Heroin and Cornflakes

The Christmas festivities are upon us however, as with most good things, there is a downside.

At Christmas, it can be hard to stay healthy.

Susan B. Roberts, PhD Professor of Nutrition and Professor of Psychiatry at Tufts University, points out it’s shockingly easy to gain 5lb or even 10lb in the three weeks between early December and the start of the New Year.(1)

The huge amounts of food prepared cause unconscious overeating — the sight and smell of it sets off metabolic signals of hunger and expand our stomach so that we need to eat more to feel equally full.

She says on Christmas Day alone, we eat about 3,000 calories more than we need with the first chocolate eaten at 8.39am (according to recent research).

So, Christmas is over and a New Year begins.  Oh no!  You can’t fasten your trouser buttons.  You feel the need to shed a few pounds. You still enjoy your food and drink, and find it hard to adhere to a strict diet regime.

So you browse the internet for a few ideas on how to lose weight.

You know exercise gets rid of calories but it’s all too laborious and damn hard work.  You Google ‘how to lose weight fast‘….low and behold – diet pills.

You’re told; ‘diet pills allow you to reduce your weight in the quickest possible time’.

The best part about these pills is that they are not expensive. A number of diet pills are available on the market. The popular ones include: Phentermine, Meridia, Orilstat, and Xenical.

But beware.  You could be losing more weight then you bargained for.

Why the concern?

Well, let’s take a look at one of these weight loss pills; Meridia (generic name: sibutramine).

The Meridia weight loss pill is a prescription diet drug designed to combat obesity. Meridia is produced by Abbott Laboratories which is a diversified pharmaceuticals health care company. It has 72,000 employees and operates in over 130 countries. In 2008, Abbott had over $29 billion in revenue.

To date, prescriptions for the Meridia weight loss pill have topped 9 million.  Individuals using the Meridia weight loss pill tend to lose around 7-11 pounds more than those who simply diet.

Generic Meridia is used to help people lose weight by acting on the appetite control centers in the brain.  It is known to inhibit the re-uptake of particular brain chemicals like serotonin and dopamine. Neurotransmitters (brain chemicals) are what nerves use to communicate messages throughout the brain and body. Serotonin and dopamine are particularly associated with the condition of being full or gratified beyond the point of satisfaction. (2)

Inhibited re-uptake results in an increase in concentration of the brain – chemically resulting in a diminishing feeling of hunger.  A lack of hunger reduces the amount of food eaten, resulting in weight loss.

Decreased serotoninergic neurotransmission has also been proposed to play a key role in the aetiology of depression. The concentration of synaptic serotonin is controlled directly by its re-uptake into the pre-synaptic terminal and, thus, drugs blocking serotonin transport have been successfully used for the treatment of depression.(3)

So it appears raised serotonin and dopamine levels in the body will enhance your mood, and in turn diminish food cravings. These claims are based on the belief that many people eat when they are feeling down and depressed.(4)

However, there’s a drawback.

The Meridia weight loss pill is classified as a Schedule IV Controlled Substance, meaning that individuals can become addicted to the pills.

This is a result of policy in the 1990’s when the International Narcotics Control Board (INCB) issued reports drawing attention to the addictive and harmful nature of “miracle diet pills” — containing amphetamine-type stimulants.

These are a group of potent drugs that act by increasing levels of dopamine and norepinephrine in the brain, inducing euphoria. However, they have a number of adverse health effects ranging from elevated blood pressure to violent behavior and paranoia.(5)

Findings by Jones et al(1999) suggest that an acute effect of amphetamine exposure is the release of serotonin in the ventral tegmental area (VTA) of the brain, which in turn modulates excitation of VTA neurons.

They say this process may be an important early component of permanent changes occurring in the reward pathway that contribute to drug addiction. (6)

Findings like these induced the INCB to remind Governments of the trend of the 1960’s and 1970’s when amphetamines were prescribed for slimming purposes and were common household items, which resulted in their massive abuse and addiction.

The introduction of efficient controls, including strict prescription requirements, 1971 Convention (RESOLUTIONS ADOPTED BY THE UNITED NATIONS CONFERENCE FOR THE ADOPTION OF A CONVENTION ON PSYCHOTROPIC SUBSTANCES) led to a significant drop in direct amphetamine abuse.

