HADCORP NEWS UPDATE: September 8, 2008

[Guest guest]

----- Forwarded Message ----From: "humanadjuvantdisease@..." <humanadjuvantdisease@...>Also in this edition:

Medicine wins when doctors say no (USA)

Pharmaland: sometimes it’s all in the name (India)

HADCORP NEWS UPDATE: September 8, 2008

French plastic surgeon gets jail sentence for 'garage surgery'

AFP

7 hours ago

MARSEILLE, France (AFP) — A French court on Monday sentenced a cosmetic surgeon to four years in prison for mutilating and endangering the lives of dozens of his patients.

Michel Maure, who claimed to be one of the world's best plastic surgeons, was arrested in Spain last month after going missing while awaiting the verdict of his trial in the southern French city of Marseille.

The sentence was handed down in absentia and Spanish authorities were expected to transfer him to French custody within the next two weeks, said his lawyer Dominique .

Maure, 59, was given a four-year sentence, one of which was suspended, on charges of false advertising, deception, and causing involuntary injury.

"He engaged in a type of garage surgery that showed a total contempt for others," said judge Turbeaux, who cited the doctor's "particularly shocking" attitude.

Close to 100 of his patients had lodged complaints against him, describing excruciatingly painful procedures carried out in unsanitary conditions at his clinic.

In rendering the verdict, Turbeaux noted that Maure did not have a qualified nurse assisting him during surgery.

"By doing this, Michel Maure knowingly put the lives of his patients at risk," he said.

The plaintiffs were awarded compensation ranging from 1,000 euros (1,400 dollars) to 7,586 euros, with the total sum equal to tens of thousands of euros.

"The masks have fallen," cheered lawyer Jerome Rambaldi, representing about a dozen of Maure's clients.

"We can only hope that pseudo-cosmetic surgeons will remember this conviction and will not engage in the same type of practices," he said.

Maure was convicted of falsifying his qualifications to lure clients to his clinic where there was little regard for basic safety rules.

Many of Maure's mostly female patients described his methods as "violent." He carried out painful procedures, such as liposuction or the insertion of breast implants, under a simple local anaesthetic, they said.

His patients complained of chronic pain and infections. Several have had to undergo reparatory surgery.

Maure, who claimed to be the "victim of a plot," was in 2007 struck off France's medical register.

Maure's lawyer said he would appeal the verdict, describing it as "extremely harsh" and argued that his client did not have the financial means to make the compensation payments.

"Since he was forced to end his practice four years ago, he has had no source of revenue," said .

Some of the patients said they were disappointed with the ruling.

"We were expecting more but the important thing is that he can no longer practice when he gets out of prison," said Nadia, who underwent surgery for breast implants at Maure's clinic.

Sandrine, 25, who suffered complications from breast implant surgery, said the damages she was awarded were not enough.

"I did not get enough for a new operation," she lamented.

BIG PHARMA

Medicine wins when doctors say no

Boston Globe

United States

By Dr. McEvoy September 8, 2008

I need to come clean about something. I did take the little black doctor bag.

Upon completing medical school, all the graduates were offered a free bag from a drug company. Since our class was full of semiradicals from the antiestablishment, war-hating tumultuous '60s, taking a free gift from "the man" was no small violation. But it was a cute little bag, and I had worked really hard to get it.

It was a small sign of things to come. Hardly a day goes by without yet another story about the evil influence of Big Pharma on medicine. Last month, Governor Deval signed legislation directing state regulators to ban most restaurant meals and small gifts that pharmaceutical companies provide doctors and requiring public disclosure of industry payments or gifts over $50. I applaud this effort to make interactions between doctors and pharmaceutical companies transparent.

Pediatricians are considered small fish by the medical industry in that we do not perform procedures using expensive (and lucrative) equipment, and the medications we use are cheap and infrequent. However, as the medical director of our practice, I have had a bird's eye view of the insidious creep of outside influence from the medical industry.

