The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Natrecor Heart Drug – Deadly and Expensive

Evelyn Pringle January 31, 2006

Let there be no mistake, Johnson & Johnson, and its subsidiary Scois, knew all about the dangers associated with its heart failure drug Natrecor, but threw caution to the wind in promoting its off-label use in pursuit of profits.

Natrecor was FDA approved in August 2001 for the sole purpose of treating patients for the most acute from of congestive heart failure to be administered intravenously to patients during hospitalization under close medical supervision.

However, the company’s aggressive off-label marketing campaign has allowed the drug to be administered in outpatient clinics at a much greater dose and for longer periods of time than recommended.

The off-label prescribing of drugs is wreaking havoc on unsuspecting patients. Guessing at drug dosage levels, medical conditions, and treatment duration for uses that were never approved is proving deadly. This is especially true with life-and-death drugs like heart medications.

As a consequence of Natrecor’s off-label use, patients have suffered serious injuries, including kidney failure, congestive heart failure, stroke, and death.

In this country, doctors are permitted to prescribe drugs to treat a condition even after the FDA has denied approval for a specific condition. Although a drug maker cannot directly promote a drug for an off-label use, a doctor can prescribe it for that use. If a company can orchestrate a doctor-backed marketing scheme, it can turn a restricted drug into a billion-dollar blockbuster.

A point has been reached, where many doctors are acting more like marketing agents than health care professionals. Doctors can spread the word of an off-label and create an exaggerated demand for a drug far and beyond its FDA approved market.

Health officials began investigating the off-label use of Natrecor in May 2005 after the New York Times published an article reporting how tens of thousands of patients were undergoing “tune-ups” at outpatient clinics by receiving weekly infusions over a period of months.

Albeit unfortunate, it is within the law for a drug company to send information to doctors about a drug’s off-label uses, as long as it is for educational purposes only. In the case of Natrecor, this loophole proved to be as wide as a barn door.

Company sales representatives were actually distributing brochures to teach doctors how to set up outpatient clinics to provide regular off-label Natrecor treatments to patients. The company then recruited doctors and nurses with experience in administering outpatient infusions to deliver presentations at medical seminars and meetings.

Some outpatient clinics went so far as to establish programs to administer Natrecor to patients twice a week for up to 12 weeks with full knowledge that there had been no study conducted to determine whether long-term treatment was safe.

Operating a Natrecor clinic was very profitable. The vast majority of patients who received the drug were 65 or older, and eligible for Medicare which covered Natrecor treatment specifically because it was an infusion therapy.

An editorial in the July 14, 2005, New England Journal of Medicine by Dr. Eric Topol, the chairman of cardiovascular medicine at the Cleveland Clinic, objected to the company’s encouragement of doctors to open clinics for Netracor infusions. Dr. Topol, noted that company documents instructed doctors to bill Medicare for a $172 observation fee for the first hour, and $408 for eight hours of observation during the treatment, above and beyond the actual cost of the drug.

The reimbursement guide told doctors to use Medicare codes that treat Natrecor like chemotherapy and allowed them to bill for larger reimbursement payments. As for Natrecor’s $500-$700 per infusion price tag, Dr Topel explained that a dose of other equally effective medications cost less than $10.

“Natrecor was never shown to be superior for reducing death or reducing the need for repeat hospitalizations,” Dr. Topol said. “How could this happen? All of a sudden we have 600,000 people using this drug.”

The good Doctor is correct, there is no logical explanation for the situation. Natrecor has not only been proven to be no better than older drugs, infusion of the drug is often lethal.

A study that appeared in the April 20, 2005 issue of the Journal of the American Medical Association, found patients treated with Natrecor were 80% more likely to die in the 30 days following the treatment than patients given a placebo. And one trial found kidney problems were occurring at a rate three times that found in patients taking a placebo, according to a June 13, 2005 report by Health Day News.

The study was conducted by researchers Dr. Jonathan Sackner-Bernstein, of the North Shore University Hospital in Manhasset, N.Y; Drs. Marcin Kowalski and Marshal Fox, of St. Luke’s-Roosevelt Hospital Center in New York; and Dr. Keith Aaronson, of the University of Michigan.

