Tag Archives: Pfizer

A (small) step in the right direction

No more letting industry help pay for developing medical guidelines. Restrictions on consulting deals. And no more pens with drug company names or other swag at conferences.

These are part of a new ethics code that dozens of leading medical groups announced Wednesday, aimed at limiting the influence that drug and device makers have over patient care.

It’s the most sweeping move ever taken by the Council of Medical Specialty Societies to curb conflict of interest — a growing concern as private industry bankrolls a greater share of medical research.

The council includes 32 medical societies with 650,000 members, from neurologists and obstetricians to family doctors and pediatricians. They include the American College of Physicians, the American College of Cardiology and the American Society of Clinical Oncology, the largest group of cancer specialists in the world.

“We take very seriously the trust that is placed in us by physicians and patients to be authoritative, independent voices in cancer care,” ASCO’s chief, Dr. Allen Lichter, said in a statement. He led the panel that developed the code.

One of its most controversial rules: requiring top leaders of any medical society and top editors of its journals to have no consulting deals or financial ties to industry.

“When a physician stands up to represent medicine and his or her specialty, there shouldn’t be any confusion as to who they’re speaking for,” said Dr. Norman Kahn, the council’s chief executive and a former rural medicine doctor from California.

The code requires groups to:

  • Publicly post any industry support the group receives, such as money for continuing education sessions.
  • Decline industry funding for developing medical practice guidelines, such as who should get a drug, a test or treatment. Require that most members of a guidelines panel be free of financial ties to industry.
  • Disclose any financial ties that leaders and board members have with companies.
  • Ban company or product names and logos from pens, bags and other giveaways at conferences.

Fourteen groups in the council, including ASCO and the College of Physicians, have already adopted the code. Most of the rest plan to by the end of the year.

Last year, leading medical journals agreed to use a uniform conflict-of-interest disclosure form for researchers publishing in their journals. The new ethics code the council is adopting should make financial ties more transparent to patients and breed professionalism and trust in doctors, Kahn said.

Via: USA Today and the Associated Press.  See Full Article

Dr. Court’s Comments

I certainly think this is a step in the right direction.  Pharmaceutical companies control medicine completely now.  They control the treatments, the research, the education and worst of all, your options.  Their reach is as far as you can possibly imagine.

Treatments that are natural, effective and inexspensive get passed over because Big Pharma wants it that way. They make sure to “educate” (indoctrinate is more like it) as many doctors as possible that any natural remedy is quackery.

Medical guidelines are written by doctors with significant ties to Big Pharma and the insurance companies reimburse treatments based on these guidelines.  Let’s use an example to illustrate:

You enter your doctor’s office and he is holding your recent blood test in his hand.  He tells you that your cholesterol is high and you need to start Lipitor right away.  You ask you doctor if there are any other treatment options, but because your doctor has just been to a conference sponsored by Pfizer (the maker of Lipitor) he tells you that there are no better options for you.  He is telling you this because he just learned that “the research” (done by Pfizer) says Lipitor is the most effective treatment for high cholesterol and that it’s the only medication studied that shows it reduces heart attack and stroke risk.  He was also told that diet and exercise only reduce cholesterol by 10%-15% so you shouldn’t bother because you need to lower it more than that.  All these “facts” he is quoting you are from research Pfizer has conducted on its own product.  And if this weren’t enough, your insurance company will pay the most for Lipitor because the guidelines written for cholesterol management were written by a team of 10 physicians, 4 of which had financial ties to Pfizer.

What he didn’t learn at his conference is that things like diet and exercise are very effective tools for reducing cholesterol when applied correctly.  Low carbohydrate is the way to go on that one.  He also did not mention that things like red yeast rice, niacin and plant sterols are very effective ways to reduce cholesterol without resorting to a poisonous chemical like Lipitor.  These things were not mentioned at his conference because alternatives would hurt overall sales.  By the way, your insurance company will reimburse you exactly $0 for anything that isn’t a drug because they don’t have billions of pharmaceutical dollars behind them.  They also won’t pay for you to go to the gym and actually get healthy.

Hopefully these new guidelines will have an effect, but because they are not federal acts I doubt they will have any real impact.  Your best bet is to be your own advocate.  If you don’t want to take a drug, find out from a nutritionally trained physician what you can do.  If you’re concerned about the effectiveness the fix is simple – do objective testing like blood work to see if what you are doing is working.  I think you’ll be surprised to find out just how effective these natural alternatives are.

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Pfizer creates fake company to take rap in criminal case….and gets away with it!

Below is a story from CNN that is a must read.  It shows everything that is wrong with the pharmaceutical industry.

CNN Article

Imagine being charged with a crime, but an imaginary friend takes the rap for you.

That is essentially what happened when Pfizer, the world’s largest pharmaceutical company, was caught illegally marketing Bextra, a painkiller that was taken off the market in 2005 because of safety concerns.

When the criminal case was announced last fall, federal officials touted their prosecution as a model for tough, effective enforcement. “It sends a clear message” to the pharmaceutical industry, said Kevin Perkins, assistant director of the FBI’s Criminal Investigative Division.

But beyond the fanfare, a CNN Special Investigation found another story, one that officials downplayed when they declared victory. It’s a story about the power major pharmaceutical companies have even when they break the laws intended to protect patients.

Big plans for Bextra

The story begins in 2001, when Bextra was about to hit the market. The drug was part of a revolutionary class of painkillers known as Cox-2 inhibitors that were supposed to be safer than generic drugs, but at 20 times the price of ibuprofen.

Pfizer and its marketing partner, Pharmacia, planned to sell Bextra as a treatment for acute pain, the kind you have after surgery.

But in November 2001, the U.S. Food and Drug Administration said Bextra was not safe for patients at high risk of heart attacks and strokes.

