UK: Drugs firms ‘creating ills for every pill / US ‘Bioshield’ Drug-Patent Plan Draws Fire

UK: Drugs firms ‘creating ills for every pill / US ‘Bioshield’ Drug-Patent Plan Draws Fire

Mon, 04 Apr 2005

Following the public revelations about the concealed safety hazards of antidepressant drugs whose risks of violence, drug dependency, and suicide, were hidden from physicians and the public, a committee of Parliament in the UK conducted a seven month investigation, broadening the focus to the overall undue influence of the pharmaceutical industry on medicine and health care.

An editorial in yesterday’s UK Observer, “Drug Firms ‘Creating Ills for Every Pill,'” highlights the committee’s essential findings which will be issued in a report this week.

The UK Parliament committee conducted a credible investigation, inviting expert critics–not just experts with financial ties to industry. The committee heard testimony about corrupt industry practices: they were presented with evidence of ‘disease-mongering’: drug firms have been shown to “effectively invent diseases for which they could then sell treatments.” Evidence was presented demonstrating that “relatively normal behaviour – from mild depression to low female sex drive” were being “re-labelled as conditions for which drugs were supposedly necessary.” They were advised that safety hazards were ignored as the company’s marketing goals were “to move sales beyond the $1 billion to the $2 billion…” And the committed heard of “drugs marketed to doctors in papers written for medical journals ostensibly by independent experts which are, in fact, ghostwritten by the firms, which pay academics to lend their names to the reports.”

The disturbing findings of the investigation have already prompted the Labour party to adopt “an election manifesto” that is expected to include a pledge to overhaul the drug licensing regime. One of the changes sought will affect who can serve on expert panels advising the government’s medicines regulator–panel members will be banned from holding financial interests in drug firms to avoid potential conflicts of interest. The report is due to be released this week.

It is astounding that on this side of the Atlantic–where the pharmaceutical industry exerts far greater influence than in the UK, and the number of people harmed by prescribed drugs, far exceeds the number in the UK–legislators seem unwilling to investigate a major health hazard that is threatening the safety of the American people. People’s lives are threatened by hazardous, licensed drugs whose deadliest risks are concealed from physicians and the public. Although the giants of the pharmaceutical industry have on more than one occasion pled guilty to criminal marketing practices, US legislators think the industry needs greater and greater financial incentives to produce drugs and vaccines.

Congress is transferring billions of taxpayer dollars to the pharmaceutical industry: the government is paying top prices for drugs and prohibiting Medicare from negotiating the price of drugs. Last year, Congress passed the Bioshield law assuring the drug industry $5.6 billion in tax money for drug and vaccine stockpiles. And, without a public debate about the ramifications, Congress approved the distribution of unlicensed medical products in an emergency. The Anthrax vaccine is such a product, which the citizenry rejected after its hazardous effects became apparent. This same unlicensed vaccine has been forced on military personnel causing thousands to become disbled.

The Wall Street Journal reports that Congress wants to broaden Bioshield even further this year, to include both anti-bioterrorism and infectious disease products, liability protection; tax incentives and extra patent exclusivity.

Congress and the administration are seriously considering increased liability protection for drug manufacturers–which will deny citizens the right to seek justice-even if manufacturers failed to adequately test the safety of those products, and even if they fraudulently marketed their drugs without warning physicians and the public about hazardous–even lethal–effects. But wait, there’s more:

Senator Joseph Lieberman is advocating the greatest give-a-way-ever–it’s called “wild-card exclusivity.”

The Wall Street Journal reports: “Under his plan, a drug maker that successfully develops a product to prevent or treat a bioterrorism illness or emerging infectious disease could get six months to two years of additional patent life for any product it chooses. As supporters explain it, if Pfizer Inc., for example, invented an effective new antibiotic or joined forces with a smaller biotechnology company to produce a new treatment for botulism, it could get more time to sell blockbuster drugs such as Viagra or cholesterol-lowering Lipitor without competition from cheaper generic rivals. Blockbuster drugs, which usually have numerous patents, can generate billions of dollars a year in sales.”

