The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

FDA Officials Sued Over Conflicts of Interests Part I

Evelyn Pringle October 1, 2007

A lawsuit recently filed in a federal court in Ohio against FDA officials on behalf of terminal cancer patients provides a rare window into the inner workings of an agency hijacked by pharmaceutical industry giants and stacked with insiders by President George Bush to guard against any threat to the profits of his top campaign contributors.

The lawsuit’s complaint describes a conspiracy orchestrated by top FDA officials to basically drive a small company, Dendreon, out of business with the obvious goal of eliminating competition in what has become a thriving new industry involving the treatment of men with prostate cancer.

The complaint gives the details of a step-by-step plot to sabotage the FDA approval process of Provenge, the first-of-a-kind vaccine that can prolong the lives of men with late-stage cancer.

Prostate cancer patients have been waiting for the approval of Provenge for years. The New York Times first reported on a study back on October 29, 2004, the day after Dendreon announced the results that showed that “an experimental vaccine extended the lives of men with advanced prostate cancer.”

The findings also were discussed by Dr Eric Small of the University of California at San Francisco in February 2005, at a meeting in Florida that was co-sponsored by the American Society of Clinical Oncology. Here, he presented the study in which Provenge was given to a group of 82 men whose cancer had progressed after surgery and radiation treatment, and a similar group of 45 men who had received a placebo.

After 36 months, the study showed that 34% of the men who received Provenge were still alive compared to only 11% of the group who received a placebo, or a 23% difference.

On February 17, 2005, the Times reported that the 4.5-month increase in survival that was achieved by Provenge is greater than the roughly 2.5-month benefit shown in clinical trials of Taxotere, a drug from Sanofi-Aventis.

“Taxotere is the only approved chemotherapy for patients, like those in the Provenge trial, whose cancer has spread beyond the prostate gland and is no longer being controlled by hormonal therapy,” the article said.

Dr Small told the Times that Provenge improved survival for all patients, not just those with less aggressive cancers, and said “the treatment was much less toxic than chemotherapy, with the main side effects being flu-like symptoms that last a short time.”

The list of plaintiffs in the lawsuit, first and foremost, includes dying cancer victims, along with their family members and doctors, who are collectively suing as members of a non-profit corporation called CareToLive (CTL).

The plaintiffs allege that “prostate cancer patients are living and dying in Ohio and families and doctors in Ohio want this treatment for their family, friends and patients.”

According to the complaint, one doctor has 12 patients waiting for treatment and a John Doe plaintiff “is one of several Ohio prostate cancer patients who may die before he can receive Provenge.”

The named defendants in the case include the current FDA Commissioner, Dr Andrew von Eschenbach, and Mike Leavitt, in his supervisory capacity over the FDA as Secretary of the US Department of Health and Human Services.

And let it be noted that the lead defendant, Dr von Eschenbach, became the FDA Commissioner following a two-month stint by Dr Lester Crawford, only because Lester was booted out of office and found guilty of charges that he failed to disclose his own financial ties to companies regulated by the FDA.

The two other named defendants in the CTL lawsuit are Dr Richard Pazdur, the head of the FDA’s Office of Oncologic Drug Division, and Dr Howard Scher, chosen by Dr Pazdur to serve on the advisory panel convened to consider the approval of Provenge.

According to the complaint, Dr Pazdur “intentionally violated Federal Regulations” by improperly controlling the make up of the advisory committee and by “applying improper pressure” on panel members and other FDA employees “in an effort to achieve a predetermined outcome of his choosing.”

The plaintiffs allege that when Dr Scher was chosen to serve on the panel, he failed to disclose all conflicts of interest and his own personal interests in urging a decision that Provenge not be approved for men dying of cancer and that Dr Scher acted in “a manner that has callously deprived cancer patients access to a safe and effective immunotherapy.”

It also should be noted that the legal filings show one lone attorney, Kerry Donahue, of the Dublin, Ohio Bellinger & Donahue law firm, up against a “dream team” of attorneys with unlimited access to tax dollars and the full force of the federal government, which includes US Attorney Gregory Lockhart, Assistant US Attorneys Mark D’Alessandro and John Stark, the Director of the Office of Consumer Litigation, Eugene M. Thirolf, along with Andrew Clarke and Daniel Crane-Hirsch, Trial Attorneys from the Office of Consumer Litigation in the US Department of Justice.

According to the lawsuit, the FDA indicated that there were sufficient data submitted from the clinical trials of Provenge to immediately evaluate the product, so Dendreon filed a Biologics License Application in December 2006, which was granted fast track approval designation in January 2007, establishing May 15, 2007 as the date for an FDA decision.

Congress established the fast track approval program to expedite the approval of drugs for terminally ill patients.

In a blatant attempt to corrupt the Provenge advisory panel, Dr Scher was granted a waiver even though he is the chief of genitourinary oncology services of the Center for Prostate Cancer, at the Memorial Sloan-Kettering Cancer Center and the Center has a received a grant for a study from a competing company valued at $100,000-$300,000 and he owns stock valued at between $5,000 and $100,000 in a company that competes with Dendreon.

He also serves as an advisory board member to the venture capital fund ProQuest Investments LP. A 1998 document, entitled “The Opportunity in Cancer: Goldberg’s Variation” says “Prostate cancer will be the focus of the ProQuest Investment LP, a new venture fund founded by Jeremy Goldberg”, and “ProQuest raised $40.5 million in its first closing.”

Dr Scher also is listed on some documents as an officer and member of the board of directors of ProQuest.

However, a later May 2000 document discusses the “Start-Up” issue and says, “ProQuest Investments is a $100 million oncology-focused investment fund, partnered by Jeremy Goldberg and Jay Moorin.”

Under “Companies”, the report lists Dr Scher’s “Memorial Sloan-Kettering Cancer Center”, among many others, but Dendreon is not one of them.

According to May 15, 2006, SEC filings, ProQuest and its principals have a major stake in Novacea. For instance, at the time of the filing, ProQuest Investments II, LP held 1,779,767 shares, ProQuest Investments II Advisors Fund, LP was listed with 75,508 shares, ProQuest Associates II LLC held 1,855,275 shares, and Jay Moorin was listed with 1,910,988 shares.

Dr Scher also is on a scientific advisory board for Novacea and is the co-lead investigator of the company’s Asentar Phase III clinical trial of patients in the same stage of prostate cancer as patients who would be treated with Provenge.