In their study, the team collected data on 1,269 heart failure patients who participated in five clinical trials comparing Natrecor with other drugs. “We found that there is a 40 to 50 percent higher risk of worsening kidney function when people are treated with nesiritide than when people are treated with other medications,” Sackner-Bernstein said, according to a March 21, 2005 article by Health Day News.

In attempt to discount this damaging analyses, in April 2005, Johnson & Johnson appointed renowned heart specialist, Dr Eugene Braunwald, to form a committee to review the drug studies. Dr Braunwald’s committee reached the same conclusion, that it was inappropriate to use Natrecor, except in acutely ill hospitalized patients.

Specifically, the panel recommended that Natreor should be used only in patients who show up at the hospital with an acute heart failure; that it should not replace diuretics, the front-line heart failure treatment; and that it should not be used for outpatients, where patients scheduled appointments to receive the drug ahead of time. The committee made the following verbatim recommendations:

1) The use of Natrecor should be strictly limited to patients presenting to the hospital with acutely decompensated congestive heart failure who have dyspnea at rest, as were the patients in the largest trial that led to approval of the drug (VMAC). Physicians considering the use of nesiritide should consider its efficacy in reducing dyspnea, the possible risks of the drug summarized above, and the availability of alternate therapies to relieve the symptoms of congestive heart failure.

2) Nesiritide should not be used to replace diuretics. Furthermore, because sufficient evidence is not currently available to demonstrate benefit for the applications listed below, nesiritide should not be used:

For intermittent outpatient infusion
For scheduled repetitive use
To improve renal function
To enhance diuresis.

3) Scios should immediately undertake a pro-active educational program to inform physicians regarding the conditions and circumstances in which nesiritide should and should not be used, as described above. Sponsor supported communications, including review articles of nesiritide, should reflect the above recommendations. Scios should ensure that current and future marketing and sales activities related to nesiritide are consistent with this educational program.

Although Scios spokespersons have argued that they can not control how doctors prescribe Natrecor, Scios itself created the problem by encouraging and praising off-label use right from the start.

Back on April 2, 2002, Scios issued a Press Release to announce that “net sales for its flagship product Natrecor(R) (nesiritide) were $15.4 million in the first quarter of 2002, a 60 percent increase over the prior quarter ended December 31, 2001.”

The company could not have been more enthusiastic about the drug’s off-label use. The press release bragged about the profits from off-label use. “We achieved better than expected sales due to greater than expected physician prescribing of Natrecor for their patients suffering from acute heart failure,” said Richard Brewer, President and CEO of Scios at the time. “Our market research shows physicians are increasingly interested in using Natrecor in a variety of clinical settings,” said Thomas Feldman, Vice President of Sales and Marketing at Scios at the time.

The company also noted that Natrecor had received a pass-through code from the Centers for Medicare & Medicaid Services that allowed reimbursement for patients treated in an outpatient setting, and said that the issuance of a code was a further indication of the growing therapeutic importance of Natrecor and would help increase use of it in outpatient settings.

“We believe this is a significant step toward making Natrecor more widely available to the physicians and patients who need it, and creates a bigger market for the product,” the Press Release said.

The code makes the economics of prescribing the product more attractive for physicians interested in using it for their patients in the outpatient setting, “an area in which Natrecor is particularly well-suited because it is easy to use, has a good safety profile and makes patients feel better,” the release said.

Doctors seeking reimbursements for off-label outpatient treatment were directed to call a toll-free hotline to obtain billing codes and forms.

Reputable doctors consider it ethically irresponsible for a drug company to promote the possibly harmful use of a drug for financial gain. The hotline prompted allegations from some of the country’s leading cardiologists that the company was improperly promoting Natrecor’s off-label use.

Doctors began speaking out against its frequent use, noting the lack of clinical trials to support outpatient treatment, and the drug’s link to kidney problems and death.

Dr Milton Packer, a cardiologist who was chairman of the FDA advisory panel that approved Natrecor in 2001, said the drug was approved for a very limited group of patients. “We said this is a drug that should be approved for patients who are short of breath at rest, who are hospitalized,” said Dr Packer. He faulted the drug’s FDA-approved label for not specifying that Natrecor was meant for hospital use, according to the May 17, 2005 New York Times.