In the early days of my practice in the 1980s, I often saw pharmaceutical representatives pull their sample-laden suitcases through the waiting rooms. A drug rep would buttonhole me and my colleagues as we moved between patient exam rooms, thrusting a recent studies at us about how a certain product had been shown to be superior. These attractive and often charismatic sales reps would somehow spit out a quick spiel before you had time to think. The path of least resistance was to accept the "unbiased study," along with several free samples for the practice. And then, of course, the treats would follow - pads of paper, pens, and perhaps a new toy for the kids in the practice - usually with drug logos stamped on them.

When Ceclor, an antibiotic used to treat resistant bacteria, was introduced in the '80s to treat ear infections, drug reps were all over pediatricians' offices. Since I had their studies in hand, samples of the "purple medicine" nearby, and easy access to dosage charts, it was the path of least resistance to use the drug, which at the time, was a good medication.

If you were a cardiologist or urologic surgeon, the treats would be more likely a posh dinner at a four-star restaurant and tickets to a ballgame.

As pharmaceuticals and medical equipment became a larger part of medical care, the stakes got higher, and the industry found new and more effective ways to influence physicians. Medical schools and hospitals have long partnered with the medical industry to sponsor educational conferences and research. As federal funding for research has leveled off, academic centers have become more dependent on industry to fund important research and educational forums. However, despite rigorous disclosure policies, it has become apparent that the slippery slope to unbiased medical practice is hard to navigate.

When I accepted the position of medical director for our practice in the mid-'90s, I had a new window on the powerful influence of the drug industry. Accepting a dinner invitation at a first-class restaurant to hear about a new cholesterol-lowering medication, I joined a group of medical directors from all over Massachusetts. The invitation seemed harmless to me at the time. I could tolerate a pitch about fat while munching on filet mignon and savoring pastries. I was concerned, though, the following week when the charming host for the evening called me and offered to pay me hundreds of dollars "under the table" if I allowed a drug rep to pitch our group at our next practice meeting. Now even a traitor who accepted a black bag from "the man" knew an ethical line had been crossed here.

Our group decided to ban all sales reps from the office a decade ago, as the medical community became more aware of the corrupting influence of pharmaceutical detailing. We would accept no more free samples. No more pizza lunches. And certainly no more posh evenings out for me. The decision was a hard one for the group, because the sample medications were often used for patients who could not afford medications. And the lunches were popular with the staff; after all, nobody was giving them free anything.

It turned out that deciding to remain drug-rep free was harder than we thought. Time went on, and before I knew it the familiar suitcases on wheels were back in the waiting room. What was going on? While it seemed that we were sabotaging our own policy, it became apparent that the staff allowed "Pharma creep" mostly in the interests of the patients. For example, it was helpful to be able to provide vomiting babies a bottle of Pedialyte in the office, and while most of our mothers breast fed their babies, the ones who did not were grateful for bottles of formula. We always needed more pens, and the pizza was really tasty. The insidious nature of the industry was difficult to fight.

While the evidence-based practice of medicine and the medical-industrial complex need each other, especially as funding becomes scarcer for research and development of life-saving medications, it is critical that we vigilantly guard against subtle pressures than can affect our judgment.

I was reminded of this just the other day, when I asked one of our staff for a pen. Guess what was on the pen: a multihued ad for Carvediol, a medication for hypertension and heart failure.

Dr. McEvoy is chief of pediatrics of the Mass. General West Medical Group and an assistant professor at Harvard Medical School.

Pharmaland: sometimes it’s all in the name

Economic Times

Gurgaon, Haryana, India

In 2005, the Food and Drug Administration of the USA was faced with a peculiar situation. A patient got confused between a diabetic drug called Amaryl and a medicine meant for those with Alzheimer’s, called Reminyl. This confusion resulted in his premature death and compelled FDA to rename the Alzheimer’s medication to Razadyne. Pharmaland is full of such stories where nomenclatural confusion has resulted in unforeseen fatalities. According to the FDA website, mistaking methadone for methylphenidate (a drug for treating attention deficit disorders) turned out to be fatal for an 8-year-old.