Another conflicted panel member chosen by Dr Pazdur, Dr Maha Hussain, a professor at the University of Michigan, was granted a waiver even though she is the principle investigator for a study funded by a competing company and her husband owns stock valued at between $15,000 and $300,000 in three competing companies.

Under Faculty Disclosure Declarations, Dr Hussain is listed as being a consultant to, and an advisory board member of, Novacea and receiving research funding from Sanofi-Aventis, the maker of the chemotherapy drug Taxotere, the only product on the market FDA approved for the treatment of the cancer patients who would benefit from the approval of Provenge.

Dr Scher is also the lead investigator on a clinical trial investigating Taxotere in treating early-stage prostate cancer – a trial that some experts say would be adversely affected by the approval of Provenge.

Another conflicted member, Dr Savio Lau-Ching Woo, a professor of gene and cell medicine at Mount Sinai School of Medicine, was granted a waiver even though an affected company has patented a gene therapy technology that he invented which is being studied in prostate and other cancers and in the last 12 months Dr Woo has received an amount less than $15,000 from the patent.

Although in the end, the industry plants failed to corrupt the decision of the advisory panel, because the committee said Provenge was safe and that the data submitted show “substantial evidence” of efficacy, the efforts to derail its approval continued and on May 8, 2007, the FDA refused to approve the vaccine.

Instead of approval, the agency issued a Complete Response letter that required Dendreon to provide additional data that could take up to 2 years to accumulate. During that time, as many as 60,000 men will die from prostate cancer – many of whom could have benefited from Provenge.

The most blatant evidence of the conspiracy alleged in the lawsuit emerged in a May 30, 2007 press release, when Novacea and industry giant Schering-Plough announced that they had entered into an exclusive worldwide license agreement for the development and commercialization of Asentar and noted that Novacea was currently conducting a large international Phase 3 trial evaluating Asentar in 900 patients with androgen-independent prostate cancer.

Under the terms of the agreement, all total Novacea will receive close to a half a billion dollars.

Filed under: 2007, Bush, cancer, Dendreon, FDA, Novacea, Pazdur, Provenge, Sanofi-Aventis, Schering-Plough, von Eschenbach

FDA Officials Sued Over Conflict of Interest Part II

Evelyn Pringle October 2, 2007

The lawsuit filed on behalf of dying cancer victims against FDA officials that describes the intentional rigging of the advisory committee that met to review the application for the approval of Provenge, a cancer vaccine, on March 29, 2007, clearly proves that the industry-controlled FDA is never going to clean up its act.

The defendants in the lawsuit include the FDA Commissioner, Dr. Andrew von Eschenbach, his boss Mike Leavitt, Secretary of the US Department of Health and Human Services, Dr Richard Pazdur, head of the FDA’s Office of Oncologic Drug Division, and Dr Howard Scher, hand-picked by Dr Pazdur to serve on the advisory committee.

Other conflicted panel members include Dr Maha Hussain, a professor at the University of Michigan, and Dr Savio Lau-Ching Woo, a professor of gene and cell medicine at Mount Sinai School of Medicine.

A law was passed back in November 2005, that required members of committees to disclose all financial ties to the pharmaceutical industry and the categories for disclosure were broken down into dollar amounts with time frames, such as less than $10,000 a year or between $10,000 and $50,000 a year.

However, as usual, a major loophole remains where FDA officials are permitted to grant waivers to panel members even when they do have extensive financial ties to drug companies. Six month after the law went into effect, on April 21, 2006, the Boston Globe reported on the actual effects of the law and determined that the FDA had granted close to 100 waivers in less than 6 months.

Apparently, Provenge (known technically as Sipuleucel-T) is but one of many cell and immune-based therapies that have been under development over the past decade. However, the Seattle-based Dendreon is the first to seek FDA approval for a product in this new class of immunotherapy for the treatment for androgen-independent (hormone-refractory) metastatic prostate cancer (AIPC).

The immune system defends the body against infections and diseases, and the Provenge vaccine is designed to stimulate the patient’s immune system to attack cancer cells in the same way that it attacks bacteria or viruses. The entire course of treatment involves 3 donations of blood over a brief period of time, each of which is processed by Dendreon and then sent back for infusion into the patient.

A study submitted by Dendreon to back the approval of the vaccine showed that after 36 months, 34% of the men who received Provenge were still alive as compared to only 11% of the group who received a placebo, or a 23% difference.

Currently, the chemotherapy drug Taxotere (docetaxel), made by Sanofi-Aventis, is the only FDA approved drug for the treatment of AIPC.

Many patients and patient advocates testified at the March 29, 2007, hearing, and some literally begged the FDA to approve Provenge. Joel Nowak, 56, traveled from Brooklyn to testify as a patient and a as representative of the advocacy groups “Raise a Voice” and “MaleCare,” for which he serves as the program director for advanced prostate cancer.

Mr Nowak was diagnosed with recurrent advanced prostate cancer in December 2005, and said, according to the National Cancer Institute, the expected mortality rate for advanced prostate cancer is over 50% within 36 months of diagnosis.

“If you take the statistical next step,” he told the panel, “since I’ve already exhausted 16 of those months, which means I may have only but 20 months left to be on this Earth.”

He noted that treatment choices are fairly non-existent. “Those of us who suffer with advanced prostate cancer have already gone through the mill of barbaric treatments,” he told the panel.

“We’ve had our prostates removed or radiated, often leaving us with varying degrees of incontinence and impotence,” he said, “and then 30 percent of us suffer a recurrence.”

Mr Nowak explained that this signals the beginning of the clock’s final countdown and described the desperate attempts by cancer victims to stay alive and stated:

“We try to buy a little more time. We try salvage radiation or surgery. We start a hormone blockade that leaves us as physical and chemical eunuchs.

“We lose the little sexual ability that we may have managed to cobble together and trade it for hot flashes, loss of muscle mass, loss of bone density, peripheral neuropathy, mood swings, and a host of other ailments.

“Despite the suffering that we endure, our cancer continues to march on. Now our only option to survive a little longer as it exists today is chemotherapy, where we have to introduce into our bodies chemicals that will hopefully kill the cancer, but will also kill us.”

He acknowledged that Provenge will not cure his disease, but said, “it does offer an opportunity to extend my life.”

