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.

[grazinggoat]

CBS: 'Top Diabetes Doc Says Glaxo Threatened Him
Says He Was Warned In 1999 He'd Be Held Responsible For Hurting Drug Sales'

-What's new? Oil cowboys and smilish Pharma corps sleep in the same bed. Giving k-backs to the same GOPs electoral cashbox. Aren't they?

-They also hate the democratics and are against anything that will help the middle-class and the poor in America save a coupl-a-bucks. They will not allow any system that makes their medication accessible to the population at a resonable price with such programs as the universal coverage the Democrats have promoted so much...

[torocaca]

"Dr. John Buse was contacted by Glaxo in 1999..."

Now there's a selfish spineless coward who possible let hundreds die because he didn't have the courage to stand up for his convictions.

The drug companies and wealthy rule and the rest of us eat ***** and bark at the moon. LOL!!

[stephanienym]

I wonder if the people who were the testing guinea pigs knew they were being studied for this drug. We are all at the mercy of these Pharmaceutical companies and really the people need to start taking a stand against them, somehow, someway!

[anniepema]

There is also a strong connection between the risk of non-familial diabetes, cancers, Alzheimer's, autism, schizophrenia, lupus, MS, etc. and the father's age at the conception of a child that the pharmaceutical companies hide from the public in order to enrich their coffers. So on top of selling drugs that can kill you they have sold the public on the glamour of older dads.

[hypnotoad72]

Money is not evil, but the love of it is.

Satan must be approaching a really big orga$m by now.

[preacherbob1]

Now dear gentle folks, you really don't believe this pack of half-truths and ill conceived memoriam, do you?

You, as well as I, know that the medical professionals and the drug companies all exist to further our good health and happiness, don't you?

Remember the Hypocritic Oath?

Dr. Robert Brown

[antoniof123]

Its so nice to know that these big companies like big religion have our best interest at heart. I am sure there is a special place in hell for this group. What is so funny they beleive that if you give enough to the religion you will be saved.

[macusweil]

Totally out of control!!

The BIG drug & insurance companies are ruining health care in America. Their economic model siphons money out of the system without creating at least equal or greater value. This will lead to the eventual outcome of bankrupting the entire US health care system.

[leidhold]

pharmaceutical companies and most doctors are in the same bed w/ each other.

THEY ARE CRIMINALS.....

WHITE COAT CRIMINALS!!!!


LEDIHOLD...
MY OPINION ALWAYS...

[future121]

My husband past away 6 years ago from heart failure due to diabetes. He was on 10 different pills one of which was advandia. Personally I think overmedication due to medication to compensate for issues from medications complicated his system and it became unbalanced. Orginally rezlin (pulled of becuase it killed people) was prescribled and I fought the doctor because it was killing people. My doctor said "I would nto knwingly give him bad medicaine" yet two weeks later the drug was pulled. Advandia was not the best choice either but it was better then rezlin. Now I find that also was "bad". I am discused with the seemingly ineptide of our drug makers and doctors who only excuse is "I would not ever do it knowingly" I would prefer they concentrate on the "knowing" and not the best guess.

[whitehorse12]

Right - Fully agree - Lets forget about asprin, insulin, penicillin, vaccines, morphine, or more recently benzedrine, thorazine, antivirals. And how about 6-mercaptopurine. Any idea how many kids died from lukemia before that was invented by Trudy Elion working for the evil pharma?

[boston1954]

Remember the Hypocritic Oath?

Dr. Robert Brown


It is possible that the average person does NOT know the wording for that.

[toldyouso21]

A 40% increase for heart attack is enough to have this product yanked from the shelves and IS enough to PANIC. Diabetes is a slow death, that usually results in the patient dying of complications rather than the illness itself. The last thing a person debilitated with diabetes needs is a heart condition or a heart attack. What was the % in mortality for this drug?

[toldyouso21]

Dr. John Buse was contacted by Glaxo in 1999..."

Now there's a selfish spineless coward who possible let hundreds die because he didn't have the courage to stand up for his convictions.
Posted by torocaca at 11:56 AM : Jun 06, 2007

Stand up and do what? Do you have any idea how the Pharmaceutical industry even operates? That often, the FDA is in their pocket? (remember the generic drug scandals of the late 1980s, early 1990s) If this man had "stood up" the only thing would have been that this company and possibly his profession would have ruined him. It took these studies and a change in the guard in Congress to even look at this. Had the GOP still held Congress--this would never have been investigated and likely would never have been reported.