A 19-year-old being treated for schizophrenia developed potentially fatal complications after he was administered clozapine instead of olanzapine. A similar mistake by a 50-year-old woman, who consumed Flomax (used to treat the symptoms of an enlarged prostate) instead of Volmax (for relieving bronchospasm), meant a trip to the hospital.

The oft-repeated cliché about the relative unimportance of a name – first appearing in the play Romeo and t, using the simile of a rose — seems unworkable when it comes to drug names. According to various estimates, 10% of all medication errors can be attributed to confusion over drug names – Serzone (an anti-depressant) is often mistaken for Seroquel (for treating schizophrenia), or iodine for Lodine (a non-steroidal anti-inflammatory drug). The FDA website says: “Adverse events that can occur when drugs are dispensed as the wrong medications underscore the need for clear interpretation and better communication between the doctors who write prescriptions and the pharmacists who fill them.”

All this means big business for a number of companies which have sprung up to fill the gap. A whole army of brand consulting companies now provide specialist services to pharma companies searching for the right name for their products. And, the charges are also quite therapeutic – anywhere between $250,000-500,000 per product. With so much riding on just one name, especially given the promise of billion dollar sales if the product turns out to be a blockbuster, pharma companies are willing to be liberal with their cheque books. Consequently, a large number of consulting companies now specialise in pharma branding.

For instance, Brand Institute, a Miami-based branding company, has a substantial drug-consulting practice and some of its naming work includes Nexium (a gastrointestinal drug from AstraZeneca), Requip (a drug for combating Parkinson’s disease, from GlaxoeKline). Igor, a San Francisco based branding company, has also done some work on pharma branding.

Sometimes, the company strikes paydirt serendipitiously, without the help of external agencies. For example, a few years ago Eli Lilly hired a drug consulting company to figure out a name for its new cancer drug. The drug’s generic name was multitargeted antifolate, or MTA, and the brief to the consultants was to find a suitable name that included the acronym. But the winning suggestion – Alimta — came from an employee and Eli Lilly was able to use the same brand across 85 countries.

Any pharmaceutical product has three names – a chemical name, a generic one and, finally, a brand name for marketing it to the ultimate consumer. The whole naming process has five distinct stages. The first stage kicks in soon after the discovery of a new molecule, or new chemical entity, and application for a patent. The second stage involves the generic naming, which typically engages a number of regulatory bodies as well as multilateral agencies, such as WHO.

Then follows the branding exercise. This is submitted to the FDA for review, which once completed, results in final approval to the company to use the permitted brand name for marketing the product to the consumers. In India, the government is planning to set up a central licensing authority to dovetail manufacturing approvals with authority to sanction a certain brand name. Today a new drug manufacturing application has to be made to Drug Controller General of India.

But, if the product already exists in the market, then the authority to approve manufacture of yet another similar product lies with the various state licensing offices. This split regulatory structure results in total chaos — a plethora of offices across the country merrily licensing manufacture of similar sounding brands, without any knowledge of what the other states are up to. In addition, the pharma industry straddles two ministries – chemicals and health.

This also provides the perfect recipe for confusion and for breeding corruption. About 35,000 applications are filed with the trade mark office every year for approval of new pharma brands. Of these, about 6,000-7,000 also are rejected because these are attempts to ride piggyback on another existing successful brand by seeking a similar-sounding brand name.

There are also occasions when a company changes its product mix but retains the old brand name to escape the dragnet of price controls. What is amazing is the lack of any study or research on the extent of confusion created by similar-sounding brand names.

If India wants to be the next medical tourism destination — with Dubai, Singapore and some other Asian countries now providing stiff competition — India will have to get its entire healthcare and pharma sector regulatory structure in place, at par with the best practices in the world.

Join the new Hadcorp group on Facebook!

http://implants.webs.com/

To unsubscribe from these mailings, click here: Please unsubscribe me