Saturday, October 22, 2011

CBS News Interview-$760 million Paid to Doctors By Pharma Past Two Years

A dozen pharmaceutical companies have given doctors and other healthcare providers more than $760 million over the past two years - and those companies' sales comprise 40 percent of the U.S. market.
The numbers come from the non-profit journalism organization Pro Publica, which assembled and continues to update a database on the payments.
The payments, says Pro Publica, are for consulting, speaking, research and expenses on the part of the providers.
Drug companies have traditionally been very tight-lipped about those payments, Pro Publica notes, but, "Over the past two years, companies have begun posting this information on their websites, some as the result of legal settlements with the federal government."
What's more, Pro Publica points out, "Federal law requires that all companies publicly report this data beginning in 2013. That information will be posted on a government website."
With bucks that big flying around, is the quality of care offered by providers accepting them compromised? "Absolutely," said Dr. John Santa, head of the Consumer Reports Health Ratings Center.
"Money works," Santa told "Early Show on Saturday Morning" co-anchor Russ Mitchell. "Doctors are human. Doctors who take money from drug companies are more likely to give you an expensive drug or more likely to give you a drug you may not need."
A recent Consumer Reports survey had 72 percent of respondents saying they believe pharmaceutical companies have too much influence on the drugs that doctors prescribe; 85 percent saying they were concerned about drug companies rewarding doctors who write a lot of prescriptions for their drugs; and 76 percent saying they were concerned about doctors providing testimonials or serving as a spokesperson for a drug.
Santa says he'd be reluctant to advise someone to go to a doctor who has that sort of relationship: "The issue is, who are you working for? Me, as the patient? Or the drug company you're taking money from?"
Do the payments result in doctors not giving patients the least expensive drugs in some cases?
"Absolutely," Santa replied. "We know from our studies and others that there are still many opportunities for doctors to prescribe generic drugs and they're not doing it, and one of the reasons is these financial relationships."
Santa pointed to three signs that could tip off patients that their doctor is getting drug company money.
First off - seeing drug company salespeople in a doctor's office. "The last time I was in a medical office," Santa says, "there were three drug representatives in the waiting room. I haven't been back."
Another sign? Free drug samples. "People think a free sample is a good thing," Santa observes. "Well, the expensive prescription that follows it, if it works, is not a good thing. It can be, again, a much more expensive drug than you may need."
Also: Marketing materials in the physician's office. "Doctors who have relationships with drug companies will often have promotional materials, will have information that they give patients that come from the drug company. You should be wary of that," Santa cautioned.
And what if you spot any of those signs?
"First of all," Santa suggested, "you shouldn't hesitate to ask, 'Do you have a relationship with a drug company? Is it your policy and your practice to take money from drug companies?' More and more, I think, it's good for consumers to ask those kinds of questions.
"What you should especially ask, though, is, 'What are my other options?'"

Wednesday, October 12, 2011

US Supreme Court Rules in Favor of Pharma on Vaccines, Data Mining and Generics. Who is Looking Out for You?

United States: Supreme Court Rules In IMS Data Mining Case
by Maria Buckley

On June 23, 2011, the Supreme Court in Sorrell, Attorney General of Vermont, et al. v. IMS Health Inc. et al1, struck down a Vermont law2 that bans the sale of physicians' prescribing information to pharmaceutical companies and further bans pharmaceutical companies from using such data to market their products. The Supreme Court's 6-3 opinion by Justice Kennedy found that the Vermont law unconstitutionally restricted the pharmaceutical companies' right to free speech.
Vermont's Prescription Confidentiality Law provides that absent the prescriber's consent, pharmacies and other related entities are prohibited from selling prescriber identifiable information for marketing purposes and that such information cannot be used by pharmaceutical manufacturers to market their products. The statue permits other uses of the data, e.g., healthcare research.
The Court found that speech in the process of pharmaceutical marketing is a form of expression protected by the free speech clause of the first amendment. Therefore, the Vermont statue must be subjected to heightened judicial scrutiny of the reasons for the restrictions on speech.
Vermont's justification was that the law was necessary to protect medical privacy, avoid physician harassment by drug company representatives, and to preserve the integrity of the doctor-patient relationship. Vermont further argued that the statute is integral to its efforts to control healthcare costs and improve public health.

Supreme Court Rules in Favor of Vaccine Manufacturers
SCOTUS makes it more difficult to sue manufacturers in autism cases.
By Meghan McCarthy
The Supreme Court Feb 22, 2011 ruled that vaccine companies cannot be sued for design defects, handing the pharmaceutical industry a victory and making it more difficult to bring cases against vaccine manufacturers for allegedly causing autism.
A 1986 law established a federal system for compensating patients injured by "unavoidable" side effects after being given a vaccine. The law aimed to make collecting damages for children injured by vaccines easier and faster by giving the Health and Human Services Department the authority to hear the cases and hand out compensation, funded by an excise tax on pharmaceutical companies making vaccines. President Obama’s fiscal 2012 budget estimated the vaccine fund would have $3 billion. The fund has paid out over $2.5 billion since its inception.
A ruling that allowed suits against the vaccine producers for a "design defect" might have opened up the pharmaceutical industry to thousands of cases alleging that vaccines caused autism in children.
The case heard by the Supreme Court, brought by Russell and Robalee Bruesewitz, alleged that their daughter Hannah was disabled by a diphtheria, tetanus, and pertussis (DTP) vaccine she received as an infant in 1992 manufactured by Lederle Laboratories, now owned by Pfizer Inc.’s Wyeth unit. After the family was denied compensation in the federal vaccine court in 1995, they filed the suit that ultimately reached the Supreme Court, charging that the defective design of the vaccine caused their daughter’s disabilities and that the company could be held liable for negligent design under Pennsylvania law.

Supreme Court Rejects Generic Drug Labeling Suits
Reuters by James Vicini June 23, 2011
(Reuters) - The Supreme Court ruled on Thursday that generic drug companies cannot be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects.
By a 5-4 vote, the justices gave a victory to Israel's Teva Pharmaceutical Industries Ltd, Mylan Inc's UDL Laboratories and Iceland-based Actavis Inc by overturning U.S. appeals court rulings that allowed such lawsuits.
The companies argued that federal law barred such lawsuits because the drug had been approved by the U.S. Food and Drug Administration (FDA). Federal law requires generic drugs to have the same labels as their brand name equivalents.
Justice Clarence Thomas in the court's majority opinion agreed. He said federal drug regulations applicable to generic drug manufacturers directly conflicted with and thus pre-empted state lawsuits.
The Supreme Court decided a related issue in 2009 when it ruled FDA drug regulations do not protect pharmaceutical companies from being sued under state law over drug labeling, a case involving Pfizer Inc's Wyeth unit and its antinausea drug Phenergan.
But in the generic drug cases, the justices reversed separate U.S. appeals court rulings that the lawsuits against the companies could go forward.
The high court agreed with the arguments of the generic drug makers that they had no choice but to use the same drug labels as the brand manufacturer.
Teva, Actavis and the Generic Pharmaceutical Association hailed the ruling.

The court ruled 6-2 to uphold the ruling of the 3rd Circuit appellate court, finding that the federal law preempts all “design-defect claims” made against vaccine manufacturers. Justice Antonin Scalia, writing for the majority, said the statute only holds manufacturers liable for proper manufacturing and labeling, not for the actual design of the drug.