Aspirine : Protéger les victimes d'infarctus

Depuis une vingtaine d'années, plusieurs études se sont succédées, indiquant les vertus préventives de ce médicament face aux maladies cardiovasculaires. L'aspirine inhibe, en effet, l'agrégation des plaquettes, donc la formation de caillots sanguins à l'intérieur des vaisseaux. Une dose aussi faible que 80 mg par jour pendant une semaine (alors que les comprimés pour adulte varient habituellement entre 300 mg et 1 g) suffit à réduire de 90 % la libération de substances agrégantes par les plaquettes et à allonger le temps de saignement. A cette action antiagrégante s'ajoute un effet anti-inflammatoire bénéfique pour la paroi vasculaire.

Des essais thérapeutiques ont montré que la prise régulière de 

Pharmaceutical mergers: Merck's manoeuvres

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THE language was reminiscent of a happier time before the credit crunch and brewing economic devastation closed the book on most such mergers. Merck’s boss, Dick Clark, called the agreed deal to acquire Schering-Plough, which was announced on Monday March 9th, a “transformational event”. He then expounded on the “strategic sense and…exceptional promise” on offer. Fred Hassan, boss of the rival American pharmaceutical giant, perhaps mindful of appearing triumphalist as the world wobbles, chipped in with a more sober vision of a “leading company” that will be “well positioned”.

Perhaps Mr Clark could be forgiven his exuberance. The deal is a (mostly) bright spot amid a global corporate landscape of bankruptcy and retrenchment. Merck will pay $41 billion for Schering-Plough, with the total made up partly of shares, $9.8 billion from cash reserves and another $8.5 billion prised from the clutches of a bank, JPMorgan. Although credit has dried up almost everywhere else, drug companies, with their cash reserves and healthy revenues, can still call on the banks. Last month Pfizer, another American drug company, was able to count on bank loans to assist in its $68 billion acquisition of Wyeth.

Big drug firms are also keen to consolidate as a way of heading off gathering problems. On Friday Switzerland’s Roche raised its offer for the 44% of Genentech, an American biotech firm, that it does not already own. Sanofi-Aventis of France is also said to be on the acquisition trail. Buying rivals is one way for drug companies to boost anaemic product pipelines, under assault from expiring patents on blockbuster medicines and generic competitors. Merck's asthma medicine, which gives it a sixth of its revenues, loses patent protection in the next few years. In one swoop Merck will double—to 18—the number of drugs it has in the later stages of development.

Drug companies are also gearing up for a reform of American healthcare. Precisely what will transpire is unclear, but it seems likely that government health schemes will demand bigger discounts from drug suppliers. Added to this is the worry that cash-strapped American consumers (the biggest single market for drugmakers) who lack insurance or who face high bills before insurance kicks in, are cutting back on spending. However Schering-Plough derives 70% of its revenues outside of America, which should spread risk. The deal will also give Merck greater access to foreign drug markets: half of the new firm’s revenues will come from beyond America’s shores.

The deal should afford the opportunity to cut costs. Mr Clark said that 15% of the combined firm’s 106,000 employees would lose their jobs. In addition to existing rounds of cost-cutting by both firms, Merck expects to make another $3.5 billion in annual savings after 2011. One difficulty for Merck is that the deal might jeopardise Schering-Plough’s co-marketing agreement with Johnson & Johnson for Remicade, a money-spinning anti-inflammatory drug. But Mr Clark is confident the structure of the deal should guard against this.

The deal goes some way to answering critics who complained that Merck was not acting as vigorously as competitors in buying rivals and moving into new markets. The challenge for Mr Clark, who will become boss of the new company, is to show that, despite a lack of experience, he can see through the big deal smoothly. Mr Clark has done a fine job of steering the firm out of the crisis caused by the safety scandal surrounding Vioxx, its blockbuster painkiller. But Merck, unlike many of its peers, has never before attempted a mega-merger of this sort: the company has preferred to grow by developing new products in it own laboratories. Mr Hassan is getting out because he fears that the macroeconomic conditions are growing more difficult for drug firms. Mr Clark must hope that the deal will help Merck to weather the storm.

Cancer drugs: Big Pharma's gripes about the FDA

TALK to anyone in the pharmaceutical industry—a private-equity investor, a drug executive, a scientist—and within three minutes Mr Pharma will start griping about the Food and Drug Administration (FDA). The agency is incredibly powerful. Its judgment of a drug's safety and efficacy is the single biggest “X Factor” in America’s enormous pharmaceutical market. In recent years, Mr Pharma will complain, the FDA’s approval process has become slower, its decisions more erratic. A few expletives will follow.

