Top Diabetes Doc: Drugmaker Threatened Me

Dr. John Buse Says He Was Warned In 1999 That He'd Be Held Responsible For Hurting Drug Sales

(CBS/AP)  The controversy surrounding GlaxoSmithKline's diabetes drug Avandia grew Wednesday as a medical expert told Congress that executives threatened to sue when he first raised questions in 1999 about the treatment's safety.

That testimony, coupled with a recent medical journal analysis highlighting the heart attack risks associated with Avandia, prompted some Democratic lawmakers to rebuke the Food and Drug Administration for failing to protect consumers, and to call for stricter industry regulation.

"Despite additional warnings from outside experts, despite the millions of patients who rely on Avandia to control their blood sugar, and despite the potential risks involved, FDA never required the manufacturer to conduct a thorough post-market study of its heart risks," Rep. Henry Waxman, D-Calif., said.

Waxman, who chairs the House Committee on Oversight and Government Reform, called Wednesday's hearing after an analysis that appeared last month in the New England Journal of Medicine concluded Avandia could raise patients' risk of heart attack by more than 40 percent.

GlaxoSmithKline calls the whole controversy overblown, reports CBS News correspondent Wyatt Andrews. CEO Jean Pierre Garnier acknowledged the need for more studies, but described Avandia as safe.

"In other words, with Avandia, the risk of a heart attack is very infrequent and not necessarily any more than other similar medicines."

Glaxo argues that its own patient studies are a more reliable measure of the drug's safety, although outside experts say the company's results are inconclusive.

Dr. John Buse told lawmakers that after he drew attention in 1999 to heart problems among some patients using Avandia, SmithKline Beecham, which later combined with GlaxoWellcome, warned him that some executives wanted to hold him accountable for a $4 billion drop in the company's stock.

In a letter to SmithKline distributed at the hearing, Buse wrote: "Please call off the dogs. I cannot remain civilized much longer under this kind of heat."

Buse, who is head of endocrinology at the University of North Carolina and is set to become president of the American Diabetes Association, said he eventually signed a clarifying statement with the company that was used to ease concerns from investors. But one year later, Buse sent a letter to the FDA raising the same concerns.

FDA Commissioner Andrew von Eschenbach told Congress his agency is still reviewing dozens of often contradictory studies and analyses on the drug's effects on diabetics. FDA has scheduled a July 30 meeting to have a group of outside experts look at the data.

Von Eschenbach revealed that FDA is ordering Glaxo and rival Eli Lilly to add black box warnings to their diabetes drugs Avandia and Actos, strengthening existing warnings about heart failure, a condition where the heart does not adequately pump blood. The issue is separate from the trend toward heart attacks highlighted in the New England Journal of Medicine.

The problem came to light two weeks ago, when the journal published a study by Dr. Steven Nissen of the Cleveland Clinic that showed pooled results of 42 studies suggesting that Avandia raised the risk of heart attacks by 43 percent and possibly heart-related deaths.

"What patients need to know is there is some evidence of cardiovascular harm from Avandia — but there is not any reason to panic," Nissen told WebMD last month.

More than 6 million people worldwide have taken Avandia or a related drug, Avandamet, since it came on the market in 1999. Glaxo reported total U.S. sales of $2.2 billion for the drug last year.

Avandia's label (.pdf) already warns about possible heart failure and other heart problems when taken with insulin. The drug also raises LDL, or bad cholesterol, and can cause fluid retention and weight gain.

For its part, Glaxo released the most recent results from a large-scale study of Avandia ahead of the hearing. The study compares Avandia with two other diabetes pills in nearly 4,500 people around the world. Drug maker GlaxoSmithKline PLC released results of the first few years of the six-year study showing similar rates of heart-related deaths and hospitalizations among those on Avandia versus those on the other drugs.

The Senate recently passed a version of a bill that makes major changes to FDA's drug safety system. Companion legislation has not yet appeared in the House. Waxman and other leading Democrats said they favor legislation that would give FDA more power to require companies to conduct drug safety studies.

Shares of GlaxoSmithKline fell 44 cents to $51.46 Wednesday on the New York Stock Exchange.

[zonate8811]

"Medical miracles" are killing people by the millions, thanks to the FDA which is owned by Big Pharma. Together, these two monsters are out to "make a killing" financially, and if they kill YOU, so what? Don't ever think these criminals give any thought to their actions.

The pharmaceutical gangsters control the entire medical profession, from medical schools to hospitals to government bureaucracies to the money-grubbing swine in the Congress and Senate.

The entire government-medical complex is a cancer on our society. They have no intention of "finding the cure" for anything. The entire focus is on "managing your disease."

If these con men are so important to our survival, how did the human race live for millions of years before their brainwashing and deceptive nonsense?

