Pharmaceutical profits come before consumer wellness

[Bernard]

Pharmaceutical profits come before consumer wellness

If you have a long, drawn-out, incurable but treatable disease, it's unfortunate for you but great for pharmaceutical companies. While you're suffering indefinitely, you're also buying expensive pharmaceutical drugs to make the disease "manageable."

"Managing" diseases is the trend in mainstream medicine, and it's the main message that pharmaceutical companies and the media market to consumers. "You have a mental disorder? That's okay. You can live a normal life, if you take these pills every day."

According to "AIDS: A Second Opinion" authors Gary Null and James Feast, the profits "stack up better" for pharmaceutical companies when people have to take treatments indefinitely for an incurable disease. HIV, for example, is a relative goldmine, since HIV-positive people have to take drug "cocktails" each day even before they develop symptomatic AIDS. Then, the profits add up even more after these people develop full-blown AIDS because they have to take drugs to treat opportunistic infections in addition to their regular drug cocktail.

Many people believe that pharmaceutical companies' hunger for profits triumphs over their desire to genuinely help the public, and that this blinded concern for profit above all has shaped -- and continues to shape -- mainstream medicine as we know it. The bottom line is simple: As Life Extension Magazine puts it, "Marketing issues frequently outweigh medical science in drug company decisions."


Modern medicine is a platform for profit, not health

This has implications that are more serious than one might initially think, especially considering the heavy role that pharmaceutical companies play in mainstream medicine. "Deep Healing" author Dr. Emmette Miller writes, "We have to remember that most medical research in this country is financed by pharmaceutical companies who are looking for new drugs they can produce and sell."

Now, things were not always this way. In his book, "Overdosed America," Dr. John Abramson describes the shift of medical research from the academic to the commercial sphere: "As the function of medical research in our society has been transformed from a fundamentally academic and scientific activity to a fundamentally commercial activity, the context in which the research is done has similarly changed: First in universities funded primarily by public sources, then in universities funded primarily by commercial sources, then by independent for-profit research organizations contracting directly with drug companies. And most recently, the three largest advertising agencies, Omnicom, Interpublic and WPP, have bought or invested in the for-profit companies that perform clinical trials." In my view, advertising agencies having financial ties to the companies that perform clinical trials – companies that are supposed to conduct objective research – is blatant conflict of interest; yet it's the basis of most mainstream medical research in the United States. In fact, according to Dr. Abramson, in the year 2000, only one-third of all medical research was performed in universities and academic medical centers.

Since, according to these and other sources, drug companies predominantly fund medical research, scientists have almost no choice but to mainly focus their time and effort on the most profitable, but not necessarily the most effective, treatments. Though an herb, which by its very nature cannot be patented, may treat and possibly even cure a disease, drug companies may nevertheless not fund research or marketing for it, leaving the general public largely ignorant of the herb's benefits. Mainstream medicine largely dismisses vitamins and minerals in the same manner as herbs.

Furthermore, research bias often continues into the doctor's office. As Gary Null writes in his Complete Guide to Health and Nutrition, "One report published in Fact magazine speculates that the principle reason vitamin C is not commonly prescribed is that it is not as profitable as those syrups and pills your doctor dispenses."


Stealing medicine from nature

However, this doesn't mean that pharmaceutical companies ignore plants and other natural medicines altogether; it's actually quite the opposite. According to Asian Health Secrets by Letha Hadady, approximately one-third of all pharmaceuticals are derived from plants' active ingredients. Though companies cannot patent natural plants in their whole form, they can patent plants' individual ingredients after a long, painstaking process of breaking down the plant into its components, isolating active ingredients and then claiming to have "discovered" these natural ingredients. However, this system, though profitable for drug companies, has a downside that Hadady reveals: "Many times the active ingredient does not work as well as the entire plant. According to tests done in Germany, Saint John's Wort, the entire herb, kills the AIDS virus in the test tube, while hypericum, the isolated active ingredient, does not." In other words, though the bottom line is simple, it means that this society is in a very dangerous predicament indeed.