US legislators seem to be addicted to pharmaceutical campaign financing contributions, thus they suffer from major paralysis. Their inaction–and that of the agencies whose responsibility is to protect the public health– rises to the level of depraved indifference to loss of human life.

Even before the lifting of barriers to the marketing of unapproved drugs and vaccines–unapproved because they have failed to demonstrate that they are safe and / or effective–has led to 100,000 preventable human casualties due to adverse drug reactions.

Contact: Vera Hassner Sharav
212-595-8974

http://www.observer.co.uk

Drugs firms ‘creating ills for every pill’
Expensive new medicines are oversold when cheaper therapies or prevention would work better, say MPs
Gaby Hinsliff, political editor
Sunday April 03 2005
The Observer

The power of Britain’s multi-billion-pound drugs industry has turned this country into an over-medicalised society that believes in a pill for every ill, a Commons inquiry will claim this week.

The report will say that the billions of pounds poured into researching and promoting new drugs have fuelled an over-emphasis on medicinal cures at the expense of cheaper and better therapies, or simple prevention.

The MPs heard evidence of ‘disease-mongering’ drugs firms effectively inventing diseases for which they could then sell treatments, with relatively normal behaviour – from mild depression to low female sex drive – re-labelled as conditions for which drugs were supposedly necessary. Lord Warner, the health minister responsible for medicines, admitted to the inquiry: ‘I have some concerns that sometimes we do, as a society, wish to put labels on things which are just part and parcel of the human condition.’

The report from the Commons health select committee is also expected to criticise the secretive process of licensing medicines in Britain, following several safety scares in which so-called ‘wonder drugs’ have turned out to have serious side effects.

The common anti-depressant Seroxat was recently linked to an increased risk of suicide in teenagers, while the widely prescribed arthritis drug Vioxx was withdrawn last year over links to fatal heart attacks and strokes.

Labour’s election manifesto is now expected to include a pledge to overhaul the drug licensing regime. Expert members of the government’s medicines regulator will be banned from holding financial interests in drug firms to avoid potential conflicts of interest.

The seven-month inquiry follows complaints from patients’ groups and senior doctors that the interests of the industry are distorting health care priorities. Prescriptions for Seroxat tripled after it was licensed for mild depression, while The Observer revealed earlier this year that it was being marketed to doctors as a treatment for ill-defined ‘social anxiety disorders’.

Drug firms are banned from advertising directly to patients in Britain, or offering bribes to doctors to prescribe a certain brand. However campaigners say the industry has discovered ways of ‘guerrilla’ promotion, including generously funding medical charities – which, the inquiry heard, raises the risk of them becoming its ‘unwitting foot soldiers’.

One mental health charity, Depression Alliance, receives almost 80 per cent of its funding from drugs companies, while Arthritis Care received money from Merck Sharp and Dohme, maker of Vioxx.

Paul Flynn, the Labour MP who has campaigned to expose the influence of the industry and gave evidence to the committee, said it deserved an ‘absolute hammering’ for its practices. ‘The whole of society has been conditioned to believe that we are dependent on medicines. I have had arthritis all my life and I haven’t taken anything for it – I believe in exercise, swimming and walking.’

The inquiry heard of drugs marketed to doctors in papers written for medical journals ostensibly by independent experts which are, in fact, ghostwritten by the firms, which pay academics to lend their names to the reports. Dr Richard Horton, editor of leading journal, the Lancet, disclosed he had been effectively offered bribes to publish papers showing drugs in a favourable light. He said firms offered to buy ‘hundreds of thousands of reprints’ – which could be worth up to half a million pounds to his magazine – if their paper went in.

However, a spokesman for the Association of the British Pharmaceutical Industry denied fuelling dependence on drugs: ‘I don’t think we have ever suggested that medicines are the only answer to health problems. ‘It is always down to the doctor to determine whether there is a real medical condition. It is right we should be informing prescribers of what medicines can be relevant.’