“The fact that the FDA doesn’t have much enforcement capability is a problem,” Dr Sackner-Bernstein told Health Day Reporter. “Then again,” he said, “where are the ethics? The people involved at Scios and others who knew about this data should be hanging their heads.”

“What is wrong with everybody,” Dr Sacker-Bernstein continued, “that you’ve got a drug that increases renal dysfunction and death, and costs 50 times as much as a regular treatment, and yet it’s given to hundreds of thousands of people?”

Whether Natrecor has been illegally marketed for off-label use, is the subject of an investigation by the Justice Department. On July 20, 2005, Johnson & Johnson acknowledged receiving a subpoena from the US Attorney’s office in Boston, MA requesting documents related to the sales and marketing of Natrecor.

The entrance of Sullivan on the scene is no doubt unwelcome news for Johnson & Johnson. He earned a reputation as the pharmaceutical industry’s adversary last year, when he secured a $430 million penalty against Warner-Lambert, with the help of an employee turned whistleblower, involving the off-label sale of Neurontin, a drug approved for epilepsy, but promoted for various other uses. By the time of the settlement, Pfizer had acquired Warner-Lambert.

As if the death rate with Natrecor listed above is not high enough, as it turns out, Johnson & Johnson did not report 2 patient deaths from the study, according to news reports in early January 2006. In addition, to not telling the FDA, the deaths were not included in the results of the study published in the October 2005 Journal of Emergency Medicine.

The October article reported five deaths of patients within 30 days of using Natrecor in hospital emergency rooms in 2001 and early 2002. Of the 237 patient covered in the study, the two new deaths raises the total number of Natrecor deaths to seven.

According to Matthew Herper, in Forbes.com, Johnson & Johnson hired private detectives from Pinkerton Consulting & Investigations, the famous gumshoe agency and the detectives found the two deaths that were not accounted for in the published study.

There seems to be a changing of the guard for Scois. After all the commotion over the hotline, since July 29, 2005, the new message recorded advises callers about the “lack of clinical data” regarding off-label use and warns that Scios “does not recommend Natrecor for this use.”

“As a result,” the message states, “the support line does not maintain or provide information regarding the physician office or hospital infusion clinic use of Natrecor.” The recording clearly seeks to discourage the off-label use of the drug.

And last but not least, on December 5, 2005, officials from the Centers for Medicare and Medicaid Services, announced that Medicare will no longer cover outpatient costs of Natrecor.

Filed under: 2006, Johnson and Johnson, MEDICAID, MEDICARE, Natrecor, stroke

Lawmakers Go After Thugs at FDA Over Avandia

Evelyn Pringle June 2007

In one of the latest developments in the Avandia diabetes drug saga, on June 7, 2007, a bipartisan group of powerful lawmakers sent a letter to FDA asking Commissioner Andrew von Eschenbach asking for an explanation of the agency’s policy on conflicts of interest regarding hiring employees directly from drug companies regulated by the FDA.

At the center of the controversy, is the conduct of FDA spokesman, Douglas Arbesfeld, who has worked for several drug companies, in sending emails to journalists in what the lawmakers refer to as “smear campaigns” against cardiologist, Dr Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, who recently waved the red flag about the risks associated with GlaxoSmithKline’s Avandia.

Dr Nissen and Kathy Wolski, MPH, a statistician, evaluated the 42 studies involving nearly 28,000 patients and compared the 15,560 patients who were using Avandia to the patients who were not using the drug and found there were 86 myocardial infarctions in the Avandia group and 72 in the control group and there were 39 deaths from cardiovascular causes in Avandia patients compared to 22 in the control group.

“Cardiovascular disease is far and away the leading cause of death in diabetes,” Dr Nissen said in the May 23, 2007 Wall Street Journal. “If you find a diabetes drug increases the risk of heart attacks,” he warned, “the consequences are so grave that it warrants urgent action.”

The June 7, 2007 letter to the FDA is signed by Senators Chuck Grassley, Max Baucus and Sherrod Brown, as well as Representatives John Dingell and Bart Stupak and they want a response to their inquiry by June 20, 2007.