Alvin Chin spoke on behalf of the Virginia Prostate Cancer Coalition and pointed out that Taxotere was approved when it extended life by only a couple months compared to a placebo. “Provenge extends life more than twice as long without the pain,” he noted.

“The loss of hair, fingernails, vitality, your dignity is something you don’t lose with Provenge,” he pointed out.

Mr Chin told the panel that men will gladly trade the side effects of hormonal and chemotherapy treatments for the few and transient side effects of Provenge and gain more life in the process.

No one wants to die a hopeless and painful death, and worst of all no one gladly accepts chemotherapy, the only treatment available to men with hormone-resistant prostate cancer, he said.

He explained that the side effects of chemo are so bad that men refuse treatment because they want to have an improved quality-of-life in their final years. “By recommending approval you will give up to 50,000 waiting men, maybe more, new hope and new life with an alternative treatment that works,” he said.

The customer base up for grabs in the prostate cancer industry is huge. According to the American Cancer Society, approximately 220,000 new cases of prostate cancer will be diagnosed in the US in this year alone and about 27,000 men face death from prostate cancer each year.

On March 29, 2007, after listening to all the presentations and testimony of cancer treatment advocates, in a unanimous vote, the committee determined that Provenge was safe, and that there was substantial evidence that the product works in treating late stage prostate cancer that no longer responds to hormone treatment by a 13-4 vote.

However, the meeting transcript reveals a calculated attempt by the conspirators to elicit the desired “no” response from committee on whether Provenge was effective, with a question that asked: “Does the submitted data establish the efficacy of Sipuleucel-T (APC-8015) in the intended population?”

This obvious stunt was quickly recognized by some panel members and the question was then rephrased to conform with the.law that requires the question to ask does the data submitted show “substantial evidence.”

After the question was rephrased, the first expert to vote, Dr Richard Alexander, changed his “no” vote to “yes” and stated: “I mean the issue is — yes, there is substantial evidence. I mean, the 150-some patients, they’re substantial evidence.”

Dr Jeffrey Chamberlain followed Dr Alexander and said: “I vote yes, there is substantial evidence.”

And after him, Dr Larry Kwak said, “Yes, substantial evidence.”

Dr Kurt Gunter voted yes and stated: “I do think it both meets the measure of substantial evidence, and I also believe that it’s pretty definitive.”

“And I think that these data,” he stated, “even though they’re complex, can be presented by oncologists to patients in a way that they can understand and make reasonable choices.”

“So I definitely support that this is an effective therapy,” he stated.

Once the question was changed, Dr Hussain stated, “to me “substantial” and “establish” are the same, and no to either. So no to both.”

When Dr Woo was asked to vote, he stated in part: “Does it rise to the level of substantial evidence that it is effective? I don’t think so, not even near.”

The sudden change in the question seemed to throw Dr Scher off kilter and when the vote got to him he stated: “We have two questions. I would say yes to one, no to the second. The first question as posed, as established, I say no.”

The panel chairman, Dr James Mule clarified that the question was “substantial evidence,” and Dr Scher replied, “I will say no.”

During the meeting, Dr Ke Liu, the FDA’s clinical reviewer of the Provenge application, explained the advantage of using overall survival rates, as noted in the draft guidance document entitled, Clinical Trial Endpoints for the Approval of Cancer Drugs in Biologics. “Overall survival,” he said, “is the most reliable cancer endpoints, usually the preferred endpoint, and the studies can be conducted to adequately to assess it.”

“Demonstration of a statistical significant improvement in overall survival,” he told the panel, “has supported new drug approvals.”

Dr Liu also said an improvement in survival is a clinical benefit, and that the endpoint is precise and easy to measure because it can be documented by the date of death.

During the meeting, no doubt by accident, Dr Sher even acknowledged that “there’s no argument that overall survial is a definitive endpoint, and that’s what we’re all seeking to achieve with our treatments.”

However, on May 8, 2007, the FDA made history when for the first time, it denied the approval of a cancer drug despite the recommendations of its own advisory committee and despite the pleas from dying cancer victims during the advisory panel hearing.

By filing their lawsuit against FDA officials, the plaintiffs “seek to immediately enjoin the Defendants from denying, for even one more day, the distribution of Provenge to them.”

Filed under: 2007, Bush, cancer, Dendreon, FDA, Pazdur, Provenge, von Eschenbach

Medicare Prescription Drug Scam Jumps From $400 Billion To Over $1 Trillion

Evelyn Pringle February 21, 2005

In December 2003, the Medicare Prescription Drug and Modernization Act was passed. Many seniors expected the new law to provide relief for the ever-rising prescription drug costs but they were sadly mistaken.

We recently learned that instead of costing tax payers $400 billion, the bill is going to cost more than $1.3 Trillion, over the next 10 years, and the only ones benefiting from it are the pharmaceutical companies and HMOs.

The new law will not save tax payers any money because it specifically bars Medicare from negotiating for better drug prices like the Department of Veterans Affairs does, and it bans the importation of cheaper drugs from neighboring Canada and other countries. The notion that the bill will provide any meaningful savings for seniors is unlikely.

Due to its insider knowledge about the pending Medicare prescription bills in Congress, and the amount of money up for grabs, the pharmaceutical industry lobbied non-stop in 2002, to make sure that its favored version of the bill got passed. It spent a record breaking $91.4 million on lobbying, and 24 separate companies and trade groups spent over $1 million each. The top 10 drug companies and trade associations together, spent an estimated $55.8 million on lobbying.

However, what’s $55 million compared to the $35.9 billion in profits that were realized by the same 10 companies in 2002. Since Bush took office, pharmaceutical industry profits have soared past all other business sectors, at a rate of more than 5 times greater than all other industries in the Fortune 500.

Prohibits Medicare From Negotiating For Lower-Priced Drugs

According to Senator Edward Kennedy, “The single most irresponsible provision in the Medicare bill is the prohibition that prevents Medicare from negotiating lower-priced prescription drugs.”

Prescriptions bought by the VA cost at least 24% less than the average retail price, said Steve Thomas, director of the program. For many drugs, the VA negotiated price is on average 40% less that what most consumers pay, Thomas said.

When Bush was asked why he barred Medicare from bargaining for lower prices on behalf of its beneficiaries, he offered the feeble excuse that he was concerned that if Medicare negotiated with drug makers, it would amount to a government monopoly and a form of price controls.