Therefore, the Board called on countries registering high prescription levels for anorectics to closely monitor the situation to prevent over-prescription.

It also calls for additional efforts to be devoted to educational campaigns to inform the medical and pharmaceutical community, as well as the general public, of the dangers of indiscriminate use of such stimulants.

In this regard, the Board emphasized the need for countries to strictly adhere to article 10 of the 1971 Convention which prohibits advertising of such substances and encourages the media in all countries to promote a more responsible attitude towards the use of stimulants as appetite suppressants.

However, today Meridia is openly promoted on the internet and can be readily brought online….see example below;

Generic Meridia 10mg Pills			Product info Top
*Meridia® is a registered trademark of Abbott Laboratories
	Quantity	Our Price	Price per pill	Order
	180	$419	$2.33  You save $355	Buy Now
	120	$289	$2.41  You save $227	Buy Now
	90	$229	$2.54  You save $158	Buy Now
	60	$199	$3.32  You save $59	Buy Now
	30	$129	$4.30	Buy Now

This disregard for INCB recommendations may soon have serious repercussions.

Recent developments have seen the re-emergence of major health concerns regarding Meridia. These risks have been feared since Meridia was first approved by the U.S. Food and Drug Agency (FDA).

The FDA is an agency within the Department of Health and Human Services.  It is responsible for advancing public health by helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Meridia was first approved in 1997, by the FDA, against the recommendations of its own FDA review board, who claimed Meridia weight loss pills had side effects that outweighed their relatively limited benefits.

Pre-approval clinical trials showed scientific evidence that patients were three times more likely to experience clinically significant electrocardiogram changes than obese patients taking placebos.

After two deaths related to the drug, Italy suspended all sales of the Meridia weight loss pill, and England and France are both reviewing hundreds of reports of side effects.

A recall of Meridia weight loss pills has been demanded by Public Citizen, an American consumer group, who first petitioned the FDA in March of 2002.

In responding to Public Citizen’s 2002 petition, the FDA said that until a large, randomized study could provide more conclusive results, Meridia would continue to be sold.

Tim Lindberg, a spokesman for Abbott Laboratories, said “science continues to support the safe use of Meridia to treat obesity.”

By March 2003, there were reports to the FDA of adverse reaction system of 49 cardiovascular deaths among patients taking Meridia. Twenty-seven of the 49 (55 percent) were in people younger than 50 years old. The number is likely higher, as the FDA estimates that only one in 10 adverse reactions to drugs are reported to the agency.

Now, the early results are in from a study called SCOUT (The Sibutramine Cardiovascular Outcome Trial) in which 10,000 people across Europe participated.

The recently released results of this study reveal a significant increase in heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients 55 or older with known or undetected cardiovascular disease who used sibutramine, compared with those given a placebo. Both groups were on the same weight management program.

The group Public Citizen announced that it had petitioned the FDA again to ban Abbott Labs’ drug Meridia in light of these results. Because each study group contained 5,000 patients, Public Citizen called the results ’statistically significant’.

According to published reports, Abbott has responded by saying that the SCOUT study was performed on patients for whom Meridia is mostly not approved or recommended.(7)

Yet the author of the report, W. Philip T. James and chairman of the Executive Steering Committee of the Abbott-sponsored SCOUT trial, has close connections to Abbot. In the past, he consulted for Abbott and lectured at Abbott-sponsored symposia.

Public Citizen urges the FDA to take immediate action to ban sibutramine. About 294,000 prescriptions for Meridia were filled in the past 12 months.(8)

In the past, David Graham, Associate Director for Science and Medicine in FDA’s Office of Drug Safety for many years, has said the agency should consider whether its benefits outweigh the risks of higher blood pressure and stroke among people taking it. “I don’t think Meridia passes that test,” and recommends it be placed on a dangerous drug shortlist.

But an FDA colleague, when asked about Graham’s short list, said, “That is clearly Dr. Graham’s opinion.” Dr. Sandra Kweder, deputy director of the FDA’s Office of New Drugs (ODS) , said there is no “magic formula” to determine which marketed drugs are most worrisome.