This horrific state of modern medicine is a uniquely American phenomenon, according to "Innocent Casualties" author Elaine Feuer. She writes, "Because the U.S. is the only major industrialized nation that does not regulate the prices or profits of drug companies, prescription drugs generally cost 25 to 40 percent more than in other countries." In fact, drug companies rely on American sales for the bulk of their profits, even though many of their products are marketed worldwide, says "Natural Alternatives to Drugs" author Dr. Michael T. Murray.

Though this is bad for the average American consumer, it's great for pharmaceutical companies. According to Mike Fillon's book, "Ephedra Fact and Fiction," the global pharmaceutical market earned $364 billion in 2001, making it the world's most profitable stock market sector. Fillon writes that more than half of this revenue is from the United States alone, so although pharmaceuticals are more expensive for the American consumer, Americans still buy more prescription drugs than any other nation.


Hawking for Big Pharma

Now, at this point, you're probably wondering about the role the U.S. government plays in all this. In "Death by Prescription," Ray D. Strand writes, "The FDA is actually listening and catering to the industry's desires." According to Strand, the FDA facilitates the drug-approval process. Many people attribute the FDA's bias against herbs and other natural medicine to the agency's close "friendship" with the pharmaceutical industry, but it seems that they can't agree about the level of corruption. According to American Medical Publishing's book, "Prescription Medicines, Side Effects and Natural Alternatives," "The government is also part of the problem because it does not have the resources or the political will to do more about the dangers of prescription drugs. Also, powerful members of the American government, from the President on down, are all lobbied heavily by the cash rich drug companies."

In order for mainstream medicine to reach the level of effectiveness that it can and should attain, the inner workings of the medical community must change, starting with the pharmaceutical companies' hold on the government agencies that are supposed to protect American consumers. As Burton Goldberg writes in "Alternative Medicine," "To realize effective health care with cost reduction requires unlocking the strangulation hold of the pharmaceutical companies, the American Medical Association (AMA) and ... the FDA on all forms of fully effective, low-cost alternative, complementary, integrative, holistic medicine." Until then, mainstream medicine will remain the same, and that's the last thing American consumers need. It's time to put concern for public health, medicine and genuine science over corporate profits.

The experts speak on pharmaceutical companies and profits:

There is probably nothing more profitable to the drug companies than interminable treatment of patients with drugs that do not work. Yet countless patients, at great cost to our nation, are kept on these treatments because they have been proven to help two-thirds of people and health-care providers have no policies or procedures to do otherwise. When those who pay the bills realize how much of their money is being wasted, and how much can be saved by requiring policies and procedures to identify patients not helped by standard treatment and select alternatives for them, it may happen.
Alternative Medicine by Burton Goldberg, page 458

Diabetes is such a profitable business that physicians will put pre-diabetic patients, with only marginally high blood sugar, onto diabetes drugs before even trying weight loss and exercise.
Prescription Alternatives by Earl Mindell RPh PhD and Virginia Hopkins MA, page 403

With the growing epidemic of obesity, the drug companies can look forward to a financial windfall. Many millions of Americans will be taking their statin drugs to lower their cholesterol levels. And they could each be spending $3 a day, or $1100 a year, for the rest of their lives.
Health Care Meltdown by Robert H Lebow MD, page 229

Drug companies are profit-driven entities, so marketing issues weigh very heavily. Manufacturers feel great pressure to keep costs down while hastening new drugs to market. And drug companies aren't held responsible for the huge costs of dose-related side effects to the healthcare system. The result is that marketing issues frequently outweigh medical science in drug company decisions.
Disease Prevention And Treatment by Life Extension Foundation, page 723

We have to remember that most medical research in this country is financed by pharmaceutical companies who are looking for new drugs they can produce and sell. Psychoneuroimmunology research is aimed at showing that the body is capable of producing its own healing substances. The bottom line is that stockholders of the companies that invest in medical research can't see how they can profit from such research and so will naturally put their developmental money into the money-making ventures instead.
Deep Healing by Emmette Miller MD, page 138

