What Are the FDA and Big Pharma Up to Now?

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Is Avandia (rosiglitazone) going to rise from the grave? Avandia is the one-time $3 billion blockbuster anti-diabetic drug that plunged into disuse in 2009 when a study published in 2007 showed, when used with other anti-diabetic agents, it increased fractures in women as well as the risk for heart failure.

Suddenly, the FDA says it is going to revisit the data on this drug. It wants to reassess safety risks. A Wall Street Journal report says: “it is too early to know what opinions the FDA will be seeking.” Is the FDA going to put Avandia back on the market without restrictions it placed earlier?

In July of 2010 FDA investigators realized the major trial, published in 2009, used to produce negative data regarding Avandia was flawed. That data forced European healthy agencies to ban Avandia while the US FDA decided to re-label it, restricting its use to patients for whom other anti-diabetic drugs didn’t work with the caveat that all prospective patients received information about its alleged risks.

Sales of Avandia declined in the aftermath of the new data to just $1.9 million in 2012. The maker of Avandia paid a $1 billion fine to the FDA regarding criminal charges that it withheld safety data from 2001-2007 for three drugs including Avandia.

Patients not warned, despite mandate

Despite the FDA mandate that patients who do receive prescription for Avandia receive information about its risks, and despite a mandate that sales representatives of drug companies inform doctors of both the risks and benefits involving their drugs, rarely do doctors ever hear about the potential harms caused by pharmaceuticals. A report in the Minnesota Post underscores the problem.

No truly safe anti-diabetic drugs

There are no truly safe and effective anti-diabetic drugs, save for metformin, and metformin depletes the body of vitamin B12which can induce neuropathy, one of the hallmark signs of diabetes. As an aside, it was recommended that vitamin B12 levels be tested among metformin users way back in the 1970s, but few doctors do that today.

The FDA first approved Avandia in 1999. But expanded safety data on FDA-approved drugs is not available till years after drugs are approved and come into wider use. Initial safety trials involve very small groups. So Avandia stayed on the market for over a decade before the FDA took action to limit its use, largely because its maker wasn’t forthcoming about adverse events associated with the drug.

Expanded safety data on many drugs still not available

Avandia is one of 90 medicines that underwent accelerated approval between 1992-2008. Only two-thirds of drugs approved by the accelerated process have followed through with expanded safety trials. So as many as 30 FDA-approved drugs are on the market with few statistically-proven benefits and unknown side effects with prolonged use. The FDA does nothing.

FDA knew prior to 2009

European reviewers, who are geographically distanced from the medical-political battles in the US, reveal that the FDA knew as early as 2001 that Avandia should not be used in combination with insulin because its combination use was associated with increased risk for heart failure. It wasn’t just the 2007 study that doomed Avandia.

A revealing report published in the Texas Heart Institute journal points out that Avandia works by increasing sensitization to insulin and therefore combined use with insulin would produce excessive fuel in heart muscle cells that can result in heart failure. The report points to metformin as the preferred drug for diabetes. It should have been a no-brainer for the FDA to limit combined use of Avandia with insulin. But the agency took no action. Mindless doctors also proceeded to over-treat.

Last year investigators in Italy, reporting in the journal Drug Safety, noted that the class of anti-diabetic drugs that Avandia belongs almost doubles the risk for bone fractures and quintuples the risk for heart attack.

But some reports claim the evidence against Avandia is equivocal. With mixed reports over its safety, some researchers suggest the FDA’s restrictions on Avandia may have been premature.

Expert reviewer weighs in

Noted pharmaceutical reviewer Bernard Cheung writes in Expert Review of Clinical Pharmacology that Avandia modestly reduces the long-term measure of blood sugar (hemoglobin A1c) by just 1% (normal HbA1c ranges from 4.0% to 5.6%) and mildly reduces blood pressure and improves sensitivity of cells to insulin. (If cells are not sensitive to insulin, glucose [sugar] cannot enter cells and blood-sugar levels rise.)

He says this drug is supposed to be used as an adjunct to diet and exercise, not as front-line treatment for diabetes. But that is what it became.

Dr. Cheung says Avandia is “thought to be a poor value for the money in institutions where treatment is paid for by public money.”

Dr. Cheung notes that Avandia induces weight gain that in turn increases the risk for diabetes itself. Every anti-diabetic drug save for metformin induces weight gain.

Dr. Cheung says an updated meta-analysis (grouped studies) still shows an increased risk for heart attack with Avandia, though there was no increased risk for cardiac death. But FDA reviewer David Graham (infamous as a whistleblower in the Vioxx drug scandal where the FDA covered for this anti-inflammatory drug when it was killing thousands), using a review of Medicare records, has found that Avandia does not produce a significant increased risk for heart attack, though it does for stroke and heart failure.

As an aside, the most promising agent that addresses the problems posed by Avandia is resveratrol, known as a red wine molecule. Researchers in The Netherlands note that Avandia induces calcification of arteries whereas resveratrol abolishes this effect in a lab dish. For diabetic patients who remain on Avandia, resveratrol may be a good companion.

Modern medicine is out-pricing itself

It’s bad enough that thousands of Americans are dying prematurely due to the side effects posed by FDA-approved drugs, but to add insult to injury, why do they have to be so expensive?

Raiding pools of insurance money is the current game for hospitals and pharmaceutical companies.

Let’s first take a look at hospitals. A cherished friend recently died suddenly after a brain hemorrhage and a 12-day ordeal in the hospital intensive care ward. The cost – over $1 million (over $80,0000 a day)! Unfortunately he had cancelled his health insurance policy the year prior and was a year away from going on Medicare. His wife is left to pay the bill.