The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain.

Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA’s judgment over which products are safe and effective. For that reason, “off-label” promotion is against the law.

But with billions of dollars of profits at stake, marketing and sales managers across the country nonetheless targeted anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. “Anyone that use[d] a scalpel for a living,” one district manager advised in a document prosecutors would later cite.

A manager in Florida e-mailed his sales reps a scripted sales pitch that claimed — falsely — that the FDA had given Bextra “a clean bill of health” all the way up to a 40 mg dose, which is twice what the FDA actually said was safe.

Doctors as pitchmen

Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.

Pfizer said in court that “the company’s intent was pure”: to foster a legal exchange of scientific information among doctors.

But an internal marketing plan called for training physicians “to serve as public relations spokespeople.”

According to Lewis Morris, chief counsel to the inspector general at the U.S. Department of Health and Human Services, “They pushed the envelope so far past any reasonable interpretation of the law that it’s simply outrageous.”

Pfizer’s chief compliance officer, Doug Lanker, said that “in a large sales force, successful sales techniques spread quickly,” but that top Pfizer executives were not aware of the “significant mis-promotion issue with Bextra” until federal prosecutors began to show them the evidence.

By April 2005, when Bextra was taken off the market, more than half of its $1.7 billion in profits had come from prescriptions written for uses the FDA had rejected.

Too big to nail

But when it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, Pfizer was considered too big to nail.

Why? Because any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.

Prosecutors said that excluding Pfizer would most likely lead to Pfizer’s collapse, with collateral consequences: disrupting the flow of Pfizer products to Medicare and Medicaid recipients, causing the loss of jobs including those of Pfizer employees who were not involved in the fraud, and causing significant losses for Pfizer shareholders.

“We have to ask whether by excluding the company [from Medicare and Medicaid], are we harming our patients,” said Lewis Morris of the Department of Health and Human Services.

So Pfizer and the feds cut a deal. Instead of charging Pfizer with a crime, prosecutors would charge a Pfizer subsidiary, Pharmacia & Upjohn Co. Inc.

The CNN Special Investigation found that the subsidiary is nothing more than a shell company whose only function is to plead guilty.

According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the great-great-grandson of the parent company.

Public records show that the subsidiary was incorporated in Delaware on March 27, 2007, the same day Pfizer lawyers and federal prosecutors agreed that the company would plead guilty in a kickback case against a company Pfizer had acquired a few years earlier.

As a result, Pharmacia & Upjohn Co. Inc., the subsidiary, was excluded from Medicare without ever having sold so much as a single pill. And Pfizer was free to sell its products to federally funded health programs.

Two years later, with Bextra, the shell company once again pleaded guilty. It was, in effect, Pfizer’s imaginary friend stepping up to take the rap.

“It is true that if a company is created to take a criminal plea, but it’s just a shell, the impact of an exclusion is minimal or nonexistent,” Morris said.

Prosecutors say there was no viable alternative.

“If we prosecute Pfizer, they get excluded,” said Mike Loucks, the federal prosecutor who oversaw the investigation. “A lot of the people who work for the company who haven’t engaged in criminal activity would get hurt.”

Did the punishment fit the crime? Pfizer says yes.

It paid nearly $1.2 billion in a criminal fine for Bextra, the largest fine the federal government has ever collected.

It paid a billion dollars more to settle a batch of civil suits — although it denied wrongdoing — on allegations that it illegally promoted 12 other drugs.

In all, Pfizer lost the equivalent of three months’ profit.

It maintained its ability to do business with the federal government.

Pfizer says it takes responsibility for the illegal promotion of Bextra. “I can tell you, unequivocally, that Pfizer perceived the Bextra matter as an incredibly serious one,” said Doug Lankler, Pfizer’s chief compliance officer.

To prevent it from happening again, Pfizer has set up what it calls “leading-edge” systems to spot signs of illegal promotion by closely monitoring sales reps and tracking prescription sales.

It’s not entirely voluntary. Pfizer had to sign a corporate integrity agreement with the Department of Health and Human Services. For the next five years, it requires Pfizer to disclose future payments to doctors and top executives to sign off personally that the company is obeying the law.

Pfizer says the company has learned its lesson.

But after years of overseeing similar cases against other major drug companies, even Loucks, isn’t sure $2 billion in penalties is a deterrent when the profits from illegal promotion can be so large.

“I worry that the money is so great,” he said, that dealing with the Department of Justice may be “just of a cost of doing business.”

Dr. Court’s Comments

This case sets a dangerous precedent.  It tells large pharmaceutical companies that they can get away with just about anything because the federal government is powerless to stop them.

When a company is criminally responsible for something they should have to pay the price.  While Pfizer makes many drugs that are life savers for many people, the vast majority of them are oversold and over hyped for reasons that are well illustrated above.

All too often drugs are pushed for their ‘off label’ use.  This means they are pushed by the pharmaceutical companies to be used for things they are not approved for.  Very frequently people are prescribed anti-depressants for anxiety or take an antihistamine to sleep better.  While they may work for these purposes, they are not intended or tested to be safe for those purposes.

I always ask my patients why they are taking a certain prescription even it is seems straight forward because I can never be too sure.

This is also why health care is so expensive.  Needless drugs drive up the cost for all of us.  In my opinion off label prescribing should be illegal and safer more conservative options should always be considered.

Large companies like Pfizer do not have the best track record when it comes to being ethical.  Big money leads to small minds when in terms of ethics and morality.  Billions and billions of dollars tends to cloud the mind apparently.

Until tight regulation of the pharmaceutical industry is achieved, these cases will continue to surface.  The bank collapse that occurred in the recent recession showed us that the financial industry needed tighter regulation.  I believe that, unfortunately, something terrible will have to happen before Big Pharma has someone watching over it.

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