Big Pharma Indicted By UK Parliamentary Health Committee

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A recent report (pdf file available here) of the UK House of Commons Health Committee sharply criticizes what has by others been called the pharmaceutical business with disease and has been recognized as a leading cause of death in the U.S.

In the in the report's summary, the Committee puts its finger on the historical reason why it could come this far.

The Department of Health has for too long optimistically assumed that the interests of health and of the industry are as one. This may reflect the fact that the Department sponsors the industry as well as looking after health. The result is that the industry has been left to its own devices for too long. It may be relevant that this is the first major select committee inquiry into the pharmaceutical industry for almost one hundred years – the last was undertaken by the Select Committee on Patent Medicines which reported in August 1914.

Members of Parliament are concerned about what has been described as the ‘medicalisation’ of society – the belief that every problem requires medical treatment – and say this may also be attributed in part to the activities of the pharmaceutical industry. While the pharmaceutical industry cannot be blamed for creating unhealthy reliance on, and over-use of, medicines, it has certainly exacerbated it. There has been a trend towards categorising more and more individuals as ‘abnormal’ or in need of drug treatment.

Inappropriate prescription of medicines by GPs is of particular concern, continues the report.

Some have prescribed SSRIs, for instance, on a grand scale. This is in part due to inadequacies in the education of medical practitioners which has meant that too few non-specialists are able to make objective assessments of the merits of drugs and too many seem not to recognise how little is known about the properties of a drug at the time of licensing, particularly about its adverse consequences. However, many prescribers have behaved responsibly and with restraint, which makes those who have not, all the more culpable. The constraints in place for hospital doctors do not apply to GPs. Drug companies are criticised for giving hospitality and recruiting ‘key opinion leaders’, but the prescribers must be equally to blame for accepting the hospitality and some ‘key opinion leaders’ for lending their names to work they did not produce, often for very considerable sums.

The recommendations cover several areas of concern, in particular the licensing process.

The key to improvement is greater transparency so that medical practitioners, experts and the public can make an independent assessment of the evidence.

The aim of new drugs should be real therapeutic benefit for patients.

Clinical trials should focus on using health outcomes that are relevant to patients.

The Government should, as a matter of urgency, fund research into the costs of drug-induced illness.

There should also be strengthened guidelines requiring the declaration of links between pharmaceutical companies and patient groups.

An important conflict of interest in the Department of Health is pointed out by the Committee and clearly that conflict must be resolved, say the reporting MPs, before things can get better.

The Department of Health has not only to promote the interests of the pharmaceutical industry but also the health of the public and the effectiveness of the NHS. There is a dilemma here which cannot be readily glossed over. The Secretary of State for Health cannot serve two masters. The Department seems unable to prioritise the interests of patients and public health over the interests of the pharmaceutical industry. We therefore recommend that sponsorship of the industry1 pass from the Department of Health to the Department of Trade and Industry.

Clearly this situation is not limited to the UK alone, but thanks to a courageous investigation, perhaps other countries can follow on and initiate a much needed reform of the public health sector.

From a U.S. perspective, Vera Hassner Sharav of the Alliance for Human Research Protection has a few comments giving a very concrete example of Neurontin - a drug on the market that is known to kill ... yet FDA remains inactive.

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ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
www.ahrp.org

The Health Committee of the British House of Commons, has just released its report, "The Influence of the Pharmaceutical Industry."

This landmark document is not just of value to UK health care officials, it provides American officials and analysts an intelligent road map for examining the much larger scope of the factors that undermine the health and safety of the American people who consume far more prescription drugs than do the British.

Many of the parliamentary committee recommendations for fixing the drug regulatory system in the UK (beginning on p. 99), apply equally to the dysfunctional US regulatory system which cannot be relied upon to protect the American public from drug-induced illness and death-as manifested in the off-label, criminal marketing of a lethal drug.

The FDA adverse drug event database, MedWatch, has received 258 documented fatal suicide reports involving patients prescribed Neurontin, for mostly unapproved, off-label uses.