As the function of medical research in our society has been transformed from a fundamentally academic and scientific activity to a fundamentally commercial activity, the context in which the research is done has similarly changed: first in universities funded primarily by public sources, then in universities funded primarily by commercial sources, then by independent for-profit research organizations contracting directly with drug companies. And most recently, the three largest advertising agencies, Omnicom, Interpublic, and WPP, have bought or invested in the for-profit companies that perform clinical trials.
Overdosed America by John Abramson MD, page 110

Moreover, if a drug company's profits increase because of slanted research, hasty marketing, and misleading advertising, other companies must adopt these same methods in order to remain competitive--and the race to the bottom accelerates. This is why in any area of endeavor, codes of behavior must be periodically reexamined. Doing so is a common occurrence in politics and sports, and it is what the drug companies must now undertake.
Overdose by Jay S Cohen, page 168

An independent research center could study other uses of new medications that were not studied by their manufacturers. It could research new uses or problems with generic drugs, which drug companies do not study because the patents of generic drugs have lapsed and there is little likelihood of profit.
Overdose by Jay S Cohen, page 175

In the United Sates, pharmaceutical companies support most medication research and development. Because they really can't earn a profit from natural substances, which they can't patent, they're reluctant to fund studies on plant estrogens. Fortunately, many medical centers are helping to bridge this research gap by establishing departments of complementary and alternative medicine. At the Rosenthal Center of Columbia University, for example, scientists are conducting studies of black cohosh and other phytoestrogens.
The Rhodiola Revolution by Richard P Brown MD and Patricia L Gerbarg MD, page 179

One of the reasons for this is economic. Herbs, by their very nature, cannot be patented. Because of this, drug companies cannot hold the exclusive right to sell a particular herb and they are not motivated to invest in testing or promoting herbs. The collection and preparation of herbal medicines cannot be as easily controlled as the manufacture of synthetic drugs, making profits less dependable.
Alternative Medicine by Burton Goldberg, page 252

The FDA estimates it costs over 7 million dollars to bring a new drug to market pharmaceutical companies put that figure closer to 70 million dollars. They say they need two million users of a substance just to break even. Since natural substances cannot be patented, there is even less room for profit in them.
Scientific Validation of Herbal Medicine by Daniel B Mowrey PhD, page 291

The pharmaceutical industry is, obviously, a very powerful force in American science, medicine, business, and politics. The industry must make large profits to realize a return on investment, particularly in a regulatory system where it costs $100 to $200 million dollars to bring a new drug to market.
Choices In Healing by Michael Lerner, page 613

While it is in the interest of such companies to find patentable cancer treatments, there is no corresponding incentive to develop non-patentable natural methods. Since it currently costs around $200 million to develop a new drug in the US, mainly to comply with Byzantine FDA regulations, the drug companies claim they must seek enormous profits from each and every drug.
Cancer Therapy by Ralph W Moss PhD, page 14

In order for pharmaceutical companies to earn a profit, they must develop drugs that are potent enough to patent and can be approved by the FDA. To gain FDA approval, these drugs must demonstrate an acceptable safety profile. However, the safe dose of potent drugs can vary considerably among individuals. What is safe for some people can be a lethal overdose for others. Yet doctors and drug companies usually recommend the same dose for everyone, even though lower doses of many prescription drugs can achieve the same beneficial effects, while dramatically reducing side effect risk and the cost of the medications.
Disease Prevention And Treatment by Life Extension Foundation, page 708

In addition, since niacin is a widely available generic agent, no pharmaceutical company stands to generate the huge profits that the other cholesterol-lowering drugs have enjoyed. As a result, niacin is not intensively advertised like the other drugs. Despite the advantages of niacin over the cholesterol-lowering drugs, niacin accounts for only 7.9 percent of all lipid-lowering prescriptions.
Encyclopedia Of Natural Medicine by Michael T Murray MD Joseph L Pizzorno ND, page 352

