Tag Archives: Johnson & Johnson

A pharmaceuticals market of 800,000 – and growing

24 Mar

“Drug companies got out of antibiotics as their attention switched to much more lucrative daily medicines for chronic diseases”

jeremy huntIn March, at the World Health Organisation’s first Ministerial Conference on Global Action Against Dementia in Geneva, Jeremy Hunt, the UK’s health secretary, announced plans to boost early-stage research into Alzheimer’s disease and other forms of dementia in order to find an effective treatment. Just three new drugs for the condition have reached market in the past 15 years and these only alleviate symptoms.

The WHO conference was supported by the Department of Health of the United Kingdom of Great Britain and Northern Ireland, and the Organization for Economic Cooperation and Development (OECD). Both days were webcast.

Ongoing lifelong drug treatment is very profitable – not so pre-emption

The $100m venture capital fund will be backed by the UK government and several of the world’s biggest pharmaceuticals companies, amongst them US investment bank JPMorgan, GlaxoSmithKline, Johnson & Johnson, Pfizer, Eli Lilly and Biogen.

Drug companies had lost billions of dollars in many failed trials and Patrick Vallance, president of research and development at GlaxoSmithKline, said the venture fund was a good way to spread risk and share expertise.

He added that there are rewarding economic incentives for research. “Nobody doubts that if you find an effective medicine for dementia it will be very profitable.”

True – and discovering and addressing the causes would remove this market opportunity.

Today’s broadcast theme:

Infectious bacteria are becoming resistant to the drugs that used to kill them. The last new class of antibiotics was discovered in the 1980s. There is little in the development pipelines of the world’s pharmaceutical industry. Drug companies got out of antibiotics as their attention switched to much more lucrative daily medicines for chronic diseases. Public funding on antibiotic research has also withered.

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Big pharma: prosecutions for discounting, bribery and ‘education’

28 Dec

Today, Euronews reports from Croatia that pharmaceutical company Farmal, and 364 individuals, have been charged with bribery and abuse of office. Farmal allegedly ran a network of doctors, giving them gifts in return for prescribing the company’s products

Only two days ago Andrew Jack reported that US fines from whistleblower and government prosecutions against the pharmaceutical industry reached $20bn in the period 1991-2010. In less than three years since then, companies have been given further penalties totalling more than $13bn.

pharma pays chart

Jack cited four examples:

  • Last year, Eli Lilly paid $29m to the US Securities and Exchange Commission after evidence showing it offered discounts to fund bribes to win business in Brazil and Kazakhstan.
  • Pfizer was fined $60m for activities including “incentive trips” to Greece for Bulgarian doctors who agreed to meet prescription targets for its drugs.
  • Johnson & Johnson  channelled more than $100,000 through a subsidiary company to a sympathetic nurse in order to boost prescriptions of Natrecor, a heart medicine; she spoke favourably about the drug in talks, trained colleagues in its use and put her name on an article in a medical journal to boost sales. J&J paid a $2.2bn fine in November for practices stretching back over a decade – the latest in an escalating series of penalties against the pharmaceutical industry for the way it markets its products.

He points out that the marketing process begins before new drugs are approved by regulators. There has been growing concern in recent years that articles in influential medical journals describing experimental products, assessed by reviewers and editors, are excessively favourable to new drugs. On occasion there has been selective design and presentation of the evidence and publication of ‘flattering’ safety data.

Building relationships with prescribers

  • Sales representatives make presentations to doctors; a study last summer showed that, on average, US doctors who received payments from companies were twice as likely as their peers to prescribe their products.
  • Money is spent on bringing doctors to conferences for “continuing medical education”, often in luxury international hotels. GSK last year settled a record $3bn fine in the US for paying prescribers to attend conferences in luxury resorts in Hawaii.
  • “Key opinion leaders” among physicians are paid as consultants to give speeches and presentations to their peers. They often sit on professional bodies that draft treatment guidelines. They may also be paid to advise on and recruit patients into lightly regulated “post-marketing” trials for drugs that are already approved.
  • Companies have also offered doctors discounts or donations of their medicines to wean them off rival products.