Among the off-label uses: migraine headache, a multitude of pain uses, and various psychiatric conditions, "such as bipolar disorder and anxiety, social phobia and general mood stabilization."

MedWatch reports represent only 1% to 10% of the actual adverse drug effects. Thus, 258 completed suicides represent between 2,580 suicides and 25,800 suicides attributed to Neurontin.

FDA's failure to take action to protect the American public from severe - even fatal - prescription drug side-effects, borders on criminal negligence.

The FDA approved Neurontin on December 30, 1993, but only for adjunctive treatment of epilepsy and seizures. Recently uncovered FDA documents, obtained during court procedures, reveal that in December,1992, FDA's medical reviewer expressed serious concerns about Neurontin's lethal hazards - which explains why the drug was only approved for very limited use:

"Serious adverse events may limit the drug's widespread usefulness. Depression, while it may not be an infrequent occurrence in the epileptic population, may become worse and require intervention or LEAD TO SUICIDE, as it has resulted in some suicidal attempts during clinical trials." (emphasis added)

FDA's current Director of Neuropharmacological Drug Products, Dr. Russell Katz, was responsible for overseeing FDA's analysis of the clinical trial data supplied by Parke-Davis Pharmaceuticals at the time that Neurontin received FDA approval.

According to newly uncovered company documents obtained by the law firm, Finkelstein & Partners, Parke-Davis (a division of Warner-Lambert) reported that during clinical trials:

"Neurontin was attributable to four people actually attempting suicide, two more having depression with suicidal ideations and twenty two participants reporting depression so severe it required pharmacologic intervention. Additionally, nineteen of the seventy eight participants who reported depression during the clinical trials had no prior history of depression." See: http://www.ahrp.org/risks/neurontinSuicide0305.pdf

Documents show that in 1996, the FDA knew about the promotion of Neurontin for off-label uses - in complete disregard of the lethal risks for unsuspecting patients - but the agency failed to exercise its regulatory authority, or to meet its public responsibility to protect consumers from drugs whose safety has not been scientifically established. As a result of FDA's inaction, Neurontin's manufacturer aggressively promoted the drug primarily for unapproved, off-label uses in violation of Food, Drug and Cosmetics Act. In 2000, Warner-Lambert was purchased by Pfizer.

In 2002, Nuerontin prescriptions for off-label uses reached 94%-among these were patients who were especially vulnerable to depression that could "lead to suicide."

In March 2004, FDA's Director, Neuropharmacological Drug Products, Dr. Russell Katz, was informed that there were thousands of cases of attempted suicides by patients taking Neurontin, and more than 100 MedWatch reports of completed (fatal) suicides.

In May 2004, a Pfizer division (Warner-Lambert) pled guilty to criminal marketing of Neurontin and agreed to pay a $240 million criminal fine plus $190 million to settle civil liability suits by 50 State Attorneys General-totaling $430 million.

In addition to committing financial fraud, the company pled guilty to criminal misbranding of the drug in promotional and advertising material suggesting that "the drug is safe and effective for uses which have not been approved by the FDA."

In his Sentencing Memorandum [CRIMINAL NO. 04-10150 RGS] the US Attorney noted:

"Although approved only as an epilepsy drug for specific indications, Parke-Davis nonetheless promoted Neurontin for a multitude of pain uses, psychiatric conditions such as bipolar disorder and anxiety, [ ] social phobia and general mood stabilization, among other unapproved uses." [p.10]

"One of the psychiatric uses for which Neurontin was promoted by Parke-Davis, bipolar disorder, was particularly troubling because the Company had very weak evidence of Neurontin's efficacy in treating this condition. Indeed, in one study sponsored by Parke-Davis, the placebo was as effective or more effective than was Neurontin." [p. 22]

The US Attorney's settlement, however, focused entirely on the company's financial fraud, but acknowledging "harm [from] the unnecessary