That excuse is ridiculous. Although Medicare might be a major player in the market, being recipients are expected to buy over $1.5 trillion worth of drugs over the next 10 years, it could hardly be considered a monopoly in a market projected to earn about $4.6 trillion.

During the debate on the Medicare bill, the Department of Health and Human Services Inspector General said, “Medicare and its beneficiaries would save $1.6 billion a year if 24 drugs were reimbursed at amounts available to the VA.” As an example of the possible savings, he listed the price of the asthma treatment drug, Albuterol, that was being sold for 47 cents, while the VA was paying only 5 cents.

Comptroller General, David Walker, of the General Accounting Office (GAO), has been recommending that Medicare should follow the VA model for years but Bush refuses to take the advice of our government experts.

Discount Drug Card Scam

Shortly after signing the new Medicare bill, Bush announced a plan for a drug discount card program. To enroll in the program seniors had to pick one of Bush’s approved providers. A card could cost up to $30, and once chosen, seniors had to remain with the same provider for a year. No discounts were guaranteed, drug prices could change at any time, and drugs offered could also change at any time.

The card program in itself, is a scam. There are over 40 million Medicare beneficiaries in the country. Multiply that number times $30 and the first expected windfall of the scam becomes obvious. However, seniors were not half as dumb as Bush thought, and only a fraction of the beneficiaries even bothered to buy the cards.

Because they had insider knowledge about the program, the drug companies simply raised prices in anticipation of the cards being issued. In the first quarter of 2004, right before the program went into effect, some drug makers raised prices almost 7 times as fast as producers of all US goods, according to a study by the senior advocacy group AARP.

Bush claimed that using the cards would result in discounts of 10 to 25%, which amounts to a 0% discount considering the fact that drug prices increased by nearly 22% over the past 3 years. The dramatic increase in prices offset any potential savings on drugs purchased with the cards. Only the drug companies stand to make money with this deal.

Due to the enormous increase in drug costs, many seniors are skipping doses, cutting pills in half, or not taking the medication at all. In the long run, these drastic measures can actually prolong an illness and add to the expense of the treatment.

Discount Card Prices Verses Non-Card Prices

In April 2004, the minority staff of the House Government Reform Committee, released a study that compared prices available to seniors who would pay the $30 to buy a card, against prices available to seniors who did not.

The study used prices from 3 card providers, ExpressScripts, Advance (Advance is owned by Bush-buddy David Halbert, who crafted major portions of the bill), and Walgreens. Prices of these companies were similar to all others. The drugs used in the study represent a month’s supply of the top 10 brand-name drugs used by seniors.

The study compared the card prices to (1) prices in Canada; (2) prices negotiated by the Department of Veterans Affairs; and (3) prices charged by internet outlets Drugstore.com and Costco.com.

Card prices were much higher than prices in Canada. A month’s supply of the 10 drugs in Canada cost $596, while prices were $972 with Walgreens, $1,046 with Advance, and $1,061 with Express. The average card price was 72% higher than in Canada.

The difference for some drugs exceeded 100%. For instance, Celebrex, costs $81.28 at Walgreens, but only $38.69 in Canada; Prevacid was $129.68 with Express, but only $56.54 in Canada.

The comparison to drugs purchased by the VA, also found card prices much higher. With the VA the10 drugs cost $587, while the average price with the cards was $1,026, or more than 75% higher.

A month’s supply of the drugs even cost less on internet sights Drugstore.com and Costco.com. While the average card price was $1,026, the drugs only cost $959 at Drugstore.com.

In June 2004, Families USA released the results from a study that tracked price changes for the top 30 brand name drugs prescribed to seniors. According to the report, between January 2001 and January 2004, the prices of the top 30 drugs increased by nearly 22%. On average, the cost of the drugs increased by 6.5%, while in the same time-frame, the overall rate of inflation, excluding energy, was only 1.5%.

Of these 30 drugs, 28 increased in price by 2 or more times the rate of inflation; 21 increased by three or more times the rate, and 14 increased in price by more than 5 times the rate of inflation.

The drug companies also raised prices at a break-neck speed right before the cards came out. For example, Nexium is used to treat heartburn, a problem for more than 40 million people. Democratic Rep Henry Waxman released a study that showed that in one month, between May 3 and June 3, 2004, the price of Nexium increased by 13%.

In 2003, the drug company AstraZeneca spent $411 million promoting the drug. And in return, it had sales of $3.3 billion, and became the 7th largest selling brand name drug according to the trade publication Pharmaceutical Executive.

Generic drug prices were also spiked. A report by the Wall Street Journal revealed that pharmacies were buying generic drugs for a few cents and marking them up nearly 200%. For example, a 90-day supply of generic Prozac costs only $4, and was sold for $14.94 at Costco.com. Yet the Medicare website showed one card sponsor charging $84.15.

Lawmakers On Both Sides Of The Isle

The importation issue is not only important to senior citizens, it affects all Americans. And they are speaking out. On December 22, 2004, Rep Bernie Sanders from Vermont issued the following statement in response to a Task Force Report, that came out against drug importation, from the Bush administration:

“It is ironic that two weeks after the HHS announcement that … flu vaccine doses will be imported from Germany, HHS is … saying drug importation cannot be done safely and affordably. This report is reflective of the entire Bush policy to protect the financial interest of the pharmaceutical industry over the health of regular Americans.”

Sanders claims it is absurd to say we can’t import drugs safely. “If we can import beef, poultry and vegetables … there is no reason we cannot figure out a way to safely import prescription drugs. The momentum remains with the American people,” he notes.

According to Senator Byron Dorgan (D-ND), “The only thing endangered by allowing Americans access to lower-priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who over-price their medicines in our market, just because they can,” he said.

Importation would be legal if it was up to Republican Congressman Dan Burton of Indiana. During the debate over the prescription drug bill, he attempted to pass a provision that would have legalized importing drugs from Canadian with safeguards.

But Burton says he couldn’t get it passed because he ran into two brick walls: the drug industry and the government: “This is a perfect example, in my opinion, of where a special interest, the pharmaceutical industry, has been able to manipulate the Congress and the government of the United States to their benefit, and to the detriment of the American taxpayer and the American people.”

How any politician can look an American citizen in the eye and argue against drug importation is beyond me.