So what’s going on here?

We’ve got one director from drug safety saying it’s dangerous, and another from a different department, attaching disrepute to his claims.

To understand what David Gratham is up against, it may help to have a knowledge of how the FDA operates and the ‘revolving door policy’.

In 1938, Congress enacted the Food, Drug and Cosmetic Act, basically creating the FDA, in response to an unfortunate incident in which about 100 children were killed by elixir of sulfanilamide, a medication that was formulated using anti-freeze. This Act required that animal toxicity testing be performed and safety information be submitted to FDA prior to approval of a drug.

In 1962, Congress enacted the Kefauver-Harris Amendments to the FD&C Act, in response to the thalidomide disaster in Europe. These Amendments increased the requirements for toxicity testing and safety information pre-approval, and added the requirement that “substantial evidence” of efficacy be submitted.

David Graham, who graduated from the Johns Hopkins University School of Medicine with a Masters in Public Health, has worked for over 20 years in the field – all of it at FDA. He came to prominence when called by the senate to testify against the dangers of Vioxx, heart attacks and the FDA.(9)

Vioxx (rofecoxib) gained widespread acceptance among physicians treating patients with arthritis and other conditions causing chronic or acute pain. Worldwide, over 80 million people were prescribed Vioxx at some time. It was marketed by Merck & Co. to treat osteoarthritis and acute pain conditions.  Merck had sales revenue of US$2.5 billion from Vioxx.

Prior to approval of Vioxx, a study was performed by Merck named, ‘090′. This study found nearly a 7-fold increase in heart attack risk with low dose Vioxx. The labeling at approval said nothing about heart attack risks. In November 2000, another Merck clinical trial named, ‘VIGOR’ found a 5-fold increase in heart attack risk with high-dose Vioxx.

The company said the drug was safe.

In 2002, a large epidemiologic study reported a 2-fold increase in heart attack risk with high-dose Vioxx. In March of 2004, another epidemiologic study reported that both high-dose and low-dose Vioxx increased the risk of heart attacks compared to Vioxx’s leading competitor, Celebrex.(10)

With these high level concerns, Gratham carried out a large epidemiologic study with Kaiser Permanente in California. This study took nearly 3 years to complete and found that Vioxx increased the risk of heart attack and sudden death by 3.7 fold for high-dose and 1.5 fold for low-dose, compared to Celebrex. Among many things, this report estimated that nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx.

When he completed his main analysis, he assembled a poster presentation describing some of his more important findings. He had planned to present this data at the International Conference on Pharmacoepidemiology, in Bordeaux, France.

He concluded that high-dose Vioxx significantly increased the risk of heart attacks and sudden death and that the high doses of the drug should not be prescribed or used by patients. However, this conclusion triggered an angry response from the Office of New Drugs, which approved Vioxx in the first place and was responsible for regulating it post marketing.

“An email from the Director for the entire Office of New Drugs, was revealing. He suggested that since FDA was ‘not contemplating’ a warning against the use of high-dose Vioxx, my conclusions should be changed.”

Gratham says; ” The response from senior management in his Office, the Office of Drug Safety, was equally stressful. I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference. One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting, and also noted that Merck needed to know our study results.”

In mid-August, despite the study results showing an increased risk of heart attack with Vioxx, and despite the results of other studies published in the literature, FDA announced it had approved Vioxx for use in children with rheumatoid arthritis.

Also, on September 22, at a meeting attended by the director of the reviewing office that approved Vioxx, the director and deputy director of the reviewing division within that office and senior managers from the Office of Drug Safety, said no one thought there was a Vioxx safety issue to be dealt with.

At this meeting, the reviewing office director asked why had I even thought to study Vioxx and heart attacks because FDA had made its labeling change and nothing more needed to be done. At this meeting a senior manager from ODS labeled his Vioxx study “a scientific rumor.”

However, eight days later, Merck pulled Vioxx from the market.

Another drug on the market around the same time was ‘Rezulin’.

Rezulin was a drug used to treat diabetes. It also caused acute liver failure, which was usually fatal unless a liver transplant was performed. The pre-approval clinical trials showed strong evidence of liver toxicity. The drug was withdrawn from the market in the United Kingdom in December 1997. With the Office of New Drugs, withdrawal didn’t occur until March 2000.