At a June 6, 2007, hearing before the US House Committee on Oversight and Government Reform, Commissioner von Eschenbach testified that Arbesfeld had been formally reprimanded with a letter in his employment file but apparently the lawmakers believe his conduct warrants more than a slap on the wrist.

“We are concerned that Mr. Arbesfeld sent this message using his Government e-mail,” the lawmaker’s letter states, “which carried his FDA signature line and work-related contact information at the bottom.”

“In several news articles on other matters,” it says, “Mr. Arbesfeld is named as the spokesman for FDA.”

“Given that he has acted in this capacity in the past,” the lawmakers wrote, “this e-mail may have given journalists the impression that the United States Government actively encourages smear campaigns against independent scientists.”

“The Committee finds it even more troubling that Mr. Arbesfeld may be using his position
with FDA to settle old scores with Dr. Nissen,” the letters states.

“Certainly, Mr. Arbesfeld is familiar with Dr. Nissen, since the two have been on opposing sides of drug safety in the past,” the lawmakers wrote.

The letter cites an April 26, 2005, New York Times article that reported quotes from Dr Nissen that were critical of Natrecor, a drug made by Johnson & Johnson

The Times noted that Dr Nissen cast the only vote against Natrecor when a FDA advisory panel recommended its approval in 2001, and the person defending Natrecor in the article was Mr Arbesfeld, as a spokesman for J&J at the time.

The lawmakers called Mr Aresfeld’s emails to journalists, “a completely unacceptable use of Government time and equipment.”

“In the Agency’s response to this incident,” the letter said, “it stated that Mr. Arbesfeld is a consultant and does not speak on behalf of FDA.”

“Accordingly,” the lawmakers pointed out, “this response may leave the media wondering how they should interpret future e-mails from FDA spokesmen and Mr. Arbesfeld, in particular.”

In a June 7, 2007 press release announcing the letter, Senator Max Baucus stated, “I have some serious questions about Mr. Arbesfeld’s use of government resources, but I am even more concerned about whether his drug company connections led him, in any way, to seek to unjustly discredit Dr. Nissen.”

“The FDA’s ultimate duty is to ensure the safety of the products it regulates,” he added, “which includes sharing credible, potentially life-saving information from any trustworthy source.”

In summary, the lawmakers want answers the following: (1) What is the justification for use of taxpayer dollars for a communications consultant? (2) What is FDA’s policy regarding the hiring employees who recently worked for the companies directly regulated by the Agency? (3) How does FDA ensure that consultants do not have relationships with companies in direct conflict with his role as FDA spokesperson? (4) Is Arbesfeld currently receiving, or has he received in the last year, income or other remuneration from companies directly regulated by FDA? (5) Does FDA have a policy regarding employees using their official e-mail accounts to express their personal opinions, which may not be FDA positions, to members of the press? (6) If there is such a policy, what is that policy?

Senator Grassley and the Senate Finance Committee is also investigating a matter involving the mistreatment by top FDA officials of Dr Rosemary Johann-Liang, the Deputy Director of the FDA’s Division of Drug Risk Evaluation (DDRE), who was rebuked in March 2006, after she approved a recommendation by an FDA safety reviewer that the labels of both diabetes drugs, Avandia and Actos, should carry additional warnings.

On June 4, 2007, the Committee sent the FDA Commissioner a letter demanding a response to questions related to this matter by June 20, 2007.

In the letter, Senator Grassley cited an internal FDA memorandum, obtained by his Committee, dated February 22, 2006 that was prepared he said, by “a very seasoned safety evaluator” in the DDRE, that made several recommendations including that Glaxo should include macular edema, a condition that involves swelling of the retina and can cause blindness, as a “serious adverse event” on Avandia’s label.

The memo also recommended that congestive heart failure be highlighted in a box warning. CHF is a condition where fluid builds up in the lungs causing severe shortness of breath and potential death and requires immediate attention.

To support the recommendation for a black box warning, the February 22, 2006 memo specifically quoted the FDA regulation that states in part that “…special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed in a prominently displayed box….”

Senator Grassley called the fact that the FDA had not yet acted on the recommendations troubling. “But another allegation,” he wrote, “has come to the Committee’s attention that is simply unconscionable.”