Unlike the standard treatments for heart disease, coconut oil is cheap, has no adverse side effects, and is readily available to everyone. Because it is a natural product that is already widely available, pharmaceutical and medical industries have no desire to fund studies or promote interest in this area. There is no profit for them. Since most of the information on MCFA and coconut oil are buried in scientific literature, few people are aware of the benefits. Knowledge about the true health aspects of coconut oil has to come from experienced clinicians, authors, and researchers who are familiar with the true facts about coconut oil. Yet they face an up-hill battle because they must fight prejudice and misguided popular opinion that is fueled by powerful profit-seeking enterprises.
Healing Miracles of Coconut Oil by Bruce Fife ND, page 85

By their very nature, prescription drugs are the perfect product for a monopoly. Drugs are patented and available from only one manufacturer, and prices can be increased at the discretion of the company with few consumer complaints. How many people who are ill question the cost of drugs prescribed by their doctor? During the 1980s, inflation rose 58 percent and pharmaceutical companies managed to triple their prices. In 1990 the drug industry was the most profitable industry in America, with 13.6 percent annual profits, more than triple the average Fortune 500 company. The 1991 median profit of a Fortune pharmaceutical company was $592 million. Because the U.S. is the only major industrialized nation that does not regulate the prices or profits of drug companies, prescription drugs generally cost 25 to 40 percent more than in other countries. For three out of four elderly Americans, prescription drugs are their biggest expense.
Innocent Casualties by Elaine Feuer, page 73

Drug costs are higher in the United States than anywhere else in the world. Most major industrial nations employ profit-control measures that limit how much a drug company can charge for a drug. Because most drug companies market the same drug throughout the world, they rely on American sales for the bulk of their profits.
Natural Alternatives To Drugs by Michael T Murray ND, page 23

The global pharmaceutical industry--which generated revenues of more than $364 billion in 2001--is the world's most profitable stock market sector. According to IMS Health, the leading drug industry market analyst, half the global drug sales are in the U.S. alone, with Europe and Japan accounting for another 37 percent.
Ephedra Fact And Fiction by Mike Fillon, page 144

 

[RobinN]

Not that this is new to any of us, but it is interesting that this was researched:

Researchers Fail to Reveal Full Drug Pay
By GARDINER HARRIS and BENEDICT CAREY

A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators.

By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.

Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley’s investigators. But even these amended disclosures may understate the researchers’ outside income because some entries contradict payment information from drug makers, Mr. Grassley found.

In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked to check again, he said he received $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found.

The Harvard group’s consulting arrangements with drug makers were already controversial because of the researchers’ advocacy of unapproved uses of psychiatric medicines in children.

In an e-mailed statement, Dr. Biederman said, “My interests are solely in the advancement of medical treatment through rigorous and objective study,” and he said he took conflict-of-interest policies “very seriously.” Drs. Wilens and Spencer said in e-mailed statements that they thought they had complied with conflict-of-interest rules.

John Burklow, a spokesman for the National Institutes of Health, said: “If there have been violations of N.I.H. policy — and if research integrity has been compromised — we will take all the appropriate action within our power to hold those responsible accountable. This would be completely unacceptable behavior, and N.I.H. will not tolerate it.”

The federal grants received by Drs. Biederman and Wilens were administered by Massachusetts General Hospital, which in 2005 won $287 million in such grants. The health institutes could place restrictions on the hospital’s grants or even suspend them altogether.

Alyssa Kneller, a Harvard spokeswoman, said in an e-mailed statement: “The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed.”

Ms. Kneller said the doctors had been referred to a university conflict committee for review.

Mr. Grassley sent letters on Wednesday to Harvard and the health institutes outlining his investigators’ findings, and he placed the letters along with his comments in The Congressional Record.

Dr. Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients. Although many of his studies are small and often financed by drug makers, his work helped to fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotic medicines in children. The Grassley investigation did not address research quality.

Doctors have known for years that antipsychotic drugs, sometimes called major tranquilizers, can quickly subdue children. But youngsters appear to be especially susceptible to the weight gain and metabolic problems caused by the drugs, and it is far from clear that the medications improve children’s lives over time, experts say.