[zonate8811]

"Medical miracles" are killing people by the millions, thanks to the FDA which is owned by Big Pharma. Together, these two monsters are out to "make a killing" financially, and if they kill YOU, so what? Don't ever think these criminals give any thought to their actions.

The pharmaceutical gangsters control the entire medical profession, from medical schools to hospitals to government bureaucracies to the money-grubbing swine in the Congress and Senate.

The entire government-medical complex is a cancer on our society. They have no intention of "finding the cure" for anything. The entire focus is on "managing your disease."

If these con men are so important to our survival, how did the human race live for millions of years before their brainwashing and deceptive nonsense?

[zonate8811]

"Medical miracles" are killing people by the millions, thanks to the FDA which is owned by Big Pharma. Together, these two monsters are out to "make a killing" financially, and if they kill YOU, so what? Don't ever think these criminals give any thought to their actions.

The pharmaceutical gangsters control the entire medical profession, from medical schools to hospitals to government bureaucracies to the money-grubbing swine in the Congress and Senate.

The entire government-medical complex is a cancer on our society. They have no intention of "finding the cure" for anything. The entire focus is on "managing your disease."

If these con men are so important to our survival, how did the human race live for millions of years before their brainwashing and deceptive nonsense?

[zonate8811]

"Medical miracles" are killing people by the millions, thanks to the FDA which is owned by Big Pharma. Together, these two monsters are out to "make a killing" financially, and if they kill YOU, so what? Don't ever think these criminals give any thought to their actions.

The pharmaceutical gangsters control the entire medical profession, from medical schools to hospitals to government bureaucracies to the money-grubbing swine in the Congress and Senate.

The entire government-medical complex is a cancer on our society. They have no intention of "finding the cure" for anything. The entire focus is on "managing your disease."

If these con men are so important to our survival, how did the human race live for millions of years before their brainwashing and deceptive nonsense?

[prinzowhales]

Merck has murdered nearly 60,000 people with Vioxx...does anyone really think that the FDA is protecting them? No one is slinging cruise missiles at their executives though they have killed twenty times as many people as al Qaeda is accused of killing. The FDA has been the bootlick of Big Pharma for decades. It was Donald Rumsfeld who, over the objections of FDA scientists got aspartame approved--countless people have cancer, migraines and Parkinsons from this Searle 'sweetner' while the same FDA burns Stevia cookbooks. To 'ell with the FDA, Big Pharma!

[drinuk]

Von Eschenbach should resign NOW, A panel of outside experts indeed! The only experts I would recommend to investigate all these scams are the FBI, time thay took a serious look at the whole crooked setup.

[hugepeter]

Are you saying that diabetes is cured. If you want to get low rate american express credit cards check out http://www.credit-card-gallery.com

[gaye5]

Well before the push for a global village and before companies were allowed to become giants, there was control, governments controlled but now business controlling even the governments.....
They have the power and money to deceive the public, they can silence any whistle blower either by threats to him/her their family or death... There is no way that any big company can ever be trusted, money speaks louder than ethics and morals.. I have no doubt that there are some conspiracies out there, but what...world control????,, we are not told even simple things like fluoride lowers the IQ, and makes people docile thus easier to control, anyone who lets the world know such things would be destroyed... they would ridicule anyone who even suggests this...
All we have to do is look at the horrific increase in disease and deaths especially our children.. but they have excuses for that also, they have to hid the real problems so as to keep pushing their drugs....
I have read that the hepatitis injections can cause diabeties??? but of course this would be denied, two of my neighbours (a husband and wife both born in different countries) got diabeties a few months after their hep injections??? concidence maybe...

[mcvet]

Should the doctor be able to prove the threat, the FDA should step in on his behalf and apply the same sanctions against the company. Is it not their job to protect the consumers against just this sort of thing?
Posted by brianbwb at 01:48 AM : Jun 07, 2007

No, like everything else since Bush took office, the FDA has been turned on it's head and is being run by those it's suppose to oversee. Just one more failure of the Worst Administration in U.S. History!!

[samrensho]

Big pharma gives hundreds of millions of dollars to the campaigns of the major Whitehouse contenders. It costs so much to get elected that no matter who wins they will be very beholding to the pharmaceutical sector and you can't expect any changes to the status quo. Serious campaign funding reform is what is needed first but the only ones who can enact such reform are the beneficiaries. Nothing will change.

[drinuk]

God Bless these three brave men. This is just a very small example of the way in which Big Pharma, threatens and bullies the medical profession worldwide. They are the scum of this planet, villians of the first order. Furthermore it is a glaring example of their incestuous relationship with the FDA and similar governing authorities around the world.

To all those medical professionals currently in Big Pharma's pocket and singing their tune, the caveat is...You are being watched, jump off the bandwagon before you are pushed off.

Whoever is elected to be the next incumbent of the White House and resonsible for the Nations welfare, they would be well advised to put Big Pharma, the FDA and corrupt medical professionals at the top of their hit list. Iraq pales into insignificance compared to the Danger to World Health caused by these evil money grabbing people.