This tension was on dramatic display this week in Washington, DC. The FDA held a two-day hearing on Avastin, a cancer drug that last year generated more than $7 billion in global sales for Genentech, a biotech firm in California, and its parent company, Roche. Avastin treats a variety of cancers, including those of the lung and kidney. In 2008 the FDA gave accelerated approval for Avastin to be used in breast cancer patients. Final approval would depend on further studies that proved Avastin’s beneficial effect.

But the glowing studies never materialised. What is more, some patients experienced severe side-effects, such as haemorrhages and holes in their gastrointestinal tracts. Last year an FDA panel decided that Avastin’s risks to breast cancer patients outweighed its benefits. Uproar followed. Genentech challenged the FDA on its decision, a remarkable move. Even more surprising, the FDA agreed to hold this week’s hearings.

But the panel upheld the earlier decision. Patients will still be able to obtain Avastin, as the drug is approved for other uses. However it is less clear that insurers will continue to cover the drug, which costs about $88,000 a year. Genentech is appealing to Margaret Hamburg, the FDA’s commissioner, who will make a final decision.

The FDA has its flaws. Big Pharma’s complaints about the agency are often justified. But in its evaluation of Avastin, the FDA has served a legitimate role. However Avastin is only the first chapter in a larger fight. The debate over oncology drugs is one of the thorniest in American health care. Americans’ spending on cancer may rise from $125 billion last year to up to $207 billion by 2020, according to Medco, a pharmacy-benefit manger. Some of the new cancer drugs hold immense promise, but others have limited efficacy and are exorbitant.

Nevertheless, a rational debate is elusive. The FDA does not consider drugs’ costs (beware talk of “rationing”). Cancer arouses intense emotion. Patients and their doctors desperately try treatments that have little chance of working. At the Avastin hearing, one patient sobbed and others booed the panelists. Regulators and politicians have a tough job. They must protect patients’ safety, encourage innovation and—soon—have a serious conversation about how much society should pay for a small extension of life. The fight over Avastin has been bitter. Much more is to come.

Justices Back Drug Industry on Overtime

WASHINGTON (AP) — The Supreme Court has ruled that sales representatives for pharmaceutical companies do not qualify for overtime pay under federal law, a big victory for the drug industry.

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In a 5-4 decision Monday, the court's conservative majority concluded that the roughly 90,000 people who try to persuade doctors to prescribe certain drugs to their patients are not covered by the federal law governing overtime pay.

Two salesmen who once worked for drug maker GlaxoSmithKline filed a class-action lawsuit claiming that they were not paid for the 10 to 20 hours they worked each week on average outside the normal business day. Their jobs required them to meet with doctors in their offices, but also to attend conventions, dinners, even golf outings.

Many sales jobs are exempt from overtime pay under the Fair Labor Standards Act. But unlike typical salespeople who often work on commission, pharmaceutical sales representatives cannot seal a deal with doctors. Federal law, in fact, forbids any binding agreement by a doctor to prescribe a specific drug.

Justice Samuel Alito, writing for the majority, said that the drug sales reps' "end goal was not merely to make physicians aware of the medically appropriate uses of a particular drug. Rather, it was to convince physicians actually to prescribe the drug in appropriate cases."

Chief Justice John Roberts and Justices Anthony Kennedy, Antonin Scalia and Clarence Thomas joined with Alito.

In dissent, Justice Stephen Breyer said the sales reps do not consummate sales and so should be allowed to claim overtime. Breyer referred to the employees not as salesmen, but as "detailers," as they are known in the industry. "The detailer's work, in my view, is more naturally characterized as involving 'promotional activities designed to stimulate sales...made by someone else,'" Breyer said, quoting from federal regulations.

Justices Ruth Bader Ginsburg, Elena Kagan and Sonia Sotomayor signed Breyer's dissent.

The Obama administration backed the sales reps and argued that they do not make sales, as the law requires for a job to be exempt from overtime.

The case is Christopher v. SmithKline Beecham Corp., 11-204.

