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Big Pharma Leaves ‘Deadly Warnings’ Out of Ads

May 26, 2010

Natural News

By David Gutierrez

The FDA has sent warning letters to four pharmaceutical companies citing them for omitting and minimizing information about risks and exaggerating potential benefits in material promoting their drugs.

The letters order the companies to cease banned marketing behaviors and instruct their employees on rules for promotions, but do not impose any fines or other sanctions.

Among the companies reprimanded are Amylin Pharmaceuticals and Eli Lilly & Co. for their diabetes drug Byetta. The FDA letter notes that at a meeting of the Endocrine Society in June, an Amylin representative told an FDA employee that the drug caused 80 percent of patients to lose seven to eight pounds in 30 weeks of treatment. When the FDA representative asked about the source of that claim, he was provided with copies of two published studies that did not support it.

The letter states that Amylin representatives made other misleading or false statements about the drug’s benefits, and suggested that it could be used as a standalone treatment. At the time of the conference, Byetta was not yet approved as a standalone drug, making it illegal for the company to promote it for that use.

Eli Lilly was also taken to task for “entirely [omitting] risk information” in a print ad for the antidepressant Cymbalta, and for minimizing risks and exaggerating benefits in another ad.

Cephalon was reprimanded for promotional cards for the lymphoma drug Treanda, which contain “an extremely limited risk presentation” and omit “important material information related to the dosing claims.”

Finally, the FDA sent a letter to Bayer over its marketing campaign for the intra-uterine device Mirena. In addition to playing down risks and making false and misleading statements, the FDA notes that Bayer’s ad campaign makes unsubstantiated statements claiming that “the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction.” The ads also promise that women who use the device will “look and feel great.”

The FDA is unaware of “any evidence suggesting that women who are using Mirena for birth control look great or feel great,” the letter reads.

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Johnson & Johnson Under Scrutiny for Illicit Drug Payoffs, Kickbacks

March 24, 2010

Natural News

By David Gutierrez

The U.S. Justice Department has announced that it is investigating pharmaceutical giant Johnson & Johnson for paying kickbacks to pharmacy benefits manager Omnicare.

Pharmacy benefits managers are supposed to negotiate on behalf of health plans and their customers to secure lower prices from drug companies and pharmacies. Yet according to the Justice Department, Omnicare took millions of dollars in payments from companies such as giant Johnson & Johnson in exchange for promoting their drugs.

“Patients have a right to depend on the integrity of the medical advice they’re getting,” said assistant attorney general Tony West. “When kickbacks are involved, the medical judgment of the provider is corrupted.”

Omnicare recently agreed to a $98 million settlement in the Justice Department lawsuit against it, while IVAX pharmaceuticals agreed to pay $14 million. According to prosecutors, IVAX paid Omnicare $8 million to recommend its generic drugs to nursing homes and their patients.

The government alleges that Johnson & Johnson also paid such kickbacks, in order to get Omnicare to promote its antipsychotic drug Risperdal and discourage doctors from prescribing alternative drugs.

Observers and insiders say that the practice of paying kickbacks is widespread in the drug business.

“Almost invariably if we see one practice in one company, it’s happening at other companies,” U.S. Attorney Mike Loucks said.

According to Brian Smith, president of pharmacy benefits manager Veritas, the practice was open and accepted within the business when he entered it in 2002.

“I thought it was just the industry standard,” he said.

Patrick Burns of Taxpayers Against Fraud says that kickbacks are one of the main ways that pharmacies get an edge on competitors who are selling fundamentally similar products.

“In the pharmaceutical industry, the business isn’t selling the best drug, it’s the best scheme of kickbacks to the prescriber,” Burns said. “Omnicare is just one of their sales points.”

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Chicago Psychiatrist Receives Money From Big Pharma

November 11, 2009

ChicagoTribune.com

By Christina Jewett, ProPublica and Sam Roe

Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma.

On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.

On the other, some worried that his research findings might be too good to be true.

As Reinstein grew irritated with what he perceived as the company’s slights, a top executive outlined the scenario in an e-mail to colleagues.

“If he is in fact worth half a billion dollars to (AstraZeneca),” the company’s U.S. sales chief wrote in 2001, “we need to put him in a different category.” To avoid scaring Reinstein away, he said, the firm should answer “his every query and satisfy any of his quirky behaviors.”

Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of mentally ill residents in Chicago-area nursing homes.

During that period, Reinstein also faced accusations that he overmedicated and neglected patients who took a variety of drugs. But his research and promotional work went on, including studies and presentations examining many of the antipsychotics he prescribed on his daily rounds.

The AstraZeneca payments, filed as exhibits in a federal lawsuit, highlight the extent to which a leading drug company helped sustain one of the busiest psychiatrists working in local nursing facilities.

