Corruption of medical science – Least adequate person appointed as head of the FDA

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In September 2015, Robert Califf was nominated by President Barack Obama to be the next Commissioner of the Food and Drug Administration, and he was confirmed by the U.S. Senate in February 2016.

According to his biography, Robert Califf is an American cardiologist who was granted tenure as professor of cardiology at Duke University School of Medicine. He was the founding director of the Duke Clinical Research Institute, which is considered “the world’s largest academic research organization”, with 1000 employees and an annual budget of $320 million, 50-60% of which is funded from industry. His relationships with the pharmaceutical industry are described at length in his Wikipedia page.

“Califf worked very closely with pharmaceutical companies at the Duke clinical trials center “convincing them to do large, expensive, and, for Duke, profitable clinical trials.” He was a paid consultant for Merck Sharp & Dohme, Johnson & Johnson, GlaxoSmithKline, AstraZeneca, and Eli Lilly per ProPublica from 2009 to 2013. The largest consulting payment was $87,500 by Johnson & Johnson in 2012, and “most of funds for travel or consulting under $5,000”, which has been called “minimal for a physician of his stature”. From 2013-2014 he was paid a total of $52,796, the highest amount was $6,450 from Merck Sharp & Dohme, followed by Amgen, F. Hoffmann-La Roche AG, Janssen Pharmaceutica, Daiichi Sankyo, Sanofi-Aventis, Bristol-Myers Squibb and AstraZeneca. He was the Director of Portola Pharmaceuticals, Inc. from July 2012 to January 26, 2015,[11] Advisor of Proventys, Inc., Chairman of the medical advisory board of Regado Biosciences, Inc. and has been member of the medical advisory board since June 2, 2009, and member of the clinical advisory board of Corgentech Inc. Forbes wrote that his close ties to the drug industry were the reason for him not being nominated for the FDA Commissioner position in 2009.”

Dr. Califf held ties to the one pharmaceutical company who has the current record of the largest case of healthcare fraud in U.S. history:

“Drug maker GlaxoSmithKline PLC agreed to plead guilty to criminal charges of illegally marketing drugs and withholding safety data from U.S. regulators, and to pay $3 billion to the government in what the Justice Department called the largest health-care fraud settlement in U.S. history.”

Prosecutors said that “GlaxoSmithKline failed to give the U.S. Food and Drug Administration safety data about its diabetes drug Avandia, in violation of U.S. law.” This was only one of the several criminal charges to which this pharmaceutical company agreed to plead guilty.

I wonder what U.S law has to say about the safety of appointing someone with close ties to the pharmaceutical industry as head of the FDA – a federal agency that plays a major role in mainstream medicine not only in the United States, but the rest of the world as well.

It is claimed that Faculty Connection, LLC, where Califf served from 2006 to 2015, had an official corporate video noting that the company:

“served over 175 different pharma, biotech medical device firms,” claiming to help faculty — researchers, doctors, and academics — work side-by-side with the pharmaceutical industry.”

Unfortunately, the video is no longer available.

For me it is especially outrageous to see that something completely unethical and that should be illegal – the appointment of someone with over 175 possible ties to the pharmaceutical and tech industry as head of the FDA – was done with practically complete acceptance and compliance in the United States. Even ONE single link to Big Pharma should have been completely unacceptable.

From an ethical standpoint, whatever role the FDA holds on evidence-based medicine should at the very least be highly questioned by the international medical community.

The medical community holds a legal and ethical relationship of trust with patients and the public. Whatever credibility the FDA holds should be seriously questioned in the strongest possible terms by the international medical community. It bears repeating, the medical profession’s only fiduciary responsibility should be to patients and the public.

New hope? Experts calling for urgent public inquiry into drugs firms’ ‘murky’ practices in the UK

Sir Richard Thompson, former-president of the Royal College of Physicians, is one of a group of six eminent doctors who came out in public last month on the influence of pharmaceutical companies on drug prescribing. The experts, led by cardiologist Dr Aseem Malhotra, claim that too often patients are given useless – and sometimes harmful – drugs that they do not need. On a separate note, you can read Dr. Aseem Malhotra’s excellent paper “From the Heart: Saturated fat is not the major issue” published in the British Medical Journal.

They maintain that drug companies are developing medicines that are profitable rather than those which are likely to be the most beneficial. And they accuse the NHS – National Health Service for England – of failing to stand up to the pharmaceutical giants. The Mail Online reports:

“Sir Richard said: ‘The time has come for a full and open public enquiry into the way evidence of the efficacy of drugs is obtained and revealed.

