pharmaceutical companies

Glaxo to report grants to U.S. healthcare groups

Anne Zieger — Mon, 25 Aug 2008 06:48:19 -0400

Bowing to emerging trends favoring such disclosures, drugmaker GlaxoSmithKline has announced plans to publicly report the grants it provides to U.S. healthcare organizations. The report, which will be issued quarterly beginning in February 2009, will include grants provided to hospitals, teaching institutions, managed care organizations, professional associations, patient advocacy groups and CME companies. Details will include the recipient's name, a grant description and the amount provided. Notably absent, however, is information on the pharmaceutical firm's consulting agreements with doctors, a source of controversy in many discussions of pharma financial relationships.

The voluntary disclosures come at a time when both state and federal officials are pushing for such. Massachusetts, in fact, has just passed a law requiring drug companies and devicemakers to report payments of more than $50 made to medical providers. Meanwhile, Sen. Chuck Grassley (R-IA) is sponsoring a federal bill that would establish similar rules.

To learn more about Glaxo's plans:
- read this Modern Healthcare piece (reg. req.)

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Boy wins right to take experimental drug

Anne Zieger — Thu, 21 Aug 2008 00:15:52 -0400

While the lawsuit was not intended to change the rules regarding clinical trials generally, observers are wondering whether a recent case may indeed change them for patients who, drugmakers say, don't meet the criteria for the trials. In the decision, a judge ruled that 16-year-old Duchenne muscular dystrophy patient Jacob Gunvalson should be allowed to use an experimental drug treatment that his parents say could be the last hope to save his life. The drug developer, PTC Therapeutics, contends that Jacob doesn't meet the criteria for the drug's clinical trial, and expects to appeal the decision. Even if PTC Therapeutics loses its appeal, the family will need federal approval to use the drug.

Jacob's mother, Cheri Gunvalson, says the suit was not intended to expand clinical trial practices at pharmaceutical companies. In her suit, she said that the drug company led her to believe that her son would be included in the trial, and discouraged her from enrolling her son until he no longer met the criteria for the study. However, observers are already wondering whether the decision will influence how drugmakers design trials, and offer special access to trial drugs, given that the process of granting such exceptions has largely been discretionary until now.

To learn more about this decision:
- read this article in The New York Times

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MA gov. signs pharma gift reporting law

Anne Zieger — Mon, 11 Aug 2008 12:27:33 -0400

Massachusetts governor Deval Patrick (D) has signed legislation that, in addition to promoting electronic medical records and boosting primary care training, imposes one of the country's toughest limits on gifts to clinicians. The new measure, which not too surprisingly drew strong opposition from the pharmaceutical companies, bans certain types of gifts (such as sports tickets and free travel) while requiring pharmaceutical companies and medical devicemakers to publicly disclose any gifts worth over $50. As controversial as the gift restrictions and reporting were, they actually weren't tough enough for some critics, who had hoped to see drugmaker and devicemaker gifts banned entirely.

In addition to banning some gifts to clinicians, the new law directs the University of Massachusetts Medical School to grow its class size to allow for training of primary care doctors, as well as helping some PCPs repay med school loans. What's more, it allocates $25 million to help award grants to doctors and hospitals who want to boost their use of health IT, particularly electronic medical records. On top of all of this, the law gives the state greater power over health plan rates than regulators have had in more than a decade, observers say. Despite the importance of these changes, the drug gift ban has gotten by far the most attention, according to Massachusetts pols. This is almost certainly because drugmakers, with their deep pockets, have stirred the pot vigorously on this issue, hoping not to see such a law enacted in other states.

To learn more about the new law:
- read this article from The Boston Globe

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MA drops planned ban on physician gifts from drugmakers

Anne Zieger — Wed, 16 Jul 2008 10:30:55 -0400

Massachusetts legislators have stripped several controversial provisions out of pending legislation that would have imposed strict new rules on pharmaceutical company relationships with doctors. The bill had originally banned drug companies from providing gifts and meals to physicians, and also required drug and medical device companies to report payments they made to doctors for consulting and speaking about their products, but these provisions were removed. Legislators have also removed a proposed $5,000 per violation fine from the measure. The new version of the bill only requires drug companies to adopt a marketing code of conduct not unlike the one announced by drugmaker trade group PhRMA, which still allows companies to cater lunches and breakfasts in doctors' offices.

The proposed bill did keep one controversial section, however: It would ban pharmaceutical companies from buying drug prescribing information identifying doctors or patients. Such measures have been fought tooth and nail in other states by the pharmas--and overturned in some cases--so it's hard to imagine they'll let it stand here either. Still, even passing such a measure would be fairly progressive.

To learn more about this measure:
- read this piece from The Boston Globe

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Psychiatric group's drugmaker ties questioned

Anne Zieger — Mon, 14 Jul 2008 11:35:50 -0400

Under attack from Congress, particularly Sen. Charles Grassley (R-IA), the psychiatric field's leading professional organization is being forced to explain its tight financial relationships with the pharmaceutical industry. The American Psychiatric Association, which got a blistering letter from Grassley questioning its funding sources, will hold a private meeting this weekend to discuss how to deal with public questions over its pharma relationships.

Without question, pharmaceutical funding does make up a significant part of the APA's budget. In 2006, for example--the latest year for which figures are available--drugmakers contributed 30 percent of the group's $62.5 million in financing. Pharmaceutical companies also have strong ties with individual doctors influential within the APA. For example, the group's president-elect, Dr. Alan Schatzberg of Stanford, has $4.8 million in stock holdings in a drug development company.

