September 15, 2014

FDA’s Huge Conflicts of Interest with Big Pharma

pin it button FDA’s Huge Conflicts of Interest with Big Pharma

FDA money 300x201 FDA’s Huge Conflicts of Interest with Big Pharma

by Alliance for Natural Health

Tragically, the drug they endorsed is killing the women who take it. Why is FDA doing this?

The birth control pills Yaz and Yasmin, which were endorsed by an FDA advisory committee last December, contain a drug called drospirenone. Women who take it are nearly seven times more likely to develop thromboembolism (obstruction of a blood vessel by a blood clot, which can cause deep vein thrombosis, pulmonary embolism, stroke, heart attack, and death) compared to women who do not take any contraceptive pill, and twice the risk of women who take a contraceptive pill containing levonorgestrel. Thousands of women have filed a lawsuit against Bayer, saying they were injured by Yaz or Yasmin.

Why would the FDA approve such a dangerous drug? An investigation by the Washington Monthly and the British medical journal BMJ found that at least four members of the advisory committee have either done work for the drugs’ manufacturers or licensees or received research funding from them. The members reported their industry ties to FDA, but FDA decided it didn’t matter and didn’t make the disclosures public.

Each of those four panelists who received money from the pill’s manufacturer voted in favor of the pill. Interestingly, the committee’s ruling that the drug’s benefit outweighs the risks was decided by a four-vote margin.

Ironically, while the FDA allowed voting by advisors with business connections to drospirenone, the agency barred another advisor and former researcher, Sidney M. Wolfe, on the grounds that he has an “intellectual conflict of interest.” Six years earlier, Wolfe had advised his readers not to take Yaz based on several years of data—and this was before the latest studies had been published. Because of this, he was barred from voting.

So apparently people with monetary conflicts of interest are allowed to vote, just not those with “intellectual” conflicts of interest!

FDA also didn’t provide the panel with recently unsealed court documents revealing that former FDA commissioner David Kessler had accused Bayer of hiding data on blood clot risks associated with Yaz and Yasmin. Kessler also reported that they paid $450,000 to a high profile gynecologist to sponsor the pill, including off-label use of the drug, during her book tour.

Bayer, of course, has a strong vested interest in getting endorsements for Yaz and Yasmin—in 2009 Yaz was top-selling birth control in the US.

This is not the first time that an FDA advisory panel has recommended an unsafe drug. As we reported three weeks ago, an FDA committee endorsed the weight loss drug Qnexa, a diet pill that has documented risks of causing birth defects and heart problems.

The conflicts of interest don’t stop with government bodies; they are also rampant among medical professionals of all kinds. Drug companies pay doctors, researchers, and medical experts for speaking engagements and “consulting” jobs—all of which is perfectly legal despite a blatant conflict of interest. The public interest news organization ProPublica has a Dollars for Docs database that shows more than $760 million in payments from drug companies to physicians and other healthcare providers for consulting, speaking, research, and expenses. (For more about pharmaceutical conflicts of interest, please see our other article in this issue!)

Many of these physicians and researchers are employed by the state and paid with tax dollars—and they are the ones shaping states’ health policies. In Texas alone, from 2009 through early 2011, researchers and physicians received at least $57 million in cash payments, research money, free meals, and other benefits—on top of their quite generous salaries. The Texas attorney general has sued Janssen Pharmaceuticals and its parent company, Johnson & Johnson, for offering kickbacks to state health officials to get the schizophrenia drug Risperdal on the approved list of medications paid for by the state.

A provision in the Obama healthcare reform act will require pharmaceutical companies and manufacturers of medical supplies to disclose all “payments of value” to physicians and medical professionals on a federal government website. This includes food, entertainment, gifts, travel, consulting fees, honoraria, research funding, stocks, conference funding, and royalties—anything in excess of $100 a year. Penalties for noncompliance can reach as high as $1 million.

Critics are concerned that the disclosure law won’t show context—some doctors, for example, might spend months studying the effects of the drug, but people visiting the website will assume that all such payments are payoffs, thus tarnishing the reputations of supposedly upright medical professionals. But how can one be truly independent if one takes money from a drug company? The disclosure provision merely attempts to bring greater transparency to the relationship without outlawing the practice altogether. The rule may also bring down healthcare costs if doctors stop recommending the more expensive drugs which are marketed so heavily.

Read the Full Article and comment here: http://www.anh-usa.org/fda-huge-conflicts-of-interest-with-big-pharma/

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CDC’s Purchase of $4 Billion of Vaccines a Conflict of Interest in Overseeing Vaccine Safety

CDC’s Purchase of $4 Billion of Vaccines a Conflict of Interest in Overseeing Vaccine Safety

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Do you trust the U.S. Centers for Disease Control (CDC) to oversee vaccine safety, when they have an annual budget of over $4 billion to purchase vaccines from drug companies? In 2015, they want to increase that amount by another half a billion dollars.

Dr. Brian Hooker says the CDC should not be trusted to oversee vaccine safety, and after 10 years of fighting legal battles with the CDC via Freedom of Information requests to secure raw data on vaccine safety studies, he now has solid evidence to back up his claim of fraud within the CDC.