It has been alleged by multiple sources, he said, both in and out of the FDA, that the Deputy Director was reprimanded verbally for signing off on the memorandum.

“I also was informed,” he wrote, “that the DDRE Deputy Director was advised that she would no longer be able to “sign off” on any matters related to Avandia in the future.”

He also noted that she was told that, “in the future, she could no longer sign off on any recommendations for major regulatory actions, like box warnings, without first checking with the DDRE Director.”

“I also sincerely hope that this is not standard practice within the FDA,” Senator Grassley wrote. “Those FDA employees dedicated to post-marketing surveillance at the FDA should be able to express their opinions in writing and independently without fear of retaliation, reprimand, or reprisal,” he said.

Post-marketing surveillance is critical to the health of this nation, he advised.

Filed under: 2007, Avandia, FDA, Natrecor

FDA Avandia Mole Defends Off Label Marketing of Natrecor

Evelyn Pringle August 12, 2007

It looks like that Mafia guy, Dr Steven Nissen, leader of the Cleveland Clinic gang, who blew the whistle on the diabetes drug Avandia and before that Vioxx, was on to something when he voted against the FDA’s approval of the heart failure drug Natrecor in 2001.

Giving once- or twice-weekly outpatient injections of Natrecor does not reduce the risk of death or hospitalization for heart or kidney problems, according to research presented at the American College of Cardiology meeting in New Orleans in March 2007.

In fact, the study of 920 patients found that outpatient use of Natrecor provided absolutely no benefit. The finding should halt the practice of giving once- or twice-weekly Natrecor to outpatients, said researcher Dr Clyde Yancy, medical director of the Baylor Heart and Vascular Institute in Dallas, Health Day reported on March 26, 2007.

Of course, the revelation that Dr Nissen was running the Cleveland Clinic Mafia and that they were out to get GlaxoSmithKline by publishing a study that showed Avandia increased the risk of heart attacks and deaths came in an email to reporters from FDA spokesman Douglas Arbesfeld, which included the warning to other drug companies, “if you don’t hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company.”

Mr Arbesfeld left his position as a highly-paid spokesperson for Johnson & Johnson to become a dedicated public servant at the FDA, if his supporters are to be believed.

When his conduct of sending the email came under scrutiny, Peter Pitts, who co-authored a June 6, 2007, critical commentary in the Washington Times about the Avandia study and fondly referred to Dr Nissen as a “Patron Saint of Drug Safety” and “Saint Steven the Pure,” put out a statement on the internet saying that, by sending the email, Mr Arbesfeld was just defending the FDA and praised his selfless work, stating:

“I know Doug Arbesfeld,” he wrote, “and he is a guy devoted to advancing the public health,” he wrote.

“He is also a guy who took a pretty significant pay cut to put in some time in public service,” Mr Pitts pointed out.

In response to that assertion, it could certainly be argued that a mole at the FDA would be in a position to earn far more money by selling invaluable insider information to all the drug companies than as media person working for one company.

It should be noted that in his email to reporters, Mr Arbesfeld also referred to Dr Nissen as St Steven – surely just by coincidence.

For the record, the Cleveland Clinic is rated as the top cardiac center in the country by US News and World Report, and Dr Nissen holds the number 72 position on Time Magazine’s list of the 100 most influential people in our world.

An effort that included at least 50 different google searches on the internet over a period of several days found no similar praise listed for Mr Arbesfeld other than Mr Pitts’ recent two-liner that showed up on about every search.

At the end of his Times commentary, Mr Pitts listed himself as the president of the Center for Medicine in the Public Interest and a former FDA associate commissioner, but a little checking revealed that he is also a Senior Vice President at the public relations firm of Manning, Selvage & Lee.

A review of the Manning website shows that the firm’s clients have included Pfizer, Eli Lilly, AstraZeneca, Sanofi-Aventis, Johnson & Johnson, Genentech, Novartis, Amgen and Hoffmann La-Roche.

A review of Mr Pitts’ articles on the internet clearly shows that he is in lockstep with his industry clients against: (1) allowing Americans to import drugs from other countries to cut costs; (2) allowing the government to negotiate lower drug prices; (3) barring drug makers from promoting their drugs for uses not approved by the FDA; (4) cutting back on direct-to-consumer advertising, and (5) adding black box warnings to product labels.