In the last 25 years, drug and device makers have displaced the federal government as the primary source of research financing, and industry support is vital to many university research programs. But as corporate research executives recruit the brightest scientists, their brethren in marketing departments have discovered that some of these same scientists can be terrific pitchmen.

To protect research integrity, the National Institutes of Health require researchers to report to universities earnings of $10,000 or more per year, for instance, in consulting money from makers of drugs also studied by the researchers in federally financed trials. Universities manage financial conflicts by requiring that the money be disclosed to research subjects, among other measures.

The health institutes last year awarded more than $23 billion in grants to more than 325,000 researchers at over 3,000 universities, and auditing the potential conflicts of each grantee would be impossible, health institutes officials have long insisted. So the government relies on universities.

Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures.

“It’s really been an honor system thing,” said Dr. Robert Alpern, dean of Yale School of Medicine. “If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don’t even know how to check on that.”

Some states have laws requiring drug makers to disclose payments made to doctors, and Mr. Grassley and others have sponsored legislation to create a national registry.

Lawmakers have been concerned in recent years about the use of unapproved medications in children and the influence of industry money.

Mr. Grassley asked Harvard for the three researchers’ financial disclosure reports from 2000 through 2007 and asked some drug makers to list payments made to them.

“Basically, these forms were a mess,” Mr. Grassley said in comments he entered into The Congressional Record on Wednesday. “Over the last seven years, it looked like they had taken a couple hundred thousand dollars.”

Prompted by Mr. Grassley’s interest, Harvard asked the researchers to re-examine their disclosure reports.

In the new disclosures, the trio’s outside consulting income jumped but was still contradicted by reports sent to Mr. Grassley from some of the companies. In some cases, the income seems to have put the researchers in violation of university and federal rules.

In 2000, for instance, Dr. Biederman received a grant from the National Institutes of Health to study in children Strattera, an Eli Lilly drug for attention deficit disorder. Dr. Biederman reported to Harvard that he received less than $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, Mr. Grassley’s letter stated.

At the time, Harvard forbade professors from conducting clinical trials if they received payments over $10,000 from the company whose product was being studied, and federal rules required such conflicts to be managed.

Mr. Grassley said these discrepancies demonstrated profound flaws in the oversight of researchers’ financial conflicts and the need for a national registry. But the disclosures may also cloud the work of one of the most prominent group of child psychiatrists in the world.

In the past decade, Dr. Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotic drugs, medications invented to treat schizophrenia.

Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic drug use in children have soared. Some 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.

Few psychiatrists today doubt that bipolar disorder can strike in the early teenage years, or that many of the children being given the diagnosis are deeply distressed.

“I consider Dr. Biederman a true visionary in recognizing this illness in children,” said Susan Resko, director of the Child and Adolescent Bipolar Foundation, “and he’s not only saved many lives but restored hope to thousands of families across the country.”

Longtime critics of the group see its influence differently. “They have given the Harvard imprimatur to this commercial experimentation on children,” said Vera Sharav, president and founder of the Alliance for Human Research Protection, a patient advocacy group.

Many researchers strongly disagree over what bipolar looks like in youngsters, and some now fear the definition has been expanded unnecessarily, due in part to the Harvard group.

The group published the results of a string of drug trials from 2001 to 2006, but the studies were so small and loosely designed that they were largely inconclusive, experts say. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale — well below the 50 percent change that most researchers now use as the standard.

Controlling for bias is especially important in such work, given that the scale is subjective, and raters often depend on reports from parents and children, several top psychiatrists said.

More broadly, they said, revelations of undisclosed payments from drug makers to leading researchers are especially damaging for psychiatry.

“The price we pay for these kinds of revelations is credibility, and we just can’t afford to lose any more of that in this field,” said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. “In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money.”

http://www.nytimes.com/2008/06/08/us/08conflict.html?_r=1&sq=june 8,%&pagewanted=print

 

[Birdbomb]

 

[RobinN]

High Court May Immunize Big Pharma
The FDA´s new "preemption" doctrine jeopardizes consumers´ right to sue for drug-caused injuries
By Terry J. Allen
Diana Levine

Diana Levine holds her prosthetic arm in the music room of her house on a dirt road in Marshfield, Vt.