Meanwhile, data suggests that cushy drugmaker deals with psychiatrists are common. While on industry consulting deals data is hard to come by, Vermont officials recently concluded that in the 2007 fiscal year, psychiatrists got more money from pharmaceutical companies than doctors in any other specialty.

To learn more about this controversy:
- read this piece from The New York Times

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Pharmas adopt voluntary marketing guidelines banning doctor gifts

Anne Zieger — Thu, 10 Jul 2008 12:22:29 -0400

Taking control of what may have otherwise been forced upon it, the pharmaceutical industry has agreed to a voluntary code of conduct that bans gifts to physicians. The rules, the Code on Interactions with Health Care Professionals, was written by the Pharmaceutical Research and Manufacturers of America, the industry's trade organization. (If these power brokers have decided that it's time to give up the gifts, they must have been all but certain that private groups and legislatures were going to force an end to the practice.) The code includes a provision asking CEOs of the large pharmaceutical firms to certify in writing that they have policies and procedures in place that will encourage compliance with the new rules.

All of this is well and good, from the standpoint of critics who'd like to see pharmaceutical companies step back from their physician relationships. However, they're still not completely happy, as the code still allows drugmakers to shower dollars with big-ticket consulting and speaking agreements and invite physicians to fancy dinners in the name of drug education. Also, the rules still allow pharmas to set up breakfasts and lunches for medical office staffs.

To learn more about the new rules:
- read this article from The New York Times

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AstraZeneca asks judge to nullify $215M drug-price lawsuit

Thu, 12 Jun 2008 06:59:56 -0400

Drugmaker AstraZeneca has asked an Alabama judge to nullify a jury verdict that ordered it to pay the state $215 million in damages in a Medicaid drug-price fraud suit. The state's 2005 suit accused the pharma with overcharging Medicaid by inflating drug prices. The jury awarded the judgment in February, but AstraZeneca appealed, saying that the state's attorneys hadn't proved their case, and had also violated a state law capping punitive damages. If the current judge doesn't throw out the verdict, the firm will appeal the judgment to the state's Supreme Court.

To learn more about the case:
- read this Modern Healthcare article (reg. req.)

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Harvard psychiatrists fail to reveal millions in pharma pay

Mon, 09 Jun 2008 06:59:57 -0400

A Harvard child psychiatrist with a global reputation whose work has helped to promote the use of antipsychotic meds in children apparently didn't report most of the $1.6 million in drug maker consulting fees he earned over the last several years.

According to information given to Congressional investigators, Dr. Joseph Biederman failed to report much of this consulting income to university officials, which he took in between 2000 and 2007. According to Sen. Chuck Grassley (R-Iowa), this may have violated federal and university research rules that attempt to limit potential conflicts of interest. Also accused of such conflicts are Dr. Timothy Wilens, who took in $1.6 million from 2000 to 2007, and Dr.Thomas Spencer, who reported earning at least $1 million during that period.

Even these large numbers may understate the case, given that the researchers' alleged incomes sometimes conflict with drug company reports, some of which contend that they give the researchers far more money than was disclosed. Given these questions, the $287 million in federal grants won by Drs. Biederman and Wilens in 2005 may be restricted, or even suspended.

To get more background on this controversy:
- read this article from The New York Times

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Walgreens agrees to $35M drug-switching settlement

Thu, 05 Jun 2008 06:59:58 -0400

Walgreen Co. has agreed to pay $35 million to the U.S. Department of Justice to resolve allegations that it had switched patients to more expensive drugs to boost its Medicaid reimbursement. In the settlement, Walgreen Co. denies any wrongdoing. The case arose from a whistle-blower suit filed in 2003; the whistleblower asserted that between 2001 and 2005, Walgreens dispensed capsules rather than tablets of generic Zantac and Prozac, and brand-name and generic Eldepryl to Medicaid patients when doctors hadn't specified. Forty-six states and Puerto Rico will share the $16.4 million, and the federal portion of the settlement is $18.6 million. Whistleblower Bernard Listiza should receive a total of $5 million, which will be drawn from those moneys.

To learn more about the case:
- read this Modern Healthcare article (reg. req.)

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Few drugs being developed for pregnant women

Wed, 04 Jun 2008 06:59:55 -0400

While the subject isn't discussed much, it's an open secret that there are few drugs that serve the health needs of the 4 million American women who give birth each year. In fact, in many cases doctors can save mothers and babies with critical pregnancy-related conditions only by delivering babies early, which creates its own set of health problems. Worldwide, scientists are actively developing on 17 medicines for material health, less than 3 percent of the 660 drugs being developed for heart disease and half as many as for Lou Gehrig's disease, which affects only 5,600 patients per year.

Meanwhile, researchers seldom tests drugs for common conditions, such as depression on pregnant women. And no new classes of drugs have been approved for conditions of pregnancy, such as pre-term labor or a liver problem known as cholestatis, leaving OBs with decades-old medicines--or forcing them to prescribe off-label drugs at a time when women and their babies are especially vulnerable, according to Nicholas Fisk, an obstetrician-gynecologist and director of the University of Queensland Centre for Clinical Research in Australia.

However, such slow development of maternal drugs is unlikely to change in the near term, given the risks of testing drugs on pregnant women, observers note. No one (especially drug makers) has forgotten the lessons of thalidomide, the morning sickness drug that caused severe limb deformities in babies, or DES, which caused cancer in daughters of women who took it. Pharmas also bear in mind the controversy over morning sickness drug Bendectin which, despite scientific tests finding no increased risk of birth defects, was blamed for such defects by some women. Merrell Dow Pharmaceuticals stopped making the drug. (Not long after, the number of pregnant women hospitalized for nausea and vomiting increased substantially.)

To learn more about this issue:
- read this USA Today article