Filed under: 2005, Bush, Drug Importation, Medicare Prescription Drug Bill, prices

Truth About Importing Prescription Drugs

Evelyn Pringle September 2004

On September 10, 2004, Peter Rost, a physician and pharmaceutical industry executive, was a featured speaker at the annual meeting of the Society for Professional Journalists, and openly criticized the high cost of prescription drugs and the efforts by the pharmaceutical industry and politicians to block the importation of cheaper drug from other countries.

For the past 20 years, Rost has been marketing pharmaceuticals and he is currently a Vice President with Pfizer. He has agreed to give Independent Media TV an exclusive interview for a series of articles aimed at dispelling the myths about importation through an insider’s window of truth on the issue.

Rost says that his #1 concern is for the people who can not afford their prescription drugs. He believes that people going without medication is a “bigger safety issue than anything else.”

Why Is Peter Rost Speaking Out On This Issue?

Rost recently wrote a favorable review on Amazon.com of the book, “The Truth About the Drug Companies: How they Deceive Us and What to do About it” by Marcia Angell, which contains a highly critical assessment of the pharmaceutical industry.

The responses he received on the review made Rost realize that he had something to contribute to the debate. On the question of why he is speaking out, Rost says, “I believe I am doing the right thing, both in the long-term for the pharma industry and in the short-term for all the patients who cannot afford life-saving drugs.”

First off, Rost wants everyone to know that when speaking publicly, he does not in any way represent Pfizer. “I’m simply using my right to free speech, guaranteed in the first amendment,” he states.

Of course he realizes that he’s not going to win any popularity contest with industry officials by speaking out but when asked whether he thinks Pfizer may take some kind of action against him for exercising his right to free speech, he says, “If they took any action against me, they would create a public martyr. I can’t see how that would be in Pfizer’s best interest.”

Rost Hopes To Improve The Image Of Industry

A study presented in the February 2004 edition of Pharmaceutical Executive revealed that 87% of Americans do not believe the pharmaceutical industry is honest and trustworthy. Rost found it disturbing that only 13% of the public had a positive view of the industry. He would like to change that perception and hopes that his coming forward and speaking up about important issues will be a first step in the right direction.

How Many Excuses Can Bush Come Up With?

Bush has fought against importation using every reason under the sun, except the real one, GREED. He has been in bed with the drug companies for so long that I’m beginning to think they’re providing him with free drugs. What else would explain all the stupid stories that he makes about importing drugs?

Come to think of it, who was he just with last week? None other than that pill-poppin idiot Rush. Maybe Bush’s cronies in the industry are supplying both of them with drugs.

Ok, if its not drugs then I’ll say this again, Bush really needs to get help for his compulsive lying disorder because his tales are becoming more far-fetched every day.

Lets take a look some of the ridiculous stories he has come up with lately, while we have the opportunity to get Rost’s take on a few.

In April, Bush claimed that allowing drug importation would lead to jobs losses (although job losses never seemed to bother him before). He had Commerce Undersecretary Grant Aldonas tell a Senate panel that if Congress allows importation, “There will be disinvestment in the United States, a loss of employment opportunities and frankly a loss of an industry that is a huge multiplier” in terms of benefits to the overall U.S. economy, Aldonas said.” [Source: Reuters, 04/27/04]

Yea right. And just where are they going? Besides, half of the drug companies are not located in the US to begin with, so we can toss that excuse out.

Here’s one where Bush pulls out the FEAR card (hey, it works for everything else). He got FDA Official, Lester Crawford, to say that tampering with prescription drugs imported from Canada could be a way for terrorists to attack Americans. And old Lester added a nice touch by claiming that action by terrorists was the most serious of his concerns about the efforts to import drugs from Canada.

“THE most serious concern?” I’m really scared now. Those terrorists have apparently invaded every country and every industry.

But then again maybe not because the American Progress Action Fund described Crawford’s comments as a way for the administration to use “the fear of terrorism” and called the warning a “cynical, baseless and transparent” tactic.

Rost doesn’t seem too worried about this either. He says, “Some people clearly are very scared about this (importation) and will put forward almost any argument.” As an example, he told about Lester saying that his main concern was that Al Qaeda might attack the supply of drugs coming from Canada, and added, “I assure you this is not a joke from Letterman.”

Could have fooled me. Was it on Saturday Night Live then? Looks like we can toss that excuse out as well.

Then there’s the old false advertising trick. Bush’s favorite way to manipulate the minds of seniors. The pharmaceutical giant GlaxoSmithKline recently began running newspaper ads that question the quality and safety of drugs obtained from Canadian.

Which just proves once again that those greedy, heartless SOBs will go to any length to rip off seniors.

Then we are force-fed that worn-out, old wife’s tale by William Hubbard, associate commissioner for policy and planning at the FDA, who says that “his agency was opposed to the drug import legislation because of fraud and safety concerns.” [Source: Reuters, 04/27/04] (I guess he hasn’t heard about Al Qaeda yet).

According to Rost, this one is as phony as all the others and he says, ” this is an argument that could only be put forward in a country in which less than one in four citizens have applied for a passport in the last ten years and even fewer have traveled overseas.” (Like America)

He points out that everyone has conveniently forgot to tell us ” stay-at-home Americans” that “in Europe, reimportation of drugs, parallel trade as it is called there, is an institution which has been in place for 20 years. The European Union has an important law that guarantees free trade within the union,” he says.

In fact, Rost says there are large pharmaceutical companies that specialize in nothing but buying drugs in southern Europe from Greece, Italy and Spain where the costs are often much less, and then shipping them to countries in northern Europe like the UK, Germany, and the Nordic countries.

Rost believes that the press has a duty to report objectively on facts and take a position when things need to change. “If, for example, you report on safety issues related to reimportation, without telling the public that this has been done safely within Europe for twenty years, you mislead the public,” he claims. Rost believes the press should act as the nation’s conscience.

The media needs to quit being so lazy, and start taking its job much more seriously. The public deserves to know the whole truth about government policies that affect their everyday lives. As long as Rost is brave enough to speak out, the media should be willing to feed the information to the public. Because if we stop and think about it, who knows when or if we will ever hear from another industry insider like Peter Rost again?