[jun3968]

I do have some concerns about Avandia but what I really want to know is; when the studied was conducted what was dosage used and how long did the patients use the drug? Because I have been on and off Avandia for the past 4 years. I haven't any problems with the drug, currently I am taking Avandamet. I have read some of the study information but it is really confusing to me, is there any way that someone can break it down into plain english, so normal people can understand the jargon. Thanks

[iceman_1960]

"Big pharmaceuticals are right up there with the arms dealers."

- The Constant Gardener, 2005 film.

[brianbwb-2009]

The part not being discussed here is the threat of a lawsuit for raising a legitimate concern, based on statistical evidence, of the harmful side effects of a drug. the company thought it better to hide this, and threaten the doctor that brought it to light.
Had I been on the jury, the company would have lost the case, been made to pay the doctor's legal fees, and his time loss, based on billable hours, for fighting the case, and a multi million dollar award as penalty and warning not to continue this practice.

Should the doctor be able to prove the threat, the FDA should step in on his behalf and apply the same sanctions against the company. Is it not their job to protect the consumers against just this sort of thing?

[andor3]

It's all about trust. Patients cannot know all the details of the drugs. Although I try: I look everything up in PDR and question my doctors. More than once I've caught something that was mis-prescribed.

Point is, if you can't trust your doctor, can't trust the FDA, can't trust the PDR even, yet taking no drugs can be a bad choice--you are in a no-win situation. You can't even make a fair assessment of the risks you incur.

The system needs to be changed to restore trust and allow patients to understand and evaluate the risks of treatment options.

I can't fault big pharma too much--even if they are doing evil things, it is only because they are part of the system. Any pharma CEO who tried to do it differently would likely be on the street because he is not doing his job which, sadly, is really only to increase shareholder value without breaking the law.

[toldyouso21]

correction:

Because many companies can copy a product once it loses its patent, there are TOO many descriptions. The PDR will usually show the brand name drug and maybe a few generic examples--be sure to match like with like. For instance if you are taking a capsule--look up the capsule NOT the tablet. there is a difference, especially in how fast one is assimilated into the system. if you look at liquids, then know if it is a parenteral or not (injectable) If it is an IV drug, then you are under medical care when you get the drug, the contraindications etc, can differ depending on the form the drug is in.

Finally, be very wary of drs who prescribe medicine by age----this does not make sense. Medicine is made by potency to body wt ratio--this means that more important than a persons age is how much they weigh. The larger the person, usually the higher the potency they can take and maybe even the more of a product they may need--while with other drugs, adipose or fat tissue could pose a problem as some medicines are stored in excess fat and could be risky.

The real danger with the PDR is the TMI--the information will scare many, if they do not understand the risk levels and circumstances for some of the info.

[toldyouso21]

toldyouso21

You are providing wonderful information. Keep up the good work!

I'd like to point out another use for the PDR. It is the description and picture of what your medication should look like. This part keeps the pharmacists honest or at least careful.
Posted by barbaraf4 at 10:18 PM : Jun 06, 2007


YOu are right to a point. the PDR usually only shows the description of the brand name product. After a license runs out, a generic company can deconstruct a drug and try to market a generic version. Because the hard research is already done, they just have to figure out how a product is put together and duplicate it to a point. This is accomplished with a C of A which tells how much of each active ingredients, and stabilizers/preservatives and in what range they must fall. The generic company then files for a license. When they make their product the bottle and pills must look different from the original brand. Because many companies can copy a product without a patent, there are two many descriptions. The PDR will usually show the brand name drug. If you do not have the brand name --you can look it up in the PDR and it will also give the chemical or generic name. You can review that to determine what the product must be like. Drug id is very important since it has been determined that hundreds of thousands of pharmacies dispense the wrong products each year.

[barbaraf4]

toldyouso21

You are providing wonderful information. Keep up the good work!

I'd like to point out another use for the PDR. It is the description and picture of what your medication should look like. This part keeps the pharmacists honest or at least careful.

[toldyouso21]

At least that is on the fact sheet they gave me when I went in to check. So based on that I am still on Avandia.
Posted by arty1sgt at 06:49 PM : Jun 06, 2007


do you take a diuretic? because if you do, then you are one of the ones that gain fluid --you just don't realize it due to the drugs you take to decrease edema.

[arty1sgt]

The Veterans Administration has determined that since the difference in the study was only 14 heart attacks (86 out 0f 14,000 on the drug and 72 out of 12,000 not on the drug) that there is no problem. They also say that people with diabetes are already in danger of heart attack anyway. They recommend that if your blood sugar is well controlled and you don't retin fluid stay with Avandia. They also recommend if you already have heart disease or retain fluid you may want to change drugs treatment. At least that is on the fact sheet they gave me when I went in to check. So based on that I am still on Avandia.