As luck would have it, a bit more checking found a December 16, 1999, press release by the Healthcare Marketing & Communications Council which reported that Mr Arbesfeld had joined Manning, Selvage & Lee as Senior Vice President.

The list of pharmaceutical companies that Mr Arbesfeld has worked for over the years includes Ciba-Geigy in 1994, and Rhone Poulenc Rorer Pharmaceuticals in 1998, the same year the company announced that it would merge with Hoechst AG to become Aventis, which merged with Sanofi-Synthelabo in 2004 to become Sanofi-Aventis.

In 1999, Mr Arbesfeld would have been working for the Manning clients listed above, and on August 5, 2002, he identified himself to Reuters as promoting a prescription drug card program called “Together Rx” for 7 drug companies that included Bristol-Myers, Aventis, GlaxoSmithKline, Johnson & Johnson, AstraZeneca, Abbott Laboratories and Novartis.

Finally, Mr Arbesfeld is listed as the contact person for Johnson and Johnson subsidiaries Janssen Pharmaceutica, Ortho-McNeil Pharmaceutical and Ortho Biotech Products in the 2005 Reporters Handbook.

While his supporters say Mr Arbesfeld’s email to reporters was justified, lawmakers on Capitol Hill see it differently and have launched an investigation into what they refer to as a smear campaign against Dr Nissen. At a June 6, 2007, hearing before the US House Oversight Government Reform Committee, in response to questions about Mr Arbesfeld email stunt, FDA Commissioner Andrew von Eschenbach claimed that he did not approve of the email and told the lawmakers, “I completely concur with you that it was inappropriate and unacceptable.”

“It was an inappropriate and unfortunate act on the part of an individual,” he said, “which has been addressed through disciplinary procedures.”

In a letter to the FDA Commissioner, the lawmakers said they found it troubling that Mr Arbesfeld might be trying to settle old scores with Dr Nissen because he cast the lone vote against the approval of the heart drug Natrecor (nesiritide) and later spoke out against the off-label use of the drug in a New York Times article in which Mr Arbesfeld spoke on behalf of the drug’s maker J&J subsidiary Scios.

The fact is, a review of the regulatory history behind Natrecor proves that Dr Nissen was right then, just as he is now about Avandia.

The drug was approved for limited use by hospitalized patients with acute congestive heart failure, to be administered intravenously under close supervision. However, due to a massive off-label marketing campaign, the drug was soon being administered in outpatient settings at a much greater dose and for longer periods of time than recommended.

In May 2005, the New York Times reported that tens of thousands of patients were undergoing “tune-ups” at outpatient clinics by receiving weekly infusions of Natrecor over a period of months.

In the July 14, 2005, New England Journal of Medicine, apparently another Mafia guy from the Cleveland Clinic gang, Dr Eric Topol, was out to get J&J because he reported that the company was encouraging physicians to open their own infusion centers to bill Medicare for Natrecor treatment and that company documents instructed doctors to bill Medicare $408 for eight hours of observation during the infusion, above and beyond the actual cost of the drug, which was around $500 per vial, he said.

In addition, the company set up a toll-free telephone hotline for “Natrecor Reimbursement Support” and published a 46-page reimbursement and billing guide to provide doctors with specific Medicare billing codes.

“Natrecor was never shown to be superior for reducing death or reducing the need for repeat hospitalizations,” Dr Topol said, and asked: “How could this happen? All of a sudden we have 600,000 people using this drug.”

He also pointed out that other drugs, costing less than $10 a dose, were equally effective.

The Natrecor infusion-for-profit scheme was indeed on a roll. J&J had recruited doctors and nurses with experience in administering infusions to deliver presentations at medical seminars, and some clinics had programs set up to administer Natrecor to patients twice a week for up to 12 weeks. In 2004, Natrecor brought in about $400 million for J&J, and sales were projected to be $700 million for 2005.