When the solution becomes the problem

Reclassification of the cholesterol-lowering drug simvastatin as an over-the-counter medicine for preventing heart disease is a classic example of the pharmaceutical industry’s worrying influence, experts warned yesterday.

The editor of The Drug and Therapeutic Bulletin , Dr Ike Iheanacho, said long-term trials had not been carried out to test the drug’s efficacy or risks in those considered to be in moderate danger of having heart problems. As people could be sold Zocor Heart-Pro, the drug by its brand name, without detailed assessment of their health, there was also a danger that those at high risk of having heart attacks were getting inadequate treatment.

‘The absence of any long-term efficacy trails for Zocor Heart-Pro in the target group means that people are, in effect, being used as guinea pigs,’ Iheanacho said.

Another example is provided by the anti-depressant Seroxat. In November, The Observer revealed that Seroxat’s manufacturer GlaxoSmithKline (GSK) was trying to market it as a cure for relatively mild forms of depression, despite the fact that the drug has been linked to suicide. ‘The thrust was to move sales beyond the $1 billion to the $2bn mark by pushing it to people who were not clinically depressed,’ Professor David Healy told the select committee, while Richard Brook, chief executive of Mind, the mental health charity, told the MPs that the plan was ‘all about developing new conditions for that drug’.

At the same time, other options are ignored. As The Observer pointed out last week, Britain’s GPs have largely ignored the advice of the Chief Medical Office that many depressed patients should be prescribed exercise programmes rather than pills.

Robin McKie
Copyright Guardian Newspapers Limited

http://online.wsj.com/article/0,,SB111231124197694876,00.html?mod=todays_us_page_one

‘Bioshield’ Drug-Patent Plan Draws Fire
Generics Makers Fight Extending Exclusivity Protection to Areas Outside Biodefense
By SARAH LUECK
Staff Reporter of THE WALL STREET JOURNAL
April 1, 2005; Page A4

Less than a year after Congress provided the pharmaceuticals industry with incentives to develop drugs for terrorism-related illnesses, a fight is brewing over efforts to offer more goodies — including the chance to extend patent rights on medications that have nothing to do with homeland security.

Last year’s legislation, signed by President Bush in July, provided $5.6 billion for the government to buy and stockpile medications to combat bioterrorism agents such as anthrax and smallpox. Now some lawmakers, convinced the measure didn’t go far enough, are developing bills that go far beyond the Bioshield law.

The new proposals would apply to a wider array of products, including ones that treat such infectious diseases as severe acute respiratory syndrome and avian influenza. And they would offer companies new protection from lawsuits, tax incentives to help fund research and production as well as various patent protections.

The most contentious idea, called wild-card exclusivity, is being pushed by Sen. Joseph Lieberman, a Connecticut Democrat. Under his plan, a drug maker that successfully develops a product to prevent or treat a bioterrorism illness or emerging infectious disease could get six months to two years of additional patent life for any product it chooses. As supporters explain it, if Pfizer Inc., for example, invented an effective new antibiotic or joined forces with a smaller biotechnology company to produce a new treatment for botulism, it could get more time to sell blockbuster drugs such as Viagra or cholesterol-lowering Lipitor without competition from cheaper generic rivals. Blockbuster drugs, which usually have numerous patents, can generate billions of dollars a year in sales.

Mr. Lieberman says incentives such as the wild-card provision are needed to entice big drug companies to join in fighting bioterrorism threats — a riskier and less-profitable business than traditional pharmaceuticals. “We are currently unprepared to respond to a bioterror attack and some infectious-disease outbreaks,” he says. “We’re racing against the clock.” He plans to introduce the bill, which is likely to be co-sponsored by Sen. Orrin Hatch, a Utah Republican, soon.

Supporters say wild-card exclusivity would be extended only to manufacturers who deliver successful products. But generic-drug makers say instead that the bar to gain the extended patent protection would be much lower.

Passage of the wild-card measure is far from assured. Many lawmakers are wary, and brand-name drug companies are split. But there is broad support and momentum in Congress this year for legislation providing additional rewards for large drug makers either to develop bioterrorism countermeasures or to help smaller biotech firms produce them on a large scale.