Consumers' right to sue for drug-caused injuries dates back to 1852. But in 2006, the FDA quietly tucked a pro-preemption phrase into the preamble of an FDA-labeling law.

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Struck by a blinding migraine, Vermont musician Diana Levine went to a clinic where she was injected with the anti-nausea drug Phenergan, produced by Wyeth Pharmaceuticals. Within weeks, the hand that had fingered her guitar was black with gangrene. Doctors amputated below the wrist and, when that failed to stop the necrosis, removed her forearm.

Wyeth´s label had warned that hitting an artery could cause irreversible damage, but it did not specifically direct physicians to avoid delivering the drug with intravenous (IV) push injection - rather than free-flowing IV drip or intramuscular shot.

Levine sued in Vermont court, charging that, because Wyeth had known for decades that using IV push to inject Phenergan directly into a vein creates avoidable risk, it should have added specific instructions on its label barring the practice.

Wyeth argued that Food and Drug Administration (FDA) approval of Phenergan and its label immunized it from state-level lawsuits. The Vermont court disagreed and awarded Levine $6.8 million.

The U.S. Supreme Court will hear Wyeth´s appeal on Nov. 3, the day before the presidential election, when few people will be paying attention. They should be.

If Wyeth´s legal defense wins, Rep. Henry Waxman (D-Calif.) said at a hearing in May, "Patients [who are] hurt by defective drugs ... would no longer have the ability to seek compensation for their injuries."

Levine is in her early 60s, has clear blue eyes and white hair that falls loosely around her unguarded face. She laughs easily and there is anger, but no bitterness, when she reflects that "all Wyeth needed to do was that simple label change. This loss of my arm, and the effect it had on my livelihood and my whole life didn´t need to happen."

As for the FDA, she says, "I know there are good hearts there and [if Wyeth wins] I want to ask them: `How do you feel about not having us little people out here to tell you when something goes wrong, and a court system to help you hold drug companies accountable?´ "

Wyeth´s defense - and the fate of the kind of liability litigation that exposed the dangers of Vioxx - rides on whether the Supreme Court accepts the FDA´s new doctrine of "preemption." The legal term means, in this instance, that a federal agency can write rules that preempt - or override - the right of a person to sue for damages in state courts. Some legal experts see the Bush administration´s embrace of preemption as part of a concerted, stealth strategy to impose, by bureaucratic fiat, the tort "reforms" that corporations failed to lobby though Congress.

"So far, seven federal agencies have issued over 51 potentially preemptive rules, often without any opportunity for public comment," wrote Kathleen Flynn Peterson, former president of the American Association for Justice.

What is at stake, then, is tens of thousands of product-liability suits against drug makers; the right of many consumers to sue if they are harmed by FDA-approved drugs; and a strong financial incentive for drug companies to set high safety standards, follow drugs after approval, update labeling and issue recalls. And, of course, there is Levine´s compensation.

Consumers´ right to sue for drug-caused injuries dates back to 1852. But in 2006, the FDA quietly tucked a pro-preemption phrase into the preamble of an FDA-labeling law.

"Preemption had never been raised by drug companies before Levine," says Richard Rubin, the small-town Vermont lawyer who won against Wyeth´s high-powered legal team, "because there had never been any preemption."

The effect, of this "radical legal doctrine," said Waxman at the May congressional hearing, is "you might have been injured by a defective product, but you can´t go and sue the manufacturer, who might have even known it was defective, because the FDA said it was not defective when they approved it. That to me is an absurd position."

But drug companies get the logic, as do other corporations subject to consumer lawsuits. Showing uncharacteristic affection for federal regulation, Boeing, Ford Motor Company, General Electric, Microsoft and R.J. Reynolds Tobacco are supporting Wyeth before the Supreme Court.

Siding with Levine are 47 U.S. states attorneys general, 18 members of Congress and a panoply of public interest groups that have filed "friend-of-the-court" amicus briefs. They are joined by former FDA commissioners Donald Kennedy and David Kessler whose August amicus brief notes that traditionally, corporations, not the FDA, bear "ultimate responsibility" for drug safety: "[P]ro-preemption arguments ... turn that understanding upside down, relieving manufacturers of front-line responsibility for the safety of their drugs, and handing that job to the FDA."