Filed under: 2004, Bush, Drug Importation, Medicare Prescription Drug Bill

$130 Billion Dollar Medicare Rip-Off

Evelyn Pringle September 2004

On July 6, 2004, the Department of Health and Human Services (HHS) Office of the Inspector General (IG) released a report stating that former Centers for Medicare and Medicaid Services (CMS) Administrator Thomas Scully pressured the agency’s chief actuary, Richard Foster, to withhold cost estimates of the Medicare Prescription Drug bill when it was being considered by Congress last year.

Foster had claimed that Scully ordered him to withhold estimates that showed the bill would cost between $500-$600 billion, well above the $395 billion estimate on which members of Congress were set to base their vote.

Specifically, Foster’s estimates were anywhere from 25 to 50% higher than those provided to members of Congress, and showed that rather than helping seniors lower prescription costs, the bill would be a windfall for drug companies, HMOs and insurance companies.

For instance, Foster’s estimates projected that the new plan would boost Medicare payments to private health plans by $46 billion (over 3 times the $14 billion Bush estimate), and that drugmakers would collect $100 billion more than the estimate provided to Congress.

Bush knew about Foster’s higher projections. On March 20, 2004, The Washington Post reported that, Trent Duffy, a Bush spokesman, acknowledged that the actuary’s cost estimates had been sent to White House officials, including Doug Badger, a special assistant to President Bush who negotiated with Congress on the Medicare bill.

The key to the success of Medicare scam was to hide Foster’s estimates from members of Congress until after they voted to pass the bill, and the strategy worked.

If revealed, Foster’s figures definitely would have threatened the passage of the bill because 13 Republicans had vowed to vote against it if the cost went over $400 billion. Even at the lower cost of $395 billion, the bill only passed by 5 votes. Had members of Congress known the truth, the bill may well have been doomed.

In January, 2004, upon submitting his budget, Bush was forced to admit that the bill would probably cost $534 billion, not $395 billion.

When Foster’s claims became public, Democrats were rightfully angry about being duped. They contend that Scully’s actions forced them to vote on a bill without full knowledge of its cost. Rep Charles Rangel, senior Democrat on the Ways and Means Committee, said: ” All I know is that the Congress did not have the best information available to make a judgment on vital legislation. … We asked for it. We were not given it.”

Many Republicans were also upset. Rep Trent Franks (R-Ariz) told the New York Times, “If anyone was truly pressured by a superior to withhold information from Congress, that is profoundly unethical and inappropriate.”

Rep Sue Myrick, one of the 13 Republicans who were set to vote against the bill, said she was “very upset” when she learned of the higher estimate. “I think a lot of people probably would have reconsidered (voting for the bill), because we said that $400 billion was our top of the line,” Myrick said.

Who Asked For The Estimates?

Members of Congress had been requesting Foster’s estimates for months. According to the New York Times, Cybele Bjorklund, an aide to California Rep Pete Stark, a member of the Ways and Means Committee, began to press Foster for his estimates in June, 2003. She said that after sending Foster an e-mail on June 17, and receiving no response, she called him on June 24. Bjorklund said that Foster told her, “I cannot give it to you; I’m afraid I could be fired.”

She then called Scully, who she says told her, “If Rick Foster gives that to you, I’ll fire him so fast that his head will spin.” Scully said that he recalls ” a heated conversation, but says he never threatened to fire Mr. Foster,” the New York Times reports.

Foster told colleagues that he would be fired if he revealed the estimates. “This whole episode which has now gone on for three weeks has been pretty nightmarish,” Foster wrote in an e-mail to colleagues on June 26. “I’m perhaps no longer in grave danger of being fired, but there remains a strong likelihood that I will have to resign in protest of the withholding of important technical information from key policy makers for political reasons.” Knight Ridder obtained a copy of the e-mail.

Bjorklund told the New York Times that in January 2004, she received a fax revealing Foster’s cost estimate for the Medicare legislation, the New York Times reports. The fax was dated June 11, 2003, and had “no hint of the sender” (New York Times, 3/18).

Scully Denial

In an interview with Knight Ridder, Scully denied Bjorklund’s assertion that he had threatened to fire Foster. He said he curbed Foster on one specific request, made by Democrats on the eve of the first House vote in June, because he thought they would use the cost estimates to disrupt the debate.

Otherwise, Scully said that Foster was available to lawmakers and their staffs.

“… I don’t think he ever felt – I don’t think anybody (in the actuary’s office) ever felt – that I restricted access. … I think it’s a very nice tradition that (the actuary) is perceived to be very nonpartisan and very accessible, and I continued that tradition.”

Scully said Liz Fowler, the chief health lawyer for the Democrats on the Senate Finance Committee, could confirm the actuary’s independence. Fowler did not. ” He’s a liar,” she said of Scully, according to Knight Ridder.

Results Of Investigation

After completing the investigation, the IG said that Scully may have violated ethical standards, but since he is no longer at CMS, recommended that no administrative action to be taken against him. She released a statement that said that Scully:

* Failed to produce premium estimates for drug coverage under the bill;
* Failed to provide congressional staff with total estimates and other information;
* Warned CMS’ chief actuary, Richard Foster, that ” disciplinary action” would be taken if Foster provided certain information in response to Congressional requests;
* Warned a Congressional staffer that Richard Foster would be fired for releasing information.

The report admitted that on 5 occasions between June and October 2003, which means before the bill was voted on, Scully blocked efforts by Foster to comply with requests from members of Congress for information about the cost of the Medicare drug bill.

And yet, the report concluded, “Our investigation failed to produce evidence that criminal statutes were violated in connection with the failure to respond to congressional requests.”

Supposedly the legal question weighed was whether Foster could speak independently of his boss or needed to obey his boss. Drews concluded that Foster’s job provides him “freedom from supervision in performing actuarial duties, not supervision of disclosure of Department records or information to the Congress.”

“Since the Chief Actuary is subject to CMS supervision, the Administrator has the right to direct the Chief Actuary, just as any other CMS employee, to provide the Administrator with information for review prior to the information being provided to the Congress, or even direct that the information not be provided,” Drews wrote.

Before Bush took office, the Medicare actuary’s estimates were customarily provided to lawmakers who were debating Medicare legislation. This finding begs the question of how is Congress supposed to legislate when experts in the executive branch fail to share information about the cost of government programs?

Results Of Other Investigations

The finding that Scully’s actions violated no laws is contrary to an April, 2004 report by the Congressional Research Service (CRS) that also investigated the matter. The CRS concluded that Scully’s threats to fire Foster probably violated a 1912 statute that says a federal employee’s right to communicate with and provide information to Congress “may not be interfered with or impeded.”