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medicament - (medicine) something that treats or prevents or alleviates the symptoms of disease

medication, medicinal drug, medicine

acyclovir, Zovirax - an oral antiviral drug (trade name Zovirax) used to treat genital herpes; does not cure the disease but relieves the symptoms

alendronate, Fosamax - a tablet (trade name Fosamax) prescribed to prevent or treat osteoporosis in women after menopause

allopurinol, Zyloprim - a drug (trade name Zyloprim) used to treat gout and other conditions in which there is an excessive buildup of uric acid

amrinone, Inocor - a drug (trade name Inocor) used intravenously in heart failure; increases strength of contraction of myocardium

analgesic, anodyne, pain pill, painkiller - a medicine used to relieve pain

angiogenesis inhibitor - a drug that is designed to prevent the growth of blood vessels that nourish tumors

antiarrhythmic, antiarrhythmic drug, antiarrhythmic medication - a drug used to treat an abnormal heart rhythm

antibacterial, antibacterial drug, bactericide - any drug that destroys bacteria or inhibits their growth

anticholinergic, anticholinergic drug - a substance that opposes or blocks the action of acetylcholine

anticholinesterase - a medicine that inhibits cholinesterase by combining with it and so has a cholinergic effect

anticoagulant, anticoagulant medication, decoagulant - medicine that prevents or retards the clotting of blood

anticonvulsant, anticonvulsant drug, antiepileptic, antiepileptic drug - a drug used to treat or prevent convulsions (as in epilepsy)

antidepressant, antidepressant drug - any of a class of drugs used to treat depression; often have undesirable side effects

antidiabetic, antidiabetic drug - a drug used to treat diabetes mellitus

antidiarrheal, antidiarrheal drug - a drug used to control or stop diarrhea

antidiuretic, antidiuretic drug - a drug that limits the formation of urine

antiemetic, antiemetic drug - a drug that prevents or alleviates nausea and vomiting

antihistamine - a medicine used to treat allergies and hypersensitive reactions and colds; works by counteracting the effects of histamine on a receptor site

antihypertensive, antihypertensive drug - a drug that reduces high blood pressure

anti-inflammatory, anti-inflammatory drug - a medicine intended to reduce inflammation

antiprotozoal, antiprotozoal drug - a medicinal drug used to fight diseases (like malaria) that are caused by protozoa

antipyretic, febrifuge - any medicine that lowers body temperature to prevent or alleviate fever

antiseptic - a substance that destroys micro-organisms that carry disease without harming body tissues

antispasmodic, antispasmodic agent, spasmolytic - a drug used to relieve or prevent spasms (especially of the smooth muscles)

antitussive - any medicine used to suppress or relieve coughing

antiviral, antiviral agent, antiviral drug - any drug that destroys viruses

APC - a drug combination found in some over-the-counter headache remedies (aspirin and phenacetin and caffeine)

astringent, astringent drug, styptic - a drug that causes contraction of body tissues and canals

atomic cocktail - an oral dose of radioactive substance used in treatment and diagnosis of cancer

azathioprine, Imuran - an immunosuppressive drug (trade name Imuran) used to prevent rejection of a transplanted organ

blocking agent, blocker - a class of drugs that inhibit (block) some biological process

bronchodilator - a drug that relaxes and dilates the bronchial passageways and improves the passages of air into the lungs

calcium blocker, calcium-channel blocker - any of a class of drugs that block the flow of the electrolyte calcium (either in nerve cell conduction or smooth muscle contraction of the heart); has been used in the treatment of angina or arrhythmia or hypertension or migraine

carminative - medication that prevents the formation of gas in the alimentary tract or eases its passing

published

Practical guidance on implementation of pharmacovigilance legislation published

The European Medicines Agency has published a set of questions and answersconcerning the initial phases of the operation of the pharmacovigilance legislation.

The document, published today, clarifies some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year. It includes the agreed position of the European Union (EU) regulatory network, following discussions between the Agency, national regulatory authorities and the European Commission services.

The document includes answers to frequently asked questions on the following topics:

• Good pharmacovigilance practice guidelines;
• Pharmacovigilance system master files and summary of the pharmacovigilance system;
• Risk management plans;
• Post-authorisation safety studies;
• Periodic safety update reports and EU reference date list;
• Literature monitoring;
• Product information and the black symbol;
• Adverse-drug-reaction reporting and signal management;
• Renewals.

The Agency will update the question-and-answer document on a regular basis with questions received at qanda-pv-legislation@ema.europa.eu. The Agency cannot reply directly to questions submitted to this address.

The Agency encourages company employees to read this document in conjunction with the questions and answers on transitional arrangements published by the European Commission in February 2012.