In an interview and in response to written questions, Reinstein said industry payments he has received for speeches and other engagements have had no bearing on his research results or patient care. He said he does not “accept any money from corporations to study their medications. This eliminates any possible conflicts of interest.”

But he does receive money from the Uptown Research Institute, a for-profit business that conducts industry- and government-funded studies on psychotropic drugs to help mentally ill patients.

Reinstein’s office in Uptown is adjacent to the research institute, which is owned by John Sonnenberg, a clinical psychologist who describes Reinstein as “a mentor of mine” and “brilliant.”

Sonnenberg said drugmakers and others pay his institute to do research, and the group, in turn, pays Reinstein a consulting fee of “under $2,000 a month” and has for many years. A decade ago, Sonnenberg said, Reinstein was an active researcher for the institute but since then has served only as an adviser.

“My research organization is separate from him, financially and organizationally,” Sonnenberg said.

While payments from drugmakers to researchers are legal, critics have long argued that they should be publicly disclosed. Legislation to make Illinois one of a handful of states to require disclosure died in Springfield this year but is included in the U.S. House and Senate versions of health care reform proposals.

“We need to know that we can fully trust the relationship we have with our doctor and that another, more lucrative relationship with industry does not outweigh it,” Sen. Herb Kohl, D-Wis., who is pushing for such reform, said in an interview.

Health professionals who have encountered Reinstein have had similar concerns. When he gave promotional presentations about various medications at Grasmere Place nursing home in Chicago, case manager Staci Burton recalled that she was pleased to get free lunches. But she said she wondered why Reinstein put his patients on twice as many drugs as other psychiatrists who treated residents.

“I was thinking, ‘Why are you using so many medications?’ ” Burton, who worked at the facility from 2004 to 2006, said in an interview. “(His patients) would have symptoms, they’d have all these side effects, and their doctor was not listening.”

Psychotropics to lose weight?Chanile Hayes, a South Side resident, says she came under Reinstein’s care at a psychiatric hospital after she suffered a nervous breakdown nearly 10 years ago. She found it odd, she said, when Reinstein told her that taking Seroquel would help her lose weight.

“I couldn’t understand why he wasn’t taking it because he was a plus-sized man himself,” said Hayes, now 37. She is one of thousands of people nationwide suing AstraZeneca on allegations it concealed Seroquel’s links to weight gain and diabetes.

While she is a plaintiff in New York state, a federal suit is playing out in Orlando, Fla. Reinstein is not a defendant in either case, but Orlando plaintiffs have cast him as a key figure: an influential promoter of Seroquel who was financially backed by AstraZeneca. They allege that Reinstein has claimed that the antipsychotic drug helps patients lose weight.

Hayes said she went from 140 pounds to nearly 300 within two years of taking the drug and later developed diabetes.

Reinstein has done studies, funded by AstraZeneca and two other drugmakers, that found that various medications, including Seroquel, carry an unexpected yet welcome side effect: They help some patients shed pounds.

That claim runs counter to established research that links so-called atypical antipsychotic drugs, such as Seroquel, to considerable weight gain. Drugs in this class, approved for schizophrenia and bipolar disorder, can have other serious side effects that include spastic movement disorders and seizures and can cause premature death among the elderly.

A Seroquel flier dated 1999 features a photograph of Reinstein on the cover. Inside, Reinstein describes one patient losing weight and no longer needing insulin shots because his diabetes had improved so much.

In a 2001 promotional telecast to 5,000 physicians nationwide, Reinstein said he had “jokingly kind of suggested to AstraZeneca” that the drug could be used for “taking away excessive appetite.”

“There’s actually some nurses in some of our facilities who have actually requested (Seroquel) because they noticed it really did suppress the appetite, and they wanted to lose weight themselves,” Reinstein said, according to a transcript of the speech, sponsored by AstraZeneca and broadcast from Somerset Place, a Chicago nursing home.

Two years after the speech, the Food and Drug Administration, armed with mounting research, asked AstraZeneca to warn patients of Seroquel’s diabetes risk. The drug’s label now cautions that the medication is linked to diabetes and weight gain — with nearly four times more patients gaining weight on Seroquel than on a placebo.

In his response to reporters, Reinstein characterized Seroquel as “generally weight neutral, although some patients gain weight and others lose weight.”

“I would never recommend” that patients take antipsychotics “to lose weight,” he wrote.

AstraZeneca spokesman Tony Jewell said plaintiffs have not proved that Seroquel was responsible for their injuries. He said the company, based in London, provided appropriate safety data about Seroquel to the FDA.

Chanile Hayes, who said she saw Reinstein during visits to his office, questioned why he prescribed her the drug: “How could you tell me that it would help me lose weight if it doesn’t help (people) lose weight?”

At AstraZeneca, early doubtsIn the corporate halls of AstraZeneca, the company’s scientific staff also questioned Reinstein’s work.

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