However, Justice Department lawyers claim that Scully was within his rights to order Foster to withhold information, as long as the directive was “not based upon an invalid or unlawful reason,” wrote Katherine Drews, a Justice Department associate general counsel.

Now what the hell does that mean? In plain language please.

Am I missing something here? Since when did it become lawful for the president to conspire with policy officials to provide members of Congress with phony cost estimates on pending legislation in order to funnel $139 billion to cronies in the health care industry?

Foster sure doesn’t agree with the findings. According to Knight Ridder, he stands by his position, ” My perception remains that Mr. Scully withheld that information for political purposes. And regardless of his legal right to withhold it, I continue to believe that it’s wrong and unethical to withhold technical information from Congress.”

Where Is Scully Now?

Unbeknownst to Congress, Scully was trolling for a job within the industry at the same time that he was working on the final Medicare bill. Knight Ridder reported that Scully “was exploring jobs in the private sector while he was pushing for passage of the prescription-drug bill, thanks to a waiver from Thompson that allowed him to conduct job interviews while he was still a federal employee.”

So that means that at the same time that he was browbeating Foster, Thompson told Scully that he didn’t have to abide by the federal law that bars presidential appointees from discussing employment with companies conducting business with their own department or agency. And neither Thompson or Scully felt a need to notify Congress of the waiver.

Where does Scully work these days? According to the July 7, 2004, Washington Post, Scully is registered as a lobbyist for major drug companies, including Abbott Laboratories and Aventis; for Caremark Rx, a pharmacy benefit manager; and for the American Chiropractic Association and the American College of Gastroenterology, among others.

All of these clients are affected by a bill that Scully helped write. But not to worry, according to Knight Ridder, the “White House announced in February that President Bush’s appointees no longer would be permitted to job-hunt while on the federal payroll.”

Who Else Was Involved In The Scam?

James Capretta, another top official on Medicare policy at the OMB, was also shown Foster’s cost estimates for the bill. So he knew that the cost of the bill was far more than Bush had advertised.

Another official in on the scam was Doug Badger, Bush’s top health policy adviser on Medicare. On March 20, 2004, The Washington Post reported that, Bush spokesman, Trent Duffy, acknowledged that “the actuary’s cost estimates had been sent to White House officials, including Doug Badger, a special assistant to President Bush who negotiated with Congress on the Medicare bill.”

On March 24, 2004, Foster told the House Ways And Means Committee that he had shared the estimates with Doug Badger and that Badger seemed to be directing Scully in imposing the gag.

One might say that Badger waltzed through the revolving door backward. He quit his lobbying job to become a Bush adviser. Before accepting the White House position, he helped bring in more than $1 million for the firm of Council Ernst & Young, from clients like Aventis, Baxter Healthcare, Biogen, Eli Lilly, Johnson & Johnson and Pfizer.

And this is not Badger’s first trip through the revolving door. He became a lobbyist after working as chief of staff to Sen Don Nickles (R-Okla) and staff director of the Senate Republican Policy Committee. He also has held positions at the DHHS and the Social Security Administration. I can’t wait to see where Badger ends up in January 2005.

Others Also Left For Private Employment

By now there must be a well-beaten path between the backdoor of the White House and companies in the Health Care Industry. Scully wasn’t the only guy trolling for private employment. Once the bill passed, members of the administration couldn’t get to their new high-paying jobs fast enough.

The bill was signed into law on December 8, 2003. Exactly 1 day later, Thomas Grissom, director of the CMS, left to become a lobbyist for medical device maker Boston Scientific. Grissom had been in charge of developing policies and regulations for the Medicare fee-for-service program and for overseeing Medicare’s $240 billion contractor budget.

I wonder how he was able to land a job the day after he quit his last one, especially in such a dire employment market? Maybe he could give some tips to the other people who are unemployed.

In January 2004, Dallas “Rob” Sweezy, the director of public and intergovernmental affairs at CMS, took a job with National Media Inc, which just happens to be the same firm that Bush paid $12 million to produce the phony TV ads touting the new bill, that the GOA determined were illegal and fraudulent.

National Media and its partner Alex Castellanos also served as consultants to both Bush campaigns and produced ads for the industry front group Citizens for Better Medicare.

However, Sweezy didn’t last long at National Media. In May 2004, he went to work for the lobbying firm Loeffler, Jonas and Tuggey, which represents Bristol-Myers Squibb, Purdue Pharma, First Health and PacifiCare.

James Capretta, Bush’s top official on Medicare policy at the OMB, left in June 2004 to join Wexler & Walker Public Policy Associates, where he will likely represent clients from firms like Amgen, Hoffman-LaRoche, PacifiCare and Wyeth.

Now where have I heard the names of those companies before?

Medicare Scam Will Cost Bush The Election

“The truth of the matter is that the only way this President and the Republican Congress could pass the fatally flawed Medicare bill was to deceive Congress,” said George Kourpias, president of the Alliance for Retired Americans. “Seniors know they’ve been dealt a raw deal with the Medicare law, and they will have their say at the ballot box.”

I look forward to seeing a record number of seniors at the polls.

Filed under: 2004, Bush, Drug Importation, Medicare Prescription Drug Bill, Scully

TeenScheme Sets The Record Wrong

Evelyn Pringle July 2005

On July 6, 2005, TeenSceen’s Web Site posted the following statement: “Recently, TeenScreen has seen growing amounts of inaccurate, intentionally deceptive misinformation about mental health screening and the TeenScreen Program proliferating primarily through one or two individuals on the Internet. Some of this inaccurate information has been posted on other websites.”

In its own defense, TeenScheme addressed several points. In this article, I will limit my remarks to their responses to whether they endorse Bush’s plan to screen all school kids and whether they actually do seek parental consent before screening children.

Here is TeenScheme’s response to the question: I have heard about active vs. passive consent. What does this mean?

Active consent requires parents to sign and return a consent form if they want their child to participate in screening. Passive consent, which is also referred to as waiver-of-consent or opt-out consent, requires parents to return a provided form only if they do not want their child to participate in the screening. When using this type of consent, letters must be mailed directly home to parents to ensure that they reach the intended readers. Local TeenScreen programs often adopt the consent procedures used by their local sponsors or school districts for similar activities. Parental consent must be obtained in order for youth to participate in the TeenScreen Program. The Columbia University TeenScreen Program recommends active consent as a best practice. Currently 85% of TeenScreen programs use active parental consent.

