Diabetes Drug to Get Second Look

(CBS)  **Update 7/20/10

On Tuesday, an FDA panel will begin deciding what to do about the controversial diabetes drug Avandia. More than half a million Americans use it, but studies have linked it to an increased risk of heart attack, stroke, even death. CBS News Chief Investigative Correspondent Armen Keteyian reports some doctors have been warning about Avandia for years.

For Dr. Mary Money the medical alarm first sounded in her Hagerstown, Maryland, office 11 years ago - shortly after she first started prescribing a new diabetes drug.

"The first patient that I put on the drug, developed severe fluid retention, severe shortness of breath," Dr. Money said.

A review of her files found more than half - 20 of the 33 patients on Avandia - had developed similar symptoms that could lead to heart failure.

So Dr. Money stopped writing new prescriptions, and started calling other doctors expressing concern about what was to become a blockbuster drug.

"From my perspective," she said, "I was trying to save lives."

The drug's manufacturer, GlaxoSmithKline, didn't see it that way. Sending the chief of staff at her hospital a letter stating Dr. Money was creating "unnecessary ... fear." Requesting she stop disseminating what it called "unsubstantiated information."

Dr. Money said it was "a very upsetting letter to receive from a company, and it did intimidate me."

"In my view, Avandia is the worst drug safety catastrophe certainly in our lifetimes," said Dr. Steven Nissen of the Cleveland Clinic.

In 2007, Dr. Nissen published analysis showing Avandia caused a 43-percent increase in the risk of heart attacks.

"When you stifle debate, particularly about drug safety, often the price that you pay is very high," Dr. Nissen said.

In fact, Senate investigators found three other incidents in which doctors who raised concerns about Avandia's safety say they were intimidated by GlaxoSmithKline. One said he was threatened with a lawsuit.

"I think that the actions of GlaxoSmithKline are certainly worse than almost any other that I can recall," Dr. Nissen said.

In a statement to CBS News, GlaxoSmithKline said it "does not condone any effort to silence scientific debate…" and only seeks to "correct inaccuracies and misstatements." It also said, "Since 2007 we have seen results from six controlled clinical trials ... and together they show that this medicine does not increase the overall risk of heart attack, stroke or death."

But now the FDA is sorting through a mountain of new evidence to see if that's true - including FDA analysis that suggests "serious flaws" in a major clinical trial, the company says, proves the drug is safe.

Dr. Money, meanwhile, remains proud of the fact she never rolled over despite all the pressure.

"We have a responsibility to our patients to do no harm and to look after them," Dr. Money said. "I think we have to be willing to take the risk regardless of what might happen."

Since questions were first raised about the drug, sales have dropped by half. But Avandia is still a billion-dollar-a-year drug.

What are the options for the FDA?

The FDA has some of its most severe warnings on Avandia, meaning doctors are being very careful before prescibing it.

This week the FDA can do nothing, and wait for the additional ongoing studies being funded by the drug company. They can add more warnings. Or it's possible they could pull it off the market altogether. Anyone who is on the drug should be paying very close attention and talking to his or her doctor.

**Update 7/29/10

Dr. Mary Money's latest researchlooks at the diagnosis and treatment for Irritable Bowel Syndrome that affects 10 to 15 percent of the U.S. population. Dr. Money says most of her patients' symptoms clear up if they are prescribed pancreatic enzymes to take a few times a day or before eating certain "trigger foods". Dr. Money says her patients who respond to the treatment are so relieved that they think she "walks on water."

[Paul123z]

There are a few interesting related write-ups to this at the Skeptic's Health Journal club. At least I consider them interesting as I wrote them. Avandia and Earwax
http://healthjournalclub.blogspot.com/2010/02/avandia-and-earwax.html
provides the background of what the Senate funded investigation into Avandia found. David Graham and the tragedy of Vioxx parts I and II discuss in part I, some of the culture at FDA and in part II the specifics of what occurred with the withdrawal of Vioxx. If anyone is interested those may be accessed here.
http://healthjournalclub.blogspot.com/search/label/Vioxx

Yes Avandia needs to be recalled, the risk/benefit ratio is not there for a me-too diabetes drug and how strange and sad that a senator had to use his own staff resources to research and bring attention to this issue, something FDA should have done on its own.

