Pharmaceutical (Drug) Industry Under Attack From Patients and Law

The Sick Get Sicker as Legal Drug Pushing Puts Profits Before the Health of Patients

by Helke Ferrie

“No doubt, one day our children’s children will learn in school that in the early part of the 21st century tens of thousands of people died every year after taking unnecessary drugs … They will learn that there were no effective laws to protect people from risky drugs … When will we stop killing the innocent with blockbuster drugs?”

- Terence H. Young, MP (Conservative) for Oakville, Ontario: www.drugsafety.com

(from Death by Prescription – A Father Takes on his Daughter’s Killer – The Multi-Billion-Dollar Pharmaceutical Industry, Key Porter, 2009)

On April 1st, the internet was buzzing with the “news” that the U.S. FDA approved a drug called Despondex, the first depressant developed to treat those estimated “20 million Americans who are insufferably cheery.” The drug industry is becoming absurd. Economic and scientific ups and downs now are full-blown, uncontrollable turbulence.

The U.S. Supreme Court ruled in March against the drug industry’s demand that they be granted full immunity against all liability for the damage their drugs cause (Wyeth vs. Levine) – a last-ditch effort to escape the consequences of dealing in harmful products. The following blockbuster drugs are about to suffer the consequences of that ruling as hundreds of legal actions involving tens of thousands of plaintiffs are already in progress: Baycol, Vytorin, Ketek, Avandia, Bextra, Celebrex, Prempro, Premarin, Zyprexa, Risperdal, Seroquel, Lexapro, Celexa, Cymbalta, Fosomax, Boniva, Effexor, Lyrica, Geodon, Ablify, Zoloft, Paxil, Prozac, Chantix, Singulair, Ambien, and Trovan. The era of blockbuster drugs is coming to an end – not because of patents running out but because patients, the court system, and the medical profession have declared a war on drugs, and Big Pharma is losing.

All blockbuster drugs follow a clear pattern: they can cause or promote the very conditions they are intended to prevent, or they may have deadly “side” effects like chronic diseases, cancer, or deregulation of the central nervous and hormonal systems.

The top blockbusters, cholesterol-lowering statins (annual sales $34 billion), interfere with the liver’s production of cholesterol. The liver is the resident omnipotent and benevolent nature. Interfering with Nature is never advisable. Cholesterol is not a pathogen – it’s a fat we need to manufacture all neurotransmitters. The most common statin side effect is a greater likelihood of heart attacks.

The 2007 Lancet review of statins (vol. 369) by Harvard’s John Abramson found no health benefits and no reduction in mortality rates. The Heart Research Institute in Sydney, Australia, published supporting evidence in the New England Journal of Medicine (May 2008), showing that people who took statin drugs had 58% higher mortality rates than people with supposedly dangerously high cholesterol levels who took no statins – and lived happily ever after. This lack of efficacy has been known for a long time, prompting Merck and Schering-Plough to attempt suppressing such evidence from their recent Ezetrol trial (Times, March 31, 2008).

As for antidepressants, they all can promote or cause Type 2 diabetes and/or cancer (most research by University of Alberta). When studies of such mental health drugs are properly designed, they deliver a punch. Case in point – placebos beat both Eli Lilly’s antidepressant Zyprexa and its ts second-generation version: the sugar pill made far more people happy than the antidepressant (veracare@ahrp.org April 14, 2009). This is not totally surprising because, since 2005, it is known that the serotonin hypothesis of depression underpinning this class of drugs is bogus (PLoS Medicine, November 8, 2005).

The Journal of the American Dental Association reported on January 1, 2009, that the famous osteoporosis drug Fosomax, taken by 10 million Americans, has been shown to cause osteonecrosis of the jaw (irreversible disintegration) in 4% of patients from just short-term use.

STARTLING STATISTICS

On January 28, 2009, researchers from Toronto’s Sunnybrook Health Science Centre reported in the Journal of the Canadian Medical Association that using proton-pump inhibitors (heartburn medication) like Losec, Prevaid, and Pariet in combination with blood thinners like Plavix increases the recurrence of heart attacks by 15%. This study has integrity because it compared heart attack survivors on these drugs with those survivors taking nothing.

The ultimate cash cow, influenza vaccines, also bottomed out. In October 2008 the Archives of Pediatric & Adolescent Medicine reported that vaccinating children against the ‘flu “had no [preventive] impact” at all.

A few years ago, the Canadian Medical Association reported that at least 23,000 people in Canada die every year from properly prescribed drugs. Drug-related injuries and deaths reached record levels in the first three months of 2008: about 5,000 deaths and over 21,000 injuries were recorded in the United States. The Institute for Safe Medication Practices estimates that actually about 830,000 fatalities and injuries happen annually because, according to the FDA, only 10% of cases are reported. The British National Health service reports that these expensive “medical blunders” increased in the UK by 60% in two years.