This response almost sounds like TeenScheme is appropriately concerned when it comes to protecting parental rights. However, if it truly does promote active consent as the best practice, a person has to wonder why the Fall 2003, Teenscreen Newsletter is devoted to explaining ways to outfox parents when it comes to the laws that govern parental consent.

The newsletter explains how TeenScreen may be able to get around the “Protection of Pupil Rights Act” (PPRA) that requires written parental consent, by having the Board of Education approve the survey as a part of the educational program.

“PPRA is a federal law that protects the rights of parents by making instructional materials available for their inspection if the materials are to be used in connection with a survey, analysis, or evaluation in which their child is participating and which is funded by the U.S. Department of Education. The law also requires written parental consent before minors are required to take part in such a survey, analysis, or evaluation.”

“If your local mental health screening program is approved by the Board of Education as part of the educational program, you are not required to get active parental consent under PPRA. Passive consent is sufficient in this circumstance.”

The underlying inference in the newsletter is that the process of obtaining any consent is a pain-in-the-butt nuisance, but unfortunately, necessary for covering-your-own-butt under the law. For instance it says: “It is best to recommend that, if passive consent is obtained from parents, then active consent should be sought from participants as a safeguard.”

The Newsletter goes on to say that if schools would screen all children as a matter of policy, the survey could be administered without parental consent:

“Active parental consent must be obtained, however, if a child is going to be removed from an instructional activity for screening. However, if the screening will be given to all students, as opposed to some, it becomes part of the curriculum and no longer requires active parental consent (i.e., if all ninth-graders will be screened as a matter of policy, it is considered part of the curriculum).”

But of course we know that this will never happen because on its website, Teenscheme says it does not endorse screening all kids in response to this question: Does the Columbia University TeenScreen Program endorse mandated mental health screening for all teens?

“No. The Columbia University TeenScreen Program does not endorse or support government mandated screening. The TeenScreen program is offered only to communities that want to sponsor suicide prevention and mental health check-up programs,” it said.

Boy, finding out that TeenScheme did not support the plan to screen all school kids sure made me feel better. Or it did until I decided to go check out a few other TeenScheme newsletters and read about what they pulled in Pennsylvania in order to screen EVERY ninth-grade student in record time.

The Spring 2004, Newsletter states: By implementing the screening process through the Student Assistance Program (SAP) already in place within the district’s schools, the Erie TeenScreen Program was able to quickly conduct close to 1,000 screenings using the computerized Diagnostic Predictive Scales (DPS) screening tool.

“After completing the pilot,” the newsletter wrote, “the Columbia University TeenScreen staff and the Erie School District immediately designed a proposal to administer the assessment to every ninth grade student in the district.”

“Our goal was to screen all four high schools in the district in 12 weeks,” Christiansen notes. “This meant screening an average of 100 to 250 students per week.”

According to the newsletter, “The Erie TeenScreen program accomplished its goal. The team screened almost 1,000 students by the end of the 12-week time period,” it reported.

And it gets better. Teenscheme really hit pay dirt in Pennsylvania. According to the newsletter, in December 2003, representatives of the TeenScreen Program provided the sole testimony before Pennsylvania legislative committees in favor of a resolution that was passed which states that “every child should be screened for mental illness once in their youth in order to identify mental illness and prevent suicide among youth.”

In directing people on what to say while pushing the TeenScheme agenda to lawmakers, under talking points, the newsletter told its promoters to specifically tell them: “We need to ensure that every American teen receives a mental health check-up once in their youth.”

And here’s how the newsletter says TeenScheme got around that pesky little legal matter of obtaining parental consent before screening kids in Pennsylvania:

“Erie was able to use waiver of consent with 1,200 parents of 9th graders by sending the letter on the superintendent’s stationery, providing one centralized number for parents’ concerns, keeping a copy of the survey available for review, and making the principal’s office aware of the significance of returned consent forms,” the newsletter said.

Below is TeenScreen’s answer to the question: “Are individual screening results shared with Columbia University?”

Individual screening results are not shared with TeenScreen staff at Columbia University. Only aggregate data (e.g., total number screened at the site) and qualitative information (e.g., feedback on how the program is working) are shared with Columbia. The aggregate data and information we collect from local TeenScreen sites are used solely for program evaluation and quality assurance purposes.

Do not buy that line for one second. They claim to need numbers for “program evaluation,” I say they need the numbers for legalized drug dealing.

The truth is, the results from the surveys will be fed to the pharmaceutical industry and sales representatives will be dispatched at record speed to specific areas where doctors will be writing out the most prescriptions. There will be a well beaten path leading to each area of the country identified.

Student names are not needed for this marketing scheme, all that is required for success are the total number of kids labeled mentally ill and the specific areas where they live and thousands of new customers will sprout up all across the county. Its a brilliant scheme.

So who are we to believe?

TeenScheme swears it always obtains parental consent and that it does not provide students with a diagnose of a mental illness.

However, a family in Indiana disputes both of those assertions. Michael and Teresa Rhoades claim that the TeenScheme survey was administered to their daughter in a public school without their consent.

They also say claim that in December 2004, their daughter came home one day and informed them that she had been diagnosed with an obsessive compulsive disorder and a social anxiety disorder, after she was screened with the survey at school.

When things go as planned with this scheme, parents are supposed to head to the corner drug store to buy pills each time a new student-customer is recruited. However, things did not go according to plans with the Rhoades family.

Michael and Teresa Rhoades were outraged, and instead of heading to the drug store, they filed the nation’s first notice of intent to sue after learning that their daughter had been tested, diagnosed, and labeled mentally ill in a public school without their consent.

A notice that is sure to be the first of many such lawsuits that will be filed as TeenScheme fans out across the country causing local school taxes to rise as legal fees accrue.

I’m afraid that now that I have seen first hand what lengths TeenScheme will go to in order to outfox parents and label kids mentally ill for profit, I shall have to decline any invitation for jury duty on the case because I have already decided that the young Ms Rhoades is, without a shadow of a doubt, the injured party in this action.

Filed under: 2005, Bush, drugging children, NFC, TeenScreen

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