But the FDA isn´t up to the job. The agency´s own Science Board found that "American lives are at risk" because the FDA "is not positioned to meet current or emerging regulatory responsibilities."

A 2006 Government Accountability Office investigation found the FDA was incapable of ensuring drug safety. After initial approval - when many problems surface - the agency lacked the resources to gather independent data and the authority to compel drug companies to provide follow-up studies.

Add to that the conflicts of interest, cronyism and corporate influence that have flourished in Bush bureaucracies, from FEMA to the Justice Department to the FDA.

The architect of FDA´s preemption policy is Daniel Troy. Before becoming the agency´s chief counsel and primary liaison to the White House, Troy had represented industry, frequently suing the agency on behalf of drug and big tobacco companies. After leaving the FDA, he slipped into a top post at drug giant GlaxoSmithKline.

The revolving door also swung Randall Lutter into the post of FDA deputy commissioner for policy, where he defended the agency´s embrace of preemption before Congress. Lutter was a member of the ExxonMobil-funded, global warming-denying Annapolis Center. He was also resident scholar at the American Enterprise Institute, a right-wing think tank that takes oil and tobacco money and advocates vigorously for "tort reform."

The Supreme Court´s acceptance of Levine falls into a pattern that suggests it is in sync with the Bush administration´s push to make preemption part of its legacy.

A March Supreme Court case surrounding Rezulin, the now-withdrawn diabetes drug linked to liver failure, could have voided the right to sue - even when a drug company commits fraud by concealing dangers from the FDA. But that case, Warner-Lambert Co. v. Kent, failed to make law because a tie vote resulted when Chief Justice John Roberts recused himself over ownership of Pfizer/Warner-Lambert stock. (Although Levine v. Wyeth will have industry-wide impact, few expect another recusal.)

In February, the court ruled 8-1 in Riegel v. Medtronic for the makers of a faulty catheter that ruptured during heart surgery. The FDA approval that immunized Medtronic from liability now protects the makers of most medical devices, including defibrillators and pacemakers, from liability suits.

Riegel is "a resounding victory for the preemption defense and for the business community," cheered Alan Untereiner, a lawyer for the Product Liability Advisory Council.

Wyeth v. Levine could be the next step for preemption - extending it to all FDA-approved pharmaceuticals, and drastically restricting the right to a jury trial.

In Reigel, Justice Stephen Breyer provocatively asked which group you rather would trust: "An expert agency, on the one hand, or 12 people pulled randomly for a jury role? ...What worries me is, what happens if the jury is wrong?"

But in the recent cases of Vioxx, Trasylol and Redux, it was not the jury that was wrong in finding for the dead and injured, it was the drug manufacturers that "withheld key information from the FDA...while continuing to market their unsafe drug to an unsuspecting public," wrote the New England Journal of Medicine in a brief supporting Levine.

The new FDA stance, then, promises Americans "the worst of both worlds ... an FDA incapable of protecting them, and no tort system to provide compensation if they are injured," Georgetown University law professor David Vladeck wrote in the July Cornell Law Review.

Despite the preventable loss of Diana Levine´s arm, Phenergan´s label still doesn´t bar intravenous push. In 2006, six years after Levine´s amputation, Marie Caschetta, an 84-year-old woman in South Daytona, Fla., suffered a similar fate after a push IV injection of the FDA-approved drug.

So, as you follow the November election results, listen for news of Wyeth v. Levine - as if your right arm depended on it.

Terry J. Allen, an In These Times senior editor, has written the magazine's monthly investigative health and science column since 2005.

 

[haird18]

That is very true!

Robin,
You're right it is not new to any of us. And suprise suprise suprise it was researched and it is still is ridiculous too!:twocents::twocents:
David

 

[RobinN]

yet the new law is...
the fact that if anything happens to you while taking drug, you will no longer be able to find the company at fault.