Examples of improved practice

US and European regulators are pushing for greater publication of clinical trial data, opening the possibility of third-party analysis of drug safety and efficacy.

Doctors and healthcare systems are being advised to pay for continuing medical education, reducing the influence of industry funding.

Some universities and hospitals already ban visits by sales representatives or consulting payments to doctors.

AstraZeneca no longer pays for physicians to attend international medical conferences. GSK last week announced similar moves, as well as plans to sever any bonuses to its marketing staff linked to individual sales targets. It wants them to be judged by the quality of medical advice they provide doctors rather than the crude volume of prescriptions.

“Health technology assessment”, the use of third-party review of the evidence of the value of treatments to guide doctors’ prescribing habits is being undertaken by the National Institute for Health and Care Excellence (NICE) in the UK; the transparency commission in France and Amnog in Germany already conduct such assessments of new medicines.

Legal advice: “Over 12 months after the UK Bribery Act was introduced, and with increasing enforcement in the pharmaceutical and medical business sectors, pharmaceutical companies should ensure that their compliance programmes are in place and updated to reflect developments over the last 12 months”.

Whistleblowers in the Orphan Medical/Jazz Pharmaceuticals settlement and cases that were part of the settlements by Amgen, Glaxo and Pfizer: http://www.forbes.com/sites/erikakelton/2013/01/04/off-label-pharma-prosecutions-wont-be-silenced-by-first-amendment-decision/

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Johnson & Johnson, who “recklessly put at risk” the health of children & dementia patients, ordered to pay $2.2 billion

15 Nov

Subhash Sule of India’s CHS-Sachetan draws our attention to the resolution of the case against Johnson & Johnson

An Arkansas judge ordered J&J and subsidiary Janssen Pharmaceutical to pay $2.2 billion to end civil and criminal investigations. They were alleged to have paid  ‘kickbacks’ and fraudulently marketed pharmaceuticals for off-label uses. The case concerned anti-psychotic drugs Risperdal and Invega and the heart drug Natrecor:

  • 1999 – 2005, J&J and its subsidiary Janssen Pharmaceuticals Inc promoted Risperdal for unapproved uses, including controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities, according to the complaint.
  • Janssen’s sales representatives “aggressively” promoted Risperdal through a special “ElderCare sales force” targetting nursing home operators.
  • The company paid millions of dollars in kickbacks to Omnicare Inc, the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients, under various guises including “educational funding.
  • In a separate civil complaint, the government alleged that J&J and its subsidiary Scios promoted its heart failure drug Natrecor as a weekly treatment for patients, despite no scientific evidence to support this approach.

U.S. Attorney General Eric Holder said that Johnson & Johnson’s conduct “recklessly put at risk” the health of children, dementia patients and others to whom the drug was prescribed at a time it was only approved by the U.S. Food and Drug Administration to treat schizophrenia adding:

“Through these alleged actions, these companies lined their pockets at the expense of American taxpayers, patients and the private insurance industry”.

Drug manufacturers have paid fines over the past decade for alleged improper marketing of several medicines.  Pfizer Inc in 2010 agreed to pay $2.3 billion to settle allegations it improperly marketed 13 drugs, including kickbacks to healthcare providers. Last year, GlaxoSmithKline Plc agreed to pay $3 billion to resolve criminal charges that it improperly targeted its Paxil depression treatment to children, sold its Wellbutrin antidepressant for unapproved uses and failed to inform U.S. regulators of safety risks seen with its Avandia diabetes drug.

Sources:

http://www.huffingtonpost.com/2013/11/04/johnson-and-johnson-drug-marketing-charges_n_4212858.html
http://www.reuters.com/article/2013/11/04/us-jnj-settlement-idUSBRE9A30MM20131104
http://www.businessinsider.com/jj-got-fined-12-billion-because-of-this-drug-2012-4#ixzz2kk0jk42C
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