100 million a year advertising it.  (You may still remember the tune to “It’s a beautiful morning…”) Merck execs continued to ignore and suppress indications that their new blockbuster was causing strokes and heart attacks.

Sales hit $2.5 billion in 2003. And when brave Dr. Graham first presented his irrefragable evidence to an FDA advisory committee in February 2004, Merck argued that the “unique benefits” of Vioxx warranted its remaining on the market. The FDA committee voted 17-15 to keep it available with a black box warning. Ten of the 32 committee members had taken money from Merck, Pfizer or Novartis (which were pushing drugs similar to Vioxx) as consultants.  If these MDs had declared their conflicts of interest, Vioxx would have been pulled from the market by a vote of 14-8. By buying an extra seven and a half months, Merck made an extra billion or two, and killed 6,000 more Americans.

Worldwide, Vioxx was used by 80 million people. Assuming their dosages were similar to the 1.4 million Kaiser Permanente patients whose records Dr. Graham analyzed, the death toll exceeds 420,000.

The great selling point to doctors —and the original rationale for developing “Cox-2 inhibitors” such as Vioxx and Celebrex— was their supposed safety compared to aspirin and other non-steroidal anti-inflammatories such as ibuprofen (Motrin, Advil) and naproxen (Aleve), which can cause gastrointestinal bleeding and peptic ulcers in some people. (There was no evidence that Cox-2 inhibitors were more effective than NSAIDs at reducing pain and inflammation.)

The NSAIDs work by inhibiting production of an enzyme, Cyclooxygenase, that helps make compounds called prostaglandins that facilitate the inflammatory response and protect the stomach lining (among other functions).  In the 1980s a researcher named Philip Needleman discovered that the body makes Cyclooxygenase in two forms —Cox-1, found in normal tissue, and Cox-2, which is more prevalent in damaged tissues associated with arthritis. The drug companies hoped that a compound that inhibited only Cox-2 production would reduce inflammation without gastric side effects. With 40 million Americans suffering from some form of Arthritis, an easier-on-the-stomach painkiller would mean blockbuster sales. And so they invested hundreds of millions of dollars in the ’90s developing compounds that would inhibit Cox-2 production, and arranging clinical trials to convince the FDA that such drugs were an improvement over the existing alternatives.

And now a word from our sponsor
If Cannabis and Cannabis-based medicines had been among the alternatives, the market for Vioxx et al would have been much smaller. (And if codeine wasn’t semi-prohibited, the market would have been smaller still.) How many drugs would lose significant market share if Cannabis-based options were available? Enough so that the pharmaceutical industry would quickly follow the housing sector down the drain.  Which is why Wall Street cannot allow legalization of the plant for medical use.

It may turn out that a cannabinoid produced by the plant, cannabidiol (CBD), exerts its anti-inflammatory effects by means of Cox-2 inhibition. A recent study shows that Cox-2 plays a role in breaking down one of the cannabinoids produced by the body, 2-AG. The breakdown product is a precursor to neuroinflammatory prostaglandins.

Let the punishment fit the crime
In 2007 Merck paid out $4.85 billion to settle claims by 27,000 Vioxx victims and their survivors. “The reason ‘so few’ people filed lawsuits,” a physician explains, “is that there is a significant background rate of heart attack. People may not have recognized their event as being related to Vioxx.”  The survivors of people who smoked cigarettes, were overweight or had other risk factors would have been discouraged by lawyers from filing claims, he added, because they’d have a hard time convincing jurors that their loved ones’ heart attacks were brought on by Vioxx use.

“No person was held liable for Merck’s conduct,” Duff Wilson of the Times reported Nov. 23.

To be fair-and-balanced in an otherwise Merck-friendly story, he quoted Erik Gordon of the University of Michigan’s Ross School of Business, commenting “It’s just a cost of doing business until a pharmaceutical executive does a perp walk.”

That sounds tough but it isn’t.  Marketing dangerous drugs would still be “just a cost of doing business” to profit-driven corporations if a few individual execs were made to do time at Camp Fed. Why shouldn’t they be charged with conspiracy to commit murder, along with every accessory to the crime that a thorough investigation could identify? (This could provide meaningful work for the currently useless Drug Enforcement Administration.) The Vioxx conspiracy involved researchers who skewed data and sales execs who framed false pitches and government officials who tried to silence whistleblowers and God knows who else… If somebody is killed in a botched robbery at a Seven Eleven, the kid driving the getaway car is charged with homicide. But Merck’s CEO throughout the Vioxx era, Ray Gilmartin, left the company in 2006 with a golden parachute and joined the Harvard Business School faculty. The class he teaches is called “Building and Sustaining Successful Enterprises.”

A more effective way to counter deadly corporate fraud would be for the government to simply stop doing business with entities convicted of major crimes. If MediCare and state Medicaid programs stopped buying Merck or Pfizer drugs for, say, five years, it just might produce the result that we, the people, require.

The day before the Vioxx settlement was reported, the Wall St. Journal ran a story (in the Marketplace section) under the headline “Pfizer Near Settlement on Bribery.”  The corporate boo-boo in this instance involved pay-offs to doctors who purchase drugs for state-owned institutions overseas. Johnson & Johnson recently settled a similar bribery case. Merck, AstraZeneca, Bristol-Myers Squibb, and GlaxoSmithKline are all in settlement negotiations with the government.