However, the profiteers were hit with a ton of bricks on April 20, 2005, when a study appeared in the Journal of the American Medical Association that reported patients treated with Natrecor were 80% more likely to die in the 30 days following the treatment than patients given a placebo, by Dr Jonathan Sackner-Bernstein of the North Shore University Hospital in Manhasset, NY; Drs Marcin Kowalski and Marshal Fox, of St Luke’s-Roosevelt Hospital Center in NY; and Dr Keith Aaronson of the University of Michigan.

On April 26, 2005, in response to the findings of the study, Mr Arbesfeld told HeartWire, “We take any question about the safety of Natrecor seriously.”

“At the same time,” he said, “a review of Scios’s full clinical study data set does not show a statistically significant difference in mortality.”

Although the collective data from the studies reflects a 23% higher death rate for those taking Natrecor, Mr Arbesfeld said, the number of patients in the studies was too small to produce conclusive results of death risk, in a Reuters article on April 25, 2007.

In response to comments about Natrecor not being approved for outpatient use, Mr Arbesfeld told the Times that the FDA label did not specify where the drug could be administered, so giving it in an outpatient setting did not run counter to its approved use.

However, that Mafia guy from the Cleveland Clinic, Dr Nissen, told the Times that treating patients in ambulatory settings was “inappropriate and cannot be recommended.”

Before long, more doctors began speaking out. Cardiologist Dr Milton Packer, chairman of the advisory panel that voted to approve the drug, told the Times on May 17, 2005, that Natrecor was not intended for outpatient use. “We said this is a drug that should be approved for patients who are short of breath at rest, who are hospitalized,” he said.

He also faulted the FDA’s approval of a label that did not specify that Natrecor was for hospital use only.

Dr Sackner-Bernstein expressed outrage in the Health Day Report. “The people involved at Scios and others who knew about this data should be hanging their heads,” he said.

“What is wrong with everybody,” he continued, “that you’ve got a drug that increases renal dysfunction and death, and costs 50 times as much as a regular treatment, and yet it’s given to hundreds of thousands of people?”

After the April study came out, J&J hired a heart specialist, Dr Eugene Braunwald, to form a committee to review the studies, and the committee reached the same conclusion, that it was inappropriate to use Natrecor except with acutely ill hospitalized patients.

Specifically, the panel said, Natrecor should be used only when patients show up at a hospital with acute heart failure; that it should not replace diuretics as the front-line treatment; and that it should not be used where patients schedule appointments to receive the drug ahead of time.

Their report also stated: “Scios should immediately undertake a proactive educational program to inform physicians regarding the conditions and circumstances in which [Natrecor] should and should not be used.”

So what did J&J do in response? According to Dr Packer, who was a member of the panel, the committee members were shocked several weeks later when they received invitations from a mass mailing to enroll in a continuing medical education program, sponsored by Scios, that appeared to promote the outpatient use.

“We were flabbergasted,” Dr Packer told the Times on August 1, 2005. “Scios was sponsoring meetings to discuss nesiritide and its potential use in outpatients.”

As so often happens these days, this drugging-for-profit scheme caught the attention of lawmakers because about 80% of the patients receiving Natrecor were on Medicare.
D-Day came on December 5, 2005, when the Centers for Medicare and Medicaid Services announced that Medicare would no longer pay for outpatient infusions.

But the Natrecor story is far from over because, according to Johnson & Johnson’s 2006 Annual Report, the company received a subpoena from the US Attorney’s Office, District of Massachusetts, in July 2005, seeking documents related to the sales and marketing of Natrecor, and in August 2005, J&J was advised that the investigation would be handled by the US Attorney’s Office for the Northern District of California in San Francisco.

The latest news came on March 12, 2007, when J&J revealed that it had received 3 new subpoenas from the US Attorneys’ offices in Philadelphia, Boston and San Francisco wanting information for the investigation into the company’s sales and marketing of Natrecor.

More recently, in an apparent repeat of the exact same scam, investigators have found that J&J and Amgen have been paying doctors to administer the anemia drugs Aranesp, Epogen and Procrit off label for profit. On May 9, 2007, the New York Times reported that drug makers are paying “hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines.”

The Times cited documents obtained from a former employee of a group of 6 cancer doctors which showed that between them, the 6 doctors received $2.7 million from Amgen for prescribing $9 million worth of anemia drugs in 2006.