John Lawrence, writing in the San Diego Free Press, says hospitals are playing a game of “your money or your life.” He opens his invective against US hospitals this way:

“Hospital care in the US has morphed into a multi-headed monster in which every advance in medical technology ups the cost of medical care.” Like a recent article characterized a lecherous Wall Street investment firm, Lawrence says US hospitals are “a great vampire squid wrapped around the face of humanity, relentless jamming their blood funnels into anything that smells like money.”

The hospital Chargemaster

Mr. Lawrence refers to “the Chargemaster,” a master file of billable items hospitals can add to a patient’s bill from a lowly aspirin tablet to 5-way heart bypass surgery.

The Chargemaster for a hospital in San Diego lists over 54,000 billable items. All price for all items are far removed from their actual cost to hospitals, says Lawrence. Both hospitals and physicians participate in schemes to run up the bill and profiteer on the side with consulting agreements, stock options, royalty agreements, research grants, and an endless list of other side amenities such as pens and scratch pads for the office and airline tickets to medical conferences.

America certainly has the most inventive doctors. Physician consultants are paid millions for their medical device inventions.

Meanwhile, the public suffers. Mr. Lawrence points to the fact 69% of those who have experience medically-related bankruptcy were insured at the time of their filing. The irony is that Obamacare is headed towards feeding this over-priced system and does nothing to reduce healthcare costs in its first decade. Lawrence points fingers at politicians who want to reduce Medicare entitlements but maintain outrageous reimbursement policies for over-priced drugs.

Blame the man at the top

Tom Freeman of Pinon Hills, California, posts a blog that blames the executive branch of government for th perilous situation in American healthcare today. Mr. Freeman says physicians are not solely to blame, though they may be cited for piling on. The blame goes much higher says Freeman. Here is how he explains it:

“When George W. Bush took office in 2001 one of the first things he did was politicize the agencies that came under his cabinet. The Food and Drug Administration was one of the first to be converted from a regulatory function to an agency assuring profits for an industry it was supposed to be regulating. This is when dangerous, even deadly drugs began appearing on the market.

The conservatives in the Bush administration said it was not fair to require a ‘box car full of paper,’ and take years to prove the safety and efficacy of newly made drugs. They went to a system using laws of probability and random evaluation.”

The results were horrible. Deadly drugs such as Vioxx killed 80,000 people worldwide, yet were approved by the FDA. Resulin, a pill to control diabetes, killed the first patient who used it, says Freeman.

25-cent drug costs $55,000 a year

As if all this weren’t enough insult to the average American, we now read of a breakthrough drug called Tecfidera, newly approved by the FDA for multiple sclerosis. It’s cost: $55,000 a year ($150 a day) for 480 milligrams of this wonder drug.

Of course, it must have taken years to develop and test this novel molecule. And exactly what is Tecfidera? Why it is dimethyl fumarate, a molecule that was first introduced in the 1950s in Germany as a remedy for psoriasis.

A 480 milligram dose of pharmaceutical-grade dimethyl fumarate, the recommended amount for daily treatment, can be purchased from a chemical company for 24.4-cents.

Tecfidera slightly decreases the relapse rate of MS over other drugs (by 49%, less than the 55% and 61% by competing drugs).

What Tecfidera’s maker obtained was a patent claim on a 50-year old molecule by claiming its dosing regimen was novel and worthy of patent protection. The drug company’s chief executive officer said in a press release that: “The patent for this dosing regimen is recognition of the remarkable innovation Tecfidera represents for the MS community.”

What is Tecfidera’s unique biological action? Why it activates something called the Nrf2 transcription factor that triggers the activity of internal antioxidants in the body.

Uninsured multiple sclerosis patients, recognizing Tecfidera is obviously over-priced, have started to search for a more economical alternative. One- patient says he has located a source of fumarate that costs $5 for two hundred 480-milligram doses. One MS patient says he refuses to accept the idea Tecfidera’s maker can charge over $50,000 for a year’s supply of the drug when it is a common food additive!

If searching for an economical alternative, MS patients might venture to a health food store. In the animal laboratory the red wine molecule resveratrol prevented nerve loss in an animal model of MS and resveratrol works without suppressing the immune system as other MS drugs do. A year’s worth of low-dose near research-grade resveratrol can be purchased for less than $400. Resveratrol activates the same Nrf2 pathway as Tecfidera.

A physician speaks out

A prominent doctor, Peter Lind, DC, who practices in Salem, Oregon, has recently spoken out against modern medicine’s current practice of regarding every malady as a drug deficiency.

Dr. Lind notes drugs cause disease, such as drug-induced Parkinson’s disease, liver poisoning by the pain reliever acetaminophen (Tylenol) which is the leading cause of liver transplants, and non-steroidal anti-inflammatory drugs that induce gastric ulcers that result in over 100,000 hospitalizations and 17,000 deaths annually.

The outspoken Dr. Lind, writing in The Washington Times, says adverse drugs events “result in an estimated 2.5 million hospitalizations and 1 million urgent care visits resulting in an additional indirect cost of $65 billion each year to the health care system and result in about 100,000 deaths. However, there are current estimates that these adverse drug events are being underreported by a factor of 10 times.”

Dr. Lind gristles at the fact drugs companies settle lawsuits for millions of dollars stemming from release of unfavorable study results while they make billions in profits. The fines and lawsuits don’t amount to much more than a slap on the wrist.

Dr. Lind boldly says: “It is time to require non-drug practices as first-line approach to health care.”

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