On the home front, Pfizer has paid $2.3 billion for violating the federal False Claims Act and bribing institutional purchasers in connection with Bextra, Lipitor, Viagra, Zithromax, Norvasc, Lyrica, Relpax, Celebrex, and Depo-provera.

The systemic corruption is getting worse.  In the 15 years between 1991 and 2005, according to Public Citizen, drug companies paid the government $5 billion in penalties and settlements in connection with kickbacks and false claims. In the five years between 2006 and 2010 the pay out was $14.8 billion.  Four companies accounted for more than half the blood money ($10.3 billion): Glaxo, Pfizer, Eli Lilly, and Schering-Plough.

In recent years the drug industry has surpassed the “defense” industry as the top defrauder of the federal government under the False Claims Act.

Where is zero tolerance when we need it?

Abbott’s Scary $8 Billion Drug

Blockbuster Drug Causes Cancer, TB and Lethal Infections

by MARTHA ROSENBERG

 

How did Abbott Laboratories’ Humira become an $8 billion a year drug, capable of anchoring an entirely new drug company as Abbott splits into two?

How did it become a blockbuster even though such drugs (which include Remicade, Enbrel and Cimzia and are called TNF blockers) are linked to TB, rare cancers and lethal infections like histoplasmosis?

How did it become a blockbuster even though Humira is only approved for the rare conditions of rheumatoid arthritis,  juvenile idiopathic arthritis, ankylosing spondylitis adults, Crohn’s disease, psoriatic arthritis and chronic plaque psoriasis?

The same way all expensive, dangerous drugs become blockbusters: an easy touch FDA, bought doctors and doctor groups, PR firms to establish diseases as “public health threats” and massive direct-to-consumer advertising!

The FDA approved Humira, the first TNF blocker to use human, not mice and hamster cells, three months early, in 2002, and its Arthritis Advisory Committee announced the following year, that TNF blockers do not, repeat not, increase the risk of lymphoma.

Abbott enlisted the public relations giant Edelman to “educate” doctors about the exciting new drug and to team with the Arthritis Foundation. It also enlisted the PR giant Young & Rubicam, and the healthcare advertising heavy, Harrison and Star to let the world know about their Humira deficiencies.

And Abbott gave out free samples of Humira to seniors in 2003 while it lobbied Congress to get the drug’s $15,000 to $20,000-a-year costs on the Medicare dole. It wasn’t even Halloween. (PS–it worked!)

In fact, Abbott advertised Humira so widely, pharmaceutical reporters asked why since the general public can neither afford the drug nor does it need it. “Rheumatoid arthritis is a market where people often don’t know what they have for a while,” and it is often “misdiagnosed,” said Abbott Vice President of Specialty Operations, Heather Mason in classic disease-selling Pharma language.

When Pharma sells a disease to justify a drug, the disease is always “under-recognized,” with “barriers” and “stigmas” preventing treatment and with under-recognized social costs and “burdens.”

Sure, Humira is expensive, Joel M. Kremer, MD, an Abbott consultant, told the New York Times in 2008 but there are unrecognized social burdens. “Inadequately treated rheumatoid arthritis typically leads to multiple joint replacements, lost productivity, lost tax revenue and a greatly diminished quality of life, as well as an increased risk of life-threatening infections and cardiovascular disease,” he said. “You have to consider what it costs to fix a bridge against what it will cost when the bridge collapses.”

In Reviews in Gastroenterological Disorders in 2007, Abbott consultant Stephen Hanauer, MD echoed the cheaper-to-treat argument. Humira treatment reduces “overall costs” and enhances “patients’ quality of life,” he says.

But is it really cheaper to give patients Humira when they could use less expensive and dangerous drugs that don’t suppress the immune system?

The Cochrane Collaboration, an international, not-for-profit drug review organization says, “Overall, in the short term biologics were associated with significantly higher rates of total adverse events, withdrawals due to adverse events and TB reactivation,” and stresses that, “There is an urgent need for more research regarding the long-term safety of biologics and the comparative safety of different biologics.”

In 2008, the FDA announced that 45 people died from fungal diseases from taking Humira, Enbrel, Remicade and Cimzia–20 percent of those who got sick! People who lived near the Ohio and Mississippi river valleys were especially at risk. The same year, the FDA investigated Humira for thirty reports of childhood cancer and its links to lymphoma, leukemia and melanoma in children. Yes, lymphoma.

This year, the FDA warned that Humira can cause, “a rare cancer of white blood cells,” in young people and five patients died during Humira trials in Italy. Other articles, this year, link drugs like Humira to heart problems.

Still, the Humira’s spin machine is humming as Abbott prepares to found an entire company on the blockbuster drug. An investigator with the Italian trials called the deaths “bad luck” and not necessarily Humira-related. (Trials were not stopped.) An avalanche of Pharma planted articles dispute the heart findings. And Abbott is seeking approvals to market Humira for ulcerative colitis and pediatric Crohn’s disease.

Maybe there will be free samples.