On May 10, 2007, the Wall Street Journal cited a document provided by a former J&J sales representative-turned-whistleblower which showed that a doctor who purchased nearly $1 million worth of Procrit over 15 months would receive $237,885.

In March 2007, the FDA ordered black box warnings on the drug’s labels about an increased risk of numerous adverse events and issued a public health advisory warning health care providers to administer the lowest possible dose necessary to treat anemia.

According to the FDA, as of March 2007, there are five clinical trials that demonstrated decreased survival time in cancer patients receiving the drugs compared with those receiving transfusion support.

The agency also reported a higher rate of blood clots, strokes, heart failure, heart attacks and death were found in patients with chronic kidney failure when the drugs were given to raise hemoglobin levels higher than recommended.

The FDA advisory also noted a higher risk of blood clots in patients who were scheduled for major surgery and received the anemia drugs and also warned of an increased rate of tumor growth in patients with advanced head and neck cancer receiving radiation therapy and metastatic breast cancer patients receiving chemotherapy, when the drugs were given to maintain levels higher than recommended.

J&J is already facing several class-action lawsuits filed by shareholders as a result of the revelation of this latest drugging-for-profit scheme, and the company has also received a subpoena from New York’s attorney general requesting information on the sales and promotional activities related to Procrit.

But then, why should J&J worry over a minor little investigation by the NY attorney general. The feds have been investigating the Natrecor fiasco for more than 2 years, and the J&J executives who reaped the benefits have probably not lost one wink of sleep.

Filed under: 2007, Amgen, anemia drugs, Aranesp, Avandia, Epogen, FDA, Johnson and Johnson, Manning, MEDICAID, MEDICARE, Natrecor, Pitts, Procrit

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Matthew Schultz killed by Effexor. Two hours old.

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Big Pharma Victim

  • I haven't been on in awhile thanks to all those who followed 3 years ago
  • @LindsayRush yay IOWA! 4 years ago
  • Another rainy day here in IOWA. Well at least i had a good time swimmin yesterday. 4 years ago
  • Hey everyone hope you have a great day! THanks to all the new followers :) and for those that continue to follow 4 years ago
  • srry if I dont get on here much I mostly just look at my facebook acct. thanks to all the new followers! 4 years ago

The Indiana Star

Christiane Schultz

  • Is not coping well at all. Loss sucks! 4 years ago
  • is scared to bond with this baby, just in case. 5 years ago
  • Happy 6 months today baby. I love you Matthew. 5 years ago
  • Living with loss, sucks. 5 years ago
  • Thinking I need to discuss plans for this baby soon or I will be having it in my doctors office. Where do I deliver? 5 years ago

Amery Schultz

Seeking Parents in Missouri for Celexa / Lexapro Class Action – Call 800-827-0087

TWEET FOR LIFE

BREATH – The Official Blog of MADNAP – momsandmeds.com

RSS BREATH

  • Untitled
    Originally posted on The Bitter Pill:Kickstarter is a website for artists to use to raise money and complete awesome projects. The best thing to come to the informed consent movement since Thomas Szasz could just be the new, upcoming film by Dan Jenski, “ADDicted” which basically gives Ritalin, Adderall, Concerta and the like a…
  • Untitled
    Originally posted on The Bitter Pill:In the studies submitted to the FDA for approving Zoloft (a drug that has killed numerous families, babies, mothers, children), the drug maker covered up the fact that Zoloft failed to outperform placebo, according to a new consumer fraud lawsuit filed by the firms Baum, Hedlund Aristei & Goldman…
  • Antidepressants Again Linked to Preterm Birth & Seizures
    In what was more than likely originally an attempt to prove that depression causes birth complications, researchers from Yale, Tufts, et al found in two new studies that antidepressants increase the risk of preterm birth and seizures. Read more at this link on the newly redesigned UNITE website.
  • Who Could Do This On Purpose
    Read this blog to find out
  • Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed
    Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed (Cross-Posted on The Bitter Pill blog) Amery and Christiane Schultz have been asked to provide input on proposed recommendations regarding psychotropic drugs in pregnancy in Canada. Amery & Christiane are hard-working activists affiliated with UNITE and MADNAP. Please send […]

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