To put this into perspective: the anti-inflammatory drug Vioxx, for which Wyeth paid out more than $4 billion in damages last year, killed as many people as soldiers died in Vietnam, and ten times as many as perished in Iraq (www.alternet.org, March 13, ‘09).

DRUG COMPANIES CHANGE TACTICS

What is a drug company to do in these desperate times? In 2008, Nature reported on November 6 and 20, and on March 19, 2009, that Big Pharma will now focus on cancer, immunology, and stem cells as the most promising areas. Haven’t they noticed that governments are turning against pesticides and other carcinogens? Most drug-based cancer therapies don’t work and survival rates haven’t changed since the 1950’s. However, the reduction in cancer incidence due to reduced environmental carcinogens will be bad for Big Pharma’s bottom line.

And what about the fact that the most (pharmaceutically) promising stem cell discovery, reported in Nature in 2002 (vol. 418), has now been shown to be fraudulent? (New Scientist, October 7, 2008)

Above all, Big Pharma pins its hopes on “biologicals” such as enzymes, monoclonal antibodies, peptides, vaccines (also known as recombinant biopharmaceuticals), i.e. genetically engineered drugs like bovine growth hormone (historically the first biological). These sci-fi drugs have already caused regulatory messes in the US and Europe due to a far greater number of associated adverse events than for traditional synthetics.

Hopes are also pinned on drugs that will “overcome the blood-brain barrier”, one of the most powerful protections nature provides against poisons entering the brain. From Big Pharma’s perspective, this “continues to hamper development of effective drugs” (www.genengnews.com, February 1, 2009). DNA testing is another hopeful, for which the “sky could be the limit”, but only if people can be “convinced of its utility.” (www.genengnews.com February 15, 2009)

THE LEGAL SYSTEM KICKS IN

After a decade of reporting on Big Pharma, I thought I was hard-boiled, but the Swedish journal, Dagens Medicin, knocked the breath out of me when reporting in December 2008 that Sweden commenced with criminal investigations into the Nobel Prize committee. Two of its members are also on the board of AstraZeneca. The Nobel committee is accused of “bribery and corruption” for allegedly taking “huge payments” from AstraZeneca “which directly benefits from the [2008] Nobel Prize winner in medicine” Harald zur Hauser, who was honoured for his discovery of the cause of cervical cancer, the human papiloma virus. This led to Astra Zeneca’s development of Gardasil which now has more recorded adverse events and deaths than all other vaccines combined. The investigation was ordered on the eve of the Nobel ceremonies. Prosecutor Christer van der Kwast said: “It was not my intention to ruin the party.” (newsmax.com, December 19, 2008).

Last year, Shahram Ahari, a drug rep for Prozac and Zyprexa, told a U.S. Senate Committee all about Big Pharma’s sales policy of “rewarding physicians with gifts and attention for their allegiance to your product and company, despite what may be ethically appropriate” or medically true or effective. “It’s my job,” Ahari explained, “to figure out what a physician’s price is.” The New England Journal of Medicine reported that 94% of all U.S. doctors are involved with drug companies and 28% are paid consultants for Big Pharma.

Senator Charles Grassley (R-Iowa) began probing the Big Pharma connections of university-based medical researchers. He found that Pfizer had at least 149 members of Harvard’s medical school on its payroll; the largest sums paid to them involved trials of anti-psychotics for children which were not approved for such use (veracare@ahrp.org). Evidence of self-harm and suicides was carefully buried along with the kids. In March of this year federal prosecutors moved in on three Harvard psychiatrists.

The New York Times reported (March 4, 2009) that surgeons getting kickbacks from medical device companies will now face jail time, and 600 human trials conducted by Washington State University were shut down because consent forms had been forged (Seattle Times, December 10, 2008). The U.S. government also initiated sting operations into many trials, finding that some of them were conducted by fictitious companies for non-existent drugs simply to abscond with federal grant money. (New York Times, March 13, 2009)

Wyeth lawyers argued in court that the synthetic HRT drug Premarin was just fine, and that patients who got cancer from it should have read the labels more carefully. It didn’t fly. (www.alternet.org/story/79759 March 16, 2008).

A Chief Judge in a U.S. District Court, David F. Hamilton, reversed his original decision, favourable to Paxil, when he dug deeper and realized how he had been deceived. He subsequently slammed GlaxoSmithKline with full responsibility for Paxil’s adverse events (International Coalition for Drug Awareness www.drugawareness.org).

In Canada, the B.C. Supreme Court rebuked the B.C. Medical Association in November 2008 for launching a campaign to discredit one of its board members, Dr. Caroline Wang, when she publicized an improper $70 million fee deal which the association was negotiating with the provincial government.