‘There is real danger that some current drug treatments are much less effective than had previously been thought.’

He said the campaign highlights the ‘often weak and sometimes murky basis on which the efficacy and use of drugs, particularly in the elderly, are judged’.

Writing for MailOnline, Dr Malhotra says commercial conflicts of interest are contributing to an ‘epidemic of misinformed doctors and misinformed patients in the UK and beyond’.

Furthermore, he adds the NHS is ‘over-treating’ its patients, and claimed that the side effects of too much medicine is leading to countless deaths.

And he claims the full trial data on statins – cholesterol-lowering drugs prescribed to millions – has never been published, and also points to questions about the power of Tamiflu, a drug that has cost the NHS nearly £500 million.

The group has called on Parliament’s Public Accounts Committee to conduct an independent enquiry into the safety of medicines.

They claim public funding is often allocated to medical research because it is likely to be profitable, not because it will be beneficial for patients.”

You can read the full report here. It is refreshing to see how more people in the medical community are standing against the corruption of the medical science in our world today. Let’s hope that similar movements will be seen in the U.S., though I’m not holding my breath.

In 2014, I came across the following quote in the article “Boston Psychiatric Unit’s imprisonment of teenager Justina Pelletier needs State investigation into reckless endangerment of psychiatric diagnosing“:

Medical care that causes severe suffering for no justifiable reason can be considered cruel, inhuman or degrading treatment or punishment, and if there is State involvement and specific intent, it is torture.” – United Nation’s 2013 Report by the Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment.

This indictment might seem too far-fetched to some people in the medical community. After all, it is a Special Rapporteur for “unfortunate detainees”. However, if health-care professionals will accept conflict of interest and its consequences in silence, then the UN’s definition of torture may well be applied not only to the above-mentioned unfortunate detainees and their torturers, but also to the current situation where tens of thousands have died as a consequence of biased research which only serves profits.

Take into consideration that Dr. Califf was a known supporter of Merck’s Vioxx, an arthritis drug which could have caused an estimated 88,000-140,000 excess cases of serious coronary heart disease in the U.S. alone since its launch in 1999. It was removed from the market in 2005 after The New York Times denounced conflicts of interest in the FDA. As former editor-in-chief of the New England Journal of Medicine, Marcia Angell, MD, reported:

“Perhaps most important, many members of the eighteen standing committees of experts that advise the FDA on drug approvals also have financial ties to the industry. After the painkiller Vioxx was removed from the market in 2005 (it increased the risk of heart attacks), the FDA convened a panel consisting of two of these committees to consider whether painkillers of the same class as Vioxx should also be removed from the market. Following three days of public hearings, the combined panel decided that, although these drugs – called COX-2 inhibitors – did increase the risk of heart attacks, the benefits outweighed the risks. It therefore recommended that all three of the drugs, including Vioxx, be permitted to remain on the market, perhaps with strong warnings on the labels.

A week after the panel’s decision, however, The New York Times revealed that of the 32 panel members, ten had financial ties to the manufacturers, and that if their votes had been excluded, only one of the drugs would have been permitted to stay on the market. As a result of this embarrassing revelation, the FDA reversed the panel and left only one of the drugs, Celebrex, on the market, with a warning on the label.”

Since then, several other COX-2 inhibitors were approved and are offered in the market today alongside Celebrex.

Let us consider the unprecedented levels of conflicts of interest and their consequences for the people. As we can see from the data denounced by the UK experts above, conflicts of interest are leading to countless of deaths.

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Comments

  1. Guyfranke  March 22, 2016

    Thank you Gabriela. Your investigative journalism path is needed. Godspeed.
    CHeers !!

    reply
  2. James van Oosterom  December 20, 2016

    Benzinga news:

    “Sources close to President-elect Donald Trump’s transition team have revealed that Dr. Scott Gottlieb could be the next head of the U.S. Food and Drug Administration (FDA). Jim O’Neill is also being considered for the position, several media outlets have previously reported.”

    That should cheer you up….

    Have a blessed Christmas, Dr Segura. And NEVER let them get you down! We’re behind you!

    reply
  3. Margie  June 23, 2017

    Please any help or advice
    Baby, 10 months, send to hospital yesterday.
    lovely parents, no injuries

    The grandson of my dearest dutch friend is in emergency room in hospital.
    Baby, 10 months, lot of crying,
    Subcutaneous bleeding, Swellings over his whole little body, Red and blue bloodshed.
    Doctors in Netherlands have no idea what it is?

    reply

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