In a shocking news story that rocked the online world but was almost totally ignored by the mainstream media a couple of weeks ago, senior vaccine scientist Dr. William Thompson was revealed as a whistleblower within the CDC, admitting that the CDC had withheld information from a key study in 2004 that supposedly showed that the MMR childhood vaccine was safe.

The CDC was forced to issue a response, and Dr. Hooker has now shown that the CDC response is clearly trying to cover up ethical lapses and explain away key data that was omitted from their original study. This data which was hidden from the public for more than 10 years was not favorable towards their own bias and what they wanted the public to believe about vaccines and autism. Dr. Hooker has clearly shown that the CDC has a conflict of interest, and cannot be trusted with research on vaccine safety when it is spending more than $4 billion of taxpayer funds to purchase vaccines from drug manufacturers.

So what’s next? Will this fraud within the CDC be allowed to continue? There are reports that there are other whistleblowers within the CDC that would like to come forward, but are too fearful at this point. Dr. William Thompson is now represented by one of the top whistleblower attorneys in the nation, and has reportedly turned over more than 1000 documents to Congressman Bill Posey.

The pharmaceutical industry is the richest and most powerful political lobby in the world, however. Will there be enough members of Congress to come forward and oppose them? Does the American public even care enough about this issue to take action and threaten lawmakers who refuse to act and remove vaccine safety oversight from the CDC? Will they demand that taxpayer funds NOT be increased by over a half billion dollars next year to fund the purchase of more vaccines that are produced by pharmaceutical companies who are convicted criminals, and whose products have not been proven safe? More:

Gardasil: The Decision I will Always Regret

Gardasil: The Decision I will Always Regret

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She was full of life UNTIL she received her first and only Gardasil vaccine and this is a decision I regret every second of every day – if only I could turn back the clock!

Bill & Melinda Gates Foundation Vaccine Empire on Trial in India

Bill & Melinda Gates Foundation Vaccine Empire on Trial in India

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While fraud and corruption are revealed on almost a daily basis now in the vaccine industry, the U.S. mainstream media continues to largely ignore such stories. Outside the U.S., however, the vaccine empires are beginning to crumble, and English versions of the news in mainstream outlets are available via the Internet.

One such country is India, where the Bill & Melinda Gates Foundation and their vaccine empire are under fire, including a pending lawsuit currently being investigated by the India Supreme Court. Narayana Kumar of The Economic Times of India has just written a scathing report of fraud and scandals surrounding the Gates vaccine empire: Controversial vaccine studies: Why is Bill & Melinda Gates Foundation under fire from critics in India?

Kumar starts out his 4 page article by focusing on the current case before the India Supreme Court regarding deaths and injuries occurring during drug trials carried out over Merck’s HPV vaccine Gardasil. Vaccine trials were conducted on thousands of girls between the ages of 9 and 15. Many of the girls fell ill, and at least 7 died, and the lawsuit is alleging that in most of these cases, the girls and their parents did not even know what kind of vaccine trial they were participating in.

Unlike the U.S., victims of vaccine harm and fraud will get their day in court as the Supreme Court in India takes up the HPV Gardasil fraud claims. Also unlike the U.S., investigative reporters like Narayana Kumar are doing their job and publishing their findings in the mainstream media, informing the public.

Over-Medication of Elderly Epidemic – New Study Links Prescription Drugs to Alzheimer’s

Over-Medication of Elderly Epidemic – New Study Links Prescription Drugs to Alzheimer’s

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A new study just published in the British Medical Journal reports that taking benzodiazepines, common drugs prescribed for anti-anxiety and insomnia, is associated with a higher risk of Alzheimer’s disease. Common benzodiazepines include Valium (diazepam), Ativan (lorazepam), Xanax (alprazolam) and Klonopin (clonazepam). The authors of the study reported in the British Medical Journal that the use of benzodiazepines for three months or more was associated with a 51% increased risk of Alzheimer’s disease.

In an accompanying commentary written by Zosia Kmietowicz, it was pointed out that in 2012 the American Geriatrics Society had updated its list of inappropriate drugs for older people to include benzodiazepines, precisely because of their unwanted cognitive side effects. Yet almost half of the elderly population continues to be prescribed these dangerous medications, and are continuing to take them.

Judge: Lawsuit Against Merck’s MMR Vaccine Fraud to Continue

Judge: Lawsuit Against Merck’s MMR Vaccine Fraud to Continue

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In a story this week that no mainstream media outlet reported, a Pennsylvania federal judge ruled in favor of whistleblowers who have accused Merck of lying about the efficacy of its mumps vaccine (currently only available in combo with MMR). We had to find this story posted on a couple of websites representing lawyers. The lawsuit is brought by two whistleblowers, virologists who worked for Merck and are accusing Merck of lying about the effectiveness of the mumps vaccine.

This story did garner mainstream news coverage back in 2012, before Merck’s attorneys appealed and tried to get the case thrown out of court. This week, U.S. District Judge C. Darnell Jones II ruled that the whistleblowers had sufficiently pled that Merck might have provided false statements to the government and that the direct purchasers had shown enough evidence to establish that these falsehoods could have helped the company gain a monopoly.

It is certainly understandable why the mainstream media does not want to touch this story, given the fact that one of the lead authors on a CDC published study in 2004 has also become a whistleblower, stating that the CDC withheld data from the public linking the MMR vaccine to a higher rate of autism among some children, specifically African American boys.

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