“If you’re building a biodefense industry, you’ve got to send a signal that this is for real,” says Frank Rapoport, a partner with McKenna, Long & Aldridge, a law firm that represents drug and vaccine companies that contract with the government.

Generics makers say the wild-card proposal would drive up drug costs by delaying the entry of cheaper copies to the market. The plan “would allow the brand industry to reach into the medicine cabinet of every American and unfairly extend exclusivity on the drug of their choice,” says Kathleen Jaeger, president and chief executive of the Generic Pharmaceutical Association, the Washington trade group for the industry.

Backed by employer groups and insurance companies — which say the wild-card idea would drive up drug costs — the generic industry is waging an offensive on Capitol Hill. Other critics say that Medicare, the federal health program for the elderly, and Medicaid, the state health program for the poor, would end up paying more for drugs if generic rivals to popular drugs were delayed.

Pfizer says it backs the wild-card proposal and other patent-related incentives as a way to “induce large companies to invest capital and divert the necessary resources to develop promising compounds for countermeasure uses,” says company spokesman Jack Cox. Last year’s Bioshield law “isn’t enough to spur the development of new drugs to counter bioterrorism attacks.”

Other big name-brand drug companies and the Pharmaceutical Research and Manufacturers of America, the industry trade group, say they aren’t taking a position on the wild-card or other intellectual-property proposals.

The debate will come to a head in the next few months. Republican leaders in the Senate have introduced a bioterrorism bill, S.3, that they say doesn’t include the wild-card idea. It “seemed from our perspective to be a non-starter,” says Gayle Osterberg, a spokeswoman for Sen. Judd Gregg, a New Hampshire Republican and the lead sponsor. Some who have seen the bill say its language is ambiguous; generic-industry experts say it contains the wild-card provision.

In any case, the generics industry objects to other patent provisions in S.3. The legislation would allow the government to award drug companies as much as two years of extra market exclusivity on existing products if they are used in an emergency. An example would be Bayer AG’s Cipro, an antibiotic the government purchased during the 2001 anthrax attacks. Under S.3, the Health and Human Services Secretary could reward Bayer with two extra years to sell Cipro exclusively. In a second possible incentive, the legislation would let the government grant extra patent protection for bioterrorism or infectious-disease drugs equal to the amount of time the manufacturers spend waiting for approval from the Food and Drug Administration. Companies wouldn’t be able to get both types of extensions, supporters said.

The generic industry contends that S.3 goes further than its Senate sponsors are willing to admit. Ms. Jaeger says, for example, that the definition of products that could qualify for extra exclusivity is overly broad and could be applied to blood-pressure or anti-anxiety drugs used to treat the secondary effects of a bioterror attack. She argues that companies should be encouraged to make novel products rather than be rewarded for existing ones.

Makers of generics support tax incentives and liability protections rather than patent extensions on brand-name drugs. They are joined in the fight by the Coalition for a Competitive Pharmaceutical Market, a group that includes insurers and employers such as General Motors Corp. and Caterpillar Inc., as well as generic drug makers.

Wild-card exclusivity, also called transferable exclusivity, has been promoted in the past by representatives of the brand-name industry as a way to stimulate research in less-profitable areas such as diseases affecting the developing world and medications for children.

These days, PhRMA says it is most interested in proposals to protect makers of bioterror products from liability suits. Brand-name drug maker Merck & Co. says it isn’t lobbying for the wild-card proposal. To get larger companies involved in bioterrorism research, “we think the two critical issues are a strong, guaranteed purchase commitment and liability protection,” says Ian Spatz, Merck’s vice president for public policy.

GlaxoSmithKline PLC has proposed the wild-card idea internationally as a way to encourage research on diseases that affect the developing world. But the brand-name drug company is “not lobbying actively” for its inclusion in this year’s bioterrorism legislation, says spokeswoman Mary Anne Rhyne. She adds, “We’re interested in seeing what the proposal actually turns out to be.”

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.