[toldyouso21]

wonder if the people who were the testing guinea pigs knew they were being studied for this drug. We are all at the mercy of these Pharmaceutical companies and really the people need to start taking a stand against them, somehow, someway!
Posted by stephanienym at 12:28 PM : Jun 06, 2007

People who participate in studies are in what are called "clinical trials" they are usually given the drugs for free, and sign waivers that remove most liabilities from the company for the privilege of trying the product.

You may recognize clinical trials: it is what you hear on the radio, when volunteers are looked for to test a new drug or product and may even be offered money to do so.

The scary part is the empirical data a company builds up. That is all the side effects they find out about their product AFTER the FDA says it is safe. Overtime, more is learned about a product from a lot of people in the public using it. This can be anything from rashes to kidney failure, brain damage or birth defects to death--so in a way, patients are always the guinea pigs to drug companies for YEARS even after the FDA says it is safe. This is because a Clinical study is controlled but does not really reflect the real world--so a lot of what is wrong with a product only comes out when ordinary people use it.

[toldyouso21]

Now I find that also was "bad". I am discused with the seemingly ineptide of our drug makers and doctors who only excuse is "I would not ever do it knowingly" I would prefer they concentrate on the "knowing" and not the best guess.
Posted by future121 at 03:00 PM : Jun 06, 2007


Hello. First I want to express sympathy for your loss. I worked in the Pharm and bio mfg for almost 2 decades as an investigator and systems auditor. There is something you need to know about medicine. Doctors do not know anything about most drugs. They only know what the drug sales reps tell them and what is written in the PDR. (Physicians Desk Reference) Everything from the chemical composition to how a drug interacts is told to them in that reference. Even drug interactions are spelled out but they cannot cover all the combinations real people experience (the variables would be limitless) instead they concentrate on known responses and interactions like MAO inhibitors, the effect on children, pregnancy, etc. I know it is too late, but now the PDR can be purchased at most Book stores. Even when you get a drug, look it up under the brand or chemical name and read what it can do. Often Drs just do not know.

In the Pharm. Industry, and health field, Drs are often thought of as the rock stars, but they could not do anything without the medicines and equipment made and TAUGHT to them by the Pharm, bio and medical deviced fields.

[toldyouso21]

Posted by whitehorse12 at 03:39 PM : Jun 06, 2007

Very few products are actually invented by anyone in the Pharm., industry. Chemicals are isolated, recombined etc--but rarely is anything original. A lot of the drugs attributed to the Pharmaceutical industry were not discovered by the industry. They are the repackaged versions of natural substances often used by indigenous people. For instance, Quinine and aspirin salicylic acid (aspirin) were used by natives to cure or treat malaria and aches respectively. Vincristine (an anticancer drug) is distilled from flower from the amazon and was used by natives to treat tumours. Biopharmacists routinely travel the world, live among tribes and try to learn their methodologies and sources for natural cures--these then are tested and retested in labs, and often tied to excipients so that whoever markets it can say the product is unique and theirs alone. For their research and trouble, they are given a a license after their MDA is approved. Often a synthetic source nmay be produced to reduce costs or to make the drug more proprietorial than leaving it in its natural state. I say this to point out that even some of the greates pharm advances was nothing more than copying the idea of others and having the good sense to market it--of course the testing and trials are why these products are so expensive--that, and that sometimes the natural ingredient is rare and cannot be synthisized.

[starleo146]

I was on avandia and guess what yep! heart attack, my heart doctor took me off of it and said it causes fluid to gather around the heart there is another that does the same thing but they haven't said anything YET, that is called Amaryll I don't know if it is spelled right you diabetics know what I'm talking about that does the same thing. These doctors and pharmaceuticals and the FDA are all in bed together and I feel like I'm being used. I can tell you a story about how they are getting away with stuff and you bring the information to the doctors attention and they look at you and say what are you going to do they got us over a barrel, now that is what I wanted to hear.

[yamuttya]

The BIG drug & insurance companies are ruining health care in America. Their economic model siphons money out of the system without creating at least equal or greater value. This will lead to the eventual outcome of bankrupting the entire US health care system
Posted by macusweil

That's right! Maybe then Americans will come to their senses, join the other western countries and adopt a Canadian style system where everybody wins. Perfect it's not, but its infinitely better than the insane US system.

[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.

[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.

[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]

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.

[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.

[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.

[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?

[iceman_1960]

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

- The Constant Gardener, 2005 film.

[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

[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.

[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.

[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!!

[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...

[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

[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.

[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!

[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?