[cktirumalai]

For myself, I would not take a drug whose safety is not unanimously established. I understand there are older, safer drugs for diabetes, though they may work less miraculously for some patients than Avandia does.
Vioxx was once hailed as a wonder drug for arthritis until problems associated with its use surfaced and were so insistent they could no longer be ignored.
Candadai Tirumalai

[haryybell]

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[alphaa10000]

THE PRICE OF INTEGRITY

CBS reports, "This week the FDA can do nothing (further to regulate the drug), (but) wait for the additional ongoing studies being funded by the drug company...
---


Some Troublesome Questions--

The FDA can do nothing but wait on the drug company?

We can be sure of this much-- the drug company will take all the time it needs to generate new data showing

its profitable drug does not increase heart attack risk by 43 percent.

Meanwhile, millions of Americans have been placed unnecessarily at grave risk of heart attack.

Again, is this any example of true regulation by the FDA in the American public interest?

Does the FDA-- chartered as a federal regulatory agency-- do its own review and verification of drug claims, or is this the sacred GOP canon of "self-regulation" by industry ?

Does the FDA, in fact, base its protection of millions of Americans on the worn-out industry sham of "trust us"?

If "trust us" is the slogan, how is this GOP-style DEregulation of drugs any different than the GOP-style DEregulation of oil that brought us BP's "Gulf Gusher"?


A Troublesome Performance--

For a new administration campaigning in 2008 for reform of Washington power politics, this is a critical period of reform for the FDA.

So cozy has been the FDA with corporations generating massive profits from new vaccines and pharmaceuticals, Sen. Bart Stupak (D, MI) asked Obama not to appoint anybody from within the agency as the FDA's new chairman.

As if to make his point, Dr. Janet Woodcock, head of the FDA's drug division, was embroiled in intense controversy over an FDA green light to importing contaminated heparin from China.

And to put an ever sharper edge on the same point, Dr. Julie Gerberding of CDC could not wait to resign to take a position with vaccine maker Merck. Gerberding had helped award huge federal budgets to vaccine makers during the H1N1 pandemic scare in fall, 2008.


The Price of Integrity--

Again and again, the price of integrity for doctors who put their patients first and drug salesmen last always has been high. Such doctors are typically idealistic, committed to their healing art with high personal and professional standards.

Why should we continue to allow them to be punished for trying to do their professional best on our behalf?

Such doctors do not get the cruises and golf junkets (pardon, the "seminars"), and the other shiny, just-below-the-adar trinkets that effectively constitute payoff, payola, kickbacks, and all the other evils of a DEregulated market.

Instead, they get legal threats, subtle warnings from their hospital, from medical associations, from even colleagues that they have "gone too far" in patient advocacy.

After all, the implicit question goes, since they cannot be serious, just whose side are they on?

Next to industry whistleblowers, theirs is the loneliest struggle on behalf of the American public interest.


A DEregulation Primer--

As with BP and federal officials of the Minerals and Mining Service branch of the US Department of the Interior, the first thing industry attempts to do is compromise regulation-- (1) ignore regulations (2) negotiate them away or finally (3) co-opt or "buy-off" the regulators and inspectors.

Critics have charged the FDA with aiding and abetting all three industry tactics.

(1) To ignore regulations, a major pharmaceutical manufacturer will "interpret" a regulation to its own convenience. If finally called by the FDA to answer for its non-compliance, the agency almost never punishes industry for an infraction or requires prompt compliance.

(2) To negotiate regulations away, GOP DEregulated industry creates a warm, fuzzy atmosphere in which parties regulated suddenly become "clients" of the regulatory agency.

The FAA during the Bush term of DEregulation specifically rewrote its regulatory manual to identify industry as a "client" for which the agency's job was to bend over backwards, and to identify the American consumer-- whose life is at risk-- as a third party.

(3) To co-opt or buy-off regulators, industry can read the manual written by BP for its training and discipline of a DEregulated Interior MMS under Reagan, Bush1, Clinton and Bush2.

In the BP view, the American public is not in charge. Our dependency on BP is divinely ordained-- BP will bring us the oil, and we gladly will pay whatever BP asks.


What Must Be Made Clear to Industry--

The FDA has become so lax and indifferent with regulation of the drug industry, the drug makers themselves embark on "search and destroy" missions against critics.

Over the past 20 years, the FDA-- assigned the mission of safeguarding Americans from unscrupulous, ineffective, dangerous and fraudulent drugs and treatments-- has become the lapdog of the drug industry.

[baileyccc]

What a surprise, major flaws from clinical trials, looks like stand operating procedures from Big Pharma to me. Damn the lives, there is profit to be made. posted by baileyccc