Gratham says the continued marketing of Rezulin probably led to thousands of Americans being severely injured or killed by the drug even though there were many other safer diabetes drugs available. During this time, Gratham states that Rezulin’s manufacturer continued to make about $2 million per day in sales.(11)

Why does it take so long for the FDA to act?

Following the testimony of Gratham, Senetor Charles Grassley stated that “awful lot of red flags” were raised before Vioxx was withdrawn, and the agency disdained, rather than listened to, its own reviewers.

Graham blames a FDA culture where supervisors intimidate scientists who uncover drug dangers, and pressure them to change their conclusions. When he determined Vioxx was a danger, he says his FDA bosses frowned on the results and refused to act. FDA was still defending Vioxx when Merck finally pulled the drug.(12)

Why would his supervisors intimidate scientists?

After all, this is a government agency – not some drugs cartel from Mexico.

Well, it helps to understand that in addition to campaign contributions to elected government officials and candidates, companies, and other organizations spend billions of dollars each year to lobby Congress and federal agencies. Some special interests retain lobbying firms, many of them located along Washington’s legendary K Street; others have lobbyists working in-house.

Top contributors so far for the 2010 cycle are;

Rank	Organization	Amount	Dems	Repubs
1	Pfizer Inc	$460,263	58%	42%
2	Amgen Inc	$405,809	63%	37%
3	Merck & Co	$304,626	52%	48%
4	Abbott Laboratories	$284,739	52%	48%

As the Center for Responsive Politics*, puts it;  ‘It’s through a door—a revolving door, that shuffles former federal employees into jobs as lobbyists, consultants and strategists just as the door pulls former hired guns into government careers.’

They say government employees may have the president’s ear or may have simply been the doorkeeper of the congressional cloakrooms.  Influence-peddlers merely have to be in a position to influence government policy on someone else’s behalf, commonly as a “hired gun” at a K Street firm, an executive of a professional trade association or as a vice president of government relations for a large company.(18)

For example, during G.W. Bush tenor, the number of records found 466 people in government employment had been through the ‘revolving door’. This is slightly lowered in the present administration of Barack Obama, where number of records found: 256 people.

People who have been through the ‘revolving door’ whose current or former place is the FDA number 57 (click here to see list).

Among this number include Tracy L. Acker who worked in various positions including drug evaluation before joining her current employee lobby firm Reed Smith LLP.  And  Robert G. Pinco whose portfolio is listed below…

2001-	Buchanan Ingersoll Revolving Door Personnel: (12)	Counsel	Firm lobbying profile
1993-1999	Akin, Gump et al Revolving Door Personnel: (111)	Partner	Firm lobbying profile
1974-1977	Food & Drug Administration Revolving Door Personnel: (57)	Dir, Over-the-Counter Drugs
1972-1974	White House Office Revolving Door Personnel: (482)	Asst General Counsel
1970-1971	US Attorney’s Office Revolving Door Personnel: (91)	Special Asst
1969-1972	Bureau of Narcotics & Dangerous Drugs Revolving Door Personnel: (2)	Attorney

Thus it is not hard to understand how men such as David Gratham, who have no conflicting interests and whose  major concern is with the safety of the public, can be intimidated when there is much money and influence being bandied around.

As Thomas Sowell says; ‘corporate lobbying is simply an example of a group having better knowledge of its interests than the people at large, do of theirs’.

Interests that include making millions of dollars to the prolonged detriment of peoples health. Maybe it’s time that people at large had a better knowledge of their interests.

Finally, a drug addiction fact comes to us by way of the Drug Abuse Warning Network (DAWN). Fourteen of the top twenty most abused controlled substances in the United States are prescription drugs.(19)

So, think twice before you undergo your weight loss regime.

Isn’t it time to dust off that exercise bike?

Related articles,

Cold Turkey, Obesity and Sterilization

Driven to ‘Ecstasy’

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Thank you

Ann Margrain

Founder, ‘Heroin and Cornflakes’ blog.

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This entry was posted Wednesday, December 16th, 2009 at 4:27 pm and is filed under general. You can leave a response, or trackback from your own site.