A report by renowned environmentalist and medical activist, Robert F. Kennedy Jr., and vaccine expert David Kirby, shows that since 1988, 1,320 families won in Vaccine Court, each having been awarded millions of dollars. They succeeded by proving neurological damage from the mercury preservative in the MMR vaccine, and by not using the term “autism”, thereby avoiding negative publicity for the MMR vaccine.

MAINSTREAM MEDICINE IS GETTING IT

Last November, disheartened FDA scientists revolted against their corrupt managers – just like Dr. Shiv Chopra and his fellow scientists had done in Canada several years ago. The core issue was that the Bush-appointee acting head of the FDA, Dr. von Eschenbach, ignored letters from FDA scientists providing proof that harmful drugs and devices were being allowed onto the market. Nature editorialized on the unacceptable secrecy permeating the FDA (Jan 15, 2009), calling on President Obama to do something about it.

Harvard’s medical students, led by pharmacy students, formally demanded that the university cut its ties with Big Pharma, stating they feel “violated” by the BS being taught which is only barely disguised marketing (New York Times, March 3, 2009). Similarly, the Journal of the American Medical Association was forced to eat humble pie after the Alliance for Human Research Protection revealed that JAMA editors used intimidation tactics against medical researchers Dr. Jonathan Leo and Jeffrey Lacasse, who disproved the serotonin hypothesis of depression. The Wall Street Journal ran with this story (March 26, 2009), and now the debunking of that hypothesis will become more publicly known.

Meanwhile, the bluff is being called by the prestigious Lancet (January 10, 2009) showing that “new generation drugs, known as atypicals… can now be regarded as invention only” and of no clinical benefit.

Significantly, JAMA published an outstanding landmark editorial on April 15, co-authored by many medical journal editors, outlining exactly how the medical profession must sever its ties to the drug industry.

Dr. Michael Goodyear of Canada’s Dalhousie University analyzed the ways in which regulatory harmonization in medicine between the US, Canada and the EU serves Big Pharma interests, but harms patients and violates the Helsinki Accord on Human Rights (BMJ, April 21, 2009).

Most encouragingly, the Obama administration is intending to analyze and compare all currently available therapies to ascertain what actually works and should be funded (Scientific American, February 2009). In Europe, legislation has been introduced following Sweden’s and Germany’s initiatives, to ensure that drugs no longer harm the environment (Nature February 5, 2009).

This month in Canada, Oakville Conservative MP Terence Young will introduce a Private Member’s Bill proposing an independent drug agency, not funded by Big Pharma as Health Canada has been since 1997. His book on the tragic death of his daughter, Vanessa, caused by the drug Prepulsid, is perhaps one of the most important acts for the public good to have happened in decades. Read it! Young teaches us to mistrust “authority” appropriately and think about medicine responsibly.

Sources and Resources:

* S. Chopra. Corrupt to the Core – Memoirs of A Health Canada Whistleblower, Kos, 2009
* R. Pelton & J. LaValle. The Nutritional Cost of Drugs: A Guide to Maintaining Good Health While Using Prescription Drugs, Morton, Second edition, 2004
* M. Petersen. Our Daily Meds, Sara Crichton Books, 2008
* U. Ravnskov MD. The Cholesterol Myth: Exposing the Myth that Saturated Fat and Cholesterol Cause Heart Disease, New Trends, 2003
* Orthomolecular Medicine News Service: omns@orthomolecular.org and www.nutriteam.com
* Drug recalls, interactions: Public Citizen’s Worst Pills – Best Pills News www.worstpills.org
* On antidepressants: www.greenspiration.org, drug-induced suicides and mass murders www.drugawareness.org and www.ssristories.com
* Report drug side effects to Health Canada: www.healthcanada.gc.ca/medeffect or 1-866-234-2345

http://www.vitalitymagazine.com/may09_helkefeature

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I always assume the worst about doctors and pharmaceuticals. This article should be no surprise to anyone.
People, doctors included, respond to incentives. OUR job as informed consumers is to question their advice. Get second opinions and feel free to reject medical advice. If you doctor is offended, get a new doctor.
Please do not expect the government to protect you. The FDA is just as likely to ban a good drug as to approve a bad one. We should admit to ourselves that the government is useless. WE must protect ourselves.
I took Zoloft for anger management for many years. Recently, at age 56, I discovered I no longer needed it. I did NOT ask permission of any MD to stop taking it. I did it myself. It is MY body so I make the final decision, not some pompous ass MD with a government license to take money from sick people. When I was 46, Zoloft was a godsend. I made much more money in business by taking Zoloft because I could suffer fools gladly.
We all must decide when the benefits of a drug outweigh the dangers.
-Richard

-Richard